UNITES OF MEETING - June 5-6 
11 
Dr. Gottesman asked for a vote on her motion, and reread the wording of 
the motion: 
"It is the sense of the Committee that the following procedures 
should be adopted for approval of requests to grow greater than 
10 liters of organisms containing recombinant DNA. RAC will 
determine if a given recombinant DNA-containing strain is in 
fact 'fully characterized and free of harmful sequences.' Such 
a determination shall include specification of a containment level 
(P-LS level). Adherence to the specified containment conditions 
is the responsibility of the local IBC and appropriate regulatory 
agencies." 
The RAC supported Dr. Gottesman' s proposal by a straw vote of sixteen in 
favor, one opposed, and one abstention. 
Dr. Young requested that two additional issues be addressed: (1) that 
RAC members be included on the Industrial Practices Subcommittee of the 
Federal Interagency Committee to facilitate both communication and action, 
and (2) that language be added to the recommended approvals of industrial 
applications to indicate that the action of the RAC should not be con- 
strued as certification of safe laboratory practices for scale-up. It 
was pointed out that the Interagency Committee is composed only of federal 
employees, and that the character of the Interagency Committee would be 
altered were Dr. Young's motion accepted. E*r. Young then withdrew his 
proposal . 
Dr. Baltimore moved that Dr. Gottesman 's motion be forwarded to the 
Federal Interagency Committee as the sense of the RAC's position, rather 
than taking precipitous action. He felt implementation of regulation by 
other agencies would take time and he preferred to see the RAC fill the 
vacuum until other agencies implement procedures. 
Ms. King opposed Dr. Baltimore's motion. She said the RAC should imple- 
ment actions which the members feel are best for the RAC. Dr. Baltimore 
reiterated his belief that adoption of an expiration deadline would 
leave aspects of industrial recombinant DNA activities, currently evaluated 
by RAC, without surveillance. Dr. Setlow called the question. The RAC 
denied Dr. Baltimore's motion by a vote of six in favor, ten opposed, and 
two abstentions. 
Ms. King moved that the principles concerning voluntary compliance approved 
by the RAC today, including any modifications voted tomorrow, be given 
to ORDA for analysis of how they can be implemented consistent with the 
Guidelines. OREA should take the necessary steps, including publication 
of language in the Federal Register , to permit the RAC to vote on imple- 
mentation of these principles at the September 1980 meeting. Dr. Novick 
asked Ms. King if the sense of the committee proposal should be forwarded 
to the Interagency Committee for its consideration. Ms. King said she 
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