Inspections, Compliance, Enforcement, and Criminal Investigations
Douglas Bennett Farm 05-Dec-08
Department of Health and Human Services
Public Health Service
New England District
VIA CERTIFIED MAIL
December 5, 2008
Mr. Douglas Bennett, Co-Owner
Douglas Bennett Farm
3026 West Route 15
Johnson, Vermont 05656
Dear Mr. Bennett:
On August 11 and 15, 2008, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 3026 West Route 15, Johnson, 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 February 18, 2008, you sold an adult dairy cow identified with farm ear tag (b)(4) for slaughter as food to (b)(4). On or about February 19, 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 sulfamethazine at 0.66 ppm (parts per million) in the liver and 32.91 ppm in the muscle and detectable levels of gentamicin in the kidney. There is no allowable tolerance for sulfamethazine in the uncooked edible tissue of adult dairy cows and no allowable tolerance for gentamicin in the uncooked edible tissues of cattle. The presence of these drugs in edible tissues from this animal 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 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 sulfamethazine. Specifically, our investigation revealed that you did not use sulfamethazine 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 (C.F R ) 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 sulfamethazine to this dairy cow without following the use in a specific animal class as stated in the approved labeling. Sulfamethazine is prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9). Further, your extralabel use of this drug resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(c). 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 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 Maren Forsyth, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, 4th floor, Stoneham, MA 02108. If you have any questions about this letter, please contact Compliance Officer Maren Forsyth at 781 596-7769.
Acting District Director
New England District Office
Mr. Louis Leny
US-Department of Agriculture/ Food Safety and Inspection Service
230 Washington, Ave. Extension
Albany, NY 12203-5369
Dr. Kristin Haas
Vermont Agency of Agriculture
116 State Street
Montpelier, VT 05620