Health Emergency Preparedness and Response

Security Sensitive Biological Agents (SSBA) regulatory scheme

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.

What's New (12 June 2008)

- SSBA Standards consultations commences

- Issue 2 Newsletter available

SSBA Regulatory Scheme Road Show

The Department of Health and Ageing is conducting an education and awareness raising campaign for the SSBA Regulatory Scheme. The major component of this campaign will be a road show. The road show will visit every capital city in Australia and provide potential stakeholders with updated information regarding the SSBA regulatory scheme including the National Health Security Act 2007, the NHS Regulations, SSBA Standards, the National Register and guidelines. This will assist the regulated community to prepare for introduction of the new regulatory scheme in 2009.

Road Show dates:

City	Date	Venue	Address
Canberra	Thursday 28 August 2008	Scarborough House	Atlantic Street
Hobart	Tuesday 2 September 2008	Old Woolstore Apartments	1 Macquarie Street
Darwin	Thursday 4 September 2008	Mirambeena Resort	64 Cavenagh Street
Adelaide	Wednesday 17 September 2008	Chifley on South Terrace	226 South Terrace
Perth	Thursday 18 September 2008	Mecure Hotel	10 Irwin Street
Brisbane	Monday 22 September 2008	The Watermark Hotel	551 Wickham Terrace
Sydney	Tuesday 23 September 2008	Rydges World Square Sydney	389 Pitt Street
Melbourne	Wednesday 24 September 2008	Mantra on Russell	222 Russell Street

Registration

If you would like to attend a road show workshop, please email your name, organisation, contact number, physical and email addresses to ssba@health.gov.au by 22 August 2008.

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SSBA Standards Consultation

The consultation period for the draft SSBA Standards is now closed.

The Department of Health and Ageing has commissioned Direkt Consulting Pty Ltd to develop standards that will support the National Health Security Act 2007.

The SSBA standards define the specific security protocols and requirements for the storage, handling, disposal and transport of SSBA.

The consultation process

The public consultation period for the draft standards was held 12 June 2008 to 1 August 2008.

Draft standards

Security-sensitive Biological Agent Standards: Consultation Draft 12 June 2008 (PDF 485 KB)

Please note that this document refers to the NHS Regulations which are currently under development and are not yet available.

Consultation workshops

In addition to provision of written comment, stakeholders were invited to attend the consultation workshops. These workshops included an overview of the propsed standards. A powerpoint presentation from the workshops is below:

SSBA Workshop presentation (PPT 812 KB)

If you have any queries about the standards process or the workshops, please do not hesitate to contact the Department by email ssba@health.gov.au or by telephone at 02 6289 4485.

The National Health Security Act 2007

The National Health Security Bill was passed in Parliament on 20 of 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
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National Health Security Agreement

Health Ministers signed the National Health Security Agreement (PDF 90 KB) 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.

SSBA Newsletter

The Security Sensitive Biological Agents Regulatory Scheme (SSBA) newsletter is produced by the Australian Government Department of Health and Ageing. Below is the first edition in PDF format.

• Issue 1 - April 2008 (PDF 122 KB)
• Issue 2 - June 2008 (PDF 122 KB)

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) identified by the review. Tier 1 agents will be regulated from January 2009 with Tier 2 agents being regulated from January 2010.

COAG Biological Agents List

Tier 1	Tier2
Abrin	African swine fever virus
Bacillus anthracis (Anthrox-virulent forms)	Capripoxvirus (Sheep pox virus and Goat pox virus)
Botulinum toxin	Classical swine fever virus
Ebolavirus	Clostridium botulinum (Botulism: toxin-producing strains)
Foot-and-mouth disease virus	Francisella tularensis (Tularemia)
Highly pathogenic influenza virus, infecting humans (such as 1918 pandemic Influenzavirus A and Influenzavirus A H5N1)	Lumpy skin disease virus
Marburgvirus	Peste-des-petits-ruminants virus
Ricin	Salmonella Typhi (Typhoid)
Rinderpest virus	Vibrio cholerae (Cholera) (serotypes O1 and O139)
SARS coronavirus	Yellow fever virus (non-vaccine strains)
Variola virus (Smallpox)
Yersinia pestis (Plague)

DoHA Responsibilities

In order to fulfil the recommendations of the COAG review a new section has been established in the Office of Health Protection, the Laboratory Capacity and Regulation Section.
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The section’s responsibilities include:

• the creation of a National Register of SSBA, which will be an up-to-date record of SSBA holdings;
• the development of Regulations and SSBA Standards to support the National Health Security Act 2007; and
• an education and awareness raising campaign for affected stakeholders.

To minimise the burden on industry by the new regulations, the Department has commenced consultations with existing regulatory bodies to discuss the ability of those bodies to act as SSBA inspectors concurrently with their present roles. This will avoid overlap of laboratory inspections and minimise disruption to the regulated facilities and staff.

Report on the Regulation and Control of Biological Agents

• Recommendations of the Report on the Regulation and Control of Biological Agents - Report recommendations (PDF 31KB)

Contact SSBA Regulatory Scheme

• For further enquires contact:

ssba@health.gov.au

Links to related sites

• www.COAG.gov.au
• www.dfat.gov.au/security/biological_weapons.html

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