Guidance on the Inventory of Select Agents and Toxins: Appendix II
Appendix II. Information required for all select toxin materials (Section 17[a][3])
Section 17(a)(3) of the select agent regulations require the registered entity to maintain “accurate, current inventory for each toxin held, including:”
- The name and characteristics.
- The quantity acquired from another individual or entity (e.g., containers, vials, tubes, etc.), date of acquisition, and the source.
- The initial and current quantity amount (e.g., milligrams, milliliters, grams, etc.).
- The toxin used and purpose of use, quantity, date(s) of the use and by whom.
- 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, including quantity amount.
- Records created under Section 16 (Transfers).
- For intra-entity transfers (sender and the recipient are covered by the same certificate of registration), the toxin, the quantity transferred, the date of transfer, the sender, and the recipient.
- Records created under Section 19 (Notification of theft, loss, or release).
- If destroyed, the quantity of toxin destroyed, the date of such action, and by whom.
Page last reviewed: December 16, 2020
Content source: Division of Regulatory Science and Compliance