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Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the
European Union or the European Commission. Neither the EU nor the EC can be held responsible for them.
SBSTTA 26 Biosafety AI’s
A policy perspective
Jens Warrie
FPS Health, Food Chain Safety & Environment
BE Cartagena Focal Point
Scope of the presentation
● Overview of topics under discussion per AI
● Historical context
● General advice for negotiators
● In depth technical context during next presentation and round of questions
SBSTTA Biosafety Agenda Items
3
AI 5: Synthetic Biology
AI 6: Risk Assessment &
Risk Management
AI 7: Detection &
Identification
AI 3: Monitoring
Framework – Target 17
SBSTTA Biosafety Agenda Items
4
AI 5: SynBio
AI 6: RARM
AI 7: D&I
AI 3: MF – T17
SBSTTA Biosafety Agenda Items
5
AI 5: SynBio
AI 6: RARM
AI 7: D&I
AI 3: MF – T17 CBD Agenda Item
CP Agenda Item
(Cartagena Protocol)
SBSTTA Biosafety Agenda Items
6
AI 5: SynBio
AI 6: RARM
AI 7: D&I
AI 3: MF – T17
SBSTTA Biosafety Agenda Items
7
AI 5: SynBio
AI 6: RARM
AI 7: D&I
AI 3: MF – T17
Establish, strengthen capacity for, and implement in all countries biosafety
measures as set out in Article 8(g) of the Convention on Biological Diversity and
measures for the handling of biotechnology and distribution of its benefits as set
out in Article 19 of the Convention.
Convention Text
Art. 8g. Establish or maintain means to regulate, manage or control the risks associated with the
use and release of living modified organisms resulting from biotechnology which are likely to have
adverse environmental impacts that could affect the conservation and sustainable use of biological
diversity, taking also into account the risks to human health;
Art. 19. (paraphrased)
1. provide for the effective participation in biotechnological research activities
2. take all practicable measures to promote and advance priority access
3. basis of the Cartagena Protocol
4. obligation to submit information on use and safety regulations of LMOs
8
Target 17 - Context
● Difficult negotiation context
○ History
○ Lots of brackets
○ Duality of the target + overlap
● Unclear how MF will be dealt with at SBSTTA 26
9
SBSTTA Biosafety Agenda Items
10
AI 5: SynBio
AI 6: RARM
AI 7: D&I
AI 3: MF – T17
SynBio – Context
● ‘Broad and regular horizon scanning’
○ Consider its outcomes (not the content!)
○ Consider its continuation
○ Consider its process
● Work on capacity building (CBD SEC & Parties)
● Work was done via call for information, Online Forum and mAHTEG
(multidisciplinary Ad Hoc Technical Expert Group)
11
SynBio – Advice
● Sensitive AI – hope for the best, prepare for the worst
● Products of SynBio vs LMOs
● Let the volume not deter you
12
SBSTTA Biosafety Agenda Items
13
AI 5: SynBio
AI 6: RARM
AI 7: D&I
AI 3: MF – T17
D&I - Context
● Originates from D&I of unauthorized LMOs  Broader now
● Main aspects of D&I discussions:
○ Training Manual on the D&I of LMOs in the Context of the CP
○ Network of Laboratories
○ Capacity Building
14
Handling, Transport, Packaging & Identification (Art. 18)
● (…) each Party shall take necessary measures to require that LMO’s (…) are
handled, packaged and transported under conditions of safety (…).
● Via documentation
○ Food & feed – “may contain LMOs” label, contact point, intended use
○ Contained use: label, contact point, safety requirements
○ Intentional introduction: label, identity & relevant traits, safety requirements, contact
point, (if appropriate) contact info importer/exporter and declaration product is in
conformity with the Protocol
15
Illegal Transboundary Movements (Art. 25)
● 1. Each Party shall adopt appropriate domestic measures aimed at preventing
and, if appropriate, penalizing transboundary movements of living modified
organisms carried out in contravention of its domestic measures to implement
this Protocol. Such movements shall be deemed illegal transboundary
movements.
● 2. Party of origin responsible for disposing of illegal LMO…
● 3. …and report to the BCH
16
SBSTTA Biosafety Agenda Items
17
AI 5: SynBio
AI 6: RARM
AI 7: D&I
AI 3: MF – T17
Risk assessment (Art. 15 & Annex III)
● General principles
○ Science-based
○ Based on precautionary principle
○ Comparative approach
○ Case-by-case
● Steps
○ Identification of characteristics with potential adverse effects
○ Evaluate the likelihood these adverse effects take place, the consequences if they do
and the overall risk by combining this.
○ A recommendation whether the risk is acceptable and/or possible management
strategies & monitoring plans
18
Risk assessment (Art. 15 & Annex III)
● Points to consider
○ Recipient organism, Donor organism, Vector
○ Characteristics of the modification
○ LMO and differences with recipient organism
○ Detection and identification methods
○ Intended use
○ Receiving environment
19
Risk management (Art. 16)
● 1. The Parties shall (…) establish and maintain appropriate mechanisms,
measures and strategies to regulate, manage and control risks identified in the
risk assessment provisions of this Protocol associated with the use, handling
and transboundary movement of living modified organisms.
● Measures take into account
○ Necessary extent to prevent adverse effects
○ Possibility of transboundary movements
○ An appropriate period of observation
○ Inter-Party cooperation on identifying adverse effects and treatment
20
RARM - Context
● Two important topics
○ Development of guidance on risk assessment
○ Taking stock of new topics to develop guidance for
● Current focus is LMOs with modified gene drives, with special focus on
mosquitos
● Important – Guidance itself not open for negotiation
○ Peer-review?
21
In general
● Read the documents
● Value in each negotiators profile
● SBSTTA is not the final station of text
● ‘History is written by those that show up’
22
Thank you for your attention!
Jens Warrie Jens.warrie@health.fgov.be
Coming soon www.coop4cbd.eu Follow COOP4CBD

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SBSTTA 26 Biosafety AI’s. A policy perspective. Jens Warrie.

  • 1. Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the European Union or the European Commission. Neither the EU nor the EC can be held responsible for them. SBSTTA 26 Biosafety AI’s A policy perspective Jens Warrie FPS Health, Food Chain Safety & Environment BE Cartagena Focal Point
  • 2. Scope of the presentation ● Overview of topics under discussion per AI ● Historical context ● General advice for negotiators ● In depth technical context during next presentation and round of questions
  • 3. SBSTTA Biosafety Agenda Items 3 AI 5: Synthetic Biology AI 6: Risk Assessment & Risk Management AI 7: Detection & Identification AI 3: Monitoring Framework – Target 17
  • 4. SBSTTA Biosafety Agenda Items 4 AI 5: SynBio AI 6: RARM AI 7: D&I AI 3: MF – T17
  • 5. SBSTTA Biosafety Agenda Items 5 AI 5: SynBio AI 6: RARM AI 7: D&I AI 3: MF – T17 CBD Agenda Item CP Agenda Item (Cartagena Protocol)
  • 6. SBSTTA Biosafety Agenda Items 6 AI 5: SynBio AI 6: RARM AI 7: D&I AI 3: MF – T17
  • 7. SBSTTA Biosafety Agenda Items 7 AI 5: SynBio AI 6: RARM AI 7: D&I AI 3: MF – T17 Establish, strengthen capacity for, and implement in all countries biosafety measures as set out in Article 8(g) of the Convention on Biological Diversity and measures for the handling of biotechnology and distribution of its benefits as set out in Article 19 of the Convention.
  • 8. Convention Text Art. 8g. Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health; Art. 19. (paraphrased) 1. provide for the effective participation in biotechnological research activities 2. take all practicable measures to promote and advance priority access 3. basis of the Cartagena Protocol 4. obligation to submit information on use and safety regulations of LMOs 8
  • 9. Target 17 - Context ● Difficult negotiation context ○ History ○ Lots of brackets ○ Duality of the target + overlap ● Unclear how MF will be dealt with at SBSTTA 26 9
  • 10. SBSTTA Biosafety Agenda Items 10 AI 5: SynBio AI 6: RARM AI 7: D&I AI 3: MF – T17
  • 11. SynBio – Context ● ‘Broad and regular horizon scanning’ ○ Consider its outcomes (not the content!) ○ Consider its continuation ○ Consider its process ● Work on capacity building (CBD SEC & Parties) ● Work was done via call for information, Online Forum and mAHTEG (multidisciplinary Ad Hoc Technical Expert Group) 11
  • 12. SynBio – Advice ● Sensitive AI – hope for the best, prepare for the worst ● Products of SynBio vs LMOs ● Let the volume not deter you 12
  • 13. SBSTTA Biosafety Agenda Items 13 AI 5: SynBio AI 6: RARM AI 7: D&I AI 3: MF – T17
  • 14. D&I - Context ● Originates from D&I of unauthorized LMOs  Broader now ● Main aspects of D&I discussions: ○ Training Manual on the D&I of LMOs in the Context of the CP ○ Network of Laboratories ○ Capacity Building 14
  • 15. Handling, Transport, Packaging & Identification (Art. 18) ● (…) each Party shall take necessary measures to require that LMO’s (…) are handled, packaged and transported under conditions of safety (…). ● Via documentation ○ Food & feed – “may contain LMOs” label, contact point, intended use ○ Contained use: label, contact point, safety requirements ○ Intentional introduction: label, identity & relevant traits, safety requirements, contact point, (if appropriate) contact info importer/exporter and declaration product is in conformity with the Protocol 15
  • 16. Illegal Transboundary Movements (Art. 25) ● 1. Each Party shall adopt appropriate domestic measures aimed at preventing and, if appropriate, penalizing transboundary movements of living modified organisms carried out in contravention of its domestic measures to implement this Protocol. Such movements shall be deemed illegal transboundary movements. ● 2. Party of origin responsible for disposing of illegal LMO… ● 3. …and report to the BCH 16
  • 17. SBSTTA Biosafety Agenda Items 17 AI 5: SynBio AI 6: RARM AI 7: D&I AI 3: MF – T17
  • 18. Risk assessment (Art. 15 & Annex III) ● General principles ○ Science-based ○ Based on precautionary principle ○ Comparative approach ○ Case-by-case ● Steps ○ Identification of characteristics with potential adverse effects ○ Evaluate the likelihood these adverse effects take place, the consequences if they do and the overall risk by combining this. ○ A recommendation whether the risk is acceptable and/or possible management strategies & monitoring plans 18
  • 19. Risk assessment (Art. 15 & Annex III) ● Points to consider ○ Recipient organism, Donor organism, Vector ○ Characteristics of the modification ○ LMO and differences with recipient organism ○ Detection and identification methods ○ Intended use ○ Receiving environment 19
  • 20. Risk management (Art. 16) ● 1. The Parties shall (…) establish and maintain appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in the risk assessment provisions of this Protocol associated with the use, handling and transboundary movement of living modified organisms. ● Measures take into account ○ Necessary extent to prevent adverse effects ○ Possibility of transboundary movements ○ An appropriate period of observation ○ Inter-Party cooperation on identifying adverse effects and treatment 20
  • 21. RARM - Context ● Two important topics ○ Development of guidance on risk assessment ○ Taking stock of new topics to develop guidance for ● Current focus is LMOs with modified gene drives, with special focus on mosquitos ● Important – Guidance itself not open for negotiation ○ Peer-review? 21
  • 22. In general ● Read the documents ● Value in each negotiators profile ● SBSTTA is not the final station of text ● ‘History is written by those that show up’ 22
  • 23. Thank you for your attention! Jens Warrie Jens.warrie@health.fgov.be Coming soon www.coop4cbd.eu Follow COOP4CBD