The first meeting of the BSAC will be held in November 
1986. Among the issues to be discussed at that meeting are 
definitions of environmental release and containment. These 
subjects are critical to EPA's current role in oversight of 
releases of certain microorganisms, and the Agency is 
addressing these issues at thi6 time because of their direct 
impact on the policies that became immediately effective with 
the publication of the June 26 biotechnology policy statement 
(51 FR 23313). Some of these issues are also central to the 
rules EPA will soon propose concerning the Agency's approach 
to regulation under the Toxic Substances Control Act. 
Because of the mutual interest of EPA and NIH, we propose 
that the RAC and the BSAC coordinate their efforts on the 
very difficult technical problems in the area of environmental 
release. We believe that a coordinated approach using the 
expertise of the two committees will result in a scientifically 
better, clearer, and more efficient resolution of complex 
scientific Issues than if the committees work separately. 
In particular, we believe that the strong ecological expertise 
of the BSAC will significantly contribute to the quality of 
recommendations concerning environmental releases of 
microorganisms. In addition, a coordinated approach involving 
these two committees would be consistent with a basic principle 
underlying the federal biotechnology regulatory policy: 
that agencies work together to develop definitions that are 
critical to their mutual oversight activities. 
In light of these considerations, we would like to ask 
the RAC to consider postponing making a recommendation to 
the Director of the NIH concerning changes in the NIH Guidelines 
which would affect oversight of deliberate releases of 
microorganisms to the environment. In making such a request, 
we do not mean to imply or suggest that discussion of the 
issues should be postponed. 
Please call if you have any questions concerning this 
letter. We look forward to working with you and the RAC on 
these challenging issues. 
Sincerely yours 
l 
John A. Moore 
Assistant Administrator 
for Pesticides 
and Toxic Substances 
Recombinant DNA Research, Volume 1 1 
[225] 
