Gene Technology (Inclusion on the GMO Register) Determination (No. 1) 2020

Administered by Department of Health, Disability and Ageing

Legislation au F2020L00919 In force Legislative Instrument

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EXPLANATORY STATEMENT

 

Gene Technology Act 2000

Gene Technology (Inclusion on the GMO Register) Determination (No. 1) 2020

Authority

Subsection 78(1) of the Gene Technology Act 2000 (the Act) provides authority for the Gene Technology Regulator (the Regulator) to determine that a dealing with a genetically modified organism (GMO) is included on the GMO Register.

 

The Act is mirrored or applied by laws of New South Wales, Victoria, Queensland, South Australia, Tasmania, the Australian Capital Territory and the Northern Territory (but not by laws of Western Australia). Subsection 78(1) of those mirror or applied laws similarly provide authority for the Regulator to determine that a dealing with a GMO is included on the GMO Register for the purposes of those laws.

Purpose

The purpose of the Gene Technology (Inclusion on the GMO Register) Determination (No. 1) 2020 (the Determination) is to specify that the dealings of import, transport, and dispose of, in relation to three altered colour carnations which are GMOs are included on the GMO Register. The dealings of import, transport, and dispose of include the possession, supply or use of the GMO for the purposes of, or in the course of, those dealings.

 

The effect of inclusion on the GMO Register is that any person will be authorised to conduct those dealings with the GMOs.

Background

In accordance with paragraph 78(1)(a) of the Act, and paragraph 78(1)(a) of the applied and mirror laws, the Regulator is satisfied that the specified dealings are authorised by a GMO licence. The specified dealings with these GMOs have been authorised under a GMO licence since October 2015.

In accordance with section 79 of the Act and section 79 of the applied and mirror laws, having regard to the matters referred to in subsections 79(2) and (3) of the Act and subsections 79(2) and (3) of the applied and mirror laws, the Regulator is satisfied that any risks posed by the dealings are minimal, and that it is not necessary for persons undertaking the dealings to hold, or be covered by, a GMO licence in order to protect the health and safety of people or to protect the environment.

The GMOs the subject of the Determination are carnations with altered colour marketed as Moonaqua™, Moonberry™ and Moonvelvet. These are imported as cut flowers for use within the floristry industry. 

The Act and the applied and mirror laws, within their respective areas of operation, prohibit dealings with GMOs unless the dealings are:

(a)  licensed by the Gene Technology Regulator;

(b)  exempt dealings;

(c)  notifiable low risk dealings;

(d)  included on the GMO Register; or

(e)  specified in an emergency dealing determination.

 

Consultation Undertaken Before the Instrument was Made

Consultation was undertaken for a 6-week period, commencing in February, which sought information on any adverse effects posed by the dealings. Consultation was conducted via electronic notification on the Office of the Gene Technology Regulator’s (OGTR) website, emailing the notification directly to recipients registered with the OGTR, publishing a notification in the Australian Government Gazette and in print media, and making a tweet on the Department of Health twitter site.

Included in those directly consulted were Australian government departments and agencies, state and territory government agencies, local government authorities across Australia and contacts in the cut flower industry.

Expert advice was sought from the Gene Technology Technical Advisory Committee.

All submissions and advice received were considered in the context of currently available scientific evidence.

The Instrument is not subject to disallowance

As the Act facilitates the establishment or operation of an intergovernmental gene technology regulation scheme and provides for the making of a GMO Register Determination as part of the scheme, subsection 44(1) of the Legislation Act 2003 (Legislation Act) operates to exempt a GMO Register Determination from disallowance under section 42 of the Legislation Act.

Commencement

This Determination commences the day after registration on the Federal Register of Legislation.

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


ATTACHMENT

 

 

Details of the Gene Technology (Inclusion on the GMO Register) Determination (No. 1) 2020

 

1 Name

Section 1 states that the name of the Determination is the Gene Technology (Inclusion on the GMO Register) Determination (No. 1) 2020.

 

2 Commencement

Section 2 states that the Determination commences on the day after the instrument is registered.

 

3 Authority

Section 3 provides that the authority for the Determination is:

(a) subsection 78(1) of the Act; and

(b) that provision as applied by:

(i) the Gene Technology (New South Wales) Act 2003 (NSW); and

(ii) the Gene Technology (Queensland) Act 2016 (Qld); and

(iii) the Gene Technology Act 2012 (Tas.); and

(iv) the Gene Technology (Northern Territory) Act 2004 (NT); and

(c) that provision as mirrored by:

(i) the Gene Technology Act 2001 (Vic.); and

(ii) the Gene Technology Act 2001 (SA); and

(iii) the Gene Technology Act 2003 (ACT).

 

By making the Determination under all of these provisions, the intention is to ensure that the dealing is included in the GMO Register under all applied and mirror laws.

 

4 Definitions

Section 4 notes that a number of expressions used in the Determination are defined in section 10 of the relevant Act referred to in section 3 of the Determination, and provides definitions for ‘registered and ‘OECD unique identifier’.

 

5 Inclusion in the GMO Register

Section 5 specifies that the dealings of import, transport and dispose of, in relation to the GMOs identified by each of their OECD unique identifiers, are included on the GMO Register. The dealings of import, transport, and dispose of include the possession, supply or use of the GMO for the purposes of, or in the course of, those dealings.

Overview

The Gene Technology (Inclusion on the GMO Register) Determination (No. 1) 2020 is an instrument introduced under the authority of the Gene Technology Act 2000, enacted to address the regulation of genetically modified organisms (GMOs) within Australia. This Determination was enacted by the Gene Technology Regulator, pursuant to subsection 78(1) of the Gene Technology Act 2000, with the explicit aim of including specific dealings related to three genetically modified coloured carnations on the GMO Register. The carnations, marketed as Moonaqua™, Moonberry™, and Moonvelvet™, are imported as cut flowers for use in the floristry industry. The Regulator's decision to include these dealings on the GMO Register is based on the assessment that any risks associated with these activities are minimal and do not necessitate a GMO licence for the protection of health, safety, or the environment. The purpose of this Determination is to ensure that any person can legally import, transport, and dispose of these carnations, encompassing their possession, supply, or use in the course of these activities. This legal framework aims to streamline and standardise the regulatory processes across the states and territories of Australia, ensuring a cohesive approach to GMO regulation. The Regulator's decision to include these dealings on the GMO Register is informed by consultation with various stakeholders, including government agencies and industry representatives, and aligns with the overarching policy objectives of the Gene Technology Act 2000 to manage risks associated with GMOs effectively.

Scope and Application

The Gene Technology (Inclusion on the GMO Register) Determination (No. 1) 2020 applies to the dealings with genetically modified organisms (GMOs) in Australia, specifically concerning the import, transport, and disposal of three altered colour carnations identified as GMOs. These dealings also encompass the possession, supply, or use of these GMOs for the purposes of, or in the course of, these activities. The determination is made under the authority provided by the Gene Technology Act 2000, and it is mirrored or applied by the relevant gene technology laws of New South Wales, Victoria, Queensland, South Australia, Tasmania, the Australian Capital Territory, and the Northern Territory. The purpose of this determination is to specify that the mentioned dealings with these GMOs are included on the GMO Register, thereby authorising any person to conduct these dealings without the need for a GMO licence, provided that the risks are minimal and do not pose a threat to health or the environment. The GMOs in question are carnations with altered colours marketed as Moonaqua™, Moonberry™, and Moonvelvet™, which are imported as cut flowers for use in the floristry industry.

Key Provisions

The main operative sections of the Gene Technology (Inclusion on the GMO Register) Determination (No. 1) 2020 pertain to the inclusion of specific dealings with genetically modified organisms (GMOs) on the GMO Register. Section 5 of the Determination specifies that the dealings of import, transport, and disposal of the three altered colour carnations identified by their OECD unique identifiers (Moonaqua™, Moonberry™, and Moonvelvet™) are included on the GMO Register. This inclusion also encompasses the possession, supply, or use of the GMOs for the purposes of or in the course of these dealings (Section 5). The authority for this inclusion is derived from subsection 78(1) of the Gene Technology Act 2000 and the corresponding provisions in the applied and mirror laws of various Australian jurisdictions (Section 3). The Act imposes certain obligations and requirements on the parties or entities it governs. Any dealings with GMOs must be authorised by a GMO licence unless they fall under the categories of exempt dealings, notifiable low risk dealings, dealings included on the GMO Register, or specified in an emergency dealing determination (Section 79 of the Act). The Regulator is mandated to assess whether the specified dealings with GMOs are authorised by a GMO licence and whether the risks posed by these dealings are minimal. If the Regulator determines that the risks are minimal, they may include the dealings on the GMO Register, thereby authorising any person to conduct these dealings without needing a GMO licence (Sections 78 and 79 of the Act). The Act also outlines the consequences for breaches of its provisions. While specific penalties are not detailed within the Determination, the Act generally provides for both civil and criminal penalties for unauthorised dealings with GMOs. Civil penalties may include fines up to a substantial amount, while criminal penalties can result in imprisonment. The exact penalties are governed by the provisions of the Gene Technology Act 2000 and the respective mirror or applied laws in the different jurisdictions. The Determination itself is exempt from disallowance under subsection 44(1) of the Legislation Act 2003, ensuring its validity and enforceability (Subsection 44(1) of the Legislation Act).

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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.