Inspections, Compliance, Enforcement, and Criminal Investigations
Roes Haven Farm 11-Feb-08
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REQUESTED
February 11, 2008
Mr. Robert A. Roes, Owner
Roes Haven Farm
20003 Strickland Road
Carthage, New York 13619
Ref: NYK 2008-08
Dear Mr. Roes:
An inspection of your dairy operation located at 20003 Strickland Road, Carthage, New York, conducted by representatives of the US. Food and Drug Administration (FDA) on October 3 and 5, 2007, confirmed that you offered a cow for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug, Phenylbutazone Injection 20%, to become unsafe under section 512 [21 U.S.C. 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
On or about August 2, 2007, you consigned a cow identified with back tag (b)(4) for slaughter as food to (b)(4) where it was purchased the same day by (b)(4) On or about August 3, 2007, this animal was slaughtered at (b)(4) United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that cow identified the presence of 8888.0 parts per billion (ppb) of phenylbutazone in the kidney tissue. No tolerance has been established for residues of phenylbutazone in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556 (21 C.F.R. 556). The presence of this drug in the edible tissues of this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] of the Act.
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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain treatment records. Food from animals held under such conditions is adulterated under section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Act.
In addition, you adulterated the drug, phenylbutazone, within the meaning of section 501(a)(5) [21 U.S.C. 351 (a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use complies with sections 512(a)(4) [21 U.S.C. 360b(a)(4)] and 512(a)(5) [21 U.S.C. 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extra label use of phenylbutazone failed to comply with these requirements.
For example, you administered phenylbutazone to a female dairy cow over 20 months of age. The extralabel use of phenylbutazone in female dairy cattle 20 months of age or older is specifically prohibited under 21 C.F.R. 530.41(a)(12). Furthermore, your extralabel use resulted in an illegal drug residue in violation of 21 C.F.R. 530.11(c). Because your use of phenylbutazone was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] of the Act.
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 Anna Alexander, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Anna Alexander at the above address, or at (718) 662-5683.
Otto D. Vitillo
cc: Dr. John P. Huntley, Director
Division of Animal Industry
New York State Department of Agriculture & Markets
10 B Airline Drive
Albany, New York 12235
Haroon Mian, District Manager
U.S. Department of Agriculture/Food Safety and Inspection Service
230 Washington Avenue Extension
Albany, New York 12203-5369
Julie A. Cornett, D.V.M.
Senior Veterinary Office
U.S. Department Agriculture/Food Safety and Inspection Service
Technical Service Center
1299 Farnam Street
Omaha, Nebraska 68102