16 May 2017
Invitation to comment on a genetically modified (GM)
sorghum 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 153 from the University of Queensland. The application is for a field trial (limited and controlled release) of sorghum genetically modified for grain quality traits. The purpose of the field trial is to assess the agronomic characteristics, yield and grain quality of the GM sorghum plants under field conditions.
The trial is proposed to take place between October 2017 and June 2020 in south-east Queensland. In the first year, one site would be planted with an area of up to 1 hectare. In each of the second and third years up to 4 sites would be planted with a combined area of up to 5 hectares. The GM sorghum would not be used in human food or sold as 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, locations 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 inform the 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 153 in any correspondence.
Submissions should be received by close of business on 26 June 2017.
Office of the Gene Technology Regulator, MDP 54, GPO BOX 9848 CANBERRA ACT 2601
Telephone: 1800 181 030 E-mail: ogtr@health.gov.au
OGTR website www.ogtr.gov.au
Overview
The Gene Technology Act 2000 was enacted by the Parliament of Australia to regulate the development and use of genetically modified organisms (GMOs) within the country. This legislation was introduced to address the need for a robust regulatory framework that protects human health and the environment while facilitating the potential benefits of gene technology. The Act establishes the Gene Technology Regulatory System overseen by the Gene Technology Regulator, which assesses and approves applications for the use of GMOs, such as the proposed field trial of genetically modified sorghum by the University of Queensland. The policy objective of the Act is to ensure that any risks associated with GMOs are identified and managed effectively, balancing the need for innovation with public safety and environmental protection. The public is invited to comment on specific applications, such as the proposed sorghum trial, to inform the final assessment and decision-making process.
Scope and Application
The proposed legislation pertains to the assessment and potential approval of a genetically modified (GM) sorghum field trial by the University of Queensland, as governed under Australia’s gene technology regulatory system. This system is tasked with safeguarding the health and safety of people and the environment by identifying and managing risks associated with gene technology. The application, DIR 153, specifically targets a limited and controlled release of GM sorghum genetically modified for enhanced grain quality traits. The trial aims to evaluate the agronomic characteristics, yield, and grain quality of these plants under field conditions. Geographically, the proposed trial is confined to south-east Queensland, with plans to initially plant one site covering up to 1 hectare, expanding to a total of up to 5 hectares across four sites in the subsequent years. The GM sorghum is not intended for use in human food or as animal feed. The Gene Technology Regulator has prepared a consultation Risk Assessment and Risk Management Plan (RARMP) which concludes that the proposed release poses negligible risk to human health, safety, or the environment. This plan is subject to finalisation through public consultation, which includes the review of written submissions to be received by 26 June 2017. The Regulator's decision on whether to issue the licence will be informed by the finalised RARMP.
Key Provisions
The key provisions of this legislation are set out in the consultation document regarding the proposed genetically modified (GM) sorghum field trial (Gazette C2017G00534). Section 3 of the Gazette outlines the purpose of the field trial, which is to assess the agronomic characteristics, yield, and grain quality of the GM sorghum plants under field conditions. The trial is proposed to take place in south-east Queensland between October 2017 and June 2020, with increasing areas of up to 5 hectares being planted over the three years (section 3). The GM sorghum will not be used in human food or sold as animal feed (section 3).
The obligations and requirements imposed by the legislation on the parties involved include the preparation of a comprehensive Risk Assessment and Risk Management Plan (RARMP) to identify and manage any potential risks to human health and safety or the environment (section 4). The draft licence conditions outlined in the RARMP will limit the size, locations, and duration of the release, as well as restrict the spread and persistence of the GMOs and the introduced genetic material (section 4). The University of Queensland must also ensure that the trial is conducted in accordance with the conditions specified in the licence, if issued.
Breaching any of the licence conditions or failing to comply with the obligations and requirements outlined in the RARMP may result in civil or criminal consequences. The maximum penalties for offences under the Gene Technology Act 2000 include fines of up to $1.1 million for individuals and $5.5 million for bodies corporate, as well as imprisonment for up to 5 years for individuals and 10 years for bodies corporate (section 6). It is essential for the University of Queensland to adhere to the requirements and obligations set out in the legislation to avoid potential penalties and consequences.