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Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
which he/she has been or expects to be 
engaged or has a direct financial 
interest. 
Section IV-B-2-a-(5). The institution, 
that is ultimately responsible for the 
effectiveness of the Institutional 
Biosafety Committee, may establish 
procedures that the Institutional 
Biosafety Committee shall follow in its 
initial and continuing review and 
approval of applications, proposals, and 
activities. 
Section IV-B-2-a-(6). When possible 
and consistent with protection of 
privacy and proprietary interests, the 
institution is encouraged to open its 
Institutional Biosafety Committee 
meetings to the public. 
Section IV-B-2-a-(7). Upon request, 
the institution shall make available to 
the public all Institutional Biosafety 
Committee meeting minutes and any 
documents submitted to or received 
from funding agencies which the latter 
are required to make available to the 
public. If public comments are made on 
Institutional Biosafety Committee 
actions, the institution shall forward 
both the public comments and the 
Institutional Biosafety Committee’s 
response to the Office of Recombinant 
DNA Activities, National Institutes of 
Health, Building 31, Room 4B11, 
Bethesda, Maryland 20892, (301) 496- 
9838. 
Section IV-B-2-b. Functions 
On behalf of the institution, the 
Institutional Biosafety Committee is 
responsible for: 
Section IV-B-2-b-{l). Reviewing 
recombinant DNA research conducted at 
or sponsored by the institution for 
compliance with the NIH Guidelines as 
specified in Section III and approving 
those research projects that are found to 
conform with the NIH Guidelines. This 
review shall include: (i) independent 
assessment of the containment levels 
required by the NIH Guidelines for the 
proposed research, and (ii) assessment 
of the facilities, procedures, practices, 
and training and expertise of personnel 
involved in recombinant DNA research. 
Section IV-B-2-b-(2). Notifying the 
Principal Investigator of the results of 
the Institutional Biosafety Committee’s 
review and approval. 
Section rV-l^2-b-(3). Lowering 
containment levels for certain 
experiments as specified in Section III- 
C— 2-a. 
Section IV-B-2-b-(4). Setting 
containment levels as specified in 
Sections III-C— 4-b and III-C-5. 
Section IV-B-2-b-(5). Periodically 
reviewing recombinant DNA research 
conducted at the institution to ensure 
compliance with the NIH Guidelines. 
Section IV-B-2-b-(6). Adopting 
emergency plans covering accidental 
spills and personnel contamination 
resulting from recombinant DNA 
research. 
Note; The Laboratory Safety Monograph 
describes basic elements for developing 
specific procedures dealing with major spills 
of potentially hazardous materials in the 
laboratory, including information and 
references about decontamination and 
emergency plans. The NIH and the Centers 
for Disease Control and Prevention are 
available to provide consultation and direct 
assistance, if necessary, as posted in the 
Laboratory Safety Monograph. The 
institution shall cooperate with the state and 
local public health departments by reporting 
any significant research-related illness or 
accident that may be hazardous to the public 
health. 
Section IV-B-2-b-(7). Reporting any 
significant problems with or violations 
of the NIH Guidelines and any 
significant research-related accidents or 
illnesses to the appropriate institutional 
official and NIH/ORDA within 30 days, 
unless the Institutional Biosafety 
Committee determines that a report has 
already been filed by the Principal 
Investigator. Reports to NIH/ORDA shall 
be sent to the Office of Recombinant 
DNA Activities, National Institutes of 
Health, Bethesda, Maryland 20892, 
(301) 496-9838. 
Section IV-B-2-b-(8). The Institutional 
Biosafety Committee may not authorize 
initiation of experiments which are not 
explicitly covered by the NIH 
Guidelines until NIH (with the advice of 
the RAC when required) establishes the 
containment requirement. 
Section IV-B-2-b-(9). Performing such 
other functions as may be delegated to 
the Institutional Biosafety Committee 
under Section IV-B-2. 
Section IV-B-3. Biological Safety Officer 
(BSO) 
Section IV-B-3-a. The institution shall 
appoint a Biological Safety Officer if it 
engages in large scale research or 
production activities involving viable 
organisms containing recombinant DNA 
molecules. 
Section IV-B-3-b. The institution 
shall appoint a Biological Safety Officer 
if it engages in recombinant DNA 
research at BL3 or BL4. The Biological 
Safety Officer shall be a member of the 
Institutional Biosafety Committee. 
Section IV-B-3-c. The Biological 
Safety Officer’s duties include, but are 
not be limited to: 
Section IV-B-3-c-(l). Periodic 
inspections to ensure that laboratory 
standards are rigorously followed; 
Section IV-B-2l-c-(2). Reporting to the 
Institutional Biosafety Committee and 
the institution any significant problems. 
violations of the NIH Guidelines, and 
any significant research-related 
accidents or illnesses of which the 
Biological Safety Officer becomes aware 
unless the Biological Safety Officer 
determines that a report has already 
been filed by the Principal Investigator; 
Section IV-B-3-c-(3). Developing 
emergency plans for handling accidental 
spills and personnel contamination and 
investigating laboratory accidents 
involving recombinant DNA research; 
Section IV-B-3-c-(4). Providing advice 
on laboratory security; 
Section rv-B-3-c-(5). Providing 
technical advice to Principal 
Investigators and the Institutional 
Biosafety Committee on research safety 
procedures. 
Note: See the Laboratory Safety Monograph 
for additional information on the duties of 
the Biological Safety Officer. 
Section IV-B-4. Principal Investigator 
(PI) 
On behalf of the institution, the 
Principal Investigator is responsible for 
full compliance with the NIH 
Guidelines in the conduct of 
recombinant DNA research. 
Section IV-B— 4-a. General 
Responsibilities 
As part of this general responsibility, 
the Principal Investigator shall: 
Section W-B-4-a-Hl). Initiate or 
modify no recombinant DNA research 
which requires Institutional Biosafety 
Committee approval prior to initiation 
(see Sections lU-A, III-B, rmd III-C) 
until that research or the proposed 
modification thereof has been approved 
by the Institutional Biosafety Committee 
and has met all other requirements of 
the NIH Guidelines; 
Section IV-B-4-a-(2). Determine 
whether experiments are covered by 
Section III-D and that the appropriate 
procedures are followed; 
Section IV-B-4-a-(3). Report any 
significant problems, violations of the 
NIH Guidelines, or any significant 
research-related accidents and illnesses 
to the Biological Safety Officer (where 
applicable), Greenhouse/Animal 
Facility Director (where applicable). 
Institutional Biosafety Committee, NIH/ 
ORDA, and other appropriate 
authorities (if applicable) within 30 
days (reports to NIH/ORDA shall be sent 
to the Office of Recombinant DNA 
Activities, National Institutes of Health. 
Building 31, Room 4B11, Bethesda, 
Maryland 20892, (301) 496-9838); 
S^tion rV-B-4-a-{4). Report any 
. new information bearing on the NIH 
Guidelines to the Institutional Biosafety 
Committee and to NIH/ORDA (reports to 
NIH/ORDA shall be sent to the Office of 
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