DNA/7 
require that each recombinant DNA activity have an emergency plan. 
This plan should be approved by the IBC as part- of the review process 
for each recombinant DNA activity. 
II-D-2. The procedures for NIH certification of host-vector 
systems (HV) were generally agreed to be among the weaker procedural 
sections of the existing DNA "Guidelines". Indeed, the "Guideline" 
violation at the University of California of San Francisco was blamed 
on ambiguities in the NIH publications laying out procedures for HV 
certification. Unfortunately , PRG-NIH does not resolve these pro- 
cedural ambiguities. II-D-2 needs to be rewritten. 
PRG-NIH (43 Fed . Rbg . 33076) states that certain new HV "may not 
be used unless they have been certified by NIH." PRG-NIH does not 
indicate which office within NIH supplies this certification. The 
person seeking certification does not know if he or she is free to use 
the HV after certification by the Recombinant DNA Advisory Committee 
(RAC) or if they must wait for approval by the NIH Director. An 
analysis of the Federal Register package does not clarify this issue. 
PRG-NIH states (43 Fed . Reg . 33076) , "When appropriate, the pro- 
posed host-vector system will be reviewed by the NIH Recombinant DNA 
Advisory Committee." 
The Environmental Impact Statement states, (43 Fed . Reg . 33115) , 
"Under the PRG-NIH, HV1 systems other than E. coli K-12 and HV2 and 
HV3 systems are considered by an expert working group and then by the 
RAC, which makes appropriate recommendations to the Director, NIH." 
PRG-NIH also states (43 Fed . Reg . 33086), "Responsibilities of 
NIH. Office of the Director, NIH. The Office of the Director shall 
be responsible for: .... Certification of new host-vector systems." 
[A-342] 
