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| NoMiracle Objectives |
The interaction between environment and health is far more complex than is commonly understood. In particular, little attention has been paid to the interaction of different pollutants in the human body as well as in the environment. Even low level exposure over a period of time to a complex cocktail of pollutants in air, water, food and consumer products is likely to contribute significantly to the health status of European citizens.
Within this project we will improve both human and environmental risk assessment procedures by addressing a series of major shortcomings that exist within the current approaches, namely that:
Although it is generally acknowledged that chemical, biological, radiological, and other physical and even psychological stressors can cause a variety of human health or ecological health effects, assessing the risks associated with them is considerably more complex methodologically and computationally than current risk assessment practices. Given these lacunas there is an urgent need for ”cumulative risk assessment” which can be defined as “an analysis, characterisation, and possible quantification of the combined risks to health or the environment from multiple agents or stressors”.
- they are based on direct effects of single compounds or products
- they apply uncertainty factors which are not strictly based on scientific principles
- they do not account for multiple stressors and indirect effects in a dynamic and heterogeneous environment
- they typically do not account for cumulative (integrated over time, space, substances) effects, and
- they do not allow for site specific and other spatially detailed evaluations
Development of a framework for such complex risk assessments will greatly improve understanding of the effects of cumulative exposures occurring under the variety of field conditions within Europe and will provide a better scientific basis for forecasting risks and associated uncertainties.
The understanding of the complexity of cumulative risks is a prerequisite for development of more efficient guidelines to provide data for future regulation of chemicals.
Science & technology objectives
- To develop new methods for assessing the cumulative risks from combined exposures to several stressors including mixtures of chemical and physical/biological agents
- To achieve more effective integration of the risk analysis of environmental and human health effects
- To improve our understanding of complex exposure situations and develop adequate tools for sound exposure assessment
- To develop a research framework for the description and interpretation of cumulative exposure and effect
- To quantify, characterise and reduce uncertainty in current risk assessment methodologies, e.g. by improvement of the scientific basis for setting safety factors
- To develop assessment methods which take into account geographical, ecological, social and cultural differences in risk concepts and risk perceptions across Europe
- To improve the provisions for the application of the precautionary principle and to promote its operational integration with evidence-based assessment methodologies
For each of these objectives, the project has set the following expected results or measures of success :
- Objective 1: To develop new methods for assessing the cumulative risks from combined exposures to several stressors including mixtures of chemical and physical/biological agents :
- Methods for assessing potential effects and for characterising cumulative risk will be developed taking into account the real characteristics of potentially exposed human and ecological receptors (sensitivity, vulnerability, value as natural resource, realistic probability of exposure, etc).
- The toxicity studies with mechanistic research at the chemical, biochemical, and genomic level, which will give understanding of the underlying mechanisms of combinatorial effects.
- Development of integrative endpoints that can be used for characterisation of cumulative risks.
- Novel spatial- and receptor-oriented approaches for assessing the integrated exposure to multiple stressors will be available.
- Objective 2: To achieve more effective integration of the risk analysis of environmental and human health effects :
- External expert will recognise the validity of the NOMIRACLE systems for toxicity testing in human toxicology and ecotoxicology especially based on advances in the understanding of molecular and cellular mechanisms and biomarkers of toxicity, providing a better transferability between ecotoxicology and human toxicology
- Since this project is the first one that investigates ecotoxicological and human toxicological test principles simultaneously, a comparison will result in a better understanding of the outputs, which is expected to help interpret the results and transferability between both.
- Direct comparability between effects of chemicals (under different conditions) on the environment and the human health.
- The uncertainty analyses will help elucidate the relative share of the human and non-human components in overall uncertainty, and the options for integration across receptors and sectors
- Objective 3: To improve our understanding of complex exposure situations and develop adequate tools for sound exposure assessment :
- Fate and exposure models that account properly for the compound-matrix interaction and resultant phase partitioning of modern bioactive agents
- Methodologies for quantifying the matrix-specific available exposure of xenobiotics that are relevant for toxic and ecotoxic effects, covering both the field and laboratory biotest systems
- Tools for improved prediction of degradation rates and pathways of organic chemicals
- Non-generic models that can be tailored to the complex exposure situations encountered in the European Union
- Indoor exposure patterns and assessment methods for homes, kindergartens and public building across Europe
- Objective 4: To develop a research framework for the description and interpretation of cumulative exposure and effect :
- Development of a biological-systems orientated approach to understanding the occurrence consequences of cumulative stress effects in the environment by linking molecular genetic and whole organism approaches.
- Understanding of the physiological mechanisms through which effects of combined exposures become manifest, allowing better estimates of when predictive models are reliable and when they may fail.
- Highlighting potential species specific and common biomarkers that can be used in monitoring of cumulative stress effects on environmental and human health.
- Development of new methods for comparative risk assessment by integration of mixture toxicity and multiple stressors (i.e., comparison of toxic stress, eutrophication and acidification)
- Objective 5: To quantify, characterise and reduce uncertainty in current risk assessment methodologies, e.g. by improvement of the scientific basis for setting safety factors :
- Development of new concepts and techniques to characterise, quantify, reduce and deal with uncertainty that are scientifically sound and practicable for cumulative risk assessment
- Improved safety factors for human and ecological risk assessment based on new scientific insights in the underlying toxicological processes that explicitly account for uncertainty
- Objective 6: To develop assessment methods which take into account geographical, ecological, social and cultural differences in risk concepts and risk perceptions across Europe :
- The methods developed for assessing exposure and for characterising risk will be integrated in a comprehensive methodology with the development of suitable models and software for assessing location-specific risk, for integrating it into a GIS and for producing (eco)toxicological risk maps.
- The methodology will allow the production of maps of predicted exposures (PECs) and estimates of other validated metrics better reflecting actual exposure, of ecosystem characteristics and vulnerability and of (eco)toxicological risk at different scales (from the local scale, i.e. specific terrestrial and aquatic ecosystems, to the regional scale, i.e. different typical Ecoregions). The method should take into account different European environmental and land use characteristics and, therefore, should be valid across the European Union.
- Objective 7: To improve the provisions for the application of the precautionary principle and to promote its operational integration with evidence-based assessment methodologies :
- The project will improve the knowledge base and methodologies for efficient implementation of the precautionary principle in managing risks from chemicals and other stressors through multi-disciplinary studies of the key cognitive, knowledge-related and social issues in risk assessment.
- These studies will elucidate ways to integrate the precautionary principle with detailed scientific risk assessments, depending on the decision situation (e.g. the chemical product, receptor and region)The work will focus on the use of scientific information in integrated assessment to provide policy-relevant advice and on related processes of inference and deliberation.
- This R and D is expected to have significant value for the development and implementation of integrated risk assessment and for risk management, be it predominantly science-based or precautionary, in a variety of contexts, primarily in the project domains but also more generally.
- The R and D in this area will, by elucidating risk views and knowledge and inference in assessment, also serve to integrate the project.