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Federal Register / Vol. 44, No. 232 / Friday, November 30, 1979 / Notices 
major actions (i.e., that a quorum be 
13) — was passed by the RAC with 10 in 
favor, 6 opposed, and 2 abstentions. 
The RAC Was Not Adequately Prepared 
To Vote on This Issue 
One new member of the RAC felt 
there may have been inadequate 
preparation "for taking action on this 
most important issue" and that 
"important recommendation may be 
made with inadequate discussion.” 
The large quantity of background 
material supplied to RAC members 
relevant to this'and many other issues is 
burdensome Even with diligent 
preparation, a member just joining the 
RAC will find the subject matter to be 
extremely complex. In reviewing the 
record, however, I am impressed with 
the many hours the RAC spent 
discussing this proposal during its last 
two meetings, and I believe that 
members in attendance at both did not 
lack time to air their views. Moreover, 
the preparation of the RAC for 
addressing this proposal included 
assignment of the question to a sub- 
group of its members for consideration 
between the May and September 
meetings. 
The RAC is a unique type of NIH 
committee. The usual NIH public 
advisory committee system is “two- 
tiered.” At the first level, technical 
experts are assembled on initial review 
groups (study sections), where 
judgments are made on the quality of 
scientific hypotheses and the likelihood 
that they can be tested by 
experimentation. At the second level, in 
separate committees, typically 
represented by the Institute Advisory 
Councils, a broader array of talents (lay 
as well as scientific) is assembled to 
advise on the relevance of the proposed 
research to NIH programs and on other 
matters of broad public interest. Until 
December 1978, advice to NIH involving 
recombinant DNA research essentially 
followed this two-tiered model. The 
RAC served primarily as an initial 
review group providing the NIH Director 
with advice on technical issues in 
recombinant DNA research. Only two of 
its sixteen members were laymen. For 
the second level review, I used the 
Advisory Committee to the Director, 
NIH. In preparing the original 1976 NIH 
Guidelines for Recombinant DNA 
Research and in drafting the 1978 
revisions, the Director’s Advisory 
Committee members provided the 
broader public perspective. 
This was changed in a major revision 
of the Guidelines in December 1978. The 
membership of the RAC was expanded 
to include more scientific disciplines 
and more lay members. The usual dual 
review was compressed into a single 
enlarged committee. 
Procedures were also changed to 
assure opportunity for prior public 
comment on issues considered by the 
RAC. In this way, both the RAC and the 
NIH Director receive the benefit of such 
opinions in the deliberation of the 
proposals for continuing revision of the 
Guidelines. 
These changes were made to 
safeguard two vital public interests in 
the use of these remarkable techniques. 
The first interest is safety. The second 
interest is access to the benefits of the 
technology. The operations of the RAC 
determine the proper balance of these 
interests. 
I have admiration for the performance 
of the RAC. The pressures upon its 
members are great from all sides. They 
have not been stampeded, and they 
have not allowed the vital stream of 
decisions they must continuously 
provide to be obstructed. I have been 
impressed with the care that the RAC 
chairman, Dr. Jane Setlow, has taken to 
allow all points of view to be aired at 
the RAC meetings, and to continue 
discussion on each issue until all 
members have had opportunity to ask 
all the questions and make all the points 
they wished. 
Prepare an Environmental Impact 
Statement 
A number of commentators requested 
that NIH prepare an environmental 
impact statement on "the proposed 
exemption." 
As discussed in Section III— E below, I 
am not proposing an exemption for 
these experiments. An environmental 
impact assessment is contained in this 
document relative to the actions I am 
taking. 
NIH prepared an environmental 
impact statement on the original 1976 
NIH Guidelines for Recombinant DNA 
Research. In the Federal Register on July 
28, 1978, a proposed revision of the NIH 
Guidelines was published for public 
comment along with an environmental 
impact assessment. The revised 
Guidelines published in the Federal 
Register on December 22, 1978, were 
again accompanied by an environmental 
impact assessment. In that document (43 
FR 60101), I explained in detail why I 
concluded that an environmental impact 
assessment rather than an 
environmental impact statement fully 
satisfied the requirements of the 
National Environmental Policy Act of 
1969 (NEPA). 
The original environmental impact 
statement on the 1976 Guidelines (137 
pages plus extensive appendices) and 
the environmental impact assessments 
published in the Federal Register on July 
28, 1978 (182 Federal Register pages ) 
and on December 22, 1978, contain 
extensive discussions on recombinant 
DNA, physical and biological 
containment, E. coli K-12, and the NIH 
Guidelines. ^luch of what was written 
there is still highly relevant. These 
earlier environmental impact 
statements/assessments, together with 
the environmenal impact assessment 
contained in this document, in our 
judgment, fully satisfy NEPA. 
Approve the ‘Exemption " 
A number of commentators endorsed 
the exemption of all recombinant DNA 
experiments in E. coli K-12. (These 
letters were received after the 
September 6-7 meeting; many such 
letters were received earlier.) One 
commentator reported on results in his 
laboratory indicating that recombinant 
DNA is spontaneously lost from E. coli 
K-12 and that insertion of foreign DNA 
into bacteriophage lambda decreases its 
growth potential. He said, "Considering 
the loss of recombinant DNA from these 
micro-organisms during ideal growth 
conditions and considering the general 
lack of competition with wild type cells, 
I cannot conceive that E. coli K-12 
containing recombinant DNA could find 
an ecological niche outside of the 
laboratory." 
For a discussion of my proposed 
decision not to exempt all E. coli K-12 
experiments, see Section III— E below. 
Delay Any Change in the NIH 
Guidelines Pending Many More Risk- 
Assessment Experiments 
One commentator wrote, “Any 
relaxation of the NIH guidelines for 
recombinant DNA research would 
appear to be quite unjustified, since the 
surface has barely been scratched with 
regard to risk-assessment studies." A 
second commentator wrote, "This 
important decision was also premature 
in terms of the present risk assessment 
studies being carried out by NIH 
contractors.” 
The original guidelines were 
constructed to minimize the effects if 
certain imaginable risks should arise 
from recombinant DNA experiments. A 
continuing reassessment of the 
probabilities that such risks exist is a 
necessity. Society expects and deserves 
a running balance between the benefits 
of using the recombinant DNA 
techniques and their possible harm. 
When certain requirements of the 
guidelines can no longer be justified, 
they should be changed. The guidelines 
limit and make considerably more 
expensive and difficult the use of 
recombinant DNA techniques that 
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