Dr. Donald S. Fredrickson 
Page 6 
November 29, 1979 
flasks which can be dropped, broken, etc., but in rigid 
stainless steel tanks with a number of safety features. 
We would make the following comments on the four agenda 
items which in some cases are extensions of those already made. 
1. The 10L limit should refer to the volume held in a 
single container. If that container reliably contains 
the 10L experiment, any additional containers or 
comparable construction surely will contain that same 
volume equally well. 
2. We do not feel an intervening category between 10i_ and 
100L need be created. We feel strongly that the 
reliability of the design and the experience with that 
equipment is the overriding pertinent fact. As indi- 
cated in our preceding comments, we do not perceive 
10L experiments to be less safe at higher volumes. 
3. We have already indicated that we feel IBC's should be 
able to approve with concurrent advisory notice to the 
Director of ORDA, any large-scale exoeriment for which 
RAC approval has been previously obtained as well as 
new experiments at the P2 HV1 level. These proposals 
do assume documentation of the appropriate procedures, 
facilities, experience, etc., of the laboratory where 
these experiments will be carried out. 
We would like to propose that RAC subcommittees or 
Working Groups have the responsibility to approve or 
recommend approval to the Director, unless within 15 
days after receipt of a new submission by the whole 
RAC, there is a clear preponderance of concern. 
Approval could then be handled by telephone by the 
subcommittee or Working Group. 
4. Fortunately, the RAC as currently constituted repre- 
sents several scientific disciplines as well as the 
public interest. These disciplines could be appro- 
priately supplemented with additional representation, 
particularly in considering submissions which clearly 
are breaking new ground as opposed to replowing old. 
In the former case we feel representation from the 
fields of infectious disease, i_.e. , microbial patho- 
logical processes, epidemiology, chemical-biochemical 
engineering, and fermentation technology particularly 
should be represented on the Working Group or sub- 
committee. We believe in many or most instances these 
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