13 
"The NIH Guidelines for Research Involving Recombinant DNA Molecules were 
original ly written to deal with NIH grantees doing biomedical research in 
the laboratory. They were subsequently adopted by other Federal agencies. 
Most of the meetings of the NIH Recanbinant ENA Advisory Canmittee (RAC) 
have been entirely open to the public. At the last RAC meeting, a portion 
of the meeting was closed (not open) to deal with a request to field test 
(not confine in the laboratory) an agricultural (not biomedical) submission 
from an industrial company (not an NIH grantee). Questions have been raised 
as to whether NIH should not redefine more circumscribed boundaries for NIH 
ard RAC oversight, and possibly encourage other Federal agencies to provide 
oversight and/or regulation beyond these boundaries. 
"I request that the followinq questions be issued for public comment, and 
placed on the agenda of the next RAC meeting. NIH would benefit frcm the 
views of the public and of the RAC before formulating an agency position 
on NIH's proper future role and steps to be taken before promulgating any 
changes from the current role. 
"1. Should the NIH Guidelines be limited strictly to work done in the 
laboratory? In this case, release to the environment including field 
tests would fall outside the jurisdiction of the Guidelines. 
"2. Should NIH accept for review only individual proposals funded by NIH or 
only proposals funded by the Federal government? In this case, revise 
of individual proposals from industry would fall outside the Guidelines. 
"3. Should all portions of all RAC meetings be open to the public? In this 
case, NIH could cease to accept any proprietary data for review and 
such would fall outside the boundaries of the Guidelines. 
"4. Should the NIH Guidelines be limited strictly to biomedical research? 
In this case, agricultural and other studies would fall outside the 
jurisdiction of the Guidelines. 
"Each of these proposals would create a new 'boundary' for the NIH Guidelines. 
It should be noted that an unusual 'boundary' already exists, since two pieces 
of ENA spliced together outside living cells constitute 'recombinant ENA' 
and fall under the Guidelines, but if the same two pieces of DNA were 
spliced together within a living cell they would not be considered recombi- 
nant DNA and, therefore, would not currently fall under the Guidelines." 
Dr. Gottesman felt that RAC and the NIH should continue their current activities. 
E^r. Amtzen suggested that NIH might take a broader view of what constitutes 
a "laboratory." He said ecologists frequently refer to a forest plot as a 
laboratory. Other members of the working group did not feel this was a feasible 
approach for all proposals. 
Dr. McGarrity asked if the working group felt RAC should restrict its review to 
NIH funded proposals. Dr. Gottesman felt RAC should review proposals from all 
sources. Dr. Arntzen pointed out that certain funding institutions are neither 
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