10 
procedure as in tab 976/3. Dr. McKinney agreed. By a vote of 
seventeen in favor, none opposed, the RAC acc^ted the prc^)osed 
language (976/3). 
B. Proposed Procedures for Change of Locale of Previously j^roved Large- 
Scale Recombinant ENA Experiments. 
Dr. Gartland posed the question of how to process changes of site 
for large-scale production using previously approved clones, i.e., 
a clone which had been approved for scale-up at one site would be 
noved to another physical facility. A second IBC might then be 
charged with oversight responsibilities. 
Dr. Baltimore, noting that the RAC no longer reviews physical facil- 
ities, felt changes of locale were therefore not appropriate RAC 
considerations. It was agreed that ORDA would administratively 
process such proposals. 
[Executive Secretary's Note: The following statement dealing with changes 
of facility has been added to the "^^plication Procedures for Large-Scale 
Recombinant DNA Experiments"; 
"7. Should a clone, previously ^proved for scale-up at one facil- 
ity, be prc^x3sed to be moved to a second facility, the IBC 
with oversight responsibility at the second site shall submit 
to ORDA a registration document and receive ORDA approval, 
prior to initiating scale-up. No RAC review would be required."] 
VII. PROPOSED CONTAINMENT FOR EXPERIMENTS INVOLVING NONPATOOGENS 
Dr. Brill introduced the proposal (tabs 966, 973, 976/2, 980, 981, 982, 
983, 984, 985, 987, and 988) to amend the Guidelines to permit use of 
norpathogenic prokaryotes and nonpathogenic lower aa)?aryotes as donors 
and recipients in reconbinant EWA experiments under PI containment condi- 
tions. Specifically, it was proposed in the Federal Register on 
November 28, 1980, that a new Section, III-0-2, would be added to the 
Guidelines as follows: 
"III-0-2. Experiments Involving Norpathogenic Prokaryotes and Lower 
EuJcaryotes . Recombinant DNA ei^riments involving prokaryotes and 
lower eukaryotes, ncxpathogenic [2A] for man, animals, or plants, 
can be conducted under PI containment." 
Changes were also proposed in other sections of the Guidelines to accom- 
plish this change. 
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