Federal Register / Vol. 50. No. 72 / Monday. April 15. 1985 / Notices 
14795 
under NEPA and the CEQ regulations." 
The NIH is initiating such a 
consideration and hereby requests 
comments on whether a programmatic 
E1S is required to fulfill NIH’s 
obligations under NEPA and the CEQ 
regulations- in connection with NIH 
approvals of proposals to release into 
the environment organisms containing 
recombinant DNA. The following 
information is provided to assist the 
public in commenting on this issue. 
A. When is a Programmatic EIS 
Required? 
In its decision of February 27, 1985, (p. 
30 of the Slip Opinion ) the Court of 
Appeals quoted a definition of a 
programmatic EIS from one of its 
previous decisions: 
A programmatic EIS reflects the broad 
environmental consequences attendant upon 
a wide-ranging federal program. The thesis 
underlying programmatic EISs is that a 
systematic program is likely to generate 
disparate yet related impacts. * * * Whereas 
the programmatic EIS looks ahead and 
assimilates 'broad issues' relevant to (the 
program), the site-specific EIS addresses 
more particularized considerations * * *. 
Nat 7 Wildlife Federation v. Appalachian 
Regional Comm 'n, * * * 677 F.2d at 888. 
The Court of Appeals also referred 
(pp. 39-31 of the Slip Opinion ) to criteria 
for determining when a programmatic 
EIS should be prepared: 
Under CEQ regulations a programmatic EIS 
should be prepared if actions are 'connected.' 
'cumulative.' or sufficiently 'similar' that a 
programmatic EIS Is 'the best way' to identify 
the environmental effects. 40 CFR § 1508.25. 
As this court has noted. Two considerations 
are especially helpful in reviewing the 
responsible officials' decision not to prepare 
a programmatic EIS: (a) Could the 
programmatic EIS be sufficiently forward 
looking to contribute to the decisionmakers’ 
basic planning of the overall program? and 
(b) Does the decisionmaker purport to 
'segment' the overall program, thereby 
unreasonably constricting the scope of * * * 
environmental evaluation?' Nat 'I Wildlife 
Federation v. Appalachian Regional Comm'n. 
* 677 F.2d at 889. Thus a programmatic 
EIS should be prepared if it can be forward- 
looking and if its absence will obstruct 
environmental review. 
B. Field Tests Approved by NIH 
To date, NIH has approved three field 
tests of organisms containing 
recombinant DNA. One involved tomato 
and tobacco plants. When this was 
reviewed by the NIH Recombinant DNA 
Advisory Committee (RAC) on October 
25. 1982. the statement was made that 
“the probability that the experiment 
would be successful is very low." In 
fact, the researcher found that the 
experiment did not succeed under 
laboratory conditions, and therefore for 
scientific reasons he does not wish to 
proceed with the field test. 
This leaves only two cases of NIH 
approval for field tests of organisms 
containing recombinant DNA in which 
the investigators wish to proceed. One is 
the Lindow-Panopoulos experiment 
involving ice-nucleation-minus bacteria 
on which the January 21. 1985. EA- 
FONSI was prepared. The other, from 
Dr. Ronald Davis of Stanford University, 
involves com plants ( Zea mays) 
transformed with com DNA. The 
environmental concerns raised by these 
two proposals are totally different and 
can only be meaningfully considered 
individually through an evaluation of the 
specific details of the proposed field test 
and the characteristics of the organisms 
proposed to be released, including their 
ecological niche, pathogenicity, viability 
and ability to escape from the field test 
site. 
C. N/H's Role in the Approval or 
Disapproval of Proposals for the 
Release into the Environment of 
Organisms Containing Recombinant 
DNA 
The Federal action for purposes of 
NEPA and the CEQ regulations is 
reviewing proposals for deliberate 
release experiments submitted to NIH 
by institutions which receive NIH funds 
for recombinant DNA research. There is 
no Federal program for the planning, 
conduct, and support of deliberate 
release experiments: there is only a 
Federal requirement that deliberate 
release experiments by NIH-funded 
institutions be approved by NIH. 
This Federal requirement does not 
involve federally planned or initiated 
actions that are directed toward a 
particular objective. Proposals are 
submitted by different researchers from 
different fields at undetermined times 
for quite different experiments. Of the 
three proposals approved to date, two 
were not funded by NIH. They were 
submitted for approval because the 
institutions proposing to conduct the 
field tests received some NIH funds for 
recombinant DNA research. 
The NIH’s Guidelines are not "aimed 
at developing new technology which, 
when applied, will affect the 
environment." Rather, the Guidelines 
are aimed at scrutinizing the 
development of technology to ensure the 
safety of that development. In the course 
of this scrutiny of proposals for the field 
testing of organisms containing 
recombinant DNA. NIH has not 
identified any common environmental 
effect which could arise for the field 
tests that have been approved by NIH 
thus far. 
The NIH does not know what 
proposals for deliberate release 
experiments may be submitted for 
approval in the future since most of the 
experiments are investigator initiated 
and are not planned by NIH. 
D. NlH’s Future Role in the Review and 
Approval of Proposals for the Deliberate 
Release Into the Environment of 
Organisms Containing Recombinant 
DNA 
Until recently, the NIH was the only 
Federal agency reviewing and approving 
proposals involving the deliberate 
release Into the environment of 
organisms containing recombinant DNA. 
That is no longer the case. 
(1) On October 17. 1984, the 
Environmental Protection Agency (EPA) 
published in the Federal Register (49 FR 
40659) and Interim Policy on Small Scale 
Field Testing of Microbial Pesticides 
which requires notification to EPA of 
proposed field tests involving certain 
microbial pesticides after which EPA 
will determine whether an Experimental 
Use Permit is required. 
Advance Genetic Sciences, Inc. 
(AGS), had previously voluntarily 
submitted a proposal for NIH review 
and approval dealing with a field test of 
Pseudomonas strains containing 
recombinant DNA. The NIH gave notice 
of the upcoming review (49 FR 17672, 
April 24, 1984), and the proposal was 
considered at the June 1. 1984, RAC 
meeting. The NIH still had the proposal 
under review when AGS in a letter of 
February 11. 1985. withdrew the 
proposal from the NIH review process, 
deciding to rely only on EPA review 
under the October 17, 1984, Federal 
Register notice. 
(2) On December 31, 1984, the Office 
of Science and Technology Policy 
published in the Federal Register (49 FR 
50856) for public comment a Proposal for 
a Coordinated Framework for 
Regulation of Biotechnology. It includes 
a proposal to establish agency-based 
scientific advisory committees modelled 
after the NIH RAC in four other agencies 
(EPA. the Food and Drug Administration 
(FDA), the Department of Agriculture 
(USDA) and the National Science 
Foundation (NSF)). 
If this new scientific advisory 
structure is established, proposals for 
deliberate release of organisms 
containing recombinant DNA that would 
have previously come to NIH for review 
and approval may go instead to EPA, 
USDA or NSF. 
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