26 
footnote one and in item (5) in the Introduction) as a current working 
document, republish it for cement, and consider it again at the next PAC 
meeting. 
By a vote of twenty in favor, none opposed, and one abstention, the RAC 
accepted the motion. Mr. Daloz abstained. 
VIII. PROPOSAL FOR A COORDINATED FRAMEWORK FOR REGULATION OF BIOTECHNOLOGY 
Mr. Mitchell said this agenda item (tabs 1208, 1211) addresses a proposal 
for a coordinated framework for regulation of biotechnology. The 
Decerrber 31, 1984, Federal Register proposed a review mechanism for the 
oversight of biotechnology. The notice stated its purpose was to provide 
a concise index of U.S. laws related to biotechnology, to clarify the 
policies of the major regulatory agencies involved in reviewing research 
and products of biotechnology, to describe a scientific advisory mechanism 
for assessment of biotechnology issues, and to explain how the activities 
of the Federal agencies in biotechnology will be coordinated. 
Mr. Mitchell said a special working group, the RAC Working Group on Biotech- 
nology Coordination, had been formed to ccrrment on the December 31, 1984, 
Federal Register notice. Mr. Mitchell, Chair of the Working Group on 
Biotechnology Coordination, constituted the group because the deadline for 
comment on the Federal Register proposal was April 1, 1985, vhile the 
next RAC meeting was May 3, 1985. He said the working group met for one 
day and attempted to offer some suggestions and observations. 
Mr. Mitchell said several major points 'were made by the working group. 
For nearly ten years the NIH Guidelines have been the sole standard for 
the oversight of reccmbinant D1PV experiments. Not only have scientists 
and industrial concerns in this country followed these NIH Guidelines, but 
other countries have adopted them as national standards. In addition, 
localities in the U.S. have based ordinances on the NIH Guidelines. The 
working group questioned how the proposal would affect countries and muni- 
cipalities which have adopted the NIH Guidelines. 
Mr. Mitchell said another concern was how the December 31, 1984, proposal 
would affect the flexibility of the NIH Guidelines. Until this time, RAC 
and NIH have had authority to modify the NIH Guidelines as Knowledge accumu- 
lated. The working group feared such flexibility might be lost under the 
December 31, 1984, proposal. 
Mr. Mitchell said the working group also expressed concern about public 
participation. The group asked whether the proposed advisory ccrrmittees 
which would be established in other agencies would have public members and 
to what extent these members would participate meaningfully. In addition, 
in order for public confidence to be maintained, agency discussions should 
be open to public scrutiny. If the subject matter is fragmented between 
five different agencies, vbere would the public go to participate in 
discussions? 
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