Inspections, Compliance, Enforcement, and Criminal Investigations
Reynolds, Newton J.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Date: May 29, 2009
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Newton J. Reynolds, Co-Owner
Ms. Darlene A. Reynolds, Co-Owner
Newton Reynolds Farm
Rural Route 2
Alburg, Vermont 05440
Dear Mr. and Ms. Reynolds,
On January 28 and 30, and February 24, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 98 Martell Road, Alburg, Vermont. 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 September 22, 2008, you consigned a dairy cow identified with farm tag (b)(4) and back tag (b)(4) for slaughter as food. On or about September 23, 2008, (b)(4) 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 oxytetracycline in the kidney at 72.22 parts per million (ppm), in the liver at 13.55 ppm, and in the muscle at 4.37 ppm, and flunixin in the liver at 5.384 ppm and in the muscle at 0.076 ppm. FDA has established a tolerance for residues of oxytetracycline in the kidney at 12 ppm, in the liver at 6 ppm and in the muscle at 2 ppm in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.500 (21 C.F.R. 556.500), and a tolerance 125 parts per billion (0.125 ppm) for residues of flunixin in the liver of cattle, as codified in 21 C.F.R. 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 drugs oxytetracycline and flunixin. 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 extralabel use under 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs is 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. § 360(b)(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 oxytetracycline without following the animal class as stated in the approved labeling. Your extralabel use of oxytetracycline was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11 (d). In addition, our investigation found that you administered flunixin without following the route of administration as stated in the approved labeling. Your extralabel use of flunixin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a) and your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11 (d). Because your extralabel uses of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the 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 foods you distribute are in compliance with the law.
You should take prompt action to correct the above violations 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 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 response should be sent to Anthony P. Costello, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02108. If you have any questions about this letter, please contact Compliance Officer Anthony P. Costello at 781 596-7716.
John R. Marzilli
New England District
Mr. Louis Leny
US Department of Agriculture/ Food Safety and Inspection Service
230 Washington Avenue
Albany, New York 12203-5369
Dr. Kristin Haas
Vermont Agency of Agriculture
116 State Street
Montpelier, Vermont 05620
Kent E. Henderson, D.V.M.
Northwest Veterinary Associates, Inc.
6 Fairfield Hill Road
Saint Albans, Vermont 05478