Responsible Official Resource Manual

Fundamental Responsibilities of the Responsible Official

The 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 Section 9 of the select agent regulations. There can be only one RO at a registered entity at any given time. In the absence of the 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. The core responsibilities of and criteria to be the RO are listed below:

  • Pass a security risk assessment (SRA) conducted by the Federal Bureau of Investigation (FBI), Criminal Justice Information Services (CJIS) and be approved by the Federal Select Agent Program (FSAP).
  • Be familiar with the select agent regulations to the extent that the RO can ensure that the entity is compliant with all of the requirements of the select agent regulations.
  • Foster open lines of communication with upper management, facility directors, principal investigators (PIs), veterinarians, contractors, local authorities and institutional oversight committees in order to manage a program compliant with the select agent regulations.
  • Ensure that annual internal inspections are conducted for each laboratory and all other 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 (and not merely a telephonic or audio/visual) presence within the principal duty station to ensure that the entity is in compliance with the select agent regulations and be able respond in a timely manner to onsite 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 and USDA OIG Hotline so 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 RO 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 CDC or APHIS immediately by phone or email.
  • Review, and revise as necessary, 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. Conduct training if changes 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.
  • Ensure limited access to select agents and toxins to SRA approved personnel only. Conduct initial and annual refresher training, and provide performance oversight and disciplinary action for employees engaged in work with select agents and toxins.

Note: The alternative Responsible Official (ARO) is responsible for carrying out the duties and responsibilities of the RO when the RO is absent or unavailable.

The primary duties of the RO include:

  • Resolving deficiencies identified during an inspection.
  • Ensuring lab safety equipment is maintained and maintenance documented
  • Ensuring that all individuals with access to BSAT are trained on biosafety, incident response, and security at least once per year.
  • Reporting the isolation of BSAT except those identified from proficiency samples.