19 March 2014
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 124 from Monsanto Australia Ltd for a commercial release of two types of GM cotton. Bollgard® III cotton has been genetically modified for insect resistance and Bollgard® III x Roundup Ready Flex® cotton has been genetically modified both for insect resistance and for tolerance to the herbicide glyphosate.
Subject to any State government requirements imposed for marketing reasons, the proposed commercial release of the GM cotton plants would be Australia wide. Products from the GM cotton plants are proposed to be used in the same way as those from non-GM and other commercially approved GM cotton.
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 124 in any correspondence.
Submissions should be received by close of business on 14 May 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, enacted by the Parliament of Australia, was introduced to address the need for a regulatory framework governing the use of gene technology in the country. This legislation aims to safeguard human health and the environment by assessing and managing potential risks associated with the use of genetically modified organisms (GMOs). In 2014, the Office of the Gene Technology Regulator, a body established under this Act, sought public comment on a proposed commercial release of genetically modified cotton varieties developed by Monsanto Australia Ltd. The proposed cotton varieties, Bollgard® III and Bollgard® III x Roundup Ready Flex®, are engineered for insect resistance and herbicide tolerance, respectively. The Regulator's assessment, based on a consultation Risk Assessment and Risk Management Plan (RARMP), indicated that the commercial release of these GM cotton varieties would pose negligible risk to human health and the environment. The public was invited to submit written feedback to aid in finalising the RARMP and informing the decision on whether to grant the commercial release licence.
Scope and Application
The Gene Technology Act 2000 applies to the regulation of gene technology in Australia, with the Office of the Gene Technology Regulator overseeing its implementation. The Act applies to entities and individuals proposing to engage in activities involving genetically modified organisms, such as the commercial release of GM cotton by Monsanto Australia Ltd, as outlined in the gazette. The geographic reach of the Act is national, with the proposed release of GM cotton intended to be Australia-wide, subject to state government marketing requirements. The Act establishes a framework for assessing and managing risks associated with gene technology to protect human health and the environment. Exclusions and exemptions from the Act are determined by the Regulator, with the application in this case focusing on the commercial release of GM cotton. Subordinate instruments may extend or restrict the application of the Act to further clarify and enforce its provisions.
Key Provisions
The main operative sections of this legislation pertain to the assessment and potential approval of a licence application (DIR 124) from Monsanto Australia Ltd for the commercial release of two genetically modified (GM) cotton varieties, namely Bollgard® III cotton and Bollgard® III x Roundup Ready Flex® cotton (Sections 1-2). These sections detail the proposed commercial release of these GM cotton plants, which have been genetically modified for insect resistance and tolerance to the herbicide glyphosate, respectively. The release would be Australia-wide, subject to any state government marketing requirements. The legislation also refers to the preparation of a Risk Assessment and Risk Management Plan (RARMP) by the Gene Technology Regulator (Section 3), which concludes that the proposed release poses negligible risk to human health and safety or the environment. This RARMP includes draft licence conditions aimed at ensuring ongoing oversight of the release. Furthermore, the legislation invites written submissions to finalise the RARMP and inform the decision on whether to issue the licence (Section 4).
The obligations imposed by this legislation on the parties and entities it governs primarily involve the Gene Technology Regulator, who is responsible for assessing the licence application and preparing the RARMP (Sections 1-3). The Regulator must consider the potential risks to human health and safety and the environment associated with the commercial release of the GM cotton varieties. The Regulator must also ensure that any proposed licence conditions are appropriate to manage these risks. Monsanto Australia Ltd, the applicant, must provide all necessary information and documentation to support the licence application and cooperate with the Regulator in preparing the RARMP. Additionally, the public is invited to submit written submissions on the RARMP by the specified deadline (Section 4).
Any breaches of the obligations and requirements outlined in this legislation may result in various consequences. For instance, failure to comply with the RARMP or licence conditions could lead to enforcement actions, including fines or other penalties, as stipulated under the relevant gene technology legislation. The maximum penalties for breaches of gene technology regulations can vary, but they may include substantial financial penalties and potential criminal charges for serious or repeated violations. These consequences are intended to ensure compliance with the legislative framework designed to protect human health, safety, and the environment.