Licence Application Summary

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 Cotton organism: Gossypium hirsutum L. Scientific name of the parent Insecticidal and herbicide tolerance organism:  chimeric cry1Ac gene from the bacterium Bacillus Modified trait(s): thuringiensis (insecticidal) Identity of the gene(s)  chimeric cry1Fa gene from the bacterium Bacillus responsible for the modified thuringiensis (insecticidal) trait(s):  pat gene from Streptomyces viridochromogenes (herbicide tolerance/selectable marker)

Proposed Location(s) 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 (28124-236, 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: Office of the Gene Technology Regulator MDP 54 GPO Box 9848 CANBERRA ACT 2601 Telephone: 1800 181 030, Facsimile: 02 6271 4202 OGTR website