Federal Register / Vol. 47, No. 77 / Wednesday. April 21, 1982 / Notices 
17191 
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 Directors, 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 is 
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 decision, at his 
discretion, may be published in the 
Federal Register for 30 days of comment 
before Rnal action is taken. The 
Director’s final decisions, 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; 
rV-E-l-b-(l)-{b). Assigning 
containment levels for types of 
experiments that are not explicity 
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 constist 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; 
IV-E-l-b-(l)-(e). Permitting 
experiments specified by Section III-A 
of the Guidelines; and 
IV-E-l-b-(l)-(f). Adopting other 
changes in the Guidelines. 
IV-E-l-b-(2). The Director is also 
responsibile 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-l-b-(2)-(b). 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-l-b-(2)-(a). Interpreting and 
determining containment levels, upon 
request by ORDA; 
rV-E-l-b-(2)-(b). Changing 
containment levels for experiments that 
are specified in the Guidelines (see 
Section III); 
lV-E-l-b-(2)-(c). Assigning 
containment levels for experiments not 
explicity considered in the Guidelines; 
IV-E-l-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 
responsibile 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): 
rV-E-l-b-(3)-(a). Interpreting the 
Guidelines for experiments to which the 
Guidelines specifically assign 
containment levels; 
rV-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). Approving minor 
modifications of already certified host- 
vector systems. (The standards and 
procedures for such modifications are 
described in Section II-D-2); 
rV-E-l-b-(3)-(d). Decertifying already 
certified host-vector systems; 
IV-E-l-b-(3)-(e). Adding new entries 
to the list of toxins for vertebrates (see 
Appendix F); and 
IV-E-l-b-(3)-(f). Approving the 
cloning of toxin genes in host-vector 
systems other than E. coli K-12 (see 
Appendix F). 
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. 
IV-E-2. Recombinant DNA Advisory 
Committee. The NIH Recombinant DNA 
Advisory Committee (RAC) is 
responsible for carrying out specified 
functions cited 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 
environment, public health; occupational 
health, or related fields. Representatives 
from Federal agencies shall serve as 
nonvoting members. Nominations for the 
RAC may be submitted to the NIH 
Office of Recombinant DNA Activities. 
Bethesda, Md. 20205. 
All meetings of the RAC will be 
announced in the Federal Register, 
including tentative agenda items, 30 
days in advance of the meeting, with 
final agendas (if modified) available at 
least 72 hours before the meeting. No 
item defined as a major action under 
Section IV-E-l-b-(l) may be added to 
an agenda after it appears in the Federal 
Register. 
The RAC shall be responsible for 
advising the Director, NIH, on the 
actions listed in Section rV-E^l-b-(l) 
and -(2). 
IV-E^. The Office of Recombinant 
DNA Activities. ORDA shall serve as a 
focal point for information on 
recombinant DNA activities and provide 
advice to all within and outside NIH, 
including Institutions, Biological Safety 
Committees, Principal Investigators, 
Federal agencies. State and local 
governments, and institutions in the 
private sector. ORDA shall carry out 
such other functions as may be 
delegated to it by the Director, NIH, 
including those authorities described in 
Section IV-E-l-b-(3). In addition, 
ORDA shall be responsible for the 
following: 
IV-E-3-a. Reviewing and approving 
Institutional Biosafety Committee (IBC) 
membership; 
IV-E-3-b. Publishing in the Federal 
Register: 
rV-E-3-b-(l). Announcements of 
Recombinant DNA Advisory Committee 
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