Guidance for Select Agent Regulation Training Requirements: Training Requirements

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 on biocontainment, biosafety, security (including security awareness) and incident response to:

• FSAP-approved individuals before they enter areas where select agents and toxins are handled or stored, or within 12 months of the date the individual was approved
• Non-FSAP-approved individuals (i.e., escorted visitors) before they enter areas where select agents and toxins are handled or stored

FSAP-approved Individuals

Training for FSAP-approved individuals must address the needs of the individual and the risks posed by the BSAT. Specific training should be based on an individual’s access or potential for access to select agents and toxins and the scope of their work. The training program should be designed to ensure that individuals can safely work with BSAT and comply with all entity procedures to mitigate risks to people, to security of the agents and toxins, to the environment or to the public.

The FSAP-approved individuals must complete the initial training within twelve months of the approval or prior to entering areas with BSAT, whichever comes first. The training should be designed to ensure that they can carry out their responsibilities without causing harm to themselves, their fellow co- workers, the public or to the environment.

Refresher Training

Refresher training on this information must be provided at least once every calendar year to all FSAP- approved individuals and whenever significant changes are made to the entity’s incident response, biosafety, biocontainment and/or security plans. Examples (not all-inclusive) of significant 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 new select agents and/or new protocols
• Modification of the security system
• A change in regulatory requirements
• Changes to the building which alter emergency access or egress routes

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

Annual refresher training may consist of a review of information provided during initial training and include any changes in regulatory requirements, entity policies and procedures since the previous training.

Non-FSAP-approved Individuals

Prior to entry into the area where BSAT are used and/or stored, non-FSAP-approved individuals (i.e. escorted 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.). The training should consist of components of biocontainment, biosafety, security (including security awareness, insider threat training as appropriate), and incident response, as it relates to the risks associated with them entering areas where BSAT is used and/or stored.