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DIR 103 Risk Assessment and Risk Management Plan Executive Summary
6 August 2010
Executive Summary of the Risk Assessment and Risk Management Plan for Application No. DIR 103 from Victorian Department of Primary Industries
Introduction
The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of application DIR 103 from the Victorian Department of Primary Industries (DPI Victoria). The licence authorises dealings involving the limited and controlled release of up to 10 lines
1 of genetically modified (GM) canola into the environment.
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 Regulator before making a decision whether or not to issue a licence to deal with a genetically modified organism (GMO). The decision is based upon a Risk Assessment and Risk Management Plan (RARMP) prepared by the Regulator in accordance with requirements of the legislation. RARMPs apply the
Risk Analysis Framework and are finalised following consultation with a wide range of experts, agencies and authorities, and the public
2.
The application
DPI Victoria has applied for a licence for dealings involving the intentional release of up to 10 lines of GM canola on a limited scale and under controlled conditions. The GM canola lines have been genetically modified for enhanced yield and delayed leaf senescence. The trial may take place at two sites at Victorian government research stations in the local government areas of Horsham and Southern Grampians, on a maximum combined area of 0.8 ha per growing season, between the date of issue of the licence and May 2012. The applicant proposed planting in both summer and winter growing seasons.
The purpose of the trial is to conduct experiments to evaluate agronomic performance, including seed yield, of the GM canola lines under field conditions. Some seed would be collected and retained for analysis and possible future trials, subject to further approval(s). Material from the GM canola will not be used in human food or animal feed.
The applicant intends to release GM canola modified to contain a gene derived from a common soil bacterium. Expression of the gene is expected to enhance yield and delay leaf senescence in the GM canola plants. The GM canola lines also contain an antibiotic resistance gene which was used to identify transformed plants during initial development of the GM plants in the laboratory.
DPI Victoria proposed a number of controls to restrict the spread and persistence of the GM canola lines and the introduced genetic materials in the environment that were considered during the evaluation of the application.
Confidential Commercial Information
Some details, including unpublished data from glasshouse experiments, have been declared Confidential Commercial Information (CCI) under section 185 of the Act. The confidential information was made available to the prescribed experts and agencies that were consulted on the RARMP for this application.
Risk assessment
The risk assessment took into account information in the application (including proposed containment measures), previous approvals and relevant scientific/technical knowledge. Advice relating to risks to human health and safety and the environment provided in submissions received during consultation on the RARMP has also been considered. No new risks to people or the environment were identified from the advice received on the consultation RARMP.
Initially, potential pathways that might lead to harm to people or the environment as a result of gene technology were postulated (risk scenarios), and these scenarios were evaluated to identify those that warrant detailed characterisation. This process is described as risk identification.
Eight 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; alter characteristics that may impact on the spread and persistence of the GM canola; or produce unintended changes in the biochemistry of the GMO. 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 eight risk scenarios in relation to both the seriousness and likelihood of harm, in the context of the control measures proposed by the applicant, did not identify any risks that required further assessment.
Risks to the health and safety of people, or the environment, from the proposed release of the GM canola lines 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 environment.
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 the licence conditions.
As none of the eight 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, conditions are imposed to restrict the spread and persistence of the GMOs and their genetic material in the environment and to limit the proposed release to the size, locations and duration requested by the applicant, as these were important considerations in establishing the context for assessing the risks.
The licence conditions require DPI Victoria to
limit the release to a total area of 0.8 ha per growing season at two sites between the date of issue of the licence and May 2012. The
control measures include containment provisions at the trial site; preventing the use of GM plant materials in human food or animal feed; destroying GM plant materials not required for further research or planting; transporting GM plant materials in accordance with the Regulator’s transportation guidelines; and conducting post-harvest monitoring at the trial sites to ensure all GMOs are destroyed.
Conclusions of the RARMP
The risk assessment concluded that this limited and controlled release of up to 10 lines of GM canola on a maximum total area of 0.8 ha per growing season over two years in the Victorian local government areas of Horsham and Southern Grampians, poses
negligible risks to the health and safety of people or the environment as a result of gene technology.
The risk management plan concluded that these
negligible risks do not require specific risk treatment measures. However, licence conditions have been imposed to limit the release to the size, locations and duration proposed by the applicant, 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.