16 
Dr. Gartland said the NIH is intending to propose in a Federal Register 
announcement that the NIH will not review proposals being reviewed by other 
agencies. He pointed out, however, that the Cabinet Council in its proposal 
' for coordinating review of biotechnology prcposals has indicated a proposal 
may be reviewed by more than one review group. He thought Dr. Miller's concerns 
would be addressed by these activities. 
i 
Dr. Miller said he wanted his proposal on the record. 
j Dr. Levin felt Dr. Miller's proposal was outside of the purview of the Working 
Group on Release into the Environment. He also questioned hew RAC would determine 
the review being conducted by another agency was adequate. 
Dr. McGarrity said Dr. Miller's proposal would require a revision of the NIH 
Guidelines. He said RAC procedures for amending the Guidelines would have to 
be followed; therefore, the language proposed by Dr. Miller could not at this 
time be added to the working group points to consider document. 
Dr. Miller said the working group could indicate support for the concept that 
working group reviews should not duplicate reviews performed by another agency. 
Dr. Gartland pointed out that the FDA supports the December 31, 1984, Federal 
Register . He questioned why Dr. Miller was preposing an action which might 
contravene that Federal Register notice. 
Dr. Mazza agreed the Working Group on Release into the Environment was not the 
appropriate forum to discuss this issue. He felt the Cabinet Council Working 
Group was reviewing such issues; and he did not think the working group should 
attempt to bias that process. 
Dr. Tolin noted the points to consider document is an attempt to offer guidance 
to investigators who wish to submit proposals for review. All the considera- 
tions included in the document are of a scientific nature. This document will 
be useful to any group in any agency reviewing field testing of modified micro- 
organisms. 
Dr. McGarrity noted that two more items remained on the working group agenda. 
He suggested the working group follcw one of two alternatives: (1) the working 
group could vote on Dr. Miller's proposal; or (2) the working group cculd 
suggest Dr. Miller officially notify OREA by letter of his concerns. 
I The working group voted on the proposal offered by Dr. Miller. By a vote of 
j three in favor, five opposed, and four abstentions, the working group refused 
j the motion offered by Dr. Miller. 
! Dr. McGarrity said the points to consider document would be published in the 
Federal Register for thirty days of public ccrrment and presented to the RAC at 
the May 3, 1985, meeting. 
[ 311 ] 
i 
