The list of agents and toxins classified by the Federal government (USDA and CDC/HHS) as Select Agents, agents or toxins deemed 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 controlled by regulation. For the most up to date listing please check http://www.selectagents.gov/select%20agents%20and%20Toxins%20list.html.
Researchers considering work with any of these materials must first contact the Biosafety Office at 392-1591 to initiate the approval process: security and containment assessments, permits, personnel security clearances and other necessary paperwork. 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. A copy of the UF Policy for Select Agent Research and a detailed listing of steps to complete select agent registration is available on request; contact the Biosafety Office. General information on select agents can be found at http://www.selectagents.gov/.
Note that the following are also considered select agents and require full registration:
- Nucleic acids that can produce infectious forms of any of the select agent viruses listed (e.g. nucleic acids from positive strand RNA viruses: Tick-borne encephalitis complex (flavi) viruses, and the togaviruses (Venezuelan Equine Encephalitis virus and Eastern Equine Encephalitis virus).
- Recombinant nucleic acids that encode for the functional forms of any toxin listed if the nucleic acids:
can be expressed in vivo or in vitro
or are in a vector or recombinant host genome and can be expressed in vivo or in vitro
- Select agents and toxins listed that have been genetically modified.
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/select%20agents%20and%20toxins%20exclusions.html. Note that the use of these strains at UF still requires the appropriate bio-agent or recombinant nucleic acid registration.
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 (a UF Acute Toxin Registration is still required though) if the amount under the control of a principal investigator, veterinarian, or treating physician does not exceed, at any time, the following.
Maximum Toxin Amounts Excluded from Select Agent Regulation
|HHS/CDC Select Agent Toxins||Amount|
|Shiga-like ribosome inactivating proteins||100mg|
|USDA Select Agent Toxins||Amount|
|Clostridium perfringens epsilon toxin||100mg|
Failure to comply with Federal Regulations for select agents is punishable by both fines and imprisonment.