Guidance for Select Agent Regulation Training Requirements: Training of Individuals
The initial training for FSAP-approved individuals must be completed within twelve months of the individual’s receipt of access approval or prior to him or her entering areas with BSAT, whichever comes first. Section 15(a) requires that that training include biocontainment, biosafety, security (including security awareness), and incident response. The training must address the particular needs of the individual, the work they will do, and the risks posed by the select agents or toxins.
All FSAP-approved individuals must receive the required training, regardless of previous experience. Each institution is unique with site-specific floor plans, equipment, protocols and policies.
Refresher training must be provided annually to all FSAP approved individuals, including those in administrative support roles.
For individuals on an extended medical or personal leave of absence, training requirements depend on the length of the absence. If the individual had been trained within a year of taking leave and then returns, the original training should be sufficient, provided there were no significant changes to laboratory procedures, biocontainment, biosafety, security, or incident response policies. If the individual has taken a leave of absence prior to their annual refresher training, they should receive refresher training immediately upon their return.
Unescorted visitors with a valid FSAP approval from another entity must also receive site-specific initial training appropriate for their work before being allowed access to BSAT at the host entity. The RO should evaluate the level of training needed before the FSAP-approved unescorted visitor receives access to BSAT.
Section 15(a)(2) requires that individuals not approved for access to select agents and toxins by the HHS Secretary or APHIS Administrator receive information and training on biocontainment, biosafety, security (including security awareness), and incident response before entering areas where select agents or toxins are handled or stored (e.g., laboratories, growth chambers, animal rooms, greenhouses, storage areas, shipping/receiving areas, production facilities, etc.).
Individuals not approved for access entering areas where BSAT is used or stored must be escorted by a FSAP-approved person, unless all BSAT is secured. Prior to entry, they must receive training appropriate for the risk associated with entering areas where BSAT is used or stored. The training that is provided is not expected to be as extensive as it is for those who have access to the select agents and toxins. It may consist of:
- Donning and doffing PPE
- Personal safety precautions while in the laboratory
- Emergency response briefing (e.g. emergency evacuation procedures)
- What to do if the visitor becomes ill after visiting the area
- Shower out procedure
- Familiarity with the restrictions in the Personnel Quarantine Policy
- Signs/symptoms of illnesses caused by used or stored BSAT
- Security provisions
Frequency of visitor training must be consistent with the entity’s policy. Visitors returning to the entity within 12 months of their last documented training may not need additional training unless there have been significant changes to the biocontainment, biosafety, security, or incident response plans or changes in entity policies or procedures after the last visit.