Responsible Official Resource Manual: Records

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The RO has oversight responsibility for the entity’s creation and maintenance of all records documenting entity select agent activities. The records should be organized so they can be readily produced if requested by FSAP inspectors. Examples of records kept by the entity:

  • Inventory – An entity is required to maintain accurate inventory records for each identification number that includes all of the information required in section 17 and an entity is accountable for each vial associated with that number. Refer to Guidance on the Inventory of Select Agents and Toxins for information regarding the inventory of select agents and toxins for long term storage, including definitions, storage criteria, and record maintenance.
  • Internal Audits – Ensure that an entity performs annual internal inspections. Refer to Entity Annual Internal Inspections policy and guidance for additional information.
  • Record of Access – Ensure that there is a record of access to rooms containing select agents and toxins and ensure that only FSAP-approved individuals have access to select agents or toxins.
  • Training – Maintain a training record for each person who is granted access to select agents and toxins and each escorted individual (e.g., laboratory workers, visitors). Include the person’s name, date of each training they received, description of the training, and means used to verify that the individual understood the training. For each person who is granted access to select agents and toxins, maintain initial and refresher training records. Refer to Guidance for Select Agent Regulation Training Requirements for meeting the training requirements of the select agent regulations. Topics include what types of training are required, training programs, frequency requirements, and training records.
  • Biosafety, Security, and Incident Response Plans – Maintain and review biosafety, security, and incident response plans at least annually. Revise as needed.
    • Refer to Biosafety/Biocontainment Plan Guidance for developing and implementing a biosafety/biocontainment plan in accordance with section 12 of the select agent regulations.
    • Refer to Incident Response Plan Guidance for developing and implementing an incident response plan in accordance with section 14 of the select agent regulations.
    • Refer to Security Plan Guidance for developing and implementing a security plan in compliance with section 11 of the select agent regulations.
  • Drills/Exercises – Develop, implement, and document drills and exercises in accordance with sections 12, 13, and 14 of the select agent regulations. Refer to Drills and Exercises Guidance for additional information.

For records not maintained in eFSAP, records must be maintained for at least three years and should be kept secure to avoid any loss or alteration. Entity policy may dictate longer retention times.