10 
Mr. William Vfelsh of the State Department said he had participated in the devel- 
opment of the December 31, 1984, Federal Register . He offered seme additional 
information on the proposed oversight scheme. He said the Cabinet Council 
Working Group had envisaged that each agency advisory canmittee would advise 
that agency's director or administrator. Each agency would develep its own 
guidelines and the Biotechnology Science Board would attempt to coordinate 
these guidelines. OSHA will soon publish a notice on how they will interact 
with the Cabinet Council Working Group proposal . 
Mr. Mitchell asked Dr. Gartland to explain how the scheme described in the 
Federal Register developed. Dr. Gartland said the original proposal was to 
create a "super-RAC" vhich would be administered by the current RAC's admini- 
strative staff. A large structure would result, however, and the NIH did not 
wish to house such a structure. The other basic science agency, the NSF, also 
was not willing to accept it. Dr. Gartland said the proposal vhich appeared 
in the December 31, 1984, Federal Register represents a compromise. 
Mr. Mitchell said the Federal Register announcement does not indicate the 
Biotechnology Science Board will have authority over the various agencies; each 
agency may wall go off in its own direction. If this happens, the type of re- 
view a proposal receives will depend upon the personalities of agency personnel. 
If the public doubts that fair reviews are being given to proposals, the credi- 
bility of the review system will be damaged. He said a centralized structure 
on the other hand provides reliability; reliability is very important to investi- 
gators and to industry. 
Mr. Mitchell asked Dr. Henry Miller of the FDA if the public has input in FDA 
decisions. Dr. Miller replied that the public is not at all involved in FE& 
decisions. Indeed, FDA does not even divulge that a proposal has been submitted 
for review. Occasionally, FDA will convene meetings of its advisory committees. 
These meetings may be open to the public, but the only data discussed at these 
meetings are already in the public domain. 
Dr. Miller said the concept of public forums is fraught with problems; many 
biotechnology proposals will contain trade secrets. He argued that vhile the 
public may have a role in risk management, scientific assessments should be 
performed by technical experts. 
Mr. Mitchell asked if any public members participate in proposal review. 
Dr. Miller replied that only FDA staff, the manufacturers, and their represent- 
atives attend these meetings. Occasionally representatives from other agencies 
will be invited to attend. 
Dr. Gartland said EPA and FDA reviews will probably be totally closed to the 
public. Representatives from other agencies might be invited to specific reviews, 
but there would have to be a very good reason for inviting them. Indeed, agency 
proceedings will be so closed that the Biotechnology Science Board will only 
receive a sanitized version of the review. Since proposals will be s limit ted 
directly to the agencies, the board will not see the actual proposal. 
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