The Federal definition of recombinant DNA (rDNA) is: (i) molecules
that are constructed outside living cells by joining natural or
synthetic DNA segments to DNA molecules that can replicate in a
living cell, or (ii) molecules that result from the replication of
those described in (i) above. (Source:
NIH Guidelines)
When preparing a protocol to create or use rDNA, investigators should specify the
proposed containment level for their activity based on the
NIH Guidelines or the BMBL.
Containment levels must be appropriate given the risk group of the
organism(s) and the nature of the experiment.
There are three levels of containment allowed at SDSU: BL1, BL2 and
BL2+. SDSU does not have a BL3 laboratory and as such no rDNA work
can be proposed or approved at BL3 or higher containment levels.
Investigators should also identify the appropriate level of
oversight for their project, based on the appropriate section in the
NIH Guidelines. Three levels of oversight are:
-
Section III-D: Committee review is required prior to project
initiation (generally BL2 or higher work)
-
Section III-E: The project may begin upon submission of the
registration document (this applies to most activity conducted
at BL1)
-
Section III-F: The project is exempt from the guidelines (BL1
practices are required for the experiments)
