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 South Carolina. A research questionnaire [pdf] must be submitted to the Institutional Biosafety Committee (IBC) Chair and the university’s Research Safety Bureau Chief at least three months before any faculty member submits a grant for this type of research, or any department hires a new faculty member planning to conduct select agent or BSL-3 or ABSL-3 research.

The next step is for the PI to prepare and submit a BSL-3 research proposal to the Biosafety Officer. This proposal must be submitted prior to pursuing internal or external funding for BSL-3 research. The amount of time required to prepare this proposal will depend on the level of pre-planning that has been completed and BSL-3 oversight experience of the PI. This BSL-3 facility proposal packet should include information

research goals/benefits
list of all biological agents and types of samples
other hazards (e.g., biological toxins, chemicals, radioisotopes)
description of experimental procedures
animal use
maximum number of facility users
laboratory equipment list
design floor plans (equipment, utilities, etc.)
personnel training/expertise
project schedule for planning, design, and construction
project budget and funding sources

The PI must describe any anticipated future research activities that may impact the BSL-3 facility design plan and require future approval prior to use. This packet must also include a description of how the BSL-3 laboratory will fulfill requirements such as:

facility inspections
biosafety/biocontainment plan
drills and exercises
training requirements
incident response plan
information security controls
occupational health program
security plan

Proposals to conduct research involving select agents will require descriptions of how the BSL-3 facility will fulfill additional regulatory requirements for the Responsible Official resource manual, security risk assessment tool, and suitability assessment program. The college(s) with research faculty using the BSL-3 facility must appoint a Responsible Official (RO) with the authority and responsibility to ensure compliance with the select agent regulations. Please contact Sherika Smith with any questions regarding a BSL-3 research proposal.

The university will appoint a committee to collaboratively evaluate the feasibility and resources required for the planning, design, renovation or construction, management, operations, and safety/compliance oversight for a new high containment facility. This evaluation will be based on the research proposal packet submitted. The packet may include design specifications and cost estimates from a qualified A/E firm specializing in BSL-3 facilities but must at a minimum include a design plan with sufficient details for the team to assess prior to investing in a complete design plan and construction estimate. Consultation with all applicable university subject matter experts is critical to address design specifications and deficiencies that may impact laboratory operations. The BSL-3 Committee will include, but may not be limited to, the following members:

BSL-3 Commissioning Agent
IBC Chair
Research Safety Bureau Chief
Biological Safety Officer
Director of DLAR (for ABSL-3 facilities)
Facilities Planning, Design & Construction
Campus security or police
Emergency management
Campus Fire Marshal
Occupational health physician
Chemical Hygiene Officer
Facilities Services
Facilities Administration & Finance
Community representative

The Principal Investigator(s) will be consulted as necessary during the review process. Other stakeholders may be involved to determine if the proposed BSL-3 facility supports the university’s strategic research mission and to assess other risk management issues. A close partnership and open communication between all stakeholders is critical for an effective risk assessment. Following completion of the assessment process, the committee will prepare a feasibility report on the proposed BSL-3 facility plans (strengths, weaknesses, opportunities, threats).

Finally, if plans for the design and construction of a new BSL-3/ABSL-3 facility are endorsed by the BSL-3 Committee, Institutional Biosafety Committee (IBC), and senior administrators, then the department or college will need to hire an experienced full-time BSL-3 Facility Manager to oversee the design, construction, commissioning, and operations of the high containment facility. All research involving select agents, BSL-3 or ABSL-3 containment that is conducted at or sponsored by the university must be reviewed and approved by the IBC (and IACUC for ABSL-3) prior to initiating research. Please contact Mark Robbins, the Research Safety Bureau Chief, with any questions regarding BSL-3 or select agents research, and contact Shayne Barlow, the Director of DLAR and attending veterinarian, with questions on ABSL-3 research.