REGISTRATION OF EXPERIMENTS INVOLVING
RECOMBINANT DNA
USC Institutional Biosafety Committee
January 2009
This outline is intended to serve as an overview of the “NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines).” It is
the responsibility of each USC investigator to make sure that his/her laboratory is in compliance. If your experiments require registration, check the
NIH Guidelines for the appropriate biosafety level (BSL) and relevant section. For additional information, please call the Biosafety office at (323)4422200.
NIH Guidelines: http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm
USC Biosafety: http://capsnet.usc.edu/LabSafety/BioSafety/index.cfm
“Non-exempt” rDNA
“Exempt” rDNA
Experiments which require registration and
Experiments which require registration and
Experiments considered exempt from the NIH
approval by IBC prior to initiation (NIH
written confirmation from Biosafety prior to Guidelines (NIH Section III-F). Note: Experiments
sections III-A, III-B, III-C, III-D).
initiation (NIH section III-E).
that fall under this category must still be
registered in order to confirm exemption status.
1. Deliberate transfer of a drug resistance
1. Experiments using vectors <2/3 of the
1. Not in organisms or viruses. NIH Section III-F-1.
trait to a microorganism not known to acquire genome of any eukaryotic virus, demonstrated
it naturally (if it could compromise the use of
to be free of helper virus components. NIH
2. DNA segments from a single non-chromosomal
the drug to control disease agents in
Section III-E-1.
or viral DNA source. NIH Section III-F-2.
humans, animals or agriculture) (Note: this
would likely exclude most subcloning
2. Transgenic or knockout rodent experiments 3. DNA from prokaryotic host when propagated
procedures using antibiotic selectable
for which BSL-1 containment is appropriate
only in that host or transferred to another host by
markers in E. coli K12 derivatives). NIH
(NOTE: the purchase or transfer of transgenic well established physical means. NIH Section III-FSection III-A-1.
rodents for BSL-1 experiments falls into the
3.
“exempt” category; however, breeding of
2. Cloning of DNA encoding toxic molecules
these animals with different strains of mice is
4. DNA from an eukaryotic host when propagated
lethal to vertebrates at an LD50 of <100 μg/kg considered non-exempt rDNA experiment).
only in that host. NIH Section III-F-4.
body weight. NIH Section III-B-1.
NIH Section III-E-3.
5. DNA segments from different species that
3. Human gene transfer/therapy experiments. 3. All rDNA experiments not specified by any
exchange DNA by known physiological processes.
NIH Section III-C-1.
other part of this chart. NIH Section III-E.
NIH Section III-F-5
4. Human or animal pathogen (defined as
Risk Group 2,3, 4, or Restricted Agents) used
as either the host organism or as a vector.
NIH Section III-D-1.
5. Cloning of DNA from all Risk Group 2, 3, 4,
or restricted human or animal pathogens
(including HIV and related viruses and
viruses capable of infecting human cells).
NIH Section III-D-2.
6. Experiments using more than 2/3 of the
genome of infectious animal or plant viruses
or defective viruses grown in the presence of
helper virus or complementing helper virus
components. NIH Section III-D-3.
7. Recombinant DNA experiments involving
whole animals, including transgenic or
knockout rodent experiments requiring BSL2
containment; or transplantation of genetically
engineered cells into animals. NIH Section
III-D-4.
8. Recombinant DNA experiments involving
whole plants. NIH Section III-D-5.
9. Large scale rDNA projects (≥10 liter
cultures at any moment in time). NIH Section
III-D-6.
6. Those that do not present a significant risk to
health or the environment. NIH Section III-F-6
 rDNA containing less than ½ of a
eukaryotic viral genome propagated in
cell culture (with the exception of
expression of DNA from Risk Group 3, 4
or restricted agents). NIH Section III-F-6,
Appendix C-I.

rDNA work involving E. coli K12
derivatives, S. cerevisiae, and B. subtilis
host-vector systems (with the exception
of DNA from Risk Group 3, 4 or restricted
agents). NIH Section III-F-6, Appendices
C-II, C-III, and C-IV.