Federal Register / Vol. 46, No. 233 / Friday, December 4, 1981 / Notices 
59415 
experiments requiring case-by-case 
review. 
IV-D-5-b-(5). Petition NIH for 
determination of containment for 
experiments not covered by the 
Guidelines. 
IV-D-5-C. Submissions by the PI to 
the IBC. The PI shall: 
IV-D-5-c-(lJ. Make the initial 
determination of the required levels of 
physical and biological containment in 
accordance with the Guidelines: 
IV-D-5-c-(2). Select appropriate 
microbiological practices and laboratory 
techniques to be used in the research; 
IV-D-5-c-(3). Submit the initial 
research protocol (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-D-5-c-(4). Remain in 
communication with the IBC throughout 
the conduct of the project. 
rV-D-5-d. PI Responsibilities After 
Approval but Prior to Initiating the 
Research. The PI is responsible for: 
IV-D-5-d-(l). Making available to the 
laboratory staff copies of the approved 
protocols that describe the potential 
biohazards and the precautions to be 
taken; 
IV-D-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-D-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-D-5-e. PI Responsibilities During 
the Conduct of the Approved Research. 
The PI is responsible for: 
IV-D-5-e-(l). Supervising the safety 
performance of the staff to ensure that 
the required safey practices and 
techniques are employed: 
IV-E)-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: 
IV-D-5-e-(3). Correcting work errors 
and conditions that may result in the 
release of recombinant DNA materials; 
IV-D-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): and 
IV-D-5-e-(5). Publications. Pis are 
urged to include, in all publications 
reporting on recombinant DNA research, 
a description of the physical and 
biological containment procedures 
employed. 
IV-E. Responsibilities of NIH. 
IV-E-1. Director. The Director, NIH, is 
responsible for (i) establishing the NIH 
Guidelines on recombinant DNA 
research, (ii) overseeing their 
implementation, and (iii) their final 
interpretation. 
The Director has a number of 
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 
opportvmity for public comment, with 
published response, before final action. 
IV-E-l-a. General Responsibilities of 
the Director, NIH. The responsibilities 
of the Director shall include the 
following: 
IV-E-l-a-(l). Promulgating 
requirements as necessary to implement 
the Guidelines. 
IV-E-l-a-(2). Establishing and 
maintaining the RAC to carry out the 
responsibilities set forth in Section IV- 
E-2. The RAC's membership is specified 
in its charter and in Section IV-E-2; 
IV-E-l-a-(3). Establishing and 
maintaining ORDA to carry out the 
responsibilities defined in Section IV-E- 
3; and 
IV-E-l-a-(4). Maintaining the Federal 
Interagency Advisory Committee on 
Recombinant DNA Research established 
by the Secretary, HEW, for advice on 
the coordination of all Federal programs 
and activities relating to recombinant 
DNA, including activities of the RAC. 
IV-E-l-b. Specific Responsibilities of 
the Director, NIH. In carrying out the 
responsibilities set forth in this Section, 
the Director 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-E-l-b-(l). The Director is 
responsible for the following major 
actions (For these, 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 
days before the meeting. In addition, the 
Director’s proposed deciwon, at his 
discretion, may be published in the 
Federal Register for 30 days for 
comment before final action is take. 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-E-l-b-(l)-(a). Changing 
containment levels for types of 
experiments that are specified in the 
Guidelines when a major action is 
involved: 
IV-E-l-b-(l)-(b). Assigning 
containment levels for types of 
experiments that are not explicitly 
considered in the Guidelines when a 
major action is involved; 
IV-F,-l-b-(l)-(c). Certifying new host- 
vector systems, with the exception of 
minor modifications of already certified 
systems. [The standards and procedures 
for certification are described in Section 
II-D-2-a. Minor modifications 
constitute, for example, those of minimal 
or no consequence to the properties 
relevant to containment. See the 
Administrative Practices Supplement 
(APS) for further information]; 
IV-E-l-b-(l)-(d). Promulgating and 
amending a list of classes of 
recombinant DNA molecules to be 
exempt from these Guidelines because | 
they consist entirely of DNA segments > 
from species that exchange DNA by ! 
known physiological processes, or f 
otherwise do not present a significant * 
risk to health or the environment (see S' 
Sections I-E-4 and -5 and the APS for ^ 
further information); ? 
IV-E-l-b-(l)-(e). Permitting p 
exceptions to the prohibited * 
experiments in the Guidelines, in order, p 
for example, to allow risk-assessment u 
studies; and i ^ 
IV-E-l-b-(l)-(f). Adopting other 
changes in the Guidelines. 
IV-E-l-b-(2). The Director is also Ll 
responsible for the following lesser jl| 
actions (For these, the Director must ' 
seek the advice of the RAC. The f 
Director’s decision will be transmitted to j 
the RAC and IBC chairpersons and M 
published in the Recombinant DNA ii 
Technical Bulletin): in 
IV-E-l-b-(2)-(a). Interpreting and fl 
determining containment levels, upon 
request by ORDA; 
IV-E-l-b-(2)-(b). Changing 
containment levels for experiments that 
are specified in the Guidelines (see ; 
Section III): | 
IV-E-l-b-(2)-(c). Assigning 
containment levels for experiments not 
explicitly considered in the Guidelines ^ 
(see Section III); 
IV-E-l-b-(2)-(d). Designating certain , 
class 2 agents as class 1 for the purpose / 
r304] 
