[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR73.17]



[Page 451-452]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 73_SELECT AGENTS AND TOXINS--Table of Contents

 

Sec.  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) 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 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),

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

storage and by whom,

    (v) The select agent used and purpose of use,

    (vi) Records created under Sec.  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

    (viii) Records created under Sec.  73.19 and 9 CFR part 121.19 

(Notification of theft, loss, or release),

    (2) Accurate, current inventory for each toxin held, including:

    (i) The name and characteristics,

    (ii) The quantity acquired from another individual or entity (e.g., 

containers, vials, tubes, etc.), date of acquisition, and the source,



[[Page 452]]



    (iii) The initial and current quantity amount (e.g., milligrams, 

milliliters, grams, etc.),

    (iv) The toxin used and purpose of use, quantity, date(s) of the use 

and by whom,

    (v) Where stored (e.g., building, room, and freezer),

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

storage and by whom including quantity amount,

    (vii) Records created under Sec.  73.16 and 9 CFR part 121.16 

(Transfers),

    (viii) 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,

    (ix) Records created under Sec.  73.19 and 9 CFR part 121.19 

(Notification of theft, loss, or release), and

    (x) If destroyed, the quantity of toxin destroyed, the date of such 

action, and by whom,

    (3) A current list of all individuals that have been granted access 

approval from the HHS Secretary or Administrator,

    (4) Information about all entries into areas containing select 

agents or toxins, including the name of the individual, name of the 

escort (if applicable), and date and time of entry,

    (5) Accurate, current records created under Sec.  73.9 and 9 CFR 

part 121.9 (Responsible Official), Sec.  73.11 and 9 CFR part 121.11 

(Security), Sec.  73.12 and 9 CFR part 121.12 (Biosafety), Sec.  73.14 

and 9 CFR part 121. 14 (Incident response), and Sec.  73.15 and 9 CFR 

part 121.15 (Training), and

    (6) A written explanation of any discrepancies.

    (b) The individual or entity must implement a system to ensure that 

all records and data bases created under this part are accurate, have 

controlled access, and that their authenticity may be verified.

    (c) All records created under this part must be maintained for three 

years and promptly produced upon request.