Executive Summary




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Risk Assessment and

Risk Management Plan for

DIR 073/2007


Limited and controlled release of GM insect resistant and insect resistant/herbicide tolerant cotton


Applicant: Deltapine Australia Pty Ltd


September 2007


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Executive Summary

Introduction


The Gene Technology Regulator (the Regulator) has made a decision to issue a licence for dealings involving the intentional release of genetically modified (GM) cotton lines into the environment, in respect of application DIR 073/2007 from Deltapine Australia Pty Ltd (Deltapine).

The DIR 073/2007 licence permits the release of up to four GM cotton lines on a limited scale and under controlled conditions.

The Gene Technology Act 20001 (the Act), the Gene Technology Regulations 2001 (the Regulations) and corresponding State and Territory law govern the process undertaken by the Regulator before a decision is made on whether or not to issue a licence. The decision is based upon a Risk Assessment and Risk Management Plan (RARMP) prepared by the Regulator in accordance with the Risk Analysis Framework and in consultation with a wide range of experts, agencies, authorities and the public.

More information on the comprehensive assessment undertaken for licence applications to release a genetically modified organism (GMO) into the environment is available from the Office of the Gene Technology Regulator (OGTR) (Free call 1800 181 030) or at <http://www.ogtr.gov.au>.

The application


Deltapine applied for a licence to conduct a small scale release of GM cotton lines2 on up to 50 sites of no more than 10 hectares each (ie maximum total area of 500 hectares) over 3 summer growing seasons (2007/08, 2008/09 and 2009/10). The release is authorised to take place in the New South Wales (NSW) shires of Bourke, Brewarrina, Gwydir, Liverpool Plains, Moree Plains, Narrabri, Narromine, Walgett and Warren, and the Queensland (QLD) shires of Balonne, Banana, Chinchilla, Dalby, Emerald, Jondaryan, Millmerran, Pittsworth, Waggamba, Wambo and Wondai.

Four GM cotton lines are approved for release into the environment. Two of the lines contain different insect resistance genes, VIP3A or modified Cry1Ab, derived from a common soil bacterium (Bacillus thuringiensis), which express proteins that are selectively toxic to the major lepidopteran caterpillar pests of cotton (Helicoverpa armigera and H. punctigera). A third line contains copies of both insect resistance genes, and the fourth line will contain both insect resistance genes and two copies of a herbicide tolerance gene (cp4 epsps), which is also derived from a soil bacterium (Agrobacterium tumefaciens).

The presence of two copies of the herbicide tolerance gene is commercially known as the Roundup Ready Flex® herbicide tolerance trait and confers tolerance to glyphosate, which can be applied to the crop to kill weeds without damaging the cotton plants. Roundup Ready Flex® GM cotton is currently licensed for commercial release in Australia.

In addition, the GM cotton lines containing the vip3A gene, also contain an antibiotic resistance marker gene, aph4, from the gut bacterium Escherichia coli which enabled identification of GM plant tissues during the initial laboratory stage of development of the GMOs.

The aims of the release are to conduct early stage research to breed and evaluate the agronomic performance of the GM cotton lines; produce seed for further trials (subject to additional approvals); and collect data for future regulatory requirements.

Deltapine proposed a number of measures to limit the spread and persistence of the GM cotton lines and the introduced genetic materials that were considered during the evaluation of the application. The GM plant material is not permitted for use in human food or animal feed. However, the applicant has approval to sell lint from the release.

Some details of the gene construct, including the plasmid map and regulatory sequences, for the modified Cry1Ab line were previously declared as Confidential Commercial Information (CCI) under DIR 065/2006. However, this CCI has now been revoked at the request of the applicant. The previously declared CCI information was contained in the application and was considered in the assessment process.
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