30 April 2012

Issue of licence DIR 113 to Bayer CropScience Pty Ltd for a limited and controlled release of GM cotton


On 13 February 2012, the Gene Technology Regulator (the Regulator) invited submissions on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) for licence application DIR 113 from Bayer CropScience Pty Ltd (Bayer).

The Regulator has now made a decision to issue a licence in respect of application DIR 113, authorising the limited and controlled release (field trial) of 11 GM cotton varieties that have been genetically modified for insect resistance and herbicide tolerance.

The release is authorised to take place at six sites per year, in the local government areas of Narrabri Shire (NSW), Wyndham-East Kimberly (WA) and Central Highlands (Qld), between May 2012 and May 2015. The maximum area of plantings will be 6 ha in the first year and 36 ha in the second and third years, giving a maximum cumulative area of 78 ha. The purpose of the trial is to assess the agronomic performance of the GM cotton varieties under field conditions, and to produce seed for use in further studies or releases. The GM cotton will not be permitted to enter 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, and the Gene Technology Technical Advisory Committee as required by the Gene Technology Act 2000 and corresponding State and Territory laws.

Issues relating to the health and safety of people and the protection of the environment raised during the consultation process were weighed against the body 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 to the size, locations and duration proposed in the application, 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. Two 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.

The Executive Summary, Technical Summary and 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 Office of the Gene Technology Regulator’s website or by contacting the Office.