Australia
June 227, 2018
The Regulator has issued licence DIR 158, authorising the commercial release of safflower genetically modified for high oleic acid composition.
The release is authorised to take place throughout Australia. The GM safflower and products derived from the GM safflower may enter general commerce, for use in industrial oil production and animal feed. There is no intention to use the GM safflower in human food.
Both the risk assessment and risk management plan (RARMP) and the licence were finalised taking into account input received during consultation with the public, State and Territory governments, Australian Government agencies, the Minister for the Environment, the Gene Technology Technical Advisory Committee and local councils. The Regulator thanks submitters for their contributions.
The finalised RARMP concludes that this commercial release poses negligible risks to people and the environment and does not require specific risk treatment measures. However, general licence conditions have been imposed to ensure ongoing oversight of the release.
The finalised RARMP, a summary of the RARMP, the Licence, and Questions and Answers about this decision, can be obtained online from the DIR 158 page of the Office of the Gene Technology Regulator’s website or requested via the contacts detailed below.
DIR 158 documents
The following documents are available for DIR 158:
Questions and Answers on licence decision
A series of questions and corresponding answers on the licence application and the Regulator’s decision to issue a licence for this application.
PDF format - 70 KB
DOCX format - 29 KB
Summary of Risk Assessment and Risk Management Plan
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 - 158 KB
DOCX format - 82 KB
Full Risk Assessment and Risk Management Plan
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) and details whether any of those risks require management. It also includes a summary of submissions received during the public consultation process.
PDF format - 1121 KB
DOCX format - 724 KB
Licence Conditions
The document explains the licence conditions imposed by the Regulator. It provides details of the licence holder’s obligations, including both general conditions required in all licences and specific conditions for this licence, as well as reporting requirements.
PDF format - 242 KB
DOCX format - 130 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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