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

Overview

The Gene Technology Act 2000 was enacted to regulate the use of genetically modified organisms and gene technology in Australia. It was introduced to address the need for a regulatory framework that ensures the safe use of genetically modified organisms while promoting innovation and research in the field of biotechnology. The Act was enacted by the Commonwealth Parliament with the policy objective of protecting the health and safety of people and the environment, while also facilitating the responsible use of gene technology. The Office of the Gene Technology Regulator is responsible for administering the Act and assessing applications for licences to conduct field trials of genetically modified organisms. Recently, the Regulator has issued a call for public comment on a proposed field trial of genetically modified wheat plants, which aims to gather research and regulatory data under field conditions. The Regulator has prepared a Risk Assessment and Risk Management Plan, which concludes that the proposed release would pose negligible risk to human health and safety or to the environment. The Regulator welcomes written submissions to finalise the Risk Assessment and Risk Management Plan, which will inform the decision on whether or not to issue the licence.

Scope and Application

The Office of the Gene Technology Regulator (OGTR) is seeking feedback on a proposed field trial of genetically modified (GM) wheat, governed by Australia's gene technology regulatory system. This system is intended to safeguard human health and the environment by assessing and managing risks associated with gene technology. The OGTR is currently evaluating a licence application (DIR 165) from the University of Melbourne for a limited and controlled release of wheat plants genetically modified to alter iron uptake, transport, and bioavailability. The field trial, which aims to collect research and regulatory data, is planned for up to 10 sites per year, covering a maximum of 20 hectares annually, spanning from April 2019 to December 2023. Potential locations for the trial sites include Victoria, New South Wales, Western Australia, and South Australia. It is important to note that the GM wheat from this trial will not be used for human food or animal feed. The consultation document, including a Risk Assessment and Risk Management Plan (RARMP), suggests that the proposed release presents negligible risks to human health, safety, or the environment. The draft licence conditions will delineate the size, locations, and duration of the release, as well as restrict the spread and persistence of the GMOs and introduced genetic material. The OGTR encourages written submissions to finalise the RARMP, which will subsequently inform the decision on whether to issue the licence. Submissions should be submitted by 13 March 2019, and the consultation RARMP and related documents are available on the OGTR website or by contacting the Office, quoting application DIR 165 in any correspondence.

Key Provisions

The main provisions of the proposed legislation as outlined in the Gazette C2019G00142 involve the assessment of a licence application (DIR 165) from the University of Melbourne for a field trial of genetically modified (GM) wheat plants. The field trial, which aims to gather research and regulatory data under field conditions, proposes to plant up to 10 sites per year, with a maximum combined area of 20 hectares per year, between April 2019 and December 2023 (sections not explicitly numbered in the text). The locations for the trial are proposed to be in Victoria, New South Wales, Western Australia, and South Australia. Importantly, the GM wheat from this trial would not be used for human food or animal feed. The obligations imposed on the parties by this legislation include the requirement for the Gene Technology Regulator to assess the proposed release and prepare a consultation Risk Assessment and Risk Management Plan (RARMP). This plan concludes that the proposed release would pose negligible risk to human health and safety or to the environment. The Regulator must also consider any written submissions received by 13 March 2019, to finalise the RARMP and inform the decision on whether to issue the licence (sections not explicitly numbered in the text). Additionally, the draft licence conditions would limit the size, locations, and duration of the release, as well as restrict the spread and persistence of the GMOs and the introduced genetic material. Failure to comply with the requirements of this legislation could result in various civil and criminal consequences. While the specific offences and penalties are not detailed in the text, it is known that breaches of gene technology regulations can lead to substantial penalties under Australian law. These penalties can include fines and imprisonment for individuals, as well as fines for corporations. The exact penalties would depend on the nature and severity of the breach, as well as any relevant case law and statutory provisions. It is essential for the parties involved to adhere to the conditions set out in the licence and the RARMP to avoid such consequences.