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Federal Register / Vol. 46. No. 233 / Friday, December 4, 1981 / Notices 
(i) reviewing and coordinating all 
activities of NIH related to the 
Guidelines, and (ii) performing other 
duties as defined in Section lV-E-3. 
rV-C-7. "Recombinant DNA Advisory 
Committee" or "RAC” means the public 
advisory committee that advises the 
Secretary, the Assistant Secretary for 
Health, and the Director of the National 
Institutes of Health concerning 
recombinant DNA research. The RAC 
shall be constituted as specified in 
Section IV-E-2. 
IV-C-6. "Director. NIH” or "Director” 
means the Director of the National 
Institutes of Health and any other officer 
or employee of NIH to whom authority 
has been delegated. 
rV-C-9. (Deleted) 
rV-C-10. [Deleted] 
rV-C-11. "Laboratory Safety 
Monograph" or "LSM" means a 
publication to accompany the NIH 
Guidelines describing practices, 
equipment, and facilities in detail. 
rV-D. Responsibilities of the 
Institution. 
Each Institution conducting or 
sponsoring recombinant DNA research 
should take responsibility for monitoring 
its own activities in this area. Any 
unusual events that might be associated 
with the use of recombinant DNA 
molecules should be reported to the 
Director, NIH. 
rV-E. Responsibilities of NIH. 
rV-E-1. Director. The Director. NIH. is 
responsible for (i) establishing the NIH 
Guidelines on recombinant DNA 
research, (ii) overseeing their 
impiementation. and (lii) 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. 
rV-E-l-a. General Responsibilities of 
the Director, .NIH. The responsibilities 
of the Director shall include the 
following: 
rV-E-l-a-(l). Promulgating 
requirements as necessary to implement 
the Guidelines: 
rV-E-l-a-{2). Establishing and 
maintaining the RAC to cany out the 
responsibilities set forth in Action IV- 
E-2. The RAC's membership is specified 
in its charter and in Section IV-^2; and 
IV-E-l-a-(3). Establishing and 
aintaining ORDA to carry out the 
responsibilities defined in Section IV-E- 
3. 
IV-E-l-b. Specific Responsibilities of 
the Director, NIH. 
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 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 will be notified of 
this decision); 
rV-E-l-b-(l)-(a). Changing 
containment levels for types of 
experiments that are specified in the 
Guidelines when a major action is 
involved: 
rV-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-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 
n-D-2-a. Minor modifications 
constitute, for example, those of minimal 
or no consequence to the properties 
relevant to containment.); 
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 for further 
information); 
IV-E-l-b-(l)-(e). (Deleted) 
IV-E-l-b-(l)-(f). Adopting other 
changes in the Guidelines. 
lV-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 pubbshed in the 
Recombinant DNA Technical Bulletin): 
IV-E-l-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: 
IV-E-l-b-(2)-(c). Assigning 
containment levels for experiments not 
explicitly considered in the Guidelines: 
IV-E-l-b-(2)-{d). (Deleted) 
lV-E-l-b-(2)-(e). (Deleted) 
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 published in 
the Recombinant DNA Technical 
Bulletin): 
lV-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 
precedents developed under Section IV- 
E-l-b-(2)-{c). 
IV-E-l-b-(3)-{c). (Deleted] 
IV-E-l-b-(3)-{d). [Deleted) 
IV-E-l-b-(3)-{e). [Deleted) 
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 Il-D-2); and 
IV-E-l-b-(3)-(g). Decertifying already 
certified host-vector systems. 
IV-E-l-b-(3)-(h). (Deleted) 
rV-E-l-b-(3}-(i). Adding new entries 
to the list of toxins for vertebrates (see 
Appendix G). 
IV-E-l-b-(3)-(j). Approving the 
cloning of toxin genes in host-vector 
systems other than E. coli K-12 (see 
Appendix G). 
lV-E-l-b-(4). [Deleted) 
IV-E-l-b-(5). (Deleted) 
IV-E-2. Recombinant DNA Advisory 
Committee. The NIH Recombinant DNA 
Advisory Committee (RAC) is 
responsible for carrying out specified 
functions dted below as well as others 
assigned under its charter or by the 
Secretary. HHS, the Assistant Secretary 
for Health, and the Director, NIH. 
The members of the committee shall 
be chosen to provide, collectively, 
expertise in scientific fields relevant to 
recombinant DNA technology and 
biological safety — e.g., microbiology, 
molecular biology, virology, genetics, 
epidemiology, infectious diseases, the 
biology of enteric organisms, botany, 
plant pathology, ecology, and tissue 
culture. At least 20 percent of the 
members shall be persons 
knowledgeable in applicable law, 
standards of professional conduct and 
practice, public attitudes, the 
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