UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 
WASHINGTQN. D.C. 20460 
SEP 2 4 1986 
Mr. Robert E. ’Mitchell pc$nc 'Of* AND TOXIC SUBSTANCES 
Attorney at Law 
13915 San Antonio Drive 
Norwalk, CA 90650 
Dear Mr. Mitchell: 
The U.S. Environmental Protection Agency (EPA) has received 
an announcement (51 FR 29423) of the proposed actions to be 
considered by the National Institutes of Health (NIH) Recombinant 
DNA Advisory Committee (RAC) at its September 29, 1986, meeting, 
and would like to take this opportunity to comment. The proposed 
amendment to Section III-A-2 (dealing with release to the 
environment) of the NIH Guidelines for Research Involving 
Recombinant DNA Molecules is of interest to EPA, as would be 
discussions of environmental release definitions and the 
applicability of the Guidelines to products released to the 
environment (discussed at the September 5, 1986, meeting of 
the RAC Working Group on Definitions). 
The purposes of this letter are: (1) to indicate that 
several EPA regulatory policies became immediately effective 
with publication of the June 26, 1986, Federal Register (51 FR 
23313); (2) to describe the role of the EPA Biotechnology 
Science Advisory Committee (BSAC) in addressing environmental 
release issues similar to those currently being considered by 
the RAC; and (3) to suggest that the RAC and the BSAC coordinate 
their activities rather than make independent recommendations 
on science issues of mutual concern. 
As you know, EPA is forming a Biotechnology Science Advisory 
Committee (BSAC) as described in the federal government's 
coordinated framework for biotechnology. The membership of 
this committee will soon be announced. Nine scientists and 
two public representatives will form the committee. The scientists 
are experts in molecular biology and genetics, marine and 
terrestrial microbial ecology, pathology, epidemiology, community 
ecology, and microbial systematics. The committee is thus 
well suited to consider laboratory and environmental issues 
associated with the development of microbial products of 
biotechnology. 
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Recombinant DNA Research, Volume 1 1 
