Invitation to comment on a genetically modified (GM) canola field trial

Overview

The Gene Technology Act 2000 was enacted to establish a regulatory framework for the control and oversight of genetically modified organisms in Australia. The Act was introduced to address the need for a comprehensive system to manage the risks associated with gene technology, particularly those that could potentially impact human health and the environment. The Act empowers the Gene Technology Regulator to assess applications for field trials and other activities involving genetically modified organisms, ensuring that these activities are conducted in a manner that minimises potential risks. The policy objective of the Act is to protect the health and safety of people and the environment by effectively identifying and managing risks posed by gene technology. The Office of the Gene Technology Regulator, under the Australian Government Department of Health, is responsible for implementing the Act. The Gene Technology Regulator is currently evaluating an application from Monsanto Australia Limited for a field trial of genetically modified canola, which is proposed to assess the agronomic performance of the genetically modified crop in various canola growing regions across Australia. The Regulator has prepared a Risk Assessment and Risk Management Plan, which concludes that the proposed trial would pose negligible risk to human health and safety or the environment. The Regulator is inviting public submissions to inform the finalisation of this plan and to assist in making a decision on whether to issue the licence for the field trial. Submissions are due by 22 October 2018, and the consultation documents are available on the Office of the Gene Technology Regulator's website.

Scope and Application

The legislation in question, C2018G00718, pertains to a field trial of genetically modified canola conducted by Monsanto Australia Limited, with the trial overseen by the Gene Technology Regulator. The Act applies to Monsanto Australia Limited as the applicant and to the proposed trial sites across multiple states in Australia, including New South Wales, Queensland, South Australia, Victoria, and Western Australia. The scope of the legislation is geographically extensive, covering all canola growing areas within these states, and is concerned with the assessment and management of risks associated with the genetically modified canola. The legislation does not specify any exclusions or exemptions from its purview but includes a consultation process for the Risk Assessment and Risk Management Plan (RARMP), inviting public submissions to inform the final decision on the licence issuance. The geographic reach of the Act is national, affecting multiple states, and it operates within the framework established by the gene technology regulatory system, which aims to safeguard human health and the environment. The application of the Act is further refined through draft licence conditions that will govern the specifics of the trial, including its size, location, duration, and measures to control the spread and persistence of the genetically modified organisms (GMOs).

Key Provisions

The main operative sections of the legislation (Gazette, 2018) pertain to the application and assessment process for a genetically modified (GM) canola field trial. Section 1 outlines the purpose of the trial, which is to evaluate the agronomic performance of GM canola across various canola-growing regions in Australia. The application, DIR 164 from Monsanto Australia Limited, seeks to conduct this trial within 140 potential local government areas in New South Wales, Queensland, South Australia, Victoria and Western Australia between 2020 and 2024. The trial aims to plant up to 15 sites in 2020, expanding to 20 sites by 2023, with a maximum combined area of 100 hectares. Importantly, the GM canola will not be used for human consumption or animal feed. The obligations and requirements imposed by the legislation on parties involved include the preparation and submission of a Risk Assessment and Risk Management Plan (RARMP). This plan, as indicated in Section 3, is crucial as it evaluates the potential risks to human health, safety and the environment. It must conclude that the proposed release poses negligible risk and outline draft licence conditions that will manage the size, location, duration, and genetic spread of the GMOs. The Office of the Gene Technology Regulator (OGTR) is responsible for assessing this RARMP and related documents to make an informed decision on whether to issue the licence for the trial. Additionally, the legislation mandates a consultation period (Section 4) during which written submissions are welcomed to finalise the RARMP. In terms of potential consequences for non-compliance, Section 6 outlines that any breaches of the terms and conditions specified in the licence or the RARMP may lead to serious legal ramifications. While the specific penalties are not detailed in the gazetted document, it is common under Australian gene technology legislation that penalties for violations could include fines and imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as the specific provisions of the applicable legislation. The overarching goal of these provisions is to ensure that any risks associated with the genetically modified canola field trial are adequately managed and mitigated.