16 March 2022
Invitation to comment on a field trial
of genetically modified canola and Indian mustard
The Gene Technology Regulator is assessing an application from Nuseed Pty Ltd to conduct a field trial of canola and Indian mustard genetically modified for altered oil content and herbicide tolerance. The trial is proposed to take place at up to 20 sites with a total area of 150 ha per year over 5 years. Sites would be in NSW, Vic and Qld. The plants grown in this field trial would not be used for commercial human food or animal feed.
The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and welcomes written submissions relating to the protection of human health and safety and the environment prior to making a decision on whether to issue the licence. The consultation RARMP and related information can be obtained via the contacts below. Submissions should reference DIR 188 and be received by 26 April 2022.
Office of the Gene Technology Regulator
MDP 54 GPO Box 9848 CANBERRA ACT 2601
Telephone: 1800 181 030 Website: www.ogtr.gov.au
E-mail: ogtr@health.gov.au
Overview
The Gene Technology Act 2000, enacted by the Australian Parliament, establishes the framework for the regulation of genetically modified organisms (GMOs) to address concerns related to their potential impact on human health, safety, and the environment. The Act was introduced to provide a systematic approach to the assessment, approval, and monitoring of genetically modified organisms in Australia. The policy objective of the Act is to ensure that any risks associated with the use and release of GMOs are identified, assessed, and effectively managed.
The Office of the Gene Technology Regulator, established under the Act, is responsible for assessing applications for field trials and commercial release of GMOs. This includes evaluating the risk assessment and risk management plans submitted by applicants. The Regulator ensures that all necessary measures are in place to protect human health and safety and the environment, while also facilitating the responsible use of biotechnology in Australia.
Scope and Application
The proposed legislation, C2022G00195, pertains to a field trial of genetically modified canola and Indian mustard, initiated by Nuseed Pty Ltd, and is subject to the oversight and approval of the Gene Technology Regulator. This application encompasses the cultivation of genetically modified canola and Indian mustard, modified to feature altered oil content and herbicide tolerance, at up to 20 specified sites across New South Wales, Victoria, and Queensland. The trial is intended for non-commercial purposes and does not involve the use of these plants for human food or animal feed. The scope of this Act includes a geographic reach limited to the aforementioned states and spans a duration of five years, with a total area of 150 hectares to be utilised annually. The Regulator has prepared a comprehensive Risk Assessment and Risk Management Plan (RARMP) to evaluate the potential impacts on human health and the environment. Submissions regarding this trial are invited and should reference DIR 188, with a deadline of 26 April 2022, to facilitate informed decision-making by the Regulator on whether to issue the requisite licence for the trial. The Act does not explicitly mention any exclusions, exemptions, or thresholds, nor does it extend its application through subordinate instruments.
Key Provisions
The key provisions of this piece of legislation concern the field trial of genetically modified (GM) canola and Indian mustard by Nuseed Pty Ltd, as outlined in sections 1 and 2 of the Gazette (C2022G00195). The proposed field trial, mentioned in section 1, is intended to examine plants genetically modified for altered oil content and herbicide tolerance. The trial, which would be conducted over a span of five years, is slated to occur at up to 20 sites across New South Wales, Victoria, and Queensland, with a total area of 150 hectares per year (sections 1 and 2). Importantly, the genetically modified plants produced in this trial would not be used for commercial human food or animal feed purposes (section 1).
The obligations and requirements imposed by this legislation are twofold. Firstly, Nuseed Pty Ltd must adhere to the Risk Assessment and Risk Management Plan (RARMP) prepared by the Gene Technology Regulator (section 3). This plan is designed to evaluate potential risks to human health and safety and the environment, ensuring that the trial is conducted in a manner that mitigates any potential negative impacts. Secondly, the Regulator has issued a call for written submissions from the public (section 4). These submissions should reference DIR 188 and should be received by 26 April 2022 (section 4). The Regulator will consider these submissions as part of its decision-making process regarding whether to issue the licence for the field trial.
Finally, the Gazette does not explicitly mention any offences, penalties, or consequences for breach of the legislation. However, it is reasonable to infer that any failure to comply with the obligations and requirements outlined in the RARMP or the submission process could result in the Regulator withholding the licence for the field trial. Additionally, any adverse effects on human health, safety, or the environment arising from the trial could lead to legal action against Nuseed Pty Ltd or the Regulator, depending on the specific circumstances. The maximum penalties for such breaches would depend on the relevant legislation governing environmental protection, health and safety, or biotechnology in Australia.