7 
Dr. McKinney suggested the document's preamble should indicate Institutional 
Biosafety Committees (IBCs) review and approve of submissions prior to RAC 
review. Dr. Gottesman did not agree that prior IBC review should always 
be required. Dr. MoGarrity also questioned whether IBC review should be 
required prior to RAC review. He said RAC and its working group might 
possess broader expertise than a loaal committee, and the IBC might wish to 
wait until they had the benefit of RAC review before approving a proposal. 
Mr. Mitchell recognized Mr. Lee Rogers the legal counsel of the Foundation 
on Economic Trends. 
Mr. Rogers said the document prepared try the Working Group on Release into 
the Environment does not constitute an environmental assessment on deliberate 
release experiments and does not bring NIH into compliance with the tbtional 
Environmental Policy Act on deliberate release experiments. He said "an 
environmental assessment would have to discuss alternatives to the deliberate 
release experiments to be an environmental assessment on deliberate release 
experiments." He said the working group document contains no discussion 
of "alternative modes of analysis or alternative contained experiments 
that would provide all or some part of the data that would be attained 
with actual field experiments." 
Mr. Rogers aided that the working group document: 
"...fails to... call for procedures for assessing the data that's to be 
collected. That is, this document does not call for ary scientific 
protocols that would enable the NIH to ascertain, minimize, the risk 
of deliberate release experiments." 
Mr. Rogers said the working group document did not include standards of 
expertise, personnel, or quality of required data; and reviews are "con- 
ducted without any such standards of either quality or quantity in these 
areas and instead are informed, entirely on a case-by-case basis, without 
structure and assurance of requisite interdisciplinary expertise." 
Mr. Rogers also contended the working group document: 
"...does not provide sufficient evidence and analysis for determining 
whether or not to prepare an environmental impact statement or a finding 
of no significant impact, either as to deliberate release experiments 
generally or for individual experiments." 
Mr. Rogers said the language in the working group document which states 
"results frcm preliminary field tests will be the best test for unexpected 
consequences" acknowledges a failure to develop a predictive ecology to date. 
Mr. Rogers believed a science of predictive ecology could be developed. He 
also believed field testing could be simulated in contained systems, and 
asked the committee to "wrestle with" this issue. 
Mr. Mitchell asked Mr. Rogers to clarify his definition of the word "alter- 
native." Mr. Rogers said the word "alternative," meant "alternatives to 
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