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Risk Assessment andRisk Management Plan for

DIR 120

Limited and controlled release of cotton genetically modified for insect resistance and herbicide

tolerance

Applicant: Monsanto Australia Ltd

July 2013

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DIR 120 – Risk Assessment and Risk Management Plan (July 2013) Office of the Gene Technology Regulator

Summary of the Risk Assessment and Risk Management Plan

for

Licence Application No. DIR 120DecisionThe Gene Technology Regulator (the Regulator) has decided to issue a licence for this application for a limited and controlled release of a genetically modified organism (GMO) into the environment. A Risk Assessment and Risk Management Plan (RARMP) for this application was prepared by the Regulator in accordance with requirements of the Gene Technology Act 2000 (the Act) and corresponding state and territory legislation, and finalised following consultation with a wide range of experts, agencies and authorities, and the public. The RARMP concludes that this field trial poses negligible risks to human health and safety and the environment and that any risks posed by the dealings can be managed by imposing conditions on the release.

The applicationApplication number DIR 120

Applicant Monsanto Australia Ltd (Monsanto)

Project title Limited and controlled release of cotton genetically modified for insect resistance and herbicide tolerance

Parent organism Cotton (Gossypium hirsutum)

Introduced gene and modified trait

vip3A(a) (vegetative insecticidal protein 3A) synthetic gene derived from a gene from the bacterium Bacillus thuringiensis (insect resistance)

cry1Ac (crystal protein 1Ac) gene from B. thuringiensis (insect resistance)

cry2Ab (crystal protein 2Ab) gene from B. thuringiensis (insect resistance)

cp4 epsps (5-enolpyruvylshikimate-3-phosphate synthase) gene from the bacterium Agrobacterium sp. strain CP4 (herbicide tolerance)

bar (phosphonithricin N-acetyltransferase) gene from the bacterium Streptomyces hygroscopicus (herbicide tolerance)

dmo (demethylase) gene from the bacterium Stenotophomonas maltophilia (herbicide tolerance)

Proposed location Sites selected from 56 possible local government areas (LGAs) in Western Australia, NSW and Queensland

Proposed release size Up to 10 sites per year in the first two years, at a maximum area of 10 hectares (ha) per site, and up to 20 sites per year in the remaining four years, at a maximum area of 30 ha per site

Proposed release dates October 2013 – October 2019

Primary purpose To assess the agronomic performance of the GM cottons under Australian field conditions and generate data for possible future commercial release

Summary I


Risk assessmentThe risk assessment concludes that risks to the health and safety of people, or the environment, from the proposed release are negligible.

The risk assessment process considered how the genetic modification and activities conducted with the GMOs might lead to harm to people or the environment. Risks were characterised in relation to both the seriousness and likelihood of harm, taking into account information in the application (including proposed limits and controls), relevant previous approvals, current scientific/technical knowledge, and advice provided in submissions received from experts, agencies, authorities and the public during consultation on the RARMP. Both the short and long term were considered.

Credible pathways to potential harm that were considered included: unintended exposure to the GM plant material; unintended effects of the genetic modification; increased spread and persistence of the GM cotton relative to unmodified plants; and transfer of the introduced genetic material to other cottons or other sexually compatible plants. Potential harms associated with these pathways included toxicity to people and other animals, allergic reactions in people and environmental harms associated with weediness. No new risks to people or the environment were identified from the advice received on the consultation RARMP.

The principal reasons for the conclusion of negligible risks are that the proposed limits and controls effectively contain the GMOs and their genetic material and minimise exposure; the introduced genetic modifications are unlikely to cause harm to people or the environment; and genes similar to the introduced genes are common in the environment.

Risk management planThe risk management plan concludes that risks posed by the proposed dealings can be managed so as to protect people and the environment by imposing conditions on the release. Risk management is used to control or mitigate risk. The risk management plan evaluates and treats identified risks, evaluates controls and limits proposed by the applicant, and considers general risk management measures. The risk management plan is given effect through licence conditions.

As the level of risk is assessed as negligible, specific risk treatment is not required. However, as this is a limited and controlled release, the licence includes limits on the size, location and duration of the release, as well as controls including: containment provisions at the trial site; prohibiting the use of GM plant materials in human food or animal feed; destroying GM plant materials (other than lint) not required for further studies; transporting GM plant materials in accordance with the Regulator’s guidelines or other specific conditions; and conducting post-harvest monitoring at the trial site to ensure all GMOs are destroyed.

Summary II


Table of ContentsSUMMARY OF THE RISK ASSESSMENT AND RISK MANAGEMENT PLAN...........................................I

DECISION ..........................................................................................................................................................ITHE APPLICATION....................................................................................................................................................IRISK ASSESSMENT..................................................................................................................................................IIRISK MANAGEMENT PLAN......................................................................................................................................II

TABLE OF CONTENTS........................................................................................................................................III

ABBREVIATIONS..................................................................................................................................................IV

CHAPTER 1 RISK ASSESSMENT CONTEXT...............................................................................................5

SECTION 1 BACKGROUND..................................................................................................................................5SECTION 2 REGULATORY FRAMEWORK.............................................................................................................5SECTION 3 THE PROPOSED DEALINGS................................................................................................................6

3.1 The proposed limits of the dealings (size, location, duration and people).......................................63.2 The proposed controls to restrict the spread and persistence of the GMOs and their genetic

material in the environment.............................................................................................................7SECTION 4 THE PARENT ORGANISM...................................................................................................................7SECTION 5 THE GM PARENTAL COTTONS..........................................................................................................8SECTION 6 THE GMOS, NATURE AND EFFECT OF THE GENETIC MODIFICATION................................................8

6.1 Introduction to the GMOs................................................................................................................86.2 The introduced genes, encoded proteins and their associated effects............................................106.3 Characterisation of the GMOs.......................................................................................................13

SECTION 7 THE RECEIVING ENVIRONMENT......................................................................................................137.1 Relevant abiotic factors..................................................................................................................137.2 Relevant biotic factors...................................................................................................................147.3 Relevant agricultural practices.......................................................................................................147.4 Presence of related plants in the receiving environment................................................................147.5 Presence of similar genes and encoded proteins in the environment.............................................15

SECTION 8 AUSTRALIAN AND INTERNATIONAL APPROVALS...........................................................................158.1 Australian approvals of GM cotton................................................................................................158.2 International approvals of GM cotton............................................................................................16

CHAPTER 2 RISK ASSESSMENT..................................................................................................................18

SECTION 1 INTRODUCTION...............................................................................................................................18SECTION 2 RISK IDENTIFICATION.....................................................................................................................19

2.1 Production of a substance toxic or allergenic to people or toxic to other organisms....................212.2 Weediness of the GM cotton plants in the environment................................................................242.3 Vertical transfer of the gene or genetic elements to sexually compatible plants...........................27

SECTION 3 RISK ESTIMATE PROCESS AND ASSESSMENT OF SIGNIFICANT RISK................................................29SECTION 4 UNCERTAINTY................................................................................................................................30

CHAPTER 3 RISK MANAGEMENT PLAN...................................................................................................31

SECTION 1 BACKGROUND................................................................................................................................31SECTION 2 RISK TREATMENT MEASURES FOR IDENTIFIED RISKS.....................................................................31SECTION 3 GENERAL RISK MANAGEMENT........................................................................................................31

3.1 Licence conditions to limit and control the release........................................................................313.2 Other risk management considerations..........................................................................................35

SECTION 4 ISSUES TO BE ADDRESSED FOR FUTURE RELEASES.........................................................................36SECTION 5 CONCLUSIONS OF THE RARMP.....................................................................................................37

REFERENCES .......................................................................................................................................................38

APPENDIX A SUMMARY OF SUBMISSIONS FROM PRESCRIBED EXPERTS, AGENCIES AND AUTHORITIES...........................................................................................................................42

APPENDIX B SUMMARY OF SUBMISSIONS FROM THE PUBLIC........................................................44

Table of Contents III


Abbreviationsthe Act Gene Technology Act 2000aad 3”(9)-O-aminoglycoside adenyltransferase geneaph4 hygromycin B phosphotransferase geneAPHIS Animal and Plant Health Inspection Service (USDA)APVMA Australian Pesticides and Veterinary Medicines AuthorityBt Bacillus thuringiensisCaMV Cauliflower mosaic virusCry Crystal proteinCSIRO Commonwealth Scientific and Industrial Research OrganisationCTP Chloroplast transit peptideDAFF Department of Agriculture, Fisheries and ForestryDIR Dealings Involving intentional ReleaseDNA Deoxyribonucleic AcidEFSA European Food Safety AuthorityEPSPS 5-enolpyruvylshikimate-3-phosphate synthaseFMV Figwort mosaic virusFSANZ Food Standards Australia New ZealandGM Genetically ModifiedGMO Genetically Modified OrganismGTTAC Gene Technology Technical Advisory Committeeha HectareHGT Horizontal gene transferLGA Local government aream metremRNA Messenger Ribonucleic AcidNAG N-Acetyl glufosinatePC1SV Peanut chlorotic streak caulimovirusRARMP Risk Assessment and Risk Management PlanRegulations Gene Technology Regulations 2001Regulator Gene Technology RegulatorT-DNA Transfer DNATEV Tobacco etch virus

Abbreviations IV

PROPOSED DEALINGSProposed activities involving the GMOProposed limits of the releaseProposed control measures

PARENT ORGANISMOrigin and taxonomyCultivation and useBiological characterisationEcology

PREVIOUS RELEASES

GMOIntroduced genes (genotype)Novel traits (phenotype)

RISK ASSESSMENT CONTEXT

LEGISLATIVE REQUIREMENTS(including Gene Technology Act and Regulations)

RISK ANALYSIS FRAMEWORK

OGTR OPERATIONAL POLICIES AND GUIDELINES

RECEIVING ENVIRONMENTEnvironmental conditionsAgronomic practicesPresence of related speciesPresence of similar genes


Chapter 1 Risk assessment contextSection 1 Background

1. An application has been made under the Gene Technology Act 2000 (the Act) for Dealings involving the Intentional Release (DIR) of genetically modified organisms (GMOs) into the Australian environment.

2. The Act in conjunction with the Gene Technology Regulations 2001 (the Regulations), an inter-governmental agreement and corresponding legislation that is being enacted in each State and Territory, comprise Australia’s national regulatory system for gene technology. Its objective is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs).

3. This chapter describes the parameters within which potential risks to the health and safety of people or the environment posed by the proposed release are assessed. The risk assessment context is established within the regulatory framework and considers application-specific parameters (Figure 1).

Figure 1. Summary of parameters used to establish the risk assessment context

Section 2 Regulatory framework4. In accordance with section 50A of the Gene Technology Act 2000 (the Act), this application is considered to be a limited and controlled release application, as its principal purpose is to enable the applicant to conduct experiments and the applicant has proposed limits on the size, location and duration of the release, as well as controls to restrict the spread and persistence of the GMOs and their genetic material in the environment. Therefore, the Gene Technology Regulator (the Regulator) was not required to consult with prescribed experts, agencies and authorities before preparation of the Risk Assessment and Risk Management Plan (RARMP; see section 50 of the Act).

5. Section 51 of the Act and regulation 9A of the Regulations outline the matters the Regulator must take into account in preparing a RARMP.

Chapter 1 – Risk assessment context 5


6. Section 52 of the Act requires the Regulator to seek comment on the RARMP from the States and Territories, the Gene Technology Technical Advisory Committee, Commonwealth authorities or agencies prescribed in the Regulations, the Minister for the Environment, relevant local council(s), and the public. The advice from the prescribed experts, agencies and authorities and how it was taken into account is summarised in Appendix A. Four public submissions were received and their consideration is summarised in Appendix B.

7. The Risk Analysis Framework (OGTR 2009) explains the Regulator’s approach to the preparation of RARMPs in accordance with the legislative requirements. Additionally, there are a number of operational policies and guidelines developed by the Office of the Gene Technology Regulator (OGTR) that are relevant to DIR licences. These documents are available from the OGTR website.

8. Any dealings conducted under a licence issued by the Regulator may also be subject to regulation by other Australian government agencies that regulate GMOs or GM products, including Food Standards Australia New Zealand (FSANZ), Australian Pesticides and Veterinary Medicines Authority (APVMA), Therapeutic Goods Administration, National Industrial Chemicals Notification and Assessment Scheme and Department of Agriculture, Fisheries and Forestry (DAFF) Biosecurity (formerly Australian Quarantine Inspection Service). These dealings may also be subject to the operation of State legislation declaring areas to be GM, GM free, or both, for marketing purposes.

Section 3 The proposed dealings9. Monsanto Australia Ltd (Monsanto) proposes to release genetically modified (GM) cottons into the environment under limited and controlled conditions.

10. The purpose of the trial is to assess the agronomic performance of the GM cotton under Australian field conditions and generate data for possible future commercial release. As well as assessing the GM cottons under Australian field conditions, the combined (or ‘stacked’) traits will also be introduced into Australian elite cotton varieties.

11. The dealings involved in the proposed intentional release would include:

conducting experiments with the GMOs

propagating, growing, raising or culturing the GMOs

breeding the GMOs

transporting the GMOs

storing the GMOs

disposing of the GMOs

possession, supply or use of the GMOs for the purposes of any of the above.

12. These dealings are detailed further below.

3.1 The proposed limits of the dealings (size, location, duration and people)13. The applicant proposes to conduct the trial over 6 growing seasons from October 2013 to October 2019 and to limit the trial to ten sites/year for the first two years of the trial, and up to 20 sites/year thereafter. Sites will be nominated from 56 local government areas (LGAs) in Western Australia, NSW and Queensland (Table 1) and each site is proposed to be up to 10 ha in area for the first two years and up to 30 ha for the remaining four years.


http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/home-1


Table 1 Local government areas proposed for field planting of the GMOsWestern Australia New South Wales QueenslandWyndham-East Kimberley Balranald Jerilderie BalonneBroome Berrigan Lachlan Banana

Bland Leeton Bundaberg RegionalBogan Liverpool Plains BurdekinBourke Moree Plains Central HighlandsBrewarrina Murray Goondiwindi RegionalCarrathool Murrumbidgee Isaac RegionalCentral Darling Narrabri Lockyer Valley RegionalCoolamon Narrandera Maranoa RegionalCoonamble Narromine ParooConargo Parkes Rockhampton RegionalDeniliquin Mildur South Burnett RegionalForbes Urana Southern Downs RegionalGilgandra Walgett Toowoomba RegionalGriffith Wagga Wagga Western Downs RegionalGunnedah Warren Whitsunday RegionalGwydir WarrumbungleHay WeddinInverell Young

14. Only trained and authorised staff would be permitted to deal with the GM cottons.

3.2 The proposed controls to restrict the spread and persistence of the GMOs and their genetic material in the environment15. The applicant has proposed a number of controls to restrict the spread and persistence of the GM cottons and the introduced genetic material in the environment. These include:

locating trial sites at least 50 m away from natural waterways

separating trial sites from other cotton crops by either an exclusion zone of 1 km or with a 20 m pollen trap of non-GM or commercially released GM cotton

cleaning all planting and harvest equipment used at field planting sites of GM material

harvesting and ginning cotton from the trial separately from other cotton

cultivating field planting sites after harvest to encourage decomposition or germination of remaining seed

post-harvest monitoring and destruction of any volunteer cotton at field planting sites for at least 12 months and until sites have been free of volunteers for six months

destroying all plant material from the trial not required for testing or future trials, except for lint which may be sold

transporting and storing the GMOs in accordance with the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs (2011)

not using GM plant material or products for human food or animal feed.

16. These controls, and the limits outlined in Section 3.2, have been taken into account in establishing the risk assessment context (this chapter), and their suitability for containing the proposed release is evaluated in Chapter 3, Section 3.1.1.

Section 4 The parent organism17. The parent organism is cultivated cotton (Gossypium hirsutum L.), which is the most commonly cultivated cotton species worldwide. Cotton is exotic to Australia and is grown as an agricultural crop in New South Wales and in southern and central Queensland, and on a trial basis in northern Queensland, northern Western Australia and in the Northern Territory.



Almost 99.5% of the Australian cotton crop is genetically modified (DAFWA). Roundup Ready Flex® cotton currently occupies about 97per cent of total cotton area, most of it stacked with the Bollgard II® trait (CSIRO 2010).

18. Cotton is grown as a source of textile and industrial fibre, cottonseed oil for food use, and cottonseed meal for animal feed. Further detailed information about the parent organism is contained in a reference document, The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton), which was produced to inform the risk assessment process for licence applications involving GM cotton plants (OGTR 2013). The document is available from the OGTR or from the OGTR website .

19. The GM cottons proposed for release were developed in G. hirsutum cultivars Coker 130 or Coker 312. These cultivars have been grown commercially in the United States but have not been commercialised in Australia. They were chosen for development of the GM cottons because of their positive response under tissue culture conditions and ready modification by standard genetic technologies. The genetic modifications have subsequently transferred into a range of G. hirsutum cultivars by conventional crossing.

Section 5 The GM parental cottons20. The GMOs proposed for release are the result of combination by conventional crossing of GM cotton containing any of the following four GM events†:

MON 88701: Dicamba- and glufosinate-tolerant cotton MON 88913: Roundup Ready Flex® cotton (glyphosate tolerant) MON 15985: Bollgard II® cotton (insect resistant) ‡

COT 102: VIP3A cotton (insect resistant).

21. In addition to non-GM cotton, information on these GM cottons will be used as baselines where relevant throughout the RARMP. The genetic modifications of the GM parental cottons and other information relevant to the risk assessment are described in Section 6.

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

6.1 Introduction to the GMOs22. The GM parental cottons were produced by Agrobacterium tumefaciens mediated plant transformation and/or biolistic bombardment. Information about these transformation methods can be found in the risk assessment reference document Methods of plant genetic modification available from the Risk Assessment References page on the OGTR website.

23. The applicant proposes to release GM cottons which combine MON 88701 (containing genes for dicamba and glufosinate herbicide tolerance) with one or more of the following: commercially approved Roundup Ready Flex® GM cotton (glyphosate herbicide tolerant); commercially approved Bollgard II® GM cotton (insect resistant); orVIP3A GM cotton (insect resistant). The GM cottons proposed for release will be generated by conventional crossing of these GM parental cottons, and could include any of the combinations shown in Table 2. The genes present in each of the parental cottons are listed in Table 3.

Table 2 GM cottons proposed for field trialGM event Common nameMON 88701 Dicamba- and glufosinate- tolerant cotton

† A GM event refers to a single unique genetic modification (ie change to the genetic material of an organism) resulting from a single transformation.‡ Bollgard II® cotton itself contains two independent GM events.


http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/riskassessments-1


http://grains.agric.wa.gov.au/node/genetically-modified-crops


GM event Common nameMON 88913 x MON 88701 Roundup Ready Flex® x Dicamba- and glufosinate- tolerant

cottonMON 15985 x MON 88913 x MON 88701 Bollgard II® x Roundup Ready Flex® x Dicamba- and

glufosinate- tolerant cottonMON 15985 x COT 102 x MON 88913 x MON 88701 Bollgard II® x VIP 3A* x Roundup Ready Flex® x Dicamba-

and glufosinate- tolerant cotton

*Bollgard II® x VIP 3A cotton is also referred to as Bollgard III® cotton

Table 3 Introduced genes in the GMOs proposed for releaseGM event Gene FunctionMON 88701 dmo dicamba herbicide tolerance

bar glufosinate herbicide toleranceMON 88913 (Roundup Ready Flex®) cp4 epsps glyphosate herbicide tolerance

cp4 epsps glyphosate herbicide toleranceMON 15985 (Bollgard II®) cry1Ac insect resistance

nptII antibiotic resistanceaad antibiotic resistancecry2Ab insect resistanceuidA reporter

COT 102 (VIP3A) vip3A insect resistanceaph4 antibiotic resistance

24. Cotton events COT 102, MON 15985 and MON 88913, alone and in combination, have been the subject of previous applications for DIR licences (see Section 8.1 and summary Table 5). Detailed descriptions of the individual events can be found in the RARMPs prepared for those releases and therefore will not be reiterated here. Assessments of Bollgard II® and Roundup Ready Flex® GM cottons in the context of commercial release throughout Australia concluded that they pose negligible risks to human health and safety and the environment.

25. MON 88701 cotton has not been previously assessed by the OGTR. However, the bar gene has been described and assessed in detail in a number of RARMPs, including that prepared for the commercial release of LibertyLink® cotton (Table 5). The dmo gene has not been the subject of any previous DIR licence application in Australia. Consequently, the focus of the current assessment is MON88701 cotton, individually and in combination with the other GM parental cottons. Details of the genetic elements used to develop this event are shown in Table 4.

26. In addition to genes conferring insect resistance and herbicide tolerance, the GM parental cottons contain antibiotic resistance genes and a reporter gene (Table 3) as well as short regulatory elements used to control expression of the genes. The GMOs proposed for trial will be generated by conventional crossing, so all of the genetic modifications present in the parental GM cottons could potentially be present. These sequences are derived from plants (including thale cress, pea, petunia and soybean), a soil bacterium (A. tumefaciens) and plant viruses (CaMV, FMV, PC1SV and TEV). The 35S sequence derived from FMV and CaMV promoters are short variants of the promoter containing a duplicate enhancer region (Kay et al 1987).

27. Additional information relevant to the genetic modifications in GM cotton event MON 88701 has been declared CCI. The confidential information was available to the prescribed experts and agencies that are consulted on the RARMP for this application.

Table 4 Genes and regulatory elements used to genetically modify cotton event MON 88701Genetic element Full name Source organism / further descriptionGene sequencesdmo dicamba O-demethylase Stenotrophomonas maltophilia. The gene has been codon

optimised for expression in plants.



Genetic element Full name Source organism / further descriptionbar Phosphinothricin N-acetyl

transferaseStreptomyces hygroscopicus

PromotersPC1SV PC1SV promoter Constitutive promoter from full length transcript of peanut

chlorotic streak caulimovirus (PC1SV)e35S CaMV 35S promoter Promoter for the 35S RNA of Cauliflower mosaic virus

(CaMV) containing duplicated enhancer region.Terminators

E6 3’ untranslated sequence of the E6 gene

Gossypium barbadense

nos 3’ untranslated sequence of the nopaline synthase gene

Agrobacterium tumefaciens

Other elementsTEV 5’ untranslated leader from RNA

of tobacco etch virus.Tobacco etch virus (TEV). Assists in regulating gene expression

Ctp2 Chloroplast transit peptide from the epsps gene

Arabidopsis thaliana (thale cress). The peptide directs transport of the DMO protein to the chloroplast.

HSP70 5’ untranslated leader of the heat shock protein 70 gene

Petunia x hybrida (petunia). Assists in regulating gene expression.

6.2 The introduced genes, encoded proteins and their associated effects28. The genes introduced into the parental GM cottons are briefly described in the following section (6.2.1). However, subsequent discussion of the encoded proteins and their effects will focus on MON 88701, as this event has not been the subject of earlier assessments by the Regulator. For more detailed information on the genetic material (genes and regulatory elements) and inherent toxicity or allergenicity of COT 102, MON 15985 and MON 88913, refer to previous RARMPs prepared for the DIRs listed in Section 8 (Table 5), which are available on the OGTR website . 6.2.1 The introduced genesIntroduced genes in event MON 88701

29. MON 88701 contains a dmo gene and a bar gene, which confer tolerance to the herbicides dicamba (2- methoxy-3,6-dichlorobenzoic acid) and glufosinate ammonium, respectively.

30. The dmo gene was derived from the aerobic, environmentally ubiquitous gram negative bacterium Stenotrophomonas maltophilia strain DI-6 (Herman et al. 2005). The dmo expression cassette encodes a precursor protein consisting of a single polypeptide of 416 amino acids. The mature protein is a dicamba mono-oxygenase that has high specificity for its substrate (D'Ordine et al. 2009; Dumitru et al. 2009) and rapidly demethylates dicamba to the herbicidally inactive metabolite 3,6-dichlorosalicylic acid (DCSA) and formaldehyde. Enzymes with structural and functional homologies to MON 88701 DMO have been described in a number of plants and bacteria, and bioinformatic information provided by the applicant shows sequence identities ranging from 42% in bacteria to 27% in crops such as canola, corn, pea, rice and soy.

31. The bar gene was isolated from Streptomyces hygroscopicus (Thompson et al. 1987), a common saprophytic, soil-borne microorganism that is not considered to be a pathogen of plants, humans, or other animals (OECD 1999). The bar expression cassette encodes a phosphinothricin N-acetyl transferase (PAT) protein, consisting of a single polypeptide of 183 amino acids (Thompson et al. 1987) that confers tolerance to glufosinate ammonium, the active component in a number of herbicides. The PAT protein expressed in MON 88701 is identical to the naturally occurring protein produced in S. hygroscopicus and is highly homologous to the proteins in commercially available glufosinate-tolerant GM crops.




Introduced genes in event MON 88913

32. MON 88913 contains two copies of the cp4 epsps gene, derived from the Agrobacterium strain CP4, a common soil-borne bacterium (Padgette et al. 1996). The gene encodes a glyphosate tolerant EPSP synthase enzyme and has been extensively used to develop GM plants with glyphosate tolerance (Dill 2005).Introduced genes in event MON 15985

33. MON 15985 contains the cry1Ac and cry2Ab genes derived from Bacillus thuringiensis subsp kurstaki, a gram positive bacterium commonly present in soil. The genes encode insecticidal proteins that are specifically toxic to caterpillar larvae of certain species of lepidopteran insects, including significant pests of cotton.Introduced genes in event COT 102

34. The insecticidal gene vip3A from COT 102 is also derived from B. thuringiensis subspecies kurstaki. It encodes the insecticidal protein VIP3A, which is toxic to caterpillar larvae of certain lepidopteran insect species.6.2.2 Regulatory elements

35. Promoters are DNA sequences that are required in order to allow RNA polymerase to bind and initiate correct transcription. Also required for gene expression in plants are mRNA terminators, including a poly-adenylation signal. Other regulatory sequences, such as enhancers, may contribute to the expression pattern of a given gene. Details of the regulatory sequences used in GM parental cottons MON88913, MON 15985 and COT 102 can be found in the corresponding DIR RARMPs (see Table 5 in Section 8, below), and for MON 88701 in Table 4. The regulatory elements present in all the parental cottons have been previously assessed as safe by the OGTR and other international agencies and the information is reviewed and updated as necessary.

36. Recently, there has been public commentary suggesting that protein P6, encoded by gene VI of the Caulimovirus and Soymovirus families, could result in harm to humans if expressed in GM plants (Latham & Wilson 2013). The cauliflower mosaic, figwort mosaic and peanut chlorotic streak viruses belong to the Caulimovirus family, and the CaMV 35S, FMV 35S and PC1SV promoters overlap sequences of gene VI. However, bioinformatic searches suggest it is extremely unlikely that the P6 protein possesses any allergenic or toxic properties (Podevin & du Jardin 2012). MON 88701 and MON 88913 contain a short variant of the 35S promoter from CaMV and FMV, respectively, that overlaps with a short, non-essential domain of the P6 protein.6.2.3 Toxicity/allergenicity associated with the introduced genesDMO protein and associated end products

37. The dmo gene encodes dicamba mono-oxygenase (DMO), which is classified as a Rieske-type non-heme iron oxygenase (ie contains a Rieske iron-sulphur cluster [2Fe-2S]). This class of oxygenases is found in diverse phyla ranging from bacteria to plants (Ferraro et al. 2005; Schmidt & Shaw 2001). DMO forms part of a three component system comprised of a reductase, a ferredoxin, and a terminal oxygenase (in this case the DMO). The three enzymes work together to catalyze the demethylation of the dicamba herbicide active ingredient 3,6-dichloro-2-methoxybenzoic acid, resulting in formation of 3,6-dichlorosalicylic acid (DCSA) and formaldehyde. MON 88701 DMO was found to be specific to dicamba when tested using structurally similar endogenous substrates as well as exogenous herbicide substrates representing a wide range of herbicide modes-of-action (data provided by applicant).

38. The applicant has provided data relating to the potential toxicity/allergenicity of the DMO protein in MON 88701. No relevant amino acid sequence similarities were found with known allergens, gliadins, glutenins, toxins, and other biologically active proteins that may



have adverse effects on mammals. In addition, MON 88701 DMO was rapidly degraded in simulated gastric and intestinal fluids and a high dose of this protein in a mouse acute oral toxicity evaluation demonstrated that it is not acutely toxic, and does not cause any adverse effect. Based on these measures, it was concluded that the DMO protein in MON 88701 is not toxic or allergenic to humans or animals.

39. Further, herbicide tolerant GM soybean (MON 87708) containing a dmo gene from S. maltophilia has been assessed by FSANZ and no potential public health and safety concerns were identified. Food derived from MON 88708 soybeans was considered to be as safe for human consumption as food derived from conventional soybeans (FSANZ 2012).

40. MON 88701 cotton plants produce DCSA and formaldehyde as reaction products in the presence of dicamba herbicide (in the absence of dicamba treatment of MON 88701 these compounds would not be produced).

41. DCSA is structurally similar to salicylic acid (SA), which is known to be involved in plant defence responses; it has been identified as a metabolite of dicamba in soil, plants and livestock. The US EPA (2006) reviewed the safety of dicamba and its metabolites, including DCSA, and concluded that DCSA would have similar toxicity to the parent herbicide. Risks to human health and the environment associated with exposure to dicamba and its metabolites were below the Agency’s level of concern for all registered uses.

42. Formaldehyde is ubiquitous in the environment and present in both plants and animals. It is readily metabolized and incorporated into the 1-carbon pool of plants through known pathways. Based on standard dicamba application rates, the maximum theoretical production of formaldehyde in MON 88701 GM cotton tissue has been estimated at 6.3 mg/kg or 33 mg/kg, depending on plant growth stage at application. These values are well within the range of formaldehyde concentrations measured for a variety of agricultural commodities, for example up to 60 mg/kg in fruits and vegetables (WHO-IPCS 1989).PAT protein and associated end products

43. Glufosinate, or its ammonium salt DL-phosphinothricin, is an active ingredient in several nonselective systemic herbicides. The bialaphos resistance (bar) gene encodes a phosphinothricin N-acetyl transferase (PAT) protein, an acetyltransferase enzyme that acetylates glufosinate to produce non-herbicidal N-acetyl glufosinate. The PAT protein expressed in MON 88701 is identical to the wild type protein produced in S. hygroscopicus and is highly homologous to the PAT proteins in commercially available glufosinate-tolerant GM crops including cotton, corn, soybean and canola.

44. The environmental safety of the PAT protein present in biotechnology-derived crops, either alone or in combination with other GM traits, has also been extensively assessed by regulatory authorities worldwide (CERA 2011). A comprehensive study on the safety of PAT proteins (Herouet et al. 2005) found that PAT enzymes are highly specific and do not possess the characteristics associated with food toxins or allergens, i.e., they have no sequence homology with any known allergens or toxins, they have no N-glycosylation sites, they are rapidly degraded in gastric and intestinal fluids, and they are devoid of adverse effects in mice after intravenous administration at a high dose level.

45. N-acetyl glufosinate (NAG) is the main metabolite formed following application of glufosinate ammonium to GM plants that express the PAT protein. NAG is considered non-toxic to plants, invertebrates, rodents and mammals, including humans (Hoerlein 1994; OECD 1999).



6.3 Characterisation of the GMOs46. Characterisation details for COT102, MON 88913 and MON 15985 have been considered and assessed in RARMPs for previous DIR licence applications (Section 8, Table 5). Information relevant to the characterisation of MON 88701 is considered below.6.3.1 Stability and molecular characterisation

47. All gene constructs used to generate MON 88701 GM cotton were sequenced prior to introduction. The applicant has provided Southern blot fingerprint analysis and segregation data showing that this event contains one copy of the introduced T-DNA that is stably integrated at a single locus and is inherited according to Mendelian principles over multiple generations. No unintended sequences from the plasmid vector have been incorporated in MON 88701, and the insert locus has been mapped.6.3.2 Phenotypic characterisation

48. No phenotypic characterisation data is currently available for MON 88701 in combination with one or more of the other parental GM cottons. However, the other cottons (alone and in some combinations) are well characterised.

49. Plant growth and development characteristics of MON 15985and MON 88913 GM cottons (Bollgard II® and Roundup Ready Flex®, respectively) were assessed in the context of their commercial release throughout Australia, and no unintended effects have subsequently been identified. In addition, in Australian field trials of MON 15985xCOT102 and MON 15985xCOT102xMON 88913 (under licence DIR 101), no unintended effects such as reduced fertility, disease susceptibility or changes in production have been observed by the licence holder.

50. The introduction of the dmo and bar genes into cotton is expected to confer tolerance to dicamba and glufosinate herbicides, respectively. The substrate specificity of MON 88701 was evaluated using a number of substrates selected on the basis of structural similarity of the compounds to dicamba and their presence in cotton, corn and soybean. The results indicated that DMO is specific for dicamba as a substrate. Similarly, the PAT protein was shown to have high substrate specificity for L-phosphinothricin, the herbicidal component of glufosinate.

Section 7 The receiving environment51. The receiving environment includes: any relevant biotic/abiotic properties of the geographic regions where the field trial would occur; intended agricultural practices, including those that may be altered in relation to normal practices; other relevant GMOs already released; and any particularly vulnerable or susceptible entities that may be specifically affected by the proposed release (OGTR 2009).

7.1 Relevant abiotic factors52. The size, locations and duration of the proposed limited and controlled release are outlined in Section 3.1. The proposed dealings involve planting the GM cottons at up to ten sites/year for the first two years of the trial, and up to 20 sites/year thereafter in current and potential cotton growing areas in 16 Qld LGAs, 38 NSW LGAs and two WA LGAs.

53. The abiotic factors relevant to the growth and distribution of commercial cotton in Australia are discussed in The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2013). To summarise, factors restricting where cotton can be grown in Australia are water availability (ie irrigation or rainfall), soil suitability and, most importantly, temperature. Cotton seedlings may be killed by frost and a minimum of 180 frost-free days of uniformly high temperatures (averaging 21-22°C) are required for crop growth (Duke 1983).



Growth and development of cotton plants below 12°C is minimal and a long, hot growing season is crucial for achieving good yields (Constable & Shaw 1988).

54. The LGAs within which the release is proposed (see Table 1 in Section 3.1, above) encompass a broad range of climate types, as defined by the Koeppen Classification system used by the Australian Bureau of Meteorology. Proposed planting areas in traditional cotton-growing regions of NSW and Qld predominantly have subtropical and grassland climate types, with small areas of temperate climate. The Qld LGA of Burdekin includes regions classified as tropical and subtropical. Cotton growing areas in Qld may experience the effects of tropical cyclones between November and April, with the possibility of extreme weather events and flooding moving into northern NSW (Bureau of Meteorology). The applicant has stated that trial sites will be selected so that they are not located in a flood prone area.

55. Proposed planting areas in WA include regions with tropical and grassland climates.

7.2 Relevant biotic factors56. The biotic factors pertaining to the growth and distribution of commercial cotton in Australia are discussed in The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2013). In addition, the following points are of particular relevance to this release:

the majority of the proposed release sites are in commercial cotton growing areas GM cottons constitute the majority of Australian cotton crops (see Sections 4 and 7.4).

57. Invertebrates, vertebrates and microorganisms are expected to be exposed to the introduced genes, their encoded proteins and end products.

7.3 Relevant agricultural practices58. The limits and controls of the proposed release are outlined in Section 3 of this Chapter. With regard to the agricultural practices, the GMOs proposed for field release would be planted with a small plot cone seeder or with commercial planting equipment. The rows would be irrigated by channel, drip or pivot irrigation and managed similar to commercial GM cotton crops with the exception that no insect resistance management (IRM) plan is required by the APVMA for a field trial, and different herbicides may be used for weed control due to the particular herbicide tolerance traits in the GM cottons.

7.4 Presence of related plants in the receiving environment59. Cotton cultivation is widespread and established in the majority of Qld and NSW LGAs in which the release is proposed. Experimental cotton crops have been grown for over a decade in WA (in the Ord River Irrigation Area and in areas near Broome) and northern Qld (in the Burdekin Bowen Basin area), and although some commercial cultivation has occurred it is not yet widespread or well established in these regions.

60. Data on the cultivation of commercial cotton in Australia are discussed in The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) document (OGTR 2013). G. hirsutum is the most common species of cotton commercially grown in Australia and G. barbadense varieties comprised less than 1% of the 2006/2007 crop (OGTR 2013).

61. Herbicide tolerant and/or insect resistant GM cotton plants (G. hirsutum) are used widely in commercial cotton production, recently comprising over 99% of commercially grown cotton crops. In contrast, non-GM cotton comprised 1% or less of commercially grown cotton. In the 2010/11 growing season, 597,000 hectares of GM cotton varieties were planted and 95% of those varieties were stacked traits for insect resistance and herbicide tolerance (see the website of the Department of Agriculture and Food, WA ) . For a list of relevant approvals for commercial releases of GM cottons in Australia, see Table 5 in Section 8, below.




http://www.bom.gov.au/


62. In southern Australia, ephemeral populations of cotton may be present outside of cultivation. Cultivated cotton can persist as a perennial plant in tropical areas and small populations of naturalised cotton (G. hirsutum and G. barbadense) exist in northern Australia, particularly in areas associated with a prolonged supply of fresh water (Hnatiuk 1990). The majority of naturalised G. hirsutum populations occur in the Northern Territory (NT), while naturalised G. barbadense occurs mainly along the eastern regions of Qld (data from Australian Virtual Herbarium).

63. There are 17 native species of Gossypium in Australia, most of which can be found in the NT and the north of WA (OGTR 2013). G. australe is the most widely distributed species throughout northern Australia, occurring from the east to west coast and predominantly north of the Tropic of Capricorn (Australian Virtual Herbarium). The native Gossypium species prefer well-drained sandy loams and are rarely found on heavy clay soils favoured by cultivated cotton (OGTR 2013). Generally, they are found in native vegetation and not in disturbed/modified habitats such as agricultural areas (Groves et al. 2002).

64. Well established genetic incompatibility prevents crossing of native cotton species with cultivated cotton in the natural environment (discussed in OGTR 2013).

7.5 Presence of similar genes and encoded proteins in the environment65. The introduced genes for all the parental GM lines are derived from common soil-borne microorganisms (see Section 6.2.1). The regulatory sequences (promoters, terminators, leader sequences) are derived from plants (cotton, soybean, pea, thale cress, petunia), plant viruses (peanut chlorotic streak caulimovirus, tobacco etch virus, cauliflower mosaic virus, figwort mosaic virus) and a common soil bacterium (Agrobacterium tumefaciens). All the source organisms for the introduced genetic elements are widespread and prevalent in the environment and thus humans and other organisms would commonly encounter their genes and encoded proteins.

Section 8 Australian and International Approvals

8.1 Australian approvals of GM cotton8.1.1 Previous releases approved by the Regulator

66. MON 88701 has not been assessed previously in Australia. However, three of the parental GM cottons, ie Bollgard II®, Roundup Ready Flex® and VIP3A cotton, individually and in combination, have been approved by the Regulator for release in Australia (see Table 5).

67. To date, the Regulator has not received any reports of adverse effects caused by these authorised releases.


http://www.anbg.gov.au/avh/

http://www.anbg.gov.au/avh/


Table 5 Summary of relevant Australian approvals for insect resistant and/or herbicide tolerant GM cottons

GM cotton DIR licence number Approval type†

Comment

MON 15985 (Bollgard II®) DIR 012/2002; DIR 059/2005; DIR 066/2006

C Approved individually and in combination with a herbicide tolerance trait.

MON 88913 (Roundup Ready Flex®)

DIR 059/2005; DIR 066/2006 C Approved individually and in combination with insect resistance traits.

COT102 (VIP3A) DIR 017/2002;DIR 025/2002; DIR 034/2003; DIR 036/2003; DIR 058/2005; DIR 065/2006; DIR 073/2007; DIR 101

L&C Approved individually or in combination with Bollgard II® or Bollgard II® x Roundup Ready Flex®.

Other GM cottons containing the bar gene (for glufosinate ammonium tolerance)

062/2005;038/2003

C;L&C

Liberty Link® cotton

Other insect resistant cottons

DIR 091;DIR 44/2003; DIR 040/2003

C;L&C

Widestrike™ cotton

† C: Commercial; L&C: Limited and Controlled

8.1.2 Approval by other government agencies

68. The Regulator is responsible for assessing risks to the health and safety of people and the environment associated with the use of gene technology. Other government regulatory requirements may also have to be met in respect of release of GMOs, including those of the Department of Agriculture, Fisheries and Forestry (DAFF) Biosecurity (formerly the Australian Quarantine and Inspection Service), Food Standards Australia New Zealand (FSANZ), and Australian Pesticides and Veterinary Medicines Authority (APVMA). This is discussed further in Chapter 3.

69. FSANZ is responsible for human food safety assessment and food labelling, including GM food. FSANZ has previously given approval for the use in food of cotton seed oil and linters derived from INGARD®, Bollgard II®, Roundup Ready Flex® and VIP3A GM cottons (under applications A341, A436, A553 and A509, respectively, assessments are available from the FSANZ website ). Three of the parental GM cottons therefore have existing approval for use in food, but additional approval for GM cottons containing MON 88701 would be necessary. However, the applicant does not intend to use materials from the GM cottons generated in the proposed release in human food.

70. APVMA has regulatory responsibility for agricultural chemicals, including herbicides and insecticidal products, in Australia. The GM cottons proposed for release meet the definition of an agricultural chemical product under the Agricultural and Veterinary Chemicals Code Act 1994, due to their production of insecticidal substances, and therefore these plants are subject to regulation by the APVMA. The applicant also intends to apply herbicide to the GM cottons during the trial and has applied to the APVMA for a research permit for this purpose.

8.2 International approvals of GM cotton71. To date, there have been no international approvals for the commercial release of MON 88701, Bollgard II® x VIP3A or Bollgard II® x VIP3A x Roundup Ready Flex® cottons.

72. Monsanto has requested a Determination of non-regulated Status for MON 88701, including all progenies derived from crosses between MON 88701 and other cotton, from the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) in July 2012, and submitted a food and feed safety and nutritional assessment in


http://www.foodstandards.gov.au/foodstandards/applications/


compliance with the U.S. Food and Drug Administration’s (FDA) 1992 policy statement regarding foods derived from new plant varieties in April 2012.

73. International approvals have been given for the environmental release of the other parent GM cottons which are to be combined in the proposed release (Table 6). In addition to the commercial release approvals listed below, approved field trials of VIP3A cotton have been conducted in Argentina (2001-2002), Burkina Faso (2004-2006), China (2001-2003), Costa Rica (2002, 2007-2009), India (2002-2006), Republic of South Africa (2002-2005), the USA (2000-2009), Vietnam (2002-2003) and Zimbabwe (2003-2004). In 2005, the United States Department of Agriculture Animal and Plant Health Inspection Service determined non-regulated status of VIP3A cotton (USDA-APHIS 2005), allowing its unconfined cultivation and agricultural use. There have also been approvals for the import of VIP3A cotton for food use in Australia and New Zealand (2005) and for food and feed in Mexico (2010).

Table 6 Years in which international approvals were granted for the widespread environmental release of Bollgard II®, Roundup Ready Flex® and VIP3A GM cottons

Country Bollgard II® Roundup Ready Flex® VIP3A

Australia 2002 2006Brazil 2009Burkina Faso 2008India 2006South Africa 2003 2007United States 2002 2004 2005


RISK ASSESSMENT PROCESS *

Risk scenarios

Identified Risk

Risk Estimate

Consequenceassessment

Likelihoodassessment

Evaluation

No identified risk

* Risk assessment terms are defined in the Risk Analysis Framework 2009

RISK IDENTIFICATION RISK CHARACTERISATION

Risk context

Postulation of risk

scenarios


Chapter 2 Risk assessmentSection 1 Introduction

74. The risk assessment identifies and characterises risks to the health and safety of people or to the environment from dealings with GMOs, posed by or as the result of gene technology (Figure 2). Risks are identified within the context established for the risk assessment (see Chapter 1), taking into account current scientific and technical knowledge. A consideration of uncertainty, in particular knowledge gaps, occurs throughout the risk assessment process.

Figure 2. The risk assessment process

75. Initially, risk identification considers a wide range of circumstances whereby the GMO, or the introduced genetic material, could come into contact with people or the environment. Consideration of these circumstances leads to postulating plausible causal or exposure pathways that may give rise to harm for people or the environment from dealings with a GMO (risk scenarios).

76. Each risk scenario is evaluated to identify those risks that warrant detailed characterisation. A risk is only identified for further assessment when a risk scenario is considered to have some reasonable chance of causing harm. Pathways that do not lead to harm, or could not plausibly occur, do not advance in the risk assessment process.

77. A number of risk identification techniques are used by the Regulator and staff of the OGTR, including checklists, brainstorming, common sense, reported international experience and consultation (OGTR 2009). In conjunction with these techniques, risk scenarios postulated in previous RARMPs prepared for licence applications of the same and similar GMOs are also considered.

78. Identified risks (i.e. those identified for further assessment) are characterised in terms of the potential seriousness of harm (Consequence assessment) and the likelihood of harm

Chapter 2 – Risk assessment 18


(Likelihood assessment). The level of risk is then estimated from a combination of the Consequence and Likelihood assessments.

Section 2 Risk Identification79. The following factors are taken into account when postulating relevant risk scenarios:

the proposed dealings, which may be to conduct experiments, develop, produce, breed, propagate, grow, import, transport, store or dispose of the GMOs, use the GMOs in the course of manufacture of a thing that is not the GMO, and the possession, supply and use of the GMOs in the course of any of these dealings

the proposed limits

the proposed controls

characteristics of the parent organism(s)

routes of exposure to the GMOs, the introduced gene(s) and gene product(s)

potential effects of the introduced gene(s) and gene product(s) expressed in the GMOs

potential exposure to the introduced gene(s) and gene product(s) from other sources in the environment

the environment at the site(s) of release

agronomic management practices for the GMOs.

80. Four risk scenarios were postulated and evaluated. These scenarios are summarised in Table 7and more detail of the evaluation of these scenarios is provided later in this Section. In the context of the control measures proposed by the applicant and considering both the short and long term, none of the risk scenarios were identified as giving rise to a risk that could be greater than negligible. Therefore, they did not warrant further detailed assessment.

81. All of the introduced regulatory sequences are derived from common plants, bacteria and viruses. Similar regulatory elements are naturally present in cotton, and the introduced elements are expected to operate in similar ways to endogenous ones. Therefore, although the transfer of introduced regulatory sequences to other sexually compatible plants could result in unpredictable effects, the impact is not likely to be greater than that arising from transfer of endogenous regulatory elements. Hence, these potential effects will not be further assessed for this application.

82. The potential for horizontal gene transfer (HGT) and any possible adverse outcomes has been reviewed in literature (Keese 2008) as well as assessed in many previous RARMPs. HGT was most recently considered in the RARMP for DIR 108 and also considered for insect resistant and herbicide tolerant GM cottons in the RARMP for DIR 101. These and other RARMPs are available via the OGTR website or by contacting the OGTR. No risk greater than negligible was identified due to the rarity of these events and because the gene sequences are already present in the environment and available for transfer via demonstrated natural mechanisms. Therefore, HGT will not be assessed further.

83. The potential for unauthorised activities to lead to an adverse outcome has been considered in previous RARMPs. The Act provides for substantial penalties for non-compliance and unauthorised dealings with GMOs. The Act also requires the Regulator to have regard to the suitability of the applicant to hold a licence prior to the issuing of a licence. These legislative provisions are considered sufficient to minimise risks from unauthorised activities, and no risk greater than negligible was identified in previous RARMPs. Therefore unauthorised activities will not be considered further.




Table 7 Summary of risk scenarios from dealings with GM cotton genetically modified for insect resistance and herbicide tolerance

Risk categoryRisk scenario Identified

risk? ReasonPathway that may give rise to harm Potential harm

Section 2.1Production of a substance toxic or allergenic to people or toxic to other organisms

1. Exposure of people, other vertebrates and micro-organisms to GM plant material containing the proteins encoded by the introduced genes and associated end products.

Allergic reactions in people or toxicity in people and other vertebrates or microorganisms

No The introduced genes are derived from soil-borne bacteria that are ubiquitous in the environment. The encoded proteins and highly similar proteins occur naturally in the environment and are not known to be toxic or allergenic to people or toxic to other organisms.

Plant material from the GMOs would not be used for human food or animal feed.

The limited scale, and other proposed limits and controls, minimise exposure of people and other organisms to the GM plant material.

2. Exposure of invertebrates to GM plant material containing the proteins encoded by the introduced genes and associated end products.

Toxicity to non-target invertebrates

No The insect resistance genes, or homologues, and their encoded proteins are widespread in the environment.

The toxicity of the proteins encoded by the individual insect resistance genes and any combination effects are expected to be limited to lepidopteran insects.

The limited scale, and other proposed limits and controls, reduces exposure of invertebrates to the products of the introduced genes

Section 2.2Weediness of the GM cotton plants in the environment

3. The genetic modifications increase weediness of the GM cottons.

Harms associated with weediness; allergic reactions in people or toxicity in people and other organisms

No Cultivated cotton is not considered to be weedy and the genetic modifications are not expected to change the weediness characteristic of the GMOs.

The genetic modifications for insect resistance and herbicide tolerance are expected to increase the fitness of GM cotton plants in managed environments, but only in situations where corresponding selective pressures are applied.

Resistance to Lepidoptera and tolerance to herbicide is unlikely to increase weediness as abiotic factors limit the spread and persistence of cotton in Australia.

The limits and controls proposed for the release would minimise spread and persistence of the GM cotton plants.



Risk categoryRisk scenario Identified

risk? ReasonPathway that may give rise to harm Potential harm

Section 2.3Vertical transfer of genes or genetic elements to sexually compatible plants

4. Expression of the introduced genes in other cotton plants.

Harms associated with weediness; allergic reactions in people or toxicity in people and other organisms.

No Cotton is predominately self-pollinating and outcrossing is limited.

The applicant proposed a number of controls, including a pollen trap or isolating the trial from other cotton plants, which would minimise gene flow via pollen.

Risk scenarios 1 – 3 associated with the genetic modifications did not constitute identified risks for people or the environment.

2.1 Production of a substance toxic or allergenic to people or toxic to other organisms84. Toxicity is the adverse effect(s) of exposure to a dose of a substance as a result of direct cellular or tissue injury, or through the inhibition of normal physiological processes (Felsot 2000).

85. Allergenicity is the potential of a substance to elicit an immunological reaction following its ingestion, dermal contact or inhalation, which may lead to tissue inflammation and organ dysfunction (Arts et al. 2006).

86. A range of organisms may be exposed directly or indirectly to the protein encoded by the introduced gene or end products of metabolic pathways regulated by the introduced proteins, if any. Workers cultivating the GM cotton would be exposed to all plant parts. Organisms may be exposed directly to the proteins through biotic interactions with GM cotton plants (vertebrates, invertebrates, symbiotic microorganisms and/or pathogenic fungi), or through contact with root exudates or dead plant material (soil biota) or indirectly through the food chain.Risk Scenario 1.Exposure of people, other vertebrates and micro-organisms to GM

plant material containing the proteins encoded by the introduced genes and associated end products

87. The proteins expressed from the introduced genes for insect resistance and herbicide tolerance could be toxic or allergenic for people, or toxic for other organisms. If humans or other organisms were exposed to the resulting compounds through ingestion, contact or inhalation of the GM plant materials, this may give rise to detrimental biochemical or physiological effects on the health of these people, other vertebrates or micro-organisms.

88. In the context of the proposed dealings, both of the following requirements would have to be met for the GM cottons to have any increased toxic or allergenic effect:

the genetic modification would have to result in production of toxic or allergenic proteins or compounds either not present in commercially grown cotton varieties or at higher levels than present in commercially grown cotton varieties, and

humans or other organisms would have to be exposed to the GM cotton plants through contact, ingestion or inhalation.

89. The introduced genes were isolated from naturally occurring bacteria that are already widespread and prevalent in the environment (see Chapter 1, Section 6.2.1 and Section 7.3). People and animals are exposed to proteins similar to those encoded by these genes through their diet and the environment. Available information does not suggest that the proteins encoded by the introduced dmo or bar genes in MON 88701 are toxic or allergenic to people, other vertebrates and micro-organisms (Chapter 1, Section 6.2.3).



90. FSANZ has approved food derived from three of the GM parent cottons (Bollgard II®, VIP3A and Roundup Ready Flex®). The GM cottons will be produced by conventional breeding and will potentially result in GM cotton containing a multiple stack of three herbicide tolerance genes and three genes for insect resistance.

91. The proteins that confer tolerance to the herbicides glyphosate, glufosinate and dicamba (CP4 EPSPS, PAT and DMO, respectively) and the Cry1Ac, Cry2Ab and Vip3A insecticidal proteins operate through independent, unrelated biochemical mechanisms. There is no evidence of any interaction between the herbicide tolerance proteins and insecticidal proteins or their metabolic pathways, and no reason to expect that this is likely to occur. There is no evidence or reasonable expectation that synergistic effects are likely to occur from combinations between the two traits, or that they would result in new or increased risks relating to human health and safety or the environment. Surveys of safety studies relating to combined GM events as compared to parental controls concluded that combining approved GM events by conventional breeding has generated no unique safety concerns (Pilacinski et al. 2011; Weber et al. 2012).

92. The applicant proposes to sell lint from the GM cottons. A study of the accumulation of mineral nutrients in G. hirsutum fruit found no detectable nitrogen in fibre fractions (Leffler & Tubertini 1976). Using more sensitive methods, specific proteins were detected at very low levels in raw, but not processed, linters and lint (Sims et al. 1996). Therefore, the safety of wearing cotton clothing or using other products made from cotton is not expected to be affected by the genetic makeup of the cotton plants from which these components have been derived, that is, whether or not it is derived from GM or non-GM cotton plants.

93. Cotton pollen may be an allergen (Chakraborty et al. 2001), although allergic responses to the commercial cultivars of cotton have not been reported in Australia. Due to the limited quantities of pollen released by cotton, it is expected that people would be exposed to small quantities, if any, of pollen. As discussed above, the encoded proteins in the GM cottons are not considered to be toxic or allergenic and the GM cotton plants are unlikely to be any more toxic or allergenic than commercially released GM or non-GM cotton.

94. In addition to the intentional effects of the introduced genes, gene technology has the potential to cause unintended effects. This may occur in a number of ways, including altered expression of an endogenous gene by random insertion of introduced DNA in the genome, increased metabolic burden due to higher expression of the introduced protein, novel traits arising out of interactions with non-target proteins and secondary effects arising from altered substrate or product levels in biochemical pathways. Unintended pleiotropic effects might result in adverse outcomes such as toxicity or allergenicity. Unanticipated changes can also be induced in plants by conventional methods of plant breeding (Haslberger 2003). The range of possible unintended effects produced by genetic modification is not likely to be greater than that from accepted traditional breeding techniques (Bradford et al. 2005; Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health 2004). More detail on potential for unintended effects as a result of the process of genetic modification can be found in the document Methods of Plant Genetic Modification available from the Risk Assessment References page on the OGTR website.

95. The proposed limits and controls of the trial (Chapter 1, Sections 3.1 and 3.2) would minimise the likelihood of exposure of people, other vertebrates and micro-organisms to GM plant materials. Human contact with, or inhalation of, GM plant materials would be limited to trained and authorised staff. There is little potential for exposure of the public to GM plant material via ingestion, as no GM plant material would be used for human food as part of this release. Similarly, livestock would not be intentionally exposed as the GM plant material would not be used as animal feed.

96. Researchers and technical staff conducting the trials would be exposed to the GM plant materials during all phases of the trial. Workers may come into contact with the proteins



encoded by the introduced genes when the plant cells have been damaged, or via pollen. Cotton plants possess leaves with sharp edges and irritating hairs, therefore workers typically wear protective clothing which reduces dermal contact. Exposure to the GM cotton is unlikely to lead to an adverse outcome as the GM cotton plants are unlikely to be any more toxic or allergenic than commercially released GM or non-GM cotton.

97. After harvest the applicant proposes to destroy GM cotton materials produced, apart from lint and some plant materials for research purposes and new plantings. These measures would minimise exposure to the GM plant material.

98. Conclusion: The potential for harm due to exposure to GM plant material containing the introduced genes, encoded proteins and end products, in the context of the limits and controls proposed by the applicant and considering both the short and long term, is not identified as a risk that could be greater than negligible. Therefore it does not warrant further assessment.Risk Scenario 2.Exposure of invertebrates to GM plant material containing the

proteins encoded by the introduced genes for insect resistance

99. The proteins expressed from the introduced genes for insect resistance are toxic for certain invertebrates and have been intentionally introduced into the GMOs for the purpose of protection against specific insect pests. If non-target invertebrates were exposed to the resulting compounds through direct or indirect ingestion of the GM plant materials, this may give rise to detrimental biochemical or physiological effects on the health of these non-target invertebrates.

100. Two of the parental GM cottons, Bollgard II® and VIP3A, contain insect resistance genes derived from Bacillus thuringiensis that are known to be toxic to a range of lepidopteran pests of cotton, including the major pests in Australia H. armigera and H. punctigera. Bollgard II®, which contains two cry genes for insect resistance (cry1Ac and cry 2Ab) has been previously assessed and approved for commercial release (see Chapter 1, Section 8). Bollgard II® constitutes over 85% of Australia’s commercial cotton plantings and no adverse outcomes on non-target invertebrates have been reported from these releases.

101. VIP3A, containing the vip3A gene, has been previously assessed and approved for limited and controlled release, most recently under DIR 101. Laboratory studies suggest that the encoded Vip3A protein is not toxic to a range of invertebrates including Coleoptera, Neuroptera, Hymenoptera and Isotomidae (Hill et al. 2003). This has been substantiated by preliminary Australian field studies which showed no differences between GM and non-GM cotton fields in terms of invertebrate species richness and diversity (Whitehouse et al. 2007).

102. The potential for synergistic, additive or antagonistic effects of the insecticidal proteins if present simultaneously in the GM cotton has also been considered previously (see the RARMP for DIR 101) and not identified as a risk that warranted further consideration. The specificities of the Vip3A, Cry1Ac and Cry2Ab proteins appear to be restricted to overlapping subsets of lepidopteran insects. Therefore, any increase in the range of sensitive insects as a result of the expression of both insecticidal proteins is expected to be confined to lepidopteran species. It is noteworthy that the same or similar proteins are present in the microbial formulations in commercial Bt insecticide preparations (Hill et al. 2003). It is not expected that the range of sensitive insects would increase beyond those sensitive to the Bt insecticides. However, some uncertainty exists in this area due to data gaps.

103. Conclusion: The potential for toxicity to non-target invertebrates as a result of exposure to GM plant materials containing the proteins encoded by the introduced genes, and considering both the short and the long term, is not identified as a risk that warrants further assessment.



2.2 Weediness of the GM cotton plants in the environment104. This section addresses the question of whether or not the proposed dealings with the GMOs may lead to harm to human health and safety or the environment as a result of an increased potential for spread and/or persistence due to the genetic modification.

105. All plants have the potential to lead to harm in certain environments. Harms that may arise from a certain plant species in a particular environment include:

adverse effects on the health of people and/or animals

reduction in the establishment, yield and/or quality of desired plants

restriction in the physical movement of people, animals, vehicles, machinery and/or water

adverse effects on environmental health, such as adverse changes to strata levels, nutrient levels, fire regime, soil salinity, soil stability, or by providing food and/or shelter to pests, pathogens and/or diseases.

106. For the purpose of this document, plant species causing significant levels of one or more of these harms are called ‘weeds’. A plant species may be weedy in one or more land uses, such as dryland cropping or nature conservation.

107. Characteristics that influence the spread (dispersal of the plant or its genetic material) and persistence (establishment, survival and reproduction) of a plant species impact on the degree of its invasiveness. These characteristics include the ability to establish in competition with other plants, to tolerate standard weed management practices, to reproduce quickly, prolifically and asexually as well as sexually, and to be dispersed over long distances by natural and/or human means. The degree of invasiveness of a plant species in a particular environment gives an indication of the likelihood of its weediness in that environment. In addition to local experience, a history of weediness overseas can be used as an indicator for weediness in Australia (Pheloung et al. 1999).

108. Baseline information on the characteristics of weeds in general, and the factors limiting the spread and persistence of non-GM cotton plants in particular, is given in The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2013). In summary, cotton does not possess any of the characteristics associated with problematic weeds, and the spread and persistence of cotton are limited by a number of biotic and abiotic factors, especially cold stress in southern Australia and water stress in non-irrigated environments throughout almost all of Australia. Cotton has been grown for centuries throughout the world without any reports that it is a serious weed, and it is likewise not considered to be a serious weed in Australia (Groves et al. 2003).Risk Scenario 3.The genetic modifications increase weediness of the GM cottons

109. In the context of the proposed dealings, in order for the GM cotton plants to have increased weediness in the environment both of the following conditions would need to be met:

GM cotton plants are present outside the limits (locations and/or duration) of the proposed trial; and

GM cotton plants are able to establish populations that cause harms associated with weediness.

Presence of GM cotton plants outside the trial limits

110. GM cotton plants could be present outside the trial limits due to survival at the trial sites after completion of the trial duration, or due to dispersal of reproductive plant material outside the site boundaries during or after the trial.



111. After completion of the trial, it is possible that whole GM plants could survive in the trial sites, ratoon plants could regrow from post-harvest stubble or new volunteer plants could grow from seeds fallen in the trial fields. The applicant proposes a number of control measures to prevent these eventualities, including:

destruction of all plant materials not required for further analysis or future planting

cultivating planting areas after harvest to encourage decomposition or germination of remaining seed

post-harvest monitoring of each trial site for at least 12 months and destruction of volunteers.

112. It is not expected that the genetic modifications for insect resistance and herbicide tolerance would increase the ability of the GMOs to survive these standard control measures.

113. Potential dispersal of reproductive GM plant material outside the site boundaries would be limited to seed or pollen, as cotton does not reproduce vegetatively under natural conditions (OGTR 2013). Gene flow via pollen is discussed in Risk Scenario 4. As the introduced genes of the GMOs are not related to seed production and dispersal traits, these characteristics are not expected to be altered in the types of GM cotton proposed for release compared to non-GM or commercially released GM cotton varieties.

114. In the field, seed cotton is present as large lint-covered bolls. Wild mammals and birds generally avoid feeding on cotton plants, in particular finding the seed unpalatable because of its high gossypol content. Therefore wild animals are unlikely to disperse bolls from the cotton fields (OGTR 2013). GM cotton seeds produced in this trial would not be used as stock feed, so would not be dispersed by stock.

115. Cotton bolls are large, heavy and remain attached to the plant (OGTR 2013), so they are not normally transported by wind or by runoff after rainfall or irrigation. The applicant has stated that sites located at least 50 m from waterways and without prior history of flooding will be selected for the trials. However, Queensland and northern NSW have in recent years experienced extreme summer weather events, including cyclones and an increasing frequency of floods (Chapter 1, Section 7.1). The Queensland wet season extends from October to April, with the initial monsoonal onset usually occurring in late December and peak flooding from December to February. Such extreme weather events have the potential to cause dispersal of seeds, either soon after sowing or late in the growth cycle when cotton bolls develop and seeds approach maturity.

116. Black seed (i.e. cleaned of lint) has the greatest potential for germination, while lint-covered seed cotton has lower likelihood of germination. Nonetheless, recently sown black seeds that are dispersed by flooding would be more likely to rot than germinate and if germination was successful plants would be unlikely to develop, as cotton is poorly adapted to waterlogging (Hodgson & Chan 1982). It is unlikely that floods in February/March would disperse viable seed from the GM plants, as the cotton bolls have not reached full maturity by then. In monitoring naturalised and volunteer populations of G. hirsutum, Eastick (2002) noted that seed maturation normally commenced after the conclusion of the wet season in Northern Australia (April-May).

117. The proposed limits and controls of the trial (Chapter 1, Sections 3.1 and 3.2) would minimise the likelihood of dispersal of the GM cotton lines proposed for release. Dispersal of seeds by authorised people entering the proposed trial sites would be minimised by cleaning of all equipment used at the trial site, including clothing. All equipment would be cleaned after use and before it is used for other purposes. Any GM plant materials would be transported in accordance with the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs, or other specific conditions, and only plant materials needed for experimentation would be


http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/transport-guide-1


transported outside the site. Spillage of GM seed during transport to and from the release sites would be rare and could be readily controlled through cleaning and monitoring of the site of the spill. Proposed controls also include destruction of plant material upon completion of the trial and implementation of a post-harvest program to prevent seed from persisting in the soil and to destroy any volunteers that germinate.

GM cotton plants establish populations that cause harms associated with weediness

118. If the expression of the introduced genes for insect resistance and herbicide tolerance were to provide the GM cotton plants with a significant selective advantage over commercially released GM or non-GM cotton plants and if they were able to establish and persist in favourable non-agricultural environments, this may give rise to lower abundance of desirable species, reduced species richness, or undesirable changes in species composition. Similarly, the GM cotton plants could adversely affect agricultural environments if they exhibited a greater ability to establish and persist than non-GM or commercially released GM cotton.

119. Non-GM or commercially released GM cotton seed is abundant in the environment through distribution pathways including residual seed bank in growing fields, roadside seed spills and dispersal through use as stock feed. Despite this, feral cotton populations are sparse and ephemeral (OGTR 2013) in all current cotton growing regions of Australia.

120. The spread and persistence of cotton plants is limited by a number of abiotic factors including water and nutrient availability, temperature and soil type (Eastick & Hearnden 2006; Farrell & Roberts 2002; OGTR 2008). The importance of these may vary between northern or southern Australia. A modelling study has indicated that cold stress is the most significant factor affecting persistence of cotton plants in southern Australia and dry stress is most significant in northern Australia (Rogers et al. 2007).

121. The GM cottons proposed for release may possess tolerance to up to three herbicides as well as insect resistance. However, in the event that the GMOs became established outside the trial site, these traits are only likely to confer an advantage in the presence of the corresponding selective pressures, ie insect predation by target insects or herbicide application. An example of this is provided by a study of GM canola containing stacked glyphosate resistance and insect resistance traits (Londo et al. 2011). For these plants there was an increase in fitness-associated traits in the presence of insects or glyphosate, while fitness of the GM canola was reduced in the absence of the selective pressures.

122. In respect to the control of cotton itself, glyphosate is generally not used against adult plants, as it usually fails to kill them. Cultivation is an effective and efficient method of controlling all types of volunteer cotton including seedling, established and ratoon (Roberts et al. 2002). Herbicide options to control seedling cotton include Spray.Seed® and Hammer® (paraquat/diquat and carfentrazone, respectively). These herbicides would also be capable of controlling GM seedling cotton volunteers possessing glyphosate, glufosinate and dicamba tolerance. It should also be noted that over 90% of the commercial G. hirsutum cotton crop in Australia is genetically modified for glyphosate tolerance.

123. Two of the parental GM cottons (Bollgard II® and Roundup Ready Flex®), alone and in combination, constitute the majority of commercial cottons grown in Australia, and the third (VIP3A) is currently under field trial. No major effects of the GM traits on plant growth or performance have been reported for these cottons, other than the introduced traits themselves. Under conditions of moderate to high insect damage, Bollgard II® cotton has been reported to mature slightly earlier than equivalent non-GM varieties, and to require less irrigation. This is believed to result from reduced insect damage to developing bolls in the crop situation but does not lead to increased seed yield (Yeates et al. 2010). MON 88701 has not yet been evaluated, but it is unlikely that expression of the genes for herbicide tolerance will alter seed production, dispersal, persistence and naturalisation potential of the GM cotton lines.



124. Unintended effects can occur as a result of genetic modifications in several ways and might result in adverse outcomes such as weediness. Significant unexpected alterations as a result of gene insertions are rarely advantageous to the plants and are likely to be detected and eliminated at early stages of GM plant generation and therefore unlikely to be perpetuated in the genome (Bradford et al. 2005; Kurland et al. 2003). The stacking of GM traits by conventional breeding and the potential for multiple gene insertions to alter genome stability has been reviewed by Weber et al (2012), who concluded it was unlikely that the genome of a GM stack would be less stable than the progeny of a cross between non-GM varieties, or of a GM plant containing a single event.

125. In the unlikely event of GM cotton plants establishing themselves beyond trial limits, small and transient GM cotton populations would be unlikely to cause harms associated with weediness such as reducing establishment of desired plants, restricting physical movement, or adversely affecting environmental health including alterations in insect population. Toxicity and allergenicity of the introduced proteins or their end products were considered in Risk Scenario 1and it is unlikely that the GM cotton plants would have higher toxicity and/or allergenicity than non-GM cotton.

126. Conclusion: The potential for harm due to the genetic modification increasing the weediness of the GMOs, in the context of the limits and controls proposed by the applicant and considering both the short and long term, is not identified as a risk that could be greater than negligible. Therefore, it does not warrant further assessment.

2.3 Vertical transfer of the gene or genetic elements to sexually compatible plants127. Vertical gene flow is the transfer of genetic information from an individual organism to its progeny by conventional heredity mechanisms, both asexual and sexual. In flowering plants, pollen dispersal is the main mode of gene flow (Waines & Hegde 2003). For GM crops, vertical gene flow could therefore occur via successful cross-pollination between the crop and neighbouring crops, plants, related weeds or native plants (Glover 2002).

128. It should be noted that vertical gene flow per se is not considered an adverse outcome, but may be a link in a chain of events that may lead to an adverse outcome. For an increased potential for adverse effects to arise as a result of gene flow of the introduced genetic elements from the GM cotton to sexually compatible plants, both of the following steps must occur:

transfer of the introduced genetic elements to sexually compatible plants

increased potential for adverse effects, such as toxicity or weediness of the recipient plants, due to expression of the introduced genes.

129. Baseline information on vertical gene transfer associated with non-GM cotton plants is provided in The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2013). In summary, cotton is predominantly self-pollinating and outcrossing is rare, although cross-pollination can occur at low levels over short distances. The only sexually compatible species present in Australia that could receive genes from the GM cotton are G. hirsutum and G. barbadense (including both cultivated GM and non-GM cotton, and naturalised cotton).

130. Most of the Australian Gossypium species have limited distributions and occur at considerable geographic distances from cultivated cotton fields. Furthermore, there is well established genetic incompatibility between native Gossypium species and cultivated cotton; the likelihood of fertile hybrids occurring between cultivated cotton and native Gossypium species is very low (summarised in OGTR 2013). Therefore, these species are not considered further.



Risk Scenario 4.Expression of the introduced genes in other cotton plants

131. If the introduced genes for insect resistance and herbicide tolerance were transferred and expressed in other cotton plants, the resulting hybrid plants could have increased toxicity or allergenicity to people, toxicity to other organisms, or weediness potential.

132. As discussed in Risk Scenario 1, the proteins encoded by the introduced genes are unlikely to be allergenic to people or toxic to people or organisms other than certain invertebrates. As discussed in Risk Scenario 2, the GM cottons are expected to be toxic to target invertebrates and there is expected to be limited toxicity to non-target invertebrates. This also applies if the introduced genes are expressed in other cotton plants.

133. It should be noted that the GM cottons proposed for trial contain up to four independent genetic modifications, so the introduced genes have inserted into different regions of the cotton genome and segregate independently of one another. This means that after any initial outcrossing of the GM cottons to other cotton, any subsequent generations of cotton volunteers may contain all of the dmo, bar, cry, vip3A and cp4 epsps genes, any subset of these genes, or none of the introduced genes. Any GM cotton produced from outcrossing containing either fewer or no genes encoding insecticidal proteins or herbicide tolerance will have equivalent or less insecticidal efficacy or herbicide tolerance than a GM cotton volunteer plant containing all the introduced genes. Therefore, segregation of the dmo, bar, cry, vip3a and cp4 epsps genes is not likely to lead to plants with increased toxicity or weediness compared to the GM cottons proposed for release, and will not be considered further.

134. Roundup Ready Flex® and Bollgard II® GM cottons have previously been described and assessed for commercial release (refer to Chapter 1, Section 8.1), in addition to other assessments for limited and controlled release. Previous assessments concluded that the commercial release of these GM cottons, alone and in combination, throughout Australia pose negligible risks to human health and safety and the environment (refer to RARMPs for DIR 059/2005 and DIR 066/2006). VIP3A has been described and assessed for field trial under DIR 101, in combination with Bollgard II® and Roundup Ready Flex®. Consequently, the expression of the introduced cp4 epsps, cry 1Ac, cry2Ab and vip3A genes in other sexually compatible plant species, including other commercially approved GM cottons, as a result of gene transfer, has been considered in these assessments. No risk greater than negligible was identified.

135. The GM cottons proposed for release may contain up to three stacked herbicide tolerance traits, which could potentially be transferred to commercial cottons already present in the environment. However, since current commercially grown GM cottons contain a subset of the herbicide tolerance genes included in the GM cottons proposed for release in this application, any outcrossing would not further expand the range of herbicide tolerance. The potential for increased weediness resulting from stacking of three herbicide tolerance traits was considered in Risk Scenario 3.

136. The applicant also proposes to include other commercially approved GM cottons in the planting area and/or pollen trap (including Widestrike® or Liberty Link® cottons), which could increase the combined number of stacked genes. As discussed above, the potential for stacking of the introduced insecticidal genes with the cry genes present in Widestrike® has been considered in previous assessments (DIR 101) and was not an identified risk. It is also unlikely that adverse effects would result from combination of the dicamba herbicide tolerance gene with the Widestrike® insect resistance or Liberty Link® herbicide tolerance genes. As outlined in Risk Scenario 1, the DMO protein that confers tolerance to the dicamba herbicide and the insecticidal proteins present in commercial GM cottons operate through independent, unrelated biochemical mechanisms. In addition, MON 88701 already contains the bar gene present in Liberty Link® cotton, so gene flow between these cottons would not increase the potential range of herbicide tolerances. Lastly, proposed control measures require all cottons planted in



the planting area or pollen trap to be treated as though they are the GMOs. In practice this means any seeds resulting from crosses between the different GM cottons would be harvested, which would restrict the potential for spread or persistence of stacked GM cottons.

137. As discussed in the The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2013) cotton is predominantly self-pollinating, with pollen that is large, sticky and heavy and not easily dispersed by wind. Cotton gene flow studies consistently show that outcrossing is localised around the pollen source and decreases rapidly with distance. Furthermore, outcrossing will only be successful between the GM cotton plants and other G. hirsutum or G. barbadense plants due to genetic incompatibility with other Gossypium species. It is unlikely that expression of the introduced genes in the GM cotton will alter pollen characteristics and/or genetic compatibility relative to non-GM or commercially released GM cotton plants.

138. The applicant has proposed a number of measures to restrict the potential for pollen flow and gene transfer to sexually compatible plants (Chapter 1, Section 3.2 and 3.3). These include surrounding the trial sites with either a 20 m pollen trap or a 1 km exclusion zone (within which intentional planting of cotton is not allowed). The applicant also proposes to perform post harvest monitoring of each site for twelve months and until the sites have been clear of volunteers for six months; and to destroy any volunteers found prior to flowering. These proposed controls would reduce the already low likelihood of gene flow from the GMOs to other cotton resulting in expression of the introduced genes.

139. Even in the rare event of vertical transfer of the introduced genetic material from the GM plants to non-GM cotton plants, the genetic material is expected to behave in similar ways as in the GM cottons. Hence, as discussed in Risk Scenarios 1- 3, the presence of the introduced gene sequences is unlikely to lead to any toxic and/or allergenic substance or any increase in weediness in recipient plants.

140. Conclusion: The potential for increased allergenicity in people, toxicity in people and other organisms, or increased weediness due to the expression of the introduced genes in other cotton plants as a result of gene transfer, in the context of the limits and controls proposed by the applicant and considering both the short and long term, is not identified as a risk that could be greater than negligible. Therefore it does not warrant further assessment.

Section 3 Risk estimate process and assessment of significant risk

141. The risk assessment begins with postulation of potential pathways that might lead to harm to the health and safety of people or the environment during the proposed release of GMOs due to gene technology, and how it could happen, in comparison to the parent organism and within the context of the receiving environment.

142. Four risk scenarios were postulated whereby the proposed dealings might give rise to harm to people or the environment. This included consideration of whether expression of the introduced genes or unintended effects of the genetic modification 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 plants. The opportunity for gene flow to other organisms and its effects if it occurred were also assessed.

143. A risk is only identified when a risk scenario is considered to have some chance of causing harm. Risk scenarios that do not lead to harm, or could not reasonably occur, do not represent an identified risk and do not advance any further in the risk assessment process.

144. The characterisation of the four risk scenarios in relation to both the seriousness and likelihood of harm, in the context of the control measures proposed by the applicant and



considering both the short and long term, did not give rise to any identified risks that could be greater than negligible and required further assessment. The principal reasons for this include:

widespread presence of the same genes or sequences in the environment

toxicity of the proteins encoded by the introduced insect resistance genes is expected to be limited to certain insects in the order Lepidoptera

limited ability and opportunity for the GM cotton plants to transfer the introduced genes to commercial cotton crops or other cotton plants

limits on the size, locations and duration of the release proposed by Monsanto

suitability of controls proposed by Monsanto to restrict the spread and persistence of the GM cotton plants and their genetic material

none of the GM plant material or products will enter human food or animal feed supply chains.

145. Therefore, any risks to the health and safety of people, or the environment, from the proposed release of the GM cotton plants into the environment are considered to be negligible. Hence, the Regulator considers that the dealings involved in this proposed release do not pose a significant risk to either people or the environment.

Section 4 Uncertainty146. Uncertainty is an intrinsic property of risk and is present in all aspects of risk analysis, including risk assessment, risk management and risk communication. Both dimensions of risk (consequence and likelihood) are always uncertain to some degree.

147. Uncertainty in risk assessments can arise from incomplete knowledge or inherent biological variability§. For field trials, because they involve the conduct of research, some knowledge gaps are inevitable. This is one reason they are required to be conducted under specific limits and controls to restrict the spread and persistence of the GMOs and their genetic material in the environment, rather than necessarily to treat an identified risk.

148. For DIR 120, uncertainty is noted particularly in relation to the characterisation of:

the potential for any unintended effects resulting in changes to biochemistry, physiology or ecology of the GM cottons

the potential for increases in toxicity to non-target invertebrates as a result of the combination of the introduced genes for insect resistance.

149. Additional data, including information to address these uncertainties, may be required to assess possible future applications for a larger scale trial, reduced containment conditions, or the commercial release of these GM cottons if they are selected for further development.

150. Chapter 3, Section 4 discusses information that may be required for future release.

§ A more detailed discussion is contained in the Regulator’s Risk Analysis Framework available from the OGTR website or via Free call 1800 181 030.





Chapter 3 Risk management planSection 1 Background

151. 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, evaluates controls and limits proposed by the applicant, and considers general risk management measures. The risk management plan informs the Regulator’s decision-making process and is given effect through licence conditions.

152. Under section 56 of the Act, the Regulator must not issue a licence unless satisfied that any risks posed by the dealings proposed to be authorised by the licence are able to be managed in a way that protects the health and safety of people and the environment.

153. All licences are subject to three conditions prescribed in the Act. Section 63 of the Act requires that each licence holder inform relevant people of their obligations under the licence. The other statutory conditions allow the Regulator to maintain oversight of licensed dealings: section 64 requires the licence holder to provide access to premises to OGTR inspectors and section 65 requires the licence holder to report any information about risks or unintended effects of the dealing to the Regulator on becoming aware of them. Matters related to the ongoing suitability of the licence holder are also required to be reported to the Regulator.

154. The licence is also subject to any conditions imposed by the Regulator. Examples of the matters to which conditions may relate are listed in section 62 of the Act. Licence conditions can be imposed to limit and control the scope of the dealings. In addition, the Regulator has extensive powers to monitor compliance with licence conditions under section 152 of the Act.

Section 2 Risk treatment measures for identified risks155. The risk assessment of risk scenarios listed in Chapter 2 concluded that there are negligible risks to people and the environment from the proposed trial of GM cottons. These risk scenarios were considered in the context of the scale of the proposed release (a maximum area of 10 ha/site at up to 10 sites for the first two years and 30 ha/site at up to 20 sites thereafter, between October 2013 and October 2019), the proposed containment measures (Chapter 1, Section 3), and the receiving environment (Chapter 1 Section 7), and considering both the short and the long term. The Risk Analysis Framework (OGTR 2009) which guides the risk assessment and risk management process, defines negligible risks as insubstantial with no present need to invoke actions for their mitigation. Therefore, there are no licence conditions to treat these negligible risks.

Section 3 General risk management156. The limits and controls proposed in the application were important in establishing the context for the risk assessment and in reaching the conclusion that the risks posed to people and the environment are negligible. Therefore, to maintain the risk context, licence conditions have been imposed to limit the release to the proposed size, location and duration, and to restrict the spread and persistence of the GMOs and their genetic material in the environment. The conditions are detailed in the licence and summarised in this Chapter.

3.1 Licence conditions to limit and control the release3.1.1 Consideration of limits and controls proposed by Monsanto

157. Sections 3.1 and 3.2 of Chapter 1 provide details of the limits and controls proposed by Monsanto in their application. These are discussed in the four risk scenarios characterised for the proposed release in Chapter 2. Many of these proposed control measures are considered

Chapter 3 – Risk management plan 31


standard for GM cotton trials and have been imposed by the Regulator in previous DIR licences. The appropriateness of these controls is considered further below.

158. The proposed duration of the release is six years, with to up to 10 sites per year for the first two years and up to 20 sites per year for the remaining four years. Each sites would be a maximum area of 10 ha in the first two years and 30 ha in the remaining four years. Sites are to be selected from 56 possible LGAs in Western Australia, NSW and Queensland. Only staff with appropriate training would be allowed to deal with the GMOs. GM plant material will not be permitted to enter commercial human or animal food supply chains. These measures will minimise the potential for unintentional exposure of humans, vertebrates and other organisms to the GMOs (Risk Scenarios 1 and 2) and the potential for the GM cotton to be dispersed outside the trial limits (Risk Scenario 3).

159. The applicant has proposed that each site would be surrounded by a 20 m wide pollen trap or a 1 km exclusion zone to restrict gene flow from the GM cottons to other cotton plants. As discussed in the The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2013), cotton is predominantly self-pollinating, with the highest level of outcrossing occurring between adjacent rows. Outcrossing is rare beyond 20 m (Llewellyn et al. 2007), and a 20 m pollen trap of non-GM cotton or GM cotton approved for commercial release would minimise gene transfer to sexually compatible plants outside the trial (Risk Scenario 4).

160. As an alternative to a 20 m pollen trap, a 1 km exclusion zone was proposed by the applicant to minimise gene flow from the GM cottons plants to other cotton crops. On the basis of the scientific literature on gene flow, international containment measures for GM cotton trials, and the rules for producing basic and certified seed, previous DIR cotton licences have imposed a 3 km isolation distance between GM cottons and intentionally planted cotton crops (see discussion in RARMP for DIR 081/2007). However, further consideration of recent literature (eg Van Deynze et al 2005, Heuberger et al 2010) suggests that a reduction in isolation distance from 3 km may be supported.

161. As discussed in the RARMP for DIR 081/2007, cotton is largely self-pollinating and honeybees are considered to be the most likely insects responsible for any cross-pollination in cotton in Australia. There is little data available on bee foraging ranges in Australia, but data from overseas indicates that mean foraging distances are at least 0.6 km with foraging ranges up to 10 km. However, studies supporting such long distance foraging/travel are based on conditions that are unlikely to occur at the proposed release sites, ie conditions under which no other food source is available are not representative of typical bee foraging. Native trees, flowers and other crops grow in the areas proposed for release and therefore bees are unlikely to be limited to foraging on the GM cotton.

162. Van Deynze et al (2005) measured pollen-mediated gene flow in California, between a herbicide tolerant pollen source field and commercial cotton fields. The fields were separated by open space and sampling occurred in each of three years, at distances of 200, 400, 800 and 1625 m away from the GM pollen source field. From this study, pollen mediated gene flow was found to vary over the three years, ranging from 0.01 to 0.1% at distances between 200 and 1625 m; on the basis of samples taken at three different sites over three years, gene flow was on average less than 0.1% at 400 m and less than 0.04% at 1625m.

163. More recently, Heuberger et al (2010) developed an empirical model for gene flow patterns for cotton in the commercial agricultural landscape which simultaneously accounted for the effects of pollinator abundance, the area of relevant surrounding fields and seed mediated gene flow over an initial range of 3 km. These authors found that pollen mediated gene flow rates were low (especially as compared with seed-mediated gene flow) and concluded that GM cotton fields at distances more than 750 m from the edge of monitored non-GM fields did not appear to contribute to outcrossing.



164. In light of the above, a licence condition has been included requiring 1.5 km isolation distance between the trial plants and any other cotton plants, if a pollen trap is not used. This represents a greater distance than the 1 km proposed by the applicant. However, there is variability in the data reported by Van Deynze (2005) and only a limited number of studies that have investigated pollen mediated gene flow under physical isolation conditions in the absence of a pollen trap. Therefore, further reduction of the isolation zone is not supported by the evidence currently available.

165. Heuberger et al (2010) also found no evidence to suggest that the emergence of volunteer plants outside planted rows contributed to gene flow. Nonetheless, it is possible that feral cotton populations derived from commercial cotton lines may occur on roadsides or in irrigation channels in cotton growing areas, and gene flow has been observed between isolated cotton plants over short distances.

166. Therefore, a licence condition has been imposed requiring a 100 m monitoring zone in conjunction with an exclusion zone; while the GM cotton is growing the surrounding monitoring zone must be inspected every 30 days and kept free of any flowering cotton plants. The combination of a monitoring zone and an exclusion zone is considered effective to restrict vertical gene transfer from GM cotton trial sites to other cotton (Risk Scenario 4).

167. The applicant proposes to locate the trial sites more than 50 m from the nearest waterway, which is a standard DIR licence condition, and to select sites that are not located in flood-prone areas. This would minimise the chance of viable plant material being washed away from the site. A licence condition is included that requires reporting of the history of flooding and cyclones for each site, as well as a condition requiring immediate notification of any extreme weather conditions affecting the site during the proposed release. These measures will minimise likelihood for the GM cotton to be dispersed outside the proposed release site (Risk Scenario 3).

168. The applicant proposes that the GM cotton would be harvested and ginned separately from other cotton crops to prevent mixing. All equipment used in connection with cultivating the GM cotton will be cleaned on site prior to removal. A licence condition has been included requiring that any gin used for the GM cotton must be cleaned immediately following its use and before any other cotton crop is ginned. These measures are expected to minimise the potential exposure of humans and other vertebrates to the GMOs (Risk Scenario 1) and the potential for the GM cotton to be dispersed outside the proposed release site (Risk Scenario 3).

169. After the GM cottons have been harvested, the applicant proposes to destroy all remaining plant material not required for further testing, and to clean the sites and all equipment used. As discussed in the The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2008), cotton seeds have low dormancy levels and do not generally form a viable seed bank. However, dormancy can be induced in cotton seeds by low soil temperature and/or soil moisture. The applicant proposes at least one post-harvest cultivation of the trial sites and pollen traps to promote cotton seed germination and minimise the persistence of a GM cotton seed bank. A licence condition has been included requiring cultivation (followed by an irrigation event) in the spring or summer following the harvest, so that soil temperature will be suitable for cotton seed germination. Each trial site would be monitored post-harvest at least every two months for a minimum of twelve months and until the site has been clear of volunteers for at least six months. These measures would limit the persistence of the GM cotton in the environment (Risk Scenario 3).

170. The applicant has stated that any plant material taken off-site for experimental analysis will be transported according to the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs. These are standard protocols for the handling of GMOs to minimise exposure of people and other organisms to the GMOs (Risk Scenarios 1 and 2), dispersal into the environment (Risk Scenario 3), and gene transfer (Risk Scenario 4). In addition to standard





conditions for transport of GM plant material, previous DIR cotton licences have authorised specific measures for the transport of harvested cotton modules. These include double wrapping, or transport in an enclosed chain bed truck designed for the purpose. More recently, there has been a shift away from traditional modules to the use of round bale pickers. A licence condition has therefore been included that extends these measures to both modules and bales. This would minimise the potential for dispersal of the GM cotton during transport.

171. Under conditions of the licence, the sale and transport of lint is permitted, as this does not contain any DNA or protein.

172. The applicant does not propose using any of the plant material for human consumption, and the GM cotton event MON 88701 has not been assessed for food use by FSANZ. Therefore a condition in the licence prohibits material from the trial from being used for human or animal feed.3.1.2 Summary of licence conditions to be implemented to limit and control the release

173. A number of licence conditions have been imposed to limit and control the proposed release, based on the above considerations. These include requirements to:

limit the release to a maximum area of 10 ha/site at up to 10 sites for the first two years and 30 ha/site at up to 20 sites thereafter, between October 2013 and October 2019

locate the proposed trial sites at least 50 metres (m) away from natural waterways

limit pollen flow using one of the following measures:

o surround the GM cotton planting area with a 20 m pollen trap of non-GM cotton or GM cotton that the Regulator has approved for commercial release or

o surround the planting area with 100 m monitoring zone and maintain a 1.5 km exclusion zone around the planting area in which no other cotton plants may be grown

remove and/or destroy any cotton plants growing in the monitoring zone prior to flowering

ensure the pollen trap plants are grown in such a way as to ensure flowering at the same time and for the same period of time as the GM cotton

harvest and gin all cotton plant materials (GM and non-GM) separately from other commercial cotton crops

clean the areas and equipment after use

apply measures to promote germination of any cotton seeds that may be present in the soil after harvest, including irrigation and shallow tillage

monitor for at least 12 months after harvest and destroy any cotton plants that may grow until no volunteers are detected for a continuous 6 month period

destroy all GM plant material not required for further analysis or future trials

not allow GM plant material to be used for human food or animal feed

transport and store material from the GMOs in accordance with the Regulator’s guidelines or other specific conditions.

174. Experiments with the GMOs or GM plant material may be conducted in certified physical containment facilities as Notifiable Low Risk Dealings (NRLDs) in accordance with all appropriate requirements of the Gene Technology Regulations 2001, and therefore this activity is not covered in the licence.



3.2 Other risk management considerations175. All DIR licences issued by the Regulator contain a number of conditions that relate to general risk management. These include conditions relating to:

applicant suitability

contingency plans

identification of the persons or classes of persons covered by the licence

reporting structures

a requirement that the applicant allows access to the trial site and other places for the purpose of monitoring or auditing.

3.2.1 Applicant suitability

176. In making a decision whether or not to issue a licence, the Regulator must have regard to the suitability of the applicant to hold a licence. Under section 58 of the Act, matters that the Regulator must take into account include:

any relevant convictions of the applicant (both individuals and the body corporate)

any revocation or suspension of a relevant licence or permit held by the applicant under a law of the Commonwealth, a State or a foreign country

the capacity of the applicant to meet the conditions of the licence.

177. On the basis of information submitted by the applicant and records held by the OGTR, the Regulator considers Monsanto suitable to hold a licence.

178. The licence includes a requirement for the licence holder to inform the Regulator of any circumstances that would affect their suitability.

179. In addition, any applicant organisation must have access to a properly constituted Institutional Biosafety Committee and be an accredited organisation under the Act.3.2.2 Contingency plan

180. Monsanto is required to submit a contingency plan to the Regulator before planting the GMOs. This plan must detail measures to be undertaken in the event of any unintended presence of the GM cottons outside of the permitted areas.

181. Monsanto is also required to provide a method to the Regulator for the reliable detection of the presence of the GMOs and the introduced genetic materials in a recipient organism. This instrument is required before planting of the GMOs.3.2.3 Identification of the persons or classes of persons covered by the licence

182. The persons covered by the licence are the licence holder and employees, agents or contractors of the licence holder and other persons who are, or have been, engaged or otherwise authorised by the licence holder to undertake any activity in connection with the dealings authorised by the licence. Prior to growing the GMOs, Monsanto is also required to provide a list of people and organizations who will be covered by the licence, or the function or position where names are not known at the time.3.2.4 Reporting requirements

183. The licence obliges the licence holder to immediately report any of the following to the Regulator:

any additional information regarding risks to the health and safety of people or the environment associated with the trial

any contraventions of the licence by persons covered by the licence



any unintended effects of the trial.

184. A number of written notices would also be required under the licence that would assist the Regulator in designing and implementing a monitoring program for all licensed dealings. The notices would include:

expected and actual dates of planting

details of areas planted to the GMOs

expected dates of flowering

expected and actual dates of harvest and cleaning after harvest

details of inspection activities.3.2.5 Monitoring for Compliance

185. The Act stipulates, as a condition of every licence, that a person who is authorised by the licence to deal with a GMO, and who is required to comply with a condition of the licence, must allow inspectors and other persons authorised by the Regulator to enter premises where a dealing is being undertaken for the purpose of monitoring or auditing the dealing. Post-release monitoring continues until the Regulator is satisfied that all the GMOs resulting from the authorised dealings have been removed from the release site.

186. If monitoring activities identify changes in the risks associated with the authorised dealings, the Regulator may also vary licence conditions, or if necessary, suspend or cancel the licence.

187. In cases of non-compliance with licence conditions, the Regulator may instigate an investigation to determine the nature and extent of non-compliance. The Act provides for criminal sanctions of large fines and/or imprisonment for failing to abide by the legislation, conditions of the licence or directions from the Regulator, especially where significant damage to health and safety of people or the environment could result.

Section 4 Issues to be addressed for future releases188. Additional information has been identified that may be required to assess an application for a large scale or commercial release of these GM cottons, or to justify a reduction in containment conditions. This includes:

additional data on the potential toxicity and allergenicity of plant materials from the GM cottons (eg susceptibility of non-target invertebrate species to the combination of insecticidal proteins)

additional phenotypic characterisation of the GM cotton lines, particularly with respect to traits that may contribute to weediness, including tolerance to environmental stresses and disease susceptibility

additional molecular and biochemical characterisation of the GM cotton lines

additional information on pollen mediated gene flow in cotton in the absence of a pollen trap.

Section 5 Conclusions of the RARMP189. The risk assessment concluded that this proposed limited and controlled release of GM cottons on a maximum area of 10 ha/site at up to 10 sites for the first two years and 30 ha/site at up to 20 sites thereafter, between October 2013 and October 2019 in NSW, Queensland and Western Australia, 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. However, licence conditions have been imposed to limit the release to the proposed size, location and duration, and to restrict the spread and persistence of the GMOs and their genetic material in the environment, as these were important considerations in establishing the context for assessing the risks.



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Appendix A Summary of submissions from prescribed experts, agencies and authorities**

The Regulator received several submissions from prescribed experts, agencies and authorities on the consultation RARMP. All issues raised in submissions that related to risks to the health and safety of people and the environment were considered in the context of the currently available scientific evidence and were used in finalising the RARMP that formed the basis of the Regulator’s decision to issue the licence. Advice received is summarised below.

Summary of issues raised Comment

Notes that the purpose of the trial is to assess the agronomic performance of the crops under field conditions for possible future commercial release. Further notes that no materials from the GM cotton will be used for human food. Would seek early notification from the applicant regarding any possible GM food application if the field trials are successful.

Noted

Does not have required scientific advice readily available, but appreciates that the invitation to comment serves to raise awareness of the application.

Noted

Considered the DIR with no comments being made. Noted

Supports the OGTR assessment that the proposed dealing posed negligible risk of harm to human health and the environment.

Noted

If cotton growers do not apply the technology carefully then use of this GM cotton with tolerance to three different herbicides may accelerate the emergence of herbicide resistance.

Herbicide resistance comes under the regulatory oversight of the APVMA. The APVMA has primary regulatory responsibility for agricultural chemicals in Australia. It assesses all herbicides used in Australia and sets their conditions of use, including for resistance management.

Offers no objections to the proposed field trial. Noted

Satisfied with the conclusions of the draft RARMP, noting the comments below.

Noted

At paragraph 36, the CaMV 35S and FMV 35S promoters are discussed. Both these promoters overlap sequences of gene VI which encodes protein P6.The PC1SV promoter in MON88701 is also a member of the Caulimovirus family and overlaps sequences of gene VI. Recommends that the PC1SV promoter also be considered in the discussion in paragraph 36 that considers the level of risk presented by promoters in the Caulimovirus family.

Consideration of the PC1SV promoter has been added to paragraph 36. As already noted there, the P6 protein is widely distributed in the environment, with no adverse consequences reported.

Recommends that paragraph 185 (“issues to be addressed in future releases”) includes collection of data on toxicity of Vip3A in combination with the other introduced insect resistance genes to non-target invertebrates.

Chapter 2 acknowledges uncertainty regarding stacking of Vip3A with other insecticidal proteins. Point one of paragraph 185 (Chapter 3) suggests “additional data on the potential toxicity and allergenicity of plant materials from the GM cottons” may be required, which could include toxicity of the combined insecticidal proteins. Point one has been modified to specify this example.

Identified no concerns with the proposed trial, given the field conditions specified in the RARMP.

Noted

Supports approval of the licence on the terms indicated in the RARMP.

Noted

** Prescribed agencies include GTTAC, State and Territory Governments, relevant local governments, Australian Government agencies and the Minister for the Environment.

Appendix A 42


Summary of issues raised Comment

Agrees with the overall conclusions of the RARMP. Noted

Supports the application, as the evidence supplied indicates that the genetic modifications are within the scope for these crops and would pose negligible risks

Noted

Appendix A 43


Appendix B Summary of submissions from the public

The Regulator received four submissions from the public on the consultation RARMP. The issues raised in these submissions are summarised in the table below. All issues raised in submissions that related to risks to the health and safety of people and the environment were considered in the context of currently available scientific evidence in finalising the RARMP that formed the basis of the Regulator’s decision to issue the licence.

Type: I: Individual

View (general tone): x = do not support

Issues raised: G: Gene flow; C: Coexistence; E: Environment; R: Resistance; M: Marketing and Trade; P: Pesticide use; T: Toxicity

Other abbreviations: Act: the Gene Technology Act 2000; APVMA: Australian Pesticides and Veterinary Medicines Authority; Bt: Bacillus thuringiensis; GM: Genetically Modified; GMO: Genetically modified organism

Submission Number

Type View Issue Summary of issues raised Comment

1 I X P, R Objects to the proposed field trial on the basis that: herbicide tolerance leads to

increased herbicide use, threatening the environment and human health

insect resistance leads to adaptation by insects which could also become a threat.

The APVMA has regulatory responsibility for the supply of agricultural chemicals, including herbicides, in Australia.The GM cottons proposed for release meet the definition of an agricultural chemical product under the Agricultural and Veterinary Chemicals Code Act 1994, due to their production of insecticidal substances, and therefore these plants are subject to regulation by the APVMA. A permit is also required from the APVMA for the application of herbicides to the GM cotton during the trial. Management of insect resistance and herbicide tolerance is a matter for the APVMA.The APVMA considers a range of issues in assessing agricultural chemicals for registration, including efficacy, resistance management and human health and environmental impacts. The APVMA will not register a chemical product unless satisfied that its approved use would not be likely to have an effect that is harmful to people or the environmentIt is also noted that this application is for a field trial, not for commercial cultivation.

E, T Comments that the desirability of trial goals should be assessed for possible impacts on health and safety of people and the environment before permission is given for trials for agronomic performance.

The Regulator must assess each application, and must not issue a licence unless risks can be managed so as to protect the health and safety of people and the environment. The RARMP concluded that risks to human health and safety and the environment are negligible as a result of this limited and controlled release of GM cotton.

Appendix B 44


Submission Number


2 I X E, T Objects to all genetically modified crops, regardless of whether or not for human consumption. Comments that genetic modification breaks the rules of nature.Argues that GM crops present real dangers to the environment, particularly bees.

Risk scenario 2 considered the potential for toxicity to non-target invertebrates as a result of exposure to GM plant materials containing the proteins encoded by the introduced genes for insect resistance; this was not identified as a risk greater than negligible.Despite occasional allegations of adverse effects from GM crops in the media, there is no credible evidence of harm to people or the environment from any GM crop authorised for environmental release in Australia. There has been speculation that some GM crops, specifically Bt corn (which is not grown in Australia), could be a potential cause of colony collapse disorder (CCD) in bees. However, current scientific evidence suggests that CCD is likely to be linked to a combination of factors contributing to the stress of honey bees and there is no evidence to support a link between CCD and GM crops.

3 I X P Strongly opposes the application.Asserts that Monsanto chemicals are destroying land, killing soil and affecting the health of livestock and humans.

Regulation of agricultural chemicals, including insecticides and herbicides, is principally the responsibility of the APVMA. The APVMA considers a range of issues in assessing agricultural chemicals for registration, including efficacy, resistance management and human health and environmental impacts. The APVMA will not register a chemical product unless satisfied that its approved use would not be likely to have an effect that is harmful to people or the environment.

C Believes that GMOs should never have been permitted in Australia and the country should have remained GM-free.

This issue is outside the scope of the Regulator’s assessments under the Act.Australia’s gene technology regulatory scheme was established in response to community concerns about the then developing area of gene technology. Extensive public consultation was conducted before passing of the Gene Technology Act in 2000, and the provisions of the Act were developed to reflect issues and comments raised by the community during that consultation.

C, P States that GMOs compromise organic or chemical free status for neighbouring farmers, and farmers can be sued if GMOs inadvertently move onto their land.

DIR 120 licence conditions impose strict controls that restrict the spread and persistence of the GMOs and their genetic material in the environment, including monitoring of trial sites to ensure no GMOs remain following completion of the trial.When deciding whether or not to issue a licence, matters that relate to marketing and trade, including coexistence of GM and non-GM crops, are outside the legislative responsibility of the Regulator. These are matters for State and Territory governments, who may designate GM free zones for marketing purposes.The independent Statutory Review of the Act, conducted in 2005/06, considered the issue of liability for contamination of non-GM crops by GMOs and noted that common law and other consumer protection legislation provided remedies to those affected by the presence of GM varieties in non-GM crops.

Appendix B 45


Submission Number


4 I X C, M Strongly opposes the application.Asserts that the world trend is towards organic and biodynamic food and by allowing the release of GM crops, Australia has lost a major economic advantage.Believes that trials such as DIR 120 allow the introduction of GM seed by stealth, thereby threatening the whole cotton industry.

These are issues relating to marketing and trade, including coexistence of GM and non-GM crops. They have been addressed in the response to submission 3 (above).While not part of the Regulator’s considerations in decision making, the cotton industry in Australia has been a strong adopter of GM technology, with GM varieties currently constituting over 99% of the cotton crop. The industry organisation Cotton Australia (http://cottonaustralia.com.au/) lists among the benefits of GM technology in cotton: 80% reduction in insecticide use; increased populations of beneficial insects and wildlife in cotton fields; reduced pesticide run off; improved farm worker and neighbour safety; more time for farmers to spend with families; a decrease in fuel usage; improved soil quality; reduced production costs; and increased yield.

Appendix B 46

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