Download DIR 115 - Licence Summary Information

22 February 2012
APPLICATION FOR LICENCE FOR INTENTIONAL RELEASE OF GMOs INTO THE
ENVIRONMENT: Application No. DIR 115
SUMMARY INFORMATION
Project Title:
Limited and controlled release of cotton genetically modified for enhanced
fibre yield1
Applicant:
The Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Common name of the
parent organism:
Cotton
Scientific name of the
parent organism:
Gossypium hirsutum L.
Modified trait(s):
Enhanced fibre yield
Antibiotic resistance as selectable marker
Identity of the gene(s)
responsible for the
modified trait(s):
GhMYB25, GhMYB25-like and GhHD1 genes from cotton (G. hirsutum L.) for
enhancing fibre yield.
Proposed Location(s):
One site per growing season in Narrabri, NSW.
Proposed Release Size:
Up to 0.5 ha per growing season
Proposed Release Dates:
August 2012–August 2015
nptII from the bacterium Escherichia coli for antibiotic resistance.
Introduction
The Gene Technology Act 2000 (the Act) in conjunction with the Gene Technology Regulations
2001, an inter-governmental agreement and corresponding legislation that is being enacted in
each State and Territory, comprise 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 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 requirements for considering applications for licences for dealings with
GMOs, including matters that the Regulator must take into account before deciding whether or
not to issue a licence. The Regulator’s Risk Analysis Framework2 outlines the assessment process
that will be followed.
The title of the licence application submitted by CSIRO is ‘Evaluation of GM traits to enhance cotton fibre yield’.
The Risk Analysis Framework and further information on the assessment of licence applications is available from
the Office of the Gene Technology Regulator (OGTR). Free call 1800 181 030 or at <http://www.ogtr.gov.au>.
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The application and the proposed dealings
The Regulator has received an application from CSIRO for a licence for dealings involving the
intentional release of genetically modified (GM) cotton into the Australian environment on a
limited scale under controlled conditions.
CSIRO proposes to release up to eight GM cotton varieties with enhanced expression of up to
three cotton transcription factor genes involved in fibre development. Enhancing expression of
these genes is expected to improve fibre yield.
The purpose of the trial is to evaluate the potential for increasing cotton fibre yield under field
conditions.
The applicant proposes to limit the trial to 1 site per growing season in Narrabri, New South
Wales between August 2012 and August 2015. The maximum area of a site will be 0.5 ha.
The applicant has proposed a number of control measures to restrict the spread and persistence of
the GMOs and their introduced genetic material that will be considered in the assessment of this
application, including:

locating the trial site at a location not prone to flooding or surface run-off

surrounding the trial site by a 20 m wide pollen trap of non-GM cotton

locating the trial site at least 50 m away from cotton lines used for breeding purposes

harvesting and ginning of GM cotton from the trial separately from any other cotton

cleaning of equipment, trial site and adjacent areas following harvest

cleaning of gins following ginning of GM cotton

destroying seed not used for evaluation or seed increase

post-harvest monitoring of the trial site, pollen trap area and any area used to clean
equipment for a period of 12 months and destroying any volunteer GM cotton

transporting and storing all GM plant material according to the Regulator’s Guidelines for
the Transport, Storage and Disposal of GMOs

not allowing GM plant material to enter the commercial human food or animal feed supply.
Parent organism
The parent organism, cultivated cotton (Gossypium hirsutum L.), is exotic to Australia but is
grown as an agricultural crop in New South Wales and southern and central Queensland, and on a
trial basis in northern Queensland and the Northern Territory. Commercial cultivation of cotton
resumed in the Ord river irrigation area in Western Australia in 2011 after almost 30 years.
G. hirsutum cultivar Cocker 315 has been utilized to develop the GM cotton lines proposed for
release. This cultivar has been adapted to tissue culture conditions and can be readily modified by
standard genetic technologies. However, it is not commercially grown in Australia.
The genetic modification and its effect
The eight cotton varieties proposed for release are genetically modified by introduction of
additional copies of one or more of three cotton genes, GhMYB25, GhMYB25-like and GhHD1.
These introduced genes are under control of regulatory sequences that will lead to their overexpression either constitutively (ie. throughout the plant) or in a seed specific manner. Both
GhMYB25 and GhMYB25-like encode proteins in the myeloblastosis (MYB) family of
transcription factors, while GhHD1 encodes a homeodomain (HD) protein-like transcription
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factor. All three genes are preferentially expressed in cotton ovules at the onset of fibre cell
development, have very low expression in the ovules of fibreless mutants and have been
implicated in cotton fibre development. Higher expression of these genes in cotton is expected to
increase fibre yield.
Method of genetic modification
Six of the eight GM cotton varieties proposed to be released were generated by Agrobacteriummediated gene transformation, which is a well established method of plant transformation for
number of plant species including cotton. These lines over-express any one of the GhMYB,
GhMYB25-like or GhHD1 genes in a constitutive or seed-specific manner. The remaining two
varieties will be developed by cross-breeding between these six GM cotton varieties
Previous releases of the same or similar GMOs
There has been no previous release of these GM cotton varieties in Australia.
GM cotton containing genes for herbicide tolerance and/or insect resistance, fungal disease
resistance, tolerance to water logging, increased water use efficiency and altered seed oil
composition have been approved in Australia for limited and controlled release. In addition, GM
cotton containing genes for insect resistance and/or herbicide tolerance are approved for
commercial release in Australia under the trade names Bollgard II®, Roundup Ready®, Roundup
Ready Flex®, Liberty Link® and WideStrike™.
There have been no reports of adverse effects on human health and safety or the environment
resulting from any of these releases.
Suitability of Applicant
Section 43(2)(f) of the Act requires the Regulator to be satisfied regarding the suitability of the
applicant to hold a licence as a pre-requisite for considering DIR applications. The matters to be
considered are outlined in section 58 of the Act and include capacity to meet the conditions of a
licence, relevant convictions and revocation of a licence or permit held under law relating to the
health and safety of people or the environment.
The Regulator has determined that CSIRO currently meets the suitability requirements and will
verify this continues to be the case prior to making any decision regarding the issuing of a
licence.
Consultation process for this DIR application
The Regulator has decided that the application qualifies as a limited and controlled release,
under section 50A of the Act. The principal purpose of the application is to enable the conduct of
experiments and the applicant has proposed limits on the size and duration of the release and
controls to restrict the spread and persistence of both the GMOs and their genetic material in the
environment.
This means that the Regulator is not required to consult on the assessment of this application until
after a consultation Risk Assessment and Risk Management Plan (RARMP) has been prepared in
accordance with section 51 of the Act. In the interim, copies of the application are available on
request from the OGTR. Please quote application number DIR 115.
The Regulator will seek comment on the consultation RARMP from the public as well as a wide
range of experts, agencies and authorities including the Gene Technology Technical Advisory
Committee, State and Territory Governments, Australian Government agencies and the Minister
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for the Environment. The RARMP will then be finalised, taking into account matters raised
relating to risks to human health and safety and the environment, and form the basis of his
decision whether or not to issue a licence.
At this stage, the RARMP is expected to be released for comment in May 2012. 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. The RARMP and other related documents
will be available on the OGTR website, or in hard copy from the OGTR.
If you have any questions about the application or the assessment process, or wish to register on
the mailing list, please contact the OGTR at:
The Office of the Gene Technology Regulator, MDP 54 GPO Box 9848 Canberra ACT 2601
Telephone: 1800 181 030 Facsimile: 02 6271 4202 E-mail: [email protected]
Website http://www.ogtr.gov.au
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