[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: 42CFR73.4]

[Page 446-447]
 
                         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. 73.4  HHS select agents and toxins.

    Except for exclusions under paragraph (f) of this section, the 
viruses, bacteria, fungi, toxins, genetic elements, recombinant nucleic 
acids, and recombinant organisms specified in paragraphs (a) through (e) 
of this part are HHS select agents and toxins.
    (a) Viruses:
    (1) Crimean-Congo haemorrhagic fever virus.
    (2) Ebola viruses.
    (3) Cercopithecine herpesvirus 1 (Herpes B virus).
    (4) Lassa fever virus.
    (5) Marburg virus.
    (6) Monkeypox virus.
    (7) South American Haemorrhagic Fever viruses (Junin, Machupo, 
Sabia, Flexal, Guanarito).
    (8) 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]).
    (9) Variola major virus (Smallpox virus) and Variola minor virus 
(Alastrim).
    (b) Bacteria:
    (1) Rickettsia prowazekii.
    (2) Rickettsia rickettsii.
    (3) Yersinia pestis.
    (c) Fungi: Coccidioides posadasii.
    (d) Toxins:
    (1) Abrin.
    (2) Conotoxins.
    (3) Diacetoxyscirpenol.
    (4) Ricin.
    (5) Saxitoxin.
    (6) Tetrodotoxin.
    (7) Shiga-like ribosome inactivating proteins.
    (e) Genetic Elements, Recombinant Nucleic Acids, and Recombinant 
Organisms:
    (1) Select agent viral nucleic acids (synthetic or naturally 
derived, contiguous or fragmented, in host chromosomes or in expression 
vectors) that can encode infectious and/or replication competent forms 
of any of the select agent viruses.

[[Page 447]]

    (2) Nucleic acids (synthetic or naturally derived) that encode for 
the functional form(s) of any of the toxins listed in paragraph (d) of 
this section if the nucleic acids:
    (i) Are in a vector or host chromosome;
    (ii) Can be expressed in vivo or in vitro; or
    (iii) Are in a vector or host chromosome and can be expressed in 
vivo or in vitro.
    (3) Viruses, bacteria, fungi, and toxins listed in paragraphs (a) 
through (d) of this section that have been genetically modified.
    (f) Exclusions:
    (1) This section does not include any select agent or toxin that is 
in its naturally occurring environment provided it has not been 
intentionally introduced, cultivated, collected, or otherwise extracted 
from its natural source.
    (2) This section does not include non-viable select agent organisms 
or nonfunctional toxins.
    (3) Paragraph (a) of this section does not include the vaccine 
strain of Junin virus (Candid 1).
    (4) Paragraph (d) of this section does not include the following 
toxins (in the purified form or in combinations of pure and impure 
forms) if the aggregate amount under the control of a principal 
investigator does not, at any time, exceed the amount specified: 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.
    (5) The HHS Secretary may exclude from this section attenuated 
strains of HHS select agents or toxins upon a determination that they do 
not pose a severe threat to the public health and safety. To apply for 
an exclusion an applicant must submit a request in writing in accordance 
with Sec. 73.21 to the HHS Secretary establishing that the attenuated 
strain or toxin is eligible for exclusion. The HHS Secretary will 
provide a written decision granting the request, in whole or in part, or 
denying the request. An exclusion will be effective upon notification to 
the applicant. Exclusions will be published in the notice section of the 
Federal Register and will be listed on the CDC Web site at http://
www.cdc.gov. Exclusions also will be referenced in this section when 
changes are made based on periodic reviews.