SEPTEMBER 6-7 - MINUTES OF MEETING 
37 
(719). He noted that the clone is fully characterized and free of harmful 
sequences, and that Saccharomyces cerevisiae has already been certified 
as HVl. The specified conditions satisfy the requirements of yeast 
containment. However, there are several problems with the proposal as 
it now stands: (1) The methods by which the products are to be handled 
are not clear. It is not known if yeast is susceptible to sterilization 
by a phenol-toluene mixture. (2) Are spores present in the mixture, and 
are these susceptible to the sterilization procedure? (3) The RAC is 
being asked to rule in an open session on material that is proprietary. 
Mr. Thornton agreed with Dr. Novick that some of the most important 
considerations for approval are documented in proprietary materials. 
Dr. Young moved to deny the proposal until more data is supplied. 
Dr. Gottesman felt that the basic question is whether the sequence to 
be cloned is fully characterized and free of harmful genes. If this is 
so, then the RAC should approve this proposal. Dr. Campbell concurred, 
saying that under the Guidelines this proposal requires Pi. Dr. Young 
stated that he moved to reject because the RAC must take a responsible 
position on knowing what the fermentation conditions would be. 
Dr. Baltimore stated that the experiment is perfectly safe. Dr. Walters 
noted that the RAC just passed procedures for the review of applications 
for large-scale experiments which specify the types of information to be 
submitted; for future meetings investigators will have to supply that 
information. Dr. Young emphasized that he felt this proposal should be 
deferred. Dr. Brill felt that the only issue here is the safety of the 
system, not the fermentation conditions. Dr. Campbell said the responsibility 
lies with the local IBC to verify that a given facility meets required 
physical containment standards. Dr. Gottesman noted under the 1976 
Guidelines anything not known to make harmful products could be grown in 
larger batches. She felt this experiment was safe. Mr. Thornton stated 
that he had intended to propose that any approval for large-scale culturing 
be conditioned on acceptance of an observer. He proposes that someone 
with the qualifications of Dr. Barkley have access to the facilities to 
observe the conditions under which the experiments are conducted. He 
stated that he would make such a motion when the industrial proposals 
are considered in closed session. Dr. Johnson asked whether this wauld 
be required prior to initiation of the experiments. Mr. Thornton responded 
that his intention was that the observer be given permission to look at 
the facilities prior to initiation, as well as during operation of the 
facility but that the experiments would not have to wait for such a 
visit. Dr. Johnson responded that Eli Lilly had reviewed diagrams of 
their fermenters with Dr. Barkley, who considers them to be totally contained. 
He added that Dr. Barkley is welcome to come out at any time to visit 
the Eli Lilly facilties, as are all the members of the RAC. 
Dr. Baltimore moved to approve Dr. Hall's proposal (719). Dr. Walters 
stated that he would vote against this motion on procedural grounds as 
the RAC does not have the data which will be required of other investigators. 
The vote was six in favor, seven opposed, with four abstentions. 
[ 186 ] 
