32 
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jl MINUTES OF MEETING - March 6-7 
I 
the working group on the large-scale standards saying they are consistent 
with good laboratory and good manufacturing practices. He made two 
suggestions concerning these standards: (1) that "non-debilitated" be 
defined, and (2) that negative pressure should be required at the P3-LS 
level rather than at P2-LS. 
Mr. Myers of NIOSH said that NIOSH and OSHA are responsible for regulating 
the workplace. He reported that these two agencies are cooperatively 
establishing a process in this area. He said these agencies view the 
RAC as a valuable source of information in the establishment of recommen- 
dations. Mr. Pauker of NIOSH noted that all of NIOSH' s comments on the 
earlier draft of the large-scale standards had not been adopted, and that 
the section on health surveillance is still not to the satisfaction of 
NIOSH. Mr. Thornton commended the working group and moved that the 
proposed large-scale standards be published in the Federal Register as 
recommended Guidelines. Dr. Harris said she supported the motion noting 
that these standards provide a framework for industry. The motion was 
passed by a vote of sixteen in favor, two opposed, and one abstention. 
Dr. Krimsky then moved that (1) the RAC review only large-scale projects 
involving no proprietary information at NIH-funded institutions, and 
(2) the RAC refer other large-scale proposals that do not fall into the 
above category, with RAC recommendations, to OSHA. Dr. Krimsky said that 
in this manner the RAC could review the material but would not certify 
either facilities or proposals. Dr. Baltimore moved to table this proposal. 
He said he believed the Committee's sentiment was that the RAC should con- 
tinue to handle these applications and that OSHA was not prepared to handle 
such proposals at present. The RAC passed the motion to table by a vote 
of eight in favor, six opposed, and four abstentions. 
XXII. PROPOSED LARGE-SCALE EXPERIMENT 
Dr. Gottesman introduced the proposal (tab 841) from Dr. Benjamin Hall 
of the thiversity of Washington. She said that Dr. Hall would like to 
grow, on a large scale, Saccharcmyces cerevisiae carrying a Saccharomyces 
cerevisiae/Escherichia coll hybrid plasmid containing a Saccharomyces 
cerevisiae gene. She said this proposal had been considered at a previous 
meeting but disapproved as the request lacked information on the fermentors. 
Genentech, Inc., had agreed to grew the cultures for Dr. Hall, but their 
75-liter fermentation system had not at that time been evaluated by the 
RAC. 
Dr. Gottesman said she had voted at the previous meeting to approve this 
proposal as she viewed the experiment as essentially self-cloning. 
Dr. Walters asked Dr. Gottesman if this experiment could be considered 
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