Gene Technology Amendment Act 2015

Administered by Department of Health, Disability and Ageing

Legislation au C2015A00121 In force Act

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No. 121, 2015

An Act to amend the Gene Technology Act 2000, and for related purposes

Contents

1 Short title

2 Commencement

3 Schedules

Schedule 1—Gene Technology Act 2000

Part 1—Reporting requirements

Gene Technology Act 2000

Part 2—Inadvertent dealings

Gene Technology Act 2000

Part 3—Public notification of risk assessment etc.

Gene Technology Act 2000

Part 4—GM products

Gene Technology Act 2000

Part 5—Restrictions on licence variations

Gene Technology Act 2000

Part 6—Technical amendments

Gene Technology Act 2000

Gene Technology Amendment Act 2015

No. 121, 2015

An Act to amend the Gene Technology Act 2000, and for related purposes

[Assented to 10 September 2015]

The Parliament of Australia enacts:

1 Short title

This Act may be cited as the Gene Technology Amendment Act 2015.

2 Commencement

(1) Each provision of this Act 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.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table	The day this Act receives the Royal Assent.	10 September 2015
2. Schedule 1	A single day to be fixed by Proclamation. However, if the provisions do not commence within the period of 6 months beginning on the day this Act receives the Royal Assent, they commence on the day after the end of that period.	10 March 2016

Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act.

(2) Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act.

3 Schedules

Legislation that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.

Schedule 1—Gene Technology Act 2000

Part 1—Reporting requirements

Gene Technology Act 2000

1 After subsection 136(1)

Insert:

(1A) The report must include information about the following:

(a) GMO licences issued during the financial year;

(b) any breaches of conditions of a GMO licence that have come to the Regulator’s attention during the financial year;

(d) any breaches of conditions of an emergency dealing determination that have come to the Regulator’s attention during the financial year;

(e) auditing and monitoring of dealings with GMOs under this Act by the Regulator or an inspector during the financial year.

Note: Auditing and monitoring may include spot checks.

2 Section 136A

Repeal the section.

3 Transitional provision

(1) If, when this item commences:

(a) the Regulator has given a report to the Minister under subsection 136A(1) of the old Act; and

(b) the Minister has not yet caused a copy of the report to be laid before each House of the Parliament in accordance with subsection 136A(3) of the old Act;

subsection 136A(3) of the old Act continues to have effect, in relation to the report, as if that subsection had not been repealed.

(2) In this item:

old Act means the Gene Technology Act 2000, as in force immediately before the commencement of this item.

Part 2—Inadvertent dealings

Gene Technology Act 2000

4 Paragraph 46A(a)

Repeal the paragraph, substitute:

(a) the dealings proposed to be authorised by the licence are limited to one or more of the following for purposes relating to disposing of a GMO:

(i) conducting experiments with the GMO;

(ii) propagating the GMO;

(iii) growing, raising or culturing the GMO;

(iv) transporting the GMO;

(v) any other dealings to be undertaken for the purposes of, or for purposes relating to, disposing of the GMO; and

5 Paragraph 49(a)

Repeal the paragraph, substitute:

(a) the dealings proposed to be authorised by the licence are limited to one or more of the following for purposes relating to disposing of a GMO:

(i) conducting experiments with the GMO;

(ii) propagating the GMO;

(iii) growing, raising or culturing the GMO;

(iv) transporting the GMO;

(v) any other dealings to be undertaken for the purposes of, or for purposes relating to, disposing of the GMO; and

6 Application

The amendments of the Gene Technology Act 2000 made by this Part apply in relation to:

(a) an inadvertent dealings application made on or after the commencement of this item; and

(b) an inadvertent dealings application made, but not decided, before that commencement.

Part 3—Public notification of risk assessment etc.

Gene Technology Act 2000

7 Paragraph 52(1)(b)

Repeal the paragraph, substitute:

(b) in one or more newspapers that the Regulator considers appropriate, having regard to the geographic area in which the dealings proposed to be authorised by the licence may occur; and

8 Paragraph 52(1)(c)

Omit “(if any)”.

Part 4—GM products

Gene Technology Act 2000

9 Section 10(1) (definition of Record)

Omit “and GM Product”.

10 Subsection 17(5)

Omit “and GM Product”.

11 Paragraph 17(6)(b)

Omit “and GM Product”.

12 Section 117 (paragraph relating to Division 6)

Omit “GMOs and GM products”, substitute “GMO dealings”.

13 Division 6 of Part 9 (heading)

Repeal the heading, substitute:

Division 6—Record of GMO Dealings

14 Section 138 (heading)

Repeal the heading, substitute:

138 Record of GMO Dealings

15 Subsection 138(1)

Omit “and GM Product”.

16 Subsection 138(2)

Omit “or GM products”.

17 Subsection 138(5)

Repeal the subsection.

18 Subsection 138(8)

Omit “(4), (5)”, substitute “(3A), (4)”.

19 Transitional provision

After this item commences, the Regulator may remove information from the Record of GMO Dealings if the information:

(a) was on the Record as at that commencement; and

(b) was included on the Record because the information involved GM products.

Part 5—Restrictions on licence variations

Gene Technology Act 2000

20 Subsection 71(2B)

Repeal the subsection, substitute:

(2B) If an application has been made for variation of a licence, the Regulator must not vary the licence unless the Regulator is satisfied that the risks posed by the dealings proposed to be authorised by the licence as varied are covered by:

(a) the risk assessment and the risk management plan in respect of the original application for the licence; or

(b) the risk assessment and the risk management plan in respect of an application for another licence, but only if that other licence was issued.

21 Application

The amendment of the Gene Technology Act 2000 made by this Part applies in relation to:

(a) an application for variation of a licence made on or after the commencement of this item; and

(b) an application for variation of a licence made, but not decided, before that commencement.

Part 6—Technical amendments

Gene Technology Act 2000

22 Paragraph 30(a)

Repeal the paragraph, substitute:

(a) whether a GMO licence is issued or refused in relation to a particular application; or

23 Subsection 74(3)

Repeal the subsection, substitute:

(3) Before the Governor‑General makes regulations declaring a dealing with a GMO to be a notifiable low risk dealing, the Regulator must consider:

(a) whether the dealing with the GMO would involve any risk to the health and safety of people, or to the environment, taking into account:

(i) the properties of the GMO as a pathogen or pest; and

(ii) the toxicity of any proteins produced by the GMO; and

(b) if there is such a risk—whether one or more of the requirements prescribed in the regulations for the purposes of subsection 75(2) would be sufficient to manage that risk; and

[Minister’s second reading speech made in—

House of Representatives on 18 June 2015

Senate on 20 August 2015]

(103/15)

Overview

The Gene Technology Amendment Act 2015 was enacted to address and refine the regulatory framework established by the Gene Technology Act 2000, primarily focusing on enhancing reporting requirements, clarifying inadvertent dealings with genetically modified organisms (GMOs), improving public notification processes, and making technical amendments to streamline the regulatory process. This Act was passed by the Parliament of Australia and received Royal Assent on 10 September 2015. The Act aims to ensure that the regulatory processes surrounding GMOs are transparent, effective, and adaptable to new scientific insights and public concerns. The various amendments introduced by this Act collectively seek to better manage the risks associated with GMOs while facilitating innovation in the field. The Gene Technology Amendment Act 2015 introduces several significant changes, including modifications to the reporting requirements to ensure more comprehensive and timely information is available to the Regulator and the public. It also refines the definition and scope of inadvertent dealings with GMOs, making it clearer what activities are permissible under such dealings. Additionally, the Act updates the public notification processes to ensure that relevant information about GMO dealings is disseminated effectively. The amendments also include technical changes aimed at improving the clarity and efficiency of the regulatory framework.

Scope and Application

The Gene Technology Amendment Act 2015 amends the Gene Technology Act 2000, which is a Commonwealth Act regulating the handling and use of genetically modified organisms (GMOs) in Australia. The amendments introduced by this Act primarily target reporting requirements, inadvertent dealings with GMOs, public notifications regarding risk assessments, and the management of GMO records, while also including technical amendments. This Act applies to any person or entity engaged in activities involving GMOs, including the issuing, variation, or revocation of licences for GMO dealings. The scope of the Act is national, applying across all states and territories of Australia. Notably, the Act does not specify any exclusions or exemptions; however, it does allow for the Regulator to remove certain information from the GMO record if it pertains specifically to genetically modified products, which were previously included under the former regime. The application of the Act is extended through subordinate instruments such as regulations and determinations, which may further define specific aspects of GMO dealings, such as the classification of low-risk dealings. The amendments generally apply to applications made on or after the commencement date of the Act, as well as to any pending applications at the time of commencement.

Key Provisions

The Gene Technology Amendment Act 2015 (C2015A00121) amends the Gene Technology Act 2000 (the "old Act") to update and refine the regulation of genetically modified organisms (GMOs) in Australia. The key changes introduced by the Amendment Act include modifications to reporting requirements, inadvertent dealings, public notification of risk assessments, and restrictions on licence variations. These changes aim to streamline the regulatory process while ensuring public safety and environmental protection. Under the new provisions, the annual report by the Regulator, as outlined in section 136 of the old Act, must now include specific details about GMO licences issued, breaches of GMO licence conditions, emergency dealing determinations, and breaches of conditions of such determinations, as well as auditing and monitoring activities related to GMO dealings (Schedule 1, Part 1). Additionally, section 136A of the old Act, which required the Minister to lay the Regulator's report before each House of the Parliament, has been repealed. However, if a report was already given to the Minister under the old Act but not yet laid before Parliament at the time of the Amendment Act's commencement, the old procedure continues to apply to that report (Schedule 1, Part 1, item 3). The Amendment Act also revises the criteria for inadvertent dealings under paragraphs 46A(a) and 49(a) of the old Act, limiting the scope to specific activities related to the disposal of GMOs (Schedule 1, Part 2). Furthermore, public notifications regarding risk assessments must now be published in newspapers deemed appropriate by the Regulator based on the geographic area where the dealings may occur (Schedule 1, Part 3, items 7 and 8). In terms of GM products, the Amendment Act removes references to GM products from the definitions and various sections of the old Act, effectively phasing out the distinction between GMOs and GM products in the regulatory framework (Schedule 1, Part 4). This includes omitting references to GM products from sections 10(1), 17(5), 17(6)(b), and 117, as well as repealing the headings of Division 6 of Part 9 and section 138 (Schedule 1, Part 4, items 9-19). The Amendment Act also modifies the restrictions on licence variations. It requires that any variation of a licence must ensure that the risks associated with the proposed dealings are covered by the original risk assessment and risk management plan or those of another issued licence (Schedule 1, Part 5, item 20). Lastly, the Regulator's consideration process before declaring a dealing with a GMO to be a notifiable low-risk dealing has been updated. The Regulator must now consider the potential risks to health and safety and the environment, including the properties of the GMO and the toxicity of any proteins it produces, and whether prescribed requirements would be sufficient to manage any identified risks (Schedule 1, Part 6, items 22 and 23). Failure to comply with the provisions of the Gene Technology Act 2000, as amended by the Gene Technology Amendment Act 2015, can result in civil or criminal penalties. The specific penalties depend on the nature and severity of the breach. For example, unauthorized dealings with GMOs can lead to substantial fines and potential imprisonment. The Act provides for maximum penalties, which can vary depending on the specific offence and the jurisdiction in which it is committed. For instance, serious offences may attract penalties of up to several thousand dollars in fines and imprisonment terms extending to several years.

Area of Law: Environmental Law
Instrument: Act
Concepts: Commencement Provisions; Reporting & Disclosure Obligations; Regulatory Standards

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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.

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