8 
Dr. McGarrity thought the loose federation of agencies proposed in the Federal 
Register might permit sufficient public access to information. He noted that 
no single information focus exists in the biomedical area; but the public 
appears to be well informed about subjects as disparate as organ transplantation, 
in vitro fertilization, and human gene therapy. 
Dr. McGarrity thought the nature of the application would determine whether 
the proposal could be discussed in a public forum. He thought proposals 
submitted to FDA ard EPA for review would probably be reviewed in closed 
session. 
Dr. Gottesman suggested the Working Group on Biotechnology Coordination 
formulate a response to the December 31, 1984, Federal Register by raising a 
series of questions about the preposed schene . She preposed the following 
questions : 
(1) What is the line between research ard conmercial application? 
(2) How safe is safe enough and who decides? 
(3) Where vrLll the burden of proof fall, on the agency or on the sifcmitter? 
(4) How does one determine whether regulation is necessary? 
(5) What is the status of laboratory research under this schene? Would labora- 
tory research face increased regulation? Seme of the definitions used by 
the EPA in the Federal Register announcement could affect the status of 
laboratory research. 
(6) What is the status of agricultural research? What would be the review 
process for laboratory research with agricultural applications? Who would 
review proposals involving field testing? 
Dr. Gottesman said the working group might also address these issues: 
(1) Does the working group like the structure preposed in the December 31, 1984, 
Federal Register? What structure does the working group think would work 
best based on RAC's experience? 
( 2 ) Does the working group think the structure preposed in the Federal Register 
will work? How efficiently? With how much paperwork? Where is the appro- 
priate point to obtain public input? Are the agencies likely to obtain 
appropriate expertise to sit on the camdttees? Will the ccmmittees' know- 
ledge ard influence be diluted out in the agency review process? 
(3) What will RAC need to do to implement the proposed scheme if the scheme as 
written takes effect? What specific responsibilities will be ranoved frem 
RAC's purview/? If the requirements of the proposed scheme increase oversight 
requirements for laboratory research, will RAC responsibilities in over- 
seeing the implementation of these requirements increase? 
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