Inspections, Compliance, Enforcement, and Criminal Investigations
Miller, David L. 5/12/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
360 Pearl Street, Suite 100
Buffalo, NY 14202
May 12, 2010
WARNING LETTER NYK 2010-16
VIA UNITED PARCEL SERVICE
David L. Miller
6471 Hudson Road
Wyoming, New York 14591
Dear Mr. Miller:
On February 1-4, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation at your residence, located at 6471 Hudson Road, Wyoming, New York. 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 the FDA's web page at www.fda.gov.
We found that you offered for sale two (2) animals that were slaughtered as food that were 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 June 30, 2009, you sold a dairy cow, identified with tags (b)(4) to (b)(4) a livestock buying station in (b)(4) on or about June 30, 2009, (b)(4) slaughtered this animal for human food. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the cow bearing tags (b)(4) identified the presence of 4.38 parts per million (ppm) of sulfamethazine in the liver and 4.825 ppm sulfamethazine in the muscle. FDA has established a tolerance for residues of sulfamethazine in the uncooked edible tissue of cattle of 0.1 ppm, as codified in Title 21 Code of Federal Regulations (C.F.R.) 556.670 (21 C.F.R. 556.670). The presence of this drug in 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 revealed that on or about July 31, 2009, you sold a dairy cow, identified with tags (b)(4) to (b)(4), a livestock buying station in (b)(4). On or about July 31, 2009 (b)(4) slaughtered this animal for human food. USDA/FSIS analysis of tissue samples collected from the cow bearing tags (b)(4) identified the presence of 0.24 ppm penicillin in the liver and 0.3 ppm penicillin in the kidney of this cow. FDA has established a tolerance for residues of penicillin in the uncooked edible tissues of cattle at 0.05 ppm, as codified in 21 C.F.R. 556.510. The presence of this drug in tissues from this animal in these amounts causes the food to be adulterated within the meaning of 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 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 drugs Albon Boluses (sulfadimethoxine) and Agri-Cillin (penicillin G procaine). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extra-label use. See 21 C.F.R. 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 C.F.R. 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 Albon boluses (sulfadimethoxine) and AgriCillin (penicillin G procaine) to cows bearing tags (b)(4), and tags (b)(4), respectively, without following the approved labeling dosage amounts. Your extralabel uses of Albon and Agri-Cillin were not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a), and your extralabel use of these drugs resulted in illegal drug residues in violation of 21 CFR 530. 11(d). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused these drugs 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 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.
Your written response should be sent to Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at 716-551-4461, extension 3168.
Ronald M. Pace
New York District
cc: Dr. John P. Huntley, Director
Division of Animal Industry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, NY 12235
Mr. Louis Leny, District Manager
US Department of Agriculture/Food Safety and Inspection Service
230 Washington Ave. Extension
Albany, NY 12203-5369
Julie A. Cornett, D.V.M.
Senior Veterinary Officer
US Department of Agriculture/Food Safety and Inspection Service
Technical Service Center
1299 Farnam Street
Omaha, NE 68102