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Regulatory aspects associated to genome editing in Australia - situation for GMOs - Peter Thygesen

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This presentation addresses the regulatory questions associated to GMOs in Australia, with a view to discussing approaches to address them.

Publicado en: Medio ambiente
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Regulatory aspects associated to genome editing in Australia - situation for GMOs - Peter Thygesen

  1. 1. Dr Peter Thygesen Clarifying the regulation of genome editing in Australia – current considerations – Situation for GMOs OECD Conference on Genome Editing: Applications in Agriculture – Implications for Health, Environment and Regulation 28 – 29 June, 2018 Paris, France
  2. 2. Australia’s National GMO Regulatory Scheme Protect people & the environment from risks posed by gene technology by regulating dealings with GMOs • Gene Technology Act 2000 (GT Act) • Gene Technology Regulations 2001 (GT Regulations) • inter-governmental Gene Technology Agreement Federal, State & Territory governments
  3. 3. • be based on a scientific assessment of risks undertaken by an independent Regulator • regulatory burden commensurate with risks • be able to be amended to respond to the development of gene technologies • efficient & effective system for the application of gene technologies Overarching framework for GMO regulation - Gene Technology Agreement:
  4. 4. Integrated regulation APVMA DAWR NICNAS FSANZ OGTR GMOs Biosecurity, Quarantine Human medicines Industrial chemicals Human food (incl GM) Pesticides, Veterinary medicines Environmental Protection Environment Minister TGA
  5. 5. GMO regulation – intent of definitions GT Regulations – exclusions: • Techniques that are not gene technology • Organisms that are not GMOs GT Act – definitions: • gene technology – broad and inclusive • GMO – broad and inclusive Original exclusions - principles: • techniques: already in use, mimic natural processes • organisms: (outcomes) can occur in nature • no unique biosafety risks • compliance: distinguish GMOs vs other organisms
  6. 6. GMO = an organism modified by gene technology = organism declared a GMO* ≠ organism declared not a GMO* gene technology = any technique for modification of genes or other genetic material, ≠ sexual reproduction, homologous recombination ≠ any technique declared not gene technology* * GT Regulations Gene Technology Act 2000 – process trigger
  7. 7. Schedule 1A – Techniques that are not gene technology • radiation & chemical mutagenesis • somatic cell nuclear transfer, protoplast fusion • a natural process* not involving genetically modified material *eg conjugation, transduction, transformation, transposon mutagenesis Schedule 1 – Organisms that are not GMOs eg • an organism that results from an exchange of DNA if: (a) the donor species is also the host species; and (b) vector DNA contains no heterologous DNA Gene Technology Regulations 2001
  8. 8. The ‘problem’ - transgenics to genome editing 35S gene nos 2000 2018 35S cisgenesis, intragenesis oligo-directed mutagenesis (ODM), NPBTs CRISPR, ZFN (SDNs) transgenics ‘recombinant DNA, genetic modification’ ‘genome editing’ = ‘GMO’ = ‘GMO’ ?
  9. 9. eg Schedule 1 – Organisms that are not GMOs Item 1: a mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (that is, non-homologous DNA, usually from another species). The ‘problem’ – definitional clarity • potential ambiguity, in light of changes in technology
  10. 10. Genome editing ‘regulatory problem’ – not unique: Risk analysis what should be regulated? Science Protection goals, Values, Policy Governments make laws define what is to be regulated Regulators administer laws regulate Courts adjudicate laws decide what is, and is not, regulated DTime,Dchanges over time, knowledge, technology, practices, circumstances change …
  11. 11. targeted changes: unguided repair template guided repair mutagenesis SDN-1 Inserting transgenes Natural mutations SDN-3 SDN-2 ODM oligonucleotide long template Extent of sequence changes Current situation – June 2018 not GMOs, not regulated potential ambiguity GMOs, regulated point mutations, deletions Process features long sequences inserted Product features
  12. 12. Current situation – general OGTR advice ‘OGTR is aware of differences of opinion ... whether organisms modified with eg ODM, SDNs are subject to regulation as GMOs ... The GT Act contains broad definitions of ‘GMO’ & ‘gene technology’. The GT Regulations provide some exclusions ... although there are challenges in applying the current definitions to some new technologies, the Regulator is obliged to ... apply the legislation as it stands today ... must take a conservative approach, consistent with the broad definitions ...’ ‘... continue to discuss queries about regulatory coverage with OGTR ...’
  13. 13. Primary aim: • Update exclusions in line with current science to provide clarity, resolve ambiguity Main consideration: • Regulation commensurate with risk Important constraint: • cannot change Policy settings of the regulatory scheme eg process trigger in the GT Act OGTR – Technical Review of GT Regulations
  14. 14. 1. No change 2. Process basis - all ODM and SDNs are gene technology, all organisms from genome editing are GMOs 3. Process basis - genome editing techniques : • with a template are gene technology (ODM, SDN2, SDN3) • without a template are not gene technology (SDN1) 4. Outcome basis - exclude genome editing techniques with the same outcomes as conventional breeding • Compliance considerations: (in)ability to distinguish genome edited vs conventionally bred organisms Regulations Review – options – 2016-17
  15. 15. Proposed changes to GT Regulations – 2017-18 • Organisms that are GMOs – new Schedule 1B • modified by ODM • modified by SDN-2 or SDN-3 with a template • Organisms that are not GMOs – Schedule 1 • modified by SDN-1 without a template • null segregants • delete Item 1 – “a mutant organism in which the mutational event did not involve ...” • Techniques that are not gene technology – Schedule 1A • exogenous application of RNAi molecules
  16. 16. mutagenesis Inserting transgenes Natural mutations SDN-3 SDN-2 and ODM oligonucleotide long template Proposed changes to GT Regulations not gene technology not GMOs, not regulated gene technology, GMOs, regulated no template + template SDN-1
  17. 17. Preliminary Report, March 2018 – Finding 3: ‘... there are existing definitions in the GT Act and Regulations that may not appropriately classify a range of advances in technology (eg ‘gene technology’ and ‘GMO’). ... the value of consistent definitions is well understood ... any examination of definitions should take into account ... the current Technical Review of the Regulations, as well as ongoing work internationally.’ [emphasis added] Policy settings – 2017 Review of the GT Act* * The GT Act Review of is being conducted by Federal & State officials supporting the national Legislative & Governance Forum on Gene Technology.
  18. 18. ‘The Technical Review of the Regulations is intended to provide an interim solution while broader policy considerations of new technologies ... progressed through the Review of the Scheme.’ [emphasis added] The Report findings also cover: • process vs product triggers, maintaining regulation commensurate with risk • increasing flexibility to respond to changes in science and understanding of risks • need for further work, particularly in the context of concurrent national and international debate & reviews GT Act Review – Preliminary report cont
  19. 19. • N.B. - no changes have been made yet • OGTR considering submissions on amendment proposals • OGTR will seek agreement to revised amendments from Federal, State & Territory governments • If agreed, Amendment Regulations will be finalised • timing to be confirmed ... Next steps – GT Regulations review
  20. 20. • N.B. - no changes proposed yet • Feedback on Preliminary Report will inform draft recommendations to the Federal, State & Territory governments • Following consideration of recommendations, a formal All Australian Governments’ Response is anticipated • timing to be confirmed ... Next steps – GT Act review
  21. 21. GT Regulations Review: www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ reviewregulations-1 National GT Scheme Review: www.health.gov.au/internet/main/publishing.nsf/Content/ gene-technology-review www.ogtr.gov.au FINIS ...
  22. 22. © Commonwealth of Australia as represented by the Department of Health 2017 Creative Commons Licence This publication is licensed under the Creative Commons Attribution 4.0 International Public License available from (www.//creativecommons.org/licenses/by/4.0/legalcode)(“Lice nce”). You must read and understand the Licence before using any material from this publication. Copyright

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