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

2. Contents Outline of the RM lectures 30.3.-7.4. State-of-the-art in environmental health assessment State-of-the-art in risk management? The reality of risk management? Discussion Introduction to the RM exercise RM in the swine flu case Lecture file: http://en.opasnet.org/w/File:Risk_management_- _state_of_the_art.ppt http://en.opasnet.org/w/File:Risk_management_- _state_of_the_art.ppt

3. 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

4. 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

5. 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?

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

7. 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

8. 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

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

10. 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?

11. 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?

12. 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

13. 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

14. 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.

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

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

17. 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 Iteratio n Chemical safety report ECHA 2008. Guidance on Information Requirements and Chemical Safety Assessment. Guidance for the Implementation of REACH.

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

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

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

21. Open assessment 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.

22. 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

23. 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.

24. 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

25. Assessment – management interaction

26. 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)

27. 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

28. 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

29. Other perspectives to RM For example: The EHRM framework by The Presidential/Congressional Commission on Risk Assessment and Risk Management Risk-based decision making framework, i.e. The NRC Silver Book approach

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

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

32. How does RM look like according to the frameworks? Mostly institutional Professional/expert-based Often considered as single-actor activity Primarily unidirectional (knowledge push) Rational Quite straightforward Implementation of decisions is not the (big) problem Is this a realistic view?

33. How does RM look like according to the frameworks? A caricature of traditional risk research Risk assessment: Scientific experts deal with scientific facts Risk management: Professional decision makers make decisions according to the scientific facts Risk communication: Commuication experts explain the decisions and the facts to the ignorant (stakeholders, NGO’s, public, …) Risk perception: Scientific experts analyze why do not the ignorant understand the facts Also in DA there are two branches What decision should be taken? How are decisions actually made? Are distinctions necessary? Does it correspond with reality and practical needs? Do these things need to be kept separate?

34. Reality of EHRM? Environment and health relevant to everyone Multiple relevant decision situations Multiple relevant questions Multiple relevant actors Multiple relevant roles Multiple relevant sources of knowledge Experts and professional (societal) decision makers of course, but also: DMs in business and industry NGO’s Common citizens

35. Reality of EHRM? Assessments conducted as research Ad hoc assessments Assessments tailored to predetermined decisions Decisions based on whatever Friends advice Hearsay Opinions …

36. Reality of EHRM? Reality is much more complex than the (common) RM frameworks recognize/describe Simplicity -> explicitness -> good guidance? Should it not be possible to expand the scope of systematic analysis/practice? The emerging approaches in EHA more or less aim to merge assessment and management into an intertwined social knowledge process Assumes a too rational and straightforward practice of assessment, management, and implementation?

37. Discussion Intro to RM exercise RM in the swine flu case

38. RM exercise Individual work Max. score 10 points Course total max. 45 points Reports are written in Opasnet Pages were created for each student in the introduction to Opasnet lecture 4.3. Presentations of reports in final seminar 11.-12.4. If needed, improvements can be made up to the final evaluation in the end of April

39. RM exercise Task description: Consider yourself in the role of the Ministry of Social and Health affairs Development of capacity to manage major public health risks Evaluate all four DA study plans from the use/r point of view: What value would each planned analysis bring you? Make use of the properties of good assessment framework: Relevance (is content relevant in relation to purpose?) Pertinence (is purpose relevant in relation to use?) Usability (does your understanding increase?) Availability (is information accessible and/or timely?) Acceptability (Would results/conclusions be acceptable to you? Why or why not?) Give an overall statement: would/could the analysis influence your practices (in the given imaginary role)? Also explain how

40. RM exercise Task description (continued): Take (one) another perspective and repeat the evaluation of the DA study plans E.g. common citizen, medical superintendent in a hospital, health researcher, journalist, nurse in public health care, principal of an elementary school, … Focus on the differences in comparison to the above evaluation Write an (freely formatted) evaluation report and present the main findings in the final seminar More detailed instructions (will be) available on the exercise web-page in Opasnet

41. Properties of good assessment

42. Reasons for changing exercise part 2 More explicit task (?) Clearer linkage between DA & RM Students can better make use of their earlier efforts in working on the DA study plans Might help in improving the study plans too! Emphasizes different perspectives to DA & RM First half of the course mostly expert/assessor point of view Activates collaboration and cross-fertilization between students and groups Collective learning!

43. Discussion: RM in the swine flu case RM in the swine flu case What risks exist(ed) in the swine flu case? What risks are/were addressed? How? Who are/were in the roles of managing the risks? Who else are/were involved? What roles do/did they take? On what basis do/did different actors take action to manage (in a way or another) the risks?

45. Concepts Some basic concepts: Performance = goodness! Assessment, Management Model Process (making/using), Product Output, Outcome Assessor, Decision/Policy maker, Stakeholder Participant, User

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

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

48. 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

49. Participation and openness “Do common current conceptions of participation, assessment, and policy making provide the sufficient framework to achieve effective participation?” Policy making: decision making upon issues of societal importance Assessments: systematic science-based endeavours of producing information to support policy making Participation: contributions from those who do not have formal roles as decision makers or experts in the assessment or policy processes in question Effective: (desired) influences on the (societal) outcomes Participation / stakeholder involvement a major issue issue in environment and health assessment and policy making literature

50. 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

51. Participation and openness Participation techniques A lot of “how to…” guidance exists, e.g.: the Netherlands Environmental Assessment Agency and Radboud University: Stakeholder Participation Guide for the Netherlands Environmental Assessment Agency OECD/NEA: Stakeholder involvement techniques - Short guide and annotated bibliography Also plenty of literature on ”Models” for participation Analysis of applicability of participation techniques Outcome effectiveness? (e.g. Newig, 2007)

52. Purposes for participation Purposes of participation Substantive, normative, and instrumental reasons (Fiorino, 1990) Ethical, political, pragmatic, and epistemological reasons (ECLAC, 2002) Substantive, procedural, and contextual effects (van den Hove, 2003) O’Faircheallaigh (2009): Obtain public input into decisions taken elsewhere Share decision making with public Alter distribution of power and structures of decision making The three above broad purposes also broken down into ten more specific purposes Participation is more focused on access and process than on outcomes (Doelle & Sinclair, 2006)

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

54. Participation and openness Participation in assessment There are various different assessment types, e.g.: Pope et al. (2004) a) ex-post, project-based assessments b) ex-ante, objectives-led assessment c) (a more theoretical) assessment for sustainability. Briggs (2008) i) diagnostic assessment (does a problem exist, is policy action needed?) ii) prognostic assessment (implications of potential policy options, which option to choose?) iii) summative assessments (effectiveness of existing policies) What is the possible influence that is allowed for participation in different assessment settings?

55. 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

56. Participation and openness Participation in policy making YVA: due to decision making structures certain aspects of assessment results cannot be taken account of Land use planning: zoning and development separate processes-> development outside assessment and participation An environmental permit case: decision maker, applicant, and stakeholders all questioned the meaningfulness of participation, although in general it was seen as important by all EIA in China: Authorities may welcome public participation if it improves the quality of information, but may not give public the power to contribute to and influence decision making by participating in the formulation of a proposal, assessment process, implementation, and evaluation Participation in altering power and decision making structures? (cf. O’Faircheallaigh, 2009)

57. 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

58. 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.

59. 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

60. Participation and openness Dimensions of openness (INTARESE): A contentual (vs. procedural) view: Everyone are participants that contribute to the issue at hand Including also the experts and decision makers woith formal roles in the process in question The framework i) provides a context for evaluation and constructive criticism of existing conventions and institutions ii) facilitates innovative application of existing means for participatory processes within and alongside the existing conventions and institutions iii) promotes development of new means, conventions and institutions for participatory practice

61. Dimension of openness analysis Dimension/a pproach Scope of participation Access to information Timing of opennessScope of contributionImpact of contribution Open assessment Everyone, e.g. decision makers, NGO's, citizens, external experts, allowed to participate. User participation particularly important. All information should be made available to all participants. ContinuousAll aspects of the issue can be addressed by everyone. Based on relevance and reasoning, not source. All relevant contributions should be taken into account. Conclusions from collaborative work intended to turn into action through collective knowledge creation among participants mediated by a shared web- workspace. IEHIASpecified users (e.g. policy makers), and stakeholders (preferably by proxy) invited to participate. ?User and stakeholder participation during issue framing, design and appraisal phases (not during execution phase). Users and stakeholders can participate in scoping and design of assessment and interpretation of results. Participant views should influence the construction of the assessment framework. Discourse in the appraisal phase regarding the assessment results, their implications for action, and their linkage to the goals defined in issue framing assumed to ensure that those involved accept the outcomes. YVAPublic, liaison authority (e.g. regional environmental center), other authorities. Assessment plan and assessment report provided to the public by the project developer. The liaison authority also has access to information regarding e.g. other plans, projects and operations relevant to the project in question. Participation in two phases. Public hearing periods, possible authority statements regarding both assessment plan and assessment report. Liaison authority gives its statements after the public and the other authority statements. Any public representative can give any statements, and the liaison authority may ask specific statements on from other authorities in both phases. The liaison authority gives an overall statement on both the assessment plan and the assessment report. Public statements filed along with the liaison authority statements. Ultimately up to the project developers and the decision makers to decide if and how public statements are taken account of in project design or decision making. The liaison authority, also taking account of public and other authority statements, can also demand e.g. certain issues to be considered in the assessment or other additional information to be provided by the project developer. Red BookN/A (Assessment for nominated scientific experts only) N/A Assessment results provided for decision makers and intended to be taken into account, alongside options evaluation, in decision making and action by federal agencies. Silver BookDecision-makers, technical specialists, and other stakeholders. Formal provisions for internal and external stakeholders at all stages. At all stages: problem formulation and scoping, planning and conduct of risk assessment, risk management. Problem formulation and scoping, confirmation of utility if risk assessment, and risk management. Stakeholders as active participants. However, participation should in no way compromise the technical assessment of risk, which is carried out under its own standards and guidelines.

62. 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

63. Participation and openness Challenges of openness Manageability of broad participation Information quality control Prevention from intentional bias Prevention from promotion of vested interests Protection from vandalism Cost and time expenditure … The problems are rather practical than fundamental in their nature Nevertheless they are real challenges to practical implementation of openness Perhaps in the end the greatest challenge lies in the scientists', assessors' and decision makers' attitudes towards openness, and the internal resistance to change contemporary research, assessment and decision making practices more open

64. Participation and openness Main conclusions: 1.Inclusion of stakeholders and public to participate in assessments and policy making upon issues of environment and environmental health is an issue of both great interest and importance. 2.The discourses on both assessments and participation in the contexts of environment and environmental health have been too much focused on processes and procedures, and too little attention has been given to their purposes and outcome effectiveness in policy making. 3.Consideration of effective participation is meaningful only in the context of purposes and effects of the assessment and policy making processes that participation relates to. 4.The dimensions of openness framework provides a conceptual means for identifying and managing the interrelations between the purposes and outcomes of participation, assessment, and policy making, and thereby also for effective application of existing participatory models and techniques. 5.The dimensions of openness framework also provides a context for evaluation and constructive criticism of contemporary conventions and institutions of participation, assessment, and policy making, and a basis for developing new conventions and institutions. 6.From a contentual point of view, it can be argued that participation, assessment, and policy making upon environmental and environmental health issues should be considered as completely open rather than exclusive processes by default. 7.Openness should not, however, be considered as an end in itself, but rather a means for advancing societal development through creation and use of broadly distributed collective knowledge upon issues of great societal relevance. 8.Openness brings about challenges, but they are mostly practical, rather than fundamental in their nature.

65. 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?

66. Discussion Role and possibilities of public in the swine flu case Dimensions of openness –analysis: THL’s narcolepsy analysis / related decision making Sources of knowledge for public

67. Open risk management: overview QRAQRA