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][1])

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:”

  1. The name and characteristics (e.g., strain designation, GenBank Accession number, etc.).
  2. The quantity acquired from another individual or entity (e.g., containers, vials, tubes, etc.), date of acquisition, and the source.
  3. Where stored (e.g., building, room, and freezer or other storage container).
  4. When moved from storage and by whom and when returned to storage and by whom.
  5. The select agent used and purpose of use, and, when applicable, final disposition.
  6. Records created under Section 16 (Transfers).
  7. 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.
  8. Records created under Section 19 (Notification of theft, loss, or release).
Page last reviewed: December 16, 2020