Axe ’Em, Jacks!
NIH Biosafety and Recombinant DNA Policy
The Biosafety Policy and Recombinant DNA Policy Program manages and evaluates the current biosafety policies for research at institutions that receive NIH support in the US and abroad to help ensure that such research is conducted in accordance with the highest standards to protect the health of researchers, the public and the environment. The program administers the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, manages the Recombinant DNA Advisory Committee, and develops relevant biosafety policy and guidance, as needed.
Refer to SFA HOP 02-413 Recombinant DNA and /or Infectious Biohazards in Teaching and Research, and the SFA Biosafety Manual for specific policies and procedures related to biological safety.
CITI training is required. Every PI and Co/PI and student must complete the CITI training.
NIH Guidelines for Research Involving Recombinant DNA Molecules (April 2024)
Section III-F. Exempt Experiments
The following recombinant DNA molecules are exempt from the NIH Guidelines and registration with the Institutional Biosafety Committee is not required:
Section III-F-1
Those that are not in organisms or viruses.
Section III-F-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.
Section III-F-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-F-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 III-F-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 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-5--Sublists of Natural Exchangers, for a list of natural exchangers that are exempt from the NIH Guidelines. Page | 4
Section III-F-6
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. See Appendix C, Exemptions under Section III-F-6 for other classes of experiments which are exempt from the NIH Guidelines.