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 (02 June 2009)

    Recently added (21 April 2009)

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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 implementation of Part 3 of the National Health Security Act 2007 during 2008 identified certain measures for enhancement of the SSBA Regulatory Scheme. The purpose of the National Health Security Amendment Bill 2009 (the Bill) is to amend Part 3 of the National Health Security Act 2007. In May 2009 the exposure draft of the Bill was released for targeted consultation. Consultation has now closed and we are considering the feedback received.

    The Bill will introduce
    • provisions to address an emergency disease situation;
    • controls relating to handling a suspected SSBA;
    • additional search and seizure powers for inspectors and provisions to enable them to seek police assistance;
    • 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 SSBA

    The Minister has established a list of biological agents under Part 3 of the National Health Security Act 2007 that she considers to be of security concern to Australia. This list is the List of Security-sensitive Biological Agents (the List of SSBA) and is set out below.
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    Regulation of the SSBAs included on the List commenced 31 January 2009.

    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 greatest risk to Australia, while Tier 2 agents are rated less likely to pose a security risk.

    The List of SSBA only contains Tier 1 agents. This is because regulation of Tier 2 agents will not commence until 2010. Review of the List will be coordinated by the Department of Health and Ageing.

    Tier 1

    Agent Reportable quantity
    Abrin 5 mg
    Bacillus anthracis (Anthrax-virulent strains)  
    Botulinum toxin 0.5 mg
    Ebolavirus  
    Foot-and-mouth disease virus  
    Highly pathogenic influenza virus, infecting humans  
    Marburgvirus  
    Ricin 5 mg
    Rinderpest virus  
    SARS coronavirus  
    Variola virus (Smallpox)  
    Yersinia pestis (Plague)  
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    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.

    Ministerial Determination (PDF 48 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.

    COAG Biological Agents List

    Below is the list of Tier 2 agents as from the COAG Report on the Regulation and Control of Biological Agents. Tier 2 agents will be regulated from 2010 and the List of SSBA, including Tier 2 agents to be regulated, will be published on the Department of Health and ageing website in late 2009.

    Tier 2
    African swine fever virus

    Capripoxvirus

    (Sheep pox virus and Goat pox virus)
    Classical swine fever virus

    Clostriduim botulinum

    (Botulism; toxin-producing strains)
    Francisella tularensis (Tularaemia)
    Lumpy skin disease virus
    Peste-des-petits-ruminants virus
    Salmonella Typhi (Typhiod)

    Vibrio cholerae (Cholera)

    (serotypes O1 and O139)
    Yellow fever virus (non-vaccine strains)
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    SSBA Standards

    These Standards have been 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. Part 1 (Scope and definitions) and Part 2 (Risk and incident management) commenced from 31 January 2009. Parts 3 to 9 will commence from 1 July 2009.

    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.

    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.
    A copy of the current SRT may be found below.
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    Security Risk Template - Version 1, December 2008 (PDF 697 KB)
    Security Risk Template - Version 1, December 2008 (Word 1055 KB)


    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) will be presenting the SSBA Regulatory Scheme Road Show in all capital cities during July and August 2009.

    The aim of the road show is to provide stakeholders with information about the National Health Security Act 2007, the National Health Security Regulations 2008, the SSBA Standards, international obligations, dual use, reporting requirements and timeframes, and an overview of the inspection scheme.

    Road show registrations are now open to all organisations and individuals who are handling SSBAs or are interested in the SSBA Regulatory Scheme.

    The road show is free. To register please send an email to ssba@health.gov.au and provide the participant name(s), organisation name, contact details (address, email and telephone) and the location of the road show you wish to attend, by 3 July 2009.

    2009 SSBA Regulatory Scheme Road Show Invitation (PDF 176 KB)

    64 Cavenagh Street, Darwin

    SSBA Road Show Dates

    Registration opens at 8.30am

    Session times 9.00am to 4.00pm
    Location
    Date
    Venue
    Canberra
    Tuesday, 28 July 2009

    Scarborough House

    Atlantic Street, Woden
    Brisbane
    Thursday, 30 July 2009

    Mantra on Queen

    570 Queen Street, Brisbane
    Sydney
    Friday, 31 July 2009

    Rydges World Square

    389 Pitt Street, Sydney

     
    Hobart
    Tuesday, 4 August 2009

    The Old Woolstore Apartments

    1 Macquarie Street, Hobart
    Melbourne
    Wednesday, 5 August 2009

    Mantra on Russell

    222 Russell Street, Melbourne
    Darwin
    Tuesday, 11 August 2009
    Mirambeena Resort
    Perth
    Thursday, 13 August 2009

    Seasons of Perth

    37 Pier Street, Perth
    Adelaide
    Friday, 14 August 2009

    Grand Chifley Adelaide

    208 South Terrace, Adelaide

    Please note: session times are subject to change.

    2008 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 Perth, Sydney, Brisbane and Melbourne and were aimed at stakeholders who handle or intend to handle Tier 1 SSBAs in 2009. Training for affected stakeholders that handle or intend to handle Tier 2 SSBAs will be provided in 2009.
    The workshops covered:
    • The National Health Security Act 2007 and the National Health Security Amendment Regulations 2008
    • International obligations and the dual use dilemma
    • SSBA Standards
    • SSBA Guidelines
    • SSBA Fact Sheets
    • The National Register and use of the Data Collection System
    • Reporting Requirements
    • Security Risk Management
    • Suspicious Behaviour
    • Security Risk Template
    SSBA Regulatory Scheme Training Workshop presentation (PPT 401 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

    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

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