Discussing the Convention on Biological Diversity; the Cartagena Protocol on Biosafety; the Nagoya Protocol on Access and Benefit Sharing. Where does modern biotechnology fit under the Cartagena Protocol on Biosafety? What is the difference between biotechnology and synthetic biology? How do we assess risks of synthetic biology? Presentation by Manoela Miranda during Redesigning the Tree of Life: Synthetic Biology and the Future of Food, 2-4 November 2017 in Toronto.

1. Synthetic Biology
and the
Convention on Biological
Diversity
Manoela Miranda (CBD Secretariat)

2. Convention on Biological
Diversity
• 1992
• 196 Parties
• Objectives:
 Conservation and sustainable use
of biodiversity
 Fair and Equitable sharing of
benefits arising from the use of
genetic resources

3. Cartagena Protocol on Biosafety
• 2000
• 171 Parties
• Objective:
 Safe use of living modified
organisms (focus on import and
export)
• Highlight: mandatory
environmental risk assessments

4. Nagoya Protocol on Access and
Benefit Sharing• 2014
• 100 Parties
• Objective:
 fair and equitable sharing of
benefits arising from the
utilization of genetic resources
(also covers traditional
knowledge)
• Highlight: prior informed consent

5. Biodiversity
+
Human Health
+
Fair & Equitable
Sharing of Benefits
Biosafety + ABS
+
Modern
Biotechnology
=
+
Uncertainties
?

6. Convention
and its
Protocols
Trade
industry
Consumers
Academia
IGOs
IPLCs
Biotech
companies
Civil
society
NGOs
IPPC
CITES
RAMSAR
CMS
UNCLOS
Religious
organizations
National
governments

7. Addressed
(Yes / No)
Organisms Y
Products and components
(non-living)
N
Import / export Y
National level N
Socio-economic, cultural
and ethical considerations
Y/N
Human Health Y/N
Modern Biotechnology under the
Cartagena Protocol on Biosafety

8. Synthetic Biology ?

9. Techniques of “classic” modern
biotechnology
► In vitro nucleic acid techniques
► Cell fusion
► Synthetic biology (?)

10. Modern Biotech versus Synthetic
Biology
• Genetic cloning and constructs
(promoter, gene, terminator)
• Slow
• Random
• Mostly plants and
microorganisms
• Genome editing, high-
throughput DNA sequencing,
epigenetic engineering, gene
drive, RNAi spraying
• Fast
• Deliberate
• All organisms

12. Biotechnology timeline
1978
First LMO
1996
LMO
commercialized
2000-2010
2012
2013
Global area
planted with
LMOs reaches
150M Ha
First GM
animal
2014-2016
Atlantic
salmon
CRISPR as tool
for genome
editing
First
CRISPR
plants
USDA: CRISPR
not regulated;
CRISPR clinical
trial
CRISPR in vivo
2017
The “big 4”

13. Synthetic Biology
What we know we do not know…
• What are the benefits?
• What are the risks?
• Are regulatory frameworks adequate?
• Are risk assessment methodologies adequate?
• How to share benefits from digital information on genetic resources?
• What are the impacts on indigenous peoples and local communities?
• ???

14. Convention
• Synbio can have benefits and negative
impacts on biodiversity
• Precautionary approach
• Operational definition
• Regulatory framework – good basis
• Synbio organisms = LMOs (exceptions?)
• Gaps?
Cartagena Protocol on Biosafety
• Risk assessment guidance needed?
Nagoya Protocol on ABS
• Digital Sequence Information
Highlights from last COP

15. Synthetic biology:
Something old or something new?
“synthetic biology is a further development and new dimension of
modern biotechnology that combines science, technology and engineering to
facilitate and accelerate the understanding, design, redesign, manufacture and/or
modification of genetic materials, living organisms and biological systems”
Living organisms from synbio = LMOs (at least for now…)

16. Synthetic biology:
Need for precaution
Urges Parties and invites other Governments to take a precautionary approach
when addressing threats of significant reduction or loss of biological diversity
posed by organisms, components and products resulting from synthetic biology
…
“can also apply to some living modified organisms containing gene drives”

17. Synthetic biology:
LMO risk assessment
methodologies – a good basis“The general principles and methodologies for risk assessment under the
Cartagena Protocol and existing biosafety frameworks provide a good basis for
risk assessment regarding living organisms developed through synthetic biology,
but such methodologies may need to be updated and adapted for current and
future developments and applications of synthetic biology”

18. “Examine any potential implications of the use of digital sequence information on
genetic resources for the conservation and sustainable use of biodiversity and the
equitable and fair sharing of benefits arising from the utilization of genetic
resources”
Digital Sequence Information
Billions of DNA, RNA and protein sequences
exchanged online – who has the right to the
benefits?

19. Possible outcomes next COP in
2018• Exceptions: synbio organisms that are not
LMOs – who will regulate them?
• Call for further precaution / moratorium(?)
on gene drive
• Need for tools to detect and monitor
• Guidance on risk assessment
• Digital sequence information in or out of
ABS?
• Future processes under CBD, CP and NP
– what is the role of other stakeholders?
• Etc…

20. Synthetic Biology and
Indigenous Peoples
A thought worth sharing…Within indigenous traditions, every plant, animal, river, stone,
mountain, star, etc has a geographical space and ecosystems,
whose resilience depends on the quality and strength of
different types of relationships.
Such relationships are carried out within the indigenous
calendar and the Cycles of Life and Agriculture. These cycles
are full of ceremonies, chants, offerings, these are activities
based on cultural identity, languages, ancestral mandates,
principles and values such as solidarity, reciprocity, care for one
another, love and protect Mother Earth, natural laws, customary
law, ancestral systems of governance and so on.

21. Synthetic Biology
The question we all need to
know…
Do the benefits outweigh the risks?

22. Thank you