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

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. 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. • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. ‘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. • 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. • 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. 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. © Commonwealth of Australia as represented by the
Department of Health 2017
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