National Health Security (SSBA Standards) Determination 2011

Administered by Department of Health, Disability and Ageing

Legislation au F2011L00950 Not in force Legislative Instrument

Legislation content

 

EXPLANATORY STATEMENT

 

Issued by the Minister for Health and Ageing

 

National Health Security Act 2007

 

National Health Security (SSBA Standards) Determination 2011

 

Subsection 35(1) of the National Health Security Act 2007 (the NHS Act) provides that the Minister may, by legislative instrument, determine standards (SSBA Standards) relating to security-sensitive biological agents (SSBAs).

 

A standard may set out requirements relating to SSBAs and biological agents suspected of being SSBAs. Requirements include specific directions for dealing with biosecurity risks and the establishment of a systematic approach to the management of the security of SSBAs and suspected SSBAs. The SSBA Standards are comprised of normative requirements that are mandatory and informative statements to assist in meeting the normative requirements. Section 56 of the NHS Act requires entities that handle SSBAs comply with the SSBA Standards. If an entity fails to comply with a direction to dispose of SSBAs as a result of non-compliance with the Standards, it may involve the commission of an offence under subsection 58(1) of the NHS Act.

The list of biological agents of security concern (the List of Security-sensitive Biological Agents) has been established by the Minister under Part 3 of the NHS Act. Tier 1 agents pose the highest risk to Australia, while Tier 2 agents pose a high risk. Tier 1 SSBAs have been regulated since 31 January 2009, with Tier 2 SSBAs and suspected SSBAs regulated from 31 January 2010. To reflect these risks, the SSBA Standards contains differing requirements for the handling of Tier 1 and Tier 2 SSBAs.

 

Background

The National Health Security (SSBA Standards) Determination 2008 (the 2008 Determination) incorporated the document entitled “Security-sensitive Biological Agent (SSBA) Standards”, dated 30 September 2008 as constituting the SSBA Standards. The 2008 determination was made by the Minister for Health and Ageing under section 35 of the NHS Act on 13 November 2008.

The SSBA Standards were revised in 2009 and were incorporated by reference into the National Health Security (SSBA Standards) Determination 2009 on 4 December 2009. These Standards came into force on 31 January 2010.

Following amendments to the NHS Act and the AusCheck Act 2007 in early 2010, ‘Part 3 – Personnel’ of the SSBA Standards was updated to prescribe requirements regarding the security status of individuals who will handle Tier 1 SSBAs, access facilities where Tier 1 SSBAs are handled or access sensitive information relating to Tier 1 SSBAs. These Standards came into force on 14 July 2010.

 

The Standards have been revised to incorporate feedback from the SSBA Regulatory Scheme inspections, the regulated community and other interested stakeholders. These revisions include the addition of two new parts to the Standards. The first new part (Part 4A) provides further guidance on storage requirements, inventory and procedures for handling working cultures.  Part 4A also provides more differentiation for the storage of Tier 1 and Tier 2 SSBAs. The second new part (Part 9A) continues the handling requirements for biological agents previously suspected of being SSBAs (Part 9 of the Standards) following receipt of a positive confirmatory test. This new part has been added to ensure the secure handing of an agent that was a suspected SSBA, and is now confirmed as an SSBA, until the agent is disposed of by being either destroyed or transferred in its entirety, within the timeframes specified under the NHS Act.

 

Consultation

Subsection 35(4) provides that certain persons must be consulted prior to the Minister determining a standard. These are persons with scientific or technical knowledge in relation to security concerns about biological agents. The states and territories are also required to be consulted.

Subsection 35(5) allows the Minister to consult any other person who the Minister considers may assist her in developing a standard.

Consultations with persons with scientific or technical knowledge of SSBAs have occurred through the Implementation Advisory and Consultative Committee (IACC). The IACC is a committee chaired by the Department of Health and Ageing to provide advice on implementation of the SSBA Regulatory Scheme and comprises of representatives from 12 government agencies, including the Australian Chemical, Biological, Radiological and Nuclear Data Centre and the Australian Security Intelligence Organisation.

Consultations have also occurred with the National Counter Terrorism Committee’s Chemical, Biological, Radiological and Nuclear (CBRN) Security Sub-Committee, which includes representatives from each state and territory as well as representatives from the emergency services. AusCheck, the agency responsible for co-coordinating National Health Security (NHS) checks, was also consulted throughout the drafting process.

The draft Standards were released for public consultation on 18 November 2010 for an eight week period and were available on the Department of Health and Ageing’s website (http://www.health.gov.au/ssba). Over 50 comments from 10 individuals or organisations were received during the consultation period and comments were incorporated where appropriate.

The Office of Best Practice Regulation (OPBR) was consulted regarding the provision of a Regulation Impact Statement (RIS) or a Business Cost Calculator (BCC). The OBPR advised that the project was assessed as having low to no impact on business, and as such a RIS or BCC was not required.

Details of the 2011 Determination are set out in the Attachment.

 

The 2011 Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.


ATTACHMENT

DETAILS OF THE NATIONAL HEALTH SECURITY (SSBA STANDARDS) DETERMINATION 2011

1. Name of Determination

 

This section provides for the correct name of this Determination as being the National Health Security (SSBA Standards) Determination 2011.

2. Commencement

 

This section provides that this Determination commences on 1 July 2011.

3. Revocation

 

This section revokes the National Health Security (SBBA Standards) Determination 2010.

4. Definition

 

This section sets out definitions of terms used in the Determination.

5. Determination

 

The effect of section 4 is to incorporate, by reference, the requirements set out in the SBBA Standards document dated July 2011.

 

 

Overview

The National Health Security (SSBA Standards) Determination 2011 was introduced to address the need for stringent management and regulation of security-sensitive biological agents (SSBAs) within Australia. Enacted under subsection 35(1) of the National Health Security Act 2007 by the Minister for Health and Ageing, the primary objective of this Determination is to establish comprehensive standards for the handling of SSBAs, ensuring biosecurity risks are adequately managed. The Determination sets out mandatory requirements and informative guidelines for entities handling these agents, with a particular focus on differentiating the handling protocols for Tier 1 and Tier 2 agents based on their respective risks. Compliance with these standards is mandatory, and failure to adhere can result in legal consequences as per subsection 58(1) of the NHS Act. The Determination reflects feedback from various stakeholders, including the regulated community and government agencies, to enhance the effectiveness and robustness of the SSBA regulatory framework. The Determination was developed through extensive consultation with experts and stakeholders, including the Implementation Advisory and Consultative Committee (IACC) and the National Counter Terrorism Committee’s CBRN Security Sub-Committee. It was also subject to public consultation, receiving over 50 comments from various entities which were incorporated where appropriate. This collaborative approach aims to ensure that the standards are practical, effective, and reflective of the current best practices in biosecurity. The Determination revokes the previous National Health Security (SBBA Standards) Determination 2010 and incorporates the updated SSBA Standards document dated July 2011, effective from 1 July 2011.

Scope and Application

The National Health Security (SSBA Standards) Determination 2011 applies to entities that handle security-sensitive biological agents (SSBAs) as defined under the National Health Security Act 2007. This includes institutions, laboratories, and other entities involved in research, production, storage, or transport of these agents. The Act's jurisdictional reach is national, extending across all states and territories in Australia. The SSBA Standards are divided into mandatory requirements that must be met and informative guidance to assist in compliance. Compliance with these standards is compulsory for entities handling SSBAs, and failure to adhere to the Standards, particularly in disposing of SSBAs, can result in criminal offences under the NHS Act. The Standards were developed through consultations with experts and the public, incorporating feedback from the regulated community and stakeholders. The Determination also revokes the previous 2010 Standards and incorporates the revised SSBA Standards document dated July 2011.

Key Provisions

The main operative sections of the National Health Security (SSBA Standards) Determination 2011 (the Determination) are sections 1 to 5. Section 1 provides the name of the Determination, section 2 sets the commencement date, section 3 revokes the previous determination, section 4 incorporates by reference the SSBA Standards dated July 2011, and section 5 sets out definitions of terms used in the Determination. The SSBA Standards, incorporated in section 4, include mandatory normative requirements and informative guidance for the handling of security-sensitive biological agents (SSBAs) and suspected SSBAs. These standards establish specific directions for dealing with biosecurity risks and the establishment of a systematic approach to the management of the security of SSBAs and suspected SSBAs. The standards differentiate between Tier 1 and Tier 2 SSBAs, with differing requirements for each tier. The Act imposes obligations on entities that handle SSBAs to comply with the SSBA Standards. This is mandated by section 56 of the National Health Security Act 2007 (the NHS Act). Entities must follow the specific directions and requirements outlined in the SSBA Standards to manage biosecurity risks effectively and ensure the secure handling, storage, and disposal of SSBAs. Failure to comply with these standards may result in the commission of an offence under section 58(1) of the NHS Act. Additionally, the Act requires the Minister to consult with relevant parties, including those with scientific or technical knowledge of SSBAs and the states and territories, before determining the SSBA Standards. Failure to comply with the SSBA Standards may result in civil and criminal consequences. Section 58(1) of the NHS Act specifies that if an entity fails to comply with a direction to dispose of SSBAs as a result of non-compliance with the Standards, it may involve the commission of an offence. The specific penalties for breaches of the SSBA Standards are not detailed in the Explanatory Statement; however, the seriousness of non-compliance underscores the importance of adhering to these requirements to prevent biosecurity risks. Ensuring compliance with the SSBA Standards is crucial for maintaining the security and safety of handling SSBAs in Australia.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.