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Environmental Health and Safety

Select Agents and Biosafety Level 3 Research

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 specialized 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. Then the Research Safety Bureau Chief and the IBC will complete an initial risk assessment for the proposed research. Next, UofSC will appoint a team to collaboratively evaluate the feasibility of a new facility, define a general summary of design requirements based on the 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 must include, but not be limited to, the Senior Biosafety Officer, IBC Chair, Facilities Project Manager, Principal Investigator(s), and Director of DLAR (for ABSL-3 facilities). The planning process may also require external consultants with extensive expertise in BSL-3/ABSL-3 facility design. 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.

Select Agents & Toxins Resources


CDC/USDA Federal Select Agent Program

Select Agent Regulations

Select Agents and Toxins List

Select Agents and Toxins Exclusions

Permissible Biological Toxin Amounts

Due Diligence Provision for Transferring Biological Toxins

UofSC Biological Toxins Inventory Form [pdf]

Biosafety in Microbiological and Biomedical Laboratories (BSL-3 & ABSL-3 Criteria)

Dual Use Research – National Science Advisory Board for Biosecurity (NSABB)

A Companion Guide for Oversight of Life Sciences Dual Use Research of Concern [pdf]


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