SSBA Fact Sheet 5 - List of Security Sensitive Biological Agents - March 2016

The purpose of the SSBA Fact Sheets is to support the education and awareness of the SSBA Regulatory Scheme and provide information to stakeholders on topics of particular interest.

Page last updated: March 2016

Release Date: March 2016

Overview

The Security Sensitive Biological Agents (SSBA) Regulatory Scheme regulates the handling of agents on the List of SSBAs. The National Health Security Act 2007 (NHS Act) provides for the establishment of a list of biological agents that the Minister for Health considers to be of security concern to Australia. The List of SSBAs is available on the SSBA website www.health.gov.au/ssba.

The List of SSBAs was originally derived from the Council of Australian Governments’ (COAG) Report on the Regulation and Control of Biological Agents. The COAG working group assessed approximately 200 biological agents and using specified criteria, identified 22 agents of security concern with these agents included in the original list of SSBAs.

The List of SSBAS

The SSBA List is derived using three principles:

  • Intelligence as to the level of interest terrorist or criminal groups of concern to Australia have in a biological agent;
  • Impact of the use of a biological agent, including factors such as morbidity, transmissibility, economic impact and the ease of treatment; and
  • Feasibility of use of a biological agent, including factors such as availability, ease of production and dissemination.

The List of SSBAs is divided into two tiers and includes 12 Tier 1 biological agents (those of the highest security concern) and 8 Tier 2 biological agents (those of a high security concern). The List of SSBAs also sets out the reportable quantities of toxins for abrin, botulinum toxin and ricin. Each Tier is set out in alphabetical order.

List of SSBAs (14 March 2016).

Tier 1 SSBAs (with toxin thresholds*) Tier 2 SSBAs
Abrin (5 mg)
African swine fever virus
Bacillus anthracis (Anthrax – virulent strains)
Capripoxvirus (Sheep pox virus and Goat pox virus)
Botulinum toxin (0.5 mg)
Classical swine fever virus
Ebolavirus
Clostridium botulinum (Botulism; toxin-producing strains)
Foot-and-mouth disease virus
Francisella tularensis (Tularaemia)
Highly pathogenic influenza virus, infecting humans
Lumpy skin disease virus
Marburgvirus
Peste-des-petits-ruminants virus
Ricin (5 mg)
Yellow fever virus (non-vaccine strains)
Rinderpest virus
SARS coronavirus
Variola virus (Smallpox)
Yersinia pestis (Plague)

Notes

  1. The agents above only refer to infectious, viable and pathogenic organisms or active toxins.
  2. ‘Highly pathogenic influenza virus infecting humans’ includes influenza viral strains that fulfil all the criteria listed below:
    • considered highly pathogenic in usual host animal;
    • proven infection of humans; and
    • involved in an outbreak of human disease.

Examples of such viral strains include the 1918 pandemic Influenza virus A and Influenza virus A H5N1.

  1. 'Botulinum toxin’ does not refer to a form approved for therapeutic use under the Therapeutic Goods Act 1989. For example, the forms of Botulinum toxin approved for therapeutic use and known under their commercial names Botox or Dysport.
  2. The List is not a legislative instrument.

No plant pathogen or pest has rated highly enough to warrant inclusion on the list at this time. However, this is not to say that a plant pathogen or pest could not be included in future.

Genes and DNA are not currently regulated. Organisms which have been genetically-modified are subject to regulation under the Gene Technology Act 2000 and associated Regulations. For more information, contact the Office of the Gene Technology Regulator at ogtr@health.gov.au.

Review of the List

To reflect changes in intelligence, feasibility of use information or impact (for example, new drug treatments or new more virulent strains), the inclusion, exclusion and ranking of listed biological agents will be reviewed from time to time.

In deciding to include a new biological agent or a reportable quantity of toxin on the List of SSBAs, the Minister must obtain, and have regard to, advice from the relevant Australian Government agencies responsible for obtaining and assessing information about the risks and threats posed by biological agents that may be of security concern, and persons with relevant scientific or technical knowledge about those agents. The Minister must also seek advice from the states and territories.

Any changes to the List will be followed by an education and awareness raising campaign and will allow time for entities handling the newly listed agents to comply with the regulatory scheme.

The first comprehensive review of the List of SSBAs was completed in 2016 and recommended the removal of Salmonella Typhi and Vibrio cholerae from the Tier 2 List of SSBAs. The Minister for Health approved this variation on 9 March 2016 and the new list came into effect on 14 March 2016.