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3. membership of the Recombinant DNA Advisory Committee (RAC) 
4. membership and responsibilities of the Institutional bio- 
safety Committees (IBCs) . 
5. confidentiality 
EDF is concerned that the poor quality of the drafting of the 
guidelines will result in confusion and compliance failures. As pre- 
sently written, instructions for persons conducting recombinant DNA 
activities are spread throughout the proposed guidelines themselves, 
the Director's decision document, the Environmental Impact Assessment (EIA) 
and appendices to tnese documents. Often, these documents contradict 
each other. But only the guidelines will have the indisputable force 
of law. Moreover, the guidelines are sometimes so vague that their 
t 
intent is unclear, and problems are sure to arise. 
The section of the Federal Register package dealing with certif- 
ication of host-vector systems exemplifies these problems. The guide- 
lines state that certain new host-vector systems "may not be used 
unless they have been certified by NIH." But there is no indication 
of what office within NIH supplies this certification. The person 
seeking certification does not know if he or she is free to use the 
host-vector system after approval by the Recombinant DNA Advisory 
Committee or if they must wait for approval of the NIH Director. Just 
this sort of ambiguity was cited by the University of California at 
San Francisco to explain their violation of the existing guidelines. 
Another example of poor drafting is in the section of the guide- 
lines dealing with exceptions from prohibited experiments. The 
Director's decision document indicates that the rationale for allowing 
exceptions is to provide for experiments for which there are compelling 
social or scientific reasons (43 Fed . Reg . 33048) . Yet the guidelines 
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