The university is committed to ensuring the safe handling, storage, and disposal of potentially hazardous agents. Various committees provide oversight for the use of hazards. These committees are a liaison between safety programs inEnvironmental Health and Safety (EHS) and the research community:
The training programs are listed on the Environmental Health and Safety website. Review the requirements here.
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:
Genetically modified microorganisms or genetic elements from organisms shown to produce or encode for a factor associated with a disease.
Genetically modified microorganisms or genetic materials that contain nucleic acid sequence coding for any of the toxins or their toxic subunits.
The USA PATRIOT Act is a law signed by President Bush in 2001 that places restrictions on persons who possess select agents and provides criminal penalties for possession of such agents that cannot be justified for specified peaceful purposes. More information can be found on the Federal Government's Select Agents website.
Everyone who handles agents on the list of Select Agents.
Principal Investigators (PIs) must register the possession of select agents with the Biological Safety officer in EH&S. Failure to comply could result in criminal penalties. In addition, the Patriot Act of 2001 prohibits restricted persons from possessing, shipping, transporting or receiving select agents. The Patriot Act prohibits the possession of a "biological agent, toxin or delivery" (a list broader than select agents) of a type or quantity that is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose.
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.
Institutional Biosafety Committee approval of an rDNA registration is for a maximum of five years or to the end of the grant period. You will need to reapply at the end of the funding period or when you make substantial changes to your research using rDNA that were not described in the original proposal.
It can be submitted when you submit and IBC protocol using Kuali Research.
You will receive a letter from the compliance office letting you know that your rDNA Protocol has been reviewed and approved.
Approval of an rDNA Protocol extends to the end of the granting period or a maximum of 5 years for projects that do not involve external funding. You will need to reapply at the end of the funding period or when you make substantial changes to your research using rDNA that were not described in the original proposal.
Graduate students can fill out an rDNA Protocolform but their PI/advisor must sign the form. Postdocs can submit a Protocol under their own name.
For more details on general compliance issues contact Alison Miller. For specific questions regarding biological safety issues contact Kristi Ohr.