played a lead role in working with pri- 
vate industry leading to the agreement 
of relevant industries to abide by the 
safety standards of the NIH guide- 
lines. 
Many of the services provided by the 
NIH to its grantees and contractors 
had not been extended to the private 
sector. After carefully considering the 
comments at the public hearing and in 
correspondence received. I now believe 
the NIH should extend certain ser- 
vices to the private sector in several of 
the areas suggested by the commenta- 
tors. A new section has been added to 
Part IV that provides the opportunity 
for private industry participation in a 
voluntary fashion. If legislation is en- 
acted, the NIH Guidelines will serve as 
the basis for regulation that will en- 
compass the private sector. 
Occupational and Environmental 
Safety. A key concern of all commenta- 
tors was the need for programs in oc- 
cupational and environmental safety, 
that would include health surveillance 
for laboratory personnel and the com- 
munity. As I stated in my Decision in 
1976, the NIH has a special responsi- 
bility for national leadership in pro- 
grams for laboratory safety. This re- 
sponsibility is a critical one and we 
must accept it. Recombinant DNA re- 
search policies have stimulated a 
broad NIH commitment and interest 
in laboratory safety. The PRG-NIH 
reflects that commitment. As previous- 
ly described, there are several training 
programs that the NIH has undertak- 
en and supported. Several NIH com- 
mittees are involved in development of 
policies in this area. The newly updat- 
ed and expanded supplement to the 
PRG-NIH entitled, “Laboratory 
Safety Monograph,” reflects the grow- 
ing experience in this area. 
A collaborative effort has been initi- 
ated between NIH and the Center for 
Disease Control (CDC) to establish a 
mechanism for providing advice, con- 
sultation, and if necessary, assistance 
regarding major accidents in laborato- 
ries involved in recombinant DNA re- 
search. It was not considered neces- 
sary to have a standing “strike force” 
as suggested by one commentator; 
however, in the event of an emergen- 
cy, a team of experts from NIH and 
CDC could be formed to respond, de- 
pending on the nature of the problem. 
Several commentators suggested 
that the NIH examine laboratory 
work involving genetic techniques 
other than recombinant DNA re- 
search. Indeed, it was recommended 
that another advisory committee akin 
to the RAC be established to propose 
standards for work involving biosafety, 
generally. I appreciate and understand 
this concern. The NIH over the past 
year and a half has created several in- 
ternal committees that are critically 
examining different areas where labo- 
NOT1CES 
ratory work is conducted with poten- 
tial biohazards. These committees are 
considering possible recommendations 
for safety standards. 
Another commentator also urged 
the NIH to consider a forum for deal- 
ing with social issues related to “genet- 
ic engineering.” The NIH responsibili- 
ty to date has been in addressing 
policy questions involving safety of re- 
combinant DNA research in single 
cells in the laboratory. I recognize the 
importance of the potential future ap- 
plication of this and other genetic re- 
search to the altering of the genetic 
character of higher forms of life in- 
cluding man. However, the application 
of this research to the “genetic engi- 
neering” of man is clearly far from im- 
minent. In light of public concern, a 
study is warranted of the ethical, 
legal, and social implications of these 
techniques. The National Commission 
for the Protection of Human Subjects 
of Biomedical and Behavioral research 
considered, but was unable to initiate, 
a study because of its pressing work- 
load. Such a study, however, should be 
a key priority for the Commission cur- 
rently being considered by Congress as 
part of the legislation to regulate re- 
combinant DNA research. 
It has also been suggested that the 
NIH work closely with other relevant 
research and regulatory agencies, par- 
ticularly the Environmental Protec- 
tion Agency and the Occupational 
Safety and Health Administration. 
Indeed, the NIH, from the inception of 
the Guidelines, has worked to foster 
cooperation among the Federal agen- 
cies. Prior to the release of the Guide- 
lines, representatives from several 
agencies met at the NIH for a briefing 
on the Guidelines. After the release of 
the Guidelines, the question of their 
extension to the rest of the Federal 
Government and the private sector 
prompted the creation of an Inter- 
agency Committee. This Federal Inter- 
agency Committee on Recombinant 
DNA Research on which I have served 
as Chairman, was created by the Sec- 
retary of HEW at the request of the 
President in October 1976. It is com- 
posed of all relevant Federal research 
and regulatory agencies and has pro- 
vided for coordination of Federal poli- 
cies concerning recombinant DNA re- 
search. In March 1977, the committee 
deve'oped recommendations for legis- 
lation. 
It was suggested by a commentator 
that the NIH address the internation- 
al implications of control of recombin- 
ant DNA research. Indeed, the Federal 
Interagency Committee issued in No- 
vember 1977 a thorough and compre- 
hensive review of all guidelines for 
such research internationally with rec- 
ommendations for continued coopera- 
tion. This report is available from the 
33067 
Office of Recombinant DNA Activi- 
ties, NIH, Bethesda, Md. 20014. 
Responsibilities of NIH ( Specific ) 
Office of the Director. As suggested 
by the commentators, for purposes of 
clarity, the responsibilities of the NIH 
Director have been grouped under a 
specific heading in the PRG-NIH enti- 
tled "Office of the Director, NIH.” 
These responsibilities (many of which 
are mentioned in Parts I, II, and III of 
the PRG-NIH, and are repeated again 
in Part IV) include: final interpreta- 
tion of the Guidelines; revision and 
amendment of the Guidelines; certifi- 
cation of new host-vector systems; pro- 
mulgating and amending a list of 
classes of recombinant DNA molecules 
to be exempt from the Guidelines; per- 
mitting specific exceptions to the Pro- 
hibitions in the Guidelines; approving 
changes in containment levels for spe- 
cific experiments; designating certain 
agents which are listed as Class 2 
agents, as Class 1 agents for the pur- 
poses of the Guidelines; and oversee- 
ing the implementation of the Guide- 
lines. For many of the responsibilities, 
appropriate notice and opportunity 
for public comment will be provided. 
Recombinant Advisory Committee. 
At the hearing in 1976, many commen- 
tators made suggestions concerning 
the structure, function, and scope of 
responsibility of the RAC. Comments 
on possible structural mechanisms for 
decision-making included suggestions 
that there be a scientific and technical 
committee and a general advisory 
public policy committee. It was also 
suggested that the scientific commit- 
tee include scientists who are to ac- 
tively engaged in recombinant DNA 
research, and that the public policy 
committee have a broad scientific and 
public representation. In response to 
those suggestions in 1976, the roles of 
the RAC and the NIH Advisory Com- 
mittee to the Director (DAC) were 
spelled out. The RAC responsibility 
has been primarily a scientific and 
technical one with recommendations 
for revisions of the Guidelines re- 
viewed by the DAC, the public adviso- 
ry group. In the main, that process 
has worked well over the past lVfe 
years and its structure is maintained 
in the PRG-NIH. 
I am acutely aware of the need for 
broad scientific representation on the 
RAC, and I have carefully considered 
these needs in the selection of new 
members. The emphasis has been to 
ensure relevant scientific representa- 
tion. It is absolutely essential that this 
committee have the technical exper- 
tise necessary to develop, modify, and 
interpret the Guidelines based on sci- 
entific evidence. Additonal representa- 
tives have been added from scientific 
disciplines, such as botany, to ensure a 
broad scientific overview. As a bridge 
FEDERAL REGISTER, VOL. 43, NO. 146— FRIDAY, JULY 28, 1978 
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