Inspections, Compliance, Enforcement, and Criminal Investigations
Will-O-Crest Farms, LP 19-Sep-06
Department of Health and Human Services
Public Health Service
300 Pearl Street, Suite 100
September 19, 2006
WARNING LETTER NYK 2006-26
RETURN RECEIPT REQUESTED
William W. and Barbara L. Young
Majority Partners and Principal Operators
Will-O-Crest Farms, LP
800 County Road 27
Clifton Springs, NY 14432-9735
Dear William W. and Barbara L. Young:
An inspection of your dairy operation located at 800 County Road 27, Clifton Springs, New York was conducted by a representative of the U.S. Food and Drug Administration (FDA) on May 1-5, 2006 It confirmed that you offered a bull calf for slaughter as food that was adulterated under section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(II) of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused [redacted] Premium White Label NT Medicated Dairy Herd & Beef Calf Milk Replacer (containing the drugs oxytetracycline and neomycin) to be unsafe within the meaning of section 512 [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(6) [21 U.S.C. § 351(a)(6)] 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 January 3, 2006 you contacted [redacted] to transport a calf from Will-O-Crest Farms, LP to [redacted] where it was identified with sale tag [redacted]. This calf was subsequently consigned from [redacted] to [redacted] and slaughtered there for human food on or about January 5, 2006. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal revealed the presence of 8.80 parts-per-million (ppm) neomycin in the kidney tissue of the calf. A tolerance of 7.20 ppm has been established for residues of neomycin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.430 (21 C.F.R. § 556.430). The presence of this drug in the edible tissues of this animal at the reported level 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.
You adulterated the medicated feed [redacted] Calf Milk Replacer, which contains the drugs oxytetracycline and neomycin, when you used it in calves to be processed for veal contrary to the warning on the label. Since the Act does not permit the extralabel use of medicated feeds, your actions caused the medicated feed to be unsafe under section 512 [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(6) [21 U.S.C. § 351(a)(6)] of the Act.
We note that this is not the first time that illegal residues have been found in animals from your farm. On or about June 9, 2005, you contacted [redacted], to transport a cow bearing farm tag 3101 from Will-O-Crest Farms, LP to [redacted] where it was further identified with back tag [redacted] and metal ear tag [redacted]. This cow was subsequently transported from [redacted] to [redacted] and slaughtered there for food on or about June 10, 2005. USDA/FSIS analyses revealed 0.152 ppm flunixin in the liver tissue of the cow. The established tolerance for flunixin in the liver tissue of cattle is 0.125 ppm (21 C.F.R. 556.286). In addition, the investigator found that you failed to use this drug in conformance with its approved labeling, which was provided to you by your veterinarian, by not following the labeled withdrawal time for this drug.
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 farther 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 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 Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration at the above address. If you have any questions about this letter, please contact Ms. Clark at the above address or by phone at (716) 551-4461, ext . 3168.
Otto D. Vitillo
Director, New York District