FAQ: Training

The individual should document that they have prepared and/or provided the entity specific training on biosafety, security and incident response to other SRA approved individuals at that entity. The training record should include the date of training and a description of the training provided.

The select agent regulations do not currently require specific training elements for the RO but the RO is evaluated by FSAP on how they conduct their responsibilities and how well their entity maintains compliance with the regulations. This does not mean that the RO should not document any training they receive in biosafety, security and incident response, but only that specific documentation is not a requirement under the current regulations.

No, biosafety, security, and incident response training can be combined into one program or divided into different training events. Training, whether separate or combined into one program, must be provided before an SRA approved individual has access to select agents and toxins or within twelve months of the individual’s receipt of SRA approval and refresher training at least annually thereafter.

Section 15 (Training) of the regulations requires that an entity provide information and training in biosafety/biosafety, security (including security awareness) and incident response for all individuals approved for access prior to granting access to select agents and toxins. Refresher training must be provided annually on this information to all SRA approved individuals. Entities with Tier 1 select agents and toxins must conduct annual insider threat awareness briefings on how to identify and report suspicious behaviors.

In this case, training requirements depend on the length of the period of temporary “opt out of access”. If the individual had been trained within a year of opting out and then returns, the original training would be sufficient provided there were no significant changes to laboratory procedures or biosafety/biocontainment, security and incident response policies. If the individual has left or taken a leave of absence prior to their annual training coming due, they must receive refresher training upon their return and prior to access to select agents and toxins.

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. Training must be based on entry into an area where a select agent is handled or stored, or within 12 months of the date the individual was approved by the HHS Secretary or the Administrator for access, whichever is earlier. If the area contains multiple select agents or toxins, then training must address them all, even if the person receiving the training does not work with all of the select agents and toxins.

General