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


Section 2 Previous Releases and International Approvals



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Section 2 Previous Releases and International Approvals


Section 2.1 Previous Australian Releases

  1. One limited and controlled release (PR-151, field trial) of the GM insecticidal cotton with COT 102 event was approved under the previous voluntary system overseen by the Genetic Manipulation Advisory Committee (GMAC) and conducted in accordance with GMAC guidelines. PR‑151 was conducted by CSIRO at the Australian Cotton Research Institute, Narrabri (NSW) and the size of the field trial was approximately 3000 plants in 0.05 hectares.

  2. In October 2002, the Regulator issued a licence to CSIRO (licence number DIR 017/2002) to conduct a limited and controlled release of the same GM cotton at three trial sites, totalling 3.0 hectares, in New South Wales during the cotton growing season - September 2002 to April 2003. In May 2003, the Regulator issued another licence to CSIRO (licence number DIR 025/2002) to conduct a limited and controlled release of the same GM cotton at three trial sites, totalling 3.0 hectares, in Western Australia during the cotton growing season - May 2003 to October 2003.

  3. Furthermore, other GM insecticidal cottons with similar genes (cry genes target different receptors in lepidopterans) derived from the same bacterium have been trialed extensively in Australia (eg. DIRs 005/2001, 006/2001, 008/2001 and 009/2001), as well as commercially released under licences DIR 012/2001 (Bollgard® II cotton) and DIR 022/2002 (INGARD® cotton).

  4. There have been no reports of adverse effects on human health and safety or the environment resulting from any of these trials.

Section 2.2 Approvals by other Australian government agencies

  1. The OGTR is responsible for assessing the biosafety risks to human health and the environment associated with development and use of GMOs. Other government regulatory requirements must also be met in respect of the release of the GMO, and the use of products of the GMO, including the requirements of the Australian Pesticides and Veterinary Medicines Authority (APVMA) and Food Standard Australia New Zealand (FSANZ).

  2. The 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.

  3. 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.

  4. Syngenta has advised that it 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.

  5. Further information about the management of insecticide resistance is available from the APVMA:

Australian Pesticides and Veterinary Medicines Authority

PO Box E240

KINGSTON ACT 2604

Phone: (02) 6272 5852

Fax: (02) 6272 4753

Email: contact@apvma.gov.au

http://www.apvma.gov.au


  1. Food Standards Australia New Zealand (FSANZ), is responsible for human food safety assessment and labelling, including for GM foods. Syngenta has advised that it has applied to FSANZ for pre-market safety assessment of material from the GM cotton for use in human food. FSANZ approval would need to be obtained before the GM insecticidal cotton could be used in human food. Further information about food safety and food labelling is available from FSANZ:

Food Standards Australia New Zealand

PO Box 7186

Canberra Mail Centre ACT 2610

Phone: (02) 6271 2222

Fax: (02) 6271 2278

E-mail: info@foodstandards.gov.au



http://www.foodstandards.gov.au
Section 2.3 International approvals

  1. The GM insecticidal cotton proposed for release has not been released outside Australia. However, GM cotton containing the same insecticidal gene has been tested in field trials in the United States. Since 2000, the US Department of Agriculture has approved a number of field trials with other backcrosses of COT102 GM insecticidal cotton. No adverse effects on human health or the environment have been reported.





















































Chapter 2 Summary of Risk assessment AND Risk management Plan

  1. The Act and the Regulations require that risks associated with dealings with GMOs are identified and assessed as to whether they can be managed to protect human health and safety and the environment (see Appendix 8).

Section 1 Issues Raised in Submissions on the Application and the Risk Assessment and Risk management plan


  1. Comments received in response to the consultation with expert groups and authorities on the preparation of the risk assessment and risk management plan (RARMP) under Section 50 of the Act, and with the same stakeholders and the public on the RARMP under Section 52 of the Act (see Appendix 8) were very important in shaping this RARMP, which forms the basis of the Regulator’s final decision on the application.

  2. Written submissions in relation to DIR 034/2003 raised the following issues relating to risks to human health, safety or the environment that have been addressed in the RARMP:

  • characterisation and stability of the inserted genes (Appendix 1, section 3, 4; Chapter 2, section 4 refers);

  • expression levels of the introduced proteins in different parts of the plant (Appendix 1, section 7; Chapter 2, section 4 refers);

  • persistence and/or accumulation of VIP3A protein in soil and water (Chapter 2, section 4 refers);

  • mode of action, molecular basis and specificity of VIP3A protein (Appendix 1, section 3, 4; Chapter 2, section 4 refers);

  • potential toxicity and allergenicity of the VIP3A protein (Appendices 2, 3 refers);

  • impact of hygromycin phosphotransferase protein on the environment (Appendix 2, 3 refers);

  • potential weediness of the insecticidal cotton, particularly in favourable habitats such as waterways and in relation to increased fitness conferred by the VIP3A toxin (Appendix 4, section 2 refers);

  • potential for transfer of the introduced genes from the GM insecticidal cotton to - non-transgenic cotton crops, naturalised cultivated cotton populations, native cottons and other native plant species, microorganisms and other organisms (Appendix 5 refers);

  • emergence of insects resistant to the VIP3A toxin (Appendix 6 refers);

  • measures to limit the unintentional dispersal in the environment of cottonseed and cotton pollen beyond the release site (Appendix 4, section 2; Appendices 5 and 7 refer);

  • seed longevity (see Biology and Ecology of Cotton on the OGTR website); and

  • data requirements for the future development of the GMO (Chapter 2, Section 4 refers).

  • The Regulator also received two submissions from the public on this application and the RARMP. These submissions did not raise any specific risks relating to the protection of human health and safety or the environment. Issues such as impacts on domestic markets and export expansion are outside the scope of evaluations conducted under the Act and therefore have not been considered as a part of the assessment process. A summary of these written submissions is provided in Appendix 9.

  1. In accordance with Section 56 of the Act, the Regulator has taken into account all issues raised in written submissions that relate to the protection of human health and safety and the environment in finalising the risk assessment and risk management plan. These issues were considered carefully and weighed against the body of current scientific information in reaching the conclusions set out in this document.

Section 2 Conclusions of the Risk Assessment and the Risk Management Plan


  1. The risk assessment process, detailed in Appendix 8, identified a number of hazards that may be posed by the proposed dealings. The risks posed by these hazards were assessed as being either ‘negligible’, ‘very low’, ‘low’, ‘moderate’, ‘high’ or ‘very high’, by considering:

  • the likelihood of the hazard occurring;

  • the likely consequences (impact) of the hazard, were it to be realised; and

  • risk management options to mitigate any identified risks.

  1. The following table lists each of the potential hazards that were considered during the risk assessment process in the Hazard Identification column and summarises the assessment of each hazard under the column headed Risk. A comprehensive assessment of each identified hazard is provided in Appendices 2 - 6, as cross-referenced in the column headed Summary of Risk Assessment.

  2. Where it is considered that risk management is necessary to protect the health and safety of humans and/or the environment, the Risk Management column identifies the selected methods and the reasons they were chosen. A risk management plan for the proposed dealing has been given effect by the conditions within the licence. These conditions are summarised in the final column, headed Licence Conditions, and detailed in Appendix 7.

  3. Further information on additional research requirements is contained in Section 4. The research is intended to confirm previous work on gene flow and validate the containment measures applied to limited and controlled GM cotton trials. It will also generate data required for the assessment of future applications.





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