Inspections, Compliance, Enforcement, and Criminal Investigations
Mullet, Ivan 27-Dec-07
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REQUESTED
December 27, 2007
2116 Lyon Road
Woodhull, New York 14898
Dear Mr. Mullet:
An investigation of your dairy operation located at 2116 Lyon Road, Woodhull, New York 14898, conducted by a representative of the U.S. Food and Drug Administration (FDA) on September 25, 2007, and October 1, 2007, confirmed that you offered a culled 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, penicillin G procaine, 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 February 12, 2007, you consigned a cow, identified with ear tag (b)(4) for slaughter as human food, (b)(4) On February 12, 2007, (b)(4) sold the cow to (b)(4) who sold the cow to (b)(4) On,February 13, 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 the animal identified the presence of 7.20 and 0.25 parts per million (ppm) of penicillin in kidney and liver tissues, respectively. A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.510(a) (21 C.F.R. 556.5I0(a)). The presence of this drug in the uncooked edible tissues from this animal at levels above the established tolerance 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 written records to document treatment of any cows on your farm, including treatment dates; name and quantity of drugs used, the route of administration, and withdrawal times for milk and beef. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 U.S.C. 342 (a)(4)] of the Act.
In addition, you caused the adulteration of penicillin G procaine 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 is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply 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 extralabel use of penicillin G procaine failed to comply with these requirements.
For example, you instructed someone working on your behalf to consign the animal as cull for slaughter without following the withdrawal period for cattle set forth in the approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the drug was unsafe under section 512(a) [21 U.S.C. 360b(a)] of the Act and your use caused it to be 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, 15 8-15 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