Guidance for Select Agent Regulation Training Requirements: Training Program

The training program should include a detailed review of any changes in entity policies or procedures. The RO should review the training program whenever a new research project is planned, new facilities or equipment is added, or the entity plans to work with different agents or toxins to confirm training content still meets the entity’s needs and the regulatory requirements.

The regulations do not require the RO to personally develop or conduct the training program. The RO may delegate the training responsibilities to other entity staff and ensure training is conducted as required. Resources may be available to the RO to help with the training requirement, but the training provided should be site specific based on the risk of work and hazards of the BSAT.

The regulations are performance based and do not specify what is considered an acceptable training program. Training records should include the means used to verify the employee understood the training. The entity has a wide range of options for how to set up a training program, including:

• PowerPoint presentations
• Requirement that staff read the appropriate standard operating procedures and plans
• On-line self-study training programs
• Entity staff member-led presentations (e.g. security training led by the entity’s head ofsecurity)
• Community expert-led training (e.g., community’s hazardous response team)

An effective BSAT training program should be risk based and include biocontainment, biosafety, security (and security awareness, insider threat training as appropriate), incident response, and specific work-related training components. Each training component is discussed in detail below.

Biosafety Training

Biosafety training should address how to work with select agents and toxins in a safe manner. Some examples of the types of topics that may be addressed include:

• Overview of biological risk assessment(s), including potential laboratory hazards
• Safety equipment used in the entity’s laboratory (e.g. safely working in a biosafety cabinet)
• Procedures for donning and doffing Personal Protective Equipment (PPE), including respirator training, if applicable
• Procedures for handling spills
• Proper use of disinfectants and decontamination procedures
• Risks posed by the select agents or toxins
• Handwashing procedures
• Waste handling procedures, including disposal of sharps
• Animal handling and carcass disposal

Biocontainment Training

Biocontainment training should address how to ensure that select agents and toxins are safely contained. Some examples of the types of topics that may be addressed include:

• Recognizing signs of vermin (insects, ectoparasites, mammalian pests)
• Recognizing and understanding that the facility is operating and functioning as intended
• Procedures for the handling of select agents and toxins in the same space with non-select agents and toxins to prevent unintentional contamination
• Shower out procedures
• Familiarity with the restrictions in a Personnel Quarantine Policy

Security Training, Including Security Awareness

Security training should consist of information on how to protect the select agents and toxins from theft and be based on the individual’s job duties. Examples include:

• What to do if a staff member loses their key or identification badge
• What to do when encountering someone in the laboratory who is not authorized to be there
• Who to notify if select agents or toxins are found to be missing
• Inventory control procedures, including control of access and what to do if inventory records are discovered to be altered or compromised
• What to do if a staff member observes suspicious activity or a suspicious package is discovered
• Information security safeguards
• Security of long-term inventory, plants, animals and animal tissues
• Shipping/receiving procedures, including unexpected packages
• Access to areas where select agents and/or toxins are used or stored, including “piggybacking”, Tier 1 barriers, after hours and visitors

Examples of security awareness include:

• How to recognize breaches in security and who to notify
• What to do if a colleague is displaying unsafe or suspicious behaviors
• What to do if individuals who are not part of your organization are asking specific questions about security procedures
• Insider threat awareness training

Incident Response Training

Incident response training should consist of information on how to react to emergencies and take into account the hazards associated with the BSAT. Examples include:

• The correct response if the fire alarm goes off
• How to exit containment in an emergency
• What to do if a colleague collapses in containment
• Where to go if there is a tornado warning
• What to do if the air handling system malfunctions
• What to do if a suspicious package is received

Specific Work-Related Training

Training must be provided to address the needs of the individual, the work they will do, and the risks posed by the select agents or toxins. The entity must ensure the following:

• An entity must ensure that training is appropriate for the work employees are performing.
  • For example, the engineer who maintains the air handling systems would not require the same type of biosafety training as the laboratory worker who conducts animal research with Bacillus anthracis using aerosol equipment.
• The training that each employee receives should be designed to ensure that they can carry out their responsibilities without causing harm to themselves, their fellow co-workers, the public or the
  • For example, FSAP-approved administrative personnel with access to areas where BSAT is used and/or stored, but do not have access to BSAT, might receive information and training that includes an overview of regulatory requirements, general entity security and incident response policies and requirements, security awareness training, and information about the specific hazards of BSAT present in the areas. An FSAP-approved laboratory worker who will handle BSAT as part of his or her job responsibilities would receive the general training previously described, but would also receive more detailed and intensive training for the risks specific to the work being conducted at the entity.
• The entity can provide specific work-related training in several different ways. One way is to provide general training in biocontainment, biosafety, security, and incident response which everyone would participate in and then specific training would be provided to individuals depending on the work they
  • For example, the animal technician would be provided the training on the risk presented by infected animals while the engineer would be trained on how to ensure equipment is decontaminated before conducting maintenance.
• The entity can also separate individuals into groups based on the risk posed and provide the appropriate training to each of these
  • Some entities may require the principal investigator or the laboratory manager to be responsible for developing and conducting the agent specific training. If this is the approach used, then the RO must ensure the training provided meets the regulatory requirements and is consistent.

Tier 1 Biological Select Agents and Toxins Training

There are additional regulatory requirements for those entities that possess Tier 1 BSAT. Entities with Tier 1 BSAT must provide training on entity policies and procedures for reporting, evaluation and corrective actions concerning the assessment of personnel suitability. The training should include entity policies related to ongoing suitability procedures, self-reporting, and peer reporting of incidents or conditions affecting a person’s ability to safely work with BSAT. Individuals with access to Tier 1 BSAT should also receive information and training about response procedures for failure of laboratory intrusion detection systems, procedures to report suspicious activities, and the entity’s occupational health program policy. Section 15(b) requires that entities with Tier 1 BSAT must conduct annual insider threat awareness briefings on how to identify and report suspicious behaviors. This requirement applies to all FSAP- approved personnel on the entity’s registration. The FSAP Security Guidance and Suitability Assessment Guidance documents provide information on insider threat awareness briefings and should be consulted. These briefings must be part of the individual’s training records.