[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 HEALTH12008-10-012008-10-01falseHHS select agents and toxins.73.3Sec. 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:
Cercopithecine herpesvirus 1 (Herpes B virus)
Crimean-Congo haemorrhagic fever virus
Lassa fever virus
Reconstructed replication competent forms of the 1918 pandemic influenza
virus containing any portion of the coding regions of all eight gene
Shiga-like ribosome inactivating proteins
South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia,
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
Variola major virus (Smallpox virus) and Variola minor virus (Alastrim)
(c) Genetic Elements, Recombinant Nucleic Acids, and Recombinant
(1) Nucleic acids that can produce infectious forms of any of the
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
(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
(iii) A copy of APHIS/CDC Form 4 must be maintained for three years.
(4) The Federal law enforcement agency reports the final disposition
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]