Select agents and toxins

(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 Tickborne encephalitis, Far Eastern Tickborne encephalitis [Russian Spring and Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic Fever]).
(9) Variola major virus (Smallpox virus) and Variola minor virus (Alastrim).

(1) Rickettsia prowazekii.
(2) Rickettsia rickettsii.
(3) Yersinia pestis.

Coccidioides posadasii.

(1) Abrin.
(2) Conotoxins.
(3) Diacetoxyscirpenol.
(4) Ricin.
(5) Saxitoxin.
(6) Tetrodotoxin.
(7) Shiga-like ribosome inactivating proteins.

(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.
(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.

(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 nonviable 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 Shigalike
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 § 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.

(1) Eastern Equine Encephalitis virus.
(2) Nipah and Hendra Complex viruses.
(3) Rift Valley fever virus.
(4) Venezuelan Equine Encephalitis virus.

(1) Bacillus anthracis.
(2) Brucella abortus.
(3) Brucella melitensis.
(4) Brucella suis.
(5) Burkholderia mallei (formerly Pseudomonas mallei).
(6) Burkholderia pseudomallei (formerly Pseudomonas pseudomallei).
(7) Botulinum neurotoxin producing species of Clostridium.
(8) Coxiella burnetii.
(9) Francisella tularensis.

Coccidioides immitis.

(1) Botulinum neurotoxins.
(2) Clostridium perfringens epsilon toxin.
(3) Shigatoxin.
(4) Staphylococcal enterotoxins.
(5) T–2 toxin.

(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.
(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.

(1) This section does not include any select agent or toxin that is in its naturally occurring environment provided that it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
(2) This section does not include nonviable select agent organisms or nonfunctional toxins.
(3) Paragraph (a) does not include the vaccine strain of Rift Valley fever virus (MP–12) or Venezuelan Equine encephalitis virus vaccine strain TC–83.
(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: 0.5 mg of Botulinum neurotoxins; 5 mg of Staphylococcal enterotoxins; 100 mg of Clostridium perfringens epsilon toxin; 100 mg of Shigatoxin; or 1,000 mg of T– 2 toxin.
(5) The HHS Secretary, after consultation with the USDA Secretary, may exclude from this section attenuated strains of overlap select agents or toxins upon a determination that they do not pose a severe threat to the public health and safety and do not meet the criteria in 9 CFR part 121 for inclusion. To apply for an exclusion, an applicant must submit a request in writing in accordance with § 73.21 to the HHS Secretary or the USDA Secretary in accordance with 9 CFR part 121, establishing that the attenuated strain is eligible for exclusion. In response to an application submitted to the HHS Secretary, 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. Also, they will be referenced in this section when changes are made based on periodic reviews.

USDA HIGH CONSEQUENCE LIVESTOCK PATHOGENS AND TOXINS (NON-OVERLAP AGENTS AND TOXINS)
Akabane virus
African swine fever virus
African horse sickness virus
Avian influenza virus (highly pathogenic)
Blue tongue virus (Exotic)
Bovine spongiform encephalopathy agent
Camel pox virus
Classical swine fever virus
Cowdria ruminantium (Heartwater)
Foot and mouth disease virus
Goat pox virus
Lumpy skin disease virus
Japanese encephalitis virus
Malignant catarrhal fever virus (Exotic)
Menangle virus
Mycoplasma capricolum/ M.F38/M. mycoides capri
Mycoplasma mycoides mycoides
Newcastle disease virus (VVND)
Peste Des Petits Ruminants virus
Rinderpest virus
Sheep pox virus
Swine vesicular disease virus
Vesicular stomatitis virus (Exotic)

LISTED PLANT PATHOGENS
Liberobacter africanus
Liberobacter asiaticus
Peronosclerospora philippinensis
Phakopsora pachyrhizi
Plum Pox Potyvirus
Ralstonia solanacearum race 3, biovar 2
Schlerophthora rayssiae var zeae
Synchytrium endobioticum
Xanthomonas oryzae
Xylella fastidiosa (citrus variegated chlorosis strain)