UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 
WASHINGTON, D.C. 20460 
FEB 3 1984 
OFFICE OF 
PESTICIDES AND TOXIC SUBSTANCES 
William J. Gartland, Jr., Ph.D. 
Director, Office of Recombinant DNA Activities 
National Institute of Allergy and Infectious Diseases 
National Institutes of Health 
Bethesda, MD. 20205 
Dear Dr. Gartland: 
Thank you for the opportunity to comment on the questions 
which the Recombinant DNA Advisory Committee (RAC) is considering 
at its February 6, 1984 meeting. 
The question on which we wish to comment is whether the NIH 
Guidelines should be limited to laboratory work. As you 
indicate, this would exclude from RAC oversight proposals 
involving "release to the environment," including field tests and 
presumably other tests taking place outside of enclosed systems. 
EPA recognizes that, as biotechnology moves out of the 
laboratory and into commercial phases, the role of other federal 
agencies will become increasingly important. However, EPA urges 
the RAC to continue in its current role until a clear delineation 
of responsibilities can be developed. We acknowledge our 
statutory responsibilities to review certain organisms which will 
be released to the environment, and that requirements also exist 
under other regulatory authorities. However, there are several 
jurisdictional, statutory, and organizational issues which need to 
be resolved before EPA can fully assume its responsibilities. 
Interagency coordination will be required to ensure that there 
are neither gaps nor overlaps in federal authorities. EPA hopes 
to cooperate with other agencies in encouraging the development 
of a sensible regulatory framework, and we believe that the RAC 
will continue to be useful in its current role until the role of 
various federal authorities can be clearly defined. 
During this period, EPA would be pleased to provide 
assistance to the RAC in reviewing research that has potential 
environmental and ecological consequences. In any case, we 
believe that the RAC should continue to function as a peer-review 
committee in this area; we also believe that having environmental 
experts on the RAC committee provides a useful perspective in 
cases where ecological effects are of concern. 
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