34502 
Federal Register / Vol. 59, No. 127 7 Tuesday, ^ly 5, 1994 / Notices 
Section Ui-D-1 . Experiments Invoking 
the 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 (see 
Section V-Q) being considered identical 
(see Section V-S)) may be propagated 
and maintained in cells in tissue culture 
using BLl containment. For such 
experiments, it must be demonstrated 
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- 
C-3 should be used. The DNA may 
contain fragments of the genome of 
viruses from more than one Family but 
each fragment shall be less than two- 
thirds of a genome. 
Section lU-D—2. Experiments Involving 
Whole Plants 
This section covers experiments 
involving recombinant DNA-modified 
whole plants, and/or experiments 
involving recombinant DNA-modified 
organisms associated with whole plants, 
except those that fall under Section III- 
A. III-B, m-C, or lU-E. It should be 
emphasized that knowledge of the 
organisms and judgment based on 
accepted scientific practices should be 
used in all cases in selecting the 
appropriate level of containment. For 
example, if the genetic modification has 
the objective of increasing pathogenicity 
or converting a non-pathogenic 
organism into a pathogen, then a higher 
level of containment may be appropriate 
depending on the organism, its mode of 
dissemination, and its target organisms. 
By contrast, a lower level of 
containment may be appropriate for 
small animals associated with many 
types of recombinant DNA-modified 
plants. 
Section UI-D-2-a. BLl-P is 
recommended for all experiments with 
recombinant DNA-oontaining plants and 
plant-associated microorganisms not 
covered in Section JII4>-2-b or other 
sections of the NIH Guidelines. 
Examples of such experiments are those 
involving recombinant DNA-modified 
plants that are not noxious weeds or 
that caimot interbreed with noxious 
weeds in the immediate geographic 
area, and experiments involving whole 
plants and recombinant DNA-modified 
non-exotic (see Section V-W) 
microorganisms that have no recognized 
potential for rapid and widespread 
dissemination or for serious detrimental 
impact on managed or natural 
ecosystems (e.g., Bhizobium spp. and 
Agrobacteiium spp.j. 
Section III-D-2-b. BL2-P or BLl-P % 
biological containment is recommended 
for the following experiments: 
Section IH-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 III-D-2-b-(2). Plants in which 
the introduced DNA represents the 
complete genome of a non-exotic 
infectious agent fsee Section V-W). 
Section III-I>-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 III-D-2-b-(4). Plants 
associated with recombinant DNA- 
modified exotic microorganisms that 
have no recognized potential for serious 
natural ecosystems (see Section V-W). 
Section RI-D-2-t^(5). Experiments 
with recombinant DNA-modified 
arthropods or small animals associated 
with plants, or with arthropods or small 
animals with recombinant DNA- 
modified microorganisms associated 
with them if the recombinant DNA- 
modified trricroorganisms 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; 
Section m-E-l. Those that are not in 
organisms or viruses. 
Section III-E-2. Those that consist 
entirely of DNA segments ft-om a single 
nonchromosomal or viral DNA source, 
though one or more of the segments may 
be a synthetic -equivalent. 
Section IlI-E-3. Those that consist 
entirely of DNA from a prokaryotic host 
including its indigenoois 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 TII-E— 4.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). 
Section IH-E-5. Those 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 NIH Director widi advice 
of the RAC after appropriate notice and 
opportunity for public comment (see 
Section rV-C-l-b-(l)-Kc)). See 
Appendices A-I throu^ A-VI for a list 
of natural exchangers Aat are exempt 
from the NIH Guidefines. 
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 NTH 
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. 
Section IV, Roles and Responsibilities 
Section TV-A. Policy 
The safe conduct of experiments 
involving recombinant DNA depends on 
the individual conducting such 
activities.' The NIH Guidelines cannot 
anticipate every possible situation. 
Motivation and good judgment are the 
key essentials to protection of health 
and the environment The NIH 
Guidelines are intended to assist the 
institution. Institutional Biosafety 
Committee, Biological Safety Officer, 
and Principal Investigator in 
determining safeguards that should be 
implement^. The NIH Gnidelines 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 NIH 
Guidelines as well as to their specifics. 
Each institution (and the Institutional 
Biosafety Committee acting on its 
behalf) is responsible for ensuring that 
recombinant DNA activities comply 
with the NIH Guidelines. General 
recognition of institutional authority 
and responsibility properly establishes 
accountability for ^e 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 the 
NIH as necessary. 
Section IV-B. Responsibilities of the 
Institution 
Section FV-B-l. General Information 
Each institntion conducting or 
sponsoring recombinant DNA research 
which is covered by the NTH Guidelines 
Recombinant DNA Research. Volume 19 
[7031 
