Better health and ageing for all Australians

Health Emergency Preparedness and Response

Security Sensitive Biological Agents

This website provides information about the Security Sensitive Biological Agents (SSBA) Regulatory Scheme.

In this section:

    The deliberate release of harmful biological agents such as viruses, bacteria, fungi and toxins has the potential to cause significant damage to human health, the environment and the Australian economy.

    In 2006, the Council of Australian Governments’ (COAG) Report on the Regulation and Control of Biological Agents identified that the regulations in place at the time focused on safety rather than security; and that there was a need to regulate the secure storage, possession, use and transport of security sensitive biological agents to minimise the risk of use for terrorism or criminal purposes.

    The aim of the SSBA Regulatory Scheme is to limit the opportunities for acts of bioterrorism or biocrime to occur using harmful biological agents and to provide a legislative framework for managing the security of SSBAs. The scheme was developed using risk management principles to achieve a balance between counter-terrorism concerns and the interests of the regulated community and aims to maintain full access to SSBAs for those with a legitimate need. The SSBA Regulatory Scheme also builds on Australia's obligations under the Biological and Toxins Weapons Convention and UN Security Council Resolution 1540.

    The SSBA Scheme can be contacted on 02 6289 7477 or by email at ssba. For postal addresses please see the Contact SSBA Regulatory Scheme.

    Table of Contents


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    What's New (September 2012)

    • Newsletter 20

    Recently added (July 2012)

    • Newsletter 20

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    In the Media

    Updated as articles of interest become available.

    Articles of Interest

    The following resources are available on the internet at the sites listed below. Both can be downloaded free of charge (NOTE – some sites may require you to register with the site before download). This website has a number of interesting articles and videos about:
      • Dual Use – The Anthrax Diaries: a film about the psychological and social issues faced by scientists who developed biological weapons.
      • The recent controversy surrounding the study of Influenza A H1N1 that produced a more transmissible strain in ferrets. The controversy revolves around how much of the information gained in the study should be published and the issues surrounding transparency of research versus the threat of the information being used for malicious purposes.
    • Article – <Guidance for enhancing personnel reliability and strengthening the culture of responsibility> (National Science Advisory Board for Biosecurity – USA).
    • Link to free on line book – <Responsible Research of Biological Agents and Toxins> (National Academy of Sciences – USA).

    The National Health Security Act 2007

    Part 3 of the National Health Security Act 2007 establishes the regulatory scheme for entities and facilities that handle suspected or known SSBAs.

    The National Health Security Act 2007 legislates the regulatory scheme and can be found at ComLaw, Commonwealth of Australia Law website:
    National Health Security Act 2007

    The National Health Security Regulations 2008

    The National Health Security Regulations 2008 (NHS Regulations) support the National Health Security Act 2007 by providing operational detail about the SSBA Regulatory Scheme.

    The NHS Regulations can be found at the ComLaw, Commonwealth of Australia Law website.

    The National Health Security Regulations 2008
    Legislative Instrument – F2010L01071

    List of SSBAs

    On 10 November 2008 the Minister established the List of SSBAs under Part 3 of the National Health Security Act 2007. The regulation of Tier 1 agents commenced on 31 January 2009 and the regulation of Tier 2 agents commenced on 31 January 2010. Tier 1 agents pose the highest security risk to Australia, while Tier 2 agents pose a high security risk.

    The List of SSBAs
    Tier 1 Agents
    Tier 2 Agents
    Abrin (reportable quantity 5 mg)African swine fever virus
    Bacillus anthracis (Anthrax—virulent strains)Capripoxvirus
    (Sheep pox virus and Goat pox virus)
    Botulinum toxin (reportable quantity 0.5 mg)Classical swine fever virus
    EbolavirusClostridium botulinum
    (Botulism; toxin-producing strains)
    Foot-and-mouth disease virusFrancisella tularensis (Tularaemia)
    Highly pathogenic influenza virus, infecting humansLumpy skin disease virus
    MarburgvirusPeste-des-petits-ruminants virus
    Ricin (reportable quantity 5 mg)Salmonella Typhi (Typhoid)
    Rinderpest virusVibrio cholerae (Cholera)
    (serotypes O1 and O139 only)
    SARS coronavirusYellow fever virus (non-vaccine strains)
    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’ include 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 Influenzavirus A and Influenzavirus A H5N1.

    3. ‘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™.

    4. The List is not a legislative instrument.

    PDF – Ministerial Determination – 10 November 2008 (PDF 48 KB)
    PDF – Ministerial Determination – 17 November 2009 (PDF 14 KB)

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    SSBA Standards

    Revised SSBA Standards

    The SSBA Standards, dated July 2011, were determined by the Minister for Health and Ageing under Section 35 of the National Health Security Act 2007 on 23 May 2011. These Standards came into force on 1 July 2011.

    SSBA Standards - July 2011

    SSBA Standards Determination

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    SSBA Regulatory Scheme Inspection Program

    The SSBA Regulatory Scheme Inspection Program commenced in August 2009. SSBA Inspectors are provided by the Office of Gene Technology Regulator and are appointed by the Secretary of the Department of Health and Ageing.

    All facilities will be inspected within the first 12 months of registration. After this initial inspection, registered facilities handling Tier 1 SSBAs will be inspected every 18 months and registered facilities handling Tier 2 SSBAs will be inspected every two years. Non-registered facilities will be inspected on an as needed basis. Spot checks of registered and non-registered facilities may occur at any time.

    Comprehensive and Mid-cycle Inspections

    Initial Inspections are Comprehensive Inspections that cover all parts of the SSBA Standards and are carried out over two days. Provided a high level of compliance is achieved, the next inspection will be a Mid-cycle Inspection that specifically covers the previous inspection outcomes, any changes to the SSBA Regulatory Scheme or any alterations to the facility’s secure areas or processes. Mini Inspections are usually carried out over one day. Subsequent inspections will alternate between a Comprehensive (two day) Inspection and a Mid-cycle Inspection.

    Spot checks and Desktop inspections

    In 2012, the SSBA Regulatory Scheme will be introducing spot checks and desktop inspections.

    Spot checks are a subset of routine monitoring and may also be conducted as part of follow-up reviews and focus on the outcome of previous inspections. Spot checks will be conducted with 24 hours notice to a facility to ensure security requirements can be met and will involve a physical inspection of the facility and review of records and interviews with staff. This type of inspection can be conducted on registered or non-registered facilities.

    Desktop inspections will be introduced in June 2012 to complement the physical inspection program. Desktop inspections are a paper-based assessment of a facility’s compliance with the SSBA Standards and require no on-site assessment of activities. The assessment could be against the complete SSBA Standards or a specific part or clause of the Standards. It could also assess a specific area of regulatory compliance, such as reporting requirements. A desktop inspection will comprise liaison with the Responsible or Contact Officers of a facility to make arrangements for the submission of the documented evidence required for the desktop inspection, a review of the paper-based records supplied by the facility and confirmation of the outcome of the desktop inspection.

    Further information on the SSBA Regulatory Scheme Inspections is contained in Guideline 10 – SSBA Regulatory Scheme Monitoring Inspections (available from the SSBA Guidelines section of this website).

    SSBA Guidelines

    The SSBA Guidelines have been developed to support the SSBA Regulatory Scheme. Stakeholders are welcome to suggest areas of interest that may warrant the development of further Guidelines. Suggestions may be sent to ssba for consideration.

    SSBA Fact Sheets

    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. Stakeholders are welcome to suggest areas of interest that may warrant the development of further Fact Sheets. Suggestions may be sent to ssba for consideration.

    Reporting Forms

    The SSBA Reporting Forms allow entities and facilities to report to the Department of Health and Ageing details of reportable events in relation to the handling of SSBAs. The first report (Initial Registration or Non-Registered Facility Report) is required to be submitted by a paper-based report and must be sent to the Department by Australia Post’s registered post service or courier. The addresses for postal reports can be found under the Contact SSBA Regulatory Scheme section.

    Where possible, it is recommended that all other reports are submitted using the online Data Collection System (DCS). DCS access will be granted to the facility following the first submission of a paper-based report. If you have forgotten your user details please email a request to ssba.

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    Security Risk Template

    The Security Risk Template (SRT) was developed as a tool to assist the regulated community to ensure that all risks associated with handing SSBAs have been identified and treated. Following feedback from the regulated community, the SRT has been revised to harmonise with current security risk management frameworks.

    The new SRT (Version 1 – February 2011) has a new format and has been designed to meet the requirements of Part 2 of the SSBA Standards dealing with the risk assessment and risk management plans.

    The use of the revised SRT is not mandatory and entities and facilities may choose to use other means to assist with risk assessment and risk management.

    The SRT will no longer be able to be used as a checklist to monitor compliance with the SSBA Standards. In order to assist entities to do this, an Internal Review Tool has been developed.

    Security Risk Template – February 2011 (Word 545 KB)
    Security Risk Template – February 2011 (PDF 221 KB)

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    Internal Review Tool

    The Internal Review Tool (IRT) has been developed to assist entities and facilities to monitor compliance with the SSBA Standards. The IRT has a series of questions based on the requirements of the SSBA Standards with a simple check box system of Yes/No and comments, and each section also includes questions about recommended practices and procedures.

    The use of the IRT is not mandatory and entities and facilities may choose to use other means to assist with compliance management.

    Please note that the word version of this document includes both locked text and fields that will expand as data is entered, and so may have some unusual formatting when printed. DoHA recommends using the PDF version if you intend to enter the information by hand.

    Internal Review Tool – September 2011

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    SSBA Newsletters

    The SSBA Newsletters have been produced by the Australian Government Department of Health and Ageing to provide information in a concise and easy to read format. If you would like to subscribe to the SSBA Newsletter, or would like to suggest a topic for inclusion, please email us at ssba with your contact details or suggested topic. Top of page

    SSBA Road Shows and Workshops

    The Department of Health and Ageing would like to thank all those who attended our workshops and road shows in 2008, 2009 and 2010.

    Copies of the presentation slides from the 2009 and 2010 workshops and road shows are below. The workshops and road shows included information about the National Health Security legislation, SSBA Standards, SSBA publications, reporting requirements, use of the Data Collection System, timeframes for reporting, the SSBA inspection scheme and awareness raising of suspicious behaviour.

    2010 SSBA Regulatory Scheme Affected Stakeholder workshop registered facility presentation (PDF 371 KB)
    2010 SSBA Regulatory Scheme Affected Stakeholder workshop non-registered facility presentation (PDF 300 KB)
    2009 SSBA Regulatory Scheme Training – Presentation (PDF 726 KB)
    2009 SSBA Regulatory Scheme Road Show presentation (PPS 465 KB)

    Contact SSBA Regulatory Scheme

    Email: ssba
    Phone: (02) 6289 7477

    Postal Address:
    Health Emergency Countermeasures Section
    Department of Health and Ageing
    GPO Box 9848, MDP 140
    Canberra ACT 2601

    Physical Address:
    Health Emergency Countermeasures Section
    Department of Health and Ageing
    Level 3, Scarborough House
    Atlantic Street
    Woden ACT 2606

    Links to related sites

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