21 
Mr. Mitchell said the scheme proposed in the December 31, 1984, Federal Register 
announcement has two major defects: (1) the failure to describe coordination 
of the activities of the various agencies and the board; and (2) the absence 
of real power and authority in the Biotechnology Science Board. If the proposed 
scheme could not fill the purpose for which it would be created, why implement it? 
Mr. Mitchell said the agency advisory committees would be superfluous if the 
agency staffs make the final decision. Why have all these committee menbers 
waiting to offer advise if that advise will not be timely or heeded particularly 
in light of the scarcity of experts who do not have conflict of interest problems? 
Dr. Landy agreed; he said the advice of the advisory committees will not be 
sought by agencies with 30 day or 90 day review clocks. 
Mr. Mitchell said under the proposed scheme the board will cxily have authority 
to cement on de facto decisions. The proposed scheme is misleading to the 
public since it appears the board will have the power to oversee biotechnology 
while in fact the board wall have little or no influence. In contrast, the 
people who sit on RAC have influence and input at all levels of review. He 
felt the ccmnittee which oversees other carmittees should have some real authority. 
He feared the Federal Register scheme is only a paper machinery which wall 
lack credibility. 
Dr. Clowes thought the Federal Register scheme did not make sense unless the board 
receives proposals and has authority on the disposition of requests. Proposals 
ought to be sufcmitted directly to the Biotechnology Science Board. He felt it 
preferable for a submitter to face a single review board than to deal with a 
federation of agencies having multiple individual agency requirenents. 
Mr. Mitchell suggested the most efficient plan would be to establish a "super-RAC 
within EHHS. This super-RAC would receive and review all prcposals, be advisory 
to all the agencies, and function as a central risk assessment group. The 
director of each agency would take final action based on the advice of the 
board. 
Dr. Clowes asked how this super-RAC would handle the large number of prcposals 
which are expected in the near future. 
Mr. Mitchell said the super-RAC could depend on working groups. Each of these 
working groups would report to the super-RAC. Two or three working groups 
could simultaneously review a single proposal if necessary. A benefit of the 
super-RAC plan is that one staff would coordinate all activities. 
Dr. McKinney said the December 31, 1984, Federal Register announcement does not 
clearly state which issues will be considered by the agency advisory boards 
and which issues by the Biotechnology Science Board nor does it indicate how 
a scientific judgment call on the classification of a proposal would be made. 
A central board or super-RAC would ob/iate these concerns. 
Dr. McKinney said cannon generic concerns would probably exist in the five 
agency advisory ccmmittees. The Federal Register anncunconent does not describe 
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