Australia
April 30, 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 162 from CSIRO. The application is for a field trial (limited and controlled release) of wheat genetically modified for enhanced rust disease resistance. The purpose of the field trial is to assess the agronomic characteristics of the GM wheat plants under field conditions.
The trial is proposed to take place in the ACT and the Hilltops Council area in NSW over five growing seasons between September 2018 and September 2023. The proposal is to plant up to 40 m2 in total in each growing season. The GM wheat grown in this field trial would not be used in 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 162 in any correspondence.
Submissions should be received by close of business on 12 June 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 162 documents
The following documents are available for DIR 162:
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 - 98 KB
DOCX format - 52 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 - 71 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 - 134 KB
DOCX format - 80 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 - 670 KB
DOCX format - 425 KB
Reference material
Risk Analysis Framework for licence applications to the Office of the Gene Technology Regulator (2013)
The biology of Tritcum aestivum L. (bread wheat)