Select Agent Regulations
The Federal Select Agent Program oversees the possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products. The Federal Select Agent Program is jointly comprised of two regulatory oversight agencies:
- Centers for Disease Control and Prevention/Division of Select Agents and Toxins
- Animal and Plant Health Inspection Service/Agriculture Select Agent Services
Requirements for Select Agents & BSL-3/ABSL-3 Research
Research involving select agents and research conducted at biosafety level 3 (BSL-3) or animal biosafety level 3 (ABSL-3) containment is more challenging and expensive to establish and maintain than any other type of research at UofSC. This research requires additional training, enhanced medical surveillance plans, complex facility management and operations, and other specialized biosafety, security, and incident response plans. A research summary must be submitted to the Institutional Biosafety Committee (IBC) Chair and UofSC’s Research Safety Bureau Chief (Senior Biosafety Officer) prior to any faculty member submitting a grant for this type of research, or any department hiring a new faculty member to conduct select agent or BSL-3/ABSL-3 research. This notification must be made several months in advance of any plans to initiate this type of research.
The UofSC will appoint a team to collaboratively evaluate the feasibility of a new
facility, define general design requirements based on the proposed research, and assess
the resources required for the complete planning, design, renovation or construction,
management, operations, and safety/compliance oversight for a new high containment
facility. This team should include, but not be limited to, the Research Safety Bureau
Chief, Biological Safety Officer, IBC Chair, Associate Dean for Research, Facilities
Project Manager, Principal Investigator(s), and Director of DLAR (for ABSL-3 facilities).
An external consultant with expertise in BSL-3/ABSL-3 facility design may be needed
for the initial feasibility and planning process. If the BSL-3/ABSL-3 facility is
approved, an experienced BSL-3 Facility Manager should be appointed to oversee the
design, construction, commissioning, and operations of the facility. All research
involving select agents, BSL-3 or ABSL-3 containment that is conducted at or sponsored
by the UofSC must be reviewed and approved by the IBC (and IACUC for ABSL-3) prior
to initiating research. Please contact the Research Safety Bureau Chief with any questions regarding BSL-3 or ABSL-3 research.