42 CFR 73.10 - Restricting access to select agents and toxins; security risk assessments.

§ 73.10 Restricting access to select agents and toxins; security risk assessments.

(a) An individual or entity required to register under this part may not provide an individual access to a select agent or toxin, and an individual may not access a select agent or toxin, unless the individual is approved by the HHS Secretary or Administrator, following a security risk assessment by the Attorney General.

(b) An individual will be deemed to have access at any point in time if the individual has possession of a select agent or toxin (e.g., ability to carry, use, or manipulate) or the ability to gain possession of a select agent or toxin.

(c) Each individual with access to select agents or toxins must have the appropriate education, training, and/or experience to handle or use such agents or toxins.

(d) To apply for access approval, each individual must submit the information necessary to conduct a security risk assessment to the Attorney General.

(e) A person with a valid approval from the HHS Secretary or Administrator to have access to select agents and toxins may request, through his or her Responsible Official, that the HHS Secretary or Administrator provide their approved access status to another registered individual or entity for a specified period of time. A Responsible Official must immediately notify the Responsible Official of the visited entity if the person's access to select agents and toxins has been terminated.

(f) An individual's security risk assessment may be expedited upon written request by the Responsible Official and a showing of good cause (e.g., public health or agricultural emergencies, national security, or a short term visit by a prominent researcher). A written decision granting or denying the request will be issued.

(g) An individual's access approval will be denied or revoked if the individual is within any of the categories described in 18 U.S.C. 175b,

(h) An individual's access approval may be denied, limited, or revoked if:

(1) The individual is reasonably suspected by any Federal law enforcement or intelligence agency of committing a crime specified in 18 U.S.C. 2332b(g)(5), knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in intentional crimes of violence, or being an agent of a foreign power (as defined in 50 U.S.C. 1801), or

(2) It is determined such action is necessary to protect public health and safety.

(i) An individual may appeal the HHS Secretary's decision to deny, limit, or revoke access approval under § 73.20.

(j) Access approval is valid for a maximum of three years.

(k) The Responsible Official must immediately notify CDC or APHIS when an individual's access to select agents or toxins is terminated by the entity and the reasons therefore.

[ 70 FR 13316, Mar. 18, 2005, as amended at 77 FR 61112, Oct. 5, 2012; 82 FR 6293, Jan. 19, 2017]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 42 published on 14-Sep-2017 03:57

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 73 after this date.

  • 2017-04-12; vol. 82 # 69 - Wednesday, April 12, 2017
    1. 82 FR 17569 - Possession, Use, and Transfer of Select Agents and Toxins—Addition of Bacillus cereus Biovar anthracis to the HHS List of Select Agents and Toxins
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Disease Control and Prevention (CDC)
      Interim rule; adoption as final and response to public comments.
      Effective April 12, 2017.
      42 CFR Part 73