Federal Register / Vol. 48, No. 106 / Wednesday, June 1. 1983 / Notices 
24559 
III— E3 — 4— b. For all experiments 
involving whole animals and plants and 
not covered by III— B — 4 — a. the 
appropriate containment will be 
determined by the IBC. 
Ill— B— 5. Experiments Involving More 
Than 10 Liters of Culture. The 
appropriate containment will be decided 
by the IBC. Where appropriate, the 
large-scale containment 
recommendations of the HIH should be 
used (45 FR 24966). 
Ill— C. Experiments that Require IBC 
Notice Simultaneously with Initiation of 
Experiments. Experiments not included 
in Sections III— A. Ill— B. Ill— D. and 
subsections of these Sections are to be 
considered in Section III-C. All such 
experiments can be carried out at Pi 
containment. For experiments in this 
category, a registration document us 
described in Section III— B must be dated 
and signed by the investigator and filed 
with the local IBC at the time of 
initiation of the experiment. The IBC 
shall review all such proposals, but IBC 
review prior to initiation of the 
experiment is not required. (The reader 
should refer to the policy statement in 
the first two paragraphs of Section IV- 
A.) 
For example, experiments in which all 
components derive from non-pathogenic 
prokaryotes and non-pathogenic lower 
eukaryotes fall under Section III-C and 
can be carried out at Pi containment. 
Caution: Experiments Involving 
Formation of Recombinant DNA 
Molecules Containing no more Than 
Two-Thirds of the Genome of any 
Eukaryotic Virus. Recombinant DNA 
molecules containing no more than two- 
thirds of the genome of any eukaryotic 
virus (all viruses from a single Family 
(17] being considered identical [19]) may 
be propagated and maintained in cells in 
tissue culture using Pi containment. For 
such experiments, it must be shown that 
the cells lack helper virus for the 
specific Families of defective viruses 
being used. If helper virus is present, 
procedures specified under Section III— 
B-3 should be used. The DNA may 
contain fragments of the genome of 
viruses from more than one Family but 
each fragment must be less than two- 
thirds of a genome. 
Ill-D. Exempt Experiments. The 
following recombinant DNA molecules 
are exempt from these Guidelines and 
no registration with the IBC is 
necessary. 
III-D-1. Those that are not in 
organisms or viruses. 
III-D-2. Those that consist entirely of 
DNA segments from a single non- 
chromosomal or viral DNA source, 
though one or more of the segments may 
be a synthetic equivalent. 
Ill— 0—3. Those that consist entirely of 
DNA from a prokaryotic host, including 
its indigenous plasmids or viruses, when 
propagated only in that host (or a 
closely related strain of the same 
species) or when transferred to another 
host by well established physiological 
means; also, those that consist entirely 
of DNA from an eukaryotic host, 
including its chloroplasts, 
mitrochondria, or plasmids (but 
excluding viruses), when propagated 
only in that host (or a close related 
strain of same species). 
II1-D-4. Certain specified recombinant 
DNA molecules that consist entirely of 
DNA segments from different species 
that exchange DNA by known 
physiological processes, though one or 
more of the segments may be a synthetic 
equivalent. A list of such exchangers 
will be prepared and periodically 
revised by the Director, NIH, with 
advice of the RAC, after appropriate 
notice and opportunity for public 
comment. (See Section IV-C-l-b-(l)- 
(c).) Certain classes are exempt as of 
publication of these Revised Guidelines. 
The list is in Appendix A. An updated 
list may be obtained from the Office of 
Recombinant DNA Activities, National 
Institutes of Health, Bcthcsda, Maryland 
20205. 
III— D— 5. Other classes of recombinant 
DNA molecules, if the Director, NIH, 
with advice of the RAC, after 
appropriate notice and opportunity for 
public comment, finds that they do not 
present a significant risk to health or the 
environment. (See Section IV-C-l-b- 
( 1 ) — (c) . ) Certain classes are exempt as of 
publication of these Revised Guidelines. 
The list is in Appendix C. An updated 
list may be obtained from the Office of 
Recombinant DNA Activities, National 
Institutes of Health, Bethesda, Maryland 
20205. 
IV. Roles and Responsibilities 
IV- 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 (IBC), 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 
intent 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. Responsibilities of the 
Institution. 
IV-B-1. General Information. 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-B-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-B-l-b. Establish an Institutional 
Biosafety Committee (IBC) that meets 
the requirements set forth in Section IV- 
B-2 and carries out the functions 
detailed in Section IV-B— 3. 
IV-B-l-c. If the Institution is engaged 
in recombinant DNA research at the 1*3 
or P4 containment level, appoint a 
Biological Safety Officer, (BSO), who 
shall be a member of the IBC and carry 
out the duties specified in Section IV-B- 
4. 
IV-B-l-d. Require that investigators 
responsible for research covered by 
these Guidelines comply with the 
provisions of Section IV-B-5, and assist 
investigators to do so. 
IV-B-l-c. Ensure appropriate training 
for the IBC chairperson and members, 
ihe BSO, Principal Investigators (Pis), 
Hnd laboratory stuff regarding the 
Guidelines, their implementation, and 
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