{ "entity_id": "B-002090", "folder": "Gene-Technology-Standing-Committee", "name": "Gene Technology Standing Committee", "type": "Advisory Body", "jurisdiction": "Commonwealth", "portfolio": "Health, Disability and Ageing", "website": "https://www.genetechnology.gov.au/", "data_status": "stub", "completeness": { "has_strategy_brief": false, "has_strategy_structured": true, "has_vision": false, "has_kpi_targets": false, "has_kpi_results": false, "has_strategy_overview": true, "has_legislation_text": true, "has_legislation_structured": false, "has_global_initiatives_text": false, "has_ideas": true, "has_artifacts": true, "n_ideas": 12, "n_legislation": 0, "n_artifacts": 1, "n_kpi_targets": 0, "n_kpi_results": 0, "n_outcomes": 0, "verified_own_data": true }, "strategy_profile": { "status": "needs_review", "confidence": "medium", "summary": "", "official_site_url": "https://www.genetechnology.gov.au/", "source_documents": [], "purpose": null, "vision": null, "strategic_priorities": [], "values": [], "outcomes": [], "performance_measures": [], "document_alignment_terms": { "must_support": [], "watch_terms": [], "avoid_claiming_without_evidence": [] }, "review_note": "Structured strategy exists but is incomplete." }, "strategy_brief_md": null, "strategy_overview_evidence_md": null, "internal_strategy_evidence_md": "# Gene Technology Standing Committee - Strategy, Performance, and Operating Profile\n\n**Generated at**: 2026-05-09T22:18:44.039428+00:00\n**Entity ID**: B-002090\n**Entity type**: Advisory Body\n**Jurisdiction**: Commonwealth\n**Portfolio**: Health, Disability and Ageing\n**Website**: https://www.genetechnology.gov.au/\n\n> Draft generated from scraped source material. Treat this as an evidence pack for editorial review, not a final judgement.\n\n## Source Coverage\n\n| Source type | Count |\n|---|---:|\n| other-pdfs | 1 |\n| pages | 6 |\n\n## Executive Readout\n\n### Purpose\n\n- [Page 23]\nOther minor amendments\n• Other minor administrative amendments are proposed\nto be made to Part 5 of the current Regulations.\n• Transitional provisions will mostly be contained in the\nAmendment Bill; however, some transitional\nregulations may be required.\n• Minor changes to Schedules 1, 1A and 1B may be\nrequired in response to the proposed exclusion of\nhuman beings from the definition of a GMO.\n• Schedules 2 and 3 will be repealed and replaced with\nnew regulations for the purpose of NDs and NNDs as\nearlier described.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- Funding announced in the 2019–20 Budget to implement the outcomes of the third review\n31 March 2019\nNews\nThe Australian Government will meet 50% of the cost of implementing the recommendations of the third review of the National Gene Technology Scheme.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- Outcome of the Gene Technology Ministers’ Meeting – 13 April 2023\n14 April 2023\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) met virtually on Thursday 13 April 2023.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- Outcome of the Gene Technology Ministers’ Meeting – July 2021\n31 July 2021\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) met virtually on Tuesday 20 July 2021.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n\n### Role and Functions\n\n- ND2 – low risk host/vector systems with modifications that may increase the\no\ncapacity of the host or vector to cause harm, or with culture volumes above the\nrelevant threshold (25L per vessel).\n*This class is intended to correspond to the current 2.1 (e), (f) and (h) of Schedule 3\nND3 – other host/vector systems where any of the following apply\no\n the host and the vector are non-pathogenic and very unlikely to cause harm, or\n the GM is unlikely to increase the ability of the host and vector to cause harm,\nor\n the dealings involve virions of a replication deficient vector, and the combined\nproperties of the host (if any), vector and donor nucleic acid are unlikely to\ncause harm.\n*This class is intended to correspond to 1.1 (c), 2.1 (c), (d), (g), (i)-(m) and 2.2 of Schedule 3 Lower risk\n1 9 • These dealings must be undertaken within 5 years of IBC assessment.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- NND1 – Dealings involving low risk host/vector systems with low-risk modifications\no\nand less than 25L in each vessel. *corresponds to Items 4 and 5 of Part 1 of Schedule 2\nNND2 – Dealings with GM animals that have genetically modified somatic cells, or\no\nto introduce genetically modified somatic cells into an animal.\n* corresponds predominantly to Items 3 and 3A of Part 1 of schedule 2 as well as an NLRD dealing\nNND3 – Dealings with C. elegans with low-risk modifications.\no\n* corresponds to Item 2 of Part 1 Schedule 2\nNND4 – Introducing genetically modified human somatic cells into a human for\no\nsomatic cell therapies such as CAR T-Cell therapy. * this is a new class\nLower risk\n2 1 • A dealing is not a non-notifiable dealing if it is a designated dealing.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 23]\nOther minor amendments\n• Other minor administrative amendments are proposed\nto be made to Part 5 of the current Regulations.\n• Transitional provisions will mostly be contained in the\nAmendment Bill; however, some transitional\nregulations may be required.\n• Minor changes to Schedules 1, 1A and 1B may be\nrequired in response to the proposed exclusion of\nhuman beings from the definition of a GMO.\n• Schedules 2 and 3 will be repealed and replaced with\nnew regulations for the purpose of NDs and NNDs as\nearlier described.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- Funding announced in the 2019–20 Budget to implement the outcomes of the third review\n31 March 2019\nNews\nThe Australian Government will meet 50% of the cost of implementing the recommendations of the third review of the National Gene Technology Scheme.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- [Page 6]\nNational Gene Technology Scheme\n• The National Gene Technology Scheme (the Scheme) was established in 2000.\n• The Scheme is authorised through the Gene Technology Agreement 2001, and is\ncomprised of Commonwealth, state and territory legislation, including the:\nGene Technology Act 2000 (the Act) Gene Technology Regulations 2001\nCorresponding state and territory legislation\n• The object of the Act is to protect the health and safety of people, and to protect the\nenvironment, by identifying risks posed by or as a result of gene technology, and by\nmanaging those risks through regulating certain dealings with genetically modified organisms\n(GMOs).\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- See the video entry\nLatest news\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nGTMM Priorities until December 2025 update\n3 December 2025\nConsultation on proposed changes to the Gene Technology Act 2000\n17 September 2024\nView more news\nSubscribe to updates\nSubscribe to stay up to date with the latest scheme information.\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n\n### Strategic Priorities\n\n- See the video entry\nLatest news\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nGTMM Priorities until December 2025 update\n3 December 2025\nConsultation on proposed changes to the Gene Technology Act 2000\n17 September 2024\nView more news\nSubscribe to updates\nSubscribe to stay up to date with the latest scheme information.\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n- Subscribe\nLatest resources\nInformation session on proposed amendments to the Gene Technology Regulations 2001\n16 February 2026\nPresentation\nGTMM priorities until 2025\n3 December 2025\nStrategy or framework\nInformation session on proposed amendments to the Gene Technology Act – Questions and answers\n6 November 2024\nFact sheet\nInformation session on proposed amendments to the Gene Technology Act\n22 October 2024\nPresentation\nView more resources\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n- ND2 – low risk host/vector systems with modifications that may increase the\no\ncapacity of the host or vector to cause harm, or with culture volumes above the\nrelevant threshold (25L per vessel).\n*This class is intended to correspond to the current 2.1 (e), (f) and (h) of Schedule 3\nND3 – other host/vector systems where any of the following apply\no\n the host and the vector are non-pathogenic and very unlikely to cause harm, or\n the GM is unlikely to increase the ability of the host and vector to cause harm,\nor\n the dealings involve virions of a replication deficient vector, and the combined\nproperties of the host (if any), vector and donor nucleic acid are unlikely to\ncause harm.\n*This class is intended to correspond to 1.1 (c), 2.1 (c), (d), (g), (i)-(m) and 2.2 of Schedule 3 Lower risk\n1 9 • These dealings must be undertaken within 5 years of IBC assessment.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- NND1 – Dealings involving low risk host/vector systems with low-risk modifications\no\nand less than 25L in each vessel. *corresponds to Items 4 and 5 of Part 1 of Schedule 2\nNND2 – Dealings with GM animals that have genetically modified somatic cells, or\no\nto introduce genetically modified somatic cells into an animal.\n* corresponds predominantly to Items 3 and 3A of Part 1 of schedule 2 as well as an NLRD dealing\nNND3 – Dealings with C. elegans with low-risk modifications.\no\n* corresponds to Item 2 of Part 1 Schedule 2\nNND4 – Introducing genetically modified human somatic cells into a human for\no\nsomatic cell therapies such as CAR T-Cell therapy. * this is a new class\nLower risk\n2 1 • A dealing is not a non-notifiable dealing if it is a designated dealing.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 23]\nOther minor amendments\n• Other minor administrative amendments are proposed\nto be made to Part 5 of the current Regulations.\n• Transitional provisions will mostly be contained in the\nAmendment Bill; however, some transitional\nregulations may be required.\n• Minor changes to Schedules 1, 1A and 1B may be\nrequired in response to the proposed exclusion of\nhuman beings from the definition of a GMO.\n• Schedules 2 and 3 will be repealed and replaced with\nnew regulations for the purpose of NDs and NNDs as\nearlier described.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- GTMM Priorities until December 2025 update\n3 December 2025\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) have agreed to update the key priorities for the work of the GTMM until 2025.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- Funding announced in the 2019–20 Budget to implement the outcomes of the third review\n31 March 2019\nNews\nThe Australian Government will meet 50% of the cost of implementing the recommendations of the third review of the National Gene Technology Scheme.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- [Page 6]\nNational Gene Technology Scheme\n• The National Gene Technology Scheme (the Scheme) was established in 2000.\n• The Scheme is authorised through the Gene Technology Agreement 2001, and is\ncomprised of Commonwealth, state and territory legislation, including the:\nGene Technology Act 2000 (the Act) Gene Technology Regulations 2001\nCorresponding state and territory legislation\n• The object of the Act is to protect the health and safety of people, and to protect the\nenvironment, by identifying risks posed by or as a result of gene technology, and by\nmanaging those risks through regulating certain dealings with genetically modified organisms\n(GMOs).\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- Outcome of the Gene Technology Ministers’ Meeting – 13 April 2023\n14 April 2023\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) met virtually on Thursday 13 April 2023.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- [pages 1,2,3,4,5,6,7,8,9,10,11,12,13,14]\n[Page 1]\nProposed amendments to the Gene\nTechnology Regulations 2001\nAvi Rebera\nAssistant Secretary\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nGuest speaker\nDanielle Chifley\nDirector – Regulatory Policy and Reform\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nKirsteen Magee\nDr Raj Bhula\nAssistant Director\nGene Technology Regulator\nGene Technology Policy & Governance\nAustralian Government Department\nAustralian Government Department of Health, Disability and Ageing\nof Health, Disability and Ageing\n1\nwww.genetechnology.gov.au\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n\n## KPIs, Targets, and Where They Are At\n\n- [Page 6]\nNational Gene Technology Scheme\n• The National Gene Technology Scheme (the Scheme) was established in 2000.\n• The Scheme is authorised through the Gene Technology Agreement 2001, and is\ncomprised of Commonwealth, state and territory legislation, including the:\nGene Technology Act 2000 (the Act) Gene Technology Regulations 2001\nCorresponding state and territory legislation\n• The object of the Act is to protect the health and safety of people, and to protect the\nenvironment, by identifying risks posed by or as a result of gene technology, and by\nmanaging those risks through regulating certain dealings with genetically modified organisms\n(GMOs).\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- ND2 – low risk host/vector systems with modifications that may increase the\no\ncapacity of the host or vector to cause harm, or with culture volumes above the\nrelevant threshold (25L per vessel).\n*This class is intended to correspond to the current 2.1 (e), (f) and (h) of Schedule 3\nND3 – other host/vector systems where any of the following apply\no\n the host and the vector are non-pathogenic and very unlikely to cause harm, or\n the GM is unlikely to increase the ability of the host and vector to cause harm,\nor\n the dealings involve virions of a replication deficient vector, and the combined\nproperties of the host (if any), vector and donor nucleic acid are unlikely to\ncause harm.\n*This class is intended to correspond to 1.1 (c), 2.1 (c), (d), (g), (i)-(m) and 2.2 of Schedule 3 Lower risk\n1 9 • These dealings must be undertaken within 5 years of IBC assessment.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- NND1 – Dealings involving low risk host/vector systems with low-risk modifications\no\nand less than 25L in each vessel. *corresponds to Items 4 and 5 of Part 1 of Schedule 2\nNND2 – Dealings with GM animals that have genetically modified somatic cells, or\no\nto introduce genetically modified somatic cells into an animal.\n* corresponds predominantly to Items 3 and 3A of Part 1 of schedule 2 as well as an NLRD dealing\nNND3 – Dealings with C. elegans with low-risk modifications.\no\n* corresponds to Item 2 of Part 1 Schedule 2\nNND4 – Introducing genetically modified human somatic cells into a human for\no\nsomatic cell therapies such as CAR T-Cell therapy. * this is a new class\nLower risk\n2 1 • A dealing is not a non-notifiable dealing if it is a designated dealing.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 23]\nOther minor amendments\n• Other minor administrative amendments are proposed\nto be made to Part 5 of the current Regulations.\n• Transitional provisions will mostly be contained in the\nAmendment Bill; however, some transitional\nregulations may be required.\n• Minor changes to Schedules 1, 1A and 1B may be\nrequired in response to the proposed exclusion of\nhuman beings from the definition of a GMO.\n• Schedules 2 and 3 will be repealed and replaced with\nnew regulations for the purpose of NDs and NNDs as\nearlier described.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- Funding announced in the 2019–20 Budget to implement the outcomes of the third review\n31 March 2019\nNews\nThe Australian Government will meet 50% of the cost of implementing the recommendations of the third review of the National Gene Technology Scheme.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- See the video entry\nLatest news\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nGTMM Priorities until December 2025 update\n3 December 2025\nConsultation on proposed changes to the Gene Technology Act 2000\n17 September 2024\nView more news\nSubscribe to updates\nSubscribe to stay up to date with the latest scheme information.\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n- Subscribe\nLatest resources\nInformation session on proposed amendments to the Gene Technology Regulations 2001\n16 February 2026\nPresentation\nGTMM priorities until 2025\n3 December 2025\nStrategy or framework\nInformation session on proposed amendments to the Gene Technology Act – Questions and answers\n6 November 2024\nFact sheet\nInformation session on proposed amendments to the Gene Technology Act\n22 October 2024\nPresentation\nView more resources\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n- Outcome of the Gene Technology Ministers’ Meeting – 13 April 2023\n14 April 2023\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) met virtually on Thursday 13 April 2023.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- [pages 1,2,3,4,5,6,7,8,9,10,11,12,13,14]\n[Page 1]\nProposed amendments to the Gene\nTechnology Regulations 2001\nAvi Rebera\nAssistant Secretary\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nGuest speaker\nDanielle Chifley\nDirector – Regulatory Policy and Reform\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nKirsteen Magee\nDr Raj Bhula\nAssistant Director\nGene Technology Regulator\nGene Technology Policy & Governance\nAustralian Government Department\nAustralian Government Department of Health, Disability and Ageing\nof Health, Disability and Ageing\n1\nwww.genetechnology.gov.au\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 9]\nRegulations consultation timeline\nConsultation opened Information session Consultation closes\n5 January 2026 6 February 2026 1 March 2026\nDraft Regulations\nDrafting instructions provided to GTMM\nSubmissions will be\nprovided to the Office approval prior to\nanalysed\nof Parliamentary presenting to the\nMarch 2026\nCounsel Federal Executive\nCouncil\n9\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 13]\nHow are we reducing regulatory overlap?\n• The draft Bill requires the Commonwealth Minister and the Gene Technology Regulator to be\nsatisfied about risks for particular decisions relating to GMOs.\n• The Amendment Bill (subsection 15A(2)) poposes that this is not required, if, the risks are\nprescribed in the Regulations and are dealt with under the following Commonwealth Acts:\n• Agricultural and Veterinary Chemicals Code Act 1994\n• Food Standards Australia New Zealand Act 1991\n• Therapeutic Goods Act 1989\n• Any other act prescribed in the regulations.\n• Importantly, risks not required to be assessed, does not preclude these risks from being\nconsidered if deemed necessary.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 14]\nAuthorisation pathways\n• Major changes to existing authorisation pathways were outlined during consultation on the draft\nBill.\n• It is proposed that entirety of Part 3 and Schedules 2 & 3 of the Regulations will be revoked.\n• The Amendment Regulations will specify classes of GMO dealings using new risk proportionate\nauthorisation pathways.\nrisk-tiering\nlower risk higher risk\nmore streamlined more scrutiny\n• Risk proportionate regulation is common in modern regulatory schemes, maintaining strong\nsafeguards against high-risk dealings, whilst enabling efficiency for low-risk dealings.\n• The Gene Technology Regulator will make rules to specify further requirements to restrict the\nGMO classes.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [pages 14,15,16,17,18,19,20,21,22,23,24]\nassessed, does not preclude these risks from being\nconsidered if deemed necessary.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- Subscribe\nFilter results\nYou can narrow down the results using the filters\nNews type\nGene technology news\n(8)\n10\nresults\nSearch\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nNews\nWe invite stakeholders to provide feedback on proposed amendments to the Gene Technology Regulations.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n\n## Key Metrics\n\n- Funding announced in the 2019–20 Budget to implement the outcomes of the third review\n31 March 2019\nNews\nThe Australian Government will meet 50% of the cost of implementing the recommendations of the third review of the National Gene Technology Scheme.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- ND2 – low risk host/vector systems with modifications that may increase the\no\ncapacity of the host or vector to cause harm, or with culture volumes above the\nrelevant threshold (25L per vessel).\n*This class is intended to correspond to the current 2.1 (e), (f) and (h) of Schedule 3\nND3 – other host/vector systems where any of the following apply\no\n the host and the vector are non-pathogenic and very unlikely to cause harm, or\n the GM is unlikely to increase the ability of the host and vector to cause harm,\nor\n the dealings involve virions of a replication deficient vector, and the combined\nproperties of the host (if any), vector and donor nucleic acid are unlikely to\ncause harm.\n*This class is intended to correspond to 1.1 (c), 2.1 (c), (d), (g), (i)-(m) and 2.2 of Schedule 3 Lower risk\n1 9 • These dealings must be undertaken within 5 years of IBC assessment.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- NND1 – Dealings involving low risk host/vector systems with low-risk modifications\no\nand less than 25L in each vessel. *corresponds to Items 4 and 5 of Part 1 of Schedule 2\nNND2 – Dealings with GM animals that have genetically modified somatic cells, or\no\nto introduce genetically modified somatic cells into an animal.\n* corresponds predominantly to Items 3 and 3A of Part 1 of schedule 2 as well as an NLRD dealing\nNND3 – Dealings with C. elegans with low-risk modifications.\no\n* corresponds to Item 2 of Part 1 Schedule 2\nNND4 – Introducing genetically modified human somatic cells into a human for\no\nsomatic cell therapies such as CAR T-Cell therapy. * this is a new class\nLower risk\n2 1 • A dealing is not a non-notifiable dealing if it is a designated dealing.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 23]\nOther minor amendments\n• Other minor administrative amendments are proposed\nto be made to Part 5 of the current Regulations.\n• Transitional provisions will mostly be contained in the\nAmendment Bill; however, some transitional\nregulations may be required.\n• Minor changes to Schedules 1, 1A and 1B may be\nrequired in response to the proposed exclusion of\nhuman beings from the definition of a GMO.\n• Schedules 2 and 3 will be repealed and replaced with\nnew regulations for the purpose of NDs and NNDs as\nearlier described.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 6]\nNational Gene Technology Scheme\n• The National Gene Technology Scheme (the Scheme) was established in 2000.\n• The Scheme is authorised through the Gene Technology Agreement 2001, and is\ncomprised of Commonwealth, state and territory legislation, including the:\nGene Technology Act 2000 (the Act) Gene Technology Regulations 2001\nCorresponding state and territory legislation\n• The object of the Act is to protect the health and safety of people, and to protect the\nenvironment, by identifying risks posed by or as a result of gene technology, and by\nmanaging those risks through regulating certain dealings with genetically modified organisms\n(GMOs).\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- See the video entry\nLatest news\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nGTMM Priorities until December 2025 update\n3 December 2025\nConsultation on proposed changes to the Gene Technology Act 2000\n17 September 2024\nView more news\nSubscribe to updates\nSubscribe to stay up to date with the latest scheme information.\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n- Subscribe\nLatest resources\nInformation session on proposed amendments to the Gene Technology Regulations 2001\n16 February 2026\nPresentation\nGTMM priorities until 2025\n3 December 2025\nStrategy or framework\nInformation session on proposed amendments to the Gene Technology Act – Questions and answers\n6 November 2024\nFact sheet\nInformation session on proposed amendments to the Gene Technology Act\n22 October 2024\nPresentation\nView more resources\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n- Outcome of the Gene Technology Ministers’ Meeting – 13 April 2023\n14 April 2023\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) met virtually on Thursday 13 April 2023.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- [pages 1,2,3,4,5,6,7,8,9,10,11,12,13,14]\n[Page 1]\nProposed amendments to the Gene\nTechnology Regulations 2001\nAvi Rebera\nAssistant Secretary\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nGuest speaker\nDanielle Chifley\nDirector – Regulatory Policy and Reform\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nKirsteen Magee\nDr Raj Bhula\nAssistant Director\nGene Technology Regulator\nGene Technology Policy & Governance\nAustralian Government Department\nAustralian Government Department of Health, Disability and Ageing\nof Health, Disability and Ageing\n1\nwww.genetechnology.gov.au\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 9]\nRegulations consultation timeline\nConsultation opened Information session Consultation closes\n5 January 2026 6 February 2026 1 March 2026\nDraft Regulations\nDrafting instructions provided to GTMM\nSubmissions will be\nprovided to the Office approval prior to\nanalysed\nof Parliamentary presenting to the\nMarch 2026\nCounsel Federal Executive\nCouncil\n9\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n\n## Key Achievements\n\n- ND2 – low risk host/vector systems with modifications that may increase the\no\ncapacity of the host or vector to cause harm, or with culture volumes above the\nrelevant threshold (25L per vessel).\n*This class is intended to correspond to the current 2.1 (e), (f) and (h) of Schedule 3\nND3 – other host/vector systems where any of the following apply\no\n the host and the vector are non-pathogenic and very unlikely to cause harm, or\n the GM is unlikely to increase the ability of the host and vector to cause harm,\nor\n the dealings involve virions of a replication deficient vector, and the combined\nproperties of the host (if any), vector and donor nucleic acid are unlikely to\ncause harm.\n*This class is intended to correspond to 1.1 (c), 2.1 (c), (d), (g), (i)-(m) and 2.2 of Schedule 3 Lower risk\n1 9 • These dealings must be undertaken within 5 years of IBC assessment.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- NND1 – Dealings involving low risk host/vector systems with low-risk modifications\no\nand less than 25L in each vessel. *corresponds to Items 4 and 5 of Part 1 of Schedule 2\nNND2 – Dealings with GM animals that have genetically modified somatic cells, or\no\nto introduce genetically modified somatic cells into an animal.\n* corresponds predominantly to Items 3 and 3A of Part 1 of schedule 2 as well as an NLRD dealing\nNND3 – Dealings with C. elegans with low-risk modifications.\no\n* corresponds to Item 2 of Part 1 Schedule 2\nNND4 – Introducing genetically modified human somatic cells into a human for\no\nsomatic cell therapies such as CAR T-Cell therapy. * this is a new class\nLower risk\n2 1 • A dealing is not a non-notifiable dealing if it is a designated dealing.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 23]\nOther minor amendments\n• Other minor administrative amendments are proposed\nto be made to Part 5 of the current Regulations.\n• Transitional provisions will mostly be contained in the\nAmendment Bill; however, some transitional\nregulations may be required.\n• Minor changes to Schedules 1, 1A and 1B may be\nrequired in response to the proposed exclusion of\nhuman beings from the definition of a GMO.\n• Schedules 2 and 3 will be repealed and replaced with\nnew regulations for the purpose of NDs and NNDs as\nearlier described.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- Funding announced in the 2019–20 Budget to implement the outcomes of the third review\n31 March 2019\nNews\nThe Australian Government will meet 50% of the cost of implementing the recommendations of the third review of the National Gene Technology Scheme.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- [Page 6]\nNational Gene Technology Scheme\n• The National Gene Technology Scheme (the Scheme) was established in 2000.\n• The Scheme is authorised through the Gene Technology Agreement 2001, and is\ncomprised of Commonwealth, state and territory legislation, including the:\nGene Technology Act 2000 (the Act) Gene Technology Regulations 2001\nCorresponding state and territory legislation\n• The object of the Act is to protect the health and safety of people, and to protect the\nenvironment, by identifying risks posed by or as a result of gene technology, and by\nmanaging those risks through regulating certain dealings with genetically modified organisms\n(GMOs).\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- See the video entry\nLatest news\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nGTMM Priorities until December 2025 update\n3 December 2025\nConsultation on proposed changes to the Gene Technology Act 2000\n17 September 2024\nView more news\nSubscribe to updates\nSubscribe to stay up to date with the latest scheme information.\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n- Subscribe\nLatest resources\nInformation session on proposed amendments to the Gene Technology Regulations 2001\n16 February 2026\nPresentation\nGTMM priorities until 2025\n3 December 2025\nStrategy or framework\nInformation session on proposed amendments to the Gene Technology Act – Questions and answers\n6 November 2024\nFact sheet\nInformation session on proposed amendments to the Gene Technology Act\n22 October 2024\nPresentation\nView more resources\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n- Outcome of the Gene Technology Ministers’ Meeting – 13 April 2023\n14 April 2023\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) met virtually on Thursday 13 April 2023.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- They discussed the achievements and progress of implementing the recommendations of the Third Review of the National Gene Technology Scheme and endorsed a new Action Plan.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- [pages 1,2,3,4,5,6,7,8,9,10,11,12,13,14]\n[Page 1]\nProposed amendments to the Gene\nTechnology Regulations 2001\nAvi Rebera\nAssistant Secretary\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nGuest speaker\nDanielle Chifley\nDirector – Regulatory Policy and Reform\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nKirsteen Magee\nDr Raj Bhula\nAssistant Director\nGene Technology Regulator\nGene Technology Policy & Governance\nAustralian Government Department\nAustralian Government Department of Health, Disability and Ageing\nof Health, Disability and Ageing\n1\nwww.genetechnology.gov.au\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 9]\nRegulations consultation timeline\nConsultation opened Information session Consultation closes\n5 January 2026 6 February 2026 1 March 2026\nDraft Regulations\nDrafting instructions provided to GTMM\nSubmissions will be\nprovided to the Office approval prior to\nanalysed\nof Parliamentary presenting to the\nMarch 2026\nCounsel Federal Executive\nCouncil\n9\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 13]\nHow are we reducing regulatory overlap?\n• The draft Bill requires the Commonwealth Minister and the Gene Technology Regulator to be\nsatisfied about risks for particular decisions relating to GMOs.\n• The Amendment Bill (subsection 15A(2)) poposes that this is not required, if, the risks are\nprescribed in the Regulations and are dealt with under the following Commonwealth Acts:\n• Agricultural and Veterinary Chemicals Code Act 1994\n• Food Standards Australia New Zealand Act 1991\n• Therapeutic Goods Act 1989\n• Any other act prescribed in the regulations.\n• Importantly, risks not required to be assessed, does not preclude these risks from being\nconsidered if deemed necessary.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n\n## Key Issues, Risks, and Recommendations\n\n- ND2 – low risk host/vector systems with modifications that may increase the\no\ncapacity of the host or vector to cause harm, or with culture volumes above the\nrelevant threshold (25L per vessel).\n*This class is intended to correspond to the current 2.1 (e), (f) and (h) of Schedule 3\nND3 – other host/vector systems where any of the following apply\no\n the host and the vector are non-pathogenic and very unlikely to cause harm, or\n the GM is unlikely to increase the ability of the host and vector to cause harm,\nor\n the dealings involve virions of a replication deficient vector, and the combined\nproperties of the host (if any), vector and donor nucleic acid are unlikely to\ncause harm.\n*This class is intended to correspond to 1.1 (c), 2.1 (c), (d), (g), (i)-(m) and 2.2 of Schedule 3 Lower risk\n1 9 • These dealings must be undertaken within 5 years of IBC assessment.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- NND1 – Dealings involving low risk host/vector systems with low-risk modifications\no\nand less than 25L in each vessel. *corresponds to Items 4 and 5 of Part 1 of Schedule 2\nNND2 – Dealings with GM animals that have genetically modified somatic cells, or\no\nto introduce genetically modified somatic cells into an animal.\n* corresponds predominantly to Items 3 and 3A of Part 1 of schedule 2 as well as an NLRD dealing\nNND3 – Dealings with C. elegans with low-risk modifications.\no\n* corresponds to Item 2 of Part 1 Schedule 2\nNND4 – Introducing genetically modified human somatic cells into a human for\no\nsomatic cell therapies such as CAR T-Cell therapy. * this is a new class\nLower risk\n2 1 • A dealing is not a non-notifiable dealing if it is a designated dealing.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- Funding announced in the 2019–20 Budget to implement the outcomes of the third review\n31 March 2019\nNews\nThe Australian Government will meet 50% of the cost of implementing the recommendations of the third review of the National Gene Technology Scheme.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- [Page 6]\nNational Gene Technology Scheme\n• The National Gene Technology Scheme (the Scheme) was established in 2000.\n• The Scheme is authorised through the Gene Technology Agreement 2001, and is\ncomprised of Commonwealth, state and territory legislation, including the:\nGene Technology Act 2000 (the Act) Gene Technology Regulations 2001\nCorresponding state and territory legislation\n• The object of the Act is to protect the health and safety of people, and to protect the\nenvironment, by identifying risks posed by or as a result of gene technology, and by\nmanaging those risks through regulating certain dealings with genetically modified organisms\n(GMOs).\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 13]\nHow are we reducing regulatory overlap?\n• The draft Bill requires the Commonwealth Minister and the Gene Technology Regulator to be\nsatisfied about risks for particular decisions relating to GMOs.\n• The Amendment Bill (subsection 15A(2)) poposes that this is not required, if, the risks are\nprescribed in the Regulations and are dealt with under the following Commonwealth Acts:\n• Agricultural and Veterinary Chemicals Code Act 1994\n• Food Standards Australia New Zealand Act 1991\n• Therapeutic Goods Act 1989\n• Any other act prescribed in the regulations.\n• Importantly, risks not required to be assessed, does not preclude these risks from being\nconsidered if deemed necessary.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 14]\nAuthorisation pathways\n• Major changes to existing authorisation pathways were outlined during consultation on the draft\nBill.\n• It is proposed that entirety of Part 3 and Schedules 2 & 3 of the Regulations will be revoked.\n• The Amendment Regulations will specify classes of GMO dealings using new risk proportionate\nauthorisation pathways.\nrisk-tiering\nlower risk higher risk\nmore streamlined more scrutiny\n• Risk proportionate regulation is common in modern regulatory schemes, maintaining strong\nsafeguards against high-risk dealings, whilst enabling efficiency for low-risk dealings.\n• The Gene Technology Regulator will make rules to specify further requirements to restrict the\nGMO classes.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [pages 14,15,16,17,18,19,20,21,22,23,24]\nassessed, does not preclude these risks from being\nconsidered if deemed necessary.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 16]\nGMO licences\nHigher risk\na permit dealing on the GMO register\no o\na notifiable dealing (ND) authorised through an Emergency\no o\nDealing Determination\na non-notifiable dealing\no\nLower risk\n1 6\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- Higher risk\no\n*This class is intended to correspond to the current 1.1 (a) and 2.1 (a), (aa) and (b) of Schedule 3.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 23]\nOther minor amendments\n• Other minor administrative amendments are proposed\nto be made to Part 5 of the current Regulations.\n• Transitional provisions will mostly be contained in the\nAmendment Bill; however, some transitional\nregulations may be required.\n• Minor changes to Schedules 1, 1A and 1B may be\nrequired in response to the proposed exclusion of\nhuman beings from the definition of a GMO.\n• Schedules 2 and 3 will be repealed and replaced with\nnew regulations for the purpose of NDs and NNDs as\nearlier described.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- Update on implementing the third review\n31 July 2021\nNews\nThe 2017 review of the National Gene Technology Scheme final report outlined 27 recommendations.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- Post-notified notifiable dealings Pre-notified notifiable dealings\n• Regulator notification after commencement • Regulator notification prior to\ncommencement\n• Require Institutional Biosafety Committee\n(IBC) assessment • Would cover some currently licenced dealings\n• Regulator rules will prescribe conditions: • Regulations will prescribe:\n- who must notify - who must notify\n- the period in which they must notify - the period in which they must notify\n- form of notification - form of notification\nLower risk\n- any documents required in notification - any documents required in notification\n1 8\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 20]\nPre-notified notifiable dealings (ND4-5)\n• Contains GMO dealings that are currently licensed but have been identified as\nHigher risk\nlow risk and or other regulators manage key risks.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- See the video entry\nLatest news\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nGTMM Priorities until December 2025 update\n3 December 2025\nConsultation on proposed changes to the Gene Technology Act 2000\n17 September 2024\nView more news\nSubscribe to updates\nSubscribe to stay up to date with the latest scheme information.\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n\n## Corporate Values and Operating Culture\n\n- ND2 – low risk host/vector systems with modifications that may increase the\no\ncapacity of the host or vector to cause harm, or with culture volumes above the\nrelevant threshold (25L per vessel).\n*This class is intended to correspond to the current 2.1 (e), (f) and (h) of Schedule 3\nND3 – other host/vector systems where any of the following apply\no\n the host and the vector are non-pathogenic and very unlikely to cause harm, or\n the GM is unlikely to increase the ability of the host and vector to cause harm,\nor\n the dealings involve virions of a replication deficient vector, and the combined\nproperties of the host (if any), vector and donor nucleic acid are unlikely to\ncause harm.\n*This class is intended to correspond to 1.1 (c), 2.1 (c), (d), (g), (i)-(m) and 2.2 of Schedule 3 Lower risk\n1 9 • These dealings must be undertaken within 5 years of IBC assessment.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- NND1 – Dealings involving low risk host/vector systems with low-risk modifications\no\nand less than 25L in each vessel. *corresponds to Items 4 and 5 of Part 1 of Schedule 2\nNND2 – Dealings with GM animals that have genetically modified somatic cells, or\no\nto introduce genetically modified somatic cells into an animal.\n* corresponds predominantly to Items 3 and 3A of Part 1 of schedule 2 as well as an NLRD dealing\nNND3 – Dealings with C. elegans with low-risk modifications.\no\n* corresponds to Item 2 of Part 1 Schedule 2\nNND4 – Introducing genetically modified human somatic cells into a human for\no\nsomatic cell therapies such as CAR T-Cell therapy. * this is a new class\nLower risk\n2 1 • A dealing is not a non-notifiable dealing if it is a designated dealing.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- [Page 23]\nOther minor amendments\n• Other minor administrative amendments are proposed\nto be made to Part 5 of the current Regulations.\n• Transitional provisions will mostly be contained in the\nAmendment Bill; however, some transitional\nregulations may be required.\n• Minor changes to Schedules 1, 1A and 1B may be\nrequired in response to the proposed exclusion of\nhuman beings from the definition of a GMO.\n• Schedules 2 and 3 will be repealed and replaced with\nnew regulations for the purpose of NDs and NNDs as\nearlier described.\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- Funding announced in the 2019–20 Budget to implement the outcomes of the third review\n31 March 2019\nNews\nThe Australian Government will meet 50% of the cost of implementing the recommendations of the third review of the National Gene Technology Scheme.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n- [Page 6]\nNational Gene Technology Scheme\n• The National Gene Technology Scheme (the Scheme) was established in 2000.\n• The Scheme is authorised through the Gene Technology Agreement 2001, and is\ncomprised of Commonwealth, state and territory legislation, including the:\nGene Technology Act 2000 (the Act) Gene Technology Regulations 2001\nCorresponding state and territory legislation\n• The object of the Act is to protect the health and safety of people, and to protect the\nenvironment, by identifying risks posed by or as a result of gene technology, and by\nmanaging those risks through regulating certain dealings with genetically modified organisms\n(GMOs).\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)`\n- See the video entry\nLatest news\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nGTMM Priorities until December 2025 update\n3 December 2025\nConsultation on proposed changes to the Gene Technology Act 2000\n17 September 2024\nView more news\nSubscribe to updates\nSubscribe to stay up to date with the latest scheme information.\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n- Subscribe\nLatest resources\nInformation session on proposed amendments to the Gene Technology Regulations 2001\n16 February 2026\nPresentation\nGTMM priorities until 2025\n3 December 2025\nStrategy or framework\nInformation session on proposed amendments to the Gene Technology Act – Questions and answers\n6 November 2024\nFact sheet\nInformation session on proposed amendments to the Gene Technology Act\n22 October 2024\nPresentation\nView more resources\n Source: `pages/homepage.html (https://www.genetechnology.gov.au/)`\n- Outcome of the Gene Technology Ministers’ Meeting – 13 April 2023\n14 April 2023\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) met virtually on Thursday 13 April 2023.\n Source: `pages/news-latest.html (https://www.genetechnology.gov.au/news)`\n\n## Global Ideas and Case Study Inputs\n\n_No global-intelligence source text found yet. Run `CLAUDE/global-ideas-scraper.py ` to populate case-study sources._\n\n## Source Artifacts Used\n\n- `pages/about.html` - pages - https://www.genetechnology.gov.au/about-gene-technology\n- `pages/contact.html` - pages - https://www.genetechnology.gov.au/contact\n- `pages/homepage.html` - pages - https://www.genetechnology.gov.au/\n- `pages/news-latest.html` - pages - https://www.genetechnology.gov.au/news\n- `pages/publications-index.html` - pages - https://www.genetechnology.gov.au/resources/publications/information-session-proposed-amendments-gene-technology-regulations-2001\n- `pages/reviews-index.html` - pages - https://www.genetechnology.gov.au/reviews-and-consultations\n- `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf` - other-pdfs - https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf\n\n## Gaps To Fix\n\n- No corporate plan text source found.\n- No annual report text source found.\n- No global comparison/case-study sources found.", "legislation_md": "# Gene Technology Standing Committee - Acts and Legislation Discovery\n\n**Generated at**: 2026-05-09T21:09:10.349823+00:00\n**Entity ID**: B-002090\n**Jurisdiction**: Commonwealth\n**Portfolio**: Health, Disability and Ageing\n\n> This is an evidence-based discovery list from scraped department material. A mention does not always mean the department administers the legislation; high-confidence and official register links should be reviewed.\n\n## Summary\n\n- Source files scanned: 7\n- Unique legislation references found: 7\n\n| Type | Count |\n|---|---:|\n| Act | 5 |\n| Regulation | 2 |\n\n## Legislation References\n\n### Gene Technology Regulations 2001\n\n**Type**: Regulation\n**Confidence**: high\n**Mentions**: 6\n**Register search**: https://www.legislation.gov.au/search?query=Gene+Technology+Regulations+2001\n\n**Sources**:\n- `pages/homepage.html`\n- `pages/news-latest.html`\n- `pages/publications-index.html`\n- `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n**Evidence contexts**:\n- .\nOverview of the scheme in Australia\nLearn about Australia's National Gene Technology Scheme and how gene technology and genetically modified organisms are regulated in Australia.\nSee the video entry\nLatest news\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nGTMM Priorities until December 2025 update\n3 December 2025\nConsultation on proposed changes to the Gene Technology Act 2000\n17 September 2024\nView more news\nSubscribe to updates\nSubscribe to stay up to date with the latest scheme information.\nS\n Source: `pages/homepage.html`\n- onsultation on proposed changes to the Gene Technology Act 2000\n17 September 2024\nView more news\nSubscribe to updates\nSubscribe to stay up to date with the latest scheme information.\nSubscribe\nLatest resources\nInformation session on proposed amendments to the Gene Technology Regulations 2001\n16 February 2026\nPresentation\nGTMM priorities until 2025\n3 December 2025\nStrategy or framework\nInformation session on proposed amendments to the Gene Technology Act – Questions and answers\n6 November 2024\nFact sheet\nInformation session on proposed amendments\n Source: `pages/homepage.html`\n- ubscribe to updates\nSubscribe to stay up to date with the latest scheme information.\nSubscribe\nFilter results\nYou can narrow down the results using the filters\nNews type\nGene technology news\n(8)\n10\nresults\nSearch\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nNews\nWe invite stakeholders to provide feedback on proposed amendments to the Gene Technology Regulations. Consultation is open from 5 January 2026 until 1 March 2026.\nGTMM Priorities until December 2025 update\n3 December 2025\nNews\nThe Gene Tec\n Source: `pages/news-latest.html`\n- Information session on proposed amendments to the Gene Technology Regulations 2001\n\nScroll down to access downloads and media.\nDownload\n[Publication] Information session on proposed amendments to the Gene Technology Regulations 2001 (PDF) as\nPDF\n- 1.89 MB\n - 28 pages\nWe aim to provide documents in an accessible format. If you're having prob\n Source: `pages/publications-index.html`\n- Information session on proposed amendments to the Gene Technology Regulations 2001\n\nScroll down to access downloads and media.\nDownload\n[Publication] Information session on proposed amendments to the Gene Technology Regulations 2001 (PDF) as\nPDF\n- 1.89 MB\n - 28 pages\nWe aim to provide documents in an accessible format. If you're having problems using a document with your accessibility tools,\nplease contact us for help\n.\nPublication type:\nPresentation\nPublication date:\n16 February 2026\nLa\n Source: `pages/publications-index.html`\n\n### Gene Technology Act 2000\n\n**Type**: Act\n**Confidence**: high\n**Mentions**: 4\n**Register search**: https://www.legislation.gov.au/search?query=Gene+Technology+Act+2000\n\n**Sources**:\n- `pages/about.html`\n- `pages/homepage.html`\n- `pages/news-latest.html`\n- `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n**Evidence contexts**:\n- produce vaccines or medicines such as insulin, or developing new ways to diagnose and treat disease\nindustrial chemicals\n– using microorganisms to decompose toxic substances and clean up industrial sites or environmental accidents.\nRegulating gene technology\nThe\nGene Technology Act 2000\nintroduced a national regulatory framework for dealing with GMOs. This helps protect the health and safety of people and the environment by identifying and managing risks posed by:\nthe use of gene technology\nGMOs.\nThe National Gene Technology Scheme is a coop\n Source: `pages/about.html`\n- nisms are regulated in Australia.\nSee the video entry\nLatest news\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nGTMM Priorities until December 2025 update\n3 December 2025\nConsultation on proposed changes to the Gene Technology Act 2000\n17 September 2024\nView more news\nSubscribe to updates\nSubscribe to stay up to date with the latest scheme information.\nSubscribe\nLatest resources\nInformation session on proposed amendments to the Gene Technology Regulations 2001\n16 February 2026\nPresentation\n Source: `pages/homepage.html`\n- 025 update\n3 December 2025\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) have agreed to update the key priorities for the work of the GTMM until 2025. Read more about the GTMM Priorities until December 2025 update.\nConsultation on proposed changes to the Gene Technology Act 2000\n17 September 2024\nNews\nWe invite stakeholders to provide feedback on the Gene Technology Amendment Bill 2024. The proposed changes to gene technology legislation address the third review of the National Gene Technology Scheme recommendations. The consultation\n Source: `pages/news-latest.html`\n- ational Gene Technology Scheme\n• The National Gene Technology Scheme (the Scheme) was established in 2000.\n• The Scheme is authorised through the Gene Technology Agreement 2001, and is\ncomprised of Commonwealth, state and territory legislation, including the:\nGene Technology Act 2000 (the Act) Gene Technology Regulations 2001\nCorresponding state and territory legislation\n• The object of the Act is to protect the health and safety of people, and to protect the\nenvironment, by identifying risks posed by or as a result of gene technology, an\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n### Act) Gene Technology Regulations 2001\n\n**Type**: Act\n**Confidence**: medium\n**Mentions**: 1\n**Register search**: https://www.legislation.gov.au/search?query=Act%29+Gene+Technology+Regulations+2001\n\n**Sources**:\n- `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n**Evidence contexts**:\n- • The National Gene Technology Scheme (the Scheme) was established in 2000.\n• The Scheme is authorised through the Gene Technology Agreement 2001, and is\ncomprised of Commonwealth, state and territory legislation, including the:\nGene Technology Act 2000 (the Act) Gene Technology Regulations 2001\nCorresponding state and territory legislation\n• The object of the Act is to protect the health and safety of people, and to protect the\nenvironment, by identifying risks posed by or as a result of gene technology, and by\nmanaging those risks through regulatin\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n### Agricultural and Veterinary Chemicals Code Act 1994\n\n**Type**: Act\n**Confidence**: low\n**Mentions**: 1\n**Register search**: https://www.legislation.gov.au/search?query=Agricultural+and+Veterinary+Chemicals+Code+Act+1994\n\n**Sources**:\n- `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n**Evidence contexts**:\n- ator to be\nsatisfied about risks for particular decisions relating to GMOs.\n• The Amendment Bill (subsection 15A(2)) poposes that this is not required, if, the risks are\nprescribed in the Regulations and are dealt with under the following Commonwealth Acts:\n• Agricultural and Veterinary Chemicals Code Act 1994\n• Food Standards Australia New Zealand Act 1991\n• Therapeutic Goods Act 1989\n• Any other act prescribed in the regulations.\n• Importantly, risks not required to be assessed, does not preclude these risks from being\nconsidered if deemed necessary.\n1 3\n\n[page 1\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n### Food Standards Australia New Zealand Act 1991\n\n**Type**: Act\n**Confidence**: low\n**Mentions**: 1\n**Register search**: https://www.legislation.gov.au/search?query=Food+Standards+Australia+New+Zealand+Act+1991\n\n**Sources**:\n- `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n**Evidence contexts**:\n- ons relating to GMOs.\n• The Amendment Bill (subsection 15A(2)) poposes that this is not required, if, the risks are\nprescribed in the Regulations and are dealt with under the following Commonwealth Acts:\n• Agricultural and Veterinary Chemicals Code Act 1994\n• Food Standards Australia New Zealand Act 1991\n• Therapeutic Goods Act 1989\n• Any other act prescribed in the regulations.\n• Importantly, risks not required to be assessed, does not preclude these risks from being\nconsidered if deemed necessary.\n1 3\n\n[page 14]\nAuthorisation pathways\n• Major changes to exi\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n### Gene Te2c6hnology Regulations 2001\n\n**Type**: Regulation\n**Confidence**: low\n**Mentions**: 1\n**Register search**: https://www.legislation.gov.au/search?query=Gene+Te2c6hnology+Regulations+2001\n\n**Sources**:\n- `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n**Evidence contexts**:\n- Technology Scheme https://www.genetechnology.gov.au/\nOffice of the Gene Technology Regulator https://www.ogtr.gov.au/about-ogtr\nhttps://consultations.health.gov.au/best-practice-regulation/draft-amendments-\nConsultation hub\nto-the-gene-technology-regulation/\nGene Te2c6hnology Regulations 2001 https://www.legislation.gov.au/F2001B00162/latest/text\nOFFICIAL\n\n[page 27]\nContact us\nFor any further queries please reach us by\nemail at\ngene.technology.implementation@health.gov.au\n2 7\n\n[page 28]\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n### Therapeutic Goods Act 1989\n\n**Type**: Act\n**Confidence**: low\n**Mentions**: 1\n**Register search**: https://www.legislation.gov.au/search?query=Therapeutic+Goods+Act+1989\n\n**Sources**:\n- `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n**Evidence contexts**:\n- ection 15A(2)) poposes that this is not required, if, the risks are\nprescribed in the Regulations and are dealt with under the following Commonwealth Acts:\n• Agricultural and Veterinary Chemicals Code Act 1994\n• Food Standards Australia New Zealand Act 1991\n• Therapeutic Goods Act 1989\n• Any other act prescribed in the regulations.\n• Importantly, risks not required to be assessed, does not preclude these risks from being\nconsidered if deemed necessary.\n1 3\n\n[page 14]\nAuthorisation pathways\n• Major changes to existing authorisation pathways\n Source: `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl`\n\n## Files Scanned\n\n- `pages/about.html` (page)\n- `pages/contact.html` (page)\n- `pages/homepage.html` (page)\n- `pages/news-latest.html` (page)\n- `pages/publications-index.html` (page)\n- `pages/reviews-index.html` (page)\n- `other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pages.jsonl` (pdf_pages)", "global_initiatives_md": null, "strategy": { "reporting_period": "2024-25", "corporate_plan_period": "2025-26", "vision": null, "vision_source_page": null, "purposes": null, "purposes_source_page": null, "how_we_deliver": null, "how_we_deliver_source_page": null, "government_priorities": [], "outcomes": [], "values": [], "values_framework_name": null, "kpi_targets_2025_26": [], "kpi_results_2024_25": [], "_source_urls": { "annual_report_url": "", "corporate_plan_url": "" } }, "ideas": [ { "entity_id": "B-002090", "entity_name": "Gene Technology Standing Committee", "folder_name": "Gene-Technology-Standing-Committee", "category": "Regulation & Policy", "scale": "small", "title": "Regulatory burden scan for forms, guidance, and reporting", "idea": "Identify the top 10 highest-friction reporting obligations and simplify guidance, forms, or evidence requirements.", "quote": "[pages 1,2,3,4,5,6,7,8,9,10,11,12,13,14]\n[Page 1]\nProposed amendments to the Gene\nTechnology Regulations 2001\nAvi Rebera\nAssistant Secretary\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nGuest speaker\nDanielle Chifley\nDirector – Regulatory Policy and Reform\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nKirsteen Magee\nDr Raj Bhula\nAssistant Director\nGene Technology Regulator\nGene Technology Policy & Governance\nAustralian Government Department\nAustralian Government Department of Health, Disability and Ageing\nof Health, Disability and Ageing\n1\nwww.genetechnology.gov.au", "impact": "High", "effort": "Low", "proof": "Evidence-backed", "beneficiaries": "Regulated entities / policy teams", "source": "other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)", "implementation": [ "Pick one high-volume process or document family.", "Name an owner and baseline current volume, time, cost, and satisfaction.", "Run a 4-8 week pilot with clear before/after metrics.", "Publish lessons and decide whether to scale." ], "risks": [ "Privacy and data quality", "Change fatigue", "Unclear accountability", "Regulatory capture", "Over-automation of judgement" ] }, { "entity_id": "B-002090", "entity_name": "Gene Technology Standing Committee", "folder_name": "Gene-Technology-Standing-Committee", "category": "Regulation & Policy", "scale": "large", "title": "Adaptive regulation program with live feedback loops", "idea": "Create an adaptive regulation model using sandboxes, industry data, risk scoring, and regular rule updates.", "quote": "[pages 1,2,3,4,5,6,7,8,9,10,11,12,13,14]\n[Page 1]\nProposed amendments to the Gene\nTechnology Regulations 2001\nAvi Rebera\nAssistant Secretary\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nGuest speaker\nDanielle Chifley\nDirector – Regulatory Policy and Reform\nOffice of Drug Control and Gene Technology Policy & Governance\nAustralian Government Department of Health, Disability and Ageing\nKirsteen Magee\nDr Raj Bhula\nAssistant Director\nGene Technology Regulator\nGene Technology Policy & Governance\nAustralian Government Department\nAustralian Government Department of Health, Disability and Ageing\nof Health, Disability and Ageing\n1\nwww.genetechnology.gov.au", "impact": "Very High", "effort": "High", "proof": "Evidence-backed", "beneficiaries": "Regulated entities / policy teams", "source": "other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)", "implementation": [ "Create a senior responsible owner and cross-functional delivery team.", "Map legislation, data, privacy, procurement, cyber, and workforce constraints.", "Co-design with users and frontline staff before technology selection.", "Stage delivery through pilots, benefits tracking, and public reporting." ], "risks": [ "Privacy and data quality", "Change fatigue", "Unclear accountability", "Regulatory capture", "Over-automation of judgement" ] }, { "entity_id": "B-002090", "entity_name": "Gene Technology Standing Committee", "folder_name": "Gene-Technology-Standing-Committee", "category": "Risk & Assurance", "scale": "small", "title": "Recommendation tracker for audits, reviews, and inquiries", "idea": "Publish a single internal tracker for audit/review recommendations, owners, due dates, and implementation evidence.", "quote": "[Page 14]\nAuthorisation pathways\n• Major changes to existing authorisation pathways were outlined during consultation on the draft\nBill.\n• It is proposed that entirety of Part 3 and Schedules 2 & 3 of the Regulations will be revoked.\n• The Amendment Regulations will specify classes of GMO dealings using new risk proportionate\nauthorisation pathways.\nrisk-tiering\nlower risk higher risk\nmore streamlined more scrutiny\n• Risk proportionate regulation is common in modern regulatory schemes, maintaining strong\nsafeguards against high-risk dealings, whilst enabling efficiency for low-risk dealings.\n• The Gene Technology Regulator will make rules to specify further requirements to restrict the\nGMO classes.", "impact": "High", "effort": "Low", "proof": "Evidence-backed", "beneficiaries": "Executives / assurance teams", "source": "other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)", "implementation": [ "Pick one high-volume process or document family.", "Name an owner and baseline current volume, time, cost, and satisfaction.", "Run a 4-8 week pilot with clear before/after metrics.", "Publish lessons and decide whether to scale." ], "risks": [ "Privacy and data quality", "Change fatigue", "Unclear accountability", "Regulatory capture", "Over-automation of judgement" ] }, { "entity_id": "B-002090", "entity_name": "Gene Technology Standing Committee", "folder_name": "Gene-Technology-Standing-Committee", "category": "Risk & Assurance", "scale": "large", "title": "Integrated assurance and lessons-learned system", "idea": "Create an assurance system that connects audit findings, risk registers, delivery reviews, and investment decisions.", "quote": "[Page 14]\nAuthorisation pathways\n• Major changes to existing authorisation pathways were outlined during consultation on the draft\nBill.\n• It is proposed that entirety of Part 3 and Schedules 2 & 3 of the Regulations will be revoked.\n• The Amendment Regulations will specify classes of GMO dealings using new risk proportionate\nauthorisation pathways.\nrisk-tiering\nlower risk higher risk\nmore streamlined more scrutiny\n• Risk proportionate regulation is common in modern regulatory schemes, maintaining strong\nsafeguards against high-risk dealings, whilst enabling efficiency for low-risk dealings.\n• The Gene Technology Regulator will make rules to specify further requirements to restrict the\nGMO classes.", "impact": "Very High", "effort": "High", "proof": "Evidence-backed", "beneficiaries": "Executives / assurance teams", "source": "other-pdfs/information-session-on-proposed-amendments-to-the-gene-technology-regulations-20.pdf (https://www.genetechnology.gov.au/sites/default/files/2026-02/information-session-on-proposed-amendments-to-the-gene-technology-regulations-2001.pdf)", "implementation": [ "Create a senior responsible owner and cross-functional delivery team.", "Map legislation, data, privacy, procurement, cyber, and workforce constraints.", "Co-design with users and frontline staff before technology selection.", "Stage delivery through pilots, benefits tracking, and public reporting." ], "risks": [ "Privacy and data quality", "Change fatigue", "Unclear accountability", "Regulatory capture", "Over-automation of judgement" ] }, { "entity_id": "B-002090", "entity_name": "Gene Technology Standing Committee", "folder_name": "Gene-Technology-Standing-Committee", "category": "Citizen Participation", "scale": "small", "title": "Consultation feedback summaries with response tracking", "idea": "Summarise consultation submissions by theme and publish what changed in response.", "quote": "Subscribe\nFilter results\nYou can narrow down the results using the filters\nNews type\nGene technology news\n(8)\n10\nresults\nSearch\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nNews\nWe invite stakeholders to provide feedback on proposed amendments to the Gene Technology Regulations.", "impact": "High", "effort": "Low", "proof": "Evidence-backed", "beneficiaries": "Citizens / stakeholders / policy teams", "source": "pages/news-latest.html (https://www.genetechnology.gov.au/news)", "implementation": [ "Pick one high-volume process or document family.", "Name an owner and baseline current volume, time, cost, and satisfaction.", "Run a 4-8 week pilot with clear before/after metrics.", "Publish lessons and decide whether to scale." ], "risks": [ "Privacy and data quality", "Change fatigue", "Unclear accountability", "Digital exclusion", "Low public trust if feedback is not acted on" ] }, { "entity_id": "B-002090", "entity_name": "Gene Technology Standing Committee", "folder_name": "Gene-Technology-Standing-Committee", "category": "Citizen Participation", "scale": "large", "title": "Always-on policy participation platform", "idea": "Create a standing participation platform where citizens and stakeholders can propose, vote, and track ideas.", "quote": "Subscribe\nFilter results\nYou can narrow down the results using the filters\nNews type\nGene technology news\n(8)\n10\nresults\nSearch\nConsultation on the proposed amendments to the Gene Technology Regulations 2001\n7 January 2026\nNews\nWe invite stakeholders to provide feedback on proposed amendments to the Gene Technology Regulations.", "impact": "Very High", "effort": "High", "proof": "Evidence-backed", "beneficiaries": "Citizens / stakeholders / policy teams", "source": "pages/news-latest.html (https://www.genetechnology.gov.au/news)", "implementation": [ "Create a senior responsible owner and cross-functional delivery team.", "Map legislation, data, privacy, procurement, cyber, and workforce constraints.", "Co-design with users and frontline staff before technology selection.", "Stage delivery through pilots, benefits tracking, and public reporting." ], "risks": [ "Privacy and data quality", "Change fatigue", "Unclear accountability", "Digital exclusion", "Low public trust if feedback is not acted on" ] }, { "entity_id": "B-002090", "entity_name": "Gene Technology Standing Committee", "folder_name": "Gene-Technology-Standing-Committee", "category": "Staff Productivity", "scale": "small", "title": "Reusable briefing and summary assistant for internal documents", "idea": "Create controlled templates for summarising reports, submissions, minutes, and ministerial briefs.", "quote": "Outcome of the Gene Technology Ministers’ Meeting – July 2021\n31 July 2021\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) met virtually on Tuesday 20 July 2021.", "impact": "High", "effort": "Low", "proof": "Evidence-backed", "beneficiaries": "APS staff / executives", "source": "pages/news-latest.html (https://www.genetechnology.gov.au/news)", "implementation": [ "Pick one high-volume process or document family.", "Name an owner and baseline current volume, time, cost, and satisfaction.", "Run a 4-8 week pilot with clear before/after metrics.", "Publish lessons and decide whether to scale." ], "risks": [ "Privacy and data quality", "Change fatigue", "Unclear accountability", "Sensitive information leakage", "Inconsistent quality of generated drafts" ] }, { "entity_id": "B-002090", "entity_name": "Gene Technology Standing Committee", "folder_name": "Gene-Technology-Standing-Committee", "category": "Staff Productivity", "scale": "large", "title": "Department-wide knowledge and briefing platform", "idea": "Build a secure knowledge platform that lets staff search, summarise, and cite approved departmental material.", "quote": "Outcome of the Gene Technology Ministers’ Meeting – July 2021\n31 July 2021\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) met virtually on Tuesday 20 July 2021.", "impact": "Very High", "effort": "High", "proof": "Evidence-backed", "beneficiaries": "APS staff / executives", "source": "pages/news-latest.html (https://www.genetechnology.gov.au/news)", "implementation": [ "Create a senior responsible owner and cross-functional delivery team.", "Map legislation, data, privacy, procurement, cyber, and workforce constraints.", "Co-design with users and frontline staff before technology selection.", "Stage delivery through pilots, benefits tracking, and public reporting." ], "risks": [ "Privacy and data quality", "Change fatigue", "Unclear accountability", "Sensitive information leakage", "Inconsistent quality of generated drafts" ] }, { "entity_id": "B-002090", "entity_name": "Gene Technology Standing Committee", "folder_name": "Gene-Technology-Standing-Committee", "category": "Data & Performance", "scale": "small", "title": "KPI evidence register with named owners", "idea": "Create a simple register mapping each KPI to source data, owner, frequency, target, and last result.", "quote": "Outcome of the Gene Technology Ministers’ Meeting – July 2021\n31 July 2021\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) met virtually on Tuesday 20 July 2021.", "impact": "High", "effort": "Low", "proof": "Evidence-backed", "beneficiaries": "Executives / Parliament / public", "source": "pages/news-latest.html (https://www.genetechnology.gov.au/news)", "implementation": [ "Pick one high-volume process or document family.", "Name an owner and baseline current volume, time, cost, and satisfaction.", "Run a 4-8 week pilot with clear before/after metrics.", "Publish lessons and decide whether to scale." ], "risks": [ "Privacy and data quality", "Change fatigue", "Unclear accountability" ] }, { "entity_id": "B-002090", "entity_name": "Gene Technology Standing Committee", "folder_name": "Gene-Technology-Standing-Committee", "category": "Data & Performance", "scale": "large", "title": "Outcome dashboard linking budget, delivery, and public impact", "idea": "Build a public-facing outcome dashboard showing spend, outputs, outcomes, and delivery confidence.", "quote": "Outcome of the Gene Technology Ministers’ Meeting – July 2021\n31 July 2021\nNews\nThe Gene Technology Ministers’ Meeting (GTMM) met virtually on Tuesday 20 July 2021.", "impact": "Very High", "effort": "High", "proof": "Evidence-backed", "beneficiaries": "Executives / Parliament / public", "source": "pages/news-latest.html (https://www.genetechnology.gov.au/news)", "implementation": [ "Create a senior responsible owner and cross-functional delivery team.", "Map legislation, data, privacy, procurement, cyber, and workforce constraints.", "Co-design with users and frontline staff before technology selection.", "Stage delivery 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