Biosecurity Amendment (Australian Centre for Disease Control and Other Measures) Regulations 2026

Administered by Department of Agriculture, Fisheries and Forestry

Legislation au F2026L00249 Regulations Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Issued by Authority of the Minister for Agriculture, Fisheries and Forestry

 

Biosecurity Act 2015

 

Biosecurity Amendment (Australian Centre for Disease Control and Other Measures) Regulations 2026

 

Legislative Authority

 

The Biosecurity Act 2015 (the Act) provides the regulatory framework for the management of diseases and pests that may cause harm to human, animal or plant health or the environment.

 

Section 645 of the Act provides that the Governor-General may make regulations prescribing matters that are required or permitted by the Act to be prescribed or that are necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

Subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws) the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.

 

Purpose

 

The purpose of the Biosecurity Amendment (Australian Centre for Disease Control and Other Measures) Regulations 2026 (the Amendment Regulations) is to amend the Biosecurity Regulation 2016 (the Principal Regulation) to align the Principal Regulation with the amendments to the Act made by the Australian Centre for Disease Control (Consequential Amendments and Transitional Provisions) Act 2025 (CDC C&T Act). Namely, the Amendment Regulations amend the Principal Regulation to:

  • replace a reference to the Director of Human Biosecurity with a reference to the Director-General of the Australian Centre for Disease Control (CDC) in paragraph 30(1)(c) of the Principal Regulation (relating to a statement of human health risks associated with the goods or the class of goods of which a biosecurity import risk analysis (BIRA) is being conducted); and
  • add references to the Director-General of the CDC, where relevant, in Chapter 8 of the Principal Regulation (relating to reviews conducted by the Inspector-General of Biosecurity).

 

The Amendment Regulations also provide authority for first point of entry determinations to be varied to update references to legislation when the Biosecurity Regulations 2026 have been registered.

 


 

Background

 

Australian Centre for Disease Control amendments

 

The Australian Centre for Disease Control Act 2025 (CDC Act) establishes the Australian Centre for Disease Control (CDC) as an independent, non-corporate Commonwealth entity. The CDC Act also establishes the Director-General of the CDC as head of the CDC, who is vested with various functions, duties and powers to administer the CDC, as well as other bodies to support the CDC.

 

The CDC C&T Act makes consequential amendments and provides transitional provisions to support the CDC Act. This includes amendments to the Act. Specifically, the amendments to the Act made by the CDC C&T Act establish a role for the CDC and the Director-General of the CDC under the Act in relation to human biosecurity and human health protection activities.

 

The administration of the human health aspects of the Biosecurity Act, including the role of the Director of Human Biosecurity and most human biosecurity functions and powers, remain with the Department of Health, Disability and Ageing.  However, under the CDC C&T Act, some powers formerly held by the Department of Health, Disability and Ageing and the Director of Human Biosecurity have transferred from the Director of Human Biosecurity to the Director-General of the CDC, particularly in relation to issues where the CDC’s communicable disease expertise and independence is especially important. This includes the transfer of responsibility to prepare a statement of human health risks, at the request of the Director of Biosecurity, for the purpose of a BIRA.

 

The CDC C&T Act also includes amendments to facilitate the Department of Health, Disability and Ageing’s administration of relevant parts of the Act following the establishment of the Australian CDC. For example, the role of the Director of Human Biosecurity has transferred from the Commonwealth Chief Medical Officer to the Secretary of Health.

 

Other amendments

 

The Amendment Regulations also enable first point of entry determinations in relation to ports and landing places to be varied or revoked when the Biosecurity Regulations 2026 have been registered.

 

A number of first point of entry determinations are in effect and refer to the Biosecurity Regulation 2016. The amendments enable those first point of entry determinations to be varied when the Biosecurity Regulations 2026 have been registered.

 

This is a technical amendment which will enable consequential amendments to be made, through a separate legislative instrument, to replace references to the Biosecurity Regulation 2016 with references to the Biosecurity Regulations 2026. This amendment is required ahead of the making of the Biosecurity Regulations 2026 so that variations to update references in first point of entry determinations can commence at the same time as the Biosecurity Regulations 2026 commence.

 

 

Impact and Effect

 

The amendment to replace the reference to the Director of Human Biosecurity with a reference to the Director-General of the CDC in paragraph 30(1)(c) of the Principal Regulation reflects that a statement of the human health risks associated with the goods or the class of goods for which a BIRA is being conducted, prepared under subsection 169(5) of the Act, is now prepared by the Director-General of the CDC instead of the Director of Human Biosecurity.

 

The amendments to add references to the Director-General of the CDC in Chapter 8 of the Principal Regulation reflects that the Director-General of the CDC has functions, powers and duties under the Act.

 

Consultation

 

The Department of Health, Disability and Ageing and the Australian Centre for Disease Control were consulted on the Amendment Regulations and were supportive of the amendments. No consultation on the amendment relating to first point of entry determinations was considered to be appropriate or reasonably practicable, because it is a technical amendment to enable consequential amendments to references to legislation in those determinations to be made when the Biosecurity Regulations 2026 have been registered. However, the Department undertook a public consultation process between October and December 2025 on the remake of the Principal Regulation (which will become the Biosecurity Regulations 2026). The public consultation process captured a range of views from industry, government and individuals. The consultation outcome was broadly positive and did not identify a need for extensive or substantive changes to the Principal Regulation.

 

Details/ Operation

 

The Amendment Regulations is a legislative instrument for the purposes of the Legislation Act 2003.

 

The Amendment Regulations commence the day after registration.

 

Details of the Amendment Regulations are set out in Attachment A.

 

Other

 

The Amendment Regulations are compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full Statement of Compatibility with Human Rights is set out in Attachment B.

ATTACHMENT A

 

Details of the Biosecurity Amendment (Australian Centre for Disease Control and Other Measures) Regulations 2026

 

Section 1 – Name

 

This section provides that the name of the instrument is the Biosecurity Amendment (Australian Centre for Disease Control and Other Measures) Regulations 2026 (the Amendment Regulations).

 

Section 2 – Commencement

 

This section provides that each provision of the Amendment Regulations specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Item 1 in the table provides that the whole of the Amendment Regulations commences on the day after it is registered on the Federal Register of Legislation.

 

The note below the table provides that the table relates only to the provisions of the Amendment Regulations as originally made. It will not be amended to deal with any later amendments of the Amendment Regulations. The purpose of this note is to clarify that the commencement of any amendments is not reflected in this table.

 

Section 3 – Authority

 

This section provides that the Amendment Regulations are made under the Biosecurity Act 2015 (the Act).

 

Section 4 – Schedules

 

This section provides for the amendment or repeal of instruments as set out in a Schedule to the Amendment Regulations. Schedule 1 to the Amendment Regulations provides for amendments to the Biosecurity Regulation 2016 (the Principal Regulation).

Schedule 1 – Amendments

 

Part 1 – Australian Centre for Disease Control amendments

 

Biosecurity Regulation 2016

 

Item [1] – Paragraph 30(1)(c)

 

Section 169 of the Act provides for the process for conducting a biosecurity import risk analysis (BIRA). Subsection 169(5), as amended by the Australian Centre for Disease Control (Consequential Amendments and Transitional Provisions) Act 2025 (CDC C&T Act), provides that for the purposes of conducting a BIRA in relation to goods, or a class of goods, the Director of Biosecurity may request the Director of the CDC to prepare a statement of the human health risks associated with the goods or the class of goods. Paragraph 170(2)(a) of the Act provides that a BIRA report must include the information prescribed by the regulations.

 

Section 30 of the Principal Regulation sets out the content which must be included in a BIRA report.

 

This item omits “Director of Human Biosecurity” and substitutes “Director-General of the CDC” in paragraph 30(1)(c) of the Principal Regulation.

 

This amendment aligns the Principal Regulation with the amendment made to subsection 169(5) of the Act made by the CDC C&T Act to reflect that a statement prepared under subsection 169(5) of the Act is now prepared by the Director-General of the CDC instead of by the Director of Human Biosecurity. The effect of this amendment is that under paragraph 30(1)(c), a BIRA report prepared by the Director of Biosecurity in relation to goods or a class of goods must include a statement prepared by the Director-General of the CDC on the human health risks associated with the goods or class of goods, if such a statement was prepared under subsection 169(5) of the Act.

 

Item [2] – Subsection 89(1) (note)

 

Section 567 of the Act allows the Inspector-General of Biosecurity to review the performance of functions, or exercise of powers, by biosecurity officials under one or more provisions of the Act. Subsection 567(4) of the Act allows the regulations to make provision for or in relation to the process to be followed in conducting a review under section 567 and the content of reports of reviews conducted under section 567. Subsection 89(1) of the Principal Regulation provides that Chapter 8 of the Principal Regulation makes provision for and in relation to those matters.

 

The note following subsection 89(1) of the Principal Regulation explains the scope of section 567 of the Act including the explanation that section 567 does not permit the Inspector-General to review the performance of functions, or exercise of powers, by human biosecurity officers, chief human biosecurity officers or the Director of Human Biosecurity under the Act because they are not biosecurity officials for the purposes of section 567 of the Act.

 

This item omits “or the Director of Human Biosecurity” and substitutes “, the Director of Human Biosecurity or the Director-General of the CDC” in the note after subsection 89(1) of the Principal Regulation.

 

This amendment has the effect that the note additionally explains that section 567 of the Act does not permit the Inspector-General of Biosecurity to review the performance of functions, or exercise of powers, by the Director-General of the CDC because the Director-General of the CDC is not a biosecurity official for the purposes of section 567 of the Act.

 

This amendment is consequential to the broader amendments to the Act made by the CDC C&T Act that provides the Director-General of the CDC with functions and powers under the Act.

 

Item [3] – After paragraph 99(1)(b)

 

Section 99 of the Principal Regulation provides for the process to be followed where it is proposed to include material in a review report that is expressly or impliedly critical of certain persons. Subsection 99(1) provides that section 99 applies if it is proposed to include material in a review report that is expressly or impliedly critical of any of the following persons:

 (a) the Director of Biosecurity;

 (b) the Director of Human Biosecurity;

 (c) a chief human biosecurity officer, a human biosecurity officer or a group of such              officers;

 (d) a biosecurity officer, a biosecurity enforcement officer or a group of such officers;

(e) any other officer or employee of a Commonwealth body;

(f) a member of the Australian Defence Force;

(g) an officer or employee of a State or Territory body;

(h) a consultant to the Department;

(i) a biosecurity industry participant.

 

This item inserts the following after paragraph 99(1)(b) of the Principal Regulation:

 

 (ba) the Director-General of the CDC;

 

This amendment has the effect that section 99 applies if it is proposed to include material in a review report that is expressly or impliedly critical of the Director-General of the CDC.

 

This amendment aligns the Principal Regulation with the broader amendments to the Act made by the CDC C&T Act that provides the Director-General of the CDC with functions and powers under the Act.

 

Item [4] – Paragraph 99(2)(a)

 

Paragraph 99(2)(a) of the Principal Regulation provides that in the case of criticism relating to the Director of Human Biosecurity or a person mentioned in paragraph 99(1)(c)—the critical material must not be included in the review report unless the Inspector-General of Biosecurity has given the Director of Human Biosecurity a reasonable opportunity to make submissions to the Inspector-General in relation to the material.

 

This item inserts “, the Director-General of the CDC” after “relating to the Director of Human Biosecurity” in paragraph 99(2)(a) of the Principal Regulation.

 

This amendment has the effect that material that is expressly or impliedly critical in relation to the Director-General of the CDC must not be included in the review report unless the Inspector-General has given the Director of Human Biosecurity a reasonable opportunity to make submissions to the Inspector-General in relation to the material.

 

This amendment aligns the Principal Regulation with the broader amendments to the Act made by the CDC C&T Act that provides the Director-General of the CDC with functions and powers under the Act.

 

Item [5] – After paragraph 103(b)

 

Section 103 of the Principal Regulation provides that in performing functions or exercising powers in relation to a review, the Inspector-General of Biosecurity must have regard to the desirability of minimising any resulting disruption to the performance of functions, or the exercise of powers, by any of the following:

 

  1.    the Director of Biosecurity;
  2.    the Director of Human Biosecurity;
  3.    a chief human biosecurity officer, a human biosecurity officer or a group of such officers;
  4.    a biosecurity officer, a biosecurity enforcement officer or a group of such officers;
  5.    any other officer or employee of a Commonwealth body;
  6.     a member of the Australian Defence Force;
  7.    an officer or employee of a State or Territory body;
  8.    a consultant to the Department;
  9.      a biosecurity industry participant.

 

This item inserts the following after paragraph 103(b) of the Principal Regulation:

 

 (ba) the Director-General of the CDC;

 

This amendment has the effect that in performing functions or exercising powers in relation to a review, the Inspector-General must have regard to the desirability of minimising any resulting disruption to the performance of functions, or the exercise of powers by the Director-General of the CDC.

 

This amendment aligns the Principal Regulation with the broader amendments to the Act made by the CDC C&T Act that provides the Director-General of the CDC with functions and powers under the Act.

 

Part 2 – Other amendments

 

Biosecurity Regulation 2016

 

Item [6] – At the end of section 57

 

Section 223 of the Act provides that the Director of Biosecurity or the Director of Human Biosecurity may determine that a specified landing place in Australian territory is a first point of entry for aircrafts or goods that are subject to biosecurity control. Section 227 of the Act allows the Director who made the first point of entry determination to vary or revoke it, or vary the conditions specified in the determination in circumstances covered by paragraphs 227(a) to (d) of the Act, or where a circumstance prescribed by the regulations has occurred (paragraph 227(e) of the Act).

 

Section 57 of the Principal Regulation is made for the purposes of paragraph 227(e) of the Act and sets out additional circumstances in which the relevant Director may vary or revoke a determination made under subsection 223(1) of the Act in relation to a landing place, or vary the conditions specified in the determination.

 

Currently, none of the circumstances set out in paragraphs 227(a) to (d) of the Act or in section 57 of the Principal Regulation allow for a determination made under subsection 223(1) of the Act in relation to a landing place to be varied to make consequential amendments to references to legislation.

 

The amendment inserts the following paragraph at the end of section 57:

 

(d) the Biosecurity Regulations 2026 have been registered.

 

This amendment has the effect of allowing a first point of entry determination in relation to a landing place to be varied when the Biosecurity Regulations 2026 have been registered. This will enable consequential amendments to be made (if required), through a separate legislative instrument, to replace any references to the Principal Regulation with references to the Biosecurity Regulations 2026. This amendment is required ahead of the making of the Biosecurity Regulations 2026 so that any such consequential amendments to first point of entry determinations can commence at the same time that the Biosecurity Regulations 2026 commence.

 

Item [7] – At the end of section 59

 

Section 229 of the Act provides that the Director of Biosecurity or the Director of Human Biosecurity may determine that a specified port in Australian territory is a first point of entry for vessels or goods that are subject to biosecurity control. Section 233 of the Act allows the Director who made the first point of entry determination to vary or revoke it, or vary the conditions specified in the determination in circumstances covered by paragraphs 233(a) to (d) of the Act, or where a circumstance prescribed by the regulations has occurred (paragraph 233(e) of the Act).

 

Section 59 of the Principal Regulation is made for the purposes of paragraph 233(e) of the Act and sets out additional circumstances in which the relevant Director may vary or revoke a determination made under subsection 229(1) of the Act in relation to a port, or vary the conditions specified in the determination.

 

Currently, none of the circumstances set out in paragraphs 233(a) to (d) of the Act or in section 59 of the Principal Regulation allow for a determination made under subsection 229(1) of the Act in relation to a port to be varied to make consequential amendments to references to legislation.

 

A number of first point of entry determinations in relation to ports are in effect and refer to the Biosecurity Regulation 2016, which is due to sunset on 1 October 2026.

 

The amendment inserts the following paragraph at the end of section 59:

 

(d) the Biosecurity Regulations 2026 have been registered.

 

This amendment has the effect of allowing a first point of entry determination in relation to a port to be varied when the Biosecurity Regulations 2026 have been registered. This will enable consequential amendments to be made, through a separate legislative instrument, to replace references to the Principal Regulation with references to the Biosecurity Regulations 2026. This amendment is required ahead of the making of the Biosecurity Regulations 2026 so that these consequential amendments to first point of entry determinations can commence at the same time that the Biosecurity Regulations 2026 commence.

 


ATTACHMENT B

Statement of Compatibility with Human Rights

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

 

Biosecurity Amendment (Australian Centre for Disease Control and Other Measures) Regulations 2026

 

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 Biosecurity Amendment (Australian Centre for Disease Control and Other Measures) Regulations 2026 (the Legislative Instrument) amends the Biosecurity Regulation 2016 (the Principal Regulation) to align the Principal Regulation with consequential amendments to the Biosecurity Act 2015 (the Act) made by the Australian Centre for Disease Control (Consequential Amendments and Transitional Provisions) Act 2025 (CDC C&T Act).

The Legislative Instrument replaces a reference to the Director of Human Biosecurity with a reference to the Director-General of the Australian Centre for Disease Control (CDC) in paragraph 30(1)(c) of the Principal Regulation (relating to a statement of human health risks associated with the goods or the class of goods of which a biosecurity import risk analysis is being conducted). This amendment aligns the Principal Regulation with amendments made to the Act by the CDC C&T Act to reflect that a statement prepared under subsection 169(5) of the Act is now prepared by the Director-General of the CDC instead of by the Director of Human Biosecurity.

The Legislative Instrument also adds references to the Director-General of the CDC, where relevant, in Chapter 8 of the Principal Regulation (relating to reviews conducted by the Inspector-General of Biosecurity). These amendments align the Principal Regulation with the broader amendments to the Act made by the CDC C&T Act that provide the Director-General of the CDC with powers and functions under the Act.

 

The Legislative Instrument also provides authority for first point of entry determinations to be varied when the Biosecurity Regulations 2026 have been registered.

 

The Legislative Instrument allows a first point of entry determination to be varied when the Biosecurity Regulations 2026 have been registered. This will enable consequential amendments to be made (if required), through a separate legislative instrument, to replace references in first point of entry determinations to the Biosecurity Regulation 2016 with references to the Biosecurity Regulations 2026 (if those regulations are made). This amendment is required ahead of the making of the Biosecurity Regulations 2026 so that any such consequential amendments to first point of entry determinations can commence at the same time as the Biosecurity Regulations 2026 commence (if those regulations are made).

 

Human rights implications

This Legislative Instrument does not engage any of the applicable rights or freedoms.

Conclusion

This Legislative Instrument is compatible with human rights as it does not raise any human rights issues.

 

The Hon. Julie Collins MP

Minister for Agriculture, Fisheries and Forestry

 

 

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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.