Federal Register / Vol. 51, No. 88 / Wednesday. May 7, 1986 / Notices 
16961 
in the absence of helper under the conditions 
specified in Section lit— O. 
I/I-B-3-a. Experiments involving the 
use of infectious Class 2 animal viruses 
[1] or defective Class 2 animal viruses in 
the presence of helper virus can be 
performed at BL2 containment. 
III-B-3-b. Experiments involving the 
use of infectious Class 3 animal viruses 
[lj or defective Class 3 animal viruses in 
the presence of helper virus can be 
carried out at BL3 containment. 
III-B-3-c. Experiments involving the 
use of infectious Class 4 viruses [1] or 
defective Class 4 viruses in the presence 
of helper virus may be carried out under 
BL4 containment. 
HI-B-3-d. Experiments involving the 
.use of infectious Class 5 [1] viruses or 
defective Class 5 viruses in the presence 
of helper virus will be determined on a 
case-by-case basis following ORDA 
review. A USDA permit is required for 
work with Class 5 pathogens (18. 20). 
HI-B-3-e. Experiments involving the 
use of infectious animal or plant viruses 
or defective animal or plant viruses in 
the presence of helper virus not covered 
by Sections III— B— 3— a. U!-B-3-b. DI-B- 
3— c. or III-B-3-d may be carried out 
under BLl containment. 
Ill-B— t — Recombinant DNA 
Experiments Involving Whole Animals 
or Plants 
Hl-B-4-a. Recombinant DNA. or RNA 
molecules derived therefrom, 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 
(18. 20]. 
III-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 EC [22]. 
I/l-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 
Molecults. should be used. 
Ill-C. Experiments That Require IBC 
Notice Simultaneously With Initiation 
of Experiments 
Experiments not included in Secticns 
Ili-A. UI-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 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 EC shall review all 
such proposals, but EC 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 TV— A.) 
For example, experiments in which all 
components derive from non-pathogenic 
prokaryotes and non-pathogenic lower 
eukaryotes fall under Section E-C and 
can be carried out at BLl containment. 
CAUTION: Experiments Involving 
Formation of Recombinant DNA 
Moiecules 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 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 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. 
III-D — Exempt Experiments 
The following recombinant DNA 
molecules are exempt from these 
Guidelines and no registration with the 
EC 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 
nonchromosomal or viral DNA source 
though one or more of the segments may 
be a synthetic equivalent 
III-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 rrom 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— 1. 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- 
(lHc)). 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 20892. 
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 20892. 
IV. Roles and Responsibilities 
TV- A — Policy 
Safety in activities involving 
recombinant DNA depends on the 
individual conducting them. The 
Guidelines cannot anticipate every 
possible situation. Motivation and goed 
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 Principal 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 EC acting on 
its behalf) is responsible for ensuring 
that recombinant DNA activities comply 
with the Guidelines. General recognition 
of institutional authority and 
Recombinant DNA Research, Volume 1 1 
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