Risk management: State-of-the-art?

1. Mikko Pohjola, THL Risk management: State-of-the-art?

2. Some concepts & abbreviations SOTA: State-of-the-art ~ best common practice DA:Decision analysis RM: Risk management RA: Risk assessment ORM: Open risk management OA: Open assessment DM: Decision making SH: Stakeholder(s) EH: Environmental health (environment and health) EHA: Environmental health assessment EHRM: Environmental health risk management BRA: Benefit-risk analysis

3. Outline of RM lectures 30.3. State-of-the-art? Theory lecture: frameworks vs. reality Discussion: RM in the swine flu case 31.3. A social learning perspective Theory lecture: participation, openness, collective learning Discussion: Citizen perspective to the swine flu RM 1.4. Facilitation of (open) risk management Theory lecture: Pragmatic knowledge services Exercise: discussion and content evaluation in Opasnet 7.4. From needs to knowledge, knowledge to action Theory lecture: TBD Discussion: TBD 8.4. Summary/overview of DA & RM 11.-12.4. Final seminar

4. Outline to RM lectures Aims to present and discuss: Conventional views to RM Open risk management as an alternative view to RM What is RM? What is it perceived to be? What should it be? Who does/should it involve?

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

6. 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

7. SOTA in EHA BEPRARIBEAN research project Manuscript: “State-of-the-art in benefit-risk analysis: Environmental health” to be published soon-ish One out of a set of six “SOTA in BRA” papers Others domains considered are: Food and nutrition,Food microbiology, Economics and marketing-finance, Medicine, Consumer perception Available in Heande (link on the course web-page) Also a “Beyond the SOTA in food and nutrition BRA” manuscript is in preparation Combines the lessons learned in above mentioned studies

8. SOTA in EHA What is the SOTA in EHA? Underlying: what could food and nutrition BRA learn from the SOTA in EHA?

9. SOTA in EHA 8 approaches to environmental health assessment: Red Book risk assessment Understanding risk IRGC risk governance framework Chemical risk assessment: REACH Environmental impact assessment: YVA Health impact assessment (HIA) Integrated environmental health impact assessment (IEHIA) Open assessment Why not: Life-cycle assessment? Nuclear safety assessment? Silver Book?

10. SOTA in EHA Analysis framework: Purpose: What need(s) does an assessment address? Problem owner: Who has the intent or responsibility to conduct the assessment? Question: What are the questions addressed in the assessment? Which issues are considered? Answer: What kind of information is produced to answer the questions? Process: What is characteristic to the assessment process? Use: What are the results used for? Who are the users? Interaction: What is the primary model of interaction between assessment and using its products? Performance: What is the basis for evaluating the goodness of the assessment and its outcomes? Establishment: Is the approach well recognized? Is it influential? Is it broadly applied?

11. SOTA in EHA Interaction: Trickle-down: Assessor's responsibility ends at publication of results. Good results are assumed to be taken up by users without additional efforts. Transfer and translate: One-way transfer and adaptation of results to meet assumed needs and capabilities of assumed users. Participation: Individual or small-group level engagement on specific topics or issues. Participants have some power to define assessment problems. Integration: Organization-level engagement. Shared agendas, aims and problem definition among assessors and users. Negotiation: Strong engagement on different levels, interaction an ongoing process. Assessment information as one of the inputs to guide action. Learning: Strong engagement on different levels, interaction an ongoing process. Assessors and users share learning experiences and implement them in their respective contexts. Learning in itself a valued goal. A continuum of increasing engagement and power sharing

12. SOTA in EHA Legend for following process diagrams: Process/work: thin-border box or bulky arrow Products: thick-border box Information flow: thin solid arrow

13. 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: Red book NRC 1983. Risk Assessment in the Federal Government: Managing the Progress. The National Research Council. National Academy Press, Washington D.C.

14. Learning and feedback Implementation Evaluation Public officials Decision Problem formulation Process design Selecting options & outcomes Information gathering Synthesis Natural and social scientists Interested and affected parties Analysis and deliberation NRC: Understanding Risk (Orange book) • Role and importance of deliberation • Risk characterization as the link between assessment and management NRC 1996. Understanding Risk: Informing Decisions in a Democratic Society. The National Research Council. National Academy Press, Washington D.C.

15. Management sphere: Decision & implementation of actions Assessment sphere: Generation of knowledge Pre assessment ▪ Problem framing ▪ Early warning ▪ Screening ▪ Determination of scientific conventions Risk management Implementation ▪ Option realization ▪ Monitoring & control ▪ Feedback from risk management practice Decision making ▪ Option identification & generation ▪ Option assessment ▪ Option evaluation & selection Risk appraisal Risk assessment ▪ Hazard identification & estimation ▪ Exposure & vulnerability assessment ▪ Risk estimation Concern assessment ▪ Risk perceptions ▪ Social concerns ▪ Socio-economic impacts Communication Tolerability & acceptability judgement Risk evaluation ▪ Judging tolerability & acceptability ▪ Need for risk reduction measures Risk characterization ▪ Risk profile ▪ Judgment of the seriousness of risk ▪ Conclusions & risk reduction options IRGC – Risk governance IRGC 2005. Risk governance – towards an integrative approach. International Risk Governance Council. Geneva.

16. 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 REACH – EU Chemical safety ECHA 2008. Guidance on Information Requirements and Chemical Safety Assessment. Guidance for the Implementation of REACH.

17. Phase 1 Phase 2 Evaluation program Statements of the ministry of employment and economy about the report Participation Opinions and statements about the program Opinions and statements about the report Participation Statements of the ministry of employment and economy about the evaluation Assessment Evaluation report YVA - regulatory EIA in Finland Pohjola et al. State of the art in benefit-risk analysis: Environmental health. Manuscript.

18. Policy and programme development phase for prospective assessments Screening Scoping Appraisal Policy implementation phase Reporting Monitoring Health impact assessment (HIA) Pohjola et al. State of the art in benefit-risk analysis: Environmental health. Manuscript.

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

20. 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 Open assessment Pohjola et al. State of the art in benefit-risk analysis: Environmental health. Manuscript.

21. Main findings EHA is a very complex field Environment? Health? No single SOTA approach exists Approaches often either academic or regulatory Assessment centered vs. management centered? Traditional and novel approaches Regulatory and traditional tend to be more established

22. EHA NOTE: this is an influence diagram (not a process diagram) Adapted from Briggs: A framework for integrated environmental health impact assessment of systemic risks. Environmental Health 2008, 7:61.

23. Main findings Purpose: All state to aim to support societal decision making Question, answer, process: Quite different operationalization of the (stated) aims Question, answer: Huge differences in scopes Process, interaction: Mostly expert activity in institutional settings Performance: Societal outcomes hardly ever considered

24. Assessment – management interaction

25. Main findings The key issues in benefit-risk analysis in environmental health are not so much related to the technical details of performing the analysis, but rather: i) the level of integration (cf. Scope) ii) the perspective to consider the relationship between assessment and use of its outcomes in different assessment approaches “Assessment push” or “needs pull” The means of aggregation are basically the same as in other fields e.g. DALY, QALY, willingness-to-pay (WTP)

26. Main findings In EHA there are tendencies towards: a) increased engagement between assessors, decision makers, and stakeholders b) more pragmatic problem-oriented framing of assessments c) integration of multiple benefits and risks from multiple domains d) inclusion of values, alongside scientific facts, in explicit consideration in assessment Indicative of the incapability of the common contemporary approaches to address the complexity of EHA? Does not necessarily show much (yet) in practice

27. Implications to RM? RM more or less included in the approaches E.g. YVA & REACH are actually RM approaches that include assessment Purpose, use, interaction, … all (somewhat) acknowledge RM and the broader societal context RM finds questions -> assessments find answers -> RM implements

28. Properties of good assessment

29. Risk management: A social learning perspective? Mikko Pohjola, THL

30. Contents Participation and openness Collective knowledge creation Discussion Openness in the narcolepsy study / risk management

31. Participation and openness Manuscript: “Openness in participation, assessment, and policy-making upon issues of environment and health” Literature review Findings from two recent EU-projects INTARESE (Integrated Assessment of Risks from Environmental Stressors in Europe), 2005-2011 BENERIS (benefit-risk assessment of food: An iterative value-of-information approach), 2006-2009

32. Participation and openness International agreements and legislation often require participation, e.g.: Principle 10 of the Rio Declaration Aarhus Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters EU Strategic Environmental Assessment Directive (2001/42/EC) EU Public Participation Directive (2003/35/EC) Finnish Environmental Impact Assessment (YVA) Act (468/94) and corresponding EIA Decree (713/2006) The Law of the People’s Republic of China on Environmental Impact Assessment

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

34. Participation and openness Participation in assessment What is the possible influence that is allowed for participation in different assessment settings? Assessments more concerned with process and procedure rather than purposes and effects (Cashmore, 2004) Participation often a certain phase in the process Participation seen as an add-on rather than an essential, substantive part of the process

35. Participation and openness Assessment-policy interaction (science-policy, research practice) An essential avenue for participatory effectiveness Policy, science, and boundary perspectives Very much discussed topics in scientific literature, main findings: Traditional model of disengaged assessment and policy making considered by policy makers and researchers as inadequate A need for more pragmatic needs-oriented question setting in assessments Deeper engagement between assessment and policy making is essential for policy effectiveness Stakeholder and public participation is essential for relevance both in assessment and policy making Values are an important aspect of the needed knowledge input for both assessment and policy making

36. Participation and openness Participation, assessment, and policy making an intertwined complex that needs to be considered as a whole, not as separate independent entities. Question of effective participation is meaningful only in the broader context also concerning the purposes and effects of related policy making and assessment. Common current practices of participation, assessment, and policy making not necessarily in line with the recent discourses in the literature.

37. Participation and openness Dimensions of openness (INTARESE): Scope of participation: Who are allowed to participate in the process? Access to information: What information available to participants? Timing of openness: When are participants invited or allowed to participate? Scope of contribution: Which aspects are participants invited or allowed to contribute to? Impact of contribution: To what extent are participant contributions allowed to have influence on the outcomes? i.e. how much weight is given to participant contributions? Contentual view: ALL are participants to contribute to the issue at hand

38. Participation and openness Implementation of openness (BENERIS, THL) Open assessment Opasnet Complete openness as the default! Inverse perspective to dimensions of openness: who should NOT be included what information should NOT be provided … Assessments need to be deeply intertwined with the decision making processes if they seriously attempt to achieve their purposes of influencing policy Decision makers a particularly essential kind of active assessment participants Assessors often credulously assume effectiveness

39. Participation and openness Lessons for RM? Participation, assessment, policy making inseparable If not, participation also vehicle for changing power and decision making structures In an open process the role of DM’s (same goes for assessors as well) becomes quite different From the center of the process to the outset Coordination, organization, and feeding of an open social knowledge process Many existing practices (of participation, assessment, policy making) remain useful, but the foundation changes How to enable collaborative knowledge processes?

40. Q R A Open risk management: overview