Australia’s gene technology regulatory scheme (GT Scheme) regulates activities with genetically modified organisms (GMOs, organisms modified by gene technology), including environmental releases. The scope of regulation, i.e. what organisms are and are not regulated, is set by the Gene Technology Act 2000 (GT Act) and GT Regulations 2001 (GT Regulations). The GT Act gives broad, overarching definitions of ‘gene technology’ and ‘GMO’ but also provides for exclusions and inclusions in the GT Regulations. Whether organisms developed with genome editing techniques are, or should be, regulated under countries’ national GMO laws is the subject of debate globally. These issues are also under active consideration in Australia. A technical review of the GT Regulations was initiated in 2016 to clarify the regulatory status of genome editing. Proposed draft amendments are structured around whether the process involves introduction of a nucleic acid template. If agreed, amendments would exclude from regulation organisms produced using site directed nuclease (SDN) 1 techniques while organisms produced using oligonucleotide mutagenesis, SDN-2 or SDN-3 would continue to be regulated as GMOs. The review of the GT Regulations is still ongoing and no legislative changes have been made to the GT Regulations. A broader policy review of the GT Scheme was undertaken in 2017–2018 and as a result further work will be undertaken on the scope and definitions of the GT Act in light of ongoing developments.
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Atanassova A, Keiper F (2018) Plant breeding innovation: a global regulatory perspective. Cereal Chem 95:8–16
Cantley M (2007) An overview of regulatory tools and frameworks for modern biotechnology: a focus on agro-food. A report prepared for OECD International Futures Project on The Bioeconomy to 2030: designing a policy agenda. http://www.oecd.org/sti/futures/long-termtechnologicalsocietalchallenges/40926623.pdf. Accessed 5 June 2019
Codex (2009) Foods derived from modern biotechnology, 2nd edn. http://www.fao.org/3/a-a1554e.pdf. Accessed 5 June 2019
Commonwealth Department of Health (2017) The Third Review of the National Gene Technology Scheme. Consultation paper: overarching issues for consideration under the Review. http://www.health.gov.au/internet/main/publishing.nsf/Content/gene-technology-review. Accessed 5 June 2019
Commonwealth Department of Health (2018a) The Third Review of the National Gene Technology Scheme. March 2018 Preliminary Report. http://www.health.gov.au/internet/main/publishing.nsf/Content/gene-technology-review. Accessed 5 June 2019
Commonwealth Department of Health (2018b) The Third Review of the National Gene Technology Scheme. October 2018 Final Report. http://www.health.gov.au/internet/main/publishing.nsf/Content/gene-technology-review. Accessed 5 June 2019
Commonwealth of Australia (2000a) Gene Technology Act 2000. The Federal Register of Legislation at https://www.legislation.gov.au/Details/C2016C00792. Accessed 5 June 2019
Commonwealth of Australia (2000b) Explanatory memorandum to the Gene Technology Bill 2000. The Federal Register of Legislation at https://www.legislation.gov.au/Details/C2004B00717/Explanatory%20Memorandum/Text. Accessed 5 June 2019
Commonwealth of Australia (2001a) Gene Technology Regulations 2001. The Federal Register of Legislation at https://www.legislation.gov.au/Details/F2016C00615. Accessed 5 June 2019
Commonwealth of Australia (2001b) Gene Technology Agreement. http://www.health.gov.au/internet/main/publishing.nsf/Content/gene-tech-agreement. Accessed 5 June 2019
Commonwealth of Australia (2001c) Explanatory statement to the Gene Technology Regulations 2001. The Federal Register of Legislation at https://www.legislation.gov.au/Details/F2001B00162/Explanatory%20Statement/Text. Accessed 5 June 2019
Convention on Biological Diversity (2000) Cartagena protocol on biosafety. https://bch.cbd.int/protocol/text/. Accessed 5 June 2019
Duensing N, Sprink T, Parrott WA, Fedorova M, Lema MA, Wolt JD, Bartsch D (2018) Novel features and considerations for ERA and regulation of crops produced by genome editing. Front Bioeng Biotechnol 6:79
EFSA Panel on Genetically Modified Organisms (2012) Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 and other Site-Directed Nucleases with similar function. EFSA J 10:2943–2974
FSANZ (2018) Preliminary report. Review of food derived using new breeding techniques—consultation outcomes. http://www.foodstandards.gov.au/consumer/gmfood/Pages/Review-of-new-breeding-technologies-.aspx. Accessed 5 June 2019
Kelly L (2018) Clarifying the regulation of genome editing in Australia - current considerations. Situation for food. In: OECD conference on genome editing: applications in agriculture - implications for health, environment and regulation 28–29 June 2018, Paris, France
Legislative & Governance Forum on Gene Technology (2018a) Joint Communique from the Legislative & Governance Forum on Gene Technology: meeting outcomes from 11 October 2018. http://www.health.gov.au/internet/main/publishing.nsf/Content/gene-technology-review. Accessed 5 June 2019
Legislative & Governance Forum on Gene Technology (2018b) Forum Action Plan 2018–2023. http://www.health.gov.au/internet/main/publishing.nsf/Content/gene-technology-review. Accessed 5 June 2019
Lin Y, Cradick TJ, Brown MT, Deshmukh H, Ranjan P, Sarode N, Wile BM, Vertino PM, Stewart FJ, Bao G (2014) CRISPR/Cas9 systems have off-target activity with insertions or deletions between target DNA and guide RNA sequences. Nucleic Acids Res 42:7473–7485
Lusser M, Davies HV (2013) Comparative regulatory approaches for groups of new plant breeding techniques. New Biotechnol 30:437–446
Lusser M, Rodriguez-Cerezo E (2012) Comparative regulatory approaches for new plant breeding techniques. Workshop proceedings. EUR 25237 EN—2012. Publications Office of the European Union. ftp://jrc.es/pub/EURdoc/JRC68986.pdf. Accessed 5 June 2019
Lusser M, Parisi C, Plan D, Rodriguez-Cerezo E (2011) New plant breeding techniques: state-of-the-art and prospects for commercial development. EUR 24760 EN—2011. Publications Office of the European Union. ftp.jrc.es/EURdoc/JRC63971.pdf. Accessed 5 June 2019
Modrzejewski D, Hartung F, Sprink T, Krause D, Kohl C, Schiemann J, Wilhelm R (2018) What is the available evidence for the application of genome editing as a new tool for plant trait modification and the potential occurrence of associated off-target effects: a systematic map protocol. Environ Evid 7:18
OECD (2016) ENV/JM/MONO(2016)5. Report of the OECD workshop on environmental risk assessment of products derived from new plant breeding techniques (February 2014). https://one.oecd.org/document/ENV/JM/MONO(2016)5/en/pdf. Accessed 5 June 2019
OGTR (2013) Risk analysis framework. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/risk-analysis-framework. Accessed 5 June 2019
OGTR (2016a) Technical Review of the Gene Technology Regulations 2001. Discussion paper: options for regulating new technologies. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reviewdiscussionpaper-htm. Accessed 5 June 2019
OGTR (2016b) General advice from the Regulator on coverage of new technologies. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/newtechnologies-htm. Accessed 5 June 2019
OGTR (2017a) Exposure Draft Gene Technology Amendment (2017 Measures No. 1) Regulations 2017. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/amendment%20proposals-1. Accessed 5 June 2019
OGTR (2017b) Updating Gene Technology Regulation in Australia—Regulation Impact Statement for consultation. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/amendment%20proposals-1. Accessed 5 June 2019
Polya R (2008) Chronology of genetic engineering regulation in Australia: 1953–2008. https://www.aph.gov.au/About_Parliament/Parliamentary_Departments/Parliamentary_Library/pubs/BN/0809/ChronGeneticEngineeringA. Accessed 5 June 2019
Spranger TM (2015) Legal analysis of the applicability of Directive 2001/18/EC on genome editing technologies. https://bfn.de/fileadmin/BfN/agrogentechnik/Dokumente/Legal_analysis_of_genome_editing_technologies.pdf. Accessed 5 June 2019
Sprink T, Eriksson D, Schiemann J, Hartung H (2016) Regulatory hurdles for genome editing: process-versus product-based approaches in different regulatory contexts. Plant Cell Rep 35:1493–1506
Zhao H, Wolt JD (2017) Risk associated with off-target plant genome editing and methods for its limitation. Emerg Top Life Sci 1:231–240
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Note added in proof: The Gene Technology Regulations 2001 were amended on 4 April 2019, see https://www.legislation.gov.au/Details/F2019L00573 Accessed 5 June 2019.
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Thygesen, P. Clarifying the regulation of genome editing in Australia: situation for genetically modified organisms. Transgenic Res 28, 151–159 (2019). https://doi.org/10.1007/s11248-019-00151-4