National Health Security (SSBA Standards) Determination 2008

Administered by Department of Health, Disability and Ageing

Legislation au F2008L04331 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 2008

 

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 including their storage, the security status of individuals who handle or dispose SSBAs and the transport of SSBAs.  Section 56 of the NHS Act requires entities that handle SSBAs to comply with the SSBA Standards.  

Background

In December 2002, COAG agreed to a national review of the regulation, reporting and security around the storage, sale and handling of hazardous materials.  The review has been conducted in four parts covering ammonium nitrate, radiological, biological and chemical material.

 

The COAG Report on the Regulation and Control of Biological Agents (COAG Report) recommended establishing a national regulatory scheme to minimise the security risks posed by biological agents that may be used for terrorist purposes.  The legislative response to the COAG Report is set out in Part 3 of the NHS Act.

 

The objective of Part 3 of the NHS Act is to give effect to Australia’s obligations to establish controls for the security of biological agents that could be used as weapons.  To achieve this, Part 3 provides for:

  • the collection, and recording on a national register, information about the nature and location of SSBAs legitimately handled by entities and facilities in Australia;
  • requirements to be complied with for the secure handling of SSBAs (including standards);
  • monitoring of compliance with reporting and handling requirements through an inspection program;
  • inspector powers; and
  • penalties for non-compliance.

 

The regulatory scheme is built around a two-tiered List of SSBAs (the List) established by the Minister under subsection 31(1) of the NHS Act.  The List is derived using intelligence information and an analysis of the impact and feasibility of the use of these agents in a terrorist act. 

 

It is intended that Tier 1 agents will be regulated from 2009 and Tier 2 agents will be regulated from 2010. 

 

Section 35 of the NHS Act provides that the Minister may, by legislative instrument, determine standards (SSBA Standards) relating to security-sensitive biological agents.  The purpose of the National Health Security (SSBA Standards) Determination 2008 (the Determination) is for the Minister to determine the SSBA Standards under section 35 of the NHS Act.  The Minister’s Determination incorporates, by reference, the document referred to as the Security-sensitive Biological Agent (SSBA) Standards dated 30 September 2008, published by the Commonwealth and that can be found on the Department’s website http://www.health.gov.au/ssba.  

 

The SSBA Standards set out minimum requirements relating to physical security, information management, decontamination and inactivation, disposal and transport of SSBAs, and the security status of individuals handling SSBAs.  They include specific directions for dealing with biosecurity risks and establish a systematic approach to the management of the security of SSBA.  The SSBA Standards are comprised of normative requirements that are mandatory and informative statements to assist in meeting the normative statements. 

 

The SSBA Standards have a number of areas where the requirements for agents listed as Tier 1 (agents of the highest security concern) or Tier 2 (agents of high security concern) differ.  This is to reflect the difference in the nature of the two tiers as noted in the COAG Report.

 

Consultation

 

Subsection 35(4) provides for the consultations of certain persons that must take place in developing the Standards.  Those persons are persons with scientific or technical knowledge in relation to the security of biological agents; and the States, the Australian Capital Territory and the Northern Territory. 

 

Subsection 35(5) provides that that provision does not prevent the Minister from consulting any other person who the Minister considers may assist the Minister in developing a standard.

 

Consultations have occurred with persons with scientific or technical knowledge of SSBAs who are members of the Department’s advisory groups: the Implementation Advisory and Consultative Committee (IACC) and the Regulation and Standards Working Group (RSWG). 

 

The IACC is a committee chaired by the Department to provide advice on implementation of the regulatory scheme and comprises representatives of twelve government agencies including the Australian Chemical, Biological, Radiological and Nuclear Data Centre and the Australian Security Intelligence Organisation.  Members of the RSWG are a group of technical experts who represent the Animal Health Committee, the Office of the Gene Technology Regulator, Department of Foreign Affairs and Trade, and the Public Health Laboratory Network.

 

Consultations have also occurred with the National Counter Terrorism Committee’s Chemical, Biological, Radiological and Nuclear (CBRN) Security Sub-Committee, which includes representatives of each State and the ACT and NT. 

 

Draft Standards were released for public consultations on 12 June 2008 and placed on the Department of Health and Ageing website (http://www.health.gov.au/ssba).  Comment was also sought from stakeholders identified in a survey conducted between February and July 2008 by the Department of Health and Ageing. 

 

During June and July 2008, consultation workshops were held in each capital city (except Darwin and Hobart) with the consultation period closing on 1 August 2008.  Attendees at the workshops included laboratories in the areas of animal health, defence, diagnostics, public health and research.

 

Over 930 comments from 26 individuals or organisations were received during the consultation period. 

 

Road shows for the SSBA Regulatory Scheme were conducted in all capital cities in August and September 2008 to further consult affected stakeholders.

 

The Office of Best Practice Regulation (OBPR) advised that a Regulation Impact Statement (RIS) would not be required for the SSBA Standards.  The OBPR advised that a Business Cost Calculator (BCC) assessment would be sufficient as further regulatory impact analysis of the costs to business.

Details of the Determination are set out in Attachment A.

 

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


ATTACHMENT A

DETAILS OF THE NATIONAL HEALTH SECURITY (SSBA STANDARDS) 2008

1. Name of Determination

 

This section provides that this Determination is the National Health Security (SSBA Standards) Determination 2008.

2. Commencement

 

This section provides that this Determination commences immediately after the commencement of Part 3 of the NHS Act.  Part 3 of that Act provides a regulatory scheme for handling SSBAs.

3. Definition

 

This section provides the definitions of:

Act means the National Health Security Act 2007.

SSBA Standards means the Security-sensitive Biological Agent (SSBA) Standards, dated 30 September 2008, published by the Commonwealth.

4. Determination

 

Subsection 4(1) provides that the SSBA Standards are determined for subsection 35(1) of the Act.

 

Subsection 4(2) provides for when this Determination comes into effect for clauses 1 and 2 of the SSBA Standards and the remainder the SSBA Standards.  Clauses 1 and 2 of the SSBA Standards come into effect immediately after the commencement of Part 3 of the NHS Act and the remainder of the Standards come into effect on 1 July 2009. 

 

Clause 1 of the SSBA Standards relates to the scope of and definitions used in the document.  Clause 2 refers to requirements related to Risk and Incident Management.  The phased in commencement of the SSBA Standards is to respond to concerns that full compliance with the SSBA Standards by January 2009 was not feasible. 

 

Clauses 1 and 2 commence first because it is important for entities to undertake a risk assessment and to formulate a risk management plan as they are integral to the understanding of the risks involved and will determine the operation of the rest of the SSBA Standards.  Entities that report after 31 January 2009 will need to be compliant with the SSBA Standards.

 

The risk mitigation strategies determined under the risk management plan will take time to implement and entities will be given until 1 July 2009 to comply with the requirements in clauses 3 to 9 of the SSBA Standards.  Entities that report after 1 July 2009 will need to be compliant with the full SSBA Standards.

 

Overview

The National Health Security Act 2007, enacted by the Parliament of Australia, was introduced to address the security risks posed by biological agents that could potentially be used for terrorist purposes. This legislation aims to give effect to Australia's obligations to establish controls for the security of such biological agents. Under the Act, the Minister for Health and Ageing has the authority to determine standards for the security-sensitive biological agents (SSBAs) through legislative instruments. The National Health Security (SSBA Standards) Determination 2008 is one such instrument, establishing the standards for the secure handling of SSBAs, including their storage, the security status of individuals who handle or dispose of them, and their transport. The objective of these standards is to provide a systematic approach to managing the security of SSBAs and to ensure compliance through monitoring, inspector powers, and penalties for non-compliance. The determination process involved extensive consultation with scientific and technical experts, government agencies, and state and territory representatives, as well as public consultations. Feedback from over 930 comments received during the consultation period was incorporated into the final standards. The SSBA Standards are phased in, with the initial requirements for risk and incident management coming into effect immediately after the commencement of Part 3 of the NHS Act, and the remaining clauses set to come into effect on 1 July 2009. This phased approach acknowledges the practical challenges of full compliance within a short timeframe.

Scope and Application

The National Health Security (SSBA Standards) Determination 2008 applies to entities that handle security-sensitive biological agents (SSBAs) within Australia. These entities are required to comply with the SSBA Standards which encompass a range of requirements including the physical security of SSBAs, information management, decontamination and inactivation, disposal, transport, and the security status of individuals who handle these agents. The Determination is a legislative instrument made under the National Health Security Act 2007 (NHS Act) and its scope is nationwide, affecting entities across all states and territories in Australia. The SSBA Standards have been phased in, with clauses 1 and 2 coming into effect immediately after the commencement of Part 3 of the NHS Act, while the remaining clauses are set to come into effect on 1 July 2009. This phased approach aims to allow entities sufficient time to implement necessary risk mitigation strategies. The SSBA Standards are divided into two tiers reflecting the level of security concern, with Tier 1 agents being of the highest security concern and Tier 2 agents being of high security concern. The Determination also extends its application through subordinate instruments, allowing for the setting of specific requirements and further regulation as deemed necessary by the Minister.

Key Provisions

The National Health Security (SSBA Standards) Determination 2008 (the Determination) sets out the minimum requirements for the secure handling of security-sensitive biological agents (SSBAs) in Australia, as specified in Section 35 of the National Health Security Act 2007 (NHS Act). The SSBA Standards determine the physical security, information management, decontamination, disposal, transport, and security status requirements for individuals handling SSBAs, with specific provisions for agents categorised as Tier 1 or Tier 2. Clauses 1 and 2 of the SSBA Standards, which cover the scope and definitions, as well as risk and incident management, came into effect immediately after the commencement of Part 3 of the NHS Act, while the remaining clauses will take effect on 1 July 2009. The phased commencement aims to allow entities sufficient time to implement the necessary risk mitigation strategies and fully comply with the SSBA Standards. Entities handling SSBAs are required to comply with the SSBA Standards, as mandated by Section 56 of the NHS Act. This includes conducting a risk assessment, formulating a risk management plan, and adhering to the physical security, information management, decontamination, disposal, transport, and security status requirements for individuals handling SSBAs. Entities must also report to the Minister any incident involving the loss, theft, unauthorised access, unauthorised release, or theft of SSBAs, in accordance with Section 58 of the NHS Act. Additionally, entities must ensure that individuals with access to SSBAs meet the specified security status requirements, and maintain records of individuals who have access to SSBAs, as per Section 59 of the NHS Act. Failure to comply with the SSBA Standards or the reporting requirements under the NHS Act may result in civil or criminal penalties. Under Section 63 of the NHS Act, an entity that contravenes a requirement under the SSBA Standards may be subject to a civil penalty of up to $210,000 for a corporation and $42,000 for an individual. In more serious cases, criminal penalties may apply, with maximum penalties of up to 10 years imprisonment and/or fines of up to $525,000 for a corporation and $105,000 for an individual, as outlined in Section 64 of the NHS Act. Furthermore, failure to report an incident involving SSBAs as required under Section 58 of the NHS Act may result in a civil penalty of up to $210,000 for a corporation and $42,000 for an individual, as per Section 65 of the NHS Act.

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National Security Law
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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.