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February 2017

Regulating gene technology in Australia

Making and working with genetically modified organisms (GMOs) in Australia is regulated through a nationally consistent legislative scheme, including the Commonwealth Gene Technology Act 2000 (the Act), the Gene Technology Regulations 2001 and corresponding state laws.

The intentional release of a GMO into the Australian environment must be licensed by the Gene Technology Regulator (the Regulator), and can only be licensed if risks can be managed to protect the health and safety of people and the environment.

The Australian regulatory scheme is science-based and uses robust risk analysis based on widely respected international standards. Before deciding to issue a licence, the Regulator conducts a comprehensive risk assessment—considering the latest available scientific information—and extensive public and expert consultation.

The Office of the Gene Technology Regulator (OGTR) also monitors scientific and other literature for any new information relevant to GM crops, and assesses that information in relation to existing licences.

Each state and territory can pass its own laws regarding trade and marketing of GMOs.

Approvals for commercial release of GM canola varieties

Since 2003, the Regulator has issued six licences for the general/commercial release of GM canola (see table 1). This means that the GM canola is allowed to be released into the environment in all canola-growing regions throughout Australia.

Table 1. Current GM canola licences for general/commercial releases
Licence number
Licence holder
Trade name
Modified trait/s
Issued
DIR 139Pioneer Hi-Bred Australia Pty LtdOptimum GLY canolaHerbicide tolerance29 Mar. 2016
DIR 138Bayer CropScience Pty LtdInVigor® x TruFlex Roundup Ready® canolaHerbicide tolerance; hybrid breeding system22 Mar. 2016
DIR 127Monsanto Australia LtdTruFlex Roundup Ready® canola (MON 88302) Herbicide tolerance21 Nov. 2014
DIR 108Bayer CropScience Pty Ltd InVigor® x Roundup Ready®canola Herbicide tolerance; hybrid breeding system2 Dec. 2011
DIR 021/ 2002Bayer CropScience Pty LtdInVigor® canolaHerbicide tolerance; hybrid breeding system25 Jul. 2003
DIR 020/ 2002Monsanto Australia LtdRoundup Ready® canolaHerbicide tolerance19 Dec. 2003

The Regulator concluded that each type of GM canola listed in the table above is as safe for human health and the environment as non-GM canola.

These decisions are based on a comprehensive risk assessment and risk management plan (RARMP) prepared for each application. You can access the RARMPs and details of the licences through the GMO Record on the OGTR website or by contacting the OGTR.

Other regulatory approvals regarding food and herbicides

The use of food derived from these GM canola varieties has been approved by Food Standards Australia New Zealand—you can access details about how GM foods are assessed and regulated from its website or by phone (02 6271 2222).

The use of herbicides on GM herbicide tolerant canola varieties is regulated by the Australian Pesticides and Veterinary Medicines Authority.

The Australian Pesticides and Veterinary Medicines Authority considers the issue of herbicide resistance management before registering these products, and applies registration conditions to minimise the potential of herbicide resistance developing and relating to using the herbicides responsibly.

The Regulator’s assessments remain current

The Office of the Gene Technology Regulator monitors scientific and other literature for any new information relevant to GM crops, and assesses that information in relation to existing licences. The Regulator has legal power to vary, suspend, cancel or transfer licences in order to be satisfied that risks are managed to protect the health and safety of people and the environment.

Monitoring and oversight of the GM canola releases

The Regulator monitors the progress of the commercial releases of GM canola. The Regulator has a post-release review framework that allows on-going oversight of general/commercial releases of GM crops in Australia.

This oversight may include:
  • licence conditions that require the licence holder to supply, or enable the Regulator to collect, specific information on the progress of the release
  • reviewing of RARMPs at an appropriate time after a licence is issued.
No information has arisen, either in Australia or internationally, to indicate that the commercial GM canola licences issued since 2003 should be varied, suspended, cancelled or transferred.

State and territory moratoria: better understanding of marketability, agricultural trade and segregation

After the Regulator approved GM canola commercial releases in 2003, all states and territories except Queensland and the Northern Territory passed laws to delay the commercial release of GM crops (including GM canola).

These moratoria allowed states and territories to further investigate issues of marketability, agricultural trade and segregation before the first commercial plantings of GM canola.

Since establishing these moratoria, some states and territories have reviewed and/or amended their GM crop laws:
  • Victoria allowed its moratorium order on commercial production of GM canola to lapse on 29 February 2008.
  • New South Wales amended its moratorium to provide for the case-by-case approval of commercial cultivation of GM food crops based on the relevant industry’s capacity to meet specified trade and marketing criteria. On 14 March 2008, the New South Wales Minister for Primary Industries, Energy, Mineral Resources and State Development approved GM canola in that state.
  • Western Australia (WA) repealed the Genetically Modified Crops Free Areas Act 2003 on 28 October 2016. This allows WA farmers to grow GM crops approved by the Regulator.
  • Tasmania extended its GM crop moratorium on 19 August 2014 until November 2019.
  • South Australia announced on 7 November 2013 that its moratorium on GM crops would be extended until at least September 2019.
  • Australian Capital Territory’s moratorium remains in force.
It is important to note that the moratoria do not relate to protection or safety of human health or the environment, and are a matter for state and territory governments, not the Regulator. You can get more information from the relevant state or territory government.

For more information

You can read, on the OGTR website, about: Or you can contact the Office of the Gene Technology Regulator by: