Records.

§ 73.17 Records.

(a) An individual or entity required to register under this part must maintain complete records relating to the activities covered by this part. Such records must include:

(1) 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 lyophilized materials), including:

(i) The name and characteristics (e.g., strain designation, GenBank Accession number, etc.),

(ii) The quantity acquired from another individual or entity (e.g., containers, vials, tubes, etc.), date of acquisition, and the source,

(iii) Where stored (e.g., building, room, and freezer or other storage container),

(iv) When moved from storage and by whom and when returned to storage and by whom,

(v) The select agent used, purpose of use, and, when applicable, final disposition,

(vi) Records created under § 73.16 and 9 CFR 121.16 (Transfers),

(vii) 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, and

This document is only available to subscribers. Please log in or purchase access.