14 
possessing the requisite expertise are being recruited by industry; these 
individuals cannot serve on agency committees because of conflict of interest 
considerations. As the number of advisory committees will be increased by 
this scheme, qualified individuals who can 9erve on the committees will become 
increasingly scarce. Mr. Mitchell agreed the Cabinet Council Working Group 
should be alerted to this issue . 
Mr. Mitchell said another concern is how and when the scheme proposed in the 
December 31 , 1984 , Federal Register will be implemented . Until the scheme is 
in place, hew should RAC proceed? 
Dr. Gottesman felt the importance of flexibility to the success of RAC oversight 
of recombinant DNA technology should be recognized. The working group should 
suggest the agencies begin to construct categories of concern. She thought the 
NIH two-tier review system consisting of the RAC and Institutional Biosafety 
Committees (IBCs) could be used as a model. Under the RAC system a single 
level of review is sufficient for simple cases, two-tiers of review are required 
for evaluation of more complex issues. 
Dr. McGarrity said the Federal Register announcement does not clearly indicate 
vhether a one or two-tiered approval process will be in place, when the submitter 
might proceed, or how long review will take. 
Dr. Walters questioned vhether the working group response should discuss the 
effectiveness of the two-tiered review system 
Mr. Mitchell asked vhether other agencies will have IBCs. Dr. Gottesman said 
other agencies would not be likely to have IBCs. She said she wished to indicate 
that RAC has categorized experiments as being of greater or lesser concern and 
assigned oversight of experiments raising lesser concern to IBCs. Dr. Gottesman 
exempted from the NIH Guidelines are a logical starting point in determining 
which applications require in-depth review. 
Dr. Landy said the most important elements in an oversight scheme are strategy 
and information. The information and experience acquired by RAC in the past 
ten years has permitted RAC to develop a strategy of exaTpting certain classes 
of experiments from oversight. He said the agencies should not have to start 
again at square one and repeat all RAC has done, lie thought this concept 
should be stressed by the working group. 
Dr. McKinney agreed the agencies should be encouraged to categorize experiments. 
He suggested the working group cite RAC's experience and urge the agencies to 
use this experience to limit the number of cases subject to the regulatory 
process . 
Dr. Vfelters pointed out that NIH's situation may not be analogous to the situ- 
ations of agencies which have statutory constraints. 
Dr. Gottesman suggested the working group response to the Cabinet Council 
Working Group might first indicate those concepts RAC has developed through 
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