DNA/21 
recommending to the Director of NIH, exceptions from classes of 
prohibited experiments and exemptions from the "Guidelines". Such 
recommendations are clearly the result of more than scientific con- 
siderations. NIH acknowledges the public policy aspects of granting 
exceptions, "In making such recommendations, weight shall be given 
both to scientific and asocietal benefits." (43 Fed . Reg . 33086) . 
The interpretation of the "significant risk" standard for allowing 
exemptions is also a public policy issue. 
IV-B-3-a- (4) . In order to minimize delays cause by paperwork, 
NIH should establish a time limit for ORDA analysis of requests for 
modifications in ongoing experiments and review of competing and non- 
competing recombinant DNA projects. EDF suggests that ORDA complete 
its independent assessment within 5 days of receipt of information 
from the IBC. There are' currently 2 persons conducting such analyses 
for ORDA. EDF suggests that at least one additional person be added 
to ORDA staff in order to further reduce the time necessary to review 
information submitted by the IBC. 
IV-B-3-a- (5) . Section IV-A-2-f of these comments discusses 
EDF's contention that all registrations should be publicly available. 
IV-b-3-a- (8) . PRG-NIH should establish a time limit for ORDA 
review of IBC membership. EDF, in section IV-A-l-a, suggests that 
institutions be required to establish their IBC within 45 days after 
promulgation of PRG-NIH in the Federal Register . ORDA review of IBC 
membership should be completed within 75 days of PRG-NIH publication 
in the Federal Register . NIH should then allow institutions 15 days 
to bring IBCs into conformity with the "Guidelines". NIH funds for 
recombinant DNA research should be halted for any institution that 
fails to meet these deadlines. Firm time limits and sanctions are 
[A-356] 
