Risk Assessment and
Risk Management Plan for
DIR 131
Limited and controlled release of safflower genetically
modified for high oleic acid composition
Applicant: Commonwealth Scientific and Industrial
Research Organisation
February 2015
PAGE INTENTIONALLY LEFT BLANK
DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Office of the Gene Technology Regulator
Summary of the Risk Assessment and Risk
Management Plan
for
Licence Application No. DIR 131
Introduction
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 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 application
Application number
DIR 131
Applicant
CSIRO
Project title
Limited and controlled release of safflower genetically modified for high
oleic acid composition
Parent organism
Safflower (Carthamus tinctorius L.)
Three gene fragments involved in altered fatty acid composition

fragment of FATB (palmitoyl-ACP thioesterase) gene from safflower

fragment of FAD2 ( Δ12 desaturase) gene from safflower

fragment of another fatty acid biosynthesis gene1 from safflower
Two selectable marker genes from bacteria

hph (hygromycin phosphotransferase, truncated) from Escherichia
coli (antibiotic resistance selectable marker)

gfp (green fluorescent protein) from Aequorea victoria (visual
marker)
Introduced genes and
modified traits
Proposed locations
602 sites in Queensland, Victoria, Australian Capital Territory, New South
Wales and Western Australia
Proposed release size
Total planting area of up to 850 hectares over 4 growing seasons:

in 2015 – up to 10 sites of 5 ha each

in 2016 & 2017 – up to 15 sites of 10 ha each per year

in 2018 – up to 20 sites of 25 ha each
Proposed release dates
January 2015 – August 2019
1
The identity of this gene has been declared as Confidential Commercial Information (CCI) under section 185 of
the Act.
2
Total number of sites clarified during consultation.
Summary
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DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Primary purpose
Office of the Gene Technology Regulator
To evaluate the oil content and agronomic performance of GM safflower
under field conditions in various regions around Australia.
To provide enough extracted oil for product development and testing in
industrial processes.
Risk assessment
The 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 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 impact are considered.
Credible pathways to potential harm that were considered included: unintended exposure to the
GM plant material; unintended effects of the genetic modification; increased spread and
persistence of the GM safflower relative to unmodified plants; and transfer of the introduced
genetic material to non-GM safflower 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 proposed limits and
controls effectively contain the GMOs and their genetic material and minimise exposure; the
introduced genetic modifications are unlikely to cause harm to people or the environment; and
genes similar to most of the introduced genes are common in the environment.
Risk management plan
The 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, 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 site to ensure all
GMOs are destroyed.
Summary
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DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Office of the Gene Technology Regulator
Table of Contents
SUMMARY OF THE RISK ASSESSMENT AND RISK MANAGEMENT PLAN ........................................... I
INTRODUCTION ...................................................................................................................................................... I
THE APPLICATION .................................................................................................................................................. I
RISK ASSESSMENT .............................................................................................................................................. II
RISK MANAGEMENT PLAN ................................................................................................................................... II
TABLE OF CONTENTS ....................................................................................................................................... III
ABBREVIATIONS ................................................................................................................................................. IV
CHAPTER 1 RISK ASSESSMENT CONTEXT ................................................................................................. 1
SECTION 1
SECTION 2
SECTION 3
3.1
3.2
SECTION 4
SECTION 5
5.1
5.2
5.3
5.4
SECTION 6
6.1
6.2
6.3
6.4
SECTION 7
7.1
7.2
BACKGROUND................................................................................................................................ 1
REGULATORY FRAMEWORK .......................................................................................................... 1
THE PROPOSED DEALINGS ............................................................................................................ 2
The proposed limits of the dealings (size, locations, duration and people) .............. 2
The proposed controls to restrict the spread and persistence of the GMOs and
their genetic material in the environment ........................................................................... 4
THE PARENT ORGANISM ................................................................................................................ 5
THE GMOS, NATURE AND EFFECT OF THE GENETIC MODIFICATION ............................................ 6
Introduction to the GMOs ........................................................................................................ 6
The introduced genes, encoded proteins and their associated effects ...................... 7
Toxicity/allergenicity associated with the introduced safflower genes ...................... 8
Characterisation of the GMOs................................................................................................ 8
THE RECEIVING ENVIRONMENT ...................................................................................................... 8
Relevant abiotic factors ........................................................................................................... 9
Relevant agricultural practices .............................................................................................. 9
Presence of related plants in the receiving environment ............................................... 9
Presence of similar genes and encoded proteins in the environment ...................... 10
RELEVANT AUSTRALIAN AND INTERNATIONAL APPROVALS ...................................................... 10
Australian approvals .............................................................................................................. 10
International approvals .......................................................................................................... 10
CHAPTER 2 RISK ASSESSMENT ................................................................................................................... 11
SECTION 1
SECTION 2
2.1
2.2
2.3
2.4
SECTION 3
SECTION 4
INTRODUCTION ............................................................................................................................. 11
RISK IDENTIFICATION ................................................................................................................... 12
Risk source ............................................................................................................................... 12
Causal pathway........................................................................................................................ 13
Potential harm .......................................................................................................................... 14
Postulated risk scenarios...................................................................................................... 14
UNCERTAINTY .............................................................................................................................. 23
RISK EVALUATION ....................................................................................................................... 24
CHAPTER 3 RISK MANAGEMENT PLAN ..................................................................................................... 26
SECTION 1
SECTION 2
SECTION 3
3.1
3.2
SECTION 4
SECTION 5
BACKGROUND.............................................................................................................................. 26
RISK TREATMENT MEASURES FOR IDENTIFIED RISKS ................................................................. 26
GENERAL RISK MANAGEMENT ..................................................................................................... 26
Licence conditions to limit and control the release ....................................................... 26
Other risk management considerations ............................................................................ 31
ISSUES TO BE ADDRESSED FOR FUTURE RELEASES ................................................................... 32
CONCLUSIONS OF THE RARMP ................................................................................................. 32
REFERENCES ...................................................................................................................................................... 33
APPENDIX A SUMMARY OF SUBMISSIONS FROM PRESCRIBED EXPERTS, AGENCIES AND
AUTHORITIES .............................................................................................................................. 38
APPENDIX B SUMMARY OF SUBMISSIONS FROM THE PUBLIC ........................................................... 41
Table of Contents
III
DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Office of the Gene Technology Regulator
Abbreviations
APVMA
ARA
CaMV
CCI
cm
CSIRO
DIR
DNA
FAD2
FATB
FSANZ
gfp
GM
GMO
GRDC
ha
HGT
hph
LA
LCPUFA
m
miRNA
mRNA
NSW
OECD
OGTR
OA
RARMP
Regulations
Regulator
RNA
RNAi
siRNA
the Act
Abbreviations
Australian Pesticides and Veterinary Medicines Authority
Arachidonic acid
Cauliflower mosaic virus
Confidential Commercial Information as declared under section 185 of the
Gene Technology Act 2000
Centimetres
Commonwealth Scientific and Industrial Research Organisation
Dealings involving Intentional Release
Deoxyribonucleic acid
Δ12 desaturase gene
Palmitoyl ACP thioesterase gene
Food Standards Australia New Zealand
Green fluorescent protein gene
Genetically modified
Genetically modified organism
Grains Research and Development Corporation
Hectare
Horizontal gene transfer
Hygromycin phosphotransferase gene
linoleic acid
Long chain polyunsaturated fatty acids
Metres
microRNA
Messenger RNA
New South Wales
Organisation for Economic Co-operation and Development
Office of the Gene Technology Regulator
Oleic acid
Risk Assessment and Risk Management Plan
Gene Technology Regulations 2001
Gene Technology Regulator
Ribonucleic acid
RNA interference
Small interfering RNA
The Gene Technology Act 2000
IV
DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Chapter 1
Office of the Gene Technology Regulator
Risk assessment context
Section 1 Background
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.
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).
This chapter describes the context 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).
RISK ASSESSMENT CONTEXT
LEGISLATIVE REQUIREMENTS
(including Gene Technology Act and Regulations)
RISK ANALYSIS FRAMEWORK
OGTR OPERATIONAL POLICIES AND GUIDELINES
PROPOSED DEALINGS
Proposed activities involving the GMO
Proposed limits of the release
Proposed control measures
GMO
Introduced genes (genotype)
Novel traits (phenotype)
PREVIOUS RELEASES
Figure 1.
PARENT ORGANISM
Origin and taxonomy
Cultivation and use
Biological characterisation
Ecology
RECEIVING ENVIRONMENT
Environmental conditions
Agronomic practices
Presence of related species
Presence of similar genes
Summary of parameters used to establish the risk assessment context
Section 2 Regulatory framework
Sections 50, 50A and 51 of the Act outline the matters which the Gene Technology
Regulator (the Regulator) must take into account, and the consultation required 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. 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, locations 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
Regulator was not required to consult with prescribed experts, agencies and authorities before
Chapter 1 – Risk assessment context
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DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Office of the Gene Technology Regulator
preparation of the Risk Assessment and Risk Management Plan (RARMP; see section 50 of the
Act).
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. Three public
submissions were received and their considerations are summarised in Appendix B.
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.
Any dealings conducted under a licence issued by the Regulator may also be subject to
regulation by other Australian government agencies that regulate GMOs or GM products,
including Food Standards Australia New Zealand (FSANZ), Australian Pesticides and
Veterinary Medicines Authority (APVMA), Therapeutic Goods Administration, National
Industrial Chemicals Notification and Assessment Scheme and Department of Agriculture.
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 dealings
The Commonwealth Scientific and Industrial Research Organisation (CSIRO) proposes
to release up to 180 lines3 of genetically modified (GM) safflower into the environment under
limited and controlled conditions.
The purpose of the trial is to evaluate the agronomic performance and oil content of the
GM safflower lines under field conditions in various regions around Australia. Oil generated
from the trial would be used for product development and testing in industrial processes. The
trial would also generate data to be used in future regulatory submissions.
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.
3.1 The proposed limits of the dealings (size, locations, duration and people)
The applicant proposes to grow GM safflower plants over four growing seasons from
January 2015 to August 2019.
The term ‘line’ is used to denote plants derived from a single plant containing a specific genetic modification
resulting from a single transformation event.
3
Chapter 1 – Risk assessment context
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DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Office of the Gene Technology Regulator
In the first year, 2015, up to 10 sites of 5 hectares (ha), in the second and third years
(2016, 2017) up to 15 sites of 10 ha each per year, and in the final year (2018) up to 20 sites of
25 ha each will be grown. The total maximum planting area is 850 ha over the period of the
trial.
The GMOs are proposed to be planted at up to 604 sites across Australia. Sites may be
located in any of 52 local government areas (LGAs) in New South Wales, 36 LGAs in
Victoria, 4 LGAs in Western Australia, 16 LGAs in Queensland and 1 LGA in the Australian
Capital Territory, as listed in Table 1. The exact sites will be determined closer to planting and
their selection will depend on a number of factors including: adequate site distribution across
Australian safflower growing areas; the ability to ensure isolation and containment; and the
ability to segregate from commercial safflower crops.
Table 1. Proposed local government areas in which GM safflower may be released.
New South Wales
Berrigan
Orange
Bland
Parkes
Blayney
Tamworth
Boorowa
Temora
Cabonne
Tumbarumba
Conargo
Tumut
Coolamon
Upper Hunter
Coonamble
Urana
Cootamundra
Wagga Wagga
Corowa
Wakool
Cowra
Walgett
Deniliquin
Warren
Dubbo
Warrumbungle
Forbes
Weddin
Gilgandra
Wellington
Greater Hume
Young
Griffith
Gunnedah
Gundagai
Gwydir
Harden
Hay
Inverell
Jerilderie
Junee
Leeton
Liverpool Plains
Lockhart
Mid-Western
Moree Plains
Murray
Murrumbidgee
Muswellbrook
Narrabri
Narrandera
Narromine
4
Queensland
Burdekin
Central Regional Highlands
Mackay
Maranoa Regional
North Burnett Regional
South Burnett Regional
Toowoomba Regional
Southern Downs Regional
Western Downs Regional
Goondiwindi Regional
Balonne
Moreton Bay
Bundaberg
Cairns
Hinchinbrook
Bowen
Western Australia
Kununurra
Mt Barker
Merredin
Katanning
Australian Capital Territory
Ginninderra
Victoria
Ararat
Ballarat
Benalla
Buloke
Greater Bendigo
Campaspe
Central Goldfields
Colac Otway
Corangamite
Gannawarra
Glenelg
Golden Plains
Greater Geelong
Greater Shepparton
Hepburn
Hindmarsh
Horsham
Indigo
Loddon
Macedon Ranges
Mildura
Mitchell
Moira
Moorabool
Mount Alexander
Moyne
Northern Grampians
Pyrenees
Southern Grampians
Strathbogie
Swan Hill
Wangaratta
West Wimmera
Wodonga
Wyndham
Yarriambiack
During consultation the total number of sites was clarified as 60, not 45 as reported in consultation RARMP
Chapter 1 – Risk assessment context
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Office of the Gene Technology Regulator
The applicant is proposing that only trained and authorised staff would be permitted to
deal with the GM safflower. Any visitors to the site would be accompanied by an authorised
CSIRO representative and would not deal with the GMOs.
3.2 The proposed controls to restrict the spread and persistence of the GMOs
and their genetic material in the environment
The applicant has proposed a number of controls to restrict the spread and persistence of
the GM safflower plants and the introduced genetic material in the environment. These include:

locating the trial sites at least 50 m from natural waterways

ensuring that no other safflower crops are grown within 400 m (Exclusion Zone) of the
trial sites

surrounding each site with a 10 m Monitoring Zone kept free of weeds or related species

surrounding the Monitoring Zone with an Isolation Zone of 190 m, or 50 m if no
safflower or related species are observed during the previous season, within which
safflower plants and related species will be controlled

restricting bird access by bird netting, bird scarers or growing a sacrificial crop attractive
to birds (such as sorghum) as appropriate to local site conditions

monitoring for and controlling rodents at trial sites

harvesting GM safflower separately to other crops or trials

cleaning equipment prior to removal from the site

destroying all plant materials not required for testing or future trials

promoting germination of residual seed by post-harvest tillage and irrigation

post-harvest monitoring of the trial sites for at least two years and destruction of any
volunteer safflower

transporting and storing GM material in accordance with the 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.
Figure 2 shows 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). Their suitability for containing the proposed release is
evaluated in Chapter 3, Section 3.1.1.
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DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
A 190 m Isolation
Zone.
Office of the Gene Technology Regulator
An Inspection Zone
occupies all or part (50 m)
of the Isolation Zone and is
inspected for the presence
of Safflower and Related
Species.
A 10 m Monitoring Zone
which is kept free of
safflower and related
species high.
A 400 m Exclusion
Zone where no other
Safflower crops may
be grown.
Figure 2.
Planting Area
where GM and
non-GM safflower
are planted
Proposed trial layout, including some of the controls (not drawn to scale)
Section 4 The parent organism
The parent organism of the GMOs is safflower (Carthamus tinctorius L.), a member of
the Asteraceae family. Safflower is exotic to Australia and is cultivated as an annual oilseed
crop. It is a branching thistle-like herbaceous plant with spiny leaves (Singh & Nimbkar 2006).
Detailed information about the parent organism is contained in the reference document The
Biology of Carthamus tinctorius L. (safflower)(OGTR 2015), which was produced to inform the
risk assessment process for licence applications involving GM safflower. This document is
available from the OGTR website. Some of the information from this document is summarised
below.
Safflower has been commercially cultivated as a minor crop in Australia since the 1950s.
The growing area of safflower has fluctuated from year to year, with a peak of 75,000 hectares
in 1979, which is less than 0.5% of the total cropping area in Australia. Over the past decade
the average annual safflower planting area has ranged from 6,000-12,000 ha, this being mainly
in New South Wales, Victoria and South Australia (ABARES 2014). It is grown in Australia
for the edible oil and industrial oil markets, but also whole safflower seeds are used for the
birdseed market (GRDC 2010). After oil is extracted from the seeds, the remaining meal can
be used as stockfeed. Cultivars of safflower are divided into two main classes. Linoleic
safflower varieties have oil rich in linoleic acid (70-75%), while oleic safflower varieties have
oil with high levels of oleic acid (70-75%) (Singh & Nimbkar 2006).
The GM safflower lines proposed for release were derived from four elite oleic safflower
selections developed from a commercially available cultivar from Mexico, CIANOL-OL.
CIANOL-OL was developed from the widely used cultivar S317. Neither of these cultivars are
currently grown in Australia.
Safflower is highly adaptable to different regions and safflower production extends from
southern Canada (about 500N) to southern Australia (about 400S). It is generally planted in the
winter or early spring in Australia. Safflower is relatively drought tolerant due to its extensive
tap root system that can access moisture from deep in the soil profile. Safflower does have a
relatively high water requirement but does not tolerate waterlogging, as this encourages
development of the fungal diseases Alternaria carthami and Phytophthora species. Safflower
seedlings at the rosette stage are resistant to cold and frosts as low as -7°C, but during stem
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Office of the Gene Technology Regulator
elongation the growing point and stem can be damaged or killed by frosts below -4⁰C. Mean
daily temperatures above 26⁰C during flowering and maturation reduce yield. Safflower is
fairly slow-growing with a period of 18-31 weeks between sowing and maturity, depending on
cultivar, sowing time and weather conditions (GRDC 2010).
Safflower is either self-pollinated or insect pollinated and its pollen is not transported
appreciably by wind beyond 1 m (Claassen 1950). Many safflower varieties are 85-90% selfpollinating with insects, primarily honey bees, responsible for the remaining 10-15% (USDAAPHIS 2008). Outcrossing rates between safflower plants in close proximity (1-1.5 m) appear
to be highly variable and can range from 0-100% (Claassen 1950) with an average outcrossing
rate of 10% (GRDC 2010). Long distance outcrossing between safflower plants has been
reported in a single experiment to occur at a rate of 0.12% and 0.01% at 50 to 100 m,
respectively (McPherson et al. 2009a).
Safflower reproduces by seeds, which are smooth and fairly large, 6-7 mm, each
weighing approximately 40 mg (GRDC 2010). The seed heads are highly resistant to
shattering. Safflower seeds have very low dormancy and ripe seeds may germinate in the head
following rainfall. The low dormancy rates means that seeds that fall to the ground during
harvest are expected to germinate readily. The little seed dormancy reported in safflower is lost
during storage. Viable safflower seed persistence in the seed bank is less than two years at the
soil surface and less than one year if the seeds are buried in the soil (McPherson et al. 2009b).
Animal predation of safflower is limited due to its spiny nature. Bird predation of safflower
seed occurs, but studies of some bird species (blackbirds, mallard ducks, pheasants & pigeons)
show that seeds that have passed through the digestive systems are no longer viable
(Cummings et al. 2008; GRDC 2010). Industry standards suggest an isolation distance of
400 m for producing basic safflower seed, which is planted to produce certified seed (OECD
2013).
Safflower seed oil and the seed meal are generally not considered to be toxic and have a
long history of safe use. However, anti-nutrient compounds such as lignan glucosides and
tannins and natural toxins such as hydrogen cyanide and oxalates are present in the seed
(Ingale & Shrivastava 2011; Kuehnl et al. 2013). These anti-nutrient compounds and toxins
are present in such low amounts that the safflower meal does not appear to be toxic when fed to
animals. High fibre content of the safflower seed or seed meal is the main factor limiting its use
in livestock feed. Safflower petal extracts have been used in Chinese herbal medicine for
centuries and there are many reports on the beneficial effects of safflower in the treatment of
several conditions (Chengaiah et al. 2010; Zhou et al. 2014). Rare cases of allergic reactions to
safflower dried flowers have been reported (Compes et al. 2006). There are also reports of
adverse effects of flower extracts examined in animal studies indicating potential teratogenicity
(Monfared 2013; Nobakht et al. 2000), cytotoxicity (Mohseni et al. 2011) and nephrotoxicity
(Liu et al. 2004).
Section 5 The GMOs, nature and effect of the genetic modification
5.1 Introduction to the GMOs
The applicant proposes to release up to 180 lines of GM safflower. All lines were
produced by Agrobacterium tumefaciens-mediated plant transformation. Information about this
transformation method 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. Details of the techniques used specifically for transformation of safflower are
described elsewhere (Belide et al. 2011).
There are nine categories of GM safflower proposed for release with each category
having 20 lines. The lines contain introduced gene silencing constructs containing fragments of
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either two or three endogenous safflower fatty acid biosynthesis genes. The categories differ in
the regulatory genetic elements used in the RNAi vectors or constructs. The function of the
silencing constructs is to suppress the expression of the corresponding (target) fatty acid
biosynthesis genes, and thus alter the oil composition of the GM safflower seeds. Specifically,
the content of the fatty acid oleic acid should be increased.
5.2 The introduced genes, encoded proteins and their associated effects
The three safflower genes that are targeted for suppression of expression are
palmitoyl-ACP thioesterase (FATB), Δ12 desaturase (FAD2) and another fatty acid
biosynthesis gene. The identity of this third gene, promoters and molecular details of the
silencing constructs were declared CCI in relation to a previous GM safflower application
(DIR 121). Three additional regulatory genetic elements have been declared as CCI in relation
to the DIR 131 application. The confidential information was made available to the prescribed
experts and agencies that were consulted on the RARMP for this application.
Suppression of the target genes is mediated by using a natural regulatory mechanism in
plants known as ribonucleic acid interference (RNAi) or gene silencing (Baykal & Zhang
2010). Using the RNAi pathway, an introduced silencing construct is transcribed into doublestranded RNA, which is processed by endogenous cellular machinery into short interfering
RNAs (siRNAs). The siRNAs direct the degradation of messenger RNA (mRNA) molecules
with matching sequence after the mRNAs are transcribed from genes and before they are
translated into proteins. The efficiency of gene silencing is generally determined by the extent
of homology between the silencing construct and the target gene (usually > 95% homology is
required) and the length of the homologous region. In plants, introduced silencing constructs
have been shown to effectively suppress expression of the target genes, but can also give rise to
silencing of non-target genes with closely matching sequences.
The target gene FATB encodes a carrier protein that mediates export of saturated fatty
acids from the plastid, where fatty acid synthesis occurs (Bonaventure et al. 2003). The effect
of suppressing expression of FATB is to retain saturated fatty acids in the plastid until they
undergo a desaturation reaction, usually to form oleic acid, and can be exported by another
carrier protein. This decreases the proportion of saturated fatty acids and increases the
proportion of oleic acid in the safflower oil.
The target gene FAD2 encodes a desaturase protein that mediates enzymatic conversion
of oleic acid to linoleic acid (Harwood 1996). The effect of suppressing expression of FAD2 is
to decrease the proportion of linoleic acid and increase the proportion of oleic acid in the
safflower oil.
The GM safflower lines produce seeds where 90-95% of the total oil content is oleic
acid. This high purity oleic oil has potential application as an industrial raw material and a
replacement to petroleum-based oils in the manufacture of plastics, lubricants and cosmetics
(Vanhercke et al. 2013).
All of the GM safflower lines also contain the introduced hph gene which provides
resistance to the antibiotic hygromycin B, and is used as a selectable marker during plant
transformation. This gene is derived from E. coli and truncated for use in plants. It is expressed
under the control of either the enhanced tobacco constitutive ubiquitous promoter (enTCUP) or
the constitutive 35S promoter from Cauliflower mosaic virus (CaMV) and the nopaline
synthase (nos) terminator from A. tumefaciens.
Some of the GM safflower lines also contain the introduced gfp gene, which encodes a
green fluorescent protein used to visually identify genetically modified plant cells. This gene is
derived from the jellyfish Aequorea victoria. It is expressed under the control of the CaMV
35S promoter and the octopine synthase (ocs) terminator from A. tumefaciens.
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The hph and gfp marker genes are commonly used in gene technology. Further details
about these genes can be found in the risk assessment reference document Marker genes in GM
plants available from the Risk Assessment References page on the OGTR website.
5.3 Toxicity/allergenicity associated with the introduced safflower genes
Insertion of safflower gene fragments as part of gene silencing constructs does not result
in expression of a protein, but only in suppression of the expression of endogenous safflower
proteins. This is not expected to lead to increased toxicity or allergenicity.
The effect of the gene silencing is to increase levels of oleic acid and decrease levels of
other fatty acids in GM safflower seed oil. Oleic acid is a common constituent of food, for
example, it is the main constituent of olive oil and canola oil. Oleic acid is associated with
health benefits and it is not associated with toxicity or allergenicity. No studies on the toxicity
or allergenicity of the GM safflower lines and their products have been undertaken. The GM
safflower is not intended to be used as human food or animal feed.
5.4 Characterisation of the GMOs
5.4.1
Stability and molecular characterisation
Transformation of the GM safflower lines was confirmed using both polymerase chain
reaction (PCR) assays and analysis of oil content. Lines were self-pollinated and selected
through single seed descent for between 2-5 generations. Standard Mendelian inheritance of
the introduced genetic material was observed. The copy numbers of the introduced genetic
material were determined by Southern blot hybridisation for only a few of the GM lines
proposed for release. Released lines will contain one or more insertions. The genomic locations
of the introduced genetic material have not been characterised for any of the GM lines.
Phenotypic characterisation
Some GM safflower lines proposed for release under this application were grown in
greenhouses under controlled conditions or in field trials under licence DIR 121. The same
genes are targeted for silencing in both DIR 121 and DIR 131, but additional regulatory
elements are included in this application. According to the applicant, no phenotypic differences
between the GM safflower plants and non-GM plants have been observed. GM safflower lines
had the same growth patterns, morphology and fertility as non-GM comparators.
Additionally, the applicant indicated that no phenotypic differences were observed for a
range of traits between non-GM safflower and GM safflower lines grown in the field under
DIR 121. Traits that were examined included germination rate, time to flowering, height, seed
count per plant and seed oil content.
Section 6
The receiving environment
The receiving environment includes: any relevant biotic/abiotic properties of the
geographic regions where the field trial would occur; intended agricultural practices, including
those that may be altered in relation to normal practices; other relevant GMOs already released;
and any particularly vulnerable or susceptible entities that may be specifically affected by the
proposed release (OGTR 2013).
The proposed dealings involve planting the GM safflower at up to 60 sites throughout
Australia. Proposed local government areas (LGAs) for release sites are listed in Table 1,
Section 3.1. Sites may be located in any of 16 LGAs in Queensland, 52 LGAs in New South
Wales, 36 LGAs in Victoria, 4 LGAs in Western Australia, and one in the Australian Capital
Territory. The sites will only be used for safflower growing, seed production and storage.
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6.1 Relevant abiotic factors
The abiotic factors relevant to the growth, distribution and cultivation of commercial
safflower in Australia can be found in Raising the Bar with Better Safflower Agronomy (GRDC
2010) and The Biology of Carthamus tinctorius L. (safflower) (OGTR 2015). The proposed
release will be carried out across a range of geographic and climatic conditions.
The applicant proposes to locate field trials at least 50 m away from natural waterways.
6.2 Relevant agricultural practices
GM safflower seeds would be planted in trial sites in winter or early spring. The trial
sites would include plots of GM safflower lines, non-GM parental safflower varieties, and nonGM commercial safflower varieties. Non-GM safflower grown at the trial sites would be
treated as if it were GM safflower.
The proposed 10 m monitoring zone surrounding each trial site may be either kept as
bare fallow or planted with vegetation maintained at a height of less than 10 cm such as grass
species, and would be kept free of weeds.
The applicant proposes to harvest all GM safflower at maturity. The GMOs would be
harvested separately from other crops. Any equipment used for harvesting or other operations
would be cleaned on-site prior to removal or use for any other purpose.
Fallen seed and non-propagative plant material remaining at the field locations after
harvest would be ploughed into the ground or buried to a depth of 1m. The sites would be
watered post-harvest to encourage seed germination and monitored for volunteers. Volunteers
would be removed by hand or killed by herbicide application.
6.3 Presence of related plants in the receiving environment
Safflower is grown as a minor commercial crop in Australia. An average of 10,000
hectares of safflower is grown annually in South Australia, New South Wales and Victoria
(ABARES 2014). Many of the proposed trial sites around Australia are within current
safflower growing areas and it is possible that non-GM safflower crops will be grown nearby.
Naturalised populations of wild safflower have been reported at low levels in all states and
territories of Australia (Atlas of Living Australia, www.ala.org.au). Wild safflower is
considered a minor weed that primarily establishes on disturbed ground (Groves et al.
2003).Wild safflower has been classified as a category 1 weed of agricultural ecosystems
specifically in Queensland, Northern Territory and South Australia; it was present but not rated
as a weed in New South Wales or Victoria. Wild safflower has been rated as a category 3 weed
of natural ecosystems in Australia, a category 3 weed is naturalised and known to be a minor
problem warranting control at 4 or more locations within a State or Territory (Groves et al.
2003).
There are four related Carthamus species reported as present in Australia: C. lanatus,
C. leucocaulos, C. dentatus and C. glaucus. All four species have a chromosome number of
n=10, whereas for safflower n=12. These related species have all been reported as naturalised
in Australia (Atlas of Living Australia). Both C. lanatus and C. leucocaulos have been declared
noxious weeds in some states or territories (Weeds Australia). There are doubts about the
existence of C. glaucus in Australia; the two specimens that formed the basis of the record of
this species in the 1986 Flora of SA have now been re-determined as C. leucocaulos, and the
same may have happened in other States (personal communication Micheala Heinson, PIRSA,
SA government). Under controlled conditions, C. leucocaulos and C. lanatus can cross with C.
tinctorius but produce sterile F1 hybrid plants (Mayerhofer et al. 2011). One study of crosses
between C. tinctorius and C. glaucus produced fertile offspring under controlled conditions,
but doubts have been raised about the identity of C. glaucus seeds supplied (Mayerhofer et al.
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2011), whereas another study indicated hybrids with C. glaucus are sterile (Ashri & Knowles
1960). Similar to the other n=10 species above, formation of viable hybrids between
C. dentatus and safflower (n = 12) is unlikely due to different chromosome numbers (see
reviews by Kumar, 1991 and McPherson et al. 2004).
6.4 Presence of similar genes and encoded proteins in the environment
The three gene fragments included in the silencing constructs are from endogenous
safflower genes that are naturally present in all safflower plants. The hph antibiotic resistance
gene is from E. coli, which is widespread and prevalent in the environment, including in the
human and animal digestive systems. The gfp gene is from jellyfish and exposure to the GFP
protein in the terrestrial environment would be unlikely.
Regulatory sequences are derived from common plants, plant viruses (CaMV) or a soil
bacterium (Agrobacterium tumefaciens) that are widespread in the environment. Although
some of the regulatory sequences are derived from plant pathogens (A. tumefaciens and
CaMV), they comprise only small parts of the total genomes and cannot of themselves cause
disease.
Section 7
Relevant Australian and international approvals
7.1 Australian approvals
7.1.1
Approvals by the Regulator
The Regulator has approved field trials of GM safflower lines with the trait of increased
oleic acid under licence DIR 121.
The Regulator has previously approved field trials of GM cotton with the trait of
increased levels of oleic acid under licences DIR 039/2003 and DIR 085/2008. Information on
these licences is available from the GMO Record on the OGTR website. There have been no
reports of adverse effects on human health or the environment resulting from any of these
releases.
7.1.2
Approvals by other government agencies
FSANZ has previously approved food derived from lines of GM soybean with the trait of
increased levels of oleic acid as safe for human consumption (FSANZ 2009; FSANZ 2011).
7.2 International approvals
None of the GM safflower lines proposed for release in this application have been
approved for release in other countries.
Field trials of different GM safflower lines, with various introduced traits, have been
approved in the United States and Canada (CFIA 2015; USDA-APHIS 2008).
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Chapter 2
Section 1
Office of the Gene Technology Regulator
Risk assessment
Introduction
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 3).
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 3. The risk assessment process
Initially, risk identification considers a wide range of circumstances whereby the GMO, or the
introduced genetic material, could come into contact with people or the environment. Consideration
of these circumstances leads to postulating plausible causal or exposure pathways that may give rise
to harm for people or the environment from dealings with a GMO (risk scenarios) in the short and
long term.
Postulated risk scenarios are screened to identify substantive risks that warrant detailed
characterisation. A substantive risk is only identified for further assessment when a risk scenario is
considered to have some reasonable chance of causing harm. Pathways that do not lead to harm, or
could not plausibly occur, do not advance in the risk assessment process.
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. 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. 2014). In addition, risk scenarios
postulated in previous RARMPs prepared for licence applications of the same and similar GMOs
are also considered.
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
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assessment). The level of risk is then estimated from a combination of the Consequence and
Likelihood assessments. Risk evaluation then combines the Consequence and Likelihood
assessments to determine level of risk and whether risk treatment measures are required. The
potential for interactions between risks is also considered.
Section 2
Risk Identification
Postulated risk scenarios are comprised of three components (Figure 4)
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.
Figure 4. Risk scenario
In addition, the following factors are taken into account when postulating relevant risk
scenarios:
the proposed dealings, which may be to conduct experiments, develop, produce, breed,
propagate, grow, import, transport 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 limit the spread and persistence of the GMO
characteristics of the parent organism(s).
Additional information relevant to the risk assessment has been declared CCI by the
Regulator (either under DIR 121 or DIR 131) and was made available to the prescribed experts and
agencies that were consulted on the RARMP for this application.
2.1 Risk source
The source 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.
As discussed in Chapter 1, the GM safflower proposed for release will be modified by the
introduction of gene silencing constructs containing fragments of either two or three endogenous
safflower genes designed to induce the suppression of fatty acid biosynthesis genes. These
introduced gene constructs are considered further as potential sources of risk.
There are nine categories of GM safflower proposed for release with 20 lines in each category.
All the GM lines contain the hph hygromycin tolerance selection marker gene and lines from
categories 1 to 3 contain the gfp visual marker gene (see Chapter 1). However, these marker genes
and their products have already been considered in detail in previous RARMPs (for example DIR
077/2007 for hph and DIR 096/2009 for gfp) and assessed as posing negligible risk to human or
animal health or to the environment by the Regulator. As these genes have not been found to pose
substantive risks to either people or the environment, their potential effects will not be further
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assessed for this application. Further information about these genes can be found in the document
Marker genes in GM plants available from the Risk Assessment References page on the OGTR
website.
All of the introduced gene constructs contain regulatory sequences that are necessary for the
desired expression characteristics of the silencing sequences and the selection marker genes. These
regulatory sequences come from A. tumefaciens, CaMV, A. thaliana, N. tabacum, and R. communis.
Specific details of the regulatory sequences have been declared CCI by the Regulator (either under
DIR 121 or DIR 131) and were made available to the prescribed experts and agencies that were
consulted on the RARMP for this application. There is no evidence that regulatory sequences
themselves have toxic or allergenic effects (EPA 1996); such effects for these sequences will not be
further assessed for this application. Although the viral sequence is derived from a plant pathogen,
it only constitutes a small part of the genome and cannot itself cause disease. However, regulatory
sequences, especially promoters, control gene expression and hence the levels of the derived RNA
molecules and proteins in the GM plants. The effects of these levels of these molecules, in
particular if they affect the toxicity and allergenicity of the GM plants and their interaction in the
environment, will be discussed below.
2.2 Causal pathway
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 effects of the introduced gene(s) and gene product(s) on the properties of the
organism
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 (invasiveness) of the GM plant, including


o establishment
o reproduction
dispersal by natural means and by people
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.

Although all of these factors are taken into account, some have been considered in previous
RARMPs or are not expected to give rise to substantive risks.
The potential for horizontal gene transfer (HGT) and any possible adverse outcomes has been
reviewed in the literature (Keese 2008) as well as assessed in many previous RARMPs. These
RARMPs are available from the GMO Record on the OGTR website or by contacting the OGTR.
No risk greater than negligible was identified due to the rarity of these events, relative to those HGT
events that occur in nature, and the limited chance of providing a selective advantage to the
recipient organism that would promote the spread and persistence of the transferred material.
Therefore, HGT will not be assessed further.
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The potential for unauthorised activities to lead to an adverse outcome has been considered in
previous RARMPs. The Act provides for substantial penalties for non-compliance and unauthorised
dealings with GMOs. The Act also requires the Regulator to have regard to the suitability of the
applicant to hold a licence prior to the issuing of a licence. These legislative provisions are
considered sufficient to minimise risks from unauthorised activities, and no risk greater than
negligible was identified in previous RARMPs. Therefore, unauthorised activities will not be
considered further.
2.3 Potential harm
Potential harms from GM plants include:







harm to the health of people or desirable organisms, including toxicity/allergenicity
reduced establishment of desirable plants, including having an advantage in comparison to
related plants
reduced yield of desirable vegetation
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)
reduced biodiversity through harm to other organisms or ecosystems.
These harms are based on those used to assess risk from weeds (Standards Australia New
Zealand & CRC for Australian Weed Management 2006). Judgements of what is considered harm
depend on the management objectives of the land where the GM plant is expected to spread and
persist. A plant species may have different weed risk potential in different land uses such as dryland
cropping or nature conservation.
2.4 Postulated risk scenarios
Three risk scenarios were postulated and screened to identify substantive risk. These scenarios
are summarised in Table 3 and more detail of these scenarios is provided later in this Section.
Postulation of risk scenarios considers impacts of the GM safflower 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.
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.
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Table 3 Summary of risk scenarios from dealings with GM safflower genetically modified for high
oleic acid composition
Risk
Risk source
scenario
1
Introduced
gene
constructs
affecting oleic
acid content
Causal pathway
Potential harm
Growing GM plants at the site

Expression of introduced genes
in GM plants

Contact with GM plant material
by people who work with the
GMOs, or by other organisms at
the trial sites
Allergic
reactions in
people or
toxicity in
people and
other organisms
Substantive
risk?
No
2
Introduced
gene
constructs
affecting oleic
acid content
Dispersal of GM seed outside
trial limits

Growth of GM plants

Expression of introduced genes
in GM plants

Spread and persistence of
populations of GM plants
outside trial limits

Exposure of people or other
organisms to GM plant material
 Allergic
reactions in
people or
toxicity in
people and
other
organisms
 Reduced
establishment
or yield of
desirable
plants
 Reduced
biodiversity
No
3
Introduced
gene
constructs
affecting oleic
acid content
Dispersal of GM pollen outside
trial limits

Vertical transfer of introduced
genes to other sexually
compatible plants (e.g. weedy
relatives or commercial
varieties of safflower)

Expression of introduced genes
in plants

Spread and persistence of
populations of GM plants
outside trial limits

Exposure of people or other
organisms to GM plant material
 Allergic
reactions in
people or
toxicity in
people and
other
organisms
 Reduced
establishment
or yield of
desirable
plants
 Reduced
biodiversity
No
Chapter 2 – Risk assessment
Reason
Insertion of the silencing
constructs does not lead to
expression of a protein.
 The biosynthetic pathway
that is the target of the
genetic modification does
not produce known toxins or
allergens.
 The proposed limits and
controls, including not using
the GM plant material for
human food or animal feed,
minimise exposure of people
and other organisms to the
GM plant.

 Insertion of the silencing
constructs does not lead to
the expression of a protein.
 The biosynthetic pathway
that is the target of the
genetic modification does
not produce known toxins
or allergens.
 The genetic modifications
are not expected to
increase the ability of the
GM plants to spread and
persist.
 The proposed limits and
controls minimise the
likelihood that GM plant
material would leave trial
limits.
 Safflower does not produce
fertile hybrids with related
weedy species in Australia.
 The introduced genes are
not expected to increase
the ability of hybrid GM
plants to spread and persist
or to be toxic or allergenic.
 The proposed limits and
controls minimise the
likelihood that GM pollen
would be transferred to
other plants
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Office of the Gene Technology Regulator
Risk scenario 1
Risk source
Introduced gene
constructs
affecting oleic
acid content
Causal pathway
Growing GM plants at the site

Expression of introduced genes in GM plants

Contact with GM plant material by people who work with the GMOs, or
by other organisms at the trial sites
Potential harm
Allergic reactions
in people or
toxicity in people
and other
organisms
Risk source
The source of potential harm for this postulated risk scenario is the introduced silencing
constructs with fragments of safflower genes.
Causal pathway
The silencing constructs with safflower gene fragments are designed to produce siRNAs that
suppress the expression of fatty acid biosynthetic genes, thus altering seed oil fatty acid content. A
range of organisms may be exposed directly or indirectly to the introduced genetic constructs or
their end products. Workers cultivating the GM safflower would be exposed to all plant parts.
People who are involved in the breeding, cultivating, harvesting, transporting and processing of the
GM safflower may be exposed to its products through contact (including inhalation of pollen). This
would be expected to mainly occur in the trial site, but could also occur anywhere the GM plant
material was transported or used for experimental analysis. Organisms, including birds, rodents and
invertebrates, may be exposed directly to GM safflower plants through biotic interactions
(vertebrates, invertebrates, symbiotic and/or pathogenic microorganisms), or through contact with
dead plant material (soil biota) or indirectly through the food chain.
The proposed limits and controls of the trial would minimise the likelihood that people or
other organisms would be exposed to GM plant material. Although people dealing with the GMOs
may directly handle the GM plant material, there is little potential for human ingestion of the GM
safflower, as no GM plant material would be used as food. Human contact with GM plant materials
would be limited to people with access to trial sites. The applicant proposes that GM plant materials
will only be handled by trained and authorised staff.
Similarly, livestock would not be intentionally exposed to the GMOs at the sites as the GM
plant material is not to be used as animal feed. The spiny nature of safflower means that larger
animals or livestock do not generally graze safflower. Rodent control measures will be used to
reduce the number of rodents and appropriate bird control measures will be employed at each site to
discourage birds from feeding on GM safflower.
Further information about the GMOs relevant to consideration of the risk scenario has been
declared CCI by the Regulator (either under DIR 121 or DIR 131) and was made available to the
prescribed experts and agencies that were consulted on the RARMP for this application.
Potential harm
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).
The introduced gene silencing construct could lead to production of substances in the GM
safflower that are toxic or allergenic for people or be toxic to other organisms. Transcription of the
gene fragments in the silencing constructs forms hairpin RNA. This double-stranded RNA enters
the RNAi pathway rather than being translated into a protein. Therefore, the introduction of the
silencing constructs does not lead to expression of a novel protein that could potentially be toxic or
allergenic. All known food allergens are proteins, those derived from plants coming chiefly from
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peanut, tree nuts, wheat and soybean (Delaney et al. 2008; Herman & Ladics 2011). In these
circumstances, there is no reasonable expectation that the introduced constructs will lead to an
increase in the level of any endogenous compound in the GM safflower that has toxic or allergenic
properties.
Humans and animals have a long history of safe exposure to non-GM safflower. There is only
one reported case of an allergenic reaction to safflower dried flowers in humans (Compes et al.
2006) and there are some reports of adverse toxic effects of safflower floral extract injections used
in Chinese alternative medicine (see Chapter 1, Section 4). However, researchers indicated that
adverse reactions may be due to other liposoluble components in the injections (Zhang et al. 2009).
Safflower seed oil is non-allergenic and suitable for use in injectable medicines and cosmetics.
By targeting fatty acid biosynthesis genes, the genetic modifications result in changed fatty
acid profiles, specifically increasing the n-9 monounsaturated fatty acid oleic acid and decreasing
other fatty acids such as the n-6-polyunsaturated fatty acid linoleic acid. There is uncertainty
whether the genetic modification may result in changes to other fatty acids. In DIR 039/2003, high
oleic GM-cotton was found to have elevated levels of two cyclopropenoid fatty acids, malvalic and
sterculic acids. If changes do occur, it is expected to result in a decrease of fatty acids such as
arachidonic acid or n-6 linoleic acid. The expected phenotypic difference between GM and non-GM
safflower is that GM safflower oil will contain a higher proportion of oleic acid and a lower
proportion of saturated (palmitic acid, stearic acid) or polyunsaturated (linoleic acid) fatty acids.
However, oleic acid is part of the normal human diet, as it is a major constituent of vegetable oils
and animal fats, and it is not considered toxic or allergenic.
Hairpin RNA transcribed from the silencing constructs is processed into siRNAs. siRNAs fall
under a general category of small RNAs that also includes microRNAs (miRNAs). siRNAs and
miRNAs are common in both plants and animals and are believed to play regulatory roles in many
biological processes. Animals and plants naturally produce thousands of different siRNA molecules
and these are consumed by humans and other organisms whenever they eat plant or animal cells.
One paper (Zhang et al. 2011) tracked the metabolic fate of a particular natural miRNA, miR-168a,
that is produced abundantly in rice and other plants and happens to have a near perfect sequence
match to a mammalian gene. In a study of mice fed a pure rice meal after fasting, the plant miRNA
was detected in mouse livers and was reported to modulate the expression of the matching
mammalian gene, reducing levels of the encoded protein in the liver by approximately 50%. The
reported effect on the mouse gene by the plant miRNA was transient and ceased when rice was no
longer included in the food intake. However, the quantity of rice fed to mice in the Zhang et al
study (2011), which is equivalent to a human eating approximately 33 kg/day of cooked rice, is an
unrealistic quantity in any human diet. A recent analysis paper (Petrick et al. 2013) suggests some
potential alternate explanations for the findings of the Zhang et al study (2011), and after reviewing
a number of other papers in the field concluded that the weight of the evidence does not suggest that
miRNAs derived from normal dietary exposure have a meaningful effect on mammalian gene
expression. However, a recent report indicated that another specific plant miRNA, miR-172,
ingested by mice can survive the gastro-intestinal (GI) system and enter the bloodstream and
various organs. In addition, miR-172 was detectable after what would be considered normal dietary
exposure (i.e. equivalent to a human eating 280 g of the food source). The researchers did state that
their results did not support general and consistent uptake of dietary plant miRNAs and additional
studies are required to establish if plant miRNAs are transferred across the GI tract in sufficient
quantity to regulate endogenous gene expression (Liang et al. 2014).
The possibility exists that siRNAs produced in GM safflower lines could modulate expression
of human or animal genes, with unknown physiological effects. The siRNAs would need to be
produced at high levels in GM safflower, a large amount of the GM safflower would need to be
consumed, the siRNA would need to match a target sequence in a human or animal gene, and be
taken up by cells expressing that gene. As noted above, the GM safflower will not be used for
human food or animal feed and the proposed limits and controls would minimise exposure of
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people and other organisms to the GMOs. Mammals do not have genes that are homologous to the
safflower fatty acid biosynthesis genes targeted by the introduced silencing constructs. Even if
siRNAs were acquired through eating GM safflower and did affect expression of a mammalian
gene, it is expected that any effect would be transient as described in Zhang et al (2011).
The genetic modifications have the potential to cause unintended effects in the GM safflower
plants in several ways including off-target siRNA-mediated silencing of genes expressed in
safflower, altered expression of endogenous safflower genes by random insertion of introduced
DNA in the genome, and secondary effects arising from altered substrate or product levels in
biochemical pathways. Unintended effects might result in adverse outcomes such as toxicity or
allergenicity. Unanticipated changes can also be induced in plants by conventional methods of plant
breeding (Haslberger 2003). However, even though conventional breeding can involve the
movement of hundreds and even thousands of genes into a plant, there has never been a report of a
completely novel toxin or allergen appearing in a new line of a plant produced by such techniques
(Steiner et al. 2013; Weber et al. 2012). The implication is that the movement into safflower of any
of the genes that are the subject of this application, which themselves do not code for any proteins,
is unlikely to result in the production (directly or indirectly) of a novel toxin or allergen. The range
of possible unintended effects produced by genetic modification is not likely to be greater than that
from accepted traditional breeding techniques (Bradford et al. 2005; Committee on Identifying and
Assessing Unintended Effects of Genetically Engineered Foods on Human Health 2004). More
detail on potential for unintended effects as a result the process of genetic modification can be
found in the document Methods of plant genetic modification available from the Risk Assessment
References page on the OGTR website.
Conclusion: Risk scenario 1 is not identified as a substantive risk due to the introduced gene
fragments not coding for any proteins, the biosynthetic pathway they will affect being involved in
the production of compounds that have not been associated with toxic or allergenic reactions, and
the proposed limits and controls are designed to minimise exposure of people and other organisms
to the GM plant material. Therefore this risk could not be greater than negligible and does not
warrant further detailed assessment.
2.4.2
Risk Scenario 2
Risk source
Introduced gene
constructs
affecting oleic
acid content
Causal pathway
Dispersal of GM seed outside trial limits

Growth of GM plants

Expression of introduced genes in GM plants

Spread and persistence of populations of GM plants outside trial limits

Exposure of people or other organisms to GM plant material
Potential harm
 Allergic reactions in
people or toxicity in
people and other
organisms
 Reduced
establishment and
yield of desirable
plants, reduced
biodiversity
Risk source
The source of potential harm for this postulated risk scenario is the introduced silencing
constructs with fragments of safflower genes.
Causal Pathway
If GM safflower seed was dispersed outside the trial limits, this seed could germinate and give
rise to GM 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.
Characteristics that influence the spread (dispersal of the plant or its genetic material) and
persistence (establishment, survival and reproduction) of a plant species impact on the degree of its
invasiveness. These characteristics include the ability to establish in competition with other plants,
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to tolerate standard weed management practices, to reproduce quickly, prolifically and asexually as
well as sexually, and to be dispersed over long distances by natural and/or human means. The
degree of invasiveness of a plant species in a particular environment gives an indication of the
likelihood of its weediness in that environment. In addition to local experience, a history of
weediness overseas can be used as an indicator for weediness in Australia (Pheloung et al. 1999).
Baseline information on the weediness of safflower is given in Chapter 1, Section 6, and more
detailed consideration is available in The Biology of Carthamus tinctorius L. (safflower) (OGTR
2015). Safflower is fairly slow-growing, with an extended rosette stage following emergence and
prior to stem development, during which it is poorly competitive with other plants (Dajue &
Mündel 1996). Safflower plants are susceptible to a wide range of herbicides as well as physical
weed management practices (GRDC 2010). Australia is the only country that currently classifies
safflower as a weed (Groves et al. 2003).
Potential dispersal of reproductive GM plant material outside the site boundaries would be
limited to seed or pollen, as safflower does not reproduce vegetatively in the field. Safflower seed
heads are resistant to shattering and the seeds lack seed dispersal characteristics such as stickiness,
burrs and hooks, which can contribute to seed dispersal via animal fur or feathers. These seed
dispersal characteristics are not expected to be altered in the GMOs. Gene flow via pollen is
discussed in Section 2.4.3.
Dispersal of viable seed could occur through a variety of ways including: endozoochory
(dispersal through ingestion by animals), transport of seeds by animals, movement of seeds by
people, or extremes of weather such as flooding or high winds. Trial sites would be located at least
50 m away from natural waterways to minimise seed dispersal in the event of flooding. Seeds
dispersed by flooding would be unlikely to survive and establish, as safflower is very susceptible to
damping off and fungal diseases in wet soil (GRDC 2010).
Safflower is very resistant to shattering or lodging (Mündel et al. 2004), so seeds are unlikely
to be dispersed by wind or via water runoff from irrigation or rainfall prior to harvest. Residual
seeds that fall during harvest could be dispersed by water runoff from rainfall or by strong winds.
However, the applicant proposes to till the trial sites post-harvest to incorporate GM plant material
into the soil.
Typical safflower seed losses during harvest are 3-4% (GRDC 2010) and the viability of these
seed may range from 26 to 84% (McPherson et al. 2009b). Most of these seeds would germinate
soon after harvest as safflower seeds have very low dormancy (see Chapter 1, Section 4). In a
Canadian study, safflower seed did not persist beyond 2 years at the surface or 1 year when buried
(McPherson et al. 2009b). Preliminary data from trials conducted under DIR 121 suggests that seed
lost at harvest germinated within the first 2 months post-harvest with no further volunteers observed
over the following seven months even though conditions were conducive for germination. It is not
expected that the genetic modifications to safflower would affect seed yield, viability or
germination. While the fatty acid composition is altered, the total fatty acid content of seeds, and
thus their stored energy content, remains constant. GM safflower seeds grown in the greenhouse
were reported to germinate and establish at the same rate as non-GM comparators. Likewise, it is
not expected that the genetic modifications would affect the ability of the GMOs to survive the
control measures being proposed, such as tilling or irrigating the trial sites and destroying any
volunteers found during post-harvest monitoring.
Small birds can feed on ripening safflower seed in the head, and cockatoos can chew off
safflower plants at the base in order to access the seeds (GRDC 2010). Safflower seeds that have
passed through the digestive systems of several bird species (blackbirds, mallard ducks, pigeons and
pheasants) were observed to be no longer viable, but did remain viable in the oesophagus, crop and
gizzard regions for several hours (Cummings et al. 2008). This study was on Northern Hemisphere
bird species and results may differ for Australian bird species such as galahs, corellas or bush
turkeys. The researchers also mentioned birds that hoard or cache seeds such as jays, crows and
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ravens, as potential transport vectors of safflower seeds. It is not known whether Australian birds
carry seeds away for later consumption. Safflower seeds did not attach to the plumage of the birds
due to the smooth nature of safflower seeds, however, seeds were transported externally on soil
attached to feet or legs of pigeons and pheasants (Cummings et al. 2008). The applicant proposes to
prevent or control bird access to trial sites by using bird netting, bird scarers, or a sacrificial crop
such as sorghum as a bird attractant, which would minimise seed dispersal through bird activity. A
sorghum sacrificial crop was effective at deterring birds from feeding on GM safflower in the field
under DIR 121.
Large animals are generally deterred from grazing on standing safflower by its spines.
Safflower seeds are firmly held within their seed heads, which limits their accessibility to rodents.
Residual GM seeds post-harvest may attract animal predation, and could be transported and hoarded
by rodents. However, the applicant proposes to till the trial sites post-harvest, which should bury the
GM seeds. A 10 m monitoring zone around the trial sites would be monitored for rodents and
maintained in a manner to minimise rodent activity. Rodents would be controlled if required.
Hence, seed dispersal through animal or rodent activity is unlikely.
Dispersal of seeds by people dealing with the GMOs would be minimised by cleaning of all
equipment prior to removal from the trial sites. People/equipment could also disperse seed from the
planting area to the adjacent monitoring zone during sowing or harvest. The applicant has proposed
to inspect the monitoring zone for related species (including other safflower plants) and if found
destroy them. Inspections would occur while the GMOs are growing and during post-harvest, thus,
establishment and persistence of the GM safflower in the monitoring zone is unlikely. All GM plant
material would be transported in accordance with the Regulator’s transport guidelines to avoid
spillage.
As discussed above, the proposed limits and controls of the trial would minimise the
likelihood of spread and persistence of the GM plants and minimising potential for dispersal of seed
and exposure to plant material by grazing livestock and people. Dispersal of GM plant material by
authorised people entering the proposed trial site would be further minimised by a standard
condition of DIR licences which requires the cleaning of all equipment used at the trial site. All
plant materials not required for testing or future trials will be destroyed. Post-harvest tillage and
irrigation is proposed to be used to encourage germination of any residual seed. The applicant
proposes to monitor the trial sites for two years and destroy any volunteers prior to flowering. All
GM plant material will be transported in accordance with the Regulator’s transport guidelines,
which will minimise the opportunity for its dispersal. The effectiveness of the limits and controls
are further discussed in Chapter 3.
Potential harm
As discussed in Section 2.3 of this Chapter, all plants have the potential to lead to harm in
certain environments. For the purposes of this document, plant species causing significant levels of
one or more of these harms are called “weeds”. A plant species may be weedy in one or more land
uses, such as dryland cropping or nature conservation.
As summarised in Chapter 1, Section 6.3, safflower is naturalised throughout Australia,
primarily as an agricultural or ruderal weed and is classified as a category 1 weed in agricultural
ecosystems or a category 3 weed in natural ecosystems in some States. Anecdotal evidence from
safflower farmers (GRDC 2010) and weed risk assessment experts (personal communication,
Stephen Johnson) in Australia indicate that safflower is not a significant weed in natural
ecosystems. In reference to native habitats, there would have to be large numbers of GM plants
before the establishment of native plants was affected.
As discussed in risk scenario 1, the introduced gene products are not expected to be toxic to
humans or other organisms and it is unlikely that the GM safflower plants would have higher
toxicity and/or allergenicity than non-GM safflower. The only expected phenotypic difference
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between GM safflower and non-GM safflower is altered fatty acid composition in the GM safflower
oil. No phenotypic changes were observed between GM safflower and non-GM safflower grown in
greenhouses or in the field under DIR 121, and a standard condition of a licence for a field trial
would be that the applicant immediately notify the OGTR of any unintended effects. In the unlikely
event of GM safflower plants establishing themselves beyond trial limits, this trait would not be
expected to lead to populations of GM safflower that cause any environmental harms associated
with weedy plants, such as reduced establishment or yield of desirable plants, or reduced
biodiversity.
Conclusion: Risk scenario 2 is not identified as a substantive risk due to the introduced gene
fragments not coding for any proteins, the biosynthetic pathway they will affect being involved in
the production of compounds that have not been associated with toxic or allergenic reactions, and
the modified trait not being associated with weediness. Further, the proposed limits and controls are
designed to minimise exposure of people and other organisms to the GM plant material and restrict
seed dispersal. Therefore this risk could not be greater than negligible and does not warrant further
detailed assessment.
2.4.3
Risk Scenario 3
Risk source
Introduced gene
constructs
affecting oleic
acid content
Causal pathway
Dispersal of GM pollen outside trial limits

Vertical transfer of introduced genes to other sexually compatible plants,
such as weedy relatives or commercial varieties of safflower

Expression of genes in plants

Spread and persistence of populations of GM plants outside trial limits

Exposure of people or other organisms to GM plant material
Potential harm
 Allergic reactions
in people or
toxicity in people
and other
organisms
 Reduced
establishment
and yield of
desirable plants,
reduced
biodiversity
Risk source
The source of potential harm for this postulated risk scenario is the introduced silencing
constructs with fragments of safflower genes.
Causal pathway
If the introduced silencing constructs were transferred and expressed in other safflower plants
or related species, the resulting hybrid plants could have increased toxicity or allergenicity to
people, toxicity to other organisms, or weediness potential.
Vertical gene flow is the transfer of genetic information from an individual organism to its
progeny by conventional heredity mechanisms, both asexual and sexual. In flowering plants, pollen
dispersal is the main mode of gene flow (Waines & Hegde 2003). For GM crops, vertical gene flow
could therefore occur via successful cross-pollination between the crop and neighbouring crops,
plants, related weeds or native plants (Glover 2002). Alternatively, if seed was dispersed outside the
trial site, GM plants may grow and subsequently disperse pollen. Hybrid plants possessing the
introduced genes may form the basis for the spread of these genes in other varieties of safflower, or
other sexually compatible plant species.
As discussed in Chapter 1, there are four weedy Carthamus species that may be present in
Australia: C. lanatus, C. leucocaulos, C. dentatus and C. glaucus. GM safflower could theoretically
cross-pollinate plants from other Carthamus species at low levels if these weedy species were
present in close proximity to the trial sites and flowered synchronously. If hybrids between GM
safflower and a related Carthamus weedy species occurred, they would be annuals like all
Carthamus species and are likely to be sterile (Mayerhofer et al. 2011). The hybrids could therefore
only be transient weeds in the immediate environs of the trial sites, and could not lead to long-term
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transfer of the introduced silencing constructs into weedy Carthamus species populations. As
described in Chapter 1, Section 6.3, interspecific hybridisation between safflower and other species
of the Carthamus genus present in Australia is difficult due to various cytogenetic barriers (e.g.
varying chromosome number) and is unlikely to occur naturally as crosses have only been obtained
under experimental conditions. The applicant has proposed to inspect the areas around the trial sites
for the presence of sexually compatible plants.
GM safflower could cross-pollinate non-GM safflower plants outside the trial if either
naturalised safflower or commodity safflower crops were present in proximity to the trial sites.
Safflower pollen is large and sticky and is not transported appreciably by wind beyond 1 m
(Claassen 1950). Safflower varieties, including S317, are 85-90% self-pollinating with insects
responsible for the remaining 10-15% (USDA-APHIS 2008). S317 is one of the parent varieties
from which the varieties used in this trial have been developed. Honey bees are the primary species
that mediate cross-pollination or outcrossing in safflower representing 70-85% of insect visitors to
safflower fields (Boch 1961). The average foraging distance of honey bees from a colony is a few
hundred metres in agricultural areas and generally honey bees do not forage past one mile (USDAAPHIS 2008). However, there is evidence of honey bees flying several kilometres between apiaries
and safflower fields (Gary et al. 1977).
In principle, GM safflower pollen could be widely dispersed, as bees forage over kilometre
ranges. However, safflower pollen transported by an insect must compete with the floret’s own
pollen to result in outcrossing. Bee-mediated cross-pollination of safflower may be less efficient
than other crops, as transported safflower pollen is only reported to potentially fertilise the next
floret visited by the bee (Cresswell 2010) in comparison to canola crops where pollen collected by a
bee at one flower may fertilise up to twenty flowers visited subsequently (Cresswell et al. 2002).
The reliable estimation of insect mediated gene flow in safflower is difficult and dependent on
a number of factors including insect numbers and type, site layout and size, and distance between
pollen donor and receptor (AOSCA 2012). Studies of outcrossing rates in safflower plants grown in
close proximity show highly variable rates of outcrossing ranging from 0-50% (Nabloussi et al.
2013; Velasco et al. 2012) with average outcrossing rates of 10% and higher frequencies of 0-100%
at the single plant and head level (Claassen 1950). Limited information is available on safflower
cross-pollination over distance. For a commercial safflower cultivar studied in Canada, crosspollination rates were measured at 1.7% at 3 m, decreasing from 0.94 to 0.12% between 10 and
50 m, and again decreasing from 0.12 to 0.01% between 50 and 100 m, with no outcrossing
observed at 300 m (McPherson et al. 2009a). This is the only study to determine safflower
outcrossing at distances beyond a few metres. It should be noted that highly variable results were
obtained for the three sites examined in this study, particularly the low outcrossing rates observed at
one site which was suggested to be due to low or different pollinator populations (AOSCA 2012).
In addition, the largest site examined was nine times the size of the other two sites and had four
times the outcrossing rate (McPherson et al. 2009b).
The OECD Seed Scheme for Varietal Certification, which applies in Australia and many other
countries, requires that crops of certified safflower seed be grown with an exclusion distance of
200 m from other safflower crops, and that basic safflower seed (the source for certified seed crops)
be grown with an exclusion distance of 400 m (OECD 2013). The AOSCA (2012) recommends an
isolation distance of 1320ft (403 m) for producing certified safflower seed of all seed classes. For
GM-safflower plants containing an introduced gene expressing a pharmaceutical product, the
USDA-APHIS (2008) has required a 2 mile (3.2 km) exclusion distance between the GM crop and
non-GM safflower crops, while in Canada an 800 m exclusion distance has been required (see CFIA
website). These international guidelines were developed for conditions in the Northern Hemisphere
where pollinators include both bumblebees and honeybees. Bumblebees are reported to be more
effective at field-to-field pollination of safflower than honeybees (Cresswell 2010), so long-distance
outcrossing rates may be reduced in mainland Australia compared to other countries due to the lack
of bumblebees. However, this is unknown and in the North Hemisphere studies, bumblebees
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represent less than 10% of insect visitors to safflower fields and in some studies bumblebees were
not found to be present in safflower fields (Cresswell 1999; Cresswell 2000).
The proposed limits and controls of the trial would minimise the likelihood of the dispersal of
seed and exposure to GM plant material (as discussed in Risk Scenarios 1 and 2). The applicant
proposes to inspect the monitoring and isolation zones, a distance of up to 200 m surrounding the
trial sites, prior to flowering of GM safflower and to destroy any safflower plants and related
species. This would minimise vertical gene flow to any safflower populations or related species
within 200 m of the trial site. The applicant also proposes to ensure that no other safflower crops are
grown within 400 m of the trial sites. The effectiveness of these control measures are discussed in
Chapter 3.
After completion of the trial, it is possible that whole GM plants could survive at the trial
sites, or new volunteer plants could grow from residual seed in the trial sites. The applicant
proposes a number of control measures to prevent these eventualities, including: destroying all plant
materials not required for testing or future trials; promoting germination of residual seed by postharvest tillage and irrigation; and post-harvest monitoring of the trial sites for two years and
destruction of any volunteer safflower prior to flowering. These measures would minimise potential
for pollen flow from volunteer GM safflower plants following the trial.
Potential harm
If the vertical transfer of the introduced genes from the GM plants causes the recipient species
to spread and persist in the environment to a degree greater than normally found amongst these
species, they may produce one or more harms. People who are exposed to the GM plant material
through contact or consumption of GM plant material may show toxic or allergenic reactions, while
other organisms may show toxic reactions from consumption of GM plant material. The GM plants
may act to reduce the establishment or yield of desired plants, and subsequently reduce biodiversity.
In the rare event of the vertical transfer of the introduced genetic material from the GM plants
to non-GM safflower plants or sexually compatible species, it is expected that this material in the
recipient will have the properties that it possesses in the GM safflower parent. As discussed in risk
scenario 1, the introduced genetic elements are not expected to result in GM plants that are
allergenic to humans or toxic to humans or other organisms. Risk scenario 2 summarises the reasons
that the introduced genetic elements are unlikely to make the GM safflower lines more weedy, these
reasons being applicable to any plants to which the genes are transferred via hybridisation.
Conclusion: Risk scenario 3 is not identified as a substantive risk due to the expected lack of
toxicity, allergenicity or increased weediness in any offspring of the GM plants and other plants,
either commercial safflower crops or other sexually compatible plants. Further, the proposed limits
and controls are designed to minimise pollen dispersal. Therefore this risk could not be greater than
negligible and does not warrant further detailed assessment.
Section 3
Uncertainty
Uncertainty is an intrinsic part of risk analysis5. There can be uncertainty about identifying the
risk source, the causal linkage to harm, the type and degree of harm, the chance of harm occurring
or the level of risk. In relation to risk management, there can be uncertainly about the effectiveness,
efficiency and practicality of controls.
Risk analysis can be considered as part of a first tier uncertainty analysis, namely a structured,
transparent process to analyse and address uncertainty when identifying, characterising and
evaluating risk. However, there is always some residual uncertainly that remains. If the residual
uncertainty is important and critical to decision making, then this residual uncertainly may be
5
A more detailed discussion of uncertainty is contained in the Regulator’s Risk Analysis Framework available from the
Risk Assessment References page on the OGTR website or via Free call 1800 181 030.
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subjected to further analysis (= second tier uncertainly analysis), such as building ‘worst case’
scenarios, or by using meta-analysis where results from several studies are combined.
There are several types of uncertainty in risk analysis (Bammer & SmithsonBammer &
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.
For DIR 131, uncertainty is noted particularly in relation to the characterisation of:
Potential for increased toxicity or allergenicity due to unintended effects
Potential for increased weediness of the GMOs due to unintended phenotypic changes
Potential for gene flow via pollen over long distance
Additional data, including information to address these uncertainties, may be required to
assess possible future applications for a larger scale trial, reduced containment conditions, or the
commercial release of these GM safflower lines if they are selected for further development.
Chapter 3, Section 4, discusses information that may be required for future release.
Section 4
Risk Evaluation
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.
Factors used to determine which risks need treatment may include:




risk criteria
level of risk
uncertainty associated with risk characterisation
interactions between substantive risks.
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 that could be greater than negligible. The principal reasons for these conclusions are
summarised in Table 3 and include:
 limits on the size, locations and duration of the release proposed by CSIRO
 controls proposed by CSIRO to restrict the spread and persistence of the GM safflower
plants and their genetic material
 the genetic modifications are unlikely to give rise to adverse effects on human health and
safety or the environment
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 widespread presence of the same and similar genes in the environment and lack of evidence
of harm from them
 limited ability and opportunity for the GM safflower plants to transfer the introduced genetic
material to commercial safflower crops or wild safflower populations
 none of the GM plant material or products will enter human food or animal feed supply
chains.
The Risk Analysis Framework (OGTR 2013), which guides the risk assessment and risk
management process, defines negligible risks as insubstantial with no present need to invoke actions
for their mitigation. Therefore, no additional 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.
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Risk management plan
Section 1 Background
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 controls and limits proposed by the applicant, as well as
general risk management measures. The risk management plan informs the Regulator’s decisionmaking process and is given effect through licence conditions.
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.
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.
The licence is also subject to any conditions imposed by the Regulator. Examples of the
matters to which conditions may relate are listed in section 62 of the Act. Licence conditions can be
imposed to limit and control the scope of the dealings. In addition, the Regulator has extensive
powers to monitor compliance with licence conditions under section 152 of the Act.
Section 2 Risk treatment measures for identified risks
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 safflower. 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 additional controls are required to treat these negligible risks.
Section 3 General risk management
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, locations and duration, and to restrict the spread
and persistence of the GMOs and their genetic material in the environment. The conditions are
detailed in the licence and summarised in this Chapter.
3.1 Licence conditions to limit and control the release
3.1.1
Consideration of limits and controls proposed by CSIRO
Sections 3.1 and 3.2 of Chapter 1 provide details of the limits and controls proposed by
CSIRO in their application. These are discussed in the three risk scenarios characterised for the
proposed release in Chapter 2. Many of these 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.
The duration of the field trial would be confined to four growing seasons, with a maximum of
10 trial sites of 5 ha during the first growing season, 15 trial sites of 10 ha during each of the second
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and third seasons, and 20 trial sites of 25 ha each during the fourth season. The size and duration of
the trial would limit the potential exposure of humans, vertebrates and other organisms to the
GMOs (Risk Scenario 1).
Only authorised personnel with appropriate training 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 would limit the potential exposure of humans to the
GMOs (Risk Scenario 1).
The applicant proposes, in line with a standard DIR licence condition, that trial sites are
located at least 50 m from natural waterways to minimise the chance of viable plant material being
washed away from the site (Risk Scenario 2). An additional licence condition has been imposed
requiring immediate notification of any extreme weather conditions affecting the trial sites during
the release. This will allow contingency measures to be taken to restrict dispersal of GM safflower
outside the proposed trial sites.
The applicant proposes to grow both GM safflower and non-GM safflower in the trial sites.
As non-GM safflower may be mingled with or fertilised by GM safflower, a standard licence
condition has been imposed requiring non-GM safflower plants grown in a trial site to be treated as
if they are GMOs.
At the trial sites, the applicant proposes to minimise bird access to the GMOs by covering the
site with bird netting, the use of commercial bird scarers and/or planting decoy crops within the
Isolation Zone. These measures would limit both exposure of wildlife to the GMOs (Risk Scenario
1) and potential dispersal of GMOs outside the trial sites (Risk Scenario 2). A licence condition
requires that for the period from 14 days after commencement of flowering of the GMOs in a trial
site until the site has been cleaned, the trial site must be either:

covered with bird netting, which must be maintained in a state adequate to deter birds; or

equipped with bird scarers that are expected to deter the main seed-eating bird species
present in the vicinity of the trial site; or

surrounded by a 10 m strip of non-GM plants, such as sorghum, as a decoy or sacrificial
crop within the Isolation Zone, and these plants must bear seed over the same period as the
safflower in the Planting Area; or

use a method approved in writing by the Regulator to achieve the above outcomes; or

use a combination of the above methods.
The applicant proposes to monitor for the presence of rodents by trapping and to control
populations by baiting if necessary. Combined with the use of a monitoring zone (below) these
measures should both limit exposure of rodents to the GMOs (Risk Scenario 1) and minimise
potential dispersal of GMOs outside the trial sites by rodents (Risk Scenario 2). A licence condition
has been imposed that requires that for the period while GMOs are being grown and until the trial
site has been cleaned, measures must be implemented to control rodents within the site.
The applicant proposes to surround each trial site with a 10 m monitoring zone, which is kept
free of weeds and any species related to safflower, monitored for rodents and maintained in a
manner to minimise rodent activity. This would serve three purposes:

to avoid attracting or harbouring rodents (Risk Scenario 2)

to remove safflower plants or related species that might hybridise with GM safflower (Risk
Scenario 3)

to facilitate detection of GM plant material that has been dispersed during sowing or
harvesting (Risk Scenario 2).
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Therefore, a licence condition has been included requiring a 10 m monitoring zone around each trial
site be maintained in a manner that does not attract or harbour rodents. Additional licence
conditions require inspection of the monitoring zone while the GMOs are growing and post-harvest
for detection and destruction of volunteer safflower plants.
The applicant proposes that the monitoring zone would be surrounded with an isolation zone
of 190 m, or 50 m if no safflower plants or related species were observed in the previous growing
season, which would be inspected every 35 days while the GMOs are flowering in a trial site, and
any safflower or related species destroyed. Separation of the GM crop from isolated safflower
plants by 200m (10 m monitoring zone plus 190 m isolation zone) is considered sufficient for
minimising gene flow to these plants, as isolated plants are less attractive to bees than are dense
populations of a particular plant species. If the isolation zone is to be reduced to 50 m, additional
measures should be taken to prevent the appearance of safflower plants in the remaining area. Since
safflower has very low seed dormancy, the most likely cause of safflower plants occurring in this
area is through planting of a safflower crop or planting of another crop which is inadvertently
contaminated with safflower seeds. The proposed isolation distances have been included as a
licence condition (referred to as an inspection zone, being 190 m or 50m surrounding the
monitoring zone), with an additional condition that requires any seed planted in a 190 m isolation
zone to be inspected for the adventitious presence of safflower seeds before planting. Separation
from other safflower crops is addressed below.
As indicated above, while the GMOs are flowering, the applicant has proposed to inspect the
monitoring and isolation zones every 35 days for the presence of safflower and related species.
Safflower requires about 45 days to develop from its inconspicuous rosette stage to flowering, but
hotter or drier environments can shorten development through the rosette and elongation/branching
phases (GRDC 2010). A higher frequency of inspection is considered appropriate to deal with this
uncertainty. An imposed licence condition requires that for the period from 14 days prior to the
expected commencement of flowering of any GMOs in a trial site, until after all GMOs have
finished flowering, the monitoring and isolation zones must be inspected every 14 days for the
presence of safflower, and any plants discovered must be destroyed prior to flowering. These
measures would minimise gene flow to naturalised safflower (Risk Scenario 3). Although the
applicant proposed to inspect for related species in these areas while the GMOs are flowering, the
available evidence does not support this measure. As discussed in Chapter 1, Section 6.3, the four
related species present in Australia are unlikely to hybridise with safflower and produce fertile
offspring. Thus, there is no requirement in the licence to inspect for related species.
The applicant proposes to ensure that no other safflower crops are grown within 400 m of the
trial sites. The safflower industry is small in Australia with on average less than 10,000 hectares
grown annually (ABARES 2014), and thus a commercial safflower crop is not likely to be close to
any particular trial site. As discussed in Chapter 2 long-distance outcrossing in safflower can be
highly variable from site to site, but generally decreases over distance with no outcrossing observed
at a distance of 300 m. Variability in outcrossing rates was thought to be due to differences in
pollinator numbers and site size (AOSCA 2012; McPherson et al. 2009a).
There is a possibility that GM safflower could pollinate dense populations of naturalised
safflower growing in the areas between 200 m and 400 m from the trial sites, but as safflower is not
a common weed, the number of wild safflower plants present in these areas is likely to be very low.
However, significant numbers of wild safflower plants might be present between 200 m and 400 m
from the trial sites if the plants were growing as volunteers following planting of a safflower crop in
the previous year. Cross-pollination events between the GMOs and other safflower crops or dense
populations of wild safflower located slightly further than 400 m from the trial sites are expected to
be rare. However, there is little published quantitative information about long-distance safflower
gene flow.
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The international guidelines for production of basic safflower seed recommend an exclusion
distance of 400 m from other safflower cultivars to produce high purity seed (OECD 2013).
However, at this exclusion distance there could still be very low levels of cross-pollination that are
acceptable for growers, and there is a lack of scientific studies addressing efficacy of exclusion
distances for safflower. In these circumstances of uncertainty, it is considered appropriate to
increase the exclusion distance by a safety factor. For a Canadian field trial of GM safflower in
2011, the Canadian Food Inspection Agency (see CFIA website) required that GM safflower plants
be reproductively isolated from other safflower plants by 800 m, and from safflower seed
production by 1600 m. However, the GM safflower in the Canadian trial expressed a
pharmaceutical compound that could potentially have adverse effects on humans or animals if
ingested, justifying a large isolation distance. In the USA, field trials of GM safflower expressing
pharmaceutical compound required an even larger isolation distance of 2 miles (3.2 km) to the
nearest commercial safflower crop (USDA-APHIS 2008). APHIS has processed over 25 safflower
permits since 2003 and has found no significant impacts to humans or the environment (USDAAPHIS 2008). In Australia, a relatively small area is planted with safflower crops, less than 10,000
ha per annum (ABARES 2014). In Risk Scenario 3, it was noted that pollen flow might occur not
only to a safflower crop, but also to safflower volunteers if these grow in abundance in the year
after planting of a safflower crop. Based on these considerations, the licence requires that GM
safflower must not be grown within 600 m of either a safflower crop that is not a part of the field
trial, or an area that was planted in the previous 12 months to a safflower crop that was not part of
the field trial. This condition would minimise gene flow to other safflower plants (Risk Scenario 3).
In line with a standard licence condition, the applicant proposes to clean equipment used with
the GMOs on-site before use for any other purpose. Inclusion of this measure as a licence condition
would minimise dispersal of GM material by humans (Risk Scenario 2).
The applicant proposes to clean the trial sites and adjacent areas after harvest by incorporating
plant material into the soil. During sowing and harvesting, plant material could be scattered into the
area immediately surrounding the trial, so there is potential for residual seed to be present in both
the trial site and the monitoring zone. In Risk Scenario 2, it was noted that the area immediately
adjacent to the planting area (the monitoring zone) would be inspected for safflower plants and any
plants found would be destroyed. Thus it is unlikely safflower seed dispersed into this area during
sowing would germinate and persist. In Risk Scenario 2, it was also noted that during the period
between harvest and cleaning, residual seed on the soil surface would be susceptible to dispersal by
animal predation, water runoff after rainfall, or strong winds. Therefore, it is appropriate to require
that cleaning occurs shortly after harvest. An imposed licence condition requires that GMO planting
areas and their associated monitoring zones must be cleaned by ploughing plant material into the
soil within 14 days after harvest of the GMOs.
The applicant proposes regular watering of the trial site post-harvest, to promote germination
of residual seed. Due to the low dormancy of safflower seeds and based on results from DIR 121,
adequate post-harvest soil moisture or rainfall is likely to occur to an extent sufficient to encourage
germination and manage survival and persistence of viable safflower seeds in the soil (Risk
Scenario 2). The requirement that GMO planting areas and their associated monitoring zones must
be irrigated at least once post-harvest during the volunteer-free period has been included as a
licence condition. Irrigation during this period would demonstrate the depletion of any residual GM
safflower seed bank.
The applicant proposes post-harvest monitoring of the trial site and any areas used to clean
equipment for 24 months, destroying any volunteer safflower plants detected before flowering. The
proposed frequency of inspections is monthly, or if no volunteers are found during six consecutive
inspections, reduced to once per three months. As safflower has low dormancy, with buried seeds
reported to have no viability beyond one year (McPherson et al. 2009b), it is considered
unnecessary to inspect the trial sites for as long as two years. Licence conditions require postharvest monitoring and destruction of volunteers at least once every 35 days for at least twelve
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months and until no volunteers are found for at least six months. Records must be kept of
monitoring activities and findings, including number and location of volunteers, which will allow
the Regulator to assess the ongoing suitability of these measures and provide additional information
for future assessments.
In line with a standard licence condition, the applicant proposes that all transport and storage
of GM plant material would comply with the Regulator’s Guidelines for the transport, storage and
disposal of GMOs, available on the OGTR website. These protocols for the handling of GMOs
would minimise exposure of people and other organisms to the GMOs (Risk Scenario 1), and
dispersal of GMOs into the environment (Risk Scenario 2) during transport. Transport and storage
of GM plant material according to the Regulator’s Guidelines has been included as a licence
condition.
Experiments with the GMOs or GM plant material may be conducted in certified physical
containment facilities as Notifiable Low Risk Dealings (NLRDs) in accordance with all appropriate
requirements of the Gene Technology Regulations 2001, and therefore this activity is not covered in
the licence.
The applicant does not propose using any of the GM plant material for human or animal
consumption, and the GM safflower has not been assessed for food use by FSANZ. Therefore, a
condition of the licence prohibits material from the trial from being used for human food or animal
feed.
3.1.2
Summary of licence conditions to be implemented to limit and control the release
A number of licence conditions have been imposed to limit and control the proposed release,
based on the above considerations. These include requirements to:

limit the duration of the field trial to four growing seasons

limit the field trial to 10 trial sites of 5 ha during the first growing season, 15 trial sites of 10
ha each during both the second and third seasons, and 20 trial sites of 25 ha each during the
fourth season

locate trial sites at least 50 m from natural waterways

ensure that no other safflower crops are grown within 600 m of the trial sites

surround each site with a 10 m monitoring zone maintained in a manner that does not attract
or harbour rodents

while the GM safflower is flowering, inspect the monitoring zone and an isolation zone of
190 m (or 50 m if approved by the Regulator) for safflower plants, and destroy any found

use bird netting, bird scarers, decoy crops or another method approved by the Regulator to
deter birds

control rodents

harvest GM safflower separately to other crops

clean equipment prior to removal from the site

destroy all plant materials not required for testing or future trials

promote germination of residual seed by post-harvest tillage and irrigation

monitor for at least 12 months after harvest, and until no volunteer safflower plants are
detected for at least 6 consecutive months, and destroy any safflower plants before flowering

transport and store GM material in accordance with the Regulator’s guidelines

not allow GM plant material or products to be used for human food or animal feed.
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3.2 Other risk management considerations
All DIR licences issued by the Regulator contain a number of conditions that relate to general
risk management. These include conditions relating to:
applicant suitability
contingency plans
identification of the persons or classes of persons covered by the licence
reporting structures
a requirement that the applicant allows access to the trial sites and other places for the
purpose of monitoring or auditing.
3.2.1
Applicant suitability
In making a decision whether or not to issue a licence, the Regulator must have regard to the
suitability of the applicant to hold a licence. Under section 58 of the Act, matters that the Regulator
must take into account include:
any relevant convictions of the applicant (both individuals and the body corporate)
any revocation or suspension of a relevant licence or permit held by the applicant under a law
of the Commonwealth, a State or a foreign country
the capacity of the applicant to meet the conditions of the licence.
On the basis of information submitted by the applicant and records held by the OGTR, the
Regulator considers the CSIRO suitable to hold a licence.
The licence includes a requirement for the licence holder to inform the Regulator of any
circumstances that would affect their suitability. 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
CSIRO 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 safflower lines outside of the permitted areas.
CSIRO is also required to provide a method to the Regulator for the reliable detection of the
presence of the GMOs and the introduced genetic materials in a recipient organism. This instrument
is required before planting of the GMOs.
3.2.3
Identification of the persons or classes of persons covered by the licence
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, CSIRO is also 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
The licence obliges the licence holder to immediately report any of the following to the
Regulator:
any additional information regarding risks to the health and safety of people or the
environment associated with the trial
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any contraventions of the licence by persons covered by the licence
any unintended effects of the trial.
A number of written notices are also required under the licence that would assist the Regulator
in designing and implementing a monitoring program for all licensed dealings. The notices would
include:
expected and actual dates of planting
details of areas planted to the GMOs
expected dates of flowering
expected and actual dates of harvest and cleaning after harvest
details of inspection activities.
3.2.5
Monitoring for Compliance
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.
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.
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 releases
Additional information has been identified that may be required to assess an application for a
large scale or commercial release of these GM safflower lines, or to justify a reduction in
containment conditions. This includes:
additional molecular and biochemical characterisation of the GM safflower lines,
particularly with respect to production of potential toxins or allergens
additional phenotypic characterisation of the GM safflower lines, particularly with respect to
traits that may contribute to weediness
additional information on long distance gene flow for safflower.
Section 5 Conclusions of the RARMP
The risk assessment concluded that this proposed limited and controlled release of GM
safflower 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.
However, conditions have been imposed to limit the release to the proposed size, locations
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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Steiner, H.Y., Halpin, C., Jez, J.M., Kough, J., Parrott, W., Underhill, L., Weber, N., Hannah,
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37
DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Office of the Gene Technology Regulator
Appendix A Summary of submissions from
prescribed experts, agencies and
authorities6
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.
Abbreviations:; GM: Genetically Modified; RARMP: Risk Assessment and Risk
Management Plan.
Sub.No:
Summary of issues raised
Comment
1
Council is grateful for opportunity but
notes the lack of scientific expertise to
comment on the RARMP.
Noted
2
Notes Council will not be submitting
comments on this application.
Noted
3
Noted that the RARMP was circulated
for comment and no adverse comments
were received. Indicated no objection to
the issue of a licence for DIR 131.
Noted
4
Noted no evident difficulties or problems Noted
associated with this release, particularly
given the small scale of production.
5
Noted agreement with the RARMP that Noted
this release poses negligible risks to
human health and safety or to the
environment where conducted under the
proposed limits and controls.
6
Supported the conclusions of the
RARMP that the proposed dealings
posed negligible risks to human health
and safety or to the environment.
Noted
7
Noted that given the control measures,
the limited scale and duration of the
release, the environmental risks posed
by the trial of the GM safflower lines are
likely to be low and manageable.
Noted
Noted that according to McPherson et al
(2004) safflower is one of the most
serious, difficult and costly thistle weeds
in New South Wales.
McPherson et al. (2004) is referring to Carhamus lanatus as a
serious weed, whereas safflower (Carthamus tinctorius) the
subject of the proposed release, is considered a minor weed
that primarily establishes on disturbed ground (Chapter 1,
section 6.3)
6
Prescribed agencies include GTTAC, State and Territory Governments, relevant local governments, Australian
Government agencies and the Minister for the Environment.
Appendix A
38
DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Sub.No:
8
9
Appendix A
Office of the Gene Technology Regulator
Summary of issues raised
Comment
Indicated that the RARMP would be
improved if it addressed possible
hazards from traits that could provide
competitive advantage to wild safflower
and related species.
The GM safflower is highly unlikely to successfully cross
pollinate with any other species under natural conditions.
Crosses made under artificial conditions tend to be sterile and
often require intervention such as embryo rescue and treatment
with colchicine. The introduced traits (increased oleic acid
content in the seed & selectable markers) are not known to
enhance weediness in plants. The licence conditions imposed
will minimise outcrossing and persistence of any offspring
(Chapter 1, section 6.3 and Chapter 2, sections 2.4.2 & 2.4.3).
Indicated phenotypic changes in GM
Arabidopsis plants modified to disrupt
the FATB gene (see Bonaventure et al.
(2003)). Expression of FATB gene is
also modified in the GM safflower
plants.
In light of the Bonaventure paper, it is
considered the RARMP is lacking in
specific details on how and what
phenotypic data was collected on the
GM safflower plants.
The Bonaventure article examined disruption of FATB
expression in Arabidopsis. The phenotypic changes in the GM
Arabidopsis noted in this article included: ~50% reduction in
plant size & fresh weight at the four-week stage, delayed
flowering by 2 weeks, shorter stems and ~50% reduction in
seed germination. Approximately 20% of the seed were very
deformed and had a germination rate of 16%. It is unlikely that
any of the above changes could lead to an increase in
weediness of the GM Arabidopsis plants compared to the nonGM parental plants.
The applicant has indicated that the GM safflower lines
proposed for release have been examined over several
generations, some lines up to the 5th generation. The GM lines
have been grown in glasshouses and/or in field trials under
DIR121. Observations on these plants indicate no phenotypic
differences between the GM and non-GM safflower for
germination rate, seed count per plant, time to flowering, plant
height and fertility (Chapter 1, section 5.4, Chapter 2, section
2.4.2). Such gross phenotypic changes observed in the GM
Arabidopsis would be difficult to overlook if they had occurred in
the GM safflower.
The proposed trial will provide further phenotypic data on the
GM safflower lines under a variety of Australian agricultural
environments.
Agrees with the identified uncertainty
and thus has indicated a desire for more
specific guidance on future data
requirement, especially on traits related
to increased weediness such as:
 relative growth rates, including
early vigour
 effect of introduced traits on grain
size, altered root structure and root
depth
 seed dormancy and germination
 disease resistance
 other characteristics of weediness
such as shattering, seed dispersal
or seed longevity.
Is supportive of the application as the
consultation RARMP indicates that the
proposed release poses negligible risks
to people or the environment.
The RARMP indicates areas of uncertainty and issues to be
addressed for future releases (Chapter 2, sections 3 & 4,
Chapter 3, Section 4). The issues raised by the submitter would
be addressed under the second dot point in Chapter 3, section
4:
 additional phenotypic characterisation of the GM safflower
lines, particularly with respect to traits that may contribute to
weediness
Rather than specifying particular experiments or data
requirements, RARMPs provide broad guidance on areas of
uncertainty to be addressed in possible future applications
larger scale or commercial release. However, the OGTR does
routinely discuss specific information requirements with
applicants prior to submission of such an application.
Agrees with the overall conclusions of
the RARMP
Noted
Noted
39
DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Sub.No:
Summary of issues raised
Comment
The Regulator should consider whether
the proposed limits are appropriate for
this trial and whether larger trial sites
can be adequately managed
The size and number of trial sites, as well as the proposed limits
and controls all formed part of the risk context (Chapter 1) and
were taken into account when assessing risks (Chapter 2) and
the appropriateness of these measures in managing any
identified risks (Chapter 3).
The risk assessment concluded that this proposed limited and
controlled release of GM safflower 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.
However, conditions have been imposed to limit the release to the
proposed size, locations 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.
Noted, inconsistencies corrected as appropriate.
Some minor inconsistencies in the
RARMP were noted.
Appendix A
Office of the Gene Technology Regulator
40
DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Office of the Gene Technology Regulator
Appendix B Summary of submissions from the
public
The Regulator received 3 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.
Issues raised: C: containment; H: Health; M: Marketing.
Other abbreviations: FSANZ: Food Standards Australia New Zealand; GM: Genetically
modified; RARMP: risk assessment and risk management plan.
Sub. Issue
No:
1
2&3
Summary of issues raised
Comment
C
Objects to the number of trial sites with no
proof of the ability of the applicant to
decontaminate (clean) the sites.
Licence conditions allow field trials of the GM safflower at
up to a total of 60 sites on a maximum cumulative area of
850 ha over a 4 year period. However, the number of sites
allowed per year and the size of the sites rises over the
four year period from 5 sites of a maximum of 10 ha each,
to 20 sites of 25 ha each in the final year. Thus, as some
sites will meet post-harvest requirements and be signed off
each year, it is unlikely that the applicant will deal with 60
sites at one time. Licence conditions for DIR 131 require
the licence holder to provide the Regulator with inspection
reports on the trials as they progress and during the postharvest monitoring phase. Additionally, OGTR inspectors
will visit trial sites to ensure the licence holder is compliant
with licence conditions. The sites will only be signed off
once the Gene Technology Regulator (the Regulator) is
satisfied that no GM safflower material remains.
H
The high oleic levels may have negative
impacts for human health.
As this application is for a limited and controlled release
(field trial), a licence condition has been imposed to prohibit
GM plant material or products being used for human food
or animal feed. Currently non-GM high oleic acid (70-80%)
safflower cultivars are grown in Australia. Oils high in oleic
acid are used as cooking oils and in cosmetics and infant
food formulations. FSANZ is responsible for human food
safety assessment and would have to approve the use of
GM safflower or products derived from it prior to their use
for human food.
C
Does not see the point of ‘restricting’ the
spread and persistence of the GMOs because
if any of the GMOs were uncontained their
populations and cross-populations may
increase at any time regardless of how many
were released.
Strict licence conditions have been imposed to limit the
area and duration of the trial, as well as to restrict the
spread and persistence of the GMOs beyond the trial.
These include obligations on the licence holder to monitor
for and destroy any GMOs remaining in the environment
following the trial. The genetic modifications are unlikely to
increase the weediness of the GM safflower plants as the
genetic modifications provide no known selective
advantage compared to non-GM safflower.
-
Object to trials of GM safflower oil unless they
are in a securely confined place. Suggest
rejecting DIR 131.
Noted.
Appendix B
41
DIR 131 – Risk Assessment and Risk Management Plan (February 2015)
Office of the Gene Technology Regulator
H
Health safety studies have not been done, so
these GM organisms should not be released to
the open-air environment until animal feeding
studies and human clinical trials have been
done which would test for toxicity and
allergenicity responses.
As this application is for a limited and controlled release
(field trial), a licence conditions has been imposed to
prohibit GM plant material or products being used for
human food or animal feed. FSANZ is responsible for
human food safety assessment and would have to approve
the use of GM safflower or products derived from it prior to
their use for human food.
H
Fish and seafood are well-known triggers for
allergic, even anaphylactic reactions. To force
jellyfish genes into the safflower DNA may
cause catastrophic side-effects in some people
when ingested, inhaled or absorbed through
the skin.
The gfp gene (derived from jellyfish) and its products have
been considered in detail in previous RARMPs (for
example DIR 096/2009) and assessed as posing negligible
risk to human or animal health or to the environment by the
Regulator. As indicated in Chapter 2, section 2.1 of the
RARMP, further information about this gene can be found
in the document ‘Marker genes in GM plants’ available
from the Risk Assessment References page on the OGTR
website. See also response to issue above.
C
There is a history of pollen and GMOs
escaping from GMO trials, which OGTR must
consider
Strict licence conditions have been imposed to restrict the
spread of the GMOs and their genetic material. These
include conditions to isolate trial sites from other safflower
plants, cleaning of equipment used with GM plants, secure
transport and storage of GM plant material, and obligations
on the licence holder to monitor for and destroy any GMOs
remaining in the environment following the trial.
M
Questioned the demand for GM safflower that
contains animal or bacterial genes and stated
that Australians do not want to consume
anything transgenic (submitter 2 only).
The Act requires the Regulator to identify and manage
risks to human health and safety and the environment
posed by or as a result of gene technology. Matters related
to marketing or consumer preferences are outside the
Regulator’s legislative responsibility. These matters are
addressed by the States and Territories and industry.
Appendix B
42