30 
MINUTES OF MEETING - June 5-6 
final action on recommended modifications to the charters of the HHS 
the HHS public advisory committees. 
Dr. Zaitlin supported Ms. Cason's position. He found the stipulation 
"representatives of industry" inappropriate. Dr. Campbell moved 
acceptance of Ms. Cason's proposed language. The RAC accepted 
Ms. Cason's proposal by a vote of ten in favor, five opposed, and two 
abstentions. 
Dr. Young said that even though he found Ms. Cason's language appro- 
priate, he felt that consideration of this issue should be deferred 
until the September 1980 meeting, and moved to reconsider the vote. 
The RAC accepted Dr. Young's motion to reconsider, by a vote of ten 
in favor, five opposed, and two abstentions. 
Dr. Young then moved to defer consideration of the proposal until 
the September 1980 meeting. Dr. Bems said he opposed the motion 
to defer; he felt RAC needed this type of expertise. He noted that 
American Society for Microbiology strongly suggested that an expert 
knowledgeable in fermentation technology be appointed to RAC. 
Mr. Thornton said he supported the motion to defer. He felt that no 
recommendation should be sent to the Secretary, HHS, in advance of 
the RAC review in September of procedures regarding large-scale 
applications. By a vote of thirteen in favor, two opposed, and three 
abstentions, the RAC deferred further discussion of the proposal 
until September 1980. 
XX. PROPOSED PROCEDURES FOR MINOR MODIFICATIONS IN LARGE-SCALE RESEARCH OR 
PRODUCTION 
Dr. Walters introduced the proposal (tab 887) of the Working Group on 
Large-Scale Procedures to revise review procedures for minor modifications 
of previously approved large-scale protocols. He said three types of 
modifications can be envisioned; (1) changes in containment vessels, 
(2) changes in host-vector systems, and (3) changes in inserted DNA. 
Under proposed modification, RAC wculd not evaluate changes in 
containment systems; system design and validation data would be reviewed 
and approved by ORDA or its designee. Dr. Johnson said that his proposal 
to modify review procedures for large-scale applications was intended 
to achieve an objective similar to that proposed by the working group. 
Dr. Baltimore questioned whether changing from a 150-liter fermentor 
system to a 10,000 gallon fermentor system should be considered a minor 
modification. Dr . Gottesman moved that discussion of this proposal be 
deferred until September. The RAC voted in favor of the motion by a 
vote of eighteen in favor, none opposed. 
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