Guidance for Select Agent Regulation Training Requirements: Frequency of Training

The select agent regulations require that individuals receive refresher training. Section 15(c) states: “Refresher training must be provided annually for individuals with access approval from the HHS Secretary or APHIS Administrator or at such time as the registered individual or entity significantly amends its security, incident response, biocontainment or biosafety plans.”

Training must be provided at least each calendar year to all individuals who have received access approval from either the HHS Secretary or APHIS Administrator.

Refresher training does not necessarily need to be as extensive as the initial training a person receives but should at least consist of an overview of biocontainment, biosafety, security and incident response and include changes to the entity’s plans. The RO may consider refresher training as an opportunity to reinforce knowledge of regulatory requirements based on observations of non-compliance. For example, the entity notices a number of laboratory workers consistently “piggybacking” or entering registered areas without presenting credentials by following closely behind a co-worker.

FSAP recommends that the time frame between annual refresher training events should be close to 12 months unless there is a reason for the training to occur sooner, such as a significant alteration to an entity’s plan or procedure. The refresher training for biocontainment, biosafety, security and incident response may be incorporated into one training session or divided into different training sessions.