SEPTEMBER 6-7 - MINUTES OF MEETING 
34 
whole panoply of characteristics necessary to produce pathogenicity. 
Dr. Young, therefore, moved to accept this proposal. Dr. Brill noted 
that this experiment cannot be done as proposed since the J gene, which 
is necessary for expression of the nitrogen fixing phenotype, is not included 
in the cloned piece of DNA. The RAC then accepted Dr. Ausubel's proposal 
by a vote of twelve in favor, none opposed, with seven abstentions. 
XVIII. PROCEDURES FOR REVIEW OF APPLICATIONS FOR LARGE-SCALE EXPERIMENTS 
Dr. Setlow introduced Dr. Irving Johnson of Eli Lilly and Company who 
had requested time to make a very brief comment to the RAC. Dr. Johnson 
cited a letter he had sent (741), and added several comments to that letter. 
He said that industry had been in a position for the past year to scale- 
up. During that time, industry tried to live within the Guidelines and 
vork with NIH to establish procedures covering industry. Dr. Johnson 
extended an invitation to the members of the RAC to visit the Eli Lilly 
production facilities. He said he had suggested that a presentation on 
scale-up should be made to the RAC and that the presentation be open to 
the public. Dr. Johnson proposed that the RAC consider suggesting to 
the Director, NIH, that experiments at P2 + EKl level or below require 
only the approval of the local IBC; with subsequent notification to ORDA. 
He also suggested that any experiments for scale-up which have a clear 
precedent of prior RAC approval simply require the approval of the local 
IBC with notification being sent to ORDA. He also felt that further 
increases in volume for an experiment which had already been approved for 
over ten liters by the RAC be left up to the discretion of the local IBC 
with subsequent notification to ORDA. 
Dr. Walters delivered the report of the Working Group on Large-Scale 
Procedures (697). He stated that the Wbrking Group was comprised of 
Drs. Emmett Barkley, Sheldon Krimsky, Frank Young and LeRoy Walters. The 
group met briefly in May at the last RAC meeting and divided the 
work into two parts; the first part of which will be dealt with at this 
meeting and has to do with procedures. The second part will be presented 
at the December RAC meeting and deals with substantive standards for 
research involving more than ten liters of culture. The Group presented a 
draft of procedures (697). Section la through lh, deals with the types 
of information which should be submitted. The Wbrking Group had seme 
second thoughts about section lc, (specifications of the total volume of 
culture to used both per batch and per week) , and would welcome other 
language for this section. Section 2-4 deals with stages of review. The 
Wbrking Group has advised a three-level review method: (1) a Wbrking 
group; (2) the entire RAC (the method of the RAC review is not specified, 
and might be at a meeting, but it also might be through mail ballot); and 
(3) the Director, NIH. Dr. Walters stated that these procedures are 
deliberately cautious. As the RAC gains confidence it can delegate more 
responsibility to a working group. The Working Group on Large-Scale 
Procedures raised four issues for consideration by the RAC (697). 
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