Australia’s Gene Technology Regulator (the Regulator) is responsible for administering the national regulatory system that seeks 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.

The Regulator has received an application from Monsanto Australia Limited (Monsanto) for a licence which, if approved, would enable the continued commercial release of a genetically modified cotton:

• DIR 022/2002 proposes continued commercial release of a genetically modified insecticidal (INGARD^Ò) cotton (Gossypium hirsutum) into the environment in the existing cotton growing areas of New South Wales and Queensland, south of latitude 22° South. INGARD^® cotton contains an insecticidal gene, derived from a common soil bacterium. This gene produces a protein that is toxic to certain insects, including the major caterpillar pests of cotton. INGARD^® cotton also contains a selectable maker gene that codes for antibiotic resistance. The commercial release of INGARD^Ò  cotton was originally approved under the previous voluntary system. The ‘deemed’ licence (GR-3) that was issued as part of the transitional arrangements to the new regulatory system is due to expire in June 2003.

Following consultation with the expert groups and authorities prescribed in the Gene Technology Act 2000 (the Act), the Regulator has prepared a risk assessment and risk management plan, including proposed licence conditions, in respect of the proposed activities for the licence application.

In accordance with the Act, the Regulator invites written submissions from the public and interested organisations on matters relating to the protection of human health and the environment in order to finalise this plan. Please note that issues such as food labelling, the use and safety of insecticides and 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.

Copies of the risk assessment and risk management plan, as well as summary information, can be obtained from the Office of the Gene Technology Regulator’s website or from the address below. Copies and summaries of the licence application are also available from the Office of the Gene Technology Regulator. Please quote the relevant application number.

Submissions should be forwarded to the Regulator by close of business on 14 March 2003.

* Approval of this application would enable the continued commercial-scale the release of the GMO that was authorised to proceed under the previous voluntary system and a ‘deemed’ licence, which expires in June 2003, issued when the new regulatory system came into effect.

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), a Commonwealth 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.

In accordance with section 190 of the Act, a ‘deemed’ licence (GR-3) for the general (commercial) release of INGARD^® cotton was issued to Monsanto Australia Ltd (Monsanto) ), before the commencement of the Act on 21 June 2001, based on an approval issued under the previous voluntary system administered by the Genetic Manipulation Advisory Committee (GMAC). The deemed licence is effective during the transition period, i.e. 2 years from the commencement of the Act. The deemed approval for commercial cultivation of INGARD^® cotton will expire in June 2003.

The OGTR has received a licence application from Monsanto for the intentional release of INGARD^® cotton into the environment in the cotton growing regions of NSW and Qld south of latitude 22º South. Approval would enable the continued commercial release of the genetically modified cotton. Monsanto also proposes the phasing-out of INGARD^® cotton over the next three years while Bollgard II^® cotton (which was approved for commercial release in September 2002, DIR 012/2002) is phased-in over the same period.

INGARD^® cotton is resistant to lepidopteran caterpillar pests that attack cotton. It contains an insecticidal gene that produces a protein that is toxic to specific insects.

It is intended that GM cotton plants and their by-products, including cottonseed, be used in the same manner as conventional cotton, including for human food and stockfeed. Cottonseed is processed for oil that is used in a variety of food products and for cotton linters (a type of fibre that does not contain any genetic material) that are used as a cellulose base for several consumer food products. Food Standards Australia New Zealand, FSANZ, (formerly the Australia New Zealand Food Authority, ANZFA) has already approved the use of oil and linters from INGARD^® cotton in human food.

As the applicant seeks approval for commercial release of the GM cotton in all Australian cotton growing regions south of latitude 22º South, no limitations on transportation or storage are proposed (see below for further explanation). However, the NRA remains responsible for determining the total planting area each season of INGARD^® cotton and currently allows up to 30% of the cotton crop to be planted to this GM cotton to guard against the emergence of resistant insects.

INGARD^® cotton was approved for general (commercial) release in 1996 (GR-3), by the National Registration Authority for Agricultural and Veterinary Chemicals (NRA), on the basis of advice from GMAC. This commercial release was restricted to the cotton-growing regions of NSW and Qld south of latitude 22° South because of concerns about the potential weediness of the cotton in tropical areas, as well as the potential for out-crossing to feral and native cotton species in these areas.

Prior to commercial release, numerous limited and controlled releases involving INGARDÒ cotton were conducted under the voluntary system overseen by GMAC, as listed below:

INGARD^® – 44 limited and controlled releases undertaken by;

• Qld Department of Primary Industries (PR-141),
• Deltapine Australia Pty Ltd (PR-17, PR-31, PR-33, PR-34, PR-47, PR-47X, PR-47X2, PR-47X3, PR-47X4, PR-50, PR-50X, PR-51, PR-51X, PR-51X2, PR-51X3, PR-51X5, PR-98, PR-98X, PR-112X and PR-112X2),
• CSIRO Plant Industry (PR-20, PR-36, PR-36X, PR-36X2, PR-36X3, PR-36X4, PR-36X6, PR-38, PR-38X, PR-44, PR-44X, PR-44X2, PR-56, PR-89, PR-89X, PR-89X2, PR-131, PR-131X and PR-131X2) and
• Western Australian Department of Agriculture (PR-87, PR-87X, PR-87X2 and PR-144).

• Deltapine Australia Pty Ltd (PR-83, PR-83X, PR-83X3, PR-109, PR-109X, PR-140, PR-140X and PR-143),
• CSIRO Division of Plant Industry (PR-94) and
• Cotton Seed Distributors (PR94X, PR-94X2 and PR-94X3).

On 28 March 2002 the Regulator issued a licence to the Western Australian Department of Agriculture for a limited and controlled release of INGARDÒ cotton (licence number DIR 008/2002) in Western Australia under the new regulatory system.

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

The parent organism is cultivated cotton (Gossypium hirsutum L.), which is exotic to Australia and is grown as an agricultural crop NSW and Queensland and on a trial basis in Western Australia and the Northern Territory.

INGARD^® cotton contains an insecticidal gene, cry1Ac, derived from a common soil bacterium, Bacillus thuringiensis (Bt). This gene produces a protein that is toxic to lepidopteran caterpillars, including the two key Helicoverpa pests of cotton.

INGARD® cotton is generated by inserting the cry1Ac, nptII and aad genes into cotton on a plasmid vector carried by A. tumefaciens (a bacterium). The vector is ‘disarmed’ since it lacks the genes that encode the tumour-inducing functions of A. tumefaciens.

This means that the Regulator is not required to seek public comment on the assessment of this proposal until the risk assessment and risk management plan has been prepared.

As required by section 50 of the Act, the Regulator is preparing a risk assessment and risk management plan in relation to the licence application and will seek input from a wide range of key stakeholders and expert groups comprising State and Territory Governments, relevant Commonwealth agencies, the Environment Minister, the Gene Technology Technical Advisory Committee and appropriate local councils.

As required by section 52 of the Act, the Regulator will again consult with these prescribed agencies and authorities in finalising the risk assessment and risk management plan that is expected to be issued in early 2003. The public will also be invited to provide comment on the risk assessment and risk management plan over a 30 day consultation period, via advertisements in the media and direct mail to anyone registered on the OGTR mailing list. Summaries and copies of the risk assessment and risk management plan will be available from the OGTR, or on the OGTR website.

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.

Further information about food safety assessments and food labelling, and the use and safety of insecticides and herbicides are available from FSANZ and the NRA, 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
 

National Registration Authority for Agricultural and Veterinary Chemicals
PO Box E240
KINGSTON ACT 2604
Phone: (02) 6272 5158
Fax: (02) 6272 4753
Email: nra.contact@nra.gov.au
http://www.nra.gov.au