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Gazette-News-Web-Mail list-Public Notice DIR 019

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Gazette-News-Web-Mail list-Public Notice DIR 019 Powered By Docstoc
					Office of the Gene Technology Regulator 15 October 2003

EXECUTIVE SUMMARY of

The Risk Assessment and Risk Management Plan
for

Application No. DIR 034/2002
from

Syngenta Seeds Pty Ltd
{Field trial of genetically modified cotton (Gossypium hirsutum) expressing an insecticidal gene (vip3A) } EXECUTIVE SUMMARY Introduction The Gene Technology Act 2000 (the Act) and the Gene Technology Regulations 2001 (the Regulations) set out requirements which the Gene Technology Regulator (the Regulator) must follow when considering an application for a licence to intentionally release a genetically modified organism (GMO) into the environment. For a licence to be issued, the Regulator must be satisfied that the release will not pose any risks to human health and safety or the environment that can not be managed. To this end, Section 51 of the Act requires the Regulator to prepare a risk assessment and risk management plan (RARMP) for each licence application, in consultation with a wide range of expert groups and stakeholders. Under Section 52 of the Act, the Regulator is required to seek comment on the RARMP from those consulted in its preparation and to invite submissions from the public. Matters raised relating to the protection of human health and safety or the environment are taken into account in finalising the RARMP, which then forms the basis of the Regulator’s decision on whether, or not, to issue a licence. The application Syngenta Seeds Pty Ltd (Syngenta) applied for a licence (application number DIR 034/2003) for the intentional release, under limited and controlled conditions, of genetically modified (GM) insecticidal cotton into the environment. Syngenta plans to carry out a trial covering a total area of less than 10 hectares at a maximum of 30 sites selected from 16 shires in Queensland and New South Wales, from October 2004 – May 2006. The GM cotton proposed for release is a backcross of an insecticidal cotton, described by Syngenta as COT102, into three elite non-GM Australian cotton cultivars. Limited and controlled field trials of COT102 have been previously approved in Australia under PR-151, DIR 017/2002 and DIR 025/2002. The Regulator is also considering another application, DIR036/2003, for field trial of GM insecticidal cotton with COT102 event and recently released a RARMP for public consultation (available at www.ogtr.gov.au). The main aim of the proposed release is to assess the agronomic performance and efficacy of the insecticidal activity of the new lines in all the major cotton growing areas of Australia.

The GM cotton contains an insecticidal gene (vip3A), derived from a common soil bacterium that encodes an insecticidal protein (VIP3A) that is toxic to lepidopteran caterpillar pests of cotton. It also contains a bacterial gene hph, conferring resistance to hygromycin, an antibiotic that was used as a selectable marker in the initial laboratory stages of developing the GM cotton. In accordance with the provisions of section 185 of the Act, Syngenta sought and received approval for details of the plasmid map, including the gene construct containing the insecticidal vip3A gene, and the regulatory sequences (promoters) to be declared Confidential Commercial Information (CCI). However, the CCI was made available to the various prescribed expert groups which were consulted on the preparation of the RARMP. The proposed field trial is part of an ongoing breeding program to develop GM insecticidal cotton varieties that are suitable for commercial release (subject to future applications and approvals) in Australian conditions. The insecticidal VIP3A protein produced by this GM cotton is different from insecticidal (Cry) proteins that are present in most other types of GM cotton that are currently being trialed or grown commercially in Australia. None of the cotton plants from the proposed release, or their by-products, will be used for human food or animal feed. The applicant proposes to sell the lint for use in clothing and upholstery. Lint does not contain genetic material or protein. As mentioned above, under the former voluntary system overseen by the Genetic Manipulation Advisory Committee (GMAC), CSIRO conducted a limited and controlled release of GM cotton containing the same insecticidal gene in less than 0.05 hectare in New South Wales (PR-151). 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 in Southern Australia in 2002-03. In May 2003, the Regulator issued a 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 in northern Australia in 2003. There have been no reports of adverse effects on human health or the environment resulting from any of the releases that have occurred to date. 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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Toxicity or allergenicity to humans: could the GM cotton be more toxic or allergenic than non-GM cotton, as a result of the novel gene products or because of unintended effects? Toxicity to non-target organisms: could the GM cotton be harmful to non-target organisms as a result of the novel gene products or because of unintended effects? Weediness: could the GM cotton be harmful to the environment because of inherent weediness or increased potential for weediness? Gene transfer: could the new genes introduced into the cottons transfer to non-GM cotton crops, feral or native cottons, or to other organisms, with adverse consequences? Insecticide resistance: could target insects develop resistance to the insecticidal protein produced by the introduced insecticidal gene in the GM cotton?

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Conclusions of the Risk Assessment The Regulator considers that the limited and controlled release of the GM insecticidal cotton will not pose risks to public health and safety, or to the Australian environment, that cannot be managed. The assessment of each potential hazard identified above is summarised under a separate heading below. Toxicity or allergenicity to humans The GM cotton is unlikely to prove more toxic or allergenic to humans than non-GM cotton. Toxicity to VIP3A protein is specific to lepidopteran caterpillars. There have been no reports of toxic or allergenic effects from previous releases and there is no sequence homology with known allergens or toxins for the expressed proteins. Humans are commonly exposed to VIP3A and Hph, as these proteins are widespread in the environment. GM cotton pollen is not wind dispersed and unlikely to

be allergenic. Lint from the release would be sold commercially for use in fabric, upholstery and other non-food products, as lint contains no DNA or protein and is not used in food. However, none of the material from the release will be used in human food or therapeutics. Therefore, the potential for human exposure to the GM cotton is very low. Food Standards Australia New Zealand (FSANZ) is responsible for human food safety assessment, and FSANZ approval would be needed before products from these GM cottons could be used in human food. The applicant has advised that it has applied to FSANZ for pre-market safety assessment of material from the GM cotton for use in human food. Toxicity to non-target organisms The GM cotton is unlikely to prove more toxic to non-target organisms than non-GM cotton. Toxicity to VIP3A protein is specific to lepidopteran caterpillars. Organisms are commonly exposed to VIP3A and Hph, as these proteins are widespread in the environment. There have been no reports of toxic effects from previous releases and there is no sequence homology with known toxins for the new proteins. The proposed release is small, limited and controlled and none of the material from the release will be used in animal feed. Therefore, the potential for non-target organism exposure to the GM cotton is very low. Weediness The risk of the GM cotton establishing as a weed is low and not likely to be greater than that of non-GM cotton. Cotton does not possess characteristics commonly associated with weediness, and is not known to be a problematic weed in any environment. Major constraints on weediness of GM and non-GM cotton are water availability, nutrient availability, plant competition, herbivory by non-lepidopteran species, frost and fire. Cotton has low dispersal by natural means. Volunteers do not spread or persist in the environment and can be easily controlled by cultivation or herbicides. The genetic modifications are unlikely to change these characteristics. The licence includes conditions to minimise this risk. Gene transfer Some gene transfer from the GM cottons to other cultivated cottons would be likely under uncontrolled conditions, even though the overall frequency of out-crossing would be very low. It is highly unlikely, that the inserted genes would alter the likelihood or frequency of such gene transfer. Even if this occurred, it would not pose any risks additional to those posed by the GM cotton itself. The potential for gene transfer to native cotton species is negligible due to geographic isolation from known populations and genetic incompatibility which prevents the production of fertile hybrids. The potential for gene transfer to feral (naturalised) cotton is low because of geographic isolation of such populations from the trial site. The likelihood of transfer of the introduced genes to other plants and organisms is negligible due to genetic incompatibility, but even if such transfer occurred it would be unlikely to pose any risk to human health and safety or the environment. The licence includes conditions to minimise this risk. Insecticide resistance This risk would be managed by the APVMA through conditions of the permit for the use of the insecticidal gene as an insecticide in the GM cotton lines.

The Risk Management Plan (Key Licence Conditions) As part of the evaluation process for this licence application, a risk management plan has been developed to addresses the risks identified (refer to Conclusions of the Risk Assessment, above). This plan is given effect by the licence conditions. The key licence conditions are outlined below. Toxicity and allergenicity to humans
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the GM cotton or any material from the GM cotton must not be used for human food or therapeutics; restricting access to the release site to authorised personnel; and securing transport and storage of the GMO and material from the GMO.

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Toxicity to non-target organisms
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GM cotton or any material from the GM cotton must not be used for animal feed; and scale of the release is small, limited and controlled.

Weediness
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a 20m pollen trap of non-GM cotton around the release site; the edge of the pollen trap farthest from the GMO (outer edge of the pollen trap) must not be within 50m of a natural waterway; restricting access to the release site to authorised personnel; destruction of any viable material not required for this or subsequent releases (which would be subject to separate applications and assessments) after the harvest; monitoring the release sites after the harvest and removing volunteers; and securing transport and storage of the GMO and material from the GMO.

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Gene transfer
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limit the total area to be planted to 10 hectare over two seasons; size of each location not to exceed one hectare; a 20m pollen trap of non-GM cotton around the release site; securing transport and storage of the GMO and material from the GMO; cleaning equipment used at release sites; destruction of any viable material not required for this or subsequent releases (which would be subject to separate applications and assessments) after the harvest; and monitoring the release sites after harvest and remove volunteers.

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Insecticide resistance No conditions have been proposed in relation to management of insecticide resistance, as this is the responsibility of the APVMA. The applicant’s obligation to comply with any such conditions imposed by the APVMA is contained in the APVMA permit issued to Syngenta for the purpose of these field trials.

General licence conditions Any licence issued by the Regulator also contains a number of general conditions, which may also be relevant to risk management. These include, for example:
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identification of the persons or classes of person covered by the licence; a requirement that the applicant allow access to the release sites by the Regulator, or persons authorised by the Regulator, for the purposes of monitoring or auditing; and a requirement to inform the Regulator if the applicant becomes aware of any additional information about risks to human health or safety or to the environment.

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Chapter 2 of the risk assessment and the risk management plan provides a tabulated summary of assessment conclusions and corresponding management conditions. Full details of the licence conditions are provided in Appendix 7. Monitoring and enforcement of compliance by the OGTR As well as the legislative capacity to enforce compliance with licence conditions, the Regulator has additional options for risk management. The Regulator can direct a licence holder to take any steps the Regulator deems necessary to protect the health and safety of people or the environment. The OGTR also independently monitors releases that it has authorised. Further Information Detailed information on the evaluation of the application, including the licence conditions imposed, is available in the risk assessment and risk management plan document for this application. This document can be obtained from the web site of the Office of the Gene Technology Regulator (www.ogtr.gov.au), or by calling 1800 181 030 (please quote application number DIR 034/2003).


				
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