Risk Assessment and Risk Management Plan



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Risk Assessment and
Risk Management Plan

Application for licence for dealings involving an intentional release into the environment


DIR 026/2002

Title: Field trial for evaluation of GM papaya to delay fruit ripening and test the expression of the introduced genes

Applicant: The University of Queensland

June 2003

Abbreviations


ACC

1-amino-cyclopropane-1-carboxylic acid

ANZFA

Australia New Zealand Food Authority (now FSANZ)

QLD


Queensland


TABLE OF CONTENTS


EXECUTIVE SUMMARY 4

Introduction 4

The application 4

The evaluation process 5

Conclusions of the risk assessment 5

The risk management plan (key licence conditions) 6

Further information 7

chapter 1 BACKGROUND 8

Section 1 The application 8

Section 2 Previous releases and international approvals 10

chapter 2 SUMMARY OF THE RISK ASSESSMENT AND THE RISK MANAGEMENT PLAN 13

Section 1 Issues raised in submissions on the application and the risk assessment and risk management plan 13

Section 2 Finalisation of the risk assessment and the risk management plan 14

Section 3 Decision on the application 14

Section 3 Identification of issues to be addressed for future releases 15

Appendix 1 INFORMATION ABOUT THE GMO 21

Section 1 Summary information about the GMOs 21

1.2.1 Down-regulation of ethylene production 23

1.2.2 Disruption of ethylene perception 24

Section 2 The parent organism 25

Section 3 The introduced genes 25

3.1.1 Mechanisms for altering capacs 1 and capacs 2 activity 26

3.2.1 Ethylene perception and plant disease resistance 28

Section 4 Method of gene transfer 30

Section 5 Characterisation of the inserted genetic material and stability of the genetic modification 30

Section 6 Expression of the introduced proteins 32

Section 7 Evaluation of Pleiotropic Effects of Genetic Modification 32

APPENDIX 2 Toxicity and allergenicity to HUMANs and other organisms 34

Section 1 Nature of the potential toxicityand allergenicity hazard 34

Section 2 Likelihood of the toxicity or allergenicity hazard occurring 35

2.2.1 Acute Toxicity Studies 37

2.2.2 Stability of the introduced proteins in the human digestive tract 37

2.2.3 Homology with known allergens 38

2.2.4 Other sources of the introduced proteins in food 38

2.2.5 Assessment by other agencies 39

2.2.6 Toxicity to invertebrates and microorganisms 40

Section 3 Conclusions regarding toxicity and allergenicity 41

appendix 3 ENVIRONMENTAL SAFETY – Weediness 42

Section 1 Nature of the weediness hazard 42

Section 2 Likelihood of the weediness hazard occurring 42

2.2.1 Effects of modified ethylene biosynthesis on weediness 43

2.2.2 Effects of modified ethylene perception on weediness 43

2.2.3 Effect of antibiotic resistance and GUS expression on weediness 45

2.3.1 Spread of pollen from the GM papayas 45

2.3.2 Spread of fruit and seeds from the GM papayas 45

Section 3 Conclusions regarding weediness 47

APPENDIX 4 ENVIRONMENTAL SAFETY - Transfer of introduced genes to other organisms 48

Section 1 Transfer of introduced genes to other plants 49

1.1.1 Transfer of genes to other papayas 49

1.1.2 Transfer of genes to other plant species 49

Section 2 Transfer of introduced genes to microorganisms 52

2.2.1 Bacteria 54

2.2.2 Viruses 56

2.2.3 Fungi 56

Section 3 Transfer of introduced genes to animals 56

3.2.1 Humans 57

Transfer to humans via bacteria 57

3.2.2 Animals 58

Section 4 Conclusions regarding gene transfer to other organisms 59

Appendix 5 Licence conditions 62

part 1 62

part 2 65

Part 3 Conditions of Licence 67

Reasons for licence Conditions 73

Location and size of release 73

Cage 73


Access and control of the Location 73

GMOs must not be eaten 73

Notification of commencement of planting, flowering, fruiting and harvesting 74

Management of flowers 74

Management of fruiting and harvesting 74

Reporting of toxic and allergenic responses 74

Reporting of plant disease incidence 74

Cleaning 74

Storage and Transportation 75

Clean-up of Location and Inspection 75

Testing Methodology 75

Contingency Plan 75

Compliance 76

Research Requirements 76

Annual Report 76

APPENDIX 6 legislative requirements for assessing dealings involving intentional releases 77

Section 1 The regulation of gene technology in Australia 77

Section 2 The licence application 77

Section 3 The initial consultation processes 78

Section 4 The evaluation processes 79

Section 5 Further consultation 80

Section 6 Decision on licence 80

appendix 7 SUMMARY of PUBLIC SUBMISSIONs ON the Risk assessment and risk management plan 83

appendix 8 References 85




RISK ASSESSMENT AND RISK MANAGEMENT PLAN FOR INTENTIONAL RELEASE OF GMOs INTO THE ENVIRONMENT: Application No. DIR 026/2002



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