Biological agents and pathogens are controlled when they are an isolated live culture of a pathogen agent, or a preparation of a toxin agent which has been isolated or extracted from any source, or material including living material which has been deliberately inoculated or contaminated with the agent. Isolated live cultures of a pathogen agent include live cultures in dormant form or in dried preparations, whether the agent is natural, enhanced or modified.
LIST OF HUMAN AND ANIMAL PATHOGENS AND TOXINS FOR EXPORT CONTROL[1]
28 February 2020
Viruses
African horse sickness virus
African swine fever virus
Andes virus
Avian influenza virus[2]
Bluetongue virus
Chapare virus
Chikungunya virus
Choclo virus
Classical swine fever virus (Hog cholera virus)
Crimean-Congo hemorrhagic fever virus
Dobrava-Belgrade virus
Eastern equine encephalitis virus
Ebolavirus: all members of the Ebolavirus genus
Foot-and-mouth disease virus
Goatpox virus
Guanarito virus
Hantaan virus
Hendra virus (Equine morbillivirus)
Japanese encephalitis virus
Junin virus
Kyasanur Forest disease virus
Laguna Negra virus
Lassa virus
Louping ill virus
Lujo virus
Lumpy skin disease virus
Lymphocytic choriomeningitis virus
Machupo virus
Marburgvirus: all members of the Marburgvirus genus
Middle East respiratory syndrome-related coronavirus (MERS-CoV)
Monkeypox virus
Murray Valley encephalitis virus
Newcastle disease virus
Nipah virus
Omsk hemorrhagic fever virus
Oropouche virus
Peste-des-petits-ruminants virus
Porcine Teschovirus
Powassan virus
Rabies virus and other members of the Lyssavirus genus
Reconstructed 1918 influenza virus
Rift Valley fever virus
Rinderpest virus
Rocio virus
Sabia virus
Seoul virus
Severe acute respiratory syndrome-related coronavirus (SARS-related coronavirus)
Sheeppox virus
Sin Nombre virus
St. Louis encephalitis virus
Suid herpesvirus 1 (Pseudorabies virus; Aujeszky’s disease)
Swine vesicular disease virus
Tick-borne encephalitis virus (Far Eastern subtype)
Variola virus
Venezuelan equine encephalitis virus
Vesicular stomatitis virus
Western equine encephalitis virus
Yellow fever virus
Bacteria
Bacillus anthracis
Brucella abortus
Brucella melitensis
Brucella suis
Burkholderia mallei (Pseudomonas mallei)
Burkholderia pseudomallei (Pseudomonas pseudomallei)
Chlamydia psittaci (Chlamydophila psittaci)
Clostridium argentinense (formerly known as Clostridium botulinum Type G), botulinum neurotoxin producing strains
Clostridium baratii, botulinum neurotoxin producing strains
Clostridium botulinum
Clostridium butyricum, botulinum neurotoxin producing strains
Clostridium perfringens, epsilon toxin producing types[3]
Coxiella burnetii
Francisella tularensis
Mycoplasma capricolum subspecies capripneumoniae (“strain F38”)
Mycoplasma mycoides subspecies mycoides SC (small colony)
Rickettsia prowazekii
Salmonella enterica subspecies enterica serovar Typhi (Salmonella typhi)
Shiga toxin producing Escherichia coli (STEC) of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups[4]
Shigella dysenteriae
Vibrio cholerae
Yersinia pestis
Toxins as follows and subunits thereof: [5]
Abrin
Aflatoxins
Botulinum toxins[6]
Cholera toxin
Clostridium perfringens alpha, beta 1, beta 2, epsilon and iota toxins
Conotoxins [6]
Diacetoxyscirpenol
HT-2 toxin
Microcystins (Cyanoginosins)
Modeccin
Ricin
Saxitoxin
Shiga toxins (shiga-like toxins, verotoxins, and verocytotoxins)
Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly known as Staphylococcus enterotoxin F)
T-2 toxin
Tetrodotoxin
Viscumin (Viscum album lectin 1)
Volkensin
Fungi
Coccidioides immitis
Coccidioides posadasii
Genetic Elements and Genetically-modified Organisms [1]:
Any genetically-modified organism which contains, or genetic element that codes for:
any gene or genes specific to any listed virus; or
any gene or genes specific to any listed bacterium [3] or fungus, and which
in itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health, or
could endow or enhance pathogenicity[4]; or
any listed toxins or their sub-units.
Technical notes:
Genetically-modified organisms include organisms in which the nucleic acid sequences have been created or altered by deliberate molecular manipulation.
Genetic elements include, inter alia: chromosomes, genomes, plasmids, transposons, vectors, and inactivated organisms containing recoverable nucleic acid fragments, whether genetically modified or unmodified, or chemically synthesized in whole or in part. For the purposes of the genetic elements control, nucleic acids from an inactivated organism, virus, or sample are considered ‘recoverable’ if the inactivation and preparation of the material is intended or known to facilitate isolation, purification, amplification, detection, or identification of nucleic acids.
These controls do not apply to nucleic acid sequences of shiga toxin producing Escherichia coli of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups, other than those genetic elements coding for shiga toxin, or for its subunits.
‘Endow or enhance pathogenicity’ is defined as when the insertion or integration of the nucleic acid sequence or sequences is/are likely to enable or increase a recipient organism’s ability to be used to deliberately cause disease or death. This might include alterations to, inter alia: virulence, transmissibility, stability, route of infection, host range, reproducibility, ability to evade or suppress host immunity, resistance to medical countermeasures, or detectability.
Warning List [1]
Bacteria
1. Clostridium tetani[7]
2. Legionella pneumophila
3. Yersinia pseudotuberculosis
4. Other strains of Clostridium species that produce botulinum neurotoxin[8]
5. Bacillus cereus biovar anthracis
Fungi
1. Fusarium langsethiae
2. Fusarium sporotrichioides
NOTE
[1] An agent/pathogen is covered by this list except when it is in the form of a vaccine. A vaccine is a medicinal product in a pharmaceutical formulation licensed by, or having marketing or clinical trial authorisation from, the regulatory authorities of either the country of manufacture or of use, which is intended to stimulate a protective immunological response in humans or animals in order to prevent disease in those to whom or to which it is administered.
Biological agents and pathogens are controlled when they are an isolated live culture of a pathogen agent, or a preparation of a toxin agent which has been isolated or extracted from any source, or material including living material which has been deliberately inoculated or contaminated with the agent. Isolated live cultures of a pathogen agent include live cultures in dormant form or in dried preparations, whether the agent is natural, enhanced or modified.
[2] This includes only those Avian influenza viruses of high pathogenicity as defined by the World Organization for Animal Health (OIE), the European Union (EU), or competent national regulatory bodies.
[3] It is understood that limiting this control to epsilon toxin-producing strains of Clostridium perfringens therefore exempts from control the transfer of other Clostridium perfringens strains to be used as positive control cultures for food testing and quality control.
[4] Shiga toxin producing Escherichia coli (STEC) includes inter alia enterohaemorrhagic E. coli (EHEC), verotoxin producing E. coli (VTEC) or verocytotoxin producing E. coli (VTEC).
[5] Excluding immunotoxins
[6] Excluding botulinum toxins and conotoxins in product form meeting all of the following criteria:
are pharmaceutical formulations designed for testing and human administration in the treatment of medical conditions;
are pre-packaged for distribution as clinical or medical products; and
are authorised by a state authority to be marketed as clinical or medical products
.
[7] The Australia Group recognizes that this organism is ubiquitous, but, as it has been acquired in the past as part of biological warfare programs, it is worthy of special caution.
[8] It is the intent of Australia Group members to add to the control list strains of species of Clostridium identified as producing botulinum neurotoxin.
