Regulatory Interpretation

Date: October 20, 2016

Subject: Regulatory Interpretation for “Annual Refresher Training”

This is in response to your email request dated August 17, 2016, for a regulatory interpretation regarding “annually” as referenced in section 15 (c) (Training) of the select agent regulations that states: “Refresher training must be provided annually for individuals with access approval from the HHS Secretary or Administrator or at such time as the registered individual or entity significantly amends its security, incident response, or biosafety plans.”

The intent of this section of the regulations was that a person should receive refresher training at least once a calendar year.  Therefore, FSAP interpretation of the annual refresher training requirement is that refresher training for an individual can be completed anytime within a calendar year.  It is important to remember that refresher training is also required “at such time as the entity significantly amends its security, incident response, or biosafety plans” so that an entity’s personnel know about and are able to implement significant changes.  

The Federal Select Agent Program (FSAP) guidance document titled Guidance for Meeting the Training Requirements of the Select Agent Regulations recommends that “the time frame should be closer to a 12‐month interval between annual refresher training events unless there is a reason for the training to occur sooner, such as significant alteration to an entity’s plan or procedure.”  The point of the guidance is that refresher training should be provided in such a way as it will be meaningful to those being trained.