SEPTEMBER 6-7 - MINUTES OF MEETING 
35 
These are: (1) the definition of large-scale experiments; (2) intermediate 
scale-up; (3) expedited review procedures; and (4) composition of a working 
group. Dr. Ahmed questioned whether the working group to perform review 
of applications prior to RAC review should be an ad hoc group or a chartered 
subcommittee of the RAC. Dr. Young recommended a flexible policy as 
each proposal might require different types of expertise, and recommended 
that the chair decide the constitution of each ad hoc group. Dr. Setlow 
added that this would be done in consultation with ORDA. Dr. Brill 
stated that large-scale culture may be safer than small-scale culture; 
i.e., one 400-liter batch might well be safer than 40 10-liter batches. 
Dr. Young reminded the RAC that very virulent organisms have been grown up in 
very large cultures, for example in the preparation of vaccines. He noted 
that industrial fermentation roans are well designed, and the design can 
go to extraordinary degrees of containment. Dr. Parkinson agreed. 
Dr. Parkinson requested that a statement be added to the report that this 
does not preempt the regulatory powers of other agencies. Ef. Ahmed 
suggested that Mr. Riseberg be asked to prepare language for such a 
statement. Dr. Young moved acceptance of the report of the Working Group 
on Large-Scale Procedures (697 pages 1 and 2) with a change in Section lc 
so that only the total volume of the fermenter to be used needs to be specified 
The motion was accepted by the RAC by a vote of fourteen for, none opposed, 
with three abstentions. The text as adopted by the RAC appears as Attachment 
V to these minutes. 
The RAC then considered the "agenda items" (697, page 3). The RAC agreed 
in response to the first question that the ten-liter limit refers to the 
volume of culture held in a single container and not the total volume of a 
single batch of culture. Dr. Walters recommended that question 2 (whether 
an intervening category be created for experiments involving more than 
10 but less than 100 liters of culture) not be dealt with at the September 
meeting. Dr. Novick raised again the question of how the RAC views its 
participation in the oversight of production runs. He felt the RAC 
should not be involved in this type of activity. Dr. Walters said that 
the RAC is being asked to evaluate industry in lieu of a parallel 
organization being instituted. Dr. Novick suggested that the RAC then 
needs fermentation engineers as RAC members or consultants. Dr. Young 
noted that there is more to be looked at than merely fermenter design; 
the scientific procedures must also be evaluated and the RAC possesses 
this expertise. Dr. Baltimore suggested that the RAC for this meeting 
dispense with the "agenda items" (697, page 3). The RAC agreed. 
Dr. Dennen of Eli Lilly and Company then presented to the RAC a talk 
with slides dealing with industrial fermentation scale-up. He noted 
that presently many types of organisms are grown in large-scale fermentation. 
These include bacteria, fungi and yeast. As an example of one of the 
most commonly used type of fermentation he offered the conversion of 
[mi 
