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one procedure would do for all? It would greatly ease 
the burden of the IBC's to treat all recombinant DNA 
projects alike. 
7. I seriously question the necessity for public discussions 
and review of each and every subsequent modification in the 
Guidelines and its Appendices. I believe the process is already 
public enough in as much as the Director's Advisory Committee 
and RAC have public members and meet in full public view, only 
after public announcement of the meeting's time and place; changes 
in the Guidelines are made in close consultation with these 
groups and final decisions are published in the Federal 
Register and Recombinant DNA Bulletin. Must every technical 
decision be the subject of the same interminable review process 
now in progress? I was struck by the number of places in 
PRG-NIH where the Director is required to provide "appropriate 
notice and opportunity for public comment" prior to making or 
implementing decisions. I believe a distinction should be made 
between purely technical and scientific matters and broader 
policy issues that frequently elicit political, ethical, religious 
and other considerations. 
8. The phrase "case by case" review occurs frequently in 
PRG-NIH, particularly where construction of recombinants in- 
volving two different viral DNAs is considered. But I found 
nothing more than general statements about how such case by case 
review would be conducted. May I suggest that an ad hoc committee 
or subcommittee of RAC formulate a plan for how such reviews will 
be conducted e.g., by whom (ORDA or RAC?), when (on demand or 
periodically), what constitutes a decision and who makes it 
(the Director, ORDA or RAC?) etc. Will such decisions also 
require public review and comment? That group could also 
construct a list of putative high, intermediate - and low-risk 
combinations to guide investigators now planning such experiments. 
For example, there is considerable interest for introducing the 
thymidine kinase gene from herpes simplex virus into either 
SV40 or polyoma DNA vectors; this is quite a straight-forward 
almost trivially simple, but nevertheless important experiment; 
yet, presently it is a forbidden experiment and unless the 
case by case reviews are expedited it will remain forbidden. 
I had not intended to write at such length but my 
justification for doing so is that you might find my comments 
useful in your deliberations. 
This summer as I sat through two Gordon Conferences 
reviewing the recent advances using the recombinant DNA methods 
I wished that you were there. I particularly wanted you to 
see and experience, first hand, the dynamism, excitement and 
explosive progress that these developments have engendered. 
The recombinant DNA methodology and rapid nucleic acid sequencing 
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