7 
PART II - MEETING OF THE SUBCOMMITTEE ALONE 
Report from NIH 
Dr. Talbot reported that at the June 5-6 meeting of the NIH Recombinant 
DNA Advisory Committee (RAC), the item which took the greatest amount of 
time--many hours over the two days of the meeting--was a consideration of 
modification of procedures for reviewing requests to exceed 10-liters in 
volume. These are primarily requests voluntarily submitted by industry. 
Dr. Fredrickson, the NIH Director, spoke to the Committee at the 
beginning of the. meeting. He said he was sympathetic to the unease of many 
RAC members about their role. He felt the RAC should continue to look at 
biological containment in such proposals but might consider no longer 
reviewing the details of physical containment. (Dr. Fredrickson asked 
that copies of the introductory remarks he made at the RAC meeting be given 
to this Subcommittee. They were distributed, and are appended as Attachment J). 
After hours of deliberation on this issue, the RAC voted 17 to 0, with one 
abstention, to publish the following statement in the Federal Register , for 
public comment, to be reconsidered by the RAC at its next (September 25-26) 
meeting: "For approval of requests to grow greater than 10-liters of 
organisms containing recombinant DMA: RAC will determine if a given recombinant 
DNA-containing strain is 'rigorously characterized and the absence of harmful 
sequences established.' Such a determination shall include specification of 
a containment level (P-LS). These determinations should not in any way be 
construed as RAC certification of safe laboratory procedures for industrial 
scale-up. Adherence to the specified containment conditions is the responsibility 
of the local I3C." 
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