determining the extent and nature of regulatory review is well 
documented, both within the federal agencies and by the comments 
and concerns of outside experts. See, e.g, "Summary: EPA 
Biotechnology Workgroup Retreat," July 31, 1985, pp. 2-3; 
"Briefing Materials" for "Briefing for Jack Moore OTS 
Biotechnology Issues," August 5, 1985 (section dealing with 
"Issue: What Commerical Products Should We Review, i.e.. What is 
'New' Under TSCA"); "OPTS Biotechnology Issues for Assistant 
Administrator Resolution," July 1985 (Draft, July 24, 1985) 
(EPA), pp. 7-9; "Review of Draft Federal Register Notice on 
Biotechnology" (Work Assignment No.: L-86-10/28-09 ) Work 
Assignment Title: Expert Review of Biotechnology Proposal, Work 
Assignment Reports (Dec. 6, 1985) (EPA) — Work Assignment Report 
by Dr. Dorothy Jones ("It is not true that genera are stable. 
. . If the terms intra- and inter-generic, which occur 
throughout the policy statement, are removed (and in my opinion 
that should be) one is left with the repetition of the rather 
clumsy 'similar' and 'dissimilar' organisms, but to my mind this 
is a better solution. It would be quite wrong to include in the 
document a statement which is just not true." (Pp. 2-3; see also 
pp. 4-8)); Work Assignment Report by Dr. Bruce R. Levin ("I 
believe that the inter- ' genus ' criteria for regulated genetic 
manipulation is, in the cases of microbes, somewhat arbitrary. . 
. . I also believe that there are problems with the pathogen, 
non-pathogen criteria for regulation" (p. 3) (and see his more 
expansive comments on the same points at pp. 5-7); Work 
Assignment Report by Dr. Daniel Simberloff ("It is odd to view 
deletion products as not having new combinations of genetic 
material. . . . [A] deletion could quite readily combine traits 
that are not normally found together." (p. 3) (and see his 
comments about the "degree of circularity in this 
[inter-intra-generic] distinction, which is the linchpin of the 
entire proposal" and that "the way around this is to emphasize 
phenotypes more." (p. 4)); Work Assignment Report of Dr. Max 
Summers (". . . it is difficult to predict how sound EPA's 
proposed policy concerning the relative hazards of inter-or 
intragenic combinations are since there is very limited 
experimental data availabe to assess this judgement in an 
environmental context. ... I think there will be many 
exceptions to the rule." (p. 1); "I would be reluctant to advise 
on the validity of EPA's proposed policy. It makes more sense 
to base the evaluation upon the nature of the gene/function/trait 
which is of question." (p. 2)); Memorandum (EPA) dated March 26, 
1985, "Subject: Comments on BSCC Definition of 'Inter-Generic 
Microorganism,' 'Pathogen' and 'Environmental Release'" from Don 
Clay, Director, Office of Toxic Substances to John A. Moore, 
Assistant Administrator for Pesticides and Toxic Substances; 
[Prepared] Testimony of Elliott A. Norse, Ph.D., Director, Public 
Affairs Office, The Ecological Society of America on The 
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