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Office of the Gene Technology Regulator RISK ASSESSMENT AND RISK MANAGEMENT PLAN AND LICENCE FOR INTENTIONAL RELEASE OF GMOs INTO THE ENVIRONMENT: Application No. DIR 010/2001 SUMMARY INFORMATION Project Title: Small and large scale trialing of InVigor® canola (Brassica napus) for development for the Australian cropping system Applicant: Aventis CropScience Pty Ltd 391-393 Tooronga Rd East Hawthorn VIC 3123 Common name of the parent organism: Canola Scientific name of the parent organism: Brassica napus Modified traits: Hybrid breeding system based on male sterile and fertility restorer lines; and Herbicide tolerance (glufosinate ammonium) Identity of the genes responsible for the modified traits: Locations: barnase gene from the bacterium Bacillus amyloliquefaciens (male sterility) barstar gene also derived from B. amyloliquefaciens (fertility restorer) bar gene from the bacterium Streptomyces hygroscopicus (herbicide tolerance) Winter trial locations selected from the Shires of: Ararat, Glenelg, Hindmarsh, Horsham, Moyne, Northern Grampians, Southern Grampians, Yarriambiack (Victoria); Grant, Naracoorte/Lucindale, Wattle Range (South Australia); Coolamon, Culcairn, Lockhart, Junee, Narrandera, Wagga Wagga (New South Wales); and Beverly, Brookton, Goomalling, Quairading, Victoria Plains, Wongan Ballidu (Western Australia). Summer trial locations selected from the Shires of: Grant, Naracoorte/Lucindale, Wattle Range, (South Australia); and Glenelg (Victoria). NB: The licence holder will notify the Regulator of the precise location details prior to planting in each season. These details will be included in the Record of GMO and GM Product Dealings. Date of Releases: Winter and Summer 2002, 2003, 2004 Trial Sizes: A maximum of 318 hectares at 90 sites over 3 years, comprising 106 hectares at 30 sites in each year including 61 hectares at 13 sites in each Winter season and 45 hectares at 17 sites in each Summer season. The maximum area for any individual site will be 9 hectares. Maximum area Maximum No. of sites Winter 61 ha 13 Summer 45 ha 17 Per year 106 ha 30 Total over 3 years 318 ha 90 Introduction The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of the application (DIR 010/2001) of Aventis CropScience Pty Ltd (Aventis). Aventis applied for a licence to undertake a limited and controlled release of genetically modified (GM) canola (InVigor® canola) into the environment. The decision was made after extensive consultation on the risk assessment and risk management plan for this application with the public, State and Territory governments, Commonwealth agencies, the Gene Technology Technical Advisory Committee, the Federal Environment Minister and relevant local councils, as required by the Gene Technology Act 2000 (the Act). The purpose of the release is to conduct plant breeding trials to develop lines suitable for use under Australian conditions and produce seed for potential commercial lines for future releases in Australia and overseas. Future releases in Australia, including commercial release, would be subject to further licence applications. InVigor® canola plants have been genetically modified to introduce a hybrid breeding system based on male sterile (MS) and fertility restorer (RF) lines to emulate the natural phenomenon of hybrid vigour, and enable the production of high purity, hybrid seed. Traditional plant breeding selects for plants with agronomically valuable characteristics but can also produce highly in-bred plants. This causes ‘inbreeding depression’, usually defined as a lowered fitness or vigour of inbred individuals compared with their non-inbred counterparts. The converse of inbreeding depression is hybrid vigour, which results when offspring of crosses of genetically distinct parents outperform the parental lines. Hybrid vigour is greatest in the first generation and declines in subsequent generations. Plant breeders have often used male sterile plants to accomplish hybrid seed production. The male sterile line of InVigor® canola contains the barnase gene from the soil bacterium Bacillus amyloliquefaciens. The barnase gene encodes the enzyme Barnase, a ribonuclease (RNase), which results in the death of the plant cells in which it is expressed. The barnase gene is controlled by an anther-specific promoter. (A promoter is a small piece of DNA that controls the level of expression of genes, acting like a switch). This means that the barnase gene is only active in the plant cells responsible for development of the anthers (the male, pollen-bearing parts of the flower). Anther-specific expression of the barnase gene results in male sterility because the flowers cannot develop anthers. The fertility restorer line of InVigor® canola contains the barstar gene, also derived from B. amyloliquefaciens. Expression of the barstar gene in InVigor® canola is also restricted to the anthers by an anther-specific promoter. The barstar gene encodes a ribonuclease inhibitor protein, Barstar, which binds specifically to the Barnase protein, suppressing the ribonuclease activity. In hybrid InVigor® canola plants derived from conventional crosses of male sterile and fertility restorer lines, both the barstar and barnase genes will be expressed during anther development. These hybrids are fully fertile because the Barstar protein blocks the action of the Barnase protein on the anther producing cells, ensuring anther development and pollen production. Both the male sterile and fertility restorer lines of InVigor® canola have been also genetically modified to be tolerant to the herbicide glufosinate ammonium (the active ingredient in Liberty® and Basta®). This was achieved by the introduction of the bar gene from the soil bacterium Streptomyces hygroscopicus. The bar gene encodes the enzyme phosphinothricin acetyltransferase (PAT) that detoxifies glufosinate ammonium. The herbicide tolerance trait is used as a selection tool for the breeding system and also enables the application of glufosinate ammonium to control weeds in the canola crop. Aventis requested approval to carry out a limited and controlled release on a maximum of 318 hectares at 90 sites over 3 years, comprising winter plantings of 61 hectares at 13 sites and summer plantings 45 hectares at 17 sites in each year. The maximum area permitted to be sown to the GM canola at any site is 9 hectares. Sites would be selected from 23 local government areas, with Winter plantings in Victoria, South Australia, New South Wales and Western Australia and summer plantings in Victoria and South Australia only. The licence imposes conditions that prohibit any releases of the GM canola beyond these limits. Aventis has indicated that a reduction in the number of sites for the winter 2002 season is likely because of the lateness of planting. Aventis has previously conducted similar releases of InVigor® canola. Winter releases were conducted in New South Wales, Victoria, Queensland, South Australia, Western Australia and Tasmania. Summer releases were conducted in South Australia and Tasmania. There have been no reports of adverse effects on human health or the environment resulting from these releases. Summary information about the genetically modified organisms (GMOs), the application and the regulatory system established by the Act is available in the document, Summary information on application number DIR 010/2001. More detailed information is available in the risk assessment and risk management plan that has been prepared in accordance with the requirements of the Act. Further background information is available in the document The biology and ecology of canola. All three documents are available from the Office of the Gene Technology Regulator (OGTR) website or from the OGTR (see contact details below). This document summarises the conclusions of the risk assessment process and the risk management plan, including the specific licence conditions, developed to manage the risks to human health and safety and the environment identified by the risk assessment. The Regulator considers that these conditions are sufficient to manage any risks posed by the current release (see below, Summary of risk management plan). Summary of risk assessment A number of possible hazards that could arise as a direct result of the genetic modification of InVigor® canola were identified. They include: the potential for the genetically modified canola to be harmful to other organisms, including humans, because it is toxic or allergenic; the potential for the genetically modified canola to be harmful to the environment because of inherent weediness or increased potential for weediness; and the potential for the new genes introduced into the canola to transfer to other organisms with adverse consequences. Risk of toxicity or allergenicity It is considered that the likelihood of adverse impacts on humans or other species, as a result of toxicity or allergenicity of InVigor® canola, is very low. No plants or plant byproducts from the trial will be used for human food or animal feed. There is no evidence that InVigor® canola will be more toxic or allergenic to humans or other organisms than conventional canola varieties. The proteins produced by the introduced genes are not considered to be toxic or allergenic. Oil derived from InVigor® canola has been approved by Food Standards Australia New Zealand (FSANZ, formerly the Australia New Zealand Food Authority (ANZFA), for details refer to ANZFA Final Assessment Report, Application A372, 2001, available from the FSANZ website www.foodstandards.gov.au). Risk of weediness Canola is not a problematic weed in habitats outside agricultural areas and the introduced genes are not likely to increase weediness. The risk of InVigor® canola spreading into the environment and causing environmental harm is low and unlikely to be greater than that for conventional canola. Tolerance to glufosinate ammonium would not confer a survival advantage on the plants in the absence of this herbicide. The use of glufosinate ammonium in Australia is currently restricted to horticultural situations and is not used as a herbicide for weed control in broad acre cropping or in the natural environment. The release will use the glufosinate ammonium tolerance trait in selection of hybrids. In addition, glufosinate ammonium may be used at some of the winter sites for weed control for demonstration purposes, or if conventional weed control strategies are ineffective. Glufosinate ammonium is not currently registered for use on canola, and its use during the release will require a permit from the National Registration Authority for Agricultural and Veterinary Chemicals (NRA). The Regulator has imposed conditions to manage any potential weediness risk (see below, Summary of risk management plan). Risk of gene transfer There is a potential for transfer of the introduced genes to non-GM canola crops but the level of outcrossing will be very low, and, given the relatively small scale of the proposed release, management measures can be imposed that will further reduce the likelihood of gene transfer occurring. The risk of gene transfer to closely related Brassica species (B. rapa and B. juncea) is even lower. The risk of gene transfer to other Brassica plants, including Brassicaceous weeds is extremely low. The risk of gene transfer to other unrelated plant species or to animals or microorganisms is negligible. The Regulator has imposed conditions on the licence issued to Aventis to manage these risks (see below, Summary of risk management plan). The conclusions with respect to each transferred gene sequence are as follows: Herbicide tolerance gene There is a low risk of transfer of the bar gene from the genetically modified canola to commercially grown non-GM canola, an even lower risk of gene transfer to other B. rapa or B. juncea, and a negligible risk of gene transfer to other Brassicaceous weeds or other organisms. There would be no adverse consequences in the natural environment if outcrossing to canola or related species occurred, as tolerance to glufosinate ammonium would not confer a survival advantage on the plants in the absence of a selection pressure from this herbicide. Canola (B. napus) is not regarded as a weed in Australia and glufosinate ammonium is not used in broad acre cropping or for control of canola in the natural environment. If gene transfer to animals or microorganisms occurred, there would be no adverse effects because herbicides are only used to control plants. Male sterility gene As with the bar gene, there is a low risk of transfer of the barnase gene to non-GM canola, an even lower risk of gene transfer to other B. rapa or B. juncea, and a negligible risk of gene transfer to other Brassicaceous weeds or other organisms. There would be no adverse consequences from transfer of the male sterility gene even if outcrossing occurred, as this is not likely to be toxic or allergenic to other organisms. Nor would it increase the weediness of the recipient plants, as a high proportion of the progeny of a plant receiving the barnase gene would be male sterile and could not reproduce and persist in the environment unless pollinated by another plant. The proportion of male sterile GM plants would decrease in subsequent generations. Fertility restorer gene There would be no adverse consequences from transfer of the barstar gene in the unlikely event that outcrossing occurred, as this is not likely to be toxic or allergenic to other organisms, or to increase the weediness of the recipient plants. The fertility restorer gene would have no impact on a plant’s phenotype apart from restoring fertility to a proportion of the progeny resulting from crosses with a male sterile InVigor® canola plant. Regulatory sequences InVigor® canola contains some regulatory sequences derived from a plant pathogen, the common soil bacterium Agrobacterium tumefaciens. These sequences only represent a very small proportion of the pathogen genome and are not, in themselves, infectious or pathogenic. A. tumefaciens and the regulatory sequences used in the genetically modified canola are already present in the environment and in the human diet. Horizontal gene transfer from plants to microorganisms, including viruses, or to animals and humans is extremely unlikely. Summary of risk management plan and specific licence conditions To give effect to the risk management plan, specific conditions have been included in the licence relating to risk management. Details of these conditions are provided in the full risk assessment and risk management plan, which can be obtained from the OGTR (see below). Risk of toxicity or allergenicity On the basis of the risk assessment, the risks of toxicity or allergenicity of InVigor ® canola are considered to be extremely low, and the scale of the release is relatively small, thereby limiting any environmental exposure to the GM canola. It is not considered necessary to include any management strategies in the risk management plan in relation to the potential toxicity or allergenicity of the GM canola. Nevertheless, the licence includes specific conditions that will minimise any risks of toxicity and allergenicity: prohibiting the use of the canola plants from the trials or their by-products in human food or animal feed; limiting the scale and location of the release; and limiting the spread and persistence of the GM canola (see below). Risks of weediness or gene transfer It has been concluded that the risks relating to weediness or gene transfer are low and can be managed to an acceptable level by implementing various measures to minimise the spread and persistence of InVigor® canola, or the modified genetic material, in the environment. The licence imposes specific conditions to implement the management strategies, detailed below, and these are considered adequate to manage the risks of weediness and gene transfer: Measures during the trial Isolation zone The GM canola must be isolated from other canola, B. rapa and B. juncea crops by an isolation zone: 1 km if no other measures to minimise pollen flow are used; 400 metres if used in conjunction with other measures to minimise pollen flow: - all of the GM canola at the site is male sterile; - all the flowers are bagged; - the GM canola is covered by an insect-proof tent; or - the GM canola is surrounded by a 15-metre pollen trap of non-GM or male sterile GM canola. Monitoring zone Destruction of sexually compatible Brassica plants and Brassicaceous weeds in the trial site and within a monitoring zone extending 50 metres from the edge of the GM canola (or pollen trap) both prior to and during flowering of the GM canola Measures after the trial After harvest of the GM canola, destroy all viable material from the trial except for seed retained for analysis or future use, or for export; Lightly till the trial site twice within twelve months after harvest to promote the germination of any remaining canola seed and deplete the seedbank; and Monitor and destroy canola volunteers that grow on the trial site, pollen trap and monitoring zone for three years and until the site is free of volunteer plants for 12 months. Other measures – notification, reporting and research In order to assist the independent monitoring conducted by the Regulator (see Monitoring and enforcement of compliance by the OGTR below), the licence imposes conditions requiring the licence holder to notify the Regulator of forecasted and actual dates of planting, flowering and harvest of the GM canola. These stages of the trial represent the times of highest likely risk of dissemination or persistence of the GM canola in the environment. The licence holder must report regularly to the Regulator on the progress of the trial and post-harvest monitoring. The licence also imposes an obligation on the licence holder to develop a program of research agreed with the OGTR to obtain data on the effectiveness of pollen traps and isolation zones and on the rate of outcrossing from canola at short distances (0-10 metres) under Australian conditions. Monitoring and enforcement of compliance by the OGTR It should be noted that, as well as imposing licence conditions, the Regulator has additional options for risk management. The Regulator has the legislative capacity to enforce compliance with licence conditions and, indeed, to direct a licence holder to take any steps the Regulator deems necessary to protect the health and safety of people or the environment. The OGTR also independently monitors authorised trials. At least 20% of all trial sites will be monitored each year, to determine whether the licence holder is complying with the licence conditions, or whether there are any unforseen problems. In identifying when to undertake routine monitoring visits, sites are selected on the basis of a risk profile. In assembling a risk profile of a site, a number of factors are taken into account, including the type of GMO(s) and its biology, and seasonal/geographical/ecological risk factors for both current and post-harvest field trial sites. For example, the critical periods for monitoring to occur in respect of GM field trials are when the trial is at its ‘higher risk’ points (ie. when there is an inherently higher risk to the health and safety of people and the environment). The licence requires the removal of related Brassicaceous plants within 50 m of the GM crop (or pollen trap if used) prior to flowering. Therefore, one crucial period for monitoring would be immediately before flowering occurred to ascertain whether sexually compatible plants had been removed from the trial site. Contact details Copies of the risk assessment and risk management plan, as well as this summary information, can be obtained from the OGTR at the address below or from the Office’s website. Copies of the licence application are also available from the Office. Please quote application Number DIR 010/2001. Office of the Gene Technology Regulator MDP 54, PO Box 100 WODEN ACT 2600 Telephone: 1800 181 030 Facsimile: 02 6271 4202 Website: http://www.ogtr.gov.au Email: [email protected]