Limited and controlled release of sugarcane genetically modified for altered sugar production




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Risk Assessment and

Risk Management Plan for

DIR 078/2007


Limited and controlled release of sugarcane genetically modified for altered sugar production


Applicant: The University of Queensland


August 2008

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Executive Summary

Introduction

The Acting Gene Technology Regulator (the Acting Regulator) has made a decision to issue a licence for dealings involving the limited and controlled release of up to 3000 lines of sugarcane genetically modified for altered sugar production into the environment in respect of application DIR 078/2007 from The University of Queensland (UQ).

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 Acting 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

UQ applied for a licence for dealings involving the intentional release of up to 3000 lines2 of genetically modified (GM) sugarcane on limited scale and under controlled conditions. The GM sugarcane lines have been modified for altered sugar production. The trial would take place at fifteen sites in the local government areas of Burdekin, Moreton Bay, Hinchinbrook, Cairns, Bundaberg and Mackay in Queensland (QLD) on a total maximum area of up to 65 hectares between September 2008 and December 2014.

The GM sugarcane lines contain one of two genes which encode an enzyme that converts sucrose into two other similar sugars. The genes are both derived from commonly occurring bacteria. Expression of the introduced gene is expected to produce sugars similar to sucrose, which could be used as alternative sweeteners.

In addition, all of the GM sugarcane lines contain two antibiotic resistance selectable marker genes, which were used to identify transformed plants during their initial development in the laboratory.

The purpose of the trial is to conduct initial field testing involving experiments to assess the agronomic properties of the GM sugarcane lines and to analyse sugar production and quality. Promising lines will be selected for propagation for possible future commercial development (subject to additional approvals) and some lines will also be crossed with non GM sugarcane under controlled conditions to evaluate the feasibility of using them in future breeding programs. A number of regulatory and protein stabilising sequences are also being tested to identify those that allow for optimum expression of the introduced genes in the various plant cellular compartments. The GM sugarcane will not be used for human food or animal feed.

UQ proposed a number of controls to restrict the dissemination or persistence of the GM sugarcane lines and the introduced genetic materials into the environment. These controls have been considered during the evaluation of the application.

Confidential Commercial Information

Some details, including the order in which the genetic elements are arranged, 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, current scientific knowledge, advice received from a wide range of experts, agencies and authorities consulted on the RARMP and submissions 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.

Seven events 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, physiology or ecology. 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 seven 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 sugarcane lines into the environment are considered to be negligible. Hence, the Acting 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 seven 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 restrict the dissemination 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 UQ to limit the release to a total area of 65 ha, at fifteen sites between September 2008 and December 2014. 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 destroyed3.

Conclusions of the RARMP

The risk assessment concludes that this proposed limited and controlled release of up to 3000 GM sugarcane lines on a maximum total area of 65 ha over six years in the Queensland local government area of Burdekin, Moreton Bay, Hinchinbrook, Cairns, Bundaberg and Mackay 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 restrict the dissemination and persistence of the GMOs and their genetic material in the environment and to limit the proposed release to the size, locations and duration requested by the applicant as these were important considerations in establishing the context for assessing the risk.


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Table of Contents


Executive Summary

Introduction

The application

Confidential Commercial Information

Risk assessment

Risk management

Conclusions of the RARMP

Table of Contents

Abbreviations

Technical Summary

Introduction

The application

Confidential Commercial Information

Risk assessment

Risk management

Licence conditions to manage this limited and controlled release

Other regulatory considerations

Identification of issues to be addressed for future releases

Suitability of the applicant

Conclusions of the RARMP

Chapter 1 Risk assessment context

Section 1 Background

Section 2 The legislative requirements

Section 3 The proposed dealings

3.1 The proposed activities

3.2 The proposed limits of the dealings (location, duration and size)

3.3 Controls to restrict the dissemination or persistence of the GMOs and their genetic material in the environment

Section 4 The parent organism

Section 5 The GMOs, nature and effect of the genetic modification

5.1 Introduction to the GMOs

5.2 The introduced genes, encoded proteins and end products

5.3 The regulatory sequences

5.4 Method of genetic modification

5.5 Characterisation of the GMOs

Section 6 The receiving environment

6.1 Relevant abiotic factors

6.2 Relevant biotic factors

6.3 Relevant agricultural practices

6.4 Presence of related plants in the receiving environment

6.5 Presence of the introduced genes or similar genes, encoded proteins and end products in the environment

Section 7 Australian and international approvals

7.1 Australian approvals of the GM sugarcane lines

7.2 International approvals

Chapter 2 Risk assessment

Section 1 Introduction

Section 2 Hazard characterisation

2.1 Production of a substance toxic or allergenic to people or toxic to other organisms

2.2 Spread and persistence of the GM sugarcane lines in the environment

2.3 Vertical transfer of genes or genetic elements to sexually compatible plants

2.4 Horizontal transfer of genes or genetic elements to sexually incompatible organisms

2.5 Unintended changes in biochemistry, physiology or ecology

2.6 Unauthorised activities

Section 3 Risk estimate process and assessment of significant risk

Section 4 Uncertainty

Chapter 3 Risk management

Section 1 Background

Section 2 Responsibilities of other Australian regulators

Section 3 Risk treatment measures for identified risks

Section 4 General risk management

4.1 Proposed licence conditions

4.2 Other risk management considerations

Section 5 Issues to be addressed for future releases

Section 6 Conclusions of the RARMP

References

Appendix A Definitions of terms in the Risk Analysis Framework used by the Regulator

Appendix B Summary of issued raised in submissions received from prescribed experts, agencies and authorities on the consultation RARMP for DIR 078/2007

Appendix C Summary of issues raised in submissions received from the public for the consultation RARMP for DIR 078/2007


Abbreviations

the Act

Gene Technology Act 2000APVMAAustralian Pesticides and Veterinary Medicines AuthorityAQISAustralian Quarantine and Inspection ServiceBLASTBasic Local Alignment Search ToolCCIConfidential Commercial Information as declared under section 185 of the Gene Technology Act 2000DIRDealings involving Intentional ReleaseDNADeoxyribonucleic AcidFAOFood and Agricultural Organization of the United NationsFSANZFood Standards Australia New Zealand GMGenetically ModifiedGMOGenetically Modified OrganismGTTACGene Technology Technical Advisory Committeeblabeta lactamase genehahectare(s)kDakilodaltonLGALocal Government AreamRNAMessenger Ribonucleic AcidNHMRCNational Health and Medical Research CouncilNICNASNational Industrial Chemicals Notification and Assessment SchemenptIIneomycin phosphotransferase type II geneOGTROffice of the Gene Technology RegulatorORFOpen Reading FrameQDPI&FQueensland Department of Primary Industries and FisheriesSISucrose isomerase UQThe University of Queensland RARMPRisk Assessment and Management Planthe RegulatorGene Technology RegulatorTGATherapeutic Goods AdministrationPAGE INTENTIONALLY LEFT BLANKTechnical Summary

Introduction

The Acting Gene Technology Regulator (the Acting Regulator) made a decision to issue a licence (DIR 078/2007) from The University of Queensland (UQ) for a limited and controlled release of genetically modified (GM) sugarcane lines into the Australian 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 GMO. The decision is based upon a Risk Assessment and Risk Management Plan (RARMP) prepared by the Acting Regulator in accordance with the Risk Analysis Framework and finalised following consultation with a wide range of experts, agencies and authorities and the public4.

The application

UQ applied for a licence for dealings involving the intentional release of up to 3000 lines5 of sugarcane cultivars Saccharum spp (interspecific hybrid of S. spontaneum and S. officinarum), that have been genetically modified to produce isomaltulose and/or trehalulose on a limited scale and under controlled conditions. The trial is authorised to take place at fifteen sites in the local government areas of Burdekin, Moreton Bay, Hinchinbrook, Cairns, Bundaberg and Mackay in Queensland (QLD) on a total area of up to 65 ha between September 2008 and December 2014.

The GM sugarcane lines contain the sucrose isomerase gene (SI) derived from a bacterium (Pantoea dispersa or Pseudomonas mesoacidophila). This gene encodes the SI protein which converts sucrose to the structural isomers6 isomaltulose or trehalulose. These sugars are produced in different ratios depending on the source of the gene. Expression of the SI gene from Pantoea dispersa is expected to produce predominantly isomaltulose whereas expression of the SI gene from P. mesoacidophila is expected to produce predominantly trehalulose in the GM sugarcane plant cells. In addition to sucrose, isomaltose and trehalulose produced in the GM plants could be purified for use as alternative sweeteners. Protein stabilising sequences will also be expressed in some lines. A number of promoters and signal sequences are also being tested in order to identify those that allow for optimum expression of the SI gene in the various plant cellular compartments.

In addition, all of the GM sugarcane lines contain the antibiotic resistance selectable marker genes bla and nptII, which are derived from the common gut bacterium, Escherichia coli. The bla gene encodes the enzyme beta-lactamase and confers ampicillin resistance. It was used to select for bacteria containing the plasmid in the laboratory prior to production of GM plants, as this gene is under the control of a bacterial promoter and thus will not be expressed in the transformed plants. The nptII gene encodes the enzyme neomycin phosphotransferase and confers resistance to neomycin or kanamycin. It was used to identify transformed plants.

The purpose of the trial is to conduct initial field testing involving experiments to assess the agronomic properties of the GM sugarcane lines and to analyse sugar production and quality. Promising lines will be selected for propagation for possible future commercial development (subject to additional approvals) and some lines will also be crossed with non GM sugarcane under controlled conditions to evaluate the feasibility of using them in future breeding programs. The GM sugarcane will not be used for human food or animal feed.

UQ proposed a number of controls to restrict the dissemination or persistence of the GM sugarcane lines into the environment. These controls have been considered during the evaluation of the application.

Confidential Commercial Information

Some details, including the order in which the genetic elements are arranged, 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 considered information contained in the application, relevant previous approvals, current scientific knowledge, and issues relating to risks to human health and safety and the environment raised in submissions received from consultation with a wide range of prescribed experts, agencies and authorities on the application (summarised in Appendix B of the RARMP). No new risks to people or the environment were identified from the advice received on the consultation RARMP.

Advice received from the public on the consultation RARMP (four submissions) and how it was considered, is summarised in Appendix C.

A reference document on the parent organism, The Biology of Saccharum spp (sugarcane) was produced to inform the risk assessment process for licence applications involving GM sugarcane plants. The document is available from the OGTR or from the website <http://www.ogtr.gov.au>.

The risk assessment begins with a hazard identification process to consider what harm to the health and safety of people or the environment could arise during this release of GMOs due to gene technology, and how it could happen, in comparison to the non-GM parent organism and in the context of the proposed receiving environment.

Seven events 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 represent an identified risk and do not advance any further in the risk assessment process.

The characterisation of the seven 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. The principle reasons for this include:

  • limits on the size and duration of the release proposed by UQ

  • suitability of controls proposed by UQ to restrict the dissemination or persistence of the GM sugarcane plants and their genetic material

  • limited ability and opportunity for the GM sugarcane lines to transfer the introduced genes to commercial sugarcane crops or other sexually related species

  • limited capacity of the GM sugarcane lines to spread and persist in the areas proposed for release

  • none of the GM plant materials or products will be used in human food or animal feed

  • widespread presence of the same or similar proteins encoded by, and end products produced as a result of the activity of, the introduced genes in the environment and lack of known toxicity or evidence of harm from them.

Therefore, any risks of harm to the health and safety of people, or the environment, from the proposed release of the GM sugarcane lines into the environment are considered to be negligible. Hence, the Acting Regulator considers that the dealings involved in this proposed release do not pose a significant risk to either people or the environment7.

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 seven events characterised in the risk assessment are considered to give rise to an identified risk that requires further assessment, the level of risk 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 restrict the dissemination 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.

Licence conditions to manage this limited and controlled release

The Regulator has imposed a number of licence conditions to limit and control the release, including requirements to:

  • conduct the release at fifteen sites in the Queensland local government areas of Burdekin, Moreton Bay, Hinchinbrook, Cairns, Bundaberg and Mackay on a total maximum area of 65 hectares, with a maximum site size of 20 ha, over a period of six years between September 2008 and December 2014.

  • not use the GMO or products in human food or animal feed

  • restrict personnel with access to the site to trained staff and UQ project staff

  • locate the trial sites on land that is not subject to flooding and located at least 50 metres away from the nearest natural waterway

  • inspect the western side of Lilliesmere lagoon at least once every 6 months for the presence of volunteers and destroy any volunteers until final harvest at the adjacent site

  • separate GM sugarcane from any adjacent commercially harvested sugarcane by two guard rows and headlands maintained free of sugarcane

  • separate GM sugarcane grown in the field from any adjacent experimental sugarcane by an isolation zone of at least 3 metres that is maintained free of sugarcane or a corresponding width of two planted rows of non-GM sugarcane

  • separate GM sugarcane from any public area (accessible without crossing privately owned or controlled land) by at least two rows of non-GM sugarcane

  • GM sugarcane plants grown at crossing facilities must be inspected every 4 days for signs of flower initiation and upon morphological transition to flowering cover the flowering stalk with a pollen lantern or prevent it from flowering by removing the flower stalks as to limit dispersal of pollen into the environment

  • GM seedlings at a nursery or crossing facilities must be clearly identifiable through eg physical separation or labelling

  • transport GM plant materials to and from the proposed trial sites in accordance with OGTR transportation guidelines

  • destroy all plant materials not required for further analysis or propagation;

  • following final harvest, clean the sites and equipment used on the sites

  • post harvest monitoring of the trial site for at least 12 months and destroying any volunteers until no volunteers are observed for a period of least 6 months.

The Regulator has issued guidelines and policies for the transport, supply and storage of GMOs (Guidelines for the transport of GMOs). Licence conditions based on these guidelines and policies have also been proposed to control possession, use or disposal of the GMOs for the purposes of, or in the course of, the authorised dealings.

Other regulatory considerations

Australia's gene technology regulatory system operates as part of an integrated legislative framework. Dealings conducted under a licence issued by the Regulator may also be subject to regulation by other agencies that also regulate GMOs or GM products including Food Standard Australia New Zealand (FSANZ), Australian Pesticides and Veterinary Medicines Authority (APVMA), Therapeutic Goods Administration (TGA), National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and Australian Quarantine Inspection Service (AQIS)8.

FSANZ is responsible for human food safety assessment, including GM food. As the trial involves proof of concept research, the applicant does not intend any material from the GM sugarcane lines proposed for release to be used in human food. Accordingly, the applicant has not applied to FSANZ to evaluate any of the GM sugarcane lines. FSANZ approval would need to be obtained before they could be used in human food in Australia.

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 any of these GM sugarcane lines that may be selected for further development, or to justify a reduction in control measures. This would include:

  • characterisation of the introduced genetic material in the plants, including genotypic stability

  • additional data on the potential toxicity and allergenicity of proteins encoded by the introduced genes, and of plant materials from the GM sugarcane lines selected for possible future releases

  • data on potential gene transfer to non-GM sugarcane and other related species

  • characteristics indicative of weediness including measurement of altered reproductive capacity, tolerance to abiotic and other environmental stresses and disease susceptibility.

Suitability of the applicant

The Regulator determined, at the commencement of the assessment process for this application, that UQ is suitable to hold a DIR licence under the requirements of section 58 of the Act. The Acting Regulator is satisfied that UQ remains suitable as no relevant convictions have been recorded, no licences or permits have been cancelled or suspended under OGTR legislation relating to the health and safety of people or the environment, and the organisation has confirmed its ability to comply with the licence conditions.

Conclusions of the RARMP

The risk assessment concludes that this proposed limited and controlled release of up to 3000 GM sugarcane lines on a maximum total area of 65 ha over six years in the Queensland local government area of Burdekin, Moreton Bay, Hinchinbrook, Cairns, Bundaberg and Mackay 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 restrict the dissemination and persistence of the GMOs and their genetic material in the environment and to limit the proposed release to the size, locations and duration requested by the applicant as these were important considerations in establishing the context for assessing the risk.

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  1. Risk assessment context

    1. Background

  1. This chapter describes the parameters within which risks that may be posed to the health and safety of people or the environment by the proposed release are assessed. These include the scope and boundaries for the evaluation process required by the gene technology legislation9, details of the intended dealings, the genetically modified organism(s) (GMO(s)) and parent organism(s), previous approvals and releases of the same or similar GMO(s) in Australia or overseas, environmental considerations and relevant agricultural practices. The parameters for the risk assessment context are summarised in Figure 1.

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