24 April 2008

Introduction

The Gene Technology Regulator (the Regulator) has made a decision to issue a licence for dealings involving the limited and controlled release of up to 1,290 banana lines modified for enhanced nutrition into the environment in respect of application DIR 076/2007 from Queensland University of Technology (QUT).

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 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.

The application

QUT applied for a licence for dealings involving the intentional release of up to 1,290 genetically modified (GM) banana lines on a limited scale and under controlled conditions. The GM banana lines would be modified for increased levels of pro-vitamin A, vitamin E or iron, or to assess promoter specificity. The trial would take place at one site in the local government area of Cassowary Coast, Queensland on a maximum total area of 1.4 hectares between May 2008 and May 2012.

Up to 390 of the GM banana lines would contain one or two of three different genes that are involved in pro-vitamin A synthesis. These genes are derived from the plants banana and maize and a common soil bacterium Erwinia uredovora.

Up to 360 of the GM banana lines would contain one or two of five different genes that are involved in vitamin E synthesis. The genes are derived from the plants thale cress, maize and rice.

Up to 120 of the GM banana lines would contain one or more of three different genes that are involved in iron accumulation. These genes are derived from the plants wild soybean and thale cress.

Up to 420 of the GM banana lines would contain a marker/reporter gene derived from the common gut bacterium Escherichia coli. This will be used to investigate the level of activity of introduced promoters (regulatory sequences that control the expression of genes) to optimise gene expression in banana fruit.

All of the GM banana lines would contain an antibiotic resistance selectable marker gene, derived from Escherichia coli. This gene was used as a selective marker to identify transformed plants during initial development of GM plants in the laboratory.

The purpose of the trial is to conduct proof of concept research involving experiments with the GM banana lines to assess growth, fruit and yield characteristics and analyse the nutrient content of fruit and vegetative parts. A number of promoters are also being tested in order to identify those that achieve best expression of the introduced genes in the fruit. GM bananas produced during the trial will not be used for human food or animal feed.

QUT proposed a number of controls to restrict the dissemination or persistence of the GM banana lines into the environment that have been considered during the evaluation of the application.

Risk assessment

The risk assessment takes into account information in the application (including proposed containment measures), relevant previous approvals, current scientific knowledge, advice received from a wide range of experts, agencies and authorities consulted on the RARMP, and a submission from the public.

A hazard identification process was used to determine potential pathways that might lead to harm to people or the environment as a result of gene technology.

Nine events, including one identified in the consultation process, were considered 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 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 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.

A risk 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 nine 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 banana 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.

Risk management

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 nine 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, a range of measures have been imposed to limit the release to the size, location and duration requested by the applicant, as these were an important part of establishing the context for assessing the risks.

The licence conditions require QUT to limit the duration of the release to between May 2008 to May 2012 on a maximum total area of 1.4 ha at one site. The control measures to restrict the spread and persistence of the GMOs include 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 OGTR transportation guidelines; and conducting post-harvest monitoring at the trial site to ensure all GMOs are destroyed2.

Conclusions of the RARMP

The risk assessment concludes that this limited and controlled release of up to 1,290 GM banana lines on a maximum total area of 1.4 ha over four years in the Queensland local government area of Cassowary Coast poses negligible risks to the health and safety of people or the environment as a result of gene technology.

The risk management plan concludes 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 requested by the applicant as these were important considerations in establishing the context for assessing the risks.


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 (Free call 1800 181 030 or at Licence Application & Assessment Process), and in the Regulator’s Risk Analysis Framework (OGTR 2007).

2The licence for DIR 076/2007 is available on the OGTR website via the link to DIR 076/2007.