September 29, 2003
Via FedEx Mail
Mathew B. Wheeler, Ph.D.
Principal Investigator
University of Illinois
Department of Animal Sciences
1207 W. Gregory Drive, Room 366
Champaign, Illinois 61801
Dear Dr. Wheeler:
We are writing to follow up on an inspection conducted by Mr. Mark G. Peterson from the Chicago District Office and Drs. Amey L. Adams, and Michele C. McGuinness from the Center for Veterinary Medicine (CVM) representing the Food and Drug Administration (FDA, Agency) between January 29 and 31, 2003. This inspection was initiated in response to a letter dated October 28, 2002 and signed by you and Dr. Sharon M. Donovan. That letter informed the Agency that you had rendered a pig from the study of double transgenic [ redacted] crossbred pigs.
This study is one of several you are conducting that involve transgenic pigs. You requested investigative new animal drug exemptions (INADs) from FDA for the conduct of these studies. FDA regulations for the conduct of studies under INAD are set forth at 21 CFR § 511.1. This rule includes the requirement that study animals may not be used for food without prior FDA authorization. To date, FDA has not permitted genetically engineered animals to be placed into the human food supply. Nevertheless, you released at least 386 pigs from INADs [ redacted ] for sale for slaughter as human food. FDA has only allowed animals from genetic engineering investigations to be rendered for incorporation into animal feed in limited circumstances. These limited circumstances do not include permission to render animals from INAD [ redacted ].
This letter serves to remind you that FDA expects documentation of plans regarding the disposition of all investigational animals. It is imperative that all safety regulations be followed scrupulously to help assure the highest level of confidence possible in the conduct of this type of research.
Please direct any written response to:
Vernon D. Toelle, Ph.D., Team Leader BIMO and Administrative Actions Team (HFV-234) Division of Compliance Office of Surveillance and Compliance Center for Veterinary Medicine 7500 Standish Place, Suite E469 Rockville, MD 20855-2773
If you have any questions please feel free to contact either Dr. Vernon D. Toelle at 301-827-0312 or Mr. George A. Prager at 301-827-7791.
Sincerely yours,
Gloria J. Dunnavan Director Division of Compliance (HFV-230)
Office of Surveillance and Compliance
Center for Veterinary Medicine
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