Federal Re^ster / Vol. 47. No. 107 / Friday, August 27, 1982 / Notices 
38053 
Investigating recombinant DNA research 
laboratory accidents; 
IV-B-4^. Providing advice on 
laboratory security: 
rV-B 4-e. Providing technical advice 
to the PI and the IBC on research safety 
procedures. 
Note. — See Laboratory Safety Monograph 
for additional information on the dutiea of the 
BSO. 
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 
general responsibility, the PI shall; 
rV-B-A-a-{l). Initiate or modify no 
recombinant DNA research requiring 
approval by the IBC prior to initiation 
(see Sections Ill-A and Ill-B) until that 
research, or the proposed modification 
thereof, has been approved by the IBC 
and has met all other requirements of 
the Guidelines: 
rV-B-S-a-(2). Determine whether 
experiments sre covered by Section 111- 
C and follow the appropriate 
procedures: 
rV-B-5-a-{3). Report within 30 days to 
the IBC and NBl (ORDA) all significant 
problems with and violations of the 
Guidelines and all significant research- 
related accidents and illnesses; 
rV-B-5-a-^4l. Report to the IBC and to 
NIH (ORDA) new information bearing 
on the Guidelines: 
IV-B-5-a-(&)- Be adequately trained 
in good microbiological techniques: 
IV-B-5-a-(6). Adhere to IBC-approved 
emergency plans for dealing with 
acddental spills and personnel 
contamination: and 
rV-B-&-a-(7). Comply with shipping 
requirements for recombinant DNA 
molecules. (See Apcndix H for shipping 
requirements and the Laboratory ^fety 
Monograph for technical 
recommendations.) 
rV-B-5-b. Submission* by the PI to 
NIH. The n shall; 
rV-B-0-b-(l). Submit information to 
NIH (ORDA) in order to have new host- 
vector systems certified: 
rV-B-6-b-(2). Petition NIH with 
notice to the DBC. for exemptions to 
these Guidelines: 
IV-B-5-tH3). PeUtion NIH. with 
concurrence of the IBC, for approval to 
conduct experiments specifi^ in 
Section lU-A of tha Guidelines: 
rV-B-5-b-(4). Pebtion NIH for 
determination of containment (or 
experiments requiring case-by-case 
review. 
IV-B-5-b-(5). Petition NIH for 
determination of contairunent for 
experiments not covered by the 
Guidelines. 
IV-B-5-C. Submissions by the PI to 
the IBC. The PI shall: 
rV-B-5-c-(l). Make the initial 
determination of the required levels of 
physical and biological contairunent in 
accordance with the Guidelines: 
IV-B-S-o-(2). Select appropriate 
microbiological practices and laboratory 
techiuques to be used in the research; 
rV-B-5-c-{3). Submit the initial 
research protocol if covered under 
Guidelines Sectiotu lU-A. 111-B, or 111-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 pro)ect. 
IV-B-5-d. P! 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-6-d-(2). Instructing and training 
staff in the practices and techniques 
required to ensure safety and in the 
procedures for dealing with accidents: 
and 
rV-B-5-d-(3). Informing the staff of 
the reasons and provisions for any 
precautionary m^ical practices advised 
or requested, such as vaccinations or 
serum collection. 
IV-B-5-e. P! 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: 
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 procedures: 
rV-8-5-e-(3). Correcting work errors 
and conditions that may result in the 
release of recombinant DNA materials: 
rV-B-5-e-(4). Ensuring the integrity of 
the physical containment (e.g., biolo^cal 
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 NTH 
Guidelines for Research Involving 
Recombinant DNA Molecules, (ii) 
overseeing their implementation, and 
(iii) their Rnal 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. 
rV-C-l-a. General Responsibilities of 
the Director, NIH. The responsibilities 
of the Director shall include the 
following; 
rV-C-l-a-(l). Promulgating 
requirements as necessary to implement 
the Guidelines: 
IV-C-l-a-(2). Establishing and 
maintaining the RAC to carry out the 
responsibilities set forth in S^tion 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-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 ).) 
IV-C-1 -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-1-1>-(1). Ma/or Actions. To 
execute major actions the Director must 
seek the advice of the RAC and provide 
an opportimity 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 
days before the meeting. In addition, the 
Director's proposed decision, at his 
discretion, may be published in the 
Federal Register for 30 days of comment 
before final action is taken. The 
Director's final decision, along with 
response to the comments, will be 
published in the Federal Register and 
the Recombinant DNA Technical 
Bulletin. The RAC and IBC chairpersons 
will be notified of this decision: 
IV-C-l-b-(l)-(a). Changing 
containment levels for types of 
experiments that are sp^fied in the 
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