28 May 2009
The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of licence application DIR 092 from the Commonwealth Scientific and Industrial Research Organisation (CSIRO). The licence authorises dealings involving the limited and controlled release of 16 lines of genetically modified (GM) wheat with altered grain composition 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 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 the Risk Analysis Framework
and finalised following consultation with a wide range of experts, agencies and authorities and the public1
CSIRO applied for a licence for dealings involving the intentional release of 16 lines of GM wheat on a limited scale and under controlled conditions. The GM wheat lines have been genetically modified for altered grain composition. The trial will take place at one site in the Australian Capital Territory, on a maximum area of 1 ha, between July 2009 and June 2012.
The GM wheat lines contain gene fragments designed to decrease expression of five genes or gene families involved in determining final grain quality, and an antibiotic resistance gene which was used to identify transformed plants during initial development of the GM plants in the laboratory. Decreased expression of the targeted genes results in alterations to starch, protein or metabolite composition of the grain.
The purpose of the trial is to evaluate grain properties of the GM wheat lines grown under field conditions. This requires generating sufficient grain for examination of dough properties and end quality of grain products, and also for rat and pig nutritional trials to determine whether altered grain composition changes the nutritional properties of the GM wheat. With the exception of rat and pig nutritional trials, the GM wheat will not be used for human food or animal feed.
CSIRO proposed a number of controls to restrict the dissemination and persistence of the GM wheat lines and the introduced genetic materials in the environment that have been considered during the evaluation of the application.
Confidential Commercial Information
Some details, including the identities of several genes and the specific phenotypic changes occurring when they are down-regulated, have been declared Confidential Commercial Information (CCI) under section 185 of the Act. The confidential information will be made available to the prescribed experts and agencies that will be consulted on the RARMP for this application.
The risk assessment took into account information in the application (including proposed containment measures), relevant previous approvals, current scientific knowledge and advice relating to risks to human health and safety and the environment provided in submissions received during consultation on the RARMP. No new risks to people or the environment were identified from the advice received on the consultation RARMP.
identification process was used in the first instance to determine potential pathways that might lead to harm to people or the environment as a result of gene technology.
Eight events were identified whereby the proposed dealings might give rise to harm to people or the environment. This included consideration of whether, or not, expression of the introduced gene fragments 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 plants; or produce unintended changes in their biochemistry or physiology. The opportunity for gene flow to other organisms and its effects if this occurred was also assessed.
is only identified when a hazard is considered to have some chance of causing harm. Events 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 events in relation to both the magnitude and probability of harm, in the context of the control measures proposed by the applicant, did not give rise to any identified risks that required further assessment.
Therefore, any risks of harm to the health and safety of people, or the environment, from the proposed release of the GM wheat lines into the environment are considered 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.
The risk management process builds upon the risk assessment to determine whether measures are required in order to protect people and/or the environment. As none of the eight events characterised in the risk assessment are considered to give rise to an identified risk that requires further assessment, the level of risk from the proposed dealings is considered 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 dissemination and persistence of the GMOs and their genetic material in the environment and to limit the release to the size, location and duration requested by the applicant as these were important considerations in establishing the context for assessing the risks.
The licence conditions require CSIRO to limit
the release to a total area of 1 ha at one site in the ACT between July 2009 and June 2012. The control
measures include containment provisions at the trial site; preventing the use of GM plant materials in human food or animal feed, except for rat and pig nutritional experiments; destroying GM plant materials not required for further studies; transporting GM plant materials in accordance with the Regulator’s transportation guidelines; and conducting post-harvest monitoring at the trial site to ensure all GMOs are destroyed.
Conclusions of the RARMP
The risk assessment concluded that this limited and controlled release of 16 GM wheat lines on a maximum total area of 1 ha over three years in the ACT, 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 restrict the dissemination and persistence of the GMOs and their genetic material in the environment and to limit the release to the size, location and duration requested by the applicant as these were important considerations in establishing the context for assessing the risks.
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