Overview

The Gene Technology Act 2000, enacted by the Parliament of Australia, addresses the regulation of genetically modified organisms, including the assessment and approval of applications for field trials. The Act was introduced to fill the gap in regulatory oversight for the safe and responsible development and use of genetic technology. The Office of the Gene Technology Regulator, as the enforcing body under the Act, is responsible for assessing applications and managing risks associated with genetically modified organisms to protect human health and the environment. In line with the policy objectives of the Act, the Regulator is currently inviting public submissions on a proposed field trial of genetically modified wheat and barley by The University of Adelaide. The trial, which is not intended for human food or animal feed purposes, aims to enhance yield and improve stress tolerance in the crops. The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and is seeking feedback on issues relating to human health and environmental protection before making a decision on whether to issue a licence for the trial.

Scope and Application

The Gene Technology Act 2000, as amended by the Gene Technology Amendment (Invitation to Comment on Genetically Modified Crops) Determination 2021, pertains to the application submitted by The University of Adelaide for a field trial of genetically modified wheat and barley. This legislation applies to the entities involved in the trial, including the University of Adelaide and the sites where the trial will be conducted in South Australia and Western Australia. The Act regulates the conduct of field trials of genetically modified organisms, ensuring that risks to human health and the environment are properly assessed and managed. The geographic reach of this legislation is national, with the Gene Technology Regulator, an agency within the Australian Government's Department of Health, overseeing compliance across state and territory boundaries. The Act includes provisions for the Regulator to prepare a Risk Assessment and Risk Management Plan (RARMP), which is an integral part of the application process. The RARMP considers the potential risks associated with the field trial and proposes measures to mitigate those risks. The exclusions and exemptions outlined in the Act typically pertain to the types of genetically modified organisms that are subject to regulation and the conditions under which trials can be conducted. The application of this Act may extend through subordinate instruments such as licences or approvals that the Regulator may issue, based on the assessment of the RARMP and any submissions received during the public consultation period.

Key Provisions

The main provisions of the Gazette C2021G00924 (paragraphs 2-3) invite written submissions on an application by The University of Adelaide to conduct a field trial of genetically modified wheat and barley. This application involves a Risk Assessment and Risk Management Plan (RARMP) which has been prepared by the Gene Technology Regulator. The public is encouraged to provide feedback on this RARMP with regard to human health and safety, and environmental protection, before the Regulator makes a decision on whether to issue a licence for the trial. Submissions must reference DIR 186 and be submitted by 14 January 2022. The obligations imposed on parties by this legislation are primarily concerned with the preparation and assessment of the RARMP. The Regulator must prepare a comprehensive RARMP that thoroughly assesses the potential risks of the proposed field trial to human health, safety, and the environment. The University of Adelaide, as the applicant, must provide all necessary information and data to facilitate the Regulator’s assessment. The public, upon receiving the RARMP, has the obligation to review the document and submit written submissions to the Regulator by the specified deadline, ensuring their feedback is referenced to DIR 186. The Gazette also outlines potential consequences for breaches of the legislative requirements. While the Gazette does not specify detailed offences or penalties, it implies that failure to comply with the submission guidelines or the obligations of the applicant and Regulator could result in non-approval of the field trial. This could have significant implications for the University of Adelaide’s research plans and for the Regulator’s oversight responsibilities. Furthermore, if the trial were to proceed without proper assessment and approval, it could potentially lead to legal repercussions under the Gene Technology Act 2000, which governs the use of genetically modified organisms in Australia. This could include civil penalties for non-compliance, although the exact penalties are not detailed in the Gazette.