SEPTEMBER 6-7 - MINUTES OF MEETING 
36 
cereal to alcohol. He noted that these processes are well-controlled. 
He said the size of the growth culture is irrelevant to the question of 
safety. 
He showed slides depicting sane of the fermenters used for large-scale 
growth, some of the procedures used for growing and handling the inoculum, 
and procedures for monitoring the fermenter. He said there is extensive 
regulation by OSHA and FDA. 
Dr. Novick offered a resolution dealing with the voluntary compliance 
supplement (Part VI of the Guidelines), which had been recommended by the RAC 
on the previous day: 
"Whereas it is desirable to establish a uniform 
standard of conduct for the performance of experiments 
involving recombinant DNA techniques, 
And whereas the RAC has recommended mandatory 
compliance with the NIH Guidelines for non-federally 
funded institutions. 
And whereas there is currently no extent legal 
framework within which this can be effected, 
The RAC congratulates the Pharmaceutical 
Manufacturers Association and its member 
companies for the cooperative spirit that they 
have shown in agreeing to comply with the NIH 
Guidelines voluntarily under provisions of the 
supplement to the Guidelines adopted by the RAC 
at its meeting of September 6-7, 1979, 
At the same time, the Committee regards the 
concept of voluntary compliance as experimental; 
in order to ensure further consideration after a 
trial period, it sets hereby an expiration date of 
June 1, 1980, subject to renewal, on these supplementary 
provisions [Section VI of the Guidelines]." 
The RAC agreed to defer consideration of this proposal until the December 
6-7 meeting. 
XIX. REVIEW OF LARGE-SCALE PROPOSAL 
Dr. Novick presented the proposal of Benjamin B. Hall of the University 
of Washington requesting permission to use a Genentech fermenter for the 
large-scale growth of Saccharomyces cerevisiae containing a yeast pBR322 
hybrid plasmid vector and yeast cytochrome c cistron as the cloned segment 
[ 185 ] 
