DNA/2 3 
will be great because of the ongoing nature of the project. 
EDF therefore maintains that no change in an ongoing project 
should be initiated with NIH approval. The error rate of IBC's 
has been variously estimated at 4-15% by NIH's Office of Recombinant 
DNA Activities (ORDA) Therefore, the potential for experiments to 
proceed without adequate safeguards is significant if IBC certifica- 
tion is not reviewed by NIH. The turn around time for ORDA review of 
2 
an IBC assessment of a recombinant DNA activity is only 4-5 days. 
Therefore, the delay to scientists seeking to begin a new or altered 
experiment is small. Because of these two reasons, EDF concludes 
that the public is better served by requiring NIH review and approval 
of IBC certificationi EDF does suggest that the staff of ORDA be 
expanded to shorten the turn around time. Currently, 2 people at 
ORDA review IBC project certifications. If DHEW adopts these suggestions, 
tne same procedure would apply to persons seeking to initiante new ex- 
periments in an ongoing NIH funded project. 
IV-B . According to this section, all non-NIH funded projects, 
even those involving P-4 containment requirements, at institutions 
that are subject to the "Guidelines" may be initiated and altered solely 
on the basis of IBC approval. Notification of IBC action must be sent 
to NIH within 30 days of IBC approval. EDF takes issue with this 
procedure . 

1 Dr. William Gartland, Director, Office of Recombinant DNA Activities, 
personal communication. 
2 Letter from Donald Fredrickson to Senator Edward Kennedy, May 22, 1978. 
[A— 358] 
