29 June 2010
The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of licence application (DIR 102) from the University of Adelaide. The licence authorises dealings involving the limited and controlled release of up to 2340 lines1 of genetically modified (GM) wheat and barley 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 public2.
The University of Adelaide has applied for a licence for dealings involving the intentional release of up to 1161 lines of GM wheat and 1179 lines of GM barley on a limited scale and under controlled conditions. The GM wheat and barley lines have been genetically modified to enhance nutrient utilisation and abiotic stress tolerance. The trial will take place at three sites, two in South Australia and one in Western Australia, on a maximum area of 0.75 ha per growing season, between June 2010 and December 2015.
The applicant will release GM wheat and barley modified to contain one of 35 genes encoding proteins expected to enhance nitrogen use efficiency, increase zinc uptake and enhance tolerance to a range of abiotic stresses including drought, cold, salt and low phosphorus. Most of the genes conferring the traits have been obtained from wheat, barley or maize. The remaining genes were derived from thale cress, moss or yeast, which are also widespread in the environment. All of the GM wheat and barley lines contain a selectable marker gene.
The purpose of the trial is to characterise growth and yield characteristics of the GM plants when grown under drought, rain fed or saline field conditions. The GM wheat and barley will not be used for human food or animal feed.
The University of Adelaide proposed a number of controls to restrict the spread and persistence of the GM wheat and barley lines and their genetic material into the environment. These controls have been considered during the evaluation of the application.
Some details, including the name and sequence of some of the genes and promoters, and associated references, 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.
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.
Initially, potential pathways that might lead to harm to people or the environment as a result of gene technology are postulated (risk scenarios), and these scenarios are evaluated to identify those that warrant detailed characterisation. This process is described as risk identification.
Eight risk scenarios were postulated. This included 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 wheat and barley; 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 give rise to any identified risks that required further assessment.
Risks to the health and safety of people, or the environment, from the proposed release of the GM wheat and barley 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 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 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 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 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 the University of Adelaide to limit the release to a total area of 0.75 ha per growing season at three sites between June 2010 and December 2015. 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 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.
The risk assessment concluded that this limited and controlled release of up to 1161 GM wheat lines and 1179 GM barley lines on a maximum total area of 0.75 ha per growing season over five years in the LGAs of Marion and Wakefield, South Australia, and Corrigin, Western Australia, 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.
1The term ‘line’ is used to denote plants derived from a single plant containing a specific genetic modification resulting from a single transformation event.
2More information on the process for assessment of licence applications to release a genetically modified organism (GMO) into the environment is available from the Office of the Gene Technology Regulator (OGTR) (Free call 1800 181 030 or at the OGTR website), and in the Regulator’s Risk Analysis Framework (OGTR 2009).