Guidance for Select Agent Regulation Training Requirements

Training Required

Section 15(a) of the select agent regulations states that entities registered to possess, use, and transfer biological select agents and toxins (BSAT) must provide site-specific information and training in biocontainment, biosafety, security (including security awareness) and incident response to:

  • Security Risk Assessment (SRA) approved individuals before they are allowed access to select agents and toxins.
  • Individuals without access approval (i.e., escorted visitors) before they are allowed to enter areas where select agents and toxins are handled or stored.

The training must address the needs of the individual and the risks posed by the BSATs they will or may come into contact with. Select agent and toxin specific training should be provided based on an individual’s access or potential for access to select agents and toxins; and their scope of work with select agents and toxins. The training program should be designed to ensure individuals can carry out their assigned duties without harm to self, other laboratory workers, the environment or the public.

The initial training for SRA approved individuals must be completed within twelve months of the individual’s receipt of access approval or prior to him or her entering into areas with BSATs, whichever comes first. The training that each person receives should be designed to ensure that they can carry out their responsibilities without causing harm to themselves, or to their fellow co‐workers, the public or the environment.

Prior to entry into the area where BSATs are used and/or stored, individuals without access approval (i.e. visitors) should receive training that addresses the hazards of the area they are entering (e.g., laboratory, growth chamber, animal room, greenhouse, storage area, shipping/receiving area, production facility, etc.).

Refresher training on this information must be provided at least once every calendar year to all SRA approved individuals and whenever substantive changes are made to the entity’s incident response, biosafety, biocontainment and/or security plans.  Examples (not inclusive) of substantive changes include

  • Renovation of the research building resulting in changes to biosafety, biocontainment, security and incident response policies and procedures.
  • A principal investigator begins a new project with select agents that have not been used at the entity before and/or new protocols.
  • The security system has been modified.
  • Regulatory requirements change.
  • Changes to the building have altered emergency access or egress routes.

Individuals with access to Tier 1 BSAT must receive an annual insider threat awareness briefing on how to identify and report suspicious behaviors.