Australia
May 12, 2021
The Gene Technology Regulator has issued licence DIR 175 to BASF Australia Ltd, authorising the commercial release of canola genetically modified (GM) for herbicide tolerance and a hybrid breeding system.
The release is authorised to take place throughout Australia. The GM canola and products derived from the GM canola may enter general commerce, including use in human food and animal feed.
The licence decision was informed by a Risk Assessment and Risk Management Plan (RARMP) undertaken by the OGTR with input from stakeholders nationwide. This included consultation with the public, state and territory governments, local councils, Australian Government agencies, the Minister for the Environment, and the Gene Technology Technical Advisory Committee. The Regulator thanks submitters for their contributions.
Submissions are summarised in Appendix B and C of the RARMP, together with information about how any issues raised relating to risks to human health and safety, and the environment were considered.
The RARMP concludes that this commercial release poses negligible risk to people and the environment.
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 & Answers can be found on the DIR 175 page of the OGTR website. You can also request them via the contacts detailed below.
Office of the Gene Technology Regulator
MDP 54 GPO Box 9848 CANBERRA ACT 2601
Tel: 1800 181 030
E-mail: ogtr@health.gov.au
OGTR Website
DIR 175 documents
The following documents are available for DIR 175:
Notification of licence decision
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
PDF format - 128 KB
DOCX format - 53 KB
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 - 125 KB
DOCX format - 24 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 - 186 KB
DOCX format - 47 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 - 1409 KB
DOCX format - 576 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 - 285 KB
DOCX format - 127 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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