14 
"...it seems to me that it'd be appropriate to develop criteria across 
the board with a universal standard dealing with both plant release 
and microbes." 
Mr. Rifkin said "I'm confused about a few things and I'd like some clarifi- 
cation." He noted the working group had stated that "the proposals so far 
submitted for their consideration have emitted information that is considered 
minimal and essential...." 
Mr. Rifkin said: 
"...what concerns me for today is the proposals this afternoon. One 
deals with a plant release into the environment and one deals with a 
microorganism. If it's true what this working group is saying, that 
the minimum standards — the minimum and essential standards — have not 
yet been developed to consider proposals and approval of proposals, 
then I find it hard-pressed to understand how two proposals can be 
calling up today, one for plant release and one for a microorganism, 
that have not been subjected to those minimum standards." 
Mr. Mitchell suggested Mr. Rifkin's comments were out of order at this time 
and would be more appropriate when the two proposals were considered in the 
afternoon. 
Mr. Rifkin asked when "the overall standards and procedures and protocols 
for inicroorganisms" will be submitted to the RAC for its review and approval. 
Dr. McGarrity said the "guidance document" for microorganisms was in a 
preliminary stage, but no definite time schedule could be given. 
Dr. Gottesman said Mr. Rifkin confused RAC's ability to review a proposal 
with the concept of a guidance document for submitters which tells an investi- 
gator caning to RAC with a proposal the type of information to submit. With- 
out such guidance, an investigator might overlook information RAC considers 
important; and RAC may have to send the proposal back to the investigator for 
rrore information. Dr. Gottesman said RAC has followed this later procedure in 
evaluating proposals and will continue to do so if it is not satisfied with 
the information submitted to it. Dr. Gottesman said in no situation has RAC 
voted approval of a project without concluding it had adequate information. 
Dr. McKinney agreed, citing a number of instances when requests were returned 
to the submitter for additional data. 
Mr. Rifkin asked one additional question. He said: 
"Assuming that the committee votes in favor of these recommendations 
this morning and assuming it's approved by the Director of the National 
Institutes of Health, was there any discussion in the meetings, or 
perhaps seme discussion new, about whether it would be appropriate to 
wait until there is a formal approval by the NIH before considering 
proposals that would fall under this? What I’m very concerned about 
is the wording, and maybe someone can clarify it, that said that the 
proposals — and I assume all of them — submitted so far to the group 
[467] 
