Section C: Exempt Recombinant DNA Experiments
(please check those sections of the NIH Guidelines under which your experiments are exempt)
Section III-F-1. Those synthetic nucleic acids that: (1) can neither replicate nor generate nucleic acids that can
replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of
replication or contain elements known to interact with either DNA or RNA polymerase), and (2) are not designed to
integrate into DNA, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms
per kilogram body weight. If a synthetic nucleic acid is deliberately transferred into one or more human research
participants and meets the criteria of Section III-C, it is not exempt under this Section.
Section III-F-2. Those that are not in organisms, cells, or viruses and that have not been modified or manipulated
(e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular membranes.
Section III-F-3. Those that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single
source that exists contemporaneously in nature.
Section III-F-4. Those that consist entirely of nucleic acids 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
Section III-F-5. Those that consist entirely of nucleic acids from a eukaryotic host including its chloroplasts,
mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the
Section III-F-6. 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 with advice of the RAC after appropriate notice and
opportunity for public comment (see Section IV-C-1-b-(1)-(c), Major Actions). See Appendices A-I through A-VI,
Exemptions under Section III-F-6--Sublists of Natural Exchangers, for a list of natural exchangers that are exempt
from the NIH Guidelines.
Section III-F-7. Those genomic DNA molecules that have acquired a transposable element, provided the transposable
element does not contain any recombinant and/or synthetic DNA.
Section III-F-8. Those that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c),
Major Actions), as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and
opportunity for public comment.
Appendix C-VII. The Purchase or Transfer of Transgenic Rodents
Appendix C-VIII. Generation of BL1 Transgenic Rodents via Breeding
The breeding of two different transgenic rodents or the breeding of a transgenic rodent and a non-transgenic
rodent with the intent of creating a new strain of transgenic rodent that can be housed at BL1 containment
will be exempt from the NIH Guidelines if:
(1) both parental rodents can be housed under BL1 containment; and
(2) neither parental transgenic rodent contains the following genetic modifications: (i) incorporation of more
than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses; or (ii)
incorporation of a transgene that is under the control of a gamma retroviral long terminal repeat (LTR); and
(3) The transgenic rodent that results from this breeding is not expected to contain more than one-half of an
exogenous viral genome from a single family of viruses.
EHS010 Registration Document For Biohazards