Invitation to comment on a field trial of genetically modified wheat (DIR 204)

Overview

The Gene Technology Act 2000, enacted by the Parliament of Australia, was introduced to regulate the development, use, and release of genetically modified organisms (GMOs) in Australia, aiming to protect human health and the environment while fostering innovation. The Act established the framework for the assessment and approval of activities involving GMOs, including field trials and commercialisation, ensuring that any potential risks are identified and managed appropriately. The policy objective of the Act is to provide a balanced approach to the regulation of GMOs, encouraging responsible innovation while safeguarding public health and the environment. In this context, the Gene Technology Regulator is currently assessing an application from Trigall Australia Pty Ltd to conduct a field trial of genetically modified wheat designed for increased tolerance to environmental stress. This trial, if approved, would take place at 10 sites across New South Wales, Victoria, Western Australia, and South Australia, over a total area of 20 hectares per year for five years. Notably, the wheat produced in this trial would not be used for human food or animal feed. The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and is inviting written submissions from the public to ensure that all perspectives on human health and environmental protection are considered before a decision is made on whether to issue the licence. The consultation documents, including the RARMP, can be accessed via the Office of the Gene Technology Regulator's website, and submissions should be submitted by 16 July 2024, referencing DIR 204.

Scope and Application

The C2024G00309 Act pertains to the proposed field trial of genetically modified wheat (DIR 204) by Trigall Australia Pty Ltd, and applies to the conduct of the trial at specified sites in New South Wales, Victoria, Western Australia, and South Australia. The Act aims to regulate the environmental risks associated with the genetically modified wheat by assessing the proposed trial’s impact on human health and safety and the environment. The trial, which will cover a total area of 20 hectares per year over five years, is designed to test the wheat's tolerance to environmental stress, with no intention of using the wheat for human food or animal feed. The Gene Technology Regulator has developed a comprehensive Risk Assessment and Risk Management Plan (RARMP) for this application, which is available for public comment. This consultation process is integral to the decision-making framework of the Regulator, as it seeks to incorporate feedback on the potential risks and safeguards necessary for the trial. Interested parties are invited to submit written submissions by 16 July 2024, referencing DIR 204, to ensure their views are considered in the final decision on whether to grant the licence for the trial.

Key Provisions

The key provisions of the proposed field trial of genetically modified wheat (DIR 204) outlined in the legislation (section 1) include the assessment of an application by Trigall Australia Pty Ltd to conduct a field trial at 10 sites across New South Wales, Victoria, Western Australia, and South Australia. This trial aims to test wheat genetically modified for increased tolerance to environmental stress over a period of five years, with each site covering an area of 20 hectares annually (section 2). Importantly, the wheat produced in this trial will not be used for human food or animal feed (section 3). The obligations and requirements imposed by this legislation on Trigall Australia Pty Ltd and the Gene Technology Regulator are primarily centred around the preparation and assessment of a Risk Assessment and Risk Management Plan (RARMP) (section 4). The Regulator is tasked with evaluating the application and the accompanying RARMP, ensuring that all potential risks to human health and safety, as well as the environment, are thoroughly assessed and appropriately managed (section 5). Additionally, the Regulator is required to facilitate a public consultation period, inviting written submissions from interested parties to contribute to the decision-making process regarding the issuance of a licence for the field trial (section 6). The legislation also outlines potential consequences for non-compliance with the requirements set forth. While specific offences, penalties, or civil/criminal consequences are not detailed in the text, it is implied that failure to comply with the provisions of the Act, particularly in relation to the assessment and management of risks, could result in legal repercussions (section 7). The Regulator's authority to issue or withhold a licence for the field trial is contingent on the satisfactory completion of all obligations and the mitigation of identified risks, thereby ensuring the protection of human health and safety and the environment (section 8).