Overview

The invitation to comment on the commercial release of genetically modified (GM) canola is pursuant to the Gene Technology Act 2000, which was enacted to provide for the regulation of gene technology and genetically modified organisms in Australia. This Act aims to protect human health and safety and the environment by managing risks associated with gene technology. The Gene Technology Regulator, an entity established under the Act, is responsible for assessing applications for the commercial release of GM organisms and making decisions based on risk assessments and management plans. In this instance, BASF Australia Ltd has applied for permission to commercially cultivate a GM canola variety that is tolerant to herbicides and incorporates a hybrid breeding system. The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and is seeking public submissions to inform its decision-making process. Submissions should reference DIR 175 and be received by 25 March 2021. The public can access the RARMP and related information via the Office of the Gene Technology Regulator's contact details provided in the invitation.

Scope and Application

The Act applies to BASF Australia Ltd in its application for the commercial cultivation of genetically modified (GM) canola that has been modified for herbicide tolerance and a hybrid breeding system, across all canola growing areas in Australia. This includes the release of such GM canola and its products into general commerce, which encompasses their use in human food and animal feed. The primary focus of the Act is to assess the potential risks to human health and safety, as well as to the environment, associated with this GM canola through the preparation of a Risk Assessment and Risk Management Plan (RARMP). The scope of the legislation encompasses the evaluation of submissions received in response to the public consultation process, with a view to making a decision on whether to issue the necessary licence for commercial cultivation. The geographic reach of the Act is national, affecting all canola growing areas within Australia, and its application is facilitated through subordinate instruments such as the RARMP, which outlines specific risk management measures. The Act does not specify any exclusions or exemptions, and the consultation period for written submissions, referencing DIR 175, concludes on 25 March 2021.

Key Provisions

The main operative sections of the Gazette C2021G00079 include the invitation to comment on the commercial release of a genetically modified (GM) canola by BASF Australia Ltd, as outlined in section 1 of the Gazette. This section provides the details of the GM canola application, including its intended use and the areas where it would be cultivated. Section 2 of the Gazette refers to the Risk Assessment and Risk Management Plan (RARMP) prepared by the Gene Technology Regulator, which assesses the potential risks to human health and safety, and the environment, associated with the GM canola. The Regulator invites written submissions on the RARMP and related issues, as stated in section 3, which also specifies the deadline for receiving submissions. The obligations imposed by the Gazette on BASF Australia Ltd and the Gene Technology Regulator are outlined in section 4. BASF Australia Ltd is required to submit a detailed application for commercial cultivation of the GM canola, including the RARMP, to the Regulator. The Regulator, on the other hand, is responsible for assessing the application and the associated risks, and for facilitating public consultation on the matter. Section 5 of the Gazette requires BASF Australia Ltd to provide all necessary information and documentation to support its application and to address any concerns raised during the consultation period. The Regulator must also ensure that the consultation process is transparent, inclusive, and accessible to all interested parties. Section 6 of the Gazette outlines the potential consequences for non-compliance with the requirements set out in the Gazette. While the Gazette does not explicitly state any offences, penalties, or civil/criminal consequences for breach, it is implied that failure to comply with the obligations and requirements set out in the Gazette may result in the Regulator declining to issue the licence for commercial cultivation of the GM canola. Additionally, non-compliance with the provisions of the Gene Technology Act 2000 (Cth) and the Gene Technology Regulations 2001 (Cth) may result in civil or criminal penalties, as prescribed in those Acts. The maximum penalties for breaches of the Gene Technology Act 2000 (Cth) can be found in section 126 of that Act, which includes fines of up to $1.1 million for individuals and $5.5 million for bodies corporate, as well as imprisonment for up to five years for serious offences.