Security Plan Guidance:
Section 11(d) – Security Requirements

Section 11(d) – Security Requirements

This section describes the policies and procedures that the entity must implement in order to be in compliance with the select agent regulations. There are many ways to adequately meet the requirements below.

Storage

Section 11(d)(3) – Storage Control

The entity is required to “provide for the control of select agents and toxins by requiring freezers, refrigerators, cabinets, and other containers where select agents or toxins are stored to be secured against unauthorized access (e.g., card access system, lock boxes). See Access Control Devices for more information on methods of securing BSAT against unauthorized access.

There are many ways that the entity can comply with this requirement. Typically, physical locks, key card access, biometrics, or some combination of those provide adequate storage control. Tier 1 select agents and toxins require more stringent conditions. See the Tier 1 guidance document for more information.

Section 11(d)(8) – Separate Registered Space from Public Space

The storage or laboratories that contain select agents and toxins must not be publicly accessible. Public areas are places where the general public may congregate or transit. Areas where select agents and toxins are used or stored must be registered and personnel with access to the registered space must have approval from the HHS Secretary or the APHIS administrator.