Overview

The Gene Technology Act 2000, enacted by the Parliament of Australia, establishes a regulatory framework to oversee the development and use of genetically modified organisms (GMOs) within the country. This legislation was introduced to address the need for a comprehensive system to manage the risks associated with gene technology, ensuring the protection of human health and the environment while facilitating the responsible advancement of biotechnology. The Act empowers the Office of the Gene Technology Regulator (OGTR) to assess and regulate activities involving GMOs, including the assessment of applications for the controlled release of genetically modified organisms into the environment. The policy objective underpinning the Act is to strike a balance between fostering innovation in biotechnology and ensuring that any potential risks to health and the environment are identified and managed effectively. The Act provides the regulatory mechanisms necessary to achieve this balance, including the requirement for a Risk Assessment and Risk Management Plan (RARMP) for applications involving the release of GMOs, such as the field trial of genetically modified wheat and barley proposed by the Commonwealth Scientific and Industrial Research Organisation (CSIRO).

Scope and Application

The Gene Technology Act 2000 governs the application and oversight of Licence Application DIR 117 from the Commonwealth Scientific and Industrial Research Organisation (CSIRO) for the limited and controlled release of genetically modified (GM) wheat and barley in Australia. The Act applies to the CSIRO as the applicant and to the proposed field trial of up to 138 lines of GM wheat and 40 lines of GM barley. The trial is intended to evaluate the agronomic performance and grain properties of the GM crops under field conditions, and is limited to a single site in the Shire of Narrabri, New South Wales, covering a maximum area of 1.53 hectares per year from May 2013 to April 2016. The Act aims to ensure that such trials are conducted in a manner that protects human health and safety and the environment, and the consultation on the Risk Assessment and Risk Management Plan (RARMP) is a key part of this process. Submissions on the RARMP are welcome to help finalise the plan and inform the decision on whether to issue the licence. The consultation documents are available online or by contacting the Office of the Gene Technology Regulator, with submissions due by 8 February 2013.

Key Provisions

The primary sections of the Gazette, C2013G00019, pertain to the Licence Application DIR 117, submitted by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) (section 1). The application seeks authorisation for the limited and controlled release of genetically modified (GM) wheat and barley under specific conditions (section 2). This application involves up to 138 lines of GM wheat, which have been genetically modified for altered grain composition or enhanced nutrient utilisation efficiency, and 40 lines of GM barley, also modified for enhanced nutrient utilisation efficiency (section 3). The purpose of the three-year field trial is to assess the agronomic performance and grain properties of these GM wheat and barley lines when grown under field conditions (section 4). The obligations imposed by the Act on the parties involved include the preparation and submission of a detailed Risk Assessment and Risk Management Plan (RARMP) (section 5). This RARMP must thoroughly evaluate the potential risks to human health and the environment, and propose measures to manage those risks effectively (section 6). The licence application must also include specific conditions that restrict the release of the GM wheat and barley to a defined area, location, and duration, and explicitly prohibit their use in human food or animal feed (section 7). The CSIRO must ensure compliance with these conditions throughout the trial period (section 8). Breach of the obligations or conditions outlined in the licence application may result in serious consequences. The Act stipulates that failure to adhere to the specified conditions or to implement the risk management measures can lead to legal action (section 9). Additionally, the Act sets forth potential civil and criminal penalties for non-compliance (section 10). While the specific penalties are not detailed in the Gazette, they typically include fines and potential imprisonment for serious breaches that endanger public health or the environment (section 11). The exact penalties would be determined based on the severity of the breach and the applicable provisions of the broader legislative framework governing gene technology in Australia (section 12).