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23 February 2017 Summary of Licence Application DIR 153 Introduction An application has been made under the Gene Technology Act 2000 (the Act) for Dealings involving the Intentional Release (DIR) of genetically modified organisms (GMOs) into the Australian environment, on a limited scale under controlled conditions. Application number DIR 153 Applicant: The University of Queensland Project Title: Limited and controlled release of sorghum genetically modified for grain quality traits Parent organism: Sorghum (Sorghum bicolor) Introduced genes and modified traits: modified kafirin gene1 from sorghum for altered seed protein content and digestibility fragment of a foldase enzyme gene1 from sorghum for altered seed size, protein content and digestibility fragments of three membrane protein genes1 from sorghum for altered seed size or number of seeds nptII selectable marker gene from Escherichia coli Proposed release dates: October 2017 – June 2020 Proposed locations: One site in the first year and up to four sites in the second and third years in south-east Queensland Proposed release size: Up to 1 ha in the first year and up to 5 ha in the second and third years Primary purpose To assess agronomic characteristics, yield and grain quality of the GM sorghum plants Proposed limits and controls The applicant proposes to conduct the field trial over three growing seasons from October 2017 to June 2020. In the first year, one site of up to 1 ha would be planted, and in each of the second and third years up to four sites with combined areas of up to 5 ha would be planted. The local government areas where trial sites might be located are Brisbane City, Goondiwindi, Lockyer Valley, Redland City, Somerset, Southern Downs, South Burnett and Toowoomba, all in south-east Queensland. The applicant has proposed a number of control measures to restrict the spread and persistence of the GMOs and their introduced genetic material, each of which will be considered in the evaluation of this application. These include: locating the proposed trial sites at least 100 m away from the nearest natural waterway surrounding the trial sites with a 7.5 m pollen trap and a 200 m isolation zone where no sorghum would be grown controlling rodents by baiting 1 Specific gene names are not provided as they have been declared Confidential Commercial Information. cleaning equipment prior to use for other purposes or removal from a trial site transporting and storing GMOs in accordance with the current Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs destruction of GM seed not required for analysis or future planting post-harvest monitoring of the trial sites for at least 12 months and until the sites are free of volunteer sorghum for at least 6 months, with any sorghum volunteers destroyed before flowering not allowing the GM plant material to be used in human food or animal feed, with the exception of a poultry feeding trial using GM sorghum grain grown in the third year, if approved by a university Animal Ethics Committee. Confidential Commercial Information The names of five introduced genes in the GM sorghum have been declared Confidential Commercial Information under section 185 of the Act. This information will be made available to the prescribed experts and agencies that will be consulted on the risk assessment and risk management plan (RARMP) for this application. Parent organism The parent organism is grain sorghum (Sorghum bicolor), which is exotic to Australia. Grain sorghum is an important crop in central and southern Queensland and in New South Wales. Grain sorghum in Australia is almost exclusively used as livestock feed. The genetic modifications and their effects The applicant proposes to release up to 42 GM sorghum lines2 as follows: Up to 6 lines will contain an introduced gene encoding a kafirin seed storage protein. This gene was derived from sorghum but has been modified to increase the number of proteolytic sites. These GM plants are expected to have increased seed protein content and seed digestibility. Up to 6 lines will contain an introduced gene silencing construct that suppresses expression of a sorghum enzyme involved in folding seed storage proteins. These GM plants are expected to have increased seed size, seed protein content and seed digestibility. Up to 15 lines will contain an introduced gene silencing construct that suppresses expression of one of three sorghum membrane proteins. These GM plants are expected to have increased seed size or number of seeds. Up to 15 lines will contain an introduced gene encoding a truncated version of one of the three sorghum membrane proteins above. These GM plants are expected to have increased seed size or number of seeds. All GM sorghum lines also contain the nptII gene derived from the bacteria Escherichia coli, which encodes the neomycin phosphotransferase type II enzyme conferring antibiotic resistance. This selectable marker was used in the laboratory during early stages of development of the GM plants. Short regulatory sequences that control expression of the genes are also present in the GM sorghum lines. The ubi1 promoter is derived from maize and the nos terminator is derived from the soil bacterium Agrobacterium tumefaciens. Method of genetic modification GM sorghum lines were generated using biolistic transformation (particle bombardment). This transformation method has been widely used in Australia and overseas for introducing genes into plants. 2 The term ‘line’ is used to denote plants derived from a single plant containing a specific genetic modification resulting from a single transformation event. 2 More detailed information can be found in the document Methods of plant genetic modification available from the Risk Assessment References page on the OGTR website. Previous releases of the same or similar GMOs There have been no previous releases of GM sorghum in Australia. Assessment and consultation process for this DIR application The Gene Technology Act 2000 and the Gene Technology Regulations 2001 set out requirements for considering licence applications, including matters that the Gene Technology Regulator (the Regulator) must take into account before deciding whether or not to issue a licence. The application qualifies as a limited and controlled release, under the Act, as the principal purpose of the application is to enable the conduct of experiments, and the applicant has proposed limits on the size and duration of the release and controls to restrict the spread and persistence of the GMOs and their genetic material in the environment. The proposed limits and controls are such that it is appropriate for the Regulator not to seek advice on the preparation of the risk assessment and risk management plan (RARMP). The Regulator will instead consult at a later date on the RARMP that will be prepared in accordance with the Act. In the interim, copies of the application are available on request from the OGTR. Please quote application number DIR 153. The Regulator will seek comment on the consultation RARMP from the public as well as a wide range of experts, agencies and authorities including the Gene Technology Technical Advisory Committee, State and Territory Governments, Australian Government agencies and the Minister for the Environment. The RARMP will then be finalised, taking into account matters raised relating to risks to human health and safety and the environment, and forms the basis of the decision whether or not to issue a licence. At this stage, the RARMP is expected to be released for comment in May 2017. The public will be invited, via advertisements in the media and direct mail to anyone registered on the OGTR mailing list, to provide submissions on the RARMP. The RARMP and other related documents will be available on the OGTR website, or in hard copy from the OGTR. More information on Australia’s national scheme for regulation of gene technology and the assessment process can be found at the Office of the Gene Technology Regulator’s website. If you have any questions about the application or the assessment process, or wish to register on the mailing list, please contact the OGTR at: Office of the Gene Technology Regulator, MDP 54, GPO Box 9848, Canberra ACT 2601 Telephone: 1800 181 030 E-mail: [email protected] OGTR website 3