Overview

The Gene Technology Act 2000, enacted by the Australian Parliament, is designed to regulate the use of gene technology within the country. This legislation aims to protect the health and safety of people and the environment by effectively managing the risks associated with gene technology. The Act establishes a regulatory framework overseen by the Office of the Gene Technology Regulator (OGTR), which is responsible for assessing applications and issuing licences for the use of genetically modified organisms (GMOs). The overarching policy objective of the Act is to ensure that gene technology activities are conducted in a manner that minimises potential risks to human health and the environment while promoting innovation and research. The Act provides a structured approach to the assessment and management of risks associated with gene technology, reflecting the need for a balanced approach that supports scientific advancement while safeguarding public and environmental interests.

Scope and Application

The Gene Technology Act 2000, administered by the Office of the Gene Technology Regulator (OGTR), applies to the proposed genetically modified (GM) buffalo grass field trial conducted by RMIT University in Victoria. This Act governs the regulation of gene technology in Australia with a view to protecting the health and safety of people and the environment. The legislation covers entities seeking to conduct gene technology activities, including research, field trials, and commercial cultivation of GM organisms. The geographic reach of this Act is national, as it is a Commonwealth Act. In this particular case, the Act applies to the specified trial of GM buffalo grass proposed to be conducted in Bundoora, Victoria, between April 2018 and April 2019. The application DIR 156 is subject to the provisions of the Act and any subordinate instruments that may extend or restrict its application. The trial is subject to a Risk Assessment and Risk Management Plan (RARMP) which, if approved, will inform the decision on whether to issue the licence. The Act provides for exclusions and exemptions, but these are not specified in the invitation for comment. The OGTR invites submissions to finalise the RARMP, with a closing date of 1 March 2018.

Key Provisions

The primary operative sections of the proposed legislation pertain to the field trial of genetically modified buffalo grass, which is subject to the assessment of the Gene Technology Regulator under section 49 of the Gene Technology Act 2000 (Cth). Section 49(1) mandates that the Regulator must determine whether to grant a licence for the trial based on the assessment of risks as outlined in a Risk Assessment and Risk Management Plan (RARMP). This plan, as described in section 49(2), is to be prepared by the applicant, in this case, RMIT University, and should include all relevant information regarding the potential risks and management strategies for the proposed trial. The specific parameters of the trial, including the location (Bundoora, Victoria), timeframe (April 2018 to April 2019), and area (maximum 200 m2), are outlined in the licence application DIR 156. The Act imposes several obligations on the parties involved in the proposed trial. Under section 51, the applicant must ensure that the trial adheres to the specified conditions outlined in the RARMP, which includes measures to prevent the spread and persistence of the genetically modified organisms (GMOs). Additionally, the applicant must submit all necessary documentation, including the RARMP, to the Regulator for review. The Regulator, under section 49(3), is responsible for assessing the application and the associated risks, making a determination on whether to issue the licence based on the information provided. Furthermore, under section 52, the Regulator may impose additional conditions on the licence if deemed necessary to manage any identified risks. In the event of a breach of the terms and conditions outlined in the Act or the licence, there are potential civil and criminal consequences. Under section 123, any person who contravenes a condition of a licence is liable to a civil penalty. The maximum penalty for an individual is 500 penalty units, while for a body corporate, the maximum penalty is 2,500 penalty units as stipulated in section 123(1). Additionally, under section 125, any person who intentionally or recklessly contravenes a provision of the Act that is punishable by imprisonment may be subject to criminal penalties. The maximum penalty for an individual is 2,000 penalty units or imprisonment for five years, or both, while for a body corporate, the maximum penalty is 10,000 penalty units or imprisonment for five years, or both. These penalties serve to enforce compliance with the regulatory requirements and to deter any non-compliance that could pose risks to human health and the environment.