NOTICES 
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tive and relatively inexpensive admin- 
istrative mechanism.” 
As in the 1976 decision, a number of 
recommendations were received re- 
garding the membership of IBC’s. In 
1976, suggestions were made for broad- 
ening IBC representation to include 
members not only from various disci- 
plines related to recombinant DNA 
molecule technology, biological safety, 
and engineering but also to include 
those knowledgeable in applicable 
laws, regulations, standards of prac- 
tice, community attitudes, and health 
and environmental considerations. 
Consequently, at that time I recom- 
mended in my decision that these di- 
verse points of view be included or 
made available to the committees. The 
language in the PRG-RAC requires a 
diversity of membership, but does not 
mandate noninstitutional members. In 
response to several requests, and in 
view of increased responsibility at the 
local level, I am now going beyond the 
RAC proposal and adding a provision 
that “no IBC may consist entirely of 
•persons who are officers, employees, 
or agents of, or are otherwise associat- 
ed with the institution, apart from 
their membership on the IBC.” Other 
specific categories for membership are 
not mandated although the PRG-NIH 
now states that “membership should 
include individuals from disciplines 
relevant to recombinant DNA technol- 
ogy, biological safety, and engineer- 
ing”; that it is recommended that “at 
least one member be a nondoctoral in- 
dividual from a laboratory technical 
staff”; and that the IBC “include 
members knowledgeable about such 
matters as applicable law, standards of 
professional conduct and practice, 
community attitudes, and the environ- 
ment.” 
The possibility of conflict between 
IBC’s and local community oversight 
committees was raised. With noninsti- 
tutional membership on IBC’s I be- 
lieve there is no need to have addition- 
al community committees. 
A number of other recommendations 
were received from public commenta- 
tors relating to more specific issues; 
they are considered below under the 
appropriate headings. 
Responsibilities of the institution (.spe- 
cific) 
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. The issue of medical monitoring is 
one of considerable interest to the 
NIH. This is a general problem not 
unique to recombinant DNA research. 
As one commentator noted, instituting 
a routine health monitoring and re- 
porting program for personnel en- 
gaged in areas of research besides re- 
combinant DNA, such as tumor viruses 
and pathogenic organisms, is impor- 
tant. However, the state-of-the-art is 
primitive in terms of what can be done 
to monitor workers’ health generally, 
but particularly in the area of recom- 
binant DNA. research where there is 
no known hazard. At my request, an 
NIH committee reviewed this area and 
has made recommendations as to what 
such a program may include. This rec- 
ommendation, which calls for monitor- 
ing illnesses, collecting serum samples, 
and keeping a register of agents han- 
dled, is responsive to several sugges- 
tions received on this issue, and it has, 
therefore, been adopted in the PRG- 
NIH, Additionally, appendix D will in- 
clude more detailed information on 
medical surveillance. 
Grievance procedures for workers 
under the guidelines were requested 
but this is not considered necessary as 
the Occupational Safety and Health 
Act (OSHA) rules and regulations al- 
ready provide such a mechanism. In 
the 1976 decision it was also noted 
that OSHA standards and procedures 
apply to most institutions, so it was 
not considered necessary then, or now, 
to require in the guidelines that IBC’s 
insure OSHA compliance. Further, the 
Federal Interagency Committee on 
Recombinant DNA Research, which I 
chair, includes representatives from 
the Occupational Safety and Health 
Administration (Department of 
Labor), assuring cooperation at the 
Federal level. 
One commentator spoke to the need 
for a biosafety control manager which 
would be similar to the head of a 
campus environmental health and 
'safety office. While such a program 
and manager may be desirable, it is 
felt that this is an institutional admin- 
istrative matter and should not be ad- 
dressed in the guidelines. 
Institutional Biosafety Committee 
(IBC). Several commentators request- 
ed more detail on IBC duties and this 
has been accomplished La the supple- 
ment to the PRG-NIH entitled, “Lab- 
oratory Safety Monograph.” For ex- 
ample, information is included here on 
facility certification, periodic inspec- 
tions and monitoring, and a model for 
IBC operation. 
There was concern about the estab- 
lishment of area biosafety committees 
and possible jurisdictional disputes be- 
tween them and institutional biosafety 
committees. This has been further 
clarified in the definitions in Part I. 
It was suggested that biosafety com- 
mittee meetings be open tc the public. 
The guidelines currently require only 
that the minutes be available to the 
public. In view of possible discussion 
of proprietary and patentable infor- 
mation, IBC meetings cannot always 
be open. I do urge, however, that local 
committees, when possible, have open 
meetings and suggest that ail meetings 
be announced. 
The question was raised concerning 
possible conflict of Interest of local 
committee members. This is an impor- 
tant point, and I have added a provi- 
sion prohibiting an individual engaged 
in, or expecting to be engaged in, or 
having a direct financial interest in, a 
recombinant DNA project from being 
involved in the review or approval of 
that project. 
Concern was expressed about the 
cost of IBC operations, and sugges- 
tions were made that the Government 
underwrite this expense. Because NIH 
already pays, through indirect costs, 
the operations of such committees, I 
have decided that there is no need at 
this time to separate them out from 
other indirect costs of the institutions. 
Biological Safety Officer. Because in- 
creased authority and responsibility 
have been given the IBC’s, it is appro- 
priate that institutions conducting P3 
or P4 level research have someone des- 
ignated to handle biological safety 
questions generally. 
I have accepted the suggestion that 
the biological safety officer shail be a 
member of the IBC because his or her 
responsibilities are so closely allied to 
the function of the committee. 
Another commentator noted that 
too much emphasis was placed in the 
PRG-RAC on the regulatory role of 
the biosafety officer rather than on 
his or her role as a technical consul- 
tant; therefore, language indicating 
this latter role has been inserted in 
the PRG-NIH. 
In response to questions on the 
qualifications of biological safety offi- 
cers, I note that the officer need not 
be an M.D. Further, it is not necessary 
that he or she be engaged in research. 
Since the passage of the Occupational 
Safety and Health Act, most institu- 
tions have established occupational 
safety and health departments or pro- 
grams with institutional safety offi- 
cers. There are no standard certifica- 
tion procedures for such individuals, 
although their qualifications, in many 
cases, could be commensurate with 
those of a biological safety officer. 
The supplement to the PRG-NIH en- 
titled, “Laboratory Safety Mono- 
graph,” provides in greater detail the 
kinds of qualifications that biosafety 
officers should have. NIH is develop- 
ing a training course for campus 
safety officers, including biological 
safety officers, and requests for infor- 
mation should be directed to Dr. 
Emmett Barkley, Director, Office of 
Research Safety, National Cancer In- 
stitute, Bethesda, Md. 20014. 
Principal Investigator. In response 
to several commentators, the steps the 
investigator needs to take in order to 
have proposed research approved at 
FEDERAL REGISTER, VOL. 43, NO. 146— FRIDAY, JULY 28, 1978 
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