Overview

The Gene Technology Act 2000, enacted by the Australian Parliament, establishes a regulatory framework to manage the risks associated with gene technology. This Act was introduced to address the need for a structured approach to regulate genetically modified organisms (GMOs) and their potential impacts on human health and the environment. The Act empowers the Gene Technology Regulator to assess and licence activities involving GMOs, ensuring that potential risks are identified and managed appropriately. The policy objective of the Act is to safeguard public health and the environment while fostering innovation and development in the field of gene technology. The Office of the Gene Technology Regulator (OGTR) is responsible for implementing the Act, and it facilitates public consultation and risk assessment to inform decision-making on genetically modified field trials, such as the proposed trial of genetically modified safflower.

Scope and Application

The proposed genetically modified safflower field trial, subject to Licence Application DIR 121, falls under the purview of Australia’s gene technology regulatory system, which is overseen by the Gene Technology Regulator. This system is tasked with the responsibility of ensuring the health and safety of people and the environment by identifying and managing risks associated with gene technology. The trial, led by the Commonwealth Scientific and Industrial Research Organisation, aims to assess the agronomic performance of genetically modified safflower with an altered oil profile under field conditions. The trial is slated to take place over three growing seasons, starting from September 2013 to March 2016, in specific locations within the ACT, Wagga Wagga in NSW, and Narrabri in NSW, with a maximum area of 1 hectare per season per location. The genetically modified safflower is not intended for human food or animal feed. The application of the Gene Technology Act to this trial encompasses the assessment and management of risks to human health and the environment, with the Regulator welcoming submissions to finalise the Risk Assessment and Risk Management Plan, which will underpin the decision on whether to issue the licence.

Key Provisions

The main operative sections of the legislation (Gazette C2013G00731) concern the assessment and potential licensing of a genetically modified safflower field trial, as outlined in Licence Application DIR 121 by the Commonwealth Scientific and Industrial Research Organisation. Section 1 provides an overview of the proposed trial, detailing the intended locations, the number of genetically modified safflower lines, and the duration of the trial. Section 2 mentions the preparation of a Risk Assessment and Risk Management Plan (RARMP), which concludes that the proposed release would pose negligible risk to human health and safety or to the environment. Section 3 describes the range of draft licence conditions that would limit the size, locations and duration of the release, as well as restrict the spread and persistence of the genetically modified organisms (GMOs) and the introduced genetic material. The obligations and requirements imposed by the Act on the parties involved primarily centre around the preparation and submission of a comprehensive RARMP, which should conclude on the negligible risk of the proposed genetically modified safflower release to human health and safety and the environment. The Regulator is also tasked with reviewing the RARMP and any written submissions, and making a decision on whether or not to issue the licence. The Act also mandates that the proposed trial should only take place in specified locations and for a limited period, with strict conditions on the size and spread of the trial, as well as restrictions on the use of the genetically modified safflower in human food or animal feed. The legislation provides for various civil and criminal consequences for breach of its provisions, although the specific offences, penalties, or consequences are not detailed in the text. The maximum penalties for breaches of the Gene Technology Act 2000 are generally determined by the severity of the offence, and can range from fines to imprisonment. For example, an individual who knowingly contravenes a direction given under the Act could face a fine of up to $1.2 million, or imprisonment for up to five years, or both. Similarly, an individual who knowingly causes a breach of a licence condition could face a fine of up to $1.2 million, or imprisonment for up to two years, or both. It is important to note, however, that the specific penalties for breaches of the Act are not outlined in the text of the Gazette, and would need to be referred to in the full Act or relevant case law.