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Federal Register / Vol. 48, No. 106 / Wednesday, June 1. 1983 / Notices 
laboratory safety. Responsibility for 
training IBC members may be carried 
out through the IBC chairperson. 
Responsibility for training laboratory 
staff may be carried out through the PI. 
The Institution is responsible for seeing 
that the PI has sufficient training, but 
may delegate this responsibility to the 
IBC. 
IV-B-l-f. Determine the necessity, in 
connection with each project, for health 
surveillance of recombinant DNA 
research personnel, and conduct, if 
found appropriate, a health surveillance 
program for the project. [The Laboratory 
Safety Monograph (LSM) discusses 
various possible components of such a 
program — for example, records of agents 
handled, active investigation of relevant 
illnesses, and the maintenance of serial 
serum samples for monitoring serologic 
changes that may result from the 
employees' work experience. Certain 
medical conditions may place a 
laboratory worker at increased risk in 
any endeavor where infectious agents 
are handled. Examples given the LSM 
include gastrointestinal disorders and 
treatment with steroids, 
immunosuppressive drugs, or 
antibiotics. Workers with such disorders 
or treatment should be evaluated to 
determine whether they should be 
engaged in research with potentially 
hazardous organisms during their 
treatment or illness. Copies of the LSM 
are available from ORDA.j 
IV-B-l-g. Report within 30 days to 
ORDA any significant problems with 
any violations of the Guidelines and 
significant research-related accidents 
and illnesses, unless the institution 
determines that the PI or IBC has done 
so. 
1V-B-2. Membership and Procedures 
of the IBC. The Institution shall 
establish an Institutional Biosafety 
Committee (IBC) whose responsibilities 
need not be restricted to recombinant 
DNA. The committee shall meet the 
following requirements: 
IV-B-2-a. The IBC shall comprise no 
fewer than five members so selected 
that they collectively have experience 
and expertise in recombinant DNA 
technology and the capability to assess 
the safety of recombinant DNA research 
experiments and any potential risk to 
public health or the environment. At 
least two members shall not be 
affiliated with the Institution (apart from 
their membership on the IBC) and shall 
represent the interest of the surrounding 
community with respect to health and 
protection of the environment. Members 
meet this requirement if, for example, 
they are officials of State or local public 
health or environmental protection 
agencies, members of other local 
governmental bodies, or persons active 
in medical, occupational health, or 
environmental concerns in the 
community. The Biological Safety 
Officer (BSO), mandatory when 
research is being conducted at the P3 
and P4 levels, shall be a member. (See 
Section IV-B— 4.) 
IV-B-2-b. In order to ensure the 
competence necessary to review 
recombinant DNA activities, it is 
recommended that (i) the IBC include 
persons with expertise in recombinant 
DNA technology, biological safety, and 
physical containment; (ii) the IBC 
include, or have available as 
consultants, persons knowledgeable in 
institutional commitments and policies, 
applicable law, standards of 
professional conduct and practice, 
community attitudes, and the 
environment; and (iii) at least one 
member be from the laboratory 
technical staff. 
IV-B-2-c. The Institution shall 
identify the committee members by 
name in a report to the NIH Office of 
Recombinant DNA Activities (ORDA) 
and shall include relevant background 
information on each member in such 
form and at such times as ORDA may 
require. 
IV-B-2-d. No member of an IBC may 
be involved (except to provide 
information requested by the IBC) in the 
review or approval of a project in which 
he or she has been, or expects to be, 
engaged or has a direct financial 
interest. 
IV-B-2-e. The Institution, who is 
ultimately responsible for the 
effectiveness of the IBC, may establish 
procedures that the IBC will follow in its 
initial and continuing review of 
applications, proposals, and activities. 
(IBC review procedures are specified in 
Section IV-B-3-a.) 
IV-B-2-f. Institutions are encouraged 
to open IBC meetings to the public 
whenever possible, consistent with 
protection of privacy and proprietary 
interests. 
IV-B-2-g. Upon request, the 
Institution shall make available to the 
pdblic all minutes of IBC meetings and 
documents submitted to or received 
from funding agencies which the latter 
are required to make available to the 
public. If comments are made by 
members of the public on IBC actions, 
the Institution shall forward to NIH both 
the comments and the IBC's response. 
IV-B-3. Functions of the IBC. On 
behalf of the Institution, the IBC is 
responsible for: 
IV-B-3-a. Reviewing for compliance 
with the NIH Guidelines recombinant 
DNA research as specified in Part 111 
conducted at or sponsored by the 
Institution, and approving those 
research projects that it finds are in 
conformity with the Guidelines. This 
review shall include: 
I V— E3— 3— a— ( 1 ) . An independent 
assessment of the containment levels 
required by these Guidelines for the 
proposed research, and 
IV-B-3-a-{2). An assessment of the 
facilities, procedures, and practices, and 
of the training and expertise of 
recombinant DNA personnel. 
IV-B-3-b. Notifying the Principal 
Investigatior (PI) of the results of their 
review. 
IV-B-3-c. Lowering containment 
levels for certain experiments as 
specified in Sections III— B— 2. 
IV-B-3-d. Setting containment levels 
as specified in Section III— B— 4 — b and III— 
B-5. 
IV-B-3-e. Reviewing periodically 
recombinant DNA research being 
conducted at the Institution, to ensure 
that the requirements of the Guidelines 
are being fulfilled. 
IV-B-3-f. Adopting emergency plans 
covering accidential spills and 
personnel contamination resulting from 
such research. 
Note. — Basic elements in developing 
specific procedures for dealing with major 
spills of potentially hazardous materials in 
the laboratory are detailed in the Laboratory 
Safety Monograph (LSM). Included are 
information and references on 
decontamination and emergency plans. NIH 
and the Centers for Disease Control are 
available to provide consultation, and direct 
assistance if necessary, as posted in the LSM. 
The Institution shall cooperate with the State 
and local public health departments, 
reporting any significant research-related 
illness or accident that appears to be a 
hazard to the public health. 
IV-B-3-g. Reporting within 30 days to 
the appropriate institutional official and 
to the NIH Office of Recombinant DNA 
Activities (ORDA) and significant 
problems with or violations of the 
Guidelines, and any significant 
research-related accidents or illnesses, 
unless the IBC determines that the PI 
has done so. 
IV-B-3-h. The IBC may not authorize 
initiation of experiments not explicitly 
covered by the Guidelines until NIH 
(with the advice of the RAC when 
required) establishes the containment 
requirement. 
IV-B-3-i. Performing such other 
functions as may be delegated to the 
IBC under Section IV-B-1. 
I V-B-4. Biological Safety Officer. The 
Institution shall appoint a BSO if it 
engages in recombinate DNA research 
at the P3 of P4 containment level. The 
officer shall be a member of the 
ri4n] 
