- What information and training must an entity provide to meet the requirements of the regulations?
- Please clarify what you mean by information and training. What is the difference?
- Who must receive this information and training and when should it be provided?
- I have received SRA approval at this entity and completed initial training. Do I need refresher select agent and toxin training?
- 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?
- What should be included in the training program for SRA approved individuals?
- What should be included in the training program for individuals without SRA approval (escorted visitors)?
- 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?
- What are the training requirements for the RO of an entity?
- Do I have to conduct separate trainings for biosafety, security, or incident response?
- What are the additional training requirements for entities that are registered for Tier 1 agents?
- What types of training records are required?
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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 document "Guidance for Meeting the Training Requirements of the Select Agent Regulations". An entity must provide information and training on biosafety, security (including security awareness) and incident response to each individual with access approval from the Health and Human Services Secretary or United States Department of Agriculture Administrator. 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. 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 Guidance for Select Agent or Toxin Facilities and Guidance for Meeting the Training Requirements of the Select Agent Regulations.
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Information is a set of facts, concepts, ideas, theories, policies, procedures, etc. An entity providing a fact sheet on the hazards of a particular biological agent or toxin is providing information. An entity providing a copy of the entity incident response plan is providing information. Training is the process of educating a person to improve upon or attain certain knowledge, skills or competencies through teaching and/or practical exercise. An instructor teaching individuals the proper way to use a biosafety cabinet or clean up a spill is training. An entity using the incident response plan in an exercise is training. Further information can be found in the Guidance for Meeting Training Requirements of the Select Agent Regulations.
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- Security Risk Assessment (SRA) approved individuals must receive initial training, appropriate for their work before they are allowed access to select agents and toxins, and given refresher training at least annually thereafter.
- 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 their visit (including non-select agent work) 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 description of the training and documentation that the individual understood the training received.
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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, the 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.
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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.
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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, 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. Further information can be found in the Guidance for Meeting Training Requirements of the Select Agent Regulations.
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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, egress and an emergency response briefing. Further information can be found in the Guidance for Meeting Training Requirements of the Select Agent Regulations.
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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.
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The select agent regulations do not currently require specific training elements for the RO but the RO is evaluated by the Federal Select Agent Program 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. Further information can be found in the Guidance for Meeting Training Requirements of the Select Agent Regulations.
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No, biosafety, security and incident response training can be combined into one program or divided into different training events. Entities possessing Tier 1 agents must also include security awareness training. Training, whether separate or combined into one program, must be provided before an SRA approved individual has access to select agents and toxins and at least annually thereafter.
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- 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 Guidance for Select Agent or Toxin Facilities.
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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). 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.
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