4 
RAC would subsequently review the proposal and the IBC statements. In this 
way, proposals would not bounce back and forth between RAC and the IBC. 
Dr. Gottesman said an investigator might not have to return to the NIH following 
RAC review; the NIH would set minimal requirements and would respect the right 
of the local IBC to impose additional constraints. 
Dr. Pramer asked how an investigator might handle the situation where one body 
approved of the proposal but the other body did not. Dr. Clowes said the IBC 
and the NIH each have veto authority. Dr. Pirone said proposals which do not 
receive both IBC and NIH approval would require a great deal more consideration. 
Dr. Sharpies moved that the following sentence be added to the first paragraph 
of the preamble: 
"The IBC is expected to make an independent evaluation, although this 
evaluation need not occur before consideration of an experiment by the 
RAC. " 
Dr. Gottesman thought the language offered by Dr. Sharpies clarified the issues 
and suggested it be added to the first paragraph of the preamble . 
Dr. Max Marsh of Eli Lilly and Company said the IBC could also review 
proposals and ascertain that appropriate information is included in the proposal. 
Dr. Gartland explained that this system was used during the period when RAC 
was reviewing large-scale applications involving recombinant organisms. He 
said most RAC reviews are currently unhinged from IBC re/iew; RAC in general 
is not informed of IBC decisions. 
Dr. Clcwes asked if the Working Group on Release into the Environment would 
review proposals involving field testing prior to RAC review. Dr. Gottesman 
said it would be useful to have some group lock at the proposal before it is 
sent to RAC for final review. She thought the sequence of review might be an 
issue for the working group to discuss in the future. 
Dr. Levin asked if NIH approval of a specific field testing project extends to 
all sites the investigator might wish to consider for testing. Dr. McGarrity 
said approval is specific for the site; if the investigator washes to test 
in a different site, the proposal writh a detailed description of the new 
site must be submitted to the NIH for review. 
By a vote of nine in favor, none opposed, and one abstention, the working group 
approved Dr. Sharpies' notion. 
Dr. McOarrity asked if other general comments could be made on the document. 
Dr. Pimentel suggested Section IV- A, Conditions of the Trial , should request 
information on the ecological effects of the modified organism on target and 
non-target organisms. He also suggested a new Section IV-E requiring the inves- 
tigator to describe procedures for evaluating the effect of the modified organism 
on target and non-target plants and other species be added to the document. 
Dr. Lacy felt this concept was cil ready stated under Section IV-B. Dr. Pimentel 
said Section IV-B does not clearly indicate when monitoring is to be performed. 
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