tices Supplement (APS) for further In- 
formation]; 
IV-E-l-lMIMd). Promulgating and 
amending a list of classes of recombin- 
ant DNA molecules to be exempt from 
these Guidelines because they consist 
entirely of DNA segments from species 
that exchange DNA by known physio- 
logical 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 infor- 
mation); 
IV-E-l-b-GMe). Permitting excep- 
tions to the prohibited experiments in 
the Guidelines, in order, for example, 
to allow risk-assessment studies; and 
IV-E-l-b-GWf). Adopting other 
changes in the Guidelines. 
IV-E-l-b-(2). The Director is also re- 
sponsible for the following lesser ac- 
tions. (For these, the Director must 
seek the advice of the RAC. The Di- 
rector'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-fc-l-b-^Mb). Changing contain- 
ment levels tor experiments that are 
specified in the Guidelines (see Sec- 
tion III); 
IV-E-l-b-<2Mc). Assigning contain- 
ment levels for experiments not ex- 
plicitly considered in the Guidelines 
(see 8ectlon III ); and 
IV-E-l-b-(2)-<d). Designating cer- 
tain class 2 agents as class 1 for the 
purpose of these Guidelines (see Foot- 
note 1 and Appendix B). 
rV-E~l-b-(3). The Director is also re- 
sponsible for the following actions 
(The Director's decision will be trans- 
mitted to the RAC and IBC chairper- 
sons and published in the Recombin- 
ant DNA Technical Bulletin): 
IV-E-l-b-OMa). Interpreting the 
Guidelines tor experiments to which 
the Guidelines specifically assign con- 
tainment levels: 
IV-E-l-b-OMb). Determining ap- 
propriate containment conditions for 
experiments according to case prece- 
dence developed under Section IV-E- 
l-b-<2>-(c). 
rV-E-l-tM3Mc). Determining ap- 
propriate containment conditions 
upon case-by-case analysis of experi- 
ments explicitly considered in the 
Guidelines but for which no contain- 
ment levels have been set (see Foot- 
note 45 in Part V; Sections III-C-1-a 
through -e; and Sections III-C -2 and 
-3Y. 
IV-E-l-b-(3)-<d). Authorizing, under 
procedures specified by the RAC. 
large-scale experiments (Le.. involving 
more than 10 liters of culture) for re- 
combinant DNAs that are rigorously 
characterized and free of harmful se- 
NOTICES 
quences (see Footnote 3 and Section I- 
D-6); 
IV-E-l-b-OMe). Lowering contain- 
ment levels one step for characterized 
clones involving primate DNA or for 
experiments using purified primate 
DNA (see Sections III-A-3-a and -b. 
and Footnotes 3 and 41); 
IV-E-l-b-<3Mf). Lowering contain- 
ment levels for experiments Involving 
other characterized clones or purified 
DNA below PI + EK1 (see Sections 
III-A-3-a and -b. and Footnotes 3 and 
41): 
IV-E-l-b-<3>-<g). Lowering contain- 
ment levels for characterized clones or 
purified DNA beyond one step (see 
Sections III-A-3-a and -b. and Foot- 
notes 3 and 41); 
IV-E-l-b-OMh). 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>-<D. Decertifying al- 
ready certified host-vector systems. 
IV-E-l-b-<4). The Director shall 
conduct, support, and assist training 
programs in laboratory safety for In- 
stitutional Biosafety Committee mem- 
bers. Biological Safety Officers. Princi- 
pal Investigators, and laboratory staff. 
IV-E-l-b-(5). The Director, at the 
end of 36 months from the time these 
Guidelines are promulgated, will 
report on the Guidelines, their admin- 
istration. and the potential risks and 
benefits of this research. In going so, 
the Director will consult with the 
RAC aad the Federal Interagency 
Committee. Public comment will be so- 
licited on the draft report and taken 
into account in transmitting the final 
report to the Assistant Secretary for 
Health and the Secretary. HEW. 
IV-E-2. Recombinant Advisory Com- 
mittee. The NIH Recombinant DNA 
Advisory Committee (RAC) is respon- 
sible for carrying out spectUed func- 
tions cited below as well a r others as- 
signed under its charter o\ by the Sec- 
retary. HEW. the Assis'ant Secretary 
for Health, and the Director. NIH. 
The members of the committee shall 
be chosen to provide, collectively, ex- 
pertise in scientific fields relevant to 
recombinant DNA technology and bio- 
logical safety— e.g., microbiology, mo- 
lecular biology, virology, genetics, epi- 
demiology. infectious dleseases. the bi- 
ology of enteric organisms, botany, 
plant pathology, ecology, and tissue 
culture. At least 20 percent of the 
members shall be persons knowledge- 
able 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 nonvot- 
ing members. Nominations for the 
RAC may be submitted to the NIH 
60127 
Office of Recombinant DNA Activi- 
ties. 
All meetings of the RAC will be an- 
nounced in the Federal Register, in- 
cluding 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 Fed- 
eral Register. 
IV-E-2-a. The RAC shall be responsi- 
ble for advising the Director, NIH, on 
the actions listed in Section IV-E-l-b- 
(1) and -<2). 
IV-E-3. The Office of Recombinant 
DNA Activities. ORDA shall serve as a 
focal point for information on recom- 
binant DNA activities and provide 
advice to all within and outside NIH. 
Including Institutions. Biological 
Safety Committees. Principal Investi- 
gators, 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 fol- 
lowing: 
IV-E-3-a. Review and approval of 
Institutional Biosafety Committee 
(IBC) membership; 
IV-E-3-b. Registration of recombin- 
ant DNA projects; and 
TV-E-3-c. Review of Memoranda of 
Understanding and Agreement 
(MU As), and approval of those that 
conform to the Guidelines. In so 
doing, ORDA shall; 
IV-E-3-c-(l). Conduct an independ- 
ent evaluation of the containment 
levels required for the research cov- 
ered by these Guidelines; 
IV-E-3-c-(2). Determine whether 
the physical and biological contain- 
ment levels approved by the IBC are 
in accordance with the requirement of 
the Guidelines; 
IV-E-3-c-<y). Notify Institutions and 
the IBC chairperson in a timely fash- 
ion when MU As (including changes in 
ongoing projects) do not conform to 
the Guidelines, and Inform them of 
corrective measures to be taken; 
IV-E-3-c-<4). Publish in the Federal 
Register; 
IV-E-c-<4)-<a). Announcements of 
Recombinant DNA Advisory Commit- 
tee (RAC) meetings and agendas 30 
days in advance, with publication of 
the Director’s proposed decision for 30 
days of public and Federal agency 
comment followed by a published re- 
sponse, on any action listed in Section 
IV-E-l-b-<l); and 
rV-E-3-c-(4Mb). Announcements of 
RAC meetings and agendas 30 days In 
advance on any action listed in Section 
IV-E-l-b-<2). 
FEOCtAl teOISTR, VOi. 41, NO. 247 — HMOAY, DCCtMItt 22. 1971 
[49] 
