Inspections, Compliance, Enforcement, and Criminal Investigations
Boman, William 27-Mar-06
Department of Health and Human Services
Public Health Service
900 U.S. Customhouse
March 27, 2006
RETURN RECEIPT REQUESTED
P.O. Box 511
Susquehanna, PA 18847
Dear Mr . Boman:
An investigation of your dairy operation located at RR #l, Union Dale, Pennsylvania and your livestock operations located at RR #1, Susquehanna, Pennsylvania (PA), conducted by a representative of the U .S . Food and Drug Administration (FDA) on December 8, 13, and 21, 2005, confirmed that you offered animals for sale for slaughter as human food that were 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 that you caused the new animal drugs [redacted] and [redacted] to become unsafe under section 512 [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of 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 purchased a dairy cow, with ear tag [redacted] and sales tag [redacted] from [redacted] and delivered it for sale for slaughter for human food to the auction house [redacted] purchased the animal and slaughtered it on June 9, 2005. United States Department of Agriculture, Food Safety and Inspection Services (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] has has been established for residues of [redacted] in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R), Section 556.510 (21 C.F.R. [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 21 C. .F .R. [redacted]. The presence of these drugs in the edible tissue of this animal at the reported levels cause the food to be adulterated within the meaning of section 402(a)(2) (ii) [21 U.S.C. § 342 (a)(2)(c)(ii)].
Our investigation also determined that in March 2005, you offered two additional animals with violative tissue residues for slaughter for human food.
Back Tag [redacted]
Sale tag [redacted
Back Tag [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 medicated animals 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 lack an adequate system for reviewing treatment records before offering an animal for slaughter, to ensure that appropriate withdrawal times have been met and you failed to maintain treatment records for certain animals. 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) ].
In addition, you adulterated [redacted] and [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 drugs in conformance with their 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)(4) and 512(a)(5) of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of [redacted] and [redacted] failed to comply with these requirements. For example, you administered the drugs without following the withdrawal period set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of these drugs was not in compliance with 21 C.F.R. Part 530, your use caused the drugs to be unsafe under section 512(a) of the Act [21 U .S .C. § 360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U .S .C. § 351(a)(5)].
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 firstname.lastname@example.org.
Thomas D . Gardine