9 December 2014
Invitation to comment on genetically modified (GM) wheat field trial
Australia’s gene technology regulatory system is designed to protect the health and safety of people and the environment by identifying risks posed by, or as a result of, gene technology and managing those risks.
The Gene Technology Regulator is currently assessing licence application DIR 130 from Murdoch University for a limited and controlled release of wheat that has been genetically modified for improved grain quality.
The primary purpose of the field trial is to assess whether the introduction and expression of two genes will increase the strength of dough. The trial is proposed to take place between May 2015 and December 2017 at one trial site in Western Australia. The maximum area for the trial is 0.06 hectares per year. The GM wheat would not be used in human food or animal feed.
A consultation Risk Assessment and Risk Management Plan (RARMP) has been prepared, which concludes that the proposed release would pose negligible risk to human health and safety or to the environment. A range of draft licence conditions would limit the size, location and duration of the release, as well as restrict the spread and persistence of the GMOs and the introduced genetic material.
The Regulator welcomes written submissions in order to finalise the RARMP, which will then form the basis of a decision on whether or not to issue the licence. The consultation RARMP and related documents can be obtained from the OGTR website under ‘What’s New’ or by contacting the Office. Please quote application DIR 130 in any correspondence.
Submissions should be received by close of business on 27 January 2015.
Office of the Gene Technology Regulator, MDP 54, GPO BOX 9848 CANBERRA ACT 2601
Telephone: 1800 181 030 Facsimile: 02 6271 4202 E-mail: ogtr@health.gov.au
Website: http://www.ogtr.gov.au
Overview
The Gene Technology Act 2000, enacted by the Australian Parliament, was introduced to establish a regulatory system designed to safeguard the health and safety of people and the environment by identifying and managing risks associated with gene technology. This Act created the framework within which the Gene Technology Regulator operates to assess and regulate activities involving genetically modified organisms (GMOs). The Act's policy objective is to ensure that any risks posed by gene technology are appropriately identified and managed to protect public health and the environment while also promoting the responsible development and use of gene technology. The Act was instrumental in setting up the regulatory mechanisms and processes necessary to evaluate applications such as the one from Murdoch University for a field trial of genetically modified wheat aimed at improving grain quality, which is subject to rigorous risk assessment and management protocols.
Scope and Application
The Gene Technology Act 2000 applies to entities and persons seeking to conduct activities involving genetically modified organisms, including field trials of genetically modified crops such as wheat. In this case, Murdoch University, as the applicant for the licence to conduct a field trial of genetically modified wheat, falls under the purview of this Act. The Act encompasses activities that involve the deliberate release of genetically modified organisms into the environment, including those for research and development purposes. The geographical reach of the Act is national, with the Commonwealth Government exercising regulatory authority over gene technology activities to ensure compliance with national standards designed to protect human health and the environment. The Act does not specify exclusions or exemptions for specific industries or types of conduct, but it does allow for the imposition of conditions on licences to manage risks associated with the proposed activities. The application process for licences, as outlined in the Act, may be further detailed through subordinate instruments, such as regulations or guidelines, which provide additional procedural and substantive requirements for applicants.
Key Provisions
The main operative sections of the Gazette (C2014G02045) concern the assessment and potential approval of a field trial for genetically modified (GM) wheat proposed by Murdoch University. Section 42 of the Gene Technology Act 2000 (Cth) outlines the process for applying for a licence to conduct a field trial, while section 43 details the considerations the Gene Technology Regulator must undertake, including the evaluation of the Risk Assessment and Risk Management Plan (RARMP). The trial in question, labelled DIR 130, is specifically aimed at assessing the impact of introducing two genes to enhance the dough strength of wheat, with the trial proposed to occur between May 2015 and December 2017 within a limited area of 0.06 hectares per year in Western Australia.
The obligations imposed by the Act on the parties involved, particularly Murdoch University as the applicant, include the preparation of a comprehensive RARMP that identifies potential risks and proposes measures to mitigate them. The Gene Technology Regulator is tasked with evaluating the application, including reviewing the RARMP, consulting with relevant stakeholders, and considering public submissions. Section 44 of the Act requires the Regulator to consider the potential environmental impacts and human health risks associated with the proposed trial. Additionally, the Regulator must ensure that any conditions imposed on the licence are adequate to manage any identified risks.
Failure to comply with the provisions of the Gene Technology Act 2000 can result in significant civil and criminal penalties. Under section 84 of the Act, unauthorised activities related to gene technology can lead to substantial fines, with penalties for corporations reaching up to $210,000,000, and for individuals up to $420,000. Furthermore, section 86 stipulates that breaches of licence conditions can result in further penalties, including fines and imprisonment. The Act also includes provisions for the Regulator to seek injunctions to prevent non-compliance, ensuring that the regulatory framework remains robust and effective in protecting health, safety, and the environment.