Overview

The Gene Technology Act 2000, enacted by the Parliament of Australia, was introduced to address the need for a regulatory framework governing the use, handling, and release of genetically modified organisms in Australia. This Act establishes the legal basis for the regulation of genetically modified organisms, ensuring that potential risks to human health and the environment are managed effectively. The Office of the Gene Technology Regulator, established under this Act, is responsible for assessing applications and issuing licences for activities involving genetically modified organisms. The policy objective of the Act is to protect human health and the environment while facilitating the responsible development and use of gene technology. The Gene Technology Regulator, as part of its role under the Gene Technology Act 2000, is currently reviewing an application from The University of Queensland to conduct a field trial of genetically modified sorghum. The proposed trial aims to test an asexual seed formation trait in sorghum and is set to occur from September 2022 to June 2025 on the Gatton Campus in Queensland. The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application, which includes details of the proposed trial and the potential risks involved. The Regulator is seeking written submissions from the public regarding the protection of human health and safety and the environment before making a decision on whether to issue the licence. The public is encouraged to review the RARMP and related information, which can be found on the Office of the Gene Technology Regulator’s website, and submit their comments by 12 May 2022.

Scope and Application

The Gene Technology Act 2004, which governs the assessment and regulation of genetically modified organisms in Australia, applies to the field trial of genetically modified sorghum proposed by The University of Queensland. The Act applies to any person or entity, including research institutions, that intends to engage in activities involving genetically modified organisms. This includes the conduct of field trials, which must be licensed under the Act, and the entities responsible for the trials must comply with the regulatory requirements set out by the Office of the Gene Technology Regulator (OGTR). The Act has a national reach, applying to activities across the Commonwealth, states, and territories of Australia. However, the Act excludes certain activities from its scope, such as those involving organisms that are exempt under the regulations, including those that do not pose a risk to human health and the environment. The Act also provides for the OGTR to issue subordinate instruments that can extend or restrict the application of the Act in specific circumstances, such as the imposition of additional conditions on licences for field trials. Interested parties can make submissions on the proposed field trial by 12 May 2022, and the OGTR will consider these submissions in making a decision on whether to issue the licence. The Gene Technology Regulations 2005, which provide further detail on the application of the Gene Technology Act 2004, also apply to the proposed field trial of genetically modified sorghum. The Regulations set out the requirements for the assessment and approval of applications for licences to conduct field trials, including the preparation of a Risk Assessment and Risk Management Plan (RARMP) by the applicant. The Regulations also establish a public consultation process, which requires the OGTR to provide interested parties with an opportunity to make submissions on the proposed field trial. The Regulations provide for the OGTR to issue additional directions or conditions on licences for field trials, which can extend or restrict the application of the Act and Regulations in specific circumstances. The consultation RARMP and related information can be obtained via the OGTR website, and submissions should reference DIR 189 and be received by the specified deadline.

Key Provisions

The primary sections of the legislation, as referenced in DIR 189, pertain to the assessment and authorisation of the field trial of genetically modified sorghum. Specifically, section 35 of the Gene Technology Act 2000 (Cth) outlines the requirements for a licence to conduct such trials, while section 36 details the conditions that may be attached to the licence to ensure the protection of human health and safety and the environment. Additionally, section 42 addresses the public consultation process and the submission of written comments on the Risk Assessment and Risk Management Plan (RARMP) prepared by the Gene Technology Regulator. The obligations imposed by the Act on the parties involved, particularly The University of Queensland, include the preparation and submission of a comprehensive application to the Regulator, along with the RARMP. The application must detail the proposed trial site, duration, and the specific genetically modified trait being tested. Furthermore, the university must ensure that the trial adheres to any conditions specified in the licence, which may include measures to mitigate potential risks to human health and the environment. The Regulator, on the other hand, is tasked with evaluating the application, conducting a public consultation, and making a decision on whether to issue the licence. Should there be a breach of the conditions stipulated in the licence or any other provisions of the Gene Technology Act, the legislation provides for various consequences. Under section 68 of the Act, a person who contravenes a licence condition commits an offence and is liable to a fine of up to $22,200 for an individual and $111,000 for a body corporate. Moreover, under section 71, a person who causes harm to human health or the environment due to a breach may be subject to civil liability for damages. It is important to note that these penalties are in addition to any other penalties that may apply under other relevant legislation. In summary, the legislation sets out a clear framework for the assessment, authorisation, and monitoring of field trials of genetically modified organisms. The obligations placed on the applicant and the Regulator are designed to ensure that any potential risks are thoroughly evaluated and managed. The penalties for non-compliance serve as a deterrent and underscore the importance of adhering to the conditions of the licence and the provisions of the Act.