27 
Mr. William Muth of Eli Lilly and Company said approval of the modification 
would permit companies greater flexibility. Dr. Gottesman said she would 
vote against the motion. She thought it appropriate that the IBC review 
the proposal before large-scale procedures were initiated. She felt the 
company would know in advance of plans to scale-up, and the company and 
the IBC could prepare accordingly. 
Dr. McKinney moved approval of the proposal. Dr. McGarrity seconded the 
notion. 
By a vote of ten in favor, eight opposed, and one abstention, the motion 
was accepted. Dr. Martin abstained. 
XI. PROPOSED MODIFICATION OF SECTION VII-D-6 OF THE PHYSICAL CONTAINMENT 
RECOMMENDATIONS 
Dr. McKinney presented the proposal (tabs 1095/II/A, 1101/III/A) to modify 
Section VII-D-6 of the Physical Containment Recommendations for Large-Scale 
Uses of Organisms Containing Recombinant CNA Molecules. Dr. McKinney said 
Mr. Richard F. Geoghegan of E. I. DuPont de Nemours and Company requested 
that Section VII-D-6 of the Large-Scale Recommendations be revised. Section 
VII-D-6 specifies that: 
"A closed system used for the propagation and growth of viable organisms 
containing recombinant DMA molecules shall be operated so that the 
space above the culture level will be maintained at or slightly 
below atmospheric pressure." 
Mr. Geoghegan proposed that Section VII-D-6 be modified to specify that 
the "closed system . . . shall be operated so that the space above the cul- 
ture level be maintained at no more than 10 psig." 
Mr. Geoghegan argued that the revision will permit fermentations more in 
line with industrial practices (high biomass production through efficent 
oxygen transfer) to be conducted without compromising safety by operating 
at unnecessarily high vessel pressures. The RAC Large-Scale Review Working 
Group, at its meeting on October 26, 1982, felt the language might appro- 
priately be modified, but felt no specific pressure limit should be indicated 
as the pressure limit should be dependent on the maximum design pressure 
of the system. The working group, thus, suggested the following language: 
"VII-D-6. A closed system used for the propagation and growth of 
viable organisms containing recombinant ENA molecules shall be operated 
so that the space above the culture level will be maintained at a 
pressure as lew as possible, consistent with equipment design, in 
order to maintain the integrity of containment features." 
The Large-Scale Review Working Group at its meeting on October 26, 1982, 
recommended this language by a vote of five in favor, none opposed, and no 
abstentions. 
1 f< 
f 112] 
