[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR73.8]

[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. 73.8  Security risk assessment.

    (a) An entity may not possess or use in the United States, receive 
from outside the United States, or transfer within the United States, 
any select agent or toxin unless approved by the HHS Secretary or the 
USDA Secretary based on a security risk assessment by the Attorney 
General. This paragraph does not apply to Federal, State, or local 
governmental agencies, but does apply to the Responsible Official and 
others working for or otherwise acting on behalf of such agencies.
    (b) An entity 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 the USDA 
Secretary, based on a security risk assessment by the Attorney General.
    (c) To obtain a security risk assessment under this section, an 
entity must submit to the Attorney General the information requested for 
the entity, the Responsible Official, any individual who owns or 
controls the entity, and any other individuals required to obtain 
approval under this section. The determinations regarding approval will 
be made by the agency that is responsible for making determinations 
regarding the corresponding certificate of registration. An entity will 
receive prompt notice of action taken in response to a request for 
approval for the entity, the Responsible Official, and individuals. An 
individual will receive prompt notice of a denial of approval.
    (d) The Attorney General will conduct a security risk assessment on 
entities and individuals whose identifying information is properly 
submitted. Based on the security risk assessment, the Attorney General 
will notify the HHS Secretary if the Attorney General identifies any 
entity, individual who owns or controls the entity, or any other 
individual who is:
    (1) A restricted person under 18 U.S.C. 175b; or
    (2) Reasonably suspected by any Federal law enforcement or 
intelligence agency of:
    (i) Committing a crime specified in 18 U.S.C. 2332b(g)(5);
    (ii) Having a 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
    (iii) Being an agent of a foreign power (as defined in 50 U.S.C. 
1801).
    (e) The HHS Secretary will deny or revoke access to any select agent 
or toxin to an entity or individual identified by the Attorney General 
as a restricted person under paragraph (d)(1). The HHS Secretary will 
deny or revoke access to any select agent or toxin to an entity or 
individual identified by

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the Attorney General as meeting the criteria of paragraph (d)(2) unless 
determined by the HHS Secretary to be warranted in the interest of the 
public health and safety or national security. For individuals meeting 
the criteria of paragraph (d)(2) the HHS Secretary may provide a limited 
approval for a specified time based upon the finding that circumstances 
warrant such action in the interest of the public health and safety or 
national security.
    (f) Unless a shorter period is granted under paragraph (e) of this 
section, an approval for an entity or individual under this section will 
be valid for five years unless terminated sooner. The HHS Secretary may 
terminate an approval for an entity or an individual based on a request 
from the entity or individual, a security risk assessment under this 
section, or a failure to comply with the provisions of this part, and 
may take such action immediately if necessary to protect the public 
health and safety, or national security.
    (g) The HHS Secretary will request the Attorney General to expedite 
the review process for an individual and will take action to expedite 
the HHS Secretary's review process for an individual upon a showing of 
good cause (e.g., public health or agricultural emergencies, national 
security, impending expiration of a research grant, a short-term visit 
by a prominent researcher). To apply for an expedited review, an entity 
must submit a request in writing in accordance with Sec. 73.21 to the 
HHS Secretary establishing the need for such action. The HHS Secretary 
will provide a written decision granting the request, in whole or in 
part, or denying the request.