Inspections, Compliance, Enforcement, and Criminal Investigations
Silver Spring Farm 28-Sep-05
Department of Health and Human Services
|Public Health Service |
Food and Drug Administration
|New York District|
300 Pearl Street, Suite 100
Buffalo, NY 14202
September 28, 2005
WARNING LETTER NYK 2005-18
RETURN RECEIPT REQUESTED
Charles F. Luchsinger, Co-owner
Susan B. Luchsinger, Co-owner
Silver Spring Farm
4349 Bussey Road
Syracuse, NY 13215
Dear Mr. & Ms. Luchsinger:
An investigation of your dairy operation conducted by a representative of the U.S. Food and Drug Administration on August 12 and 15, 2005, confirmed you offered an animal 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 you caused the new animal drug [redacted] penicillin-dihydrostreptomycin in oil, to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] and unsafe within the meaning of section 512 [21 U.S.C. 360b] of the Act. You can find the Act and its associated regulations on the Internet through links in FDA's web page at www.fda.gov.
On or about June 13, 2005 you consigned a dairy cow identified with barn tag X-98 (Sunny) to [redacted] for slaughter as food at [redacted]. When the cow was picked up at your farm it was further identified with sale tag 74 and ear tag NYC07137. On or about June 14, 2005 this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence 6.37 ppm dihydrostreptomycin in kidney tissue. A tolerance of 2.0 ppm has been established for residues of dihydrostreptomycin in uncooked, edible kidney tissue of cattle, as codified in Title 21, Code of Federal Regulations, Part 556.200. The presence of this drug in edible tissue from 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)].
Our investigation also found you hold animals under conditions 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 drugs from edible tissues. For example, you failed to maintain complete treatment records, and you lack an adequate inventory system for determining the quantities of drugs used to medicate your animals. 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 adulterated [redacted] 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)(41 and 512(a)(5) of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of [redacted] failed to comply with these requirements.
For example you administered the [redacted] without following the withdrawal period set forth in the approved labeling, and contrary to the instructions of the supervising veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(c). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the 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) [21 U.S.C. 301(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. This may include seizure 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 timeframe 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 Compliance Officer James M. Kewley at the above address. If you have any questions about this letter, please contact Mr. Kewley at the above address or by phone at (716) 541-0328.
Jerome G. Woyshner
Director, New York District