2 
Mr. Mitchell, Chair, called the Working Group on Biotechnology Coordination to 
order at 9:00 a.m. on March 1, 1985. 
Mr. Mitchexl first informed the working group of the death of Dr. John Harvin, 
a Recombinant Dm Advisory Committee (RAC) rmentoer . He said he deeply regretted 
Dr. Harvin' s passing ard said the RAC had been fbrtinate in having Dr. Harvin' s 
advice and counsel. 
Mr. Mitchell said he was intent on gaining a consensus at this meeting and 
producing a document; he would, therefore, confine the discussion primarily to 
working group members although he would attempt to recognize speakers from the 
floor. 
Mr. Mitchell said this special working group had been formed to comment before 
the April 1, 1985, deadline on the December 31, 1984, Federal Register proposal 
of an oversight scheme for biotechnology (Attachment II) . Mr. Mitchell felt 
RAC, which has to date overseen development of recombinant DNA technology, 
would be remiss if it or a working group did not comment on the Federal Register 
announcement . Mr. Mitchell said RAC should contribute its experience and 
knowledge to the attempt to institute a coordinated review effort. 
Mr. Mitchell said the RAC approach to oversight of recombinant DNA technology 
has worked well; new an expanded oversight structure may be necessary because 
of the rapid pace of application of this technology. Before leaving a safe 
harbor, howsver , RAC wishes to knew the next port of call. 
Mr. Mitchell said the National Institutes of Health (NIH) RAC has an excellent 
track record and a great decil of experience yet the NIH hesitated to assume 
this additional oversight responsibility, because it is not within the scope 
of NIH's traditional responsibilities. Because of litigation and Congressional 
interest in this area, the intensity and volume of work can be an intimidating 
distraction, and the NIH has questioned whether it has the resources to deal 
with this expanded activity. 
Mr. Mitchell said the December 31, 1984, Federal Register proposed an independent 
scientific review mechanism. The advisory structure would be two-tiered, 
consisting of five agency scientific advisory committees and a Biotechnology 
Science Board. Each of five Federal agencies, the Environmental Protection 
Agency (EPA) , Food and Drug A3ministration (FDA), U.S. Department of Agriculture 
(USDA) , National Institutes of Health (NIH), and National Science Foundation 
(NSF) , would select distinguished scientists as members of these agency scientific 
advisory carmittees . The scientific advisory committees will provide detailed 
scientific review of individual applications or issues submitted by the Federal 
agencies . 
Each of the agencies will address specific areas. The RAC will continue 
to serve as the scientific advisory committee for biomedical research, operating 
under procedures specified by the NIH Guidelines for Research Involving Recom- 
binant DNA Molecules. The National Science Foundation will establish a scientific 
advisory committee to examine the potential effects of environmentally related 
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