Inspections, Compliance, Enforcement, and Criminal Investigations
Rainbow Acresa 15-Nov-05
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REQUESTED
November 15, 2005
Mr. Eugene L. Fobare
131 Johnson Road
Rensselaer Falls, New York 13680
Dear Mr. Fobare:
On September 16 and 20, 2005,U.S. Food and Drug Administration (FDA) investigators conducted an inspection at your farm located in Rensselaer Falls, New York. This inspection confirmed that you offered an animal for sale for food that was adulterated within the meaning of 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 on FDA's web page at www.fda.gov.
On June 13, 2005, you delivered for sale a bob veal calf identified with ear tag [redacted] to [redacted] of [redacted] where it was slaughtered on June 14, 2005, 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 1.47 parts per million (ppm) of penicillin in kidney tissue. A tolerance level of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556.510. 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. For example, you failed to adequately segregate treated animals from non-treated animals intended for sale. Specifically, you allowed a bob veal calf access to a lactating dairy cow treated with penicillin. The calf was allowed to feed on the treated cow and was then sold for slaughter for human food. Further, you failed to maintain treatment records for dry and sick cows which have been treated with [redacted], Penicillin [redacted]" Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act (21 U.S.C. § 342 (a)(4)].
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 assuring your overall operation and the food you distribute is in compliance with the law.
You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to achieve prompt corrective action 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 farm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step you have 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 Lillian C. Aveta, 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 Lillian Aveta at (718) 662-5576.
Jerome G. Woyshner