Inspections, Compliance, Enforcement, and Criminal Investigations
Graham Farms 11/16/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
November 16, 2009
Thomas N. Toms, President
The Graham Farm
P.O. Box 1108
Moore Haven, Florida 33471
Dear Mr. Toms:
On April 29 and May 1, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 3144 Graham Dairy Road, Moore Haven,
Florida. 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 December 6, 2008, you sold to (b)(4) a calf, later identified by (b)(4) with ear tag 254, for slaughter as food. On or about December 10, 2008, (b)(4), Inc., located in (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 126.95 parts per million (ppm) of sulfamethazine in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.670 (21 C.F.R. 556.670). The presence of this drug in edible tissue from this animal in this amount 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 for medicated calves, and failed to maintain complete treatment records for other animals. 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, NADA 120-615. Specifically, our investigation revealed that you did not use sulfamethazine, NADA 120-615, as directed by its approved labeling. Use of this drug in this manner is an extra1abel use. 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 the drug sulfamethazine, NADA 120-615, to a class of animal (calf under one month of age) not set forth in the approved labeling and you did so without following the extralabel use directions of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use of sulfamethazine, NADA 120-615, resulted in an illegal residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of the drug sulfamethazine, NADA 120-615, was not in compliance with 21 C.F.R. Part 530, this drug was unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and your use caused it to be 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 written response should be sent to Jimmy E. Walthall, Director, Compliance Branch, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have any questions about this letter, please contact Mr. Walthall at (407) 475-4734.
Emma R. Singleton
Director, Florida District