* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download Application No. DIR 115 - Office of the Gene Technology Regulator
Survey
Document related concepts
Therapeutic gene modulation wikipedia , lookup
Public health genomics wikipedia , lookup
Site-specific recombinase technology wikipedia , lookup
Biology and consumer behaviour wikipedia , lookup
Gene expression programming wikipedia , lookup
Gene expression profiling wikipedia , lookup
Artificial gene synthesis wikipedia , lookup
Genome (book) wikipedia , lookup
Genetic engineering wikipedia , lookup
Nutriepigenomics wikipedia , lookup
Designer baby wikipedia , lookup
Microevolution wikipedia , lookup
Genetically modified food wikipedia , lookup
Genetically modified crops wikipedia , lookup
Genetically modified organism containment and escape wikipedia , lookup
Transcript
21 May 2012 TECHNICAL SUMMARY OF THE RISK ASSESSMENT AND RISK MANAGEMENT PLAN (CONSULTATION VERSION) FOR APPLICATION NO. DIR 115 FROM THE COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION (CSIRO) Introduction A licence application (DIR 115) has been received from Commonwealth Scientific and Industrial Research Organisation (CSIRO) for a limited and controlled release of genetically modified (GM) cotton. The Gene Technology Act 2000 (the Act), the Gene Technology Regulations 2001 and corresponding state and territory law govern the comprehensive and highly consultative process undertaken by the Gene Technology Regulator (the Regulator) before making a decision whether or not to issue a licence to deal with a genetically modified organism (GMO). In accordance with the gene technology legislation, a detailed Risk Assessment and Risk Management Plan (RARMP) for the dealings proposed by the applicant has been prepared for consultation. The Regulator now invites submissions in order to finalise the document, which will then form the basis of his decision whether or not to issue a licence. The application CSIRO has applied for a licence for dealings involving the intentional release of eight types of GM cotton into the environment on a limited scale and under controlled conditions. The GM cotton plants have been genetically modified for enhanced fibre yield. The applicant proposes to conduct the trial between August 2012 and August 2015 at one site per growing season at the local government area of Narrabri, New South Wales. The maximum area of a site would be 0.5 ha. The purpose of the trial is to evaluate the potential for increasing fibre yield by increasing expression of one or more of the three cotton genes that are all involved in regulation of fibre development. The trial will establish whether these regulatory genes are valid targets for genetic modification for enhancing fibre yield and will also generate information on genetic regulation of fibre development. The GM cotton would not be permitted to enter the human or animal food supply chains. The applicant proposes to release eight types of GM cotton plants modified to over-express one or more of the GhMYb25, GhMYB25-like and GhHD1 genes either constitutively or in a seed specific manner. All the three genes are from cultivated cotton Gossypium hirsutum and encode gene transcription factors (proteins that regulate expression of their target genes). The GM cotton plants intended for release are expected to have higher fibre yield as compared to the parent cultivar. All Office of the Gene Technology Regulator the GM cotton plants also contain an antibiotic resistance marker gene, nptII, which was used to select the GM plants during development of the plants in the laboratory. The GM cotton plants also contain short regulatory sequences that control expression of the introduced genes. Regulatory sequences were derived from plants (Petunia hybrida, Flavaria bidentis) or plant viruses (Subterranean Clover Stunt Virus). Six of the eight types of GM cotton plants proposed for release contain a single genetic modification or ‘transformation’ event (primary lines1). The remaining two types of the GM cotton will contain two or more transformation events combined or ‘stacked’ (stacked lines) by conventional cross-breeding between the primary lines. None of the GM cotton plants has been previously approved by the Regulator for limited and controlled release in Australia or by regulatory authorities in other countries. CSIRO proposes a number of controls to restrict the spread and persistence of the GM cotton plants and their genetic material into the environment. These controls have been considered during the evaluation of the application. Risk assessment The risk assessment takes into account information in the application (including proposed containment measures), relevant previous approvals and current scientific/technical knowledge. A reference document, The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton), was produced to inform the risk assessment process for licence applications involving GM cotton plants. The document is available from the OGTR or from the website <http://www.ogtr.gov.au>. Initially, potential pathways that might lead to harm to people or the environment as a result of gene technology are postulated (risk scenarios), and those that warrant detailed characterisation are determined. This process is described as risk identification. Four risk scenarios were postulated, including consideration of whether or not expression of the introduced genes could result in products that are toxic or allergenic to people or other organisms or alter characteristics that may impact on the spread and persistence of the GM cotton The opportunity for gene flow to other organisms, and its effects if it were to occur, was also assessed. A risk is only identified for further assessment when a risk scenario is considered to have some chance of causing harm. Pathways that do not lead to an adverse outcome, or could not reasonably occur, do not advance in the risk assessment process. The characterisation of the four risk scenarios in relation to both the seriousness and likelihood of harm, in the context of the control measures proposed by the applicant and considering both the short and the long term, did not give rise to any identified risks that required further assessment. The principal reasons for this include: widespread presence of the same or similar proteins encoded by the introduced genes in the environment and lack of known toxicity or evidence of harm from them. plant characteristics and abiotic factors limiting the ability of GM or non-GM cotton plants to establish and persist in non-cultivated environments limited ability and opportunity for the GM cotton plants to transfer the introduced genes to commercial cotton crops or other cotton plants The term ‘line’ is used to denote plants derived from a single plant containing a specific genetic modification resulting from a single transformation event. 1 2 Office of the Gene Technology Regulator limits on the size, location and duration of the release proposed by CSIRO the controls proposed by CSIRO to restrict the spread and persistence of the GM cotton plants and their genetic material none of the GM plant materials or products will be permitted to enter commercial human or animal food supply chains. Risks to the health and safety of people, or the environment, from the proposed release of the GM cotton into the environment are assessed to be negligible. Hence, the Regulator considers that the dealings involved in this limited and controlled release do not pose a significant risk to either people or the environment2. Risk management plan Risk management is used to protect the health and safety of people and to protect the environment by controlling or mitigating risk. The risk management plan evaluates and treats identified risks, evaluates controls and limits proposed by the applicant, and considers general risk management measures. The risk management plan is given effect through proposed licence conditions. As none of the four risk scenarios characterised in the risk assessment give rise to an identified risk that requires further assessment, the level of risk from the proposed dealings is assessed to be negligible. The Regulator's Risk Analysis Framework defines negligible risks as insubstantial, with no present need to invoke actions for their mitigation in the risk management plan. However, a range of conditions are proposed to restrict the spread and persistence of the GMOs and their genetic material in the environment and to limit the release to the size, locations and duration proposed in the application, as these were important considerations in establishing the context for assessing the risks. Proposed licence conditions The Regulator has proposed a number of licence conditions, including requirements to: limit the release to 0.5 ha per growing season in the LGA of Narrabri, NSW between August 2012 and August 2015 restrict gene flow via pollen from the field trial site by surrounding the trial site with a 20 m pollen trap of non-GM cotton harvest and gin any GM cotton plant material required for analysis or future planting separately from other cotton crops clean all equipment used in connection with the cotton plant material destroy any excess plant material not required for analysis or future planting after cleaning of sites, apply measures to promote germination of any cotton seeds that may be present in the soil after cleaning of sites, monitor for and destroy any GM cotton that may grow for at least 12 months, and until no volunteers are observed for a continuous 6 month period transport and store the GM plant material in accordance with the Regulator’s guidelines or other specific conditions 2 If the Regulator considers that none of the proposed dealings pose a significant risk to people or the environment, section 52(2)(d)(ii) of the Act mandates a minimum period of 30 days for consultation on a RARMP. However, the Regulator has allowed up to 6 weeks for the receipt of submissions from prescribed experts, agencies and authorities and the public. 3 Office of the Gene Technology Regulator not allow GM plant material or products to be used for human food or animal feed. Other regulatory considerations Australia's gene technology regulatory system operates as part of an integrated legislative framework that avoids duplication and enhances coordinated decision making. The Regulator is responsible for assessing risks to the health and safety of people and the environment associated with the use of gene technology. However, dealings conducted under a licence issued by the Regulator may also be subject to regulation by other Australian government agencies that regulate GMOs or GM products, including Food Standards Australia New Zealand (FSANZ), Australian Pesticides and Veterinary Medicines Authority, Therapeutic Goods Administration, National Industrial Chemicals Notification and Assessment Scheme and Department of Agriculture, Fisheries and Forestry (DAFF) Biosecurity3. FSANZ is responsible for human food safety assessment and food labelling, including GM food. The applicant does not intend to use materials generated from the GM cotton plants in the proposed release in human food or in animal feed. In addition, dealings authorised by the Regulator may be subject to the operation of State legislation declaring areas to be GM, GM free, or both, for marketing purposes. In addition, dealings authorised by the Regulator may be subject to the operation of State legislation declaring areas to be GM, GM free, or both, for marketing purposes. Identification of issues to be addressed for future releases Additional information has been identified that may be required to assess an application for a large scale or commercial release of these GM cotton plants, or to justify a reduction in containment conditions. This includes: additional phenotypic characterisation of the GM cotton plants, in particular of traits which may contribute to weediness additional molecular and biochemical characterisation of the GM cotton plants including potential for increased toxicity. Conclusions of the consultation RARMP The risk assessment concludes that this limited and controlled release of eight types GM cotton planted at one site per growing season with a maximum area of 0.5 ha over three years in Narrabri, New South Wales poses negligible risks to the health and safety of people or the environment as a result of gene technology. The risk management plan concludes that these negligible risks do not require specific risk treatment measures. If a licence were to be issued, conditions are proposed to limit the release in size, locations and duration, and to require controls in line with those proposed by the applicant as these were important considerations in establishing the context for assessing the risks. More information on Australia’s integrated regulatory framework for gene technology is contained in the Risk Analysis Framework available from the Office of the Gene Technology Regulator (OGTR). Free call 1800 181 030 or at <http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/riskassessments-1>. 3 4