Australia
June 14, 2018
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 163 from Nuseed Pty Ltd. The application is for a field trial (limited and controlled release) of canola plants genetically modified for altered oil content and herbicide tolerance. The purpose of the field trial is to gather data, under field conditions for agronomic performance, oil profile and content, nutritional assessment, compositional analysis, molecular analysis and genetic stability.
The trial sites are proposed to be selected in 95 possible local government areas in New South Wales, Victoria and Queensland. The field trial may occur over five growing seasons between November 2018 and December 2023. The proposal is to plant a total maximum of 150 ha per year on up to 20 sites. The GM canola grown in this field trial would not be used for commercial human food or 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. A range of draft licence conditions would limit the size, locations and duration of the release, as well as restrict the spread and persistence of the GMOs and the introduced genetic material.
The Regulator welcomes written submissions in order to finalise the RARMP, which will then inform the decision on whether or not to issue the 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 163 in any correspondence.
Submissions should be received by close of business on 26 July 2018.
Office of the Gene Technology Regulator, MDP 54, GPO BOX 9848 CANBERRA ACT 2601
Telephone: 1800 181 030
E-mail: ogtr@health.gov.au
OGTR website
DIR 163
Limited and controlled release of canola genetically modified for altered oil content and herbicide resistance – Nuseed Pty Ltd.
DIR 163 documents
The following documents are available for DIR 163:
Invitation to comment
The document invites written submissions from the public on the Risk Assessment and Risk Management Plan (consultation version) prepared by the Regulator as part of the assessment of this application. It explains how the public can access or obtain the consultation documents and the due date for submissions.
PDF format - 100 KB
DOCX format - 53 KB
Questions and Answers on consultation on Risk Assessment
A series of questions and corresponding answers on the licence application and the Regulator’s assessment and proposed limits and controls for this application. It also explains how the public can access or obtain the consultation documents, due date for submissions and next steps in the decision making process.
PDF format - 72 KB
DOCX format - 29 KB
Summary of Risk Assessment and Risk Management Plan (consultation version)
The document summarises the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.
PDF format - 155 KB
DOCX format - 84 KB
Risk Assessment and Risk Management Plan (consultation version)
The document details the risk assessment and risk management plan prepared as part of the Regulator’s decision making process for this application. It explains the risk assessment context, provides an assessment of risks posed by the GMO(s), details whether any of those risks require management and lists the proposed licence conditions.
PDF format - 895 KB
DOCX format - 614 KB
Reference material
Risk Analysis Framework for licence applications to the Office of the Gene Technology Regulator (2013)
The biology of Brassica napus L. (canola) and Brassica juncea (L.) Czern. & Coss. (Indian mustard)
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