Risk Assessment and
Risk Management Plan for
DIR 093
Limited and controlled release of wheat and barley genetically modified for altered grain starch composition
Applicant: CSIRO
June 2009
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DIR 093 – Risk Assessment and Risk Management Plan Office of the Gene Technology Regulator
Executive Summary
Introduction
The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of licence application DIR093 from the Commonwealth Scientific and Industrial Research Organisation (CSIRO). The licence authorises dealings involving the limited and controlled release of three lines[2] of genetically modified (GM) wheat and one line of GM barley with altered grain starch composition 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 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 the Risk Analysis Framework and finalised following consultation with a wide range of experts, agencies and authorities and the public[3].
The application
CSIRO applied for a licence for dealings involving the intentional release of three lines of wheat and one line of barley which have been genetically modified for altered grain starch composition on a limited scale and under controlled conditions. The trial will take place at one site in the Australian Capital Territory (ACT), on a maximum area of 1 hectare per year between July 2009 and June 2012.
The genetic modifications are expected to suppress the function of endogenous genes resulting in altered grain starch composition. Evaluation of glasshouse grown GM wheat and barley lines has shown altered grain starch composition as a result of the genetic modification. This has resulted in grains with a higher resistant starch content which in turn contributes to the total dietary fibre intake. These changes may contribute to enhanced nutritional properties and improve digestive bowel health. The GM wheat and barley lines also contain an antibiotic resistance gene which was used to identify transformed plants during the initial development of the GM plants in the laboratory.
The purpose of the trial is to evaluate grain properties of the GM wheat and barley lines grown under field conditions. This would involve generating sufficient grain to make flour for laboratory evaluation of how the flour performs in foods. This would then be fed to rats and pigs in laboratory experiments to determine whether altered grain properties change the nutritional value of the GM wheat and barley. Products made from GM wheat may also be consumed by a limited number of volunteers as part of a carefully controlled nutritional study.
CSIRO proposes a number of controls to restrict the dissemination and persistence of the GM wheat and barley lines and the introduced genetic materials in the environment that have been considered during the evaluation of the application.
Confidential Commercial Information
Some details, including the names of genes expected to alter grain starch composition, the specific phenotypic changes occurring when they are down-regulated and its application, have been declared Confidential Commercial Information (CCI) under section 185 of the Act. The confidential information will be made available to the prescribed experts and agencies that will be consulted on the RARMP for this application.
Risk assessment
The risk assessment took into account information in the application (including proposed containment measures), relevant previous approvals and 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.
A hazard identification process was used in the first instance to determine potential pathways that might lead to harm to people or the environment as a result of gene technology.
Eight events were identified 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 constructs 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 were 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 eight 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 wheat and barley 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 eight 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, conditions are 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 CSIRO to limit the release to a total area of 1 ha at one site in the ACT between July 2009 and June 2012. 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 rat and pig nutritional experiments, and the human nutritional experiments; 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 proposed limited and controlled release of three GM wheat lines and one GM barley line on a maximum total area of 1 ha over 3 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 restrict the dissemination and persistence of the GMOs and their genetic material in the environment and 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.
Executive Summary (June 2009) III
DIR 093 – Risk Assessment and Risk Management Plan Office of the Gene Technology Regulator
Table of Contents
Executive Summary I
Introduction I
The application I
Confidential Commercial Information II
Risk assessment II
Risk management II
Conclusions of the RARMP III
Table of Contents IV
Abbreviations VI
Technical Summary 1
Introduction 1
The application 1
Confidential Commercial Information 2
Risk assessment 2
Risk management 3
Licence conditions to manage this limited and controlled release 3
Other regulatory considerations 4
Identification of issues to be addressed for future releases 5
Suitability of the applicant 5
Conclusions of the RARMP 5
Chapter1 Risk assessment context 6
Section1 Background 6
Section2 The legislative requirements 7
Section3 The proposed release 7
3.1 The proposed dealings 7
3.2 The proposed activities 8
3.3 The proposed limits of the release 9
3.4 The proposed controls to restrict the dissemination and persistence of the GMOs and their genetic material in the environment 10
Section4 The parent organisms 10
Section5 The GMOs, nature and effect of the genetic modification 11
5.1 Introduction to the GMOs 11
5.2 Background on grain starch and its synthesis 13
5.3 The introduced constructs and associated end products 16
5.4 The regulatory sequences 18
5.5 Method of genetic modification 19
5.6 Characterisation of the GMOs 19
Section6 The receiving environment 22
6.1 Relevant abiotic factors 22
6.2 Relevant biotic factors 22
6.3 Relevant agricultural practices 23
6.4 Presence of related plants in the receiving environment 24
6.5 Presence of the introduced sequences or similar genes and encoded proteins in the environment 24
Section7 Australian and international approvals 25
7.1 Australian approvals of GM wheat and GM barley 25
7.2 International approvals of GM wheat and GM barley 26
Chapter2 Risk assessment 27
Section1 Introduction 27
Section2 Hazard characterisation and the identification of risk 28
2.1 Production of a substance toxic/allergenic to people or toxic to other organisms 31
2.2 Spread and persistence of the GM wheat and barley lines in the environment 32
2.3 Vertical transfer of gene or genetic elements to sexually compatible plants 35
2.4 Horizontal transfer of genes or other genetic elements 38
2.5 Unintended changes in biochemistry, physiology or ecology 39
2.6 Unauthorised activities 43
Section3 Risk estimate process and assessment of significant risk 44
Section4 Uncertainty 44
Chapter3 Risk management 46
Section1 Background 46
Section2 Responsibilities of other Australian regulators 46
Section3 Risk treatment measures for identified risks 47
Section4 General risk management 47
4.1 Licence conditions 47
4.2 Other risk management considerations 54
Section5 Issues to be addressed for future releases 56
Section6 Conclusions of the RARMP 56
References 57
Appendix A Definitions of terms in the Risk Analysis Framework used by the Regulator 64
Appendix B Summary of issues raised in submissions received from prescribed experts, agencies and authorities on the consultation RARMP for DIR 093 66
Appendix C Summary of issues raised in submissions received from the public on the consultation RARMP for DIR 093 68
Table of Contents (March 2009) V
DIR 093 – Risk Assessment and Risk Management Plan Office of the Gene Technology Regulator
Abbreviations
the Act / Gene Technology Act 2000APVMA / Australian Pesticides and Veterinary Medicines Authority
AQIS / Australian Quarantine and Inspection Service
BLAST / Basic Local Alignment Search Tool
CCI / Confidential Commercial Information as declared under section 185 of the Gene Technology Act 2000
CaMV / Cauliflower mosaic virus
CFIA / Canadian Food Inspection Agency
CSIRO / Commonwealth Scientific Industrial Research Organisation
DIR / Dealings involving Intentional Release
DNA / Deoxyribonucleic Acid
DP / Degree of Polymerisation
EST / Expressed Sequence Tag
EFSA / European Food Safety Authority
FSANZ / Food Standards Australia New Zealand (formerly ANZFA)
GBSS / Granular Bound Starch Synthase
GM / Genetically Modified
GMO / Genetically Modified Organism
GTTAC / Gene Technology Technical Advisory Committee
ha / Hectare
hpt / gene encoding aminocyclitol phosphotransferase
km / kilometre
m / metre
mRNA / Messenger Ribonucleic Acid
NHMRC / National Health and Medical Research Council
NICNAS / National Industrial Chemicals Notification and Assessment Scheme
nptII / gene encoding neomycin phosphotransferase type II
OGTR / Office of the Gene Technology Regulator
PCR / Polymerase Chain Reaction
RARMP / Risk Assessment and Risk Management Plan
the Regulations / Gene Technology Regulations 2001
the Regulator / Gene Technology Regulator
RNA / Ribonucleic Acid
RNAi / Ribonucleic Acid interference
RS / Resistant Starch
SE / Starch Enzyme
TGA / Therapeutic Goods Administration
US FDA / United States Food and Drug Administration
USDA APHIS / United States Department of Agriculture Animal and Plant Health Inspection Service
Abbreviations (June 2009) VI
DIR 093 – Risk Assessment and Risk Management Plan Office of the Gene Technology Regulator
Technical Summary
Introduction
The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of licence application DIR093 from the Commonwealth Scientific and Industrial Research Organisation (CSIRO). The licence authorises dealings involving the limited and controlled release of three lines of genetically modified (GM) wheat and one line of GM barley with altered grain starch composition 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 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 the Risk Analysis Framework and finalised following consultation with a wide range of experts, agencies and authorities and the public[4].
The application
CSIRO applied for a licence for dealings involving the intentional release of three lines[5] of wheat (Triticum aestivum L.) and one line of barley (Hordeum vulgare L.) which have been genetically modified for altered grain starch composition on a limited scale and under controlled conditions. The trial is will to take place at one site in the Australian Capital Territory (ACT), on a maximum area of 1 hectare per year between July 2009 and June 2012.
The purpose of the trial is to evaluate grain properties of the GM wheat and barley lines grown under field conditions. This would involve generating sufficient grain to make flour for laboratory evaluation of how the flour performs in foods, and to feed to rats and pigs in laboratory experiments to determine whether altered grain properties change the nutritional value of the GM wheat and barley. Products made from GM wheat may also be consumed by a limited number of people as part of a carefully controlled nutritional study.