Risk Assessment and Risk Management Plan Application for licence for dealings involving intentional release of a genetically modified organism into the environment dir 034/2003 Title: Field Trial of Genetically Modified Cotton

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The Evaluation Process

Licence application DIR034/2002 from Syngenta has been evaluated and a RARMP has been prepared, in accordance with the Act and the Regulations, using a Risk Analysis Framework. This framework was developed by the Regulator in consultation with the public and key State, Territory and Commonwealth government stakeholders and the Gene Technology Technical Advisory Committee, and is available at www.ogtr.gov.au/pdf/public/raffinal.pdf.

Details of the process that the Regulator must follow, including the prescribed consultation process on the application, and the matters that must be considered in preparing a RARMP, are set out in Appendix 8 of the RARMP. The complete RARMP can be obtained from the Office of the Gene Technology Regulator’s (OGTR’s) website at www.ogtr.gov.au or by contacting this office.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has a complimentary regulatory role in respect of this application due to its responsibility for agricultural chemical use, including insecticides and herbicides in Australia under the Agricultural and Veterinary Chemicals (Code) Act 1994. For commercial products, the normal form of approval is through registration, but the APVMA may also issue permits allowing restricted use of an insecticide or herbicide, for example for a limited period of time or for a limited area.

In considering applications for registration or permits, the APVMA also considers a number of issues that are outside the scope of the Gene Technology Regulator’s assessment, such as the efficacy of herbicides and insecticides, and herbicide and insect resistance management. The APVMA can impose conditions on the use of herbicides or insecticides in registrations and permits. Registration conditions are normally incorporated in the label of the product. Further information about how the APVMA’s assessment and approval processes can be obtained from their website http://www.apvma.gov.au/.

Syngenta has submitted a separate application to the APVMA for obtaining research permits for the use of the insecticidal gene. The APVMA and the OGTR work closely together to ensure thorough coordinated assessments are undertaken and, wherever possible, that timing of assessments and decisions by both agencies coincide.

The risk assessment considered information contained in the application (including information required by the Act and the Regulations on the GMO, the parent organism, and the proposed dealings and on potential impacts on human health and safety and the environment), submissions received during consultation and current scientific knowledge.

Through this process, potential hazards to human health and safety or the environment that may be posed by the release of the GM cotton were identified. These were evaluated on the basis of the likelihood of the hazard occurring and the likely impact of the hazard, were it to be realised. The identified potential hazards relate to:

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