19 
"A large-scale review subcommittee of the RAC shall be esta- 
blished with the responsibility for advising the entire RAC 
on large-scale standards and the Director of NIH on procedures 
and facilities design for large-scale operations." 
"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 operations and 
issue recommendations to the Director on plant design, health 
surveillance, and environmental monitoring. The Director shall 
advise institutions of recommended design parameters and opera- 
tional procedures. The determination shall not be construed 
as NIH certification of industrial operations." 
"The subcommittee shall invite participation from NIH's Biosafety 
Division, 05HA, NIOSH, CDC, FDA, EPA and USDA." 
Dr. Krimsky said that it is the intent of his motion that the subcommittee 
will deal with prior review of individual applications. Dr. Federoff said 
that Dr. Krimsky 's proposed language would introduce delays in the procedure. 
Mr. Thornton called the question on Dr. Krimsky 's proposed amended language. 
By a vote of three in favor, fifteen opposed, the RAC opposed Dr. Krimsky' s 
proposed amended language. 
Mr. Thornton then returned to Dr. Gottesman's proposed amended language. 
It was suggested that the words " . . .pertaining to large-scale operations" 
be substituted for the words "...pertaining to applications for large-scale 
operations" in the first paragraph of the motion. Dr. Gottesman agreed. 
It was reiterated that the subcommittee would not perform prior review of 
individual applications. 
Mr. Thornton then called the vote on Dr. Gottesman's amendment to 
Dr. Krimsky 's original motion. By a vote of thirteen in favor, four 
opposed , an d one abstention, the RAC agreed to the amendment. 
Dr. Campbell offered an amendment to add the words "and on the performance 
of local IBCs in reviewing physical containment facilities." The amended 
motion would read as follows: 
"A large-scale review subcommittee of the RAC shall be esta- 
blished with responsibility for advising the RAC on procedures 
and facilities design pertaining to large-scale operations, 
and on the performance of local IBCs in reviewing physical 
containment facilities. The subcommittee shall invite parti- 
cipation from NIH's biosafety staff plus OSHA, NIOSH, CDC, 
FDA, EPA and USDA." 
[178] 
