Peter Libassi 
page two 
1. IBCs do not necessarily have access to the expertise 
required to make the determinations of potential risk. 
2. IBCs are even closer than the NIH to those who are in the 
biggest hurry to proceed. The pressure that will be 
placed on a "recalcitrant" member should not be under- 
estimated. 
We have no problem with IBC approval of changes which clearly 
could present "no significant risk", but feel strongly that 
changes in location, principal investigator, and particularly 
changes in biological materials (host-vector systems or source 
of DNA) are important enough to warrant prior ORDA approval. 
Furthermore, no researcher should be allowed to switch to the 
recombinant DNA technique without prior NIH review. 
There is simply no compelling rationale for these changes that 
a special "expedited ORDA procedure" could not address as easily 
and with much more safety. 
An expedited ORDA procedure could also be developed to approve 
single step reductions in containment levels which meet the "no 
significant risk" criteria. "Free of harmful genes," we hope you 
will agree, is a terrible standard, particularly for interpretation 
by several hundred local committees. 
To reiterate: 
1. Allow the IBCs to do what they are best suited for, local 
oversight and inspection. 
2. Develop a "priority procedure" for significant changes in 
ongoing projects and for approval of lowered containment 
levels . 
3. Allow IBCs to approve "non-significant" changes in protocols. 
4. Give IBCs the authority to raise containment for safety 
reasons related to local conditions. 
One other point I feel worth repeating relates to training 
which is probably the single most important aspect to insure the 
safety of this research. Biological safety officers should be 
required to attend a NIH training seminar which should teach them: 
1. How to train others in standard microbiological technique. 
2. Emergency procedures. 
3. Health monitoring and uniform record-keeping 
The guidelines should then clearly delegate these responsibil- 
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