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Federal Regiatbr / Vol. 47, No. 102 / Wednesday, May 26. 1982 / Notices 
experiments according to case 
precedents developed under Section IV- 
C— 1— b— (2)— (c). 
rV-C-l-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. 
rV-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 Heal^, and the Director. NIH. 
The members of the committee shall 
be chosen to provide, collectively, 
expertise in scientific Belds relevant to 
recoombinant 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 
ciilture. 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 
RAS 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, %vith 
final agendas (if modified] available at 
least 72 hours before the meeting. No 
item defined as a major action under 
Section rV-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 lV-C-l-b-(2). 
rV-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 rV-C-l-b-(3). In addition, 
ORDA shall be responsible for the 
following; 
rV-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 hours in 
advance of the meeting. 
rV-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. 
rV-C-3-c. Publishing the Recombinant 
DNA Technical Bulletin-, and 
rV-C-3-d. Serving as executive 
secretary of the RAC. 
rV-C-4. Other NIH Components. 
Other NTH components shall be 
responsible for certifying P4 facilities, 
inspecting them periodically, and 
inspecting other recombinant DNA 
facilities as deemed necessary. 
rV-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. AH 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 
any or all recombinant DNA projects at 
the Institution. 
rV-D-2. AH 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) 
suspension, limitation, or termination of 
NIH funds for 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-3. Information concerning 
noncompliance with the Guidelines may 
be brought forward by any person. It 
should be delivered to both NTH 
(ORDA) and the relevant Institution. 
The Institution, generally through the 
IBC, shall take appropriate action. The 
Insitution shall forward a complete 
report of the incident to ORDA, 
recommending any further action 
indicated. 
IV-D-4. In cases where NIH proposes 
to suspend, limit, or terminate financial 
assistance because of noncompliance 
with the Guidelines, applicable DHHS 
and Public Health Service Procedures 
shall govern. 
Note. — Other Federal agencies which have 
adopted the NIH Guidelines may have the 
authority to terminate funding to their 
grantees should these grantees not comply 
with the NIH Guidelines. 
IV-D-5. Voluntary Compliance. Any 
individual, corporation, or institution 
that is not otherwise covered by the 
Guidelines is encouraged to conduct 
recombinant DNA research activities in 
accordance with the Guidelines, through 
the procedures set forth in Part VI. 
V. Footnotes and References of Sections I-IV 
1. The original reference to organisms as 
Class 1. 2. 3. 4, or 5 refers to the classiFication 
in the publication Classification ofEtiologic 
Agents on the Basis of Hazard, 4th Edition, 
July 1974; U.S. Department of Health, 
Education, and Welfare, Public Health 
Service. Centers for Disease Control. Office 
of Biosafety. Atlanta, Georgia 30333. 
The Director. NIH, with advice of the 
Recombinant DNA Advisory Committee, may 
revise the classification for the purposes of 
these Guidelines (see Section IV-C-l-b-(2)- 
(d)). The revised list of organisms in each 
class is reprinted in Appendix B to these 
Guidelines. 
2. In Part III of the Guidelines, there are a 
number of places where judgments are to be 
made. In all these cases the principal 
investigator is to make the judgment on these 
matters as part of his responsibility to “make 
the initial determination of the required 
levels of physical and biological containment 
in accordance with the Guidelines” (Section 
IV^-5-c-(l)). In the cases falling under 
Sections III-A, -B or -C, this judgment is to 
be reviewed and approved by the 
Institutional Biosafety Committee as part of 
its responsibility to make "an independent 
assessment of the containment levels 
required by these Guidelines for the proposed 
research" (Section IV-B-3-a-(l)). If die IBC 
wishes, any specific cases may be referred to 
the NIH Office of Recombinant DNA 
Activities as part of ORDA's functions to 
"provide advice to all within and outside 
NIH" (Section IV-C-3). and ORDA may 
request advice from the Recombinant DNA 
Advisory Committee as part of the RAC's 
responsibility for "interpreting and 
determining containment levels upon request 
by ORDA” (Section IV-C-l-b-(2)-(a)). 
3. Laboratory Safety at the Center for 
Disease Control (Sept. 1974). U.S. Department 
of Health, Education, and Welfare 
Publication No. CDC 75-8118. 
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