Better health and ageing for all Australians

Health Emergency Preparedness and Response

Security Sensitive Biological Agents (SSBA)

This website provides information about the implementation of the Security Sensitive Biological Agents (SSBA) Regulatory Scheme. The regulatory scheme is being implemented to improve the security of biological agents of security concern in Australia. It builds on Australia's obligations under the Biological and Toxins Weapons Convention and UN Security Council Resolution 1540.

In this section:

    Table of Contents



    What's New (1 February 2010)

    Guideline 3 (updated)

    Recently added (27 January 2010)

    Reporting Forms
    SSBA Newsletter

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    The National Health Security Act 2007

    The National Health Security Bill was passed in Parliament on 20 September 2007 and received Royal Assent on 28 September 2007.

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

    National Health Security Amendment Bill 2009

    The National Health Security Amendment Bill 2009 (the Bill) was passed by Parliament during the Spring 2009 sittings. The Bill has now been enacted and received Royal Assent on 7 October 2009.

    The following provisions commenced on 8 October 2009:
    • provisions to address an emergency disease situation; and
    • additional search and seizure powers for inspectors and provisions to enable them to seek police assistance.

    The following provisions will come into force on a date that will be fixed by proclamation as 31 January 2010:
    • controls relating to handling a suspected SSBA;
    • requirements to report certain SSBA-related events to local police forces;
    • requirements to provide ‘nil’ reports of reportable events;
    • provisions to enable the cancellation of registration of facilities no longer handling SSBAs; and
    • a new definition of ‘biological agents’.

    The National Health Security Regulations 2008

    The National Health Security Amendment Regulations 2008 (NHS Regulations) were made by Her Excellency Ms Quentin Bryce AC, Governor-General of the Commonwealth of Australia on 12 December 2008. Consultation on the draft NHS Regulations was held from 2 October 2008 to 22 October 2008. These regulations support the National Health Security Act 2007 by providing operational detail about the SSBA Regulatory Scheme. The NHS Regulations have been compiled and can be found at the ComLaw, Commonwealth of Australian Law website.

    National Health Security Agreement

    Health Ministers signed the National Health Security Agreement on 18 April 2008. The Agreement establishes a framework for clear, quick and informed decision making to support a coordinated national response to public health emergencies.

    The Agreement was developed to support the practical operation of the National Health Security Act 2007 and enhances communicable disease surveillance systems. It also provides criteria to identify events to be reported to the Commonwealth to assess if they require a coordinated national response or referral to the World Health Organization as potential emergencies of international concern.

    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 List of SSBAs only contained Tier 1 agents and the regulation of Tier 1 agents commenced on 31 January 2009.

    On 17 November 2009 the Minister varied the List of SSBAs to also include Tier 2 agents. The regulation of Tier 2 agents will commence on 31 January 2010.

    The inclusion of agents on the List is derived from the Council of Australian Governments (COAG) Report on the Regulation and Control of Biological Agents, which developed the COAG Biological Agents list (the COAG list) in November 2006. The working group assessed nearly 200 biological agents and using specified criteria, divided them into two tiers: Tier 1 agents pose the highest security risk to Australia, while Tier 2 agents pose a high security risk.

    The List of SSBAs as varied by the Minister on 17 November 2009 is set out below.

    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)

    H1N1 Influenza 09 (Human Swine Influenza) Virus

    Included on the List of SSBA is 'Highly pathogenic influenza virus, infecting humans'. As at 28 May 2009, the H1N1 influenza 09 (Human Swine Influenza) virus is not an SSBA for the purposes of the National Health Security Act 2007. This is because the virus does not meet all the criteria in note 2 of the List of SSBA.

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    2009 SSBA Regulatory Scheme Training

    The Department of Health and Ageing would like to thank all those who attended the SSBA Regulatory Scheme training workshops. The training workshops were held in Canberra, Brisbane, Melbourne, Adelaide, Sydney and Perth and were aimed at stakeholders who handle or intend to handle SSBAs or suspected SSBAs.

    The workshops covered:
    • The National Health Security Act 2007, including the 2009 amendments
    • The National Health Security Regulations 2008
    • The SSBA Standards including the Standards for suspected SSBAs
    • Security and risk
    • Reporting requirements and timeframes including the Data Collection System
    • Awareness raising of suspicious behaviour.
    A copy of the presentation slides from the SSBA Regulatory Scheme training workshop is below.

    2009 SSBA Regulatory Scheme Training – Presentation (PDF 585 KB)

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    SSBA Standards

    The SSBA Standards, dated 1 October 2009, were determined by the Minister for Health and Ageing under Section 35 of the National Health Security Act 2007 on 4 December 2009. These Standards will come into force on 31 January 2010.

    SSBA Standards - 1 October 2009 (PDF 425 KB)
    National Health Security (SSBA Standards) Determination 2009 (PDF 43 KB)

    Background checking

    Stakeholders will be notified when a background checking process has been established through legislation. It is expected that background checking will begin in mid 2010 and Standards, incorporating the requirements for background checks, will be available prior to commencement of regulation in this area.

    Business Cost Calculator

    The Office of Best Practice Regulation (OBPR) advised that the revision of the SSBA Standards and the incorporation of new standards for handling suspected SSBAs would not require a Regulation Impact Statement (RIS) or a Business Cost Calculator (BCC) as there were no significant costs associated with the changes. The BCC for the 2008 Standards still applies and is included below.

    BCC Report

    Current Standards

    Important Information
    The SSBA Standards, dated 30 September 2008, will be in force until 31 January 2010. After this date, these Standards will be revoked and replaced by the SSBA Standards, dated 1 October 2009, as determined under the National Health Security (SSBA Standards) Determination 2009.

    The SSBA Standards, dated 30 September 2008, were determined by the Minister for Health and Ageing under Section 35 of the National Health Security Act 2007 and were lodged on the Federal Register of Legislative Instruments on 24 November 2008.

    The National Health Security (SSBA Standards) Amendment Determination 2009 (No.1) (Determination) was made on 26 June 2009 and lodged on the Federal Register of Legislative Instruments on 30 June 2009. This Determination modifies the SSBA Standards by removing the requirement for background checking of 'authorised persons' and 'persons recruited' to handle Tier 1 SSBAs or sensitive information at clauses 3.3 and 3.4 of Part 3 of the SSBA Standards. The Determination should be read with the SSBA Standards.

    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@health.gov.au for consideration.

    SSBA Fact Sheets

    The purpose of the SSBA Fact Sheets is to support the education and awareness of the SSBA Regulatory Shceme 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@health.gov.au for consideration.

    Reporting Forms

    The SSBA Regulatory Scheme requires entities and facilities to report to the Department of Health and Ageing details of reportable events in relation to the handling of SSBAs. It is recommended that where possible, this is done through the online Data Collection System except in the instance of Initial Registration, whereby it is mandatory to submit a paper form. The paper forms may be accessed by clicking on the hyperlinks below. Postal and physical address details for the submission of paper forms may be found under the Contact SSBA Regulatory Scheme section.

    Word version
    PDF version
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    Security Risk Template

    The Security Risk Template (SRT) has been developed as a checklist for entities and facilities to use after completing a security risk assessment to ensure all risks have been identified and treated. The SRT may also assist entities and facilities develop a security conscious work environment and can be used as a mechanism to check for compliance with the SSBA Standards. This template is a suggested tool only and entities/facilities may use another template if desired.
    The SRT below aligns with the SSBA Standards - 1 October 2009:

    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@health.gov.au with your contact details or suggested topic.
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    2009 SSBA Regulatory Scheme Road Show

    The Department of Health and Ageing (DoHA) would like to thank all those who attended the 2009 SSBA Regulatory Scheme Road Show which visited each capital city in Australia. Training for affected stakeholders who handle or intend to handle Tier 2 SSBAs will be provided in November and December 2009.

    The road show covered:
    • the National Health Security Act 2007;
    • the National Health Security Regulations 2008;
    • international obligations;
    • SSBA Standards;
    • SSBA Publications;
    • the National Register and the Data Collection System;
    • reporting requirements and timeframes; and
    • the SSBA inspection scheme
    A copy of the DoHA presentation slides from the SSBA Regulatory Scheme Road Show is below.
    2009 SSBA Regulatory Scheme Road Show presentation (PPT 465 KB)

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    Background

    In 2002, the Council of Australian Governments (COAG) agreed to a national review of the regulation, reporting and security surrounding the storage, sale and handling of hazardous materials, with the aim of minimising the risk of these materials being used for unauthorised purposes. The COAG review consists of four parts covering: ammonium nitrate; radiological material; hazardous chemicals and harmful biological agents. This falls under the National Chemical, Biological, Radiological and Nuclear (CBRN) Security Strategy.

    COAG endorsed the review of harmful biological agents and recommendations in April 2007. The first recommendation in the review is the establishment of a two-tiered list of security-sensitive biological agents (SSBA's) identified by the review. Regulation of Tier 1 agents commenced 31 January 2009 with Tier 2 agents being regulated from January 2010.

    Report on the Regulation and Control of Biological Agents

    Contact SSBA Regulatory Scheme

    For futher enquiries contact the SSBA Regulatory Scheme at:

    Email: ssba@health.gov.au
    Phone: (02) 6289 7477

    Postal Address:
    Laboratory Capacity and Regulation Section
    Department of Health and Ageing
    GPO Box 9848, MDP 140
    Canberra ACT 2601

    Physical Address:
    Laboratory Capacity and Regulation Section
    Department of Health and Ageing
    Level 3, Scarborough House
    Atlantic Street
    Woden ACT 2606

    Links to related sites

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