Guidance on the Inventory of Select Agents and Toxins: Appendix III
Appendix III. Material Containing Select Agents or Regulated Nucleic Acids (Section 17 [a])
Section 17(a)(8) of the select agent regulations requires the entity to provide the following if they possess select agents, material containing select agents, or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a validated inactivation or removal procedure:
- A written description of the validated inactivation procedure or viable select agent removal method used, including validation data.
- A written description of the viability testing protocol used.
- A written description of the investigation conducted by the entity Responsible Official involving an inactivation or viable select agent removal failure and the corrective actions taken.
- The name of each individual performing the validated inactivation or viable select agent removal method.
- The date(s) the validated inactivation or viable select agent removal method was completed.
- The location where the validated inactivation or viable select agent removal method was performed.
- A certificate, signed by the Principal Investigator, that includes the date of inactivation or viable select agent removal, the validated inactivation, or viable select agent removal method used, and the name of the Principal Investigator. A copy of the certificate must accompany any transfer of inactivated or select agent removed material.
The information specified in Section 17(a)(8)(vii) must be retained by the entity that performs the inactivation of viable select agent removal and must accompany the inactivated sample regardless of who it goes to. The certificate needs to be a written certification of the information but doesn’t require any specific format. For example, the required information can be added to the inventory log or other documentation. Further, the PI does not have to be present during the performance of the inactivation or select agent removal procedure. This documentation can be batched and recorded outside of containment; however, the information must accompany the samples regardless of the recipient or location transferred to, and the certificate must be signed before samples are removed from registered space. The signature denotes that the PI that is responsible for the specific agent and has reviewed the inactivation procedure used and the validation or verification data. The certificate should be signed as close to the date of inactivation as possible. If the PI is transferring inactivated select agent to their unregistered laboratory, then the signed certificate with the required information must accompany that sample.
There is no regulatory requirement for the receiver to keep the certificate, but it is strongly recommended that this information is kept so long as the inactivated sample exists. However, the sender or the PI that performed the inactivation procedure must keep the certificate for 3 years. In the absence of that PI, an individual designated by that PI and approved by the entity’s Responsible Official can sign the certificate but only during the duration of the PI’s absence. Each absence of a PI requires a new delegation. Once non-viability, non-infectivity, and/or non-toxicity have been demonstrated, and the record requirements are met, the material is no longer subject to the regulations. While it is not a regulatory requirement, it is recommended that entities maintain records that identify the recipients of inactivated materials.