11 December 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 139 from Pioneer Hi-Bred Australia Pty Ltd for a commercial release of Optimum™ GLY Canola. This canola variety has been genetically modified for tolerance to the herbicide glyphosate.
Subject to any State government restrictions imposed for marketing reasons, the proposed commercial release of the GM canola would be Australia-wide. The GM canola and its 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 number DIR 139 in any correspondence.
Submissions should be received by close of business on 11 February 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 for gene technology activities, including the commercial release of genetically modified organisms, in order to ensure the protection of human health and the environment. The Office of the Gene Technology Regulator, which operates under the auspices of the Commonwealth of Australia, administers this Act to manage the risks associated with gene technology. The policy objective of the Act is to facilitate the safe development and application of gene technology while minimising potential risks. In response to a licence application from Pioneer Hi-Bred Australia Pty Ltd for the commercial release of a genetically modified canola variety, the Regulator has issued a public invitation for comment on the risk assessment and management plan, seeking to finalise these documents to inform the decision-making process on the proposed release of the GM canola into the Australian market.
Scope and Application
The scope of the legislation pertains to the commercial release of genetically modified (GM) canola in Australia, specifically focusing on the assessment of application DIR 139 from Pioneer Hi-Bred Australia Pty Ltd for the release of Optimum™ GLY Canola. This legislation applies to the entity responsible for the GM canola, Pioneer Hi-Bred Australia Pty Ltd, and extends to the agricultural industry and any activities related to the cultivation and commercialisation of the GM canola. The geographic reach of this legislation is Australia-wide, although it is subject to any state-imposed restrictions for marketing purposes. The GM canola and its products are intended to enter general commerce, including use in human food and animal feed. The legislation is designed to ensure that the release of GM canola poses negligible risk to human health and safety or to the environment, with draft licence conditions proposed to maintain ongoing oversight of the release. The application of this legislation is primarily managed by the Gene Technology Regulator, who will consider written submissions to finalise the Risk Assessment and Risk Management Plan (RARMP) before deciding whether to issue a licence for the commercial release.
Key Provisions
The key provisions of this legislation revolve around the assessment and potential commercial release of genetically modified (GM) canola in Australia. Under section 1, the Gene Technology Regulator is currently reviewing an application (DIR 139) from Pioneer Hi-Bred Australia Pty Ltd to release a GM canola variety called Optimum™ GLY Canola. This variety has been engineered for glyphosate tolerance, which is a type of herbicide. The Regulator is assessing this application to determine if the proposed release poses any risks to human health, safety, or the environment. If approved, the GM canola would be available for commercial use Australia-wide, including for human consumption and animal feed, subject to any state-imposed marketing restrictions.
The obligations under this legislation primarily rest with the Gene Technology Regulator, who is responsible for the assessment of the GM canola's potential risks and benefits. The Regulator must thoroughly evaluate the Risk Assessment and Risk Management Plan (RARMP) that has been prepared, which includes a detailed analysis of any potential risks and proposed measures to mitigate those risks. Once the Regulator has reviewed the RARMP and any public submissions, they will make a decision on whether to issue a licence for the commercial release of the GM canola. The Regulator must also ensure that any draft licence conditions are designed to provide ongoing oversight of the release.
In terms of breaches and penalties, the legislation does not explicitly detail specific offences or penalties within the text. However, it is implied that failure to comply with the regulatory process or the conditions of any granted licence could result in legal consequences. These could include administrative actions such as fines, revocation of the licence, or other regulatory sanctions. The maximum penalties would be determined by the relevant legislation governing gene technology regulation in Australia, which may include provisions in the Gene Technology Act 2000 and its associated regulations. These potential penalties serve to enforce compliance with the regulatory requirements and to safeguard public health and the environment.