pseudorabies vaccine at Baylor College of Medicine and/or Texas A 
& M University (tests conducted by Dr. Saul Kitt and Novagene, 
Inc., with participation by USDA) in violation of the NIH 
Guidelines. See Memorandum dated October 9, 1986, from Director, 
NIGMS, to Director, NIH. It is certainly preferable to have the 
RAC-NIH review conducted before, rather than after, licensing, 
approval, and marketing of a product by another agency, as 
occurred in that instance. 
While it would be desirable that other federal agencies have 
the experience and expertise that NIH has in reviewing 
recombinant experiments, the fact is that many of them do not. 
Yet at this time, there is a growing need for such expertise. 
The proposal in question, then, is counter-productive at this 
time, for assuring adequate and timely review of proposed 
experiments. Nothing should be done at this time to encourage 
researchers to bypass the IBCs or RAC where they may well prove 
to be the most appropriate reviewing institutions. 
II. Because of the overlapping nature of the proposals in 
part II and III of the Notice, certain of the comments herein 
also refer to segments of part III. 
As a preliminary matter, each of the proposed revisions to 
Section III-A-2 of the Guidelines attempt to define "deliberate 
release" as "a planned introduction . . . into the environment." 
The difficult questions — alluded to, but not resolved in the 
publication entitled "Coordinated Framework for Regulation of 
Biotechnology," 51 Fed. Reg. 23302 (June 26, 1986) — as to when 
and under what circumstances an organism (however defined) may be 
deemed to have been introduced "into the environment" are not 
addressed in the Notice in question. The several federal 
agencies dealing with this issue may well have differing views as 
to its resolution. For example, EPA's definition of deliberate 
release for purposes of the superfund law (CERCLA) may be 
different from that deemed appropriate by NIH or USDA. 
The definition of "deliberate release" as determined by the 
meaning of the phrase "into the environment" will be of great 
significance in many instances in determining whether a 
deliberate release is involved. Inasmuch as NIH is attempting to 
coordinate its review/decision efforts with those of other 
agencies (as is reflected, for example, in proposal I in the 
Notice discussed above), and that both NIH and applicants need 
guidance as to the applicability of Section III-A-2, that 
definition is of practical importance. 
We therefore suggest that NIH address that question as part 
of its proposed amendments by developing, at this time, general 
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