EXPLANATORY STATEMENT
National Health Security Act 2007
Proclamation
Subsection 2(1) the National Health Security Act 2007 (the Act) provides for the commencement of various provisions of the Act. Item 3 of the table in subsection 2(1) specifies that Part 3 of the Act commences on a day or days to be fixed by Proclamation, but that if any of the provisions of Part 3 have not commenced within 18 months of the Royal Assent, they will commence on the first day after the end of that period. The Act received the Royal Assent on 28 September 2007.
The purpose of the Proclamation is to fix 31 January 2009 as the day on which Part 3 of the Act commences. Part 3 provides a regulatory scheme for biological agents that are considered to be of security concern to Australia.
In December 2002, the Council of Australian Governments (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 regulate all aspects of the supply chain 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 Act, which provides a regulatory scheme for security-sensitive biological agents (SSBAs).
The objective of Part 3 of the 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.
A separate Minute recommends that amendments be made to the National Health Security Regulations 2008 to provide further operational detail to the objectives of Part 3.
There has been wide dissemination about the early commencement of the SSBA regulatory scheme. Commencing in April 2008, all material (newsletters, website and mailouts) produced by the Department of Health and Ageing has stated that regulation of Tier 1 agents will occur from January 2009. This was particularly emphasised during the road shows conducted during September 2008 to affected stakeholders in all States and Territories who included representative from laboratories in the areas of animal health, defence, diagnostics, public health and research.
The Department of Health and Ageing will conduct training on compliance requirements for affected stakeholders in early December 2008.
The Proclamation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The National Health Security Act 2007 was enacted to address the security risks posed by biological agents that could be used as weapons, particularly in the context of potential terrorist activities. The Act was introduced by the Australian Parliament and was designed to give effect to Australia’s obligations to establish controls for the security of biological agents. One of the key issues it sought to resolve was the need for a comprehensive regulatory scheme to manage security-sensitive biological agents (SSBAs), following recommendations from the Council of Australian Governments (COAG) Report on the Regulation and Control of Biological Agents. The Act aims to ensure that there are stringent controls over the handling, storage, and distribution of SSBAs to mitigate any potential threats to national security. Part 3 of the Act, which is set to commence on 31 January 2009, outlines the regulatory framework that includes the establishment of a national register, compliance requirements, inspection programs, inspector powers, and penalties for non-compliance.
Scope and Application
The National Health Security Act 2007 applies to entities and facilities that handle security-sensitive biological agents (SSBAs) within Australia. This includes but is not limited to entities in the animal health, defence, diagnostics, public health, and research sectors. The Act provides for the regulation of SSBAs to ensure their secure handling and to mitigate risks associated with their potential use for terrorist purposes. Part 3 of the Act, which specifically addresses SSBAs, was proclaimed to commence on 31 January 2009, although there was an expectation for early implementation, with awareness campaigns and training programs rolled out in the preceding months. The geographic reach of this legislation is national, encompassing all states and territories of Australia. However, the Act allows for its provisions to be extended or modified through subordinate instruments, such as the National Health Security Regulations 2008, which provide further operational detail to the objectives of Part 3.
Key Provisions
The National Health Security Act 2007 (the Act) contains several key provisions, particularly in Part 3 which addresses security-sensitive biological agents (SSBAs). Section 2(1) of the Act provides for the commencement of various provisions, with Part 3 set to commence on 31 January 2009, as specified in the Proclamation. This date was chosen to give entities sufficient time to prepare for the new regulations. Part 3 of the Act establishes a regulatory scheme for SSBAs, which are biological agents considered to be of security concern to Australia, potentially used for terrorist purposes. The scheme includes the collection and recording of information about SSBAs on a national register (section 23), requirements for the secure handling of these agents (section 24), and an inspection program to monitor compliance with these requirements (section 28). Inspectors appointed under the Act are granted specific powers to ensure compliance with the regulatory scheme (section 32).
Entities and facilities handling SSBAs in Australia are required to comply with several obligations under the Act. Firstly, they must report and record information about the nature and location of SSBAs they handle on the national register (section 23). This includes providing details such as the type of biological agent, its location, and the entity handling it. Secondly, they must adhere to the secure handling requirements for SSBAs, which include implementing standards for the safe storage, transport, and disposal of these agents (section 24). Thirdly, they must cooperate with inspectors who are authorised to enter premises, inspect records, and conduct investigations (section 32). Failure to comply with these obligations can result in enforcement actions by the authorities.
The Act imposes penalties for non-compliance with its provisions. Section 35 outlines various offences related to the handling and reporting of SSBAs, with maximum penalties for individuals and corporations. For instance, wilful failure to report information about SSBAs can result in a fine of up to $210,000 for an individual or $1,050,000 for a corporation. Similarly, wilful failure to comply with secure handling requirements can lead to fines of up to $1,050,000 for an individual or $5,250,000 for a corporation. These penalties are designed to deter non-compliance and ensure that entities take the necessary steps to handle SSBAs securely. The Act also provides for civil and criminal consequences for breaches, including the potential for prosecution and imprisonment in serious cases.