The regulatory framework in Australia for gene drive modified insect - - PowerPoint PPT Presentation

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the regulatory framework in australia for gene drive
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The regulatory framework in Australia for gene drive modified insect - - PowerPoint PPT Presentation

Oct 24, 2022 34 likes •258 views

The regulatory framework in Australia for gene drive modified insect pests OECD Conference, 5-6 October 2016 Owain Edwards Group Leader, Environmental & Synthetic Genomics , CSIRO Land & Water, Perth Peter Thygesen Principal Regulatory

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OECD Conference, 5-6 October 2016

The regulatory framework in Australia for gene drive modified insect pests

Owain Edwards Group Leader, Environmental & Synthetic Genomics, CSIRO Land & Water, Perth Peter Thygesen Principal Regulatory Scientist, Office of the Gene Technology Regulator, Canberra

CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

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  • 1. Overview of Australia’s gene technology regulation
  • 2. Formal processes for stakeholder consultation
  • 3. Informal consultation – Regulatory Science Network

Overview

CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

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EU NPBT working group 2008 Voluntary oversight begins in Australia Bt cotton in Australia 1996 Asilomar 1975 uncertainty OECD ‘blue book’ 1986

GMO laws

GT Act + OGTR, EC 2001/18 2001 UN Cartagena Protocol on Biosafety 2000 GM tobacco plant produced 1983 GMAC 1987 NPBT workshops FSANZ, EC-JRC, OECD, ILSI 2011-14

GM history

2011 GT Act review 2009/10 GT Regs review rec DNA GMOs NBTs

synthetic biology, Gene Drives

commercial GM crops & food 2006/7 GT Act review 2004-6 GT Regs review CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

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CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

The very short story …

  • Gene Technology Act 2000
  • GT Regulations 2001
  • Intergovernmental Gene Technology Agreement

Process based ‘regulatory trigger’ Dealings with GMOs regulated independent Gene Technology Regulator science based, case by case, risk assessment & management transparency and public consultation

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a. conduct experiments with GMO b. make, develop, produce or manufacture GMO c. breed the GMO d. propagate the GMO e. use the GMO to manufacture a thing that is not the GMO f. grow, raise or culture the GMO g. import the GMO h. transport the GMO i. dispose the GMO and possess, supply or use of GMO for (a) – (i)

Dealings with GMOs

CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

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Scope of the GT legislation

Licensing scheme – dealings with GMOs prohibited unless authorised Risk assessment & risk management – risk not benefits Accreditation of organisations – Institutional Biosafety Committees (IBCs) Certification of containment facilities – PC1, PC2, PC3, PC4 Monitoring and enforcement powers

CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

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States and Territories Public Gene Technology Standing Committee

Technical Regulatory Consultation TGA Environment Minister Local Councils FSANZ APVMA NICNAS

DAWR Biosecurity

Gene Technology Regulator OGTR

advise LGFGT

  • r Regulator

Intergovernmental Agreement

Gene Technology Acts

Legislative and Governance Forum

  • n Gene Technology (Ministers)

GMO regulation in Australia

GTTAC GTECCC Regulated Community

CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

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GMO regulation – other regulators

FSANZ APVMA DAWR NICNAS TGA

OGTR

live and viable GMOs

  • Reciprocal advice
  • OGTR regulates GMOs. Some

intersection with other agencies

  • Avoid duplication & align decision

making (as far as possible). Biosecurity, biologicals, Import RAs Human therapeutics Industrial chemicals Food Ag chemicals Vet therapeutics (EPBC Act) Environment Minister

CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

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CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

Context - international

Regulatory trigger process EU, Australia, (gene technology) Argentina, etc. product novelty Canada, New Zealand*

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International context – CBD synbio AHTEG

3

Dec 2015

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Amending legislation

Legislation

Risk, Science Societal values Protection goals

Broad consultation and discussion

Consultation processes

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States and Territories Public Gene Technology Standing Committee

Technical Regulatory Consultation TGA Environment Minister Local Councils FSANZ APVMA NICNAS

DAWR Biosecurity

Gene Technology Regulator OGTR

advise LGFGT

  • r Regulator

Intergovernmental Agreement

Gene Technology Acts

Legislative and Governance Forum

  • n Gene Technology (Ministers)

GMO regulation - dramatis personae

GTTAC GTECCC Regulated Community

CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

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CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

OGTR Technical Review of GT regulations

FOCUS: Provide clarity about whether organisms developed using a range of new technologies are subject to regulation as GMOs and ensure that new technologies are regulated in a manner commensurate with the risks they pose CONTEXT: Since the last technical review, several technologies have developed rapidly, in particular site-directed nuclease and oligo- directed mutagenesis PROGRESS: Public consultation on an Options Paper (Oct-Nov 2016), including questions on gene drives For details http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/content/regs-process-1 NEXT STEPS: Draft proposals for amendments, Consultation on proposed amendments, Agreement of State/federal governments.

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EU NPBT working group 2008 Voluntary oversight begins in Australia Bt cotton in Australia 1996 Asilomar 1975 uncertainty OECD ‘blue book’ 1986

GMO laws

GT Act + OGTR, EC 2001/18 2001 UN Cartagena Protocol on Biosafety 2000 GM tobacco plant produced 1983 GMAC 1987 NPBT workshops FSANZ, EC-JRC, OECD, ILSI 2011-14 2011 GT Act review 2009/10 GT Regs review rec DNA GMOs NBTs

synthetic biology, Gene Drives

commercial GM crops & food 2006/7 GT Act review 2004-6 GT Regs review CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

History of formal reviews

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Formal review process

CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

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CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

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Informal consultation

CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

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Outcomes of Symposium and Roundtable

CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

  • Currently no gene drive specific regulation for contained

research, same minimum requirements as any other GMOs

  • Proposal that additional specific containment measures might be warranted

for gene drive organisms

  • Current regulations for GMO contained work require institutional

biosafety committees (IBCs) to consider if facility is at appropriate containment level.

  • Communication from OGTRs to IBCs on considerations for gene drive work

suggested in the interim

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Presentation title | Presenter name | Page 20

Gene drive regulation – other regulators ?

FSANZ APVMA DAWR NICNAS TGA

OGTR

live and viable GMOs

Biosecurity, biologicals, Import RAs Human therapeutics Industrial chemicals Food Ag chemicals Vet therapeutics (EPBC Act) Environment Minister

GD ?

Biological Control Act, S/T legislation

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Summary

CSIRO SYNTHETIC BIOLOGY FUTURE SCIENCE PLATFORM

  • Australia has a process-based regulatory

framework for gene technologies

  • Science-based oversight by the Office of the Gene

Technology Regulator (OGTR), with the cooperation

  • f other regulatory agencies
  • Regulations subjected to periodic review,

including broad consultation

  • The Regulatory Science Network offers additional
  • pportunities for stakeholder consultation
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BIOSECURITY FLAGSHIP

Thank you