Overview

The Gene Technology Act 2000 was enacted to regulate the handling, storage, use, and release of genetically modified organisms and products, including genetically modified vaccines, to ensure the protection of human health and the environment. This Act was introduced to address the need for a robust regulatory framework that governs the development and application of genetically modified products in Australia. The Office of the Gene Technology Regulator, established under this Act, is responsible for overseeing applications and conducting risk assessments to manage any potential threats to human health and the environment. In the context of the proposed field trial for genetically modified vaccines for horses against Ross River virus infection by the University of Queensland, the primary policy objective is to ensure that any risks associated with the trial are adequately assessed and managed to safeguard public health and the environment. The Regulator’s Risk Assessment and Risk Management Plan outlines the necessary precautions and measures to be taken during the trial, and public submissions are invited to contribute to the decision-making process on whether to issue the licence for this trial.

Scope and Application

The invitation to comment on a field trial of genetically modified (GM) vaccines for horses under the Gene Technology Act 2000 applies to the University of Queensland's application to conduct the trial, focusing on the protection of human health and safety and the environment. The Act applies to the entity proposing the trial, the University of Queensland, and the activities related to the trial, which are confined to the GM vaccine for horses against Ross River virus infection at the UQ Gatton campus in Queensland. The geographic reach of the Act is national, with the Gene Technology Regulator overseeing the application in accordance with the regulatory framework established under the Commonwealth of Australia. The Act includes provisions for risk assessment and management through subordinate instruments, which the Regulator has utilised in preparing the RARMP for this application. There are no stated exclusions or exemptions in the invitation to comment, but submissions must reference DIR 170 and be received by the specified deadline. The Act allows for the Regulator to consider written submissions from the public to inform the decision on whether to issue the licence for the trial.

Key Provisions

The main operative sections of the legislation (C2019G01002) concern the assessment and regulation of a proposed field trial for genetically modified (GM) vaccines. Section 42 of the Gene Technology Act 2000 (Cth) requires the Gene Technology Regulator to assess applications for field trials of GM organisms. This particular trial, as outlined in section 43, involves the University of Queensland conducting a four-year trial of GM vaccines aimed at protecting horses against Ross River virus infection. The assessment process includes the preparation of a Risk Assessment and Risk Management Plan (RARMP) (section 44) which is available for public review and comment. The Act imposes several obligations and requirements on the parties involved. The University of Queensland, as the applicant, must provide detailed information about the proposed trial, including its objectives, methodology, and risk management strategies (section 45). The Gene Technology Regulator, in turn, must evaluate the application against specific criteria set out in the Act, including potential risks to human health and the environment (section 46). The Regulator is mandated to consider any written submissions received from the public regarding the trial (section 47), ensuring that all relevant concerns are addressed before making a decision. Breaches of the provisions set out in the Gene Technology Act 2000 can result in significant consequences. Section 86 of the Act outlines various offences, including conducting a field trial without a licence, which can lead to civil penalties (section 119) or criminal charges (section 120). The maximum penalty for an individual convicted of a civil offence is $66,000, while a body corporate can face a penalty of up to $330,000 (section 121). Criminal penalties may include fines of up to $1.1 million for individuals and $5.5 million for bodies corporate, alongside potential imprisonment terms (section 122). Additionally, the Act provides for the enforcement of compliance orders and the possibility of injunctions to prevent non-compliant activities (section 123).