Federal Register / Vol. 45, No. 20 / Tuesday, January 29, 1980 / Notices 
6739 
molecule are exempt (•#) from the 
Guidelines. 
IV. Roles and Responsibilities 
1V-A. Policy. Safety in activities 
involving recombinant DNA depends on 
the individual conducting them. The 
Guidelines cannot anticipate every 
possible situation. Motivation and good 
judgment are the key essentials to 
protection of health and the 
environment. 
The Guidelines are intended to help 
the Institution, the Institutional 
Biosafety Committee (1BC). the 
Biological Safety Officer, and the 
Principal Investigator determine the 
safeguards that should be implemented. 
These Guidelines will never be complete 
or final, since all conceivable 
experiments involving recombinant 
DNA cannot be foreseen. Therefore, it is 
the responsibility of the Institution and 
those associated with it to adhere to the 
purpose of the Guidelines as well as to 
their specifics. 
Each Institution (and the IBC acting 
on its behalf] is responsible for ensuring 
that recombinant DNA activities comply 
with the Guidelines. General recognition 
of institutional authority and 
responsibility properly establishes 
accountability for safe conduct of the 
research at the local level. 
The following roles and 
responsibilities constitute an 
administrative framework in which 
safety is an essential and integral part of 
research involving recombinant DNA 
molecules. Further clarifications and 
interpretations of roles and 
responsibilities will be issued by NIH as 
necessary. 
IV-B. General Applicability. The 
Guidelines are applicable to all 
recombinant DNA research within the 
United States or its territories which is 
conducted at or sponsored by an 
Institution that receives any support for 
recombinant DNA research from NIH. 
This includes research performed by 
NIH directly. 
An individual receiving support for 
research involving recombinant DNA 
must be associated with or sponsored 
by an Institution that can and does 
assume the responsibilities assigned in 
these Guidelines. 
The Guidelines are also applicable to 
projects done abroad if they are 
supported by NIH funds. If the host 
country, however, has established rules 
for the conduct of recombinant DNA 
projects, then a certificate of compliance 
with those rules may be submitted to 
NIH in lieu of compliance with the NIH 
Guidelines. NIH reserves the right to 
withhold funding if the safety practices 
to be employed abroad are not 
reasonably consistent with the NIH 
Guidelines. 
IV-C. General Definitions. The 
following terms, which are used 
throughout the Guidelines, are defined 
as follows: 
IV-C-1. "DNA" means 
deoxyribonucleic acid. 
1V-C-2. "Recombinant DNA" or 
"recombinant DNA molecules" means 
either (i) molecules which are 
constructed outside living cells by 
joining natural or synthetic DNA 
segments to DNA molecules that can 
replicate in a living cell, or (ii) DNA 
molecules which result from the 
replication of a molecule described in (i) 
above. 
IV-C-3. "Memorandum of 
Understanding and Agreement" or 
"MUA" is a document that (i) provides 
to NIH or other Federal funding agency 
an Institution's certification that the 
recombinant DNA research project 
complies with the NIH Guidelines and 
(ii) contains other essential data as 
required in the Administrative Practices 
Supplement. 
1V-C-4. "Institution" means any 
public or private entity (including 
Federal. State, and local government 
agencies). 
IV-C-5. "Institutional Biosafety 
Committee" or "IBC" means a 
committee that (i) meets the 
requirements for membership specified 
in Section IV-D-2, and (ii) reviews, 
approves, and oversees projects in 
accordance with the responsibilities 
defined in Sections IV-D-2 and -3. 
IV-C-0. "NIH Office of Recombinant 
DNA Activities" or "ORDA" means the 
office within NIH with responsibility for 
(i) reviewing and coordinating all 
activities of NIH related to the 
Guidelines, and (ii) performing other 
duties as defined in Section IV-E-3. 
IV-C-7. "Recombinant DNA Advisory 
Committee" or "RAC" means the public 
advisory committee that advises the 
Secretary, the Assistant Secretary for 
Health, and the Director of the National 
Institutes of Health concerning 
recombinant DNA research. The RAC 
shall be constituted as specified in 
Section IV-E-2. 
IV-C-8. "Director. NIH" or "Director" 
means the Director of the National 
Institutes of Health and any other officer 
or employee of NIH to whom authority 
has been delegated. 
IV-C-9. "Federal Interagency 
Advisory Committee on Recombinant 
DNA Research" means the committee 
established in October 1976 to advise 
the Secretary, HEW, the Assistant 
Secretary for Health, and the Director, 
NIH on the coordination of those 
aspects of all Federal programs and 
activities w'hich relate to recombinant 
DNA research. 
IV-C-10. "Administrative Practices 
Supplement" or "APS" means a 
publication to accompany the NIH 
Guidelines specifying administrative 
procedures for use at NIH and at 
Institutions. 
IV-C-11. "Laboratory Safety 
Monograph" or "LSM" means a 
publication to accompany the NIH 
Guidelines describing practices, 
equipment, and facilities in detail. 
IV-D. Responsibilities of the 
Institution 
IV-D-1. Each Institution conducting or 
sponsoring recombinant DNA research 
covered by these Guidelines is 
responsible for ensuring that the 
research is carried out in full conformity 
with the provisions of the Guidelines. In 
order to fulfill this responsibility, the 
Institution shall: 
IV-D-l-a. Establish and implement 
policies that provide for the safe 
conduct of recombinant DNA research 
and that ensure compliance with the 
Guidelines. The Institution, as part of its 
general responsibilities for implementing 
the Guidelines, may establish additional 
procedures, as deemed necessary, to 
govern the Institution and its 
components in the discharge of its 
responsibilities under the Guidelines. 
This may include (i) statements 
formulated by the Institution for general 
implementation of the Guidelines and 
(ii) whatever additional precautionary 
steps the Institution may deem 
appropriate. 
IV-D-l-b. Establish an Institutional 
Biosafety Committee (IBC) that meets 
the requirements set forth in Section IV- 
D-2 and carries out the functions 
detailed in Section 1V-D-3. 
IV-D-l-c. Submit, for each 
recombinant DNA project that meets 
with its approval, a Memorandum of 
Understanding and Agreement (MUA) to 
the funding agency for approval and 
registration. 
Note. — No MUA is required for 
experiments described in Section III— 0).) All 
projects, however, can proceed upon IBC 
approval (before submission of the MUA to 
the funding agency) except for the following, 
which require prior approval by NIH (or other 
funding agency designated by NIH for this 
purpose): 
IV-D-l-c-(l). Projects for which 
containment levels are not specified by 
the Guidelines or NIH, 
IV-D-l-c-(2). Projects requiring P4 
containment, 
IV-D-l-c-(3). Reductions of 
containment levels for characterized or 
purified DNA preparations or clones 
(see Section III— A— 3), 
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