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

Contents Overview to the RM lectures SOTA in EHA Other perspectives to RM The reality of RM? Discussion Introduction to the RM analysis exercise RM in the swine flu case Questions, actors, roles etc.?

Overview to RM lectures State-of-the-art? Theory lecture Discussion in the context of the swine flu case A social learning perspective Theory lecture Discussion in the context of the swine flu case 1.4. Facilitation of (open) risk management Theory lecture Web collaboration exercise 7.4. From needs to knowledge, knowledge to action Theory lecture Discussion in the context of the swine flu case 8.4. Summary/overview of DA & RM Final seminar

Overview to RM lectures Conventional views to RM Open risk management as an alternative view What is RM? What is it perceived to be? What should it be? Who does/should it involve?

General RA/RM framework Systematic analysis according to societal needs

Societal setting 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

State-of-the-art in environmental health assessment Based on BEPRARIBEAN research project Manuscript: “State of the art in benefit-risk analysis: Environmental health” to be published soon One out of a set of six “State of the art in benefit-risk analysis” papers Others domains considered are: Food and nutrition,Food microbiology, Economics and marketing-finance, Medicine, Consumer perception Also a “beyond the state of the art in food and nutrition benefit-risk analysis” is in preparation Combines the lessons learned in above mentioned studies

State-of-the-art in environmental health assessment 8 approaches to environmental health assessment analyzed: 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? (see table 2 for options) 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?

State-of-the-art in environmental health assessment 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.

State-of-the-art in 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

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

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 Understanding Risk: Informing Decisions in a Democratic Society. The National Research Council. National Academy Press, Washington D.C.

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 Communicatio n 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 Risk governance – towards an integrative approach. International Risk Governance Council. Geneva.

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 Guidance on Information Requirements and Chemical Safety Assessment. Guidance for the Implementation of REACH.

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.

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

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

Open assessment Assessment Participant’s knowledge Participant’s updated knowledge Updated assessment Participant’s updated knowledge Decision Decision making Perception Contribution

Main findings EHA is very complex No single SOTA approach Academic and regulatory approaches Traditional and novel approaches

EHA

Assessment – management interaction

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

Main findings EHA is a very complex field No single SOTA approach exists Academic and regulatory approaches Traditional and novel approaches

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

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 ii) the perspective to consider the relationship between assessment and use of its outcomes in different assessment approaches “Assessment push” or “needs pull”

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

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

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

What do the approaches tell about RM? Institutional Professional/expert-based Single-actor activity Unidirectional (assessment push) Rational Implementation of decisions is not the (big) problem Is this realistic?

What do the approaches tell about RM? Traditional division of labour in risk science Risk assessment is about experts producing scientific facts Risk management is about decision makers using the scientific facts Risk communication is about passing information about the decisions and their factual basis to the ignorant (stakeholders, NGO’s, public, …) Risk perception is about wondering how come the ignorant do not understand the facts Also in DA there are two branches What decision should be taken? How are decisions actually made? Are the distinctions necessary? Should these things be kept separate?

Reality of RM? Who make decisions that have societal importance? On what basis do they make decisions?

Introduction to the RM analysis exercise Instructions available on the DARM exercise page in Opasnet Individual work Max. score 10 points Of total max. 45 points Write your brief report on your own RM analysis page in Opasnet Presentations of reports in final seminar If needed, improvements can be made up to the final evaluation in the end of April

Discussion: RM in the swine flu case RM in the swine flu case Questions, actors, roles etc.?