Australia
July 12, 2013
Issue of licence DIR 120 to Monsanto Australia Ltd for a field trial of GM cotton
On 29 April 2013, the Gene Technology Regulator invited submissions on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) for licence application DIR 120 from Monsanto Australia Ltd (Monsanto).
The Regulator has issued a licence in respect of application DIR 120, authorising the limited and controlled release (field trial) of cottons that have been genetically modified (GM) for insect resistance and herbicide tolerance.
The trial is authorised to take place between October 2013 and October 2019 on up to 10 sites of 10 hectares (ha) for the first two years and up to 20 sites of 30 ha in subsequent years. Sites are to be selected from 56 possible local government areas (LGAs) in Western Australia, NSW and Queensland. The primary purpose of the field trial is to assess the agronomic performance of the GM cottons under Australian field conditions. The GM cottons will not be used for human food or animal feed.
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, location and duration, as these were important considerations in the evaluation process.
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. Four 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 complete 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 120 page of the Office of the Gene Technology Regulator’s website or requested via the contacts detailed below.
Office of the Gene Technology Regulator
PDF version of DIR 120 - Notification of decision on GM cotton field trial
PDF version of DIR 120 Questions & Answers
PDF version of DIR 120 Summary of the Risk Assessment and Risk Management Plan (RARMP)
PDF version of DIR 120 - Full Risk Assessment and Risk Management Plan (RARMP)
PDF version of DIR 120 - Licence Application Summary
PDF version of DIR 120 - GM cotton 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 Gossypium hirsutum L. and Gossypium barbadense L. (cotton) in Australia)