Inspections, Compliance, Enforcement, and Criminal Investigations
Richards, Douglas L. 09-Oct-08
Department of Health and Human Services
Public Health Service
New York District
October 9, 2008
WARNING LETTER NYK 2009-01
Douglas L. Richards
556 Eureka Road
Rome, New York 13440
Dear Mr. Richards:
On June 18, and July 2 and 10, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 556 Eureka Road, Rome, 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 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 March 17, 2008, you sold a dairy cow, identified with ear tag [redacted] and sale tag [redacted] for slaughter as food. On or about March 18, 2008, [redacted] 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 9.58 parts per million (ppm) in the liver tissue and 8.79 ppm in the muscle tissue. FDA has not established a tolerance for residues of sulfamethazine in lactating dairy cattle. The presence of sulfamethazine 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 Sulfa-Max III Calf Bolus (8.02 g sulfamethazine per bolus), NADA 120-615. Specifically, our investigation revealed that you did not use Sulfa-Max III Calf Bolus (8.02 g sulfamethazine per bolus), NADA 120-615, as directed by its approved labeling. Use of this drug in this manner is an extralabel use, as codified in Title 21, Code of Federal Regulations, Section 530.3(a), 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 Sulfa-Max III Calf Bolus (8.02 g sulfamethazine per bolus), NADA 120-615, to lactating dairy cows without following the animal class as stated in the approved labeling. Sulfa-Max III Calf Bolus (8.02 g sulfamethazine per bolus), NADA 120-615, is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. 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 are 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 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 response should be sent to James M. Kewley, 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 James M. Kewley at (716) 551-4461, extension 3128.
Otto D. Vitillo
New York District