[Title 42 CFR 73.3]
[Code of Federal Regulations (annual edition) - October 1, 2008 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN]
[Subchapter F - QUARANTINE, INSPECTION, LICENSING]
[Part 73 - SELECT AGENTS AND TOXINS]
[Sec. 73.3 - HHS select agents and toxins.]
[From the U.S. Government Printing Office]


42PUBLIC HEALTH12008-10-012008-10-01false73.3Sec. 73.3PUBLIC HEALTHPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMANQUARANTINE, INSPECTION, LICENSINGSELECT AGENTS AND TOXINS
Sec. 73.3  HHS select agents and toxins.

    (a) Except for exclusions under paragraphs (d) and (e) of this 
section, the HHS Secretary has determined that the biological agents and 
toxins listed in this section have the potential to pose a severe threat 
to public health and safety.
    (b) HHS select agents and toxins:

Abrin
Cercopithecine herpesvirus 1 (Herpes B virus)
Coccidioides posadasii
Conotoxins
Crimean-Congo haemorrhagic fever virus
Diacetoxyscirpenol
Ebola viruses
Lassa fever virus
Marburg virus
Monkeypox virus
Reconstructed replication competent forms of the 1918 pandemic influenza 
virus containing any portion of the coding regions of all eight gene 
segments.
Ricin
Rickettsia prowazekii
Rickettsia rickettsii
Saxitoxin
Shiga-like ribosome inactivating proteins
South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, 
Flexal, Guanarito)
Tetrodotoxin
Tick-borne encephalitis complex (flavi) viruses (Central European Tick-
borne encephalitis, Far Eastern Tick-borne encephalitis [Russian Spring 
and Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic 
Fever])
Variola major virus (Smallpox virus) and Variola minor virus (Alastrim)
Yersinia pestis

    (c) Genetic Elements, Recombinant Nucleic Acids, and Recombinant 
Organisms:
    (1) Nucleic acids that can produce infectious forms of any of the 
select

[[Page 436]]

agent viruses listed in paragraph (b) of this section.
    (2) Recombinant nucleic acids that encode for the functional form(s) 
of any of the toxins listed in paragraph (b) of this section if the 
nucleic acids:
    (i) Can be expressed in vivo or in vitro, or
    (ii) Are in a vector or recombinant host genome and can be expressed 
in vivo or in vitro.
    (3) HHS select agents and toxins listed in paragraph (b) of this 
section that have been genetically modified.
    (d) HHS select agents or toxins that meet any of the following 
criteria are excluded from the requirements of this part:
    (1) Any HHS select agent or toxin that is in its naturally occurring 
environment provided the select agent or toxin has not been 
intentionally introduced, cultivated, collected, or otherwise extracted 
from its natural source.
    (2) Non-viable HHS select agents or nonfunctional HHS toxins.
    (3) HHS toxins under the control of a principal investigator, 
treating physician or veterinarian, or commercial manufacturer or 
distributor, if the aggregate amount does not, at any time, exceed the 
following amounts: 100 mg of Abrin; 100 mg of Conotoxins; 1,000 mg of 
Diacetoxyscirpenol; 100 mg of Ricin; 100 mg of Saxitoxin; 100 mg of 
Shiga-like ribosome inactivating proteins; or 100 mg of Tetrodotoxin.
    (e) An attenuated strain of a HHS select agent or toxin may be 
excluded from the requirements of this part based upon a determination 
that the attenuated strain does not pose a severe threat to public 
health and safety.
    (1) To apply for an exclusion, an individual or entity must submit a 
written request and supporting scientific information. A written 
decision granting or denying the request will be issued. An exclusion 
will be effective upon notification to the applicant. Exclusions will be 
published periodically in the notice section of the Federal Register and 
will be listed on the CDC Web site at http://www.cdc.gov/.
    (2) If an excluded attenuated strain is subjected to any 
manipulation that restores or enhances its virulence, the resulting 
select agent or toxin will be subject to the requirements of this part.
    (3) An individual or entity may make a written request to the HHS 
Secretary for reconsideration of a decision denying an exclusion 
application. The written request for reconsideration must state the 
facts and reasoning upon which the individual or entity relies to show 
the decision was incorrect. The HHS Secretary will grant or deny the 
request for reconsideration as promptly as circumstances allow and will 
state, in writing, the reasons for the decision.
    (f) Any HHS select agent or toxin seized by a Federal law 
enforcement agency will be excluded from the requirements of this part 
during the period between seizure of the select agent or toxin and the 
transfer or destruction of such agent or toxin provided that:
    (1) As soon as practicable, the Federal law enforcement agency 
transfers the seized select agent or toxin to an entity eligible to 
receive such agent or toxin or destroys the agent or toxin by a 
recognized sterilization or inactivation process,
    (2) The Federal law enforcement agency safeguards and secures the 
seized select agent or toxin against theft, loss, or release, and 
reports any theft, loss, or release of such agent or toxin, and
    (3) The Federal law enforcement agency reports the seizure of the 
select agent or toxin to CDC or APHIS.
    (i) The seizure of Ebola viruses, Lassa fever virus, Marburg virus, 
South American Haemorrhagic Fever virus (Junin, Machupo, Sabia, Flexal, 
Guanarito), Variola major virus (Smallpox virus), Variola minor 
(Alastrim), or Yersinia pestis must be reported within 24 hours by 
telephone, facsimile, or e-mail. This report must be followed by 
submission of APHIS/CDC Form 4 within seven calendar days after seizure 
of the select agent or toxin.
    (ii) For all other HHS select agents or toxins, APHIS/CDC Form 4 
must be submitted within seven calendar days after seizure of the agent 
or toxin.
    (iii) A copy of APHIS/CDC Form 4 must be maintained for three years.
    (4) The Federal law enforcement agency reports the final disposition 
of

[[Page 437]]

the select agent or toxin by submission of APHIS/CDC Form 4. A copy of 
the completed form must be maintained for three years.

[70 FR 13316, Mar. 18, 2005, as amended at 70 FR 61049, Oct. 20, 2005]