Risk Assessment and Risk Management Plan Application for licence for dealings involving intentional release of a genetically modified organism into the environment dir 034/2003 Title: Field Trial of Genetically Modified Cotton



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Risk Assessment

and

Risk Management Plan


Application for licence for dealings involving

intentional release of a genetically modified organism

into the environment


DIR 034/2003

Title: Field Trial of Genetically Modified Cotton

(Gossypium hirsutum) Expressing

an Insecticidal Gene (vip3A)

Applicant: Syngenta Seeds Pty Ltd



15 October 2003


Abbreviations



ANZFA

Australia New Zealand Food Authority (now FSANZ)

APVMA

Australian Pesticides and Veterinary Chemicals Authority

Bt

Bacillus thuringiensis

Btk

Bacillus thuringiensis variety kurstaki

CaMV

cauliflower mosaic virus

CCI

Confidential Commercial Information

CSIRO

Commonwealth Scientific and Industrial Research Organisation

DIR

dealing involving intentional release

DNA

deoxyribonucleic acid

ELISA

Enzyme linked immunosorbent assay

EMBL

European Molecular Biology Laboratory

FAO

Food and Agricultural Organisation

FSANZ

Food Standards Australia New Zealand (formerly ANZFA)

g

gram

GM

genetically modified

GMAC

Genetic Manipulation Advisory Committee

GMO

genetically modified organism

GTTAC

Gene Technology Technical Advisory Committee

ha

hectare

hph

hygromycin resistance gene

Hph

hygromycin phosphotransferase protein

IgE

immunoglobulin E

IgG

immunoglobulin G

IPCS

International Program on Chemical Safety

m

metre

mRNA

messenger ribonucleic acid

ng

nannogram

NRA

OECD


OGTR

National Registration Authority for Agricultural and Veterinary Chemicals

Organisation for Economic Cooperation and Development

Office of the Gene Technology Regulator


PCR

polymerase chain reaction

PR

Planned Release

RARMP

Risk Assessment and Risk Management Plan

T-DNA

TGA


transfer deoxyribonucleic acid

Therapeutic Goods Administration



US EPA

United States Environmental Protection Agency

US FDA

United States Food and Drug Administration

vip3A

vegetative insecticidal protein gene (insecticidal gene)

VIP3A

vegetative insecticidal protein

WHO

World Health Organisation

μg

micrograms


TABLE OF CONTENTS

TABLE OF CONTENTS 3

Introduction 4

The application 5

The Evaluation Process 6

Conclusions of the Risk Assessment 7

The Risk Management Plan (Key Licence Conditions) 8

Further Information 10

chapter 1 BACKGROUND 11

Section 1 The Application 11



Section 1.1 The proposed dealings 11

Section 1.2 Parent organism 12

Section 1.3 Genetic modification and its effect 12

Section 1.4 Method of gene transfer 12

Section 2 Previous Releases and International Approvals 13



Section 2.1 Previous Australian Releases 13

Section 2.2 Approvals by other Australian government agencies 13

Section 2.3 International approvals 14

Chapter 2 Summary of Risk assessment AND Risk management Plan 16

Section 1 Issues Raised in Submissions on the Application and the Risk Assessment and Risk management plan 16

Section 2 Conclusions of the Risk Assessment and the Risk Management Plan 17

Table Summary of the risk assessment and the risk management plan (including licence conditions) 18

Section 3 Decision on the application 22

Section 4 Research Requirements 22

Appendix 1 INFORMATION ABOUT THE GMO 24

Section 1 Summary Information About the GMO 24

Section 2 The Parent Organism 24

Section 3 The Introduced Genes 25



Section 3.1 The insecticidal gene 25

Section 3.2 The antibiotic resistance marker gene 25

Section 4 Bt Toxin 25

Section 5 Method of Gene Transfer 26

Section 5.1 General brief summary of Agrobacterium-mediated transformation 26

Section 5.2 Agrobacterium-mediated transformation of vip3A cotton 27

Section 6 Characterisation of the Inserted Genetic Material and Stability of the Genetic Modification 27

Section 7 Expression of the Introduced Proteins 27

Section 7.1 VIP3A Protein 27

Section 7.2 Hph Protein 28

Section 8 Pleiotropic Effects of the Genetic Modification 28



Appendix 2 Toxicity and allergenicity to humans 30

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. 30

Section 1 Nature of the Potential Toxicity or Allergenicity Hazard 30

Section 2 Likelihood of the Toxicity or Allergenicity Hazard Occurring 31

Section 2.1 Toxicity and allergenicity of conventionally bred cotton 31

Section 2.2 Exposure of people to the GM insecticidal cotton and its products 31

Section 2.3 Toxicity and allergenicity hazards of the introduced proteins expressed in the GM cotton 33

Section 2.4 Exposure to introduced proteins from other sources in the environment 35

Section 3 Conclusions Regarding Toxicity and Allergenicity 35



Appendix 3 TOXICITY TO NON-TARGET ORGANISMS 37

Section 1 Nature of the Potential Toxicity Hazard 37

Section 2 Likelihood of the Toxicity Hazard Occurring 37

Section 2.1 Toxicity of conventionally bred cotton 38

Section 2.2 Potential for exposure to GM cotton and toxicity of the introduced proteins 38

Section 2.3 Exposure to introduced proteins from other sources in the environment 42

Section 3 Conclusions Regarding Toxicity to Non-Target Organisms 42



appendix 4 Weediness 44

Section 1 Nature of the Weediness Hazard 44

Section 2 Likelihood of the Weediness Hazard Occurring 45

Section 2.1 Inherent weediness of conventional cotton 45

Section 2.2 Dispersal of cottonseed in the environment 46

Section 2.3 Potential weediness of the GM insecticidal cotton 46

Section 2.4 Potential selective advantage conferred by the introduced proteins 48

Section 3 Conclusions Regarding Weediness 49



APPENDIX 5 Transfer of introduced genes to other organisms 51

Section 1 Transfer of Introduced Genes to Other Plants 52



Section 1.1 Nature of the gene transfer hazard 52

Section 1.2 Likelihood of gene transfer hazard occurring 53

Section 1.3 Conclusions regarding gene transfer to other plants 55

Section 2 Transfer of Introduced Genes to Other Organisms (Humans, Animals and Micro-organisms) 55



Section 2.1 Nature of the gene transfer hazard 55

Section 2.2 Likelihood of the gene transfer from the GM cotton to other organisms 57

Section 2.3 Conclusions regarding gene transfer from GM cotton to other organisms 62

appendix 6 Insecticide resistance 64

Section 1 Insecticide Resistance Development 65

Section 2 Conclusions Regarding Insecticide Resistance 65

Appendix 7 Licence conditions 66

APPENDIX 8 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 10 References 84




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