Overview

The Gene Technology Act 2000 was enacted to regulate the use of genetically modified organisms (GMOs) in Australia, addressing the need for a comprehensive system to safeguard public health and the environment. The Act established the Office of the Gene Technology Regulator (OGTR) to oversee the licensing of GMOs and manage associated risks. The primary policy objective of the Act is to ensure that any risks posed by GMOs are identified and appropriately managed, thereby protecting both human health and the environment. This legislation was introduced to address gaps in the regulation of GMOs, ensuring a systematic approach to risk assessment and management. The OGTR, as the enacting body, is currently assessing a licence application for a field trial of genetically modified wheat designed to resist rust disease. This trial aims to evaluate the agronomic traits of the GM wheat under field conditions, with no intended use in food or feed. The application is accompanied by a Risk Assessment and Risk Management Plan (RARMP), which concludes that the trial poses negligible risk. The Regulator is inviting public submissions to refine the RARMP, which will inform the final decision on whether to issue the licence for the trial. This process ensures transparency and public participation in the regulation of gene technology in Australia.

Scope and Application

The gazetted notice C2018G00310 pertains to a field trial application for a genetically modified wheat variety proposed by the Commonwealth Scientific and Industrial Research Organisation (CSIRO). This trial, aimed at evaluating the agronomic traits of genetically modified wheat with enhanced resistance to rust disease under real-world conditions, is subject to Australia's gene technology regulatory system which seeks to safeguard human health and environmental integrity by identifying and mitigating risks associated with gene technology. The application, DIR 162, seeks to conduct the trial in the Australian Capital Territory and the Hilltops Council area in New South Wales over a span of five growing seasons, with a maximum planting area of 40 square meters per season. Importantly, the GM wheat intended for the trial is not intended for human consumption or animal feed, and a consultation Risk Assessment and Risk Management Plan has been formulated, indicating negligible risk to human health, safety, or the environment. The Gene Technology Regulator has invited public submissions to refine the Risk Assessment and Risk Management Plan, which will ultimately influence the decision on whether to grant the licence. The geographic and jurisdictional reach of this application is limited to the specified areas in the ACT and NSW, and the application is subject to the conditions set forth in the gazetted notice.

Key Provisions

The main operative sections of the legislation (Gazette C2018G00310) pertain to the field trial of genetically modified (GM) wheat proposed by CSIRO, with application DIR 162 (section 1). The field trial, which is to be conducted in the ACT and the Hilltops Council area in NSW over five growing seasons from September 2018 to September 2023, is intended to assess the agronomic characteristics of the GM wheat under field conditions (section 2). The total area for planting in each growing season would be up to 40 m², and the GM wheat will not be used for human food or animal feed (section 3). The Office of the Gene Technology Regulator (OGTR) has prepared a consultation Risk Assessment and Risk Management Plan (RARMP) that concludes the proposed release poses negligible risk to human health and safety or the environment (section 4). Draft licence conditions are proposed to limit the size, locations, and duration of the release, as well as restrict the spread and persistence of the GMOs and introduced genetic material (section 5). The Act imposes several obligations and requirements on the parties involved, including CSIRO as the applicant and the OGTR as the Regulator. CSIRO must adhere to the proposed draft licence conditions that limit the trial’s size, locations, and duration, as well as restrict the spread and persistence of the GMOs and introduced genetic material (section 6). The OGTR is responsible for assessing the licence application and finalising the RARMP based on written submissions from the public (section 7). The OGTR must also ensure that all measures are in place to protect human health and safety and the environment during the field trial (section 8). The public is invited to submit written comments and feedback to aid in finalising the RARMP and inform the decision on whether or not to issue the licence (section 9). Breaches of the Act or failure to comply with the imposed obligations and requirements can result in various civil or criminal consequences, including potential offences and penalties. The specific penalties for breaches are not detailed in the Gazette, but generally, the Act provides for enforcement actions, including fines and imprisonment, depending on the severity and nature of the breach (section 10). It is essential for all parties involved to adhere strictly to the requirements set forth in the Act to avoid any potential legal consequences (section 11). The OGTR may take enforcement actions against any party found to be in breach of the Act, ensuring compliance with the regulatory framework designed to protect human health, safety, and the environment (section 12).