Inspections, Compliance, Enforcement, and Criminal Investigations
Valentine, Joseph 05-Apr-06
Department of Health and Human Services
Public Health Service
April 5, 2006
RETURN RECEIPT REQUESTED
P.O . Box 106
Union Dale, PA 18470
Dear Mr . Valentine :
An investigation of your dairy operation located at RR #l, Union Dale, Pennsylvania conducted by a representative of the U.S. Food and Drug Administration (FDA) on December 13, and 15, 2005, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) and 402 (a) (4) [21 U.S.C. 342 (a) (2) (C) (ii) and 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 the FDA's web page at www.fda.gov.
On or about June 7, 2005, you sold a dairy cow identified with ear tag [redacted] and sale tag [redacted] to [redacted] Mr. [redacted] offered the animal for sale at auction house [redacted] where it was purchased by [redacted] and slaughtered for human food on June 9, 2005. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from the animal identified the presence of [redacted] parts per million (ppm) [redacted] in the kidney tissue and [redacted] ppm [redacted] in the liver tissue of the animal. A tolerance of [redacted] ppm has been established for residues of [redacted] in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (21 CFR),[redacted]. A tolerance of,[redacted] parts per billion (which is equivalent to [redacted] ppm) has been established for residues of [redacted] in liver tissue of cattle as codified in [redacted].
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 treatment records. Food from animals held or sold 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 as 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, including 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 violation and prevent its 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 response should be sent to James C. Illuminati, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania, 19106. If you have any questions about this letter, please contact Compliance Officer, James C. Illuminati, at 215-717-3078 or via e-mail at James.IlluminatiCfda.hhs .gov.
Thomas D . Gardine