-5- 
significant increase in risk over that present in nature. Criteria should 
be specified in detail. The meaning of "DNA exchange by known physiological 
processes," a category of exemptions, should also be defined. Serious con- 
sideration should be given to listing exchangers by species rather than 
genus. 
The commitment simply to give "appropriate notice and opportunity for 
public comment" perpetuates the present uncertainties with regard to NIH 
procedures. The guidelines should provide for advance notice in the 
Federal Register of proposals for exemptions, classifications, and 
reclassifications. All material relating to the proposal should be avail- 
able to the public. A public comment period should be specified, and 
notice of the agency's action should also be published in the Federal Register. 
These recommendations regarding procedures and criteria apply with equal 
force to the certification of host-vector systems. 
4) Compliance 
The new guidelines would delegate greater but not altogether clear 
responsibility for approval of recombinant DNA projects and changes in 
those projects to institutional biosafety committees. The General 
Applicability section implies that any restarch project approved by the 
institutional committee may be initiated without prior NIH approval. Else- 
where, it is indicated that prior NIH approval is required except for 
[A-423] 
