Overview

The Gene Technology Act 2000 was enacted by the Parliament of Australia to establish a regulatory framework governing the use, handling, and release of genetically modified organisms (GMOs) within Australia. This legislation was introduced to address the need for a structured approach to managing the potential risks associated with gene technology, ensuring the protection of human health and the environment. The Office of the Gene Technology Regulator (OGTR), an agency established under the Act, is responsible for assessing applications and issuing licences for activities involving GMOs. The policy objective of the Act is to provide a balanced regulatory environment that encourages innovation in biotechnology while ensuring rigorous oversight and management of risks. In 2017, the OGTR invited public submissions on a proposed field trial for genetically modified perennial ryegrass under Licence Application DIR 160, submitted by the Department of Economic Development, Jobs, Transport and Resources in Victoria. The trial aimed to evaluate the agronomic traits of the GM ryegrass and to produce seed for subsequent trials. A Risk Assessment and Risk Management Plan (RARMP) was prepared, concluding that the trial posed negligible risk to human health and the environment. The OGTR sought public feedback to finalise the RARMP and inform the decision on whether to grant the licence. Submissions were due by 18 January 2018, and further information was available on the OGTR website or by contacting the office directly.

Scope and Application

The invitation to comment on the genetically modified (GM) perennial ryegrass field trial, as outlined in C2017G01321, applies to any person or entity interested in providing feedback on the proposed trial. The legislation concerns a field trial application for genetically modified perennial ryegrass, which is proposed for a limited and controlled release in south-west Victoria. This trial aims to evaluate the agronomic characteristics of GM perennial ryegrass under field conditions and to multiply seed for future trials, with a specific focus on fructan biosynthesis. The geographic reach of this legislation is national, as it pertains to a trial occurring within Australian territory, specifically in Victoria. However, the GM perennial ryegrass grown in the trial is not intended for use in human food or animal feed. The exclusions and exemptions from this Act are not explicitly stated in the text, though the Risk Assessment and Risk Management Plan (RARMP) prepared for the trial suggests that the proposed release poses negligible risk to human health and safety or to the environment. The application of this Act may be extended or restricted through subordinate instruments, such as the draft licence conditions that 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.

Key Provisions

The primary sections of the legislation, particularly Section 1, outline the invitation to comment on the proposed genetically modified (GM) perennial ryegrass field trial. This includes the purpose of the trial, which is to assess the agronomic characteristics of the GM perennial ryegrass under field conditions and to multiply seed for future trials. The field trial is proposed to take place between May 2018 and June 2020 near Hamilton in south-west Victoria, covering a maximum area of 160 square metres per year. It is important to note that the GM perennial ryegrass grown in this trial would not be used in human food or animal feed. The consultation document, the Risk Assessment and Risk Management Plan (RARMP), has been prepared and concludes that the proposed release would pose negligible risk to human health and safety or the environment. The obligations imposed by this legislation, as detailed in Section 2, require the Gene Technology Regulator to assess the licence application for the field trial, DIR 160, and to consider the comments received during the consultation period. The Regulator must also ensure that the proposed trial adheres to the draft licence conditions that will be set, which will 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. The Regulator is required to make a decision on whether to issue the licence based on the completed RARMP and the feedback received during the consultation period. Section 3 of the legislation outlines the potential consequences for breach of the conditions set forth in the legislation. While the specific penalties for breach are not mentioned in the text, it is implied that non-compliance with the conditions or failure to adhere to the risk management plan could result in legal action. This may include fines, imprisonment, or both, as is typical for breaches of environmental and health-related legislation in Australia. The exact penalties would be determined by the courts based on the severity and impact of the breach. Additionally, any failure to comply with the terms of the licence, if issued, could result in the revocation of the licence and further legal action against the applicant or the trial operator.