Health Emergency Preparedness and Response
Security Sensitive Biological Agents
This website provides information about the Security Sensitive Biological Agents (SSBA) Regulatory Scheme.
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
- What's New (May 2013)
- Recently added (July 2012)
- In the Media
- The National Security Act 2007
- The National Security Regulations 2008
- List of SSBAs
- SSBA Standards
- SSBA Regulatory Scheme Inspection Program
- SSBA Guidelines
- SSBA Fact Sheets
- Reporting Forms
- Security Risk Template
- Internal Review Tool
- SSBA Newsletters
- SSBA Road Shows and Workshops
- Contact SSBA Regulatory Scheme
- Links to related sites
What's New (May 2013)
- Updated Legislation to the National Health Security Act
- Updated Legislation to the National Health Security Regulation
- Updated Standards
Recently added (July 2012)
- Newsletter 20
In the MediaUpdated as articles of interest become available.
Articles of InterestThe 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).
- Website - The Virtual Biosecurity Centre.
- 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 2007Part 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 2008The 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 – F2012L00474
List of SSBAsOn 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|
(Botulism; toxin-producing strains)
|Foot-and-mouth disease virus||Francisella tularensis (Tularaemia)|
|Highly pathogenic influenza virus, infecting humans||Lumpy skin disease virus|
|Ricin (reportable quantity 5 mg)||Salmonella Typhi (Typhoid)|
|Rinderpest virus||Vibrio cholerae (Cholera)|
(serotypes O1 and O139 only)
|SARS coronavirus||Yellow fever virus (non-vaccine strains)|
|Variola virus (Smallpox)|
|Yersinia pestis (Plague)|
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.
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.
Word - Ministerial Determination - 10 November 2008 (Word 26 KB)
PDF – Ministerial Determination – 10 November 2008 (PDF 48 KB)
Word - Ministerial Determination - 17 November 2009 (Word 16 KB)
PDF – Ministerial Determination – 17 November 2009 (PDF 14 KB)
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Revised SSBA StandardsThe 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.
Please note: As of April 2013, a new version of the Standards is available. The website is currently being updated to reflect these changes. Please contact the SSBA team for a copy. Email: ssba
SSBA Regulatory Scheme Inspection ProgramThe 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 InspectionsInitial 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 inspectionsIn 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 GuidelinesThe 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 SheetsThe 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 FormsThe 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 TemplateThe 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 ToolThe 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 NewslettersThe 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.
- Issue 20 - October 2012
- Issue 19 - July 2012
- Issue 18 - May 2012
- Issue 17 - February 2012
- Issue 16 - October 2011
- Issue 15 – July 2011
- Issue 14 – April 2011
- Issue 13 - January 2011
- Issue 12 – October 2010
- Issue 11 – July 2010
- Issue 10 – April 2010
- Issue 9 - January 2010
- Issue 8 - October 2009
- Issue 7 - July 2009
- Issue 6 - April 2009
- Issue 5 - January 2009
- Issue 4 - October 2008
- Issue 3 - August 2008
- Issue 2 - June 2008
- Issue 1 - April 2008
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 can be obtained by emailing ssba. 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.
Contact SSBA Regulatory SchemeEmail: ssba
Phone: (02) 6289 7477
Health Emergency Countermeasures Section
Department of Health and Ageing
GPO Box 9848, MDP 140
Canberra ACT 2601
Health Emergency Countermeasures Section
Department of Health and Ageing
Level 3, Scarborough House
Woden ACT 2606
Links to related sites
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