Biosecurity (Listed Human Diseases) Determination 2026

Administered by Department of Health, Disability and Ageing

Legislation au F2026L00548 In force Legislative Instrument

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EXPLANATORY STATEMENT

Biosecurity Act 2015

Biosecurity (Listed Human Diseases) Determination 2026

Authority

The Biosecurity Act 2015 (the Act) provides the primary legislative means and a regulatory framework for the Australian Government to manage the risk of pests and diseases from entering Australian territory and causing harm to animal, plant and human health, the environment and the economy. The Act manages biosecurity risks – including the risk of listed human diseases – entering Australian territory, or emerging, establishing themselves or spreading in Australian territory or a part of Australian territory.

 

Subsection 42(1) of the Act provides that the Director-General of the Australian Centre for Disease Control (CDC) may, in writing, determine a human disease is a listed human disease under the Biosecurity (Listed Human Diseases) Determination 2026 (the LHD determination), if the Director-General considers that the disease may be communicable and may cause significant harm to human health.

 

The Biosecurity (Listed Human Diseases) Determination 2016 is due to sunset (automatically repeal) on 1 October 2026.

 

Purpose

The purpose is to remake the Biosecurity (Listed Human Diseases) Determination 2016 with the current listed human diseases and to add Andes virus infection. The nine diseases are required to be listed in the LHD determination to allow human biosecurity measures under Chapter 2 of the Act to be imposed, thereby enabling Australia to manage and respond to biosecurity risks to human health caused by those diseases.

 

Background

The nine diseases determined to be listed human diseases satisfy the legislative threshold in subsection 42(1) for listed human diseases as they may be communicable and may cause significant harm to human health.

 

It is time-critical to add Andes virus infection to the listed human diseases under the LHD determination following the suspected human-to-human transmission of Andes virus on a cruise ship, reported to the World Health Organization on 2 May 2026. Although the risk to the public is currently assessed as low, Andes virus infection meets the communicability threshold under paragraph 42(1)(a) of the Act with documented human-to-human transmission and has the potential to cause significant harm to human health under paragraph 42(1)(b) of the Act. Andes virus infection causes hantavirus pulmonary syndrome, a severe acute disease characterised by significant morbidity and mortality.

 

Most powers under Chapter 2 of the Act require that the disease be a listed human disease for the power to apply. These powers include the ability to screen incoming passengers for signs and symptoms of a listed human disease, the ability to impose Human Biosecurity Control Orders and implementing further risk mitigation measures.

 

To implement appropriate measures under the Act that are adapted to managing the risk, it is necessary for Andes virus infection to be determined as a listed human disease. The inclusion of Andes virus infection enables application of appropriate measures to manage these infections and their potential for human-to-human transmission as required.

 

Consultation

Subsection 42(2) of the Act requires that, before exercising the power to make the LHD determination, the Director-General must consult with the chief health officer (however described) for each state and territory, the Director of Biosecurity and Director of Human Biosecurity.

 

The Director-General consulted in writing with the chief health officers in each state and territory, the Director of Biosecurity and the Director of Human Biosecurity, both on the remaking the instrument ahead of its scheduled sunsetting on 1 October 2026, and on the addition of Andes virus infection as a listed human disease. Chief health officers in each state and territory, the Director of Biosecurity and the Director of Human Biosecurity all supported the remaking of the instrument and the addition of Andes virus infection as a listed human disease.

 

This instrument commences on the day after it is registered.

 

This instrument is a legislative instrument for the purposes of the Legislation Act 2003.

 

A provision-by-provision description of the Instrument is contained in Attachment A.

 

Authority: Section 42 of the Biosecurity Act 2015

 


 

ATTACHMENT A

 

Provision by provision description of the Biosecurity (Listed Human Diseases) Determination 2026

 

  1.       Name

Section 1 states that the name of the instrument is Biosecurity (Listed Human Diseases) Determination 2026.

 

  1.       Commencement

Section 2 provides that this legislative instrument commences on the day after it is registered.

 

  1.       Authority

Section 3 specifies that this instrument is made under the Biosecurity Act 2015.

 

  1.       Listed human diseases

Section 4 lists human diseases that are classified as listed human diseases. These diseases may require certain biosecurity measures be implemented to manage risks to human health. These diseases are:

 

(a) Andes virus infection;

(b) human coronavirus with pandemic potential;

(c) human influenza with pandemic potential;

(d) Middle East respiratory syndrome;

(e) plague;

(f) severe acute respiratory syndrome (SARS);

(g) smallpox;

(h) viral haemorrhagic fevers;

 (i) yellow fever

 

Overview

The Biosecurity (Listed Human Diseases) Determination 2026 was enacted under the Biosecurity Act 2015 with the purpose of identifying human diseases that may pose significant risks to human health. The Act was designed to provide a comprehensive framework to manage biosecurity risks, including those posed by listed human diseases, entering or spreading within Australian territory. The determination lists specific diseases that meet the criteria of being communicable and capable of causing significant harm to human health, thereby enabling the implementation of necessary human biosecurity measures. The need to update the list arose from the evolving nature of disease threats, and the addition of Andes virus infection reflects recent concerns about its potential for human-to-human transmission and severe health impacts. The determination was made in consultation with relevant health officers and biosecurity directors, all of whom supported the update and inclusion of the new disease. The Biosecurity (Listed Human Diseases) Determination 2026, effective from the day after its registration, identifies nine diseases that necessitate specific biosecurity measures. This update follows the sunsetting of the previous determination on 1 October 2026 and includes Andes virus infection due to its recent documented human-to-human transmission and significant health risks. The inclusion of this disease is critical for enabling Australia to implement appropriate measures to mitigate the risks associated with its potential spread. This legislative instrument ensures that Australia's biosecurity framework remains adaptive to emerging health threats, thereby safeguarding public health and enabling timely responses to new disease risks.

Scope and Application

The Biosecurity (Listed Human Diseases) Determination 2026 is an instrument made under the Biosecurity Act 2015, providing a framework for the Australian Government to manage the risk of listed human diseases entering Australian territory. This determination applies to nine specific human diseases, including the newly added Andes virus infection, which meets the legislative criteria of being communicable and having the potential to cause significant harm to human health. The determination enables the implementation of human biosecurity measures under the Act, such as screening incoming passengers and imposing Human Biosecurity Control Orders, to manage the risk of these diseases. The Director-General of the Australian Centre for Disease Control consulted with relevant health officers before making this determination, which commenced on the day after its registration. The determination is a legislative instrument under the Legislation Act 2003, and its purpose is to ensure the current listed human diseases are included, while also adding Andes virus infection to allow for appropriate biosecurity measures to be applied in response to emerging health risks.

Key Provisions

The Biosecurity (Listed Human Diseases) Determination 2026 (LHD determination) identifies specific diseases that are classified as listed human diseases (section 4). These diseases include Andes virus infection, human coronavirus with pandemic potential, human influenza with pandemic potential, Middle East respiratory syndrome, plague, severe acute respiratory syndrome (SARS), smallpox, viral haemorrhagic fevers, and yellow fever. The classification of these diseases under the determination enables the implementation of specific biosecurity measures to manage the risks they pose to human health. These measures may include screening incoming passengers for signs and symptoms of these diseases and imposing Human Biosecurity Control Orders (subsection 42(1) of the Biosecurity Act 2015). The LHD determination imposes obligations on the Director-General of the Australian Centre for Disease Control (CDC) to classify human diseases as listed human diseases if they are considered to be communicable and capable of causing significant harm to human health (subsection 42(1) of the Biosecurity Act 2015). To do this, the Director-General must consult with the chief health officers of each state and territory, the Director of Biosecurity, and the Director of Human Biosecurity (subsection 42(2) of the Biosecurity Act 2015). The determination of a disease as listed requires a thorough assessment of its potential for human-to-human transmission and its impact on human health. Failure to comply with the requirements of the LHD determination may result in civil and criminal penalties under the Biosecurity Act 2015. For example, a person who contravenes a Human Biosecurity Control Order may be liable for a civil penalty of up to 500 penalty units (subsection 464(2) of the Biosecurity Act 2015). In addition, a person who knowingly contravenes a Human Biosecurity Control Order may be liable for a criminal penalty of up to 10,000 penalty units or imprisonment for up to five years, or both (subsection 464(3) of the Biosecurity Act 2015). The penalties for contravening the LHD determination are intended to deter non-compliance and to ensure that appropriate measures are taken to manage the risks posed by listed human diseases.

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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.