Full Risk Assessment and Risk Management Plan

Risk Assessment and

Risk Management Plan for

DIR 089

Limited and controlled release of white clover genetically modified to resist infection by
Alfalfa mosaic virus

Applicant: Victorian Department of Primary Industries

January 2009

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DIR 089 – Risk Assessment and Risk Management Plan Office of the Gene Technology Regulator

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 white clover genetically modified for resistance to Alfalfa mosaic virus (AMV) into the environment in respect of application DIR 089 from the Victorian Department of Primary Industries (DPI Victoria).

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 public[2].

The application

DPI Victoria applied for a licence for dealings involving the intentional release of one line[3] of GM white clover on a limited scale and under controlled conditions. The GM white clover line has been genetically modified to resist infection by AMV. The release will involve one site in the local government area of Corowa, NSW, on a maximum area of 633m2 per year, between March 2009 and August2011.

The GM white clover contains a gene from a virus which provides resistance to AMV, as well as an antibiotic resistance gene which was used to identify transformed plants during initial development of the GM plant in the laboratory.

The purpose of the trial is to conduct experiments to evaluate the agronomic performance, including seed yield, of the GM white clover line under field conditions. Some seed would be collected and retained for analysis and possible future trials, subject to further approval(s). The GM white clover will not be used for human food or animal feed.

DPI Victoria proposed a number of controls to restrict the dissemination or persistence of the GM white clover line and the introduced genetic materials in the environment that have been considered during the evaluation of the application.

Confidential Commercial Information

Some details, including screening protocols, data from previous field trials and unpublished data produced to support weediness and gene flow assessments, 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 took into account information in the application (including proposed containment measures), relevant previous approvals, 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.

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.

Nine 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 advance in the risk assessment process.

All events were characterised in relation to both the magnitude and probability of harm in the context of the controls proposed by the applicant to limit the spread and persistence of the GMO in both time and space. This detailed consideration identified one event requiring further assessment. The potential adverse outcome to the environment associated with this event was enhanced spread and persistence (weediness). The remaining eight events were not assessed further as they were considered not to give rise to an identified risk to human health and safety or the environment (refer to Chapter 2 for more information). The principle reasons comprise:

· limits on the size, location and duration of the release proposed by DPI Victoria

· suitability of controls proposed by DPI Victoria to restrict the dissemination or persistence of the GM white clover plants and their genetic material

· 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 the introduced genes in the environment and lack of known toxicity or evidence of harm from them.

Risk of weediness

The event that might result in the introduced gene causing greater weediness than the parent non-GM white clover was:

· Expression of the introduced AMV CP gene in other white clover plants as a result of gene transfer leading to increased spread and persistence in native plant habitats. (Identified Risk1).

The consequence and likelihood of harm that might result from the above event was assessed in the context of the current trial. The estimate of risk for the identified risk is negligible.

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. The level of risk to health and safety of people or the environment for the identified risk was estimated as 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 GMO and its 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 DPI Victoria to limit the release to a total area of 633m2 per year at one site between March 2009 and August2011. 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 OGTR transportation guidelines; and conducting post-harvest monitoring at the trial site to ensure all GMOs are destroyed [4].

Conclusions of the RARMP

The risk assessment concluded that this limited and controlled release of one GM white clover line on a maximum total area of 633m2 per year over two and a half years in the NSW local government area of Corowa, 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 GMO and its 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.

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Executive Summary (January 2009) IV

DIR 089 – 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 I

Risk assessment II

Risk of weediness II

Risk management II

Conclusions of the RARMP III

Table of Contents V

Abbreviations VII

Technical Summary 1

Introduction 1

The application 1

Confidential Commercial Information 2

Risk assessment 2

Risk management 4

Licence conditions to manage this limited and controlled release 4

Other regulatory considerations 5

Identification of issues to be addressed for future releases 6

Suitability of the applicant 6

Conclusions of the RARMP 6

Chapter1 Risk assessment context 7

Section1 Background 7

Section2 The legislative requirements 8

Section3 The proposed dealings 8

3.1 The proposed activities 8

3.2 The proposed limits of the dealings (size, location and duration) 9

3.3 The proposed controls to restrict the dissemination or persistence of the GMO and its genetic material in the environment 9

Section4 The parent organism 10

Section5 The GMO, nature and effect of the genetic modification 11

5.1 Introduction to the GMO 11

5.2 The introduced genes and their encoded proteins 11

5.3 The regulatory sequences 14

5.4 Method of genetic modification 14

5.5 Characterisation of the GMO 15

Section6 The receiving environment 19

6.1 Relevant abiotic factors 19

6.2 Relevant biotic factors 19

6.3 Relevant agricultural practices 20

6.4 Presence of related plants in the receiving environment 21

6.5 Presence of the introduced genes or similar genes and encoded proteins in the environment 21

Section7 Australian and international approvals 22

7.1 Australian approvals of GM white clover 22

7.2 International approvals of GM plants expressing viral coat proteins 23

Chapter2 Risk assessment 24

Section1 Introduction 24

Section2 Hazard characterisation and the identification of risk 25

2.1 Production of a substance toxic/allergenic to people or toxic to other organisms 27

2.2 Spread and persistence of the GM white clover line in the environment 29

2.3 Vertical transfer of gene or genetic elements to sexually compatible plants 32

2.4 Horizontal transfer of genes or genetic elements to sexually incompatible organisms 33

2.5 Unintended changes in biochemistry, physiology or ecology 36

2.6 Unauthorised activities 38

Section3 Risk estimate process and assessment of significant risk 38

Chapter3 Risk estimates for weediness 40

Section1 Background 40

Section2 Consequence and likelihood assessments 40

2.1 Identified Risk 1: Expression of the introduced AMV CP gene in other white clover plants as a result of gene transfer leading to increased spread and persistence in native plant habitats 41

Section3 Risk estimates 50

Section4 Uncertainty 51

Chapter4 Risk management 53

Section1 Background 53

Section2 Responsibilities of other Australian regulators 53

Section3 Risk treatment measures for identified risks 54

Section4 General risk management 54

4.1 Licence conditions 54

4.2 Other risk management considerations 57

Section5 Issues to be addressed for future releases 59

Section6 Conclusions of the RARMP 60

References 61

Appendix A Definitions of terms in the Risk Analysis Framework used by the Regulator 72

Appendix B Summary of issues raised in submissions received from prescribed experts, agencies and authorities on the consultation RARMP for DIR 089 74

Appendix C Summary of issues raised in submissions received from the public on the consultation RARMP for DIR 089 77

Table of Contents (January 2009) VI

DIR 089 – Risk Assessment and Risk Management Plan Office of the Gene Technology Regulator

Abbreviations

the Act / Gene Technology Act 2000
APVMA / Australian Pesticides and Veterinary Medicines Authority
AQIS / Australian Quarantine and Inspection Service
AMV / Alfalfa mosaic virus
AMVCP / gene encoding Alfalfa mosaic virus coat protein
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
DIR / Dealings involving Intentional Release
DNA / Deoxyribonucleic Acid
DPI Victoria / Victorian Department of Primary Industries
FSANZ / Food Standards Australia New Zealand (formerly ANZFA)
GM / Genetically Modified
GMO / Genetically Modified Organism
GTTAC / Gene Technology Technical Advisory Committee
ha / Hectare
km / kilometre
m / metre
mm / millimetre
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
qPCR / Quantitative Polymerase Chain Reaction
RARMP / Risk Assessment and Risk Management Plan
the Regulations / Gene Technology Regulations 2001
the Regulator / Gene Technology Regulator
RNA / Ribonucleic Acid
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

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Abbreviations (January 2009) VII

DIR 089 – Risk Assessment and Risk Management Plan Office of the Gene Technology Regulator

Technical Summary

Introduction

The application

DPI Victoria applied for a licence for dealings involving the intentional release of one line[6] of white clover (Trifolium repens L.) which has been genetically modified to resist infection by AMV on a limited scale and under controlled conditions. The trial is authorised to take place at one site in the local government area of Corowa, NSW, on a maximum area of 633m2 per year between March 2009 and August2011.

The GM white clover line proposed for release was produced by transforming plants of the white clover cultivar ‘Irrigation’. The GM plants were then conventionally bred with the white clover cultivar ‘Mink’ and then the white clover cultivar ‘Grasslands Sustain’ to produce the GM white clover proposed for release.