Federal Register / Vol. 59, No. 127 / Tuesday. July 5. 1994 / Notices 
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plant-a.ssociated microorganisms not 
covered in Section III-D-2-b or otlier 
sections of the NIH Guidelines. 
E.xamples of such experiments are those 
involving recombinant DNA-modified 
plants that are not noxious weeds or 
that cannot interbreed with noxious 
weeds in the immediate geographic 
area, and experiments involving whole 
plants and recombinant DNA-modified 
non-exotic (see Section V-\V) 
microorganisms that have no recognized 
potential for rapid and widespread 
dissemination or for serious detrimental 
impact on managed or natural 
ecosystems (e.g., Rhizobium spp. and 
Agrobacterium spp.). 
Section III-D-2-b. BL2-P or BLl-P + 
biological containment is recommended 
for the following experiments: 
Section IlI-D-2-b-(l). Plants modified 
by recombinant DNA that are noxious 
weeds or can interbreed with noxious 
weeds in the immediate geographic 
area. 
Section Ill-D-2-b-(2). Plants in which 
the introduced DNA represents the 
complete genome of a non-exotic 
infectious agent (see Section V-\V). 
Section III-D-2-b-(3). Plants 
associated with recombinant DNA- 
modified non-exotic microorganisms 
that have a recognized potential for 
serious detrimental impact on managed 
or natural ecosystems (see Section V-W). 
Section IlI-D-2-b-(4). Plants 
associated with recombinant DN.A- 
modified exotic microorgani.sms that 
have no recognized potential for, serious 
natural ecosystems (see Section V-W). 
Section IIl-D-2-b-(5). Experiments 
with recombinant DNA-modified 
arthropods or small animals associated 
with plants, or with arthropods or small 
animals with recombinant DNA- 
modified microorganisms assoc;iated 
with them if the recombinant DNA- 
modified microorganisms have no 
recognized potential for serious 
detrimental impact on managed or 
natural ecosystems (see Section V-W) 
Section III-E. Exempt Experiments 
The following recombinant DNA 
molecules are exempt from the NIH 
Guidelines and registration with the 
Institutional Biosafety Committee is not 
required: 
bection Ul-E-1. Those that are not in 
organisms or viru.ses. 
Section III-E-2. Those that consist 
entirely of DNA segments from a single 
nonchromosomal or viral DNA source, 
though one or more of the segments may 
a synthetic equivalent. 
Section IlI-E-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. 
Section III-E— 4. Those that consi.st 
entirely of DNA from an eukary^otic 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). 
Section III-E-5. Those that consist 
entirely of DNA segments from different 
species that e.xchange 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 NIH Director with advice 
of the RAC after appropriate notice and 
opportunity for public comment (see 
Section IV-C-l-b-(l)-(c)). See 
Appendices A-I through A-VI for a list 
of natural exchangers that are exempt 
from the NIH Guidelines. 
Section III-E-6. Those that do not 
present a significant risk to health or the 
environment (see Section IV-C-l-b-(l)- 
(c)). as determined by the NIH Director, 
with the advice of the RAC, and 
following appropriate notice and 
opportunity for public comment. See 
Appendix C for other classes of 
experiments which are exempt from the 
NIH Guidelines." 
D. Amendment to Section IV, Roles and 
Responsibilities of the NIH Guidelines 
The amended version of Section IV- 
C-l-b reads as follows: 
Section IV-C-l-b. Specific 
Responsibilities (NIH Director) 
In carrying out the responsibilities .set 
forth in this section, the NIH Director, 
or a designee shall weigh each proposed 
action through appropriate analysis and 
consultation to determine whether it 
complies with the NIH Guidelines and 
presents no significant risk to health or 
the environment. 
Section IV-C-l-b-(l). Major Actions 
To execute Major Actions, the NIH 
Director shall seek the advice of the 
R^C and provide an opportunity for 
public and Federal agency comment. 
Specifically, the Notice of Meeting and 
Proposed Adions to the NIH Guidelines 
shall be published in the Federal 
Register at least 15 days before the RAC 
meeting (not applicable for Expedited 
Review single patient human gene 
transfer experiments considered under 
Appendix M-VI). The NIH Director’s 
decision, at his/her discretion, may be 
published in the Federal Register for 15 
days of comment before final action is 
taten I he NIH Director’s final decision. 
along with responses to public 
comments, shall be published in the 
Federal Register. The RAC and 
In.stitutional Biosafety Committee Chairs 
shall be notified of the following 
decisions: 
Section IV-C-l-b-(l)-(a). Changing 
containment levels for types of 
experiments that are specified in the 
NIH Guidelines when a Major Action is 
invoUed; 
Section IV-C-l-b-(l)-(b). Assigning 
containment levels for types of 
experiments that are not explicitly 
considered in the NIH Guidelines when 
a Major Action is involved; 
Section lV-C-l-b-(l)-(c). 
Promulgating and amending a list of 
classes of recombinant DNA molecules 
to be exempt from the NIH Guidelines 
because they consist entirely of DN.A 
segments from species that exchange 
DNA by known physiological processes 
or otherwise do not present a significant 
risk to health or the environment; 
Section IV-C-l-b-(l)-(d). Permitting 
experiments specified by Section III-A; 
Section IV-C-l-b-(l)-(e). Certifying 
new host-vector systems with the 
exception of minor modifications of 
already certified systems (the standards 
and procedures for certification are 
described in Appendix I-II). Minor 
modifications constitute (e.g., those of 
minimal or no consequence to the 
properties relevant to containment); and 
Section IV-C-l-b-(l)-(0. Adopting 
other changes in the NIH Guidelines. 
Section IV-C-l-b-(2). Minor Actions 
NIH/ORD.'\ shall carry out certain 
functions as delegated to it by the NIH 
Director (see Section IV-C-3). Minor 
Actions (as determined by NIH/ORDA 
in consultation with the RAC Chair and 
one or more RAC members, as 
necessary) will be transmitted to the 
RAC and Institutional Biosafety 
Committee Chairs: 
Section lV-C-l-b-(2)-(a). Reviewing 
and approving certain experiments 
involving the deliberate transfer of 
recombinant DNA or DNA or RNA 
derived from recombinant DNA into one 
or more human subjects that qualify for 
the Accelerated Review process (.see 
Section lIl-B-2); 
Section IV-C-l-b-(2)-(b). Reviewing 
and approving minor changes to human 
gene transfer protocols under Section 
llI-A-2 and IIl-B-2; 
Seciion IV-C-l-b-(2)-(c). Changing 
containment levels for experiments that 
are specified in Section 111; 
Seciion IV-C-l-h-(2)-(d). Assigning 
containment levels for experiments not 
explicitly considered in the NIH 
Guidelines; and 
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Recombinant DNA Research, Volume 19 
