May 13, 2003
[Name of University President]
[Every Land Grant University]
[Address]
Re: Recent Incident at the University of Illinois
Dear Dr. [Name]:
We are writing to apprise you of an unfortunate situation that recently occurred at the University of Illinois at Champaign-Urbana. The Food and Drug Administration (FDA) has determined that pigs involved in certain genetic engineering studies at the University may not have been properly disposed of, and instead, entered the food supply. To prevent future similar occurrences at institutions, the FDA is proactively informing other universities of this incident and asking for your help to raise awareness about your collective responsibilities when conducting research, especially when it includes the use of genetic engineering in food-producing animals.
FDA, like the scientific community at large, believes that research with genetically engineered animals may hold great promise for agriculture and for improvements in many aspects of daily living. However, the ultimate proof of these hopes rests in obtaining interpretable data from well-conducted, well-designed scientific studies. Many institutions are involved in very important research involving genetically engineered livestock, poultry and fish. The results of this research will help all of us understand more fully the positive and negative implications of the genetic manipulation of food animals and will help assure that science- and public-health-based decisions regarding these animals can be made in the future.
This letter serves to remind those involved in research involving genetic engineering in animal species commonly used for food that such research may require an investigational new animal drug exemption (INAD) or another type of regulatory approval from the Center for Veterinary Medicine (CVM), FDA. See 21 CFR 511.1(b). FDA also expects documentation of plans regarding the disposition of all investigational animals after their participation in the study is completed. 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.
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As the incident at the University of Illinois highlights, this type of research, although holding potential promise, also creates great anxiety in many parts of our society. Because much is yet to be learned about the positive and negative facets of this type of research, it is imperative that all safety regulations be followed scrupulously. By doing so, it will help assure the highest level of confidence possible in the conduct of this type of research.
Please share this letter with those in your institution who are responsible for monitoring and conducting this type of research. If they have any questions about their FDA regulatory responsibilities, please have them contact John Matheson at jmatheso@cvm.fda.gov, (301) 827-6649, for further information. Additional information can also be found on the FDA Center for Veterinary Medicine Biotechnology Webpage.
Thank you for your time and help in this matter.
Sincerely yours,
Stephen F. Sundlof, DVM, PhD
Director, Center for Veterinary Medicine
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