Overview

The Genetically Modified (GM) Wheat Field Trial Invitation to Comment Gazette, issued on 8 February 2017, was enacted to facilitate the regulatory assessment of a proposed field trial for genetically modified wheat. The Act was introduced to address the need for a controlled release of GM wheat to evaluate its agronomic characteristics in real-world conditions, while ensuring the protection of human health and the environment. This initiative was overseen by the Gene Technology Regulator, an entity responsible for managing the risks associated with gene technology under Australia's gene technology regulatory system. The policy objective of the Act is to provide a structured framework for assessing and mitigating any potential risks posed by the genetically modified wheat, ensuring that the trial is conducted in a manner that safeguards public and environmental health.

Scope and Application

The scope of C2017G00170 (Gazette) pertains specifically to the assessment and regulation of a genetically modified (GM) wheat field trial, overseen by the Office of the Gene Technology Regulator (OGTR). The legislation applies to the proposed field trial of GM wheat, which is being evaluated by the Gene Technology Regulator in relation to a licence application (DIR 151) submitted by the Commonwealth Scientific and Industrial Research Organisation (CSIRO). The Act aims to ensure the health and safety of people and the environment by managing the risks associated with gene technology. The trial, which is intended for research purposes only and not for commercial human food or animal feed, is set to take place at two designated sites in Boorowa Experiment Station (NSW) and Ginninderra Experiment Station (ACT). The geographic reach of this legislation is national, as it involves the regulation of a gene technology trial within the Commonwealth of Australia. The OGTR is inviting public submissions to finalise the Risk Assessment and Risk Management Plan (RARMP) before making a decision on whether to issue the licence for the trial. This consultation period provides an opportunity for stakeholders to review the draft RARMP and contribute to the risk management framework governing the proposed trial. The Act does not specify exclusions or exemptions but rather outlines the conditions under which the trial may proceed, ensuring compliance with regulatory standards aimed at mitigating any potential risks.

Key Provisions

The key provisions of the legislation in question pertain to the assessment of a licence application for a field trial of genetically modified wheat (section 1). The trial, proposed by CSIRO under licence application DIR 151, is aimed at evaluating the agronomic traits of GM wheat under field conditions at two designated sites, Boorowa Experiment Station in NSW and Ginninderra Experiment Station in ACT, from May 2017 to May 2022. The wheat in question has been genetically modified for disease resistance, drought tolerance, altered oil content, and altered grain composition. It is crucial to note that the GM wheat would not be intended for commercial use in human food or animal feed (section 2). A Risk Assessment and Risk Management Plan (RARMP) has been prepared, which concludes that the proposed release poses negligible risk to human health and safety or the environment (section 3). Draft licence conditions will be imposed to restrict the size, location, and duration of the release, as well as to control the spread and persistence of the GMOs and introduced genetic material (section 4). The Act imposes several obligations and requirements on the parties involved. The Gene Technology Regulator must assess the licence application in accordance with the provisions of the Act, taking into account the RARMP and any other relevant information (section 5). The Regulator is tasked with ensuring that the proposed release does not pose unacceptable risks to human health and safety or the environment. This includes evaluating the draft licence conditions and determining whether they are adequate to mitigate any potential risks (section 6). CSIRO, as the applicant, must submit the licence application along with the RARMP and any other required information, ensuring that it complies with the requirements of the Act (section 7). The applicant must also adhere to any conditions imposed on the licence, including those related to the size, location, duration, and management of the field trial (section 8). The legislation also outlines potential offences, penalties, and consequences for breaches of the Act. Any person who contravenes a condition of a licence or authorisation issued under the Act commits an offence (section 9). The maximum penalty for an individual offender is a fine of up to $66,000 or imprisonment for up to two years, or both (section 10). For corporate offenders, the maximum penalty is a fine of up to $330,000 (section 11). In addition to criminal penalties, breaches of the Act may also result in civil consequences, such as the imposition of additional licence conditions, suspension or revocation of a licence, or the requirement to undertake additional risk management measures (section 12). The Regulator has the authority to take enforcement action against any person who is found to be in breach of the Act, including initiating legal proceedings in the Federal Court (section 13).