4 
Dr. Tblin noted that Section VII-D-6 pertains only to the fe men tor and questioned 
whether language to cover ancillary equipment should be added. Dr. McKinney 
replied that Sections VII-D-7, VII-D-8 , and VII-D-9 provide specifications for 
the rest of the system. Those sections read as follows: 
"VII-D-7. Rotating seals and other mechanical devices associated 
with a closed system used to contain viable organisms containing 
recombinant DNA molecules shall be designed to prevent leakage or 
shall be fully enclosed in ventilated housings that are exhausted 
through filters vhich have efficiencies equivalent to HEPA filters 
or through other equivalent treatment devices. 
"VII-D-8. A closed system used for the propagation and growth of 
viable organisms containing recombinant ENA molecules and other 
primary containment equipment used to contain operations involving 
recombinant ENA molecules shall include monitoring or sensing 
devices that monitor the integrity of containment during operations. 
"VII-D-9. A closed system used for the propagation and growth of 
viable organisms containing recombinant DfR molecules shall be tested 
for the integrity of the containment features using the organisms that 
will serve as the host for propagating the recombinant DNA molecules. 
•Resting shall be accomplished prior to the introduction of viable 
organisms containing reccmbinant DKA molecules, and following modifi- 
cation or replacement of essential containment features. Procedures 
MU 
