Policy Statement

Date: March 22, 2019

Subject: FSAP Policy Statement: Entity Annual Internal Inspections Required by Section 9(a)(6) of the Select Agent Regulations

Note: This policy statement replaces the FSAP Policy Statement: Entity Annual Internal Inspections Required by Section 9(a)(6) of the Select Agent Regulations dated August 9, 2018.

Policy Statement:

Section 9(a)(6) of the select agent regulations requires a Responsible Official (RO) to ensure that an annual inspection is conducted for each registered space where select agents and toxins are stored or used in order to determine compliance with the requirements of the select agent regulations.

It is the policy of the FSAP that the annual inspection include the following four sections of the select agent regulations to address whether:

  1. Section 12: The entity’s biosafety/biocontainment plan remains appropriate and is being fully and effectively implemented.
  2. Section 11: The entity’s security plan remains appropriate and is being fully and effectively implemented.
  3. Section 14: The entity’s incident response plan remains appropriate and whether the entity has the ability to fully and effectively implement the plan.
  4. Section 15: Each individual with access approval from the HHS Secretary or Administrator has received the appropriate training.

This policy statement is effective March 22, 2019.

Authority:

Section 9 (a) An individual or entity required to register under this part must designate an individual to be the Responsible Official. The Responsible Official must:

(6) Ensure that annual inspections are conducted for each registered space where select agents or toxins are stored or used in order to determine compliance with the requirements of this part. The results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected and the corrections documented.