60102 
NOTICES 
cepted, and assesses at some length 
the anticipated environmental effects 
of the changes NIH proposed to make. 
In my view the EIA represents a con- 
scientious. thoughtful, and thorough 
effort to carry out our responsibilities 
under NEPA. As one correspondent 
noted, the assessment is a "thorough 
and fully documented analysis * * * 
that describes the technical aspects of 
this research and its conjectural risks 
and benefits.” The EIA took a "hard 
look" at the current Guidelines, the 
various alternatives, and the environ- 
mental implications of the proposed 
changes. By soliciting public comment 
and conducting a public hearing, rele- 
vant areas of environmental concern 
were identified. I believe that a con- 
vincing case is made in the EIA that 
the proposed changes would have no 
significant environmental impact. 
My Decision accompanying these 
final Guidelines reviews at some 
length exemptions from the Guide- 
lines in light of the comments made 
by correspondents and witnesses. And 
indeed, a lengthy analysis of the list of 
exempt organisms in Appendix A doc- 
uments the prudence and caution in 
which NIH is proceeding. On the basis 
of comments, the list has been modi- 
fied and the scope of experiments re- 
stricted. 
It was also asserted by witnesses 
that the filing of an EIS would provide 
for public Input in the Government's 
decisions affecting the environment. 
In my view. NIH's overall response to 
the issues raised by recombinant DNA 
research has been to ensure a full' 
public hearing of all issues. When 
these issues first arose. NIH conducted 
public hearings, solicited public com- 
ment. developed Guidelines, and pub- 
lished an EIS. which ultimately re- 
ceived judicial approval. 
Since that time scientific evidence 
has shown that the Initial concerns 
about the hazards of this research 
may have been exaggerated. Accord- 
ingly. we proposed to relax some as- 
pects of the Guidelines. In doing so. 
we again conducted hearings and solic- 
ited public comment. And the NIH- 
propostd revised Guidelines were pub- 
lished for comment, followed by a 
hearing under the aegis of a DHEW 
committee chaired by Peter Libassi. 
the DHEW General Counsel. In addi- 
tion. all of the proceedings and all doc- 
uments have been published in an on- 
going series of volumes that document 
the basis for NIH policies. The docu- 
ments contain relevant proceedings of 
the executive, legislative, and judicial 
branches. A fourth volume will be pub- 
lished in January containing the tran- 
script of the September 15. 1978. hear- 
ing. all correspondence received by 
NIH commenting on the proposed 
Guidelines of July 28. 1978, and all 
other relevant documents. 
RISK ASSESSMENT 
Several witnesses raised issues con- 
cerning the concepts of risk and safety 
as outlined in the Environmental 
Impact Assessment (EIA). One witness 
emphasized the concept of risk as "a 
relatively objective measurement of 
hazards” and safety as “a subjective 
expression of the level of risk which is 
acceptable to a population." He be- 
lieves the NIH Guidelines and Assess- 
ment confuse these two concepts. The 
Guidelines, in his view, do not provide 
adequate institutional mechanisms to 
ensure that the value issues involved 
in safety are thoroughly aired by the 
general public. Thus, because safety is 
"value-laden, subjective, and in a 
sense, political," the Guidelines must 
reflect these values by ensuring ade- 
quate mechanisms for determining 
safety standards and their implemen- 
tation. 
The October 1977 EIS on the origi- 
nal NIH Guidelines and the July 1978 
EIA on the proposed revisions address 
in great detail occupational and envi- 
ronmental health and safety concerns. 
As noted in the EIA (Federal Regis- 
ter. p. 33131, middle column), several 
changes are proposed In the revised 
Guidelines "in the Implementation, 
review, and monitoring of recombinant 
DNA activities at the local and nation- 
al levels, to insure appropriate safety 
practices and procedures that would 
minimize any significant environmen- 
tal Impact." 
These modifications focus on a re- 
structuring of roles and responsibil- 
ities. The applicability of the Guide- 
lines has been extended to all recom- 
binant DNA reseach at Institutions 
that receive any recombinant DNA re- 
search support from NIH. Biosafety 
committees have been given broader 
responsibilities. At the request of sev- 
eral commentators. Appendix D to the 
original Guidelines has been revised 
and updated as Laboratory Safety 
Monograph— A Supplement to the NIH 
■ Guidelines. The monograph is a com- 
pendium of useful safety Information, 
including Instructions on emergency 
procedures, laboratory techniques for 
biohazard control, and decontamina- 
tion and disposal methods. It provides 
much detail on the responsibilities of 
the local institution for safety prac- 
tices and procedures. The impact of 
these actions and the restructuring of 
part IV of the Guidelines will be the 
promotion of safer conduct of this re- 
search. affording a greater measure of 
protection to the environment, with 
emphasis on occupational health and 
safety. 
Several commentators also urged 
NIH to initiate and fund a comprehen- 
sive risk -assessment program to pro- 
vide a scientific basis for defining ap- 
propriate containment requirements 
for recombinant DNA experiments. 
The DHEW Committee reviewed NIH 
efforts in this regard. It was noted 
that recombinant DNA research ex- 
periments provide a great deal of in- 
formation on risks. In addition. NIH is 
supporting a number of studies in risk 
assessment. The participants at the 
Falmouth Conference* recommend 
studies in six areas, and NIH is follow- 
ing up on those recommendations. 
The Rowe-Martin polyoma experi- 
ments are discussed in the Decision 
Document. In addition, intramural 
NIH scientists are collaborating with 
scientists from other institutions in 
testing the virulence in mice of E. eoli 
K-12 containing "shotgun clones” of 
recombinant DNA derived from other 
species. 
A number of contractors of the Na- 
tional Institute of Allergy and Infec- 
tious Diseases are testing the biologi- 
cal containment capabilities of various 
derivatives of E. coli K-12. Some are 
testing the survival and capacity of 
plasmid and phase vectors to be trans- 
mitted to secondary bacteial hosts in 
the gastrointestinal tract of man and 
mouse. Others are assessing these pa- 
rameters in model sewage treatment 
systems and in situations simulating 
accidental spills and other types of ac- 
cidental release of the organisms for 
experimental procedures. 
In addition, invistigators proposing 
systems to be certified by NIH as HV1 
or HV2 must perform certain specified 
tests on these systems relevant to 
their survival and transmission proper- 
ties. It is also anticipated that if inves- 
tigators seek exceptions to the prohi- 
bitions for specified clones. NIH will 
request substantial risk-assessment ex- 
periments to be performed to evaluate 
claims of safety. 
Another commentator noted that 
Dr. Sidney Brenner of the Medical Re- 
search Council's Laboratory for Molec- 
ular Biology in Cambridge. England, 
had stated that he believed the whole 
method of risk-assessment up to now 
is "fragmentary” and that what is 
needed is a "more systematic ap- 
proach.” which he was trying to take. 
Dr. Brenner, when asked for more in- 
formation on his studies, explained 
that the method of risk-assessment he 
referred to is not a new experimental 
approach but a new analytical ap- 
proach. Dr. Brenner’s work will be fol- 
lowed closely for any new information 
that sheds light on potential risks or 
safety of experiments under the 
Guidelines. 
SOCIAL ETHICS 
A witness at the September 15th 
hearing noted that "the steps taken to 
insure containment are of great imme- 
diate importance and the present 
guidelines should be continued.” But 
•See Journal of Infectious Diseases. 
137:704- 708, May 1978 
FEDERAL REGISTER, VOL 43. NO. 347— FRtOAY DECEMBER 23, 1978 
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