BOX 5-2Select Agent Regulations—Records Section (42 CFR 73.17)a

§ 73.17 Records.

  1. An individual or entity required to register under this part must maintain complete records related to the activities covered by this part. Such records must include:
    1. Accurate, current inventory for each select agent (including viral genetic elements, recombinant nucleic acids, and recombinant organisms) held in long-term storage (placement in a system designed to ensure viability for future use, such as in a freezer of 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),
      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,
      6. Records created under § 73.16 and 9 CFR 121.16 (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, and
      8. Records created under § 73.19 and 9 CFR part 121.19 (Notification of theft, loss, or release),
    2. Accurate, current inventory for each toxin held, including:
      1. The name and characteristics,
      2. The quantity acquired from another individual or entity (e.g., containers, vials, tubes, etc.), date of acquisition, and the source,
      3. The initial and current quantity amount (e.g., milligrams, milliliters, grams, etc.),
      4. The toxin used and purpose of use, quantity, date(s) of the use and by whom,
      5. Where stored (e.g., building, room, and freezer),
      6. When moved from storage and by whom and when returned to storage and by whom including quantity amount,
      7. Records created under § 73.16 and 9 CFR part 121.16 (Transfers),
      8. 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,
      9. Records created under § 73.19 and 9 CFR part 121.19 (Notification of theft, loss, or release), and
      10. If destroyed, the quantity of toxin destroyed, the date of such action, and by whom.
a

Equivalent regulations for record-keeping for animal and plant select agents and toxins appear in § 331.17 of 7 CFR 331 and § 121.17 of 9 CFR 121.

From: 5, Managing BSAT Research and the Select Agent Program

Cover of Responsible Research with Biological Select Agents and Toxins
Responsible Research with Biological Select Agents and Toxins.
National Research Council (US) Committee on Laboratory Security and Personnel Reliability Assurance Systems for Laboratories Conducting Research on Biological Select Agents and Toxins.
Washington (DC): National Academies Press (US); 2009.
Copyright © 2009, National Academy of Sciences.

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