Wrestling with a Medusa

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Front page for deliverables
Project no. / 003956
Project acronym / NoMiracle
Project title / Novel Methods for Integrated Risk Assessment of Cumulative Stressors in Europe
Instrument / IP
Thematic Priority / 1.1.6.3, ‘Global Change and Ecosystems’
Topic VII.1.1.a, ‘Development of risk assessment methodologies’
Deliverable reference number and title:
D.4.3.15 Wrestling with a Medusa - Integrated assessment and management of cumulative risks from multiple stressors according to EU chemicals regulators and stakeholder experts
Due date of deliverable:Not scheduled / Actual submission date:October27
Start date of project: 1 November 2004 / Duration: 5 years
Organisation name of lead contractor for this deliverable: Finnish Environment Institute, SYKE
Revision [draft, 1]: draft reviewed by Ad Ragas
Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006)
Dissemination Level
PU / Public / PU
PP / Restricted to other programme participants (including the Commission Services)
RE / Restricted to a group specified by the consortium (including the Commission Services)
CO / Confidential, only for members of the consortium (including the Commission Services)
Authors and their organisation:
Timo Assmuth, Matthieu Craye
Partner 19, SYKE, Helsinki, Finland
Partner 18, JRC, Ispra, Denmark /
Deliverable no:
4.3.15 / Nature:
R / Dissemination level:
Pu / Date of delivery:
27 October2009
Status:
Reviewed draft / Date of publishing:
Reviewed by (name and period):
Ad Ragas, Research Pillar 4, Oct 2009; Claire Mays, Pillar 5.3, Oct 2009

D.4.3.15 Suggested main title:

Wrestling with a Medusa

- Integrated assessment and management of cumulative risks from multiple stressors according to EU chemicals regulators and stakeholder experts

Timo Assmuth, Matthieu Craye

PREFACE

In recent years, integrated risk assessment and risk management or governance have attracted considerable interest, both in scientific and policy making communities. In the European Union and in other international settings, various attempts have been made to clarify, develop and implement such integration. In particular, risk assessment of chemicals has been increasingly extended to account for the existence of cumulative risks from multiple stressors.

Attempts at integrated treatment of risks have emerged from straightforward practical grounds in management contexts or following theoretical or research-driven considerations. In both cases the focus has usually been on the natural scientific and technical aspects of risk assessment.

Until now, integrated risk assessments have however not in the first place been based on detailed or explicit consideration of the particular needs they have to address, on their possibilities and limits in this respect, and neither on their (possible) roles and usefulness in the policy context. There has been a lack of structured information regarding the views on these aspects among regulators and stakeholders that play key roles in the development and uptake of more integrated approaches. The various interpretations and underlying concepts of integrated risk assessment, multiple stressors and cumulative effects have not yet been mapped. As a result, knowledge of the barriers to and opportunities for the introduction and uptake of integrated risk assessments has been scarce.

In the present report we will present and discuss the results of a series of interviews that aimed to shed light on the possible role and further uptake of integrated risk assessment in the interface of science and policy making in Europe, in the field of chemicals and of multiple stressors in general. We explore how judgments of integrated risk assessment are influenced by more general underlying views about risks, their assessment and management, and the related uncertainties and complexities. The overall objective of our study is thereby to contribute to future developments that could help to bridge the gaps between production and use of more integrated and richer knowledge on risks, including awareness of the related limits of knowledge.

TABLE OF CONTENTS

Executive summary

Foreword

1 Introduction

1.1 The challenge of multiple and complex risks and of narrow risk assessments

1.2 NoMiracle project as a response to the challenge

1.3 Objectives

2 Methods and materials

2.1 General

2.2 Interviews

2.3 Materials obtained

3 Synthesis of results by interview themes

3.1 Framings and concepts of integrated risk assessment

3.2 Addressing cumulative risks and multiple stressors in policy making

3.2 1 The need to develop policies for dealing with cumulative risks

3.2.2 Challenges for addressing cumulative risks of multiple stressors

3.2.3 Participation and communication in addressing cumulative risks

3.3 The roles of information, knowledge, uncertainty and precaution

3.3.1 Status of the knowledge base, opportunities and limitations

3.3.2 Treatment of uncertainties

3.3.3 The role of precaution

3.4 Integration in risks, risk assessment and risk management, and its uptake in the policy sphere

3.4.1 Integration: why, what types and which limits?

3.4.2 Interaction between assessment and management

3.4.3 Obstacles to and possible problems with more integrated assessment and management

3.5 Integrated chemicals assessment and management in relation to REACH legislation

3.5.1 Integrated treatment of risks in REACH

3.5.2 Challenges to the implementation of REACH

3.5.3 The generation, collection, processing and transmittal of information in REACH

4 Interpretation and relationships with the survey of expert and stakeholder opinions

4.1 General considerations

4.2 Summary of relevant findings from the survey

4.3 Comparisons of the survey and the interviews

4.4 Variations in views on policy-related dimensions of integration

4.5 Commonalities and key notions in framing integrated risk assessment

4.5.1 The need for integration: addressing the limits of approaches and methodologies to address complex situations

4.5.2 Effective communication between science and policy: assuring management relevance of innovative approaches

5 Barriers and opportunities for integrated risk assessment

5.1 Categories and general characteristics of barriers

5.2 Epistemological and ontological barriers

5.3 Regulatory barriers

5.4 Socio-political barriers

6 Conclusions, directions and opportunities for further development

6.1 General considerations

6.2 Working principles for developing and implementing strategies for integrated treatment of risks

6.2.1 Co-production of policy initiatives and knowledge on cumulative risks

6.2.2 Clarifying and reinforcing links between assessment and management

6.2.3 Addressing complexity in the context of adaptive risk management strategies

6.3 Prioritising areas on which to focus integrated approaches

6.4 Summary of recommendations and suggestions

6.4.1 Research and methods development

6.4.2 Forward-looking expert-stakeholder-policy deliberations

6.4.3 Policy development and application

Acknowledgments

References

Annexes

1 Structure of the interviews and specific questions

2 Letter of invitation to participate in interviews

EXECUTIVE SUMMARY

As part of the EU's R&D project NoMiracle (Novel Methods for Integrated Risk Assessment of Cumulative Stressors in Europe), views among regulators and stakeholders on integrated risk assessment and management were studied. The study was based on 16 semi-structured interviews that aimed at clarifying underlying concepts of those views. The interviews were carried out in 2007 and complemented an earlier Internet survey among experts and stakeholders. The study took place in the context of research activities that included also other empirical studies such as focus groups and workshops, literature studies and document analyses, and theoretical background studies.

During the interviews, integrated risk assessment of cumulative stressors was first addressed in a general and broad way in order to clarify framings of these concepts. Subsequently, the interviews focused on integrated risk assessment in the context of chemicals control in the EU, specifically in connection with the REACH legislation. Its development and implementation challenges were used as a case to discuss more general issues in (integrated) risk assessment and governance.

A variety of interpretations of key concepts such as integrated risk assessment, cumulative risks and multiple stressors was observed. Some were based on optimistic beliefs that risks, specifically those from chemicals, can be largely known and controlled, even though their multiplicity was commonly seen as a major challenge. Other interpretations were grounded in an increased and more explicit awareness of the myriad uncertainties and ambiguities in risk assessment and management. Respondents also referred to many institutional and broader societal challenges, specifically in the aftermath of controversies that surrounded the development of the REACH legislation.

Typically, cumulative risks from multiple stressors were seen as a challenge that can be addressed in the longer term only, not least because of current administrative pressures in the EU chemicals control. Explicitly addressing uncertainties and ambiguities in assessments was also often seen as a complication rather than an opportunity to direct attention to crucial issues and knowledge options.

Interviewees acknowledged both the need and some opportunities for integrated risk assessment, specifically in the area of chemicals, and also in other areas where more integrative approaches to risks have been adopted, such as environmental and public health and occupational safety. On the other hand, needs to specify, narrow down and decompose risk problems were also expressed. Many felt that the relevance and efficiency of risk assessments could be enhanced through integrating risk-benefit considerations throughout the process, while such an idea was remote to others.

Regarding the REACH legislation, some interviewees pointed to the requirements for more integrative assessment that are already present in REACH procedures: a more comprehensive treatment of environmental compartments, target organisms, product life-cycle stages and phases of risk policy cycles, especially assessment and management. All in all, however, despite some provisions for addressing chemical mixtures, the focus of REACH was seen as being still on single substances.

Views about the interaction between the assessment and management phases in risk governance varied and showed some inconsistencies. In general, a need for more interfacing between assessment and management was recognized, although quite some skepticism was expressed that this could endanger the independence of assessors. Statements on the precautionary principle confirmed the existence of its multiple interpretations and the persisting confusion in its implementation.

Notwithstanding the broad variety of views expressed during the interviews, the obtained material allows to discern, at general level, some commonalities in the challenges for integrated assessment: such framing could be seen to converge around two key notions that characterize both the need for integrated assessment and the key challenge in its conduct, namely ‘more realism’ and ‘manageable approaches’ in dealing with complex risk issues. Interviewees repeatedly expressed the concern that integrated approaches should not become too complicated, risking to be irrelevant for policy.

The interview results allowed us to identify a number of conceptual and structural (social and institutional) barriers for the development and deployment of integrated risk assessment. These include:

• The inherent complexity of combined and cumulative risks from multiple stressors, implying conceptual and resource constraints for meaningful knowledge development, fears of lacking relevance and realism of produced knowledge and fears of confusing messages to its use context
• A regulatory environment that favors reasoning in terms of narrowly specified mandates, individual liabilities and separated consideration of risks rather than their integration
• A related difficulty to discern, even when emphasizing integration, between justified and excessive or unfeasible integration of risks, and to combine integrative and differentiating approaches
• A socio-political and cultural environment in which actors tend to be locked in established approaches such as the single substance approach to chemical risks, not least because it gives reasonable certainty of what they can expect in relation to the confines of their field and to their mindsets, liabilities and objectives. The opportunities opened up by considering integration and novel approaches to combined risks were thus often assessed in terms of the possible implications for the interests and particular views of actors.

The interpretation of the obtained material delivers suggestions for furthering the development and deployment of integrated approaches. These include:

• Clear priority setting and concentration of efforts on a number of areas where combined treatment of risks is, in a broad collective deliberation, judged most feasible in terms of research effort, policy developments and information requirements and can lead to tangible and useful results in the not-so-long term. Analysis of the interview material provides clues that can inform the priority setting for integrative approaches:

• Build further on experiences (be it in policy domains or scientific fields) where combined risks and integrated assessment have been practiced
• Concentrate the development of integrated approaches in first instance within regulatory frameworks that are receptive
• Develop integrated approaches in areas where the positions of stakeholders are favourable, i.e. where they think that addressing ‘combined risks’ could lead to policies that fit well within their positions and perspectives
• Build on discussions on the qualities context-dependencies, limits and opportunities of risk integration to define acceptable and workable specific configurations for it.

• Connect integrated approaches firmly with their context of use (social debates and processes, policy, regulation, decision-making) to enhance their relevance. To this end, a number of guiding principles are proposed for accompanying activities: co-production of policy initiatives and knowledge development on cumulative risks; participatory deliberation on the meanings, goals and means of integrated treatment of risks; clarifying and reinforcing links between assessment and management; addressing complexity in the context of adaptive and stepwise approaches.

1 INTRODUCTION

1.1 The challenge of multiple and complex risks and of narrow risk assessments

Traditional, well established risk assessment, based on study or prediction of one effect caused by one agent, is often seen by regulators, stakeholders and other actors as inadequate and too narrow. It does not take into account a number of aspects that are increasingly seen as crucially important, such as the possible cumulative, interacting and indirect effects of exposure to multiple agents, the complexity and indeterminacy of risk situations (impacts on different environmental compartments, the possibility of many simultaneous exposure routes, the dependency of risks on hard-predicted factors such as human behavior, and so forth). Furthermore, much of the related uncertainties and conceptual ambiguity of risks – entailing questions about the relevant spatial and time scale, the accumulation and lags in risks and the multiple, also non-technical, dimensions of risk issues – are not explicitly addressed in such traditional risk assessments.

Among other fields, chemicals control shows evidence of an increased awareness to broaden traditional narrow risk assessments in order to address more adequately complex mixtures of potentially harmful (and useful) substances (CEC, 2001). Additionally, the need is recognized to relate risks from chemicals to those from other stressors, e.g. to identify priorities in environmental, health and other policies. On various occasions, in many ways and for different applications, official EU policy documents have stressed the importance of a more integrated treatment of risks (CEC, 2003b; CEC DG SANCO, 2002-2008; EP and EC, 2002, 2008).

The multiplicity and complexity of risks present a challenge both for data gathering, technical information and the development and dissemination of scientific knowledge as well as for management and governance including regulation. While there is increasing awareness in policy making circles of the need to look at risks from a broader and more inclusive perspective, very often narrow framings remain imposed by the regulatory context (specific pieces of legislation and the administrative and institutional structures and functions in place).

Within chemicals control, a key development has been the preparation and enactment of the EU's REACH (Registration, Evaluation and Authorization of Chemicals) legislation. REACH has a certain rationale, framing and structure, and includes some provisions for integrative risk assessment and management (CEC, 2006; see also CEC, 2003a). These are however limited by its fundamental orientation: even REACH, as the most influential new legislation on chemicals, mainly addresses single substances (Assmuth et al., 2009c). Its relationships with other areas of regulation affecting chemicals are also an issue that still needs to be developed.

A particular challenge to integrated risk assessment is that it should not only address more complicated risk situations in terms of the simultaneous presence of causative agents and types of effects. Ideally, the efforts to address in a broader and more realistic way the biophysical phenomena in risk situations should go hand in hand with attention to a plurality of meanings and interpretations of these risk experiences (Wynne, 1996). Traditional biophysical interpretations often need to be complemented by considering social aspects of risks, including the concerns of affected citizens and large segments of societies (Kasperson et al., 1988; Horlick-Jones, 1998; Renn and Klinke, 2002; Aven and Christensen, 2005; Renn and Benighaus, 2006; Renn, 2007, 2008).

Interpretations of 'integrated' or 'cumulative' risk assessment have varied widely in regulatory contexts (IPCS, 2001, 2004; CEC, 2003a, CEC DG-SANCO, 2003a, b; Bridges, 2003; Munns et al., 2003; USEPA, 2003; NRC, 2008), but have seldom included societal dimensions (see Renn, 1992; Assmuth and Hildén, 2008; Assmuth et al., 2009a-c). This reflects interpretations of risks in general, often seen mainly in natural scientific or technical terms. For instance, in their discussion of opportunities for integrated risk assessment, Vermeire et al. (2007) consider some socio-political aspects but only in terms of scientific and technical consequences: "The major emerging opportunities for an integrated approach stem from the increasing societal and political pressure to move away from vertebrate testing leading to a demand for scientific integrated approaches to … testing, as well as to computer simulations, in so-called Intelligent Testing Strategies".

R&D projects, also in EU programmes, provide an opportunity to develop and test novel ways to deal with the multiplicity and complexity of risks. However, even here traditional interpretations and approaches to risks often dominate. For instance, among the multitude of EU RTD projects addressing environmental or health risks in the area of chemicals and water, most have had a technical and natural scientific orientation (Assmuth, 2008). A main challenge then is to better match the R&D and policy agendas, enhance multi-disciplinarity, and facilitate a co-production of innovative but practicable approaches to multiple risks.