Responsible Official Resource Manual:
Knowledge of the Select Agent Regulations

The select agent regulations state that the RO must be familiar with the regulatory requirements (see section 9(a)(2)) and is responsible for ensuring that the registered entity maintains regulatory compliance (see section 9(a)(4)). The RO is also responsible for the security, containment, and safe use of select agents and toxins at his or her entity. The RO should have a sufficient understanding of the work objectives within their operations to make appropriate management decisions regarding security, biocontainment and biosafety, and incident response, to ensure compliance with the regulations.

The FSAP website external iconis intended to assist ROs in maintaining compliance at their entities. The website provides current guidance, policies, and helpful information, such as frequently asked questions (FAQs) and the eFSAP Resource Center.

An FSAP Point of Contact is assigned to each entity to serve as an additional resource for information or general inquiry. In addition, FSAP employs science, security, facility, and biosafety personnel who evaluate the applicable components of registered facilities and provide guidance. Periodically, FSAP conducts workshops specifically targeted to the RO. The purpose of these workshops is to keep the RO current about upcoming changes, concerns FSAP may have, and to listen to RO concerns. The RO is notified when these workshops are available through e-mails.

Page last reviewed: December 10, 2020, 10:25 AM