21 March 2012

Introduction

The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of licence application (DIR 112) from the Commonwealth Scientific and Industrial Research Organisation (CSIRO). The licence authorises dealings involving the limited and controlled release of genetically modified (GM) wheat 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 public1.

The application

CSIRO has applied for a licence for dealings involving the intentional release of up to 118 lines of GM wheat and 40 lines of GM barley on a limited scale and under controlled conditions. Of the wheat lines, 23 have been genetically modified for altered grain composition, while the remainder, and all the barley lines, have been genetically modified for enhanced nutrient (nitrogen) utilisation efficiency.
The trial is authorised to take place at a site in the New Genes for New Environments (NGNE) facility, near Merredin, Western Australia (WA), between May 2012 and June 2015. This facility is operated by the Department of Agriculture and Food, Western Australia (DAFWA).

The GM wheat lines with altered grain composition contain a genetic modification for the down-regulation of the expression of the glucan water dikinase gene. Such a change in the expression of this gene is expected to alter the starch composition of the grain. Those GM wheat and barley plants genetically modified for enhanced nitrogen utilisation efficiency contain an alanine aminotransferase gene. The derived protein product of this gene is involved in the shuttling of carbon and nitrogen in plants. Most of the GM plants contain selectable marker genes.

The primary purpose of the three year field trial is to assess whether the respective genetic modifications result in increased biomass and yield of the GM plants with respect to unmodified plants. Further, some grain will be retained each year for replicated field trials in years two and three. Finally, the trial will provide material to assess the impact of the respective genetic modifications on grain protein composition, dough making properties and end product quality.

A number of the GM wheat and barley lines authorised for release have previously been approved by the Regulator for field trial under other licences. The risk assessments conducted for those applications included consideration of all the genes and partial gene sequences that are the subject of this licence.

Risk assessment

The risk assessment took into account information in the application (including proposed containment measures), relevant previous approvals and current scientific/technical knowledge. Advice relating to risks to human health and safety and the environment provided in submissions received during consultation on the RARMP was also considered. No new risks to people or the environment were identified from the advice received on the consultation RARMP.

Two reference documents, The Biology of Triticum aestivum L. em Thell. (Bread Wheat) and The Biology of Hordeum vulgare L. (barley), were produced to inform the risk assessment process for licence applications involving GM wheat and barley plants. The documents are available from the OGTR or from the website.

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.

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.

Six 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 wheat and barley lines; 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.

The characterisation of the six 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 long term, did not identify any risks that could be greater than negligible. Therefore, they did not warrant further detailed assessment. The principal reasons for this include:
    • limits on the size, location and duration of the release proposed by CSIRO
    • suitability of controls proposed by CSIRO to restrict the spread and persistence of the GM wheat and barley plants and their genetic material
    • the genetic modifications are unlikely to give rise to adverse affects on human health and safety or the environment
    • widespread presence of the same and similar genes and gene sequences in the environment and lack of evidence of harm from them
    • limited ability and opportunity for the GM wheat and barley plants to transfer the introduced genes to commercial wheat and barley crops or other sexually related species
    • the potential of the GM wheat and barley to spread and persistence would be restricted by a range of environmental factors that restrict non-GM wheat and barley
    • none of the GM plant materials or products will enter human food or animal feed supply chains.

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.

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 six 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 have been proposed 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, 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 1.0 ha per year at one site between May 2012 and June 2015, inclusive. 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 or other specific condition; and conducting post-harvest monitoring at the trial site to ensure all GMOs are destroyed.

Licence conditions

The Regulator has imposed a number of licence conditions, including requirements to:
    • limit the release to a total area of up to 1 ha per growing season at one site in the fenced NGNE facility between May 2012 and June 2015
    • surround the site by a 10 m monitoring zone in which sexually compatible plants must be destroyed before flowering or prevented from flowering
    • surround the monitoring zone with a 190 m isolation zone in which no other crops of wheat and barley may be grown, and where sexually compatible species plants must be destroyed before flowering or prevented from flowering
    • the monitoring zone must be maintained in a manner that does not attract or harbour rodents, and if rodent activity is detected in the site, measures must be implemented to control the rodents
    • harvest the GM wheat and barley plant material separately from other crops
    • clean the areas and equipment after use
    • apply measures to promote germination of any wheat and barley seeds that may be present in the soil after harvest, including irrigation and tillage
    • monitor for at least 24 months after harvest and destroy any wheat and/or barley plants that may grow until no volunteers are detected for a continuous 6 month period
    • all material from plants, whether GM or non-GM, grown within the site of the trial must be treated as if is GM
    • destroy all GM plant material not required for further analysis or future trials
    • if other sexually compatible GMOs are later approved and grown in the site, seed derived from concurrent trials must not be used for later commercial development
    • not allow GM plant material to be used for human food or animal feed
    • transport material from the GMOs in accordance with the Regulator’s guidelines.

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 Australian Quarantine Inspection Service1.

FSANZ is responsible for human food safety assessment and food labelling, including GM food. The applicant does not intend to use materials from the GM wheat and barley plant lines in human food, accordingly an application to FSANZ has not been submitted. FSANZ approval would need to be obtained before materials from these GM plant lines could be sold as food.

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 wheat and barley lines, or to justify a reduction in containment conditions. This includes:
    • additional data on the potential toxicity and allergenicity of plant materials from the GM wheat and barley lines
    • additional phenotypic characterisation of the GM wheat and barley lines, particularly with respect to traits that may contribute to weediness, including tolerance to environmental stresses and disease susceptibility
    • additional molecular and biochemical characterisation of the GM wheat and barley lines.

Suitability of the applicant

The Regulator has assessed the suitability of CSIRO to hold a DIR licence as required by the Act. CSIRO is considered suitable as the Regulator is satisfied that no relevant convictions have been recorded, no licences or permits have been cancelled or suspended under laws relating to the health and safety of people or the environment, and the organisation has the capacity to meet the conditions of the licence.

Conclusions of the consultation RARMP

The risk assessment concluded that this proposed limited and controlled release of up to 118 GM wheat lines and 40 GM barley lines on a maximum total area of 1 ha per year over three growing seasons in the shire Merredin (WA), 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, location 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.
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1More 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, and in the Regulator’s Risk Analysis Framework (OGTR 2009).