Australia
February 17, 2012
DIR 111 - Notification of decision to issue a licence on application
NOTIFICATION OF DECISION
Issue of licence DIR 111 to the Commonwealth Scientific and Industrial Research Organisation for a limited and controlled release of GM wheat and barley
On 5 December 2011, 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 111 from the Commonwealth Scientific and Industrial Research Organisation (CSIRO).
The Regulator has now made a decision to issue a licence in respect of application DIR 111, authorising the limited and controlled release of a range of GM wheat and barley lines that have been genetically modified (GM) for altered grain composition, nutrient utilisation efficiency, disease resistance or stress tolerance.
The release is authorised to take place at one site in the Australian Capital Territory, on a maximum area of 2.3 ha per year between May 2012 and June 2017. The purpose of the trial is to assess the agronomic performance and grain properties of the GM wheat and barley lines grown under field conditions. The GM wheat and barley will not be used in commercial human food or animal feed. However, products derived from the grain of a few GM wheat and barley lines with altered grain composition may be used for a range of carefully controlled small scale animal nutritional trials, and products from the same GM wheat lines may be used in human nutritional trials.
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 in the size, location and duration requested by the applicant, 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. Three 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 111 - Questions and Answers
DIR 111 - Risk Assessment and Risk Management Plan (RARMP) Executive Summary
DIR 111 - Risk Assessment and Risk Management Plan (RARMP) Technical Summary
DIR 111 - Full Risk Assessment and Risk Management Plan (RARMP) for the limited and controlled release of wheat and barley genetically modified for altered grain composition, nutrient utilisation efficiency, disease resistance or stress tolerance
DIR 111 - Licence Application Summary
DIR 111 - GM wheat and barley licence conditions
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