Commercial release of canola genetically modified for herbicide tolerance and a hybrid breeding system (InVigor® X Roundup Ready® canola)




НазваниеCommercial release of canola genetically modified for herbicide tolerance and a hybrid breeding system (InVigor® X Roundup Ready® canola)
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Risk Assessment and

Risk Management Plan for


DIR 108


Consultation Version


Commercial release of canola genetically modified for herbicide tolerance and a hybrid breeding system (InVigor® x Roundup Ready® canola)


Applicant: Bayer CropScience Pty Ltd


August 2011


PAGE INTENTIONALLY LEFT BLANK


Executive Summary

Introduction

A licence application (DIR 108) has been received from Bayer CropScience Pty Ltd (Bayer) for a commercial release of genetically modified (GM) canola.

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 Gene Technology Regulator (the Regulator) before making a decision whether or not to issue a licence to deal with a genetically modified organism (GMO).

In accordance with the gene technology legislation, a detailed Risk Assessment and Risk Management Plan (RARMP) for the dealings proposed by the applicant has been prepared for consultation. The Regulator now invites submissions in order to finalise the document, which will then form the basis of his decision whether or not to issue a licence1.

The application

Bayer has applied for a licence for dealings involving the intentional release of GM InVigor® x Roundup Ready® canola. Bayer is seeking approval to release the GM canola in all commercial canola growing areas of Australia. The GM canola and products derived from the GM canola would enter general commerce, including use in human food and animal feed.

Note that cultivation of GM canola may also be subject to other requirements in some Australian States and Territories for marketing reasons.

GM InVigor® x Roundup Ready® canola was produced by conventional breeding between GM InVigor® canola and GM Roundup Ready® canola, which were individually approved by the Regulator in 2003 for commercial release under licences DIR 021/2002 and DIR 020/2002, respectively.

The GM InVigor® x Roundup Ready® canola proposed for commercial release contains genes from common bacteria conferring tolerance to the herbicides glufosinate ammonium and glyphosate. In addition, some of the GM canolas proposed for release contain genes from common bacteria conferring a hybrid breeding system and/or an antibiotic resistance gene. The antibiotic resistance gene, which confers tolerance to the antibiotic kanamycin, was used to select genetically modified plants during their initial development in the laboratory.

GM InVigor® x Roundup Ready® canola has been previously approved for field trials in Australia under licences DIR 069/2006 and DIR 104 issued to Bayer.

Food Standards Australia New Zealand (FSANZ) has approved the use of food derived from GM InVigor® canola and GM Roundup Ready® canola for human consumption. These approvals also cover GM InVigor® x Roundup Ready® canola.

APVMA has regulatory responsibility for the supply of agricultural chemicals, including herbicides, in Australia. Amendments to the labels of glufosinate ammonium and glyphosate herbicides would be required for them to be used on InVigor® x Roundup Ready® canola.

An AQIS permit would be required to allow the importation of seed.

Risk assessment

The risk assessment takes into account information in the application, relevant previous approvals, current scientific knowledge and advice received from a wide range of experts, agencies and authorities consulted on the preparation of the RARMP. In taking into account a potential risk, the Regulator must consider the probability and impact of a potential adverse outcome over the foreseeable future.

Initially, potential pathways that might lead to harm to people or the environment as a result of gene technology are postulated (risk scenarios), and those that warrant detailed characterisation are determined. This process is described as risk identification.

Five risk scenarios were postulated, including consideration of whether or not expression of the introduced genes could result in products that are toxic or allergenic to people or other organisms, or alter characteristics that may impact on the spread and persistence of the GM canola. The opportunity for gene flow to other organisms, and its effects if it were to occur, was also assessed.

A risk is only identified for further assessment when a risk scenario is considered to have some chance of causing harm. Pathways that do not lead to an adverse outcome, or could not reasonably occur, do not advance in the risk assessment process.

The characterisation of the five risk scenarios in relation to both the seriousness and likelihood of harm, in the context of the large scale of the release proposed by the applicant, did not identify any risks that could be greater than negligible. Therefore, they did not warrant further detailed assessment.

Risks to the health and safety of people, or the environment, from the proposed release of GM canola into the environment are assessed to be negligible. Hence, the Regulator considers that the dealings involved in this commercial release do not pose a significant risk to either people or the environment2.

Risk management

Risk management is used to protect the health and safety of people and to protect the environment by controlling or mitigating risk. The risk management plan evaluates and treats identified risks and considers general risk management measures. The risk management plan is given effect through proposed licence conditions.

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. As the risks, either in the short or long term, to the health and safety of people, or the environment, from the proposed dealings are assessed to be negligible, no specific risk treatment measures are proposed.

The proposed licence, detailed in Chapter 4 of the RARMP, contains a number of general conditions relating to ongoing licence holder suitability, auditing and monitoring, and reporting requirements, which include an obligation to report any unintended effects.

Conclusions of the consultation RARMP

The risk assessment concludes that this proposed commercial release of GM InVigor® x Roundup Ready® canola, to be grown in all commercial canola growing areas of Australia, and the entry of products derived from the GM canola into general commerce Australia wide, poses negligible risks to the health and safety of people or the environment as a result of gene technology.

The risk management plan concludes that these negligible risks do not require specific risk treatment measures. If a licence were to be issued, general conditions are proposed to ensure that there is ongoing oversight of the release.

Call for comment

The Gene Technology Regulator (the Regulator) invites comments on the Risk Assessment and Risk Management Plan (RARMP) for application DIR 108, including the licence conditions proposed if a licence were to be issued to Bayer CropScience Pty Ltd for this release. The closing date for written submissions is 18 October 2011.

The Regulator would particularly value comments relating to risks to the health and safety of people or the environment posed by the proposed release.

All comments relating to the protection of people or the environment that are received by the closing date will be considered by the Regulator in finalising the RARMP, which will then form the basis of his decision whether or not to issue a licence.

Please note that issues such as food safety and labelling, the use of agricultural chemicals and marketability and trade implications do NOT fall within the scope of the evaluations that the Regulator is required to conduct under the Gene Technology Act 2000 and corresponding State and Territory legislation as these are the responsibilities of other agencies and authorities.

The consultation RARMP can be accessed on the OGTR website under 'What's New' or you can request a copy of the RARMP or the application from the OGTR. Please quote application number DIR 108.

The Regulator's Risk Analysis Framework and a review document, The Biology of Brassica napus L. (canola), and a plain English Questions and Answers on this application can also be accessed on the OGTR website or obtained from the OGTR.

If you have any questions about the RARMP or the evaluation process, please contact:

The Office of the Gene Technology Regulator

MDP 54 GPO Box 9848 Canberra ACT 2601

Tel: 1800 181 030

Fax: 02 6271 4202

Email: ogtr@health.gov.au

Website: http://www.ogtr.gov.au


Table of Contents

Executive Summary

Introduction

The application

Risk assessment

Risk management

Conclusions of the consultation RARMP

Call for comment

Table of Contents

Abbreviations

Technical Summary

Introduction

The application

Risk assessment

Risk management plan

Proposed licence conditions

Other regulatory considerations

Conclusions of the consultation RARMP

Chapter 1 Risk assessment context

Section 1 Background

Section 2 The legislative requirements

Section 3 The proposed release

3.1 The proposed dealings

Section 4 The parent organism

4.1 Toxicity of non-GM canola

4.2 Weediness of non-GM canola

Section 5 The parental GM canola lines

5.1 The introduced genes, their encoded proteins and their associated effects

5.2 The regulatory sequences

5.3 Method of genetic modification

5.4 Toxicity/allergenicity of the parental GM canola lines

5.5 Weediness of the parental GM canola lines

5.6 Potential for gene transfer from the parental GM canola lines

Section 6 The GMO, nature and effect of the genetic modification

6.1 Introduction to the GMO

6.2 Characterisation of the GMO

Section 7 The receiving environment

7.1 Relevant abiotic factors

7.2 Relevant biotic factors

7.3 Relevant agricultural practices

Section 8 Australian and international approvals

8.1 Australian approvals of InVigor® x Roundup Ready® canola

8.2 International approvals

Chapter 2 Risk assessment

Section 1 Introduction

Section 2 Risk Identification

2.1 Production of a toxic or allergenic substance

2.2 The potential for spread and persistence of the GM canola in the environment

2.3 Vertical transfer of genes to sexually compatible plants

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

Section 3 Risk estimate process

Section 4 Uncertainty

Chapter 3 Risk management

Section 1 Background

Section 2 Risk treatment measures for identified risks

Section 3 General risk management

3.1 Applicant suitability

3.2 Testing methodology

3.3 Identification of the persons or classes of persons covered by the licence

3.4 Reporting requirements

3.5 Monitoring for Compliance

Section 4 Post release review

4.1 Adverse effects reporting system

4.2 Requirement to monitor specific indicators of harm

4.3 Review of the RARMP

Section 5 Conclusions of the RARMP

Chapter 4 Proposed licence conditions

Section 1 Interpretations and Definitions

Section 2 Licence conditions

Section 3 Reporting and Documentation Requirements

Chapter 5 References

Appendix A Summary of issues raised in submissions received from prescribed experts, agencies and authorities on any matters considered relevant to the preparation of a Risk Assessment and Risk Management Plan for DIR 108

Abbreviations

the ActAPHISAPVMAAQISCaMVCMPEFSAEPSPSDIRDNAEFSAELISAFSANZFMVGMGMACGMOGOXGTTACHGTkDLGAmmmmRNAMSNICNASnptIIOECDOGTROSAPATPRRRARMPthe Regulationsthe RegulatorRFRNAT-DNATiTGATTUSDAUS EPAUS FDA

Gene Technology Act 2000Animal and Plant Health Inspection Service of the US Department of AgricultureAustralian Pesticides and Veterinary Medicines AuthorityAustralian Quarantine and Inspection ServiceCauliflower mosaic virusCrop Management PlanEuropean Food Safety Authority5-enolpyruvylshikimate-3-phosphate synthaseDealing involving Intentional ReleaseDeoxyribonucleic AcidEuropean Food Safety AuthorityEnzyme linked immunosorbent assayFood Standards Australia New Zealand Figwort mosaic virusGenetically ModifiedGenetic Manipulation Advisory CommitteeGenetically Modified Organismglyphosate oxidoreductaseGene Technology Technical Advisory CommitteeHorizontal gene transferkilodaltonLocal Government Areametremillimetremessenger ribonucleic acidMale-sterileNational Industrial Chemicals Notification and Assessment Schemeneomycin phosphotransferase II geneOrganisation for Economic Co-operation and DevelopmentOffice of the Gene Technology RegulatorOutside scope of the assessmentphosphinothricin acetyl transferasePost release reviewRisk Assessment and Management PlanGene Technology Regulations 2001Gene Technology RegulatorRestorer of fertilityRibonucleic AcidTransfer DNATumour inducingTherapeutic Goods AdministrationTriazine tolerantUnited States Department of Agriculture United States Environmental Protection AgencyUnited States Food and Drug AdministrationPAGE INTENTIONALLY LEFT BLANKTechnical Summary

Introduction

A licence application (DIR 108) has been received from Bayer CropScience Pty Ltd (Bayer) for a commercial release of genetically modified (GM) canola.

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 Gene Technology Regulator (the Regulator) before making a decision whether to issue a licence to deal with a genetically modified organism (GMO).

In accordance with the gene technology legislation, a detailed Risk Assessment and Risk Management Plan (RARMP) for the dealings proposed by the applicant has been prepared for consultation. The Regulator now invites submissions in order to finalise the document, which will then form the basis of his decision whether or not to issue a licence3.

The application

Bayer has applied for a licence for dealings involving the intentional release of GM InVigor® x Roundup Ready® canola. Bayer is seeking approval to release the GM canola in all commercial canola growing areas of Australia. The GM canola and products derived from the GM canola would enter general commerce, including use in human food and animal feed.

Note that cultivation of GM canola may also be subject to other requirements in some Australian States and Territories for marketing reasons.

GM InVigor® x Roundup Ready® canola was produced by conventional breeding between GM InVigor® canola and GM Roundup Ready® canola, which were individually approved by the Regulator in 2003 for commercial release under licences DIR 021/2002 and DIR 020/2002, respectively.

All GM InVigor® x Roundup Ready® canola proposed for commercial release contains genes conferring tolerance to the herbicides glufosinate ammonium and glyphosate. In addition, some of the GM canolas proposed for release contain genes conferring a hybrid breeding system and/or an antibiotic resistance gene, depending on the specific GM InVigor® parent line4.

Glyphosate tolerance is conferred by expression of the goxv247 gene (a modified version of the gox gene obtained from the soil bacterium Ochrobactrum anthropi strain LBAA) and the cp4 epsps gene obtained from the soil bacterium Agrobacterium tumefaciens strain CP4. The goxv247 gene encodes glyphosate oxidoreductase, an enzyme capable of degrading glyphosate into non-toxic metabolites. The cp4 epsps gene encodes a 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) enzyme. EPSPS enzymes participate in a biosynthetic pathway found in both plants and microorganisms that is required for the synthesis of some essential amino acids. Most plant EPSPS enzymes are inhibited by glyphosate, which results in plant death due to the lack of essential amino acids. However, CP4 EPSPS has a much lower affinity for glyphosate than related plant EPSPS enzymes and can continue to function in the presence of glyphosate.

Glufosinate ammonium herbicide tolerance may be provided by expression of the pat gene obtained from Streptomyces viridochromogenes or the bar gene obtained from Streptomyces hygroscopicus. Both genes encode functionally equivalent phosphinothricin acetyltransferase enzymes that alter the structure of the active component in glufosinate ammonium herbicides, rendering the herbicide inactive.

Some of the GM canolas proposed for release contain the barnase and/or barstar genes obtained from the soil bacterium Bacillus amyloliquefaciens. Barnase encodes a ribonuclease enzyme (BARNASE), and barstar encodes a specific inhibitor of the BARNASE enzyme. BARNASE is produced specifically in the anthers of GM flowers and prevents pollen production, resulting in male-sterility. Production of BARSTAR in the same cells inhibits BARNASE activity to restore fertility of the flower.

Some of the GM canolas also contain the nptII gene obtained from the bacterium Escherichia coli. The nptII gene encodes the enzyme neomycin phosphotransferase II which confers resistance to kanamycin and structurally related antibiotics. During development of the GM canola, this marker gene enabled selection of genetically modified plant tissues.

Short regulatory sequences necessary to control expression of the novel genes are present in GM InVigor® x Roundup Ready® canola. These sequences have been derived from: the common soil bacterium A. tumefaciens; the plant species Arabidopsis thaliana (thale cress), Nicotiana tabacum (tobacco) and Pisum sativum (pea); and the plant viral pathogens Cauliflower Mosaic Virus and Figwort Mosaic Virus. Although A. tumefaciens, Cauliflower Mosaic Virus and Figwort Mosaic Virus are plant pathogens, the regulatory sequences comprise only a small part of their total genome, and are not in themselves capable of causing disease.

GM InVigor® x Roundup Ready® canola has been previously approved for field trials in Australia under licences DIR 069/2006 and DIR 104 issued to Bayer.

Risk assessment

The risk assessment takes into account information in the application, relevant previous approvals, current scientific knowledge, and advice received from a wide range of experts, agencies and authorities consulted on the preparation of the RARMP. In taking into account a potential risk, the Regulator must consider the probability or impact of an adverse outcome over the foreseeable future.

A reference document, The Biology of Brassica napus (canola), was produced to inform the risk assessment process for licence applications involving GM canola plants. The document is available from the OGTR or from the website
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