White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals

https://doi.org/10.1016/j.scitotenv.2015.03.065Get rights and content

Highlights

  • Integrated risk assessment improves health- and environmental-based decision making.

  • Integrated risk assessment helps reduce animal testing and economic burden.

  • Integrated risk assessment drives harmonization of models and methodologies.

  • Opportunities for integrated risk assessment exist in European chemical regulations.

  • Socio-economic and socio-behavioural considerations improve risk analysis.

Abstract

The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more effective risk evaluation and consideration of the risks and benefits associated with the use of chemicals.

Introduction

Since the late 1970s, risk assessment (RA) of chemicals has served the needs of health and environment protection policies worldwide. While extensive cumulative experience has been gained over time in chemical RA, and new regulations have been established for a wide range of chemical stressors, current regulatory RA practice for chemicals faces substantial challenges to meet present and future scientific, ethical and policy needs.

Anticipating the changing needs of RA processes, an international expert group involving the European Commission (EC), the US Environmental Protection Agency (US EPA) and the Organisation for Economic Cooperation and Development (OECD) was set up in 1998 under the umbrella of the International Programme on Chemical Safety (IPCS) of the World Health Organization (WHO) to advance the integration of approaches for human health risk assessment (HHRA) and ecological (environmental) risk assessment (ERA) to better inform risk-based decision making. Their seminal report (WHO, 2001) outlined a generic framework for integrated risk assessment (IRA) which can be used as guidance applicable to all chemical categories and which addresses real life multi-chemical, multimedia, multi-route and multispecies exposures. IRA was defined as “a science-based approach that combines the processes of risk estimation for humans, biota and natural resources in one assessment” (WHO, 2001). Based on four case studies (Hansen et al., 2003, Ross and Birnbaum, 2003, Sekizawa et al., 2003, Vermeire et al., 2003), benefits, opportunities, limitations and obstacles to using the framework were identified, and research recommendations were made to improve and facilitate integrated approaches (Munns et al., 2003).

In 2003, the EC highlighted IRA as a key element of future action in its European Environment and Health Strategy (EC, 2003), paving the way for the development of the IRA concept as new EU research projects under the 6th Framework Programme (FP6) (e.g. HEIMTSA (http://cordis.europa.eu/project/rcn/81281_en.html), INTARESE (http://www.intarese.org/), NoMiracle (http://nomiracle.jrc.ec.europa.eu/), OSIRIS (http://www.ufz.de/osiris/), 2-FUN (http://www.2-fun.org/)) were funded to better characterize the link between environmental risk factors and health-related impacts. Building on this legacy, the FP7 coordination project HEROIC1 aimed to consolidate the existing knowledge and identify what is necessary to further develop and promote IRA.

Based on the HEROIC project's major findings, this white paper presents a vision of IRA focused on opportunities and challenges in relation to specific EU chemical regulatory frameworks, including policy recommendations on how to promote the implementation of IRA. Although our focus is on regulatory RA in the context of sectorial chemical regulations and marketing authorization of chemicals, we appreciate that the concept of IRA can also be applied to other areas and types of RA, e.g. community-based RA, which is associated with public health issues and deals with population-based or ecological requirements.

Section snippets

What is integrated risk assessment?

Integration can be applied in various contexts and at different levels of complexity in chemical RA (Bridges, 2003, Briggs, 2008, Kortenkamp and Faust, 2004, Suter et al., 2003). One can integrate components such as exposure and effects; in silico, in vitro, in vivo or monitoring data; multiple chemicals, multiple species/target organisms, multiple toxicological endpoints, multiple exposure routes; spatial and temporal scales; a product's life cycle; or socio-economic aspects (Suter et al., 2003

What does integrated risk assessment want to achieve?

IRA should not be considered as a new scientific concept but as an evolutionary process which serves the vision of a sustainable and safe use of chemicals in order to protect human health, preserve the environment and maintain the ecosystem services for the benefit of human welfare (Suter et al., 2005), while at the same time better managing the scientific, societal and economic challenges related to present and future safety testing development and chemical policy making.

We believe that IRA

Why is integrated risk assessment needed?

Our vision of IRA addresses the challenges which modern RA practice faces:

  • For historical and practical reasons, HHRA and ERA for chemicals have generally developed independently and are today typically separated, using largely separate data, models and assumptions to characterize health or environmental risks, which hampers the mutual understanding, exchange and coordination of best RA practices between the human and environmental scientific disciplines (Bridges, 2003, Suter et al., 2005).

  • This

What is the added value of integrated risk assessment?

IRA answers these scientific, societal and policy needs, because it better manages the balance between increasing public demand for safety and the increasing lack of acceptability of additional animal testing, while reducing at the same time the economic burden of the regulatory system on industry. IRA offers the opportunity for more comprehensive, efficient and cost effective RA (Suter et al., 2005, Vermeire et al., 2007, WHO (World Health Organization), 2001).

A systematically coordinated

What are the opportunities for integrated risk assessment in the present European regulatory landscape?

In recent years, significant scientific advances, changes in the chemical legislation and increasing environmental consciousness have created a favourable scientific and regulatory environment to further develop and promote the concept and vision of IRA. The HEROIC project has identified several opportunities that address general challenges in current RA practice as well as more specific opportunities in selected European regulatory frameworks for chemicals.

What is required for the implementation of integrated risk assessment?

To facilitate the implementation of IRA, the HEROIC project evaluated short-term and medium-term opportunities for the further development, promotion and stepwise implementation of IRA as a feature of European regulatory frameworks in the following areas:

  • 1.

    Development of RA science (hazard assessment, exposure assessment, mixtures assessment; harmonization of RA terminology, models and methodologies);

  • 2.

    Regulatory development (including harmonization of legal requirements for HHRA and ERA;

Roadmap

The promotion of the development and implementation of an IRA framework in regulatory practice will require a concerted effort and sustained dialogue between all stakeholders, and will necessitate policy and regulatory changes.

Implementation of a full IRA at larger scale will require international agreement, and major coordination and harmonization efforts.

The following roadmap is proposed:

Acknowledgments

The HEROIC coordination action project was funded under the European Commission's 7th Framework Programme (grant number 282896) with the contribution of the following partners: Thomas Backhaus, Zoran Banjac, Damià Barceló, Jean-Marc Brignon, Ettore Capri, Agathi Charistou, Philippe Ciffroy, Abigail Dalzell, Marinella Farré, Richard Glass, Paola Grasso, Mathias Grotte, Barbara Intelmann, Efrosini Katsanou, Katerina Kyriakopoulou, Kyriaki Machera, Albrecht Paschke, Alexandre Péry, Bertille

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