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Federal Register / Vol. 51, No. 88 / Wednesday, May 7. 1986 / Notices 
scientific and technical. In certain 
circumstances, there is specific 
opportunity for public comment with 
published response before final action. 
IV-C-l-a. General Responsibilities of 
the Director, NIH. The responsibilities 
of the director shall include the 
following: 
IV-C-l-a-(l). Promulgating 
requirements as necessary to implement 
the Guidelines: 
IV-C-l-a-(2J. Establishing and 
maintaining the RAC to carry out the 
responsibilities set forth in Section IV- 
C-2. The RAC’s membership is specified 
in its charter and in Section IV-C-2: 
IV-C-l-a-{3). Establishing and 
maintaining ORDA to carry out the 
responsibilities defined in Section IV-C- 
3. 
IV-C-l-b. Specific Responsibilities of 
the Director, NIH. In carrying out the 
responsibilities set forth in this section, 
the director or a designee 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-C-l-b-ll). Major Actions. To 
execute major actions 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 
Tederal Register at least 30 days before 
the meeting, and the director will also 
publish the proposed actions in the 
Federal Register for comment as 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 Reco;nbir.ant DNA Technical 
Bulletin. The RAC and IBC chairpersons 
will be notified of this decision: 
IV-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-( 1 )-( 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-(l)-(c). 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 III— 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-(l)-(f). Adopting other 
changes in the Guidelines. 
IV-C-l-b-(2J. 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 
publiched 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-(2j-(c). Assigning 
containment levels for experiments not 
explicitly considered in the Guidelines: 
IV-C-l-b-(2)-(d). Revising the 
“Classification of Eticlogic Agents" for 
the purpose of these Guidelines (1). 
IV-C-l-b-(3). Other Actions. The 
director's decision will be transmittede 
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; 
lV-C-2-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 ether than E. coli K-12 (see 
Appendix F); and 
IV-C-l-b-(3 )-(g /Determining 
appropriate containment conditions for 
experiments according to case 
precedents developed under Section IV- 
C -l-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 Advisor}- 
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. NTH. 
The committee shall consist of 25 
members including the chair, appointed 
by the Secretary or his or her 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 20892. 
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-C-l-b-(l) may be added to 
an agenda after it appears in the Federal 
Register. 
The PvAC 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. The 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. 
The 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: 
lV-C-3-b-fl). Announcements of 
RAC meetings and agendas at least 30 
days in advance: 
Recombinant DNA Research, Volume 1 1 
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