38054 
Federal Register / Vol. 47, No. 167 / Friday, August 27, 1982 / Notices 
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-(lHc). 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 signihcant 
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-(lHf). 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: 
rV-C-l-b-(2}-{a)- Interpreting and 
determining containment levels, upon 
request by ORDA; 
IV-C-l-b-{b). Changing containment 
levels for experiments that are specified 
in the Guidelines (see Section III]; 
rV-C-l-b-(2]-(c]. assigning 
containment levels for experiments not 
explicityly considered in the Guidelines; 
' -IV-C-l-b-(2Hd]. Revising the 
“Classification of Etiologic Agencts” for 
the purpose of these Guidelines [1]. 
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 Ul-^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-(3Hd]. 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 
IV-C-l-b-(3Hg], Determining 
appropriate containment conditions for 
experiments according to case 
precedents developed under Section IV- 
C-l-b-(2]-(c]. 
IV-C-l-^(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-C-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-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, 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-C-l-b-(3]. In addition, 
ORDA shall be responsible for the 
following: 
IV-C-3-a. Reviewing and approving 
Institutional Biosafety Committee (IBC] 
membership; 
IV-C-3-b. Publishing in the Federal 
Register: 
IV-C-3-b-(l]. Announcements of 
Recombinant DNA Advisory Committee 
(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 hous in advance of the meeting. 
IV-C-3-b-(2]. Proposed major actions 
of the type falling under Section IV-C- 
l-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 recombinbnt 
DNA Technical Bulletin; and 
IV-C-3-d. Serving as executive 
secretary of the RAC. 
rV-C-4. Other NIH Components, 
Other NIH components shall be 
responsible for certifying P4 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, Intitutions 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. 
Noncopliance 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 
any or all recombinant DNA projects at 
the Institution. 
IV-D-2. All non-NIH funded projects 
involving recombinant DNA techniques 
conducted at or sponsored by an 
Institution that receives NIH funds for 
projects involving such techniques must 
comply with the NIH Guidelines. 
Noncompliance may result in (i] 
[8] 
