31 August 2016
Invitation to comment on commercial release
of genetically modified (GM) cotton
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 145 from Monsanto Australia Ltd for a commercial release of two types of GM cotton: Xtend Flex™ and Bollgard® 3 Xtend Flex™ cotton. Xtend Flex™ cotton has been modified for tolerance to the herbicides glyphosate, glufosinate and dicamba. Bollgard® 3 Xtend Flex™ cotton has been genetically modified for insect resistance as well as tolerance to the three herbicides.
Subject to any State government restrictions imposed for marketing reasons, the proposed commercial release of the GM cottons would be Australia-wide. Products from the GM cotton plants would be used in the same way as those from non-GM and other commercially approved GM cottons.
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 number DIR 145 in any correspondence.
Submissions should be received by close of business on 26 October 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, enacted by the Commonwealth Parliament, establishes a regulatory framework designed to safeguard human health and environmental integrity by addressing the risks associated with gene technology. This Act was introduced to fill the legislative gap in managing the potential hazards posed by genetically modified organisms, ensuring a systematic approach to risk assessment and management. The policy objective of the Act is to allow for the safe and controlled use of gene technology, ensuring that any potential risks to human health and the environment are identified and mitigated. The Office of the Gene Technology Regulator, as the enforcing body, is currently evaluating an application from Monsanto Australia Ltd for the commercial release of genetically modified cotton varieties, Xtend Flex™ and Bollgard® 3 Xtend Flex™. This evaluation includes a consultation process to gather public input on the Risk Assessment and Risk Management Plan, aiming to make an informed decision on whether to approve the commercial release of these genetically modified cottons.
Scope and Application
The Gene Technology Act 2000, which governs the regulation of gene technology in Australia, applies to the proposed commercial release of genetically modified cotton varieties Xtend Flex™ and Bollgard® 3 Xtend Flex™ by Monsanto Australia Ltd. The Act applies to the entities seeking to release these genetically modified organisms (GMOs) and the products derived from them. It encompasses the conduct and transactions associated with the commercial release of GMOs, ensuring that these activities are carried out in a manner that protects human health and safety as well as the environment. The geographic scope of this Act is national, with any commercial release subject to the approval of the Gene Technology Regulator and any relevant state or territory restrictions. The Act does not specify exclusions or thresholds but allows for the establishment of licence conditions through subordinate instruments to manage risks effectively. The public is invited to submit comments on the proposed release, which will inform the final decision on whether to issue a licence, thereby facilitating a transparent and inclusive regulatory process.
Key Provisions
The legislation under discussion concerns the proposed commercial release of two types of genetically modified (GM) cotton, Xtend Flex™ and Bollgard® 3 Xtend Flex™, in Australia, specifically Licence Application DIR 145 from Monsanto Australia Ltd. Section 3 of the legislation outlines the key provisions of the application, which includes a Risk Assessment and Risk Management Plan (RARMP) prepared by the Gene Technology Regulator. This plan evaluates the potential risks to human health and the environment posed by the GM cottons, concluding that the proposed release would pose negligible risk.
The obligations imposed by this legislation on the parties involved are primarily centred around the assessment and management of potential risks associated with the GM cottons. The Gene Technology Regulator, under Section 6, is responsible for evaluating the RARMP, assessing any written submissions, and determining whether to issue a licence for the commercial release of the GM cottons. Monsanto Australia Ltd, as the applicant, must provide detailed information about the GM cottons, including their genetic modifications, intended uses, and potential environmental impacts. Additionally, they must comply with any conditions imposed by the Regulator to ensure ongoing oversight of the release.
In terms of consequences for non-compliance or breaches of the legislation, the Act does not specify particular offences or penalties in the provided text. However, it is reasonable to infer that any failure to comply with the conditions set by the Gene Technology Regulator could result in legal actions to enforce compliance or revoke the licence. The Regulator may also impose fines or other sanctions if the GM cottons are found to pose greater risks than those identified in the RARMP, thereby breaching the terms of the licence or the overarching objectives of the gene technology regulatory system to protect health and the environment.