Overview

The Gene Technology Act 2000, enacted by the Parliament of Australia, was introduced to establish a regulatory framework for the use and release of genetically modified organisms (GMOs) in Australia, addressing the need to manage potential risks to human health and the environment. The Act mandates that any commercial release of GMOs, including genetically modified canola, must undergo a rigorous assessment process overseen by the Office of the Gene Technology Regulator (OGTR). The policy objective of the Act is to ensure that any potential risks associated with the commercial release of GMOs are identified and appropriately managed before approval is granted. The OGTR is currently assessing an application from BASF Australia Ltd for the commercial cultivation of genetically modified canola designed for herbicide tolerance and a hybrid breeding system across all canola growing areas in Australia. The GM canola and its products would be available for general commerce, including for human consumption and animal feed. The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and is inviting written submissions on issues relating to human health and safety and environmental protection before making a decision on whether to issue the licence. Submissions referencing DIR 178 must be received by 12 August 2021. Further information and the RARMP can be obtained from the OGTR via the contact details provided.

Scope and Application

The scope of C2021G00459 (Gazette) pertains to the assessment of an application for the commercial release of genetically modified (GM) canola by BASF Australia Ltd. This Act applies to the proposed commercial cultivation of GM canola in all canola growing areas of Australia, encompassing the GM canola lines and their products entering general commerce, including human food and animal feed. The Act is concerned with the implications for human health and safety as well as environmental considerations. The jurisdiction of this legislation falls under the Commonwealth, with the Gene Technology Regulator, as a regulatory body, being responsible for the evaluation of the application and the subsequent decision on whether to issue a licence. The Regulator invites submissions from interested parties on the Risk Assessment and Risk Management Plan (RARMP) prepared for this application, with a deadline of 12 August 2021. Submissions should reference DIR 178 and are intended to inform the Regulator's decision-making process. The Act does not specify exclusions, exemptions, or thresholds; however, it may be subject to modification through subordinate instruments issued by the Regulator.

Key Provisions

The primary sections of the legislation (C2021G00459) concern the assessment of an application by BASF Australia Ltd for the commercial cultivation of genetically modified (GM) canola (section 1). The GM canola in question is designed for herbicide tolerance and employs a hybrid breeding system. It is intended for use in all canola-growing areas of Australia, entering general commerce including human food and animal feed. The Gene Technology Regulator is responsible for evaluating the application, with a focus on the associated Risk Assessment and Risk Management Plan (RARMP) (section 2). The obligations and requirements imposed by the legislation involve a thorough evaluation of the potential risks to human health and safety, as well as the environment (section 3). BASF Australia Ltd must provide comprehensive data and studies supporting the safety and efficacy of the GM canola, which the Regulator will review. The public is also invited to submit written comments referencing DIR 178, focusing on any concerns about health, safety, or environmental impacts (section 4). The Regulator will consider these submissions as part of the decision-making process for issuing a licence. The legislation outlines potential consequences for non-compliance or breaches of its provisions (section 5). While the specific penalties are not detailed in the text, breaches of gene technology regulations can generally result in substantial civil and criminal penalties under Australian law. These may include fines, imprisonment, or other legal sanctions depending on the severity and nature of the breach. The Regulator's decision to issue or withhold a licence will be based on the assessment of the submitted RARMP and any public submissions received by the specified deadline (section 6).