6 
Dr. McKinney suggested that Section VII-D-6 might be deleted from the Large-Scale 
Recommendations; the operator would then utilize whatever pressure is necessary 
for successful fermentation. Dr. Vtest said every specification should be 
examined and evaluated before any one specification is deleted. 
Dr. Chen of the Occupational Safety and Health Administration (OS HA) suggested 
that the language of Section VII-D-6 be modified to read " that the space 
above the culture level will be maintained at safe and appropriate pressure." 
Dr. IPlin moved the following language: 
"VII-D-6. A closed system used for the propagation and growth 
of viable organisms containing recombinant DfiA molecules shall 
be operated so that the space above the culture level will be 
maintained at a pressure level appropriate for the equipment 
design and for the test organism." 
Dr. West said he would like to add language specifying that the integrity of 
the containment system design must be maintained. Dr. Iblin agreed to the 
amendment, and modified her motion bo read in part: 
"... so that the space above the culture level will be maintained 
at a pressure level appropriate for the equipment design and the 
test organism to maintain the required containment." 
Dr. Bems asked Dr. Tolin why her motion mentioned the organism. He suggested 
mention of the organism is unnecessary as the operator will select optimal 
growth conditions. Dr. IPlin agreed to delete the language. Dr. Tolin's 
motion then read in part: 
[431 
