Federal Register / Vol. 49, No. 3 / Thursday, January 5, 1984 / Notices 
697 
2 . Amendment of Section HI- A. 
Section III— A would be amended by 
adding at the end thereof the following 
paragraph: 
A programmatic environmental impact 
statement (EIS) is required under the 
National Environmental Policy Act (NEPA), 
42 U.S.C. 4332, and the Council on 
Environmental Quality Regulations (CEQ 
Regs) implementing NEPA. 40 CFR 1502.1- 
1520.25, for the program involving deliberate 
releases into the environment of recombinant 
DNA molecules. 
Messrs. Rifkin and Rogers, in their 
submission, provide a detailed 
explanation for this proposed 
modification. 
3. Additional Amendment of Section 
IH-A. Section IJI-A would be further 
amended by adding after the material 
set forth in the prior amendment the 
following paragraph: 
Individual experiments involving 
deliberate releases into the environment of 
an organism containing recombinant DNA 
require the preparation of either an 
environmental impact statement or an 
environmental assessment 
In explanation of this proposed 
change, Messrs. Rifkin and Rogers state: 
Where it is uncertain whether a particular 
experiment may or may not have a significant 
impact on the environment then, at the least, 
an environmental assessment (EA) must be 
prepared explaining the conclusion reached 
on the question of significant impact, and the 
relevant environmental agencies must be 
involved in that assessment process. See 
CEQ Regs. §§ 1501.3. 1501.4, and 1508.9. At 
issue here are the great variety of deliberate- 
release experiments that have potential 
environmental impacts. 
D. Comments by the Director. National 
Institute of Allergy and Infectious 
Diseases, on the Amendments Proposed 
by Messrs. Rifkin and Rogers 
The NIH Recombinant DNA Advisory 
Committee (RAC) does not have the 
responsibility to determine, and it is not 
appropriate for the NIH Guidelines for 
Recombinant DNA Research to state, 
what is, or is not, required by the 
National Environmental Policy Act 
(NEPA) (42 U.S.C. 4321 et seq.) and the 
regulations (40 CFR Part 1500) 
promulgated by the Council on 
Environmental Quality (CEQ) to assure 
the uniform implementation of that Act. 
It is not the function of the RAC to 
determine what NEPA and the CEQ 
regulations require. The RAC is not 
constituted to interpret points of law 
and the requirements of NEPA. 
Specifically, it is not a function of RAC 
to determine when an environmental 
impact statement or an environmental 
assessment is required by NEPA. 
Furthermore, the Foundation on 
Economics Trends, Jeremy Rifkin, 
Michael W. Fox, Environmental Action, 
Inc., and the Environmental Task Force 
have raised these issues in a lawsuit 
against the Department of 1 leal th and 
Human Services, the National Institutes 
of Health, and the' National Institute of 
Allergy and Infectious Diseases. The 
suit (Civil Action No. 83-2714) seeks to 
have the United States District Court for 
the District of Columbia decide if 
additional environmental review is 
required by NEPA and the CEQ 
guidelines with respect to the 
procedures in the Guidelines for NIH 
approval of releases into the 
environment of organisms containing 
recombinant DNA and specific 
approvals given under those procedures. 
The decision of the District Court, or a 
higher court if an appeal is taken, will 
be binding on all the parties. 
It should also be noted that a proposal 
similar to that now proposed by Messrs. 
Rifkin and Rogers was considered and 
rejected by the Director, NIH, at the time 
of the revision of the NIH Guidelines in 
December 1978. NIH Director Donald 
Fredrickson wrote in the Federal 
Register (43 FR 60083, December 22, 
1978), "Another commentator urged that 
for waiver of the prohibition of 
deliberate release into the environment, 
the Guidelines explicitly require 
compliance with the National 
Environmental Policy Act (NEPA) and 
any additional safeguards to be 
stipulated by EPA. Others urged that full 
Environmental Impact Statements be 
filed on most exceptions to the 
prohibitions. As 1 noted in my Decision 
accompanying the PRG on July 28, 1978, 
all waiver decisions will include a 
careful consideration of the potential - 
environmental impact. Some decisions 
may be accompanied by a formal 
assessment or statement — a 
determination, however, that can only 
be made on a case-by-case basis.” 
II. Questions Concerning Boundaries for 
NIH and RAC Oversight 
Dr. Bernard Talbot, Deputy Director of 
the National Institute of Allergy and 
Infectious Diseases, has requested that a 
series of questions be issued for public 
comment and placed on the agenda for 
the next RAC meeting. He wrote: 
The NIH Guidelines for Research Involving 
Recombinant DNA Molecules were originally 
written to deal with NIH grantees, doing 
biomedical research, in the laboratory. They 
were subsequently adopted by other Federal 
agencies. Most of the meetings of the NIH 
Recombinant DNA Advisory Committee 
(RAC) have been entirely open to the public. 
At the last RAC meeting, a portion of the 
meeting was closed (not open) to deal with a 
request to field test (not confine in the 
laboratory) an agricultural (not biomedical) 
submission from an industrial company (not 
an NIH grantee). Questions have been raised 
as to whether NIH should not redefine more 
circumscribed boundaries for NIH and RAC 
oversight, and possibly encourage other 
Federal agencies to provide oversight and/or 
regulation beyond these boundaries. 
I request that the following questions be 
issued for public comment, and placed on the 
agenda of the next RAC meeting. NTH would 
benefit from the views of the public and of 
the RAC before formulating an agency 
position on NIH's proper future rule and steps 
to be taken before promulgating any 
changes form the current role. 
1. Should the NIH Guidelines be limited 
strictly to work done in the laboratory? In 
this case, "release to the environment" 
including field tests would fall outside the 
jurisdiction of the Guidelines. 
2. Should NIH accept for review only 
individual proposals funded by NIH or only 
proposals funded by the Federal government? 
In this case, review of individual proposals 
from industry would fall outside the 
Guidelines. 
3. Should all portions of all RAC meetings 
be open to the public? In this case, NIH could 
cease to accept any proprietary data for 
review and such would fall outside the 
boundaries of the Guidelines. 
4 . Should the NIH Guidelines be limited 
strictly to biomedical research? In this case, 
agricultural and other studies would fall 
outside the jurisdiction of the Guidelines. 
Each of these proposals would create a 
new "boundary” for the NIH Guidelines. It 
should be noted that an unusual "boundary" 
already exists, since two pieces of DNA 
spliced together outside Living ceils constitute 
“recombinant DNA" and fall under the 
Guidelines, but if the same two pieces of 
DNA were spliced together within a living 
cell they would not be considered 
"recombinant DNA" and, therefore, would 
not currently fall under the Guidelines. 
III. Request for Permission to Lower 
Containment Conditions for the Cloning 
of the Gene for Shiga-Like Toxin From 
E. Coli 
Dr. Alison O’Brien of the Uniformed 
Services University of the Health 
Sciences (USUHS) requested 
permission, in collaboration with Dr. 
Randall Holmes (USUHS), to clone in 
Escherichia coli K-12 the structural 
gene of the Shiga-like toxin from 
clinically isolated strains of E. coli. The 
E coli. Shiga-like toxin has activity 
similar to the activity of Shigella 
dysenteriae toxin. The investigators 
proposed to clone the Shiga-like toifln 
gene in E. coli EKl host-vector systems 
using plasmid, cosmid, or lambda 
cloning vectors. In support of their 
proposal, Drs. O'Brien and Holmes 
offered the following arguments: 
1. Clinical isolates of E coli have 
already been demonstrated to elaboraie 
large amounts of toxin indistinguishable 
from that produced by Shigella 
dysenteriae 1 (Shiga). Therefore, the 
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