Australia
September 10, 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 164 from Monsanto Australia Limited. The application is for a field trial (limited and controlled release) of canola plants genetically modified for herbicide tolerance. The purpose of the field trial is to assess agronomic performance of the GM canola in all canola growing areas of Australia.
The trial sites are proposed to be selected in 140 possible local government areas in New South Wales, Queensland, South Australia, Victoria and Western Australia between January 2020 and January 2024. The proposal is to plant up to 15 sites with a maximum combined area of 30 ha per year in 2020, increasing to 20 sites with a maximum combined area of 100 ha in 2023. The GM canola grown in this field trial would not be used for 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 164 in any correspondence.
Submissions should be received by close of business on 22 October 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 www.ogtr.gov.au
DIR 164 documents
The following documents are available for DIR 164:
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 - 115 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 - 28 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 - 151 KB
DOCX format - 82 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 - 941 KB
DOCX format - 451 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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