NOTICES 
33131 
noted that the Guidelines established 
an administrative framework for as- 
signing responsibility to insure safety 
in NIH-supported recombinant DNA 
research— a responsibility shared 
among principal investigators, their in- 
stitutions, and NIH. The institutions 
were required to establish biohazards 
committees to carry out institutional 
responsibilities. 
As discussed in the Final EIS, there 
were several factors contributing to 
the expectation that NIH grantees, 
contractors, and intramural scientists 
would comply with the Guidelines. 
They included the fact that noncom- 
pliance could result in the termination 
of funding; that investigators and 
their institutions share responsibilities 
for compliance; and that peer pressure 
on investigators for compliance would 
be accomplished through responsible 
institutional officers, local biohazards 
committees, and NIH review. 
The Final EIS also discussed, in re- 
sponse to commentators, general Fed- 
eral regulations of all such research to 
insure that work beyond the aegis of 
NIH would be done under the safety 
standards of the Guidelines. A Federal 
Interagency Committee, chartered by 
the Secretary of HEW with the ap- 
proval of the President, was convened 
under the chairmanship of Dr. Donald 
S. Fredrickson, Director, NIH. In 
March 1977 that committee with rep- 
resentatives of all relevant research 
and regulatory agencies recommended 
to the Secretary of HEW that legisla- 
tion be enacted to regulate all recom- 
binant DNA research. HEW Secretary 
Califano had legislation developed in 
light of the committee’s recommenda- 
tions.. An administration bill drafted 
by the Department was introduced in 
the Senate by Senator Edward M. 
Kennedy, Chairman of the Subcom- 
mittee on Health and Scientific Re- 
search of the Senate Committee on 
Human Resources, and in the House 
by Representatives Paul C. Rogers, 
Chairman of the Subcommittee on 
Health and the Environment of the 
Interstate and Foreign Commerce 
Committee. Congressional hearings 
were held, and respective committee 
bills were drafted, but not acted upon 
by Congress in its first session. New 
committee bills are pending congres- 
sional action. 
The PRG-NIH, Parts I through III, 
reflect in large measure the safety of 
many of the experiments that would 
be exempt from the Guidelines or al- 
lowed at lower containment condi- 
tions. These changes are now proposed 
following an assessment that there 
would be no significant impact on the 
environment from the proposed revi- 
sions. The changes in Part IV largely 
reflect the concerns of the environ- 
mental commentators for greater em- 
phasis on training in occupational and 
environmental safety and on explicit 
penalties for noncompliance. In addi- 
tion, measures are provided that 
would allow private-sector engagement 
with the NIH, including registration of 
recombinant DNA activities. 
To address occupational and envi- 
ronmental health and safety concerns, 
several changes are proposed in the 
implementation, review, and monitor- 
ing of recombinant DNA activities at 
the local and national levels, to insure 
appropriate safety practices and proce- 
dures that would minimize any signifi- 
cant environmental impact. These 
modifications primarily focus on a re- 
structuring and amplification of Part 
IV, “Roles and Responsibilities,” and 
an important and significantly ex- 
panded delegation of authority to 
local institutions. 
These major changes from the 1976 
Guidelines, which extend beyond the 
PRG-RAC, have resulted from a care- 
ful consideration of many comments 
received. The foremost concern during 
this process was to insure occupational 
and environmental safety, while at the 
same time refining the interdependent 
roles necessary to achieve this goal. 
Also, it was desirable to try to simplify 
and clarify administration of the 
Guidelines, as suggested by several 
commentators, thereby promoting a 
more successful application of their 
safety features. The revisions that 
have been proposed for Part IV repre- 
sent a further step toward insuring 
the safe conduct of this research and 
minimizing the possibility of any unto- 
ward environmental effects. 
In response to several requests for 
expanding the applicability of the 
guidelines, institutions receiving NIH 
funds for recombinant DNA projects 
and their “biosafety committees” (the 
propo'sed new designation for bioha- 
zards committees) are given responsi- 
bility for reviewing all recombinant 
DNA work conducted at the institu- 
tion regardless of source of funds. This 
increase in the scope of review will 
better insure the safe conduct of re- 
combinant DNA research. 
Further, biosafety committees 
(IBCs) have been given broader re- 
sponsibilities. The PRG-RAC pro- 
posed to allow the IBC’s to approve 
single-step reductions in containment 
levels in experiments with purified 
DNA or characterized clones. This is 
retained in the PRG-NIH. In response 
to other comments, however, it is 
deemed necessary to specify IBC re- 
sponsibilities for determining contain- 
ment levels required by the guidelines. 
The PRG-NIH requires the IBC’s to 
make independent evaluations of 
these containment levels. This should 
strengthen safety considerations local- 
ly. 
It was also suggested that NIH dele- 
gate to biosafety committees the re- 
sponsibility for approving or disap- 
proving, on behalf of the institution, 
proposed recombinant DNA research, 
based on their independent assessment 
of the safety standards applied, and 
that IBC approval be sufficient for the 
research to proceed. NIH, through 
ORDA, would review all local commit- 
tee actions to insure compliance with 
the guidelines, thereby maintaining 
national standards. This proposal has 
a number of advantages. It would sim- 
plify previous approval procedures and 
minimize delays due to NIH adminis- 
tration. Accountability for safe con- 
duct of the research would reside at 
the local level, with appropriate Fed- 
eral overview. 
It is believed that incorporation of 
these recommendations for increased 
local authority would enhance imple- 
mentation of the guidelines, since im- 
portant responsibilities are clarified 
and more suitably located. 
As mentioned earlier, another major 
change includes the restructuring and 
amplification of Part IV of the guide- 
lines. Publication of the Director’s de- 
cision on the 1976 guidelines, the draft 
EIS, and the PRG-RAC elicited nu- 
merous comments calling for more dis- 
cussion and information on implemen- 
tation, particularly for further clarifi- 
cation of responsibilities and roles at 
the local level. Accordingly, the con- 
tents of Part IV are presented in a 
format different from the current 
guidelines and the PRG-RAC, with 
the intent of more clearly alining the 
various duties. 
At the request of several commenta- 
tors, Appendix D, dropped from the 
PRG-RAC, has been revised and up- 
dated as "Laboratory Safety Mono- 
graph— A Supplement to the NIH 
Guidelines for Recombinant DNA Re- 
search.” It provides a compendium of 
useful safety information, including 
instructions on emergency procedures, 
laboratory techniques for biohazard 
control, and decontamination and dis- 
posal methods. Expanded to include 
complementary information on roles 
and responsibilities, it provides direc- 
tions for the operation of a biosafety 
committee, suggestions to increase the 
biological safety officer’s efficiency, 
and more detail on the elements of a 
medical surveillance program. Criteria 
for certifying biological safety cabi- 
nets illustrate the level of detail. It is 
believed that the PRG-NIH, strength- 
ened by these additions, provide a 
higher measure of protection for re- 
searchers, the public, and the environ- 
ment. 
Considerable attention has been fo- 
cused on the institutional biosafety 
committees. Commentators have 
raised questions concerning the com- 
mittees’ role, membership, and oper- 
ation. Consideration of various sugges- 
FEDERAL REGISTER, VOL. 43, NO. 146— FRIDAY, JULY 28, 1978 
[ 92 ] 
