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

Contents

• Overview to the RM lectures 30.3.-7.4.

• 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• 30.3. State-of-the-art?

• Theory lecture• Discussion in the context of the swine flu case

• 31.3. 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• 11.-12.4. 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

Assessment Use

Assessmentprocess

Assessmentproduct

Decision making

Knowledgeneed

Productrequirement

Processrequirement

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 assessment Risk management

Observations

NRC 1983. 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

DecisionProblem formulation

Process design

Selecting options & outcomes

Information gathering

Synthesis

Public officials

Natural and social scientists

Interested and affected parties

ImplementationEvaluation

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.

IRGC – Risk governanceAssessment sphere:

Generation of knowledge

Risk managementImplementation▪ 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 appraisalRisk 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.

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

no yes

noyes

Iteratio

n

Chemical safety report

ECHA 2008. 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

Pa

rticipa

tion

Pa

rtic

ipa

tion

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 knowledge

Participant’s knowledge

Participant’s updated knowledge

Updated assessment

Participant’s updated knowledge

Decision

Decision m

aking

Perce

ption

Perception

Contributio

n

Con

trib

utio

n

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 2009. 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 11.-12.4.

• 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.?