Federal Register / VoL 49, No. 227 / Friday, November 23, 1984 / Notices 
46271 
IV-B-4. Biological Safety Officer. The 
Institution shall appoint a BSO if it 
engages in recombinant DNA research 
at the BL3 or BL4 containment level. The 
officer shall be a member of the IBC, 
and his or her duties shall include (but 
need not be limited to): 
IV-B^t-a. Ensuring through periodic 
inspections that laboratory standards 
are rigorously followed; 
lV-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 the 
BSO becomes aware unless the BSO 
determines that the PI has done so; 
IV-B-4-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^i-e. Providing technical advice 
to the PI and the IBC on rsearch safety 
procedures. 
Note — See LSM for additional information 
on the duties of the BSO. 
IV-BS. Principal Investigator (PI). 
On behalf of the Institution, the PI is 
responsible for complying fully with the 
Guidelines in conducting any 
recombinant DNA research. 
IV-BS-a. PI — General. As part of this 
general responsibility, the PI shall: 
lV-B-5-a(1). 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-BS-a-(2). Determine whether 
experiments are covered by Section III— 
C and follow the appropriate 
procedures; 
lV-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; 
/ V-B-5~a-( 4). Report to the IBC and to 
NIH (ORDA) new information bearing 
on the Guidelines; 
!V-B-5-a-(5). Be adequately trained 
in good microbiological techniques; 
IV~B-5-a-(6). Adhere to IBC- 
approved emergency plans for dealing 
with accidential spills and personel 
contamination; and 
lV-B-5—a-{7). Comply with shipping 
requirements for recombinant DNA 
molecules. (See Appendix H for shipping 
requirements and the LSM for technical 
recommendations.) 
lV-B—5-b. Submissions by the PI to 
NIH. The PI shall: 
IV-BS-b-(l). Submit information to 
NIH (ORDA) in order to have new host- 
vector systems certified; 
!V-B~5~b-(2). Petition NIH with 
notice to the IBC for exemptions to these 
Guidelines; 
IV-BS-b-(3). Petition NIH with 
concurrence of the IBC for approval to 
conduct experiments specified in 
Section III— A of the Guidelines; 
IV-B-5-b-(4). Petition NIH for 
determination of containment for 
experiments requiring case-by-case 
review; 
IV-B-5-b-(5). Petition NIH for 
determination of containment for 
experiments not covered by the 
Guidelines. 
IV-BS-c. Submissions by the PI to 
the IBC. The PI shall: 
lV-B~5-c-(l). Make the initial 
determination of the required levels of 
physicial and biological containment in 
accordance with the Guidelines; 
rV-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 be 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: 
rv~B-5-d-(l). 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 
IV-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 safety 
performance of the staff to ensure that 
the required safety practices and 
techniques are employed; 
lV~B-5-e~(2). Investigating and 
reporting in writing to ORDA, the BSO 
(where applicable), and the IBC any 
significant problems pertaining to the 
operation and implementation of 
containment practices and procedures; 
IV-B-5-e-(3). Correcting work errors 
and conditions that may result in the 
release of recombinant DNA materials; 
lV-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) Establishment 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 ORDA 
and 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. 
IV-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; 
I\ r -C-l-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; 
IV-C-l-a-(3). Establishing and 
maintaining ORDA to carry out the 
responsibilities defined in Section IV-C- 
3; and 
IV-C-l-b-(4). Maintaining the Federal 
Interagency Advisory Committee on 
Recombinant DNA Reseach 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 is 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 the 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 
the meeting, and the Director will also 
publish the proposed actions in the 
Federal Register for comment at least 30 
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