9 
Dr. Gottesman said RAC's responsibilities might increase since the Federal 
Register announcement proposed that each agency send its advisory committee a 
summary of applications relating to recombinant DNA, recombinant RNA, ard ceil 
fusion regardless of whether the agency is requesting a scientific review. 
The NIH receives thousands of grant applications a year, ard RAC might be 
required to review these applications. 
Dr. Gottesman said the working group might also ask how risk/benefit issues 
will be weighed at the board level. 
Dr. McKinney suggested Car. Gottesman add one additional consideration to the 
list: What are the circumstances under which the RAC could adjust the NIH 
Guidelines? Dr. McKinney said this question specifically should ask whether 
modifications in the NIH Guidelines would have to be approved by the Biotech- 
nology Science Board and/or other agencies. 
Mr. Mitchell said another consideration is vhether the EPA could place additional 
oversight burdens on research and laboratory investigators. 
Dr. Clowes felt regulations for commercial applications should not impinge on 
research activities. Increased oversight of research should not be the outcome 
of the proposed oversight structure. 
Dr. Gartland said seme EPA positions proposed in the December 31, 1984, Federal 
Register have already been implemented; i.e., EPA has recently imposed additional 
regulation on research. He explained that in the past, EPA considered any field 
test involving less than 10 acres research are not covered by the Federal Insec- 
ticide, Fungicide, and Rodenticide Act (FIFRA) statutes. Now, however, EPA 
has eliminated the acreage limit. If an NIH funded investigator wished to 
field test an organism EPA defines as a pesticide, that NIH-f ended experiment 
would fall under the FIFRA statutes and would be regulated by EPA. 
Dr. Landy proposed one additional issue the Working Group on Biotechnology 
Coordination should address: any concerns working group members have about the 
EPA position should be included in the working group response since the public 
has been asked to c ament on questions posed by the EPA. 
Dr. McKinney suggested working group members might respond as individual citizens 
to EPA's questions. Ffe felt the working group should focus on providing advice 
to the NIH. 
Dr. Landy felt the working group should respond to the EPA questions since part 
of RAC's mandate is to address these types of issues. To drep this mandate and 
adept the Federal Register proposal prematurely would increase public anxiety 
about the applications of recombinant DNA technology. 
Dr. Clowes agreed; he felt the working group has an obligation to see that RAC 
continues to function in a beneficial way. 
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