6742 
Federal Register / Vol. 45, No. 20 / Tuesday, January 29, 1980 / Notices 
the required safety practices and 
techniques are employed; 
lV-D-5-e-(2J. 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 
lV-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 ofNIH. 
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 
opportunity 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 chapter 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 RCA 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-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— 1— b— (1)— (b). Assigning 
containment levels for types of 
experiments that are not explicitly 
considered in the Guidelines when a 
major action is involved; 
IV-E-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 
otherwise do not present a significant 
risk to health or the environment (see 
Sections I-E-4 and -5 and the APS for 
further information); 
IV-E-l-b-(l)-(e). Permitting 
exceptions to the prohibited 
experiments in the Guidelines, in order, 
for example, to allow risk-assessment 
studies; and 
IV-E-l-b-(l)-(f). Adopting other 
changes in the Guidelines. 
IV-E-l-b-(2). The Director is also 
responsible for the following lesser 
actions (For these, the Director must 
seek the advice of the RAC. The 
Director’s decision will be transmitted to 
the RAC and IBC chairpersons and 
published in the Recombinant DNA 
Technical Bulletin ): 
IV— E— 1— b— (2)— (a). Interpreting and 
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); and 
IV— E— 1— b— (2)— (d). Designating certain 
class 2 agents as class 1 for the purpose 
of these Guidelines (see Footnote 1 and 
Appendix B). 
IV-E-l-b-(3). The Director is also 
responsible for the following actions 
(The Director’s decision will be 
transmitted to the RAC and IBC 
chairpersons and published in the 
Recombinant DNA Technical Bulletin ): 
IV-E-l-b-(3)-(a). Interpreting the 
Guidelines for experiments to which the 
Guidelines specifically assign 
containment levels; 
IV-E-l-b-(3)-{b). Determining 
appropriate containment conditions for 
experiments according to case 
precedence developed under Section 
IV-E-l-b-(2)-(c). 
IV-E-l-b-(3)-(c). Determining 
appropriate containment conditions 
upon case-by-case analysis of 
experiments explicitly considered in the 
Guidelines but for which no 
containment levels have been set (see 
Footnote 45 in Part V; Sections III-C-1-a 
through -e; and Sections III-C-2 and -3); 
IV-E-l-b-(3)-(d). Authorizing, under 
procedures specified by the RAC, large- 
scale experiments (i.e., involving more 
than 10 liters of culture) for recombinant 
DNAs that are rigorously characterized 
and free of harmful sequences (see 
Footnote 3 and Section I— D— 6); 
IV-E-l-b-(3)-(e). Lowering 
containment levels for characterized 
clones or purified DNA (see Sections III— 
A-3-a and -b, and Footnotes 3 and 41); 
IV-E-l-b-(3)-(f). Approving minor 
modifications of already certified host- 
vector systems (The standards and 
procedures for such modifications are 
described in Section II-D-2-a); and 
IV-E-l-b-{3)-(g). Decertifying already 
certified host-vector systems. 
IV-E-l-b-{4). The Director shall 
conduct, support, and assist training 
programs in laboratory safety for 
Institutional Biosafety Committee 
members, Biological Safety Officers, 
Principal Investigators, and laboratory 
staff. 
r 34j 
