National Health Security (SSBA Standards) Determination 2013

Administered by Department of Health, Disability and Ageing

Legislation au F2013L01065 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 2013

 

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 the SSBA Standards were 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 were reviewed and revised in 2011 to incorporate feedback from the SSBA Regulatory Scheme inspections and workshops, the regulated community and other interested stakeholders. These revisions included the addition of two new parts to the Standards. The first new part (Part 4A) provided further guidance on storage requirements, inventory and procedures for handling working cultures.  Part 4A also provided more differentiation for the storage of Tier 1 and Tier 2 SSBAs. The second new part (Part 9A) continued the handling requirements for biological agents previously suspected of being SSBAs (Part 9 of the Standards) following receipt of a positive confirmatory test.

 

Following amendments to the NHS Act and SSBA Regulations in 2012, the SSBA Standards have been revised to include new provisions including emergency maintenance, temporary handling of SSBAs and clarification of record keeping for stakeholders. These amendments reflect concerns and feedback received from the SSBA Regulatory Scheme inspectors, the regulated community and other interested stakeholders.

 

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 with the Office of the Gene Technology Regulator, the Department of Agriculture, Fisheries and Forestry, the Australian Chemical, Biological, Radiological and Nuclear Data Centre and the Public Health Laboratory Network.  AusCheck, the agency responsible for coordinating National Health Security (NHS) checks, was also consulted throughout the drafting process.

Consultations have also occurred with the Australia New Zealand 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 emergency services.

The draft Standards were released for public consultation on 7 December 2012 for a four week period and were available on the Department of Health and Ageing’s website (http://www.health.gov.au/ssba). Comments received from individuals or organisations during the consultation period were incorporated where appropriate.

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

 

The 2013 Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

The 2013 Determination will commence on the day after registration on the Federal Register of Legislative Instruments (FRLI).

 

The Human Rights Statement relating to this Determination is provided at Attachment B.


ATTACHMENT A

DETAILS OF THE NATIONAL HEALTH SECURITY (SSBA STANDARDS) DETERMINATION 2013

1. Name of Determination

 

This section provides for the correct name of this Determination as being the National Health Security (SSBA Standards) Determination 2013.

2. Commencement

 

This section provides that this Determination commences on the day after registration on the Federal Register of Legislative Instruments (FRLI).

3. Revocation

 

This section revokes the National Health Security (SBBA Standards) Determination 2011.

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 March 2013.


ATTACHMENT B

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health Security (SSBA Standards) Determination 2013 was enacted to address the need for robust and updated standards in the handling and management of security-sensitive biological agents (SSBAs) in Australia. The legislation is an instrument under the National Health Security Act 2007, introduced by the Minister for Health and Ageing. The primary objective of the Determination is to establish mandatory standards for entities handling SSBAs, ensuring they comply with stringent biosecurity measures to mitigate risks associated with these agents. The policy objective is to safeguard Australia's health security by implementing a systematic approach to the management and oversight of SSBAs, thereby preventing potential misuse and unauthorised access. Consultations with relevant stakeholders, including scientific and technical experts, government agencies, and the public, were integral to the development of the Determination. The 2013 Determination updates the previous standards to incorporate new requirements and address emerging concerns, reflecting a commitment to maintaining high biosecurity standards. By setting forth these revised standards, the legislation aims to enhance the security framework for managing SSBAs and ensure compliance among entities handling these sensitive materials.

Scope and Application

The National Health Security (SSBA Standards) Determination 2013 applies to entities handling security-sensitive biological agents (SSBAs) as outlined in the National Health Security Act 2007. These entities include laboratories, research facilities, and other organisations that manage biological agents deemed to pose a significant biosecurity risk to Australia. The Standards mandate specific security measures for the management and disposal of these agents, with particular emphasis on differentiating between Tier 1 agents, which pose the highest risk, and Tier 2 agents, which pose a high risk. The Act's jurisdictional reach is national, applying across all states and territories within Australia, thereby ensuring a unified approach to biosecurity management. Any failure to comply with the Standards can lead to penalties under the NHS Act, underscoring the seriousness of adherence to these regulations. The Determination itself is a legislative instrument that came into effect upon registration on the Federal Register of Legislative Instruments, superseding the previous 2011 Determination. The process of determining these standards involves consultation with relevant scientific and technical experts, government agencies, and the public, ensuring that the regulations are both comprehensive and practical.

Key Provisions

The National Health Security (SSBA Standards) Determination 2013 establishes the mandatory standards for the security of security-sensitive biological agents (SSBAs) in Australia. Pursuant to subsection 35(1) of the National Health Security Act 2007 (NHS Act), the Minister has the authority to determine these standards, which are incorporated by reference in the Determination (section 4). These standards apply to both Tier 1 and Tier 2 SSBAs, with specific requirements for each tier based on their respective risks. Entities that handle these agents must comply with these standards, as mandated by section 56 of the NHS Act. Failure to comply with the Standards can lead to significant consequences, including potential breaches of other provisions of the NHS Act, such as those outlined in subsection 58(1). Entities handling SSBAs are subject to a range of obligations under the SSBA Standards. These include the establishment of a systematic approach to the management of the security of SSBAs, specific directions for dealing with biosecurity risks, and the implementation of measures to ensure the secure handling and disposal of these agents. For example, entities must ensure that only authorised personnel with the appropriate security clearances and qualifications handle SSBAs. Additionally, entities must maintain detailed records of all SSBAs in their possession, including their acquisition, use, storage, transfer, and disposal. These records must be kept for a specified period and made available for inspection by authorised officers. The Standards also require entities to implement measures to prevent unauthorised access to SSBAs, including physical security measures and access controls. Breaching the requirements set out in the SSBA Standards can result in serious legal consequences. Under the NHS Act, an entity that fails to comply with a direction to dispose of SSBAs as a result of non-compliance with the Standards may be committing an offence. The maximum penalties for such offences can be substantial, reflecting the high risk posed by SSBAs. For example, individuals can face fines of up to $126,000 and imprisonment for up to two years, while corporations can be fined up to $630,000. Additionally, entities found in breach of the Standards may face civil penalties, including orders to cease certain activities or to rectify non-compliance. These penalties underscore the importance of strict adherence to the Standards to ensure the security and safety of 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.