15 August 2014
Invitation to comment on genetically modified (GM)
sugarcane 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 129 from Sugar Research Australia for a limited and controlled release of sugarcane that has been genetically modified for herbicide tolerance.
The primary purpose of the field trial is to continue the evaluation of field performance of GM herbicide tolerant sugarcane currently conducted under DIR 096. The trial is proposed to take place between November 2015 and November 2021 at six trial sites in Bundaberg, Mackay, Burdekin, Moreton Bay and Cairns in Queensland. The collective maximum area for the trial is 25 hectares per year. The GM sugarcane 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 and 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 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 129 in any correspondence.
Submissions should be received by close of business on 24 September 2014.
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 was enacted by the Commonwealth Parliament to establish a regulatory framework for the assessment and approval of genetically modified organisms (GMOs) in Australia. This Act was introduced to address the need for a robust system that ensures the safe use of gene technology, protecting both human health and the environment from potential risks associated with GMOs. The Office of the Gene Technology Regulator, as part of the Department of Health, is responsible for overseeing the implementation of the Act, which includes the assessment of applications for the release of GMOs into the environment, such as the genetically modified sugarcane field trial proposed by Sugar Research Australia. The policy objective of the Act is to manage risks posed by GMOs through rigorous evaluation and regulation, ensuring that any potential adverse effects on health and the environment are identified and mitigated.
Scope and Application
The legislation pertains to the assessment of Licence Application DIR 129 from Sugar Research Australia, which seeks approval for a limited and controlled field trial of genetically modified (GM) sugarcane with herbicide tolerance. This Act applies to the entities directly involved in the proposed trial, including Sugar Research Australia and any associated personnel, as well as the Office of the Gene Technology Regulator, which is responsible for assessing and regulating the trial. The geographic scope of the Act is confined to specific trial sites in Queensland, namely Bundaberg, Mackay, Burdekin, Moreton Bay, and Cairns, with the collective maximum area for the trial set at 25 hectares per year. Notably, the GM sugarcane is not intended for use in human food or animal feed. The Act is part of Australia’s broader gene technology regulatory system, which aims to protect human health and the environment by managing the risks associated with gene technology. The consultation process for this legislation invites written submissions to finalise the Risk Assessment and Risk Management Plan (RARMP), which will inform the decision on whether to issue the licence. The submissions deadline is 24 September 2014.
Key Provisions
The main operative sections of this legislation are those that outline the proposed genetically modified (GM) sugarcane field trial under Licence Application DIR 129 (1). This application, submitted by Sugar Research Australia, seeks approval for a controlled release of GM sugarcane that has been genetically modified for herbicide tolerance. The proposed trial aims to continue evaluating the field performance of this GM sugarcane, which has already been under evaluation under DIR 096. The trial is set to take place between November 2015 and November 2021 at six trial sites across Bundaberg, Mackay, Burdekin, Moreton Bay, and Cairns in Queensland, with a maximum trial area of 25 hectares per year (1). Importantly, the GM sugarcane would not be used for human food or animal feed (1).
The Gene Technology Act imposes several obligations and requirements on the parties involved in the proposed field trial. Sugar Research Australia must submit a comprehensive Risk Assessment and Risk Management Plan (RARMP) to the Gene Technology Regulator. This plan must detail the potential risks to human health and safety and the environment and outline measures to manage those risks (1). The Regulator is responsible for assessing the RARMP and deciding whether to issue the licence based on the information provided. Additionally, the Regulator welcomes public submissions to finalise the RARMP, ensuring that all relevant concerns and considerations are addressed before making a decision (1).
Breaching the conditions outlined in the Gene Technology Act can result in significant consequences. The Act includes provisions for both civil and criminal penalties for non-compliance (2). Civil penalties may include fines, with the maximum penalty varying depending on the severity of the breach. Criminal penalties can also be imposed, including imprisonment, with the maximum penalty again dependent on the nature of the offence (2). These penalties serve as deterrents to ensure compliance with the Act’s provisions and protect human health and the environment.