List of Biological Agents for Export Control

October 2009

Core List^[1]

Viruses

1. Chikungunya virus
2. Congo-Crimean haemorrhagic fever virus
3. Dengue fever virus
4. Eastern equine encephalitis virus
5. Ebola virus
6. Hantaan virus
7. Junin virus
8. Lassa fever virus
9. Lymphocytic choriomeningitis virus
10. Machupo virus
11. Marburg virus
12. Monkey pox virus
13. Rift Valley fever virus
14. Tick-borne encephalitis virus (Russian Spring-Summer encephalitis virus)
15. Variola virus
16. Venezuelan equine encephalitis virus
17. Western equine encephalitis virus
18. Yellow fever virus
19. Japanese encephalitis virus
20. Kyasanur Forest virus
21. Louping ill virus
22. Murray Valley encephalitis virus
23. Omsk haemorrhagic fever virus
24. Oropouche virus
25. Powassan virus
26. Rocio virus
27. St Louis encephalitis virus
28. Hendra virus (Equine morbillivirus)
29. South American haemorrhagic fever (Sabia, Flexal, Guanarito)
30. Pulmonary & renal syndrome-haemorrhagic fever viruses (Seoul, Dobrava, Puumala, Sin Nombre)
31. Nipah virus

Rickettsiae

1. Coxiella burnetii
2. Bartonella quintana (Rochalimea quintana, Rickettsia quintana)
3. Rickettsia prowazeki
4. Rickettsia rickettsii

Bacteria

1. Bacillus anthracis
2. Brucella abortus
3. Brucella melitensis
4. Brucella suis
5. Chlamydia psittaci
6. Clostridium botulinum
7. Francisella tularensis
8. Burkholderia mallei (Pseudomonas mallei)
9. Burkholderia pseudomallei (Pseudomonas pseudomallei)
10. Salmonella typhi
11. Shigella dysenteriae
12. Vibrio cholerae
13. Yersinia pestis
14. Clostridium perfringens, epsilon toxin producing types^[2]
15. Enterohaemorrhagic Escherichia coli, serotype O157 and other verotoxin producing serotypes

Toxins as follow and subunits thereof:^[3]

1. Botulinum toxins^[4]
2. Clostridium perfringens toxins
3. Conotoxin
4. Ricin
5. Saxitoxin
6. Shiga toxin
7. Staphylococcus aureus toxins
8. Tetrodotoxin
9. Verotoxin and shiga-like ribosome inactivating proteins
10. Microcystin (Cyanginosin)
11. Aflatoxins
12. Abrin
13. Cholera toxin
14. Diacetoxyscirpenol toxin
15. T-2 toxin
16. HT-2 toxin
17. Modeccin toxin
18. Volkensin toxin
19. Viscum Album Lectin 1 (Viscumin)

Fungi

1. Coccidioides immitis
2. Coccidioides posadasii

^[1] Biological agents 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.

An agent 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.

^[2] 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.

^[3] Excluding immunotoxins.

^[4] Excluding botulinum toxins and conotoxins in product form meeting all of the following criteria:

• are pharmaceutical formulations designed for testing and human dministration 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.

Genetic Elements and Genetically-modified Organisms:

1. Genetic elements that contain nucleic acid sequences associated with the pathogenicity of any of the microorganisms in the list.
2. Genetic elements that contain nucleic acid sequences coding for any of the toxins in the list, or for their sub-units.
3. Genetically-modified organisms that contain nucleic acid sequences associated with the pathogenicity of any of the microorganisms in the list.
4. Genetically-modified organisms that contain nucleic acid sequences coding for any of the toxins in the list or for their sub-units.

Technical note:

Genetic elements include inter alia chromosomes, genomes, plasmids, transposons, and vectors whether genetically modified or unmodified.

Nucleic acid sequences associated with the pathogenicity of any of the micro-organisms in the list means any sequence specific to the relevant listed micro-organism:

• that in itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health; or
• that is known to enhance the ability of a listed micro-organism, or any other organism into which it may be inserted or otherwise integrated, to cause serious harm to human, animal or plant health.

These controls do not apply to nucleic acid sequences associated with the pathogenicity of enterohaemorrhagic Escherichia coli, serotype O157 and other verotoxin producing strains, other than those coding for the verotoxin, or for its sub-units.

Warning List^[1]

Bacteria

1. Clostridium tetani^*
2. Legionella pneumophila
3. Yersinia pseudotuberculosis

^* Australia Group recognises 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.

^[1] Biological agents 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.

An agent 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.

Genetic Elements and Genetically-modified Organisms:

1. Genetic elements that contain nucleic acid sequences associated with the pathogenicity of any of the microorganisms in the list.
2. Genetic elements that contain nucleic acid sequences coding for any of the toxins in the list, or for their sub-units.
3. Genetically-modified organisms that contain nucleic acid sequences associated with the pathogenicity of any of the microorganisms in the list.
4. Genetically-modified organisms that contain nucleic acid sequences coding for any of the toxins in the list or for their sub-units.

Technical note:

Genetic elements include inter alia chromosomes, genomes, plasmids, transposons, and vectors whether genetically modified or unmodified.

Nucleic acid sequences associated with the pathogenicity of any of the micro-organisms in the list means any sequence specific to the relevant listed micro-organism:

• that in itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health; or
• that is known to enhance the ability of a listed micro-organism, or any other organism into which it may be inserted or otherwise integrated, to cause serious harm to human, animal or plant health.