Overview

The Office of the Gene Technology Regulator has published a consultation on the potential commercial release of genetically modified cotton developed by Monsanto Australia Pty Ltd, under licence application DIR 173. The Gene Technology Act 2000, enacted by the Commonwealth Parliament, established Australia's gene technology regulatory system to ensure the health and safety of people and the environment are protected from risks posed by gene technology. The policy objective of this Act is to provide a robust framework for the regulation of genetically modified organisms, including thorough risk assessments and management plans for any proposed releases. In this instance, the Regulator is seeking public comment on the Risk Assessment and Risk Management Plan prepared for the proposed commercial cultivation of MON 88701 cotton, which contains genes for herbicide tolerance. The consultation is open for submissions until 24 August 2020, with the final decision on whether to issue the licence informed by the feedback received and the completed RARMP.

Scope and Application

The legislation C2020G00555 pertains to the assessment and regulation of the commercial release of genetically modified cotton in Australia, specifically MON 88701 cotton developed by Monsanto Australia Pty Ltd. The Act applies to Monsanto as the entity seeking approval for the commercial cultivation of this GM cotton across all cotton growing areas in Australia, as well as to the products derived from this cotton, which are intended for use in human food and animal feed. The legislation is governed by the Commonwealth through the Office of the Gene Technology Regulator (OGTR), ensuring that the health and safety of people and the environment are protected by managing the risks associated with gene technology. The scope of this legislation encompasses the assessment of the risks and the management plans for mitigating any identified risks through the proposed licence conditions. While the primary focus is on the commercial release of MON 88701 cotton, the Act also extends its reach through subordinate instruments to include any additional conditions or requirements that may be necessary for the oversight of the GM cotton release. The public is invited to submit written comments on the Risk Assessment and Risk Management Plan, which will be used to inform the final decision on whether to issue the licence for commercial cultivation.

Key Provisions

The primary sections of the legislation include Section 13 which refers to the invitation for comments on the commercial release of genetically modified cotton, and Section 173 which pertains to the specific licence application submitted by Monsanto Australia Pty Ltd. Under Section 13, the Gene Technology Regulator is inviting the public to comment on the proposed release of genetically modified cotton, specifically MON 88701, into the Australian market. This includes its use in human food and animal feed. Section 173 details the application for the commercial cultivation of this genetically modified cotton by Monsanto, including the draft licence conditions proposed to manage any risks associated with its release. The obligations and requirements imposed by this legislation include the necessity for the Gene Technology Regulator to assess the risks associated with the proposed release of genetically modified cotton. The Regulator must consider the Risk Assessment and Risk Management Plan (RARMP) prepared by Monsanto, which evaluates the potential risks to human health, safety, and the environment. The Regulator must also ensure that the proposed licence conditions are adequate to manage any identified risks. Additionally, the legislation requires Monsanto to provide a comprehensive RARMP and any other relevant documentation to support their application. The Regulator must make this RARMP publicly available for comment. Failure to comply with the provisions of this legislation may result in civil or criminal penalties. While specific offences and penalties are not detailed in the legislation, the overarching Gene Technology Act 2000 may provide guidance on potential consequences for non-compliance. This could include fines, imprisonment, or both, depending on the severity of the breach. The Regulator is tasked with enforcing compliance with the legislation and may take legal action against any party found to be in breach of the requirements. Overall, the legislation aims to ensure that any risks associated with the commercial release of genetically modified cotton are identified and managed effectively. It mandates a thorough assessment process and requires public consultation to gather input on the potential risks and benefits of such a release. The proposed licence conditions and regulatory oversight are designed to mitigate any potential harm to human health, safety, and the environment.