Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
46269 
l/I-B—4-a. DNA from any source 
except for greater than two-thirds of a 
eukaryotic viral genome may be 
transferred to any non-human 
vertebrate organism and propagated 
under conditions of physical 
containment comparable to BLl and 
appropriate to the organism under study 
(2). It is important that the investigator 
demonstrate that the fraction of the viral 
genome being utilized does not lead to 
productive infection. A USDA permit is 
required for work with Class 5 agents. 
( 10 , 20 ) 
lll-B—4-b. For all experiments 
involving whole animals and plants and 
not covered by Section III— B — 4 — a, the 
appropriate containment will be 
determined by the IBC (22). 
III-B-5. Experiments Involving More 
Than 10 Liters of Culture. The 
appropriate containment will be decided 
by the IBC. Where appropriate. 
Appendix K, Physical Containment for 
Large-Scale Uses of Organisms 
Containing Recombinant DNA 
Molecules, should be used. 
III-C. Experiments that Require IBC 
Notice Simultaneously with Initiation of 
Experiments. Experiments not included 
in Sections III-A, III— B. III-D, and 
subsections of these sections are to be 
considered in Section III-C. All such 
experiments can be carried out at BLl 
containment. For experiments in this 
category, a registration document as 
described in Section HI— 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 BLl 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 eukeryolic 
virus (all viruses from a single Family 
(17) being considered identical (75)) may 
be propagated and maintained in cells in 
tissue culture using BLl 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 presented, 
procedures specified under Section II— 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. 
UI-D. Exempt Experiments. The 
following recombinant DNA molecules 
are exempt from these Guidelines and 
no registration with the IBC is 
necessary: 
lll-D-1. Those that are not in 
organisms or viruses. 
lll-D-2. Those that consist entirely of 
DNA segments from a single 
nonchromosomal or viral DNA source 
though one or more of the segments may 
be a synthetic equivalent. 
lll-D-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, mitochondria, 
or plasmids (but excluding viruses) 
when propagated only in that host (or a 
closely related strain of the same 
species). 
III-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 
periodicaly 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. 
This list is in Appendix A. An updated 
list may be obtained from the Office of 
Recombinant DNA Activities, National 
Institutes of Health, Building 31, Room 
3B10, Bethesda, 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-(l)- 
(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, Building 31. Room 
3B10, 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, Institutional Biosafety 
Committee (IBC), Biological Safety 
Officer (BSO), and Principle Investigator 
(PI) 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-l. 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 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 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 BL3 
or BL4 containment level, appoint a 
BSO, who shall be a member of the IBC 
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