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Office of the Gene Technology Regulator
APPLICATION FOR LICENCE FOR INTENTIONAL RELEASE OF GMOs
INTO THE ENVIRONMENT: Application No. DIR 044/2003
SUMMARY INFORMATION
Project Title:
Agronomic assessment and seed increase of
transgenic cottons expressing insecticidal genes
(cry1Ac and cry1Fa) from Bacillus thuringiensis
Applicant:
Dow AgroSciences Australia Pty Ltd
Locked Bag 502
Frenchs Forest NSW 1640
Common name of the parent organism:
Cotton
Scientific name of the parent organism:
Gossypium hirsutum L.
Modified trait(s):
Insecticidal and herbicide tolerance
Identity of the gene(s) responsible for the
modified trait(s):

chimeric cry1Ac gene from the bacterium Bacillus
thuringiensis (insecticidal)

chimeric cry1Fa gene from the bacterium Bacillus
thuringiensis (insecticidal)

Proposed Location(s)
pat gene from Streptomyces viridochromogenes
(herbicide tolerance/selectable marker)
Shires of Balonne, Banana, Bauhinia, Emerald,
Millmerran, Murilla, Pittsworth, Waggamba, Wambo and
Warroo in Queensland; Shires of Bourke, Carrathool,
Gunnedah, Moree Plains, Narrabri, Walgett and Warren
in New South Wales; Shires of Wyndham/East
Kimberley and Derby/West Kimberley in Western
Australia and Katherine Municipality in the Northern
Territory.
Proposed Release Size:
A maximum of 25 sites covering up to a total of 10
hectares
Proposed Time of Release
May 2004-May 2006
Season
No of Sites
Total Area (ha)
Winter 2004
1
0.5
Summer 2004/5
11
1.0
Winter 2005
2
4.0
Summer 2005/6
11
4.0
Total
25
9.5
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 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 Dow AgroSciences Australia Limited (Dow
AgroSciences) for a licence for the intentional release of three genetically modified (GM)
insecticidal/herbicide tolerant cotton lines (281-24-236, 3006-210-23 and Widestrike™) into
the environment, on a limited scale and under controlled conditions on up to 25 sites covering a
total area of 10 hectares over 4 seasons (two summer and two winter) from May 2004 to May
2006.
The aims of the proposed release are to test the efficacy of the two-gene insecticidal cotton line
(Widestrike™) against lepidopteran caterpillar pests of cotton as compared to its two parental
lines, containing either transformation events 281-24-236 (introducing the chimeric cry1Fa
gene) or 3006-210-23 (introducing the chimeric cry1Ac gene) and to evaluate their respective
agronomic performance in a range of Australian cotton growing regions. All three lines
contain a herbicide tolerance marker gene that confers tolerance to the herbicide glufosinate
ammonium.
Dow AgroSciences proposes a small scale, multi-site trial in a range of cotton growing regions
and to develop insect resistance management plans. The applicant also intends to measure the
expression levels of the insecticidal proteins in cotton leaves and roots and residues of these
proteins in soil, and to test the effect of GM cotton lines on non-target organisms. Seed would
also be retained for potential future releases, which would require further licence applications
and separate assessment processes.
Some specific Dow AgroSciences documents, which contain details of the gene constructs,
gene sequence information and molecular characterisation of the inserted genetic materials,
have previously been declared as Confidential Commercial Information (CCI) under Section
185 of the Act, in connection with licence application DIR 040/2003. 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.
None of the cotton plants from the release, or their by-products, would be used for animal feed
or human food. Following harvest, plant material remaining at the site will be slashed and
incorporated into the soil by cultivation. Seed from pollen traps will be destroyed. Any
regrowth will be controlled by herbicide and/or cultivation. Seed cotton will be transported in
sealed containers in enclosed vehicles, in accordance with OGTR guidelines.
Previous releases of the GMO
One of the GM cotton lines (Widestrike™ cotton) proposed for release is currently being
trialed under limited and controlled conditions on two sites covering a total area of
0.04 hectares in New South Wales (DIR 040/2003). There have been no previous releases of
either of the two single-gene insecticidal (chimeric cry1Ac or cry1Fa) GM cotton lines in
Australia.
All three cotton lines proposed for release in the current application have been released for field
trials in the United States of America and Argentina since 2001.
Previously, other GM cottons containing cry insecticidal genes derived from the same
bacterium (Bacillus thuringiensis) have been trialed extensively in Australia, as well as
commercially released under licences DIR 022/2002 (INGARD® cotton) and DIR 012/2001
(Bollgard® II cotton). The cry1Ac gene present in both INGARD® and Bollgard® II cottons
differs from the chimeric cry1Ac gene in two GM cotton lines proposed for release in the
current application.
GM plants containing the pat gene have also been trialed previously in Australia (eg. DIRs
010/2001 and 015/2002).
There have been no reports of adverse effects on human health and safety 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 New South Wales and Queensland and on a trial basis in
Western Australia and the Northern Territory.
Genetic modification and its effect
The GM cottons are toxic to the major lepidopteran caterpillar pests of cotton, such as
Helicoverpa species, due to expression of insecticidal genes, chimeric cry1Ac and/or cry1Fa,
derived from the common soil bacterium Bacillus thuringiensis (Bt). Both the genes are
chimeric, cry1Ac consists of part of cry1Ac, cry1Ca3 and cry1Ab1 and cry1Fa has parts of
cry1Fa, cry1Ca3 and cry1Ab1. These genes encode proteins (Bt toxins), Cry1Ac and Cry1Fa.
In addition to the chimeric cry1Ac and/or cry1Fa genes, these cotton lines, contain a selectable
marker gene (pat) from the common soil bacterium Streptomyces viridochromogenes, which
confers tolerance to the herbicide glufosinate ammonium. During development of the GM
cotton lines, this marker gene enabled identification and selection of plant tissues in which
insecticidal gene(s) was (were) also present.
Short regulatory sequences that control expression of the genes are also present in the GM
cottons. These are derived from a plant, Zea mays (corn), and from a common soil bacterium,
Agrobacterium tumefaciens. Although A. tumefaciens is a plant pathogen, the regulatory
sequences comprise only a small part of its total genome, and are not in themselves capable of
causing disease.
Method of gene transfer
The chimeric cry1Ac and cry1Fa genes were introduced separately into cotton plants
(American cotton variety GC510) to generate transformation events 3006-210-23 and
281-24-236, respectively. Each insecticidal gene was introduced in combination with a
selectable marker gene, the pat gene, providing a means of selection of plant cells expressing
the desired modifications. The genes were introduced into cottons on plasmid vectors carried
by A. tumefaciens. The vectors were ‘disarmed’ since they lacked the genes that encode the
tumour-inducing functions of A. tumefaciens.
Following crossing of each event into an elite commercial cotton variety (PSC355, an
American cotton variety), the two insecticidal genes were combined by conventional breeding
to generate the third GM line (Widestrike™ cotton). This GM cotton line contains two copies
of the pat gene.
Consultation on draft 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 scale and 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 a risk assessment and risk management plan (RARMP) has been prepared.
At this stage, the consultation version of the RARMP is expected to be issued for comment in
early March 2004. In the interim, copies of the application are available on request from the
OGTR. Please quote application number DIR 044/2003.
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 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 with the public in finalising the RARMP. The public
will be invited to provide submissions on the RARMP over a consultation period of up to six
weeks, 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: [email protected]
Website www.ogtr.gov.au