Guidance on the Inventory of Select Agents and Toxins: Additional Information

If an entity has archived specimens that are accessed infrequently, the container may be sealed with tamper-proof material (e.g., security tape) following inventory verification, and the sealed container can be verified during self-audits. However, any or all archived containers may be required to be opened during inspection to perform vial-by-vial count verifications.

Each entity should have a written policy to manage its select agent inventory held in long-term storage, including identifying specific individual responsibilities for inventory oversight, an internal audit system to check that appropriate procedures are followed to document changes to the inventory, and training as appropriate for personnel with access to select agent inventory. In addition, the entity should have protocols in place for the transfer (either intra-entity or inter-entity) and accountability of all toxins possessed and all long-term storage inventories of select agents, at all times, including when the investigator responsible for the inventory departs the entity as a result of change in employment, retirement, death, sabbatical, or other reasons.