all recombinant microorganisms must be killed, it may be very 
difficult in some processes to do so without compromising the 
product. Killing the organism prior to opening the containment 
system is not pharmaceutical industry practice in certain 
fermentations such as those used for some antibiotics. While 
this situation does not call for a present solution, we wish to 
alert the Working Group as to its potential for causing 
difficulties as more fermentations move to the large-scale step. 
3 . IBC Review Has Proved Satisfactory . 
The IBC plays a key role under the present NIH Guide- 
lines. Our experience with IBCs has been favorable and we 
believe that they are the most appropriate entity for the 
detailed monitoring of large-scale work. We strongly recommend 
their continued use. 
Our members have generally found the IBCs to be useful 
and productive. For example, IBCs are valuable in assuring the 
community that independent review of experiments does exist. 
While we are convinced by worldwide experience that rDNA research 
is safe, the IBCs will help establish an expanded data base which 
will further demonstrate the safety of this work. In addition, 
IBCs bring together many different expertises and allow all 
safety Issues to be addressed in a single forum within a company. 
Most of the work being performed by IBA members is 
classified as exempt or PI, We feel that a full-blown IBC review 
prior to initiation of an exempt large-scale experiment is not 
necessary. We recommend that exempt experiments require only 
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