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

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

8. Does risk analysis pay off? Risk assessmentRisk management Hazard identification Exposure assessment Dose-response assessment Risk communication Options generation Policy selection & implementation Policy effect evaluation Options evaluation Risk characterization 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 Extrapolation Measurements and population characteristics Hazard identification Dose-response assessment Exposure assessment Risk characterization Regulatory options Evaluation of options Decisions and actions Risk assessmentRisk management Observations 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 Hazard assessment ▪ Hazard identification ▪ Classification & labeling ▪ Derivation of threshold levels ▪ PBT/vPvB assessment Exposure assessment ▪ Exposure scenarios building ▪ Exposure estimation Risk characterisation Information: available vs. required/needed ▪ Substance intrinsic properties ▪ Manufacture, use, tonnage, exposure, risk management Dangerous or PBT/vPvB Risk controlled noyes noyes Iteration 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 Assessment Participation Outcome Decision making

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. Open risk management: overview QRAQRA

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 System OutcomeUse

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 A collaborative game of questions and answers Experts PublicStakeholders Decision makers Other influence Outcome

31. Opasnet Assessment Participant’s knowledge Participant’s updated knowledge Updated assessment Participant’s updated knowledge Decision Decision making Perception Contribution 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. Different ways of sharing knowledge in a group Live discussion Written discussion Formal argumentation Quantitative model  There is a need for tools that bring these different ways closer and make it easier to cross the barriers.

39. Objective: improve action as much as possible Does not require that everybody understand the knowledge, as long as the knowledge guides them. It is enough that people accept and act based on the outcome of a discussion by the group, even if they don’t know the details, understand them, or even agree with them. Example: Pandemrix use?Pandemrix use?

40. Scientific method: steps Mathematical method Scientific method 1Understanding Characterization from experience and observation 2AnalysisHypothesis: a proposed explanation 3Synthesis Deduction: prediction from the hypothesis 4ReviewReview/ExtendExtendTest and experiment George Polya in http://en.wikipedia.org/wiki/Scientific_method

41. Inference rules: axioms and concepts. Axioms of open assessment define the things that cannot be verified by observation, so there is no other way to know but just to believe. Axioms of open assessment Statement is a presentation of opinion or position about something that is (ie., a scientific statement) or something that should be (ie., a moral statement). Statement A group in open assessment means one or more individuals who participate in some activity, e.g. performing or reading an assessment.groupopen assessment A belief system is a collection of statements that are considered valid by a person or group.belief systemstatementsgroup A belief system that is considered valid by a group is called a shared belief system.group shared belief system

42. Discussion rules in practice An argument is valid if it is promoted and not attacked by a valid argument. The order of arguments: 1.Valid attacking arguments 2.Invalid attacking arguments 3.Valid defending arguments 4.Invalid defending arguments 5.Comments and branches

43. Successful attacks Successful attacks are based on arguments showing that the attacked statement – is not true or – is not relevant in its context and – the attacking argument itself is not attacked. Note: if a statement is weak – it is easier to defend – it has smaller impact on the resolution.  Try to optimise the strength of your statements.

44. Inference rules (1/2) Anyone can promote a statement about anything.statement A promoted statement is considered valid unless it is invalidated (i.e., convincingly shown not to be true, or successfully attacked).statement A priori beliefs are updated into a posteriori beliefs based on and only on – observations (in case of scientific statements) orstatements – opinions (in case of moral statements) andstatements – open criticism that is based on shared rules. In practice, this means the use of scientific method. open criticismscientific method There may be uncertainty about whether a statement is true. This can be quantitatively measured with subjective probabilities.uncertaintystatementsubjective probabilities There can be other rules than these inference rules for deciding what a group should believe. Rules are treated as statements.groupstatements The validity of a statement is always conditional to a particular group.statement group

45. Inference rules (2/2) If two people within a group promote conflicting statements, the a priori belief is that each statement is equally likely to be true.group A statement always has a field in which it can be applied. By default, a scientific statement applies in the whole universe and a moral statement applies within a group that considers it valid.statement Two moral statements by a single group may be conflicting only if the fields of application do not overlap.statements Opinions of each person are given equal weight.

46. Evaluation of page content in Opasnet

47. Discussion Argumentation on use/ban of Pandemrix