Responsible Official Resource Manual:
Delegating Responsibility as an RO

The entity may designate one or more AROs. Each ARO must have the ability to assume the full authority and undertake all of the responsibilities of the RO as needed in accordance with section 9(b).

While specific roles (e.g., fulfilling the responsibilities of an absent RO) may be fulfilled only by an approved ARO, some duties may be delegated to other individuals. Delegated duties may include:

  • Developing risk assessments
  • Developing written security, incident response, and biosafety plans
  • Training select agent personnel
  • Developing and maintaining safety, security, or incident response protocols
  • Maintaining records

Although the RO may delegate certain functions to others, including the ARO, the RO:

  • Retains his or her overall responsibility for oversight of the delegated functions
  • Maintains control over all aspects of an entity’s program relevant to the select agent regulations
  • Must be aware and responsible for all submissions to FSAP
  • Must be fully engaged in his or her duties when on site, to ensure efficient and timely communications with FSAP

While duties may be delegated, the RO is still responsible for maintaining current knowledge of what is occurring within the registered entity and ensuring compliance with the select agent regulations.

Page last reviewed: August 27, 2020, 10:05 AM