I 
DNA/19 
containment levels. Ironically, there is less enthusiasm for asking 
the same people to participate in those decision-making processes. 
Secretary Califano by convening the National Conference on Health 
■ 
Research Principles, recognizes that scientists and the public can 
differ on the proper directions for scientific research. 
RAC is more than the typical advisory committee. It is a working 
group responsible for drafting proposed agency "Guidelines". The 
narrow experience of current RAC members is particularly visible in 
Section IV of PRG-NIH. RAC wrote this section yet RAC members have 
little experience in administrative law or regulation. (EDF is 
not familiar with Professor Redford's background.) PRG-NIH bears sad 
witness to this lack of expertise. Peter Barton Hutt, a member of the 
Advisory Committee to the Director of NIH and former General Counsel 
of the Food and Drug Administration, commented on PRG-RAC, "From an 
administrative law standpoint, the Guidelines are pedestrian and in- 
deed, defective. The procedures embodied in the Guidelines simply do 
not reflect adequate attention to elemental concepts of law. This is 
understandable, since they were developed by scientists rather than by 
experts in administrative law . 11 ^ (emphasis added) 
EDF therefore recommends that the membership of RAC be reconsti- 
tuted to include meaningful representation of individuals who represent 
the spectrum of the interests of the general public and who have dem- 
onstrated experience in regulatory affairs. PRG-NIH is completely 
silent on RAC membership. This is unacceptable. 
Letter from Peter Barton Hutt to Donald S. Fredrickson, March 31, 
1978. 
[A-354] 
