Responsible Official Resource Manual:
Authority and Responsibility

Section 9(a)(3) of the regulations requires that the RO has the authority and responsibility to act on behalf of the entity for its select agent program.

The entity must delegate to the RO the authority to effectively manage the security, biocontainment and biosafety, and incident response of select agents and toxins at their facility. This authority of the RO includes the following:

  • The ability to provide direct input to affect changes as needed in operations, personnel, and facilities at the registered entity in order to fulfill his or her responsibilities.
  • Be in an authoritative position in the organization such that employees engaged in select agent and toxin activities at the entity recognize the RO’s authority to maintain compliance with the select agent
  • The ability and opportunity to effectively communicate with senior laboratory and management officials within the entity in order to gain support and facilitate actions as needed in carrying out the responsibilities. For example, the RO should have the ability to either make budget decisions or influence these decisions to ensure that the entity takes necessary actions for equipment maintenance, repairs of the biocontainment facilities, and physical security systems used to protect and secure select agents and toxins in compliance with the select agent
  • The ability to engage institutional oversight committees, if needed, charged with review of the entity’s select agent program. If created, the RO should be engaged in determining how these oversight committees should facilitate, but not limit, the authority and responsibility of the RO’s involvement in these

The RO can delegate duties to others to achieve effective oversight in an efficient manner; however, the RO retains responsibility to ensure that the registered entity is in full compliance with the select agent regulations.

In addition, given the scope of the responsibilities of the RO, communication and coordination with the entity’s safety and security programs can be valuable in ensuring the safety and security of select agents and toxins.

Page last reviewed: August 26, 2020, 04:55 PM