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NCT'CES 
trative process in regard to gaining ap- 
proval for research to proceed. 
In view of the unreliability of Feder- 
al surveillance to enforce these stand- 
ards. it is essential to increase the au- 
thority and responsibility of the local 
institution. It was requested that the 
IBC's have a role if legislation in this 
area is adopted. This concept is en- 
dorsed by the House Committee on In- 
terstate and Foreign Commerce in Its 
Bill Report of March 24. 1978. on the 
Recombinant DNA Act: 
It Is the view of the committee that the 
appropriate portions of the administrative 
requirements of section IV of the NIH 
Guidelines are a reasonable model upon 
which the Secretary could base administra- 
tive regulations. In particular, the current 
practice In the NIH Guidelines of delegating 
to local biohazards committees most of the 
responsibility for the Inspection of facilities 
and the approval of the specific safety re- 
quirements appropriate to each project or 
activity la an effective and relatively Inex- 
pensive administrative mechanism. 
A number of recommendations were 
received regarding the membership of 
IBCs. In 1978. suggestions were made 
for broadening IBC representation to 
cover not only various disciplines re- 
lated to recombinant DNA technology, 
safety, and engineering, but also to In- 
clude members Itnowiedgeable in ap- 
plicable laws and regulations, stand- 
ards of practice, community attitudes, 
and health and environmental consid- 
erations. These diverse points of view 
were either to be Included or made 
available to the committees. The lan- 
guage in the PRC- RAC calls for a di- 
versity of membership, but would not 
mandate public members. In response 
to several requests, and in view of in- 
creased responsibility at the local 
level, a provision is included in the 
PRG-NIH that "no IBC may consist 
entirely of persons who are officers, 
employees, or agents of. or are other- 
wise associated with the institution, 
apart from their membership on the 
IBC. 
A number of other recommendations 
were received from public commenta- 
tors relating to more specific Issues 
concerning the various responsibilities 
of the institution and its constituents. 
These recommendations and the PRG- 
NIH decision are considered below 
under the appropriate headings. 
Institution. A number of points were 
raised by commentators concerning 
health monitoring by Institutions. 
NIH was requested to develop a model 
for Institutional medical surveillance 
for recombinant DNA research work- 
ers. An NIH committee is reviewing 
this area and has made recommenda- 
tions as to what such a program might 
include. This proposal, which calls for 
monitoring illnesses, collecting serum 
samples, and keeping a register of 
agents handled, is responsive to sever- 
al suggestions received on this issue. 
and has therefore been adopted in the 
PRG-NIH. Additionally, Appendix D 
will include more detailed information 
on medical surveillance. 
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 conducting recombinant DNA re- 
search. It was not considered neces- 
sary to have a standing "strike force" 
as suggested by one commentator, but 
in the event of an emergency, a team 
of experts from NIH and CDC could 
be formed to respond. 
The issue of medical monitoring is 
one of considerable interest to NIH. 
This is a general problem not unique 
to DNA research. As one commentator 
noted, a routine health monitoring 
and reporting program might well be 
instituted Iz? personnel engaged in 
areas of research besides recombinant 
DNA. such as tumor viruses and 
pathogenic organisms. The state-of- 
the-art, however, is primitive in terms 
of what can be done to monitor work- 
ers’ health, and particularly tn the 
area of recombinant DNA research, 
where there is no known hazard. 
Grievance procedures for workers 
under the Guidelines were requested, 
but this Is not considered necessary, as 
the rules and regulations of the Occu- 
pational Safety and Health Act 
(OSHA) already provide such a mech- 
anism. OSHA standards and proce- 
dures apply to most institutions, so it 
is not considered necessary to require 
in the Guidelines that IBCs ensure 
OSHA compliance. Further, the Fed- 
eral Interagency Committee on Re- 
combinant DNA Research includes the 
Occupational Safety and Health Ad- 
ministration (Department of Labor >. 
assuring cooperation at the Federal 
level. 
Institutional Biosafety Committee. 
Several commentators requested more 
detail on IBC duties. This has been ac- 
complished in "Laboratory Safety 
Monograph— A Supplement to the 
NIH Guidelines for Recombinant DNA 
Research.” For example, information 
is included there on facility certifica- 
tion. periodic Inspections, and moni- 
toring. 
It was suggested that biosafety com- 
mittee meetings be open to the public. 
The Guidelines currently require only 
that the minutes by publicly available. 
In view of possible discussion of pro- 
prietary information and patent 
rights, meetings cannot always be 
open. Local committees, however, 
should consider having open meetings 
when possible. 
The question was raised concerning 
conflict of interest of local committee 
members. Addressing this Important 
point, a provision In the PRG-NIH 
prohibits an individual from being in- 
volved in the review of ? recombinant 
DNA project in which he or she was 
engaged or had a direct financial in- 
terest. 
Biological Safety Officer. Since the 
passage of OSHA, most institutions 
have established occupational safety 
and health departments with safety 
officers. There are no standard certifi- 
cation procedures for such individuals, 
although their qualifications, in many 
cases, could be commensurate with 
those of a biological safety officer. 
The Laboratory Safety Monograph 
provides in detail the kinds of qualifi- 
cations biosafety officers should have. 
NIH is developing a training course for 
biological safety officers and other 
campus safety personnel. Requests for 
information should be directed to Dr. 
Emmett Barkley. Office of Research 
Safety, National Cancer Institute. 
NIH. 
Princial Investigator. Commentators 
remain concerned about the quality 
and uniformity of safety training. NIH 
is responding to this by placing as a 
high priority the development of 
training standards and courses. Cur- 
rently. NIH is supporting a Working 
Panel of the American Society for Mi- 
crobiology (ASM) that is considering 
standards of training in micro- biologi- 
cal techniques for recombi- nant DNA 
research. When a report is submitted 
to NIH. it will be shared with institu- 
tions. IBC's. and principal investiga- 
tors for their use. National certifica- 
tion. however, should not be attempt- 
ed until the ASM-NIH criteria for 
training have been adopted and evalu- 
ated. 
It should be noted that, aside from 
the Nuclear Regulatory Commission's 
standards for training in radioisotope 
work, there seem to be no other train- 
ing criteria at present in biomedical re- 
search. Thus, the work of the ASM 
Panel will establish a precedent. For 
these reasons NIH should proceed 
carefully and in stages while promot- 
ing safety training for researchers. 
NIH will develop training courses 
based on these standards and will 
make them widely available. 
NIH responsibilities 
As in the public hearing on the 
Guidelines as proposed in 1976. many 
commentators again urge openness, 
candor, and public participation in the 
revision process, emphasizing shared 
responsibility and accountability from 
the local to the national level. 
Due-Process Considerations. A focus 
of public comment at the December 
1977 hearing was on "procedural due 
process” to ensure public participation 
in the development of NIH recombin- 
ant DNA policies. Much of the public 
testimony and comment in letters fo- 
cused on public representation on 
FEDERAL REGISTER, VOL 43, NO. 144— FRIDAY, JULY 28. 1978 
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