Overview

The Gene Technology Act 2000, enacted by the Australian Parliament, establishes the framework for regulating gene technology activities in Australia, with the primary objective of safeguarding human health and the environment by identifying and managing risks associated with gene technology. The Act introduced a critical gap by providing a comprehensive regulatory system to ensure the safe and responsible development and application of genetically modified organisms (GMOs). The Office of the Gene Technology Regulator (OGTR) is the body responsible for assessing and regulating activities involving GMOs under this Act. The policy objective is to allow for the safe application of gene technology while protecting public health and the environment. In February 2016, the OGTR issued an invitation to comment on a proposed field trial of genetically modified wheat, specifically engineered to improve nitrogen and water use efficiency. This trial, which is not intended for human food or animal feed, aims to evaluate the agronomic performance of the GM wheat lines under field conditions. The trial, proposed to occur at a single site in Horsham, Victoria, between May 2016 and May 2018, involves a maximum planting area of 3 hectares per year. The OGTR, through the consultation process, seeks to finalise the Risk Assessment and Risk Management Plan (RARMP), which concludes that the proposed release poses negligible risk to human health and the environment, and will use the feedback to inform its decision on whether to issue the licence.

Scope and Application

The Gene Technology Act 2000, which governs genetically modified (GM) organisms in Australia, applies to the proposed field trial of GM wheat in Horsham, Victoria. This Act, administered by the Gene Technology Regulator, seeks to safeguard human health and environmental integrity by regulating gene technology. The specific application under review, DIR 142, is submitted by the Victorian Department of Economic Development, Jobs, Transport and Resources, targeting the field trial of wheat genetically modified for better nitrogen and water use efficiency. This trial, which does not involve the GM wheat in human food or animal feed, will span from May 2016 to May 2018 within a limited area of up to 3 hectares annually. The Act's jurisdiction extends nationally, with the trial confined to Victoria, and its regulatory framework includes a Risk Assessment and Risk Management Plan (RARMP) to evaluate and mitigate potential risks. The Regulator solicits public submissions to refine the RARMP before deciding on the licence issuance. The application process and related documents are accessible via the Office of the Gene Technology Regulator’s website or through direct contact with the office.

Key Provisions

The primary operative sections of the legislation revolve around the assessment and regulation of the proposed GM wheat field trial. Section 16 of the legislation outlines the process for the Gene Technology Regulator to assess the licence application, while Section 17 mandates the preparation of a Risk Assessment and Risk Management Plan (RARMP) to evaluate the potential risks to human health, safety, and the environment. Section 18 details the specific licence conditions that may be imposed to manage the risks associated with the trial, including restrictions on the size, location, and duration of the release. The Act imposes several obligations on the parties involved. For the applicant, the Victorian Department of Economic Development, Jobs, Transport and Resources, the primary obligation is to submit a detailed licence application, including the RARMP, and to ensure compliance with any licence conditions imposed by the Regulator. The Regulator, on the other hand, must conduct a thorough risk assessment, engage in public consultation, and make a decision on whether to issue the licence based on the information provided. Public entities and individuals also have the obligation to submit written submissions on the RARMP to assist in the Regulator's decision-making process. In terms of consequences for breach, the legislation does not explicitly detail specific offences, penalties, or consequences for non-compliance with the provisions. However, it is implied that failure to comply with the imposed licence conditions could result in legal actions, such as revocation of the licence, fines, or other penalties as prescribed under the broader Gene Technology Act 2000. The Regulator retains the authority to enforce compliance through these means to ensure the protection of health and safety, as well as the environment, in accordance with the objectives of the legislation.