Woden, ACT, Australia
September 29, 2004
Early-bird
notification: Coming soon, your chance to comment on the Risk
Assessment and Risk Management Plans for dealings involving
intentional release of genetically modified cottons: DIR
055/2004
Source:
http://www.ogtr.gov.au/pdf/ir/dir055ebnotific.pdf
Application
The Office of
the Gene Technology Regulator (OGTR) has received an application
under section 40 of the Gene Technology Act 2000
(the Act) from Monsanto
Australia Limited (Monsanto) which, if approved, would
involve a limited and controlled release of genetically modified
organisms (GMOs) into the Australian environment.
Details of DIR 055/2004 are as follows:
· Monsanto
Australia Limited is seeking approval to undertake a large scale
field trial of herbicide tolerant (Roundup Ready®
Flex MON 88913) and herbicide tolerant/insect resistant (Roundup
Ready® Flex MON 88913/Bollgard II®)
GM cottons.
· These
GM cottons differ from previous commercially released Roundup
Ready® and Roundup Ready®/Bollgard II®
cottons in that tolerance to glyphosate is prolonged due to the
introduction of two copies of a gene that provides tolerance to
glyphosate, the active ingredient in Roundup®
herbicide. Roundup® can be applied at later stages
of growth than for Roundup Ready® cotton which
contains only one copy of the gene. The applicant states that
the modification is intended to give growers increased
flexibility in timing of herbicide application for integrated
weed management and is not expected to increase the overall
amount of herbicide use.
· The
aims of the proposed trials are to incorporate the Roundup Ready®
Flex MON 88913 (RR Flex) trait into Australian elite cotton
varieties, test the agronomic performance of these varieties and
conventional crosses with Bollgard II® GM cotton,
produce seed and collect data required for future commercial
release applications to the OGTR and other regulators.
· Monsanto
proposes to carry out field trials on up to 99 sites covering a
total area of up to 1811 hectares over two planting seasons (the
2005/06 summer growing season and the 2006 winter growing
season).
Purpose of this
notification
As the Gene Technology Regulator, I would
like to advise people who have previously expressed interest in
knowing about work with GMOs in Australia that they now have the
opportunity to access information about this application,
including the application itself.
You can obtain a copy of the application from
my Office (see contact details below). When contacting the
office, please quote the reference number of the application you
are interested in. As the application is quite lengthy, you may
prefer to view a summary of the application, which is posted on
our website with this document (under “What’s New”). If you
would like to receive a hard copy of the summary, please contact
us and we will post it to you.
A comprehensive ‘Risk Assessment and Risk
Management Plan’ (RARMP) for this application is now being
prepared with input from a broad range of expert groups and
stakeholders, including State and Territory Governments,
relevant local councils, key Australian Government agencies, the
Minister for the Environment and Heritage and the Gene
Technology Technical Advisory Committee. The RARMP is expected
to be released for public comment in mid January 2005.
The Act specifies a 30 day minimum consultation period.
However, at this stage I anticipate allowing six weeks
for submissions to be received.
If you have questions about the application,
or how you can provide comment, please contact us at:
The Office of the Gene Technology Regulator
MDP 54
PO Box 100
WODEN ACT 2606
Tel: 1800 181 030
Fax: 02 6271 4202
Email:
ogtr@health.gov.au
Website
www.ogtr.gov.au
APPLICATION FOR LICENCE FOR INTENTIONAL
RELEASE OF GMOs INTO THE ENVIRONMENT: Application No. DIR
055/2004
DIR 055/2004
- cotton licence application summary (PDF file)
Source:
http://www.ogtr.gov.au/pdf/ir/dir055.pdf
SUMMARY
INFORMATION
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Project
Title: |
Field
trials of herbicide tolerant (Roundup Ready® Flex
MON 88913) and herbicide tolerant/insect resistant
(Roundup Ready® Flex Mon 88913/Bollgard II®)
cottons |
|
Applicant: |
Monsanto Australia Ltd
PO Box 6051
Melbourne, VIC 8008 |
|
Common name of the parent organism:
Scientific name of the parent
organism:
Modified trait(s):
Identity of the gene(s) responsible for the modified
trait(s):
|
Cotton
Gossypium hirsutum
L.
Enhanced herbicide tolerance, insecticidal action,
antibiotic resistance, reporter gene expression
·
cp4 epsps
gene
from Agrobacterium sp. strain CP4 (herbicide
tolerance)
·
cry1Ac
and cry2Ab genes from the bacterium Bacillus
thuringiensis (insecticidal)
·
nptII
gene from the bacterial Tn5 transposon (antibiotic
resistance)
·
uidA
gene from Escherichia coli (reporter gene) |
|
Proposed Location(s) |
New
South Wales (NSW), Queensland (Qld), northern Western
Australia (WA), Northern Territory (NT) (see Appendix
for possible local government areas for releases) |
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Proposed release sizes and dates: |
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Introduction
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 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), an Australian Government regulatory agency
located within the Health and Ageing portfolio.
The legislation
sets out the requirements for considering applications for
licences for dealings with GMOs, which includes the preparation
of a risk assessment and risk management plan (RARMP) for each
proposed intentional release of a GMO into the environment, and
the matters that the Regulator must take into account before
deciding whether, or not, to issue a licence.
The
application and the proposed dealings
The OGTR has
received an application from Monsanto Australia Limited
(Monsanto) for a licence for the intentional release of
genetically modified (GM) herbicide tolerant cotton
(Roundup Ready® Flex MON 88913) and herbicide
tolerant/insect resistant cotton (Roundup Ready® Flex
MON 88913/Bollgard II®) into the environment, under
limited and controlled conditions.
Monsanto proposes to carry out field trials
on up to 99 sites covering a total area of up to 1811 hectares
over two planting seasons, the southern summer growing season
and the northern winter growing season, between September 2005
and November 2006. The summer trials (maximum of 1769 hectares,
including four large sites comprising 100 hectares each) would
be conducted in the cotton growing regions of NSW and southern
Qld, and the winter trials (maximum of 42 hectares) in northern
WA, the NT and northern Qld.
GM Roundup Ready® Flex MON 88913
cotton (abbreviated here as RR Flex cotton) contains two copies
of the cp4 epsps gene that provides tolerance to
glyphosate, the active ingredient in the herbicide Roundup®.
Conventional cotton is susceptible to glyphosate damage. The
use of RR Flex cotton allows the application of the herbicide
Roundup® for the control of weeds that emerge in the
crop, without damaging the crop itself.
RR Flex cotton differs from the previous
commercially released Roundup Readyâ
cotton in that tolerance to Roundup® herbicide is
prolonged. Currently, yield loss occurs if Roundup®
is applied to Roundup Readyâ
cotton beyond the four leaf growth stage. RR Flex cottons are
able to tolerate application of Roundup® at later
stages of plant growth without yield loss, allowing a wider
window to apply herbicide during growth of the cotton crop.
This is intended to give growers increased flexibility in timing
of herbicide application for integrated weed management and is
not expected to increase the overall amount of herbicide use.
Roundup
Ready® Flex MON 88913/Bollgard II®
(RR Flex/Bollgard II®) cotton was produced by
conventional breeding of Roundup Ready® Flex MON
88913 cotton with Bollgard II® cotton which contains
two insecticidal genes (cry1Ac and cry2Ab) that
provide resistance to the major caterpillar pests of cotton.
The aims of the
proposed release are to:
Ø
incorporate the RR Flex trait into elite cotton varieties
suitable for use under Australian conditions;
Ø
test agronomic performance including disease resistance
(bacterial blight, fusarium and verticillium wilt);
Ø
produce seed for future release;
Ø
set up demonstration sites for industry, government, researchers
and the wider community; and
Ø
collect data required for future applications to the OGTR and
other regulators for commercial release such as levels of novel
protein expression and seed composition (required by the OGTR
and Food Standards Australia New Zealand (FSANZ)) and data on
the GM cottons’ tolerance to glyphosate, weed control and
glyphosate residue levels (required by the Australian Pesticides
and Veterinary Medicines Authority (APVMA)).
The APVMA is responsible for the use and
safety of herbicides in Australia. Glyphosate is currently not
registered for use on cotton beyond the four leaf stage of
growth. A research permit from the APVMA for use of glyphosate
after this stage on RR Flex (and RR Flex/Bollgard II) cotton
will be required for the proposed field trials. If the trials
were successful and a new pattern of glyphosate use were
proposed in relation to commercial release of RR Flex cotton,
this would require registration by the APVMA. Further
information about the APVMA can be obtained from
www.apvma.gov.au.
None of the cotton plants from the release,
or their by-products, would be used for animal and human food.
An approval from FSANZ would be required before oil from RR Flex
cotton could be used for human consumption. However, the
applicant proposes to sell lint from the release for use as
fibre in the textile industry. Lint does not contain genetic
material or protein.
Transport and storage of the GM material
would be conducted in accordance with the guidelines issued by
the Regulator. Following harvest, plant material remaining at
the site will be removed and/or destroyed. Any cottonseed not
kept for research purposes or possible future releases (which
would require separate applications) would also be destroyed.
Details of the
gene construct, including the plasmid map and some of the
regulatory sequences have previously been declared as
Confidential Commercial Information (CCI) under section 185 of
the Act, in connection with licence application DIR 35/2003.
However, the CCI will be made available to the various
prescribed expert groups that will be consulted on the
preparation of the risk assessment and risk management plan for
this application.
Previous
releases of the GMOs
RR Flex and RR Flex/Bollgard IIâ
cotton were previously approved for limited and controlled
releases under licence DIR 35/2003. These field trials (total
area of 946 hectares) are being conducted from 2003 to 2005 in
NSW, Qld, NT and northern WA. The DIR 35/2003 licence
conditions contain a requirement to conduct a research program
that would assist the evaluation of future applications. Data
gathered from the 2003/04 summer trials are provided in the
current application and data from the 2004 winter trials will be
available prior to the finalisation of the RARMP for this
application.
Roundup Ready® cotton, containing
one copy of the cp4 epsps herbicide tolerance
gene, was approved for general (commercial) release in 2000
(GR-9), by the Minister for Health and Aged Care, on the basis
of advice from GMAC (Genetic Manipulation Advisory Committee).
After
commencement of the Act, on 21 June 2001,
Roundup Ready® cotton was
re-assessed in accordance with the requirements of the
regulatory system and the Regulator issued a licence for
commercial release in June 2003 (DIR 023/2003). Roundup Ready®
cotton is tolerant to the application of the herbicide Roundup®
only up to the four leaf stage of growth.
Bollgard II® and Bollgard II®/Roundup Ready®
cotton were approved for commercial release by the Regulator in
2002 (licence DIR 012/2002).
All of these commercial releases were
restricted to the cotton growing regions of NSW and Qld south of
latitude 22º South because of concerns about the potential
weediness of the GM cottons in the northern tropical areas. The
licence also authorised some field trials under limited and
controlled conditions north of latitude 22º South to gather data
to further evaluate this issue.
Prior to obtaining approval for commercial
release, numerous limited and controlled releases of Roundup
Ready®, Bollgard II® and Roundup Ready®/Bollgard
II® cotton were conducted under the voluntary system
overseen by GMAC, and four licences for limited and controlled
releases of Bollgard II® and Roundup Ready®/Bollgard
II® cotton were approved by the Regulator, as listed
below:
Roundup Ready® cotton - 23 limited
and controlled releases undertaken by:
·
CSIRO Division of Plant Industry (PR-55, PR-55X, PR-55X2,
PR-55X3 and PR-55X5 and PR-55X6);
·
Deltapine Australia Pty Ltd (PR-32, PR-52, PR-52X, PR-52X2,
PR-52X3, PR-71, PR-71X, PR-71X2, PR-83, PR-83X, PR-83X3, PR-140,
PR-140X and PR-143);
·
Monsanto (PR-83X2 and PR-83X4); and
·
Cotton Seed Distributors Pty Ltd (PR 55-X4).
Bollgard II® and Roundup Ready®/Bollgard
II® cotton - 20 limited and controlled releases
undertaken by:
·
CSIRO Division of Plant Industry (PR-123, PR-123X, PR-123X2,
PR-131, PR-131X, PR-131X2, PR-131X3);
·
Deltapine Australia Pty Ltd (PR-51X4, PR-112, PR-112X, PR-112X2,
PR-118, PR-118X, PR-118X2);
·
Cotton Seed Distributors (Bollgard II® and
Bollgard II®/Roundup Ready® cotton in Qld;
DIR 005/2001);
·
CSIRO (INGARD®, Bollgard II® and
Bollgard II®/Roundup Ready® cotton in WA
and NT; DIR 006/2001);
·
Department of Agriculture (WA) (Bollgard II® cotton
in WA; DIR 009/2002); and
·
Monsanto (Bollgard II® and Roundup Ready®/Bollgard II®
cotton in northern WA, NT and northern Qld; DIR 012/2002).
There have been no reports of adverse effects
on human health or the environment resulting from these
releases.
Parent organism
The parent organism is cultivated cotton (Gossypium
hirsutum L.), which is exotic to Australia and is grown as
an agricultural crop in NSW and southern Qld and on a trial
basis in northern Qld, WA and the NT.
Genetic modification and its effect
RR Flex cotton contains two copies of a
herbicide tolerance gene, cp4 epsps, derived from a
common soil bacterium, Agrobacterium sp. strain CP4. The
native plant cp4 epsps gene encodes an enzyme that is
critical for the synthesis of aromatic amino acids (essential
building blocks for proteins). Glyphosate, the active
ingredient in Roundup® herbicide inhibits this enzyme
and as a result kills conventional cotton. The bacterial gene
encodes an enzyme that is not as sensitive to glyphosate as the
plant’s own equivalent enzyme.
Roundup Ready® cotton contains
only one copy of the cp4 epsps gene and has little
tolerance to glyphosate in reproductive tissues. This means
that glyphosate can currently only be applied up to the four
leaf stage of growth (ie prior to flowering) to control weeds,
as after this stage, application of the herbicide can lead to
yield loss. The applicant has indicated that, as RR Flex cotton
has prolonged expression of the cp4 epsps gene and is
tolerant to glyphosate at later stages of growth, the window in
which glyphosate can be applied for weed control is longer,
giving growers increased flexibility in timing herbicide
applications for integrated weed management.
RR Flex/Bollgard II® cotton was
obtained by conventional crossing of the two GM varieties. The
plants contain, in addition to the herbicide tolerance genes,
two insecticidal genes cry1Ac and cry2Ab, derived
from a common soil bacterium, Bacillus thuringiensis
(Bt). The insecticidal genes encode proteins that are toxic to
lepidopteran caterpillars, including the two key Helicoverpa
pests of cotton.
No antibiotic resistance marker genes are
present in RR Flex cotton. However, RR Flex/Bollgard II®
plants contain bacterial genes, as a result of the crossing with
Bollgard II®, conferring resistance to the
antibiotics kanamycin and neomycin (nptII gene), and
streptomycin and spectinomycin (aad gene). The aad
gene is not expressed in the plants because the bacterial
regulatory sequence that controls its expression is not active
in plants. This gene was used in the laboratory prior to the
production of the genetically modified plants to select for
bacteria containing the modified DNA.
A reporter gene (uidA) from the bacterium
Escherichia coli is also present in the
RR Flex/Bollgard II® cotton plants. This gene
encodes the enzyme
b-glucuronidase
(GUS) that enables visual identification of plant tissues in
which it is being expressed.
Short regulatory sequences that control
expression of the genes are also present in the genetically
modified cottons. These sequences are derived from the
cauliflower mosaic virus, figwort mosaic virus, Agrobacterium
tumefaciens and from soybean and two other plant
species. Although the first three of these organisms are plant
pathogens, the regulatory sequences comprise only a small part
of their total genome and are not in themselves capable of
causing disease.
Method of genetic modification
The two copies of the cp4 epsps
gene and associated regulatory sequences were introduced into
Roundup Ready® MON 88913 cotton on a plasmid vector
carried by Agrobacterium tumefaciens. The vector
is ‘disarmed’ since it lacks the genes that encode the
tumour-inducing functions of A. tumefaciens.
Bollgard II® cotton was derived by
particle bombardment of the cry2Ab and uidA genes
into the GM INGARD® cotton containing the cry1Ac,
nptII and aad genes. This technique involves
coating the DNA containing the cry2Ab and uidA
genes onto very small particles which were ‘shot’ into the
cotton tissue, followed by selection of plants that contained
single, functional copies of the genes.
RR Flex/Bollgard II® cotton was
generated through conventional breeding of GM RR Flex and GM
Bollgard II® cotton.
Consultation on preparation of the Risk
Assessment and Risk Management Plan
The Regulator has made an initial assessment
as to whether the proposed release may pose significant risks to
human health and safety or the environment, in accordance with
section 49 of the Act. Due to the low risk potential of the
GMOs, the control measures that will be imposed, and the limited
scope of the dealings, the Regulator has decided that the
proposed release does not pose a significant risk to human
health and safety or the environment.
This means that the Regulator is not
required to seek public comment on the assessment of this
proposal until after a risk assessment and risk management plan
(RARMP) has been prepared. In the interim, copies of the
application are available on request from the OGTR. Please
quote application number DIR 055/2004.
In preparing the RARMP, the Regulator will
seek input from a wide range of key stakeholders and expert
groups comprising State and Territory Governments, relevant
Australian Government agencies, the Minister for the Environment
and Heritage, the Gene Technology Technical Advisory Committee
and appropriate local councils, as required by section 50 of the
Act. In accordance with section 52 of the Act, the Regulator
will again consult with these prescribed agencies and
authorities and the public in finalising the RARMP.
At this stage, the
consultation version of the
RARMP is expected to be issued for a six week
consultation period in mid January 2005. The public will
be invited to provide submissions on the RARMP via
advertisements in the media and direct mail to anyone registered
on the OGTR mailing list. Summaries and copies of the RARMP
will be available from the OGTR, or on the OGTR website.
If you have any questions about the
application or the assessment process, please contact the OGTR
at:
The Office of the Gene Technology Regulator
MDP 54
PO Box 100
WODEN ACT 2606
Tel: 1800 181 030
Fax: 02 6271 4202
Email:
ogtr@health.gov.au
Website
www.ogtr.gov.au
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