MINUTES OF MEETING - June 5-6 
29 
B. Proposal to Add a New Subsection to Section IV-E-2-b 
The committee considered Dr. Johnson's proposal (tab 877, 881/18/C) 
to add a new subsection IV-E-2-b to the Guidelines to read as follows: 
"IV-E-2-b. A permanent subcommittee of the RAC shall be responsible 
for advising the Director of NIH, on the actions listed in Section 
IV-E-l-b-(3)-(d) pertaining to large-scale applications. Submis- 
sions that are in compliance with the Guidelines may be recommended 
by the subcommittee to the Director of NIH for approval. The sub- 
committee shall also be authorized to consider preliminary plans 
for large-scale operations and to recommend approval contingent 
upon completion of the large-scale facility according to these 
plans. The subcommittee will be responsible for expeditiously 
processing appl ications . " 
Mr. Thornton said the proposal would be more properly considered at 
the September 1980 meeting when the RAC would be voting on the imple- 
mentation of the principles voted earlier in the meeting (Section II 
of these minutes). A motion to table the proposal passed by a vote 
of eighteen in favor, none opposed. 
C. Proposal to Amend Section IV-E-2 of the Guidelines 
Ms. Cason introduced Dr. Johnson's proposal (tab 877,881/18/B) to 
amend Section IV-E-2 of the Guidelines, by adding the following 
sentence : 
"Appropriate representatives of industry shall also be chosen to 
provide expertise in fermentation technology, engineering, and 
other aspects of large-scale production." 
Ms. Cason agreed that it would be desirable to have someone with 
expertise in fermentation technology appointed as a RAC member, parti- 
cularly if RAC continues to review the details of physical containment 
in applications submitted under the program of voluntary compliance. 
She disagreed, however, with Dr. Johnson's language requiring that 
the person be a "representative of industry" and proposed that the 
sentence should read as follows: 
"Members should also be chosen to provide expertise in fermentation 
technology, engineering, and other aspects of large-scale pro- 
duction." 
Dr. Talbot pointed out that if the RAC recommended Dr. Johnson's 
proposal, this would require an amendment to the RAC Charter, and 
such an action cannot be approved by the Director, NIH. Rather, the 
Secretary of the Department of Health and Human Services (HHS) takes 
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