7 CFR 331.17 - Records.

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There is 1 rule appearing in the Federal Register for 7 CFR 331. View below or at eCFR (GPOAccess)
§ 331.17 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);
(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 § 331.16 (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 § 331.19 (Notification of theft, loss, or release);
(2) An accurate, current accounting of any animals or plants intentionally or accidentally exposed to or infected with a select agent (including number and species, location, and appropriate disposition);
(3) An 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;
(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 § 331.16 (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 § 331.19 (Notification of theft, loss, or release);
(x) If destroyed, the quantity of toxin destroyed, the date of such action, and by whom.
(4) A current list of all individuals that have been granted access approval by the Administrator or the HHS Secretary;
(5) Information about all entries into areas containing select agents or toxins, including the name of the individual, name of the escort (if applicable), and the date and time of entry;
(6) Accurate, current records created under § 331.9(c) (Responsible official), § 331.11 (Security), § 331.12 (Biocontainment), § 331.14 (Incident response), and § 331.15 (Training); and
(7) A written explanation of any discrepancies.
(b) The individual or entity must implement a system to ensure that all records and databases created under this part are accurate, have controlled access, and can be verified for authenticity.
(c) All records created under this part must be maintained for 3 years and promptly produced upon request.
[70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61077, Oct. 5, 2012]

Title 7 published on 2014-01-01

The following are only the Rules published in the Federal Register after the published date of Title 7.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-05-12; vol. 79 # 91 - Monday, May 12, 2014
    1. 79 FR 26829 - Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service
      Final rule; technical amendment.
      Effective Date: May 12, 2014.
      7 CFR Part 331

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United States Code

Title 7 published on 2014-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 7 CFR 331 after this date.

  • 2014-05-12; vol. 79 # 91 - Monday, May 12, 2014
    1. 79 FR 26829 - Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service
      Final rule; technical amendment.
      Effective Date: May 12, 2014.
      7 CFR Part 331