15 
experience. The first section of the document would include the following 
general cone lu s ions : 
I-( 1) Laboratory research using reconbinant ENA and FNA is appropriately overseen 
by current RAC Guidelines. Any new regulatory scheme should confirm that 
laboratory research continue to be exonpt from regulation per se. 
Other agencies may want to urge their applicants to abide by the NIH 
Guidelines during the laboratory research phase of commercial product 
development . 
I— ( 2 ) Flexibility has been critical in NIH' s development of the NIH Guidelines in 
this rapidly developing field. NIH's flexibility should be retained, and 
we strongly recommend that sufficient flexibility be incorporated into the 
oversight programs of other agencies. 
I— ( 3 ) Open discussion of the appropriate use of biotechnology by RAC has helped 
to ensure public input into and confidence in policy decisions in this 
field. Therefore, vhile specific decisions on specific proposals may 
necessarily be done in closed sessions, it is important that scientific 
oversight committees continue to provide a public forum to the extent 
possible. 
I- (4) The RAC has exenpted seme classes of experiments from all special review 
and has assigned IBCs the responsibility for oversight of other experiments. 
This leaves RAC free to concentrate on the cases vhich are of major concern . 
Vhile seme review of all release of genetically engineered organisms may 
be necessary, we recommend that the exempt classes of experiments be con- 
sidered carefully as examples of possible categories of organises vhich 
might be appropriate for expedited re/iew. Not all applications need to 
be seen by the full regulatory structure. 
Dr. Gottesman suggested a second section of the working group document could 
address seme specific concerns and questions. These would include: 
II- (l) Vhere will the line between research and commercial application be drawn? 
Will a common line be determined for all agencies? For release into the 
environment as opposed to growth in contained facilities? 
There was particular concern about the fate of basic agricultural research 
vhich might involve field testing . 
II- (2) Will laboratory research be treated any differently under this proposal 
that it is currently? Will recombinant ENA research continue to be under 
the oversight of the RAC and NIH? Is it proposed that cell fusion be 
regulated at the laboratory research level? Would any of the broad 
definitions for biotechnology proposed by EPA apply to laboratory research? 
II-(3 ) What is the flexibility of the structure? Would the NIH Guidelines be 
allowed to continue to evolve? Would changes in the NIH Guidelines 
require the approval of the Biotechnology Science Board? 
[345] 
