SUMMARY INFORMATION
 

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 Bayer CropScience Pty Ltd (Bayer) for a licence to intentionally release genetically modified (GM) herbicide tolerant cotton (LLCotton25) into the environment.  The aim of the proposed release is to commercially release LLCotton25 into the Australian agricultural system, and undertake ongoing product research and development.

No specific containment measures have been proposed and Bayer intends that the GM cotton plants and their products would be used in the same manner as conventional and other GM cotton. Hence, the dealings would include use in human food (subject to approval, see below) transportation and use as stockfeed anywhere in Australia, sale of lint and exporting seed. 

LLCotton25 contains the bar gene which confers tolerance to the herbicide glufosinate ammonium (also called phosphinothricin), the active constituent of the herbicides Basta^®, Finale^®, Buster^® and Liberty^®.  LLCotton25 plants can be sprayed with glufosinate ammonium to kill problem weeds without damaging the crop itself. 

Bayer requests approval to commercially plant LLCotton25 wherever conditions are suitable for cotton cultivation. The rate of market uptake will be determined by market acceptance, and seed and variety availability.  However, the applicant anticipates a phased introduction over 3 years, involving large scale grower evaluations and seed increases, and the development of additional lines adapted for particular regional conditions.  Initially, Bayer expects the most substantial adoption of the GM cotton to occur in the existing cotton growing regions of New South Wales (NSW), Queensland (QLD), followed by uptake in potential future cotton growing areas in these states, the Northern Territory (NT), four shires in Western Australia (WA), and two shires close to the NSW border in both South Australia (SA) and Victoria (VIC).  Small scale use for demonstrations and educational purposes is also proposed outside these areas.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has regulatory responsibility for the use of herbicides in Australia.  Bayer currently has a research permit for small scale use of glufosinate ammonium on the GM cotton, and intends to submit an application to the APVMA to register the herbicide for commercial scale use.

Cotton seed is processed for oil that is used in a variety of food products and for cotton linters (a type of short fibre that does not contain any genetic material) that are used as a cellulose base for several consumer food products.  Bayer has submitted an application to Food Standards Australia New Zealand (FSANZ) for approval of oil and linters derived from LLCotton25 for human food use. 

Previous releases of the and other GM Cottons

Under the former voluntary system overseen by the Genetic Manipulation Advisory Committee (GMAC), CSIRO conducted five limited and controlled releases of LLCotton25, known as Liberty^® cotton {PR-82, PR82X, PR-124, PR-124X and PR-124X(2)}.  Two trials have been approved the current regulatory system (DIR 015/2002 and DIR 038/2003).  The locations were in NSW and QLD and the size of the trials ranged from 0.04 to 135 hectares. 

Other GM cottons containing either the bar herbicide tolerance gene, or the related pat gene, have been (DIR 016/2002), or are currently being (DIR 036/2003, DIR 040/2003 and DIR 044/2003), trialed in NSW, QLD, WA and the NT.

Previously issued DIR licences for the commercial release of GM cotton (DIRs 12/2002, 22/2002 and 23/2002) authorise the commercial scale planting of insecticidal and/or insecticidal/herbicide tolerant varieties. Due to uncertainty whether insecticidal genes confer a survival advantage in northern Australia, where insect feeding may be a factor in limiting their survival and spread, the release of these GM cottons is only permitted under limited and controlled conditions north of latitude 22°S, pending the conduct of further research. LLcotton25 does not contain any insecticidal genes and is tolerant to a different, less widely used herbicide.

There have been no reports of adverse effects on human health and safety or the environment resulting from any previous releases.

Parent organism

The parent organism is cultivated cotton (Gossypium hirsutum), which is exotic to Australia and is grown as an agricultural crop in NSW and southern QLD and on a trial basis in WA, the NT and northern QLD.

The cotton variety Coker 312 was used to produce the initial GM plants because of its ease of use in the tissue culture system used in the genetic modification process.  The GM cotton varieties proposed for release are backcross progeny of conventional crosses between LLCotton25 and a number of elite Australian cotton cultivars that are suitable for current Australian cotton production areas.

Genetic modification and its effect

The GM cotton plants contain a single copy of the bar gene derived from the common soil bacterium Streptomyces hygroscopicus.  The bar gene encodes the phosphinothricin acetyltransferase (PAT) enzyme, which converts glufosinate ammonium, the active constituent in Basta^® and Liberty^® herbicides, into an inactive form.

The bar gene confers tolerance to the herbicide glufosinate ammonium in both laboratory cultures during the initial stage of selection of GM plants and when applied to whole plants in the field.  No other selectable marker was used.

Short regulatory sequences that control expression of the gene are also present in the GM cotton.  These are derived from Cauliflower mosaic virus and the common soil bacterium Agrobacterium tumefaciens.  Although these two organisms are plant pathogens, the regulatory sequences comprise only a small part of their total genomes, and are not in themselves capable of causing disease.

Method of genetic modification

The bar gene was introduced into cotton on a plasmid vector carried by A. tumefaciens.  The vector is ‘disarmed’ since it lacks the genes that encode the tumorigenic functions of A. tumefaciens.  This method has been widely used in Australia and overseas for introducing new genes into plants without causing any biosafety problems.

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. The Regulator has decided that the proposed release does not pose a significant risk to human health and safety or the environment for the following reasons:

Ø      there have been a number of field trials of this GMO and commercial releases of other GM cottons in Australia with no reported adverse effects on human health and safety or the environment;

Ø      based on the initial analysis of the application, the risk of toxicity, allergenicity, pathogenicity, weediness and outcrossing to native cottons and other plant species are considered negligible; and

Ø      this GM cotton does not contain any introduced insecticidal genes which may provide a survival advantage in northern Australia where the insect pressure is high and could limit the persistence and spread of cotton.

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 056/2004.

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 as well as the public in finalising the RARMP.

At this stage, the consultation version of the RARMP is expected to be issued for an extended 8 week consultation period in January 2004.  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.

Issues to be considered by the Regulator

In making a decision on whether to issue a licence for the proposed release, the Regulator is required to consider applications and submissions within the context of the object of the Act, which focuses upon protecting the health and safety of people and the environment.

Please note that issues such as food labelling, the use and safety of herbicides, marketability and trade implications do NOT fall within the scope of the evaluations conducted under the Act as these are the responsibility of other agencies and authorities.

Further information about food safety assessments and food labelling, and the use and safety of herbicides are available from FSANZ and the APVMA, respectively:

Food Standards Australia New Zealand
PO Box 7186
Canberra Mail Centre  ACT  2610
Phone:  (02) 6271 2222
Fax:  (02) 6271 2278
E-mail:  info@foodstandards.gov.au
http://www.foodstandards.gov.au
 

Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON  ACT  2604
Phone: (02) 6272 5158
Fax:  (02) 6272 4753
Email: contact@apvma.gov.au
http://www.apvma.gov.au


Issues relating to impacts upon marketability and trade implications posed by the commercialisation of GM crops in Australia were intentionally excluded from the assessment process as they fall within the jurisdiction of State and Territory Governments.

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

Early-bird notification:

Coming soon

Your chance to comment on the Risk Assessment and Risk Management Plan for dealings involving commercial release of genetically modified cotton: DIR 056/2004

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 Bayer CropScience Pty Ltd (Bayer) which, if approved, would involve a commercial release of a genetically modified organism (GMO) into the Australian environment.

Summary details of DIR 056/2004 are as follows:

The licence application proposes the commercial release of GM cotton (Gossypium hirsutum) into the Australian agricultural environment, without specific containment measures, wherever conditions are suitable for cotton cultivation.  The GM cotton (LLCotton25, formerly known as Liberty^® cotton) has been modified to be tolerant to the herbicide glufosinate ammonium (the active constituent of the herbicides Basta^®, Finale^®, Buster^® and Liberty^®). Bayer anticipates a phased introduction over three years to commercial scale planting of the GM cotton commencing in the current cotton growing regions of New South Wales (NSW) and Queensland (QLD).  Approval is also sought for commercial scale plantings in other potential cotton growing areas in NSW, QLD, the Northern Territory, four shires in northern Western Australia, and two shires each in South Australia and Victoria close to the NSW border. Small scale use outside these areas for demonstration and educational purposes is also proposed.

Bayer intends that the GM cotton and its products would be used in the same manner as conventional and other GM cottons, including human food use (subject to approval by Food Standards Australia and New Zealand), transportation and use as stockfeed in all areas of Australia, sale of lint, and export of seed.

Notwithstanding my assessment (which will evaluate risks to people and/or the environment from the intentional release of LLCotton25), cultivation of this GMO may be otherwise restricted in some States and Territories by laws that prohibit the commercial release of certain GMOs on marketing grounds. Accordingly, in addition to any licence that may be issued by me under the Act and corresponding State and Territory gene technology regulation laws, the commercial release of LLCotton25 in some jurisdictions may require additional approvals from that State or Territory Government.

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.  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 late January 2005.  The Act specifies a 30 day minimum consultation period.  However, at this stage I anticipate allowing eight weeks for submissions to be received.

In the interim, members of the public are welcome to advise me of issues relating to risks to human health and safety and to the environment that they believe may be posed by the proposed release and which they believe should be considered in the preparation of the risk assessment and risk management plan.  (Please note that issues such as food labelling, herbicide use, and marketability or trade implications posed by the commercialisation of GM crops in Australia do not fall within the scope of assessments conducted under the Act).

In order to assist us to take this feedback into account and meet our timeframes, I would be grateful if it could be provided in writing and reach this office by 15 December 2004.

If you have questions about the application, or how you can provide comment, please contact us at:

The Office of the Gene Technology Regulator
PO Box 100
Woden,  ACT,  2606
Website:  www.ogtr.gov.au
E-mail:  ogtr@health.gov.au
Phone:  1800 181 030
Fax:  (02) 6271 4202

If you are interested in knowing more about the Gene Technology Act 2000 and development of the regulatory system, please visit this link: http://www.ogtr.gov.au/about/index.htm.

(Dr) Sue D Meek
Gene Technology Regulator
3 November 2004

Questions & Answers on Licence Application DIR 056/2004 for Commercial Release of Genetically Modified Cotton

What is this application for?

Bayer CropScience (Bayer) is seeking approval to commercially release genetically modified (GM) cotton, including cultivation, transport and sale of LLCotton25 and its products as well as ongoing product research and development. The GM cotton (formerly known as Liberty^® cotton) is tolerant to glufosinate ammonium, the active constituent of the herbicides Basta^®, Finale^®, Buster^® and Liberty^®. The genetic modification will allow the plants to be sprayed with glufosinate ammonium to kill problem weeds without damaging the crop itself.

How is glufosinate ammonium currently used?

Currently the Australian Pesticides and Veterinary Medicines Authority has registered glufosinate ammonium for use on fruit crops and vines and in some non-agricultural areas. Bayer would need to obtain permission to extend this use to LLCotton25 (see other regulatory approvals below). Glufosinate ammonium is not used in broad-acre cropping in Australia, except on InVigor^â, a hybrid GM canola which was also modified to be tolerant to glufosinate ammonium, should this be permitted for commercial scale growing by States and Territory Governments.

Where is cotton currently grown in Australia?

Cotton is grown mainly in central and north-western NSW and central and southern QLD. Around 70% of Australia’s cotton is produced in NSW, with the major production area stretching south from the Macintyre River and embracing the Gwydir, Namoi and Macquarie valleys, as well as regions along the Baron and Darling Rivers and smaller areas south. The remaining cotton is grown in QLD- in the Darling Downs, St George, Dirranbandi and Macintyre Valley in the state’s south, and Emerald, Theodore and Biloela, in central QLD (1).

Where would the proposed commercial release occur?

Bayer proposes to commercially plant LLCotton25 wherever conditions are suitable for cotton cultivation in Australia. Bayer proposes a phased introduction over 3 years (commencing mid-late 2005) to commercial scale planting of the GM cotton commencing in the current cotton growing regions of New South Wales (NSW) and Queensland (QLD).  Approval is also sought for commercial scale plantings in other potential cotton growing areas in NSW, QLD, the Northern Territory (NT), four shires in northern Western Australia (WA), and two shires each in South Australia and Victoria close to the NSW border. Small scale use outside these areas for demonstration and educational purposes is also proposed.

Is this the first release of this herbicide tolerant GM cotton?

No.  Five limited and controlled releases (field trials) of LLCotton25, then known as Liberty^® cotton, were authorised under the former voluntary system overseen by the Genetic Manipulation Advisory Committee, and two limited and controlled releases of LLCotton25 have been approved under the current regulatory system (DIR 015/2002 and DIR 038/2003). Four licences for trials of other GM cottons containing the same or similar introduced genes have also been approved under the current regulatory system. These trials were conducted in NSW, QLD, WA and the NT. There have been no reports of adverse effects on human health or the environment resulting from these releases.

Is this application different from other commercial GM cotton approvals ?

Yes.  The three types of GM cottons already approved for commercial release include two insecticidal cottons, Ingard^â and Bollgard^â II (that provide resistance to the major caterpillar insect pests of cotton), Roundup Ready^â herbicide tolerant cotton (that provides tolerance to the herbicide glyphosate), and combinations of insecticidal and herbicide tolerant GM cottons derived by conventional crossing. The assessment of these applications identified uncertainty whether reduced insect herbivory (grazing) might enable insecticidal GM cottons to survive better than conventional (non-GM) cotton in northern Australia. Because of this, only limited and controlled trials of these GM cottons have been allowed north of latitude 22° S to conduct further research on the potential weediness of insecticidal cottons in tropical conditions.  However, this current application is for herbicide tolerant cotton only.  It has no introduced insecticidal properties and is not expected to have any competitive environmental advantages over conventional cotton, except where the herbicide to which it is tolerant is applied (see glufosinate ammonium use above).  The similarities and differences between this cotton and previously approved cottons will be examined in detail during the assessment of this application.

Will other regulatory approvals be required?

The OGTR operates in an integrated regulatory framework with other regulatory authorities that have complimentary responsibility and specialist expertise. As well as avoiding duplication, this arrangement also enhances coordinated decision making. The applicant will also require approvals from the Australian Pesticides and Veterinary Medicines Authority to apply glufosinate ammonium to LLCotton25 for weed control, and from Food Standards Australia New Zealand for the use of oil and linters in human food.

How will this application be assessed?

Under the Commonwealth Gene Technology Act 2000  and corresponding State and Territory legislation, the release of genetically modified organisms (GMOs) is prohibited unless the Gene Technology Regulator (the Regulator) is satisfied that potential hazards to human health and safety or the environment have been comprehensively assessed, and that any identified risks can be managed.

A range of expert groups and authorities including other Australian government regulators (especially the APVMA and FSANZ), the Environment Minister, the Gene Technology Technical Advisory Committee, State and Territory governments,  and local councils where LLCotton25 may be commercially cultivated, have been invited to comment on matters regarding risks to human health and safety and the environment which should be taken into account in preparing the risk assessment and risk management plan (RARMP) for this application.

The consultation version of the RARMP will then be prepared by the Office of the Gene Technology Regulator (OGTR) and the Regulator will invite public comment and feedback from the same prescribed expert groups and authorities that were consulted on the application. Once submissions have been received, the Regulator will take comments relating to risks to human health and safety and to the environment into account in deciding whether, or not, to issue a licence for the commercial release to proceed.

How can I have my say?

The Risk Assessment and Risk Management Plan for this application is expected to be released in late January 2005 for public comment over an eight week period.  Further information on this application, the assessment process (and the RARMP when it is released) is available on the OGTR website: www.ogtr.gov.au.

If you are interested in receiving information about the work of the OGTR on an ongoing basis you can also register on our electronic or postal mailing lists on the website or by contacting the  Office on Freecall 1800 181 039.