20 
Board attempting to provide coordination. This proposal is described in the 
December 31, 1984, Federal Register and is essentially a ccmprcmise between 
the first and second proposals. 
Mr. Walsh said the advantages of the first proposal are that the "super-RAC" 
would provide a single oversight focus and would be located in a nonregulatory 
agency divorced fron the decision-making processes of the regulatory agencies. 
Mr. Mitchell asked Mr. Walsh why the "super-RAC" proposal was ultimately 
rejected. Mr. Walsh replied the "super-RAC" proposal had been accepted by all 
the agencies; however, the NIH did not wash to accept responsibility for the 
proposed "super-RAC." Dr. Brandt, the Assistant Secretary for Health at EHHS, 
at that time announced his resignation and recused himself fron the discussion. 
Mr. Walsh said sane concern also existed about how proprietary information 
would be handled under the "super-RAC" proposal. 
Dr. Gottesman said the issue is whether a single national review body would 
function more efficiently than the proposed federation of agencies. She said 
the function and responsibilities of the agency advisory committees are not 
clearly defined under the proposed scheme; she wondered whether these caxmittees 
would function efficiently. 
Mr. Mitchell asked Dr. Goldhammer if he could inform the working group of the 
IBA's position regarding the scheme proposed in the December 31, 1984, Federal 
Register . Dr. Goldhammer said the IBA does not support the schane proposed in 
the Federal Register ♦ He said at this time the IBA would prefer a system of 
interagency agr eanents . 
Dr. McKinney said an Interagency Working Group on Recombinant ENA once existed 
but was eventually disbanded since meetings generally consisted of a report by 
the NIH on its activities. He suggested this group might be resurrected and pro- 
vide interagency interaction. He felt the scheme proposed in the Federal 
Register would not be efficient and an interagency working group might be 
preferable. Bor example, an interagency working group might iron out jurisdic- 
tional problems in more expeditious fashion than the Federal Register schane 
which does not adequately address the issue of proposals requiring multiple 
agency review. 
Dr. Walters said his greatest concern about the Federal Register schane is 
that most meetings wall be closed to the public. He thought the same problem 
would present itself with an interagency working group. He felt the public 
nature of RAC contributed to a great extent to the support RAC has with the 
public . 
Dr . McGarrity said the issue of whether the Federal Register provides for a 
one-tier or a two-tier review systen must be addressed. The question of what 
authority will be vested in the Biotechnology Science Board must also be 
addressed. Dr. Walters said he would prefer the board rather than the agencies 
have the ultimate power. 
[350] 
