The Federal Select Agent Program (jointly comprised of the CDC/HHS and USDA APHIS) oversees the possession, use and transfer of biological agents and toxins which have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products. Any possession, use, transfer or shipment of these materials is strictly regulated. For the current list of select agents, please check http://www.selectagents.gov/SelectAgentsandToxinsList.html.
If you are considering work with any Select Agents or Toxins, you must first contact the Biosafety Office to discuss the feasibility of the proposed work. All registration activities for these agents must be coordinated through the Biosafety Office; researchers cannot register directly with the USDA or CDC. Be aware that UF/federal approval can take 6 months or more to complete in advance of any project. General information on select agents can be found at http://www.selectagents.gov/.
Certain attenuated strains are excluded from the select agent regulations provided there is no reintroduction of factor(s) associated with virulence or other manipulations that modify the attenuation to restore or enhance virulence. A current list of excluded strains can be found at http://www.selectagents.gov/SelectAgentsandToxinsExclusions.html. Note that the use of these strains at UF still requires project registration through Gator TRACS (link).
Some types of diagnostic work with select agents is exempt from full federal registration, but restrictions apply. Please contact the Biosafety Office to discuss diagnostic work or work with non-confirmed specimens.
Select agent toxins do not require full federal registration if the amount under the control of a principal investigator, veterinarian or treating physician does not exceed, at any time, the amounts listed in the Permissible Toxin Amounts on the Select Agent website. The use of these toxins must still be registered with the Biosafety Office using the Gator TRACS Biohazard Project Registration (link).
Failure to comply with Federal Regulations for select agents is punishable by both fines and imprisonment.
Specific avenues of research involving select agents may be subject to The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. For more information regarding Dual Use Research of Concern (DURC), please refer to the University of Florida Institutional Biosafety Committee (IBC) guidance.