17 ! : 
on procedures and facilities design pertaining to appli- 
cations for large-scale operations." 
I 
"After the full RAC has reviewed the biological containment 
requirements for a large-scale proposal, the subcommittee 
shall examine the applicant's plans for large-scale opera- 
tions and issue recommendations to the Director on plant 
design, health surveillance, and environmental monitoring. 
The Director shall advise firms of recommended design para- 
meters and operational procedures. The determination shall 
not be construed as NIH certification of industrial operations." 
"The subcommittee shall invite participation from NIH's bio- 
safety staff, OSHA, NIOSH, CDC, Food and Ctug Administration 
(FDA), EPA and the U. S. Department of Agriculture (USDA)." 
i 
Dr. Talbot pointed out that; (1) ad hoc "working groups" on specific issues 
can be established by the RAC Chairman; "subcommittees" can be established 
only by modification of the Committee charter, which requires approval of 
the Secretary of Health and Human Services. 
Dr. Fedoroff expressed concern about the delays if first the full RAC, 
and then subsequently a subcorrmittee, were to be involved in the review 
process. Dr. Goldstein favored Dr. Krimsky's proposal as it would allow 
NIOSH, OSHA, etc., to participate more intimately in the decision making 
process. Dr. Gottesman said that she was opposed to continuation of 
review of equipment design in individual applications by either the full 
RAC or a subcommittee. 
Dr. McGarrity suggested that the American Society for Microbiology (ASM), 
might develop specifications for large-scale fermentors and auxiliary 
equipment to minimize personnel exposure and biohazards as has been done 
with safety specifications of laminar flow biological safety cabinets. 
Dr. Johnson of Eli Lilly said that Dr. Krimsky's proposal contradicted 
the proposal passed by the RAC earlier (Section V). He expressed a belief 
that industrial large-scale growth of microorganisms affords higher levels 
of containment than procedures in university laboratories. Dr. Simon of 
Genex Corporation suggested that Dr. Krimsky substitute the word "institu- 
tions" for the word "firms" in his proposal. Dr. Krimsky agreed. 
Dr. Mason suggested that the proposed subcommittee would have to advise 
the full RAC on each recommendation; if the subcommittee is empowered with 
final authority without reporting to the full RAC, he would not consider 
it to be a subcommittee of the RAC. A procedure involving a repqrt to 
the full RAC would entail considerable delay. He said the RAC should 
either (1) accept responsibility for full RAC review of physical "facilities 
or (2) delegate that authority to the IBC as voted by the RAC yesterday, 
the option he preferred. 
[ 176 ] 
