General

1. Does the "Guidance for the Responsible Official" indicate that the Responsible Official (RO) should not have other duties outside his/her responsibilities as the RO?

   The guidance document states, "Although it is not a violation of the select agent regulations for an individual serving as an RO to have other responsibilities, the Federal Select Agent Program would not recommend this--especially at institutions with large and/or complex select agent programs." As with any other position of responsibility having an impact on the health and safety of individuals, animals, and plants inside and outside the entity, the entity should evaluate the individual's duties based on the size of the entity, the amount of personnel, and the scope of the RO resources.

2. Is it a requirement to have the RO or Alternate RO (ARO) on- site during normal business hours?

   Yes, regulations in section 9(a)(5) require that the RO have a physical (and not merely a telephonic or audio/visual) presence at the registered entity to ensure that the entity is in compliance with the select agent regulations and is able to quickly respond to on-site incidents involving select agents and toxins. Ideally, the RO should be co-located with the entity, or within reasonable distance of all the entity's registered areas, to be able to quickly respond to emergencies and to provide appropriate oversight on a day-to-day basis. There must be an approved RO or ARO (who assumes full RO responsibilities in the absence of the RO) at a registered entity during normal business hours and the RO or ARO must be available for emergencies after normal business hours.

   There are situations where registered entities have two or more registered laboratory facilities dispersed over a defined geographical location (e.g., a university campus or business complex). The Federal Select Agent Program considers this one general physical location which can be managed as one registration. The intent of the requirement that the RO have a physical presence at the registered entity is not to require that an RO is assigned to each laboratory but to ensure that an RO is physically located on-site.

3. What is the position of the Federal Select Agent Program for ROs who hold the title but aren't engaged in the entity's select agent program?

   By definition, the RO must be engaged in the entity’s select agent program. The registered entity must not only assign the RO the responsibility to ensure compliance with the select agent regulations, the entity must also ensure that it delegates to the RO sufficient authority to speak and act on behalf of the entity. A registered entity which fails to vest in its RO sufficient authority to ensure compliance with all of the requirements of the select agent regulations has failed in one of its primary responsibilities.

4. Is there guidance on what the RO should review during the annual audit of the entity's select agent program? Alternatively, would an inspection by a biosafety organization be adequate?

   Yes, the regulations in section 9(a) (6) require the RO ensure that annual inspections are conducted for each registered space where select agents and toxins are stored or used (all registered areas) in order to determine compliance with the requirements of the select agent regulations. Therefore, the RO does not have to specifically conduct the inspection. It should be noted that the inspections conducted by the Federal Select Agent Program would not meet this requirement.

   Establishing an internal annual inspection program provides a means for the RO to monitor compliance with the select agent regulations and identify deviations from acceptable laboratory safety or security practices. As such, the RO needs to ensure that annual reviews are conducted and appropriately documented, including the scope of the review, date(s) of the review, findings, and the appropriate corrective action(s) taken for any deficiencies found. The annual inspection should encompass every aspect of safety, security, and incident response at the entity, and should also include a review of the entity's inventory procedures to ensure that individuals with access to inventories are following appropriate procedures for access and recording changes to the inventory. This can be separate from an overall periodic reconciliation of the entire inventory (recommended every 3 years).

   The inspection could be conducted by the entity's biosafety organization as long as the above requirements are met.