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U.S. Department of Health and Human Services

Animal & Veterinary

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Reminder to Scientists Involved in Research with Genetically Engineered Animals

FDA Veterinarian Newsletter July/August 2003 Volume XVIII, No 4

FDA has sent letters to all Land Grant universities reminding those involved in research involving genetic engineering in animals that such research may need to be performed under the authority of an investigational new animal drug (INAD) exemption or a similar provision. The INAD regulations are published in the Code of Federal Regulations, Title 21, Part 511.1(b). As part of the INAD submission, 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. This is important in the case of animal species commonly used for food.

FDA sent these letters to help prevent another situation similar to one that occurred at the University of Illinois at Champaign-Urbana. FDA has determined that pigs involved in certain genetic engineering studies at the University were not properly disposed of, and instead, entered the food supply (http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01197.html ).

To date, FDA has not permitted genetically engineered animals to be placed into the human food supply. Likewise, only in certain circumstances has the FDA allowed animals from genetic engineering investigations to be rendered and incorporated into animal feed.

Researchers who have questions about their responsibilities may contact John Matheson at jmatheso@cvm. fda.gov, (301) 827-6649, for further information. They also may want to consult the FDA Center for Veterinary Medicine (CVM) Biotechnology Home Page. A copy of the letter sent to Land Grant universities is posted on this same page.