Australia
February 5, 2019
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 165 from the University of Melbourne. The application is for a field trial (limited and controlled release) of wheat plants genetically modified for altered iron uptake, transport and bioavailability. The purpose of the field trial is to gather research and regulatory data under field conditions.
The application proposes to plant up to 10 field trial sites per year, with a maximum combined area of 20 ha per year, between April 2019 and December 2023. The trial sites could be located in Victoria, New South Wales, Western Australia and South Australia. The GM wheat 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 165 in any correspondence.
Submissions should be received by 13 March 2019.
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 165
Limited and controlled release of wheat genetically modified for altered iron uptake, transport and bioavailability – University of Melbourne
DIR 165 documents
The following documents are available for DIR 165:
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 - 127 KB
DOCX format - 50 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 - 83 KB
DOCX format - 24 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 - 167 KB
DOCX format - 69 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 - 1116 KB
DOCX format - 465 KB
Reference material
Risk Analysis Framework for licence applications to the Office of the Gene Technology Regulator (2013)
The biology of Triticum aestivum L. (bread wheat)
Topics
Species
