MINUTES OF MEETING - June 5-6 
31 
Dr. Walters then described part two of the proposal. He said criteria 
previously developed to identify and review minor modifications in host- 
vector systems used in small-scale manipulations would be applied to 
large-scale manipulations. Review and approval of minor modifications 
of host-vector systems used in large-scale manipulations would thus be 
reviewed by at least one member of a working group with a three-week 
comment period for all members of the working group. 
Dr. Gottesman said she did not believe that the small-scale standards 
which were written specifically for minor modifications of previously 
approved HV2 systems (Attachments 1 1- IV to the RAC minutes of May 21-23, 
1979) were applicable to all changes in host-vector systems. They include 
no language discussing changes either in the protein expressed or the 
level of protein expression. She said that while she favored the concept 
of expedited review for minor modifications of previously approved appli- 
cations, new language defining such minor modifications should be con- 
structed, and moved deferral. The RAC voted in favor of the motion by a 
vote of eighteen in favor, none opposed. 
The RAC then discussed part three of the proposal dealing with changes in 
the inserted DNA. Dr. Berns asked if a harmful product could ever be 
produced by deleting sequences from a gene producing no harmful product. 
Dr. Williams suggested that part three of the proposal should also be 
considered with parts one and two, and moved deferral until September 
1980. The RAC voted in favor of the motion by a vote of seventeen in 
favor, none opposed. 
XXI. PROPOSAL TO INCLUDE SACCHAROMYCES CEREVISIAE HOST-VECTOR SYSTEMS UNDER 
SECTION III-O OF THE GUIDELINES 
Dr. Setlow introduced Dr. Gerald Fink of Cornell University, an ad hoc 
consultant. Dr. Broadbent reviewed the history of the proposal (tab 871, 
872, 873, 881/4, 891) to include laboratory strains of Saccharomyces cere- 
vis iae under Section III-O of the Guidelines. He noted that Dr. Setlow 
at the March 6-7, 1980, RAC meeting proposed this amendment to the Guide- 
lines. He summarized the arguments supporting inclusion of Saccharomyces 
cerevisiae under Section III-O: (1) Saccharomyces cerevisiae is sensitive 
to autoclaving and disinfecting agents, (2) Saccharomyces cerevisiae 
does not colonize animals, (3) Saccharomyces~cerevisiae~ Fas been consumed 
by humans in both food and drink for millenia with no ill effects, (4) 
the laboratory strains of Saccharomyces cerevisiae do not compete or sur- 
vive well in nature, (5) the possibility of transmission of recombinant 
DNA from laboratory to wild-type strains of Saccharomyces cerevisiae is 
extremely small, and (6) mammalian genes cloned in Saccharomyces cere- 
visiae are not automatically expressed. Dr. Broadbent moved to recommend 
incorporation of this proposal into the Guidelines. Dr. Williams supported 
Dr. Broadbent' s motion. 
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