Inspections, Compliance, Enforcement, and Criminal Investigations
Byma, Benjamin 09-Jun-06
Department of Health and Human Services
Public Health Service
New York District
June 9, 2006
WARNING LETTER NYK 2006-20
RETURN RECEIPT REQUESTED
615 Spohn Road
Ilion, NY 13357
Dear Mr. Byma:
An investigation of your dairy farm conducted by a representative of the U.S. Food and Drug Administration on February 13 and 21, 2006, confirmed that 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). 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 September 26, 2005 a cow was shipped from your farm to [redacted] for sale for human food. Your cow was purchased from that [redacted] on September 26, 2005 by [redacted] and was transported on September 27, 2005 to [redacted]. On or about September 28, 2005 the cow was further transported to [redacted] where it was subsequently slaughtered for human food.
United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 9.24 ppm sulfadimethoxine in muscle tissue and 9.53 ppm sulfadimethoxine in liver tissue. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle, as codified in Title 21, Code of Federal Regulations section 556.640 (21 C.F.R. 556.640). 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 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 o otentially hazardous drugs from edible issues. For example, you administered [redacted] to your cows for treatment of foot rot but failed to maintain treatment records identifying the dates of admimstration, dosage administered, route of admini stration or withholding times for meat and milk. In addition, you lacked 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.
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 m 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 betaken 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.
Steven B. Simpson