Dr. William J. Gartland, Jr. 
National Institutes of Health 
May 30, 1984 
Page Two 
local IBCs with an increasing degree of flexibility in looking at data 
and making decisions relative to an institution's plans to conduct 
research. This proposal continues in that same vein and covers the scale 
up of only those experiments that are exempt from the guidelines at small 
scale. Scaling up of such experiments would not be expected to pose 
health or environmental risks. 
It is only those experiments that might have commercial potential 
that are likely to be scaled up. In these cases the host-vector system 
is well characterized as opposed to those in the research phase. IBC 
review of a process involving a specific host-vector system will also 
include occupational and environmental exposures which will be based on 
facility and equipment design, containment features, as well as other 
manufacturing procedures. 
This proposal would permit a case by case evaluation of large scale 
fermentation experiments and should not be construed as establishing a 
new class of lesser requirements. It would permit some flexibility 
within Pl-LS which is in keeping the RAC's concept of physical and 
biological containment. We support this type of approach to increased 
flexibility in the guidelines and appreciate the opportunity to offer 
these comments. 
Sincerely , 
[ 697 ] 
