17 
Dr. McKinney strongly supported a statement that oversight of academic research 
should renain in the NIH domain. He thought "academic" research could be 
zonducted in both the industrial and university setting. He noted that EPA 
states university research should continue to be covered by the NIH Guidelines; 
EPA also states, however, that NIH's mandate does not extend to industrial settings. 
Dr. Gottesman thought the working group could recommend ail laboratory research 
continue to be under the purview of RAC and the NIH. A sentence questioning the 
distinction between research and application could also be added to the working 
group statement. Point II-(l) would then read: 
"Where will the line between research and commercial applications be drawn? 
Will a cannon line be determined for all agencies? Ft>r release into the 
environment as opposed to growth in contained facilities? 
"In particular it not clear how basic research with potential agricultural 
applications will be reviewed prior to the time it would be ' environmental ly- 
related . ' We recommend that all laboratory and greenhouse research continue 
under the purview of the NIH Guidelines and the RAC." 
Dr. Gottesman suggested point I— ( 1 ) referring to laboratory research be modified 
to include the phrase "and should continue to be overseen." Dr. Lardy suggested 
the work "all" be added to the first sentence of this point; this section would 
then clearly include plants and animals. Dr. Pirone agreed this language would 
then include agriculturally and environmentally related research. 
Dr. McGarrity thought point I-(l) should state the phrase "regardless of potential 
and eventual applications." 
On the basis of this discussion point I— ( 1 ) was deveicped to read as for lows : 
"All laboratory research using recombinant DNA and RNA regardless of its 
potential or eventual applications is appropriately overseen and should 
continue to be overseen by RAC under the NIH Guidelines. Any new regulatory 
schane should confirm that laboratory research continue to be exempt frcm 
regulation per se. Other agencies may want to urge their applicants to 
abide by the NIH Guidelines during the laboratory research phase of 
camiercial product development." 
Dr. Gottesman suggested point II-(3) could be viewed as a subset of point I-(2). 
She suggested point II-(3) address the issue of flexibility of NIH actions and 
the NIH Guidelines as regards the Biotechnology Science Board. The working 
group agreed. 
Dr. Gottesman suggested the issue of risk assessment should be included on the 
list of issues that must be addressed by RAC. Mr. Mitchell felt a consensus 
was developing in the working group that risk assessment should be the province 
of the NIH. 
[347] 
