Security Plan Guidance:
Section 11(e) – Inventory Audits

Section 11(e) – Inventory Audits

An inventory audit is an examination of a portion of the inventory or collection sufficient to verify that inventory controls are effective. Note: This inventory is not a part of the requirements of section 17external icon. Section 11(e) of the select agent regulations requires the entity to perform a complete inventory audit for all BSAT under the control of a PI whenever:

  1. The BSAT is physically relocated to another registered space.
  2. There is a change (departure or new arrival) of the PI in control of the BSAT.
  3. There is a theft or loss of BSAT under the control of the PI.

Entities have discretion on how they conduct these audits. The depth of an audit should depend on the circumstances. Entities should consider the following when determining the depth of an entity audit:

  1. The timing of the inventory audit.
  2. The circumstances that require the inventory audit. For example, an ‘emergency’ movement to another location (freezer malfunction) may result in a focus on counting full racks and a confirmation of a targeted, smaller number of vials. In the case of a shipment to a new building or campus where there is sufficient time to plan, entities are encouraged to inventory more thoroughly.
  3. The criteria used to determine which samples are audited. In the case of a large inventory, the entity may choose to focus on the most recently manipulated samples. In the case of a small inventory, the entity may choose to focus on the entire inventory.
  4. Any additional storage measures. If the material is stored in tamper evident systems, the entity may choose to count the sealed containers instead of the individual vials within those containers.
  5. The size of the collection being audited and the manner it is stored. Inventories which are intermixed with other samples may require a ‘vial by vial’ audit.

See the Inventory Audit Conditions table for more detailed instructions for when an inventory audit is necessary.

Keep audit records in accordance with section 73.17(c). Changes to the inventory must be recorded in accordance with section 73.17(a) as well.

Page last reviewed: August 26, 2020, 04:20 PM