Biological and Environmental Safety

A Select Agent is a microorganism (virus, bacterium, fungus, rickettsia) or toxin that has been determined to have the potential to pose a severe threat to human, animal, or plant health. Some common examples include Botulinum neurotoxin, Ebola virus,  SARS-associated coronaviruses, Avian influenza virus, and ricin. The term also includes: 

1. Genetically modified microorganisms or genetic elements from organisms shown to produce or encode for a factor associated with a disease.
2. Genetically modified microorganisms or genetic materials that contain nucleic acid sequence coding for any of the toxins or their toxic subunits.

In the context of the NIH Guidelines, recombinant DNA (rDNA) molecules are defined as either: 

• molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that replicate in a living cell or 
• molecules that form from the replication of those described above

Experiments are typically exempt when they involve rDNA that is: 

• Not in organisms and viruses 
• DNA segments from a single non chromosomal or viral DNA source 
• Entirely from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host or when transferred into another host by well established physiological means 
• Entirely from a eukaryotic host including its chloroplasts, mitochondria, or plasmids when propagated only in that host or a closely related strain of the same species 
• Segments from a different species that exchange DNA by known physiological processes, though one or more may be a synthetic equivalent
• Not a significant risk to health or the environment as determined by the NIH Director

Research listed above may not be exempt if it also involves: 

• The deliberate transfer of a drug resistance trait to microorganisms not known to acquire the trait naturally if such transfer could compromise the use of a drug to control disease agents in humans, veterinary medicine or agriculture 
• Deliberate formation of rDNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms/kilogram of body weight, or 
• The deliberate transfer of rDNA or DNA or RNA derived from rDNA into human research subjects.