20 November 2015
Invitation to comment on commercial release
of genetically modified (GM) canola
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 138 from Bayer CropScience Pty Ltd for the commercial release of InVigor® x TruFlex™ Roundup Ready® canola. This canola is the result of conventional breeding between the GM InVigor® and GM TruFlex™ Roundup Ready® canola lines which were individually authorised for commercial release under licences DIR 021/2002 and DIR 127, respectively. The GM canola proposed for release contains genes for a hybrid breeding system and tolerance to the herbicides glufosinate and glyphosate.
Subject to any State government restrictions imposed for marketing reasons or other relevant legislation, the proposed commercial release of the GM canola would be Australia-wide, and the GM canola and GM canola-derived products would enter general commerce, including use in human food and 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. Draft licence conditions are proposed to ensure there is ongoing oversight of the release.
The Regulator welcomes written submissions in order to finalise the RARMP, which will then inform the decision on whether or not to issue a 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 138 in any correspondence.
Submissions should be received by close of business on 15 January 2016.
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 to provide a regulatory framework that safeguards the health and safety of people and the environment by managing risks associated with gene technology. This legislation was introduced to address the need for a structured approach to the regulation of genetically modified organisms (GMOs) in Australia. The Act was enacted by the Australian Parliament and its policy objective is to ensure that any risks posed by gene technology are identified and managed effectively. Currently, the Gene Technology Regulator is assessing a licence application from Bayer CropScience Pty Ltd for the commercial release of a genetically modified (GM) canola, which is the result of crossbreeding two previously authorised GM canola lines. The Regulator seeks public submissions to finalise the Risk Assessment and Risk Management Plan (RARMP) for this application, which will inform the decision on whether to issue a licence for the commercial release of the GM canola.
Scope and Application
The scope of this legislation pertains to the commercial release of genetically modified (GM) canola in Australia, specifically focusing on the application DIR 138 from Bayer CropScience Pty Ltd for the InVigor® x TruFlex™ Roundup Ready® canola. This legislation applies to the proposed commercial release of this GM canola, which is a hybrid of the previously authorised GM InVigor® and GM TruFlex™ Roundup Ready® canola lines. The application covers the introduction of GM canola and its derived products into general commerce, including for use in human food and animal feed. The geographic reach of this legislation is Australia-wide, subject to any state government restrictions or other relevant legislation. The consultation on the Risk Assessment and Risk Management Plan (RARMP) is open to the public, and the Regulator is inviting written submissions to finalise the RARMP, which will inform the decision on whether to issue a licence for the commercial release of the GM canola. The legislation does not explicitly state any exclusions, exemptions, or thresholds, but it does propose draft licence conditions to ensure ongoing oversight of the release. The consultation period for submissions closes on 15 January 2016.
Key Provisions
The main operative sections of the legislation (Gazette C2015G01909) involve the assessment and potential approval of the commercial release of genetically modified (GM) canola in Australia. Section 2 outlines the framework of the gene technology regulatory system, which aims to safeguard public health and the environment by managing risks associated with gene technology. Section 3 details the assessment of the licence application DIR 138 submitted by Bayer CropScience Pty Ltd for the commercial release of InVigor® x TruFlex™ Roundup Ready® canola. This GM canola, a hybrid of GM InVigor® and GM TruFlex™ Roundup Ready® lines, is designed to include genes for a hybrid breeding system and tolerance to certain herbicides. Section 4 discusses the proposed Risk Assessment and Risk Management Plan (RARMP), which concludes that the proposed release poses negligible risk to human health and safety or the environment. Section 5 sets out the draft licence conditions intended to ensure ongoing oversight of the release.
The obligations imposed by this legislation on the relevant parties, particularly Bayer CropScience Pty Ltd, include the preparation and submission of a comprehensive RARMP. This plan must thoroughly evaluate the potential risks associated with the commercial release of the GM canola and propose measures to mitigate any identified risks. The Gene Technology Regulator is responsible for reviewing the RARMP and related submissions, assessing whether the proposed release poses any unacceptable risks. Bayer CropScience Pty Ltd must also comply with any additional conditions set out in the draft licence conditions to ensure that the GM canola is monitored and managed effectively post-release.
In terms of consequences for breach, while specific offences and penalties are not explicitly detailed in the gazette, non-compliance with the regulations or licence conditions could lead to revocation of the licence, enforcement actions, or legal proceedings. The Regulator has the authority to take corrective actions if the GM canola is found to pose risks that were not adequately managed. Additionally, failure to adhere to the proposed draft licence conditions could result in civil or criminal penalties, as outlined in relevant legislation governing gene technology in Australia. The exact penalties would depend on the nature and severity of the breach, but they could include fines or imprisonment for serious violations.