Application for licence for dealings involving an intentional release of a genetically modified organism into the environment




НазваниеApplication for licence for dealings involving an intentional release of a genetically modified organism into the environment
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Risk Assessment

and

Risk Management Plan

Application for licence for dealings involving an intentional release of a genetically modified organism into the environment

DIR 038/2003


Title: Field trial for breeding and pre-commercial evaluation of GM cotton expressing tolerance to the herbicide glufosinate ammonium


Applicant: CSIRO


November 2003


Abbreviations


ANZFA

Australia New Zealand Food Authority (now FSANZ)

APVMA

Australian Pesticides and Veterinary Medicines Authority (formerly NRA)

AQIS

Australian Quarantine Inspection Service

bar

Bar gene

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 Agriculture Organisation of the United Nations

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/s

IgE

immunoglobulin E

IgG

immunoglobulin G

IOGTR

Interim Office of the Gene Technology Regulator

IPCS

International Program on Chemical Safety

km

kilometre

m

metre

MRL

maximum residue limit

mRNA

messenger ribonucleic acid

ng

nanogram

NHMRC

National Health and Medical Research Council

NICNAS

National Industrial Chemicals Notification and Assessment Scheme

nos

nopaline synthase

NRA

National Registration Authority for Agricultural and Veterinary Chemicals (now APVMA)

OECD

Organisation for Economic Cooperation and Development

OGTR

Office of the Gene Technology Regulator

ppm

parts per million

PAT

phosphino N-acetyl transferase protein

PR

Planned Release

PCR

Polymerase chain reaction

RARMP

Risk Assessment and Risk Management Plan

T-DNA

transfer deoxyribonucleic acid

TGA

Therapeutic Goods Administrations

TGAC

Technical Grade Active Constituent

US EPA

United States Environmental Protection Agency

US FDA

United States Food and Drug Administration

WHO

World Health Organisation

mg

micrograms


TABLE OF CONTENTS

TABLE OF CONTENTS Error: Reference source not found

Executive Summary Error: Reference source not found

The ReGULATION OF GENETICALLY MODIFIED ORGANISMS Error: Reference source not found

The application Error: Reference source not found

The evaluation process Error: Reference source not found

Conclusions of the risk assessment Error: Reference source not found

The Risk Management Plan (Key Licence Conditions) Error: Reference source not found

FURTHER INFORMATION Error: Reference source not found

chapter 1 BACKGROUND Error: Reference source not found

Section 1 The application Error: Reference source not found

Section 1.1 The proposed dealings Error: Reference source not found

Section 1.2 Parent organism Error: Reference source not found

Section 1.3 Genetic modification and its effect Error: Reference source not found

Section 1.4 Method of gene transfer Error: Reference source not found

Section 2 Previous releases and international approvals Error: Reference source not found

Section 2.1 Previous Australian Releases of similar GM cottons Error: Reference source not found

Section 2.2 Approvals by other Australian government agencies Error: Reference source not found

Section 2.3 International approvals Error: Reference source not found

Chapter 2 Summary of Risk assessment AND Risk management Plan Error: Reference source not found

Section 1 Issues raised in consultation on the application Error: Reference source not found

Section 2 conclusions of the risk assessment and the risk management plan Error: Reference source not found

Section 3 Decision on the application Error: Reference source not found

Section 4 Identification of issues to be addressed for future releases Error: Reference source not found

Appendix 1 INFORMATION ABOUT THE GMO Error: Reference source not found

Section 1 Summary information about the GMO Error: Reference source not found

Section 2 The parent organism Error: Reference source not found

Section 3 The introduced genes Error: Reference source not found

Section 3.1 The herbicide tolerance bar gene Error: Reference source not found

Section 4 Method of gene transfer Error: Reference source not found

Section 4.1 Agrobacterium mediated transformation Error: Reference source not found

Section 4.2 Agrobacterium-mediated transformation of LibertyÒ cotton Error: Reference source not found

Section 5 Characterisation of the inserted genetic material and stability of the genetic modification Error: Reference source not found

Section 6 Expression of the introduced protein Error: Reference source not found

Section 6.1 The PAT protein Error: Reference source not found

Section 7 Pleiotropic Effects of the Genetic Modification Error: Reference source not found

Appendix 2 Toxicity and allergenicity to humans Error: Reference source not found

Section 1 Nature of the potential toxicity or allergenicity hazard Error: Reference source not found

Section 2 Likelihood of the toxicity or allergenicity hazard occurring Error: Reference source not found

Section 2.1 Toxicity and allergenicity of conventional cotton Error: Reference source not found

Section 2.2 Possible routes of exposure of people to GM herbicide tolerant cotton and its products Error: Reference source not found

Section 2.3 Toxicity Error: Reference source not found

Section 2.4 Homology with known allergens Error: Reference source not found

Section 2.5 Toxicity of the metabolites of glufosinate ammonium Error: Reference source not found

Section 3 Conclusions regarding toxicity and allergenicity TO HUMANS Error: Reference source not found

Appendix 3 TOXICITY TO other ORGANISMS Error: Reference source not found

Section 1 Nature of the Potential Toxicity Hazard Error: Reference source not found

Section 2 Likelihood of the Toxicity Hazard Occurring Error: Reference source not found

Section 2.1 Toxicity of conventionally bred cotton Error: Reference source not found

Section 2.2 Potential for exposure of to GM cotton and toxicity of the introduced protein. Error: Reference source not found

Section 3 Conclusions regarding toxicity to other organisms Error: Reference source not found

appendix 4 Weediness Error: Reference source not found

Section 1 Nature of the weediness hazard Error: Reference source not found

Section 2 Likelihood of the weediness hazard occurring Error: Reference source not found

Section 2.1 Inherent weediness of conventional cotton Error: Reference source not found

Section 2.2 Dispersal ofcottonseed in the environment Error: Reference source not found

Section 2.3 Potential weediness of the GM herbicide tolerant cotton Error: Reference source not found

Section 2.4 Potential selective advantage conferred by the PAT protein Error: Reference source not found

Section 2.5 Findings of environmental monitoring program for Roundup ReadyÒ and Roundup ReadyÒ/INGARDÒ cotton Error: Reference source not found

Section 3 Conclusions regarding weediness Error: Reference source not found

APPENDIX 5 Transfer of introduced genes to other organisms Error: Reference source not found

Section 1 transfer of introduced gene to other plants Error: Reference source not found

Section 1.1 Nature of the gene transfer hazard Error: Reference source not found

Section 1.2 Likelihood of a hazard arising through gene transfer from GM herbicide tolerant cotton to other plants Error: Reference source not found

Section 1.3 Conclusions regarding gene transfer to other plants Error: Reference source not found

Section 2 GenE transfer of introduced genes to other organisms (Humans, Animals, and microorganisms) Error: Reference source not found

Section 2.1 Nature of the gene transfer hazard Error: Reference source not found

Section 2.2 Likelihood of hazard arising through gene transfer from GM cotton to other organisms Error: Reference source not found

Section 3 Conclusions regarding gene transfer to other organisms Error: Reference source not found

appendix 6 Herbicide Resistance Error: Reference source not found

Section 1 Herbicide tolerance hazard Error: Reference source not found

Section 2 Conclusions regarding herbicide resistance Error: Reference source not found

Appendix 7 Licence Conditions Error: Reference source not found

APPENDIX 8 legislative requirements for assessing dealings involving intentional releases Error: Reference source not found

Section 1 The regulation of gene technology in Australia Error: Reference source not found

Section 2 The licence application Error: Reference source not found

Section 3 The initial consultation processes Error: Reference source not found

Section 4 The evaluation process Error: Reference source not found

Section 5 Further consultation Error: Reference source not found

Section 6 Decision on licence Error: Reference source not found

APPENDIX 9 Summary of public submissions ON THE RISK ASSESSMENT AND RISK MANAGEMENT PLAN Error: Reference source not found

APPENDIX 10 REFERENCES Error: Reference source not found

Executive Summary

The ReGULATION OF GENETICALLY MODIFIED ORGANISMS

The Gene Technology Act 2000 (the Act) and the Gene Technology Regulations 2001 (the Regulations) set out requirements which the Gene Technology Regulator (the Regulator) must follow when considering an application for a licence to intentionally release a genetically modified organism (GMO) into the environment.


For a licence to be issued, the Regulator must be satisfied that the release will not pose any risks to human health and safety and the environment that cannot be managed. To this end, Section 51 of the Act requires the Regulator to prepare a risk assessment and risk management plan (RARMP) for each licence application, in consultation with a wide range of expert groups and stakeholders.


Under Section 52 of the Act, the Regulator is required to seek comment on the RARMP from those consulted in its preparation and invite submissions from the public. In accordance with Section 56 of the Act, matters raised relating to the protection of human health and safety and the environment are taken into account in finalising the RARMP, which then forms the basis of the Regulator’s decision on whether, or not, to issue a licence.


The application

CSIRO has applied for a licence (application number DIR 038/2003) for the intentional release, under limited and controlled conditions, of genetically modified (GM) herbicide tolerant cotton (Liberty®) into the environment. CSIRO plans to carry out the trials at a maximum of 16 sites selected from 17 shires in New South Wales and Queensland covering a total area of less than 45 hectares (ha) from October 2003 to May 2006. All the proposed trial sites are south of latitude 22º.


The GM herbicide tolerant cotton proposed for release comprises backcrosses of the LL25 transformation event into elite Australian cotton varieties. Early generations of these backcrosses were released under DIR 015/2002 and advanced (F3 and F4 homozygous) generations are proposed for release under DIR 038/2003. GM cottons containing the LL25 transformation event were also previously trialed under the former voluntary system (see below).


The proposed release is part of an on going breeding program to develop lines suitable for commercial release (subject to further assessments and approvals). The trial will assess the agronomic performance, disease susceptibility and efficacy of the herbicide tolerance trait in the GM cotton. CSIRO proposes to retain some cottonseeds from selected Liberty® cotton lines for future breeding programs (subject to further assessments and approvals).


The GM cotton contains the bar gene from the bacterium Streptomyces hygroscopicus. The gene encodes the PAT (phosphino N-acetyl transferase) protein that confers tolerance to glufosinate ammonium, the active ingredient of the herbicide LibertyÒ. Conventional cotton is susceptible to glufosinate ammonium damage. The use of LibertyÒ cotton allows the application of LibertyÒ herbicide to control weeds that emerge early in the crop (up to the four-leaf growth stage). The bar gene was used as the sole selectable marker gene in the initial laboratory stages of developing the LibertyÒ cotton.

In accordance with section 184 of the Act, details of the plasmid map, plasmid name, the order of regulatory elements, and data on molecular characterisation have been declared Confidential Commercial Information (CCI). However this information was made available to the various prescribed expert groups who were consulted on the preparation of the risk assessment and risk management plan.


None of the cotton plants from the proposed release, or their by-products will be used for human food or animal feed. However CSIRO proposes to sell lint from the GM and non-GM plants (from the pollen trap zone). Processed lint does not contain genetic material or protein. After ginning the linters will be destroyed along with the cottonseeds that are not required for possible future planting.

As mentioned above, under the former voluntary system overseen by the Genetic Manipulation Advisory Committee (GMAC), CSIRO conducted five planned releases of Liberty® cotton (PR-82, PR-82X, PR-124, PR-124X, PR-124X(2)) from 1997.


Licences issued for all the planned releases have expired. However, in October 2002, the Regulator issued a licence to CSIRO (DIR015/2002) which is a continuation of PR124, PR124X and PR124X(2), for a limited and control release of Liberty® cotton in New South Wales. DIR 015/2002 is now at the post harvest monitoring stage. The scales of the trials were between 0.04 and 2 ha.


There have been no reports of adverse effects on human health and safety and the environment as a result of these releases.


A field trial of GM herbicide and insecticide tolerant cotton containing the bar and vip3A genes (DIR036/2003) has recently been approved for limited and controlled release by the Regulator.


The evaluation process

Licence application DIR038/2003 from CSIRO has been evaluated and a RARMP has been prepared, in accordance with the Act and the Regulations, using a Risk Analysis Framework. This framework was developed by the Regulator in consultation with the public and key State, Territory and Commonwealth government stakeholders and the Gene Technology Technical Advisory Committee, and is available at www.ogtr.gov.au/pdf/public/raffinal.pdf.

Details of the process that the Regulator must follow, including the prescribed consultation process on the application, and the matters that must be considered in preparing a RARMP, are set out in Appendix 8 of the RARMP. The complete RARMP can be obtained from the Office of the Gene Technology Regulator’s (OGTR’s) website at www.ogtr.gov.au or by contacting the Officer.

The risk assessment considered information contained in the application (including information required by the Act and the Regulations on the GMO, the parent organism, and the proposed dealings and on potential impacts on human health and safety and the environment), current scientific knowledge and submissions received during consultation.

Through this process, potential hazards to human health and safety and the environment that may be posed by the proposed release of LibertyÒ cotton were identified. These have been evaluated on the basis of the likelihood of each hazard occurring and their likely impact of each hazard would this be realised. These hazards were considered and evaluated previously for the same LibertyÒ cotton under DIR 015/2002, but were reassessed to determine whether the increase in scale and inclusion of more sites for the proposed release would pose any different risks to human health and safety and the environment. The identified potential hazards relate to:


  • toxicity and allergenicity for humans: could the herbicide tolerant LibertyÒ cotton be more toxic or allergenic than non-GM cotton, as a result of the novel gene product or because of unintended effects?

  • toxicity for other organisms: could the herbicide tolerant LibertyÒ cotton be more toxic or allergenic than non-GM cotton, to other organisms as a result of the novel gene product or because of unintended effects?

  • weediness: could the genetic modification of the herbicide tolerant LibertyÒ cotton be harmful to the environment by increasing the potential of GM cotton to establish as problem weeds?

  • transfer of introduced gene to other organisms: could the new gene introduced into the cottons transfer to non-GM cotton crops, feral or native cottons, or to other organisms, with adverse consequences?

  • herbicide resistance: could weeds develop resistance to the herbicide if the LibertyÒ cotton crop-herbicide combination is used inappropriately?

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has a complimentary regulatory role in respect of this application due to its responsibility for agricultural chemical use, including insecticides and herbicides in Australia under the Agricultural and Veterinary Chemicals (Code) Act 1994. Further information about the APVMA’s assessment and approval processes is contained in Chapter 2 and Appendix 6 of the RARMP


For commercial products, the normal form of approval is through registration, but the APVMA may also issue permits allowing restricted use of an insecticide or herbicide, for example for a limited period of time or for a limited area. The APVMA can impose conditions on the use of herbicides or insecticides in registrations and permits.


CSIRO has submitted an application to the APVMA for a research permit for the use of the herbicide Liberty® (a formulation of glufosinate ammonium) on the GM cotton. The APVMA and the OGTR are working closely to ensure the thorough, coordinated assessment of these parallel proposals.


Conclusions of the risk assessment

The Regulator considers that the limited and controlled release of the GM cotton will not pose risks to human health and safety, or to the Australian environment, that cannot be managed. The assessment of each potential hazard identified above is summarised under a separate heading below.

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