UNIVERSITY OF WASHINGTON 
SEATTLE, WASHINGTON 9819S 
Program in Social Management 6 Technology 
June 20, 1978 
Dr. Donald S. Fredrickson 
Director, National Institutes of Health 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
I am a member of the faculty of the above Program, teaching and doing 
research in the areas of technology assessment, technology and public 
policy, and the like. For the past year and a half, I have been a 
member of the University of Washington's Biohazards Committee which 
oversees research with recombinant DNA. During this time I have been 
very active in participating in the public policy discussions which 
have occurred about necessary forms of regulation for this research, 
appearing on radio and television programs, participating in a 
colloquium at the February meeting of the AAAS, and providing input 
into the staff of Senate and House committees working on proposed 
DNA legislation. 
I am writing to you because of my concerns for both the procedure and 
substance of proposed revisions to the Guidelines for Recombinant DNA 
Research which were approved at the meeting of the Recombinant DNA 
Advisory Committee, April 27 and 28. I urge you to slow down the 
regulatory process so that adequate public consideration can be given 
to the proposed revisions. 
In terms of process, I believe that the NIH has been remiss in consistently 
failing to follow the procedures required by the National Environmental 
Policy Act. A full impact statement should be developed and published 
on the proposed revisions. Adequate public hearings and other procedures 
to insure citizen input should be conducted. 
As regards some of the substantive provisions of the revisions, I am con- 
cerned about the following items. At this time, I do not believe that 
sweeping delegation of authority for initial approval of experiments should 
be made from the NIH to local biohazard committees. The whole question of 
the most appropriate balance of authority between a central federal agency 
(which could assure that requisite technical and policy considerations are 
brought to bear on aspects of the guidelines) and local biohazard committees 
(which could assure sensitivity to local conditions and provide expanded 
means of public participation in the regulatory process) needs to be further 
developed. I have previously taken a position against sweeping federal pre- 
emption (as would have been provided by the bill authored by Representative 
Rogers); however, because many local biohazard committees do not yet provide 
316 Guggenheim, FS-15 / Telephone: (206) 543-7029 
[Appendix A — 324] 
