7 
| in the field and does not clearly indicate how basic agricultural research 
with potential commercial applications would be reviewed prior to the tine it 
would be "environmentally-related." Dr. Pirone said the Federal Register is 
also vague as to how submitters would choose the appropriate review forum; 
research appears to be covered by the NIH Guidelines vhile NSF oversight is 
indicated once the experiment moves into field testing. He felt "shopping 
abound" for the most advantageous review could occur in this situation. 
| Dr. Pirone pointed out that while tte NSF panel described in the Federal Registe r 
would possess ecological expertise, a balance of molecular biologists, geneticists, 
and experts in agricultural applications are needed to appropriately evaluate 
agricultural proposals. 
Dr. Pirone expressed concern that the Federal Register announcement does not 
indicate vhich USDA agency will regulate biotechnology. He said he would 
j personally prefer an agency with research responsibilities be assigned this 
| responsibility. 
| Dr. CL ewes said he would prefer to see a third generation RAC implemented. 
; He said the proposed Biotechnology Science Board could fill this role; a certain 
amount of NIH and RAC experience could go into the formation of this board . 
i EPA, FDA, and USEA could function as working groups of the board. With these 
modifications, the scheme proposed in the Federal Register could be used and 
the positive tradition began by RAC could be preserved. 
Dr. McGarrity thought one problem with the preposed scheme is that no attempt 
| is made to predict future applications of biotechnology or the area where the 
greatest number of proposals would appear. 
Dr. McGarrity thought it may be more efficient to review a great number of 
diverse proposals on the basis of preposed application as suggested by the 
December 31, 1985, Federal Register . Cross-checking and coordination between 
the agencies would be very important, however, for the success of such a scheme. 
He said he cannot think of any example of agencies interacting as proposed in 
the Federal Register . 
Dr. McGarrity noted that the Federal Register announcement had not supplied 
definitions in recombinant DNA, molecular biology , and biotechnology. He said 
these definitions and a uniformity of language will be very important in deter- 
mining which agency would oversee vhich application. 
, Dr. McGarrity said another problem with the preposed scheme is that many experts 
will be asked to participate on the various agency advisory carmittees. The 
committees may met very frequently; a great decil of responsibility will be placed 
on a large number of experts. 
j Dr. McGarrity agreed public participation is important, but noted the increasing 
sophistication of the technology reduces many scientific members of RAC to public 
members if their expertise does not impinge on the proposal under consideration. 
He thought the same process would occur with the proposed advisory committees. 
[ 337 ] 
i 
