Why do we govern biotechnology? Who governs biotechnology? Who gets to be involved? Does synthetic biology change anything? What international agreements exist relating to genetic resources? How do we assess and manage risk? Presentation by Deborah Scott, University of Edinburgh, during Redesigning the Tree of Life: Synthetic Biology and the Future of Food, 2-4 November 2017 in Toronto.

1. governing synthetic biology:
why, how, & who
Deborah Scott
University of Edinburgh

2. why do we govern
biotechnology?

3. why do we govern
biotechnology?
does synthetic biology change anything?

4. how do we govern
biotechnology?

5. • Convention on Biodiversity
• Cartagena Protocol on Biosafety
• Nagoya Protocol
• International Treaty on Plant Genetic
Resources
• Interlaken Declaration and Plan of
Action on Animal Genetic Resources
• Convention on the Conservation of
Antarctic Marine Living Resources
• Genebank Standards
• Code of Conduct Plant Germplasm
Collection and Transfer
• Convention on International Trade in
Endangered Species
• OIE Terrestrial and Aquatic Animal
Health Codes and Manuals
• International Plant Protection
Convention
• WHO International Health
Regulations
• WHO Laboratory Biosafety Manual
• WHO Laboratory Biosecurity
Guidance
• WHO Guidance on Regulations for the
Safe Transport of Infectious
Substances
• WHO Pandemic Influenza
Preparedness Framework
• Codex Principles on Foods Derived
from Modern Biotechnology
• Codex Guidelines Food Safety
Assessment: Recombinant DNA
Animals; Recombinant DNA Plants;
Recombinant DNA Microorganisms
• WTO Sanitary and Phytosanitary
Agreement
• Trade Related Aspects of Intellectual
Property Rights Agreement
• Convention on the Protection of New
Varieties of Plants
• Budapest Treaty on the Deposit of
Microorganisms for the Purpose of
Patent Procedure
• UN Declaration on the Rights of
Indigenous Peoples
• Indigenous and Tribal Peoples
Convention
• Universal Declaration on Bioethics
and Human Rights
• International Declaration on Human
Genetic Data
• Universal Declaration on the Human
Genome and Human Rights
• UN Convention on the Law of the Sea
• Biological and Toxin Weapons
Convention
from Catherine Rhodes
International agreements relating to genetic resources

6. how do we govern biotechnology?
• Risk Assessment & Risk Management: Triggers
• process
• product
• novel trait

7. how do we govern biotechnology?
does synthetic biology change anything?
• Risk Assessment & Risk Management: Trigger
nature.com

8. how do we govern biotechnology?
does synthetic biology change anything?
• Risk Assessment & Risk Management: Adequacy?
• gene drives & contained research
• accidental gene drive production

9. Krishnan &
Gillum 2017

10. how do we govern biotechnology?
does synthetic biology change anything?
• Risk Assessment & Risk Management: Adequacy?
• gene drives & contained research
• accidental gene drive production
• gene drives & deliberate environmental release

11. how do we govern biotechnology?
does synthetic biology change anything?
• Risk Assessment & Risk Management: Adequacy?
• gene drives & contained research
• accidental gene drive production
• gene drives & deliberate environmental release
what counts as environmental release?
can field trials be conducted safely?
is containment possible?
how to assess ecosystem impacts?
what is sufficient evidence of potential impacts?
who gives consent for a project with potentially global impact?

12. how do we govern biotechnology?
does synthetic biology change anything?
• Beyond the environment and human health…
• What is assessed?
• Political economy of scientific research & commercialization
• Intellectual property rights

13. how do we govern biotechnology?
does synthetic biology change anything?
• Beyond the environment and human health…
• What is assessed?
• Political economy of scientific research & commercialization
• Intellectual property rights

14. how do we govern biotechnology?
does synthetic biology change anything?
• Beyond the environment and human health…
• What is assessed?
• Political economy of scientific research & commercialization
• Intellectual property rights
• Biosecurity concerns

15. who governs biotechnology?

16. Sequence information &
ABS
Risk Assessment /
Management
Shaping Responsible
Research & Innovation
ITPGRFA (International
Treaty on Plant Genetic
Resources for Food and
Agriculture)
OECD UN Committee on Food
Security
World Health Organization
- Pandemic Influenza
Preparedness Framework
IUCN (International Union
for Conservation of Nature
and Natural Resources)
UN Technology Facilitation
Mechanism
CBD / Nagoya Protocol CBD / Cartagena Protocol
on Biosafety
Commission on Genetic
Resources for Food and
Agriculture
Biological and Toxin
Weapons Convention
Biological and Toxin
Weapons Convention

17. Sequence information &
ABS
Risk Assessment /
Management
Shaping Responsible
Research & Innovation
ITPGRFA (International
Treaty on Plant Genetic
Resources for Food and
Agriculture)
OECD UN Committee on Food
Security
World Health Organization
- Pandemic Influenza
Preparedness Framework
IUCN (International Union
for Conservation of Nature
and Natural Resources)
UN Technology Facilitation
Mechanism
CBD / Nagoya Protocol CBD / Cartagena Protocol
on Biosafety
Commission on Genetic
Resources for Food and
Agriculture
Biological and Toxin
Weapons Convention
Biological and Toxin
Weapons Convention

18. who gets to be involved?
Beyond technical
• need for broad range of expertise
• greater uncertainties demand more
• exclusion is not a shortcut

19. www.stis.ed.ac.uk/engineeringlife
ENGINEERING LIFE