Dr. William J. Gartland, Jr. 
January 20, 1987 
small volumes (most participants used or had access to 
standard 10L laboratory fermenters). 
D. As expressed in the current Guidelines, the IBC has the 
responsibility for setting containment requirements for 
large-scale fermentations using exempt microorganisms. 
Most IBCs , including ours, look to the Guidelines for 
guidance on these issues. The explicit proposed wording 
is most helpful in providing that guidance. 
We appreciate the opportunity to comment on these proposed 
changes to the Guidelines. Experience has indicated that as more 
scientific information accumulates and more experience is gained, 
such modifications in the Guidelines are appropriate. 
Sincerely yours, 
ISJ/rl 
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