Office of the Gene Technology Regulator
Risk Assessment and Risk
Management Plan
Application for licence for dealings involving an
intentional release into the environment
DIR 012/2002
Title: Commercial release of Bollgard II® cotton
Applicant: Monsanto Australia Ltd
September 2002
Abbreviations
aad aminoglycoside adenylyltransferase
ANZFA Australia New Zealand Food Authority (now FSANZ)
AQIS Australian Quarantine Inspection Service
Bt Bacillus thuringiensis
B. t.k Bacillus thuringiensis variety kurstaki
CaMv cauliflower mosaic virus
CMoVb caulimovirus figwort mosaic virus
CSD Cotton Seed Distributors Ltd
CSIRO Commonwealth Scientific and Industrial Research Organisation
DIR dealing involving intentional release
DNA deoxyribonucleic acid
DNIR dealing not involving intentional release
ELISA enzyme linked immunosorbent assay
EMBL European Molecular Biology Laboratory
FSANZ Food Standards Australia New Zealand (formerly ANZFA)
EPSPS 5-enolpyruvylshikimate-3-phosphate synthase
GM genetically modified
GMAC Genetic Manipulation Advisory Committee
GMO genetically modified organism
gox glyphosate oxidoreductase
GTTAC Gene Technology Technical Advisory Committee
GUS -glucuronidase
IgE immunoglobulin E
IgG immunoglobulin G
IOGTR Interim Office of the Gene Technology Regulator
IPCS International Program on Chemical Safety
JETACAR Joint Expert Advisory Committee on Antibiotic Resistance
MAFF UK Ministry of Agriculture, Fisheries and Food
MRL maximum residue limit
mRNA messenger ribonucleic acid
NHMRC National Health and Medical Research Council
NICNAS National Industrial Chemicals Notification and Assessment Scheme
NOS nopaline synthase
nptII neomycin phosphotransferase II
NLRD Notifiable Low Risk Dealing
NRA National Registration Authority for Agricultural and Veterinary Chemicals
OGTR Office of the Gene Technology Regulator
ppm parts per million
TGA Therapeutic Goods Administrations
TGAC Technical Grade Active Constituent
US EPA United States Environmental Protection Agency
US FDA United States Food and Drug Administration
WHO World Health Organisation
w/v weight per volume
X-gluc 5-bromo-4-chloro-3-indolyl ß-D-glucuronic acid
μg/g micrograms per gram
TAB LE OF CONTENTS
PREFACE 1
SECTION 1 THE REGULATION OF GENE TECHNOLOGY IN AUSTRALIA ............................................. 1
SECTION 2 THE INITIAL CONSULTATION PROCESSES....................................................................... 1
SECTION 3 THE EVALUATION PROCESS ........................................................................................... 3
SECTION 4 THE STRUCTURE OF THIS DOCUMENT ............................................................................ 5
CHAPTER 1 INTRODUCTION 8
SECTION 1 THE LICENCE APPLICATION ........................................................................................... 8
SECTION 2 SUBMISSIONS ON THE APPLICATION AND RISK ASSESSMENT AND RISK MANAGEMENT
PLAN ............................................................................................................................ 10
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES
13
SECTION 1 THE APPLICATION COMPLIED WITH LEGISLATIVE REQUIREMENTS ............................. 13
SECTION 2 ABOUT THE ORGANISMS TO BE RELEASED .................................................................. 13
SECTION 3 PREVIOUS LIMITED RELEASES OF THESE GMOS IN AUSTRALIA ................................. 14
SECTION 4 RESULTS FROM AUSTRALIAN RELEASES OF BOLLGARD II® AND
BOLLGARD II®/ROUNDUP READY® COTTON ............................................................... 15
SECTION 5 RISK ASSESSMENT AND RISK MANAGEMENT PLANS FOR GENERAL RELEASE OF INGARD®
®
AND ROUNDUP READY COTTON ................................................................................ 17
SECTION 6 APPROVALS FOR GENERAL RELEASE OF INGARD® AND ROUNDUP READY® COTTON AND
ISSUING OF DEEMED LICENCES .................................................................................... 18
SECTION 7 ENVIRONMENTAL MONITORING PROGRAM FOR ROUNDUP READY® AND
ROUNDUP READY®/INGARD® COTTON...................................................................... 20
SECTION 8 APPROVALS FOR INGARD®, ROUNDUP READY® AND BOLLGARD II® COTTON IN OTHER
COUNTRIES .................................................................................................................. 22
SECTION 9 INTERFACE WITH OTHER REGULATORS AND GOVERNMENT BODIES............................ 25
SECTION 9.1 NATIONAL REGISTRATION AUTHORITY FOR AGRICULTURAL AND VETERINARY
CHEMICALS (NRA) .................................................................................................... 25
SECTION 9.2 FOOD STANDARDS AUSTRALIA NEW ZEALAND (FSANZ) ...................................... 26
CHAPTER 3 INFORMATION ABOUT THE GMOS 29
SECTION 1 SUMMARY INFORMATION ABOUT THE GMOS ............................................................. 29
SECTION 2 THE PARENT ORGANISM .............................................................................................. 30
SECTION 3 THE INTRODUCED GENES ............................................................................................. 31
SECTION 3.1 THE CRY1AC GENE ..................................................................................................... 31
SECTION 3.2 THE CRY2AB GENE ..................................................................................................... 32
SECTION 3.3 THE CP4 EPSPS GENE .............................................................................................. 33
SECTION 3.4 THE UIDA REPORTER GENE ....................................................................................... 34
SECTION 3.5 THE NPTII GENE ......................................................................................................... 35
SECTION 3.6 THE AAD GENE ............................................................................................................ 36
SECTION 4 BT TOXINS ................................................................................................................... 36
SECTION 5 METHOD OF GENE TRANSFER ...................................................................................... 39
SECTION 5.2 INGARD® COTTON .................................................................................................... 39
SECTION 5.1 BOLLGARD II® COTTON ............................................................................................. 40
SECTION 5.3 BOLLGARD II®/ROUNDUP READY® COTTON ............................................................ 40
SECTION 6 CHARACTERISATION OF THE INSERTED GENETIC MATERIAL AND STABILITY OF THE
GENETIC MODIFICATION .............................................................................................. 41
SECTION 6.1 BOLLGARD II® COTTON ............................................................................................. 41
SECTION 6.2 BOLLGARD II®/ROUNDUP READY® COTTON ............................................................ 41
SECTION 7 EXPRESSION OF THE INTRODUCED PROTEINS .............................................................. 42
SECTION 7.1 YOUNG LEAVES AND SEEDS ....................................................................................... 43
SECTION 7.2 MATURE COTTON PLANTS ......................................................................................... 44
SECTION 7.3 POLLEN ....................................................................................................................... 45
SECTION 7.4 BOLLGARD II®/ROUNDUP READY® COTTON ............................................................ 49
SECTION 7.3 ROUNDUP READY® COTTON ...................................................................................... 50
CHAPTER 4 RISK ASSESSMENT 51
SECTION 1 THE RISK ANALYSIS FRAMEWORK ............................................................................. 51
SECTION 2 THE RISK ASSESSMENT PROCESS ................................................................................. 51
SECTION 3 SUMMARY OF RISK ASSESSMENT CONCLUSIONS ......................................................... 53
SECTION 3.1 HAZARD IDENTIFICATION ......................................................................................... 53
SECTION 3.2 RISK ASSESSMENT CONCLUSIONS ............................................................................. 54
SECTION 3.3 CONSIDERATION OF RISKS RELATING TO COMBINATION OF THE BOLLGARD II® AND
®
THE ROUNDUP READY TRAITS ................................................................................ 56
SECTION 3.4 IDENTIFICATION OF ISSUES TO BE ADDRESSED FOR COMMERCIAL RELEASE OF
BOLLGARD II® AND BOLLGARD II®/ROUNDUP READY® COTTON .......................... 57
SECTION 4 DECISION TO ISSUE THE LICENCE................................................................................ 58
CHAPTER 5 TOXICITY OR ALLERGENICITY 59
CHAPTER 6 WEEDINESS 85
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS 97
SECTION 1 TRANSFER OF INTRODUCED GENES TO OTHER PLANTS ............................................... 97
SECTION 2 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS (MICROORGANISMS AND
ANIMALS) ................................................................................................................... 101
CHAPTER 8 INSECTICIDE RESISTANCE 107
CHAPTER 9 RISK MANAGEMENT PLAN 113
SECTION 1 SUMMARY OF RISK ASSESSMENT CONCLUSIONS ....................................................... 113
SECTION 2 RISK MANAGEMENT PLAN ......................................................................................... 114
SECTION 2.1 RISK OF TOXICITY OR ALLERGENICITY ................................................................. 114
SECTION 2.2 RISKS OF INSECTICIDE RESISTANCE ....................................................................... 114
SECTION 2.3 RISKS OF WEEDINESS OR GENE TRANSFER ............................................................. 115
SECTION 2.4 GENERAL LICENCE CONDITIONS ............................................................................. 116
SECTION 2.5 MONITORING AND ENFORCEMENT OF COMPLIANCE BY THE OGTR ................... 117
SECTION 3 SPECIFIC RISK MANAGEMENT LICENCE CONDITIONS ................................................. 117
CHAPTER 10 CONSIDERATION OF ISSUES RAISED IN PUBLIC SUBMISSIONS 121
REFERENCES 123
APPENDIX 1 SPECIFIC LICENCE CONDITIONS 151
APPENDIX 2 REASONS FOR LICENCE CONDITIONS 171
APPENDIX 3 – PUBLIC SUBMISSION SUMMARY 179
PREFACE
SECTION 1 THE REGULATION OF GENE TECHNOLOGY IN AUSTRALIA
1. The Gene Technology Act 2000 (the Act) took effect on 21 June
2001. The Act, supported by the Gene Technology Regulations 2001,
an inter-governmental agreement and corresponding legislation that is
being enacted in each State and Territory, underpins Australia‘s
nationally consistent regulatory system for gene technology. Its
objective is to protect the health and safety of people, and the
environment, by identifying risks posed by or as a result of gene
technology, and managing those risks by regulating certain dealings
with genetically modified organisms (GMOs). The regulatory system
replaces the former voluntary system overseen by the Genetic
Manipulation Advisory Committee (GMAC).
2. The Act establishes a statutory officer, the Gene Technology
Regulator (the Regulator), to administer the legislation and make
decisions under the legislation. The Regulator is supported by the
Office of the Gene Technology Regulator (OGTR), a Commonwealth
regulatory agency located within the Health and Ageing portfolio.
3. The Act prohibits persons from dealing with GMOs unless the
dealing is exempt, a Notifiable Low Risk Dealing, on the Register of
GMOs, or licensed by the Regulator (see Section 31 of the Act).
4. The requirements under the new legislation for consultation and
for considering and assessing licence applications and preparing risk
assessment and risk management plans are discussed in detail in
Division 4, Part 5 of the Act and Chapter 4 and summarised below.
SECTION 2 THE INITIAL CONSULTATION PROCESSES
5. Under Section 49 of the Act, the Regulator must decide whether
any proposed dealings involving an intentional release into the
environment may pose significant risks to the health and safety of
people or to the environment. If satisfied that at least one of the
dealings proposed to be authorised by a licence may pose a significant
risk, the Regulator must seek written submissions on the application
PREFACE 1
from the public. Regardless of the decision under Section 49, the
Regulator must seek advice on the application from certain prescribed
agencies, and must also seek written submissions from the public and
the prescribed agencies on the risk assessment and risk management
plan prepared in respect of a licence application, in accordance with
Sections 50 and 52 of the Act.
6. In making a decision under section 49 of the Act, section 49(2)
requires that the Regulator must have regard to:
the properties of the organism to which the dealings relate
before it became, or will become, a GMO;
the effect, or the expected effect, of genetic modification that
has occurred, or will occur, on the properties of the organism;
provisions for limiting the dissemination or persistence of the
GMO or its genetic material in the environment;
the potential for spread or persistence of the GMO or its
genetic material in the environment;
the extent or scale of the proposed dealings; and
any likely impacts of the proposed dealings on the health and
safety of people.
7. After taking into account all the matters set out in subsection 49(2),
the Regulator was satisfied that the dealings proposed by these
applications did not pose significant risks to human health, or to the
environment south of latitude 22º South. However, pending the
analysis of additional information supplied by the applicant, she was
unable to determine conclusively from the preliminary assessment
whether or not the proposed releases may pose a significant risk to the
environment north of latitude 22º South. The main reasons for this
were that:
the insecticidal genes may confer a selective advantage on the
cotton in northern Australia, and this could result in the
GMOs becoming a weed;
feral cotton populations that outcross with the GMOs may
become a weed.
PREFACE 2
8. Accordingly, the Regulator invited written submissions from the
public on the application under section 49(3) of the Act, on matters
relevant to the preparation of this risk assessment and risk management
plan.
9. As required under Section 50 of the Act, the Regulator also sought
advice on the application to assist the preparation of this risk
assessment and risk management plan from the following prescribed
agencies:
State and Territory Governments;
the Gene Technology Technical Advisory Committee
(GTTAC);
prescribed Commonwealth agencies (Regulation 9 of the Gene
Technology Regulations 2001 (the Regulations) refers);
the Environment Minister; and
relevant local council(s).
10. In accordance with Sections 50 and 51 of the Act, the Regulator
has taken account all issues raised in written submissions on the
application in preparing the risk assessment and risk management plan
(see Chapters 1 and 10).
11. All expert groups and key stakeholders, including the public, were
then consulted on the risk assessment and risk management plan in
accordance with Section 52 of the Act.
12. The Regulator has taken into account all issues raised in written
submissions on the risk assessment and risk management plan, relating
to the protection of human health and safety and the environment, in
finalising the risk assessment and risk management plan, and in making
a decision to issue a licence for the proposed release as required under
Section 56 of the Act (see Chapter 9).
SECTION 3 THE EVALUATION PROCESS
13. An assessment of the potential hazards and likely risks associated
with the proposed release was carried out in accordance with the Act,
PREFACE 3
using the Risk Analysis Framework developed by the Regulator (see
Chapter 4, Section 1). A risk assessment and risk management plan,
including proposed licence conditions, was then prepared to address
these risks.
14. In preparing the risk assessment and risk management plan,
information presented by the applicant, the scientific literature,
information from other national regulatory agencies, advice from
scientific experts, as well as submissions from the public and advice
from the Environment Minister, State and Territory Governments,
GTTAC, and Commonwealth agencies (see Regulation 9 of the
Regulations) and local Councils where the release is proposed were
considered and assessed by the Regulator.
15. The legislation requires the Regulator to consider a number of
specific issues in preparing the risk assessment and risk management
plan (see Chapter 4, Section 2). These include: the properties of the
parent organism; the effect of the genetic modification; the potential for
dissemination or persistence of the GMO or its genetic material in the
environment and any provisions for limiting this; the extent or scale of
the proposed dealings; and any likely impacts of the proposed dealings
on the health and safety of people.
16. The legislation also requires the Regulator to consider the potential
of the GMO, in the short and long term, to: be harmful to other
organisms; adversely affect any ecosystems; transfer genetic material to
other organisms; spread or persist in the environment; have a selective
advantage in the environment; and be toxic, allergenic or pathogenic to
other organisms.
17. This document presents the finalised version of the risk assessment
and risk management plan prepared after consideration of all relevant
advice and issues received, in accordance with the legislation, from the
public, interested organisations, States and Territory Governments,
GTTAC, the Environment Minister and the Commonwealth
government agencies, as prescribed by the Act and outlined in
Regulation 9 of the Gene Technology Regulations 2001.
18. Further details about the application can be found in Chapter 3 of
this document. Please note that while copies are available from the
PREFACE 4
OGTR, the application is not available electronically. In the future,
the OGTR hopes that electronic submission of applications will be
possible, enhancing the accessibility of such information for interested
people in the community.
SECTION 4 THE STRUCTURE OF THIS DOCUMENT
19. The document sets out the various matters that were considered by
the Regulator in accordance with Section 51 of the Act in preparing this
risk assessment and risk management plan, and outlines the
consultation processes undertaken under Sections 50 and 52 of the Act.
20. Written submissions sought through these consultation processes
relating to the protection of human health and safety and the
environment have been taken into account by the Regulator in
finalising the risk assessment and risk management plan and were
considered by the Regulator before making a final decision on the
application. This consultation phase was, therefore, an important part
of the decision making process.
21. The structure of the document reflects the matters which the Act
and Regulations require the Regulator to consider in preparing the risk
assessment and risk management plan. This document:
provides an introduction to the licence application and a
summary of the submissions received on the application and
the risk assessment and risk management plan. Chapter 1
refers.
summarises the legislative background of the licence
application, and provides background information relating to
previous intentional releases of the GMOs and other related
GMOs. Chapter 2 refers.
provides detailed information about the parent organism(s),
the GMO(s), and the introduced genes. Chapter 3 refers.
details the risk assessment undertaken to date in accordance
with the Risk Analysis Framework developed by the
Regulator. Chapter 4 refers.
PREFACE 5
details the risk assessment on the hazards of toxicity and
allergenicity of Bollgard II® and
Bollgard II®/Roundup Ready® cotton. Chapter 5 refers.
details the risk assessment on the hazard of weediness of
Bollgard II® and Bollgard II®/Roundup Ready® cotton.
Chapter 6 refers.
details the risk assessment on the hazard of transfer of
introduced genes to other organisms. Chapter 7 refers.
details the risk assessment on the hazard of insecticide
resistance. Chapter 8 refers.
sets out the conclusions reached as a result of the risk
assessment and presents a risk management plan to manage
the identified risks. Conditions included in the licence to give
effect to the risk management plan are also provided.
Chapter 9 refers.
sets out the specific licence conditions. Appendix 1 refers.
explains the reasons for specific licence conditions. Appendix
2 refers.
summarises public submissions on the application.
Chapter 10 and Appendix 3 refer.
22. It should be noted that the OGTR has also produced a reference
document entitled ‗The Biology and Ecology of Cotton
(Gossypium hirsutum L.) in Australia‘(OGTR 2002), which summarises
the current literature and information on cotton, on issues such as
growth and agronomy, outcrossing rates, taxonomy and distribution of
feral cotton and native Australian cotton species and weediness. This
document is referred to throughout the risk assessment and risk
management plan.
PREFACE 6
PREFACE 7
CHAPTER 1 INTRODUCTION
23. The Gene Technology Act 2000 (the Act) and the Gene Technology
Regulations 2001 (the Regulations) set out requirements which the Gene
Technology Regulator (the Regulator) must follow when considering an
application for a licence to intentionally release a genetically modified
organism (GMO) into the environment. Section 51 of the Act requires
the Regulator to prepare a risk assessment and risk management plan
for each licence application. Details of the process which the Regulator
must follow are set out in the Preface.
SECTION 1 THE LICENCE APPLICATION
24. This risk assessment and risk management plan has been prepared
in response to the licence application from Monsanto Australia Ltd
(Monsanto) for the intentional release of genetically modified (GM)
cotton into the environment (DIR 012/2001).
25. Written submissions were sought through the consultation
processes undertaken under Sections 50 and 52 of the Act. These
submissions have been taken into account by the Regulator in finalising
the risk assessment and risk management plan and were considered by
the Regulator before making a final decision on the application.
26. Monsanto applied for a licence to commercially release genetically
modified (GM) insecticidal cotton, registered under the trade name
Bollgard II® cotton, and GM insecticidal/herbicide tolerant cotton,
referred to as Bollgard II®/Roundup Ready® cotton.
27. Bollgard II® cotton is derived from GM insecticidal INGARD®
cotton which contains an insecticidal gene that makes it resistant to the
lepidopteran caterpillar insect pests of cotton. Bollgard II® cotton
contains a second insecticidal gene that increases its insecticidal
activity. Bollgard II®/Roundup Ready® cotton was produced by
conventional breeding of Bollgard II® cotton with GM
Roundup Ready® cotton which contains a gene for tolerance to the
herbicide glyphosate (Roundup®).
28. INGARD® cotton was approved for commercial release in
Australia in 1996, by the National Registration Authority for
CHAPTER 1 INTRODUCTION 8
Agricultural and Veterinary Chemicals (NRA), with advice from the
Genetic Manipulation Advisory Committee (GMAC) which oversaw the
former voluntary system for regulation of gene technology in Australia.
Roundup Ready® cotton was also approved for commercial release in
Australia in 2000, under the voluntary system.
29. These releases were restricted to south of latitude 22 South
because of the concerns about the potential weediness of the cotton in
tropical areas as well as potential for outcrossing to native cotton
species.
30. Monsanto requested approval for the commercial cultivation of
Bollgard II® and Bollgard II®/Roundup Ready® cotton in all Australian
cotton growing areas, including potential cotton growing areas in the
Northern Territory, Western Australia and Queensland, outside the
area previously approved for commercial release of GM cotton.
However, the risk assessment identified a potential risk of weediness in
northern Australia, and the commercial release was not approved for
north of latitude 22º South. The release of GM cotton in the northern
Australia will be restricted to field trials and will be subject to a
number of specific licence conditions to minimise the risk of weediness
by limiting the spread and persistence of the GM cotton in the
environment (see Section 2 of this Chapter and Chapters 6 and 9).
31. Monsanto proposed the phased introduction of the GM
Bollgard II® cotton over three years, associated with the phasing-out of
INGARD® cotton. The total release area for Bollgard II® and
Bollgard II®/Roundup Ready® cotton will be subject to any
requirements that may be imposed by Australian regulatory authorities
for insecticide resistance management (See Chapter 8), but could
eventually encompass a high proportion of the Australian cotton crop
(currently about 484 000 hectares).
32. There have been several limited and controlled releases of
Bollgard II® and Bollgard II®/Roundup Ready® cotton in Australia.
These include trials under the former voluntary system as well as three
licences for limited and controlled releases of Bollgard II® and/or
Bollgard II®/Roundup Ready® cotton issued under the new regulatory
system (see Chapter 2, Section 4).
CHAPTER 1 INTRODUCTION 9
33. It is proposed that the cotton plants and their by-products would
be used in the same manner as conventional cotton, as fibre for the
textile industry as well as in human food and stockfeed. Cotton seed is
processed for oil that is used in a variety of food products. Cotton
linters (a type of short fibre) are used as a cellulose base for several
consumer products, including food.
34. Food Standards Australia New Zealand (FSANZ, formerly the
Australia New Zealand Food Authority, ANZFA), has approved the use
in human food of oil and linters derived from INGARD® cotton and
Roundup Ready® cotton. FSANZ is currently evaluating an
application from Monsanto to approve the use in human food of oil and
linters derived from Bollgard II® cotton. In two previous assessments
of Bollgard II® cotton, FSANZ indicated that it considers products from
Bollgard II® cotton to be as safe for human consumption as those from
conventional cotton (ANZFA 2002).
35. More detailed information about the GMO, the genetic
modification process, the genes that have been introduced and the new
proteins expressed in the GMO is set out in Chapter 3.
SECTION 2 SUBMISSIONS ON THE APPLICATION AND RISK ASSESSMENT AND
RISK MANAGEMENT PLAN
36. Extensive consultation with a range of expert groups and key
stakeholders, including the public, was undertaken in accordance with
sections 50, 51 and 52 of the Act. Issues raised in submissions that
related to public health and safety and the environment were taken into
account in finalising the risk assessment and risk management plan and
the Regulator‘s decision on the application.
37. A summary of the issues follows, along with information on where
they were considered in the risk assessment and risk management plan:
health concerns including potential toxicity or allergenicity.
These issues are addressed in ‗The Biology and Ecology of
Cotton (Gossypium hirsutum) in Australia‘ (OGTR 2002;
available on the OGTR website) and Chapter 5 of the Risk
Assessment and Risk Management Plan (RARMP);
CHAPTER 1 INTRODUCTION 10
whether the insecticidal protein in the GM cotton might be
toxic for non-target species. This issue is addressed in
Chapter 5;
whether the interaction of insecticidal and herbicide-tolerant
traits might be toxic to non-target organisms and soil biota.
This is addressed in Chapter 5.
whether the GMO may pose a risk as a weed in the
environment, particularly in northern Australia, and whether
herbicide resistant weeds might develop. These issues are
addressed in ‗The Biology and Ecology of Cotton (Gossypium
hirsutum) in Australia‘ (OGTR 2002) and Chapters 6 and 7;
whether the introduced genes could transfer to other
organisms, including to feral cotton and non-GM cotton crops
and what impacts this might have. These issues are
addressed in ‗The Biology and Ecology of Cotton (Gossypium
hirsutum) in Australia‘ (OGTR 2002) and Chapters 7 and 8
38. Submissions on the risk assessment and risk management plan in
the second round of consultation expressed concerns about river
systems between latitudes 20 and 22 South that can flow towards the
north-west and potentially carry GM material into areas where only
limited and controlled release will be permitted. Based on these
concerns, the risk assessment and risk management plan was revised to
limit the commercial release of the GM cottons to south of latitude
22º South, rather than to 20º South, as proposed in the original risk
assessment and risk management plan.
39. Submissions on the risk assessment and risk management plan
following the second round of consultation confirmed concerns about
the potential weediness of Bollgard II® and
Bollgard II®/Roundup Ready® cotton north of latitude 22º South and
made suggestions regarding their control. Submissions were also
received regarding post-harvest management of the sites including
control of post harvest uses, monitoring of the sites and destruction of
volunteers; transport of GM seed; and whether resistance to the
insecticidal action of the cotton could develop in target pests.
CHAPTER 1 INTRODUCTION 11
40. Submissions also suggested that the following specific issues should
be considered:
pollen dispersal and buffer zones (see ‗The Biology and
Ecology of Cotton (Gossypium hirsutum) in Australia‘ (OGTR
2002) and Chapters 7 and Chapter 8);
seed dormancy and seed dispersal (see ‗The Biology and
Ecology of Cotton (Gossypium hirsutum) in Australia‘ (OGTR
2002) and Chapter 6);
the potential toxicity of the Cry2Ab protein for dipteran
insects (flies and mosquitoes)
41. Accordingly the Licence is subject to a number of specific licence
conditions to minimise the risk of weediness north of latitude 22º South,
by restricting the spread and persistence of the GM cotton in the
environment.
42. Other issues raised in submissions indicated the need for ongoing
monitoring after the release, particularly in relation to the potential for
development of insects resistant to the insecticidal action of the cotton
and herbicide-resistant weeds
43. Submissions from the public are discussed in more detail in
Chapter 10 and Appendix 3.
CHAPTER 1 INTRODUCTION 12
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS
AND PREVIOUS RELEASES
44. This chapter provides information about the proposed release and
summary information about the GMOs, including information about
previous releases into the environment of relevant GMOs.
SECTION 1 THE APPLICATION COMPLIED WITH LEGISLATIVE REQUIREMENTS
45. The proposal was submitted in accordance with the requirements
of Section 40 of the Act. As required by Schedule 4, Part 2 of the
Regulations, the application included information about:
the parent organism;
the GMO;
the proposed dealing with the GMO;
interaction between the GMO and the environment;
risks the GMO may pose to the health and safety of people;
risk management;
previous assessments of approvals; and
the suitability of the applicant.
46. The application also contained:
additional information required for a GMO that is a plant;
additional information for a GMO that is intended to be used
as food for human or vertebrate animal consumption; and
supporting information from the Institutional Biosafety
Committee.
47. A copy of the application is available on request from the OGTR.
SECTION 2 ABOUT THE ORGANISMS TO BE RELEASED
48. The organisms to be released are Bollgard II® and
Bollgard II®/Roundup Ready® cotton.
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 13
49. Bollgard II® cotton, previously known as TWINGARD® cotton,
contains two genes (cry1Ac and cry2Ab) from a soil bacterium, Bacillus
thuringiensis (abbreviated as Bt), that code for insecticidal toxins (Bt
toxins) and make the cotton resistant to lepidopteran caterpillar insect
pests. The cotton also contains bacterial antibiotic resistance genes
(nptII and aad) that were used in the genetic modification process to
select cells containing the desired genes. The nptII gene confers
resistance to kanamycin and neomycin. The aad gene confers
resistance to streptomycin and spectinomycin, but it is not expressed in
plants because the promoter that controls its expression is not active in
plants. A reporter gene (uidA) from Escherichia coli that enables
visual identification of plant tissues in which this gene is being
expressed is also present.
50. Bollgard II®/Roundup Ready® cotton in addition tolerates the
herbicide glyphosate, the active constituent in Roundup® herbicide.
Glyphosate tolerance is conferred by the CP4 EPSPS gene from a soil
bacterium, Agrobacterium strain CP4.
51. Further details about the parent organisms, the genetic
modification process and the introduced genes are provided in
Chapter 3.
SECTION 3 PREVIOUS LIMITED RELEASES OF THESE GMOS IN AUSTRALIA
52. Nineteen limited and controlled releases (field trials) of
Bollgard II® and Bollgard II®/Roundup®Ready have been carried out to
assess the agronomic performance of the GM cotton and its behaviour
in the Australian environment. These releases were carried out under
conditions to minimise potential risks posed by the GM cotton. They
included:
16 releases approved under the former voluntary system
overseen by GMAC: PR-51X(4), PR-112, PR-112X,
PR-112X(2), PR-118, PR-118X, PR-118X(2), PR-123,
PR-123X, PR-123X(2), PR-131, PR-131X, PR-131X(2),
PR-131X(3), PR-140 and PR-140X; and
3 releases approved by the Regulator under the new
regulatory system: DIR005/2001, DIR 006/2001, and DIR
009/2001.
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 14
53. The first release of Bollgard II® cotton was in 1999. In the early
releases, Bollgard II® cotton was called TWINGARD® cotton and the
cry2Ab gene was designated as the ‗cryX‘ gene. Each of these releases
was carried out under controlled conditions to limit the spread and
persistence of the GMO in the environment.
54. Bollgard II® and Bollgard II®/Roundup Ready® cotton have been
grown in various Australian locations and conditions, in NSW, QLD,
the NT and WA, to select the best varieties for further development.
Organisations that have been involved in carrying out the releases
include the Western Australia Department of Agriculture, CSIRO and
the Queensland Department of Primary Industries (QDPI), as well as
the cotton seed companies Cotton Seed Distributors Ltd (CSD) and
Deltapine Australia Ltd. In the largest trial, the approved planting
area was 712 hectares.
55. Previous releases conducted under the former voluntary system
were carried out in accordance with GMAC guidelines. To enable
public comment for consideration in the assessment process, each
proposed release was notified in the Gazette, on the GMAC or the
Interim Office of the Gene Technology Regulator (IOGTR) website and
by direct mail to the GMAC or IOGTR mailing list. Relevant local
government councils were also advised directly. Reports were
provided to GMAC or to the OGTR at the conclusion of each release.
No adverse effects on human health and safety or the environment were
reported for any of the previous releases.
56. For releases approved under the regulatory system, consultation
processes were undertaken and risk assessment and risk management
plans prepared in accordance with legislative requirements discussed in
the Preface and Chapter 4. These releases are still in progress, and
reports will be supplied to the OGTR at the end of the release.
SECTION 4 RESULTS FROM AUSTRALIAN RELEASES OF BOLLGARD II® AND
BOLLGARD II®/ROUNDUP READY® COTTON
57. Factors assessed in previous limited and controlled releases (field
trials) of Bollgard II® and Bollgard II®/Roundup Ready® cotton include
agronomic performance, the quality of cotton fibres, possible effects of
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 15
the Cry1Ac and Cry2Ab toxins on non-target invertebrates, and the
levels of insecticidal activity and herbicide tolerance.
Section 4.1 Agronomic performance
58. Previous field trials in Australia of the Bollgard II® and
Bollgard II®/Roundup Ready® varieties proposed for release have
demonstrated that their growth characteristics, disease resistance, yield
and fibre quality are within the range of current conventional
commercial cotton varieties, and that they have no aberrant
morphological characteristics. Similar studies conducted in the United
States of America (USA) have drawn the same conclusions (data
provided by Monsanto). Effective levels of insecticidal activity and
herbicide tolerance also have been demonstrated under Australian
conditions (Fitt 2000; Greg Constable, Program Leader, Cotton
Improvement and Production, CSIRO Plant Industry, personal
communication).
Section 4.2 Insecticidal activity
59. The insecticidal proteins produced by Bollgard II® cotton target
lepidopteran insects (see Chapter 5), including the major caterpillar
pests of cotton. Studies by CSIRO indicate that Bollgard II® cotton
gives much higher levels of control of the major Helicoverpa caterpillar
species in Australia than INGARD® cotton (Dr G. Fitt, CSIRO
Entomology, CEO Australian Cotton Research Institute, personal
communication). The data suggest that the second protein in
Bollgard II® augments the insecticidal activity of the cotton, relative to
that of INGARD® cotton, by both extending the time over which the
plants express the toxins and by expressing higher levels of toxin (see
Chapter 3, Table1), confirming previous studies undertaken over a
three year period in the USA (Jackson et al. 2000; Akin et al. 2001;
Penn et al. 2001; Stewart et al. 2001; Marchosky et al. 2001).
Section 4.3 Performance of Bollgard II®/Roundup Ready® cotton
60. Field trials in Australia of the Bollgard II®/Roundup Ready®
varieties proposed for release demonstrated that there was no
antagonistic interaction between the insecticidal and herbicide tolerant
traits of Bollgard II®/Roundup Ready® cotton. The level of expression
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 16
of Bt proteins and the insecticidal activity of
Bollgard II®/Roundup Ready® cotton was equivalent to the same indices
of performance of Bollgard II® cotton (data supplied by Monsanto).
Section 4.4 Target range
61. Various researchers have investigated the potential impact of
Bollgard II® cotton on non-target invertebrates, both overseas (Naranjo
and Ellsworth 2002) and in Australia (Addison 2001a; Addison 2001b;
Addison 2001c; see Chapter 5 for details). With the exception of
lepidopteran insects, there were no significant negative effects of
Bollgard II® cotton on the abundance or diversity of non-target
invertebrates.
SECTION 5 RISK ASSESSMENT AND RISK MANAGEMENT PLANS FOR GENERAL
® ®
RELEASE OF INGARD AND ROUNDUP READY COTTON
62. In assessing and establishing the conditions of the initial approvals
for INGARD® (insecticidal) and Roundup Ready® (herbicide tolerant)
cotton, there was extensive co-operation between the NRA, GMAC, the
IOGTR (the OGTR‘s predecessor under the voluntary system),
Commonwealth bodies including Environment Australia, the
Environment Protection Agency and the Australia New Zealand Food
Authority, as well as State and Territory agencies. The NRA and the
IOGTR also undertook public consultation as part of the assessment
process. Responses were received from representatives of consumer,
environmental, farming, cotton industry, and scientific and academic
interests.
63. The potential risks to human health and the environment were
thoroughly assessed by the NRA, GMAC and the IOGTR. They
concluded that risks from both introduced traits to human health were
negligible and that risks to the environment, particularly in the
southern cotton-growing regions of QLD and NSW, were low and could
be managed. The environmental risks identified by GMAC were that
there was a very low risk of outcrossing with native Australian cotton
species, particularly in northern Australia where most of these species
occur. For INGARD® cotton it was considered that there was a low
risk that it might persist as a weed in tropical regions of Australia,
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 17
where naturalised populations of cotton are known to occur, and in
regions where insect resistance might confer a selective advantage (see
Chapter 6, and OGTR 2002).
64. GMAC considered that these risks could be managed by restricting
planting of INGARD® cotton to locations where contact with native
cotton species would be unlikely. GMAC recommended that the
release of both INGARD® and Roundup Ready® cotton be restricted in
location and scale, until further data were available to fully assess the
weediness of the GM cotton, and the likelihood and consequences of
outcrossing with native cotton. The original registration conditions
therefore restricted the general release of the GM cotton to the area
below latitude 26º South and required environmental monitoring to
obtain further information about the potential risks.
65. In 1997, the approved area was extended by the NRA, on the basis
of advice from GMAC, to south of latitude 22º South, as the
cotton-growing industry extended further north in QLD. The
cotton-growing regions of WA and the NT, where the main risks
relating to weediness and outcrossing to native species were considered
to lie, are still excluded.
66. Copies of the licence conditions for INGARD® and
Roundup Ready® cotton are available on the OGTR website. The
licence numbers are GR-3 for INGARD® cotton and GR-9 for
Roundup Ready® cotton. A copy of the risk assessment and risk
management plan for Roundup Ready® cotton (including the risk
assessment and risk management plan for Roundup Ready®/INGARD®
cotton) is also available on the website.
SECTION 6 APPROVALS FOR GENERAL RELEASE OF INGARD® AND
ROUNDUP READY® COTTON AND ISSUING OF DEEMED LICENCES
67. On 5 August 1996, the insecticidal gene present in INGARD®
cotton was registered as an agricultural chemical product by NRA, on
the basis of advice provided by GMAC and other Commonwealth and
State Government Agencies. Commercial planting of INGARD®
cotton initially was limited to 30 000 hectares, but the area has been
extended gradually. The NRA remains responsible for determining the
total planting area each season and for other conditions of registration
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 18
including the implementation of insecticide resistance management
plans (discussed in Chapter 8). In June 2000, the NRA varied the
conditions of registration allowing up to 30% (165 000 hectares) of the
cotton crop to be planted to INGARD® cotton for the 2000-2001 season.
68. Roundup® Ready and Roundup® Ready/INGARD® cotton (GR-9)
were approved for general (commercial) release on 14 September 2000,
by the Minister for Health and Aged Care, the Hon Dr Michael
Wooldridge MP, on the basis of advice from GMAC and the IOGTR.
The Commonwealth Government entered into a legally binding Deed of
Agreement with Monsanto Australia Ltd to ensure compliance with the
agreed conditions. The NRA‘s 30 % cap on INGARD® cotton planting
is still in place and includes Roundup Ready®/INGARD® cotton.
However, no restrictions on the planting area (total hectares) for
Roundup Ready® cotton were imposed. The NRA is responsible for
setting conditions on the new use of Roundup® on cotton crops,
including conditions relating to herbicide resistance management (see
Section 9 of this chapter).
69. Although GMAC concluded from the risk assessment and risk
management plan that led to the approval for general release (Section 5
of this Chapter) that there were no significant risks to the natural
environment arising from the genetic modification of Roundup Ready®
and Roundup Ready®/INGARD® cotton, it recommended that the
release of these GM cottons be reviewed by the OGTR after five years.
Under transitional arrangements set out in Section 190 of the Act,
GMAC‘s advice to proceed with the general release of INGARD®,
Roundup Ready® and Roundup Ready®/INGARD® cotton, issued to
Monsanto, were deemed as licences for the purposes of the Act. The
deemed licences took effect with the commencement of the new
legislation on 21 June 2001. However, the transitional arrangements
under the Gene Technology Act 2000 meant that the approval for
Roundup Ready® and Roundup Ready®/INGARD® cotton could only be
for a maximum of two years after the legislation took effect, on 21 June
2001. As a consequence of these transitional arrangements, the review
of Roundup Ready® cotton is due by June 2003 which is two years
earlier than GMAC‘s recommendation.
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 19
70. Under the Deed of Agreement, Monsanto was required to conduct
an environmental monitoring program for Roundup Ready® and
Roundup Ready®/INGARD® cotton over three years. This research
program included surveys of:
the incidence of volunteer Roundup Ready® in
non-agricultural situations (e.g. roadsides);
the incidence of volunteer Roundup Ready® in non-GM crop
farm situations; and
any shifts in weed resistance associated with the cultivation of
Roundup Ready® cotton.
71. The progress and the results from this program to date are
summarised below (Section 7 of this chapter).
SECTION 7 ENVIRONMENTAL MONITORING PROGRAM FOR ROUNDUP READY®
® ®
AND ROUNDUP READY /INGARD COTTON
72. The Roundup Ready® and Roundup Ready®/INGARD® cotton
environmental monitoring program was developed through
consultation with GMAC, the cotton industry, scientists, cotton growers
and other interested parties. In addition to the research program
summarised in Section 6 of this Chapter, the consultation established
the following protocols for the management of Roundup Ready® cotton
farming systems:
integrated weed management guidelines for Australian cotton
production that limit the development of herbicide resistance
in weed species;
a management plan for controlling Roundup Ready® cotton
volunteers;
a stewardship program for the Roundup Ready® cotton
technology, comprising a course developed by Monsanto that
each potential grower is required to attend and pass; and
an annual survey/audit of compliance with the herbicide
resistance management plan that has been ratified by the
herbicide-tolerant subcommittee of the Transgenic and Insect
Management Strategy (TIMS) Committee of the Australian
Cotton Grower‘s Research Association.
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 20
73. The environmental monitoring program for Roundup Ready®
cotton is being conducted by the Australian Cotton Cooperative
Research Centre in the cotton growing area of the Namoi valley, NSW
and Darling Downs in Queensland (Qld). The data gathered to date
were available for this evaluation. The final reports are due by
September 2003. A summary of the results of the research program is
provided in Sections 7.1 – 7.3, below.
Section 7.1 Roundup Ready® cotton in non-agricultural situations
(roadsides)
74. A survey was conducted to determine the incidence of
Roundup Ready® cotton volunteers along roadsides in the lower Namoi
valley. On a total of 700 km of roadside surveyed, an average of 4.3
volunteers/km road were found. However, the volunteers were not
distributed evenly but rather, were clumped in favourable habitats such
as ditches and roadside drains. Evidence from this survey indicates
that control of these volunteers can be managed easily either
mechanically, or with herbicides other than the glyphosate.
Section 7.2 Farm survey for Roundup Ready® cotton volunteers
75. Monsanto provided data for the 2000 - 2001 and 2001 - 2002
seasons relating to surveys of farms in Qld and NSW on which
Roundup Ready® cotton was grown. In the 2000 - 2001 cotton growing
season, about 1,300 hectares of Roundup Ready® cotton were grown
and in the 2001- 2002 season, this increased to 8,600 hectares. The
survey focussed on fields in which Roundup Ready® cotton previously
had been grown, but also included some fields adjacent to the
Roundup Ready® cotton fields. The farm survey showed that 80 – 90
% of the volunteers were Roundup Ready® cotton. In all cases, the
volunteers were controlled easily by cultivation and/or with alternative
herbicides and were not considered to be a problem.
Section 7.3 Survey for shifts in weeds resistant to glyphosate
76. A preliminary report indicates that compliance with an integrated
weed management program and the adoption of Monsanto‘s
stewardship program for Roundup Ready® cotton will significantly
limit the development of weeds resistant to the herbicide, glyphosate.
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 21
An audit of GM cotton growers indicates that a high proportion of
farmers growing Roundup Ready® cotton comply with Monsanto‘s
technology stewardship program and the herbicide resistance
management plan endorsed by TIMS.
77. The survey of Roundup Ready® cotton volunteers on farms and
roadsides and shifts in the weeds that may develop resistance to
glyphosate is ongoing and will be finalised by September 2003.
SECTION 8 APPROVALS FOR INGARD®, ROUNDUP READY® AND
BOLLGARD II® COTTON IN OTHER COUNTRIES
Section 8.1 Approvals for INGARD® cotton in other countries
78. Countries that have assessed the use of INGARD® cotton include:
The United States: The US Department of Agriculture and
the Food and Drug Administration approved the commercial
release and use in food of INGARD® cotton in 1995;
Canada: The Canadian Food Inspection Agency and Health
Canada approved the commercial release and use in food of
INGARD® cotton in 1996;
Japan: The Japanese Ministries of Agriculture, Forestry and
Fisheries, and Health and Welfare approved the commercial
release and use in food of INGARD® cotton in 1997;
China: Approved the commercial release and use of
INGARD® cotton in food and feed in 1997;
Mexico: Approved the commercial release and use of
INGARD® cotton in food and feed in 1997;
Argentina: Approved the commercial release and use of
INGARD® cotton in food and feed in 1998;
Indonesia: The National Biosafety Committee approved the
limited commercial release and use in food of INGARD®
cotton in 1999;
South Africa: The Department of Agriculture approved the
commercial release and use in food of INGARD® cotton in
2000; and
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 22
India: Approved the commercial release and use of
INGARD® cotton in food and feed in 2002.
79. Other countries where INGARD® varieties have been approved, or
are pending approval, include Israel, and the European Union.
80. No country has refused an application for the release of INGARD®
cotton.
Section 8.2 Approvals for Roundup Ready® cotton in other countries
81. Countries that have assessed the use of Roundup Ready® and
INGARD® cotton include:
The United States: The US Department of Agriculture and
the Food and Drug Administration approved the commercial
release and use in food of Roundup Ready® cotton in 1995;
Canada: The Canadian Food Inspection Agency and Health
Canada approved the commercial release and use in food of
Roundup Ready® cotton in 1996;
Japan: The Japanese Ministries of Agriculture, Forestry and
Fisheries, and Health and Welfare approved the commercial
release and use in food of Roundup Ready® cotton in 1997.
Its use in animal feed was approved in 1998;
Argentina: Approved the commercial release of
Roundup Ready® cotton in 1999 and its use in human food
and as stock feed in 2001;
82. In these countries, Roundup Ready®/INGARD® cotton is not
currently regulated separately from the two parental lines. Once the
parental lines were approved for commercial release, the Roundup
Ready®/INGARD® variety was also permitted to be released
commercially.
83. Other countries where both Roundup Ready® varieties have been
approved, or are pending approval, include India, Israel, Mexico, and
the European Union.
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 23
84. No country has refused an application for the release of Roundup
Ready® cotton.
Section 8.2 Approvals for Bollgard II® cotton in other countries
85. Limited and controlled releases of Bollgard II® cotton have been
approved and carried out in Argentina, Costa Rica, India, Japan,
Mexico, South Africa and the USA. Limited and controlled releases of
Bollgard II®/Roundup Ready®cotton have been approved and carried
out in the USA. An application for limited release of
Bollgard II®/Roundup Ready® cotton in Argentina is under
consideration.
86. Commercial release of Bollgard II® is currently being assessed by
regulators in the USA. Applications seeking approval for the use in
human food of oil and linters from Bollgard II® cotton have been lodged
in the USA and Japan. As noted in Section 1 of this Chapter, FSANZ
(formerly ANZFA) has previously approved the use in human food of
oil and linters from INGARD® and Roundup Ready® cotton and has
indicated that it considers oil and linters from Bollgard II® cotton to be
as safe for human consumption as conventional cotton.
87. No country is known to have refused an application to release
Bollgard II®, Roundup Ready® cotton or Bollgard II®/Roundup Ready®
cotton. No adverse effects on human health and safety or the
environment have been reported in countries in which releases of the
GM cotton have been made.
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 24
SECTION 9 INTERFACE WITH OTHER REGULATORS AND GOVERNMENT BODIES
88. The OGTR is responsible for assessing the biosafety risks to
human health and the environment associated with development and
use of GMOs. Other government regulatory requirements must also
be met in respect of the release of the GMOs, and the use of products of
the GMO, including the requirements of the NRA and FSANZ.
Section 9.1 National Registration Authority for Agricultural and Veterinary Chemicals
(NRA)
89. Bollgard II® and Bollgard II®/Roundup Ready® cotton fall under
the Agricultural and Veterinary Chemicals Code (1994) definition of an
agricultural chemical product, due to their production of insecticidal
substances, and are therefore subject to regulation by the NRA.
90. As Bollgard II® and Bollgard II®/Roundup Ready® are genetically
modified to resist key insect pests of cotton and, in the case of
Bollgard II®/Roundup Ready® cotton, to tolerate the herbicide
glyphosate, the NRA has imposed conditions in connection with the
insecticidal activity of these cottons to manage the development of
insecticide resistance in the cotton industry as a whole. These are
likely to include specifying maximum areas for release of the GMOs.
91. The NRA has also imposed conditions on the use of the herbicide,
glyphosate (the active ingredient of Roundup®) used in connection with
Roundup Ready® cotton as part of an overall strategy to limit the
development of glyphosate resistant weeds.
92. Therefore, the OGTR has not imposed conditions in relation to
insect resistance management or herbicide tolerance management in
relation to agricultural practices, as these matters will be managed in
the context of the NRA scheme.
93. Further information about the management of insecticide
resistance and on the use and safety of herbicides are available from the
NRA
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 25
National Registration Authority for Agricultural and Veterinary
Chemicals
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6272 5158
Fax: (02) 6272 4753
Email: nra.contact@nra.gov.au
http://www.nra.gov.au
Section 9.2 Food Standards Australia New Zealand (FSANZ)
94. The safety and labelling of foods derived from genetically modified
plants are the responsibility of FSANZ (formerly ANZFA), rather than
the OGTR.
95. In previous risk assessments of genetically modified INGARD® and
Roundup Ready® cotton, FSANZ found that refined oil and processed
linters derived from these GM cottons are as safe for human
consumption as refined oil and processed linters derived from other
commercial cotton varieties. Similarly, in two previous assessments,
FSANZ has concluded that the oil and linters from Bollgard II® cotton
are as safe for human consumption as those from other conventional
varieties of cotton (ANZFA 2002).
96. Further details of this risk analysis and information about food
labelling are available from ANZFA:
Food Standards Australia New Zealand
PO Box 7186
Canberra Mail Centre ACT 2610
Phone: (02) 6271 2222
Fax: (02) 6271 2278
E-mail: info@foodstandards.gov.au
http://www.foodstandards.gov.au
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 26
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 27
CHAPTER 3 INFORMATION ABOUT THE GMOS
97. In preparing the risk assessment and risk management plan, the
Regulator is required under Section 49 (2) of the Act to consider the
properties of the parent organism and the effects of genetic
modification.
98. This part of the document addresses these matters and provides
detailed information about the GMOs for release, the parent organism,
the genetic modification process, the genes that have been introduced
and the new proteins that are expressed in the genetically modified
cotton.
99. Further information and analysis of the properties of the parent
organism are contained in the reference document that was prepared
by the OGTR entitled ‗The Biology and Ecology of Cotton (Gossypium
hirsutum) in Australia‘ (OGTR 2002), available at the OGTR website.
SECTION 1 SUMMARY INFORMATION ABOUT THE GMOS
100. Bollgard II® cotton contains two insecticidal genes, cry1Ac and
cry2Ab, both derived from the common soil bacterium Bacillus
thuringiensis variety kurstaki. The Cry1Ac and Cry2Ab proteins (Bt
toxins) are highly specific insecticidal proteins that are toxic to
lepidopteran caterpillar pests of cotton (Van Rei et al. 1989; Widner &
Whiteley 1989; Van Rie et al. 1990; Dankocsik et al. 1990), including
Helicoverpa armigera (cotton bollworm) and H.punctigera (native
budworm). Further details on the Bt toxins and the cry1Ac and cry2Ab
genes are provided in Sections 3 and 4 of this Chapter.
101. Bollgard II®/Roundup Ready® cotton is also tolerant to the
herbicide glyphosate, the active constituent in Roundup® herbicide.
The herbicide tolerance is conferred by the CP4 EPSPS gene from a soil
bacterium Agrobacterium strain CP4, and was introduced into
Bollgard II® cotton through conventional breeding with GM
herbicide-tolerant Roundup Ready® cotton. Roundup Ready® cotton
was approved for commercial release in 2000 (see Chapter 2, Section 6).
CHAPTER 3 INFORMATION ABOUT THE GMOS 29
102. The modified cotton plants also contain antibiotic resistance genes.
These genes were used as selectable marker genes in the early
laboratory stages of development of the plants, to enable selection of
plant cells or bacteria containing the desired genetic modification.
Potential risks relating to transfer of these genes to bacteria are
discussed in Chapter 7. The antibiotic resistance genes are the
bacterial neomycin phosphotransferaseII (nptII) gene, conferring
resistance to the antibiotics kanamycin and neomycin, and the
aminoglycoside adenylyltransferase (aad) gene. The aad gene confers
spectinomycin and streptomycin resistance and is linked to a bacterial
promoter that does not function in plants, so the protein is not
expressed in Bollgard II® cotton. The antibiotic resistance genes are
discussed in more detail in Section 3 of this Chapter.
103. A gene from Escherichia coli, the uidA gene, which codes for the
bacterial enzyme -glucuronidase (GUS), is also present in the plants.
The GUS protein is a reporter or ‗marker‘ that allows the detection of
genetically modified tissues in the laboratory using a simple
biochemical stain. More information about the uidA gene and GUS
proteins is provided in Section 3 of this Chapter.
104. The cotton lines proposed to be released are backcross progeny of
conventional crosses between Bollgard II® transformation event 15895
and elite Australian cotton cultivars that are suitable for Australian
cotton production areas. In addition, some lines proposed for release
derive from conventional crossing of Bollgard II® cotton and Australian
lines of Roundup Ready® cotton.
105. The methods used to introduce the genes into cotton are discussed
in Section 5 of this Chapter.
SECTION 2 THE PARENT ORGANISM
106. A comprehensive review of the parent organism, Gossypium
hirsutum L. (cultivated cotton), is provided in the document, ‗The
Biology and Ecology of Cotton (Gossypium hirsutum) in Australia‘
(OGTR 2002), available on the OGTR website.
CHAPTER 3 INFORMATION ABOUT THE GMOS 30
SECTION 3 THE INTRODUCED GENES
Section 3.1 The cry1Ac gene
107. The cry1Ac gene in Bollgard II® cotton is in fact a chimeric gene
that combines parts of two genes isolated from Bacillus thuringiensis
variety kurstaki (B.t.k.). Part of the B.t.k cry1Ab gene (nucleotides 1 -
1398, corresponding to amino acids 1 - 466 (Fischhoff et al. 1987)) was
linked to a portion of the native B.t.k cry1Ac gene (nucleotides
1399-3534, corresponding to amino acids 467 - 1178 (Adang et al.
1985)). The cry1Ab region is identical to the analogous region of the
cry1Ac gene with the exception of 6 amino acid substitutions. The
hypervariable region responsible for insecticidal specificity is from the
B.t.k cry1Ac gene. The chimeric gene is therefore referred to in this
document as the cry1Ac gene.
108. Bacterial genes often contain some sequences with potential to act
as polyadenylation sites (often A+T rich), a higher G+C content than is
frequently found in dicotyledonous plant genes, concentrated stretches
of G and C, residues and codons that are not frequently used in
dicotyledonous plant genes.
109. To ensure the bacterial gene was expressed optimally in plants, a
plant-preferred version of the chimeric cry1Ac gene was synthesised
using the strategy described by Perlak et al. (1990; 1991). The amino
acid sequence encoded by the synthetic gene is identical to that of the
native B.t.k protein with the exception that a serine is encoded at
position 766, rather than leucine. This was the result of an
unintentional change that occurred during the synthesis of the
plant-preferred version of the gene. However, the altered amino acid
is not present in the insecticidally-active trypsin-resistant core and will
not change the host range, which is determined by the amino-terminal
portion of the protein (Bietlot et al. 1989). The Cry1Ac protein
expressed in Bollgard II® cotton is 99.4% identical to the B.t.k Cry1Ac
protein (Adang et al. 1985). The properties of the protein are
discussed in Section 4 of this Chapter and Chapter 5.
110. Expression of the cry1Ac gene is driven by a modified 35S
promoter from cauliflower mosaic virus (CaMV; Odell et al. 1985; Kay
et al. 1987). A promoter is a piece of DNA that determines whether or
CHAPTER 3 INFORMATION ABOUT THE GMOS 31
not a gene is expressed, and to what extent. An mRNA termination
region, including a polyadenylation signal, is also required for gene
expression in plants, and is provided by the 3‘ non-translated region of
the soybean alpha subunit of the beta-conglycinin gene (referred to as
the 7S 3‘ termination sequence) (Schuler et al. 1982).
Section 3.2 The cry2Ab gene
111. The cry2Ab gene (also designated as cryIIB, cryB2, P2) in
Bollgard II® cotton was also isolated from B.t.k (Donovan et al. 1988b;
Dankocsik et al. 1990). Very little Cry2Ab protein is produced by
Bacillus thuringiensis due to an inefficient promoter (Dankocsik et al.
1990).
112. There are two very closely related B.t.k cry2Ab genes, cry2Ab1 and
cry2Ab2. They encode identical proteins of 633 amino acids. The
cry2Ab gene in Bollgard II® cotton is the cry2Ab2 gene.
113. The sequence of the cry2Ab gene is 89% identical to another closely
related B.t.k gene, the cry2Aa gene. This represents 88% amino acid
identity (Widner & Whiteley 1989; Dankocsik et al. 1990).
114. A plant preferred version of the cry2Ab gene was constructed as
discussed above for the cry1Ac gene.
115. Expression of the cry2Ab gene is also driven by the modified CaMV
35S promoter (Odell et al. 1985; Kay et al. 1987). This is linked to the
PetHSP70 5‘untranslated leader sequence, from the Petunia hybrida
heat shock protein 70 gene, and the chloroplast transit peptide (CTP)
coding sequence, from the Arabidopsis thaliana EPSPS gene (see below).
The mRNA termination region is provided by the 3‘ non-translated
region of the nopaline synthase (NOS) gene from A. tumefaciens
(Depicker et al. 1982).
116. The chloroplast transit peptide (CTP) coding sequence from the
Arabidopsis thaliana EPSPS gene targets the Cry2Ab protein to the
chloroplast. In plants, EPSPS is synthesised as a preprotein (ie.
containing the CTP) by free cytoplasmic ribosomes. The precursor is
transported into the chloroplast stroma and proteolytically processed to
yield the mature enzyme (della-Cioppa et al. 1986). Once cleaved,
chloroplast transit peptides are rapidly degraded (Bartlett et al. 1982;
CHAPTER 3 INFORMATION ABOUT THE GMOS 32
della-Cioppa et al. 1986). Information provided by Monsanto indicates
that the Cry2Ab protein expressed in Bollgard II® cotton is predicted to
contain three additional amino acids due to processing of the CTP.
117. The Cry2Ab protein expressed in Bollgard II® cotton also contains
a single amino acid addition at the N-terminus, compared to the wild
type amino acid sequence, due to the creation of a restriction enzyme
cleavage site introduced for cloning purposes.
118. The properties of the Cry2Ab protein are discussed in Section 4 of
this Chapter and Chapter 5.
Section 3.3 The CP4 EPSPS gene
119. The gene for CP4 EPSPS, which confers tolerance to glyphosate
(N-(phosphonomethyl) glycine), the active ingredient of Roundup®
herbicide, was isolated from Agrobacterium sp. strain CP4. EPSPS
(5-enolpyruvylshkikimate-3-phosphate synthase) is a critical enzyme in
aromatic amino acid biosynthesis, catalysing the addition of the
enolpyruvyl moiety of phosphoenolpyruvate to shikimate-3-phosphate.
This enzyme is the target of the herbicide glyphosate. Inhibition of
EPSPS by glyphosate prevents the synthesis of chorismate-derived
aromatic amino acids and secondary metabolites (Steinrucken &
Amrhein 1980). CP4 EPSPS naturally resists inhibition by glyphosate
(Padgette et al. 1993).
120. A plant-preferred version of the CP4 EPSPS gene was synthesised
by site-directed mutagenesis (Padgette et al. 1993) and used in the
vector for transformation of cotton plants. Although the gene
sequence has been altered, the protein produced from the
plant-preferred gene has exactly the same sequence as the
Agrobacterium protein. The plant-preferred coding sequence has been
expressed in E. coli from a PRecA-gene 10L vector (Olins et al. 1988).
The proponent states that the activity of the EPSPS protein was
unaltered when compared with the native CP4 EPSPS gene.
121. The CP4 EPSPS gene is driven by the CMoVb promoter (34S
promoter of the caulimovirus figwort mosaic virus) (Richins et al. 1987;
Gowda et al. 1989; Sanger et al. 1990). This is linked to the CTP coding
region from the Arabidopsis thaliana EPSPS gene (Klee et al. 1987). As
CHAPTER 3 INFORMATION ABOUT THE GMOS 33
discussed above for the cry2Ab2 gene, this targets the CP4 EPSPS to the
chloroplast (the site of aromatic amino acid biosynthesis). The mRNA
termination region is from the 3‘ non-translated region of the NOS gene
from Agrobacterium tumefaciens.
122. CP4 EPSPS was detected by Western blot analysis of protein
extracts of Roundup Ready® cotton seed (Barry et al. 1993). An
antibody specific for CP4 EPSPS reacted with a protein of 48 kD. This
is the expected molecular weight for the protein minus the CTP,
confirming that this peptide is cleaved during transport into the
chloroplast.
Section 3.4 The uidA reporter gene
123. The uidA or gusA gene, encoding the enzyme ß-glucuronidase
(GUS), is the most widely used reporter gene in GM plants (Jefferson et
al. 1986; Gilissen et al. 1998). Reporter genes encode enzymes that are
easily assayed and, therefore, are used to ‗report‘ the expression of a
gene or promoter of interest. In this case, it can be used as a simple
biochemical tag to enable visual identification of GM plant tissues.
124. The GUS enzyme cleaves the chromogenic substrate X-gluc
(5-bromo-4-chloro-3-indolyl ß-D-glucuronic acid), resulting in the
production of an insoluble blue colour in those plant cells expressing
GUS activity. Non-GM plant cells do not in general contain any GUS
activity, although there are unconfirmed reports of a GUS-like activity
in some plant tissues. Therefore, the production of a blue colour in a
particular cell after staining with X-gluc indicates that the cell has been
successfully genetically modified to contain the uidA gene. Thus the
uidA gene serves as a ‗marker‘ gene, since its expression marks tissue in
which other co-introduced genes are also present and likely to be
expressed (Jefferson et al. 1987; Jefferson & Wilson 1991).
125. Particle bombardment is not particularly efficient at introducing
genes into plants, and screening for the uidA reporter gene facilitates
identification and recovery of plant material containing the genetic
modification. Tight linkage between the uidA gene and the cry2Ab
genes (see Section 6.1 of this Chapter) has the additional advantage that
GUS staining can be used to follow the segregation of Bollgard II®
CHAPTER 3 INFORMATION ABOUT THE GMOS 34
cotton‘s two insecticidal genes in segregating populations in backcross
breeding programs.
126. The uidA gene is from the bacterium Escherichia coli. This
bacterium has evolved to survive in the mammalian intestine, and the
enzyme encoded by the uidA gene enables it to utilise as its sole carbon
source -glucuronides excreted in mammalian guts as by-products of
the detoxification of compounds including certain antibiotics and
hormones.
127. Escherichia coli GUS protein, a monomer with a molecular weight
of about 68200 daltons, is probably active in a tetrameric form. GUS is
an exo-hydrolase; it will not cleave glucuronides in internal positions
within polymers. The enzyme is specific for -D-glucuronides, with
some tolerance for -galacturonides. It is inactive against -glucosides,
-galactosides, -mannosides, or glycosides in the alpha configuration.
128. Expression of the uidA gene in Bollgard II® cotton is controlled by
the CaMV 35S promoter (Odell et al. 1985; Kay et al. 1987). The
mRNA termination region is provided by the 3‘non-translated region of
the NOS gene from A.tumefaciens (Depicker et al. 1982).
129. Monsanto has recently provided DNA sequence analysis of the
uidA gene in Bollgard II®. These analyses demonstrate that the
plant-expressed version of the uidA gene encodes a single amino acid
substitution at position 377 in the GUS protein, relative to the GUS
protein produced in E.coli. This substitution predicts the replacement
of a glutamic acid (E) with a lysine (K) at this position. Modelling
studies and amino acid and protein structure comparisons of
-glucuronidases from a variety of sources indicate that the amino acid
substitution is not likely to confer any significant structural or
functional changes in the GUS protein produced in Bollgard II® cotton.
The amino acid substitution was present in the original Bollgard II®
cotton varieties used to obtain the experimental data provided to the
OGTR and other regulatory agencies for safety assessments.
Section 3.5 The nptII gene
130. The nptII gene was isolated from the bacterial Tn5 transposon
(Beck et al. 1982). It encodes the enzyme neomycin
CHAPTER 3 INFORMATION ABOUT THE GMOS 35
phosphotransferase type II (NPTII) which confers resistance to
aminoglycoside antibiotics such as kanamycin and neomycin.
131. The NPTII enzyme uses ATP to phosphorylate neomycin, and the
related kanamycin, thereby inactivating the antibiotic and preventing it
from killing the NPTII producing cell. The nptII gene functions as a
selectable marker in the initial laboratory stages of cotton plant cell
selection following transformation (Horsch et al. 1984; De Block et al.
1984), allowing transformed cells to grow while effectively inhibiting
the growth of non-transformed cells. It is also expressed in the
Bollgard II® and Bollgard II®/Roundup Ready® cotton plants.
132. The gene is controlled by the CaMV 35S promoter (Odell et al.
1985; Kay et al. 1987). The mRNA termination region of the gene is
from the 3‘ non-translated region of the NOS gene from A. tumefaciens
(Rogers et al. 1985).
Section 3.6 The aad gene
133. The aad gene was isolated from the bacterial Tn7 transposon and is
under the control of its own bacterial promoter. This gene encodes an
enzyme, 3‘(9)-O-aminoglycoside adenylyltransferase (AAD), which
adenylates either the 3‘-hydroxy on the amino-hexose III ring of
streptomycin or the 9-hydroxyl on the actinamine ring of spectinomycin
(Davies & Benveniste 1974), allowing growth of bacteria on medium
containing these antibiotics. The gene was used in the laboratory,
prior to the production of the genetically modified plants, to select for
bacteria containing the desired modified DNA. The gene is not
expressed in the Bollgard II® or Bollgard II®/Roundup Ready® cotton
because the bacterial promoter is not active in plants. The nucleotide
sequence of this gene in the Tn7 transposon has been determined (Fling
et al. 1985).
SECTION 4 BT TOXINS
134. Bacillus thuringiensis is a gram-positive bacterium found in soil
and other habitats throughout the world. During sporulation, B.
thuringiensis produces a parasporal crystal composed of proteins
known as -endotoxins or insecticidal crystal proteins. The crystal
proteins are often specifically toxic to certain insect species.
CHAPTER 3 INFORMATION ABOUT THE GMOS 36
135. Cry1Ac and Cry2Ab are two of a diverse family of insecticidal
proteins (Bt proteins or Bt toxins) found in the bacterium Bacillus
thuringiensis. The Bt proteins have been classified depending on the
target specificity and the degree of amino acid homology (Hofte &
Whiteley 1989). The current classification is defined by the latter
criterion (Crickmore et al. 1998).
136. Cry1Ac toxins are highly specific to lepidopteran insects (moths
and butterflies) (Widner & Whiteley 1989; Dankocsik et al. 1990;
Macintosh et al. 1990). Cry2A toxins are also specific to lepidoptera,
but certain subclasses of Cry2A proteins may also be toxic to particular
groups of Diptera (flies and mosquitoes; Sims 1997) (see Chapter 5).
137. The Cry2Ab proteins were previously referred to as CryX,
Cry2Ab1, Cry2Ab2, CryIIAb, CryIIB or CryB2 (Widner & Whiteley
1989; Widner & Whiteley 1990; Liang & Dean 1994; Crickmore et al.
1998).
138. The native crystal proteins found in B. thuringiensis are protoxins
that must be digested by the insect to become activated. In susceptible
insects, during ingestion, the Bt protein crystal dissolves in the alkaline
environment of the larval insect gut. In many cases, activation of the
toxin by cleavage with specific proteases in the gut is required,
particularly for the larger protoxins, such as Cry1Ac, of 130-140 kDa
(Gill et al. 1992). Proteases cleave the carboxy-terminal domain of the
Cry1Ac protein and approximately 28 amino acids from the
amino-terminal end of the protein, leaving an active protease-resistant
core of approximately 600 amino acids (Bietlot et al. 1989; Chroma &
Kaplan 1990).
139. The Cry2 proteins are smaller than the other Cry protein classes
(Cry2Aa and Cry2Ab are both 633 amino acids) and may not require
protease cleavage for activation (Gill et al. 1992; English et al. 1994;
Karim et al. 2000).
140. The active Bt toxins diffuse through the midgut membrane of the
target lepidopteran insects and bind to specific high affinity receptors
on the midgut epithelium surface (Hofmann et al. 1988; Van Rei et al.
1989; Van Rie et al. 1990; Karim et al. 2000). Non-target insects,
CHAPTER 3 INFORMATION ABOUT THE GMOS 37
mammals, birds and fish do not possess these receptors and therefore
are not susceptible to the toxic effects of these insecticidal proteins.
141. Binding of activated Bt toxins to the epithelial gut cell receptors
leads to formation of pores in the cell membrane, allowing leakage of
intracellular contents (for example potassium ions) into the gut lumen
and water into the cell (Sacchi et al. 1986; English & Slatin 1992;
Knowles & Dow 1993). The larval gut epithelial cells swell due to
osmotic pressure and lyse. The gut becomes paralysed because of
changes in the electrolyte and pH balance and the insects stop eating
and die (Goldburg et al. 1990).
142. Competition studies indicate that Cry1Ac and Cry2Aa bind to
different receptors in target insects (Morse et al. 2001). The mode of
action of Cry2A has also been studied and compared to that of Cry1Ac
(English et al. 1994). The two proteins exhibit differences in solubility,
binding capacity and ion channel formation. Unlike Cry1Ac, Cry2A
did not exibit saturable binding on the midgut brush border membrane
of Helicoverpa zea. Cry2A did not block Cry1Ac binding but Cry1Ac
did block the initial binding of Cry2A to the brush border, suggesting
that some component of binding must be shared between the two toxins.
Although Cry2A was found to be less soluble than Cry1Ac, Cry2A
arrested the feeding of third instar H. zea as rapidly as did Cry1Ac.
Larvae fed on Cry1Ac tended to regurgitate more rapidly than those
fed on Cry2A. Insects fed with Cry2A were not seen to recover from
the intoxication, as did some insects fed with Cry1Ac, when removed
from the toxin-laced diet. It was suggested that the differences in the
mode of action between the two toxins made Cry2A a more rapidly
toxic agent.
143. The Cry1Ac protein expressed in INGARD® cotton was compared
by Western blot analysis with commercially available microbial
pesticides containing Bt toxin (Berberich & Fuchs 1992). This study
showed that the protein expressed by INGARD® cotton is of similar
molecular weight and immunological reactivity to one or more proteins
contained in the commercial Bt products Dipel® (Abbott Laboratories)
and Thuricide® (Sandoz Inc.). Further, it has been demonstrated that
the biological activity and species-specificity of the full-length Cry1Ac
CHAPTER 3 INFORMATION ABOUT THE GMOS 38
protoxin expressed in INGARD® cotton is equivalent to that of the
active B.t.k Cry1Ac core toxin (Sims 1994a).
SECTION 5 METHOD OF GENE TRANSFER
Section 5.2 INGARD® cotton
144. Bollgard II® cotton is derived from INGARD® cotton (known as
Bollgard® cotton in the USA). INGARD® cotton contains the cry1Ac,
nptII and aad genes, originally inserted into the genomic DNA of the
Coker 312 cotton variety (transformation event 531). Coker 312 was
released in 1974 by the Coker Pedigree Seed company. The Coker 312
cultivar was used because of its positive response to the tissue culture
system used to produce transgenic plants. However, it is now grown
commercially on a very limited basis, if at all.
145. The genes were inserted by Agrobacterium-mediated DNA
transformation (Zambryski 1992). The plasmid vector that was used,
PV-GHBK04, is a binary, single-border transformation vector. The
plasmid contains well-characterised DNA segments required for
selection and replication of the plasmid in bacteria as well as
Agrobacterium sequences. The above characteristics are essential for
DNA transfer from Agrobacterium and integration in the plant cell
genome (Bevan 1984; Wang et al. 1984)
146. Agrobacterium tumefaciens is a common gram-negative soil
bacterium that causes crown gall disease in a wide variety of plants.
Plants can be genetically transformed by the transfer of DNA (T-DNA,
located between specific border sequences) from A. tumefaciens,
through the mediation of genes from the vir (virulence)7 region of Ti
plasmids. Disarmed Agrobacterium strains have been constructed
specifically for plant transformation. The disarmed strains do not
contain the genes (iaaM, iaaH and ipt) responsible for the
overproduction of auxin and cytokinin, which are required for tumour
induction and rapid callus growth (Klee & Rogers 1989). A useful
feature of the Ti plasmid is the flexibility of the vir region to act in
either cis or trans configurations to the T-DNA. This has allowed the
development of two types of transformation systems:
CHAPTER 3 INFORMATION ABOUT THE GMOS 39
co-integration vectors that join the T-DNA that is to be
inserted into the plant and the vir region in a single plasmid
(Stachel & Nester 1986); and
binary vectors that have the T-DNA and vir regions
segregated on two plasmids (Bevan 1984).
147. Both provide functionally equivalent transformation systems.
Agrobacterium-mediated transformation has been widely used in
Australia and overseas for introducing new genes into plants without
causing any biosafety problems.
Section 5.1 Bollgard II® cotton
148. Bollgard II® cotton was produced by inserting the cry2Ab and uidA
genes into the genomic DNA of INGARD® cotton variety DP50B.
Isolated DNA fragments were delivered into the cotton meristematic
cells by projectile bombardment (transformation event15985) (McCabe
& Martinell 1993).
149. Projectile bombardment is a physical delivery system whereby
minute gold or tungsten beads coated with DNA are shot into cells that
have the capacity to develop or differentiate into shoots or whole plants.
The uidA gene is used as a marker to identify plant tissue that is
containing the introduced gene of interest so that the transformed tissue
or seed can be selected and recovered.
Section 5.3 Bollgard II®/Roundup Ready® cotton
150. Bollgard II®/Roundup Ready® cotton was produced by
conventional cross breeding of Bollgard II® cotton and
Roundup Ready® cotton. Roundup Ready® cotton was produced by
inserting the CP4 EPSPS, nptII and aad genes on a plasmid vector
carried by disarmed strain of A.tumefaciens into the genomic DNA of
cotton variety Coker 312. The method used to insert the genes was the
same as that described above for generating INGARD® cotton, that is
via Agrobacterium-mediated transfer, using a binary, single-border
transformation vector, plasmid vector PV-GHGT07 (Bevan 1984;
Wang et al. 1984).
CHAPTER 3 INFORMATION ABOUT THE GMOS 40
SECTION 6 CHARACTERISATION OF THE INSERTED GENETIC MATERIAL AND
STABILITY OF THE GENETIC MODIFICATION
Section 6.1 Bollgard II® cotton
151. Southern blot analysis of Bollgard II® DNA shows that one
full-length copy of each of the cry2Ab and uidA (GUS) genes is present
(Doherty et al. 2000a; Doherty et al. 2000b). Recent PCR and sequence
analyses provided by Monsanto demonstrate the linkage of elements
contained within the insert that contains the cry2Ab and uidA genes
(Pineda et al. 2002). The cry1Ac and cry2Ab genes have been
maintained as single dominant Mendelian traits over many generations
of crossing and backcrossing, with no significant variation from
expected segregation ratios for the two insecticidal genes (Shappley
2002b). These data demonstrate that cry1Ac and cry2Ab segregate
independently of one another, and have therefore as expected been
inserted at regions of the plant genome distant from each other.
152. The stability of the DNA insert and expression of the Cry2Ab
protein in Bollgard II® cotton across five generations has been
confirmed by data from Southern blot, ELISA and Western blot
analysis (Bookout et al. 2001; Pineda et al. 2002).
Section 6.2 Bollgard II®/Roundup Ready® cotton
153. As noted above, Bollgard II®/Roundup Ready® was produced by
conventional breeding of Bollgard II® cotton and Roundup Ready®
cotton. The genes introduced into Roundup Ready® cotton are also
present, therefore, in Bollgard II®/Roundup Ready® cotton.
154. Southern blot analysis was used to demonstrate that a single copy
of the nptII, CP4 EPSPS and aad genes has been inserted in
Roundup Ready® cotton. The insert was maintained in a stable
condition within the cotton genome for three generations (data
supplied by Monsanto Australia Ltd). The gox gene, from the
bacterium Ochromobacterium anthropii (encoding the glyphosate
oxidoreductase enzyme (GOX)), although present in the intermediate
plasmid vector, was not transferred to the plant genome. The T-DNA
region of the insert was truncated before the gox gene began (this is not
CHAPTER 3 INFORMATION ABOUT THE GMOS 41
uncommon, see for example Bakkeren et al. (1989) and De Block et al.
(1984)).
155. No data have been presented for Bollgard II®/Roundup Ready®
cotton in relation to the stability of the genetic modifications.
However, Monsanto have supplied data from analyses of
INGARD®/Roundup Ready® cotton demonstrating that segregation
ratios for the cry1Ac and CP4 EPSPS genes in
INGARD®/Roundup Ready® cotton do not differ significantly from
those that are expected based on Mendelian genetics (Shappley 2002a).
The data also demonstrate that the cry1Ac and CP4 EPSPS genes are
stably integrated at separate loci in the genome of
INGARD®/Roundup Ready® cotton (Shappley 2002a).
156. The combination of Bollgard II® and Roundup Ready® traits in the
one GMO was achieved by conventional breeding, and the stability of
the genetic modifications in Bollgard II®/Roundup Ready® cotton can
be inferred from the stability of Bollgard II® and Roundup Ready®
cotton over several generations. This is also supported by the stability
and segregation data presented for INGARD®/Roundup Ready® cotton.
157. More direct evidence for the stability of the genetic modifications
in the Bollgard II®/Roundup Ready® cotton comes from glasshouse and
field studies that have demonstrated continued efficacy of the
Bollgard II® insecticidal and Roundup Ready® herbicide tolerance
traits, in releases carried out since 1999 (Dr D.Llewellyn, Senior
Principal Research Scientist, CSIRO Plant Industry, personal
communication).
SECTION 7 EXPRESSION OF THE INTRODUCED PROTEINS
158. Expression levels of Cry2Ab, Cry1Ac, GUS and AAD proteins
were estimated in samples Bollgard II®, INGARD® and conventional
cotton. Samples of young leaves, whole plants, seed and pollen were
collected and analysed using an enzyme-linked immunosorbent assay
(ELISA) (information provided by Monsanto Australia Ltd). Tissue
samples were collected from plants grown in eight of the major cotton
production regions of the USA and comprised regions representing a
variety of environmental conditions. Samples were collected in both
the 1998 and 1999 cotton-growing seasons.
CHAPTER 3 INFORMATION ABOUT THE GMOS 42
159. Additionally, variation in the expression of Cry2Ab was examined
in young leaves sampled every four weeks from two sites, to investigate
variation in the level of protein expression within the growing season.
Such seasonal variation was also examined in both 1998 and 1999.
Section 7.1 Young leaves and seeds
160. Mean expression of Cry2Ab in young leaves was about 6g/gand
24g/gof tissue (equivalent to ppm, i.e. parts per million), in 1998 and
1999, respectively (Table 1), and was consistent across all sampled
regions. Variation in protein levels between years probably reflects
differing environmental conditions, notably extreme rainfall in the 1998
American cotton-growing season (data provided by Monsanto). As the
levels of protein are measured per fresh weight of tissue, it is likely that
variation in plant moisture between years contributed to the observed
differences. Significantly higher rainfall during the 1998 season would
have ensured that plants received comparatively more moisture and
that the leaves would have been more turgid. In 1998, the amount of
protein as a proportion of fresh leaf weight would, therefore, have been
comparatively low.
161. Within the cotton-growing season, expression of Cry2Ab protein in
young leaves peaked at 55 and 85 days after planting in 1998 (40g/g)
and 1999 (17g/g), respectively. Expression continued at high levels
for at least 108 days (Table 2). As noted, differing rainfall between
years probably accounts for the variation in peak expression levels. As
expected, Cry2Ab protein was undetectable in young leaves of both
INGARD® and conventional cotton (Table1).
162. Cry2Ab protein levels in seeds of Bollgard II® cotton were higher
than in young leaves — about 43g/g in 1998 and 57g/g in 1999,
respectively (Table 1). Again, Cry2Ab was undetectable in the seeds of
either the INGARD® or conventional cotton controls for this protein.
163. Mean expression levels of Cry1Ac were consistently lower than
those of Cry2Ab in all sampled tissues of both Bollgard II® and
INGARD® cotton. Expression of Cry1Ac in Bollgard II® was similar to
that in INGARD® in both 1998 and 1999 (Table 1). The results
indicated that the expression of Cry1Ac proteins is not altered by the
additional genetic modification. Independent data also indicate that
CHAPTER 3 INFORMATION ABOUT THE GMOS 43
expression of Cry2Ab in Bollgard II® cotton has no significant effect on
expression of Cry1Ac, compared to the levels of Cry1Ac in INGARD®
cotton (Greenplate et al. 2000).
164. In 1998 levels of Cry1Ac in young leaves and seeds (≤ 3.35g/g)
were marginally higher than in 1999 (≤ 2.64g/g). In contrast to the
within-season levels of Cry2Ab, levels of Cry1Ac declined significantly
to negligible levels at the end of the season, after peaking about
half-way through the season in both 1998 and 1999 (Table 2).
165. In a separate study, Cry1Ac levels in the fruit and terminals of
transgenic cotton have also been reported to decline steadily as the
growing season progresses (Greenplate 1999). Cry1Ac protein levels in
the fruiting positions dropped from 10-15 g/g at 40 days after planting
to 1-2 g/g at 120 days. Similarly, Cry1Ac levels in terminal foliage
declined from approximately 20 g/g to 5g/g between 40 and 120 days
after planting.
166. Expression of NPTII protein in Bollgard II® cotton was similar to
that in INGARD® cotton (ca. 4.6 - 16.6 g/g and 4.3 – 15.2 g/g, for
Bollgard II® and INGARD® cotton, respectively; Table 1). The results
indicated that as for Cry1Ac, expression of the NPTII protein in seed
and leaf tissues is unaffected by the insertion of the cry2Ab gene.
167. GUS protein was detected at high levels in both young leaves (≤
120g/g) and seeds (≤ 104g/g) in 1998 and 1999, respectively (Table 1).
As expected, GUS could not be detected in either the INGARD® or
conventional cotton controls for this assay.
168. AAD protein was not detected in the leaf or seed tissue of any of
the cotton lines that were assayed. This outcome was expected since
the gene is under the control of a bacterial promoter that is not active in
plants.
Section 7.2 Mature cotton plants
169. The level of Cry2Ab in mature Bollgard II® plants was generally
lower than in leaf and seed tissue, with averages of 8.8g/g and 20.8g/g
in 1998 and 1999, respectively (Table 1). Cry2Ab was not detected in
whole plant samples of the control lines, as expected.
CHAPTER 3 INFORMATION ABOUT THE GMOS 44
170. Within a season, Cry1Ac was detected at similar levels in both
Bollgard II® and INGARD® cotton (Table 1). Seasonal variation in
expression of Cry1Ac probably reflects different environmental
conditions, as outlined above for variation in expression of Cry2Ab. In
Bollgard II® cotton, levels of Cry1Ac were much lower than levels of
Cry2Ab (Table 1). GUS and NPTII protein levels were not analysed in
whole cotton plants.
Section 7.3 Pollen
171. To provide information on the potential for non-target insect
exposure to the toxin, the levels of Cry proteins in pollen were
estimated. In both 1998 and 1999, negligible amounts (≤ 0.32 g/g) of
protein encoded by the inserted genes were detected in pollen from both
Bollgard II® and INGARD® cotton (Table1).
172. Quantitative bioassays (Greenplate 1999) with Heliothis virescens
incorporating plant tissues in synthetic diets compared to known
concentrations of purified Cry1Ac, were used to evaluate the overall
insecticidal activity of different tissues to lepidoptera. The mean
insecticidal activity was expressed as g Cry1Ac equivalents/g dry
weight (Penn et al. 2001). In Bollgard II® plants this represents the
combined insecticidal activity of the Cry1Ac and Cry2Ab proteins. In
INGARD® cotton insecticidal activity was highest in growing tips (24 g
Cry1Ac equivalents/g tissue), slightly lower in flower buds (20 g
Cry1Ac equivalents/g tissue) and lower still in large leaves (18 g
Cry1Acequivalents/g tissue). Bollgard II® had consistently higher
mean lepidopteran activity with 81, 90 and 50 g Cry1Ac equivalents/g
dry weight in growing tips, flower buds and large leaves, respectively.
173. Averaged over all sites, tissues and seasons Bollgard II® cotton was
3.9 times more effective in controlling H. virescens than the
corresponding INGARD® cotton line. The relatively high expression
level of the Cry2Ab compensates for its lower insecticidal activity
against many of the target insect pests. These data support the
observed higher efficacy of insect control of Bollgard II® towards a
range of important lepidopteran pests (Akin et al. 2001; Stewart et al.
2001).
CHAPTER 3 INFORMATION ABOUT THE GMOS 45
174. The bioassays described above were also used to measure the mean
insecticidal activity of small flower buds from Bollgard II® and
INGARD® cotton over an eight-week period following planting (Penn et
al. 2001). The insecticidal activity of Bollgard II® cotton dropped from
107 g Cry1Ac equivalents/g tissue at 2 weeks to 52g Cry1Ac
equivalents/g tissue by eight weeks, but was still 2.9 fold higher than the
single gene INGARD® cotton that had declined from 25 to 18 g
Cry1Ac equivalents/g tissue in the same period. Similar observations
have been reported by (Stewart et al. 2001) and highlight the relatively
low efficacy of INGARD® cotton at the end of the growing season.
Further, they suggest that Bollgard II® cotton should have
comparatively high insecticidal efficiency late in the growing season.
CHAPTER 3 INFORMATION ABOUT THE GMOS 46
Table 1. Mean protein expression levels* in various tissues of Bollgard II® (event 15985), INGARD® (line DP50B)
and conventional cotton (line DP50), as detected by ELISA, ± standard deviation.
Protein Cotton type Leaf Seed Whole plant Pollen
1998 1999 1998 1999 1998 1999 1998 1999
®
Cry2A Bollgard II 23.8 ± 6.3 6.4 ± 1.443.2 ± 5.7 57.4 ± 8.8 ± 1.2 20.8 ± 300. Six of these sites were particularly productive,
producing a total of ≥20 bolls, with estimates suggesting that individual plants
produced comparable numbers of bolls to those produced by cultivated cotton
plants. Significantly, these were disturbed sites (drain and cattleyard
habitats), with high levels of soil nutrients and/or moisture. A sample of 3
bolls produced by INGARD® cotton at one of the less productive sites
suggested that both seed production and seed viability was low. These
characteristics of seeds produced during the experiment were not investigated
in either Bollgard II® or conventional cotton at any of the other sites. They
are likely to vary by site, associated with variation in the maternal
environment (Mazer & Gorchov 1996).
318. Formal analyses of total site fruit production was not possible for all sites
because of low numbers. However, Monsanto reported detailed statistical
analyses for three of the productive disturbed sites. At two of these,
Bollgard II® cotton produced significantly more fruit than conventional
cotton by the end of the first season, although for one of the sites, the impact
was statistically significant (P < 0.01) only in plots that were sown with seeds
at high density. After two years, the advantage apparently conferred by the
insecticidal genes remained significant at only one of the two sites. The
analyses have not yet been finalised, but it appears that the productivity of
Bollgard II® cotton may have been marginally lower than that of conventional
cotton at the second site, in the second year. The third productive site was
established one year after the other sites, so boll production was scored for 12
months only. At the end of the growing season boll production did not differ
significantly between Bollgard II® and conventional cotton at this third site.
CHAPTER 6 WEEDINESS
319. Preliminary analyses of experiments to test whether enhanced nutrient
availability is responsible for the increased boll production suggest that this
may not be the case (Rowena Eastick, personal communication). The results
of these experiments have not yet been provided to the OGTR for evaluation.
In their absence, it is concluded that these potentially productive sites, which
are most likely to be in areas immediately associated with agricultural
production rather than in the natural environment, the risk of Bollgard II®
cotton establishing could be managed relatively easily by monitoring for, and
removing, potential volunteers.
Invasiveness
320. To provide a broad indication of potential invasiveness, Monsanto
compared net population growth rate (‗invasiveness‘) of Bollgard II®,
INGARD® and conventional cotton at each study site. Calculating this index
requires considering any deaths that may occur, as well as any new recruits
into the population. The term therefore integrates elements of germination,
survival, and reproduction (fecundity), as detailed above. Invasiveness
values greater than one imply that the population is growing, and that it will
continue to grow until some resource(s) becomes limiting, as occurs under
normal environmental conditions. Invasiveness values less than one imply
that the population is in decline. The function is therefore similar to the
population growth rate function (λ) discussed by several authors (see Crawley
et al. 1993; Parker & Kareiva 1996). Generally, Monsanto‘s data suggest
that cotton is rarely invasive in northern Australia, irrespective of inserted
insecticidal genes, because at most study sites invasiveness values were
considerably less than one. However, at the three disturbed, nutrient-rich
sites at which boll production was high (see above), indices of invasiveness
approached, or exceeded one. At two of these sites, the index was greater
than one for Bollgard II® cotton, but marginally less than one for
conventional cotton, implying that if the habitat is suitable, Bollgard II®
cotton may be more invasive than conventional cotton. Suitable habitats are
likely to be nutrient-rich, with an adequate supply of fresh water and
protected from other limiting environmental variables such as fire.
321. The risk of Bollgard II® cotton spreading as a problematic weed in the
natural environment is low because soil moisture and/or nutrients,
particularly phosphorous, are likely to limit germination, growth and fruit
production. Even in potentially suitable habitats within the natural
CHAPTER 6 WEEDINESS
environment such as creek or river banks, Bollgard II® cotton is unlikely to be
more problematic than conventional cotton, or existing feral cotton
populations, unless nutrient levels are increased significantly. Naturally,
most Australian soils, including those of northern Australia, have low levels
of key nutrients, particularly phosphorous.
322. It should be noted that while indices of invasiveness can be derived, the
ability of a plant to invade a community is a function of both its ‗invasiveness‘
and the community‘s ‗invasibility‘ (Lonsdale 1999), which itself may be
affected by community diversity, disturbance and various other
environmental variables. Monsanto‘s index of invasiveness does not account
for community invasibility, since study plots were cleared of competing
vegetation. The invasiveness of Bollgard II® cotton in specific, high-nutrient,
low-competition habitats, is therefore likely to reflect a ‗worst case scenario‘.
Moreover, it underscores the conclusion of several similar studies with
genetically modified insecticidal plants, that the selective advantage of these
plants is only manifested at sites characterised by particular combinations of
plant competition, herbivory or growth-limiting resources such as soil
nutrients or space (Crawley et al. 1993; Bergelson 1994; Stewart et al. 1997).
HERBICIDE RESISTANCE
323. There is a significant likelihood that selection of glyphosate-resistant
weeds in Bollgard II®/Roundup Ready® cotton crops could eventually occur.
Glyphosate-resistant weeds have already been identified, including Lolium
rigidum (annual ryegrass) in Australia and California and Eleusine indica
(goose-grass) in Malaysia. These weeds arose after repeated annual
application of glyphosate on conventional crops over many years.
324. The likelihood of this occurring would be minimised by the
implementation of effective farm management plans that avoid overuse of
glyphosate, and ensure ongoing monitoring and destruction of any
glyphosate-resistant weeds that do occur.
325. The potential for eventual unintended ‗stacking‘ of different herbicide
tolerances in a single plant, or for overuse of glyphosate if other
Roundup Ready® crops were used in rotation, would also be minimised if
appropriate management practices for the crops were in place. This is not a
problem that needs to be addressed for the current proposal, since no other
varieties of herbicide-tolerant cotton or other Roundup Ready® crop varieties
CHAPTER 6 WEEDINESS
are commercially available in Australia. It is however a factor that would
need to be considered for any future proposed releases of Roundup Ready®
crops or cotton with tolerance to herbicides other than Roundup.
326. The NRA sets limits on the new use of herbicides to manage the risk of
developing herbicide-resistant weeds through inappropriate use of herbicides
(see Chapter 8). In addition, users of Monsanto‘s Roundup Ready® and
Bollgard II®/Roundup Ready® cotton must comply with the company‘s
Technology User Agreement, which requires the adoption of an integrated
weed management strategy, to limit the development of herbicide resistance.
Integrated weed management in Monsanto‘s GM glyphosate resistant cottons
will significantly reduce the likelihood of developing glyphosate resistance in
weed species (Roberts and Charles, in press).
C: Conclusions regarding weediness
327. It is concluded that the risk of Bollgard II® or Bollgard II®/
Roundup Ready® cotton establishing as a weed in the southern
cotton-growing regions of NSW and Queensland is low, and not likely to be
greater than that of conventional cotton GM insecticidal INGARD® cotton, or
Roundup Ready® cotton.
328. The risk of Bollgard II® or Bollgard II®/ Roundup Ready® cotton
establishing as a weed in the cotton-growing regions of northern WA and the
NT is also likely to be low, however further information is required before
this can be determined conclusively. Nevertheless, it is considered that the
risks of cotton spreading as a weed could be managed to an acceptable level
by implementing various strategies to minimise the spread and persistence of
the GM cotton in the environment in northern WA and the NT.
329. The Regulator has imposed licence conditions to limit the planting of the
GM cotton in northern Australia, and to ensure that the GM cotton does not
spread from the release site, or persist at the site after harvest, thus reducing
the potential for the GM cotton to establish as a weed outside the release site
in northern Australia (see Chapter 9, Section 3).
330. Provision of additional information relating to potential environmental
risks in northern Australia will also be a condition of the licence and this
information would be required before commercial release could be extended
to the cotton-growing regions of WA and the NT (see Chapter 9 for details).
CHAPTER 6 WEEDINESS
331. There is some potential for development of herbicide-resistant weeds if
the crop-herbicide combination is used inappropriately. A herbicide
resistance management plan is required to minimise this risk. Prior to the
commercial release of Roundup Ready® cotton in 2000, a crop management
plan was developed in consultation with the Transgenic and Insect
Management Strategy (TIMS) Committee of the Australian Cotton Growers
Research Association. The NRA has responsibility for setting registration
conditions for the use of glyphosate on cotton crops, including herbicide
resistant management conditions.
332. There are also potential adverse effects on agricultural systems that
could arise from the development of insects resistant to Bollgard II® cotton.
Implementation of an insect resistance management plan (see Chapter 8) will,
therefore, be required as part of the licence. The possibility of interference
between the insect resistance and herbicide resistance management plans was
considered, however it has been concluded the management issues for the two
traits are independent of each other.
CHAPTER 6 WEEDINESS
CHAPTER 6 WEEDINESS
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER
ORGANISMS
333. In general terms, the types of hazards that have been considered here are
whether the transfer of the genes introduced into INGARD®, Bollgard II® or
Bollgard II®/Roundup Ready® cotton to other organisms could result in the
production of insecticidal or herbicide-tolerant weeds. If this was to occur,
there may be potential for such weeds to compete with native flora, thereby
reducing biodiversity. The possibility of whether gene transfer might lead to
antibiotic-resistant pathogens, with potential to harm human or animal
health, is also considered.
334. The potential hazards are addressed in the following sections, with
respect to:
other plants (Section 1 of this Chapter); and
other organisms (Section 2 of this Chapter).
SECTION 1 TRANSFER OF INTRODUCED GENES TO OTHER PLANTS
A: Nature of the gene transfer hazard
TRANSFER OF GENES TO OTHER CULTIVATED OR FERAL COTTON
335. Transfer of the introduced genes to other cotton plants would present the
same hazards and have the same potential impacts as the presence of the
genes in Bollgard II® or Bollgard II®/Roundup Ready® cotton (see Chapters
5, 6 and 8). However, if transfer occurred to other cultivated or feral cotton,
this would further increase the possibility that the genes could spread in the
environment, with flow-on impacts depending on the nature of the gene and
the species to which it transfers.
TRANSFER OF GENES TO OTHER PLANT SPECIES
336. Transfer of the introduced genes into other plant species, in particular to
native flora, may have adverse effects on biodiversity. Other potential
hazards specific to the transferred gene sequences that were considered are:
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS 97
Insecticidal genes:
whether plants could become resistant to lepidopteran insects. This
could confer a fitness advantage on plants normally controlled by
these insects, and could result in increased weediness. There could
also be impacts on the lepidopteran insect populations, or specialist
predators and parasitoids that feed on them.
Antibiotic resistance marker genes:
whether plants could become resistant to the antibiotics. This
would only have an impact if the antibiotics were used on the plants.
uidA (GUS) marker gene:
whether plants would produce the GUS protein.
Herbicide tolerance gene:
whether plants could become resistant to glyphosate. This would
have an impact only if the plant is controlled by glyphosate, on the
farm or as a weed in the environment.
CaMV 35S promoter and other regulatory sequences:
If gene transfer did occur, there could be unintended or unexpected
effects if the introduced regulatory sequences altered the expression
of endogenous plant genes. If such perturbation of normal plant
gene expression did occur, the impact would depend on the
phenotype.
Some of these sequences are derived from plant pathogens
(cauliflower mosaic virus, figwort mosaic virus, Agrobacterium
tumefaciens). The possibility should also be considered that they
might have pathogenic properties.
B: Likelihood of the gene transfer hazard occurring
TRANSFER OF GENES TO OTHER CULTIVATED OR FERAL COTTON
337. The most likely means by which the inserted genes could be transferred
to other cotton plants is by a GM cotton plant cross-pollinating (outcrossing
to) another cotton plant. For a detailed consideration of the likelihood of this
occurring, including an overview of the pollination biology of cotton, see the
accompanying document, ‗The Biology and Ecology of Cotton
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS 98
(Gossypium hirsutum) in Australia‘ (OGTR 2002), available on the OGTR
website.
338. In summary, a low level of transfer to other cotton in a cropping
situation would be likely. As is currently the case for commercially released
GM INGARD and Roundup Ready cotton, no measures are proposed to
limit outcrossing and no specific segregation measures will be in place, other
than standard measures for seed production. Conventional farming
practices, such as the use of certified (pure) seed will ensure any
contamination is kept to a minimum;
339. Transfer to feral naturalised cotton populations is unlikely, because of
the geographic distances between these feral populations and the
cotton-growing regions, particularly in the cotton-growing regions of NSW
and QLD. In northern Australia measures will be imposed to limit gene flow
(see Chapter 9).
TRANSFER OF GENES TO OTHER PLANT SPECIES
340. There is effectively zero probability of transfer to any other plant
species, even for the most closely related native Australian Gossypium species
(OGTR 2002). This is due both to genetic incompatibility and, for most of
the native Gossypium species, their limited geographic distribution relative to
the cotton-growing regions.
C: Conclusions regarding gene transfer to other plants
In summary:
The likelihood of some gene transfer from the GM cotton to
cultivated cotton is high, but the overall frequency of out-crossing
would be very low. This would not pose any risks additional to the
negligible risks posed by Bollgard II® or
Bollgard II®/Roundup Ready® cotton itself, covered in detail in this
document. Conventional farming practices, such as the use of
certified (pure) seed will ensure any contamination is kept to a
minimum;
The potential for transfer of the introduced genes to wild or native
cotton is functionally zero because of the geographical isolation and
genetic incompatibility with the native species; and
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS 99
341. The conclusions with respect to the specific transferred gene sequences
are as follows:
Insecticidal genes:
It is possible that if these genes were transferred to feral or
cultivated cotton, the plants might have a survival advantage in
regions where lepidopteran insect predation limits their growth or
regulates their populations. Consideration of data on the potential
weediness of Bollgard II® and Bollgard II®/Roundup Ready® cotton
(see Chapter 6) suggests, however, that in most circumstances,
including in natural ecosystems, this is unlikely. The distribution
of cotton is determined largely by soil type and soil moisture, more
so than by insect pressure. In specific high-nutrient habitats where
weedy volunteers may occur, these will be managed by removing the
plants or by spraying with an appropriate herbicide.
Antibiotic resistance genes:
There would be no adverse impacts even if gene transfer occurred,
since antibiotics are not generally used on plants outside of the
laboratory. Streptomycin is used in some other countries to control
fire blight, a bacterial disease of fruit trees. However, fire blight
does not occur in Australia, is not a disease of cotton, and plants in
Australia are therefore not treated with streptomycin.
uidA GUS marker gene:
There would be no adverse consequences even if gene transfer
occurred. GUS is not likely to be toxic or allergenic to other
organisms, or to increase the weediness of the cotton (Chapters 5
and 6).
Herbicide tolerance gene:
There would be no adverse consequences even if outcrossing to
cotton occurred, since cotton species are not regarded as weeds in
Australia and are not controlled by glyphosate on the farm or in the
natural environment. As noted above, the likelihood of transfer to
plants other than cotton that might be controlled by glyphosate is
effectively zero.
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS 100
CaMV 35S promoter and other regulatory sequences:
The probability of a hazard arising due to outcrossing of these
sequences to other plants is remote. Plants are already exposed in
nature to the bacteria and viruses from which these sequences are
derived.
Although some of the regulatory sequences transferred to the plants
are derived from plant pathogens, they only represent a very small
proportion of the pathogen genome. The sequences are not, in
themselves, infectious or pathogenic. It should be noted that CaMV
is already ubiquitous in the environment and in the human diet
(Hodgson 2000a).
SECTION 2 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS
(MICROORGANISMS AND ANIMALS)
A: Nature of the gene transfer hazard
342. The following potential hazards, with respect to the transfer of specific
gene sequences, were considered:
Insecticidal genes:
This would not present a hazard to human health or the
environment.
Antibiotic resistance genes:
Transfer of the genes to animals (including humans) or
microorganisms other than bacteria (such as viruses) would not
present a hazard to human health or the environment. However,
bacteria that acquired the antibiotic resistance gene(s) could become
resistant to those antibiotics. The consequences of this would
depend on:
the pathogenicity of the microorganism;
the use and significance of the antibiotic(s) in clinical
and/or veterinary practice;
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS 101
whether resistance to the antibiotic(s) is already widespread
in the microbial population.
uidA marker gene:
Transfer of the gene to animals (including humans) or
microorganisms other than bacteria (such as viruses) would not
present a hazard to human health or the environment.
Herbicide tolerance gene:
This would not present a hazard to human health or the
environment.
CaMV 35S promoter and other regulatory sequences:
If gene transfer occurred, there could be unintended or unexpected
effects if the introduced regulatory sequences alter the expression of
endogenous genes. If such perturbation of normal gene expression
occurred, the impact would depend on the resultant phenotype.
Some of these sequences are derived from plant pathogens
(cauliflower mosaic virus, figwort mosaic virus, Agrobacterium
tumefaciens). The possibility should be considered that they might
have pathogenic properties.
The possibility that the regulatory sequences could recombine with
the genome of another virus infecting the plants to create a novel
recombinant virus should also be considered.
B: Likelihood of the gene transfer hazard occurring
343. The likelihood of genes transferring from cotton to other organisms has
been considered in detail in the accompanying document, ‗The Biology and
Ecology of Cotton (Gossypium hirsutum) in Australia‘ (OGTR 2002),
available on the OGTR website. In summary, the transfer of the introduced
genes from INGARD®, Bollgard II® or Bollgard II®/Roundup Ready cotton
to humans or other animals, or microorganisms including bacteria and
viruses is extremely unlikely.
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS 102
C: Conclusions regarding gene transfer to other organisms
344. In summary, the likelihood of transfer of the introduced genes to other
organisms is negligible, but even if such transfer occurred would be unlikely
to pose any hazard to human health and safety or the environment.
345. Horizontal gene transfer from plants to animals (including humans) or
microorganisms is extremely unlikely. It should be noted that the cry1Ac
and cry2Ab insecticidal genes are already widespread in the environment
(they were originally isolated from a common soil bacterium, Bacillus
thuringiensis). The nptII, uidA and aad genes are also prevalent in naturally
occurring bacteria found in soil and in animal and human digestive systems.
The nptII and aad genes occur naturally on transmissible genetic elements
(transposons and plasmids) that are readily transferable between bacterial
species (Flavell et al. 1992; Langridge 1997; Pittard 1997; US FDA 1998;
Draft GuidAnce Document on Use of Antibiotic Resistance Marker Genes in
Transgenic Plants, 1998). Transfer of the genes from these naturally
occurring bacteria, through well documented mechanisms for horizontal
transfer between bacteria (Nielsen et al. 1998; Nielsen KM 1998;
Doblhoff-Dier et al. 2000), is far more likely than transfer of the same genes
from GM cotton.
346. The conclusions with respect to the specific gene sequences are as
follows:
Insecticidal genes:
There would be no adverse consequences even if gene transfer
occurred.
Antibiotic resistance genes:
Transfer of these genes to organisms other than bacteria would not present a
hazard, since the antibiotics in question are only used to treat or prevent
bacterial infections. Horizontal transfer to bacteria is also extremely
unlikely and is considered to pose negligible risks to human health or the
environment for the following reasons.
Bollgard II® and Bollgard II®/Roundup Ready® cotton contain genes that
confer resistance to neomycin, kanamycin, streptomycin and spectinomycin.
None of these antibiotics are extensively used in clinical medicine.
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS 103
Streptomycin was formerly used in the treatment of tuberculosis, but is not
routinely used today because of its toxicity and the relatively high frequency
at which streptomycin-resistant mutants emerge. Only neomycin and
kanamycin are used in veterinary practice, and alternative antibiotics are
readily available.
The use of antibiotic-resistance markers in genetically modified plants and
microorganisms to be released into the environment has been researched and
reviewed extensively. It has been concluded that the presence of
kanamycin-resistance genes in genetically modified plants represents no
significant risk to biosafety (Flavell et al. 1992; Langridge 1997; Pittard 1997;
FDA 1998b; JETACAR 1999). Flavell et al. (1992) note that the human
health analyses need to be viewed against the knowledge that humans
continually ingest kanamycin-resistant microorganisms. The diet, especially
raw salad, is the major source: at a conservative estimate, each human ingests
1.2 x 106 kanamycin-resistant microorganisms daily. Previous concerns that
the NPTII protein may, itself be toxic or active in human or other animal
digestive systems have been effectively eliminated by the work Fuchs et al.
(1993b; 1993c).
The existence of the streptomycin/spectinomycin resistance gene on
transposons and plasmids found in both gram positive and gram negative
bacteria indicates its extensive distribution through the microbial world
(Shaw et al. 1993). Although this particular mechanism of resistance does
not occur in mycobacteria, resistance to streptomycin and spectinomycin as a
result of spontaneous mutations in genes encoding ribosomal RNA occurs at a
relatively high frequency because, unlike the enteric microorganisms,
mycobacteria contain only a single copy of such genes.
In summary, the incidence of naturally occurring bacterial strains resistant to
the antibiotics in question is already very high, and the antibiotic resistance
genes in these bacteria are often located on transmissible genetic elements
that are readily transferable between bacterial species. So, in the unlikely
event that the aad or nptII genes were transferred from INGARD®,
Bollgard II® or Bollgard II®/ Roundup Ready® cotton to a bacterium, this
would be unlikely to have any detectable impact on the existing level of
resistance in microbial populations. Furthermore, the antibiotics in question
are not of major clinical or veterinary significance.
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS 104
uidA GUS marker gene:
There would be no adverse consequences even if gene transfer
occurred.
Herbicide tolerance gene:
There would be no adverse consequences even if gene transfer
occurred.
CaMV 35S promoter and other regulatory sequences:
There would be no adverse consequences even if gene transfer
occurred.
While Ho et al. (2000) have postulated that there are risks posed
through recombination of the CaMV 35S promoter with the
genomes of other viruses infecting the plants to create new viruses,
or of integration of the CaMV35S promoter into other species
causing mutations, cancer or reactivation of dormant viruses, these
claims have been challenged in the scientific literature (eg Hull et al.
2000; Morel & Tepfer 2000; Hodgson 2000b; Hodgson 2000c;
Tepfer 2002).
Although some of the regulatory sequences transferred to the plants
are derived from pathogens, the pathogens only infect plants. In
any case, the regulatory sequences only represent a very small
proportion of the pathogen genome and are not, in themselves,
infectious or pathogenic. It should be noted that CaMV is already
ubiquitous in the environment and in the human diet (Hodgson
2000a).
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS 105
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS 106
CHAPTER 8 INSECTICIDE RESISTANCE
A: Nature of the insecticide resistance hazard
347. Extensive cultivation of Bollgard II® cotton could potentially result in the
emergence of resistance to the Cry1Ac and Cry2Ab proteins in the target
species (Helicoverpa armigera and H. punctigera) and other susceptible
lepidopteran species feeding on cotton. This would result in a reduction of
the efficacy of Bollgard II® and Bollgard II®/Roundup Ready® cotton for
control of insect pests, and could also have impacts on the use of Bt microbial
sprays to control insects in other agricultural systems. Potential adverse
effects include attenuation of the benefits to the environment, and possibly
human health of growing Bollgard II® or Bollgard II®/Roundup Ready®
cotton or using Bt sprays. These benefits include the use of less chemical
insecticide on crops.
348. It should be noted that similar risks are also posed by the use of Bt
sprays or chemical insecticides in agricultural systems and, as such, are not
unique to the risk associated with cultivation of GM Bollgard II® cotton.
Although the Regulator has given detailed consideration to these risks,
ultimate responsibility for oversight of insect resistance management
requirements for GM insecticidal cotton currently lies with the National
Registration Authority (see part C of this Chapter).
B: Likelihood of the insecticide resistance hazard occurring
349. The emergence of insects resistant to the Cry1Ac and/or Cry2Ab protein
would almost certainly occur eventually if Bollgard II® or
Bollgard II®/Roundup Ready® cotton were grown widely without taking any
steps to deal with the problem. However, Bollgard II® cotton was developed
with the specific intention of reducing this risk (Gould 1998; Roush 1998b;
Benedect & Altman 2001).
350. The expression of two insecticidal proteins (‗pyramiding‘) in
Bollgard II® cotton is expected to delay selection of insects resistant to the
insecticidal proteins by a factor of 10 compared to INGARD® cotton (Roush
1994; Roush 1998a).
351. The two insecticidal genes are expressed over the duration of the
growing cycle. The increased insecticidal activity of the Bollgard II® cotton,
CHAPTER 8 INSECTICIDE RESISTANCE
relative to INGARD® cotton, especially during the later stages of the
cotton-growing season (see Chapter 2, section 5.2), is also expected to delay
the emergence of resistant insects (‗high dose strategy‘; Roush 1998a).
OCCURRENCE OF RESISTANCE IN INSECTS
352. Several studies have shown that resistance to Bt toxins can be selected in
the laboratory by repeated exposure of insects to the toxins (Peferoen 1997;
Tabashnik et al. 2000b). For example, two laboratory strains of Heliothis
virescens were selected to become resistant to Cry1Ac and other Bt derived
toxins (Gould et al. 1995a), and Akhurst et al. (2000) have isolated a
laboratory strain of the Australian Helicoverpa armigera that is resistant to
Cry1Ac. Moar et al. (1995) have selected strains of Spodoptera exigua
resistant to Cry1C and these insects were cross-resistant to Cry1Ab, Cry9C
and Cry2A as well as to a recombinant Cry1E-Cry1C fusion protein.
Recent studies have found evidence of cross-resistance between Cry1Ac and
Cry2A proteins in Cry1Ac-resistant strains of Pectinophora gossypiella,
Helicoverpa zea and H. armigera (Burd et al. 2000; Tabashnik et al. 2000a;
Akhurst 2001).
353. Bt resistance has also been studied in field populations of the
diamondback moth, Plutella xylostella (Tabashnik et al. 1990). The
diamondback moth, a major pest of cruciferous vegetables around the world,
receives frequent exposure to insecticides and shows extensive resistance to
most chemical insecticides in many growing areas. High levels of resistance
to Cry1A toxins have been found in populations of the diamondback moth
from the Philippines, Hawaii, Florida and Asia (Tabashnik et al. 1990;
Tabashnik 1994).
354. Resistance to Bt insecticide appears to be due to one (Tang et al. 1997a)
or at most a few genes (Tabashnik et al. 1992; Ferre et al. 1995; Gould et al.
1995a; Tabashnik et al. 1998). The mechanisms of insecticidal activity
include reduced binding of the toxin to the midgut (Tabashnik et al. 1994b;
Gould et al. 1995b; Tang et al. 1997b), slower interaction of gut proteinases
with the protoxin, or the absence of a major gut protein (Oppert et al. 1997).
355. Genetic crosses of the laboratory-selected insecticidal strains of
Heliothis virescens demonstrated that a major portion of the resistance in this
case was encoded by a single gene (or a set of linked genes) with mostly
recessive inheritance (Gould et al. 1995a; Gould et al. 1997; Tabashnik et al.
CHAPTER 8 INSECTICIDE RESISTANCE
1997a). Studies of resistance in insects from field populations suggest that
the common mode of resistance is characterised by a high level of resistance
(over 500-fold), reduced toxin binding and a recessive mutation. However,
there appear to be other modes of resistance which are not recessive and
which are not associated with reduced toxin binding (Moar et al. 1995;
Tabashnik et al. 1997b).
356. Gould et al. (1997) estimated the frequency of alleles for resistance in
field populations of H.virescens as 1.5 x 10-3. Genetic models indicate that a
recessive allele present at this frequency could lead to rapid evolution of
resistant populations if Bt toxin-producing cotton is grown without adequate
refuges for toxin-susceptible larvae (Roush 1994; Gould et al. 1997). A
recessive allele that confers resistance to the Cry1Ac toxin in pink bollworm
in Arizona cotton fields has been reported at frequencies roughly 100-fold
higher than those reported by Gould et al. (1997) for resistance to H.
virescens. However, the frequency of this allele did not increase significantly
between 1997 and 1999, even though the Bt cotton was grown in over half the
100 000 hectares planted to cotton. Moreover, the efficacy of the Bt cotton
against the target pests remained extremely high (Tabashnik et al. 2000b).
357. Reversal of resistance in laboratory strains of diamondback moth
derived from resistant field populations has been observed when exposure to
Bt insecticide was discontinued over many generations. Reversal of
resistance was associated with restoration of binding of Cry1Ac to
brush-border membrane vesicles (Tabashnik et al. 1994a).
RESULTS FROM MONITORING FOR RESISTANT INSECTS IN AUSTRALIA
358. No monitoring has yet been conducted to investigate the incidence of
resistance to the Cry2Ab protein in Australian Helicoverpa populations
because there has as yet been only very limited exposure to this protein, in
trials of Bollgard II® cotton. In commercial Bt pest control products such as
Dipel® and Crymax®, Cry2Ab protein is not expressed due to an inefficient
expression of the Cry2Ab gene (Dankocsik et al. 1990). The only exposure of
Helicoverpa species in Australia to the Cry2Ab protein has been through
limited field trials Bollgard II® cotton conducted since 1999.
359. Monitoring for resistance to Bt microbial sprays containing the Cry1Ac
toxin in field populations of Helicoverpa armigera and H. punctigera has been
carried out by the NSW Department of Agriculture and the Australian
CHAPTER 8 INSECTICIDE RESISTANCE
Cotton Research Institute since 1993. Larvae are collected from the field
and fed a diet containing Bt toxins at a level (the discriminatory dose) that is
calibrated to kill most of the population. Increased survival at the
discriminatory dose would indicate increased resistance in the insect
population. No changes in susceptibility to discriminating doses of
commercial Bt sprays have been recorded in any of the Australian field
populations of H. armigera and H. punctigera collected from cotton between
1993 and 2000 (Holloway & Dang 2000). These results indicate that there
has been no shift towards insect resistance in INGARD® crops since the
commercial release of INGARD® cotton in 1996, and provide evidence for the
efficacy of the resistance management plans currently in place for INGARD®
cotton (see below).
360. During the 2000 - 2001 season the NSW Department of Agriculture
recorded an increase in resistance (from 7.1 to 9.2 %) of H. armigera larvae to
Cry1Ac. However, this apparent increase coincided with a change in the
bioassay method. The significance of this result is currently being
investigated by Monsanto and the NSW Department of Agriculture.
Preliminary analyses suggest that the differences in susceptibility are within
the limits of natural variation and therefore not significant.
C: Conclusions regarding insecticide resistance
361. Even though the Bollgard II® cotton is expected to significantly delay the
development of insecticide resistance compared with INGARD cotton (see
Part B of this Chapter), emergence of insects resistant to the Cry1Ac and/or
Cry2Ab protein would almost certainly occur unless preventative strategies
are implemented. Given the potentially unrestricted scale of the proposed
release, the likelihood of emergence of insects resistant to the Cry1Ac and/or
Cry2Ab proteins, as a result of the release, is considered significant.
Therefore, the licence will require implementation of insecticide resistance
management strategies, in accordance with the insecticide resistant
management requirements of the NRA, including obtaining approval from
the NRA before planting can proceed.
362. As a condition of registration by the NRA of INGARD® cotton, growers
are required to implement insecticide resistance management plans developed
by the Transgenic and Insect Management Strategy (TIMS) Committee of the
Australian Cotton Growers‘ Research Association. The plans are designed
CHAPTER 8 INSECTICIDE RESISTANCE
to minimise resistance development, and require growers to employ a number
of measures (see below).
363. An insecticide resistance management plan for Bollgard II® and
Bollgard II®/Roundup Ready® cotton is being developed currently by the
TIMS Committee of the Australian Cotton Growers‘ Research Association in
consultation with the NRA, but the plan is yet to be finalised. If it approves
the registration of Bollgard II® cotton, the NRA will require implementation
of the plan as a condition of registration. It is likely that different insecticide
resistance management plans will be required for releases in the NT and WA,
because the climate of these potential cotton-growing regions differs from
that in the southern cotton-growing areas. This is likely to affect the number
of generations of insect pests that are produced each year, with associated
implications for the potential development of resistance.
INSECTICIDE RESISTANCE MANAGEMENT PLAN
364. The insecticide resistance management plans are designed to minimise
resistance development, and require growers to employ a number of
measures. These are likely to include requirements to:
limit the total area planted to the GM cotton;
plant refuges of non-GM unsprayed cotton or other plants where
the insect pests can breed freely (this provides a population of
susceptible insects to dilute out resistance genes if these develop in
the insect pests);
plant by a certain date;
control volunteer cotton;
after harvest, to cultivate soil to prevent Helicoverpa larvae in the
soil surviving to adulthood (‗pupae-busting‘, see OGTR 2002).
CHAPTER 8 INSECTICIDE RESISTANCE
CHAPTER 9 RISK MANAGEMENT PLAN
365. This part of the document recaps the main conclusions from the risk
assessment relating to risks to human health and safety or the environment,
and details the risk management plan developed by the Regulator to manage
these risks.
SECTION 1 SUMMARY OF RISK ASSESSMENT CONCLUSIONS
366. It has been concluded that the proposed release of Bollgard II® and
Bollgard II®/Roundup Ready® cotton in NSW and QLD will not pose any
additional risks to human health and safety or to the environment in
cotton-growing areas of NSW and QLD. However, based on the available
evidence it has not been possible to determine conclusively that the proposed
release would not pose an environmental risk in cotton-growing areas of NT
and WA. The main conclusions from the risk assessment are that:
Bollgard II® and Bollgard II®/Roundup Ready® cotton are not likely
to prove more toxic or allergenic to humans or other organisms
(other than lepidopteran insects including the target pests) than
conventional cotton.
the risk of Bollgard II® or Bollgard II®/ Roundup Ready® cotton
establishing as a weed in southern Australia is low, and not likely to
be greater than that of conventional cotton. In northern Australia,
the risk of Bollgard II® or Bollgard II®/Roundup Ready® cotton
establishing as a weed is also likely to be low, however further
information is required before this can be determined conclusively;
there is some potential for development of herbicide-resistant weeds
if the crop-herbicide combination is used inappropriately;
the likelihood of some gene transfer from the GM cotton to
cultivated cotton is high, but the overall frequency of out-crossing
would be very low. This would not pose any risks additional to the
negligible risks posed by Bollgard II® or
Bollgard II®/Roundup Ready® cotton itself, covered in detail in this
document. Conventional farming practices, such as the use of
certified (pure) seed will ensure any contamination is kept to a
minimum;
CHAPTER 9 RISK MANAGEMENT PLAN
the potential for transfer of the introduced genes to wild or native
cotton is functionally zero because of the geographical isolation and
genetic incompatibility with the native species;
the likelihood of transfer of the introduced genes to other organisms
is negligible, but even if such transfer occurred it would be unlikely
to pose any hazard to human health and safety or the environment;
and
the risk of development of target insects resistant to the insecticidal
proteins is very low, due to the presence of two insecticidal proteins
and the development of insecticide resistance management plans
that are tailored to different cotton-growing environments.
SECTION 2 RISK MANAGEMENT PLAN
Section 2.1 Risk of toxicity or allergenicity
367. It is not considered necessary to include any specific management
strategies in the risk management plan in relation to the potential toxicity or
allergenicity of the cotton, since the risks are negligible. However, the
licence contains a general condition requiring the licence holder to notify the
Regulator of any adverse effects on human health and safety (for example,
allergic reactions to the cotton through occupational exposure), or to the
environment. It should be noted that FSANZ (formerly ANZFA) has
previously approved the use in food of oil and linters from Roundup Ready
and INGARD cotton, and has concluded in two previous assessments that
products from Bollgard II® cotton are as safe as those from conventional
cotton. Final approval from FSANZ would be required before oil and linters
from Bollgard II® or Bollgard II®/Roundup Ready® cotton would be
permitted for use in human food.
Section 2.2 Risks of insecticide resistance
368. There is some potential for the development of insects resistant to the
insecticidal proteins present in the GM cotton. However, the NRA sets limits
on the total area (hectares) that may be planted to GM insecticidal cottons,
and other conditions in relation to compliance with insecticide resistance and
herbicide use management plans.
CHAPTER 9 RISK MANAGEMENT PLAN
Section 2.3 Risks of weediness or gene transfer
369. The risk of transfer of genes from the GM cotton to organisms other than
cotton, including the risk of transfer to native Australian cottons, is
considered to be negligible. The risk of it spreading as a weed in southern
Australia is low and no management strategies are considered necessary to
manage this risk for releases in southern Australia. Release of Bollgard II®
and Bollgard II®/Roundup Ready cotton without specific management
conditions (i.e. general release) will be permitted south of latitude 20º South,
covering all current cotton-growing regions in NSW and Queensland. This
represents an extension above the area approved for general release of
INGARD and Roundup Ready cotton, i.e. south of latitude 22º South (see
Chapter 2).
370. The initial general release of INGARD cotton was restricted to south of
latitude 26º South, and this was later extended to accommodate expansion of
the cotton industry in Queensland. The extension of the area approved for
general release of Bollgard II® and Bollgard II®/Roundup Ready cotton is to
cover subsequent expansions. However, the cotton-growing regions of WA
and the NT, where it is considered that the main risks relating to weediness
and out-crossing to native species occur, are still excluded.
371. Extension to latitude 20º South does not increase the potential for
exposure of native Gossypium species or feral cotton populations to the GM
cotton (data from Australia‘s Virtual Herbarium:
http://www.cpbr.gov.au/avh.html and the Northern Territory Herbarium).
372. Licence conditions will be imposed for releases above latitude 20º South
to manage the potential weediness of the GM cotton in northern Australia, by
limiting gene flow and the spread and persistence of the GM cotton in the
environment. This will include requirements to:
isolate the GM cotton crop from other cotton by at least 50 metres
or to surround the release sites with 20 metre buffer rows of
conventional cotton;
prohibit the cultivation of the GM cotton within 100 metres of
known feral cotton populations;
CHAPTER 9 RISK MANAGEMENT PLAN
after the release, destroy any viable material not required for
subsequent trials (which would require separate licences), unless
exported or used for stockfeed; and
after the release, monitor for and destroy any cotton plants
(volunteers) that germinate or regrow on the release site for a
period of at least 12 months, during which no cotton could be grown
on the site; and
where viable seed is used for stockfeed north of latitude 20º South,
to monitor stockyards and relevant transport routes for volunteers
and destroy them.
373. The licence will also contain other conditions relating to the harvest,
cleaning of equipment and locations, transport and post-harvest use of the
sites, including management practices specifically designed to reduce the seed
bank of the GMO. The conditions also include a requirement for the
applicant to have in place contingency plans to deal with any unintended
release of the GMOs outside the release sites in northern Australia.
374. The NRA sets limits on the new use of herbicides to manage the risk of
developing herbicide-resistant weeds through inappropriate use of herbicides.
TIMS committee of the Australian cotton Growers‘ association annually
review and audit Roundup Ready® cotton growers for any shifts in herbicide
resistance. In addition, users of Monsanto‘s Roundup Ready® cotton must
comply with the company‘s Technology User Agreement. This agreement
requires the adoption of an integrated weed management strategy, which
effectively limits the development of glyphosate resistant weeds (Roberts and
Charles, in press).
375. The proposed licence conditions, and the reason behind them, are set out
in detail in Section 3 of this Chapter and Appendix 1.
Section 2.4 General licence conditions
376. In addition to the specific risk management conditions discussed in
Section 3 of this Chapter, the licence issued by the Regulator contains a
number of general conditions including statutory conditions relating to
requirements under Sections 61 to 65 of the Act. These conditions apply to
all licences issued by the Regulator, and may also be relevant to risk
management. For example, there are conditions that will:
CHAPTER 9 RISK MANAGEMENT PLAN
identify the persons or classes of person covered by the licence;
specify the authorised dealings; and
require the applicant to:
inform people covered by the licence of their obligations under the
licence;
allow access to the release sites by the Regulator, or persons
authorised by the Regulator for the purposes of monitoring or
auditing;
inform the Regulator if the applicant becomes aware of any
additional information about risks to human health or safety or to
the environment, any unintended effects of the release, or any
contraventions of the licence conditions; and
ensure appropriate training for persons covered by the licence.
Section 2.5 Monitoring and enforcement of compliance by the OGTR
377. It should be noted that, as well as imposing licence conditions, the
Regulator has additional options for risk management. The Regulator has
the legislative capacity to enforce compliance with licence conditions, and
indeed, to direct a licence holder to take any steps the Regulator deems
necessary to protect the health and safety of people or the environment. The
OGTR also independently monitors trial sites to determine whether the
licence holder is complying with the licence conditions, or whether there are
any unforseen problems.
378. The OGTR undertakes risk profiling during the planning of monitoring
activities. For these releases, factors which may represent higher risk,
including times of planting, flowering and harvest of the GMO, and the likely
times of germination of cotton volunteers will be taken into account in the
timing of monitoring visits.
SECTION 3 SPECIFIC RISK MANAGEMENT LICENCE CONDITIONS
379. The licence conditions set out in Appendix 1 are intended to manage the
identified risks, largely through preventing dissemination in northern
Australia of the GMOs or their genetic material into habitats in which the
CHAPTER 9 RISK MANAGEMENT PLAN
potential weediness of Bollgard II®, Bollgard II®/Roundup Ready® and feral
cotton may be increased.
380. To ensure that any future limited and controlled releases of GM cotton
can be conducted under appropriate levels of containment, the conditions
include a requirement to develop an agreed research program to collect data
relating to the effectiveness of containment measures, as part of the release.
The proponent will also be required to develop a research program to provide
information on potential environmental impacts of the GM cotton,
particularly in northern Australia.
381. The proposed conditions also include a requirement for the applicant to
have in place contingency plans to deal with any unintended release of the
GMOs outside the release sites in northern Australia.
382. Detailed reasons for the individual licence conditions are set out in
Appendix 2.
383. Monsanto will be required, under licence conditions, to be proactive in
reviewing and assessing any new information that comes to light about the
risks and the efficacy of the proposed management strategies during the
course of the release. Any licence is able to be varied at any time to add new
conditions, for instance to manage any new risks that are identified, or to
improve the existing management strategies.
384. The Regulator will also be proactive in reviewing any new information
about risks of the proposed release and may amend licence conditions on the
basis of this. Under section 68 of the Act the Regulator may suspend or
cancel a licence if a condition of the licence has been breached or if the
Regulator becomes aware of risks that the licence holder is not adequately
managing.
385. Finally, it should be noted that, the Regulator is reviewing all licence
conditions for licences carried over from the voluntary system under the
transitional arrangements set out in the Act. If as a result of this review, new
information becomes available about risks relevant to the proposed release,
any licence issued to Monsanto would be amended if necessary.
CHAPTER 9 RISK MANAGEMENT PLAN
CHAPTER 9 RISK MANAGEMENT PLAN
CHAPTER 10 CONSIDERATION OF ISSUES RAISED IN PUBLIC
SUBMISSIONS
386. Comments received in written submissions on the application and risk
assessment and risk management plan were very important in shaping the
final risk assessment and risk management plan and in informing the
Regulator‘s final decision on the application.
387. The OGTR received 48 submissions from the public, which are
summarised in Appendix 3 along with an indication of where identified risks
to human health and safety and the environment were considered in the risk
assessment and risk management plan. In summary, the submissions
suggested that the following issues should be addressed:
toxicity and allergenicity of the GM cotton, for humans and other
organisms (see Chapter 5);
weediness of the GM cotton, particularly in northern Australia, and
the potential for development of herbicide-resistant weeds (see
Chapter 6);
potential of transfer of the introduced genes, to other plants
(particularly native Gossypium species in northern Australia) and
other organisms and the subsequent impact (see Chapter 7); and
the potential for development in target pests resistance to the
insecticidal toxins in the cotton (see Chapter 8);
388. It is important to note that the legislation requires the Regulator to base
the licence decision on whether risks posed by the proposed dealings are able
to be managed so as to protect human health and safety and the environment.
Matters in submissions that do not address these issues and/or concern
broader issues outside the objective of the legislation can not be considered in
the assessment process. In most instances, as determined in the extensive
consultation process that led to the development of the legislation, they fall
within the responsibilities of other authorities.
389. For example, many submissions raised issues that related to matters that
are the responsibility of other regulatory authorities, in particular, labelling
and safety of foods derived from GMOs, and the use and safety of herbicides.
These are issues that are dealt with by Food Standards Australia New
Zealand (FSANZ, formerly the Australia New Zealand Food Authority) and
CHAPTER 10 CONSIDERATION OF ISSUES RAISED IN PUBLIC SUBMISSIONS 121
the National Registration Authority for Agricultural and Veterinary
Chemicals (NRA) respectively. Further information about food safety
assessments and food labelling and the use and safety of herbicides are
available from FSANZ and the NRA:
Food Standards Australia New Zealand
PO Box 7186
Canberra Mail Centre ACT 2610
Phone: (02) 6271 2222
Fax: (02) 6271 2278
E-mail: info@foodstandards.gov.au
http://www.foodstandards.gov.au
National Registration Authority for Agricultural and Veterinary Chemicals
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6272 5158
Fax: (02) 6272 4753
Email: nra.contact@nra.gov.au
http://www.nra.gov.au
390. In addition, issues such as marketability and trade implications posed by
the commercialisation of GM crops in Australia do not fall within the scope of
the evaluations. These matters are being actively considered by the
Commonwealth, State and Territory Governments (both individually and
through forums such as the Primary Industries Ministerial Council and its
Plant Industries Committee); Agriculture, Fisheries and Forestry Australia
(AFFA) through its Supply Chain Management of GM Products project; and
by industry through groups such as the Gene Technology Grains Committee.
391. The issues raised in relation to the proposed release and risks to human
health and safety and the environment in the submissions were considered
carefully, and weighed against the body of current scientific information, in
reaching the conclusions set out in this document. A summary of public
submissions and an indication of where such issues were taken into account is
provided at Appendix 3.
CHAPTER 10 CONSIDERATION OF ISSUES RAISED IN PUBLIC SUBMISSIONS 122
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Serdy FS, Berberich S, and Sharota E (1995) Petition for determination of
non-regulated status Bollgard® cotton lines 757 and 7076 (Gossypium
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Monsanto Company, St. Louis, Mo.
Shappley Z (2002a) Assessment of the stability of genetic inserts in combined
Roundup Ready cotton event 1445 and Bollgard cotton event 531 by trait
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Shappley Z (2002b) Independent inheritance data for cotton insect control
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Sims S and Martin J (1996) Effect of the Bacillus thuringiensis insecticidal
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Sims SR, Berberich SA (1996) Bacilus thuringiensis insecticidal proteins
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APPENDIX 1 SPECIFIC LICENCE CONDITIONS
Note in relation to herbicide and insect resistance
The Gene Technology (Consequential Amendments) Act (2000) requires the
National Registration Authority for Agricultural and Veterinary Chemicals
(NRA) to consult the Gene Technology Regulator for the purposes of making
certain decisions regarding registration or issuing a permit for a chemical
product that is or contains a genetically modified product.
The genetically modified organisms referred to in this licence fall into the
Agricultural and Veterinary Chemicals Code (1994) definition of an
agricultural chemical product, due to their production of insecticidal
substances, and are therefore subject to regulation by the NRA.
As some of these organisms are genetically modified to be resistant to a
herbicide, the NRA will assess the new use pattern of the herbicide used in
connection with these organisms.
The NRA may impose conditions in connection with the insecticidal activity of
these genetically modified organisms, including specifying maximum areas
for release and for the purpose of managing weeds resistant to the herbicide
used.
The OGTR has not, in this licence, imposed conditions in relation to insect
resistance management or herbicide resistance management in relation to
agricultural practices. These matters are expected to be satisfactorily
managed in the context of the NRA scheme.
PART 1
This instrument, including its attachments, is a licence authorising dealings
involving the intentional release of GMOs into the environment. It is issued
by the Gene Technology Regulator (the Regulator) pursuant to the Gene
APPENDIX 1
Technology Act 2000 (Cth).
Holder of licence
1.1 The holder of this licence (‗the licence holder‘) is Monsanto Australia
Ltd
Project Supervisor
2.1 The Project Supervisor in respect of this licence is the person identified
at ‗Project Supervisor‘ at Attachment A.
Persons covered by licence
3.1 The persons covered by this licence are the licence holder and
employees, agents or contractors of the licence holder and other persons who
are, or have been, engaged to undertake any activity in connection with a
GMO grown in a Location pursuant to this Licence (including growing,
harvesting, ginning or transportation of the GMO, and persons who feed
ginned GM cotton to stock).
(Explanatory Note: Each person covered by this licence is a ‘person covered by
a GMO licence’ for the purposes of the Gene Technology Act 2000 (Cth)).
Description of GMO covered
4.1 The GMO covered by this licence (‗the GMO‘) is identified and
described at ‗GMO Description‘ at Attachment B.
Dealings authorised by licence
5.1 This licence authorises the licence holder and persons covered by the
licence to conduct certain limited dealings with the GMO subject to the
limitations on dealing with the GMO that are contained elsewhere in the
conditions in this licence.
Period covered by licence
6.1 This licence remains in force until it is cancelled or surrendered. No
dealings with the GMO are authorised during any period of suspension.
APPENDIX 1
(Note: If adverse effects are reported by the Licence holder or detected through
the research program, these must be reported to the Gene Technology Regulator
immediately, who will then vary the Licence conditions to protect the health and
safety of people and the environment)
APPENDIX 1
PART 2
Interpretation and Definitions
Words and phrases used in this licence have the same meanings as they do in
the Gene Technology Act 2000 (the Act) and the Gene Technology Regulations
2001.
Words importing a gender include any other gender.
Words in the singular include the plural and words in the plural include the
singular.
Words importing persons include a partnership and a body whether
corporate or otherwise.
References to any statute or other legislation (whether primary or
subordinate) is to a statute or other legislation of the Commonwealth of
Australia as amended or replaced from time to time unless the contrary
intention appears.
Where any word or phrase is given a defined meaning, any other part of
speech or other grammatical form in respect of that word or phrase has a
corresponding meaning.
In this licence:
‘Clean’ (or ‘Cleaned’ or ‘Cleaning’) means, as the case requires:
(a) in relation to a Location or an area, the destruction of the GMO,
viable Material from the GMO, Pollen Trap plants or viable
Material from Pollen Trap plants in that Location or area, to the
reasonable satisfaction of the Regulator; or
(b) in relation to Equipment, the removal and destruction of the
GMO and viable Material from the GMO, Pollen Trap plants or
viable Material from Pollen Trap plants from the Equipment, to
the reasonable satisfaction of the Regulator.
‘Cotton’ means plants of the species Gossypium hirsutum L.
APPENDIX 1
‘Covered Vehicles’ means vehicles that use tight fitting covers to prevent
spillage of the seed transported in them (for example, vehicles that contain
seed in steel or aluminium bulk bins covered with tight, well fitting
weather-proof tarpaulins or similar).
‘Destroy’, (or ‘Destroyed’ or ‘Destruction’) means, as the case requires, killed
by one or more of the following methods:
(a) stalk pulling; or
(b) uprooting by ploughing; or
(c) burning; or
(d) treatment with herbicide; or
(e) hand weeding.
Note: ‘As the case requires’ has the effect that, depending on the circumstances,
one or more of these techniques may not be appropriate. For example, in the
case of killing the remains of harvest of the GMO, treatment of post harvest
remains by herbicide would not be a sufficient mechanism.
‘Equipment’ includes harvesters, seeders, storage equipment, transport
equipment (eg bags, containers, trucks), ginning facilities, clothing and tools.
‘Feral cotton’ means naturalised, self-perpetuating populations of
Gossypium hirsutum L. and/or Gossypium barbadense L.
‘GM’ means genetically modified.
‘GMO’ means Bollgard II® and Bollgard II®/Roundup Ready® cotton, which
are genetically modified cotton, as described at ‗GMO Description‘ at
Attachment B.
‘Isolation Zone’ means an area of land, extending outwards 50 metres in all
directions from the outer edge of a Location.
‘Location’ means an area of land where the GMO is planted and grown.
Note: In this licence, before the GMO is planted and grown in a field or other
area, this licence refers to that field or area as an area or place. Once the GMO
is planted in a field or place, while it is being grown and thereafter, this licence
refers to that field or place as a Location
APPENDIX 1
‘Material from Pollen Trap plants’ means seed, stubble, pollen or any GM
material (including parts of a plant) that is derived from or produced by
cotton from a Pollen Trap.
‘Material from the GMO’ means GM seed, stubble, pollen or any other GM
material (including part of GMO) that is derived from or produced by the
GMO, but does not include cotton lint derived from ginning.
Note: cotton lint derived from ginning is not intended to be controlled by any
licence conditions in this licence.
‘Natural Waterways’ means waterway other than irrigation channel, holding
dam or storage pond used to collect water runoff from irrigated areas.
‗NRA‘ means the National Registration Authority for Agricultural and
Veterinary Chemicals.
‘OGTR’ means the Office of the Gene Technology Regulator.
‘Pollen Trap’ means an area of land, extending at least 20 metres in all
directions from the outer edge of a Location, containing non-genetically
modified cotton that is grown in such a way as to reasonably promote a dense
and vigorous growth and flowering of the non-genetically modified cotton at
the same time as the GMO.
‘Pollen Trap plant’ means a cotton plant from a Pollen Trap.
‘Restricted Zone’ means north of latitude 22º South in NT, QLD and WA.
‘Volunteer plant’ means progeny of the GMO or of a Pollen Trap plant.
APPENDIX 1
PART 3
Conditions of licence
The licence holder and persons covered by this licence must comply with the
conditions of this licence.
SECTION 1 GENERAL CONDITIONS
Informing people of their obligations
1.1 The licence holder must inform each person covered by this licence of the
obligations imposed on them as a result of the conditions in this licence.
1.2 The licence holder must provide the Regulator, on the Regulator‘s
written request, a signed statement from each person covered by this
licence that the licence holder has informed the person of the conditions
of this licence that apply to that person.
1.3 It is a condition of a licence that the licence holder inform the Regulator
if the licence holder:
(a) becomes aware of additional information as to any risks to the
health and safety of people, or to the environment, associated
with the dealings authorised by the licence; or
(b) becomes aware of any contraventions of the licence by a person
covered by the licence; or
(c) becomes aware of any unintended effects of the dealings
authorised by the licence.
Material Changes in circumstances
2.1 The licence holder must immediately, by notice in writing, inform the
Regulator of:
(a) any relevant conviction of the licence holder occurring after the
commencement of this licence;
(b) any revocation or suspension of a licence or permit held by the
licence holder under a law of the Commonwealth, a State or a
foreign country, being a law relating to the health and safety of
people or the environment;
(c) any event or circumstances occurring after the commencement of
this licence that would affect the capacity of the holder of his
licence to meet the conditions in it.
APPENDIX 1
Remaining an Accredited organisation
3.1 The licence holder must, at all times, remain an accredited organisation
and comply with any conditions of accreditation set out in the Guidelines for
Accreditation of Organisations.
Changes to details
4.1 The licence holder must immediately notify the Regulator in writing if
any of the contact details of the Project Supervisor change.
SECTION 2 SPECIFIC CONDITIONS IN CONNECTION WITH ANY RELEASE OF THE GMO
IN AUSTRALIA SOUTH OF LATITUDE 22º SOUTH (OUTSIDE THE
RESTRICTED ZONE)
1. The licence holder and persons covered by this licence must not deal
with the GMO South of latitude 22 degrees South (i.e., outside the Restricted
Zone) except as expressly authorised or contemplated by this licence.
Note: The conditions in this Section 2 apply to both Bollgard II ® and Bollgard
II®/Roundup Ready® cotton.
Locations and size of Release
2. Dealings with the GMO may be conducted outside the Restricted Zone.
Research on gene flow and environmental impacts
3. The licence holder must, in consultation with the OGTR, survey farms
to seek to determine the incidence of Volunteer plants on those farms and
their management by farmers. The survey results must be included in the
written report that must be submitted to the Regulator within 90 days of each
anniversary of this licence.
Note: A condition below requires annual written reporting to the Regulator.
See below.
4. The licence holder must, in consultation with the OGTR, develop an
agreed research program to ensure the ongoing effectiveness of management
actions and to monitor the environmental impacts of the GMO. This must
include (but need not be limited to) collecting information on:
(a) the effects of the GMO on key pests and beneficial insects
(including Diptera) and soil microorganisms; and
APPENDIX 1
(b) the potential development of pests resistant to the insecticidal
activity of the GMO.
5. The licence holder must, in consultation with the OGTR, survey for
shifts in weed resistance associated with growing Bollgard II/Roundup Ready
cotton. The survey results must be included in the written report that must
be submitted to the Regulator within 90 days of each anniversary of this
licence.
Note: A condition below requires annual written reporting to the Regulator.
See below.
Testing methodology
6. The licence holder must provide a written instrument to the Regulator
describing an experimental method that is capable of reliably detecting the
presence of the GMO and any transferred genetically modified material that
might be present in a recipient organism. The instrument must be provided
within 30 days of planting of the GMO.
Reporting
7. The licence holder must provide the Regulator with a written report
within 90 days of each anniversary of this licence, in accordance with any
Guidelines issued by the Regulator in relation to annual reporting.
SECTION 3 SPECIFIC CONDITIONS IN CONNECTION WITH ANY RELEASE OF THE GMO
IN AUSTRALIA WITHIN THE RESTRICTED ZONE
GMO not permitted in Restricted Zone except as contemplated by this licence
8. The GMO and Material from the GMO are not permitted in the
Restricted Zone (including the growing of the GMO and the transportation of
the GMO into or within the Restricted Zone), except in accordance with the
following specific conditions.
Note: The conditions in this Section 3 apply to both Bollgard II and Bollgard
II/Roundup ready cotton.
APPENDIX 1
Locations and size of release
9. The GMO may be planted and grown at up to 20 (and not more than
20) Locations at any one point in time.
No single Location may exceed 200 hectares in area.
The maximum area of all Locations under all Licences planted to the GMO at
any one point in time must not exceed 800 hectares.
10. The GMO must not be planted within 50 metres of a Natural
Waterway.
Notification of Locations
11. Prior to planting the GMO at an area, the area‘s GPS coordinates and
either a street address or other directions to the area must be provided to the
Regulator by notice in writing. The notice must identify the GMO proposed
to be grown at the area, by reference to its ‗GMO details‘ as set out at
Attachment B. If more than one of the GMOs identified at ‗GMO details‘ at
Attachment B is proposed to be grown at the area, the notice must provide
additional details about where, within the area, the different GMOs are
proposed to be grown.
Licence holder must be able to access and control places used in connection with
this licence
12. The licence holder must be able to access and control a Location or
other area used in connection with this licence, other than areas where stock
are fed GM cotton seed and areas where stock fed with GM cotton seed are
subsequently grazed, to the extent necessary to comply with this licence, for
the duration of the life of the licence.
Notification of planting of the GMO
13. The licence holder must provide notices in writing to the Regulator in
respect of each of the following:
(a) the short term forecasted date or dates of commencement of
planting of the GMO at each area proposed to be planted (and
Pollen Trap in respect of each area, if any) ('the short term
forecast planting date notice'). This notice must be provided at
least 7 days, and not more than 20 days, prior to the forecasted
date or dates of commencement of planting set out in the notice;
APPENDIX 1
(b) the actual date or dates of commencement of planting of the
GMO at each Location (and Pollen Trap in respect of the
Location, if any) (‗the actual planting date notice‘). This notice
must be provided within 7 days of commencement of planting of
the GMO at the Location.
Notification of commencement of seed set of the GMO
14. The licence holder must provide notices in writing to the Regulator in
respect of each of the following:
(a) the short term forecasted date or dates of commencement of seed
set of the GMO at each Location (and Pollen Trap in respect of
each Location, if any) ('the short term forecast seed set date
notice'). This notice must be provided at least 7 days, and not
more than 20 days, prior to the forecasted date or dates of
commencement of seed set, as set out in the notice;
(b) the actual date or dates of commencement of seed set of the GMO
at each Location (and Pollen Trap in respect of each Location, if
any) ('the actual seed set date notice'). This notice must be
provided within 7 days of commencement of seed set of the GMO
at the Location.
Notification of commencement of harvest of GMO
15. The licence holder must provide notices in writing to the Regulator in
respect of each of the following:
(a) the short term forecasted date or dates of commencement of
harvesting of the GMO at each Location (and Pollen Trap in
respect of each Location, if any) ('the short term forecast harvest
date notice'). This notice must be provided at least 7 days, and
not more than 20 days, prior to the forecasted date or dates of
commencement of harvesting set out in the notice;
(b) the actual date or dates of commencement of harvesting of the
GMO at each Location (and Pollen Trap in respect of each
Location, if any) ('the actual harvest date notice'). This notice
must be provided within 7 days of commencement of harvesting
of the GMO at the Location.
Measures to manage gene flow – Locations must be surrounded by Pollen Traps or
Isolation Zones
16. Each Location must be surrounded by either:
APPENDIX 1
(a) a Pollen Trap; or
(b) an Isolation Zone.
Conditions relating to Pollen Traps
17. If a Pollen Trap is planted, the plants in it (Pollen Trap plants) must be
handled and controlled as if they are the GMO (ie subject to other applicable
conditions elsewhere in this licence), and Material from Pollen Trap plants
must be handled and controlled as if it is Material from the GMO (ie subject
to applicable conditions elsewhere in this licence).
18. A Pollen Trap must be able to be accessed and controlled by the licence
holder to an extent that is commensurate with the licence holder‘s rights to
access the Location within it.
Note: Specific conditions about Cleaning Pollen Traps occur elsewhere in this
licence.
Conditions relating to Isolation Zones
19. No cotton of any kind may be grown in an Isolation Zone while the
GMO is being grown at the Location within it.
20. An Isolation Zone must be able to be accessed and controlled by the
licence holder to an extent that is commensurate with the licence holder‘s
rights to access the Location within it.
Harvest and post-harvest procedures
21. If the GMO or Pollen Trap plants are harvested, they must be
harvested separately from any other cotton.
22. If seed cotton harvested from the GMO or from Pollen Trap plants is
ginned, it must be ginned separately from any other cotton.
23. Following ginning, seed from the GMO and Pollen Trap plants must be:
(a) stored in a sealed container that is signed so as to indicate that it
contains GM cotton seed, within a locked facility that is signed so
as to indicate that GM cotton seed is stored within the facility; or
(b) exported; or
(c) transported south of latitude 22º South; or
APPENDIX 1
(d) used for stockfeed in accordance with the conditions in this
licence (see below); or
(e) rendered non-viable by roller crushing or extrusion; or
(f) incinerated.
24. Any cotton seed obtained from harvest may only be transported to the
extent necessary to gin it and then to comply with this licence.
Note: This licence contains other conditions relating more specifically to
transportation of the GMO and GM Material from the GMO.
The GMO and GM Material may be used as animal feed
25. Following ginning, the GMO and Material from the GMO may be fed
to stock in the Restricted Zone only if feeding takes place inside stockyards,
feedlots or dairies.
26. The licence holder must inform:
(a) cotton gins and persons using the GM cotton seed as stockfeed, of
the licence conditions below relating to monitoring of areas where
stock are fed the GMO and destruction of Volunteer plants; and
(b) encourage recipients of ginned GM cotton seed to adopt the
conditions as farm practices.
27. If stock are fed the GMO or viable Material from the GMO, the licence
holder must take reasonable steps to monitor the following areas for the
existence of Volunteer plants:
(a) All areas where the stock were fed;
(b) All areas where stock were grazed within, 25 days of feeding the
GMO; and
(c) All areas where the stock were subsequently housed, within 25
days of feeding the GMO.
28. The Licence holder must ensure that monitoring is performed by a
person who is able to recognise Volunteer plants and that reasonable steps
are taken to destroy any Volunteer plants detected during monitoring before
they set seed.
APPENDIX 1
Cleaning – post harvest and generally
29. Where Equipment (including harvesters, storage equipment, transport
equipment, ginning facilities and clothing), a Location or other area is used
pursuant to this licence in respect of the GMO, viable Material from GMO,
Pollen Trap plants or viable Material from Pollen Trap plants, it must be
Cleaned.
30. For each Location, either within 14 days of harvest of the GMO or 9
months after planting, whichever occurs first, the Location must be Cleaned.
31. Within 14 days of either harvest or Cleaning of the GMO at a Location,
whichever occurs first, the area containing the Pollen Trap in respect of that
Location, if any, must be harvested or Cleaned.
32. When Equipment is Cleaned, the area in which the Equipment is
Cleaned must also be Cleaned.
Note: For the sake of clarity, it is not necessary for Equipment to be Cleaned
only at a Location.
33. Cleaning must occur immediately or as soon as practicable after the use
and before use for any other purpose.
Note: For example, if seed is harvested with a mechanical harvester, the
harvester must be Cleaned immediately following its use and before any other
cotton is harvested.
Post-harvest monitoring
34. Following Cleaning of each Location, the following places must be
monitored for the existence of Volunteer plants:
(a) the Location;
(b) the Pollen Trap in respect of the Location, if any;
(c) any areas used to Clean Equipment used in connection with the
GMO or to destroy the GMO, viable Material from the GMO,
Pollen Trap plants or viable Material from Pollen Trap plants;
and
APPENDIX 1
(d) irrigation channels or drains through which water used on the
Location (or Pollen Trap, if any) flows.
35. Monitoring must be performed by a person who is able to recognise
Volunteer plants.
36. Any Volunteer plants detected during monitoring must be Destroyed
before setting seed.
37. All the places required to be monitored must be monitored at least once
every 60 days for at least:
(a) 12 months from the last day of Cleaning of the Location; or
(b) if a cotton crop is planted at the Location in the growing season
following the growth of the GMO, until such time as the
subsequent cotton crop is planted.
Note: This licence allows a single crop of cotton (either GM cotton or non-GM
cotton) to be planted in the growing season after the GMO is grown, in certain,
limited situations (see the conditions in connection with this below). If a
second cotton crop is grown at a Location, the condition above requires
monitoring of the Location to take place between the time of Cleaning of the
GM cotton at the Location and the planting of the second cotton crop. After
harvest or Cleaning of the second cotton crop, monitoring of the Location must
then be recommenced for a further 12-month period.
38. The results of monitoring activities must be reported to the Regulator
in writing within 30 days of any day on which monitoring occurs. Reporting
must include:
(a) details of the areas monitored;
(b) details of the date of monitoring;
(c) the names of the person or persons who undertook the monitoring
and details of the experience, training or qualification that
enabled them to recognise Volunteer plants;
(d) the number of Volunteer plants observed, if any;
(e) details of whether the Volunteer plants observed, if any, occurred
in the Location, the Pollen trap, areas used to Clean Equipment
or in irrigation channels or drains;
(f) details of the development stages reached by the Volunteer plants,
if any;
APPENDIX 1
(g) details of methods used to Destroy Volunteer plants identified, if
any; and
(h) details of the date on which Volunteer plants were Destroyed.
General conditions on use of Locations post-harvest
39. These general conditions on the use of Locations post-harvest
immediately below are subject to special conditions in connection with
subsequent growing of a single cotton crop that appear below these general
conditions.
40. If the GMO is grown at a Location, no other cotton plant of any kind
may be grown at the Location, or Pollen Trap in respect of the Location, if
any, after harvest of the GMO or Pollen Trap plants, until monitoring
obligations are completed.
41. If the GMO is grown at a Location, no plants may be planted at the
Location, or Pollen Trap in respect of the Location, if any, until monitoring
obligations are completed unless:
(a) the plants are grasses (grass pastures), cereals (cereal crops); or
(b) the plants are plants agreed to in writing by the Regulator; and
(c) the Regulator is satisfied that monitoring and Destruction of
Volunteer plants prior to setting seed will not be adversely
affected by the planting.
Special conditions on use of Locations post-harvest - single crop of cotton may be
planted in growing season immediately following GMO growing season in limited
situations
42. If no cotton of any kind was grown at a Location in the 12 months
preceding the growing of the GMO at the Location, then a single crop of
non-GM cotton may be grown at the Location and pollen Trap in the growing
season immediately following the growing of the GMO. If non GM-cotton is
grown at the Location in the growing season immediately following the
growing of the GMO, the cotton shall be taken to be the GMO for the
purposes of this Licence.
Note: This means that the conditions in this licence, as they apply to the GMO
(for example as they apply to areas and Equipment used in connection with the
GMO) are applicable to the subsequent non-GM cotton crop. These conditions
APPENDIX 1
are intended to allow a single crop of non-GM cotton to be planted at a Location
in the growing season immediately following the season in which the GMO is
grown at the Location.
If a subsequent cotton crop is grown, the conditions above are intended to have
the effect that regardless of whether the subsequent cotton crop is actually GM
or not, that cotton must be regarded as, and handled and controlled under this
licence as if it is GM cotton. It is intended that the licence conditions in this
licence will be applicable to that subsequent cotton crop, regardless of the fact
that the cotton may not be GM. For example, where a second cotton crop is
grown, it is intended that the cotton will form part of the 800 hectare limit in
that period, that the cotton will be surrounded by an Isolation Zone or Pollen
Trap, that the Location will be harvested, Cleaned and monitored and the cotton
transported in accordance with the other licence conditions in this licence.
Transportation of the GMO, Material from the GMO, Pollen Trap plants and
Material from Pollen Trap plants
43. Subject to the other transport conditions below, the GMO, Material
from the GMO, Pollen Trap plants and Material from Pollen Trap plants
must not be transported within or into the Restricted Zone unless contained
within a primary, sealed container that is packed in a secondary, unbreakable
container.
Note: Cotton lint derived from ginning is not subject to these transportation
conditions.
44. Cotton modules may be used to transport the GMO, Material from the
GMO, Pollen Trap plants and Material from Pollen Trap plants, if they are
covered with a tarpaulin, then wrapped securely in shadecloth in such a way
as to prevent dissemination of cotton seed, and then placed inside a sealed
chain-bed truck.
45. Seeds from the GMO or Pollen Trap plants that have been ginned may
only be transported for export in sealed, airtight shipping containers.
46. Seeds from the GMO or Pollen Trap plants that have been ginned may
be transported to stockyards, feedlots or dairies (for use as stockfeed) in
APPENDIX 1
Covered Vehicles.
47. Every container used to transport the GMO, viable Material from the
GMO, Pollen Trap plants or viable Material from Pollen Trap plants must be
labeled:
(a) to indicate that it contains genetically modified cotton; and
(b) with telephone contact numbers for the licence holder and
instructions to contact the licence holder in the event that the
container is broken or misdirected.
48. The licence holder must have in place accounting procedures to verify
whether the same quantity of GMO, viable Material from the GMO, Pollen
Trap Plants or Material from Pollen Trap plants sent is delivered. Routes,
methods and procedures used for transportation of the GMO, viable Material
from the GMO, Pollen Trap plants and viable Material from Pollen Trap
plants must be documented.
Contingency Plan
49. Within 30 days of the date of the commencement of this licence, a
written Contingency Plan must be submitted to the Regulator detailing
measures to be taken in the event of the unintended presence of the GMO,
viable Material from the GMO, Pollen Trap plants or viable Material from
Pollen Trap plants outside a Location, Pollen trap in respect of a Location or
other area that must be monitored.
50. The Contingency Plan must include details of procedures to:
(a) ensure the Regulator is notified immediately if the licence holder
becomes aware of an event;
(b) destroy any of the GMO, viable Material from the GMO, Pollen
Trap plants or viable Material from Pollen Trap plants; and
(c) monitor for and destroy any Volunteer plants that may exist as a
result of the event.
51. The Contingency Plan must be implemented in the event that the
unintended presence of the GMO, viable Material from the GMO, Pollen
Trap plants or viable Material from Pollen Trap plants is discovered outside
an area that must be monitored.
APPENDIX 1
Compliance Management Plan
52. Prior to planting the GMO, a written Compliance Management Plan
must be provided to the Regulator. The Compliance Management Plan must
describe in detail how the licence holder intends to ensure compliance with
these conditions and to document that compliance.
Research on gene flow and environmental impacts
53. The licence holder must, in consultation with the OGTR, conduct an
annual survey of:
(a) areas where the stock were fed; and
(b) areas where stock subsequently moved after feeding;
in order to seek to determine the prevalence of Volunteer plants in these
places. The survey results must be included in the written report that must
be submitted to the Regulator within 90 days of each anniversary of this
licence.
Note: A condition below requires annual written reporting to the Regulator.
See below.
54. The licence holder must, in consultation with the OGTR, develop an
agreed research program to ensure the ongoing effectiveness of management
actions and to monitor the environmental impacts of the GMO. This must
include (but need not be limited to) collecting information on:
(a) the potential weediness of GM cotton in northern Australia;
(b) the effects of the GMO on key pests and beneficial insects
(including Diptera) and soil microorganisms; and
(c) the potential development of pests resistant to the insecticidal
activity of the GMO.
The licence holder is encouraged to conduct research in connection with the
following:
(a) the distribution of Feral cotton in northern Australia;
(b) the effectiveness of any Pollen Trap in preventing gene flow from
the GMO to non-genetically modified cotton, including Feral
cotton;
APPENDIX 1
(c) the effectiveness of any Isolation Zone in preventing gene flow
from the GMO to non-genetically modified cotton, including
Feral cotton;
(d) the relative prevalence and impact on Feral cotton in northern
Australia of lepidopteran and other arthropod herbivores;
(e) integrated pest management strategies for Bollgard II® and
Bollgard II®/Roundup Ready® cotton, particularly in northern
Australia;
(f) the distribution of volunteer cotton along transport routes in
northern Australia.
Note: The OGTR will review licence conditions, including approval for further
planting, in light of results from the research program after two years from the
date of issue of this licence (or earlier).
Testing methodology
55. The licence holder must provide a written instrument to the Regulator
describing an experimental method that is capable of reliably detecting the
presence of the GMO and any transferred genetically modified material that
might be present in a recipient organism. The instrument must be provided
within 30 days of planting of the GMO.
Reporting
56. The licence holder must provide the Regulator with a written report
within 90 days of each anniversary of this licence, in accordance with any
Guidelines issued by the Regulator in relation to annual reporting.
APPENDIX 1
APPENDIX 2 REASONS FOR LICENCE CONDITIONS
The reasons for inclusion of the specific licence conditions follow (with
reference to the numbering of the conditions in the licence). The object of
most of the conditions is to limit the potential for spread and persistence of
the GM cotton in the environment outside release sites in the Restricted Zone
(north of latitude 22South in QLD, NT and WA) in order to reduce the
potential for risks to the environment.
Note: Conditions 8 to 56 only apply to releases north of latitude 22South.
Conditions 1, 2 and 9 to 11 Location and size of release
These conditions limit the dealings that may be undertaken by the licence
holder to those that have been sought by the licence holder and considered
and assessed by the Regulator. The Regulator requires detailed information
about release site locations north of latitude 22South prior to
commencement of any release in order to maintain the GMO Record, as well
as to plan OGTR monitoring of the Locations. Dealings other than those
authorised in the licence are prohibited and would require separate
assessment by the Regulator.
Conditions 3 to 5, 53 and 54 Research
This condition requires information to be collected and provided to the
Regulator on the environmental impact of the GM cotton and on the efficacy
of management actions, to assist the Regulator in future risk assessments.
Research must be planned in consultation with the OGTR, so that the OGTR
can assess whether any study is sufficiently rigorous to provide meaningful
data. The research will include an annual survey of the prevalence of GM
cotton volunteers associated with the use of using GM cotton seed as a
stockfeed in northern Australia.
Conditions 6 and 55 Testing methodology
This condition addresses the risk of persistence or dissemination of the GM
cotton or its genetic material in the environment going unidentified. The
condition requires the licence holder to provide a method that will detect the
GM cotton or its genetic material, for example if transferred to other cotton
plants. The ability to test for the presence or absence of the GMO or its
genetic material will enable the Regulator to be satisfied that risks are being
APPENDIX 3
adequately managed, or alternatively that additional measures may need to
be imposed to manage risks.
Conditions 7 and 56 Reporting
This condition requires the licence holder to provide an annual report to the
Regulator, thereby satisfying the Regulator that risks are being adequately
managed by the licence holder.
Condition 8 Dealings in the Restricted Zone
This condition requires further specific conditions to apply if the GMO or
viable material from the GMO is grown or transported north of latitude
22South in QLD, NT or WA (the Restricted Zone).
Conditions 9 to 11
See ‗Conditions 1, 2 and 9 to 11‘ above.
Condition 12 Access to Locations
This condition requires that the licence holder or persons covered by this
licence have access to any Location, Pollen Trap, Isolation zone or other area
used in connection with this licence, to enable them to comply with other
conditions of this licence.
Condition 13 to 15 Notification of the planting, seed set and harvesting of the
GMO
This condition ensures that minimum advance information about the likely
higher risk times of releases north of latitude 22South (namely the likely
planting, flowering and harvest dates) is provided to the OGTR to ensure
proper planning of the OGTR monitoring of the Locations. The OGTR
monitoring strategy is an integral component of the overall management
strategy for the proposed release north of latitude 22South. The Regulator
considers that these conditions are necessary and adequate to ensure
management of the risks posed north of latitude 22South at the higher risk
times of planting, flowering and harvest.
APPENDIX 3
Conditions 16 to 20 Measures to manage gene flow (Pollen Traps, Isolation
Zones)
These conditions are intended to minimise the risk of gene flow from the GM
cotton to other cotton crops or to feral cotton north of latitude 22South by
physical separation. Pollen Traps and Isolation Zones serve as barriers to
pollen movement, by either wind or insect pollinators, to plants outside the
Location. Access to the these areas by the licence holder or persons covered
by the licence ensures the licence holder can continue to meet the obligations
of the licence. The Regulator considers that these conditions are necessary
and adequate to manage the risk of gene flow north of latitude 22South.
Conditions 21 to 24 Harvest and post-harvest procedures
These conditions seek to reduce the risk of the GMO being disseminated or
persisting in the environment north of latitude 22 South through spillage or
contamination of seed at harvest or during ginning. The Regulator considers
that these conditions are necessary to adequately minimise this risk.
Harvesting and ginning of the GM cotton separately from any other cotton
reduces the risk of contamination of other crops. Immediate storage of seed
in sealed, clearly labelled containers, export of seed or destruction of seed
after ginning, coupled with minimum transportation of the GMO, is
necessary to ensure minimum risk of the GMO disseminating into the
environment.
Conditions 25 to 28 Use as animal feed
These conditions are to limit, monitor for and control the spread of the GMO
as a result of its use as animal feed north of latitude 22South. The
Regulator considers that these conditions are necessary and adequate to
manage the risks of persistence and dissemination of the GMO north of
latitude 22South as a result of its use as animal feed.
Conditions 29 to 33 Cleaning – post harvest and generally
These conditions describe the cleaning requirements for equipment,
Locations and other areas used in releases north of latitude 22 South, in
order to minimise the risk of spread or persistence of the GMO outside the
release site.
Cleaning of equipment used in connection with the GM cotton is considered
necessary to adequately minimise the risk of dissemination of the GMO, for
APPENDIX 3
example through the spread of GM cotton seeds during subsequent use of
equipment.
Cleaning of the Location and Pollen Trap ensures that the GM cotton and
material from the GM cotton are destroyed, and is considered necessary to
adequately minimise the risk of the GMO persisting at or spreading beyond
the Location.
Cleaning as soon as possible after the specified activity is considered
necessary to further reduce the risk of dissemination and persistence of the
GMO.
Conditions 34 to 38 Monitoring – post harvest and generally
These conditions are considered necessary to minimise the risks of persistence
and dissemination of the GMO or its genetic material after harvest for
releases north of latitude 22 South arising from volunteer cotton germinating
and setting seed. These conditions are also considered necessary because the
Cleaning conditions are not considered to be sufficient, of themselves, to
adequately manage these risks.
The Regulator considers that regular monitoring north of latitude 22 South,
and destruction of volunteer cotton prior to seed set on the release site, any
areas used for cleaning equipment, and irrigation channels and drains
through which water used at the release site flows is necessary and adequate
to minimise and manage the risks.
The Regulator considers that requiring monitoring for at least 1 year is
necessary and adequate to manage the risks of persistence and dissemination
of the GMO or it genetic material. If a Location is to be used in the
subsequent (second) season for growth of GM cotton, monitoring for 6
months between harvest and replanting is considered adequate to manage the
risks, as the Location will be subject to monitoring after the second season
harvest.
These conditions require regular reporting to the Regulator of the results of
monitoring activities, including the incidence, developmental stage and
methods of destruction of volunteers. This condition is considered necessary
to demonstrate that the licence holder is managing the risks and complying
with the conditions of the licence, and to identify whether any additional
APPENDIX 3
management actions might need to be implemented to adequately manage the
risks.
Conditions 39 to 42 Use of Locations post-harvest
These conditions are considered necessary and adequate to manage the risk of
persistence or dissemination of the GM cotton or its genetic material in the
environment north of latitude 22 South during subsequent use of the
Location.
The condition permitting the planting of cereals and grass pastures is
considered compatible with management of the risks of persistence and
dissemination of the GMO because these crops enable the ready identification
and destruction of volunteer cotton. The growth habits of these crops also
suppress the development of volunteer cotton seedlings. The planting of
these crops is considered to reduce the risk of persistence or dissemination of
the GM cotton.
The condition requiring approval in writing from the Regulator for the
planting of alternative crops is considered necessary to manage the risks of
persistence and dissemination of the GMO, allowing the Regulator to assess
whether the risks posed by the emergence of volunteer cotton can be
adequately addressed through the ready identified and destruction of
volunteer cotton in those crops.
The condition permitting the growing of non-GM cotton (to be treated as if it
were GM cotton) at a Location in the season following the GM cotton crop is
considered compatible with management of the risks of persistence and
dissemination of the GMO. Any GMO persisting after the first season will
continue to be dealt with in accordance with OGTR licence conditions,
including monitoring following harvest of the second season crop.
Conditions 43 to 48 Transport
This condition addresses the risks of persistence or dissemination of the GM
cotton in the environment north of latitude 22 South posed by transport,
especially unintentional release through spillage or contamination. These
risks are managed by this condition by requiring all material from GM cotton
to be double contained during transport north of latitude 22 South, that it be
APPENDIX 3
clearly labelled, and that all viable material from GM cotton is accounted for
during transport.
Conditions 49 to 51 Contingency plans
This condition addresses the risks posed through unintended presence of the
GMO or its genetic material north of latitude 22 South. The condition
requires the licence holder to supply the Regulator with a documented
contingency plan that will be enacted in the event of unintended presence of
the GMO north of latitude 22 South. This will enable the Regulator to be
satisfied that the licence holder will be able to implement measures which will
effectively manage any risks posed by such an eventuality. It also enables the
Regulator to revise the contingency plan or impose licence conditions to
require any other measures that might be necessary to prevent the continued
spread or persistence of the GMO. This condition also requires that the plan
must have procedures to ensure immediate notification of the Regulator in the
event of an unintentional presence of the GMO north of latitude 22 South, so
that the Regulator can take any actions necessary to protect the environment.
Condition 52 Compliance Management Plan
This condition requires the licence holder to document to the Regulator that
they can comply with the conditions of the licence. This enables the
Regulator to be satisfied that the risks posed by the dealing with the GMO
can be adequately managed through compliance with the management
measures set out in the licence.
Conditions 53 and 54
See ‗Conditions 3 to 5, 53 and 54‘ above.
Condition 55
See ‗Conditions 6 and 55‘ above.
Condition 56
See ‗Conditions 7 and 56‘ above.
APPENDIX 3
APPENDIX 3
APPENDIX 3 PUBLIC SUBMISSIONS ON THE APPLICATION AND RISK
ASSESSMENT AND RISK MANAGEMENT PLAN
a
Submission from: A: agricultural organisation; I: individual; E: environmental organisation;
F: food interest organisation; C: consumer/public interest organisation
b
Refers to Ch (Chapter), OSA: outside scope of the assessment; NR: No specific response; CBD:
‗The Biology and Ecology of Cotton (Gossypium hirsutum) in Australia‘, available online at
www.ogtr.gov.au.
Sub. Consideration
TypeA
No:
Summary of issues raised of issueB
1 I …summary documentation…by GTR…makes a Ch 9
convincing case to reject application…for extension to
area…where GM cotton can be grown
…applicant provides no scientific evidence that earlier Ch2 & Ch 6
decision…was wrong…[to] restrict the release GM
cotton be restricted to areas south of 22º South
….Act requires that decisions by Regulator be based on Noted
scientific evidence…if at all possible by scientific
experimentation
…application based on opinions not experimentation Noted
….Regulator should require that experiments be done Ch 9 &
to test implied assertion of the applicant that earlier Appendix 1
restrictions were incorrect
…should not approve the application until those Noted
experiments have been done and assessed.
[Gives examples of types of experiments that needs to Ch 9 &
be conducted] Appendix 1
2 I ….genetically modified products and inventions…are Ch 5
not good for humans…like any other artificial things
that come in the market they all poses health hazards
to human life
…fact of life natural products are best…why…include Ch 5
artificial things if …ruin our health
…profit motivates those who invent this artificial OSA
resources…[which] only create more problems…it
contradicts nature which is the source we produce and
consume. We drawn our resources from it as a means
of our existence so why replace it with flawed
alternatives.
APPENDIX 3
…genetically modified technology not good to be Ch 5
released commercially, nor…large scale trial…once
released…bad effects that it could cause can never be
remedied…why…try something…not good for
humans…what benefits…if we are already exposed…to
the negative effects this genetically modified products
brought in our lives
…only people…benefits…GM products are those who OSA
created them through wealth from profits….at the
expense of all human beings.
different kinds of illnesses existed…might be caused Ch 5
through the GM products …people are consuming
without their knowledge.
…because of the profit motives as the driving force of OSA, Ch 5
GM technology founders they will do anything to
succeed at the expense of the peoples health just to
acquire wealth.
…final decision depends on the intuition of the OSA
regulators of this technology, whether they will listen to
their conscience or to the wealth it will create for them.
3 A …vehemently protest planting of GM cotton (in fact Noted
ANY GM CROP) in Katherine (or ANYWHERE in
Australia)
…well known that Monsanto…DISMAL record of Ch 9
controlling trialed releases of GM crops.
…no one can control GM organisms…they will Ch 7
contaminate not only organic farms but conventional CBD
farms
…Monsanto original makers of DDT and Agent OSA
Orange and of course glyphosate containing herbicide
– still promoted as safe, soft option (despite the state of
New York successfully suing Monsanto for its claim
that glyphosate containing herbicide is both
bio-degradable and safe).
…cotton is a notorious user of precious water, OSA
Insecticides, and Herbicides (glyphosate).
…The Pope has just spoken out against GM, so has the Noted
Prince of Wales – many scientists (not lined to
Bio-Tech companies) have also spoken out against GM.
4 I [NB: this is an independent submission, despite its Noted
similarity to that of similar submissions including, for
example, submission no. 3]
vehemently protest planting of GM cotton (in fact ANY
GM CROP) in Katherine (or ANYWHERE in
Australia)
…well known that Monsanto…DISMAL record of Ch 9
controlling trialed releases of GM crops.
APPENDIX 3
…no one can control GM organisms…they will Ch 7
contaminate not only organic farms but conventional CBD
farms
…Monsanto original makers of DDT and Agent OSA
Orange and of course glyphosate containing herbicide
– still promoted as safe, soft option (despite the state of
New York successfully suing Monsanto for its claim
that glyphosate containing herbicide is both
bio-degradable and safe).
…cotton is a notorious user of precious water, OSA
Insecticides, and Herbicides (glyphosate).
…The Pope has just spoken out against GM, so has the Noted
Prince of Wales – many scientists (not lined to
Bio-Tech companies) have also spoken out against GM.
5 I …strongly oppose use of GM seeds Noted
…no controlling of a live form that can be blown miles Ch 7 & CBD
by the wind, carried by birds, moved on car tyres – to
cross pollinate other crops and natives
…support [letter from Bio-Dynamic (Farming & Noted
Gardening) Network NT sub No. 3 above]
6 I …apposed to Monsanto‘s application to release Noted
genetically modified cotton in the region of Katherine
(NT)
...Monsanto has not yet made their case Noted
…recent New Zealand elections shows how uneasy OSA
many people feel about the rush to adopt GM
technology…Australia would be well advised to take
the careful NZ approach which will make our clean
green produce more and more desirable overseas
7 I [NB: this is an independent submission, despite its Noted
similarity to that of similar submissions including, for
example, submission no. 3]
…our bodies are designed to be healthy, and heal
themselves in the natural environment that was created
for them – DON‘T MESS WITH IT – IT MAKES US
SICK!!!!
…vehemently protest planting of GM cotton (in fact Noted
ANY GM CROP) in Katherine (or ANYWHERE in
Australia)
…well known that Monsanto…DISMAL record of Noted
controlling trialed releases of GM crops.
…no one can control GM organisms…they will Ch 7
contaminate not only organic farms but conventional CBD
farms
APPENDIX 3
…Monsanto original makers of DDT and Agent OSA
Orange and of course glyphosate containing herbicide
– still promoted as safe, soft option (despite the state of
New York successfully suing Monsanto for its claim
that glyphosate containing herbicide is both
bio-degradable and safe).
…cotton is a notorious user of precious water, OSA
Insecticides, and Herbicides (glyphosate).
…The Pope has just spoken out against GM, so has the Noted
Prince of Wales – many scientists (not lined to
Bio-Tech companies) have also spoken out against GM.
…would you grow this crop in your backyard and let OSA
your children play in it
8 A no issues with the information supplied…supportive of Noted
the introduction of Bollgard II
…positive contribution Ingard and Bollgard II have Noted
and will make to integrated pest management…this too
is part of risk assessment in the environment.
…our experience in the field has seen a significant Noted
reduction in pesticide use through use of
Ingard…expecting Bollgard II to provide even greater
benefits
…has allowed improved use of natural predatory Noted
insects or ‗beneficials‘ which have greatly
enhanced…ability to operate more robust and stable
integrated pest management systems at a commercial
level
...from a human safety prospective…technologies like Noted
Bollgard II further reduce chemical application
activities
9 I …dismay and disapproval…Monsanto...getting Noted
permission to release GM crops anywhere in Australia.
Australia has opportunity…world leader of clean, OSA
chemical free products…up to us to seize this chance as
more and more of worlds people are demanding this
type of product…to present ourselves this way…the
integrity has to be there and organics and other
products must be GM free
…if we allow GM products …don‘t know what we are Ch 5, Ch 6
doing to nature nor the whole cycle Ch 7, Ch 8
CBD
…Public Health, the environment and the security of Ch 5, Ch 6
our farmers…is at stake Ch 7, Ch 8
CBD
10 I …express concern regarding the release of genetically Noted
modified seed in the Katherine region (and elsewhere
in Australia)… not to approved
APPENDIX 3
…feel that genetic modification of our food is strongly Ch 5
contributing to the constantly rising rate of cancers
and other serious health issues experienced by Western
Cultures…isolated communities who do not have
access to GM foods, pesticides etc and who have clean
and uncontaminated water live healthy lives well into
their 90‘s and even their 100‘s
…wish for myself, my children, their children etc to Ch 5, Ch 6
live long and healthy lives in a healthy environment Ch 7, Ch 8
which will not be possible if we continue to CBD
contaminate our bodies and our planet with artificial
toxins
...how will GM seed be prevented from contaminating Ch 7
other crops in region…would be an impossibility
…ecosystem of the Northern Territory cannot sustain OSA
an activity such as cotton growing…waterways, native
flora and fauna will be destroyed and then what?
Murray/Darling river systems and surrounding OSA
countryside has been decimated by cotton
growing…we don‘t want a repeat here
11 I …register opposition to the general release of Bollgard Noted
II cotton as set out in the licence application
The recent report (J. App. Ecol. vol. 39)…of Ch 7
cross-breeding of weeds from genetically modified
sugar beet crops underlies the likelihood of
unanticipated and irreversible changes which can
follow such releases
…similar results from Ohio State University relating to Noted
sunflowers support the view that much more
investigation should proceed general release
12 C …express opposition to the possible production of Noted
[GM] cotton in the Katherine/Daly areas
…effects on water quality through land clearing, OSA
chemical runoff and water usage…will impact on both
Katherine and Daly Rivers
…no environmental impact study has been done and Noted, but see
the time frame for the licence to be granted has grave Chapters 5-8
concerns for local and tourists that wish to use these
rivers
13 C …lodge our objections to the Monsanto Noted
application…for commercial release of BT II or
Bollgard II / Roundup Ready cotton
…insufficient research has been completed for Chapters 5-7
conditions associated with agriculture for cotton in
tropical Australia…premature approval of genetically
modified varieties is not the way to overcome the array
of unique idiosyncrasies surrounding the Top End of
Australia
APPENDIX 3
…recognise that tropical savannahs are most OSA
depauperate and least understood landscapes…soils
are severely leached nutrients and require huge input
to achieve even modest gains…this fact alone raises
serious alarm bells for us on ecological grounds
…most of the research with the BT 2 variety has OSA
probably carried out under conditions associated with
the traditional areas in the southern states…aware of
small trial plots in Katherine…however this is not
considered to be adequate in our view in the
understanding of the long term ecological and
economic viability of large scale broad-acre
agribusiness in tropical savannah regions
…insufficient information and understanding is not the Noted
way forward…cost of reparation verses cost of
protection…is estimated to be at least 100:1
…concerned that the trial assessing the economic and OSA
environmental sustainability, being undertaken…is not
completed
researchers…have found that…toxin from BT corn is Ch 5
released into the soil from roots….scientists say more
research is needed to determine whether this exuded
toxin has a good, bad, or neutral effect organisms in
soil…situation where beneficial insects, and all insects
have a place in the environment, are at a possible
threat, because of excessive build up of these toxins
through genetic engineering, then the research and
understanding is not at a level where community
confidence will support continuation or further release
of genetically modified organisms
Broad acre agriculture of any crop does irreparable OSA
damage to the environment…we have grave
reservations about the environmental consequences
from large scale farming as a whole in tropical
savannah areas
…release of BT2 may be the only trigger needed for OSA
wholesale clearing of woodlands and subsequent water
harvesting on a massive scale that will…lead
to…environmental disaster for the rivers in question
[and gives examples]
…what will happen to rivers when demand by OSA
irrigators for water is high and river level is
low…examples of rivers in NSW and central southern
Queensland… we call on you to look at the big picture
in your assessment
APPENDIX 3
…although the press statements and reports regarding Ch 2, Ch 6 &
‗super weeds‘ may be emotive and selective CBD,
quoting…there may be some truth to these Ch 7
reports…the reports are yet to be scientifically
reviewed by peers of the authors…whether the findings
are confirmed or over turned is yet to be determined
however their research or preliminary results should at
least raise the issue and draw the attention to the
possibility of this gene transfer occurring. We must
wait further analysis and research
…view of the Amateur Fishermen‘s Association of the Noted
Northern Territory is one of precaution…must not let
the destruction of rivers occur through water
harvesting, wholesale land clearing and ecological
modification by short term unsustainable agribusiness
14 I …cotton grower… past 15 years…have been growing Noted
GMO cotton crops (Ingard) [since 1996]…found the
crop…extremely beneficial…in terms of profitability,
yield, input costs and sustainability
…during this time [since 1996] …experienced a Noted
reduction in chemical usage…Bollgard II with its
enhanced efficacy on Heliothis will be of even greater
benefit to my farming operations…and… the
environment
…support the release Bollgard II…[it] will minimise Noted
the risk of developing populations of resistant insects,
due to the presence of two, rather than one, insecticide
genes.
15 A …major concern is risk of cotton becoming a weed in Chapter 6-9 &
northern areas of Australia…especially as application CBD
has stated that the risk of gene transfer from GM
cotton to cultivated cotton is high
…outcrossing…would become a more serious problem Ch 7
were the plant become a weed
…taking this into consideration, Monsanto should not Noted
be permitted to use testing sites in northern Australia
for two reasons…
…firstly if there is a risk of the GM cotton becoming a Ch 6 & CBD,
weed during the trial phase one doesn‘t believe the Ch 9
plant should be used in a commercial capacity in this
area and thus there is no reason to undertake trials
here…
…secondly, Monsanto have access to sites in southern Noted
Australia for trials where there is minimal risk of the
plant becoming a weed
16 I …concerns that the size of the release cannot be Ch 6 & CBD
justified because of unaddressed issues such as
‗weediness in Northern Australia‘
APPENDIX 3
…lack of acknowledgment in the application about Ch 5
possible future risks…needs to be a requirement for Ch 6 & CBD
periodic risk assessments to enable identification of Ch 7, Ch 8
unforseen health and environment outcomes
…regulators should insist on the presence of traceable Appendix 1
genetic markers for tracking the transmission of such
release
…the possible transfer to livestock or plants for human Ch 7
consumption is poorly addressed…more limited and
controlled releases needed
…potential long term impacts on natural biodiversity Ch 6 & CBD
are not addressed adequately in the
application…possible setup of ‗seed banks‘ by
commercial release applicants to preserve natural
biodiversities
…weediness of GM cotton in Northern Australia has Ch 6 & CBD
not been addressed in this application…factors such as
‗water availability‘ as stated by the applicant should be
tested in these environments
…commercial releases should be first approved in the Noted
applicant‘s country…Australia should not be a ‗testing
ground‘ for future commercial releases of GM crops
…data for risk assessments completed needs to be Noted
peer-reviewed, weight of evidence material and not
selectively chosen or referenced…use of testing
organisations such as CSIRO by applicants which
would raise credibility and easier licence approvals
17 C …Monsanto have been in some of the world‘s worst Noted
environmental and human catastrophes…no respect
for the safety of humans and the environment
…concerns about human health after exposure to Ch 5
Roundup
…risk of genetic transfer with native relative Ch 7
species…concerns about the ‗Terminator technology‘
with the suicide mechanism which would allow
Monsanto the ability to self destruct great tracts of
plants worldwide
…environmental uncertainty due to insufficient data Noted
available for our tropical woodlands of Northern
Australia
…concerns about insect resistance, particularly from Ch 5
pesticides released through the roots into the
soil…effects of pollen etc on the health of insects such
as bees and butterflies
…lack of clear, unbiased non profit based data to the Noted
community and govts.
APPENDIX 3
…risk that natural varieties will become lost or OSA
replaced of natural diversity, by engineered varieties of
low or zero diversity
18 I …environmental concerns regarding consequences of OSA
farming cotton and the effects it will have in the
Katherine region such as degradation of rivers and
wetlands, rising salinity etc
…uncertainties associated with the issues of Ch 7 & CBD
cross-pollination and pest resistance in Bollgard II
Cotton
…undeniable evidence in other parts of the world that Ch 5
these types of proposals can lead to irreversible Ch 6 & CBD
damage Ch 7, Ch 8
19 I …should be a referendum ‗Does Australia want GM Noted
farming‘…claims serious risks ahead, now and in the
future for no apparent benefit
20 I …any technology or system that can help address the OSA
cost/price squeeze, urbanisation, reducing the number
of chemicals used & pressure from the environmental
sectors in the community would be considered a
desirable benefit
21 I …advantages such as reduced spraying from 16 down OSA
to 2 or 3, less chance of chemical drift onto houses and
neighbourhoods, increased profitability
22 C …concerns about the potential weediness problem as Ch 6 & CBD
there has not been enough research carried out
…risk of contamination [by Bt] during the wet season Ch 5, Ch 7
threatening aquatic life
…believe strong public opinion should also be Noted
considered as well as scientific evidence
23 I …concerns about farms being able to claim GM free OSA
status
…concerns that the GM crop will generate resistance Ch 7
to natural bacteria and that this will transfer to natural
vegetation
…contamination by a herbicide resistant crop will lead Noted
to more extreme herbicides to stop the
spreading…neighbouring fields will not be able to
claim the clean healthy label, leading to a loss of
exports
…health concerns that 450 scientists signed a letter Ch 5
saying the risks of GE foods were acute toxic shock,
delayed immunological reactions, auto-immune
reactions, cancer and the spread of antibiotic resistant
bacteria
…concerns about the trustworthiness of Monsanto Noted
with a bad track record
APPENDIX 3
24 E …highlighted the Regulator‘s concerns about her Noted
inability to conclusively exclude a significant risk to the
environment north of 22 degrees South
…lack of supporting evidence as not all approved Noted
limited and controlled release trials were carried out
…insect resistance would occur sooner rather than Ch 8 & Ch 9
later unless preventative measures were carried out
…overall lack of information for the regulator to Noted
approve this application
25 I …concerns regarding soil micro organisms Ch 5, Ch 7,
Appendix 1
…claims of contradictions in the RARMP Noted
26 I …will see a decrease of reliance on the conventional Noted
methods of insect control…no downside to this
technology
27 I …reduce insecticide use; reduce contamination of Noted
towns, river etc; allow areas previously unable to grow
cotton to be able to grow it; increase productivity; and
allow for a more competitive industry
28 I …reduction of insecticides allowing it to be planted in Noted
environmentaly sensitive areas
29 E …claims there is insufficient evidence to conclusively Ch 5
show that there is any risk to human health and the
environment…some information provided by
Monsanto has been biased and not available to the
public
…only small areas of trials in Northern Australia Noted
providing limited results
…no commercial releases worldwide for Bollard II OSA
have been approved and inference that it is ‗safe‘
because no application for commercial release has been
refused is misleading
…no long-term work has been done on the long-term Ch 6 & CBD
impacts on native species Ch 7
[quoted the Regulator]… that ‗based on available Noted
evidence it has not been possible to determine
conclusively that the proposed release would not pose
an environmental risk‘
…concerns regarding the implications of extending the Noted, but see
area of application from 22 degrees to 20 degrees Ch 2, Ch 6 &
Ch 9
…inadequate buffer zones and concerns regarding Ch 6 & CBD
contamination, particularly due to the wet season Ch 7
…insect resistance would occur sooner rather than Ch 9
later, particularly insects in the soil as a result of
continued exposure
APPENDIX 3
…the applicant should be required to collect data, Ch 9 &
prior to the commercial release as this information is Appendix 1
crucial to assessing the risks…data should be collected
on potential for weediness and non-target species and
should also include marsupial, mammals, fish etc
30 E …concerns regarding the extension of the area to 20 Ch 1, Ch 6
degrees south
…protection from the natural predator will increase Ch 6 & CBD
weediness and survival rate in wild conditions
…against the use of unpublished data and considers Noted
data that isn‘t open to peer review or public scrutiny as
suspect
…Gene Technology Act 2000 is fundamentally flawed Noted
…dispersal and spread of seeds by natural processes, Ch 6 & CBD
particularly waterways Ch 7
…status of QLD in relation to the release of GMOs Noted
31 C …opposes the release prior to the conclusion of the Noted
research program currently underway in Katherine by
the NT Govt., CSIRO and the Australian Cotton
CRC…expansion of trials to incorporate issues such as
weediness, effects of hybridisation on natives &
impacts on the environment and human health
…overuse of herbicides such as glyphosate and effects Ch 5
on ground water, soil and watercourses
…concern about the lack of publicly available Noted
information
…lack of field trials on potential weediness of cotton in Ch 6 & CBD
Northern Australia …further trials relating to
invasiveness much also be conducted
…concern about the potential to hybridise with native Ch 7
Gossypium species which may create another weed
species or loss of biodiversity
…inadequate buffer zones, particularly for the high CBD
rainfall north
32 E …potential creation of ‗superweeds‘ in the NT Ch 6 & CBD
…significant increased levels of Roundup into the Ch 2, Ch 5,
environment Ch 6 & CBD
…potential negative impacts on people, native insects, Ch 6 & CBD
flora and fauna Ch 5, Ch 7
…no identification of specific NT locations, nor the size Ch 9, Appendix 1
of the proposed GM crops
…water issues: allocation, monitoring and lack of flood OSA
mitigation
…lack of public consultation Noted
33 A …enhancing sustainability of small rural areas that Noted
rely on the cotton industry to provide employment
APPENDIX 3
…reduction in chemical usage…thus a reduction in Noted
production costs without affecting employment
34 I [NB: this is an independent submission, despite its OSA
similarity to that of similar submissions including, for
example, submission no. 33]
enhancing sustainability of small rural areas that rely
on the cotton industry to provide employment
…reduction in chemical usage…thus a reduction in Noted
production costs without affecting employment
35 C …effects of water quality through land clearing, OSA
chemical runoff and high levels of water usage will
impact both Katherine and Daly Rivers
…no environmental impact study has been OSA
done…grave concerns for locals and tourists who wish
to use these rivers
36 A …supports on-going commitment to the development Noted
of appropriate resistance management plans
…supports management plans tailored for local areas Noted
…assumed difference of generations of insect pests Ch 9
does not appear to take into account the proposed
winter cropping for cotton, which would mean the
number of generations exposed would be similar to
that in the southern regions...therefore on its own does
not justify a different resistance management plan
37 A …cotton CRC is committed to R&D…ensures the Noted
ongoing sustainability of Australian cotton
industry…other than this we have no vested interested
in the proposal
…cotton CRC is supportive of the approval for Noted
commercial use of Bollard II cotton particularly in
existing cotton areas
…Bollard II varieties hove demonstrated higher Noted
efficacy than INGARD and so offer sound prospects
for further reductions in pesticide applications
…with two independent insecticidal proteins…greatly Noted
reduce the risk of Bt resistance evolving in key target
pests…maximise environmental benefits
…INGARD cottons…important part of Integrated Pest Noted
Management (IPM) systems being widely adopted in
cotton industry…data shows higher abundance of
beneficial insects in INGARD cotton...these play a key
role in IPM…Bollard II will… be compatible with IPM
systems
…we accept that all human health and environmental Noted
risks have been addressed in the RARMP…note that
no impediments for commercial release in southern
production regions are identified.
APPENDIX 3
…regard to…areas north of 22º South…no particular Noted
position on commercial release…accept that only
…Ord river region of WA could contemplate a
commercial cotton industry in near future…Cotton
CRC policy no commercial production could be
contemplated with anything less than Bollard II or
equivalent two gene types
…Northern Australia…further information may be Ch 6, CBD &
required on potential weediness of GM Appendix 1
cotton…although…risk of weediness is…likely to be
low
…see less urgency in a commercial approval for Noted
Northern Australia
…provided on specific comment on certain clauses in Noted
the RARMP where there appear to be technical errors
or misunderstandings or where the basis for a clause is
unclear
38 A supported OGTR‘s recommendations provided that Noted
there are no substantive additional risks to public
health and safety, or to the environment…the release of
Bollard II cotton without specific management
conditions be permitted below latitude 20 degrees south
39 C …signed by 22 people from the Mildura region Noted
(Victoria) against the Commercial release
…reasons include a release would violate the Ch 5
precautionary principle, violate the principle of Ch 6 & CBD
inter-generational equity, scientific uncertainty, lack of Ch 7
independent reliable public research data to verify
claims by Monsanto, enhancement of Bt resistance in
the insect population and possible spread of resistance
to closely related species, become a troublesome weed,
human health relating to bacterial antibiotic resistance
& lack of research into redesigning agricultural
methods so that genetically modified crops are not
needed
40 C …signed by 23 people from the Katherine region Noted
against the Commercial Release…same as the
Katherine Town Council‘s letter
…GMO trials are far from complete and suitability of Noted
the GM cotton is inconclusive to viability and
environmental sustainability
…the weediness potential has not been established Ch 6, CBD & Ch
inconclusively 9
…no evidence that the introduction will have no impact Ch 6
on the resistance to Roundup
…no evidence that the gene traits of species will not Ch 7
spread to other non-target insects or plant species
APPENDIX 3
…only research being trialed is based on agronomic OSA
aspects, not on the human health and environmental
sustainability aspects
…research on the effect of this industry on water OSA
quality and tropical riverine environments has not
taken place
…potential hazards of the GMO in the tropical north Ch 9
have not been fully addressed
41 C …signed by 80 people from the Katherine region Noted
against the Commercial Release
…aerial spraying of chemicals poses a risk to OSA
neighbouring flora, non-GM species and commercial
interests such as the cattle industry
…no research in the public domain to show that GM Ch 6 & CBD
cotton poses no risk through weediness in northern
Australia
…trials are focussing on agronomic aspects, not Ch 5
researching the potential impact to human health and Ch 6 & CBD
the environmental issues…specifically for this region Ch 7, Ch 8
…Public Health Association of Australia has raised Ch 5
serious concerns about the effects of GMO‘s in humans
and questions research on the lacking of longitudinal
studies and long term survey of patient dietary habits
42 C [NB: this is an independent submission, despite its Noted
similarity to that of similar submissions including, for
example, submission no. 41]
signed by 81 people from the Katherine region against
the Commercial Release
…aerial spraying of chemicals poses a risk to OSA
neighbouring flora, non-GM species and commercial
interests such as the cattle industry
…no research in the public domain to show that GM Ch 6 & CBD
cotton poses no risk through weediness in northern
Australia
…trials are focussing on agronomic aspects, not Ch 5
researching the potential impact to human health and Ch 6 & CBD
the environmental issues…specifically for this region Ch 7, Ch 8
…Public Health Association of Australia has raised Ch 5
serious concerns about the effects of GMO‘s in humans
and questions research on the lacking of longitudinal
studies and long term survey of patient dietary habits
43 A …industry will be mindful of the social, economic and Noted
environmental management demands of the
marketplace and will have to work to have appropriate
responses / partnerships implemented to respond to
such demands…as long as it complies with legislation
and is fully researched
APPENDIX 3
…supports the need to actively seek both internal and Noted
external stakeholder advice on how to use
biotechnology effectively
…supports the need to consult with both internal and Noted
external stakeholders about research and ensure that
the information is made available to the public in a
balanced way regarding food, seed and fibre products
…supports the need to collaborate with members of the Noted
wider agricultural community, local communities, end
users and environmental group stakeholders, develop a
set of measures to assess the effectiveness of the
application throughout the industry…preventing cross
contamination of other types of cotton, weed and insect
resistance, yield losses, increase in overall pesticide
usage, loss of crop or product quality etc.
…supports the idea of promoting the adoption of a Noted
wider IPM system throughout the industry and the use
of this GMO…if it can be demonstrated not to have
negative effects
…supports the work of our research bodies ensuring Noted
that the environmental and resistance issues are
carefully addressed and are confident of the result
presented
…recognises the industry‘s commitment to proactive Noted
management of resistance and the importance it places
on compliance with resistance management strategies
required by the OGTR and NRA
…supports the use of biotechnology where the benefits Noted
to growers, environment, human health and the end
user are significant
…believes that members of the cotton industry should Noted
have the right to choose from a range of technologies
and production management systems that will
contribute to enhanced sustainability and lead to the
minimisation of environmental impact
44 C …concerns regarding food…and the lack of Ch 5
information in the RARMP that actually deals with
public health and safety
…claims Bt can cause allergy and there is no testing Ch 5
offered to show this is not the case with this
crop…other health matters such as carcinogenicity are
never addressed
…concerns of losing some of Northern Australia‘s Ch 5
insect species (ie Butterflies) due to glyphosate‘s
affinity for these insects
APPENDIX 3
…concerns regarding the link between Acrylamide and Ch 5
Glyphosate (a separate paper was attached)…and the
lack of investigation into a possible public health and
safety link by OGTR, NRA & FSANZ
…raised the issue of weediness and gene transfer…and Ch 6 & CBD
should these genes transfer to other plants, the Ch 7
consequences or demise of beneficial or non-pest
insects
…refers to a British Royal Society report (Sept 1998) Ch 5
on the call for ending the use of antibiotic resistance
marker genes in engineered food products…and that it
is a completely unacceptable risk, however slight, to
human health
…herbicide tolerance gene transfers…the muddying of Ch 5
the gene pool cannot be good for either biodiversity or Ch 6 & CBD
the environment Ch 7
…horizontal gene transfer has not been given enough Ch 7
consideration and is too lightly dismissed
…due to the fact that genetically altered DNA has been Ch 5, Ch 7
found to able to transfer to the gut of other species,
council is of the opinion material from this trial should
not be used for either human or animal food
…the call for all intentional commercial releases be Ch 9
monitored at least twice annually
45 I …express our support and approval for the release of Noted
Bollard II for this planting season
…growing INGARD cotton for five years… enormous Noted
reduction in use of pesticides…80%…trial data
suggests Bollard II…even more efficacious
…has benefits in area of workplace health and safety Noted
and the environment
…increased profitability and enhance sustainability Noted
46 C [NB: this is an independent submission, despite its Noted
similarity to that of similar submissions including, for
example, submission no. 41]
…signed by 82 people from the Katherine region
against the Commercial Release
…aerial spraying of chemicals poses a risk to OSA
neighbouring flora, non-GM species and commercial
interests such as the cattle industry
…no research in the public domain to show that GM Ch 6 & CBD
cotton poses no risk through weediness in northern
Australia
…trials are focussing on agronomic aspects, not Ch 5
researching the potential impact to human health and Ch 6 & CBD
the environmental issues…specifically for this region Ch 7, Ch 8
APPENDIX 3
…Public Health Association of Australia has raised Ch 5
serious concerns about the effects of GMO‘s in humans
and questions research on the lacking of longitudinal
studies and long term survey of patient dietary habits
47 C …supports the submission made by …National Council Noted
of Women [submission number 44]
48 I …concern that there is still potential for adverse Ch 5
impact on humans due to potential
toxicity/allergenicity…even if potential is very low,
there is still a likelihood of occurrence
…have studies been carried out over generations and Noted
across broad sections of all communities or has
company research been only recent….less than one
generation
…even if potential for weediness is low in Roundup Ch 2, Ch 6 &
species [cotton]…a risk still exists, making it CBD
potentially unsafe to the environment
...if risk of gene transfer is high…potential for harm Ch 7
to environment since this is a trial and long term
effects are unknown
…if there is even a low risk of Bollard II…becoming a Ch 6, CBD, Ch 9
weed in northern Australia…should not be released in & Appendix 1
this area…commercially or trialed due to
environment risk…would be a huge community
problem of containing and ‗weediness‘ and gene
transfer especially where licence conditions to limit
spread are not carried out stringently.
…what will happen if herbicide tolerance is Ch 2, Ch 6 &
transferred to already noxious weeds or plants which CBD & Ch 9
have potential to become weeds?
……how do we foresee that insecticide resistance Ch 8
management strategies will not be breached by
unscrupulous persons or companies
…larger danger to environment due to potential for Ch 2, Ch 6 &
herbicide resistant weeds developing where crop CBD & Ch 9
herbicide combination is used inappropriately.
…whole point of ‗Roundup ready cotton‘…spray more Ch 5
heavily with herbicide…poses potential health risks to Ch 6 & CBD
humans and to environment if overspraying occurs Ch 7, Ch 8
[Leading to] ...increased levels of herbicide in the plant Ch 2 & Ch 5
will be transferred to the food chain with increased
human consumption of herbicide
[Leading to] ...more herbicide washed into the Ch 2 & Ch 5
environment – do we know the long term effects of this
chemical over 50 years or more
…glyphosate…is not used for control of cotton plants OSA
in agriculture or the natural environment…why do we
need Roundup ready cotton at all?
APPENDIX 3
…[jeopardise] huge potential billion dollar export OSA
market for GE free produce
APPENDIX 3