| Review/Revised Date: 03/16/2023
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INTRODUCTION
The purpose of this policy is to establish a framework for the University of Alabama at Birmingham Biosafety Program, intended to protect students, employees, volunteers, visitors, and the environment from the hazards associated with recombinant, biological, or potentially infectious agents or materials used and stored on campus. UAB’s Biosafety Program is based on federal, state, and local regulatory codes.
SCOPE
This policy applies to all members of the UAB community, including students, employees, volunteers, and visitors and to all research and teaching activities in UAB facilities (owned and leased) where students, employees, and visitors may be exposed to potentially hazardous biological agents and materials. This policy also extends to any facility or activity subject to UAB’s Biosafety Program by virtue of a formal agreement.
DEFINITIONS
For the purposes of this policy, the following definitions apply:
Biological Agents – Any biological organism, including viruses and invasive species, that pose a real or potential hazard to humans, animals, plants, or the environment.
Biological Materials – prions, biological toxins, blood, tissues, cells, bodily fluids, and recombinant nucleic acid molecules.
Biosafety Manual (BSM) – The Biosafety Manual is a written program, developed and implemented, to describe the procedures, work practices, equipment, and other control measures required to protect students, staff, and visitors from the hazards presented by biological agents used on campus.
Biological Safety Officer (BSO) – The BSO is a Department of Environmental Health and Safety (EHS) employee with expertise in biological hazards and biocontainment controls. The BSO provides guidance in the development and implementation of the provisions of the Biosafety Manual and oversees the UAB Biosafety Program.
The Responsible Official (RO) – The RO is an EHS employee that is designated with the authority and responsibility to act on behalf of UAB to ensure compliance with the Federal Select Agent regulations.
Select Agents (SA) – Biological agents identified by the Federal Select Agent Program to have potential to pose severe threat to public, animal, or plant health, or to animal or plant products.
UAB Select Agent Program – UAB policies, procedures, training, and containment controls for SA work, implemented to ensure compliance with the Federal Select Agent Program regulations.
POLICY STATEMENT
UAB is committed to maintaining a safe environment for all individuals participating in UAB-approved research activities and ensuring compliance with federal, state, and local regulatory codes. The standard operating procedures in the BSM outline the roles and responsibilities of administrators and individuals working in UAB laboratory facilities and demonstrate UAB’s commitment to safety.
NONCOMPLIANCE
Violations of federal, state, and local regulations can lead to criminal and civil penalties for individuals and the institution. Confirmed violations of this policy or any of the associated elements described in the BSM are subject to commensurate consequences, up to and including termination, dismissal, or severance of other relationships with UAB.
IMPLEMENTATION
The Associate Vice President for Research Facilities and Infrastructure and the Chief Facilities Officer share responsibility for the implementation and maintenance of UAB campus safety programs to ensure UAB-approved activities remain compliant with federal, state, and local regulatory codes, as described in applicable UAB handbooks, policies, and safety manuals.
The Vice President for Research is responsible for appointing an Institutional Biosafety Committee (IBC), which is tasked with review of UAB policies and activities involving infectious and/or recombinant agents or materials, and stipulates containment conditions required for final approval and compliance with the NIH Guidelines
The Senior Vice President for Finance and Administration, through the Department of Environmental Health and Safety (EHS), is responsible for administering the Institutional Biosafety Program. The BSO is a member of EHS and, with support from EHS staff, has the overall responsibility for developing, implementing, and maintaining a Biosafety Program at UAB that is compatible with all local and federal regulations. The RO, also a member of EHS, supports the activities of the BSO and manages the UAB Select Agent Program.
Related Policies and Procedures
UAB Biosafety Manual