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Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
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 1BC chairpersons 
will be notified of this decision: 
lV-C~l-b-( l}-(a). Changing 
containment levels for types of 
experiments that are specified in the 
Guidelines when a major action is 
involved: 
IV-C-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-C-l-b-fl)-fc). 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; 
IV-C-l-b-(l)-(d). Permitting 
experiments specified by Section UI-A 
of the Guidelines; 
IV-C-l-b~( l)-(e). Certifying new host- 
vector systems with the exception of 
minor modifications of already certified 
systems (the standards and procedures 
for certification are described in 
Appendix I-II-A. Minor modifications 
constitute, for example, those of minimal 
or no consequence to the properties 
relevant to containment); and 
IV-C-l-b-flJ-{f). Adopting other 
changes in the Guidelines. 
IV-C-l-b-(2). Lesser Actions. To 
execute lesser actions, 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-C~l-b-(2)-(a). Interpreting and 
determining containment levels upon 
request by ORDA; 
IV-C-l-b-(2}-(b). Changing 
containment levels for experiments that 
are specified in the Guidelines (see 
Section III); 
lV-C-l-b-(2)-(c). Assigning 
containment levels for experiments not 
explicitly considered in the Guidelines; 
!V-C-l-b-(2)-(d). Revising the 
"Classification of Etiologic Agents" for 
the purpose of these Guidelines (i). 
IV-C-l-b-(3). Other Actions. The 
Director's decision will be .transmitted to 
the RAC and IBC chairpersons and 
published in the Recombinant DNA 
Technical Bulletin: 
IV-C-l-b-(3)-(a). Interpreting the 
Guidelines for experiments to which the 
Guidelines specifically assign 
containment levels; 
IV-C-l-b-(3)-(b). Setting containment 
under Section III-B-l-d and Section III— 
B-3-d; 
IV-C-l~b-(3)-(c). Approving minor 
modifications of already certified host- 
vector systems (the standards and 
procedures for such modifications are 
described in Appendix I— II); 
IV-C-l-b-(3)-(d). Decertifying 
already certified host-vector systems; 
IV-C-l-b-(3)-(e). Adding new entries 
to the list of molecules toxic for 
vertebrates (see Appendix F); 
IV-C-l-b-(3)~(f). Approving the 
cloning of toxin genes in host-vector 
systems other than E. coli K-12 (see 
Appendix F); and 
lV-C-l~b-(3)-(g). Determining 
appropriate containment conditions for 
experiments according to case 
precedents developed under Section IV- 
C— 1— b— (2)— (c). 
IV-C-l-b-(4). The Director shall 
conduct, support, and assist training 
programs in laboratory safety for IBC 
members, BSOs, Pis, and laboratory 
staff. 
IV-C-2. Recombinant DNA Advisory 
Committee. The 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 committee shall consist of 25 
members, including the chair, appointed 
by the Secretary or designee, at least 
fourteen of whom shall be selected from 
authorities knowledgeable in the fields 
of molecular biology or recombinant 
DNA research or in scientific fields 
other than molecular biology or 
recombinant DNA research, and at least 
six of whom 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 
non-voting members Nominations for 
the RAC may be submitted to the Office 
of Recombinant DNA Activities, 
National Institutes of Health, Building 
31, Room 3B10, 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 
items defined as a major action under 
Section IV-C-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 IV-C-l-b-(l) and 
IV-C-l-b-(2). 
IV-C-3. 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, BSOs, Pis, 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-C-1- 
b-(3). In addition, ORDA shall be 
responsible for the following: 
IV-C-3-a. Reviewing and approving 
IBC membership; 
IV-C-3-b. Publishing in the Federal 
Register 
IV-C-3-b-(l). Announcements of RAC 
meetings and agendas at least 30 days in 
advance; 
Note. — If the agenda for an RAC meeting is 
modified, ORDA shall make the revised 
agenda available to anyone upon request at 
least 72 hours in advance of the meeting. 
IV-C-3-b-(2). Proposed major actions 
of the type falling under Section IV-C-1- 
b-(l) at least 30 days prior to the RAC 
meeting at which they will be 
considered; and 
IV-C-3-b-(3). The NIH Director’s final 
decision on recommendations made by 
the RAC. 
IV-C-3-c. Publishing the Recombinant 
DNA Technical Bulletin: and 
IV-C-3-d. Serving as executive 
secretary of the RAC. 
IV-C-4. Other NIH Components. Other 
NIH components shall be responsible for 
certifying maximum containment (BL4) 
facilities, inspecting them periodically, 
and inspecting other recombinant DNA 
facilities as deemed necessary. 
IV-D. Compliance. As a condition for 
NIH funding of recombinant DNA 
research, Institutions must ensure that 
such research conducted at or 
sponsored by the Institution, 
irrespective of the source of funding, 
shall comply with these Guidelines. The 
policies on noncompliance are as 
follows: 
IV-D-1. All NIH-funded projects 
involving recombinant DNA techniques 
must comply with the NIH Guidelines. 
Noncompliance may result in: (i) 
Suspension, limitation, or termination of 
financial assistance for such projects 
and of NIH funds for other recombinant 
DNA research at the Institution, or (ii) a 
requirement for prior NIH approval of 
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