Recombinant DNA Advisory Committee - 10/16/90 
techniques?” 
He noted that the resounding response to this question was that 
there was no indication that any of these techniques posed any 
new or unique risks. 
The third question was: 
3. "Should the RAC consider a plan whereby more of 
the review responsibilities are transferred to the 
local Institutional Biosafety Committees (IBCs) , 
with fewer review responsibilities for the RAC 
itself? (An example would involve adding plant 
pathologists to the IBCs to facilitate 
consideration of protocols which require 
environmental release.)" 
Dr. Wivel said that in general there was a mixed response to this 
question. One thing that was clear was that the majority of 
experiments being submitted to local IBCs are exempt and that the 
exercise is mainly one of paperwork. He recalled that during the 
hearings it was noted that the NIH Guidelines are incorporated 
into local laws and regulations. NIH is deemed to be acting as a 
third party which lends credibility to the local IBCs and 
facilitates acceptance of their oversight role in the local 
communities. 
The fourth question was: 
4. "Under the current system of review, a process- 
oriented approach is used to identify those 
experiments which should be evaluated, and a 
product-based approach is used to determine the 
level of risks, and thus the level of containment. 
Is this system adequate or should significant 
changes be considered to make the process more 
risk-based?" 
Dr. Wivel said the general feeling was that a process-based entry 
point for oversight applicability and then a product-based risk 
assessment is seen as a practical way to go, although there was 
some feeling that a completely product-based assessment would be 
the ideal. 
The fifth question was: 
5. "With the advent of gene therapy protocols, is 
there a perceived need for orientation materials 
to be provided to the local IBCs?" 
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Recombinant DNA Research, Volume 14 
