Application for licence for dealings involving an intentional release into the environment dir 025/2002



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Risk Assessment

and Risk Management Plan

Application for licence for dealings involving an

intentional release into the environment
DIR 025/2002

Title: Seed increase and efficacy studies

in Northern Australia of transgenic cotton expressing a

new insecticidal protein gene (vip3A)

Applicant: CSIRO
May 2003
Abbreviations


ANZFA

Australia New Zealand Food Authority (now FSANZ)

APVMA

Australian Pesticides and Veterinary Chemicals Authority

m


metre

mRNA

messenger ribonucleic acid

OGTR

Office of the Gene Technology Regulator

PCR

polymerase chain reaction

US EPA


United States Environmental Protection Agency

μg


micrograms


TABLE OF CONTENTS


EXECUTIVE SUMMARY 4

Introduction 4

The application 4

The risk assessment and evaluation process 5

Conclusions of the risk assessment 5

Summary of the risk management plan 6



Management of the toxicity or allergenicity risks 6

Management of the weediness risks 6

Management of the gene transfer risks 6

Management of the insecticide resistance risks 7

Summary of risk management conditions 7

Monitoring and enforcement of compliance by the OGTR 7

Further information 8

chapter 1 BACKGROUND 9

Section 1 The application 9



Section 1.1 The proposed dealings 9

Section 2.3 Parent organism 9

Section 2.4 Genetic modification and its effect 10

Section 2.5 Method of gene transfer 10

Section 2 Previous releases and international approvals 10



Section 2.1 Previous Australian Releases 10

Section 2.3 Approvals by other Australian government agencies 10

Section 2.4 International approvals 11

Chapter 2 Summary of Risk assessment AND Risk management Plan 12

Section 1 Issues raised in consultation on the application 12

Section 2 Finalisation of the risk assessment and the risk management plan 13

Section 3 Decision on the application 13

Section 4 Identification of issues to be addressed for future releases 13

Appendix 1 INFORMATION ABOUT THE GMO 22

Section 1 Summary information about the GMO 22

Section 2 The parent organism 22

Section 3 The introduced genes 23



Section 3.1 The insecticidal gene 23

Section 3.2 The antibiotic resistance marker gene 23

Section 4 Bt toxin 23

Section 5 Method of gene transfer 24

Section 5 Characterisation of the inserted genetic material and stability of the genetic modification 25

Section 6 Expression of the introduced proteins 25

Appendix 2 human health and safety 26

Under section 51 of the Act, the Regulator is required to consider risks to human health and safety and the environment in preparing the risk assessment and risk management plan. This Appendix considers potential hazards that may be posed to human health and safety as a result of any toxicity or allergenicity of the GMO or its novel proteins. 26

Section 1 Nature of the potential toxicity or allergenicity hazard 26

Section 2 Likelihood of the toxicity or allergenicity hazard occurring 26

Section 2.1 Exposure of people to the GM insecticidal cotton 26

Section 2.2 Exposure to other sources of the introduced proteins in the environment 27

Section 2.3 Toxicity and allergenicity hazards for people working with GM cotton (occupational exposure) 27

Section 2.4 Toxicity and allergenicity hazards for people wearing cotton clothing 28

Section 2.5 Toxicity and allergenicity hazards for people through general environmental exposure 28

Section 3 Conclusions regarding toxicity and allergenicity 29



Appendix 3 TOXICITY TO NON-TARGET ORGANISMS 30

Section 1 Nature of the potential toxicity hazard 30

Section 2 Likelihood of the toxicity hazard occurring 30

Section 2.1 Toxicity hazard of the GM insecticidal cotton for mammals and wildlife, including birds and fish 30

Section 2.2 Toxicity hazard of the GM cotton for invertebrates, including beneficial insects 32

Section 3 Conclusions regarding toxicity to non-target organisms 33



appendix 4 Weediness 35

Section 1 Nature of the weediness hazard 35

Section 2 Likelihood of the weediness hazard occurring 35

Section 3 Conclusions regarding weediness 37



APPENDIX 5 Transfer of introduced genes to other organisms 38

Section 1 transfer of introduced genes to other plants 38



Section 1.1 Nature of the gene transfer hazard 38

Section 1.2 Likelihood of a hazard arising through gene transfer to other plants 39

Section 2 transfer of introduced genes to other organisms (microorganisms and animals) 40



Section 2.1 Nature of the gene transfer hazard 40

Section 2.2 Likelihood of a hazard arising through gene transfer other organisms 40

Section 2.3 Likelihood of gene transfer from plants to microorganisms 41

Section 2.4 Likelihood of gene transfer from plants to animals 42

Section 3 Conclusions regarding gene transfer to other organisms 42



Section 3.1 Conclusions regarding gene transfer to other plants 42

Section 2.4 Conclusions regarding gene transfer to other organisms (microorganisms and animals) 43

appendix 6 Insecticide resistance 44

Section 1 Nature of the insecticide resistance hazard 44

Section 2 Likelihood of the insecticide resistance hazard occurring 44

Section 3 Conclusions regarding insecticide resistance 44



Appendix 7 Licence conditions 45

Part 1 Definitions 45

Part 2 Specific Conditions 47

Part 3 Reasons for licence conditions 51



APPENDIX 8 legislative requirements for assessing dealings involving intentional releases 55

Section 1 The regulation of gene technology in Australia 55

Section 2 The licence application 55

Section 3 The initial consultation processes 56

Section 4 The evaluation processes 56

Section 5 Further consultation 57

Section 6 Decision on licence 58

appendix 9 SUMMARY of PUBLIC SUBMISSIONs ON the RARMP 60

appendix 10 References 64


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