Australia
February 13, 2018
On 5 October 2017, the Gene Technology Regulator invited submissions on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) for licence application DIR 155 from Nuseed Pty Ltd.
The Regulator has now issued a licence in response to application DIR 155, authorising the commercial release of canola genetically modified for omega-3 oil content (known as DHA canola).
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. Food Standards Australia New Zealand has approved the use in food of material derived from this GM canola. Note that cultivation of GM canola is subject to restrictions in some Australian States and Territories for marketing reasons.
The Regulator’s decision to issue the licence was made after consultation on the RARMP with the public, State and Territory governments, Australian Government agencies, the Minister for the Environment, the Gene Technology Technical Advisory Committee and local councils, as required by the Gene Technology Act 2000 and the corresponding State and Territory legislation.
The Regulator considered all submissions provided during the consultation process that related to the health and safety of people or the protection of the environment. The comments were considered in the context of current scientific information and used in finalising the RARMP. The finalised RARMP informed the Regulator’s decision to issue the licence.
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.
Appendices A and B of the RARMP summarise the advice received from prescribed experts, agencies and authorities, and indicate how issues raised relating to risks to human health and safety or the environment were considered in preparing and finalising the document. One submission was received from the public on the consultation RARMP and the issues raised, and their consideration, are summarised in Appendix C of the RARMP.
The finalised RARMP, together with a summary of the RARMP, a set of Questions and Answers on this decision and a copy of the licence, can be obtained online from the DIR 155 page of the Office of the Gene Technology Regulator’s website or requested via the contacts detailed below.
DIR 155 documents
The following documents are available for DIR 155:
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 - 67 KB
DOCX format - 25 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 - 160 KB
DOCX format - 81 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 - 844 KB
DOCX format - 571 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 - 202 KB
DOCX format - 66 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) V 2.1 (2017)
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