Training FAQ's

General

  1. What information and training must an entity provide to meet the requirements of the regulations?

    The regulatory requirements for training are found in Section 15 and Section 11(f)(ii) of the select agent regulations with more detailed information provided in the Guidance for Meeting the Training Requirements of the Select Agent Regulations. An entity must provide information and training on biosafety/biocontainment, security (including security awareness) and incident response to each individual with access approval from the Federal Select Agent Program. The training must address the particular needs of the individual and the work they will do and the risks posed by the select agents or toxins they will or may come into contact with. The initial training for SRA approved individuals must be completed within twelve months of the individual’s receipt of access approval or prior to him or her entering into areas with BSATs, whichever comes first. Individuals or visitors not approved for access to select agents and toxins that enter areas where select agent toxins are handled or stored must also receive training based on the hazards of the areas they are entering.

    Entities possessing Tier 1 biological select agents and toxins must also conduct annual insider threat awareness briefings on how to identify and report suspicious behaviors for individuals with access to Tier 1 biological select agents and toxins. Further information can be found in the Guidance for Suitability Assessments and Security Plan Guidance and Guidance for Meeting the Training Requirements of the Select Agent Regulations.

  2. Who must receive this information and training and when should it be provided?
    • Security Risk Assessment (SRA) approved individuals must receive initial training, appropriate for their work before they are allowed access to select agents and toxins, or within twelve months of the individual’s receipt of access approval. Refresher training must be provided at least each calendar year to all SRA-approved individuals who have received access approval from either the HHS Secretary or APHIS Administrator.
    • Non-escorted visitors with a valid SRA from another entity must also receive initial training appropriate for their work before they are allowed access to select agents and toxins.
    • Individuals without access approval (i.e., escorted visitors) must receive training appropriate for the risk that the person is likely to encounter in the area before they are allowed to enter areas where select agents and toxins are handled or stored.
    • Individuals with access to Tier 1 biological select agents and toxins must also receive annual insider threat awareness briefings on how to identify and report suspicious behaviors.

    Records for each individual trained must be maintained for a minimum of three years in accordance with Section 17 of the select agent regulations and should include a the date of training, a description of the training and documentation that the individual understood the training received.

  3. I have received SRA approval at this entity and completed initial training. Do I need refresher select agent and toxin training?

    Yes. You must receive annual refresher training after you have received initial training on select agents and toxins. If the entity makes significant changes to the biosafety, security or incident response plans then the entity needs to update their training programs and provide training to the staff. Anytime a new research project is planned, new facilities or equipment is added, or the entity plans to work with different agents or toxins, your Responsible Official (RO) should evaluate the training program to confirm that it is still meeting regulatory requirements. Further information can be found in the Guidance for Meeting Training Requirements of the Select Agent Regulations.

  4. I have visitors who received information and training on select agents and toxins within the last year, and they will be returning to enter areas where select agents and toxins are handled or stored. Do they need to receive information and training again?

    Frequency of visitor training must be consistent with the entity’s policy, but must occur at least annually. Visitors returning to the entity within a year of their last documented training may not need additional training unless there have been significant changes to the biosafety, security, or incident response plans or changes in entity policies or procedures subsequent to the last visit.

  5. What should be included in the training program for SRA approved individuals?

    The regulatory requirements for training are found in Section 15 and Section 11(f)(ii) of the select agent regulations. There are no specific requirements in the regulations regarding specific training program elements other than that the training must address the needs of the individual, the work they will do, and the risks posed by the select agents or toxins. Training must contain information on biosafety/biocontainment, security (including security awareness) and incident response. In general, training should address how to work with select agents and toxins in a safe manner and protect the select agent and toxin from theft and/or loss. Incident response training should address how to react to emergencies and take into account the hazards associated with the select agents and toxins. There are additional training requirements for individuals with access to Tier 1 select agents and toxins. Further information can be found in the Guidance for Meeting Training Requirements of the Select Agent Regulations.

  6. What should be included in the training program for individuals without SRA approval (escorted visitors)?

    This training should be based on the risk associated with accessing areas where select agents and toxins are used and/or stored. This training may not be as extensive as it is for SRA-approved individuals but at a minimum should include safe access, personal safety precautions while in the laboratory, egress, an emergency response briefing and what to do if a visitor becomes ill after visiting the area. Further information can be found in the Guidance for Meeting Training Requirements of the Select Agent Regulations.

  7. If an SRA approved individual, including the Responsible Official (RO) or alternate Responsible Official (ARO), is the one who develops and/or provides training at the entity, how does that individual document that they received the required 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.

  8. What are the training requirements for the RO of an entity?

    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.

  9. Do I have to conduct separate trainings for biosafety, security, or incident response?

    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.

  10. What are the additional training requirements for entities that are registered for Tier 1 agents?
    • Employees with access to Tier 1 select agents and toxins must be trained on entity policies and procedures for reporting, evaluation, and corrective actions concerning the assessment of personnel suitability.
    • Employees with access to Tier 1 select agents and toxins must also have an annual insider threat awareness briefing. Further information can be found in the Guidance for Suitability Assessments and Security Plan Guidance.
  11. What types of training records are required?

    The regulatory requirements for training records are found in Section 15 of the select agent regulations. The records must include the name of the individual who received the training, the date that they received the training, a description of the training provided, and the means used to verify understanding of training (i.e. quiz). All training records, including visitor training records, must be kept for at least three years in accordance with Section 17 of the select agent regulations. Further information can be found in the Guidance for Meeting Training Requirements of the Select Agent Regulations.

  12. What guidance do you have for training when an annual mandatory training occurs during a period when an individual temporarily "opts out of access"? Do you train the individuals before they resume access and reset their annual date to this training date?

    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.

  13. Regarding training for support administration (i.e., an individual is listed on a registration as administrative support function, but does not have access to Select Agents), is it required that they have annual refresher training or is the initial training sufficient?

    Yes, refresher training must be provided annually for all individuals with access approval, including those in administrative support roles, who have received approval to have access through the security risk assessment (SRA) process. Individuals must receive entity specific training in 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.

  14. Does the RO need to maintain hard copies (not just electronic) of all training documents, ready to produce at any time?

    No, electronic records are acceptable as long as that record includes all of the information required in Section 15 (Training) and Section 17 (Records) of the regulations and the RO is able to provide access to the electronic record upon request. The Responsible Official must ensure that a record of the training provided to each individual with access to select agents and toxins and each escorted individual (e.g., laboratory workers, visitors, etc.) is maintained. The record must include the name of the individual, the date of the training, a description of the training provided, and the means used to verify that the employee understood the training. The records must be maintained for at least three years and produced promptly upon request.

  15. Does training have to include all select agents and toxins listed on the entity’s registration or can training be specific to the needs of each laboratory?

    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.