Federal Register / Vol. 48, No. 106 / Wednesday, June 1, 1983 / Notices 
24561 
Institutional Biosafety Committee (IBC), 
and his or her duties shall include (but 
need not be limited to): 
IV-B-4-a. Ensuring through periodic 
inspections that laboratory standards 
are rigorously followed; 
IV-B-4-b. Reporting to the IBC and 
the Institution all significant problems 
with and violations of the Guidelines 
and all significant research-related 
accidents and illnesses of which BSO 
becomes aware, unless the BSO 
determines that the Principal 
Investigator (PI) has done so; 
IV-B-^l-c. Developing emergency 
plans for dealing with accidental spills 
and personnel contamination, and 
investigating recombinant DNA research 
laboratory accidents; 
IV-B-4-d. Providing advice on 
laboratory security; 
IV-B-M-e. Providing technical advice 
to tfie PI and the IBC on research safety 
procedures. 
Note. — See Laboratory Safety Monograph 
for additional information on the duties of the 
I1SO. 
IV-B-5. Principal Investigator. On 
behalf of the Institution, the PI is 
responsible for complying fully with the 
Guidelines in conducting any 
recombinant DNA research. 
IV-B-5-a. PI — General. As part of this 
special responsibility, the PI shall: 
IV-B-5-a-(l). Initiate or modify no 
recombinant DNA research requiring 
approval by the IBC prior to initiation 
(see Sections III— A and III— B) until that 
research, or the proposed modification 
thereof, has been approved by the IBC 
and has met all other requirements of 
the Guidelines; 
IV-B-5-a-(2). Determine whether 
experiments are covered by Section III— 
C and follow the appropriate 
procedures; 
IV-B-5-a-(3). Report within 30 days to 
the IBC and NIH (ORDA) all significant 
problems with and violations of the 
Guidelines and all significant research- 
related accidents and illnesses; 
IV-B-5-a-(4). Report to the IBC and to 
NIH (ORDA) new information bearing 
on the Guidelines; 
I V-B-5-a-(5). Be adequately trained 
in good microbiological techniques; 
I V— B — 5— a— (G). Adhere to IBC-approved 
emergency plans for dealing with 
accidental spills and personnel 
contamination; and 
IV-B-5-a-(7). Comply with shipping 
requirements for recombinant DNA 
molecules. (See Appendix H for shipping 
requirements and the Laboratory Safety 
Monograph for technical 
recommendations.) 
JV-B-5-b. Submissions by the P! to 
Mil. The RI shall: 
I V— B--5— b— ( 1 ). Submit information to 
NIH (ORDA) in order to have new host- 
vector systems certified; 
I V— T3— 5— b— (2). Petition NIH, with 
notice to the IBC. for exemptions to 
these Guidelines; 
I V— B— 5— b— (3). Petition NIH, with 
concurrence of the IBC, for approval to 
conduct experiments specified in 
Section III— A of the Guidelines; 
I V— B — 5— 1>— (4). Petition NIH for 
determination of containment for 
experiments requiring case-by-case 
review; 
I V— B— 5 — b— (5). Petition NIH Tor 
determination of containment for 
experiments not covered by the 
Guidelines. 
IV-B-5-c. Submissions by the PI to 
the IBC. The PI shall: 
I V-B~5-c-(l). Make the initial 
determination of the required levels of 
physical and biological containment in 
accordance with the Guidelines; 
I V— B — 5 — c-(2). Select appropriate 
microbiological practices and laboratory 
techniques to be used in the research; 
IV-B-5-c-(3). Submit the initial 
research protocol if covered under 
Guidelines Sections III— A, III— B, or III— C 
(and also subsequent changes — e.g., 
changes in the source of DNA or host- 
vector system) to the IBC for review and 
approval or disapproval; and 
IV-B-5-c-(4). Remain in 
communication with the IBC throughout 
the conduct of the project. 
IV-B-5-d. PI Responsibilities Prior to 
Initiating Research. The PI is 
responsible for; 
I V— B— 5— d— ( 1 ). Making available to the 
laboratory staff copies of the protocols 
that describe the potential biohazards 
and the precautions to be taken; 
IV-B-5-d-(2). Instructing and training 
staff in the practices and techniques 
required to ensure safety and in the 
procedures for dealing with accidents; 
and 
I V— B — 5 — d— ( 3 ) . Informing the staff of 
the reasons and provisions for any 
precautionary medical practices advised 
or requested, such as vaccinations or 
serum collection. 
IV-B-5-e. PI Responsibilities During 
the Conduct of the Research. The PI is 
responsible for: 
IV-B-5-e-(l). Supervising the safely 
performance of the staff to ensure that 
the required safety practices and 
techniques are employed; 
IV-B-5-e-(2). Investigating and 
reporting in writing to ORDA, the 
Biological Safety Officer (where 
applicable), and the IBC any significant 
problems pertaining to the operation 
and implementation of containment 
practices and proci dures; 
I V-B-5-e-(3). Correcting work errors 
and conditions that may result in the 
release of recombinant DNA materials; 
(V-B~5-e-(4). Ensuring the integrity of 
the physical containment (e.g., biological 
safety cabinets) and the biological 
containment (e.g., purity, and genotypic 
and phenotypic characteristics). 
IV-C. Responsibilities of NIH. 
IV-C-1. Director. The Director. NIH, is 
responsible for (i) establishing the NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules, (ii) 
overseeing their implementation, and 
(iii) their final interpretation. 
The Director has responsibilities 
under the Guidelines that involve the 
NIH Office of Recombinant DNA 
Activities (ORDA) and the Recombinant 
DNA Advisory Committee (RAC). 
ORDA's responsibilities under the 
Guidelines are administrative. Advice 
from the RAC is primarily scientific and 
technical. In certain circumstances, 
there is specific opportunity for public 
comment, with published response, 
before final action. 
lV-C-l-a. General Responsibilities of 
the Director, NIH. The responsibilities 
of the Director shall include the 
following; 
IV-C-l-a(l). Promulgating 
requirements as necessary to implement 
the Guidelines; 
IV-C-1 -a~(2). Establishing and 
maintaining the RAC to carry out the 
responsibilities set forth in Section IV- 
C-2. The RAC’s membership is specified 
in its charter and in Section IV-C-2; 
I V— C— 1 a— (3). Establishing and 
maintaining ORDA to carry out the 
responsibilities defined in Section IV-C- 
3; and 
I V-C-l-a-(4). Maintaining the Federal 
Interagency Advisory Committee on 
Recombinant DNA Research established 
by the Secretary, HEW (now HHS), for 
advice on the coordination of all Federal 
programs and activities relating to 
recombinant DNA, including activities 
of the RAC. (See Appendix J.) 
IV-C-l-b. Specific Responsibilities of 
the Director. NIH. In carrying out the 
responsibilities set forth in this Section, 
the Director or a designee shall weigh 
each proposed action, through 
appropriate analysis and consultation, 
to determine that it complies with the 
Guidelines and presents no significant 
risk to health or the environment. 
IV-C-l-b-(l). Major Actions. To 
execute major actions tire Director must 
seek the advice of the RAC and provide 
an opportunity for public and Federal 
agency comment. Specifically, the 
agenda of the RAC meeting citing the 
major actions will be published in the 
Federal Register at least 30 days before 
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