National Health Security Amendment Regulation 2013 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L00476 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Select Legislative Instrument 2013 No. 30

 

National Health Security Act 2007

 

National Health Security Amendment Regulation 2013 (No. 1)

Section 95 of the National Health Security Act 2007 (the Act) provides that the        Governor-General may make regulations prescribing matters required or permitted by the Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

The object of Part 3 of the Act is to give effect to Australia’s obligations to establish controls for the security of certain biological agents that can be used as weapons.  Entities must comply with the requirements of the Act, including reporting and registration requirements, and the Security-Sensitive Biological Agent (SSBA) Standards.  The National Health Security Regulations 2008 (the Principal Regulations) provide for the operational details of the SSBA Regulatory Scheme.

 

Unless excluded from these requirements, entities must comply with the requirements of Division 4A relating to suspected SSBAs or Division 5 relating to confirmed SSBAs.

 

The regulation amends the Principal Regulations to facilitate streamlined reporting arrangements by repealing the requirement for periodic or regular reports and stipulating that reportable events are reported as they occur.  Any other changes are made as consequential to the amendments to the Act.

Details of the regulation are set out in the Attachment.

The Act specifies no conditions that need to be satisfied before the power to make the regulation may be exercised.

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

 

The regulation commences on the commencement of Schedule 1 to the National Health Security Amendment Act 2012, on 31 March 2013. 

There have been extensive consultations during the development of the Bill and the NHS Regulations.  Agencies consulted include the Department of Prime Minister and Cabinet, the Australian Security Intelligence Organisation, the Australian Chemical, Biological, Radiological and Nuclear (CBRN) Data Centre and the Australia and New Zealand Counter-Terrorism Committee’s CBRN Security Subcommittee.  Comments were also sought from other targeted stakeholders including the Public Health Laboratory Network and the Sub Committee of Animal Health Laboratory Standards.

There was general support for the proposed changes.

 Authority:  Section 95 of the National   
                           Health Security Act 2007

 ATTACHMENT

 

Details of the National Health Security Amendment Regulation 2013 (No. 1)

 

Section 1 – Name of regulation

 

This section provides that the title of the regulation is the National Health Security Amendment Regulation 2013 (No. 1).

 

Section 2 – Commencement

 

This section provides that the regulation commences on the commencement of Schedule 1 to the National Health Security Amendment Act 2012. 

 

Section 3 – Amendment of National Health Security Regulations 2008

 

This section provides that Schedule 1 to the regulation amends the National Health Security Regulations 2008 (the Principal Regulations).

 

Schedule 1 – Amendments

 

Regulation of Security-Sensitive Biological Agents (SSBA)

 

Item [1] – Division 3.4, heading    

The title change clarifies that this division relates only to registered entities as opposed to entities that temporarily handle security-sensitive biological agents (SSBA).

 

Items [2], [5] and [6] – Division 3.5 headings

Division 3.5 has been incorporated into Division 3.4 as both Divisions deal with registered entities and Items [2], [5] and [6] reflect this. 

 

Item [3] – Subdivision 3.5.1, heading; and Item [4] – Regulation 3.40, heading

Changes have been made to headings to accurately reflect the purpose of the clauses and current drafting policy.

 

Item [7] – Regulation 3.45

Changes have been made to this clause to more succinctly describe the requirements of a reportable event.

 

Item [8] – Subdivision 3.5.3

Subdivision 3.5.3 (Regulations 3.46 – 3.51) is deleted as periodic reporting is currently being phased out.

 

Item [9] – Before Division 3.7

Item [9] inserts a new Division 3.5 related to reportable events for entities that temporarily handle SSBAs.  This item inserts a regulation that prescribes the circumstances in which temporary handling of an SSBA is not authorised for the purposes of subparagraph 60AF(1)(b)(ii) of the Act.  Temporary handling is not authorised where it is not compliant with the requirements in Part 10 of the SSBA Standards.


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health Security Amendment Regulation 2013 (No. 1)

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

The Security Sensitive Biological Agent (SSBA) Regulatory Scheme was established as an outcome related to the recommendations of the Council of Australian Government’s (COAG) Report on the Regulation and Control of Biological Agents. The National Health Security Act 2007 (NHS Act) establishes controls for SSBAs that could be used as            bio-weapons.

The NHS Act is supported by the National Health Security Regulation 2008 (NHS Regulations) and the SSBA Standards. Section 95 of the NHS Act provides that the Governor-General may make regulations prescribing matters required or permitted by the NHS Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the NHS Act.

Entities must comply with the requirements of the Act, including reporting and registration requirements, and the SSBA Standards. The NHS Regulations provide for the operational details of the SSBA Regulatory Scheme.

The National Health Security Amendment Regulation 2013 (No. 1) (the Amendment Regulation) makes some amendments to the NHS Regulations to facilitate the streamlined reporting arrangements that will be provided for in amendments to the Act and to make other changes that are consequential to the amendments to the Act.

Human rights implications

Certain regulations require reporting to the Secretary of the Department of Health and Ageing. This is potentially a limitation on the right to privacy and reputation as the information includes the name and business contact information of a person acting as a representative of the entity. This information ensures that the report is made by an authorised representative of the entity and that data is verified. Contact information is held at an appropriate security level.

It is considered that the limitations imposed are reasonable, necessary and proportionate to the level of risk and the national security context of handling SSBAs. This Legislative Instrument does not engage any of the applicable rights or freedoms.

Conclusion

This Legislative Instrument is compatible with human rights because to the extent that it may limit human rights, those limitations are reasonable, necessary and proportionate.

 

Tanya Plibersek, 

Minister for Health

 

Overview

The National Health Security Act 2007, enacted by the Australian Parliament, aims to establish controls for the security of certain biological agents that can be used as weapons. This Act responds to Australia's obligations under international agreements to prevent the misuse of biological agents that pose a threat to public health and national security. The Act, supported by the National Health Security Regulations 2008, mandates entities to comply with reporting and registration requirements, as well as the Security-Sensitive Biological Agent (SSBA) Standards. The National Health Security Amendment Regulation 2013 (No. 1) further refines the operational details of the SSBA Regulatory Scheme by streamlining reporting arrangements and making consequential amendments to the regulations. These amendments ensure that reportable events are communicated as they occur, rather than through periodic reports, thereby enhancing the responsiveness and effectiveness of the regulatory framework. The regulation was developed through extensive consultations with various agencies and stakeholders, including the Department of Prime Minister and Cabinet, the Australian Security Intelligence Organisation, and the Australian Chemical, Biological, Radiological and Nuclear (CBRN) Data Centre. The policy objective of these amendments is to facilitate a more efficient and timely reporting system while maintaining stringent controls over the handling of SSBAs. The regulation is compatible with human rights as the limitations on privacy and reputation are deemed reasonable, necessary, and proportionate given the national security context of managing SSBAs.

Scope and Application

The National Health Security Act 2007, as amended by the National Health Security Amendment Regulation 2013 (No. 1), applies to entities involved in the handling of Security-Sensitive Biological Agents (SSBA) that could be used as bio-weapons. This includes entities that are registered to handle SSBAs as well as those temporarily handling such agents. The Act applies across Australia, providing a national framework for the regulation of SSBAs. The regulation primarily focuses on the streamlined reporting of events involving SSBAs, repealing the requirement for periodic reports and stipulating that reportable events must be reported as they occur. The changes are designed to enhance the efficiency and effectiveness of the regulatory scheme, ensuring that relevant information is communicated promptly to the appropriate authorities. The regulation also includes amendments to clarify and refine the operational details of the SSBA Regulatory Scheme, ensuring that the requirements are clearly understood and uniformly applied. There are no stated exclusions, exemptions, or thresholds in this particular regulation; however, the Act and its subordinate instruments may provide for specific exclusions in certain circumstances. The regulation is a legislative instrument under the Legislative Instruments Act 2003 and commenced on 31 March 2013, aligning with the commencement of the amendments to the Act.

Key Provisions

The National Health Security Amendment Regulation 2013 (No. 1) introduces several key changes to the National Health Security Regulations 2008, primarily to streamline reporting arrangements and align with amendments to the National Health Security Act 2007 (NHS Act). One of the main operative sections is Item [9], which inserts a new Division 3.5 that addresses reportable events for entities that temporarily handle security-sensitive biological agents (SSBAs). This division prescribes circumstances under which temporary handling of an SSBA is not authorised, ensuring that it complies with the requirements in Part 10 of the SSBA Standards (Item [9]). Furthermore, Item [8] removes Subdivision 3.5.3 (Regulations 3.46–3.51) because periodic reporting is being phased out, and Item [7] revises Regulation 3.45 to more accurately describe the requirements of a reportable event (Items [7] and [8]). The Amendment Regulation imposes several obligations on the entities governed by the NHS Act. Firstly, entities must comply with the reporting requirements as stipulated in the new Division 3.5, ensuring that any reportable events are reported as they occur rather than through periodic or regular reports (Item [8]). Secondly, entities must adhere to the updated SSBA Standards, particularly Part 10, which outlines the criteria for authorised temporary handling of SSBAs (Item [9]). Thirdly, entities must ensure that any information reported to the Secretary of the Department of Health and Ageing includes the name and business contact information of a person acting as a representative of the entity, thereby verifying the authorised nature of the report (Item [9]). The regulation also outlines potential consequences for non-compliance. While the specific offences and penalties are not detailed within the Amendment Regulation, breaches of the NHS Act or the SSBA Standards could lead to civil or criminal penalties. For instance, failure to comply with reporting requirements may result in fines, imprisonment, or both, depending on the severity of the breach. The maximum penalties for such offences are determined by the provisions of the NHS Act itself, which could include substantial financial penalties and imprisonment terms that vary based on the nature and impact of the non-compliance. Compliance with these regulations is crucial to avoid these adverse outcomes and to ensure the security 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.