Federal Register / Vol. 46. No. 126 / Wednesday. July 1. 1981 / Notices 
34479 
experiments in the Guidelines, in order, 
for example, to allow risk-assessment 
studies; and 
IV-E-l-b-(lHn- Adopting other 
changes in the Guidelines. 
The Director it also 
responsible for the following lesser 
actions (For these, the Director must 
seek the advice of the RAC. The 
I Director's decision %vill be transmitted to 
the RAC and IBC chairpersons and 
I published in the Recombinant DNA 
Technical Bulletin): 
rV-E-l-b-{2H®)- Interpreting and 
determining containment levels, upon 
request by ORDA: 
IV-E-l-b-(2)-{b). Changing 
containment levels for experiments that 
are speciRed in the Guidelines (see 
Section III): 
IV-E-l-b-(2)-(c). Assigning 
containment levels for experiments not 
explicitly considered in the Guidelines 
(see Section III): 
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-tH2He). Assigning 
containment levels for experiments with 
recombinant DNA from Class 3 
organisms (1| and assigning containment 
levels for experiments which increase 
the host-range and virulence of plant 
pathogens beyond that which occurs by 
natural genetic exchange. 
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 IBC 
chairpersons and published In the 
Recombinant DNA Technical Bulletin): 
IV-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-tH2Hc). 
IV-&-l-l>-(3Hc). Determining 
appropriate containment conditions 
upon case-by-case analysis of 
experiments explicitly considered in the 
Guidelines but for which no 
containment levels have been set (see 
Footnote 45 in Part V; Sections Ill-C-l-a 
through -e: and Sections IIl-C-2 and -3); 
IV-E-l-b-(3Hd)- Authorizing, under 
procedures specified by the RAC. large- 
scaie experiments (i.e.. involving more 
than 10 liters of culture) for recombinant 
DNAs that are rigorously characterized 
and free of harmful sequences (see 
Footnote 3 and Section I-D-6): 
IV-E-l-b-(3He)- Lowering 
containment levels for characterized 
clones or purified DNA (see Sections III- 
A-3-a and -b. and Footnotes 3 and 4I)\ 
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-(3Hh)- Assigning 
containment levels for experiments in 
which both donor and recipient are 
nonpathogenic prokaryotes and/or 
nonpathogenic lower eukaryotes (see 
Section II1-0-2). 
IV-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). 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-l-b-(5). The Director, at the end 
of 36 months from the time these 
Guidelines are promulgated, will report 
on the Guidelines, their administration, 
and the potential risks and benefits of 
this research. In doing so. the Director 
will consult with the RAC and the 
Federal Interagency Committee. Public 
comment will be solicited on the draft 
report and taken into account in 
transmitting the final report to the 
Assistant Secretary for Health and the 
Secretary. HHS. 
IV-E-2. Recombinant 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 chapter 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. 
IV-E-2-a. The RAC shall be 
responsible for advising the Director, 
NIH. on the actions listed in Section IV- 
E-J-b -(1) and -(2). 
IV-E-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. 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. Review and approval of 
Institutional Biosafety Committee (IBC) 
membership; 
IV-E-3-b through IV-E-3-c-(3). 
(Deleted) 
IV-E-3-c-(4). Publish in the Federal 
Register. 
IV-E-3-c-(4)-(a). Announcements of 
Recombinant DNA Advisory Committee 
(RAC) meetings and agendas 30 days in 
advance, with publication of th& 
Director's proposed decision for 30 days 
of public and Federal agency comment 
followed by a published response, on 
any action listed in Section lV-E-l-(b)- 
(1): and 
IV-E-3-c-(4)-(b). Announcements of 
RAC meetings and agendas 30 days in 
advance on any action listed in Section 
IV-E-l-b-(2). 
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-E-3-c-(5). Publish the 
Recombinant DNA Technical Bulletin: 
and 
IV-E-3-c-(6). Serve as executive 
secretary to the RAC. 
IV-E-4. Other NIH Components. 
Other NIH components shall be 
responsible for: 
IV-E-4-a. (Deleted) 
IV-E-4-b. Certifying P4 facilities, 
inspecting them periodically, and 
[ 167 ] 
