The Food and Drug Administration reminds universities conducting genetic engineering research that involves animals that they may need to perform this research under the authority of an investigational new animal drug exemption or a similar provision. As part of the new animal drugs for investigational use submissions, those conducting this type of research must document their plans regarding the disposition of all investigational animals after their participation in the study is completed.
The FDA is issuing the reminder now to help prevent situations similar to one that occurred at the University of Illinois at Champaign-Urbana. In late 2002, the agency determined that pigs involved in certain genetic engineering studies at this university might have entered the food supply because of improper disposal (see JAVMA, April 1, 2003, page 926).
To date, the FDA has not permitted genetically engineered animals to enter the human food supply, and only in certain circumstances has the agency allowed these animals to be rendered and incorporated into animal feed.
Individuals can find the INAD regulations in the Code of Federal Regulations, Title 21, Part 511.1(b), www.access.gpo.gov/nara/cfr/waisidx_02/21cfr511_02.html. Researchers who have questions about their responsibilities may contact John Matheson at email@example.com or (301) 827-6649. They can also consult the FDA Center for Veterinary Medicine at www.fda.gov/cvm/biotechnology/bio_drugs.html.