Download Risk Assessment and Risk Management Plan

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 017/2002
Title: Agronomic assessments and efficacy studies of
transgenic cotton expressing a new insecticidal gene
Applicant: CSIRO
October 2002
Abbreviations
ANZFA
AQIS
Bt
B.t.k
CaMV
CSIRO
DIR
DNA
DNIR
ELISA
EMBL
FAO
FSANZ
g
GM
GMAC
GMO
GTTAC
ha
IgE
IgG
IOGTR
IPCS
kDa
km
m
MAFF
MRL
mRNA
ng
NHMRC
NICNAS
NOS
NLRD
NRA
OECD
OGTR
ppm
T-DNA
TGA
TGAC
US EPA
US FDA
WHO
w/v
μg/g
Australia New Zealand Food Authority (now FSANZ)
Australian Quarantine Inspection Service
Bacillus thuringiensis
Bacillus thuringiensis variety kurstaki
cauliflower mosaic virus
Commonwealth Scientific and Industrial Research Organisation
dealing involving intentional release
deoxyribonucleic acid
dealing not involving intentional release
enzyme linked immunosorbent assay
European Molecular Biology Laboratory
Food and Agriculture Organisation of the United Nations
Food Standards Australia New Zealand (formerly ANZFA)
gram
genetically modified
Genetic Manipulation Advisory Committee
genetically modified organism
Gene Technology Technical Advisory Committee
hectare
immunoglobulin E
immunoglobulin G
Interim Office of the Gene Technology Regulator
International Program on Chemical Safety
kiloDalton
kilometre
metre
UK Ministry of Agriculture, Fisheries and Food
maximum residue limit
messenger ribonucleic acid
nanogram
National Health and Medical Research Council
National Industrial Chemicals Notification and Assessment Scheme
nopaline synthase
Notifiable Low Risk Dealing
National Registration Authority for Agricultural and Veterinary Chemicals
Organisation for Economic Cooperation and Development
Office of the Gene Technology Regulator
parts per million
transfer deoxyribonucleic acid
Therapeutic Goods Administrations
Technical Grade Active Constituent
United States Environmental Protection Agency
United States Food and Drug Administration
World Health Organisation
weight per volume
micrograms per gram
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
TABLE OF CONTENTS
PREFACE ............................................................................................................................................................. 1
SECTION 1
SECTION 2
SECTION 3
SECTION 4
CHAPTER 1
THE REGULATION OF GENE TECHNOLOGY IN AUSTRALIA ............................................................ 1
THE INITIAL CONSULTATION PROCESSES ..................................................................................... 1
THE EVALUATION PROCESS ......................................................................................................... 2
THE STRUCTURE OF THIS DOCUMENT .......................................................................................... 2
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 ORGANISMS TO BE RELEASED ................................................................................... 7
SECTION 3 PREVIOUS RELEASE OF THE GMO IN AUSTRALIA ........................................................................ 8
SECTION 4 APPROVALS FOR THE GM 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 INTRODUCED GENES AND PROTEINS .................................................................................. 11
Section 3.1
The insecticidal gene and toxin ........................................................................................... 11
Section 3.2
The antibiotic resistance marker gene ................................................................................ 12
Section 3.3
The regulatory sequences .................................................................................................... 12
SECTION 4 METHOD OF GENE TRANSFER ....................................................................................................... 12
SECTION 5 ....... CHARACTERISATION OF THE INSERTED GENETIC MATERIAL AND STABILITY OF THE GENETIC
MODIFICATION........................................................................................................................... 13
SECTION 6 EXPRESSION OF THE INTRODUCED PROTEINS ............................................................................. 13
CHAPTER 4
RISK ASSESSMENT ............................................................................................................ 15
SECTION 1 THE RISK ANALYSIS FRAMEWORK ............................................................................................ 15
SECTION 2 THE RISK ASSESSMENT PROCESS ............................................................................................... 15
SECTION 2 SUMMARY OF RISK ASSESSMENT CONCLUSIONS ........................................................................ 16
Section 2.1
Hazard identification........................................................................................................... 16
Section 2.2
Risk assessment conclusions ............................................................................................... 17
Section 2.3
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 .......................................................................................................................... 25
CHAPTER 7
TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS ........................... 27
SECTION 1 TRANSFER OF INTRODUCED GENES TO OTHER COTTON PLANTS ................................................. 27
SECTION 2 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS (MICROORGANISMS AND ANIMALS) 29
CHAPTER 8
INSECTICIDE RESISTANCE ............................................................................................. 31
CHAPTER 9
RISK MANAGEMENT PLAN ............................................................................................. 33
SECTION 1 SUMMARY OF RISK ASSESSMENT CONCLUSIONS ........................................................................ 33
SECTION 2 RISK MANAGEMENT PLAN ......................................................................................................... 33
Section 2.1
Risk of toxicity or allergenicity ........................................................................................... 33
Section 2.2
Risks of weediness or gene transfer .................................................................................... 33
Section 2.3
Risks of insecticide resistance ............................................................................................. 34
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
Section 2.4
General licence conditions .................................................................................................. 34
Section 2.5
Monitoring and enforcement of compliance by the OGTR .................................................. 34
SECTION 3 SPECIFIC RISK MANAGEMENT LICENCE CONDITIONS .................................................................. 35
CHAPTER 10
CONSIDERATION OF ISSUES RAISED IN PUBLIC SUBMISSIONS ......................... 37
REFERENCES ................................................................................................................................................... 39
APPENDIX 1
SPECIFIC LICENCE CONDITIONS ................................................................................. 41
APPENDIX 2
REASONS FOR SPECIFIC LICENCE CONDITIONS .................................................... 53
APPENDIX 3
PUBLIC SUBMISSION SUMMARY .................................................................................. 57
DIR 017/2002 - 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:

State and Territory Governments;

the Gene Technology Technical Advisory Committee (GTTAC);

prescribed Commonwealth agencies (Regulation 9 of the Gene Technology
Regulations 2001 refers);

the Environment Minister; and

relevant local council(s).
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 groups and key stakeholders, including the public, were then consulted on
the risk assessment and risk management plan in accordance with Section 52 of the Act.
8.
The Regulator has taken into account all issues relating to the protection of human
health and safety and the environment raised in written submissions on the risk assessment
and risk management plan, in finalising the plan (see Chapter 10), and in making a decision
PREFACE
1
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
to issue a licence for the proposed release as required under section 56 of the Act (see
Chapter 9).
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 the Risk Analysis Framework
developed by the Regulator (see Chapter 4). A risk assessment and risk management plan,
including 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 submissions from the public and advice from the
Environment Minister, State and Territory Governments, GTTAC, and Commonwealth
agencies (see Regulation 9 of Gene Technology 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 about 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 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 section 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
PREFACE
2
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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.
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 provides
background information relating to previous intentional releases of the GMO and
other related GMOs. Chapter 2 refers.

provides detailed information about the parent organism(s), the GMO(s), and the
introduced genes. Chapter 3 refers;

details the risk assessment undertaken to date in accordance with the Risk
Analysis Framework developed by the Regulator. Chapter 4 refers;

details the risk assessment on the hazards of toxicity and allergenicity of the GM
cotton. Chapter 5 refers;

details the risk assessment on the hazard of weediness of the GM cotton.
Chapter 6 refers;

details the risk assessment on the hazard of transfer of introduced genes to other
organisms. Chapter 7 refers;

details the risk assessment on the hazard of development of insecticide resistance.
Chapter 8 refers;

sets out the conclusions reached as a result of the risk assessment and presents a
risk management plan to manage the identified risks. Conditions which could be
included in the licence to give effect to the risk management plan are also
provided. Chapter 9 refers;

sets out the specific licence conditions. Appendix 1 refers;

explains the reasons for specific licence conditions. Appendix 2 refers; and

summarises public submissions on the application. Chapter 10 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 017/2002 - 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 Regulator (The
Regulator) must follow when considering an application for a licence to intentionally release
a genetically modified organism (GMO) into the environment. Section 51 of the Act
requires the Regulator to prepare a risk assessment and risk management plan for each
licence application. Details of the process which the Regulator must follow are set out in the
Preface.
SECTION 1
THE LICENCE APPLICATION
20. This 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 017/2002).
21. CSIRO has applied for a licence for the limited and controlled release of a GM
insecticidal cotton. The release is proposed to be undertaken on three sites in New South
Wales, covering a total area of 3 hectares.
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 GM cotton contains a new insecticidal gene, derived from the soil bacterium
Bacillus thuringiensis, that makes it resistant to lepidopteran caterpillar pests. The gene
encodes an insecticidal protein which is toxic to lepidopteran insects, including caterpillar
pests (Helicoverpa armigera and H. punctigera) of cotton. The protein is different from the
Cry1Ac and Cry2Ab insecticidal proteins present in other types of GM cotton currently
available commercially or being trialed in Australia. The new gene may provide additional
options to manage the risk of development of insects resistant to Cry1Ac and Cry2Ab or
other insecticidal proteins. Some of the GM cotton also contains an antibiotic resistance
marker gene which was used during the initial stage of selection of transgenic plants in the
laboratory.
24. The purpose of the proposed release is to evaluate the agronomic performance of the
GM cotton and the efficacy of the insecticidal action. 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. 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.
26. 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 GM cotton is set out in Chapter 3.
CHAPTER 1 INTRODUCTION
5
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
27. Some details of the gene construct, including the identity of the insecticidal gene and
the antibiotic resistance gene, and identity/origin of the regulatory sequences, as well as the
specific cultivar proposed for release have been declared as Confidential Commercial
Information (CCI) under Section 185 of the Gene Technology Act 2000. However, the
CSIRO has reduced the extent of its original request for CCI and this document contains
information about the source of the gene and the transformation method that was not included
in the consultation version of the plan.
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 developing and 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 insecticidal protein in the GM cotton might be toxic to non-target
species. This issue is addressed in Chapter 5;

whether the GMO may pose a risk as a weed in the environment. This issue is
addressed in ‘The Biology and Ecology of Cotton (Gossypium hirsutum) in
Australia’ (OGTR 2002) and Chapter 6; and

whether the introduced genes 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 10 and
Appendix 3.
CHAPTER 1 INTRODUCTION
6
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
CHAPTER 2 BACKGROUND ON THE APPLICATION, THE GMO
AND PREVIOUS RELEASES
31. This chapter 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:
33.
34.

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.
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.
A copy of the application is available on request from the OGTR.
SECTION 2 ABOUT THE ORGANISMS TO BE RELEASED
35. The organism to be released is GM insecticidal cotton, which also contains an antibiotic
resistance marker gene.
36. The GM cotton contains a new insecticidal gene derived from Bacillus thuringiensis, a
common soil bacterium. This gene encodes a different protein from the Cry1Ac and Cry2Ab
insecticidal proteins derived from the same bacterium that are present in other types of GM
cotton currently available commercially or being trialed in Australia. The protein is a
species specific toxin, which makes the cotton resistant to lepidopteran caterpillar pests
(Helicoverpa armigera and H. punctigera). The new gene may provide additional options to
manage the risk of development of insects resistant to Cry1Ac and Cry2Ab or other
insecticidal proteins.
CHAPTER 2
BACKGROUND ON THE APPLICATION, THE GMO AND PREVIOUS RELEASES
7
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
37. The antibiotic resistance gene is derived from the bacterium Escherichia coli, and was
used as marker gene during the initial selection of transgenic plants in the laboratory. The
antibiotic resistance gene will serve no function during the release.
38. Further details about the genetic modification process and the introduced genes are
provided in Chapter 3.
SECTION 3 PREVIOUS RELEASE OF THE GMO IN AUSTRALIA
39. One limited and controlled release (field trial) of this GM cotton (PR-151) has
previously been approved by GMAC and conducted in accordance with GMAC guidelines.
PR-151 was conducted by CSIRO at the Australian Cotton Research Institute, Narrabri
(NSW) and the size of the field trial was approximately 3000 plants in 0.05 hectares.
40. A number of previous limited and controlled releases of similar insecticidal cottons
(INGARD® and Bollgard II® cotton) have been undertaken in Australia, under the former
regulatory system overseen by GMAC, as well as under the new regulatory system (e.g.
DIR 005/2001, DIR 006/2002, DIR 008/2002 and DIR 009/2002). Both have subsequently
been approved for general or commercial release (GR-3 and DIR 12/2002).
41. Each proposed release was notified in the Gazette, on the GMAC or IOGTR/OGTR
website and by direct mail to the GMAC or IOGTR/OGTR mailing list to enable public
comment for consideration in the assessment process. A diverse range of expert groups and
key stakeholders were also consulted during the consultation process. Relevant local
government councils were also advised directly. Reports were provided to the GMAC or the
IOGTR/OGTR at the conclusion of each release.
42. Each of the limited and controlled releases was carried out under conditions designed to
limit the spread and persistence of the GMO in the environment, and minimise potential risks
posed by the GM cotton. No adverse effects on human health and safety or the environment
were reported for any of these releases.
43. Factors assessed in the previous releases included the agronomic performance of the
cotton and the levels of insecticidal activity.
SECTION 4 APPROVALS FOR THE GM COTTON IN OTHER COUNTRIES
44. The GM cotton proposed for release has not been released outside Australia, however,
GM cotton containing the same insecticidal gene has been tested in field trials in the United
States. Since 2000, the US Department of Agriculture has approved a number of field trials
of the same GM cotton line proposed for release. No adverse effects on human health or the
environment have been reported.
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 GMO, and the use of products
of the GMO, including the requirements of the NRA and FSANZ.
CHAPTER 2
BACKGROUND ON THE APPLICATION, THE GMO AND PREVIOUS RELEASES
8
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
Section 5.1
National Registration Authority for Agricultural and Veterinary Chemicals
(NRA)
46. The NRA undertakes the safety assessment of agricultural and veterinary chemicals,
including herbicides and pesticides. Currently, this includes GM plants modified with
insecticidal genes, which are regarded as plant pesticides. The applicant will require
approval by the NRA to grow the GM cotton.
47. The NRA is responsible for imposing conditions where necessary to prevent the
emergence of insect resistance. Therefore, the OGTR has not imposed conditions in respect
of these matters.
48. Further information about the management of insecticide resistance 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: [email protected]
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 by FSANZ. Any use of the GM cotton or its
by-products in human food would necessitate an application to FSANZ.
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: [email protected]
http://www.foodstandards.gov.au
CHAPTER 2
BACKGROUND ON THE APPLICATION, THE GMO AND PREVIOUS RELEASES
9
DIR 017/2002 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 the genetic modification.
53. This part of the document addresses these matters and provides detailed information
about the GMO 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. Some details of the gene construct, including the identity of the insecticidal gene and
the antibiotic resistance gene, and identity/origin of the regulatory sequences, as well as the
specific cultivar proposed for release have been declared as Confidential Commercial
Information (CCI) under Section 185 of the Gene Technology Act 2000. However, the
CSIRO has reduced the extent of its request for CCI, and this document contains information
about the source of the gene and the transformation method that were not included in the
consultation version of the plan.
SECTION 1 SUMMARY INFORMATION ABOUT THE GMO
55. The GM cotton contains a new insecticidal gene derived from a common soil
bacterium, Bacillus thuringiensis. Further information on the insecticidal gene is provided
in Sections 3 and 4 of this Chapter.
56. The GM cotton also contains an antibiotic resistance gene from the common bacterium
Escherichia coli, which was used as marker gene during the initial selection of transgenic
plants in the laboratory. The antibiotic resistance gene is discussed in more detail in
Section 3 of this Chapter. Potential risks relating to transfer of the gene to other
microorganisms are discussed in Chapter 5, Section 5.3.
57. The method used to introduce the genes into cotton are discussed in Section 5 of this
Chapter.
SECTION 2 THE PARENT ORGANISM
58. 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 from the OGTR website
(www.ogtr.gov.au).
SECTION 3
Section 3.1
THE INTRODUCED GENES AND PROTEINS
The insecticidal gene and toxin
59. The new insecticidal gene used to produce insect protected cotton in this application is
isolated from a common soil bacterium, Bacillus thuringiensis. It is a possible alternative to
the cry1Ac and cry2Ab genes derived from the same bacterium that are present in other types
of insecticidal GM cotton (e.g. INGARD® and Bollgard II® cotton). This is discussed
CHAPTER 3
INFORMATION ABOUT THE GMOS AND THE PARENT ORGANISM
11
DIR 017/2002 RISK ASSESSMENT AND RISK MANAGEMENT PLAN
further in Chapter 8. The insecticidal protein expressed by the new gene has a highly
specific insecticidal activity against several lepidopteran pests (moths and butterflies)
including Helicoverpa armigera and H. punctigera that attack cotton crops (see Chapter 5).
It shows no homology to the Cry1Ac and Cry2Ab proteins, and is therefore likely to act via a
different mechanism, although, like the Cry1Ac and Cry2Ab proteins, it acts by binding to
receptors in the insect gut and causing lysis of the gut cells.
Section 3.2
The antibiotic resistance marker gene
60. The GM cotton also contains an antibiotic resistance marker gene from
Escherichia coli. The gene was used in the initial laboratory stages of development of the
plants, to enable selection of cells containing the desired genetic modification. It is in
common use as a selectable marker in the production of GM plants and will serve no function
during this trial. The potential toxicity of the antibiotic resistance gene and potential risks in
relation to gene transfer are discussed in Chapters 5 and 6 respectively.
Section 3.3
The regulatory sequences
61. Expression of genes in plants requires regulatory sequences, including a promoter (a
piece of DNA that determines whether or not a gene is expressed, and to what extent) and an
mRNA termination region, including a polyadenylation signal. Expression of the
insecticidal and antibiotic resistance genes is driven by one of two promoters derived from a
plant closely related to a species used for food. The promoters are constitutive, that is they
are expected to drive protein expression throughout the life of the GM cotton and in most of
its tissues. The termination signals are provided by the 3’ non-translated region of the
nopaline synthase gene from Agrobacterium tumefaciens (Depicker et al. 1982).
SECTION 4 METHOD OF GENE TRANSFER
62. The GM cotton line was generated by Agrobacterium-mediated transformation, and has
been propagated by selfing.
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.
CHAPTER 3
INFORMATION ABOUT THE GMOS AND THE PARENT ORGANISM
12
DIR 017/2002 RISK ASSESSMENT AND RISK MANAGEMENT PLAN
SECTION 5 CHARACTERISATION OF THE INSERTED GENETIC MATERIAL AND
STABILITY OF THE GENETIC MODIFICATION
65. The DNA used for the genetic modification was sequenced to confirm the identity of
the genes before they were inserted into the GM cotton. Segregation data and PCR and
Southern blot analysis indicate that a single copy of both the insecticidal and the selectable
marker gene is present in the GM cotton line. These genes appear to be stable and have been
maintained as single dominant traits over three generations of breeding.
SECTION 6 EXPRESSION OF THE INTRODUCED PROTEINS
66. It is expected that the insecticidal protein will be expressed in most cotton tissues
throughout the life of the GM cotton plant (see Section 3.3 above). Quantitative analysis of
the insecticidal protein in the original GM cotton line indicated relatively low levels of
expression in a number of different tissues, with a maximum of 309 ng of the insecticidal
protein per mg soluble protein (0.03%). No information is available on the levels of
expression of the antibiotic resistance gene.
67. More detailed information on the levels of expression of both of the introduced proteins
would be required before any application for commercial release of the cotton could be
approved.
CHAPTER 3
INFORMATION ABOUT THE GMOS AND THE PARENT ORGANISM
13
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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 GMO 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
application for GM cotton containing the new insecticidal gene;

submissions or advice from States and Territories, Commonwealth agencies and
the Environment Minister and the public;

advice from GTTAC;

information from other national 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 9);

the potential for spread or persistence of the GMO or its genetic material in the
environment (see Chapters 6 and 7);

the extent or scale of the proposed dealings (see Chapters 1 and 9);
CHAPTER 4
RISK ASSESSMENT
15
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN

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 2 and 4);

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 8. In each of these Chapters:

Part A explains the nature of the potential hazard and any adverse impacts it
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 2 SUMMARY OF RISK ASSESSMENT CONCLUSIONS
Section 2.1
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
Regulation 9 of the Regulations. The potential hazards considered in the risk assessment
were:
CHAPTER 4
RISK ASSESSMENT
16
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN

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 (see Chapter 6);

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); and

whether, in the long term, the target insects can develop resistance to the
insecticidal proteins produced by the introduced genes in the GM cotton (see
Chapter 8).
Section 2.2
Risk assessment conclusions
78. In summary, it is concluded that there are no substantive additional risks to public
health and safety or to the environment arising from the genetic modification of GM cotton
containing the new insecticidal gene, compared to those posed by conventional cotton
because:

the GM cotton is not likely to prove more toxic or allergenic to humans or other
organisms, (other than some lepidopteran insects including the target pests), than
conventional cotton;

the risk of the GM 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 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; and

the risk of development of target insects resistant to the insecticidal protein is low
due to the small size of the release.
Section 2.3
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 of the GM
cotton or similar cotton varieties could be contemplated. These include further information
and data on:

the potential toxicity of the GM cotton, including more information on potential
toxicity to non-target pests;

the potential weediness of the GM cotton in northern Australia;
CHAPTER 4
RISK ASSESSMENT
17
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN

genetic segregation and molecular characterisation of the genetic modification;

the expression levels of the introduced proteins; and

insecticide resistance management strategies for the GM cotton.
80. If the GM cotton demonstrated commercial potential under Australian conditions, the
OGTR would consult with the applicant, representatives from the cotton industry, and
Australian cotton researchers to develop a program to collect information on the potential
environmental impacts of the GM cotton.
81. The general issue of the use of antibiotic resistance marker genes may also need to be
considered in the longer term, although it is not directly relevant to the current application,
nor to applications likely to be made in the near future. This issue has been addressed
recently by international food standard setting bodies, including the FAO/WHO Expert
Consultation on Foods Derived from Biotechnology (29 May-2 June 2000, Geneva
Switzerland) and the Codex Ad Hoc Intergovernmental Taskforce on Foods Derived from
Biotechnology (November 2000, Tokyo) and the OECD.
82. The international bodies accept that there is no evidence of human health and safety
problems with the use of antibiotic resistance marker genes in GM foods (e.g. the nptII gene).
However, they have also stated that alternative transformation technologies that do not result
in antibiotic resistance marker genes in foods are encouraged in the future development of
recombinant DNA plants, where such technologies are available and demonstrated to be safe.
SECTION 4 DECISION TO ISSUE THE LICENCE
83. 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.
CHAPTER 4
RISK ASSESSMENT
18
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
CHAPTER 5 TOXICITY OR ALLERGENICITY
A:
Nature of the potential toxicity or allergenicity hazard
84. The possibility was considered of whether the GM insecticidal cotton might be harmful
to organisms other than lepidopteran insects. This could occur if the genetically modified
cotton were toxic or allergenic, because of the novel gene products expressed in the plants or
because of unforeseen, unintended effects of the genetic modification.
TOXICITY OR ALLERGENICITY FOR HUMANS
85.
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.
86.
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
87. If the GM cotton is toxic for other non-target organisms, there could be potential
impacts relating to:

toxicity to beneficial insects (pollinators, parasitoids, predators of insect pests) 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
CHAPTER 5
TOXICITY OR ALLERGENICITY
19
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN

88.
B:
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.
Toxicity for the lepidopteran target organisms, may also present indirect impacts:

secondary effects on populations of specialist parasitoids and predators that feed
on lepidopteran insects; and

secondary effects on populations of organisms that are preyed on by lepidopteran
insects.
Likelihood of the toxicity or allergenicity hazard occurring
89. In assessing the likelihood of adverse impacts due to toxicity or allergenicity of the GM
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 proteins expressed in the cotton
(the insecticidal protein and an enzyme that inactivates an antibiotic);

information about the likely levels and routes of exposure to the GM cotton and
the introduced proteins, 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 INTRODUCED PROTEINS
90. The GM cotton differs from conventional cotton in the expression of two additional
proteins, the insecticidal protein and an enzyme that inactivates an antibiotic. Both have
been considered for their potential toxicity and allergenicity.
Toxicity or allergenicity of the insecticidal protein
91. The insecticidal protein present in the GM cotton is a naturally occurring toxin (see
Chapter 3). The protein is expressed in common soil bacteria, Bacillus thuringiensis, and
therefore is already widely present in the environment and in food chains.
Toxicity of the insecticidal protein for vertebrate animals including humans, and allergenicity
92. The insecticidal protein is one of a diverse family of insecticidal proteins found in the
bacterium Bacillus thuringiensis (Bt) and is highly specific for lepidopteran insects (moths
and butterflies) (see below). The protein is present in commercial Bt formulations, produced
by fermentation of the same strain of bacterium from which the gene was derived. These
have been used traditionally in agriculture over several decades, especially by organic
farmers (Cannon 1993). These are used widely to control insects in many food crops,
including fresh produce such as berry crops, lettuce, cabbage, celery, spinach and tomatoes
(EPA 1998). In fact, the first commercial microbial Bt product (Sporeine) was produced in
CHAPTER 5
TOXICITY OR ALLERGENICITY
20
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
1938 in France (Weiser 1986 cited by Entwistle 1993). The public has thus potentially been
exposed to the insecticidal protein in the diet through consumption of commercially available
fruit and vegetables, over a long period.
93. The World Health Organisation’s (WHO) International Program on Chemical Safety
(IPCS) report on environmental health criteria for Bt concluded that ‘Bt has not been
documented to cause any adverse effects on human health when present in drinking water or
food’ (IPCS 2000). There have been no confirmed adverse effects on health either through
occupational exposure or ingestion of fresh produce sprayed with Bt insecticides, despite
significant oral, dermal and inhalation exposure to the product (Entwistle 1993; US EPA
2001).
94. The insecticidal protein is unlikely to be a major allergen. It does not display
characteristics common to known food allergen proteins, for example: presence as a major
component of the food; glycosylation; resistance to degradation by heat, acid and proteases of
the digestive system; or derivation from a known allergenic source (Taylor & Lehrer 1996;
Kimber et al. 1999).
95. The insecticidal protein, purified from a bacterial source or in material derived from
GM corn, was very rapidly degraded under simulated conditions of the mammalian
gastrointestinal system. Searches of allergen sequence databases have shown no significant
matches of the insecticidal protein to known allergens (Dr. D. Llewellyn, personal
communication).
96. Most allergens are present as major protein components in the specific food,
representing from 2-3% up to 80% of total protein (Fuchs & Astwood 1996). In contrast, the
insecticidal protein is present at low levels in the GM cotton plants (see Chapter 3).
97. While there have also been reports in the US claiming allergic reactions to Bt products
in topical sprays, it was determined by the US EPA that these reactions were not due to the
bacterium itself (US EPA 2001).
98. A survey conducted in farm workers who picked vegetables treated with Bt microbial
products, indicates that exposure to Bt products may lead to allergic skin sensitisation and
induction of IgE and IgG antibodies. However, there were no reports of clinical allergic
disease in any of the workers (Bernstein et al. 1999).
99. A two-year chronic rat feeding study was undertaken with Bt microbial products at
doses of up to 8400 mg/kg of body weight/day. A decrease in weight gain was observed at
the highest dose, but in the absence of any other adverse findings this was not considered to
be related to Bt protein toxicity (McClintock et al. 1995).
100. Acute oral toxicity studies have been carried out in mice and bobwhite quail (data
supplied by applicant). No apparent toxicity was observed in mice or quail at doses of
2700 or 400 mg insecticidal protein/kg body weight, respectively.
Toxicity of the insecticidal protein for other animals including insects
101. The applicant states that the protein is toxic to a range of lepidopteran pests, including
Helicoverpa armigera (cotton bollworm) and Helicoverpa punctigera (native budworm), the
CHAPTER 5
TOXICITY OR ALLERGENICITY
21
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
major caterpillar pests of cotton (OGTR 2002) and that preliminary data indicate that the
insecticidal protein is not toxic to any of the non-target insects tested so far (see Table 1).
CHAPTER 5
TOXICITY OR ALLERGENICITY
22
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
Table 1.
Non-target species insensitive to the insecticidal protein
Order
Lepidoptera
Diptera
Homoptera
Coleoptera
Isotomidae
Neuroptera
Thysanoptera
Species
Ostrinia nubilalis
Plodia interpunctella
Hyphantria cunea
Plutella xylostella
Danaus plexippus
Musca domestica
Drosophila melanogaster
Culex pipiens
Myzus persicae
Diabrotica virgifera
Diabrotica longicornis
Popillia japonica
Leptinotarsa decemlineata
Tenebrio molitor
Diabrotica undecimpunctata
Coleomegilla maculata
Folsomia candida
Chrysoperla carnea
Frankliniella occidentalis
Common name
European corn borer
Indian meal moth
Fall webworm
Diamondback moth
Monarch butterfly
House fly
Fruit fly
Northern house mosquito
Green peach aphid
Western corn rootworm
Northern corn rootworm
Japanese beetle
Colorado potato beetle
Yellow meal worm
Southern corn rootworm
Pink spotted ladybeetle
Springtails
Green lacewings
Western flower thrips
102. The applicant would be required to provide further information in relation to the
potential environmental impacts, including more comprehensive data on effects on non-target
insects, before any commercial release of the GM cotton could be approved.
Toxicity or allergenicity of the antibiotic resistance protein
103. The clinical and veterinary uses of the antibiotic, and mechanisms of resistance are
discussed in more detail in Chapter 7. The antibiotic resistance protein is found in bacteria
isolated from animals and humans. It is therefore already present in the environment and in
food chains to at least some extent. The protein is not known to be toxic to vertebrate
animals. The antibiotic is not in current clinical use, therefore the potential for inactivation
of orally dosed antibiotic in humans consuming plant material containing the marker gene
would not be an issue. Although the antibiotic is used in veterinary medicine, the restricted
scale of the release would limit any exposure of animals to the GM cotton.
104. The applicant would be required to provide a detailed safety evaluation package in
relation to the potential toxicity or allergenicity of the protein before any commercial release
of the GM cotton could be approved.
POTENTIAL FOR EXPOSURE TO THE GM COTTON AND THE INTRODUCED PROTEINS
105. 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.
106. The overall level of expression of the insecticidal protein is expected to be low (less
than 0.03% of soluble protein, see Chapter 3). Expression of the antibiotic resistance gene
CHAPTER 5
TOXICITY OR ALLERGENICITY
23
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
would also be expected to be relatively low, based on previous expression data for the plant
promoter used to control its expression. Consequently the level of exposure to the novel
proteins in the genetically modified crop is not likely to be significant, and may be further
limited depending on possible routes of exposure. Relevant information on the potential for
exposure of humans, other animals and soil biota to proteins expressed in GM cotton, for
example occupational exposure, is discussed in detail in the DIR 012/2002 Risk Assessment
and Risk Management Plan, available on the OGTR website.
107. The insecticidal and antibiotic resistance genes are derived from bacteria that are found
commonly in soil and/or in mammalian digestive tracts, thus the proteins are already present
in the environment. As noted above, the insecticidal protein is also present in microbial
sprays commonly used on fruit and vegetables. The amount of the insecticidal proteins
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.
108. Further data on the potential for exposure of humans, other animals and soil biota to
proteins expressed in GM cotton, including information on the biodegradability of the
introduced protein would be required before commercial release of the GM cotton could be
approved. The potential for exposure to the GM cotton during this trial will be limited
because of the small scale of the proposed release.
C:
Conclusions regarding toxicity and allergenicity
109. It is considered that the likelihood of adverse impacts on humans or other species (other
than lepidopteran insects), as a result of toxicity or allergenicity of the GM cotton in the
proposed release is very low.
110. There is no evidence that the GM cotton will be more toxic or allergenic to humans or
other organisms than conventional cotton. The introduced proteins are 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.
111. The Regulator has imposed conditions to ensure that none of the cotton plants from the
release or their by-products would be used for human food or animal feed (see Chapter 8,
Section 3). The scale of the 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.
112. A potential secondary impact resulting from the toxicity of GM cotton for lepidopteran
insects is that populations of specialist parasitoids or predators that feed on lepidopterans may
be affected. It has not been investigated in detail whether such impacts on non-target
predators and parasitoids may occur, due to indirect toxicity or from the decreased abundance
of lepidopteran hosts or prey. Such effects are likely to be minimal, as the lepidopteran
insects that feed on cotton have alternative plant hosts. The impacts of the insecticidal
cotton on non-target insect species is likely to be far less than the impacts of the insecticides
applied to conventional cotton. The impacts would in any case be negligible for the
proposed release because of the very small area involved.
CHAPTER 5
TOXICITY OR ALLERGENICITY
24
DIR 017/2002 RISK ASSESSMENT AND RISK MANAGEMENT PLAN
CHAPTER 6 WEEDINESS
A:
Nature of the weediness hazard
113. The possibility was considered that GM 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 in changes
such as increased fitness due to higher levels of insect resistance 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.
B:
Likelihood of the weediness hazard occurring
114. Preliminary data from US and Australian glass-house and field trials indicate that the
agronomic characteristics of the GM cotton are within the range of current commercial
conventional cotton varieties. The only difference that one would expect between the
modified and non-modified cotton is the expression of the insecticidal and antibiotic
resistance genes.
115. 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) and 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. There may be some limited potential for cotton to spread as a weed in northern
Australia, because of climatic factors, and because insecticidal genes may confer a selective
advantage to the GM cotton in this region. However, 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. The risk is further reduced for
the current proposal because of the limited scale of the release. This issue would however
need to be considered before any future commercial release of the GM cotton.
116. The antibiotic resistance gene will not confer a selective advantage on the cotton, since
antibiotics are not used on cotton crops and there is no evidence, nor any reason to believe,
that expression of the protein would alter any of the characteristic attributes of cotton
important for weediness (OGTR 2002).
C:
Conclusions regarding weediness
117. It is concluded that the risk of the GM cotton establishing in the environment, and
spreading and causing harm, is low, particularly in New South Wales where the release
would be located, and that this risk is unlikely to be greater than for conventional cotton.
118. 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
does not spread from the release site, or persist at the site after harvest (see Chapter 9,
Section 3).
CHAPTER 6
WEEDINESS
25
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
CHAPTER 7 TRANSFER OF INTRODUCED GENES TO OTHER
ORGANISMS
119. In general terms, the types of hazards that might result from transfer of the genes
introduced into GM cotton to other organisms could include the production of insecticidal
weeds with potential to compete with native flora thereby reducing biodiversity or disrupting
ecosystems.
120. The potential hazards are addressed in the following sections, with respect specifically
to:

other cotton or other plants (Section 1 of this Chapter); and

other organisms (Section 2 of this Chapter).
SECTION 1 TRANSFER OF INTRODUCED GENES TO OTHER COTTON PLANTS
A:
Nature of the gene transfer hazard
TRANSFER OF GENES TO OTHER CULTIVATED OR FERAL COTTON
121. 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 the
GM cotton itself (see this Chapter and Chapters 5, 6 and 8). 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.
TRANSFER OF GENES TO OTHER PLANT SPECIES
122. Transfer of the introduced genes 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 have been considered are as follows:

Insecticidal gene:
whether the plants could become resistant to lepidopteran insects. This could
confer a fitness advantage on plants normally controlled by these insects, and
could result in increased weediness. There could also be impacts on the
lepidopteran insect populations, or specialist predators and parasitoids that feed
on them.

Antibiotic resistance marker gene:
whether the plants could become resistant to the antibiotics. This would not in
itself have any significant impacts, since the antibiotic in question is not used on
plants outside of the laboratory.

Promoters and other regulatory sequences:
whether if gene 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.
CHAPTER 7
TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS
27
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
Some of these sequences are derived from a plant pathogen
(Agrobacterium tumefaciens). The possibility has been considered as to whether
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
123. The most likely means by which the inserted genes could be transferred to non-GM
cotton plants is by a GM cotton plant cross-pollinating (outcrossing to) non-GM cotton
plants. 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.
124. 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.
125. Transfer of the introduced genes from GM cotton to feral cotton or other plant species,
including native Australian cotton species, is also addressed in the 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/or genetic
incompatibility with the native species. The risk is the same for unrelated plants.
C:
Conclusions regarding gene transfer to other plants
126. 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 Chapter
9); and

the potential for transfer of the introduced genes to wild or native cotton is
functionally zero because of the geographical isolation and/or genetic
incompatibility with the native species.
127. CSIRO propose various measures, including isolation and treatment with pesticides
during the flowering period, to limit any possible outcrossing to other cotton. The Regulator
has imposed licence conditions to ensure appropriate measures are in place (see Chapter 9).
128. The conclusions with respect to the specific transferred gene sequences are as follows:
CHAPTER 7
TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS
28
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN

Insecticidal gene:
It is possible that if these genes were transferred to feral or cultivated cotton, the
plants might have a survival advantage in northern Australian regions where
lepidopteran insect pests may limit their growth or regulate their populations.
However, cotton and its native relatives are not regarded as weeds in Australia,
and their distribution is determined largely by soil type, soil moisture, nutrient
availability and temperature, more so than by insect pressure.

Antibiotic resistance genes:
There would be no adverse consequences even if outcrossing occurred. The
antibiotic in question is not used on plants outside of the laboratory.

Promoters and other regulatory sequences:
The probability of a hazard arising due to outcrossing of these sequences to other
plants is unlikely, given the very low likelihood of gene transfer by outcrossing.
Plants are already exposed in nature to the bacteria from which some of these
sequences are derived.
Although some of the regulatory sequences transferred to the plants are derived
from a plant pathogen (Agrobacterium tumefaciens), they only represent a very
small proportion of the pathogen genome. The sequences are not, in themselves,
infectious or pathogenic.
SECTION 2 TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS
(MICROORGANISMS AND ANIMALS)
A:
Nature of the gene transfer hazard
129. Potential hazards, with respect to the specific gene sequences, are as follows:

Insecticidal gene:
whether transfer of the insecticidal gene may pose some hazard. No hazards
were identified.

Antibiotic resistance gene:
whether transfer of the gene to other organisms may pose some hazard. No
hazards were identified for transfer to animals (including humans) or viruses.
However, the possibility was considered of whether transfer of the gene to other
disease-causing organisms, that could be treated with the antibiotic in question
(see below), could cause them to be resistant to this antibiotic. The
consequences of this would depend on:
 the pathogenicity of the organism;
 the use and significance of the antibiotic in clinical and/or veterinary
practice;
 whether resistance to the antibiotic is already widespread in the natural
populations.

Promoters and other regulatory sequences:
whether if gene transfer did occur, there could be unintended or unexpected
effects if the introduced regulatory sequences alter the expression of endogenous
genes. If such perturbation of normal gene expression occurred, the impact
CHAPTER 7
TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS
29
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
would depend on the resultant phenotype.
Some of these sequences are derived from a plant pathogen (Agrobacterium
tumefaciens). The possibility has been considered that they might have
pathogenic properties.
B:
Likelihood of the gene transfer hazard occurring
130. The likelihood of genes transferring from cotton to other organisms has been
considered in detail in ‘The Biology and Ecology of Cotton (Gossypium hirsutum) in
Australia’ (OGTR 2002). In summary, the transfer of the introduced genes from the GM
cotton to animals and microorganisms including bacteria and viruses is extremely unlikely.
C:
Conclusions regarding gene transfer to other organisms
131. 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. Horizontal gene transfer from plants to animals (including
humans) or microorganisms is extremely unlikely.
132. It should be noted that the insecticidal and antibiotic resistance genes are already
widespread in the environment and in food chains (they were originally isolated from bacteria
commonly present in soil and/or mammalian digestive systems).
133. The conclusions with respect to the specific gene sequences are as follow:

Insecticidal gene:
There would be no adverse consequences even if gene transfer occurred.

Antibiotic resistance gene:
The antibiotic in question is not used to treat bacterial infections in clinical or
veterinary medicine. Although used in veterinary medicine to control parasitic
worms, alternative antibiotics are available. The antibiotic resistance gene is
present in natural clinical and veterinary bacterial isolates, located on
transmissible genetic elements that are readily transferable between bacterial
species. So, in the unlikely event that the antibiotic resistance gene were
transferred from the GM cotton to a bacterium, this would be unlikely to have any
detectable impact on the existing level of resistance in microbial populations.
Furthermore, as noted above, the antibiotics in question are not used to treat
bacterial infections.

Promoters and other regulatory sequences:
There would be no adverse consequences even if gene transfer occurred.
Although some of the regulatory sequences transferred to the plants are derived
from a pathogen, the pathogen only infests 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.
CHAPTER 7
TRANSFER OF INTRODUCED GENES TO OTHER ORGANISMS
30
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
CHAPTER 8 INSECTICIDE RESISTANCE
A:
Nature of the insecticide resistance hazard
134. Extensive cultivation of the GM cotton could potentially result in the emergence of
resistance to the insecticidal toxin in the target species (Helicoverpa armigera and
H. punctigera) and other susceptible lepidopteran species feeding on cotton. This would
result in a reduction of the efficacy of the GM cotton for control of insect pests, and could
also have impacts on the use of Bt microbial sprays to control insects in other agricultural
systems. Potential adverse effects include attenuation of the benefits to the environment and
human health of growing the GM cotton or of using Bt sprays. These benefits stem from the
use of less chemical insecticides on crops.
B:
Likelihood of the insecticide resistance hazard occurring
135. The likelihood of emergence of insects resistant to the insecticidal protein is negligible
because of the very small scale of the proposed release.
136. The occurrence of resistance to insect pests due to the use of Bt cotton containing
Cry1Ac and Cry2Ab insecticidal proteins has been discussed extensively in the
DIR 012/2002 Risk Assessment and Risk Management Plan. The same principles discussed
in that document in relation to mechanisms of resistance and resistance management
strategies would apply to the GM cotton proposed for release under the current application.
C:
Conclusions regarding insecticide resistance
137. Selection of insects resistant to the insecticidal protein would almost certainly occur if
the GM cotton were grown widely without taking any steps to deal with this problem. Given
the limited scope of the proposed release in scale and time, the likelihood of emergence of
insects resistant to the insecticidal protein as a result of the proposed release is considered
negligible.
138. It should be noted that similar risks are also posed by the use of Bt sprays or chemical
insecticides in agricultural systems and, as such, are not unique to cultivation of the GM
cotton. Although the Regulator has given detailed consideration to these risks, responsibility
for oversight of insect resistance management for GM insecticidal cotton lies with the NRA
(see Chapter 2, Section 5.1). The applicant will require approval from the NRA to grow the
GM cotton.
CHAPTER 8
INSECTICIDE RESISTANCE
31
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
CHAPTER 9 RISK MANAGEMENT PLAN
139. 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
140. It has been concluded that the proposed release of the GM cotton in NSW would not
pose any additional risks to human health and safety or to the environment in cotton growing
areas of NSW. The main conclusions from the risk assessment are that:

the GM cotton is not likely to prove more toxic or allergenic to humans or other
organisms, (other than some lepidopteran insects ie. moths and butterflies) than
conventional cotton;

the risk of the GM 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 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 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; and

the risk of development of target insects resistant to the insecticidal protein is
negligible due to the small scale of the release.
SECTION 2 RISK MANAGEMENT PLAN
Section 2.1
Risk of toxicity or allergenicity
141. It is not considered necessary to include any management strategies in relation to the
potential toxicity or allergenicity of the cotton 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 GM cotton. Licence conditions have been imposed 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
142. 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
CHAPTER 9
RISK MANAGEMENT PLAN
33
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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.
143. The licence also 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).
Section 2.3
Risks of insecticide resistance
144. The risk of development of resistance to the insecticidal protein in target pests is
negligible for the current trial because of the very small area involved. The NRA will
consider whether any specific insecticide resistance management strategies should be
imposed in its assessment of the release.
145. The licence conditions, and the reasons behind them, are set out in detail in
Appendices 1 and 2.
Section 2.4
General licence conditions
146. In addition to the specific risk management conditions discussed in Section 3 of this
Chapter, the licence issued also contains a number of general conditions including statutory
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:
Section 2.5

inform people covered by the licence of their obligations under the licence;

allow access to the release sites by the Regulator, or persons authorised by
the Regulator for the purposes of monitoring or auditing;

inform the Regulator if the applicant becomes aware of any additional
information about risks to human health or safety or to the environment,
any unintended effects of the release or any contraventions of the licence
conditions; and

ensure appropriate training for persons covered by the licence.
Monitoring and enforcement of compliance by the OGTR
147. 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
CHAPTER 9
RISK MANAGEMENT PLAN
34
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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 unforeseen
problems.
148. 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
149. The licence conditions set out in Appendix 1 are intended to manage the identified
risks, largely through preventing dissemination of the GMO or its genetic material outside the
release site. The conditions also include contingency provisions to cover any unintended
release of the GMO 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.
150. Detailed reasons for the individual licence conditions are set out in Appendix 2.
151. 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
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.
152. 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.
153. 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 9
RISK MANAGEMENT PLAN
35
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
CHAPTER 10 CONSIDERATION OF ISSUES RAISED IN PUBLIC
SUBMISSIONS
154. 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.
155. 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 (see Chapter 6);

potential for transfer of the introduced genes to other plants (particularly native
Gossypium species) and other organisms and the subsequent impact (see
Chapter 7); and

the potential for development, in target pests, of resistance to the insecticidal
toxin present in the GM cotton (see Chapter 8).
156. 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.
157. 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.
158. 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: [email protected]
http://www.foodstandards.gov.au
CHAPTER 10
CONSIDERATION OF ISSUES RAISED IN PUBLIC SUBMISSIONS
37
DIR 017/2002 - 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: [email protected]
http://www.nra.gov.au
159. 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 10
CONSIDERATION OF ISSUES RAISED IN PUBLIC SUBMISSIONS
38
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
REFERENCES
1. Bernstein IL, Bernstein JA, Miller M, Tierzieva S, Bernstein DI, Lummus Z, Selgrade
MK, Doerfler DL, Seligy VL (1999) Immune responses in Farm workers after exposure
to Bacillus thuringiensis pesticides. Environmental Health Perspectives 107: 575-582.
2. Bevan M (1984) Binary Agrobacterium vectors for plant transformation. Nucleic Acids
Research 12: 8711-8721.
3. Cannon RJC (1993) Prospects and progress for Bacillus thuringiensis-based pesticides.
Pesticide Sciences 37: 331-335.
4. 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.
5. Entwistle PF (1993) Bacillus thuringiensis, An environmental biopesticide: Theory and
Practice. John Wiley and sons, Guilford, UK
6. EPA. (1998) R.E.D. Facts: Bacillus thuringiensis. EPA 738-F-98-001.
7. Fuchs RL, Astwood JD (1996) Allergenicity assessment of foods derived from
genetically modified plants. Food Technology 83-88.
8. IPCS (2000) International programme on Chemical Safety- Environmental health
Criteria 217: Bacillus thuringiensis.
(http://www.inchem.org/documents/ehc/ehc/ehc217.htm).
9. Kimber I, Kerkvliet NL, Taylor SL, Astwood JD, Sarlo K, Dearman RJ (1999)
Toxicology of protein allergenicity: Prediction and characterization. Toxicological
Sciences 48: 157-162.
10. 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.
11. McClintock JT, Schaffer CR, Sjoblad RD (1995) A comparative review of the
mammalian toxicity of Bacillus thuringiensis- based pesticides. Pesticide Science 45:
95-105.
12. OGTR (2002) The Biology and Ecology of Cotton (Gossypium hirsutum) in Australia.
13. 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.
14. Taylor SL, Lehrer SB (1996) Principles and characteristics of food allergens. Review of
Food Science and Nutrition 36(S): S91-S118.
15. US EPA (2001) Biopesticides registration action document: Bacillus thuringiensis
plant-incorporated protectants. US EPA.
REFERENCES
39
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
APPENDIX 1 SPECIFIC LICENCE CONDITIONS
Note in relation to insect resistance
The genetically modified organisms referred to in this licence fall into the Agricultural and
Veterinary Chemicals Code (1994) definition of an agricultural chemical product, due to their
production of insecticidal substances, and are therefore subject to regulation by the National
Registration Authority for Agricultural and Veterinary Chemicals (NRA) as plant pesticides.
The NRA will consider whether any specific insect resistance management strategies are
required in relation to this release.
Accordingly, the OGTR has not, in this licence, imposed conditions in relation to this matter
as it is expected to be satisfactorily managed in the context of the NRA assessment and
approval process.
APPENDIX 1
SPECIFIC LICENCE CONDITIONS
41
DIR 017/2002 - 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
41
DIR 017/2002 - 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.
APPENDIX 1
SPECIFIC LICENCE CONDITIONS
41
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
‘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
41
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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
1.2
1.3
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.
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.
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
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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 be only 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 Shires of Narrabri
and Moree Plains in New South Wales.
1.3
If the GMO is planted, the maximum size of all land planted to the GMO must not
exceed 3 hectares.
1.4
If the GMO is planted, the total number of areas that may be planted to the GMO
must not exceed 3.
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)
APPENDIX 1
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
SPECIFIC LICENCE CONDITIONS
41
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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:
(a)
the effects of the GMO on key pests and beneficial insects; and
(b)
the potential development of pests resistant to the insecticidal activity of the
GMO; and
APPENDIX 1
SPECIFIC LICENCE CONDITIONS
41
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
(c)
the effectiveness of Pollen Traps in preventing gene flow from the GMO to
non-genetically modified cotton.
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)
8.4
destroyed by burning.
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.
APPENDIX 1
SPECIFIC LICENCE CONDITIONS
41
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
Post-harvest monitoring
10.1 Following Cleaning of each Location, the following places must be monitored for the
existence of Volunteer plants:
(a) the Location;
(b) the Pollen Trap in respect of the Location;
(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.
APPENDIX 1
SPECIFIC LICENCE CONDITIONS
41
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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
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)
(b)
(c)
ensure the Regulator is notified immediately if the licence holder becomes
aware of the event;
to destroy any of the GMO, viable GM Material from the GMO, Pollen Trap
plants or viable Material from Pollen Trap plants;
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.
APPENDIX 1
SPECIFIC LICENCE CONDITIONS
41
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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
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.
APPENDIX 1
SPECIFIC LICENCE CONDITIONS
41
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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 the these areas by
the licence holder or persons covered by the licence ensures the licence holder can continue
to meet the obligations of the licence. The Regulator considers that these conditions are
necessary and adequate to manage the risk of gene flow.
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
53
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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
APPENDIX 2
REASONS FOR LICENCE CONDITIONS
54
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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.
APPENDIX 2
REASONS FOR LICENCE CONDITIONS
55
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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.
APPENDIX 2
REASONS FOR LICENCE CONDITIONS
56
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
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
No:
1
I
2
3
C
I
4
A
5
C
SUMMARY OF ISSUES RAISED
CONSIDERATION
OF ISSUE B

…don’t want you to go ahead with trials…not being able
to control the cross pollination problems…unless… you
can control the wind factor Nationally
 …what about our GM free markets for Beef, Grain’s
 …request for draft and final reports
 …so long as it is labeled so that we never have to buy it
or wear it
 …please advise which agencies are responsible for the
issues of herbicide resistance and market impacts
DIR 014/2002
 our comments on 012/2002 remain the same and are
applicable to DIR 014/2002.
Ch 7
OSA
Noted
OSA
Replied by Mail
Application
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
OSA
 … trialed in USA since 1977. Has application been
made for commercial release in the USA…will Australia be
the first?
Noted
 ….no adverse effects… from 30 field trials. ….how are
‘adverse effects’ defined, and what was looked for?
Ch 1
 ….OGTR states [information on RARMPs] can be found
on their website. It assumes that all people have access to
electronic technology. This is not so.
Ch 4, Ch 7
 …two reputable scientists expounding two completely
different views [on CaMV promoter]. Which one has ‘sound
science’ on their side... how does the OGTR determine this?
Noted
 Applaud the lack of the use of an antibiotic resistant
gene.
Trans configuration
 …unease at the use of a trans configuration [[in Ti
in plasmid relates to
plasmids]…trans fatty acids [such as in polyunsaturated
location of DNA
margarine] are not healthy fats…. conceivably could end up
sequences - has
in the diet.
nothing to do with
fats
APPENDIX 3
PUBLIC SUBMISSION SUMMARY
57
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
 …the sale of lint should not be approved.
 While toxicity and allergenicity are considered,
carcinogenicity is not.
 …no data…on the biodegradability of the PAT
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…
inevitably lead to gene stacking with more herbicide use
required, not less.
 Application is considered in a void, as if no other
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
food chain.
 more appropriate to [test the promoters] in a crop which
is intended to go on to commercial production…
 …already been releases…so why is it necessary to
conduct this particular trial.
 …to date there has only been one study conducted on
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
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
communication… all applications should stand alone.
Ch 5
Noted
Ch 5, CBD
OSA
Ch 4
Ch 5
OSA
OSA
Ch 7, CBD
OSA
Documents
available from
OGTR
Ch 4, Ch 7
 …we ask which scientists, either Ho et al, or Hull et al,
Hodgson, are considered to have ‘sound science’ for their
claims and why?
Trans configuration
 …concern with the use of the Ti Plasmid whose
in
plasmid relates to
flexibility allows the vir region to act in either cis or trans
formation…noting the health aspects which resulted from the location of DNA
trans formation with hydrogenation of oils to margarine…we sequences - has
nothing to do with
are asking whether this .. is the same with genetic
fats
modification….
 ….high expression of Cry1Ab protein in leaves and
seeds….some concern as the seeds are used in… food.
 …transfer of introduced genes to organisms other than
cotton. We do not believe this should be so readily
dismissed.
 …because the [expression of the] insecticidal protein is
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
through independent mechanisms…. [Reference provided.]
APPENDIX 3
PUBLIC SUBMISSION SUMMARY
Ch 5
Ch 7, CBD
Ch 8
Noted
58
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
 concern…potential for inducing the synthesis of
poisonous or toxic compounds following the introduction of a
foreign gene.
 …the [EPA] is emphasizing false similarities between
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
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
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
of the larger environmental picture.
 Council does not consider weediness would constitute a
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…
[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
…FSANZ…NRA…OGTR all have partial responsibility.
DIR 017/2002
 This Application….should not have approval to sell
lint…There is so much in this Application that is hidden from
public scrutiny…
 …concerned that the ever increasing number of
modifications will have unforseen adverse effects. Genes do
not work in isolation…
 …the new Bt protein … likely to act via a different
mechanism… therefore impossible to comment upon it or
determine whether or not it represents a hazard.
 antibiotic resistance marker gene…in ‘common use’…no
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
related to a species used for food’…comment cannot be
informed.
APPENDIX 3
PUBLIC SUBMISSION SUMMARY
Ch 5
Ch 5
Ch 5
Ch 4, Ch 5
Ch 4
Noted
Ch 8
Noted
Ch 5
Noted
Ch 3
Ch 4
Noted (CCI)
59
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
Trans configuration
 …the use of the trans configuration resulting from
in plasmid relates to
hydrogenation in the production of margarine…change to
location of DNA
heart and artery health…Has the use of a trans configuration
sequences - has
in this present context been thoroughly investigated?
nothing to do with
fats
6
A
7
I
APPENDIX 3
 Council would be interested to know what is considered
to constitute biosafety problems and how they were looked
for.
 No information on the levels of expression of the
antibiotic resistance gene.
 OGTR has drawn virtually the same conclusions for all
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
produced continually in the plant are different.
 As always there are no studies offered with regard to
carcinogenicity
 …it is not helpful to contributors for the OGTR to keep
referring to RARMPs already approved for other
Applications. All Applications…should stand alone.
 …all RARMP plans are practically identical, whatever
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.
DIR 014, 015, 016, 017 /2002
 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.
 [DIR 017]… there is no scientific guarantee that there is
no risk associated with plantings
 …FSANZ regulations do not guarantee against negative
outcomes…Who is responsible?
PUBLIC SUBMISSION SUMMARY
Ch 4
Noted (CCI)
Ch 9
Noted
Noted
Noted
Ch 4
Ch 5
Ch 4
OSA
60
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
8
APPENDIX 3
I
…biotechnology companies often claim that …GMOs
--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
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
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
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).
PUBLIC SUBMISSION SUMMARY
OSA
OSA
OSA
OSA
61
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
 …integration of the seed and chemical industries…
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
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
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,
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
OSA
OSA
Ch 5
OSA
62
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
 …transgenic plants which produce their own insecticides
closely follow the pesticide paradigm, which is itself rapidly
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
of "integrated pest management" (IPM), which is that reliance
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
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
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
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).
APPENDIX 3
PUBLIC SUBMISSION SUMMARY
OSA, but see Ch 8
(of DIRs 16 & 17)
OSA, but see Ch 8
(of DIRs 16 & 17)
OSA
Noted
OSA
63
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
OSA
 …the use of herbicide resistant crops undermine the
possibilities of crop diversification thus reducing
agrobiodiversity in time and space (Altieri l994).
Chs 6 & 7
 … the potential transfer through gene flow of genes from
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).
Ch 5
 …massive use of Bt crops affects non-target organisms
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).
Ch 5
 …moreover, Bt toxin present in crop foliage plowed
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).
Chs 5 & 7
 …there is potential for vector recombination to generate
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
Noted
 …ecological risks have often been pursued from a narrow
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.
OSA
 …a main concern is that international pressures to gain
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 .
Noted, but see Ch 5
 …there are many unanswered ecological questions
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
APPENDIX 3
PUBLIC SUBMISSION SUMMARY
64
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
 As the private sector has exerted more and more
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
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
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
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
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
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
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.
APPENDIX 3
PUBLIC SUBMISSION SUMMARY
OSA
Noted
OSA
Noted
Noted
OSA
OSA
65
DIR 017/2002 - RISK ASSESSMENT AND RISK MANAGEMENT PLAN
APPENDIX 3
PUBLIC SUBMISSION SUMMARY
66