MINUTES OF MEETING - December 6-7 
33 
from the Guidelines for research with smaller volumes. He said 
that a policy decision was made that representatives of public 
interest groups or representatives of industry would not be 
consulted during the initial development of the standards. As 
the standards are new in draft form, comments from interested 
parties or groups would be welcomed. 
Dr. Barkley said that the large-scale standards employ an 
extension of the philosophies and concepts behind the Guidelines 
for laboratory scale experimentation. The format of Section 
II-B was followed with emphasis on those activities that relate 
to large-scale. Primary emphasis is placed on the vessels used 
for the production of large volumes. These vessels are self 
contained and capable of providing excellent primary containment. 
The working group emphasized the need for active certification 
of the containment features of the vessels before use in large- 
scale production. 
Dr. Young said that he was concerned with one aspect of the 
safety features, namely whether a simple plug or stop of the 
primary drain in the fermentor apron is adequate. He said he 
would recommend a requirement for an additional valve that could 
be turned off below any drain within the apron. He noted that 
such a valve would aid in decontamination. 
Dr. Gottesman asked why the working group had specified P2 and 
P3 levels of large-scale containment when not every large-scale 
grewth of a recombinant molecule is going to require that level 
of containment. Dr. Walters replied that the design of large 
facilities ordinarily provides greater than PI containment. 
Dr. Gottesman said that she is concerned that the RAC will spend 
time evaluating trivial, very safe, proposals. She stated that 
proposals absolutely without hazard should be handled in a simpler 
fashion. 
Dr. Ahmed noted that there is no provision for P4 containment in 
the large-scale standards. Dr. Gottesman said that she did not 
think any project which would require P4 would be approved for 
large-scale growth. 
Dr. Barkley noted that the draft standards require procedures 
for inactivating accidental spills. Dr. Wright said that whereas 
one sort of laboratory procedure would suffice for small spills. 
[ 426 ] 
