REPLACEMENT EXPLANATORY STATEMENT
Gene Technology Act 2000
Gene Technology (Inclusion on the GMO Register) Determination (No. 1) 2024
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) 2024 (the Determination) is to specify that all dealings (as defined in section 10 of the Act) with MON-ØØØ73-7 canola (Brassica napus L.) are included on the GMO Register.
The effect of inclusion on the GMO Register is that any person will be authorised to conduct dealings with the GMO.
Background
The GMO subject of the Determination is MON-ØØØ73-7 canola (Brassica napus L.). It is an agricultural crop cultivated under licence DIR 020/2002 and authorised for commercial cultivation, or for import, processing and use as human food and animal feed, in many other countries for over two decades.
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 this GMO have been authorised under a GMO licence since 2003.
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 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 an 8-week period closing on 31 March 2022, 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, and publishing a notification in the Australian Government Gazette and in print media.
Included in those directly consulted were Australian government departments and agencies, state and territory government agencies and local government authorities across Australia.
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.
The Instrument is not subject to sunsetting
Part 4, ‘[s]unsetting of legislative instruments’, of the Legislation Act provides that legislative instruments are automatically repealed after a fixed period of time (subject to some exceptions). Within that Part, paragraph 54(2)(b) provides that Part 4 does not apply in relation to a legislative instrument if it is prescribed by regulation for the purposes of this paragraph.
Section 12 of the Legislation (Exemptions and Other Matters) Regulation 2015, made under the Legislation Act, states that for paragraph 54(2)(b) of the Legislation Act, sunsetting of legislative instruments does not apply to a legislative instrument referred to in the following table. Item 31A of that table provides an instrument made under the Gene Technology Act 2000 (the Act).
The Instrument is a legislative instrument and is made under the Act and is exempt from sunsetting under section 12 of the Legislation (Exemptions and Other Matters) Regulation 2015.
The Instrument is exempted from sunsetting for the following reasons:
- the rule-maker has been given a statutory role independent of the Government;
The Gene Technology Regulator is a statutory appointee under the Act given independence from Government, and discretion in the exercise of their powers, under section 30 of the Act.
- the instrument is designed to be enduring and not subject to regular review;
The effect of the instrument is to provide enduring authorisation for any person to conduct dealings with the GMO. It is not subject to regular review for this reason, however it may be revoked or varied by the Regulator by a future instrument at any time.
- commercial certainty would be undermined by sunsetting;
After commencement the instrument is relied upon by industry to avoid committing the offence of ‘[p]erson not to deal with a GMO without a licence’ under section 32 or 33 of the Act. Sunsetting would create uncertainty with regulatory compliance, with the potential of adversely affecting large scale commercial agriculture.
- the instrument is part of an intergovernmental scheme.
The instrument is made under eight Commonwealth, state and territory Acts, effected through the intergovernmental National Gene Technology Scheme. The Scheme is underpinned by the Gene Technology Agreement 2001, an agreement between all Australian governments that supports a nationally consistent regulatory system for gene technology. Sunsetting of instruments made under the Gene Technology Act could give rise to uncertainty and inconsistencies within the Scheme.
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) 2024
1 Name
Section 1 states that the name of the Determination is the Gene Technology (Inclusion on the GMO Register) Determination (No. 1) 2024.
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 (Tasmania) 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 all dealings (as defined in section 10 of the Act) in relation to the GMO, identified by its OECD unique identifier, are included on the GMO Register. The dealings include the possession, supply or use of the GMO for the purposes of, or in the course of, those dealings.