27 
Mr. Mitchell said the working group felt the cooperation and confidence of 
scientific investigators rust be maintained. A very bureaucratic and 
complex system would have a chilling effect on the scientific community. 
It is also necessary to maintain the confidence of industry and of the 
public. 
Mr. Mitchell said the RAC working group suggested a distinction should be 
drawn between regulating products and regulating processes. 
Mr. Mitchell said the working group also considered the structure of the 
proposed oversight mechanism. The issue appeared to working group members 
to boil down to whether a single agency approach or a federation of agencies 
is more efficient. A loose federation of agencies can work; the question 
is how the agencies will be coordinated and which agency will assure 
coordination. The more the working group considered the matter, the more 
it appeared a single review committee with appropriate working groups 
might be a better oversight mechanism. Mr. Mitchell said he had sent a 
letter expressing these working group concerns to the Cabinet Council 
Working Group on Biotechnology. 
Dr. Gottesrran said the most important points in the Working Group on 
Biotechnology Coordination discussion were: (1) Research should not be 
subjected to ary additional regulation. The working group appeared to 
define research and application differently than the December 31, 1984, 
proposal. (2) How will the various agencies fulfill their oversight 
•function? For example, will the agencies be required to review every 
document submitted? Will most reviews be performed by in-house agency 
staff? Would advisory groups only deal with policy? How the advisory 
groups cure set up will differ depending on what is expected of them. 
Dr. Clowes said the RAC working group viewed the proposed oversight 
mechanism as too complicated . The preposed mechanism adds an extra level 
of regulation and may lead to a lack of coordination and uniformity of 
review. The major problem, however, is that the preposed mechanism may 
not provide the continuity of experience RAC has provided. The Federal 
Register proposal would replace an effective organization with new and 
untried bodies uhich may need time to learn to function effectively. In 
the interim, a climate of insecurity may result; and this climate would 
likely have a negative effect on scientific progress and on its commercial 
application. 
Dr. Clowes said he would like to offer the concept of an expanded RAC 
as a potential alternative solution to the ccnplicated structure proposed 
in the December 31, 1904, Federal Register . Modifications could be made 
in the present structure and could take the form of additional working 
groups with qreater cooperation and interaction fron other agencies. 
These working groups might function as voting members of the RAC. This 
modified structure would retain the experience, confidence, and goodwill 
RAC has built up over the years. Dr. Clowes said he and several other 
members of the working group would prefer such a structure. 
[147] 
