Risk Assessment and
Risk Management Plan for
DIR 120
Limited and controlled release of cotton
genetically modified for insect resistance and herbicide
tolerance
Applicant: Monsanto Australia Ltd
July 2013
PAGE INTENTIONALLY LEFT BLANK
DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Office of the Gene Technology Regulator
Summary of the Risk Assessment and Risk
Management Plan
for
Licence Application No. DIR 120
Decision
The Gene Technology Regulator (the Regulator) has decided to issue a licence for this
application for a limited and controlled release of a genetically modified organism (GMO) into
the environment. A Risk Assessment and Risk Management Plan (RARMP) for this
application was prepared by the Regulator in accordance with requirements of the Gene
Technology Act 2000 (the Act) and corresponding state and territory legislation, and finalised
following consultation with a wide range of experts, agencies and authorities, and the public.
The RARMP concludes that this field trial poses negligible risks to human health and safety
and the environment and that any risks posed by the dealings can be managed by imposing
conditions on the release.
The application
Application number
DIR 120
Applicant
Monsanto Australia Ltd (Monsanto)
Project title
Limited and controlled release of cotton genetically modified for
insect resistance and herbicide tolerance
Parent organism
Cotton (Gossypium hirsutum)
 vip3A(a) (vegetative insecticidal protein 3A) synthetic gene
derived from a gene from the bacterium Bacillus thuringiensis
(insect resistance)
 cry1Ac (crystal protein 1Ac) gene from B. thuringiensis (insect
resistance)
 cry2Ab (crystal protein 2Ab) gene from B. thuringiensis
(insect resistance)
 cp4 epsps (5-enolpyruvylshikimate-3-phosphate synthase)
gene from the bacterium Agrobacterium sp. strain CP4
(herbicide tolerance)
 bar (phosphonithricin N-acetyltransferase) gene from the
bacterium Streptomyces hygroscopicus (herbicide tolerance)
 dmo (demethylase) gene from the bacterium Stenotophomonas
maltophilia (herbicide tolerance)
Sites selected from 56 possible local government areas (LGAs) in
Western Australia, NSW and Queensland
Introduced gene and
modified trait
Proposed location
Proposed release size
Up to 10 sites per year in the first two years, at a maximum area
of 10 hectares (ha) per site, and up to 20 sites per year in the
remaining four years, at a maximum area of 30 ha per site
Proposed release dates
October 2013 – October 2019
Primary purpose
To assess the agronomic performance of the GM cottons under
Australian field conditions and generate data for possible future
commercial release
Summary
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DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Office of the Gene Technology Regulator
Risk assessment
The risk assessment concludes that risks to the health and safety of people, or the environment,
from the proposed release are negligible.
The risk assessment process considered how the genetic modification and activities conducted
with the GMOs might lead to harm to people or the environment. Risks were characterised in
relation to both the seriousness and likelihood of harm, taking into account information in the
application (including proposed limits and controls), relevant previous approvals, current
scientific/technical knowledge, and advice provided in submissions received from experts,
agencies, authorities and the public during consultation on the RARMP. Both the short and
long term were considered.
Credible pathways to potential harm that were considered included: unintended exposure to the
GM plant material; unintended effects of the genetic modification; increased spread and
persistence of the GM cotton relative to unmodified plants; and transfer of the introduced
genetic material to other cottons or other sexually compatible plants. Potential harms
associated with these pathways included toxicity to people and other animals, allergic reactions
in people and environmental harms associated with weediness. No new risks to people or the
environment were identified from the advice received on the consultation RARMP.
The principal reasons for the conclusion of negligible risks are that the proposed limits and
controls effectively contain the GMOs and their genetic material and minimise exposure; the
introduced genetic modifications are unlikely to cause harm to people or the environment; and
genes similar to the introduced genes are common in the environment.
Risk management plan
The risk management plan concludes that risks posed by the proposed dealings can be managed
so as to protect people and the environment by imposing conditions on the release. Risk
management is used to control or mitigate risk. The risk management plan evaluates and treats
identified risks, evaluates controls and limits proposed by the applicant, and considers general
risk management measures. The risk management plan is given effect through licence
conditions.
As the level of risk is assessed as negligible, specific risk treatment is not required. However,
as this is a limited and controlled release, the licence includes limits on the size, location and
duration of the release, as well as controls including: containment provisions at the trial site;
prohibiting the use of GM plant materials in human food or animal feed; destroying GM plant
materials (other than lint) not required for further studies; transporting GM plant materials in
accordance with the Regulator’s guidelines or other specific conditions; and conducting postharvest monitoring at the trial site to ensure all GMOs are destroyed.
Summary
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DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Office of the Gene Technology Regulator
Table of Contents
SUMMARY OF THE RISK ASSESSMENT AND RISK MANAGEMENT PLAN........................................... I
DECISION
........................................................................................................................................................ I
THE APPLICATION ................................................................................................................................................... I
RISK ASSESSMENT ................................................................................................................................................. II
RISK MANAGEMENT PLAN ..................................................................................................................................... II
TABLE OF CONTENTS ....................................................................................................................................... III
ABBREVIATIONS ................................................................................................................................................ IV
CHAPTER 1
RISK ASSESSMENT CONTEXT .............................................................................................. 5
SECTION 1
SECTION 2
SECTION 3
3.1
3.2
SECTION 4
SECTION 5
SECTION 6
6.1
6.2
6.3
SECTION 7
7.1
7.2
7.3
7.4
7.5
SECTION 8
8.1
8.2
BACKGROUND ................................................................................................................................ 5
REGULATORY FRAMEWORK ............................................................................................................ 5
THE PROPOSED DEALINGS ............................................................................................................... 6
The proposed limits of the dealings (size, location, duration and people) ..................................... 6
The proposed controls to restrict the spread and persistence of the GMOs and their genetic
material in the environment ............................................................................................................ 7
THE PARENT ORGANISM .................................................................................................................. 7
THE GM PARENTAL COTTONS ......................................................................................................... 8
THE GMOS, NATURE AND EFFECT OF THE GENETIC MODIFICATION ................................................ 8
Introduction to the GMOs .............................................................................................................. 8
The introduced genes, encoded proteins and their associated effects ........................................... 10
Characterisation of the GMOs ...................................................................................................... 13
THE RECEIVING ENVIRONMENT ..................................................................................................... 13
Relevant abiotic factors ................................................................................................................ 13
Relevant biotic factors .................................................................................................................. 14
Relevant agricultural practices ..................................................................................................... 14
Presence of related plants in the receiving environment .............................................................. 14
Presence of similar genes and encoded proteins in the environment............................................ 15
AUSTRALIAN AND INTERNATIONAL APPROVALS .......................................................................... 15
Australian approvals of GM cotton .............................................................................................. 15
International approvals of GM cotton .......................................................................................... 16
CHAPTER 2
RISK ASSESSMENT ................................................................................................................ 18
SECTION 1
SECTION 2
2.1
2.2
2.3
SECTION 3
SECTION 4
INTRODUCTION ............................................................................................................................. 18
RISK IDENTIFICATION ................................................................................................................... 19
Production of a substance toxic or allergenic to people or toxic to other organisms ................... 21
Weediness of the GM cotton plants in the environment............................................................... 24
Vertical transfer of the gene or genetic elements to sexually compatible plants .......................... 27
RISK ESTIMATE PROCESS AND ASSESSMENT OF SIGNIFICANT RISK ................................................ 29
UNCERTAINTY .............................................................................................................................. 30
CHAPTER 3
RISK MANAGEMENT PLAN ................................................................................................. 31
SECTION 1
SECTION 2
SECTION 3
3.1
3.2
SECTION 4
SECTION 5
BACKGROUND .............................................................................................................................. 31
RISK TREATMENT MEASURES FOR IDENTIFIED RISKS ..................................................................... 31
GENERAL RISK MANAGEMENT ...................................................................................................... 31
Licence conditions to limit and control the release ...................................................................... 31
Other risk management considerations ........................................................................................ 35
ISSUES TO BE ADDRESSED FOR FUTURE RELEASES......................................................................... 36
CONCLUSIONS OF THE RARMP .................................................................................................... 37
REFERENCES ..................................................................................................................................................... 38
APPENDIX A SUMMARY OF SUBMISSIONS FROM PRESCRIBED EXPERTS, AGENCIES AND
AUTHORITIES ......................................................................................................................... 42
APPENDIX B
Table of Contents
SUMMARY OF SUBMISSIONS FROM THE PUBLIC ....................................................... 44
III
DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Office of the Gene Technology Regulator
Abbreviations
the Act
aad
aph4
APHIS
APVMA
Bt
CaMV
Cry
CSIRO
CTP
DAFF
DIR
DNA
EFSA
EPSPS
FMV
FSANZ
GM
GMO
GTTAC
ha
HGT
LGA
m
mRNA
NAG
PC1SV
RARMP
Regulations
Regulator
T-DNA
TEV
Abbreviations
Gene Technology Act 2000
3”(9)-O-aminoglycoside adenyltransferase gene
hygromycin B phosphotransferase gene
Animal and Plant Health Inspection Service (USDA)
Australian Pesticides and Veterinary Medicines Authority
Bacillus thuringiensis
Cauliflower mosaic virus
Crystal protein
Commonwealth Scientific and Industrial Research Organisation
Chloroplast transit peptide
Department of Agriculture, Fisheries and Forestry
Dealings Involving intentional Release
Deoxyribonucleic Acid
European Food Safety Authority
5-enolpyruvylshikimate-3-phosphate synthase
Figwort mosaic virus
Food Standards Australia New Zealand
Genetically Modified
Genetically Modified Organism
Gene Technology Technical Advisory Committee
Hectare
Horizontal gene transfer
Local government area
metre
Messenger Ribonucleic Acid
N-Acetyl glufosinate
Peanut chlorotic streak caulimovirus
Risk Assessment and Risk Management Plan
Gene Technology Regulations 2001
Gene Technology Regulator
Transfer DNA
Tobacco etch virus
IV
DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Chapter 1
Section 1
Office of the Gene Technology Regulator
Risk assessment context
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 parameters within which potential risks to the health and
safety of people or the environment posed by the proposed release are assessed. The risk
assessment context is established within the regulatory framework and considers applicationspecific 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.
Section 2
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
Regulatory framework
In accordance with section 50A of the Gene Technology Act 2000 (the Act), this
application is considered to be a limited and controlled release application, as its principal
purpose is to enable the applicant to conduct experiments and the applicant has proposed limits
on the size, location and duration of the release, as well as controls to restrict the spread and
persistence of the GMOs and their genetic material in the environment. Therefore, the Gene
Technology Regulator (the Regulator) was not required to consult with prescribed experts,
agencies and authorities before preparation of the Risk Assessment and Risk Management Plan
(RARMP; see section 50 of the Act).
Section 51 of the Act and regulation 9A of the Regulations outline the matters the
Regulator must take into account in preparing a RARMP.
Chapter 1 – Risk assessment context
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DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Office of the Gene Technology Regulator
Section 52 of the Act requires the Regulator to seek comment on the RARMP from the
States and Territories, the Gene Technology Technical Advisory Committee, Commonwealth
authorities or agencies prescribed in the Regulations, the Minister for the Environment,
relevant local council(s), and the public. The advice from the prescribed experts, agencies and
authorities and how it was taken into account is summarised in Appendix A. Four public
submissions were received and their consideration is summarised in Appendix B.
The Risk Analysis Framework (OGTR 2009) explains the Regulator’s approach to the
preparation of RARMPs in accordance with the legislative requirements. Additionally, there
are a number of operational policies and guidelines developed by the Office of the Gene
Technology Regulator (OGTR) that are relevant to DIR licences. These documents are
available from the OGTR website.
Any dealings conducted under a licence issued by the Regulator may also be subject to
regulation by other Australian government agencies that regulate GMOs or GM products,
including Food Standards Australia New Zealand (FSANZ), Australian Pesticides and
Veterinary Medicines Authority (APVMA), Therapeutic Goods Administration, National
Industrial Chemicals Notification and Assessment Scheme and Department of Agriculture,
Fisheries and Forestry (DAFF) Biosecurity (formerly Australian Quarantine Inspection
Service). These dealings may also be subject to the operation of State legislation declaring
areas to be GM, GM free, or both, for marketing purposes.
Section 3
The proposed dealings
Monsanto Australia Ltd (Monsanto) proposes to release genetically modified (GM)
cottons into the environment under limited and controlled conditions.
The purpose of the trial is to assess the agronomic performance of the GM cotton under
Australian field conditions and generate data for possible future commercial release. As well as
assessing the GM cottons under Australian field conditions, the combined (or ‘stacked’) traits
will also be introduced into Australian elite cotton varieties.
The dealings involved in the proposed intentional release would include:
conducting experiments with the GMOs
propagating, growing, raising or culturing the GMOs
breeding the GMOs
transporting the GMOs
storing the GMOs
disposing of the GMOs
possession, supply or use of the GMOs for the purposes of any of the above.
These dealings are detailed further below.
3.1 The proposed limits of the dealings (size, location, duration and people)
The applicant proposes to conduct the trial over 6 growing seasons from October 2013 to
October 2019 and to limit the trial to ten sites/year for the first two years of the trial, and up to
20 sites/year thereafter. Sites will be nominated from 56 local government areas (LGAs) in
Western Australia, NSW and Queensland (Table 1) and each site is proposed to be up to 10 ha
in area for the first two years and up to 30 ha for the remaining four years.
Chapter 1 – Risk assessment context
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DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Table 1
Office of the Gene Technology Regulator
Local government areas proposed for field planting of the GMOs
Western Australia
Wyndham-East Kimberley
Broome
New South Wales
Balranald
Jerilderie
Berrigan
Lachlan
Bland
Leeton
Bogan
Liverpool Plains
Bourke
Moree Plains
Brewarrina
Murray
Carrathool
Murrumbidgee
Central Darling
Narrabri
Coolamon
Narrandera
Coonamble
Narromine
Conargo
Parkes
Deniliquin
Mildur
Forbes
Urana
Gilgandra
Walgett
Griffith
Wagga Wagga
Gunnedah
Warren
Gwydir
Warrumbungle
Hay
Weddin
Inverell
Young
Queensland
Balonne
Banana
Bundaberg Regional
Burdekin
Central Highlands
Goondiwindi Regional
Isaac Regional
Lockyer Valley Regional
Maranoa Regional
Paroo
Rockhampton Regional
South Burnett Regional
Southern Downs Regional
Toowoomba Regional
Western Downs Regional
Whitsunday Regional
Only trained and authorised staff would be permitted to deal with the GM cottons.
3.2 The proposed controls to restrict the spread and persistence of the GMOs
and their genetic material in the environment
The applicant has proposed a number of controls to restrict the spread and persistence of
the GM cottons and the introduced genetic material in the environment. These include:
locating trial sites at least 50 m away from natural waterways
separating trial sites from other cotton crops by either an exclusion zone of 1 km or
with a 20 m pollen trap of non-GM or commercially released GM cotton
cleaning all planting and harvest equipment used at field planting sites of GM material
harvesting and ginning cotton from the trial separately from other cotton
cultivating field planting sites after harvest to encourage decomposition or germination
of remaining seed
post-harvest monitoring and destruction of any volunteer cotton at field planting sites
for at least 12 months and until sites have been free of volunteers for six months
destroying all plant material from the trial not required for testing or future trials, except
for lint which may be sold
transporting and storing the GMOs in accordance with the Regulator’s Guidelines for
the Transport, Storage and Disposal of GMOs (2011)
not using GM plant material or products for human food or animal feed.
These controls, and the limits outlined in Section 3.2, have been taken into account in
establishing the risk assessment context (this chapter), and their suitability for containing the
proposed release is evaluated in Chapter 3, Section 3.1.1.
Section 4
The parent organism
The parent organism is cultivated cotton (Gossypium hirsutum L.), which is the most
commonly cultivated cotton species worldwide. Cotton is exotic to Australia and is grown as
Chapter 1 – Risk assessment context
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Office of the Gene Technology Regulator
an agricultural crop in New South Wales and in southern and central Queensland, and on a trial
basis in northern Queensland, northern Western Australia and in the Northern Territory.
Almost 99.5% of the Australian cotton crop is genetically modified (DAFWA). Roundup
Ready Flex® cotton currently occupies about 97per cent of total cotton area, most of it stacked
with the Bollgard II® trait (CSIRO 2010).
Cotton is grown as a source of textile and industrial fibre, cottonseed oil for food use, and
cottonseed meal for animal feed. Further detailed information about the parent organism is
contained in a reference document, The Biology of Gossypium hirsutum L. and Gossypium
barbadense L. (cotton), which was produced to inform the risk assessment process for licence
applications involving GM cotton plants (OGTR 2013). The document is available from the
OGTR or from the OGTR website.
The GM cottons proposed for release were developed in G. hirsutum cultivars Coker 130
or Coker 312. These cultivars have been grown commercially in the United States but have not
been commercialised in Australia. They were chosen for development of the GM cottons
because of their positive response under tissue culture conditions and ready modification by
standard genetic technologies. The genetic modifications have subsequently transferred into a
range of G. hirsutum cultivars by conventional crossing.
Section 5
The GM parental cottons
The GMOs proposed for release are the result of combination by conventional crossing
of GM cotton containing any of the following four GM events1:




MON 88701: Dicamba- and glufosinate-tolerant cotton
MON 88913: Roundup Ready Flex® cotton (glyphosate tolerant)
MON 15985: Bollgard II® cotton (insect resistant) 2
COT 102: VIP3A cotton (insect resistant).
In addition to non-GM cotton, information on these GM cottons will be used as baselines
where relevant throughout the RARMP. The genetic modifications of the GM parental cottons
and other information relevant to the risk assessment are described in Section 6.
Section 6
The GMOs, nature and effect of the genetic
modification
6.1 Introduction to the GMOs
The GM parental cottons were produced by Agrobacterium tumefaciens mediated plant
transformation and/or biolistic bombardment. Information about these transformation methods
can be found in the risk assessment reference document Methods of plant genetic modification
available from the Risk Assessment References page on the OGTR website.
The applicant proposes to release GM cottons which combine MON 88701 (containing
genes for dicamba and glufosinate herbicide tolerance) with one or more of the following:
commercially approved Roundup Ready Flex® GM cotton (glyphosate herbicide tolerant);
commercially approved Bollgard II® GM cotton (insect resistant); orVIP3A GM cotton (insect
resistant). The GM cottons proposed for release will be generated by conventional crossing of
1
A GM event refers to a single unique genetic modification (ie change to the genetic material of an organism)
resulting from a single transformation.
2
Bollgard II® cotton itself contains two independent GM events.
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Office of the Gene Technology Regulator
these GM parental cottons, and could include any of the combinations shown in Table 2. The
genes present in each of the parental cottons are listed in Table 3.
Table 2
GM cottons proposed for field trial
GM event
MON 88701
Common name
Dicamba- and glufosinate- tolerant cotton
MON 88913 x MON 88701
Roundup Ready Flex® x Dicamba- and glufosinate- tolerant
cotton
Bollgard II® x Roundup Ready Flex® x Dicamba- and
glufosinate- tolerant cotton
Bollgard II® x VIP 3A* x Roundup Ready Flex® x Dicambaand glufosinate- tolerant cotton
MON 15985 x MON 88913 x MON 88701
MON 15985 x COT 102 x MON 88913 x MON 88701
*Bollgard II® x VIP 3A cotton is also referred to as Bollgard III® cotton
Table 3
Introduced genes in the GMOs proposed for release
GM event
MON 88701
MON 88913 (Roundup Ready Flex®)
MON 15985 (Bollgard II®)
COT 102 (VIP3A)
Gene
dmo
bar
cp4 epsps
cp4 epsps
cry1Ac
nptII
aad
cry2Ab
uidA
vip3A
aph4
Function
dicamba herbicide tolerance
glufosinate herbicide tolerance
glyphosate herbicide tolerance
glyphosate herbicide tolerance
insect resistance
antibiotic resistance
antibiotic resistance
insect resistance
reporter
insect resistance
antibiotic resistance
Cotton events COT 102, MON 15985 and MON 88913, alone and in combination, have
been the subject of previous applications for DIR licences (see Section 8.1 and summary
Table 5). Detailed descriptions of the individual events can be found in the RARMPs prepared
for those releases and therefore will not be reiterated here. Assessments of Bollgard II® and
Roundup Ready Flex® GM cottons in the context of commercial release throughout Australia
concluded that they pose negligible risks to human health and safety and the environment.
MON 88701 cotton has not been previously assessed by the OGTR. However, the bar
gene has been described and assessed in detail in a number of RARMPs, including that
prepared for the commercial release of LibertyLink® cotton (Table 5). The dmo gene has not
been the subject of any previous DIR licence application in Australia. Consequently, the focus
of the current assessment is MON88701 cotton, individually and in combination with the other
GM parental cottons. Details of the genetic elements used to develop this event are shown in
Table 4.
In addition to genes conferring insect resistance and herbicide tolerance, the GM parental
cottons contain antibiotic resistance genes and a reporter gene (Table 3) as well as short
regulatory elements used to control expression of the genes. The GMOs proposed for trial will
be generated by conventional crossing, so all of the genetic modifications present in the
parental GM cottons could potentially be present. These sequences are derived from plants
(including thale cress, pea, petunia and soybean), a soil bacterium (A. tumefaciens) and plant
viruses (CaMV, FMV, PC1SV and TEV). The 35S sequence derived from FMV and CaMV
promoters are short variants of the promoter containing a duplicate enhancer region (Kay et al
1987).
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Additional information relevant to the genetic modifications in GM cotton event MON
88701 has been declared CCI. The confidential information was available to the prescribed
experts and agencies that are consulted on the RARMP for this application.
Table 4
Genes and regulatory elements used to genetically modify cotton event MON 88701
Genetic element
Gene sequences
dmo
Full name
Source organism / further description
dicamba O-demethylase
bar
Phosphinothricin N-acetyl
transferase
Stenotrophomonas maltophilia. The gene has been codon
optimised for expression in plants.
Streptomyces hygroscopicus
Promoters
PC1SV
PC1SV promoter
e35S
CaMV 35S promoter
Constitutive promoter from full length transcript of peanut
chlorotic streak caulimovirus (PC1SV)
Promoter for the 35S RNA of Cauliflower mosaic virus
(CaMV) containing duplicated enhancer region.
Terminators
E6
nos
3’ untranslated sequence of the
E6 gene
3’ untranslated sequence of the
nopaline synthase gene
Gossypium barbadense
5’ untranslated leader from RNA
of tobacco etch virus.
Chloroplast transit peptide from
the epsps gene
5’ untranslated leader of the heat
shock protein 70 gene
Tobacco etch virus (TEV). Assists in regulating gene
expression
Arabidopsis thaliana (thale cress). The peptide directs
transport of the DMO protein to the chloroplast.
Petunia x hybrida (petunia). Assists in regulating gene
expression.
Agrobacterium tumefaciens
Other elements
TEV
Ctp2
HSP70
6.2 The introduced genes, encoded proteins and their associated effects
The genes introduced into the parental GM cottons are briefly described in the following
section (6.2.1). However, subsequent discussion of the encoded proteins and their effects will
focus on MON 88701, as this event has not been the subject of earlier assessments by the
Regulator. For more detailed information on the genetic material (genes and regulatory
elements) and inherent toxicity or allergenicity of COT 102, MON 15985 and MON 88913,
refer to previous RARMPs prepared for the DIRs listed in Section 8 (Table 5), which are
available on the OGTR website.
6.2.1
The introduced genes
Introduced genes in event MON 88701
MON 88701 contains a dmo gene and a bar gene, which confer tolerance to the
herbicides dicamba (2- methoxy-3,6-dichlorobenzoic acid) and glufosinate ammonium,
respectively.
The dmo gene was derived from the aerobic, environmentally ubiquitous gram negative
bacterium Stenotrophomonas maltophilia strain DI-6 (Herman et al. 2005). The dmo
expression cassette encodes a precursor protein consisting of a single polypeptide of 416 amino
acids. The mature protein is a dicamba mono-oxygenase that has high specificity for its
substrate (D'Ordine et al. 2009; Dumitru et al. 2009) and rapidly demethylates dicamba to the
herbicidally inactive metabolite 3,6-dichlorosalicylic acid (DCSA) and formaldehyde.
Enzymes with structural and functional homologies to MON 88701 DMO have been described
in a number of plants and bacteria, and bioinformatic information provided by the applicant
shows sequence identities ranging from 42% in bacteria to 27% in crops such as canola, corn,
pea, rice and soy.
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The bar gene was isolated from Streptomyces hygroscopicus (Thompson et al. 1987), a
common saprophytic, soil-borne microorganism that is not considered to be a pathogen of
plants, humans, or other animals (OECD 1999). The bar expression cassette encodes a
phosphinothricin N-acetyl transferase (PAT) protein, consisting of a single polypeptide of 183
amino acids (Thompson et al. 1987) that confers tolerance to glufosinate ammonium, the active
component in a number of herbicides. The PAT protein expressed in MON 88701 is identical
to the naturally occurring protein produced in S. hygroscopicus and is highly homologous to
the proteins in commercially available glufosinate-tolerant GM crops.
Introduced genes in event MON 88913
MON 88913 contains two copies of the cp4 epsps gene, derived from the Agrobacterium
strain CP4, a common soil-borne bacterium (Padgette et al. 1996). The gene encodes a
glyphosate tolerant EPSP synthase enzyme and has been extensively used to develop GM
plants with glyphosate tolerance (Dill 2005).
Introduced genes in event MON 15985
MON 15985 contains the cry1Ac and cry2Ab genes derived from Bacillus thuringiensis
subsp kurstaki, a gram positive bacterium commonly present in soil. The genes encode
insecticidal proteins that are specifically toxic to caterpillar larvae of certain species of
lepidopteran insects, including significant pests of cotton.
Introduced genes in event COT 102
The insecticidal gene vip3A from COT 102 is also derived from B. thuringiensis
subspecies kurstaki. It encodes the insecticidal protein VIP3A, which is toxic to caterpillar
larvae of certain lepidopteran insect species.
6.2.2
Regulatory elements
Promoters are DNA sequences that are required in order to allow RNA polymerase to
bind and initiate correct transcription. Also required for gene expression in plants are mRNA
terminators, including a poly-adenylation signal. Other regulatory sequences, such as
enhancers, may contribute to the expression pattern of a given gene. Details of the regulatory
sequences used in GM parental cottons MON88913, MON 15985 and COT 102 can be found
in the corresponding DIR RARMPs (see Table 5 in Section 8, below), and for MON 88701 in
Table 4. The regulatory elements present in all the parental cottons have been previously
assessed as safe by the OGTR and other international agencies and the information is reviewed
and updated as necessary.
Recently, there has been public commentary suggesting that protein P6, encoded by gene
VI of the Caulimovirus and Soymovirus families, could result in harm to humans if expressed
in GM plants (Latham & Wilson 2013). The cauliflower mosaic, figwort mosaic and peanut
chlorotic streak viruses belong to the Caulimovirus family, and the CaMV 35S, FMV 35S and
PC1SV promoters overlap sequences of gene VI. However, bioinformatic searches suggest it is
extremely unlikely that the P6 protein possesses any allergenic or toxic properties (Podevin &
du Jardin 2012). MON 88701 and MON 88913 contain a short variant of the 35S promoter
from CaMV and FMV, respectively, that overlaps with a short, non-essential domain of the P6
protein.
6.2.3
Toxicity/allergenicity associated with the introduced genes
DMO protein and associated end products
The dmo gene encodes dicamba mono-oxygenase (DMO), which is classified as a
Rieske-type non-heme iron oxygenase (ie contains a Rieske iron-sulphur cluster [2Fe-2S]).
This class of oxygenases is found in diverse phyla ranging from bacteria to plants (Ferraro et
al. 2005; Schmidt & Shaw 2001). DMO forms part of a three component system comprised of
a reductase, a ferredoxin, and a terminal oxygenase (in this case the DMO). The three enzymes
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work together to catalyze the demethylation of the dicamba herbicide active ingredient 3,6dichloro-2-methoxybenzoic acid, resulting in formation of 3,6-dichlorosalicylic acid (DCSA)
and formaldehyde. MON 88701 DMO was found to be specific to dicamba when tested using
structurally similar endogenous substrates as well as exogenous herbicide substrates
representing a wide range of herbicide modes-of-action (data provided by applicant).
The applicant has provided data relating to the potential toxicity/allergenicity of the
DMO protein in MON 88701. No relevant amino acid sequence similarities were found with
known allergens, gliadins, glutenins, toxins, and other biologically active proteins that may
have adverse effects on mammals. In addition, MON 88701 DMO was rapidly degraded in
simulated gastric and intestinal fluids and a high dose of this protein in a mouse acute oral
toxicity evaluation demonstrated that it is not acutely toxic, and does not cause any adverse
effect. Based on these measures, it was concluded that the DMO protein in MON 88701 is not
toxic or allergenic to humans or animals.
Further, herbicide tolerant GM soybean (MON 87708) containing a dmo gene from
S. maltophilia has been assessed by FSANZ and no potential public health and safety concerns
were identified. Food derived from MON 88708 soybeans was considered to be as safe for
human consumption as food derived from conventional soybeans (FSANZ 2012).
MON 88701 cotton plants produce DCSA and formaldehyde as reaction products in the
presence of dicamba herbicide (in the absence of dicamba treatment of MON 88701 these
compounds would not be produced).
DCSA is structurally similar to salicylic acid (SA), which is known to be involved in
plant defence responses; it has been identified as a metabolite of dicamba in soil, plants and
livestock. The US EPA (2006) reviewed the safety of dicamba and its metabolites, including
DCSA, and concluded that DCSA would have similar toxicity to the parent herbicide. Risks to
human health and the environment associated with exposure to dicamba and its metabolites
were below the Agency’s level of concern for all registered uses.
Formaldehyde is ubiquitous in the environment and present in both plants and animals. It
is readily metabolized and incorporated into the 1-carbon pool of plants through known
pathways. Based on standard dicamba application rates, the maximum theoretical production of
formaldehyde in MON 88701 GM cotton tissue has been estimated at 6.3 mg/kg or 33 mg/kg,
depending on plant growth stage at application. These values are well within the range of
formaldehyde concentrations measured for a variety of agricultural commodities, for example
up to 60 mg/kg in fruits and vegetables (WHO-IPCS 1989).
PAT protein and associated end products
Glufosinate, or its ammonium salt DL-phosphinothricin, is an active ingredient in several
nonselective systemic herbicides. The bialaphos resistance (bar) gene encodes a
phosphinothricin N-acetyl transferase (PAT) protein, an acetyltransferase enzyme that
acetylates glufosinate to produce non-herbicidal N-acetyl glufosinate. The PAT protein
expressed in MON 88701 is identical to the wild type protein produced in S. hygroscopicus and
is highly homologous to the PAT proteins in commercially available glufosinate-tolerant GM
crops including cotton, corn, soybean and canola.
The environmental safety of the PAT protein present in biotechnology-derived crops,
either alone or in combination with other GM traits, has also been extensively assessed by
regulatory authorities worldwide (CERA 2011). A comprehensive study on the safety of PAT
proteins (Herouet et al. 2005) found that PAT enzymes are highly specific and do not possess
the characteristics associated with food toxins or allergens, i.e., they have no sequence
homology with any known allergens or toxins, they have no N-glycosylation sites, they are
rapidly degraded in gastric and intestinal fluids, and they are devoid of adverse effects in mice
after intravenous administration at a high dose level.
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N-acetyl glufosinate (NAG) is the main metabolite formed following application of
glufosinate ammonium to GM plants that express the PAT protein. NAG is considered nontoxic to plants, invertebrates, rodents and mammals, including humans (Hoerlein 1994; OECD
1999).
6.3 Characterisation of the GMOs
Characterisation details for COT102, MON 88913 and MON 15985 have been
considered and assessed in RARMPs for previous DIR licence applications (Section 8,
Table 5). Information relevant to the characterisation of MON 88701 is considered below.
6.3.1
Stability and molecular characterisation
All gene constructs used to generate MON 88701 GM cotton were sequenced prior to
introduction. The applicant has provided Southern blot fingerprint analysis and segregation
data showing that this event contains one copy of the introduced T-DNA that is stably
integrated at a single locus and is inherited according to Mendelian principles over multiple
generations. No unintended sequences from the plasmid vector have been incorporated in
MON 88701, and the insert locus has been mapped.
6.3.2
Phenotypic characterisation
No phenotypic characterisation data is currently available for MON 88701 in
combination with one or more of the other parental GM cottons. However, the other cottons
(alone and in some combinations) are well characterised.
Plant growth and development characteristics of MON 15985and MON 88913 GM
cottons (Bollgard II® and Roundup Ready Flex®, respectively) were assessed in the context of
their commercial release throughout Australia, and no unintended effects have subsequently
been identified. In addition, in Australian field trials of MON 15985xCOT102 and
MON 15985xCOT102xMON 88913 (under licence DIR 101), no unintended effects such as
reduced fertility, disease susceptibility or changes in production have been observed by the
licence holder.
The introduction of the dmo and bar genes into cotton is expected to confer tolerance to
dicamba and glufosinate herbicides, respectively. The substrate specificity of MON 88701 was
evaluated using a number of substrates selected on the basis of structural similarity of the
compounds to dicamba and their presence in cotton, corn and soybean. The results indicated
that DMO is specific for dicamba as a substrate. Similarly, the PAT protein was shown to have
high substrate specificity for L-phosphinothricin, the herbicidal component of glufosinate.
Section 7
The receiving 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 2009).
7.1 Relevant abiotic factors
The size, locations and duration of the proposed limited and controlled release are
outlined in Section 3.1. The proposed dealings involve planting the GM cottons at up to ten
sites/year for the first two years of the trial, and up to 20 sites/year thereafter in current and
potential cotton growing areas in 16 Qld LGAs, 38 NSW LGAs and two WA LGAs.
The abiotic factors relevant to the growth and distribution of commercial cotton in
Australia are discussed in The Biology of Gossypium hirsutum L. and Gossypium barbadense
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L. (cotton) (OGTR 2013). To summarise, factors restricting where cotton can be grown in
Australia are water availability (ie irrigation or rainfall), soil suitability and, most importantly,
temperature. Cotton seedlings may be killed by frost and a minimum of 180 frost-free days of
uniformly high temperatures (averaging 21-22°C) are required for crop growth (Duke 1983).
Growth and development of cotton plants below 12°C is minimal and a long, hot growing
season is crucial for achieving good yields (Constable & Shaw 1988).
The LGAs within which the release is proposed (see Table 1 in Section 3.1, above)
encompass a broad range of climate types, as defined by the Koeppen Classification system
used by the Australian Bureau of Meteorology. Proposed planting areas in traditional cottongrowing regions of NSW and Qld predominantly have subtropical and grassland climate types,
with small areas of temperate climate. The Qld LGA of Burdekin includes regions classified as
tropical and subtropical. Cotton growing areas in Qld may experience the effects of tropical
cyclones between November and April, with the possibility of extreme weather events and
flooding moving into northern NSW (Bureau of Meteorology). The applicant has stated that
trial sites will be selected so that they are not located in a flood prone area.
Proposed planting areas in WA include regions with tropical and grassland climates.
7.2 Relevant biotic factors
The biotic factors pertaining to the growth and distribution of commercial cotton in
Australia are discussed in The Biology of Gossypium hirsutum L. and Gossypium barbadense
L. (cotton) (OGTR 2013). In addition, the following points are of particular relevance to this
release:


the majority of the proposed release sites are in commercial cotton growing areas
GM cottons constitute the majority of Australian cotton crops (see Sections 4 and 7.4).
Invertebrates, vertebrates and microorganisms are expected to be exposed to the
introduced genes, their encoded proteins and end products.
7.3 Relevant agricultural practices
The limits and controls of the proposed release are outlined in Section 3 of this Chapter.
With regard to the agricultural practices, the GMOs proposed for field release would be planted
with a small plot cone seeder or with commercial planting equipment. The rows would be
irrigated by channel, drip or pivot irrigation and managed similar to commercial GM cotton
crops with the exception that no insect resistance management (IRM) plan is required by the
APVMA for a field trial, and different herbicides may be used for weed control due to the
particular herbicide tolerance traits in the GM cottons.
7.4 Presence of related plants in the receiving environment
Cotton cultivation is widespread and established in the majority of Qld and NSW LGAs
in which the release is proposed. Experimental cotton crops have been grown for over a decade
in WA (in the Ord River Irrigation Area and in areas near Broome) and northern Qld (in the
Burdekin Bowen Basin area), and although some commercial cultivation has occurred it is not
yet widespread or well established in these regions.
Data on the cultivation of commercial cotton in Australia are discussed in The Biology of
Gossypium hirsutum L. and Gossypium barbadense L. (cotton) document (OGTR 2013).
G. hirsutum is the most common species of cotton commercially grown in Australia and
G. barbadense varieties comprised less than 1% of the 2006/2007 crop (OGTR 2013).
Herbicide tolerant and/or insect resistant GM cotton plants (G. hirsutum) are used widely
in commercial cotton production, recently comprising over 99% of commercially grown cotton
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crops. In contrast, non-GM cotton comprised 1% or less of commercially grown cotton. In the
2010/11 growing season, 597,000 hectares of GM cotton varieties were planted and 95% of
those varieties were stacked traits for insect resistance and herbicide tolerance (see the website
of the Department of Agriculture and Food, WA). For a list of relevant approvals for
commercial releases of GM cottons in Australia, see Table 5 in Section 8, below.
In southern Australia, ephemeral populations of cotton may be present outside of
cultivation. Cultivated cotton can persist as a perennial plant in tropical areas and small
populations of naturalised cotton (G. hirsutum and G. barbadense) exist in northern Australia,
particularly in areas associated with a prolonged supply of fresh water (Hnatiuk 1990). The
majority of naturalised G. hirsutum populations occur in the Northern Territory (NT), while
naturalised G. barbadense occurs mainly along the eastern regions of Qld (data from
Australian Virtual Herbarium).
There are 17 native species of Gossypium in Australia, most of which can be found in the
NT and the north of WA (OGTR 2013). G. australe is the most widely distributed species
throughout northern Australia, occurring from the east to west coast and predominantly north
of the Tropic of Capricorn (Australian Virtual Herbarium). The native Gossypium species
prefer well-drained sandy loams and are rarely found on heavy clay soils favoured by
cultivated cotton (OGTR 2013). Generally, they are found in native vegetation and not in
disturbed/modified habitats such as agricultural areas (Groves et al. 2002).
Well established genetic incompatibility prevents crossing of native cotton species with
cultivated cotton in the natural environment (discussed in OGTR 2013).
7.5 Presence of similar genes and encoded proteins in the environment
The introduced genes for all the parental GM lines are derived from common soil-borne
microorganisms (see Section 6.2.1). The regulatory sequences (promoters, terminators, leader
sequences) are derived from plants (cotton, soybean, pea, thale cress, petunia), plant viruses
(peanut chlorotic streak caulimovirus, tobacco etch virus, cauliflower mosaic virus, figwort
mosaic virus) and a common soil bacterium (Agrobacterium tumefaciens). All the source
organisms for the introduced genetic elements are widespread and prevalent in the environment
and thus humans and other organisms would commonly encounter their genes and encoded
proteins.
Section 8
Australian and International Approvals
8.1 Australian approvals of GM cotton
8.1.1
Previous releases approved by the Regulator
MON 88701 has not been assessed previously in Australia. However, three of the
parental GM cottons, ie Bollgard II®, Roundup Ready Flex® and VIP3A cotton, individually
and in combination, have been approved by the Regulator for release in Australia (see Table 5).
To date, the Regulator has not received any reports of adverse effects caused by these
authorised releases.
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Table 5
Office of the Gene Technology Regulator
Summary of relevant Australian approvals for insect resistant and/or herbicide
tolerant GM cottons
GM cotton
DIR licence number
Approval
type†
Comment
MON 15985 (Bollgard II®)
DIR 012/2002; DIR 059/2005;
DIR 066/2006
C
Approved individually and in
combination with a herbicide
tolerance trait.
MON 88913 (Roundup
Ready Flex®)
DIR 059/2005; DIR 066/2006
C
Approved individually and in
combination with insect resistance
traits.
COT102 (VIP3A)
DIR 017/2002;DIR 025/2002;
DIR 034/2003; DIR 036/2003;
DIR 058/2005; DIR 065/2006;
DIR 073/2007; DIR 101
L&C
Approved individually or in
combination with Bollgard II® or
Bollgard II® x Roundup Ready
Flex®.
Other GM cottons
containing the bar gene (for
glufosinate ammonium
tolerance)
062/2005;
038/2003
C;
L&C
Liberty Link® cotton
Other insect resistant
cottons
DIR 091;
DIR 44/2003; DIR 040/2003
C;
L&C
Widestrike™ cotton
†
C: Commercial; L&C: Limited and Controlled
8.1.2
Approval by other government agencies
The Regulator is responsible for assessing risks to the health and safety of people and the
environment associated with the use of gene technology. Other government regulatory
requirements may also have to be met in respect of release of GMOs, including those of the
Department of Agriculture, Fisheries and Forestry (DAFF) Biosecurity (formerly the
Australian Quarantine and Inspection Service), Food Standards Australia New Zealand
(FSANZ), and Australian Pesticides and Veterinary Medicines Authority (APVMA). This is
discussed further in Chapter 3.
FSANZ is responsible for human food safety assessment and food labelling, including
GM food. FSANZ has previously given approval for the use in food of cotton seed oil and
linters derived from INGARD®, Bollgard II®, Roundup Ready Flex® and VIP3A GM cottons
(under applications A341, A436, A553 and A509, respectively, assessments are available from
the FSANZ website ). Three of the parental GM cottons therefore have existing approval for
use in food, but additional approval for GM cottons containing MON 88701 would be
necessary. However, the applicant does not intend to use materials from the GM cottons
generated in the proposed release in human food.
APVMA has regulatory responsibility for agricultural chemicals, including herbicides
and insecticidal products, in Australia. The GM cottons proposed for release meet the
definition of an agricultural chemical product under the Agricultural and Veterinary Chemicals
Code Act 1994, due to their production of insecticidal substances, and therefore these plants are
subject to regulation by the APVMA. The applicant also intends to apply herbicide to the GM
cottons during the trial and has applied to the APVMA for a research permit for this purpose.
8.2 International approvals of GM cotton
To date, there have been no international approvals for the commercial release of
MON 88701, Bollgard II® x VIP3A or Bollgard II® x VIP3A x Roundup Ready Flex® cottons.
Monsanto has requested a Determination of non-regulated Status for MON 88701,
including all progenies derived from crosses between MON 88701 and other cotton, from the
Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture
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(USDA) in July 2012, and submitted a food and feed safety and nutritional assessment in
compliance with the U.S. Food and Drug Administration’s (FDA) 1992 policy statement
regarding foods derived from new plant varieties in April 2012.
International approvals have been given for the environmental release of the other parent
GM cottons which are to be combined in the proposed release (Table 6). In addition to the
commercial release approvals listed below, approved field trials of VIP3A cotton have been
conducted in Argentina (2001-2002), Burkina Faso (2004-2006), China (2001-2003), Costa
Rica (2002, 2007-2009), India (2002-2006), Republic of South Africa (2002-2005), the USA
(2000-2009), Vietnam (2002-2003) and Zimbabwe (2003-2004). In 2005, the United States
Department of Agriculture Animal and Plant Health Inspection Service determined
non-regulated status of VIP3A cotton (USDA-APHIS 2005), allowing its unconfined
cultivation and agricultural use. There have also been approvals for the import of VIP3A cotton
for food use in Australia and New Zealand (2005) and for food and feed in Mexico (2010).
Table 6
Years in which international approvals were granted for the widespread
environmental release of Bollgard II®, Roundup Ready Flex® and VIP3A GM cottons
Country
Bollgard II®
Roundup Ready Flex®
Australia
Brazil
Burkina Faso
India
South Africa
United States
2002
2009
2008
2006
2003
2002
2006
Chapter 1 – Risk assessment context
2007
2004
VIP3A
2005
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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 2). Risks are identified within the context established for the risk assessment (see
Chapter 1), taking into account current scientific and technical knowledge. A consideration of
uncertainty, in particular knowledge gaps, occurs throughout the risk assessment process.
RISK ASSESSMENT PROCESS *
Postulation
of risk
scenarios
Risk
context
Consequence
assessment
Evaluation
Risk
Estimate
Identified
Risk
Risk
scenarios
Likelihood
assessment
No identified risk
RISK IDENTIFICATION
RISK CHARACTERISATION
* Risk assessment terms are defined in the Risk Analysis Framework 2009
Figure 2.
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).
Each risk scenario is evaluated to identify those risks that warrant detailed
characterisation. A risk is only identified for further assessment when a risk scenario is
considered to have some reasonable chance of causing harm. Pathways that do not lead to
harm, or could not plausibly occur, do not advance in the risk assessment process.
A number of risk identification techniques are used by the Regulator and staff of the
OGTR, including checklists, brainstorming, common sense, reported international experience
and consultation (OGTR 2009). In conjunction with these techniques, risk scenarios postulated
in previous RARMPs prepared for licence applications of the same and similar GMOs are also
considered.
Identified risks (i.e. those identified for further assessment) are characterised in terms of
the potential seriousness of harm (Consequence assessment) and the likelihood of harm
Chapter 2 – Risk assessment
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(Likelihood assessment). The level of risk is then estimated from a combination of the
Consequence and Likelihood assessments.
Section 2
Risk Identification
The following factors are taken into account when postulating relevant risk scenarios:
the proposed dealings, which may be to conduct experiments, develop, produce, breed,
propagate, grow, import, transport, store or dispose of the GMOs, use the GMOs in the
course of manufacture of a thing that is not the GMO, and the possession, supply and
use of the GMOs in the course of any of these dealings
the proposed limits
the proposed controls
characteristics of the parent organism(s)
routes of exposure to the GMOs, the introduced gene(s) and gene product(s)
potential effects of the introduced gene(s) and gene product(s) expressed in the GMOs
potential exposure to the introduced gene(s) and gene product(s) from other sources in
the environment
the environment at the site(s) of release
agronomic management practices for the GMOs.
Four risk scenarios were postulated and evaluated. These scenarios are summarised in
Table 7and more detail of the evaluation of these scenarios is provided later in this Section. In
the context of the control measures proposed by the applicant and considering both the short
and long term, none of the risk scenarios were identified as giving rise to a risk that could be
greater than negligible. Therefore, they did not warrant further detailed assessment.
All of the introduced regulatory sequences are derived from common plants, bacteria and
viruses. Similar regulatory elements are naturally present in cotton, and the introduced
elements are expected to operate in similar ways to endogenous ones. Therefore, although the
transfer of introduced regulatory sequences to other sexually compatible plants could result in
unpredictable effects, the impact is not likely to be greater than that arising from transfer of
endogenous regulatory elements. Hence, these potential effects will not be further assessed for
this application.
The potential for horizontal gene transfer (HGT) and any possible adverse outcomes has
been reviewed in literature (Keese 2008) as well as assessed in many previous RARMPs. HGT
was most recently considered in the RARMP for DIR 108 and also considered for insect
resistant and herbicide tolerant GM cottons in the RARMP for DIR 101. These and other
RARMPs are available via the OGTR website or by contacting the OGTR. No risk greater than
negligible was identified due to the rarity of these events and because the gene sequences are
already present in the environment and available for transfer via demonstrated natural
mechanisms. Therefore, HGT will not be assessed further.
The potential for unauthorised activities to lead to an adverse outcome has been
considered in previous RARMPs. The Act provides for substantial penalties for noncompliance 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.
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Table 7
Office of the Gene Technology Regulator
Summary of risk scenarios from dealings with GM cotton genetically modified for
insect resistance and herbicide tolerance
Risk category
Section 2.1
Production of a
substance toxic or
allergenic to
people or toxic to
other organisms
Section 2.2
Weediness of the
GM cotton plants
in the environment
Risk scenario
Pathway that may
Potential harm
give rise to harm
Identified
risk?
Reason
1. Exposure of
people, other
vertebrates and
micro-organisms to
GM plant material
containing the
proteins encoded by
the introduced
genes and
associated end
products.
Allergic reactions
in people or
toxicity in people
and other
vertebrates or
microorganisms
No

The introduced genes are derived from
soil-borne bacteria that are ubiquitous in
the environment. The encoded proteins
and highly similar proteins occur
naturally in the environment and are not
known to be toxic or allergenic to people
or toxic to other organisms.
 Plant material from the GMOs would not
be used for human food or animal feed.
 The limited scale, and other proposed
limits and controls, minimise exposure of
people and other organisms to the GM
plant material.
2. Exposure of
invertebrates to GM
plant material
containing the
proteins encoded by
the introduced
genes and
associated end
products.
Toxicity to nontarget
invertebrates
No

3. The genetic
modifications
increase weediness
of the GM cottons.
Harms associated
with weediness;
allergic reactions
in people or
toxicity in people
and other
organisms
No

The insect resistance genes, or
homologues, and their encoded proteins
are widespread in the environment.
 The toxicity of the proteins encoded by
the individual insect resistance genes
and any combination effects are
expected to be limited to lepidopteran
insects.
 The limited scale, and other proposed
limits and controls, reduces exposure of
invertebrates to the products of the
introduced genes
Cultivated cotton is not considered to be
weedy and the genetic modifications are
not expected to change the weediness
characteristic of the GMOs.
 The genetic modifications for insect
resistance and herbicide tolerance are
expected to increase the fitness of GM
cotton plants in managed environments,
but only in situations where
corresponding selective pressures are
applied.
 Resistance to Lepidoptera and tolerance
to herbicide is unlikely to increase
weediness as abiotic factors limit the
spread and persistence of cotton in
Australia.
 The limits and controls proposed for the
release would minimise spread and
persistence of the GM cotton plants.
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Risk category
Section 2.3
Vertical transfer of
genes or genetic
elements to
sexually
compatible plants
Risk scenario
Pathway that may
Potential harm
give rise to harm
4. Expression of
the introduced
genes in other
cotton plants.
Harms associated
with weediness;
allergic reactions
in people or
toxicity in people
and other
organisms.
Office of the Gene Technology Regulator
Identified
risk?
No
Reason
Cotton is predominately self-pollinating
and outcrossing is limited.
 The applicant proposed a number of
controls, including a pollen trap or
isolating the trial from other cotton
plants, which would minimise gene flow
via pollen.
 Risk scenarios 1 – 3 associated with the
genetic modifications did not constitute
identified risks for people or the
environment.

2.1 Production of a substance toxic or allergenic to people or toxic to other
organisms
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).
A range of organisms may be exposed directly or indirectly to the protein encoded by the
introduced gene or end products of metabolic pathways regulated by the introduced proteins, if
any. Workers cultivating the GM cotton would be exposed to all plant parts. Organisms may be
exposed directly to the proteins through biotic interactions with GM cotton plants (vertebrates,
invertebrates, symbiotic microorganisms and/or pathogenic fungi), or through contact with root
exudates or dead plant material (soil biota) or indirectly through the food chain.
Risk Scenario 1.
Exposure of people, other vertebrates and micro-organisms to GM
plant material containing the proteins encoded by the introduced
genes and associated end products
The proteins expressed from the introduced genes for insect resistance and herbicide
tolerance could be toxic or allergenic for people, or toxic for other organisms. If humans or
other organisms were exposed to the resulting compounds through ingestion, contact or
inhalation of the GM plant materials, this may give rise to detrimental biochemical or
physiological effects on the health of these people, other vertebrates or micro-organisms.
In the context of the proposed dealings, both of the following requirements would have
to be met for the GM cottons to have any increased toxic or allergenic effect:
the genetic modification would have to result in production of toxic or allergenic
proteins or compounds either not present in commercially grown cotton varieties or at
higher levels than present in commercially grown cotton varieties, and
humans or other organisms would have to be exposed to the GM cotton plants through
contact, ingestion or inhalation.
The introduced genes were isolated from naturally occurring bacteria that are already
widespread and prevalent in the environment (see Chapter 1, Section 6.2.1 and Section 7.3).
People and animals are exposed to proteins similar to those encoded by these genes through
their diet and the environment. Available information does not suggest that the proteins
encoded by the introduced dmo or bar genes in MON 88701 are toxic or allergenic to people,
other vertebrates and micro-organisms (Chapter 1, Section 6.2.3).
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FSANZ has approved food derived from three of the GM parent cottons (Bollgard II®,
VIP3A and Roundup Ready Flex®). The GM cottons will be produced by conventional
breeding and will potentially result in GM cotton containing a multiple stack of three herbicide
tolerance genes and three genes for insect resistance.
The proteins that confer tolerance to the herbicides glyphosate, glufosinate and dicamba
(CP4 EPSPS, PAT and DMO, respectively) and the Cry1Ac, Cry2Ab and Vip3A insecticidal
proteins operate through independent, unrelated biochemical mechanisms. There is no evidence
of any interaction between the herbicide tolerance proteins and insecticidal proteins or their
metabolic pathways, and no reason to expect that this is likely to occur. There is no evidence or
reasonable expectation that synergistic effects are likely to occur from combinations between
the two traits, or that they would result in new or increased risks relating to human health and
safety or the environment. Surveys of safety studies relating to combined GM events as
compared to parental controls concluded that combining approved GM events by conventional
breeding has generated no unique safety concerns (Pilacinski et al. 2011; Weber et al. 2012).
The applicant proposes to sell lint from the GM cottons. A study of the accumulation of
mineral nutrients in G. hirsutum fruit found no detectable nitrogen in fibre fractions (Leffler &
Tubertini 1976). Using more sensitive methods, specific proteins were detected at very low
levels in raw, but not processed, linters and lint (Sims et al. 1996). Therefore, the safety of
wearing cotton clothing or using other products made from cotton is not expected to be
affected by the genetic makeup of the cotton plants from which these components have been
derived, that is, whether or not it is derived from GM or non-GM cotton plants.
Cotton pollen may be an allergen (Chakraborty et al. 2001), although allergic responses
to the commercial cultivars of cotton have not been reported in Australia. Due to the limited
quantities of pollen released by cotton, it is expected that people would be exposed to small
quantities, if any, of pollen. As discussed above, the encoded proteins in the GM cottons are
not considered to be toxic or allergenic and the GM cotton plants are unlikely to be any more
toxic or allergenic than commercially released GM or non-GM cotton.
In addition to the intentional effects of the introduced genes, gene technology has the
potential to cause unintended effects. This may occur in a number of ways, including altered
expression of an endogenous gene by random insertion of introduced DNA in the genome,
increased metabolic burden due to higher expression of the introduced protein, novel traits
arising out of interactions with non-target proteins and secondary effects arising from altered
substrate or product levels in biochemical pathways. Unintended pleiotropic effects might
result in adverse outcomes such as toxicity or allergenicity. Unanticipated changes can also be
induced in plants by conventional methods of plant breeding (Haslberger 2003). The range of
possible unintended effects produced by genetic modification is not likely to be greater than
that from accepted traditional breeding techniques (Bradford et al. 2005; Committee on
Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human
Health 2004). More detail on potential for unintended effects as a result of the process of
genetic modification can be found in the document Methods of Plant Genetic Modification
available from the Risk Assessment References page on the OGTR website.
The proposed limits and controls of the trial (Chapter 1, Sections 3.1 and 3.2) would
minimise the likelihood of exposure of people, other vertebrates and micro-organisms to GM
plant materials. Human contact with, or inhalation of, GM plant materials would be limited to
trained and authorised staff. There is little potential for exposure of the public to GM plant
material via ingestion, as no GM plant material would be used for human food as part of this
release. Similarly, livestock would not be intentionally exposed as the GM plant material
would not be used as animal feed.
Researchers and technical staff conducting the trials would be exposed to the GM plant
materials during all phases of the trial. Workers may come into contact with the proteins
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encoded by the introduced genes when the plant cells have been damaged, or via pollen. Cotton
plants possess leaves with sharp edges and irritating hairs, therefore workers typically wear
protective clothing which reduces dermal contact. Exposure to the GM cotton is unlikely to
lead to an adverse outcome as the GM cotton plants are unlikely to be any more toxic or
allergenic than commercially released GM or non-GM cotton.
After harvest the applicant proposes to destroy GM cotton materials produced, apart from
lint and some plant materials for research purposes and new plantings. These measures would
minimise exposure to the GM plant material.
Conclusion: The potential for harm due to exposure to GM plant material containing the
introduced genes, encoded proteins and end products, in the context of the limits and controls
proposed by the applicant and considering both the short and long term, is not identified as a
risk that could be greater than negligible. Therefore it does not warrant further assessment.
Risk Scenario 2.
Exposure of invertebrates to GM plant material containing the
proteins encoded by the introduced genes for insect resistance
The proteins expressed from the introduced genes for insect resistance are toxic for
certain invertebrates and have been intentionally introduced into the GMOs for the purpose of
protection against specific insect pests. If non-target invertebrates were exposed to the resulting
compounds through direct or indirect ingestion of the GM plant materials, this may give rise to
detrimental biochemical or physiological effects on the health of these non-target invertebrates.
Two of the parental GM cottons, Bollgard II® and VIP3A, contain insect resistance genes
derived from Bacillus thuringiensis that are known to be toxic to a range of lepidopteran pests
of cotton, including the major pests in Australia H. armigera and H. punctigera. Bollgard II®,
which contains two cry genes for insect resistance (cry1Ac and cry 2Ab) has been previously
assessed and approved for commercial release (see Chapter 1, Section 8). Bollgard II®
constitutes over 85% of Australia’s commercial cotton plantings and no adverse outcomes on
non-target invertebrates have been reported from these releases.
VIP3A, containing the vip3A gene, has been previously assessed and approved for
limited and controlled release, most recently under DIR 101. Laboratory studies suggest that
the encoded Vip3A protein is not toxic to a range of invertebrates including Coleoptera,
Neuroptera, Hymenoptera and Isotomidae (Hill et al. 2003). This has been substantiated by
preliminary Australian field studies which showed no differences between GM and non-GM
cotton fields in terms of invertebrate species richness and diversity (Whitehouse et al. 2007).
The potential for synergistic, additive or antagonistic effects of the insecticidal proteins if
present simultaneously in the GM cotton has also been considered previously (see the RARMP
for DIR 101) and not identified as a risk that warranted further consideration. The specificities
of the Vip3A, Cry1Ac and Cry2Ab proteins appear to be restricted to overlapping subsets of
lepidopteran insects. Therefore, any increase in the range of sensitive insects as a result of the
expression of both insecticidal proteins is expected to be confined to lepidopteran species. It is
noteworthy that the same or similar proteins are present in the microbial formulations in
commercial Bt insecticide preparations (Hill et al. 2003). It is not expected that the range of
sensitive insects would increase beyond those sensitive to the Bt insecticides. However, some
uncertainty exists in this area due to data gaps.
Conclusion: The potential for toxicity to non-target invertebrates as a result of exposure
to GM plant materials containing the proteins encoded by the introduced genes, and
considering both the short and the long term, is not identified as a risk that warrants further
assessment.
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2.2 Weediness of the GM cotton plants in the environment
This section addresses the question of whether or not the proposed dealings with the
GMOs may lead to harm to human health and safety or the environment as a result of an
increased potential for spread and/or persistence due to the genetic modification.
All plants have the potential to lead to harm in certain environments. Harms that may
arise from a certain plant species in a particular environment include:
adverse effects on the health of people and/or animals
reduction in the establishment, yield and/or quality of desired plants
restriction in the physical movement of people, animals, vehicles, machinery and/or
water
adverse effects on environmental health, such as adverse changes to strata levels,
nutrient levels, fire regime, soil salinity, soil stability, or by providing food and/or
shelter to pests, pathogens and/or diseases.
For the purpose of this document, plant species causing significant levels of one or more
of these harms are called ‘weeds’. A plant species may be weedy in one or more land uses,
such as dryland cropping or nature conservation.
Characteristics that influence the spread (dispersal of the plant or its genetic material) and
persistence (establishment, survival and reproduction) of a plant species impact on the degree
of its invasiveness. These characteristics include the ability to establish in competition with
other plants, to tolerate standard weed management practices, to reproduce quickly, prolifically
and asexually as well as sexually, and to be dispersed over long distances by natural and/or
human means. The degree of invasiveness of a plant species in a particular environment gives
an indication of the likelihood of its weediness in that environment. In addition to local
experience, a history of weediness overseas can be used as an indicator for weediness in
Australia (Pheloung et al. 1999).
Baseline information on the characteristics of weeds in general, and the factors limiting
the spread and persistence of non-GM cotton plants in particular, is given in The Biology of
Gossypium hirsutum L. and Gossypium barbadense L. (cotton) (OGTR 2013). In summary,
cotton does not possess any of the characteristics associated with problematic weeds, and the
spread and persistence of cotton are limited by a number of biotic and abiotic factors,
especially cold stress in southern Australia and water stress in non-irrigated environments
throughout almost all of Australia. Cotton has been grown for centuries throughout the world
without any reports that it is a serious weed, and it is likewise not considered to be a serious
weed in Australia (Groves et al. 2003).
Risk Scenario 3.
The genetic modifications increase weediness of the GM cottons
In the context of the proposed dealings, in order for the GM cotton plants to have
increased weediness in the environment both of the following conditions would need to be met:
GM cotton plants are present outside the limits (locations and/or duration) of the
proposed trial; and
GM cotton plants are able to establish populations that cause harms associated with
weediness.
Presence of GM cotton plants outside the trial limits
GM cotton plants could be present outside the trial limits due to survival at the trial sites
after completion of the trial duration, or due to dispersal of reproductive plant material outside
the site boundaries during or after the trial.
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After completion of the trial, it is possible that whole GM plants could survive in the trial
sites, ratoon plants could regrow from post-harvest stubble or new volunteer plants could grow
from seeds fallen in the trial fields. The applicant proposes a number of control measures to
prevent these eventualities, including:
destruction of all plant materials not required for further analysis or future planting
cultivating planting areas after harvest to encourage decomposition or germination of
remaining seed
post-harvest monitoring of each trial site for at least 12 months and destruction of
volunteers.
It is not expected that the genetic modifications for insect resistance and herbicide
tolerance would increase the ability of the GMOs to survive these standard control measures.
Potential dispersal of reproductive GM plant material outside the site boundaries would
be limited to seed or pollen, as cotton does not reproduce vegetatively under natural conditions
(OGTR 2013). Gene flow via pollen is discussed in Risk Scenario 4. As the introduced genes
of the GMOs are not related to seed production and dispersal traits, these characteristics are not
expected to be altered in the types of GM cotton proposed for release compared to non-GM or
commercially released GM cotton varieties.
In the field, seed cotton is present as large lint-covered bolls. Wild mammals and birds
generally avoid feeding on cotton plants, in particular finding the seed unpalatable because of
its high gossypol content. Therefore wild animals are unlikely to disperse bolls from the cotton
fields (OGTR 2013). GM cotton seeds produced in this trial would not be used as stock feed,
so would not be dispersed by stock.
Cotton bolls are large, heavy and remain attached to the plant (OGTR 2013), so they are
not normally transported by wind or by runoff after rainfall or irrigation. The applicant has
stated that sites located at least 50 m from waterways and without prior history of flooding will
be selected for the trials. However, Queensland and northern NSW have in recent years
experienced extreme summer weather events, including cyclones and an increasing frequency
of floods (Chapter 1, Section 7.1). The Queensland wet season extends from October to April,
with the initial monsoonal onset usually occurring in late December and peak flooding from
December to February. Such extreme weather events have the potential to cause dispersal of
seeds, either soon after sowing or late in the growth cycle when cotton bolls develop and seeds
approach maturity.
Black seed (i.e. cleaned of lint) has the greatest potential for germination, while lintcovered seed cotton has lower likelihood of germination. Nonetheless, recently sown black
seeds that are dispersed by flooding would be more likely to rot than germinate and if
germination was successful plants would be unlikely to develop, as cotton is poorly adapted to
waterlogging (Hodgson & Chan 1982). It is unlikely that floods in February/March would
disperse viable seed from the GM plants, as the cotton bolls have not reached full maturity by
then. In monitoring naturalised and volunteer populations of G. hirsutum, Eastick (2002) noted
that seed maturation normally commenced after the conclusion of the wet season in Northern
Australia (April-May).
The proposed limits and controls of the trial (Chapter 1, Sections 3.1 and 3.2) would
minimise the likelihood of dispersal of the GM cotton lines proposed for release. Dispersal of
seeds by authorised people entering the proposed trial sites would be minimised by cleaning of
all equipment used at the trial site, including clothing. All equipment would be cleaned after
use and before it is used for other purposes. Any GM plant materials would be transported in
accordance with the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs,
or other specific conditions, and only plant materials needed for experimentation would be
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transported outside the site. Spillage of GM seed during transport to and from the release sites
would be rare and could be readily controlled through cleaning and monitoring of the site of
the spill. Proposed controls also include destruction of plant material upon completion of the
trial and implementation of a post-harvest program to prevent seed from persisting in the soil
and to destroy any volunteers that germinate.
GM cotton plants establish populations that cause harms associated with weediness
If the expression of the introduced genes for insect resistance and herbicide tolerance
were to provide the GM cotton plants with a significant selective advantage over commercially
released GM or non-GM cotton plants and if they were able to establish and persist in
favourable non-agricultural environments, this may give rise to lower abundance of desirable
species, reduced species richness, or undesirable changes in species composition. Similarly, the
GM cotton plants could adversely affect agricultural environments if they exhibited a greater
ability to establish and persist than non-GM or commercially released GM cotton.
Non-GM or commercially released GM cotton seed is abundant in the environment
through distribution pathways including residual seed bank in growing fields, roadside seed
spills and dispersal through use as stock feed. Despite this, feral cotton populations are sparse
and ephemeral (OGTR 2013) in all current cotton growing regions of Australia.
The spread and persistence of cotton plants is limited by a number of abiotic factors
including water and nutrient availability, temperature and soil type (Eastick & Hearnden 2006;
Farrell & Roberts 2002; OGTR 2008). The importance of these may vary between northern or
southern Australia. A modelling study has indicated that cold stress is the most significant
factor affecting persistence of cotton plants in southern Australia and dry stress is most
significant in northern Australia (Rogers et al. 2007).
The GM cottons proposed for release may possess tolerance to up to three herbicides as
well as insect resistance. However, in the event that the GMOs became established outside the
trial site, these traits are only likely to confer an advantage in the presence of the corresponding
selective pressures, ie insect predation by target insects or herbicide application. An example of
this is provided by a study of GM canola containing stacked glyphosate resistance and insect
resistance traits (Londo et al. 2011). For these plants there was an increase in fitness-associated
traits in the presence of insects or glyphosate, while fitness of the GM canola was reduced in
the absence of the selective pressures.
In respect to the control of cotton itself, glyphosate is generally not used against adult
plants, as it usually fails to kill them. Cultivation is an effective and efficient method of
controlling all types of volunteer cotton including seedling, established and ratoon (Roberts et
al. 2002). Herbicide options to control seedling cotton include Spray.Seed® and Hammer®
(paraquat/diquat and carfentrazone, respectively). These herbicides would also be capable of
controlling GM seedling cotton volunteers possessing glyphosate, glufosinate and dicamba
tolerance. It should also be noted that over 90% of the commercial G. hirsutum cotton crop in
Australia is genetically modified for glyphosate tolerance.
Two of the parental GM cottons (Bollgard II® and Roundup Ready Flex®), alone and in
combination, constitute the majority of commercial cottons grown in Australia, and the third
(VIP3A) is currently under field trial. No major effects of the GM traits on plant growth or
performance have been reported for these cottons, other than the introduced traits themselves.
Under conditions of moderate to high insect damage, Bollgard II® cotton has been reported to
mature slightly earlier than equivalent non-GM varieties, and to require less irrigation. This is
believed to result from reduced insect damage to developing bolls in the crop situation but does
not lead to increased seed yield (Yeates et al. 2010). MON 88701 has not yet been evaluated,
but it is unlikely that expression of the genes for herbicide tolerance will alter seed production,
dispersal, persistence and naturalisation potential of the GM cotton lines.
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Unintended effects can occur as a result of genetic modifications in several ways and
might result in adverse outcomes such as weediness. Significant unexpected alterations as a
result of gene insertions are rarely advantageous to the plants and are likely to be detected and
eliminated at early stages of GM plant generation and therefore unlikely to be perpetuated in
the genome (Bradford et al. 2005; Kurland et al. 2003). The stacking of GM traits by
conventional breeding and the potential for multiple gene insertions to alter genome stability
has been reviewed by Weber et al (2012), who concluded it was unlikely that the genome of a
GM stack would be less stable than the progeny of a cross between non-GM varieties, or of a
GM plant containing a single event.
In the unlikely event of GM cotton plants establishing themselves beyond trial limits,
small and transient GM cotton populations would be unlikely to cause harms associated with
weediness such as reducing establishment of desired plants, restricting physical movement, or
adversely affecting environmental health including alterations in insect population. Toxicity
and allergenicity of the introduced proteins or their end products were considered in Risk
Scenario 1and it is unlikely that the GM cotton plants would have higher toxicity and/or
allergenicity than non-GM cotton.
Conclusion: The potential for harm due to the genetic modification increasing the
weediness of the GMOs, in the context of the limits and controls proposed by the applicant and
considering both the short and long term, is not identified as a risk that could be greater than
negligible. Therefore, it does not warrant further assessment.
2.3 Vertical transfer of the gene or genetic elements to sexually compatible
plants
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).
It should be noted that vertical gene flow per se is not considered an adverse outcome,
but may be a link in a chain of events that may lead to an adverse outcome. For an increased
potential for adverse effects to arise as a result of gene flow of the introduced genetic elements
from the GM cotton to sexually compatible plants, both of the following steps must occur:
transfer of the introduced genetic elements to sexually compatible plants
increased potential for adverse effects, such as toxicity or weediness of the recipient
plants, due to expression of the introduced genes.
Baseline information on vertical gene transfer associated with non-GM cotton plants is
provided in The Biology of Gossypium hirsutum L. and Gossypium barbadense L. (cotton)
(OGTR 2013). In summary, cotton is predominantly self-pollinating and outcrossing is rare,
although cross-pollination can occur at low levels over short distances. The only sexually
compatible species present in Australia that could receive genes from the GM cotton are
G. hirsutum and G. barbadense (including both cultivated GM and non-GM cotton, and
naturalised cotton).
Most of the Australian Gossypium species have limited distributions and occur at
considerable geographic distances from cultivated cotton fields. Furthermore, there is well
established genetic incompatibility between native Gossypium species and cultivated cotton;
the likelihood of fertile hybrids occurring between cultivated cotton and native Gossypium
species is very low (summarised in OGTR 2013). Therefore, these species are not considered
further.
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Office of the Gene Technology Regulator
Expression of the introduced genes in other cotton plants
If the introduced genes for insect resistance and herbicide tolerance were transferred and
expressed in other cotton plants, the resulting hybrid plants could have increased toxicity or
allergenicity to people, toxicity to other organisms, or weediness potential.
As discussed in Risk Scenario 1, the proteins encoded by the introduced genes are
unlikely to be allergenic to people or toxic to people or organisms other than certain
invertebrates. As discussed in Risk Scenario 2, the GM cottons are expected to be toxic to
target invertebrates and there is expected to be limited toxicity to non-target invertebrates. This
also applies if the introduced genes are expressed in other cotton plants.
It should be noted that the GM cottons proposed for trial contain up to four independent
genetic modifications, so the introduced genes have inserted into different regions of the cotton
genome and segregate independently of one another. This means that after any initial
outcrossing of the GM cottons to other cotton, any subsequent generations of cotton volunteers
may contain all of the dmo, bar, cry, vip3A and cp4 epsps genes, any subset of these genes, or
none of the introduced genes. Any GM cotton produced from outcrossing containing either
fewer or no genes encoding insecticidal proteins or herbicide tolerance will have equivalent or
less insecticidal efficacy or herbicide tolerance than a GM cotton volunteer plant containing all
the introduced genes. Therefore, segregation of the dmo, bar, cry, vip3a and cp4 epsps genes is
not likely to lead to plants with increased toxicity or weediness compared to the GM cottons
proposed for release, and will not be considered further.
Roundup Ready Flex® and Bollgard II® GM cottons have previously been described and
assessed for commercial release (refer to Chapter 1, Section 8.1), in addition to other
assessments for limited and controlled release. Previous assessments concluded that the
commercial release of these GM cottons, alone and in combination, throughout Australia pose
negligible risks to human health and safety and the environment (refer to RARMPs for
DIR 059/2005 and DIR 066/2006). VIP3A has been described and assessed for field trial under
DIR 101, in combination with Bollgard II® and Roundup Ready Flex®. Consequently, the
expression of the introduced cp4 epsps, cry 1Ac, cry2Ab and vip3A genes in other sexually
compatible plant species, including other commercially approved GM cottons, as a result of
gene transfer, has been considered in these assessments. No risk greater than negligible was
identified.
The GM cottons proposed for release may contain up to three stacked herbicide tolerance
traits, which could potentially be transferred to commercial cottons already present in the
environment. However, since current commercially grown GM cottons contain a subset of the
herbicide tolerance genes included in the GM cottons proposed for release in this application,
any outcrossing would not further expand the range of herbicide tolerance. The potential for
increased weediness resulting from stacking of three herbicide tolerance traits was considered
in Risk Scenario 3.
The applicant also proposes to include other commercially approved GM cottons in the
planting area and/or pollen trap (including Widestrike® or Liberty Link® cottons), which could
increase the combined number of stacked genes. As discussed above, the potential for stacking
of the introduced insecticidal genes with the cry genes present in Widestrike® has been
considered in previous assessments (DIR 101) and was not an identified risk. It is also unlikely
that adverse effects would result from combination of the dicamba herbicide tolerance gene
with the Widestrike® insect resistance or Liberty Link® herbicide tolerance genes. As outlined
in Risk Scenario 1, the DMO protein that confers tolerance to the dicamba herbicide and the
insecticidal proteins present in commercial GM cottons operate through independent, unrelated
biochemical mechanisms. In addition, MON 88701 already contains the bar gene present in
Liberty Link® cotton, so gene flow between these cottons would not increase the potential
range of herbicide tolerances. Lastly, proposed control measures require all cottons planted in
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the planting area or pollen trap to be treated as though they are the GMOs. In practice this
means any seeds resulting from crosses between the different GM cottons would be harvested,
which would restrict the potential for spread or persistence of stacked GM cottons.
As discussed in the The Biology of Gossypium hirsutum L. and Gossypium barbadense L.
(cotton) (OGTR 2013) cotton is predominantly self-pollinating, with pollen that is large, sticky
and heavy and not easily dispersed by wind. Cotton gene flow studies consistently show that
outcrossing is localised around the pollen source and decreases rapidly with distance.
Furthermore, outcrossing will only be successful between the GM cotton plants and other
G. hirsutum or G. barbadense plants due to genetic incompatibility with other Gossypium
species. It is unlikely that expression of the introduced genes in the GM cotton will alter pollen
characteristics and/or genetic compatibility relative to non-GM or commercially released GM
cotton plants.
The applicant has proposed a number of measures to restrict the potential for pollen flow
and gene transfer to sexually compatible plants (Chapter 1, Section 3.2 and 3.3). These include
surrounding the trial sites with either a 20 m pollen trap or a 1 km exclusion zone (within
which intentional planting of cotton is not allowed). The applicant also proposes to perform
post harvest monitoring of each site for twelve months and until the sites have been clear of
volunteers for six months; and to destroy any volunteers found prior to flowering. These
proposed controls would reduce the already low likelihood of gene flow from the GMOs to
other cotton resulting in expression of the introduced genes.
Even in the rare event of vertical transfer of the introduced genetic material from the GM
plants to non-GM cotton plants, the genetic material is expected to behave in similar ways as in
the GM cottons. Hence, as discussed in Risk Scenarios 1- 3, the presence of the introduced
gene sequences is unlikely to lead to any toxic and/or allergenic substance or any increase in
weediness in recipient plants.
Conclusion: The potential for increased allergenicity in people, toxicity in people and
other organisms, or increased weediness due to the expression of the introduced genes in other
cotton plants as a result of gene transfer, in the context of the limits and controls proposed by
the applicant and considering both the short and long term, is not identified as a risk that could
be greater than negligible. Therefore it does not warrant further assessment.
Section 3
Risk estimate process and assessment of significant
risk
The risk assessment begins with postulation of potential pathways that might lead to
harm to the health and safety of people or the environment during the proposed release of
GMOs due to gene technology, and how it could happen, in comparison to the parent organism
and within the context of the receiving environment.
Four risk scenarios were postulated whereby the proposed dealings might give rise to
harm to people or the environment. This included consideration of whether expression of the
introduced genes or unintended effects of the genetic modification could: result in products that
are toxic or allergenic to people or other organisms; or alter characteristics that may impact on
the spread and persistence of the GM plants. The opportunity for gene flow to other organisms
and its effects if it occurred were also assessed.
A risk is only identified when a risk scenario is considered to have some chance of
causing harm. Risk scenarios that do not lead to harm, or could not reasonably occur, do not
represent an identified risk and do not advance any further in the risk assessment process.
The characterisation of the four risk scenarios in relation to both the seriousness and
likelihood of harm, in the context of the control measures proposed by the applicant and
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considering both the short and long term, did not give rise to any identified risks that could be
greater than negligible and required further assessment. The principal reasons for this include:
widespread presence of the same genes or sequences in the environment
toxicity of the proteins encoded by the introduced insect resistance genes is expected to
be limited to certain insects in the order Lepidoptera
limited ability and opportunity for the GM cotton plants to transfer the introduced genes
to commercial cotton crops or other cotton plants
limits on the size, locations and duration of the release proposed by Monsanto
suitability of controls proposed by Monsanto to restrict the spread and persistence of the
GM cotton plants and their genetic material
none of the GM plant material or products will enter human food or animal feed supply
chains.
Therefore, any risks to the health and safety of people, or the environment, from the
proposed release of the GM cotton plants into the environment are considered to be negligible.
Hence, the Regulator considers that the dealings involved in this proposed release do not pose
a significant risk to either people or the environment.
Section 4
Uncertainty
Uncertainty is an intrinsic property of risk and is present in all aspects of risk analysis,
including risk assessment, risk management and risk communication. Both dimensions of risk
(consequence and likelihood) are always uncertain to some degree.
Uncertainty in risk assessments can arise from incomplete knowledge or inherent
biological variability3. For field trials, because they involve the conduct of research, some
knowledge gaps are inevitable. This is one reason they are required to be conducted under
specific limits and controls to restrict the spread and persistence of the GMOs and their genetic
material in the environment, rather than necessarily to treat an identified risk.
For DIR 120, uncertainty is noted particularly in relation to the characterisation of:
the potential for any unintended effects resulting in changes to biochemistry,
physiology or ecology of the GM cottons
the potential for increases in toxicity to non-target invertebrates as a result of the
combination of the introduced genes for insect resistance.
Additional data, including information to address these uncertainties, may be required to
assess possible future applications for a larger scale trial, reduced containment conditions, or
the commercial release of these GM cottons if they are selected for further development.
Chapter 3, Section 4 discusses information that may be required for future release.
A more detailed discussion is contained in the Regulator’s Risk Analysis Framework available from the OGTR
website or via Free call 1800 181 030.
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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 evaluates and treats
identified risks, evaluates controls and limits proposed by the applicant, and considers general
risk management measures. The risk management plan informs the Regulator’s 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 trial of GM cottons. These
risk scenarios were considered in the context of the scale of the proposed release (a maximum
area of 10 ha/site at up to 10 sites for the first two years and 30 ha/site at up to 20 sites
thereafter, between October 2013 and October 2019), the proposed containment measures
(Chapter 1, Section 3), and the receiving environment (Chapter 1 Section 7), and considering
both the short and the long term. The Risk Analysis Framework (OGTR 2009) which guides
the risk assessment and risk management process, defines negligible risks as insubstantial with
no present need to invoke actions for their mitigation. Therefore, there are no licence
conditions to treat these negligible risks.
Section 3 General risk 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, location and duration, and to
restrict the spread and persistence of the GMOs and their genetic material in the environment.
The conditions are detailed in the licence and summarised in this Chapter.
3.1 Licence conditions to limit and control the release
3.1.1
Consideration of limits and controls proposed by Monsanto
Sections 3.1 and 3.2 of Chapter 1 provide details of the limits and controls proposed by
Monsanto in their application. These are discussed in the four risk scenarios characterised for
the proposed release in Chapter 2. Many of these proposed control measures are considered
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standard for GM cotton trials and have been imposed by the Regulator in previous DIR
licences. The appropriateness of these controls is considered further below.
The proposed duration of the release is six years, with to up to 10 sites per year for the
first two years and up to 20 sites per year for the remaining four years. Each sites would be a
maximum area of 10 ha in the first two years and 30 ha in the remaining four years. Sites are to
be selected from 56 possible LGAs in Western Australia, NSW and Queensland. Only staff
with appropriate training would be allowed to deal with the GMOs. GM plant material will not
be permitted to enter commercial human or animal food supply chains. These measures will
minimise the potential for unintentional exposure of humans, vertebrates and other organisms
to the GMOs (Risk Scenarios 1 and 2) and the potential for the GM cotton to be dispersed
outside the trial limits (Risk Scenario 3).
The applicant has proposed that each site would be surrounded by a 20 m wide pollen
trap or a 1 km exclusion zone to restrict gene flow from the GM cottons to other cotton plants.
As discussed in the The Biology of Gossypium hirsutum L. and Gossypium barbadense L.
(cotton) (OGTR 2013), cotton is predominantly self-pollinating, with the highest level of
outcrossing occurring between adjacent rows. Outcrossing is rare beyond 20 m (Llewellyn et
al. 2007), and a 20 m pollen trap of non-GM cotton or GM cotton approved for commercial
release would minimise gene transfer to sexually compatible plants outside the trial (Risk
Scenario 4).
As an alternative to a 20 m pollen trap, a 1 km exclusion zone was proposed by the
applicant to minimise gene flow from the GM cottons plants to other cotton crops. On the basis
of the scientific literature on gene flow, international containment measures for GM cotton
trials, and the rules for producing basic and certified seed, previous DIR cotton licences have
imposed a 3 km isolation distance between GM cottons and intentionally planted cotton crops
(see discussion in RARMP for DIR 081/2007). However, further consideration of recent
literature (eg Van Deynze et al 2005, Heuberger et al 2010) suggests that a reduction in
isolation distance from 3 km may be supported.
As discussed in the RARMP for DIR 081/2007, cotton is largely self-pollinating and
honeybees are considered to be the most likely insects responsible for any cross-pollination in
cotton in Australia. There is little data available on bee foraging ranges in Australia, but data
from overseas indicates that mean foraging distances are at least 0.6 km with foraging ranges
up to 10 km. However, studies supporting such long distance foraging/travel are based on
conditions that are unlikely to occur at the proposed release sites, ie conditions under which no
other food source is available are not representative of typical bee foraging. Native trees,
flowers and other crops grow in the areas proposed for release and therefore bees are unlikely
to be limited to foraging on the GM cotton.
Van Deynze et al (2005) measured pollen-mediated gene flow in California, between a
herbicide tolerant pollen source field and commercial cotton fields. The fields were separated
by open space and sampling occurred in each of three years, at distances of 200, 400, 800 and
1625 m away from the GM pollen source field. From this study, pollen mediated gene flow
was found to vary over the three years, ranging from 0.01 to 0.1% at distances between 200
and 1625 m; on the basis of samples taken at three different sites over three years, gene flow
was on average less than 0.1% at 400 m and less than 0.04% at 1625m.
More recently, Heuberger et al (2010) developed an empirical model for gene flow
patterns for cotton in the commercial agricultural landscape which simultaneously accounted
for the effects of pollinator abundance, the area of relevant surrounding fields and seed
mediated gene flow over an initial range of 3 km. These authors found that pollen mediated
gene flow rates were low (especially as compared with seed-mediated gene flow) and
concluded that GM cotton fields at distances more than 750 m from the edge of monitored nonGM fields did not appear to contribute to outcrossing.
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In light of the above, a licence condition has been included requiring 1.5 km isolation
distance between the trial plants and any other cotton plants, if a pollen trap is not used. This
represents a greater distance than the 1 km proposed by the applicant. However, there is
variability in the data reported by Van Deynze (2005) and only a limited number of studies that
have investigated pollen mediated gene flow under physical isolation conditions in the absence
of a pollen trap. Therefore, further reduction of the isolation zone is not supported by the
evidence currently available.
Heuberger et al (2010) also found no evidence to suggest that the emergence of volunteer
plants outside planted rows contributed to gene flow. Nonetheless, it is possible that feral
cotton populations derived from commercial cotton lines may occur on roadsides or in
irrigation channels in cotton growing areas, and gene flow has been observed between isolated
cotton plants over short distances.
Therefore, a licence condition has been imposed requiring a 100 m monitoring zone in
conjunction with an exclusion zone; while the GM cotton is growing the surrounding
monitoring zone must be inspected every 30 days and kept free of any flowering cotton plants.
The combination of a monitoring zone and an exclusion zone is considered effective to restrict
vertical gene transfer from GM cotton trial sites to other cotton (Risk Scenario 4).
The applicant proposes to locate the trial sites more than 50 m from the nearest
waterway, which is a standard DIR licence condition, and to select sites that are not located in
flood-prone areas. This would minimise the chance of viable plant material being washed away
from the site. A licence condition is included that requires reporting of the history of flooding
and cyclones for each site, as well as a condition requiring immediate notification of any
extreme weather conditions affecting the site during the proposed release. These measures will
minimise likelihood for the GM cotton to be dispersed outside the proposed release site (Risk
Scenario 3).
The applicant proposes that the GM cotton would be harvested and ginned separately
from other cotton crops to prevent mixing. All equipment used in connection with cultivating
the GM cotton will be cleaned on site prior to removal. A licence condition has been included
requiring that any gin used for the GM cotton must be cleaned immediately following its use
and before any other cotton crop is ginned. These measures are expected to minimise the
potential exposure of humans and other vertebrates to the GMOs (Risk Scenario 1) and the
potential for the GM cotton to be dispersed outside the proposed release site (Risk Scenario 3).
After the GM cottons have been harvested, the applicant proposes to destroy all
remaining plant material not required for further testing, and to clean the sites and all
equipment used. As discussed in the The Biology of Gossypium hirsutum L. and Gossypium
barbadense L. (cotton) (OGTR 2008), cotton seeds have low dormancy levels and do not
generally form a viable seed bank. However, dormancy can be induced in cotton seeds by low
soil temperature and/or soil moisture. The applicant proposes at least one post-harvest
cultivation of the trial sites and pollen traps to promote cotton seed germination and minimise
the persistence of a GM cotton seed bank. A licence condition has been included requiring
cultivation (followed by an irrigation event) in the spring or summer following the harvest, so
that soil temperature will be suitable for cotton seed germination. Each trial site would be
monitored post-harvest at least every two months for a minimum of twelve months and until
the site has been clear of volunteers for at least six months. These measures would limit the
persistence of the GM cotton in the environment (Risk Scenario 3).
The applicant has stated that any plant material taken off-site for experimental analysis
will be transported according to the Regulator’s Guidelines for the Transport, Storage and
Disposal of GMOs. These are standard protocols for the handling of GMOs to minimise
exposure of people and other organisms to the GMOs (Risk Scenarios 1 and 2), dispersal into
the environment (Risk Scenario 3), and gene transfer (Risk Scenario 4). In addition to standard
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conditions for transport of GM plant material, previous DIR cotton licences have authorised
specific measures for the transport of harvested cotton modules. These include double
wrapping, or transport in an enclosed chain bed truck designed for the purpose. More recently,
there has been a shift away from traditional modules to the use of round bale pickers. A licence
condition has therefore been included that extends these measures to both modules and bales.
This would minimise the potential for dispersal of the GM cotton during transport.
Under conditions of the licence, the sale and transport of lint is permitted, as this does not
contain any DNA or protein.
The applicant does not propose using any of the plant material for human consumption,
and the GM cotton event MON 88701 has not been assessed for food use by FSANZ.
Therefore a condition in the licence prohibits material from the trial from being used for human
or animal feed.
3.1.2 Summary of licence conditions to be implemented to limit and control the
release
A number of licence conditions have been imposed to limit and control the proposed
release, based on the above considerations. These include requirements to:
limit the release to a maximum area of 10 ha/site at up to 10 sites for the first two years
and 30 ha/site at up to 20 sites thereafter, between October 2013 and October 2019
locate the proposed trial sites at least 50 metres (m) away from natural waterways
limit pollen flow using one of the following measures:
surround the GM cotton planting area with a 20 m pollen trap of non-GM cotton or
GM cotton that the Regulator has approved for commercial release or
surround the planting area with 100 m monitoring zone and maintain a 1.5 km
exclusion zone around the planting area in which no other cotton plants may be
grown
remove and/or destroy any cotton plants growing in the monitoring zone prior to
flowering
ensure the pollen trap plants are grown in such a way as to ensure flowering at the same
time and for the same period of time as the GM cotton
harvest and gin all cotton plant materials (GM and non-GM) separately from other
commercial cotton crops
clean the areas and equipment after use
apply measures to promote germination of any cotton seeds that may be present in the
soil after harvest, including irrigation and shallow tillage
monitor for at least 12 months after harvest and destroy any cotton plants that may grow
until no volunteers are detected for a continuous 6 month period
destroy all GM plant material not required for further analysis or future trials
not allow GM plant material to be used for human food or animal feed
transport and store material from the GMOs in accordance with the Regulator’s
guidelines or other specific conditions.
Experiments with the GMOs or GM plant material may be conducted in certified physical
containment facilities as Notifiable Low Risk Dealings (NRLDs) in accordance with all
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appropriate requirements of the Gene Technology Regulations 2001, and therefore this activity
is not covered in the licence.
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 site 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 Monsanto 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
Monsanto is required to submit a contingency plan to the Regulator before planting the
GMOs. This plan must detail measures to be undertaken in the event of any unintended
presence of the GM cottons outside of the permitted areas.
Monsanto is also required to provide a method to the Regulator for the reliable detection
of the presence of the GMOs and the introduced genetic materials in a recipient organism. This
instrument is required before planting of the GMOs.
3.2.3
Identification of the persons or classes of persons covered by the licence
The persons covered by the licence are the licence holder and employees, agents or
contractors of the licence holder and other persons who are, or have been, engaged or
otherwise authorised by the licence holder to undertake any activity in connection with the
dealings authorised by the licence. Prior to growing the GMOs, Monsanto is also required to
provide a list of people and organizations who will be covered by the licence, or the function or
position where names are not known at the time.
3.2.4
Reporting requirements
The licence obliges the licence holder to immediately report any of the following to the
Regulator:
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any additional information regarding risks to the health and safety of people or the
environment associated with the trial
any contraventions of the licence by persons covered by the licence
any unintended effects of the trial.
A number of written notices would also be required under the licence that would assist
the Regulator in designing and implementing a monitoring program for all licensed dealings.
The notices would include:
expected and actual dates of planting
details of areas planted to the GMOs
expected dates of flowering
expected and actual dates of harvest and cleaning after harvest
details of inspection activities.
3.2.5
Monitoring for Compliance
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 cottons, or to justify a reduction in
containment conditions. This includes:
additional data on the potential toxicity and allergenicity of plant materials from the GM
cottons (eg susceptibility of non-target invertebrate species to the combination of
insecticidal proteins)
additional phenotypic characterisation of the GM cotton lines, particularly with respect
to traits that may contribute to weediness, including tolerance to environmental stresses
and disease susceptibility
additional molecular and biochemical characterisation of the GM cotton lines
additional information on pollen mediated gene flow in cotton in the absence of a
pollen trap.
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Section 5 Conclusions of the RARMP
The risk assessment concluded that this proposed limited and controlled release of GM
cottons on a maximum area of 10 ha/site at up to 10 sites for the first two years and 30 ha/site
at up to 20 sites thereafter, between October 2013 and October 2019 in NSW, Queensland and
Western Australia, poses negligible risks to the health and safety of people or the environment
as a result of gene technology.
The risk management plan concludes that these negligible risks do not require specific risk
treatment measures. However, licence conditions have been imposed to limit the release to the
proposed size, location and duration, and to restrict the spread and persistence of the GMOs
and their genetic material in the environment, as these were important considerations in
establishing the context for assessing the risks.
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Thompson, C.J., Movva, N.R., Tizard, R., Crameri, R., Davies, J., Lauwereys, M., Botterman,
J. (1987). Characterization of the herbicide-resistance gene bar from Streptomyces
hygroscopicus. EMBO Journal 6: 2519-2523
US EPA (2006). Reregistration eligibility decision for dicamba and associated salts.
USDA-APHIS (2005). Approval of Syngenta Petition (03-155-01p) Seeking a Determination
of Non-regulated Status for Bt VIP3A Insect Resistant Cotton Line COT102.
Van Deynze, A.E., Sundstrom, F.J., Bradford, K.J. (2005). Pollen-mediated gene flow in
California cotton depends on pollinator activity. Crop Science 45: 1565-1570
Waines, J.G., Hegde, S.G. (2003). Intraspecific gene flow in bread wheat as affected by
reproductive biology and pollination ecology of wheat flowers. Crop Science 43: 451-463
Weber, N., Halpin, C., Hannah, L.C., Jez, J.M., Kough, J., Parrott, W. (2012). Editor's Choice:
Crop Genome Plasticity and Its Relevance to Food and Feed Safety of Genetically Engineered
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Whitehouse, M.E.A., Wilson, L.J., Constable, G.A. (2007). Target and non-target effects on
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Yeates, S., Roberts, J., Richards, D. (2010) High insect protection of GM Bt cotton changes
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References
41
DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Office of the Gene Technology Regulator
Appendix A Summary of submissions from
prescribed experts, agencies and authorities4
The Regulator received several submissions from prescribed experts, agencies and authorities
on the consultation RARMP. All issues raised in submissions that related to risks to the health
and safety of people and the environment were considered in the context of the currently
available scientific evidence and were used in finalising the RARMP that formed the basis of
the Regulator’s decision to issue the licence. Advice received is summarised below.
Summary of issues raised
Comment
Noted
Notes that the purpose of the trial is to assess the
agronomic performance of the crops under field conditions
for possible future commercial release. Further notes that no
materials from the GM cotton will be used for human food.
Would seek early notification from the applicant regarding
any possible GM food application if the field trials are
successful.
Does not have required scientific advice readily available,
but appreciates that the invitation to comment serves to
raise awareness of the application.
Noted
Considered the DIR with no comments being made.
Noted
Supports the OGTR assessment that the proposed dealing
posed negligible risk of harm to human health and the
environment.
Noted
If cotton growers do not apply the technology carefully then
use of this GM cotton with tolerance to three different
herbicides may accelerate the emergence of herbicide
resistance.
Herbicide resistance comes under the regulatory oversight of
the APVMA. The APVMA has primary regulatory responsibility
for agricultural chemicals in Australia. It assesses all herbicides
used in Australia and sets their conditions of use, including for
resistance management.
Offers no objections to the proposed field trial.
Noted
Satisfied with the conclusions of the draft RARMP, noting
the comments below.
Noted
At paragraph 36, the CaMV 35S and FMV 35S promoters
are discussed. Both these promoters overlap sequences of
gene VI which encodes protein P6.The PC1SV promoter in
MON88701 is also a member of the Caulimovirus family and
overlaps sequences of gene VI. Recommends that the
PC1SV promoter also be considered in the discussion in
paragraph 36 that considers the level of risk presented by
promoters in the Caulimovirus family.
Consideration of the PC1SV promoter has been added to
paragraph 36. As already noted there, the P6 protein is widely
distributed in the environment, with no adverse consequences
reported.
4
Prescribed agencies include GTTAC, State and Territory Governments, relevant local governments, Australian
Government agencies and the Minister for the Environment.
Appendix A
42
DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Summary of issues raised
Office of the Gene Technology Regulator
Comment
Recommends that paragraph 185 (“issues to be addressed
in future releases”) includes collection of data on toxicity of
Vip3A in combination with the other introduced insect
resistance genes to non-target invertebrates.
Chapter 2 acknowledges uncertainty regarding stacking of
Vip3A with other insecticidal proteins. Point one of paragraph
185 (Chapter 3) suggests “additional data on the potential
toxicity and allergenicity of plant materials from the GM cottons”
may be required, which could include toxicity of the combined
insecticidal proteins. Point one has been modified to specify this
example.
Identified no concerns with the proposed trial, given the field
conditions specified in the RARMP.
Noted
Supports approval of the licence on the terms indicated in
the RARMP.
Noted
Agrees with the overall conclusions of the RARMP.
Noted
Supports the application, as the evidence supplied indicates
that the genetic modifications are within the scope for these
crops and would pose negligible risks
Noted
Appendix A
43
DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Office of the Gene Technology Regulator
Appendix B Summary of submissions from the
public
The Regulator received four submissions from the public on the consultation RARMP. The
issues raised in these submissions are summarised in the table below. All issues raised in
submissions that related to risks to the health and safety of people and the environment were
considered in the context of currently available scientific evidence in finalising the RARMP
that formed the basis of the Regulator’s decision to issue the licence.
Type: I: Individual
View (general tone): x = do not support
Issues raised: G: Gene flow; C: Coexistence; E: Environment; R: Resistance; M: Marketing
and Trade; P: Pesticide use; T: Toxicity
Other abbreviations: Act: the Gene Technology Act 2000; APVMA: Australian Pesticides
and Veterinary Medicines Authority; Bt: Bacillus thuringiensis; GM: Genetically Modified;
GMO: Genetically modified organism
Submission Type View Issue
Number
1
Appendix B
I
X
Summary of issues raised
Comment
P, R
Objects to the proposed field trial on
the basis that:
 herbicide tolerance leads to
increased herbicide use,
threatening the environment and
human health
 insect resistance leads to
adaptation by insects which
could also become a threat.
The APVMA has regulatory responsibility for the
supply of agricultural chemicals, including herbicides,
in Australia.
The GM cottons proposed for release meet the
definition of an agricultural chemical product under
the Agricultural and Veterinary Chemicals Code Act
1994, due to their production of insecticidal
substances, and therefore these plants are subject to
regulation by the APVMA. A permit is also required
from the APVMA for the application of herbicides to
the GM cotton during the trial. Management of insect
resistance and herbicide tolerance is a matter for the
APVMA.
The APVMA considers a range of issues in assessing
agricultural chemicals for registration, including
efficacy, resistance management and human health
and environmental impacts. The APVMA will not
register a chemical product unless satisfied that its
approved use would not be likely to have an effect
that is harmful to people or the environment
It is also noted that this application is for a field trial,
not for commercial cultivation.
E, T
Comments that the desirability of trial
goals should be assessed for possible
impacts on health and safety of
people and the environment before
permission is given for trials for
agronomic performance.
The Regulator must assess each application, and
must not issue a licence unless risks can be managed
so as to protect the health and safety of people and
the environment. The RARMP concluded that risks to
human health and safety and the environment are
negligible as a result of this limited and controlled
release of GM cotton.
44
DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Submission Type View Issue
Number
Office of the Gene Technology Regulator
Summary of issues raised
Comment
2
I
X
E, T
Objects to all genetically modified
crops, regardless of whether or not for
human consumption. Comments that
genetic modification breaks the rules
of nature.
Argues that GM crops present real
dangers to the environment,
particularly bees.
Risk scenario 2 considered the potential for toxicity to
non-target invertebrates as a result of exposure to
GM plant materials containing the proteins encoded
by the introduced genes for insect resistance; this
was not identified as a risk greater than negligible.
Despite occasional allegations of adverse effects from
GM crops in the media, there is no credible evidence
of harm to people or the environment from any GM
crop authorised for environmental release in
Australia. There has been speculation that some GM
crops, specifically Bt corn (which is not grown in
Australia), could be a potential cause of colony
collapse disorder (CCD) in bees. However, current
scientific evidence suggests that CCD is likely to be
linked to a combination of factors contributing to the
stress of honey bees and there is no evidence to
support a link between CCD and GM crops.
3
I
X
P
Strongly opposes the application.
Asserts that Monsanto chemicals are
destroying land, killing soil and
affecting the health of livestock and
humans.
Regulation of agricultural chemicals, including
insecticides and herbicides, is principally the
responsibility of the APVMA. The APVMA considers a
range of issues in assessing agricultural chemicals for
registration, including efficacy, resistance
management and human health and environmental
impacts. The APVMA will not register a chemical
product unless satisfied that its approved use would
not be likely to have an effect that is harmful to people
or the environment.
C
Believes that GMOs should never
have been permitted in Australia and
the country should have remained
GM-free.
This issue is outside the scope of the Regulator’s
assessments under the Act.
Australia’s gene technology regulatory scheme was
established in response to community concerns about
the then developing area of gene technology.
Extensive public consultation was conducted before
passing of the Gene Technology Act in 2000, and the
provisions of the Act were developed to reflect issues
and comments raised by the community during that
consultation.
States that GMOs compromise
organic or chemical free status for
neighbouring farmers, and farmers
can be sued if GMOs inadvertently
move onto their land.
DIR 120 licence conditions impose strict controls that
restrict the spread and persistence of the GMOs and
their genetic material in the environment, including
monitoring of trial sites to ensure no GMOs remain
following completion of the trial.
When deciding whether or not to issue a licence,
matters that relate to marketing and trade, including
coexistence of GM and non-GM crops, are outside
the legislative responsibility of the Regulator. These
are matters for State and Territory governments, who
may designate GM free zones for marketing
purposes.
The independent Statutory Review of the Act,
conducted in 2005/06, considered the issue of liability
for contamination of non-GM crops by GMOs and
noted that common law and other consumer
protection legislation provided remedies to those
affected by the presence of GM varieties in non-GM
crops.
C, P
Appendix B
45
DIR 120 – Risk Assessment and Risk Management Plan (July 2013)
Submission Type View Issue
Number
4
Appendix B
I
X
C, M
Office of the Gene Technology Regulator
Summary of issues raised
Comment
Strongly opposes the application.
Asserts that the world trend is towards
organic and biodynamic food and by
allowing the release of GM crops,
Australia has lost a major economic
advantage.
Believes that trials such as DIR 120
allow the introduction of GM seed by
stealth, thereby threatening the whole
cotton industry.
These are issues relating to marketing and trade,
including coexistence of GM and non-GM crops. They
have been addressed in the response to submission
3 (above).
While not part of the Regulator’s considerations in
decision making, the cotton industry in Australia has
been a strong adopter of GM technology, with GM
varieties currently constituting over 99% of the cotton
crop. The industry organisation Cotton Australia
(http://cottonaustralia.com.au/) lists among the
benefits of GM technology in cotton: 80% reduction in
insecticide use; increased populations of beneficial
insects and wildlife in cotton fields; reduced pesticide
run off; improved farm worker and neighbour safety;
more time for farmers to spend with families; a
decrease in fuel usage; improved soil quality; reduced
production costs; and increased yield.
46