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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 015/2002
Title: Agronomic assessments and seed increase of
transgenic cotton expressing tolerance to the herbicide
glufosinate ammonium
Applicant: CSIRO
October 2002
Abbreviations
aad aminoglycoside adenylyltransferase
ANZFA Australia New Zealand Food Authority (now FSANZ)
AQIS Australian Quarantine Inspection Service
bar bialaphos or phosphinothricin resistance gene
Bt Bacillus thuringiensis
B.t.k Bacillus thuringiensis variety kurstaki
CaMV cauliflower 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
FAO Food and Agriculture Organisation of the United Nations
FSANZ Food Standards Australia New Zealand (formerly ANZFA)
g gram
GM genetically modified
GMAC Genetic Manipulation Advisory Committee
GMO genetically modified organism
GTTAC Gene Technology Technical Advisory Committee
ha hectare
IgE immunoglobulin E
IgG immunoglobulin G
IOGTR Interim Office of the Gene Technology Regulator
IPCS International Program on Chemical Safety
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
OECD Organisation for Economic Cooperation and Development
OGTR Office of the Gene Technology Regulator
PAT Phosphinothricin acetyl transferase
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
μg/g micrograms per gram
TABLE 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 ............................................................................................................ 2
SECTION 4 THE STRUCTURE OF THIS DOCUMENT ............................................................................................. 2
CHAPTER 1 INTRODUCTION .................................................................................................................... 5
SECTION 1 THE LICENCE APPLICATION ............................................................................................................ 5
SECTION 2 SUBMISSIONS ON THE APPLICATION AND RISK ASSESSMENT AND RISK MANAGEMENT PLAN .......... 6
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMO AND PREVIOUS RELEASES 7
SECTION 1 THE APPLICATION COMPLIED WITH LEGISLATIVE REQUIREMENTS .................................................. 7
SECTION 2 ABOUT THE ORGANISM TO BE RELEASED........................................................................................ 7
SECTION 3 PREVIOUS LIMITED RELEASES OF THIS GMO IN AUSTRALIA .......................................................... 8
SECTION 4 APPROVALS FOR LIBERTY® COTTON IN OTHER COUNTRIES ............................................................ 8
SECTION 5 INTERFACE WITH OTHER REGULATORS AND GOVERNMENT BODIES ................................................ 8
Section 5.1 National Registration Authority for Agricultural and Veterinary Chemicals (NRA) ............ 9
Section 5.2 Food Standards Australia New Zealand (FSANZ) ................................................................ 9
CHAPTER 3 INFORMATION ABOUT THE GMO ................................................................................. 11
SECTION 1 SUMMARY INFORMATION ABOUT THE GMO ................................................................................ 11
SECTION 2 THE PARENT ORGANISM ............................................................................................................... 11
SECTION 3 THE BAR GENE .............................................................................................................................. 11
SECTION 4 METHOD OF GENE TRANSFER ....................................................................................................... 12
SECTION 5 CHARACTERISATION OF THE INSERTED GENETIC MATERIAL AND STABILITY OF THE GENETIC
MODIFICATION ............................................................................................................................. 12
SECTION 6 EXPRESSION OF PHOSPHINOTHRICIN ACETYL TRANSFERASE (PAT) PROTEIN ............................... 13
CHAPTER 4 RISK ASSESSMENT ............................................................................................................. 15
SECTION 1 THE RISK ANALYSIS FRAMEWORK .............................................................................................. 15
SECTION 2 THE RISK ASSESSMENT PROCESS ................................................................................................. 15
SECTION 3 SUMMARY OF RISK ASSESSMENT CONCLUSIONS ........................................................................... 16
Section 3.1 Hazard identification........................................................................................................... 16
Section 3.2 Risk assessment conclusions ............................................................................................... 17
Section 3.3 Identification of issues to be addressed for future releases ................................................. 17
SECTION 4 DECISION TO ISSUE THE LICENCE................................................................................................. 18
CHAPTER 5 TOXICITY OR ALLERGENICITY .................................................................................... 19
CHAPTER 6 WEEDINESS .......................................................................................................................... 23
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS ............................ 25
SECTION 1 TRANSFER OF GENES TO OTHER PLANTS ....................................................................................... 25
SECTION 2 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS (MICROORGANISMS AND ANIMALS) ... 27
CHAPTER 8 RISK MANAGEMENT PLAN ............................................................................................. 29
SECTION 1 SUMMARY OF RISK ASSESSMENT CONCLUSIONS ........................................................................... 29
SECTION 2 RISK MANAGEMENT PLAN ............................................................................................................ 29
Section 2.1 Risk of toxicity or allergenicity ........................................................................................... 29
Section 2.3 Risks of weediness or gene transfer .................................................................................... 29
Section 2.4 General licence conditions .................................................................................................. 30
Section 2.5 Monitoring and enforcement of compliance by the OGTR .................................................. 30
SECTION 3 SPECIFIC RISK MANAGEMENT LICENCE CONDITIONS .................................................................... 31
CHAPTER 9 CONSIDERATION OF ISSUES RAISED IN PUBLIC SUBMISSIONS ......................... 33
REFERENCES .................................................................................................................................................. 35
APPENDIX 1 SPECIFIC LICENCE CONDITIONS .................................................................................. 37
APPENDIX 2 REASONS FOR SPECIFIC LICENCE CONDITIONS..................................................... 49
APPENDIX 3 PUBLIC SUBMISSION SUMMARY ................................................................................... 55
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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 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 summarised below.
SECTION 2 THE INITIAL CONSULTATION PROCESSES
5. In accordance with Section 50 of the Act, the Regulator sought advice on the
application to assist in preparing a risk assessment and risk management plan, from:
the State and Territory Governments;
the Gene Technology Technical Advisory Committee (GTTAC);
prescribed Commonwealth agencies (Regulation 9 of the Gene Technology
Regulations 2001 (Regulations) refers);
the Environment Minister; and
relevant local council(s) where the release is proposed.
6. 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 Chapter 1, Section 2).
7. All expert group 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.
8. The Regulator has taken into account all issues raised, relating to the protection of
human health and safety and the environment, in written submissions on the risk assessment
and risk management plan in finalising the plan (see chapter 9) and in making a decision to
issue a licence for the proposed release, as required under section 56 of the Act.
PREFACE 1
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
SECTION 3 THE EVALUATION PROCESS
9. An assessment of the potential hazards and likely risks associated with the proposed
release was carried out in accordance with the Act, using a Risk Analysis Framework
developed by the Regulator (see Chapter 4). A risk assessment and risk management plan,
including proposed licence conditions, was then prepared to address these risks.
10. 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 submission from the public and advice from the
Environment Minister, State and Territory Governments, GTTAC, and Commonwealth
agencies (see Regulation 9 of the Regulations 2001) and local Councils where the release is
proposed were considered and assessed by the Regulator.
11. 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.
12. 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.
13. 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
Government, 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.
14. Further details of the application can be found in Chapter 3 of this document. Please
note that while copies are available from the OGTR, the application is not available
electronically. In the future, the OGTR hopes that electronic submission of the applications
will be possible, enhancing the accessibility of such information for interested people in the
community.
SECTION 4 THE STRUCTURE OF THIS DOCUMENT
15. 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.
16. 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.
PREFACE 2
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
17. 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 of the licence application and 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 provide
background information relating to previous intentional releases of the GMOs and
other related GMOs. Chapter 2 refers.
provides detailed information about the parent organism, the GMO 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.
details the risk assessment on the hazards of toxicity and allergenicity of the
GMO. Chapter 5 refers.
details the risk assessment on the hazard of weediness of the GMO. Chapter 6
refers.
details the risk assessment on the hazard of transfer of introduced genes to other
organisms. Chapter 7 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 which could be
included in the licence to give effect to the risk management plan are also
provided. Chapter 8 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 9 and Appendix 3
refer.
18. 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 3
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
CHAPTER 1 INTRODUCTION
19. The Gene Technology Act 2000 (the Act) and the Gene Technology Regulations 2001
(the Regulations) set out requirements which the Gene Technology Regulations 2001 (the
Regulations) 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 Gene Technology Regulator (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
20. The risk assessment and risk management plan has been prepared in response to the
licence application from the Commonwealth Scientific and Industrial Research Organisation
(CSIRO) for the intentional release of genetically modified (GM) cotton into the environment
(DIR 015/2002).
21. CSIRO has applied for a licence for the limited and controlled release of GM
herbicide-tolerant cotton, registered under the trade name Liberty® cotton. The release is
proposed to be undertaken on one site in New South Wales, covering a total area of 2
hectares in the 2002 – 2003 season.
22. 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.
23. The cotton plants have been genetically modified to be tolerant to the herbicide
glufosinate ammonium. They contain a single copy of the bar gene derived from a soil
bacterium Streptomyces hygroscopicus, which encodes the phosphinothricin acetyl
transferase (PAT) enzyme. The PAT enzyme detoxifies glufosinate ammonium (also known
as phosphinothricin), the active constituent in Basta®, Liberty® and a number of other
herbicides (hence the name Liberty® cotton).
24. The purpose of the proposed release is to continue small-scale evaluation of agronomic
performance, under Australian environmental conditions, of cotton obtained by crossing
Liberty® cotton with elite varieties, and continue breeding work to produce commercially
useful cultivars. In addition, CSIRO is proposing to produce seed from selected lines for
possible future releases, which would be subject to separate application and assessment
processes.
25. There have been several previous limited and controlled releases of Liberty® cotton in
Australia under the former voluntary system that was overseen by the Genetic Manipulation
Advisory Committee (GMAC). These releases were also carried out in New South Wales.
26. None of the cotton plants produced in the trial, or their by-products, will be used in
animal feed or human food. However, it is proposed to sell lint from the release. Cotton
lint does not contain any protein or DNA.
CHAPTER 1 INTRODUCTION 5
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
27. More detailed information about the GMO, the parent organism, 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
28. 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.
29. Submissions were received from prescribed agencies, other government bodies and the
public on the application and the risk assessment and risk management plan received in
response to the consultations. 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 and allergenicity of the GM cotton,
for humans and other organisms. These issues are addressed in ‘The Biology
and Ecology of Cotton (Gossypium hirsutum) in Australia’ (OGTR 2002;
available on OGTR website) and Chapter 5;
whether the GMO may pose a risk as a weed in the environment 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; and
whether the introduced genes or regulatory sequences could transfer to other
plants (particularly feral and native Gossypium species) and other organisms, and
the subsequent impact 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.
30. Submissions from the public are discussed in more detail in Chapter 9 and Appendix 3.
CHAPTER 1 INTRODUCTION 6
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMO
AND PREVIOUS RELEASES
31. This part of the document provides information about the licence application, and
summary information about the GMO, including information about previous releases into the
environment of relevant GMOs.
SECTION 1 THE APPLICATION COMPLIED WITH LEGISLATIVE REQUIREMENTS
32. 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.
33. 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 (noting that material from this release will not be permitted to be
used for human consumption or as animal feed); and
supporting information from the Institutional Biosafety Committee.
34. A copy of the application is available on request from the OGTR.
SECTION 2 ABOUT THE ORGANISM TO BE RELEASED
35. The organism to be released is Liberty® cotton. It has been genetically modified to be
tolerant to the herbicide glufosinate ammonium.
36. Liberty® cotton contains the bar gene, from the soil bacterium
Streptomyces hygroscopicus. The bar gene encodes the enzyme phosphinothricin acetyl
transferase (PAT) that detoxifies glufosinate ammonium (also known as phosphinothricin),
the active constituent in Basta®, Liberty® and a number of other herbicides. It is expected
that use of Liberty® cotton plants will allow more effective weed control by allowing the crop
to be sprayed with glufosinate ammonium to kill problem weeds without damaging the crop
itself.
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 7
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
37. 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 THIS GMO IN AUSTRALIA
38. Five limited and controlled releases (field trials) of Liberty® cotton have been carried
out to assess the agronomic performance of the GM cotton and its behaviour in the Australian
environment. The releases were assessed under the former voluntary system that was
overseen by the Genetic Manipulation Advisory Committee (GMAC). They were PR-82,
PR-82X, PR-124, PR-124X and PR-124X(2).
39. All previous releases were assessed and conducted under GMAC’s oversight and in
accordance with GMAC guidelines. Each proposed release was notified in the Gazette, on
the GMAC or IOGTR website, and by direct mail to the GMAC or IOGTR mailing list, to
enable public comment for consideration in the assessment process. Relevant local
government councils were also advised directly. Reports were provided to the GMAC or the
OGTR at the conclusion of each release.
40. Each of these releases was carried out under controlled conditions to limit the spread
and persistence of the GMO in the environment, and minimise potential risks posed by the
GM cotton.
41. The releases were conducted in NSW and ranged in size from less than 0.04 to
1.4 hectares.
42. Factors assessed in the previous releases included the agronomic performance of the
cotton, residue studies on plants sprayed with commercial formulations of Basta®, integrated
weed management studies and evaluation of how this herbicide and herbicide-tolerant cotton
would fit into the cotton production system in Australia. The residue studies are required by
the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) before
herbicides can be applied to herbicide-tolerant crops, including GM herbicide tolerant cotton.
SECTION 4 APPROVALS FOR LIBERTY® COTTON IN OTHER COUNTRIES
43. Liberty® cotton has not yet been released commercially any country. However,
glufosinate ammonium-tolerant cotton, including Liberty® cotton, has been trialled in the
United States since 1997. No adverse effects have been reported from 30 field trials of
glufosinate ammonium-tolerant cotton.
44. Other GM plants, such as corn, canola and soybeans, containing the bar herbicide
tolerance gene present in Liberty® cotton, have been released commercially in the United
States.
SECTION 5 INTERFACE WITH OTHER REGULATORS AND GOVERNMENT BODIES
45. 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 Food Standards Australia New
Zealand (FSANZ).
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMOS AND PREVIOUS RELEASES 8
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
Section 5.1 National Registration Authority for Agricultural and Veterinary Chemicals
(NRA)
46. The NRA undertakes safety assessments of agricultural and veterinary chemicals,
including herbicides and pesticides. The applicant will require a permit from the NRA for
the use of glufosinate ammonium on the GM cotton in this trial. Any future application
proposing the commercial release of Liberty® cotton would require full registration from the
NRA for the new use pattern of glufosinate ammonium. Registration would be conditional
on the provision of data to enable the NRA’s evaluation and assessment process including
information on the efficacy and maximum residue limits of the herbicide on the GMO.
47. The NRA is responsible for imposing conditions where necessary to prevent the
emergence of herbicide resistance. Therefore, the OGTR has not imposed licence conditions
in relation to herbicide resistance management.
48. Further information about the management of herbicide resistance and on the use and
safety of herbicides is available from the NRA:
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 5.2 Food Standards Australia New Zealand (FSANZ)
49. The safety and labelling of foods derived from genetically modified plants are the
responsibility of FSANZ (formerly ANZFA).
50. None of the cotton plants from the proposed release, or any of their by-products, will be
used in human food, so no approval is required from FSANZ. Any use of this GM cotton or
its by-products in human food would necessitate an application to FSANZ and would include
the provision of detailed data on the toxicity and allergenicity of Liberty® cotton and its
by-products.
51. Further details of this risk analysis and information about food labelling are available
from FSANZ:
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 9
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
CHAPTER 3 INFORMATION ABOUT THE GMO
52. 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.
53. This part of the document addresses these matters and provides detailed information
about the GMOs proposed 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.
54. Further information and analysis of the properties of the parent organism are contained
in the reference document that was prepared by the OGTR entitled, ‘Biology and Ecology of
Cotton (Gossypium hirsutum) in Australia’ (OGTR 2002). This is available at the OGTR
website (www.ogtr.gov.au).
SECTION 1 SUMMARY INFORMATION ABOUT THE GMO
55. Liberty® cotton contains the bar gene, derived from the common soil bacterium
Streptomyces hygroscopicus (Thompson et al. 1987). The bar gene encodes the
phosphinothricin acetyl transferase (PAT) protein which detoxifies glufosinate ammonium
(also known as phosphinothricin), the active constituent in Basta®, Liberty® and a number of
other herbicides. It is expected that use of Liberty® cotton plants will allow more effective
weed control in cotton crops by allowing the crop to be sprayed with glufosinate ammonium
to kill problem weeds without damaging the crop itself.
SECTION 2 THE PARENT ORGANISM
56. 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-line at the OGTR website
(www.ogtr.gov.au).
SECTION 3 THE BAR GENE
57. Expression of the bar gene in Liberty® cotton is driven by the 35S promoter from
cauliflower mosaic virus (CaMV) (Odell et al. 1985; De Block et al. 1987). A promoter is a
piece of DNA that determines whether or 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 this is provided by the 3’ non-translated region of the nopaline
synthase (NOS) gene of Agrobacterium tumefaciens (Depicker et al. 1982).
58. Liberty® cotton plants do not contain antibiotic resistance marker genes. The bar gene
confers tolerance to the herbicide both in culture (during the initial stage of selection of
genetically modified plants in the laboratory) and when applied to whole plants, and therefore
no other selectable marker was required.
CHAPTER 3 INFORMATION ABOUT THE GMOS AND THE PARENT ORGANISM 11
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
59. More information on the bar gene, including the properties and the mode of action of
the protein (PAT) encoded by the gene, can be found in the risk assessment and risk
management plan for a limited and controlled release of GM glufosinate ammonium -tolerant
canola (DIR 010/2002, available on the OGTR website).
60. Expression of the PAT protein in Liberty® cotton is discussed in Section 6 of this
Chapter and Chapter 5.
SECTION 4 METHOD OF GENE TRANSFER
61. The parental line for Liberty® cotton is Gossypium hirsutum L., cultivar Coker 312.
The Coker 312 cultivar was used because of its positive response to the tissue culture system
used to produce transgenic plants, but is now grown commercially on a very limited basis, if
at all.
62. The bar gene was inserted into the genomic DNA of the Coker 312 cotton variety by
Agrobacterium-mediated transformation, to generate Liberty® cotton (LL 25 event).
63. 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) 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:
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).
64. 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 CHARACTERISATION OF THE INSERTED GENETIC MATERIAL AND
STABILITY OF THE GENETIC MODIFICATION
65. Southern blot analysis was used to demonstrate that one T-DNA copy inserted into the
genome of Liberty® cotton at a single insertion site. Segregation data support the presence
of the bar gene at a single locus. The inserted DNA in the Liberty® cotton (LL25) is
identical to that in the construct that was used to generate Liberty® cotton. This data was
supplied by Aventis CropScience Pty Ltd (Aventis). Segregation data from the CSIRO plant
breeding program indicates that the DNA insert is stable. The bar gene has been maintained
as a single dominant Mendelian trait over a number of generations of crossing and
back-crossing since introduction of the GM cotton to Australia in 1997. The applicant has
CHAPTER 3 INFORMATION ABOUT THE GMOS AND THE PARENT ORGANISM 12
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
indicated that more detailed molecular characterisation would be carried out if the cotton
demonstrates commercial potential.
SECTION 6 EXPRESSION OF PHOSPHINOTHRICIN ACETYL TRANSFERASE (PAT)
PROTEIN
66. The expression of the PAT protein from the bar gene was demonstrated through the
tolerance of Liberty® cotton plants to glufosinate ammonium. Because it is under the control
of the CaMV promoter, the PAT protein is expected to be expressed at highest levels in the
leaves and seeds of Liberty® cotton plants, but only at negligible levels in the pollen and
nectar. Preliminary analysis indicates that PAT protein represents about 1% of the total
extractable protein in Liberty® cotton leaves.
67. The applicant has indicated that more detailed data would be obtained for a future
licence application if the agronomic performance evaluations indicate that a commercial
release may be warranted.
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CHAPTER 4 RISK ASSESSMENT
68. This part of the document discusses the risk assessment framework (Section 1),
explains the risk assessment process (Section 2) and outlines the potential hazards that have
been considered, the conclusions of the risk assessment (Section 3) and the decision to issue
the licence (Section 4). Chapters 5, 6 and 7 provide a detailed analysis of the risks posed by
each of the hazards identified in the risk assessment process.
SECTION 1 THE RISK ANALYSIS FRAMEWORK
69. The risk assessment was carried out in accordance with the Gene Technology Act 2000
(the Act) and Gene Technology Regulations 2001, using the Risk Analysis Framework (the
Framework) developed by the Regulator (available on the OGTR website). It also takes into
account the guidelines and risk assessment strategies used by related agencies both in
Australia and overseas. The Framework was developed in consultation with the States and
Territories, Commonwealth government agencies, GTTAC and the public. Its purpose is to
provide general guidance to applicants and evaluators and other stakeholders in identifying
and assessing the risks posed by GMOs and in determining the measures necessary to manage
any such risks.
SECTION 2 THE RISK ASSESSMENT PROCESS
70. In undertaking the risk assessment, the following were considered and analysed:
the data presented in the proponent’s application;
data provided previously to GMAC or the interim OGTR in respect of previous
applications for limited and controlled release of Liberty® cotton;
submissions or advice from States and Territories, Commonwealth agencies and
the Environment Minister;
advice from GTTAC;
information from other national and international regulatory agencies; and
current scientific knowledge and the scientific literature.
71. In considering this information and preparing the risk assessment and risk management
plan, the following specific matters were taken into account, as required by section 51 of the
Act and set out in section 49:
the risks posed to human health and safety or risks to the environment;
the properties of the organism to which the dealings relate before it became, or
will become, a GMO (see Chapter 3, Section 1; and (OGTR 2002);
the effect, or the expected effect, of genetic modification that has occurred, or
will occur, on the properties of the organism (see Chapter 3, Sections 3 and 6);
provisions for limiting the dissemination or persistence of the GMO or its genetic
material in the environment (see Chapter 8);
the potential for spread or persistence of the GMO or its genetic material in the
environment (see Chapters 6 and 7);
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the extent or scale of the proposed dealings (see Chapters 1 and 8);
any likely impacts of the proposed dealings on the health and safety of people
(see Chapters 5 and 7).
72. In accordance with Regulation 10 of the Regulations, the following were also taken into
account:
any previous assessment, in Australia or overseas, in relation to allowing or
approving dealings with the GMO (see Chapter 2, Sections 4-6);
the potential of the GMO concerned to:
be harmful to other organisms (see Chapter 5);
adversely affect any ecosystems (see Chapters 6 and 7);
transfer genetic material to another organism (see Chapter 7);
spread, or persist, in the environment (see Chapter 6);
have, in comparison to related organisms, a selective advantage in the
environment (see Chapter 6); and
be toxic, allergenic or pathogenic to other organisms (see Chapter 5).
73. As required by Regulation 10, the Regulator also considered the short and long term
when taking these factors into account.
74. Through the risk assessment process, a number of potential hazards were identified.
The risks posed by these hazards were evaluated by considering:
the likelihood of the hazard occurring;
the likely consequences if the hazard were to be realised; and
the availability of mechanisms for effectively managing identified risks.
75. Each potential hazard identified in Section 3.1 of this Chapter is addressed in detail in
Chapters 5 to 7. In each of these Chapters:
Part A explains the nature of each potential hazard and any adverse impacts these
might cause.
Part B examines the likelihood of the potential hazard occurring; and
Part C draws conclusions about the risks and their possible impacts.
SECTION 3 SUMMARY OF RISK ASSESSMENT CONCLUSIONS
Section 3.1 Hazard identification
76. This part of the risk analysis presents a summary of the possible hazards that were
identified and assessed, and the conclusions that were drawn.
77. A number of possible hazards arising from the genetic modification of cotton were
identified through: assessment of the application; review of the scientific literature; and
review of data from other regulatory bodies and overseas bodies as referenced in
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Regulation 9 of the Regulations. The potential hazards considered in the risk assessment
were:
whether the GM cotton can be harmful to organisms, if it is more toxic or
allergenic than non-GM cotton as a result of the novel gene products or because
of unforeseen or unintended effects (see Chapter 5);
whether the GM cotton can be harmful to the environment because of inherent
weediness or increased potential for weediness, or whether inappropriate
management of the crop-herbicide combination could lead to the development of
herbicide resistant weeds (see Chapter 6); and
whether the new genes introduced into the GM cotton can transfer to non-GM
cotton crops, feral or native cottons, or to other organisms, with adverse
consequences for the environment (see Chapter 7).
Section 3.2 Risk assessment conclusions
78. In summary, it is concluded that there are no substantive additional risks to public
health and safety or to the Australian environment in the proposed release area, arising from
the genetic modification of Liberty® cotton, compared to those posed by conventional cotton
because:
the Liberty® cotton is not likely to prove more toxic or allergenic to humans or
other organisms than conventional cotton;
the risk of the Liberty® cotton establishing as a weed as a result of the proposed
release is low and not likely to be greater than that of conventional cotton;
the likelihood of some gene transfer from the GM cotton to cultivated cotton is
very low but would not pose any risks additional to those posed by the GM cotton
itself. Licence conditions have been imposed to manage this risk;
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 risk of development of herbicide-resistant weeds is negligible due to the low
likelihood of gene transfer and the small scale of the release; and
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.
Section 3.3 Identification of issues to be addressed for future releases
79. During the current evaluation process, a range of data and information requirements
were identified which would be required before any future commercial release could be
contemplated. These include further information and data on:
the potential weediness of GM cotton in northern Australia;
genetic segregation and molecular characterisation of the genetic modification;
the expression levels and biodegradability of the introduced protein; and
crop-herbicide management strategies for Liberty® cotton.
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80. If the elite varieties of Liberty® cotton evaluated by CSIRO demonstrate commercial
potential under Australian conditions, the OGTR would consult with the applicant,
representatives from the cotton industry and Australian cotton researchers to develop a
research program to collect information on the potential environmental impacts of Liberty®
cotton, prior to any approval for commercial release.
SECTION 4 DECISION TO ISSUE THE LICENCE
81. As required under sections 51 and 52 of the Act, the Regulator has considered all issues
relating to human health and safety and the environment raised in written submissions from
prescribed stakeholders, expert groups and the public in finalising the risk assessment and
risk management plan, and in making a decision to issue a licence for the release, as required
under section 56 of the Act.
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CHAPTER 5 TOXICITY OR ALLERGENICITY
A: Nature of the potential toxicity or allergenicity hazard
82. The possibility was considered of whether Liberty® cotton may be harmful to other
organisms if the GM cotton were toxic or allergenic because of the novel gene product
expressed in the plants, or if there were unforeseen, unintended effects of the genetic
modification.
TOXICITY OR ALLERGENICITY FOR HUMANS
83. If the GM cotton is toxic or allergenic, there could be impacts relating to:
the safety of human foods containing cottonseed oil (for example blended
vegetable oils, margarine, or salad dressings) or cotton linters (which may be used
in smallgoods casings, toothpaste, or ice cream); and
the safety of human foods where cotton products are present in the food chain (for
example, livestock, poultry or fish that have been fed cotton by-products).
However, none of the cotton from this release, or its by-products, will be used for human
consumption or animal feed. Food Standards Australia New Zealand (FSANZ, formerly the
Australia New Zealand Food Authority, ANZFA) has the responsibility for assessing the
safety of food for human consumption. Nevertheless, the Regulator is required to seek
advice from FSANZ on both the application and the risk assessment and risk management
plan.
84. There could also be impacts relating to:
occupational health and safety (for example, for farm workers, or factory workers
involved in cotton processing);
people wearing cotton clothing or using other products containing cotton fibre
(for example, medical dressings or tampons) or cottonseed oil (for example, as a
pharmaceutical excipient or in cosmetics); and
environmental exposure (for example, people breathing cotton pollen).
TOXICITY FOR OTHER ORGANISMS
85. If the GM cotton is toxic for other organisms, there could potentially be impacts
relating to:
toxicity for insects or soil biota, with direct impact on growth of crops on farms,
as well as secondary ecological effects with potential to harm the natural
environment (for example, adverse impacts on native biodiversity);
toxicity for grazing animals, including native animals; and
animal feed safety (for example, animals fed cottonseed meal or hulls).
However, as noted above, none of the GM cotton plants produced in the release
or their by-products will be used in animal feed.
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B: Likelihood of the toxicity or allergenicity hazard occurring
86. In assessing the likelihood of adverse impacts due to toxicity or allergenicity of
Liberty® cotton, a number of factors were considered including:
the potential toxicity or allergenicity of conventional cotton (OGTR 2002);
the potential toxicity or allergenicity of the new protein expressed in the cotton
(the PAT protein);
information about the likely levels and routes of exposure to Liberty® cotton and
the introduced protein, for example in food or feed, in non-food products
containing cottonseed oil or fibre, in residues generated in manufacturing
processes, or through direct contact with the crop or contact with soil in which the
crop is grown.
TOXICITY OR ALLERGENICITY OF THE PAT PROTEIN
87. Liberty® cotton differs from conventional cotton in the expression of one new protein,
the phosphinothricin acetyl transferase (PAT) protein. The potential toxicity and
allergenicity of this protein is addressed in detail in the DIR 010/2002 Risk Assessment and
Risk Management Plan (available on the OGTR website at www.ogtr.gov.au). In summary,
the likelihood of adverse impacts on humans or other species as a result of toxicity or
allergenicity is very low since the introduced proteins do not match the profiles of substances
likely to be allergenic. The USEPA concludes that toxicity data support the prediction that
the PAT protein would be non-toxic to humans. Other Governmental regulatory authorities
in Canada, Japan and the European Union have also concluded that the presence of the PAT
protein in plants does not render them unsafe.
POTENTIAL FOR EXPOSURE TO LIBERTY® COTTON AND THE INTRODUCED PROTEIN
88. As noted above, none of the GM cotton plants from the release, or their by-products,
will be used in human food or animal feed.
89. The PAT protein is present at a low level in Liberty® cotton, representing around 1 %
of the total extractable protein in the leaves. The level of PAT protein in the pollen and
nectar is expected to be negligible (see Chapter 3). Consequently the level of exposure to
the novel protein in the genetically modified crop is not likely to be significant, and may be
further limited depending on possible routes of exposure.
90. No data has been provided on the biodegradability of the PAT protein. However, data
relating to the stability of the PAT protein to digestion in mammalian digestive systems does
not indicate any unusual degree of stability. The PAT protein is rapidly degraded in the
gastric environment and is also readily denatured by heat or low pH (DIR 010/2002 Risk
Assessment and Risk Management Plan, available on the OGTR website). The potential for
exposure of humans, other animals and soil biota to other proteins expressed in GM cotton is
discussed in detail in the DIR 012/2002 Risk Assessment and Risk Management plan,
available on the OGTR website.
91. Streptomyces hygroscopicus, the source of the bacterial bar gene, is a common soil
bacterium, and therefore the PAT protein is already present in the environment. CSIRO
states that the amount of PAT protein added to the soil from the GM cotton is likely to very
small compared to the amount already present in the soil, derived from microorganisms.
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C: Conclusions regarding toxicity and allergenicity
92. It is considered that the likelihood of adverse impacts on humans or other species as a
result of toxicity or allergenicity of Liberty® cotton in the proposed release is very low.
93. There is no evidence that Liberty® cotton will be more toxic or allergenic to humans or
other organisms than conventional cotton. The introduced protein is already present in the
natural environment and in food chains. Because of a number of factors outlined or referred
to above, exposure to the genetically modified cotton and any additional exposure to the
introduced proteins will be minimal.
94. The Regulator has imposed conditions to ensure that none of the cotton plants from the
release or their by-products are used for human food or animal feed (see Chapter 8,
Section 3). The scale of the proposed release is relatively small on an agricultural scale, and
any environmental impacts due to toxicity are likely to be localised to the specific release site
and would, therefore, be manageable.
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CHAPTER 6 WEEDINESS
A: Nature of the weediness hazard
95. The possibility was considered that Liberty® cotton might have the potential to be
harmful to the environment, because of increased potential for weediness either as a direct
result of the genetic modification or as a result of pleiotropic effects. This could result from
changes such as increased fitness due to higher levels of herbicide tolerance or increased
fecundity. If the GM cotton were to spread in the environment as a weed, this could result in
impacts such as loss of native biodiversity or adverse effects on agricultural systems.
96. The possibility of potential adverse effects from inappropriate management of the
crop-herbicide combination, including the selection of herbicide-resistant weeds, was also
considered.
B: Likelihood of the weediness hazard occurring
97. Detailed information on the potential weediness of conventional cotton and GM
insecticidal cotton is available in the review document ‘The Biology and Ecology of Cotton
(Gossypium hirsutum) in Australia’ (OGTR 2002). Other relevant data are included in the
risk assessment and risk management plan for DIR 012/2002, available on the OGTR website
(www.ogtr.gov.au). In summary, cotton is not considered to have invasive weedy
characteristics as an annual plant in Australia. While there may be some limited potential
for cotton to spread as a weed in northern Australia, the risks of insecticidal cotton spreading
as a weed in southern Australia, including the proposed release site, are considered low, and
unlikely to be greater than for conventional cotton.
98. Liberty cotton contains the PAT protein, which makes the plants tolerant to the
herbicide glufosinate ammonium. This could confer a survival advantage in the presence of
glufosinate ammonium. However, glufosinate ammonium is not used to control cotton
plants in agriculture or in other limited instances where cotton may occur in the environment
(for example on roadsides). Glufosinate ammonium is mainly used to control weeds in
grapevines, fruit tree and vegetables. There are alternative management strategies (e.g.
cultivation or other herbicides), which can control GM cotton effectively where this may
prove necessary. Issues relating to the potential for the PAT protein to cause increased
weediness are discussed in the DIR 010/2002 risk assessment and risk management plan,
available on the OGTR website (www.ogtr.gov.au).
99. The risk of development of glufosinate ammonium-resistant weeds is considered
negligible for the current proposal because of the limited scale of the release (only
2 hectares).
C: Conclusions regarding weediness
100. It is concluded that the risk of Liberty® cotton establishing in the environment, and
spreading and causing harm, is low, particularly in southern Australia where the release
would be located, and that this risk is unlikely to be greater than for conventional cotton.
101. It is considered that the risks could be managed to an acceptable level by implementing
various strategies to minimise the spread and persistence of the GM cotton in the
environment. The Regulator has imposed licence conditions to ensure that the GM cotton
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does not spread from the release site, or persist at the site after harvest (see Chapter 8,
Section 3).
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CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER
ORGANISMS
102. In general terms, the types of hazards that might result from transfer of the gene
introduced into Liberty cotton to other organisms could include the production of
herbicide-tolerant weeds with potential to compete with native flora thereby reducing
biodiversity or disrupting ecosystems.
103. The potential hazards are addressed in the following sections, with respect specifically
to:
other plants (Section 1 of this Chapter); and
other organisms (Section 2 of this Chapter).
SECTION 1 TRANSFER OF GENES TO OTHER PLANTS
A: Nature of gene transfer hazard
TRANSFER OF GENES TO OTHER COTTON PLANTS
104. Transfer of the introduced gene or regulatory sequences to other cotton plants would
generally present the same hazards and have the same potential impacts as those posed by
Liberty cotton itself (see this Chapter and Chapters 5 and 6). However, if transfer occurred
to other cultivated or feral cotton, this would further increase the possibility that the gene
could spread in the environment, with flow-on impacts depending on the nature of the gene
and the species to which it transfers.
105. There could also be potential for eventual unintended ‘stacking’ of different herbicide
tolerances in a single plant, if the herbicide tolerance genes transferred to a cotton variety
tolerant to a different herbicide. It should be noted that Roundup Ready cotton, which is
tolerant to the herbicide glyphosate, has been grown commercially in Australia south of
latitude 22º South since 2000.
TRANSFER OF GENES TO OTHER PLANT SPECIES
106. Transfer of the introduced gene into other plant species, in particular to native flora,
might have adverse effects on biodiversity. Other potential hazards specific to the
transferred gene sequences that were considered are:
Herbicide tolerance gene:
whether plants could become resistant to glufosinate ammonium and become
weeds. This would have an impact only if glufosinate ammonium is used to
control the plant, on the farm or as a weed in the environment. If the plants were
tolerant to another herbicide, ‘stacking’ could occur, as discussed above.
CaMV 35S promoter and other regulatory sequences:
whether, if the gene sequence transfer did occur, there could be unintended or
unexpected effects if the introduced regulatory sequences alter the expression of
endogenous plant genes. If such perturbation of normal plant gene expression
did occur, the impact would depend on the phenotype.
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These sequences are derived from plant pathogens (cauliflower mosaic virus and
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 OR OTHER PLANT SPECIES
107. The most likely means by which the inserted gene 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 (Gossypium hirsutum) in Australia’ (OGTR 2002). Although there would be a low
likelihood of some gene transfer from the GM cotton to cultivated cotton if no restrictions
were placed on the growing of the GM cotton, the overall frequency of outcrossing would be
very low, and further minimised in the proposed release because of the limited scale (only 2
hectares). Licence conditions, including a requirement that GM cotton is isolated from other
cotton by a 20 metre pollen trap, have been imposed to manage this risk.
108. Data from previous trials with cotton have demonstrated the effectiveness of 20 metre
pollen traps in isolating GM cotton trial plants from other cotton plants. Therefore, the
licence conditions will require the use, as a minimum, of 20 metre pollen traps around these
cotton trial sites.
109. Transfer of the introduced gene to other cultivated or feral cotton or other plant species,
including native Australian cotton species, is addressed in further detail in the risk assessment
and risk management plan prepared for licence application DIR 012/2002 (available on the
OGTR website). In summary, it is considered that 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 risk is the same for unrelated plants.
C: Conclusions regarding gene transfer to other plants
110. In summary:
the likelihood of gene transfer from the GM cotton to cultivated cotton is very
low and would not pose any risks additional to those posed by the GM cotton
itself. Licence conditions have been imposed to manage this risk (see below);
and
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 gene transfer to unrelated plants leading to the production of
glufosinate ammonium-resistant weeds is similarly low.
111. CSIRO propose various measures, including isolation and treatment with pesticides
during the flowering period, to limit any possible outcrossing to other cotton. Furthermore,
the Regulator has imposed licence conditions to ensure appropriate measures are in place (see
Chapter 8, Sections 2 and 3).
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112. The conclusions with respect to the specific transferred gene sequences are as follows:
Herbicide tolerance gene:
There would be no adverse consequences even if outcrossing to cotton occurred,
since cotton is not regarded as a weed in Australia and is not controlled by
glufosinate ammonium, either on the farm or in other limited cases where cotton
may occur in the environment (for example, on roadsides). In the unlikely event
that gene stacking produced cotton that was also resistant to glyphosate,
alternative pesticides or other strategies would be available to control cotton
volunteers. As noted above, the likelihood of transfer to plants other than cotton
is effectively zero.
The potential for development of herbicide-resistant weeds is negligible, because
of the low likelihood of gene transfer and the limited scale of the proposed
release. In the event of commercialisation of glufosinate ammonium tolerant
crops, farm management plans would need to be implemented to minimise these
risks, by ensuring appropriate use of the herbicide-crop combination and ongoing
monitoring and destruction of any glufosinate ammonium-resistant weeds if they
occur. Responsibility for assessment of herbicide safety, prescribing safe
conditions and levels of use, and ensuring appropriate management lies with the
National Registration Authority for Agricultural and Veterinary Chemicals
(NRA). The applicant will require approval from the NRA to use glufosinate
ammonium on the cotton for this trial.
CaMV 35S promoter and other regulatory sequences:
The probability of a hazard arising due to outcrossing of these sequences to other
plants is remote, given the low likelihood of gene transfer by outcrossing. 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; Hodgson 2000b).
SECTION 2 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS
(MICROORGANISMS AND ANIMALS)
A: Nature of the gene transfer hazard
113. Potential hazards, with respect to the specific gene sequences, are as follows:
Herbicide tolerance gene:
whether transfer of the herbicide tolerance gene may pose some hazard. No
hazards were identified.
CaMV 35S promoter and other regulatory sequences:
whether, if gene transfer occurred, there could be unintended or unexpected
effects if the introduced regulatory sequences alter the expression of endogenous
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genes. If such perturbation of normal gene expression occurred, the impact
would depend on the resultant phenotype.
These sequences are derived from plant pathogens (cauliflower mosaic virus and
Agrobacterium tumefaciens). The possibility was 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 was also
considered.
B: Likelihood of the gene transfer hazard occurring
114. 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).
115. In summary, the transfer of the introduced genes from Liberty® cotton to humans or
other animals, or microorganisms including bacteria and viruses is extremely unlikely.
C: Conclusions regarding gene transfer to other organisms
116. 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.
117. Horizontal gene transfer from plants to animals (including humans) or microorganisms
is extremely unlikely. It should be noted that the bar gene is already widespread in the
environment (it was originally isolated from the common soil bacterium
Streptomyces hygroscopicus).
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 CaMV 35S
promoter into other species causing mutations, cancer or reactivation of dormant
viruses, these claims have been comprehensively addressed in the scientific
literature (eg Hull et al. 2000; Hodgson 2000a; Hodgson 2000b; Tepfer 2002).
SCSV and CaMV are already ubiquitous in the environment and in the human
diet and the promoters are expressed at far higher levels in naturally infected
plants than in transgenic plants.
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.
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CHAPTER 8 RISK MANAGEMENT PLAN
118. 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
119. It has been concluded that the proposed release of Liberty® cotton would not pose any
additional risks to human health and safety or to the environment as a result of the genetic
modification of the cotton. The main conclusions from the risk assessment are that:
the Liberty® cotton is not likely to prove more toxic or allergenic to humans or
other organisms, than conventional cotton;
the risk of the Liberty® cotton establishing as a weed as a result of the proposed
release is low and not likely to be greater than that of conventional cotton;
the likelihood of some gene transfer from the GM cotton to cultivated cotton is
very low and would not pose any risks additional to those posed by the GM
cotton itself. Licence conditions have been imposed to manage these risk;
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 risk of development of herbicide-resistant weeds is negligible due to low
likelihood of gene transfer and the small scale of the release; and
the likelihood of transfer of the introduced genes to organisms other than cotton is
negligible, but even if such transfer occurred would be unlikely to pose any
hazard to human health and safety or the environment.
SECTION 2 RISK MANAGEMENT PLAN
Section 2.1 Risk of toxicity or allergenicity
120. It is not considered necessary to include any management strategies in relation to the
potential toxicity or allergenicity of the cotton risk in the risk management plan. The risks
are very low, and the scale of the release is relatively small, limiting any environmental or
occupational exposure to the Liberty® cotton. Licence conditions have been included in the
licence to ensure that products from this release are not used in human food or animal feed.
Section 2.2 Risks of weediness or gene transfer
121. The risk of transfer of the genes to organisms other than cultivated cotton is effectively
zero. The risks relating to weediness of the GM cotton or gene transfer to cultivated cotton
are low and could be managed to an acceptable level by implementing various strategies to
minimise the spread and persistence of GM cotton, or the modified genetic material, in the
environment. For example, data from previous trials with cotton have demonstrated the
effectiveness of 20 metre pollen traps in isolating GM cotton trial plants from other cotton
plants. Therefore, the licence conditions will require the use, as a minimum, of 20 metre
pollen traps around these cotton trial sites. The risk of developing herbicide-resistant weeds
is negligible because of the likelihood of gene transfer and the small area involved. The
CHAPTER 8 RISK MANAGEMENT PLAN 29
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NRA is responsible for regulating herbicide use. Therefore, no licence conditions have been
imposed in relation to herbicide resistance management. This matter will be managed in the
context of the NRAs assessment process for the CSIRO’s application to use glufosinate
ammonium during this trial.
122. The licence includes a number of specific conditions relating to risk management. The
proposed conditions include requirements to:
isolate the GM cotton from other cotton crops;
destroy any viable material not required for subsequent releases (subject to
separate approvals and assessments) after the harvest; and
monitor the release site after the release and remove cotton plants that regrow or
sprout from seed remaining on the ground after harvest (volunteers).
123. The licence conditions, and the reasons behind them, are set out in detail in
Appendices 1 and 2.
Section 2.3 General licence conditions
124. In addition to the specific risk management conditions discussed in Section 3 of this
Chapter, the licence also 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:
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 site 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 2.4 Monitoring and enforcement of compliance by the OGTR
125. 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.
CHAPTER 8 RISK MANAGEMENT PLAN 30
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
126. 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
127. The licence conditions set out in Appendix 1 are intended to manage the identified
risks, largely through preventing dissemination of the GMOs or their genetic material outside
the release site. The conditions also include contingency provisions to cover any unintended
release of the GMOs outside the release site. In addition, the conditions include a
requirement to gather data relating to the potential environmental impacts of the GM cotton.
The OGTR will be consulting with the applicant, representatives from the cotton industry,
and Australian cotton researchers to develop a program to collect this information.
128. Detailed reasons for the individual licence conditions are set out in Appendix 2.
129. CSIRO 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.
130. 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.
131. 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 CSIRO would be amended if
necessary.
CHAPTER 8 RISK MANAGEMENT PLAN 31
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
CHAPTER 9 CONSIDERATION OF ISSUES RAISED IN PUBLIC
SUBMISSIONS
132. 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.
133. The OGTR received 8 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 and the potential for development of
herbicide-resistant weeds (see Chapter 6); and
potential for transfer of the introduced genes to other plants (particularly native
Gossypium species) and other organisms and the subsequent impact (see
Chapter 7).
134. 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.
135. 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.
136. For example, some 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 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
CHAPTER 9 CONSIDERATION OF ISSUES RAISED IN SUBMISSIONS 33
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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
137. 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.
CHAPTER 9 CONSIDERATION OF ISSUES RAISED IN SUBMISSIONS 34
DIR 015/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
REFERENCES
1. Bevan M (1984) Binary Agrobacterium vectors for plant transformation. Nucleic Acids
Research 12: 8711-8721.
2. De Block M, Botterman J, Vandewiele M, Dockx J, Thoen C, Gossele V, Rao Movva
N, Thompson C, Van Montagu M, Leemans J (1987) Engineering herbicide resistance
in plants by expression of a detoxifying enzyme. The EMBO Journal 6: 2513-2518.
3. Depicker A, Stachel S, Dhaese P, Zambryski P, Goodman HM (1982) Nopaline
synthase: transcript mapping and DNA sequence. Journal of Molecular and Applied
Genetics 1: 561-573.
4. Ho MW, Ryan A, Cummins J (2000) Cauliflower mosaic viral promoter - a recipe for
disaster? Microbial Ecology in Health and Disease 11: 194-197.
5. Hodgson J (2000a) Reply to hazardous CaMV promoter? Nature Biotechnology 18:
363.
6. Hodgson J (2000b) Scientists avert new GMO crisis. Nature Biotechnology 18: 13.
7. Hull R, Covey SN, Dale P (2000) Genetically modified plants and the 35S promoter:
assessing the risks and enhancing the debate. Microbial Ecology in Health and Disease
12: 1-5.
8. Klee HJ, Rogers SG (1989) Plant gene vectors and genetic transformation: Plant
transformation systems based on the use of Agrobacterium tumefaciens. Cell Culture
and somatic Cell Genetics of Plants 6: 1-23.
9. Odell JT, Nagy F, Chua NH (1985) Identification of DNA sequences required for
activity of the cauliflower mosaic virus 35S promoter. Nature 313: 810-812.
10. OGTR (2002) The Biology and Ecology of Cotton (Gossypium hirsutum) in Australia.
11. Stachel SE, Nester EW (1986) The genetic and transcriptional organisation of the Vir
region of the A6 Ti plasmid of Agrobacterium tumefaciens. EMBO Journal 5(7):
1445-1454.
12. Tepfer M (2002) Risk assessment of virus-resistant transgenic plants. Annual Review of
Phytopathology 40: 467-491.
13. Thompson CJ, Movva Rao N, Tizard R, Crameri R, Davies J, Lauwereys M, Botterman
J (1987) Characterization of the herbicide-resistance gene bar from Streptomyces
hygroscopicus. EMBO Journal 6: 2519-2523.
REFERENCES 35
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APPENDIX 1 LICENCE CONDITIONS
Note in relation to herbicide resistance
The genetically modified organism approved for limited and controlled release in this licence
is cotton that has been genetically modified to tolerate a herbicide (glufosinate ammonium).
The applicant (CSIRO) will require approval by the National Registration Authority for
Agricultural and Veterinary Chemicals (NRA) before it can use glufosinate ammonium
during this trial on the genetically modified organisms.
Accordingly, the OGTR has not, in this licence, imposed conditions in relation to herbicide
resistance management. These matters are expected to be satisfactorily managed in the
context of the NRA’s evaluation and approval process.
APPENDIX 1 SPECIFIC LICENCE CONDITIONS 37
DIR 015/2002 Risk assessment and Risk Management Plan
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 Technology Act 2000 (Cth).
Holder of licence
1 The holder of this licence (‘the licence holder’) is CSIRO.
Project Supervisor
2 The Project Supervisor in respect of this licence is the person identified at ‘Project
Supervisor’ at Attachment A.
Persons covered by licence
3 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).
(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 The GMO covered by this licence (‘the GMO’) is identified and described at ‘GMO
Description’ at Attachment B.
Dealings authorised by licence
5 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 This licence remains in force until it is cancelled or surrendered. No dealings with the
GMO are authorised during any period of suspension.
(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 SPECIFIC LICENCE CONDITIONS 38
DIR 015/2002 Risk assessment and Risk Management Plan
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.
‘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.
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‘Equipment’ includes harvesters, seeders, storage equipment, transport equipment (eg bags,
containers, trucks), ginning facilities, clothing and tools.
‘GM’ means genetically modified.
‘GMO’ means genetically modified organisms authorised for release by this licence.
‘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
‘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.
‘Volunteer plant’ means progeny of the GMO or of a Pollen Trap plant.
APPENDIX 1 SPECIFIC LICENCE CONDITIONS 40
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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 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.
Remaining an Accredited organisation
3 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 The licence holder must immediately notify the Regulator in writing if any of the
contact details of the Project Supervisor change.
APPENDIX 1 SPECIFIC LICENCE CONDITIONS 41
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Section 2: Specific Conditions
Only dealings contemplated by this licence are authorised
The licence holder and persons authorised by this licence must not deal with the GMO except
as expressly authorised or contemplated by this licence.
Locations and size of release
1.1 The GMO may only be planted during the Summer planting season of 2002 between
14 October 2002 and 31 January 2003.
1.2 If the GMO is planted, it must not be planted at areas outside the Shire of Narrabri in
New South Wales.
1.3 If the GMO is planted, the maximum size of all land planted to the GMO must not
exceed 2 hectares.
1.4 If the GMO is planted, the total number of areas that may be planted to the GMO
must not exceed 2.
1.5 The GMO must not be planted within 50 metres of a Natural Waterway.
1.6 If the GMO is planted it may be grown.
1.7 Prior to commencing to grow 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.
1.8 The licence holder must be able to access and control a Location to the extent
necessary to comply with this licence, for the duration of the life of the licence.
Notification of planting of the GMO
2 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) ('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;
(b) the actual date or dates of commencement of planting of the GMO at each area
(and Pollen Trap in respect of the area) ('the actual planting date notice'). This
notice must be provided within 7 days of commencement of planting of the GMO
at the area.
Notification of commencement of flowering of the GMO
3 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 flowering of the
GMO at each area proposed to be planted (and Pollen Trap in respect of each
area) ('the short term forecast flowering date notice'). This notice must be
APPENDIX 1 SPECIFIC LICENCE CONDITIONS 42
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provided at least 7 days, and not more than 20 days, prior to the forecasted date or
dates of commencement of flowering set out in the notice;
(b) the actual date or dates of commencement of flowering of the GMO at each area
(and Pollen Trap in respect of each area) ('the actual planting date notice'). This
notice must be provided within 7 days of commencement of flowering of the
GMO at the area.
Notification of commencement of harvest of GMO
4 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 area proposed to be planted (and Pollen Trap in respect of each
area) ('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 area
(and Pollen Trap in respect of each area) ('the actual harvest date notice'). This
notice must be provided within 7 days of commencement of harvesting of the
GMO at the area.
Measures to manage gene flow – Locations must be surrounded by Pollen Traps
5 Each Location must be surrounded by a Pollen Trap.
Note: ‘Detailed explanation of the term included in the Definitions Section
Conditions relating to Pollen Traps
6.1 Plants in a Pollen Trap (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).
6.2 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.
Research on environment impacts
7 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 may include (but need not be limited to)
collecting information on the effectiveness of Pollen Traps in preventing gene flow
from the GMO to non-genetically modified cotton.
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Harvest and post-harvest procedures
8.1 If the GMO or Pollen Trap plants are harvested, they must be harvested separately from
any other cotton.
8.2 If seed cotton harvested from the GMO or from Pollen Trap plants is ginned, it must be
ginned separately from any other cotton.
8.3 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) destroyed by burning.
8.4 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.
Cleaning – post harvest and generally
9.1 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.
9.2 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.
9.3 Within 14 days of either harvest or Cleaning of the GMO at a Location, whichever
occurs first, the Pollen Trap in respect of that Location must be harvested or Cleaned.
9.4 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.
9.5 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
10.1 Following Cleaning of each Location, the following places must be monitored for the
existence of Volunteer plants:
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(a) the Location;
(b) the Pollen Trap in respect of the Location;
(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
(d) irrigation channels or drains through which water used on the Location (or
Pollen Trap) flows.
10.2 Monitoring must be performed by a person who is able to recognise Volunteer plants.
10.3 Any Volunteer plants detected during monitoring must be Destroyed before setting
seed.
10.4 All the places required to be monitored must be monitored at least once every 60 days
for at least 12 months from the last day of Cleaning of the Location.
10.5 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;
(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
11.1 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, after harvest of the GMO or
Pollen Trap plants, until monitoring obligations are completed.
11.2 If the GMO is grown at a Location, no plants may be planted at the Location, or Pollen
Trap in respect of the Location, 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.
Transportation of the GMO, Material from the GMO, Pollen Trap plants and Material
from Pollen Trap plants
12.1 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 unless
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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.
12.2 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 or a second tarpaulin, in such a way as to prevent
dissemination of cotton seed, and transported inside a sealed chain-bed truck.
12.3 Every container used to transport the GMO, viable Material from the GMO, Pollen
Trap plants or viable Material from Pollen Trap plants must be labelled:
(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.
12.4 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 Plans
13.1 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 GM Material from the GMO, Pollen Trap
plants or viable Material from Pollen Trap plants outside a Location or other area that
must be monitored.
13.2 The Contingency Plan must include details of procedures to:
(a) ensure the Regulator is notified immediately if the licence holder becomes
aware of the event;
(b) to destroy any of the GMOs, viable GM Material from the GMOs, Pollen Trap
plants or viable Material from Pollen Trap plants;
(c) monitor and destroy any Volunteer plants that may exist as a result of the
event.
13.3 The Contingency Plan must be implemented in the event that the unintended presence
of the GMO, viable GM Material from the GMO, Pollen Trap plants or viable Material
from Pollen Trap plants is discovered outside an area that must be monitored.
Compliance Management Plan
14 Prior to growing 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 document that
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compliance.
Testing methodology
15 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
16 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.
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APPENDIX 2 REASONS FOR SPECIFIC 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 and the pollen traps, since this would increase the potential for risks to human health and
safety or to the environment.
Condition 1 Location and size of release
This condition limits 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 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 2, 3 and 4 Notification of the planting, flowering and harvesting of the GMO
These conditions ensure that minimum advance information about the likely higher risk times
of the trials (namely the likely planting, flowering and harvest dates) is provided to the
OGTR to ensure proper planning of the OGTR monitoring of the release sites. The OGTR
monitoring strategy is an integral component of the overall management strategy for the
proposed release. The Regulator considers that these conditions are necessary and adequate
to ensure management of the risks posed at the higher risk times of planting, flowering and
harvest.
Conditions 5 and 6 Measures to manage gene flow (Pollen Traps)
These conditions are intended to minimise the risk of gene flow from the GM cotton to other
cotton crops by physical separation. Pollen Traps serve as barriers to pollen movement, by
either wind or insect pollinators, to plants outside the Location. Access to 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.
Condition 7 Research on environmental impacts
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.
Condition 8 Post harvest management
This condition seeks to reduce the risk of the GMO being disseminated or persisting in the
environment through spillage or contamination of seed at harvest or during ginning. The
Regulator considers that this condition is necessary to 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, with
APPENDIX 2 REASONS FOR LICENCE CONDITIONS 49
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minimum transportation of the GMO, is necessary to ensure minimum risk of the GMO
disseminating into the environment.
Condition 9 Cleaning – post harvest and generally
This condition describes the cleaning requirements for equipment, Locations and other areas
used in connection with the release, 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 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.
Condition 10 Monitoring – post harvest and generally
This condition is considered necessary to minimise the risks of persistence and dissemination
of the GMO or its genetic material after harvest, arising from volunteer cotton germinating
and setting seed. The condition is 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 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.
This condition also requires 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 management actions might need to be implemented to adequately manage the
risks.
Condition 11 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 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
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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.
Condition 12 Transport
This condition addresses the risks of persistence or dissemination of the GM cotton in the
environment 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, that it be clearly labelled, and that all viable
material from GM cotton is accounted for during transport.
Condition 13 Contingency plans
This condition addresses the risks posed through unintended presence of the GMO or its
genetic materials. 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. 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, so that the Regulator can take any actions necessary to protect the environment.
Condition 14 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.
Condition 15 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
adequately managed, or alternatively that additional measures may need to be imposed to
manage risks.
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Condition 16 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.
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APPENDIX 3 PUBLIC SUBMISSIONS SUMMARY
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. Type a SUMMARY OF ISSUES RAISED CONSIDERATION
No: OF ISSUE
B
1 I …don’t want you to go ahead with trials…not being able Ch 7
to control the cross pollination problems…unless… you
can control the wind factor Nationally
…what about our GM free markets for Beef, Grain’s OSA
2 C …request for draft and final reports Noted
3 I …so long as it is labeled so that we never have to buy it OSA
or wear it
4 A …please advise which agencies are responsible for the Replied by Mail
issues of herbicide resistance and market impacts
5 C DIR 014/2002
our comments on 012/2002 remain the same and are Application
applicable to DIR 014/2002. withdrawn,
assessment
discontinued
…far smaller area…which would make compliance with,
and monitoring of RARMP easier.
…no information…advising whether … it is intended to use
product from this trial as either human or animal food. We
believe it should not.
DIR 015/2002
… trialed in USA since 1977. Has application been OSA
made for commercial release in the USA…will Australia be
the first?
….no adverse effects… from 30 field trials. ….how are Noted
‘adverse effects’ defined, and what was looked for?
….OGTR states [information on RARMPs] can be found Ch 1
on their website. It assumes that all people have access to
electronic technology. This is not so.
…two reputable scientists expounding two completely Ch 4, Ch 7
different views [on CaMV promoter]. Which one has ‘sound
science’ on their side... how does the OGTR determine this?
Applaud the lack of the use of an antibiotic resistant Noted
gene.
…unease at the use of a trans configuration [[in Ti Trans configuration
plasmids]…trans fatty acids [such as in polyunsaturated in plasmid relates to
margarine] are not healthy fats…. conceivably could end up location of DNA
in the diet. sequences - has
nothing to do with
fats
APPENDIX 3 PUBLIC SUBMISSION SUMMARY 53
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…the sale of lint should not be approved. Ch 5
While toxicity and allergenicity are considered, Noted
carcinogenicity is not.
…no data…on the biodegradability of the PAT Ch 5, CBD
protein….difficult…to see how ‘the likelihood of transfer of
the introduced gene to organisms other than cotton is
negligible’.
…eventual contamination of non-g.e. crops, weeds, etc… OSA
inevitably lead to gene stacking with more herbicide use
required, not less.
Application is considered in a void, as if no other Ch 4
applications exist….fall within the same district of
Narrabri,…the larger picture should also be considered.
DIR 016/2002
…no by-product from the trial should….end up in the Ch 5
food chain.
more appropriate to [test the promoters] in a crop which OSA
is intended to go on to commercial production…
…already been releases…so why is it necessary to OSA
conduct this particular trial.
…to date there has only been one study conducted on Ch 7, CBD
humans …this showed foreign DNA can enter the human gut.
We do not believe the absence of testing constitutes safety.
The OGTR should be aware …. There is evidence… in OSA
Canada that g.m. canola has become a superweed…do not
believe it can be claimed that there have been no adverse
effects on human health or the environment.
…assuming that all submitters have access to electronic Documents
communication… all applications should stand alone. available from
OGTR
…we ask which scientists, either Ho et al, or Hull et al, Ch 4, Ch 7
Hodgson, are considered to have ‘sound science’ for their
claims and why?
…concern with the use of the Ti Plasmid whose Trans configuration
flexibility allows the vir region to act in either cis or trans in plasmid relates to
formation…noting the health aspects which resulted from the location of DNA
trans formation with hydrogenation of oils to margarine…we sequences - has
are asking whether this .. is the same with genetic nothing to do with
modification…. fats
….high expression of Cry1Ab protein in leaves and Ch 5
seeds….some concern as the seeds are used in… food.
…transfer of introduced genes to organisms other than Ch 7, CBD
cotton. We do not believe this should be so readily
dismissed.
…because the [expression of the] insecticidal protein is Ch 8
likely to be increased…..insect resistance could be
hastened….releases should not be considered in isolation,
particularly in environmental matters.
reassure that all these various modifications operate Noted
through independent mechanisms…. [Reference provided.]
APPENDIX 3 PUBLIC SUBMISSION SUMMARY 54
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concern…potential for inducing the synthesis of Ch 5
poisonous or toxic compounds following the introduction of a
foreign gene.
…the [EPA] is emphasizing false similarities between Ch 5
chemicals and engineered organisms. By ignoring the
differences between chemical pesticides and living plant
pesticides, the agency allows the industry’s faulty scientific
approach to go unchallenged. [Reference provided.]
The OGTR appears to be satisfied that there is no risk to Ch 5
human health…from the use of the Bt or the Cry toxins.
Evidence presented to the EPA disagrees….who’s ‘sound
science’ the OGTR is accepting. [Reference provided.]
Toxicity to other animals, including insects is also Ch 4, Ch 5
considered not to be a problem. We refer the OGTR to
reference (4) where different conclusions are drawn, some
from the same studies quoted. [Reference provided.]
Many ‘small scale releases’ should be considered as part Ch 4
of the larger environmental picture.
Council does not consider weediness would constitute a Noted
risk in this particular application…would be interested to
know what pesticides CSIRO intend using during the
flowering period, should a licence be granted.
…because of the limited scope of the proposed release… Ch 8
[the risk of insecticide resistance] is considered to be
negligible. However every release adds to the developing
problem...he advent of genetic engineering has hastened the
resistance process….to the detriment to organic farmers and
others.
…frustration that the public has no ‘one stop’ shop Noted
…FSANZ…NRA…OGTR all have partial responsibility.
DIR 017/2002
This Application….should not have approval to sell Ch 5
lint…There is so much in this Application that is hidden from
public scrutiny…
…concerned that the ever increasing number of Noted
modifications will have unforseen adverse effects. Genes do
not work in isolation…
…the new Bt protein … likely to act via a different Ch 3
mechanism… therefore impossible to comment upon it or
determine whether or not it represents a hazard.
antibiotic resistance marker gene…in ‘common use’…no Ch 4
reason to approve further [uses]….scientific advice from
WHO…advising their use should be phased-out. When, if
ever, will the OGTR begin refusing applications that continue
to use antibiotic resistance marker genes?
…two new promoters….derived from a ‘plant closely Noted (CCI)
related to a species used for food’…comment cannot be
informed.
APPENDIX 3 PUBLIC SUBMISSION SUMMARY 55
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…the use of the trans configuration resulting from Trans configuration
hydrogenation in the production of margarine…change to in plasmid relates to
heart and artery health…Has the use of a trans configuration location of DNA
in this present context been thoroughly investigated? sequences - has
nothing to do with
fats
Council would be interested to know what is considered Ch 4
to constitute biosafety problems and how they were looked
for.
No information on the levels of expression of the Noted (CCI)
antibiotic resistance gene.
OGTR has drawn virtually the same conclusions for all Ch 9
applications…in this batch….only if new GM cotton lines
demonstrate commercial potential is further information, such
as…on page 17 of DIR 017…why isn’t such information
required before the crop is released into the environment?
…the actions of a topical spray and that of the toxin Noted
produced continually in the plant are different.
As always there are no studies offered with regard to Noted
carcinogenicity
…it is not helpful to contributors for the OGTR to keep Noted
referring to RARMPs already approved for other
Applications. All Applications…should stand alone.
…all RARMP plans are practically identical, whatever Ch 4
parameter is being considered is invariably explained away as
not a problem….no account taken of the accumulative effect
of muddying of the gene pool…the futility of replying to
these Applications is becoming increasingly apparent.
6 A DIR 014, 015, 016, 017 /2002 Ch 5
Cottonseed meal comprises up to 5% of pig’s diet in
Australia…Australian pork exporters are now required to
provide written assurance….that the diets of their pigs are
GMO free…need for cotton growers and policy makers to
consider…tracking and tracing, communication strategies and
appropriate labelling, not just for the end product but also for
GM inputs.
7 I [DIR 017]… there is no scientific guarantee that there is Ch 4
no risk associated with plantings
…FSANZ regulations do not guarantee against negative OSA
outcomes…Who is responsible?
APPENDIX 3 PUBLIC SUBMISSION SUMMARY 56
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8 I …biotechnology companies often claim that …GMOs OSA
--specifically genetically altered seeds -- are essential
scientific breakthroughs needed to feed the world, protect the
environment, and reduce poverty in developing
countries…The Consultative Group on International
Agricultural Research (CGIAR) and its constellation of
international centers … charged with research to enhance
food security in the developing world echo this view, which
rests on two critical assumptions… [firstly]… is that hunger
is due to a gap between food production and human
population density or growth rate… [secondly]… genetic
engineering is the only or best way to increase agricultural
production and thus meet future food needs.
…there is no relationship between the prevalence of OSA
hunger in a given country and its population. For every
densely populated and hungry nation like Bangladesh or
Haiti, there is a sparsely populated and hungry nation like
Brazil and Indonesia. The world today produces more food
per inhabitant than ever before…the real causes of hunger are
poverty, inequality and lack of access. Too many people are
too poor to buy the food that is available (but often poorly
distributed) or lack the land and resources to grow it
themselves (Lappe, Collins and Rosset l998).
…most innovations in agricultural biotechnology have OSA
been profit-driven rather than need-driven.... [eg] herbicide
resistant crops such as Monsanto's "Roundup Ready"
soybeans, seeds that are tolerant to Monsanto's herbicide
Roundup, and …"Bt" crops which are engineered to produce
their own insecticide. In the first instance, the goal is to win a
greater herbicide market-share for a proprietary product and
in the second to boost seed sales at the cost of damaging the
usefulness of a key pest management …relied upon by many
farmers, including most organic farmers, as a powerful
alternative to insecticides.
…these technologies …intensify farmers' dependence OSA
upon seeds protected by so-called" intellectual property
rights," which conflict directly with the age-old rights of
farmers to reproduce, share or store seeds (Hobbelink l991)…
corporations will require farmers to buy company's brand of
inputs and will forbid farmers from keeping or selling seed.
By controlling germplasm from seed to sale, and by forcing
farmers to pay inflated prices for seed-chemical packages,
companies are determined to extract the most profit from
their investment (Krimsky and Wrubel l996).
APPENDIX 3 PUBLIC SUBMISSION SUMMARY 57
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…integration of the seed and chemical industries… OSA
destined to accelerate increases in per acre expenditures for
seeds plus chemicals, delivering significantly lower returns to
growers….shift{ing] as much per acre cost as possible from
the herbicide onto the seed via seed costs and/or technology
charges. Increasingly price reductions for herbicides will be
limited to growers purchasing technology packages. In
Illinois, Three years ago, the average seed-plus-weed control
costs on Illinois farms was $26 per acre, and represented 23%
of variable costs; today they represent 35-40% (Benbrook
l999). Many farmers are willing to pay for the simplicity and
robustness of the new weed management system, but such
advantages may be short-lived as ecological problems arise.
…recent experimental trials have shown that genetically OSA
engineered seeds do not increase the yield of crops. A recent
study by the USDA Economic Research Service shows that
in 1998 yields were not significantly different in engineered
versus non-engineered crops in 12 of 18 crop/region
combinations. In the six crop/region combinations were Bt
crops or HRCs fared better, they exhibited increased yields
between 5-30%. Glyphosate tolerant cotton showed no
significant yield increase in either region where it was
surveyed. This was confirmed in another study examining
more than 8,000 field trials, where it was found that Roundup
Ready soybean seeds produced fewer bushels of soybeans
than similar conventionally bred varieties (USDA l999).
…recent evidence… shows that there are potential risks Ch 5
of eating such foods as the new proteins produced in such
foods could: act themselves as allergens or toxins, alter the
metabolism of the food producing plant or animal, causing it
to produce new allergens or toxins, or reduce its nutritional
quality or value as in the case of herbicide resistant soybeans
that contained less isoflavones, an important phytoestrogen
present in soybeans, believed to protect women from a
number of cancers...
because genetically engineered food remains unlabeled, OSA
consumers cannot discriminate between GE and non-GE
food, and should serious health problems arise, it will be
extremely difficult to trace them to their source. Lack of
labeling also helps to shield the corporations that could be
potentially responsible from liability (Lappe and Bailey,
l998).
APPENDIX 3 PUBLIC SUBMISSION SUMMARY 58
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…transgenic plants which produce their own insecticides OSA, but see Ch 8
closely follow the pesticide paradigm, which is itself rapidly (of DIRs 16 & 17)
failing due to pest resistance to insecticides. Instead of the
failed "one pest-one chemical" model, genetic engineering
emphasizes a "one pest-one gene" approach, shown over and
over again in laboratory trials to fail, as pest species rapidly
adapt and develop resistance to the insecticide present in the
plant (Alstad and Andow l995). Not only will the new
varieties fail over the short-to-medium term, despite so-called
voluntary resistance management schemes (Mallet and Porter
l992), but in the process may render useless the natural
pesticide "Bt," which is relied upon by organic farmers and
others desiring to reduce chemical dependence. needed by
farmers that want out of the pesticide treadmill (Pimentel et al
l989).
Bt crops violate the basic and widely accepted principle OSA, but see Ch 8
of "integrated pest management" (IPM), which is that reliance (of DIRs 16 & 17)
on any single pest management technology tends to trigger
shifts in pest species or the evolution of resistance through
one or more mechanisms (NRC l996). …the greater the
selection pressure across time and space, the quicker and
more profound the pests evolutionary response…it reduces
pest exposure to pesticides, retarding the evolution of
resistance…when the product is engineered into the plant
itself, pest exposure leaps from minimal and occasional to
massive and continuous exposure, dramatically accelerating
resistance (Gould l994). Bt will rapidly become useless, both
as a feature of the new seeds and as an old standby sprayed
when
…the global fight for market share markets is leading OSA
companies to massively deploy transgenic crops around the
world… without proper advance testing of short- or
long-term impacts on human health and ecosystems.
In the U.S., private sector pressure led the White House Noted
to decree "no substantial difference" between altered and
normal seeds, thus evading normal FDA and EPA testing.
Confidential documents …revealed that the FDAs own
scientists do not agree with this determination. One reason is
that many scientists are concerned that the large scale use of
transgenic crops poses a series of environmental risks that
threaten the sustainability of agriculture (Goldberg,
l992;Paoletti and Pimentel l996; Snow and Moran l997;
Rissler and Mellon l996; Kendall et al l997 and Royal
Society l998):
…the trend to create broad international markets for OSA
single products, is simplifying cropping systems and creating
genetic uniformity in rural landscapes. History has shown
that a huge area planted to a single crop variety is very
vulnerable to new matching strains of pathogens or insect
pests. ..the widespread use of homogeneous transgenic
varieties will unavoidably lead to "genetic erosion," as the
local varieties used by thousands of farmers in the developing
world are replaced by the new seeds (Robinson l996).
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…the use of herbicide resistant crops undermine the OSA
possibilities of crop diversification thus reducing
agrobiodiversity in time and space (Altieri l994).
… the potential transfer through gene flow of genes from Chs 6 & 7
herbicide resistant crops to wild or semidomesticated
relatives can lead to the creation of superweeds (Lutman
l999)…there is potential for herbicide resistant varieties to
become serious weeds in other crops (Duke l996, Holt and Le
baron l990).
…massive use of Bt crops affects non-target organisms Ch 5
and ecological processes. Recent evidence shows that the Bt
toxin can affect beneficial insect predators that feed on insect
pests present on Bt crops (Hilbeck et al l998), and that
windblown pollen from Bt crops found on natural vegetation
surrounding transgenic fields can kill non-target insects such
as the monarch butterfly (Losey et al l999).
…moreover, Bt toxin present in crop foliage plowed Ch 5
under after harvest can adhere to soil colloids for up to 3
months, negatively affecting the soil invertebrate populations
that break down organic matter and play other ecological
roles (Donnegan et al l995 and Palm et al l996).
…there is potential for vector recombination to generate Chs 5 & 7
new virulent strains of viruses, especially in transgenic plants
engineered for viral resistance with viral genes. In plants
containing coat protein genes, there is a possibility that such
genes will be taken up by unrelated viruses infecting the
plant. In such situations, the foreign gene changes the coat
structure of the viruses and may confer properties such as
changed method of transmission between plants. The second
potential risk is that recombination between RNA virus and a
viral RNA inside the transgenic crop
…ecological risks have often been pursued from a narrow Noted
perspective that has downplayed the seriousness of the risks
(Kendall et al. 1997; Royal Society 1998). …risk assessment
of transgenic crops are not well developed (Kjellsson and
Simmsen 1994) and there is justifiable concern that current
field biosafety tests tell little about potential environmental
risks associated with commercial-scale production of
transgenic crops.
…a main concern is that international pressures to gain OSA
markets and profits is resulting in companies releasing
transgenic crops too fast, without proper consideration for the
long-term impacts on people or the ecosystem .
…there are many unanswered ecological questions Noted, but see Ch 5
regarding the impact of transgenic crops…results emerging
from the environmental performance of released transgenic
crops suggest that in the development of "resistant crops", not
only is there a need to test direct effects on the target insect or
weed, but the indirect effects on the plant (i.e. growth,
nutrient content, metabolic changes), soil, and non-target
organisms… It is a tragedy-in-the-making that so many
millions of hectares have been planted without proper
biosafety standards... genetic pollution, unlike oil spills,
cannot be controlled by throwing a boom
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As the private sector has exerted more and more OSA
dominance in advancing new biotechnologies, the public
sector has had to invest a growing share of its scarce
resources in enhancing biotechnological capacities in public
institutions…in evaluating and responding to the challenges
posed by incorporating private sector technologies into
existing farming systems…funds would be much better used
to expand support for ecologically based agricultural
research, as all the biological problems that biotechnology
aims at can be solved using agroecological approaches
… the dramatic effects of rotations and intercropping on Noted
crop health and productivity, as well as of the use of
biological control agents on pest regulation have been
confirmed repeatedly by scientific research.
..there is also an urgent need to challenge the patent OSA
system and intellectual property rights intrinsic to the WTO
which not only provide multinational corporations with the
right to seize and patent genetic resources, but that will also
accelerate the rate at which market forces already encourage
monocultural cropping with genetically uniform transgenic
varieties.
…based on history and ecological theory, it is not Noted
difficult to predict the negative impacts of such
environmental simplification on the health of modern
agriculture (Altieri l996).
…there may be some useful applications of Noted
biotechnology (i.e. the breeding drought resistant varieties or
crops resistant to weed competition) much of the needed food
can be produced by small farmers located throughout the
world using agroecological technologies (Uphoff and Altieri
l999).
…new rural development approaches and low-input OSA
technologies spearheaded by farmers and NGOs around the
world are already making a significant contribution to food
security at the household, national and regional levels in
Africa, Asia and Latin America (Pretty l995)...yield increases
are being achieved by using technological approaches, based
on agroecological principles that emphasize diversity,
synergy, recycling and integration; and social processes that
emphasize community participation and empowerment
(Rosset l999)….when such features are optimized, yield
enhancement and stability of production are achieved, as well
as a series of ecological services such conservation of
biodiversity, soil and water restoration and conservation,
improved natural pest regulation mechanisms, etc (Altieri et
al l998).
… failure to promote such people-centered agricultural OSA
research and development due to diversion of funds and
expertise to biotechnology, will forego a historical
opportunity to raise agricultural productivity in economically
viable, environmentally benign and socially uplifting ways.
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APPENDIX 3 PUBLIC SUBMISSION SUMMARY 62
