Risk Assessment and
Risk Management Plan for
DIR 128
Limited and controlled release of wheat and barley genetically modified for abiotic stress tolerance or micronutrient uptake
Applicant: The University of Adelaide
August2014
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DIR 128 – Risk Assessment and Risk Management PlanOffice of the Gene Technology Regulator
Summary of the Risk Assessment and Risk Management Plan
for
Licence Application DIR 128
Decision
The Gene Technology Regulator (the Regulator) has decided to issue a licence for this application for a limited and controlled release of a genetically modified organism (GMO) into the environment. A Risk Assessment and Risk Management Plan (RARMP) for this application was prepared by the Regulator in accordance with requirements of the Gene Technology Act 2000 (the Act) and corresponding state and territory legislation, and finalised following consultation with a wide range of experts, agencies and authorities, and the public. The RARMP concludes that this field trial poses negligible risks to human health and safety and the environment and that any risks posed by the dealings can be managed by imposing conditions on the release.
The application
Application number / DIR 128Applicant: / The University of Adelaide
Project Title: / Limited and controlled release of wheat and barley modified for abiotic stress tolerance or micronutrient uptake
Parent organisms: / Bread wheat (TriticumaestivumL.) and barley (Hordeum vulgare L.)
Introduced genes and modified traits: /
- Thirty-three genes that are involved in salt tolerance, aluminium tolerance, drought tolerance (water use efficiency), nitrogen use efficiency, or micronutrient uptake.[†]
- Two selectable marker genes from bacteria
Proposed release dates: / August 2014 – December 2019
Proposed locations: / Five sites, two in South Australia and three in Western Australia
Proposed release size: / Total of 2.5 hectaresper season
Primary purpose: / To assess whether the introduction and expression of the specified group of genes in plants affects yield potential under field conditions
Risk assessment
The risk assessment concludes that risks to the health and safety of people, or the environment, from the proposed release are negligible.
The risk assessment process considers how the genetic modification and activities conducted with the GMOs might lead to harm to people or the environment. Risks are characterised in relation to both the seriousness and likelihood of harm, taking into account information in the application (including proposed limits and controls), relevant previous approvals, current scientific/technical knowledge, and advice received from a wide range of experts, agencies and authorities consulted on the RARMP. Both the short and long term potential harms are considered.
Credible pathways to potential harm that were considered included: unintended exposure to the GM plant material; increased spread and persistence of the GM wheat and barleyrelative to unmodified plants; and transfer of the introduced genetic material to non GM wheat or barley,or other sexually compatible plants. Potential harms associated with these pathways included toxicity to people and other animals, allergic reactions in people and environmental harms associated with weediness.
The principal reasons for the conclusion of negligible risks are that the introduced genetic modifications are unlikely to cause harm to human health or safety or to the environment,the introduced genes are similar to those already existing in the environment, and furthermore,the proposed limits and controls effectively contain the GMOs and their genetic material and minimise exposure.
Risk management plan
The risk management plan concludes that risks posed by the proposed dealings can be managed so as to protect people and the environment by imposing conditions on the release.
Risk management is used to protect the health and safety of people and to protect the environment by controlling or mitigating risk. The risk management plan evaluates and treats identified risks, evaluates controls and limits proposed by the applicant, and considers general risk management measures. The risk management plan is given effect through licence conditions.
As the level of risk is assessed as negligible, specific risk treatment is not required. However, as this is a limited and controlled release, the licence includes limits on the size, locations and duration of the release, as well as controls including containment provisions at the trial site; prohibiting the use of GM plant materials in human food or animal feed; destroying GM plant materials not required for further studies; transporting GM plant materials in accordance with the Regulator’s guidelines; and conducting post-harvest monitoring at the trial sites to ensure all GMOs are destroyed.
Summary 1
DIR 128 – Risk Assessment and Risk Management PlanOffice of the Gene Technology Regulator
Table of Contents
Summary of the Risk Assessment and Risk Management Plan
Decision
The application
Risk assessment
Risk management plan
Table of Contents
Abbreviations
Chapter1Risk assessment context
Section1Background
Section2Regulatory framework
Section3The proposed dealings
3.1The proposed limits of the dealings (size, locations, duration and people)
3.2The proposed controls to restrict the spread and persistence of the GMOs and their genetic material in the environment
Section4The parent organisms
Section5The GMOs, nature and effect of the genetic modification
5.1Introduction to the GMOs
5.2The introduced genes, encoded proteins and their associated effects
5.3Toxicity/allergenicity associated with the introduced genes, their encoded proteins and associated products
5.4Characterisation of the GMOs
Section6The receiving environment
6.1Relevant abiotic factors
6.2Relevant agricultural practices
6.3Presence of related plants in the receiving environment
6.4Presence of similar genes and encoded proteins in the environment
Section7Relevant Australian and international approvals
7.1Australian approvals
7.2International approvals of GM wheat and barley
Chapter2Risk assessment
Section1Introduction
Section2Risk Identification
2.1Risk source
2.2Causal pathway
2.3Potential harm
2.4Postulated risk scenarios
Section3Uncertainty
Section4Risk evaluation
Chapter3Risk management
Section1Background
Section2Risk treatment measures for identified risks
Section3General risk management
3.1Licence conditions to limit and control the release
3.2Other risk management considerations
Section4Issues to be addressed for future releases
Section5Conclusions of the RARMP
References
Appendix ASummary of submissions from prescribed experts, agencies and authorities
Appendix BSummary of submissions from the public
Table of Contents1
DIR 128 – Risk Assessment and Risk Management PlanOffice of the Gene Technology Regulator
Abbreviations
APVMA / Australian Pesticides and Veterinary Medicines AuthorityCaMV / Cauliflower mosaic virus
CCI / Confidential Commercial Information as declared under section 185 of the Gene Technology Act 2000
DAFWA / Department of Agriculture and Food, Western Australia
DIR / Dealings involving Intentional Release
FSANZ / Food Standards Australia New Zealand
GM / Genetically modified
GMO / Genetically modified organism
ha / Hectare
hph / Hygromycinphosphotransferase
LGA / Local government area
m / Metres
NGNE / New Genes for New Environments
NLRD / Notifiable low risk dealings
nptII / neomycin phosphotransferase II
OGTR / Office of the Gene Technology Regulator
PC2 / Physical Containment level 2
PR / Pathogenesis-related
RARMP / Risk Assessment and Risk Management Plan
Regulations / Gene Technology Regulations 2001
Regulator / Gene Technology Regulator
TGA / Therapeutic Goods Administration
the Act / The Gene Technology Act 2000
Abbreviations 1
DIR 128 – Risk Assessment and Risk Management PlanOffice of the Gene Technology Regulator
Chapter1Risk assessment context
Section1Background
1.An application has been made under the Gene Technology Act 2000 (the Act) for Dealings involving the Intentional Release (DIR) of genetically modified organisms (GMOs) into the Australian environment.
2.The Act in conjunction with the Gene Technology Regulations 2001 (the Regulations), an inter-governmental agreement and corresponding legislation that is being enacted in each State and Territory, comprise Australia’s national regulatory system for gene technology. Its objective is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs).
3.This chapter describes the parameters within which potential risks to the health and safety of people or the environment posed by the proposed release are assessed. The risk assessment context is established within the regulatory framework and considers application-specific parameters (Figure 1).
Figure 1 Summary of parameters used to establish the risk assessment context
Section2Regulatory framework
4.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 with, in 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.In accordance with section 50A of the Gene Technology Act 2000 (the Act), this application is considered to be a limited and controlled release application, as its principal purpose is to enable the applicant to conduct experiments and the applicant has proposed limits on the size, location and duration of the release, as well as controls to restrict the spread and persistence of the GMOs and their genetic material in the environment. Therefore, the Gene Technology Regulator (the Regulator) was not required to consult with prescribed experts, agencies and authorities before preparation of the Risk Assessment and Risk Management Plan (RARMP; see section 50 of the Act).
5.Section 52 of the Act requires the Regulator to seek comment on the RARMP from the States and Territories, the Gene Technology Technical Advisory Committee, Commonwealth authorities or agencies prescribed in the Regulations, the Minister for the Environment, relevant local council(s), and the public. The advice from the prescribed experts, agencies and authorities and how it was taken into account is summarised in Appendix A. Thirteen public submissions were received and their considerations are summarised in Appendix B.
6.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.
7.Any dealings conducted under a licence issued by the Regulator may also be subject to regulation by other Australian government agencies that regulate GMOs or GM products, including Food Standards Australia New Zealand (FSANZ), Australian Pesticides and Veterinary Medicines Authority (APVMA), Therapeutic Goods Administration (TGA), National Industrial Chemicals Notification and Assessment Scheme and Department of Agriculture. These dealings may also be subject to the operation of State legislation declaring areas to be GM, GM free, or both, for marketing purposes.
Section3The proposed dealings
8.The University of Adelaide proposes to release up to 1262 lines[‡] of genetically modified (GM) wheat and barley into the environment under limited and controlled conditions.
9.The purpose of the trial is to evaluate the candidate genes for yield potential under field conditions. In addition, the release will allow the applicant to produce sufficient grain for subsequent replicated trials.
10.The dealings involved in the proposed intentional release include:
- conducting experiments with the GMOs
- breeding the GMOs
- propagating the GMOs
- growing or culturing the GMOs
- transporting the GMOs
- disposing of the GMOs
and the possession, supply or use of the GMOs for the purposes of, or in the course of, any of the above.These dealings are detailed further below.
3.1The proposed limits of the dealings (size, locations, duration and people)
11.The applicant proposes to grow GM wheat and barley plants between June 2014 and December 2019.
12.The GMOs are proposed to be planted at five sites, two of which are in South Australia and three in Western Australia. The South Australian sites are located in the LGAs of Marion and Wakefield, and the Western Australian sites in the LGAs of Corrigin, Merredin, and Katanning. The latter two sites represent the New Genes for New Environment (NGNE) facilities operated by the Department of Agriculture and Food, Western Australia (DAFWA).
13.The collective area of the trial (over 5 sites) would be up to 2.5 hectares (ha) per growing season.
14.The applicant proposes that only trained and authorised staff would be permitted to deal with the GM wheat and barley. Any other visitors to the sites would be accompanied by an authorised University of Adelaide representative and would not deal with the GMOs.
3.2The proposed controls to restrict the spread and persistence of the GMOs and their genetic material in the environment
15.The applicant has proposed a number of controls to restrict the spread and persistence of the GM wheat and barley linesand the introduced genetic material in the environment, including:
- locating the trial sites at least 200 m from other wheat and barley plants, unless such plants represent those (GM or non-GM) planted at another location as part of this trial or those approved for trial at the site under a separate DIR licence
- surrounding each trial site with a fence, and controlling plant growth in a 10 m wide zone outside the fence by mowing, herbicide treatment and/or weeding
- surrounding each location (in the fenced trial site) by a 2 m wide buffer where plant growth will be controlled by mowing, herbicide treatment and/or weeding
- monitoring each location for volunteers, beginning two weeks prior to the expected start of flowering and continuing on a fortnightly basis until flowering has finished
- during flowering, inspecting a 190 m wide zone surrounding the 10 m wide zone for wheat and barley (but see next point)
- if there has been no cultivation or detection of wheat and barley in the 190 m wide zone in the previous two years, reducing inspection of that area to the 50 m wide area directly surrounding the 10 m wide zone
- after harvest, monitoring locations for volunteers and related species at least once every 35 days for a period of two years; during this time period at least three irrigations will be performed to encourage germination of volunteers
- destroying volunteers and related species
- cleaning equipment used in harvesting, and threshing on site or transporting the heads to approved facilities for analysis or processing
- storing seed remaining from analysis in an approved facility or destroying the seed by autoclaving or any other method approved by the Regulator
- destroying waste material derived from harvest, and any stubble, by ploughing back into the soil, burning or burial
- transporting and storing GM material in accordance with the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs (2011)
- restricting access to trial sites to authorised staff
- not allowing GM plant material or products to be used for human food or animal feed.
16.Figure 2shows the proposed site layout including some of these controls. These controls, and the limits outlined above, have been taken into account in establishing the risk assessment context (this Chapter), and their suitability for containing the proposed release is evaluated inChapter3, Section 3.1.1.
Figure 2Proposed trial layout, including some of the controls (not drawn to scale)
Section4The parent organisms
17.The parent organisms are bread wheat (Triticumaestivum L.) and barley (Hordeumvulgare L.), both 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. Barley is cultivated in these same areas, although a small amount is also grown in Tasmania.
18.The wheat cultivars used to generate the GM wheat lines are Bobwhite and Gladius, but some genes have been backcrossed into the commercial cultivars EGA Bonnie Rock, EGA-Burke, IGW-2971, Magenta, Frame and Drysdale. GM barley lines were generated in Golden Promise and WI4330, but some genes were backcrossed into the commercial cultivars Flagship, Gairdner, Commander.
19.Detailed information about the parent organisms are contained in the reference documents The Biology of TriticumaestivumL. emThell (bread wheat)(OGTR 2008b) and The Biology ofHordeumvulgareL. (barley)(OGTR 2008a), which were produced to inform the risk assessment process for licence applications involving GM wheat and barley plants. These documents are available from the OGTR website.
Section5The GMOs, nature and effect of the genetic modification
5.1Introduction to the GMOs
20.The applicant proposes to release up to 1262 lines of GM wheat and barley. The lines were produced using either Agrobacterium tumefaciens orbiolistics mediated plant transformation. Information about these transformation methods can be found in the risk assessment reference document Methods of plant genetic modification available from the Risk Assessment References page on the OGTR website.
21.Each GM wheat and barley line has been transformed with a single gene from 33 genes of interest. On the basis of the trait that they are expected to induce, the genes can be divided into five groups: (i) drought tolerance; (ii) salt tolerance; (iii) aluminium tolerance; (iv) nitrogen use efficiency; and (v) micronutrient uptake. The GMOs also contain selectable marker genes, these being the neomycin phosphotransferase II (nptII) gene and/or thehygromycinphosphotransferase (hptII) gene, both originating from E.coli.
22.A summary of these groups is presented in Table 1, with details provided in the following sections.
Table 1 Summary of GM wheat and barley lines proposed for release.
GMO class / Gene of interest# / Plant transformed / Approx no. of linesDrought tolerance
1 / SIGNALLING PROTEIN 2 / T. aestivum / 18
2 / TRANSCRIPTION FACTOR 1 / T. aestivum / 72
3 / TRANSCRIPTION FACTOR 3 / T. aestivum / 54
4 / TRANSCRIPTION FACTOR 4 / T. aestivum / 54
5 / TRANSCRIPTION FACTOR 5 / T. aestivum / 54
6 / TRANSCRIPTION FACTOR 6 / T. aestivum / 54
H. vulgare / 36
7 / TRANSCRIPTION FACTOR 7 / T. aestivum / 90
8 / PHOTOSYNTHESIS AND METABOLISM GENE 3 / T. aestivum / 18
9 / PHOTOSYNTHESIS AND METABOLISM GENE 4 / T. aestivum / 18
10 / PHOTOSYNTHESIS AND METABOLISM GENE 5 / T. aestivum / 18
11 / CELL SPECIFICATION, PROLIFERATION AND DIVISION GENE 2 / T. aestivum / 36
12 / CELL SPECIFICATION, PROLIFERATION AND DIVISION GENE 3 / T. aestivum / 36
13 / RNA METABOLISM PROCESSING GENE 1 / H. vulgare / 6
14 / RNA METABOLISM PROCESSING GENE 2 / H. vulgare / 6
15 / RNA METABOLISM PROCESSING GENE 3 / T. aestivum / 72
H. vulgare / 72
16 / RNA METABOLISM PROCESSING GENE 4 / T. aestivum / 72
H. vulgare / 72
Salt tolerance
17 / ScNHA1 (Saccharomyces cerevisiae) / H. vulgare / 40
T. aestivum / 20
18 / PpENA1(Physcomitrella patens) / H. vulgare / 40
T. aestivum / 20
19 / AtAVP (A. thaliana) / H. vulgare / 10
T. aestivum / 5
20 / AtCIPK16 (A. thaliana) / T. aestivum / 20
H. vulgare / 20
Aluminium tolerance
21 / TaALMT1(T. aestivum) / T. aestivum / 14
H. vulgare / 12
22 / TaALMT1_minus_insert(T. aestivum) / H. vulgare / 9
23 / ION TRANSPORTER 5 / T. aestivum / 9
H. vulgare / 9
24 / ION TRANSPORTER 6 / T. aestivum / 9
H. vulgare / 9
25 / ION TRANSPORTER 7C / T. aestivum / 9
H. vulgare / 9
26 / ScALMT1.M39.1_wt(Secalecereale) / T. aestivum / 8
H. vulgare / 6
27 / ScALMT1.M39.1_plus insert(Secalecereale) / H. vulgare / 6
28 / HvAACT1(H. vulgare) / T. aestivum / 2
H. vulgare / 4
Nitrogen use efficiency
29 / TRANSCRIPTION FACTOR 2 / T. aestivum / 20
30 / TRANSCRIPTION FACTOR 8 / T. aestivum / 12
31 / Aminotransferase / T. aestivum / 32
H. vulgare / 32
32 / CELL SPECIFICATION, PROLIFERATION AND DIVISION GENE 1 / T. aestivum / 12
Micronutrient uptake
33 / OsNAS2 (Oryzasativa) / T. aestivum / 6
# The identities of some of these genes have been declaredas CCI. The applicant has assigned an identifier to these genes.