6. Class III-F experiments

Class III-F experiments are exempt from the NIH Guidelines; however, registration with the IBC through submission of an rDNARD is required. These experiments include:

  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. 
  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.
  3. Those that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature. 
  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 another host by well-established physiological means.
  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 same species).
  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 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.
  7. Those genomic DNA molecules that have acquired a transposable element, provided the transposable element does not contain any recombinant and/or synthetic DNA.
  8. Those that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c)) as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and opportunity for public comment.  See also Appendix C of the NIH Guidelines(3).

Experiments involving cross-breeding of rodents housed at ABSL1 containment conditions, do not need to be registered with the IBC for approval.