DNA/2 
only suggested and do not have to be followed rigorously. NIH has 
revealed its . sensitivity to the language of the proposed "Guidelines" 
in its recommendation to change the name of the Institutional Biohazard 
Committees to Institutional Biosafety Committees. It should manifest 
this sensitivity again and term these proposed procedures regulations. 
(Hereafter, these comments will refer to the proposed "Guidelines" as 
PRG-NIH) . 
PRG-NIH should apply to all recombinant DNA research con- 
ducted at an institution that receives DHEW funds for any purpose . 
Clearly, recombinant DNA research poses the same risk no matter where 
the research is carried out. DHEW should therefore expand the coverage 
of PRG-NIH to the maximum extent legally possible. 
I-C. Paragraph three of this section conveys the false sense 
that all recombinant DNA research, regardless of the physical and 
biological containment levels required, can proceed solely on the 
basis of local approval. This section should be rewritten to indicate 
that according to PRG-NIH, prior NIH approval is required for initia- 
tion of all recombinant DNA activities, except changes in ongoing 
projects below the P-4 level and single-step reductions in containment 
levels for experiments with purified DNA and characterized clones. 
(EDF's contention that all. changes in ongoing experiments should be 
initiated only after NIH approval is discussed in the last section of 
these comments.) EDF finds it shocking that the General Applicability 
section of PRG-NIH could contradict the rest of PRG-NIH on so fund- 
amental an issue. 
All NIH funded projects, regardless of where they are carried 
out, should meet the requirements of PRG-NIH. Projects carried out 
in countries with more lenient requirements should still have to meet 
[A-337] 
