17 February 2012

Introduction

The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of application DIR 111 from the Commonwealth Scientific and Industrial Research Organisation (CSIRO). The licence authorises dealings involving the limited and controlled release 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 Gene Technology Regulator (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 GM wheat and barley into the environment on a limited scale and under controlled conditions.
The GM wheat and barley lines2 have been genetically modified for altered grain composition, nutrient utilisation efficiency, disease resistance or stress tolerance. The field trial is authorised to take place at one site in the Australian Capital Territory (ACT), on a maximum area of 2.3 ha per year between May 2012 and June 2017.

The purpose of the trial is to:
    • evaluate the agronomic performance of the GMOs under conditions of biotic (exposure to fungal disease) and abiotic (drought/heat) stress
    • analyse any changes in grain composition, nutritional characteristics, dough making properties and end product quality
    • collect GM material and seeds for subsequent trials.

Flour derived from the grain of a few GM wheat and barley lines with altered grain composition may be used for a range of carefully controlled, small scale animal nutritional trials, and the same GM wheat lines may be used in nutritional trials with human volunteers. The GM wheat and barley are not permitted to enter the commercial human food or animal feed supply chains.

The applicant proposed to release a maximum of 292 GM wheat and 41 GM barley lines. Based on similarities in the introduced genes and modified traits, the GMOs can be broadly classified into two categories:
    • Category 1 consists of 50 wheat lines and one barley line genetically modified for altered grain composition using four partial gene sequences derived from wheat and two genes from barley.
    • Category 2 consists of 242 wheat lines and 40 barley lines genetically modified for improved agronomic performance in drought/heat-prone environments and enhanced disease resistance using a total of 28 genes derived from wheat or barley. Among these, 26 genes are expected to enhance carbon assimilation, water use efficiency and photosynthesis, one gene is expected to enhance nutrient use efficiency and one gene is responsible for enhanced rust resistance.

Most of the GM wheat and barley lines also contain a selectable marker gene, which was used to select genetically modified plant cells and plants during initial development of the GM plants in the laboratory.

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 the licence, with the exception of those for enhanced dietary fibre content and rust resistance.

CSIRO proposed a number of controls to restrict the spread and persistence of the GM wheat and barley lines and the introduced genetic materials in the environment that were considered during the evaluation of the application.

Confidential Commercial Information

Some details, including the identities of some of the genes and sequences, 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.

Risk assessment

The risk assessment takes 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 is also 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 are postulated (risk scenarios), and those that warrant detailed characterisation are determined. This process is described as risk identification.

Seven 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; or produce unintended changes in the biochemistry of the GMOs. 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 seven 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 require further assessment.

Risks to the health and safety of people, or the environment, from the proposed release of the GM wheat and barley lines 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 licence conditions.

As none of the seven 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, 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 2.3 ha per year at one site between May 2012 and June 2017, inclusive. 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 a range of carefully controlled, small scale animal and human nutritional trials; 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 up to 292 lines of GM wheat and 41 lines of GM barley on a maximum total area of 2.3 ha per year over five 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 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 or in the Regulator’s Risk Analysis Framework (OGTR 2009).


2The term ‘line’ is used to denote plants derived from a single plant containing a specific genetic modification made by one transformation event.