6 
( 2 ) the potential of the nenetically modified organism to transmit the 
recombinant ENA to pathogens. 
Dr. Gottesman said she supported the concept that each proposal must be reviewed 
on a case-by-case basis. She thought arranging the administrative structure 
so that all proposals receive appropriate review will be the more difficult 
task. Dr. Fcwle of the EPA noted that the Interagency Risk Management Council 
( IRMC) was to look at three areas (cancer risk assessment, biotechnology, 
formaldehyde) in vhich interagency cooperation is essential. The biotechnology 
initiative, however, has been put on hold. Dr. Tolin pointed out that the IRMC 
at any rate does not possess the requisite scientific expertise to review 
proposals in biotechnology. 
Dr. Mazza of the EPA said currently there are no firm plans in government for 
evaluating the situation on an interagency basis; he thought the Working 
Group on Release into the Environment might suggest the need for such an evalu- 
ation. Dr. Fowle said EPA intends to involve RAC in EPA's procedures and 
will attempt to coordinate with the NIH. 
Dr. Scandalios said RAC is a scientific cormittee; he did not think any other 
type of committee could adequately review proposals involving recombinant ENA 
containing organisms. 
Dr. Scandalios felt creating another review committee would be redundant. He 
preferred to see RAC maintained as RAC is viable, adaptable, experienced, and 
has a good track record. He felt RAC should remain within the NIH. Dr. McGarrity 
pointed out that NIH does not have regulatory authority. Dr. Gottesman said 
RAC does, however, possesses the necessary scientific expertise. She suggested 
that structuring a committee such as RAC so that it advises several agencies 
might meet the perception that the review body should have regulatory authority. 
Dr. Gottesman suggested that the Federal agencies could use RAC as a resource in 
this transition period during vhich agencies are defining their procedures. 
Dr. McGarrity asked how RAC review and approval might administratively be accepted 
by other agencies. Dr. Mazza said the EPA Administrator could refer to RAC for 
advice but would not be bound by RAC's recommendations. Dr. Gottesman pointed 
out that RAC is an advisory body; its recommendations are not binding on the 
NIH and would not be binding on other agencies. 
Dr. Scandalios said there will not be a "perfect" committee, but a committee 
like RAC could review proposals and direct further review to the appropriate 
agency. The regulatory aaencies could beef up their internal recombinant ENA 
ccrrmittees . 
Dr. Molar rity summarized three possible mechanisms to obtain review of proposals 
involving release of modified organisms to the environment: (l) the government 
could establish an Interagency Task Force for Environmental Release, (2) the 
aovernment could create a "super-RAC," or (3) RAC would continue its oversight 
fom ct ions . 
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