Australia November 21, 2018 The Regulator has issued licence DIR 164 to Monsanto Australia Proprietary Limited, authorising the limited and controlled release (field trial) of canola genetically modified (GM) for herbicide tolerance. The RARMP and the licence were finalised taking into account input received during consultation with the public, State and Territory governments, Australian Government agencies, the Minister for the Environment, the Gene Technology Technical Advisory Committee and local councils. The Regulator thanks submitters for their contributions. Submissions are summarised in Appendix A and Appendix B of the RARMP, together with information about how the issues raised relating to risks to human health and safety or the environment were considered in preparing and finalising the document. The finalised RARMP concludes that this field trial poses negligible risks to the health and safety of people and the environment, thus it does not require specific risk treatment measures. However, licence conditions have been imposed to restrict spread and persistence of the GMOs and their genetic material in the environment and to limit the size, location and duration of the release, as these were important considerations for risk assessment. The finalised RARMP, a summary of the RARMP, the Licence and Questions and Answers about this decision, can be obtained online from the DIR 164 page of the Office of the Gene Technology Regulator’s website or requested via the contacts detailed below. An interactive map showing locations of field trial sites can also be found on the OGTR website. Office of the Gene Technology Regulator MDP 54 GPO Box 9848 CANBERRA ACT 2601 Tel: 1800 181 030 E-mail: ogtr@health.gov.au OGTR website DIR 164 Limited and controlled release of canola genetically modified for herbicide tolerance – Monsanto Australia Limited DIR 164 documents The following documents are available for DIR 164: Questions and Answers on licence decision A series of questions and corresponding answers on the licence application and the Regulator’s decision to issue a licence for this application. PDF format - 85 KB DOCX format - 27 KB Summary of Risk Assessment and Risk Management Plan The document summarises the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan. PDF format - 150 KB DOCX format - 82 KB Full Risk Assessment and Risk Management Plan The document details the risk assessment and risk management plan prepared as part of the Regulator’s decision making process for this application. It explains the risk assessment context, provides an assessment of risks posed by the GMO(s) and details whether any of those risks require management. It also includes a summary of submissions received during the public consultation process. PDF format - 828 KB DOCX format - 418 KB Licence Conditions The document explains the licence conditions imposed by the Regulator. It provides details of the licence holder’s obligations, including both general conditions required in all licences and specific conditions for this licence, as well as reporting requirements. PDF format - 425 KB DOCX format - 173 KB Reference material Risk Analysis Framework for licence applications to the Office of the Gene Technology Regulator (2013) The Biology of Brassica napus L. (canola) and Brassica juncea (L.) Czern. & Coss. (Indian mustard)
Australian regulators cleared Monsanto ’s field trial for genetically modified canola . The licence was given to Monsanto Australia plc and a Risk Assessment and Risk Management Plan ( RARMP ) said the field trial posed “ negligible ” health risks . The licence was granted after consultation with national and local government agencies and local councils . restrictions were imposed , however , to stop the spread of the genetically modified species and to limit the trial duration .