- 2 - 
at NSF allowed a breakthrough in this particular logjam. It seems 
to me that the limits of ORDA's policy-making authority should be 
clearly defined in light of its limited scientific expertise, and 
questions of interpretation of the guidelines should be referred to 
the Committee rather than commented upon. Possibly such interpreta- 
tive authority should be granted, in a limited way, to the local 
committees, as is the case in Human Experimentation. Whatever happened 
to the role of the Study Sections in this process? 
3. The Memoranda of Understanding should be simplified. As it 
is now, the pronouncements in the N.I.H. Guide make it appear that 
each experiment requires a new MUA, even if the investigator already 
has an approved P2 or P3 facility. It should be possible to allow an 
approved facility to operate within the entire range of permissible 
experiments at the approved level of containment. After all, if one 
has an MUA for any P3 experiment, then it seems a good assumption that 
the Principal Investigator and his local committee are well-informed. 
Why not allow the local committee to have latitude within the entire 
range of permissible experiments, relying upon it to submit marginal 
cases to ORDA, rather than making everyone go through all the paper- 
work every time anew? Perhaps a published list of permissible shotgun 
experiments should be published along with the appropriate containment 
and updated as new MUA's are approved by ORDA. Then the local committees 
could have explicit guidance in this area and could act without ambi- 
guity on all proposed experiments involving these DNAs . 
This is only a sample of my own thinking. In order to get a 
realistic idea of how the Guidelines are working in practice, and 
to inform the Recombinant DNA Committee of the problems and opportuni- 
ties for simplification, I urge you to consider a meeting along the 
lines I suggested above. 
Thanks for your patience, and please let me know if there is 
anything further I can do in this matter. 
Sincerely yours. 
<- -—"David Botstein 
Associate Professor of Genetics 
DB : po 
[Appendix A — 268] 
