department of health · web viewfor. licence application no. dir 1. 42. decision. the gene...

Risk Assessment andRisk Management Plan for

DIR 142

Limited and controlled release of wheat genetically modified for enhanced nitrogen use efficiency and water

use efficiency

Applicant: Department of Economic Development, Jobs, Transport and Resources, Victoria

April 2016

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DIR 142 – Risk Assessment and Risk Management Plan (April 2016) Office of the Gene Technology Regulator

Summary of the Risk Assessment and Risk Management Plan

forLicence Application No. DIR 142

DecisionThe Gene Technology Regulator (the Regulator) has decided to issue a licence for this application for a limited and controlled release (field trial) 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 the 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 142

Applicant Department of Economic Development, Jobs, Transport and Resources (DEDJTR), Victoria

Project title Limited and controlled release of wheat genetically modified for enhanced nitrogen use efficiency and water use efficiency†

Parent organism Wheat (Triticum aestivum L.)

Introduced genes and modified traits

Sixteen‡ genes involved in enhanced nitrogen use efficiency (NUE) Eight2 genes involved in water use efficiency (WUE)

1. Note that one of the genes is used for both traits, hence a total of 23 genes are proposed to be used. pat gene from bacterium Streptomyces viridochromogenes as a

selectable marker that confers resistance to herbicide glufosinate

Proposed location One site in Horsham, Victoria

Proposed release size Up to 3 hectares (ha) per season

Proposed release dates May 2016 – May 2018

Primary purpose To evaluate the agronomic performance of the GM wheat lines under field conditions.

DEDJTR proposes to conduct a field trial of up to 10 lines§ for each introduced gene for each of the two traits.

† The title of the project as supplied by the applicant is ‘Genetically modified wheat for enhanced nitrogen use efficiency and drought resistance’.‡ In the original application the applicant had proposed twenty genes for NUE and eleven genes for WUE, but since has amended to use sixteen genes and eight genes, respectively. The identity of the introduced genes has been declared as Confidential Commercial Information under Section 185 of the Act.§ The term ‘line’ is used to denote plants derived from a single plant containing a specific genetic modification resulting from a single transformation event.

Summary I


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

The risk assessment process considers how the genetic modification and proposed 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 current scientific/technical knowledge, information in the application including proposed limits and controls, relevant previous approvals, and advice received from wide range of experts, agencies and authorities consulted on the RARMP. Both the short and long term impacts were considered.

Credible pathways to potential harm that were considered included exposure of people or animals to the GM plant material, dispersal of GM seed leading to spread and persistence of the GMOs, and transfer of the introduced genetic material to sexually compatible plants. Potential harms associated with these pathways included toxicity or allergenicity to people, toxicity to other desirable organisms, and environmental harms due to weediness.

The principal reasons for the conclusion of negligible risks are that the GM plant material will not be used for human food or animal feed, the proposed limits and controls effectively contain the GMOs and their genetic material and minimise exposure; and the GM wheat has limited ability to establish populations outside cultivation or transfer the introduced genetic material to other plants.

Risk management planThe risk management plan describes measures to protect the health and safety of people and to protect the environment by controlling or mitigating risk. The risk management plan is given effect through licence conditions.

As the level of risk is considered negligible, specific risk treatment is not required. However, since this is a limited and controlled release, the licence includes limits on the size, location and duration of the release, as well as controls to prohibit the use of GM plant material in human food or animal feed, to minimise dispersal of GM seed or GM pollen from trial sites, to transport GMOs in accordance with the Regulator’s guidelines, to destroy GMOs not required for testing or further planting, and to conduct 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...........................................................................................................1

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

3.1 The proposed limits of the dealings (duration, size, location and people)...............................................23.2 The proposed controls to restrict the spread and persistence of the GMOs in the environment..............2

SECTION 4 THE PARENT ORGANISM............................................................................................................................3SECTION 5 THE GMOS, NATURE AND EFFECT OF THE GENETIC MODIFICATION........................................................3

5.1 Introduction to the GMOs.........................................................................................................................35.2 The introduced genes, encoded proteins and their associated effects......................................................55.3 Toxicity/allergenicity of the proteins associated with the introduced genes............................................65.4 Characterisation of the GMOs..................................................................................................................7

SECTION 6 THE RECEIVING ENVIRONMENT................................................................................................................76.1 Relevant abiotic factors............................................................................................................................86.2 Relevant agricultural practices.................................................................................................................86.3 Presence of related plants in the receiving environment..........................................................................86.4 Presence of similar genes and encoded proteins in the environment.......................................................9

SECTION 7 RELEVANT AUSTRALIAN AND INTERNATIONAL APPROVALS....................................................................97.1 Australian approvals.................................................................................................................................97.2 International approvals.............................................................................................................................9

CHAPTER 2 RISK ASSESSMENT..............................................................................................................................10

SECTION 1 INTRODUCTION.......................................................................................................................................10SECTION 2 RISK IDENTIFICATION.............................................................................................................................11

2.1 Risk source.............................................................................................................................................112.2 Causal pathway.......................................................................................................................................122.3 Potential harm.........................................................................................................................................132.4 Postulated risk scenarios.........................................................................................................................13

SECTION 3 UNCERTAINTY........................................................................................................................................20SECTION 4 RISK EVALUATION..................................................................................................................................21

CHAPTER 3 RISK MANAGEMENT PLAN..............................................................................................................23

SECTION 1 BACKGROUND.........................................................................................................................................23SECTION 2 RISK TREATMENT MEASURES FOR SUBSTANTIVE RISKS.........................................................................23SECTION 3 GENERAL RISK MANAGEMENT................................................................................................................23

3.1 Licence conditions to limit and control the release................................................................................233.2 Other risk management considerations...................................................................................................27

SECTION 4 ISSUES TO BE ADDRESSED FOR FUTURE RELEASES.................................................................................28SECTION 5 CONCLUSIONS OF THE CONSULTATION RARMP....................................................................................28

REFERENCES.................................................................................................................................................................29

APPENDIX A.............SUMMARY OF SUBMISSIONS FROM PRESCRIBED EXPERTS, AGENCIES AND AUTHORITIES........................................................................................................................................34

APPENDIX B.....................................................SUMMARY OF SUBMISSIONS FROM THE PUBLIC...................................................................................................................................................................35

Table of Contents


AbbreviationsAPVMA Australian Pesticides and Veterinary Medicines AuthorityCCI Confidential Commercial InformationDEDJTR Department of Economic Development, Jobs, Transport and ResourcesDIR Dealings involving Intentional ReleaseDNA Deoxyribonucleic acidFSANZ Food Standards Australia New ZealandGM Genetically modifiedGMO Genetically modified organismha HectareHGT Horizontal gene transferkm Kilometresm MetresNLRD Notifiable Low Risk DealingNUE Nitrogen use efficiencyOGTR Office of the Gene Technology Regulatorpat Phosphinothricin acetyltransferasePBC Plant Breeding CentrePC2 Physical Containment level 2RARMP Risk Assessment and Risk Management PlanRegulations Gene Technology Regulations 2001Regulator Gene Technology Regulatorthe Act The Gene Technology Act 2000WUE Water use efficiency

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 in States and Territories, 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 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. Sections 50, 50A and 51 of the Act outline the matters which the Gene Technology Regulator (the Regulator) must take into account, and who must be consulted, when preparing the Risk Assessment and Risk Management Plans (RARMPs) that inform the decisions on licence applications. In addition, the Regulations outline further matters the Regulator must consider when preparing a RARMP.

5. In accordance with section 50A of 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

Chapter 1 – Risk assessment context 1


material in the environment. Therefore, the Regulator was not required to consult with prescribed experts, agencies and authorities before preparation of the RARMP.

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.

7. The Risk Analysis Framework (OGTR 2013) 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), the Australian Pesticides and Veterinary Medicines Authority (APVMA), the Therapeutic Goods Administration and the Department of Agriculture and Water Resources. 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. The Victorian Department of Economic Development, Jobs, Transport and Resources (DEDJTR) proposes to release up to 160 lines of wheat genetically modified for nitrogen use efficiency (NUE) and 80 lines of wheat genetically modified for water use efficiency (WUE) into the environment under limited and controlled conditions. The purpose of the release is to evaluate the agronomic performance of the GM wheat under Australian field conditions.

10. The dealings involved in the proposed intentional release are:

conducting experiments with the GMOs

propagating the GMOs

growing the GMOs

transporting the GMOs

disposing of the GMOs and

possession, supply or use of the GMOs for any of the purposes above. These dealings are detailed further below.

3.1 The proposed limits of the dealings (duration, size, location and people)11. The release is proposed to take place on one site at the DEDJTR’s Plant Breeding Centre (PBC) in Horsham, Victoria on a maximum area of 3 ha per season between May 2016 and May 2018.

12. Only trained and authorised staff would be permitted to deal with the GM wheat.

3.2 The proposed controls to restrict the spread and persistence of the GMOs in the environment13. The applicant proposed a number of controls to restrict the spread and persistence of the GM wheat and the introduced genetic material in the environment. These include:

locating the trial at least 2 km away from the nearest natural waterway



surrounding the trial site with a 2 m buffer zone

surrounding the trial site with a 10 m monitoring zone, maintained in a manner that does not attract or harbour rodents, and in which related species must be prevented from flowering

surrounding the monitoring zone with a 190 m isolation zone, in which no other crops of wheat may be grown, and where growth of related species is controlled

restricting animal access by surrounding the trial site with a livestock and rabbit proof fence

use of rodent baiting inside the fence perimeter as required

conducting the trial on a departmental research facility thus restricting public access

destroying all plant material from the trial not required for testing or future trials and incorporating any plant material/stubble remaining after harvest into the soil

using dedicated farm machinery and equipment that will be cleaned at the trial site

promoting germination of any residual seed post-harvest by tillage and irrigation, and monthly post-harvest monitoring of the trial site for at least 2 years for identification and destruction of any wheat volunteers before flowering

transporting and storing GM plant materials in accordance with the current Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs

not allowing GM plant material or products to be used for human food or animal feed.

Section 4 The parent organism14. The parent organism is bread wheat (Triticum aestivum L.) which is exotic to Australia. Commercial wheat cultivation occurs in the wheat belt from south eastern Queensland through New South Wales, Victoria, Tasmania, southern South Australia and southern Western Australia.

15. The cultivar to be used is a former commercial bread wheat cultivar, Bobwhite SH 98 26 (Bobwhite) selected for the high ability to regenerate and be genetically modified in plant tissue culture (Pellegrineschi et al. 2002). Bobwhite is a generic name that refers to all sister lines derived from the cross CM 33203 with the pedigree Aurora/Kalyan/Bluebird/3/Woodpecker developed by the International Maize and Wheat Improvement Centre bread wheat program in the early 1970s.

16. Detailed information about the parent organism is contained in the reference document The Biology of Triticum aestivum L. (Bread Wheat) (OGTR 2016) which was produced to inform the risk assessment process for licence applications involving GM wheat. Baseline information from this document will be used and referred to throughout the RARMP.

Section 5 The GMOs, nature and effect of the genetic modification

5.1 Introduction to the GMOs17. The applicant proposes to release up to ten lines for each of the sixteen candidate gene constructs, i.e. up to 160 lines, of GM wheat modified for NUE (Table 1) and up to ten lines for each of the eight candidate gene constructs, i.e. up to 80 lines, of GM wheat modified for WUE (Table 2). One of the introduced genes is expected to confer both the traits, thus a total of 23 candidate genes are proposed to be used.

18. The introduced genes for NUE and WUE are derived from either Lolium perenne (perennial rye grass) or Deschampsia antarctica (Antarctic hair grass). The method for


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


identifying candidate genes was to subject L. perenne and D. antarctica plants to nitrogen or water stress regimes. The expressed gene sequences were mapped to the reference transcriptome of Brachypodium distachyon, a model grass species and selected based on their relative abundance. The final list was derived following comparison with Brachypodium, rice and Arabidopsis expressed sequence annotations on the publicly available database GenBank.

19. The applicant has provided brief descriptions for each of the candidate genes based on the matches with known gene sequences. These descriptions have been declared Confidential Commercial Information (CCI). The confidential information was made available to the prescribed experts and agencies that were consulted on the RARMP for this application. The applicant intends to gather more information on the effects of the introduced genes under this limited and controlled trial.

20. The lines were produced using Agrobacterium tumefaciens mediated plant transformation. Information about this transformation method can be found in the document Methods of plant genetic modification available from the OGTR Risk Assessment References page.

Table 1 Candidate genes for increased nitrogen use efficiency

Gene ID# Functional classification Class I Class II Source

P200001 Transcription factor HSF L. perenne

P200002 Transcription factor bZIP L. perenne

P200003 Transcription factor HD-ZIP L. perenne

P202001 Transcription factor HSF D. antarctica

P201003 Transcription factor bZIP D. antarctica

P201013 Transporter Amino acid D. antarctica

P200032 Transporter Unknown L. perenne

P201042 Transporter Peptide D. antarctica

P201017 Transporter Unknown D. antarctica

P200030 Transporter Unknown L. perenne

P200038 Enzyme ATPase L. perenne

P201035 Enzyme Cell wall synthesis D. antarctica

P201036 Enzyme Nucleoside D. antarctica

P200014 Enzyme Cell wall synthesis L. perenne

P200021 Signalling Chemotaxis L. perenne

P200028 Unknown - L. perenne

# The genes to be tested under this field trial have each been assigned an identifier.


http://www.ncbi.nlm.nih.gov/genbank/


Table 2 Candidate genes for increased water use efficiency

Gene ID# Functional classification Class I Class II Source

P202007 Transcription factor bZIP D. antarctica

P202010 Transcription factor HD-ZIP D. antarctica

P200002 Transcription factor bZIP L. perenne

P202019 Transporter Metal D. antarctica

P202006 Transporter Unknown D. antarctica

P202053 Proteolysis Cysteine D. antarctica

P202050 Signalling Polyinositide D. antarctica

P202015 Unknown - D. antarctica

# The genes to be tested under this field trial have each been assigned an identifier.

21. All GM wheat lines will also contain a herbicide tolerance selectable marker, the pat gene sourced from the soil bacterium Streptomyces viridochromogenes. The pat gene encodes phosphinothricin acetyltransferase which confers tolerance to the herbicide glufosinate and was used as a selective marker during early stages of development to screen for GM plants.

22. In each GM wheat line, short regulatory elements are used to control expression of the candidate genes (Table 3). These sequences are derived from maize and a soil bacterium, A. tumefaciens.

Table 3 Regulatory sequences introduced into the GM wheat lines proposed for releaseElement Description Source Used in GM wheat lines

ZmUBI-1Constitutive promoter with expression highest in young actively growing grass tissues

Zea maysP200002, P200038, P202001, P201003, P201042, P201036, P201017 and all WUE lines

ZmZrp2 Root preferential promoter Zea maysP200001, P201013, P200032, P200003, P200028, P201035, P200021, P200030 and P200014

nos-t Terminator and polyadenylation signal A. tumefaciens All GM wheat lines

OsActli-p Promoter for the pat gene Oryza sativa All GM wheat lines

CaMV35S-t Terminator for the pat gene Cauliflower mosaic virus

All GM wheat lines

5.2 The introduced genes, encoded proteins and their associated effects23. Both NUE and WUE are abiotic stress tolerance traits. The natural mechanisms by which plants deal with abiotic stresses can be classified as either avoidance or tolerance, the former referring to those that noticeably affect the morphology and/or physiology of a plant, and the latter to molecular changes that may have no visual effects (Howles & Smith 2013).

24. NUE is an important factor in crop plant productivity and hence is a target for research to develop plants that absorb and use this element more efficiently. It can be described as the product of two components: uptake efficiency and utilisation efficiency (Witcombe et al. 2008). Increasing the efficiency of nitrogen use would reduce the need for fertilisers in agriculture and the pollution that nitrogen can cause in the environment.



25. The availability of water is the most important factor that limits crop yield globally (Castiglioni et al. 2008). Increased WUE would reduce the susceptibility of crops to failure during drought.

26. Abiotic stress tolerances are multigenic traits, involving the interaction of genes for which the protein products may be involved in different biochemical pathways. Further information on plant responses to abiotic stresses can be found in the RARMP for DIR 102. Evidence of cross tolerance to different abiotic stresses has led researchers to conclude that the signalling pathways for abiotic stress tolerance are not strictly isolated (Yamaguchi-Shinozaki & Shinozaki 2006). At this early stage of research, the potential for the candidate genes to exhibit cross-tolerance to multiple abiotic stresses is not known. This uncertainty will be taken into account in the risk analysis process.

5.2.1 NUE and WUE genes

27. Based on sequence homology to annotated genes on the publicly available GenBank database (NCBI), the introduced genes for NUE and WUE are predicted to encode for transcription factors, transporters, signalling molecules or enzymes involved in structural function or a protein involved in proteolysis. The introduced genes most likely function by regulating expression of endogenous genes, or modulating molecular pathways in GM wheat plants. In this respect, while there may be changes in levels of products produced as a result of the activity of the introduced genes, no new products are expected to be produced by their expression.

28. Further information on individual candidate NUE and WUE genes has been declared CCI. The confidential information was made available to the prescribed experts and agencies that were consulted on this RARMP.

5.2.2 The pat gene

29. The pat gene codes for the enzyme phosphinothricin acetyltransferase (PAT), which confers tolerance to herbicides containing glufosinate, and is used in the laboratory to select GM plants during the early stage of development. Expression of the pat gene is driven by a constitutive promoter, therefore the PAT protein is expected to be present in all plant tissues in the GM wheat.

5.3 Toxicity/allergenicity of the proteins associated with the introduced genes30. The genes conferring enhanced NUE and WUE were obtained from perennial ryegrass and Antarctic hair grass. Perennial ryegrass is widespread in Australia, whereas the Antarctic hair grass is indigenous to Antarctica and southern South America and is not found in Australia.

31. Perennial ryegrass is a commonly used pasture grass in southern Australia, so is widely used as livestock feed (Bell et al. 2013). Perennial ryegrass pollen can cause allergies and its allergens have been well characterised. Among these, the Lol p I, Lol p II and Lol p V proteins have been identified as the main allergenic determinants contributing to more than 80% of grass pollen allergenic interactions (Singh et al. 1991; Smith et al. 1994).

32. Antarctic hair grass is one of the two species of flowering plants native to Antarctica and is known for its frost tolerance. Antarctic hair grass is considered to be a pasture grass of low forage value but fair palatability in the Falkland Islands (McAdam & Olave 2014). No reports of harm to humans or the environment were found in the literature related to Antarctic hair grass.

33. The encoded proteins have homologues that occur naturally in a range of organisms, including plants consumed by people and animals. On this basis, people and other organisms have a long history of exposure to homologues of the introduced proteins.


http://www.ncbi.nlm.nih.gov/genbank/

http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/DIR102


34. No studies on toxicity/allergenicity have been performed on any of the GM wheat plants or purified proteins as the proposed trial is at preliminary research stage.

35. Bioinformatic analysis may assist in the assessment process by predicting, on a purely theoretical basis, the toxic or allergenic potential of a protein. The results of such analyses are not definitive and should be used only to identify those proteins requiring more rigorous testing (Goodman et al. 2008). Potential identities between each introduced protein product and allergenic proteins listed in the AllergenOnline database from the Food Allergy Research and Resource Program (FARRP) were evaluated using the FASTA sequence alignment program (Pearson & Lipman 1988). None of the predicted proteins matched the 35% or higher identity (a standard used as threshold for comparing allergenicity) to any of the known allergens of the database indicating a lack of immunological relevance.

36. No adverse health effects were reported by the staff who handled the GMOs during the screening trials in the glasshouse.

37. The proteins encoded by some homologues of one of the genes, P200014, introduced for NUE have been reported to have allergenic properties. Further information on this gene has been declared CCI. The confidential information was made available to the prescribed experts and agencies that were consulted on the RARMP for this application.

38. The pat gene confers tolerance to the herbicide glufosinate and has been used as a selectable marker for early selection of transformed plants. A number of GM crops, including food crops, containing the pat or bar gene encoding the PAT protein, have been approved for commercial release both in Australia (DIR 021/2003, DIR 062/2005, DIR 091 and DIR 108) and overseas. No adverse effects on humans, animals or the environment have been reported from any such releases (CERA 2011). FSANZ has approved several food crops containing the PAT protein as safe for human consumption (FSANZ 2006; FSANZ 2014).

5.4 Characterisation of the GMOs5.4.1 Phenotypic characterisation

39. The GM plants for the proposed trial were chosen from a large number of GM plants based on their performance in glasshouse screens for NUE and WUE.

40. The applicant has conducted initial evaluations under glasshouse conditions under water stress. Relative growth characteristics were generally similar to non-GM wheat.

41. Preliminary data indicates that expression of certain candidate genes for increased NUE is associated with increase in chlorophyll content, tiller number or vegetative biomass production.

42. The expression of certain candidate genes for increased WUE was associated with increase in vegetative biomass production under water limiting conditions.

Section 6 The receiving environment43. The receiving environment forms part of the context in which the risks associated with dealings involving the GMOs are assessed. Relevant information about the receiving environment includes abiotic and biotic interactions of the crop with the environment where the release would occur; agronomic practices for the crop; presence of plants that are sexually compatible with the GMO; and background presence of the gene(s) used in the genetic modification (OGTR 2013).

44. Information relevant to the growth and distribution of commercial wheat in Australia is discussed in The Biology of Triticum aestivum L. ( Bread Wheat) (OGTR 2016).



http://farrp.unl.edu/

http://www.allergenonline.org/


6.1 Relevant abiotic factors45. The release is proposed to take place at Horsham, Victoria at the DEDJTR Plant Breeding Centre (PBC). The PBC is a dedicated fenced field trial site of approximately 11 ha and has been used previously for licenced field trials. Access to the research station is restricted to authorised staff. DEDJTR has control over the management of the paddocks immediately surrounding the proposed trial site.

46. The proposed site is located approximately 2 km away from the nearest natural water source and was not affected by the one in two hundred year flood experienced in Horsham in 2011 (information provided by applicant).

6.2 Relevant agricultural practices47. The limits and controls of the proposed release are outlined in Sections 3.1 and 3.2 of this Chapter. It is anticipated that the agronomic practices for the cultivation of the GM wheat by the applicant will not differ significantly from industry best practices used in Australia. GM wheat seeds would be planted in the trial in winter or early spring.

48. It is proposed to grow the GM wheat and a reference wheat cultivar for both the two traits. The seed would be sown with a plot cone-seeder.

49. The crop would be maintained in a similar fashion to commercial wheat crops; with respect to pest and disease management with the application of appropriate chemicals, if required. Weed management would be by manual means or through appropriate herbicide application.

50. Harvesting of wheat would be either manual (for sampling within plots) or with a small scale plot harvester which is dedicated for use on GM plants.

6.3 Presence of related plants in the receiving environment51. Both bread and durum wheats are commonly grown in Australia and are widely cultivated in the surrounding regions of the proposed field site. The paddocks adjoining the PBC are owned and controlled by DEDJTR and are routinely used for non-GM pulse and legume trials. Non-GM wheat has not been grown within 400 m of the GM field trial site since 2007.

52. The applicant has indicated that non-GM parental and commercial wheat lines would also be planted at the location to evaluate the agronomic traits of the GM wheat lines. All non-GM wheat planted at the location would be treated as if it were the GM wheat proposed for release.

53. Wheat (Triticum aestivum L.) is sexually compatible with a number of species within the tribe Triticeae that occur in Australia. Of particular importance are durum wheat (Triticum turgidum ssp. Durum), rye (Secale cereale), and Triticale (X Triticosecale). Hybridisation with durum wheat occurs readily (Wang et al. 2005), whereas that with rye (Dorofeev 1969; Leighty & Sando 1928; Meister 1921) and Triticale (Ammar et al. 2004; Kavanagh et al. 2010) is rarer. Wheat also readily hybridises with Aegilops species (goatgrasses), but no Aegilops species are considered to be naturalised in Australia. Any specimens of Aegilops that have been collected in Australia presumably originate from seed accidently introduced amongst wheat seed, or straying from that brought in for breeding programs (AVH 2012).

54. Australasia possesses four native Triticeae genera - Australopyrum, Stenostachys, Anthosachne (Elymus), and Connorochloa (Barkworth & Jacobs 2011) – as well as a number of introduced species of Triticeae, such as Elytrigia repens (couch grass) and at least four Thinopyrum species (Bell et al. 2010). Thinopyrum ponticum (tall wheatgrass) has been used as a saltland pasture plant in Australia, and in some regions has come to be classified as a weed (Barrett-Lennard 2003; NYNRMP 2011). There has been no concerted investigation on



natural hybridisation of these native and introduced Triticeae species of wheat. Factors such as genome incompatibilities, the necessity for the parent plants to be in close proximity, concurrent flowering, and the ability of the hybrid progeny to set viable seed, combine to make it extremely unlikely that any of these Triticeae would ever naturally cross with wheat.

6.4 Presence of similar genes and encoded proteins in the environment55. The introduced NUE and WUE genes have been sourced from perennial ryegrass and Antarctic hair grass. Perennial ryegrass is widespread in Australia while Antarctic hair grass not found in Australia. Information provided by the applicant indicates that most of the genes derived from Antarctic hair grass are homologous to genes that are widespread in common plants. Therefore, people are naturally exposed to these genes.

56. The pat selectable marker gene is derived from the soil bacterium Streptomyces viridochromogenes, which is widespread in the environment.

Section 7 Relevant Australian and international approvals

7.1 Australian approvals7.1.1 Approvals by the Regulator

57. None of the GM wheat lines included in this application have previously been approved by the Regulator for release in Australia.

58. Information on previous DIR licences for GM wheat is available from the OGTR GMO Record. The Regulator has previously approved 17 field trial releases of GM wheat. There have been no credible reports of adverse effects on human health or the environment resulting from any of these releases.7.1.2 Approvals by other government agencies

59. There are no approvals of these GM wheat lines, including pending approvals, from other Australian authorities.

7.2 International approvals60. None of the GM wheat lines covered in this application has been approved for release in any other countries.



Chapter 2 Risk assessmentSection 1 Introduction

61. 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

62. 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 in the short and long term. These are called risk scenarios.

63. A number of risk identification techniques are used by the Regulator and staff of the OGTR, including checklists, brainstorming, reported international experience and consultation (OGTR 2013). A weed risk assessment approach is used to identify traits that may contribute to risks from GM plants, as this approach addresses the full range of potential adverse outcomes associated with plants. In particular, novel traits that may increase the potential of the GMO to spread and persist in the environment or increase the level of potential harm compared with the parental plant(s) are used to postulate risk scenarios (Keese et al. 2013). Risk scenarios postulated in previous RARMPs prepared for licence applications of the same or similar GMOs are also considered.

64. Postulated risk scenarios are screened to identify those that are 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.

65. Substantive 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 (Likelihood

Chapter 2 – Risk assessment 10


assessment). Risk evaluation then combines the Consequence and Likelihood assessments to estimate the level of risk and determine whether risk treatment measures are required. The potential for interactions between risks is also considered.

Section 2 Risk Identification66. Postulated risk scenarios are comprised of three components:

i. The source of potential harm (risk source).

ii. A plausible causal linkage to potential harm (causal pathway).

iii. Potential harm to an object of value, people or the environment.

67. When postulating relevant risk scenarios, the risk context is taken into account, including the following factors:

the proposed dealings, which may be to conduct experiments, develop, produce, breed, propagate, grow, import, transport 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 including the extent and scale of the proposed dealings

the proposed controls to restrict the spread and persistence of the GMO and

the characteristics of the parent organism(s).

2.1 Risk source68. The sources of potential harms can be intended novel GM traits associated with one or more introduced genetic elements, or unintended effects/traits arising from the use of gene technology.

69. As discussed in Chapter 1, the GM wheat lines have been modified by the introduction of one of the twenty three genes sourced from L. perenne and D. antarctica. These introduced genes are considered further as potential sources of risk.

70. In addition, all of the GM wheat lines contain the pat herbicide tolerance selectable marker gene. This gene and its product have already been extensively characterised and assessed as posing negligible risk to human or animal health or to the environment by the Regulator as well as by other regulatory agencies in Australia and overseas. Information on previous GM crops incorporating the pat gene has been described in Section 5.3. As the pat gene has not been found to pose a substantive risk to either people or the environment, its potential effects will not be further considered for this application.

71. The introduced genes are controlled by introduced regulatory sequences. The regulatory sequences are derived from two food crops, a bacterium and a virus (see Chapter 1, Section 5.1). Although the bacterial and viral sequences are derived from plant pathogens, they only constitute small fractions of the genomes and cannot themselves cause disease. Regulatory sequences are naturally present in plants, and the introduced elements are expected to operate in similar ways to endogenous elements. The regulatory sequences are DNA that is not expressed as a protein, and dietary DNA has no toxicity (Society of Toxicology 2003). Hence, potential harms from the regulatory elements will not be considered further. However, the introduced regulatory sequences, especially the promoters, control gene expression and hence the distribution and concentration of the proteins derived from the introduced genes in the GM plants. The effects of protein levels, especially in relation to toxicity and allergenicity, will be considered below.

72. The genetic modifications have the potential to cause unintended effects in several ways including altered expression of endogenous genes by random insertion of introduced DNA in the genome, increased metabolic burden due to expression of the introduced proteins, novel traits



arising out of interactions with non-target proteins and secondary effects arising from altered substrate or product levels in biochemical pathways. However, these types of effects also occur spontaneously and in plants generated by conventional breeding. Accepted conventional breeding techniques such as hybridisation, mutagenesis and somaclonal variation can have a much larger impact on the plant genome than genetic engineering (Schnell et al. 2015). Plants generated by conventional breeding have a long history of safe use, and there are no documented cases where conventional breeding has resulted in the production of a novel toxin or allergen in a crop (Steiner et al. 2013). Conventional breeding has been used to produce plants with improved NUE and WUE. There is no evidence that conventional breeding for NUE and WUE has generated wheat that has had adverse environmental effects beyond those normally associated with the cultivation of this species. Therefore, the processes of genetic modification resulting in unintended effects will not be considered further.

2.2 Causal pathway73. The following factors are taken into account when postulating plausible causal pathways to potential harm:

routes of exposure to the GMOs, the introduced gene(s) and gene product(s) 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 spread and persistence of the GMOs (e.g. reproductive characteristics, dispersal pathways

and establishment potential) tolerance to abiotic conditions (e.g. climate, soil and rainfall patterns) tolerance to biotic stressors (e.g. pest, pathogens and weeds) tolerance to cultivation management practices gene transfer to sexually compatible organisms gene transfer by horizontal gene transfer (HGT) unauthorised activities.

74. Although all of these factors are taken into account, some are not included in risk scenarios because they are regulated by other agencies or have been considered in previous RARMPs.

75. The PBC facility has hosted other GM wheat field trials under different licences issued to DEDJTR. Pollen from the GM plants of one trial could inadvertently fertilise other sexually compatible GM plants, including volunteers, inside a site. Currently, the only licence that is authorised to trial GM plants in the PBC facility that are sexually compatible with those of this application is DIR 122. This licence authorises the growth of GM wheat for enhanced yield. In 2016, when the proposed trial is planned to commence, DIR 122 will be in post-harvest monitoring phase with licence conditions requiring that volunteer wheat plants are destroyed prior to flowering. Hence the possibility of hybridisation of GM plants of the proposed trial with those of another trial will not be considered further.

76. The potential for horizontal gene transfer (HGT) from GMOs to species that are not sexually compatible, and any possible adverse outcomes, have been reviewed in the literature (Keese 2008) and assessed in many previous RARMPs. HGT was most recently considered in the RARMP for DIR 108. Although the DIR 108 RARMP is for GM canola, the HGT considerations are the same for the current RARMP: HGT events rarely occur and the wild-type gene sequences are already present in the environment and available for transfer via demonstrated natural mechanisms. Therefore, no substantive risk was identified in previous assessments and HGT will not be further considered for this application.




77. The potential for unauthorised activities to lead to an adverse outcome has been considered in many previous RARMPs, most recently in the RARMP for DIR 117. In previous assessments of unauthorised activities, no substantive risk was identified. The Act provides for substantial penalties for unauthorised dealings with GMOs or non-compliance with licence conditions, and also requires the Regulator to have regard to the suitability of an applicant to hold a licence prior to the issuing of the licence. These legislative provisions are considered sufficient to minimise risks from unauthorised activities. Therefore, unauthorised activities will not be considered further.

2.3 Potential harm78. Potential harms from GM plants include:

harm to the health of people or desirable organisms, particularly toxicity/allergenicity reduced biodiversity through harm to other organisms or ecosystems reduced establishment or yield of desirable plants reduced products or services from the land use restricted movement of people, animals, vehicles, machinery and/or water reduced quality of the biotic environment (e.g. providing food or shelter for pests or

pathogens) or abiotic environment (e.g. negative effects on fire regimes, nutrient levels, soil salinity, soil stability or soil water table).

79. These harms are based on those used to assess risk from weeds (Keese et al. 2013; Standards Australia Ltd et al. 2006). Judgements of what is considered harm depend on the management objectives of the land where the GM plant may be present. A plant species may have different weed risk potential in different land uses such as dryland cropping or nature conservation.

2.4 Postulated risk scenarios80. Three risk scenarios were postulated and screened to identify substantive risk. These scenarios are summarised in Table 4, and discussed individually below. Postulation of risk scenarios considers impacts of the GM wheat or its products on people undertaking the dealings, as well as impacts on people and the environment if the GM plants or genetic material were to spread and/or persist.

81. In the context of the activities proposed by the applicant and considering both the short and long term, none of the three risk scenarios gave rise to any substantive risks.

Table 4 Summary of risk scenarios from the proposed dealingsRisk scenario

Risk source Causal pathway Potential harm/s Substantive risk?

Reasons

1 Introduced genes for NUE and WUE

Growing GM plants at the site

Expression of genes in GM plants

Exposure of people who deal with the GM plant material or other organisms that come into contact with the GM plant material in the trial site

Toxicity or allergenicity in people or toxicity to desirable organisms

No GM plant material would not be used in human food or animal feed.

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

The balance of the evidence indicates that the introduced proteins are unlikely to be toxic or allergenic.




Risk scenario

Risk source Causal pathway Potential harm/s Substantive risk?

Reasons


Dispersal of GM seed outside trial limits

GM seed germinates

Establishment of populations of the GM plants


Reduced establishment or yield of desirable plants

No The proposed limits and controls minimise the likelihood that GM plant material would leave a trial site.

Wheat has limited ability to survive outside agricultural settings.

The GM wheat is susceptible to standard weed control measures.


Pollen from GM plants fertilises sexually compatible plants outside the trial site

GM hybrid seed germinates

GM hybrids spread and persist


Reduced establishment or yield of desirable plants

No Wheat has limited ability to outcross.

The proposed limits and controls would minimise pollen flow to sexually compatible plants outside the trial site.

Risk scenarios 1 and 2 did not identify toxicity, allergenicity or weediness of the GMOs as substantive risks.

2.4.1 Risk scenario 1

Risk source Introduced genes for NUE and WUE

Causal pathway

Growing GM plants at the site

Expression of genes in GM plants

Exposure of people who deal with the GM plant material or other organisms that come into contact with the GM

plant material in the trial site

Potential harm Toxicity or allergenicity in people or toxicity to desirable organisms

Risk source

82. The source of potential harm for this postulated risk scenario is the introduced genes for NUE and WUE.

Causal pathway

83. The NUE and WUE genes are expressed in the plant tissues. People who are involved in cultivating, harvesting, transporting and processing of the GM wheat may be exposed to its products through contact (including inhalation of pollen). This would be expected to mainly occur in the trial sites, but could also occur anywhere the GM plant material was transported or used for experimental analysis. Organisms that may be present in the trial sites, including birds, rodents and invertebrates, may be exposed to the GM plant material.

84. The proposed limits and controls of the trial would minimise the likelihood that people or other organisms would be exposed to GM plant material. The GM plant material would not be used for human food or animal feed. The site would only be accessed by authorised people and would be surrounded by a fence to exclude livestock and other large animals. Further, as the proposed trial is limited to a single site totalling a maximum of 3 ha per season for two years, only a small number of people would deal with the GM plant material and a small number of organisms are likely to be exposed to it.



Potential harm

85. 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). 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. People exposed to the proteins expressed from the introduced genes may show toxic or allergenic reactions, while other organisms may show toxic reactions.

87. Proteins are not generally associated with toxic effects. As opposed to small molecular weight chemicals (e.g. pesticides), proteins have a number of properties that limit their ability to produce toxic effects upon ingestion, these including their likely digestion in the gastrointestinal tract and difficulties they encounter in traversing plasma membranes (Hammond et al. 2013). However, a small number of proteins have been shown to be toxic to humans and mammals, these originating mainly from animals (e.g. snakes, scorpions) and bacteria (Henkel et al. 2010; Karalliedde 1995). Lectins and protease inhibitors are plant proteins that have toxic properties, but for most people the level of exposure and response to the majority of these compounds is such that they are often classified as anti-nutrients (Delaney et al. 2008). The best known plant proteins that are definitely toxic to humans are the lectins that consist of a ribosome-inactivating peptide (RIP) linked to a carbohydrate binding peptide, examples being ricin, abrin and modeccin (de Virgilio et al. 2010; Stirpe 2005; Wu & Sun 2011). Other plant proteins, found to be toxic at least to mice, include the urease-like-protein canatoxin from jack beans (Follmer et al. 2001) and an acidic protein and a glycoprotein from soybean (Morais et al. 2010; Vasconcelos et al. 2008; Vasconcelos et al. 1994).

88. All known food allergens are proteins, those derived from plants coming chiefly from peanut, tree nuts, wheat and soybean (Delaney et al. 2008; Herman & Ladics 2011). The structural and functional properties of plant food allergens can be used to classify them into approximately 30 families, these then being grouped into a small number of superfamilies (Hauser et al. 2008; Radauer & Breiteneder 2007; Salcedo et al. 2008). The major superfamilies are the prolamins, cupins, pathogenesis-related (PR) proteins, profilins and protease inhibitors. Beyond toxicity and allergenicity, specific proteins and chemicals have been associated with autoimmune diseases and food intolerances (ASCIA 2014; Barragan-Martinez et al. 2012; Selmi et al. 2012).

89. Chapter 1, Section 5.3 presents a review of the potential toxic and allergenic properties of the proteins encoded by the introduced genes. The genes were derived from Antarctic hair grass and perennial ryegrass. Antarctic hair grass is not known to be toxic or allergenic, and perennial ryegrass is not known to be toxic. Perennial ryegrass pollen can be allergenic, but the L. perenne genes introduced into the GM wheat are not the L. perenne genes associated with allergenicity.

90. Bioinformatic comparison of the introduced genes to toxin and allergen databases did not identify any safety concerns. The applicant has not reported any allergenicity or toxicity to people dealing with the GM wheat plants in glasshouse facilities.

91. Most of the introduced genes were found to be members of gene families that are present in common plants, including food plants, and not known to cause toxicity or allergenicity. There is uncertainty regarding potential toxic or allergenic properties of P202015, which did not have homology to any other characterised genes. P200014 is a member of a gene family where some other family members are reported to have allergenic properties; therefore it is possible that P200014 may be allergenic. However, P200014 is proposed to be expressed under the control of a root-preferential promoter. As the protein will be preferentially expressed in the root, it is less likely that the encoded protein would be present in the GM wheat pollen, which could be inhaled, or in the stems and leaves (Held et al. ). People cultivating the GM wheat would generally not have contact with underground root material, which is not harvested. Therefore, exposure of people to the encoded protein of P200014 would be minimal.



92. Non-GM wheat flour can produce allergic and other immune responses in susceptible individuals on inhalation or ingestion. Several types of allergic and immune reactions to wheat products have been recorded, with baker’s asthma and coeliac disease being the best characterised. Bakers asthma is a respiratory allergy to inhaled flour and dust from grain processing, which is one of the most important occupational allergies in many countries (reviewed by Arts et al (2006) and Tatham & Shewry (2008)). Coeliac disease is an autoimmune (genetic) disorder that is triggered by the consumption of gluten (Denham & Hill 2013; Hischenhuber et al. 2006). It is characterised by the immune system attacking the small intestine and inhibiting the absorption of nutrients into the body, sometimes leading to permanent tissue damage. These undesirable properties of cereals are not expected to be altered in the GM wheat lines proposed for release.

93. Conclusion: Risk scenario 1 is not identified as a substantive risk due to the proposed limits and controls designed to minimise exposure of people and other organisms to the GM plant material and because the balance of the evidence indicates that the introduced proteins are unlikely to be toxic or allergenic. Therefore, this risk could not be greater than negligible and does not warrant further detailed assessment.


Risk source Introduced genes for NUE and WUE

Causal pathway

Dispersal of GM seed outside trial limits

GM seed germinates

Establishment of populations of the GM plants

Potential harm Toxicity or allergenicity in people or toxicity to desirable organisms and reduced establishment or yield of desirable plants

Risk source

94. The source of potential harm for this postulated risk scenario is the introduced NUE and WUE genes.

Causal pathway

95. If GM wheat seed was dispersed outside the trial site or persisted at the site after completion of the trial, this seed could germinate and give rise to plants expressing the introduced genes. These plants could spread and persist in the environment outside the trial limits and people and other organisms may be exposed to GM plant materials.

96. Dispersal of GMOs outside the limits of the trial site could occur through the activity of people, including the use of agricultural equipment. The proposed trial site would be surrounded by a fence with lockable gates and only approved staff with appropriate training will have access to the site. This will reduce inadvertent access by humans thus minimising dispersal of GM plant material. Dispersal of GM plant material by authorised people entering the proposed trial site would be minimised as the applicant proposes cleaning of all equipment used at the trial site. All GM plant material would be transported in accordance with the Regulator’s transport guidelines, which will minimise the opportunity for its dispersal.

97. The activity of animals such as rodents, herbivores and birds could lead to dispersal of the GMOs outside the limits of the trial site. Wheat lacks seed dispersal characteristics such as stickiness, burrs and hooks, which can contribute to seed dispersal via animal fur (Howe & Smallwood 1982). The intended introduced traits of the GM plants, NUE and WUE, are not expected to alter these characteristics of seeds. Wheat seeds could be dispersed and germinate after



passage through the digestive system of some mammals or birds. For example, viable wheat seeds have been detected in cattle dung (Kaiser 1999). However, reports on seed dispersal for wheat through endozoochory are rare. Seeds which survive chewing and digestion by animals are typically small and dormant (Malo & Suárez 1995). Though birds can cause damage to cereal crops during germination and seed ripening, only emus are known to transport and disperse wheat seed through endozoochory (Temby & Marshall 2003). Corellas were shown to excrete some viable wheat seeds, although the proportion is extremely low (Woodgate et al. 2011).

98. Kangaroos, rabbits and rodents are known pests of wheat crops, and cattle or sheep may graze cereals. However, the proposed site will be fenced with a livestock and rabbit proof fence, limiting the possibility of seed dispersal by large animals or rabbits. Rodents are opportunistic feeders and their diet include seeds and other plant material (Caughley et al. 1998). They may not only eat and destroy seed at the seed source but also hoard seeds (AGRI-FACTS 2002), which increases the possibility of seed dispersal. The applicant is proposing a 10 m monitoring zone around the GM planting area to be maintained in a manner that does not attract or harbour rodents (such as keeping it bare or mown) and implementation of rodent control measures if rodents are detected. These standard measures minimise the potential for seed dispersal by rodents.

99. Extreme weather events could lead to spread of the GMOs. The applicant has proposed to conduct the trial at least 2 km from permanent natural waterways and man-made waterways that flow into natural waterways. This is considered to minimise the potential for seed dispersal during flooding. It is unlikely that high winds could lead to dispersal of GM wheat seed as they lack structures which will aid windborne dispersal, however, this could be possible in the event of a severe storm.

100. Persistence of GMOs at the trial site could occur through dormancy of seeds in the seed bank. However, white wheat cultivars have little seed dormancy (OGTR 2016). The applicant proposes to promote germination of any residual GM wheat seed by post-harvest tillage and irrigation, and to monitor the trial site and destroy wheat volunteers for at least two years. These measures are considered to minimise the likelihood of persistence of GMOs after completion of the trial.

101. Characteristics that influence the spread (dispersal of the plant or its genetic material) and persistence (establishment, survival and reproduction) of a plant species determine 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.

102. Baseline information on the weediness of wheat, including factors limiting the spread and persistence of non-GM plants of these species, is given in The Biology of Triticum aestivum L. ( Bread Wheat) (OGTR 2016). In summary, wheat has some characteristics of invasive plants, such as being capable of out-crossing (although it is predominantly self-pollinating) and the ability to germinate or to produce seed in a range of environmental conditions. However, it lacks most of the characteristics that are common to invasive plants, such as the ability to produce a persisting seed bank, rapid growth to flowering, continuous seed production as long as growing conditions permit, high seed output, high seed dispersal and long-distance seed dispersal (Keeler 1989). In addition, wheat has been bred to avoid seed shattering (OGTR 2016) which greatly reduces its dispersal characteristics. Although wheat is the most widely grown crop in Australia, so has had extensive opportunity to naturalise, it has not become a significant weed in any Australian ecosystem (Groves et al. 2003).

103. The expected phenotypic differences between the GM wheat lines and their non-GM progenitors are either increased NUE or WUE. These introduced traits are not expected to alter the reproductive or dispersal characteristics of the GM plants. The introduced traits may provide a survival advantage, as there is the potential for the GM plants to have an increased distribution in the natural environment and agricultural settings, particularly in areas with lower availability of nitrogen or water. There is some uncertainty regarding increased survival as the performance of the





GM plants in the field is yet to be determined. However, due to wheat’s lack of other weedy characteristics, as described in the previous paragraph, the GM wheat would be unlikely to successfully compete with established weedy species when not under cultivation. In addition, a large number of herbicides are registered to control volunteer wheat (APVMA website), and these herbicides, or non-chemical weed management methods, would be as effective on GM wheat as on non-GM wheat.

104. Genes that have been associated with abiotic stresses have frequently been shown to have pleiotropic effects, a phenomenon that is likely due to most such genes playing important roles in regulation. Not only can a gene provide tolerance to multiple individual abiotic stress (eg both cold and salinity), but even impart both abiotic and biotic stress tolerances (Howles & Smith 2013). Also, pollen from GM plants could inadvertently fertilise other GM plants within the trial site leading to stacked GM plants. If such hybridisation occurred, the progeny could have stacked traits of both NUE and WUE, in addition to any unintended stress tolerance traits due to pleiotropic effects. Therefore, any GM wheat seed dispersed from the trial site could possess multiple stress tolerances. However, as outlined above, due to other characteristics of wheat it is unlikely that the GM wheat or its progeny from any hybridisation could become a significant weed in the environment.

Potential harm

105. If GM wheat plants were to establish beyond the trial limits, they could potentially cause toxicity or allergenicity in people, or toxicity to desirable organisms, or reduced establishment or yield of desirable plants.

106. As discussed in risk scenario 1, the introduced gene products are not expected to be toxic or allergenic to people or to other organisms. This would apply even if the GM wheat plants established beyond the trial limits.

107. GM wheat plants established beyond the trial limits could potentially impact the environment by reducing the establishment of desired plants. In turn, this could lead to a reduction in the biodiversity of regions where the GM plants grew.

108. The potential of these harms can be evaluated against the experience of conventional breeding. No commercially released variety of wheat that is the product of any form of conventional breeding has been reported to have negatively impacted the environment beyond the levels normally associated with the cereal, and subsequently been flagged as an environmental weed (Department of Environment National Weeds Lists). In this context, it is relevant to note that a number of these non-GM varieties have been bred for abiotic stress tolerances, and none have been recorded as causing harm to the environment.

109. Therefore, the presence in wheat of any of the introduced genes, or a combination of any two of these genes through hybridisation, is unlikely to result in the GM plants possessing a trait that leads them to being classified as a weed.

Conclusion: Risk scenario 2 is not identified as a substantive risk due to the limited ability of wheat to spread and persist outside cultivation, the proposed limits and controls designed to restrict dispersal of the GM wheat, and the susceptibility of the GM wheat to standard weed control measures. Therefore, this risk could not be greater than negligible and does not warrant further detailed assessment.


Risk source Introduced genes for NUE and WUECausal pathway

Pollen from GM plants fertilises sexually compatible plants outside the trial site


http://www.environment.gov.au/biodiversity/invasive/weeds/weeds/lists/

https://portal.apvma.gov.au/pubcris


GM hybrid seed germinates

GM hybrids spread and persist

Potential harms

Toxicity or allergenicity in people or toxicity to desirable organisms and reduced establishment or yield of desirable plants

Risk source

110. The source of potential harm for this postulated risk scenario is the introduced NUE and WUE genes.

Causal Pathway

111. Pollen from the GM plants could be transferred outside of a trial site (eg via wind) and fertilise sexually compatible plants, whether they be non-GM wheat or plants from another species. Hybrid plants possessing the introduced genes may lead to spread of these genes in other varieties of wheat, or other sexually compatible species. People and other organisms could be exposed to the proteins expressed from the introduced genes through contact with (including inhalation of pollen) or consumption of GM plant material deriving from the plants to which the genes have been transferred.

112. 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. Baseline information on vertical gene transfer associated with non-GM wheat plants can be found in The Biology of Triticum aestivum L.(Bread Wheat) (OGTR 2016).

113. Wheat plants are predominantly self-pollinating and the chances of natural hybridisation occurring with commercial crops or other sexually compatible plants are low and decrease with distance from the GM plants. Outcrossing rates decline significantly over distance, with most pollen falling within the first few metres (Gatford et al. 2006). Rates are also influenced by the genotype of the variety, and environmental conditions, such as wind direction and humidity. The genetic modifications for NUE and WUE are unlikely to increase the propensity of the GM wheat to outcross.

114. Wheat is sexually compatible with many species within the genus Triticum, and in closely related genera such as Aegilops, Secale (rye) and Elytrigia (Chapter 1, Section 6.3). Durum wheat (other than bread wheat, the only Triticum species present in Australia) can cross with wheat, although gene flow from bread wheat beyond 40 m is very unlikely (Matus-Cadiz et al. 2004). Hybrids between wheat and Secale cereale are sterile, but treatment with colchicine doubles the chromosome number and results in a fertile plant, the commercialised Triticale (Knupffer 2009). Natural hybridisation between wheat and Triticale rarely occurs (Ammar et al. 2004; Kavanagh et al. 2010), at least partly due to both species being largely self-fertilising (Acquaah 2007). Elytrigia repens does occur as an introduced plant in Australia, but a review of possible means of pollen-mediated gene flow from GM wheat to wild relatives in Europe concluded that there was a minimal possibility of gene flow from wheat to Elytrigia spp. (Eastham & Sweet 2002). Species of Aegilops are not known in Australia. Although there is some uncertainty due to data gaps, it is unlikely that hybridisation of wheat with the four native Australasian Triticeae genera occurs under natural conditions due to low fitness and genetic incompatibility.

115. The proposed limits and controls of the trial would minimise the likelihood of the dispersal of pollen and exposure to GM plant material. The applicant proposes to control related species within 200 m of the trial site. Isolation from related species and other wheat cultivation will greatly restrict the potential for pollen flow and gene transfer. In addition, the applicant proposes to perform post-harvest monitoring and to destroy any volunteer plants found at the site prior to flowering to ensure that no GM wheat remains that could then hybridise with sexually compatible plants.





116. The applicant has indicated that both bread and durum wheats are grown in the surrounding regions of the proposed field site. However, the paddocks adjoining the PBC are owned and controlled by DEDJTR and are routinely used for conventional pulse and legume trials. Non-GM wheat has not been grown within 400m of the PBC since GM wheat field trials commenced in 2007.

Potential harms

117. Vertical transfer of the introduced genes from the GM plants to related species may produce one or more harms. People who are exposed to the proteins expressed from the introduced genes or their associated products through contact or consumption of GM plant material may show toxic or allergenic reactions, while organisms may show toxic reactions from consumption of GM plant material. If the hybrid GM plants have greater ability to spread and persist in the environment than normally found amongst these species, the hybrids may act to reduce the establishment and yield of desired plants and potentially reduce biodiversity.

118. In the unlikely event of the vertical transfer of the introduced genetic material from the GM plants to non-GM wheat plants or sexually compatible species, it is expected that this material in the recipient will impart similar properties to its traits in the GM wheat parent. As discussed in risk scenario 1, the balance of the evidence indicates that the introduced proteins are unlikely to be toxic or allergenic. Risk scenario 2 summarises the reasons that the introduced genes are unlikely to make the GM wheat lines become weedy, these reasons likewise being applicable if the genes are transferred via hybridisation to bread or durum wheat. If the introduced genes were transferred to related species with fewer domesticated traits, increased abiotic stress tolerance could contribute to weediness, but such hybrids would be likely to have low fitness due to genetic incompatibilities.

Conclusion: Risk scenario 3 is not identified as a substantive risk due to the limited ability of wheat to outcross, and the proposed limits and controls designed to restrict pollen flow from the GM wheat. Further, risk scenarios 1 and 2 did not identify toxicity, allergenicity or weediness of the GMOs as substantive risks. Therefore, this risk could not be greater than negligible and does not warrant further detailed assessment.

Section 3 Uncertainty119. Uncertainty is an intrinsic property of risk analysis and is present in all aspects of risk analysis**.

120. There are several types of uncertainty in risk analysis (Bammer & Smithson 2008; Clark & Brinkley 2001; Hayes 2004). These include:

uncertainty about facts:

– knowledge – data gaps, errors, small sample size, use of surrogate data

– variability – inherent fluctuations or differences over time, space or group, associated with diversity and heterogeneity

uncertainty about ideas:

– description – expression of ideas with symbols, language or models can be subject to vagueness, ambiguity, context dependence, indeterminacy or under-specificity

– perception – processing and interpreting risk is shaped by our mental processes and social/cultural circumstances, which vary between individuals and over time.

121. Uncertainty is addressed by approaches such as balance of evidence, conservative assumptions, and applying risk management measures that reduce the potential for risk scenarios

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


http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/risk-analysis-framework


involving uncertainty to lead to harm. If there is residual uncertainty that is important to estimating the level of risk, the Regulator will take this uncertainty into account in making decisions.

122. As field trials of GMOs are designed to gather data, there are generally data gaps when assessing the risks of a field trial application. However, field trial applications are required to be limited and controlled. Even if there is uncertainty about the characteristics of a GMO, limits and controls restrict exposure to the GMO, and thus decrease the likelihood of harm.

123. For DIR 142, uncertainty is noted particularly in relation to:

Potential increases in toxicity or allergenicity as a result of the genetic modification and

Potential for increased spread and persistence of the GMOs, including in land uses outside of agriculture.

124. Additional data, including information to address these uncertainties, may be required to assess possible future applications with reduced limits and controls, such as a larger scale trial or the commercial release of these GMOs.

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

Section 4 Risk Evaluation126. Risk is evaluated against the objective of protecting the health and safety of people and the environment to determine the level of concern and, subsequently, the need for controls to mitigate or reduce risk. Risk evaluation may also aid consideration of whether the proposed dealings should be authorised, need further assessment, or require collection of additional information.

127. Factors used to determine which risks need treatment may include:

risk criteria level of risk uncertainty associated with risk characterisation interactions between substantive risks.

128. Three risk scenarios were postulated whereby the proposed dealings might give rise to harm to people or the environment. In the context of the control measures proposed by the applicant, and considering both the short and long term, none of these scenarios were identified as substantive risks. The principal reasons for these conclusions are summarised in Table 4 and include:

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

the balance of the evidence indicates that the introduced proteins are unlikely to be toxic or allergenic

limited ability of the GM wheat plants to establish populations outside cultivation limited ability of the GM wheat plants to transfer the introduced genetic material to other

plants limits on the size, location and duration of the release proposed by DEDJTR suitability of controls proposed by DEDJTR to restrict the spread and persistence of the GM

wheat plants and their genetic material.

129. Therefore, risks to the health and safety of people, or the environment, from the proposed release of the GM wheat plants into the environment are considered to be negligible. The Risk Analysis Framework, which guides the risk assessment and risk management process, defines negligible risks as risks of no discernible concern with no present need to invoke actions for mitigation. Therefore, no controls are required to treat these negligible risks. Hence, the Regulator



considers that the dealings involved in this proposed release do not pose a significant risk to either people or the environment††.

††



Chapter 3 Risk management planSection 1 Background

130. 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 addresses risks evaluated as requiring treatment and considers limits and controls proposed by the applicant, as well as general risk management measures. The risk management plan informs the Regulator’s decision-making process and is given effect through licence conditions.

131. 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.

132. 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.

133. 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 substantive risks134. The risk assessment of risk scenarios listed in Chapter 2 concluded that there are negligible risks to people and the environment from the proposed field trial of GM wheat. These risk scenarios were considered in the context of the scale of the proposed release (Chapter 1, Section 3.1), the proposed containment measures (Chapter 1, Section 3.2), and the receiving environment (Chapter 1, Section 6), and considering both the short and the long term. The risk evaluation concluded that no specific risk treatment measures are required to treat these negligible risks. Limits and controls proposed by the applicant and other general risk management measures are discussed below.

Section 3 General risk management135. 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 discussed and summarised in the Chapter and listed in detail in the licence.

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

136. Sections 3.1 and 3.2 of Chapter 1 provide details of the limits and controls proposed by DEDJTR in their application. These are taken into account in the three risk scenarios postulated for the proposed release in Chapter 2. Many of the proposed control measures are considered standard for GM crop trials and have been imposed by the Regulator in previous DIR licences. The appropriateness of these controls is considered further below.

Chapter 3 – Risk management 23


137. The applicant proposed that the duration of the field trial would be confined to two growing seasons. The trial would be limited to a single site with a maximum area of 3 ha per season. The small size and duration of the trial would limit the potential exposure of humans and other organisms to the GMOs (risk scenario 1).

138. There are currently two other DIR licences at the PBC: DIR 122 (GM wheat) and DIR 103 (GM canola). At the time of release, DIR 122 will be in the post-trial monitoring phase with licence conditions that ensure volunteer wheat plants are destroyed prior to flowering. Moreover, the planting area and associated zones with the exception of the isolation zone of the proposed field trial will not overlap with those of DIR 122. This effectively excludes any conflict of management issues between the trials as the isolation zone is only required while the crop is growing, not during post-harvest monitoring. As the planting area and associated zones of DIR 122 will be routinely monitored for volunteer wheat plants and any volunteers destroyed prior to flowering, pollen transfer between GM plants of the two trials is highly unlikely.

139. DIR 103 licences GM canola and the associated licence conditions are not expected to impact on the DIR 142 proposed licence planting area, buffer and monitoring zones for the year 2016. The planting area for the 2017 growing season for DIR 142 is proposed to be conducted within the area covered by DIR 103 post-harvest monitoring. However, the applicant expects to complete all their monitoring obligations of the site covered under licence DIR 103. No planting will occur under the DIR 142 proposed trial until all the monitoring obligations for the site under the DIR 103 licence have been completed.

140. The applicant proposed that the fenced site will have lockable gates. The applicant also proposed that only authorised personnel would be permitted to deal with the GMOs. A standard licence condition requires all people dealing with the GMOs to be informed of relevant licence conditions. These measures limit the potential exposure of humans to the GMOs (risk scenario 1). Since restricting the dealings to only authorised personnel is considered appropriate for limiting exposure of humans to the GMOs, it is not considered necessary to have the gates locked and hence is not a licence condition.

141. The trial site is located within the DEDJTR research station which is surrounded by a livestock- and rabbit-proof fence. This will minimise the potential exposure of desirable animals to the GMOs (risk scenario 1) and the potential for dispersal of the GMOs by large animals or rabbits (risk scenario 2).

142. The applicant proposed to monitor for the presence of rodents by placing rodent baits surrounding the planting area and buffer zone, and to control rodents if present. Combined with the use of a monitoring zone (below), this measure should minimise potential dispersal of GMOs outside the trial site by rodents (risk scenario 2). A licence condition requires that for the period while GMOs are being grown, and until a trial site has been cleaned, measures must be implemented to control rodents within the site.

143. Birds are known to cause damage to cereal crops mostly during germination in autumn, but may feed on the crop at different times including during grain ripening (Temby & Marshall 2003). An extensive search of the literature did not identify any reports of birds other than emus transporting and dispersing wheat seed (e.g. through the digestive tract or taking panicles containing viable seed) or seedlings from wheat crops. The white wheat varieties have a thin seed coat (Hansen 1994) and are readily digested by birds (Yasar 2003). Therefore, it is considered appropriate that no measures are needed to prohibit the access of birds to the trial site.

144. The applicant proposed to surround the trial site with a 2 m buffer zone and a 10 m monitoring zone. It has been a requirement of GM wheat licences that the monitoring zone is maintained in a manner that does not attract or harbour rodents, such as keeping the area either free of vegetation or planted with vegetation mown to a height of less than 10 cm. This would serve the following purposes:



to reduce rodent activity (risk scenario 2)

to facilitate detection of GM plant material that has been dispersed during sowing or harvesting (risk scenario 2)

to facilitate detection of wheat or related species that might hybridise with GM wheat (risk scenario 3).

145. The applicant proposed that the monitoring zone would be surrounded with a 190 m isolation zone where no sexually compatible species will be grown. In addition, a licence condition would require that the planting area, buffer zone, monitoring zone and isolation zone be inspected for presence of related (sexually compatible) species while the GMOs are flowering, and any volunteers or related species found must be destroyed prior to flowering.

146. The potential for pollen movement and gene flow between GM wheat and other sexually compatible species has been addressed at some length in previous RARMPs, the latest being DIR 112 . On the basis of the evidence detailed there, including scientific literature on gene flow, international containment measures for GM wheat trials, and the rules for producing basic and certified seed, an isolation distance of 200 m is considered adequate to minimise gene flow from the GM wheat plants to other wheat plants or other sexually compatible species outside the release site. Therefore, the combination of a 10 m monitoring zone, surrounded by a 190 m isolation zone, will manage gene flow to other wheat crops and related species (risk scenario 3).

147. The applicant proposed to locate the trial at least 2 km away from the nearest natural waterway, which would reduce the likelihood of plant material being washed away from the site (risk scenario 2). It has been a DIR licence condition that trial sites be located at least 50 m from waterways to limit the dispersal of viable GM plant material in the event of flooding. A licence condition requires immediate notification of any extreme weather condition affecting the site during the release to allow assessment and management of any risks.

148. The applicant proposed a number of measures to minimise the persistence of any GM wheat plants and seeds in the seed bank at the release site after harvest of the trial (risk scenario 2). These measures are light tillage and irrigation to promote germination of remaining seed, and monitoring of the trial on a monthly basis for two years. Volunteer plants that emerge will be destroyed before flowering.

149. There is a difference in germination rates between buried grain and grain lying on the surface; grains remaining near the surface, e.g. following shallow tillage after harvest, can generally easily germinate and become established (Ogg & Parker 2000). Shallow tillage after harvest, combined with irrigation, will germinate much of the seed lying on the surface (Ogg & Parker 2000). However, deep cultivation in certain soil types can reduce seed viability but can also encourage prolonged dormancy in seeds as a result of a cool, moist low oxygen environment (Ogg & Parker 2000; Pickett 1989).

150. It is therefore considered appropriate by the Regulator that under Australian conditions, a post-harvest monitoring period of at least two years, with monthly inspections, and with no volunteers detected for a minimum of 6 months prior to the end of the time period, would effectively manage survival and persistence of viable wheat seeds in the soil. The area should receive at least 3 irrigations, at intervals of at least 28 days, with the last required irrigation occurring at a time that would promote germination of volunteers within the final volunteer-free period. A period of natural rainfall may be taken as irrigation only with the agreement of the Regulator. Evidence (such as rainfall measurements, photos etc.) that the rainfall has been sufficient to promote germination needs to be provided. Additionally, prior to the last irrigation the area should be tilled to a depth no greater than the depth of sowing. These treatments will ensure seeds are exposed to sufficient moisture and placed at an appropriate depth for germination, as well as encouraging the microbial decomposition of any residual seed. These measures will minimise the persistence of the GMOs in the environment and are included as licence conditions.




151. In considering potential for spread and persistence of the GMOs, it is important to consider the potential dispersal of grain during sowing and harvesting (mechanical dispersal). This is most likely to result in dispersal of grain into the area immediately around the trial. The licence requires that a 2 m buffer zone and any other areas where GM material has been dispersed, including during harvest or threshing, must be monitored to manage the possibility of mechanical dispersal of seed from the trial location and its persistence after the trial. The licence also requires that harvest of GM wheat be conducted separately from other crops. The applicant also proposed that all equipment used in connection with cultivating and harvesting the GMOs, such as harvesters, seeders, storage equipment, irrigation piping etc., would be cleaned on site, which would minimise human-mediated dispersal of GM plant material (risk scenario 2).

152. The applicant proposed to destroy any GMOs not required for experimentation or future planting. Any plant material taken off-site for experimental analysis or future planting will be transported and stored 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 scenario 1), dispersal into the environment and gene flow/transfer (risk scenarios 2 and 3).

153. The applicant did not propose using any of the plant material for human or animal consumption. FSANZ conducts mandatory premarket assessments of GM products in human foods. As the GM wheat has not been assessed by FSANZ, a condition in the licence prohibits material from the trial from being used for human food or animal feed. This control will limit exposure of humans and other organisms to the GMOs (risk scenario 1).3.1.2 Summary of licence conditions to be implemented to limit and control the release

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

limit the release to the PBC facility in Horsham, Victoria between May 2016 and May 2018

limit the maximum area of planting to 3 ha per growing season

surround the area where GMOs are grown with a 2 m buffer zone

surround the trial site with a 10 m monitoring zone, maintained in a manner that does not attract or harbour rodents, and in which related species must be prevented from flowering

surround the monitoring zone with a 190 m isolation zone, in which no other crops of wheat may be grown, and where growth of related species are controlled

implement measures to control rodents within the planting area

harvest the GM wheat plant material separately from other crops

clean equipment after use

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

monitor for at least 24 months after harvest, and destroy any wheat 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

transport and store GM material in accordance with the Regulator’s guidelines

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



3.2 Other risk management considerations155. 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 requirements and

access for the purpose of monitoring for compliance.3.2.1 Applicant suitability

156. 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, for either an individual applicant or a body corporate, include:

any relevant convictions of the applicant

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 and

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

157. On the basis of information submitted by the applicant and records held by the OGTR, the Regulator considers DEDJTR suitable to hold a licence. The licence includes a requirement for the licence holder to inform the Regulator of any information that would affect their suitability.

158. 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

159. DEDJTR is required to submit a contingency plan to the Regulator before planting the GMOs. This plan would detail measures to be undertaken in the event of any unintended presence of the GM wheat outside permitted areas.

160. DEDJTR is also required to provide the Regulator with a method to reliably detect the GMOs or the presence of the genetic modifications in a recipient organism. This methodology is required before planting the GMOs.3.2.3 Identification of the persons or classes of persons covered by the licence

161. 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, DEDJTR is required to provide a list of people and organisations that will be covered by the licence, or the function or position where names are not known at the time.3.2.4 Reporting requirements

162. The licence requires 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 and

any unintended effects of the trial.



163. A number of written notices are also required under the licence to assist the Regulator in designing and implementing a monitoring program for all licensed dealings. The notices 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, and

details of inspection activities.3.2.5 Monitoring for compliance

164. 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.

165. 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.

166. 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 releases167. Additional information has been identified that may be required to assess an application for a commercial release of these GM wheat lines, or to justify a reduction in limits and controls. This includes:

additional molecular and biochemical characterisation of the GM wheat plants, particularly with respect to potential for increased toxicity and allergenicity;

additional phenotypic characterisation of the GM wheat plants, particularly with respect to traits which may contribute to weediness.

Section 5 Conclusions of the consultation RARMP168. The RARMP concludes that the proposed limited and controlled release of GM wheat poses negligible risks to the health and safety of people or the environment as a result of gene technology, and that these negligible risks do not require specific risk treatment measures.

169. However, 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‡‡

Advice received by the Regulator from prescribed experts, agencies and authorities on the consultation RARMP is summarised 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 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.

Sub.No: Summary of issues raised Comment

1 No issues were raised in response to the RARMP circulated to the agencies within the NSW Government.

Noted.

2 Suggested consistent use of the wording around rodent control measures by referring to detection and control of rodents rather than just control.

The wording differences in the RARMP relate to the differences between what the rodent control measures proposed by the applicant and those imposed in the licence. The applicant proposed to implement rodent control measures if rodents are detected. The licence imposes mandatory rodent control as a preventative measure, as once rodents are detected, seed dispersal may have occurred. Licence holders are also required to keep records of the control measures taken and any rodent activity.

Suggested inclusion of more information on the expression of proteins by the root preferential promoter in tissues other than roots. Noted that the conclusions of the RARMP for this limited and controlled release remain valid.

Added wording regarding the uncertainty on the expression profile driven by the root-preferential promoter.

3 Agrees with the conclusion of the RARMP, that the risk of this release to the environment is negligible and agrees that limits and controls are appropriately addressed.

Noted.

Observes that there is no evidence that genetic variation due to conventional breeding for NUE or WUE has generated a variety of wheat that has had an adverse environmental effect beyond those normally associated with the cultivation of this species. Suggests this point is mentioned in the RARMP.

A sentence has been added in Chapter 2.1 to emphasise lack of adverse environmental effect due to conventional breeding for varieties with NUE and WUE traits.

Suggests that greater emphasis be made in the RAMP that domesticated varieties of wheat have non-shattering heads which greatly restricts invasiveness.

A sentence has been added in Chapter 2.4.2 to reflect reduced dispersal characteristics as a result of selective breeding favouring non-shattering heads.

‡‡ Prescribed agencies include the Gene Technology Technical Advisory Committee, State and Territory Governments, relevant local governments, Australian Government agencies and the Minister for the Environment.

References 34


Appendix B Summary of submissions from the public

The Regulator received two submissions from the public on the consultation RARMP. The issues raised in these submissions are summarised in the table below. All issues raised in the 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.

Abbreviations:

Issues raised: E: Environment, H: Health, T: trade

Other abbreviations: GMO: genetically modified organism, LC: Licence conditions, RARMP: Risk Assessment and Risk Management Plan, Regulator: Gene Technology Regulator.Submission

numberIssue Summary of issues raised Comment

1 E Supports the need to fast-track development of drought tolerant wheat in the context of the drying agricultural climate of WA and not slow down with an administrative burden.

Noted.

T Emphasises the need to free up innovative plant breeding techniques for the sake of agricultural viability and profitability and meet level playing field globally.

Noted. Marketing and trade issues are outside the scope of assessments conducted by the Regulator. These issues are the responsibility of States and industry.

2 T ‘100% against this’. Cites ban of GMOs in Europe.

Marketing and trade issues are outside the scope of assessments conducted by the Regulator. These issues are the responsibility of States and industry.

H, E Cites GMO outbreak in Brazil. There have no credible reports of any GMO “outbreak” in Brazil. The RARMP concluded that this field trial poses negligible risks to the health and safety of people and the environment. Licence conditions have been imposed to restrict the spread and persistence of the GMOs and their genetic material in the environment.

References 35

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