Australia
March 21, 2012
DIR 112 - Notification of decision to issue a licence on application
NOTIFICATION OF DECISION
Issue of licence DIR 112 to Commonwealth Scientific and Industrial Research Organisation for a limited and controlled release of GM wheat and barley
On 21 December 2011, the Regulator invited submissions on the consultation version of the Risk Assessment and Risk Management Plan (RARMP) for licence application DIR 112 from Commonwealth Scientific and Industrial Research Organisation (CSIRO).
The Gene Technology Regulator has now made a decision to issue a licence in respect of application DIR 112, authorising the limited and controlled release of up to 118 lines of GM wheat and 40 lines of GM barley that have been modified for altered grain composition and nutrient utilisation efficiency.
The release is authorised to take place at one site in the New Genes for New Environments (NGNE) facility, near Merredin, Western Australia, on a maximum area of 1.0 ha per year between May 2012 and June 2015, inclusive. This facility is operated by the Department of Agriculture and Food, Western Australia (DAFWA). The purpose of the three year field trial is to assess whether the respective genetic modifications result in increased biomass and yield of the GM plants with respect to unmodified plants. The GM wheat and barley will not be permitted to enter the human food or animal feed supply chains.
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 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 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. Forty-four submissions were received from the public on the consultation RARMP and the issues raised 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 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 http://www.ogtr.gov.au
DIR 112 - Questions and Answers
DIR 112 - Risk Assessment and Risk Management Plan (RARMP) Executive Summary
DIR 112 - Risk Assessment and Risk Management Plan (RARMP) Technical Summary
DIR 112 - Full Risk Assessment and Risk Management Plan (RARMP) for the limited and controlled release of wheat and barley genetically modified for altered grain composition and nutrient utilisation efficiency
DIR 112 - Licence Application Summary
DIR 112 - GM wheat and barley licence conditions
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