Responsible Official Resource Manual:
Fundamental Responsibilities of the Responsible Official
The Responsible Official (RO) is the individual designated by the registered entity with the authority and responsibility to act on behalf of the entity to ensure compliance with the select agent regulations. There can be only one RO at a registered entity at any given time. In the absence of an RO, a previously appointed and approved alternate Responsible Official (ARO) must assume the RO’s responsibility and has the authority to act on behalf of the registered entity. It is FSAP policy that an individual will not be approved by the FSAP to be an RO at more than one entity, nor will an individual who has been approved to be an RO at one entity also be approved by the FSAP to be an ARO at another registered entity. It is also the policy of the FSAP that an individual who has been approved by the FSAP to be an ARO at one entity can be approved by the FSAP to be an ARO at another registered entity if, when they serve as RO, they can meet the provisions outlined in section 9 of the select agent regulations. The core responsibilities of and criteria to be the RO are listed below:
- Be approved by FSAP following a security risk assessment (SRA) by the Federal Bureau of Investigation (FBI).
- Be familiar with the select agent regulations to the extent that the RO can ensure the entity is compliant with all requirements.
- Communicate with upper management, facility directors, principal investigators (PIs), veterinarians, scientists, contractors, local authorities, and institutional oversight committees in order to manage a successful program compliant with the select agent regulations.
- Ensure that annual internal inspections are conducted for all registered areas where select agents or toxins are stored or used in order to determine compliance with the requirements of the select agent regulations. Document the results of each inspection, correct any deficiencies identified during inspection, and document the corrections.
- Have a physical, not merely a telephonic or audio/visual, presence within a reasonable distance of all of the entity’s registered areas (the principal duty station) to ensure that the entity is in compliance with the select agent regulations. Be able to respond in a timely manner to on-site incidents involving select agents and toxins in accordance with the entity’s incident response plan.
- Have the authority to speak and act on behalf of the entity.
- Ensure that individuals listed on the entity’s select agent registration are provided the contact information for the HHS OIG Hotline external iconand USDA OIG Hotline external iconso that they may anonymously report any safety or security concerns related to select agents and toxins.
- Investigate to determine the reason for any failure of a validated inactivation procedure or any failure to remove viable select agent from material. If the entity is unable to determine the cause as a deviation from a validated inactivation procedure or a viable select agent removal procedure, or receives a report of any inactivation failure after the movement of material to another location, the RO must report the inactivation or viable agent removal procedure failure to FSAP immediately by phone or email.
- Review and approve each of the entity’s validated inactivation procedures and viable select agent removal procedures. Conduct and document the review annually or after any change in PI, change in the validated inactivation procedure or viable select agent removal procedure, or failure of the validated inactivation procedure or viable select agent removal procedure. Ensures that training is conducted for those personnel performing the procedures for any changes that occur to the validated inactivation procedure, viable select agent removal procedure, or viability testing protocol.
- For entities registered to possess, store, or use Tier 1 select agents and toxins, the RO must coordinate their efforts with the entity’s safety and security professionals to ensure security of Tier 1 select agents and toxins and share, as appropriate, relevant information.
- Limit access to select agents and toxins to FSAP-approved personnel only.
- Ensure that current and accurate information related to the entity is provided through eFSAP.
- Conduct site-specific drills or exercises at least annually to validate or test the effectiveness of the security, biosafety, and incident response plans. Document drills and exercises to include how the plans were tested and evaluated, any identified problems and corrective actions taken, and the names of drill or exercise participants.