Guidance on the Inventory of Select Agents and Toxins: Appendix I
Appendix I. Information required for all select agent materials in long-term storage (Section 17[a])
Section 17(a)(1) of the select agent regulations require the entity to maintain an “accurate, current inventory for each select agent (including viral genetic elements, recombinant and/or synthetic nucleic acids, and organisms containing recombinant and/or synthetic nucleic acids) held in long-term storage (placement in a system designed to ensure viability for future use, such as in a freezer or other storage container or lyophilized materials), including:”
- The name and characteristics (e.g., strain designation, GenBank Accession number, etc.).
- The quantity acquired from another individual or entity (e.g., containers, vials, tubes, etc.), date of acquisition, and the source.
- Where stored (e.g., building, room, and freezer or other storage container).
- When moved from storage and by whom and when returned to storage and by whom.
- The select agent used and purpose of use, and, when applicable, final disposition.
- Records created under Section 16 (Transfers).
- For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the select agent, the quantity transferred, the date of transfer, the sender, and the recipient.
- Records created under Section 19 (Notification of theft, loss, or release).