Australia
March 20, 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 assessing licence application DIR 158 from GO Resources Pty Ltd for commercial cultivation of genetically modified (GM) safflower. The two GM safflower lines have been genetically modified to produce more oleic acid in the seed. They also contain an introduced marker gene for antibiotic resistance, used to select the GM plants in the laboratory.
GO Resources Pty Ltd is seeking approval to commercially grow the GM safflower in all safflower growing areas of Australia. The GM safflower and its derived products would enter general commerce, with the oil derived from the GM safflower intended for commercial industrial oil production. Products derived from the GM safflower are not intended for use in human food.
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 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 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 158 in any correspondence.
Submissions should be received by close of business on 15 May 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 158 documents
The following documents are available for DIR 158:
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 - 97 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. 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 - 91 KB
DOCX format - 26 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 - 175 KB
DOCX format - 67 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 - 887 KB
DOCX format - 688 KB
Reference material
Risk Analysis Framework for licence applications to the Office of the Gene Technology Regulator (2013)
The Biology of Carthamus tinctorius L. (safflower) V 1.1 (2018)
Topics
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