Risk management: From needs to knowledge, knowledge to action

1. Mikko Pohjola, THL Risk management: From needs to knowledge, knowledge to action

2. Contents Lecture Round-up of (open) EHRM Development of shared beliefs to guide action Discussion Agumentation on the use/ban of Pandemrix

3. Round-up of (open) EHRM

4. Round-up EHRM is “the practice of organizing decision making and taking actions upon known and perceived risks to environment and health” i.e. trying to influence what actually happens regarding risks Many factors drive RM - systematic science-based decision support (assessments) is one of them Is or should it be the most important/influential?

5. Societal setting for RA/RM Risk assessment is collection, synthesis and interpretation of scientific information and value judgments for use of the society Risk management is use and implementation of that information

6. Round-up Systematic RM identifies needs for assessments and implements knowledge from assessments (and elsewhere) to practice Basically the aim of assessment and management is (or should be!) the same: good societal decisions and actions -> Decision-oriented assessment (DA)

7. Risk assessment Risk management Hazard identification Options generation Exposure assessment Dose-response assessment Options evaluation Policy effect evaluation Policy selection & implementation Risk characterization Risk analysis Lessons from the KTL Centre of excellence in environmental health risk analysis

8. Risk assessment Risk management Hazard identification Options generation Exposure assessment Dose-response assessment Options evaluation Policy effect evaluation Risk characterization Policy selection & implementation Risk communication Does risk analysis pay off? Million euro cycle Billion euro cycle

9. General RA/RM framework Systematic analysis according to societal needs

10. Why do we do modelling? (2) • Decision options are difficult to compare. Models can summarise important points and help us choose.

11. Round-up EH is complex in many ways Causes, effects, actors, roles, relations, … Physical, chemical, biological, social, technological, economical, political, … Many approaches exist, most confine themselves to certain specifics of EH Useful within their own boundaries, but not sufficient to address all complexity of EH

12. NRC: Red book Risk assessment Risk management Observations Hazard identification Regulatory options Extrapolation Dose-response assessment Risk characterization Evaluation of options Measurements and population characteristics Exposure assessment Decisions and actions NRC 1983. Risk Assessment in the Federal Government: Managing the Progress. The National Research Council. National Academy Press, Washington D.C.

13. REACH – EU Chemical safety Information: available vs. required/needed ▪ Substance intrinsic properties ▪ Manufacture, use, tonnage, exposure, risk management Hazard assessment ▪ Hazard identification ▪ Classification & labeling ▪ Derivation of threshold levels ▪ PBT/vPvB assessment Exposure assessment ▪ Exposure scenarios building ▪ Exposure estimation Iteration no Dangerous or PBT/vPvB yes Risk characterisation yes no Risk controlled Chemical safety report ECHA 2008. Guidance on Information Requirements and Chemical Safety Assessment. Guidance for the Implementation of REACH.

14. Round-up The traditional model of separating expert, decision maker and stakeholder/public contributions does not serve “knowledge-based societal actions upon issues relevant to environment and health” optimally Well-reasoned, sustainable policies & practices? Influence of assessment on policy/practice? Meaningfulness/effectiveness of participation?

15. Purposes for participation Other factors Outcome Assessment Decision making Participation

16. IDEA framework (IEHIA/INTARESE) Briggs: A framework for integrated environmental health impact assessment of systemic risks. Environmental Health 2008, 7:61.

17. Round-up EXAMPLE: climate change is a major (and extremely complex) environmental health issue Think of e.g. CC related decision making and actions in the City of Kuopio What risks are related? What causes (for risks) are there? What effects do they have? Whose actions relate to the causes? Who are influenced by the effects? Who can influence (manage) the risks? How? Who are relevant actors regarding the risks? On what basis does/should they act upon the risks? Do common/traditional assessment/management approaches serve the needs of CC related DM?

18. Round-up No common solid theory for EHRM exists Common frameworks are mostly procedural and oversimplified Reality of RM is sometimes far from what is imag(in)ed in EHRM and assessment frameworks A proper theory should better …recognize the nature of actual needs …serve the plurality of ways to address the needs …be applicable across the whole range of needs, from the simplest to the most complex

19. EHRM framework The Presidential / Congressional commission on Risk Assessment and Risk Management: Final Report Volume 1, 1997.

20. NRC: Science and decisions (Silver book) NRC 2009. Science and Decisions: Advancing Risk Assessment. The National Research Council. National Academy Press, Washington D.C.

21. Round-up Change is needed… …and it is already starting to happen Assessment-management-stakeholders intertwined Practice-driven (needs-driven) search for knowledge Broad scoping: EH issues inherently within a broader context Opinions and values as valid inputs Success determined according to outcomes

22. Research question for open risk management • How can scientific information and value judgements be organised for improving societal situations by identifying potential decisions and relevant outcomes in a situation where open participation is allowed? • Emphasis: The decision situation should be clarified.

23. Research question for open assessment • How can scientific information and value judgements be organised for improving societal decision-making in a situation where open participation is allowed? • Emphasis: The decision situation is clear, focus on evaluating and choosing good options.

24. Q R A Open risk management: overview

25. Round-up Methods, tools and practices to enable ORM/OA are being developed Collaborative learning Technical support for: Collective knowledge creation (=learning) Implementation of knowledge …in a social context, for practical needs E.g. Opasnet

26. Three metaphors of learning

27. Round-up (increased) openness becoming easier to reason for and easer to be accepted, but many hindrances exist in practice A cultural change is needed Plenty of examples come up everyday Purpose Method Use Outcome System

28. Round-up From Process-centeredness Separation and disengagement Narrow scopes Individual learning (monologue) Producing and sharing information (dialogue) Curiosity-driven question setting …

29. Round-up Towards Focusing on content Openness (in all its aspects) Rich contextuality and situatedness Collaboration, co-creation of knowledge (trialogue) Practice/needs-driven questions Outcome-orientation …

30. Open risk management Experts Other influence A collaborative game of questions and answers Outcome Decision makers Outcome Outcome Stakeholders Public

31. Participant’s knowledge Participant’s updated knowledge Participant’s knowledge Contribution Perception Participant’s updated knowledge Decision making Perception Assessment Decision Updated assessment Contribution Participant’s knowledge Opasnet Pohjola et al. State of the art in benefit-risk analysis: Environmental health. Manuscript.

32. Outcome-oriented modelling approach Matthews et al.: Raising the bar? – The challenges of evaluating the outcomes of environmental modelling and software. Environmental Modelling & Software, March 2011, Pages 247-257.

33. Properties of good assessment

34. Round-up summary/conclusions In the end it is all about developing well-founded shared belief systems to guide actions upon issues with great societal relevance Intentionally created collective knowledge is a means towards (collectively) desired ends

35. Example: what makes a good hammer?

36. Development of shared belief systems

37. Science and shared belief systems • Falsification and “scientific method” • Justified true belief and its problems • Inference rules • Shared belief systems • Shared belief systems as artifacts (intentionally produced objects) • Hypothesis development and testing • Abductive reasoning and argumentation • Game of questions and answers • Evaluation of page content in Opasnet

38. Discussion Argumentation on use/ban of Pandemrix