Australia
November 13, 2013
DIR 123 – Notification of decision on GM canola field trial
Issue of licence DIR 123 to Nuseed Pty Ltd for a field trial of GM canola
13 November 2013
On 4 September 2013, the Gene Technology Regulator invited submissions on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) for licence application DIR 123 from Nuseed Pty Ltd (Nuseed).
The Regulator has issued a licence in respect of application DIR 123, authorising the limited and controlled release (field trial) of canola lines that have been genetically modified (GM) for altered oil content.
The release is authorised to take place between March 2014 and March 2019, with trial sites selected from 153 possible local government areas (LGAs) in New South Wales, Victoria and Western Australia. The trial will be conducted at a maximum of four sites of up to 2 hectares (ha) in 2014, six sites of up to 10 ha in 2015 and ten sites of up to 20 ha in each subsequent year.
The primary purpose of the field trial is to evaluate the agronomic characteristics, oil content and genetic stability of the GM canola under field conditions. The GM canola will not enter the human food or animal feed supply but some GM material may be used for small-scale experimental animal feeding studies.
The decision to issue the licence was made after extensive 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 relevant local councils, as required by the Gene Technology Act 2000 and the corresponding State and Territory legislation.
Issues relating to the health and safety of people and the protection of the environment raised during the consultation process were considered in the context of current scientific information in reaching the conclusions set out in the finalised RARMP and in making the decision to issue the licence.
The finalised RARMP concludes that this limited and controlled release poses negligible risks to people and the environment. Licence conditions have been imposed to restrict spread and persistence of the GMOs and their genetic material in the environment and to limit the release in size, locations and duration, as these were important considerations in the evaluation process. While individual trial sites have not been identified at this time, characteristics of the broad geographic regions where the release is proposed to occur were taken into consideration in the risk assessment. Details of the GM canola field trial sites will be notified on the OGTR website as they are provided by the licence holder.
Appendix A of the RARMP summarises the submissions that were received from prescribed experts, agencies and authorities, and indicates how issues raised relating to risks to human health and safety or the environment were considered in the document. 14 submissions were received from the public on the consultation RARMP and the issues raised, and their consideration, are summarised in Appendix B of the RARMP.
A Summary and the finalised RARMP, together with a set of Questions and Answers on this decision and a copy of the licence, can be obtained on-line from the DIR 123 page of the Office of the Gene Technology Regulator’s website or requested via the contacts detailed below.
Office of the Gene Technology Regulator, MDP 54, GPO BOX 9848 CANBERRA ACT 2601
Telephone: 1800 181 030 Facsimile: 02 6271 4202 E-mail: OGTR Website
DIR 123 - Questions and Answers
DIR 123 Summary of the Risk Assessment and Risk Management Plan (RARMP)
DIR 123 Full Risk Assessment and Risk Management Plan (RARMP)
GM canola field trial licence conditions
Reference material
Risk Analysis Framework for Licence Applications to the Office of the Gene Technology Regulator (3rd Edition) 2009
The Biology of Brassica napus L. (canola)
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