[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR73.15]

[Page 459-460]
 
                         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. 73.15  Records.

    The Responsible Official must maintain complete records relating to 
the activities covered by this Part. Such records include:
    (a) An entity required to register under this part must maintain an 
up-to-date, accurate list of the individuals approved under Sec. 73.8 
for access to select agents and toxins.

[[Page 460]]

    (b) The entity must maintain an accurate, current inventory of each 
select agent and toxin held. The inventory records must include the 
following information for each select agent and toxin:
    (1) The name, characteristics, and source data;
    (2) The quantity held on the date of the first inventory (toxins 
only);
    (3) The quantity acquired, the source, and date of acquisition;
    (4) The quantity, volume, or mass destroyed or otherwise disposed of 
and the date of each such action;
    (5) The quantity used and date(s) of the use (toxins only);
    (6) The quantity transferred, the date of transfer, and individual 
to whom it was transferred (this includes transfers within an entity 
when the sender and the recipient are covered by the same certificate of 
registration);
    (7) The current quantity held (toxins only);
    (8) Any select agent or toxin lost, stolen, or otherwise unaccounted 
for; and
    (9) A written explanation of any discrepancies.
    (c) The entity must maintain the following records:
    (1) For access to the select agents or toxins:
    (i) The name of each individual who has accessed any select agent or 
toxin;
    (ii) The select agent or toxin used;
    (iii) The date when the select agent or toxin was removed, if 
removed from long-term storage or holdings for stock cultures;
    (iv) The quantity removed (toxins only);
    (v) The date the select agent or toxin was returned to the long-term 
storage or holdings for stock cultures; and
    (vi) The quantity returned (toxins only);
    (2) For access to the area where select agents are used or stored:
    (i) The name of each individual who has accessed the area;
    (ii) The date and time the individual entered the area;
    (iii) The date and time the individual left the area; and
    (iv) For individuals not approved under Sec. 73.8, the individual 
approved under Sec. 73.8 who accompanied the unapproved individual into 
the area.
    (d) The entity must implement a system to ensure that all records 
and databases created under paragraphs (b) and (c) of this section are 
accurate, and that the authenticity of records may be verified.
    (e) The entity must create a record concerning inspections conducted 
under Sec. 73.10(b).
    (f) Safety, security, and emergency response plans.
    (g) Training records.
    (h) Transfer documents (CDC Form EA-101) and permits.
    (i) Safety and security incident reports.
    (j) The entity must maintain all records created under this part for 
three years.