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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Section 4 Research Requirements


  1. As part of the OGTR’s ongoing commitment to review of data, research conditions have been imposed for a number of cotton DIR licences. This research is intended to confirm previous research on pollen and gene flow undertaken prior to the implementation of the Gene Technology Act 2000. For the proposed release, the following research is required:

  • detailed study on efficacy of pollen traps in controlling gene transfer through pollen to non-GM cotton and feral cotton.

  • the potential toxicity of the GM insecticidal cotton, including more information on potential toxicity to non-target organisms and effect on soil micro-organisms; and

  • the potential weediness of the GM cotton under Australian field conditions.

  1. Before any application for a significantly larger-scale release and/or reduced containment or commercial release of the GM cotton containing the vip3A gene could be evaluated, more detailed information will be required:

  • the levels of expression of the introduced genes in different parts of the plant under Australian field conditions;

  • characterisation of molecular basis and details of specificity of the insecticidal VIP3A protein;

  • genetic segregation, molecular characterisation and stability of the inserted genetic material; and

  • the potential for the introduced proteins to accumulate and persist in the soil and water.

  1. It should be noted that provision of the above data during the proposed release are not required to ensure the management of risks to human health and safety and the environment from the proposed release. The risk management measures summarised in the Table above and given effect by the licence conditions, will achieve this purpose.

  2. In addition, the results of research required as a condition of licences for other releases of this GMO (DIR 017/2002 and DIR 025/2002) would also be available to the Regulator.



Appendix 1 INFORMATION ABOUT THE GMO



  1. In preparing the risk assessment and risk management plan, the Regulator is required under Section 49 (2) of the Act to consider the properties of the parent organism and the effects of the genetic modification.

  2. This Appendix addresses these matters and provides detailed information about the GMO proposed for release, the parent organism, the genetic modification process, the genes that have been introduced and the new proteins that are expressed in the genetically modified cotton.

  3. In accordance with Section 185 of the Act, details of the gene construct, including the plasmid map and the regulatory sequences have been declared as Confidential Commercial Information (CCI). However, all CCI was made available to the prescribed expert groups which were consulted in the preparation of the risk assessment and risk management plan.



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