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Ecological risk assessment (ERA) is defined as an iterative process that evaluates the likelihood of adverse ecological effects resulting from exposure to one or more stressors. Although ERA is recognized as a valuable procedure to better address efforts and strategies for site remediation, in Europe a common framework for the implementation of ERA in the management of contaminated sites is lacking. In Italy, there are no legally binding provisions regulating the direct assessment of potential likelihood of ecological risks. In this context, the main objective of this article was to develop a guideline to facilitate ERA application in support of an effective and sustainable management of contaminated sites in Italy and to facilitate a multistakeholder dialogue. The work was based on a critical review of existing ERA guidelines in the international context, as well as other regulatory documents and technical approaches dealing with the evaluation of ecological effects of chemical contaminants in different environmental compartments. Approaches and tools available in these documents were then used to prepare a proposed guideline for the Italian context; the proposed ERA guideline is meant to represent a flexible but robust approach that can be useful in evaluating existing data (e.g., from past investigations) as well as in the planning of site-specific investigations. To facilitate the direct application of the ERA procedure, the guideline was prepared including several templates of summary tables, checklists, and examples. The proposed ERA guideline could facilitate the decision-making process for contaminated sites with ecological values, although its application would necessarily require, at least in the initial phase, testing of its suitability to the Italian context and setting-up of a close dialogue and collaboration with local authorities and other stakeholders. Integr Environ Assess Manag 2022;00:1-7. © 2022 SETAC.

Additional file 1: Table S1. Information about estimated amount of species detected after leaching experiments by employing standard leaching test methods used in studies included in Table 1.

Based on the data gap analysis performed in the first step of MEDCIS, the Medcis team on contaminant proposed a road map associated with a time-schedule in order to improve harmonization in Mediterranean region for 2024 GES assessment. Partner countries shared information on monitored substances and biological effects, thresholds used, matrix/matrices used for the monitoring of each substance/family of substances, the limit of quantification (LQ) of each chemical measurement, and the proportion of censored data

MERLIN-Expo is a new tool for integrated exposure assessment recently developed under the FP7 project “4FUN”. MERLIN-Expo incorporates advanced models simulating the fate of chemicals in the environment and in human body (PBPK model) into an easy-to-use tool. Models available in the MERLIN-Expo library are implemented on a common platform to facilitate integrated full-chain assessments for combined exposures. Models can be used to simulate fate of organic (PAHs, PCBs, dioxins) and inorganic contaminants. Software enables end-user to apply set of functionalities such as uncertainty and sensitivity analysis, dynamic deterministic and probabilistic simulations in order to address different exposure and chemical fate problems. MERLIN-Expo was applied to assess long term ecological and human exposure to PCBs and PCDDs in the Venice lagoon (Italy). Data from literature describing pollution historical trends in the lagoon, estimated in dated sediment cores, were used as time-dependent model input. In order to simulate bioaccumulation in specific aquatic food web three models were implemented in MERLIN-Expo library: Phytoplankton, Aquatic Invertebrate and Fish, allowing to represent specific organisms. Aquatic food web model was then coupled to PBPK model to simulate chemical concentration in aquatic organisms and in human serum after dietary exposure to contaminated seafood. Modelling results are then tested against available monitoring data on chemical concentrations in edible aquatic species and concentrations in serum of adult men in Venice area to assess the accuracy and applicability of the proposed tool to real complex scenarios. Full chain exposure assessment is then complemented by uncertainty and sensitivity analysis including local sensitivity methods, screening methods (e.g. Morris method), global regression methods (e.g. Standardised Regression Coefficients), and global variance based methods (e.g. FAST, EFAST, Sobol). These methods allow to follow for instance WHO (2008) recommendations to perform three stage uncertainty/sensitivity analysis, adopting qualitative, semi-qualitative, and quantitative methods. Integration of environmental and human exposure models in MERLIN-Expo allows comprehensive assessment of exposure and thus better characterisation of overall risk to human and environment especially in the case of higher tier assessment. Finally, MERLIN-Expo follows a Quality Assurance and Standardisation process for documentation in collaboration with CEN (European Committee for Standardisation). This makes the tool interesting and promising for potential applications in different regulatory domains.last decade has witnessed an increasing interest in assessing health risks caused by contaminants present in several environmental media, i.e. soil, air, and water. To that end, mathematical models describing the fate of compounds in the environment (multi-media models) and in the human body (toxicokinetic models) can be combined to simulate realistic exposure scenarios of the human populations. These models can also be integrated in a Geographic Information System (GIS) to produce maps of exposure and reveal spatial patterns. The aim of this study was to develop a spatial stochastic multimedia and human exposure model for detecting vulnerable populations and analyzing exposure determinants at a fine resolution and regional scale. This approach was applied to the exposure to lead of children in the Region Nord-Pas-de-Calais in France.

Risk managers and decision makers are in need of tools that inform environmental and human exposures in different spatial and temporal dimensions. We demonstrate a new modelling tool for the integrated assessment of exposure to chemicals, called MERLIN-Expo, which is currently being refined and validated within the FP7 project "4FUN". This tool provides a library of exposure models which can be flexibly combined to explore complex scenarios, coupling on the same platform multimedia and physiologically-based pharmacokinetic (PBPK) models for estimating human intake and internal exposure. The models can be used to dynamically simulate fate and exposure for all organic (e.g., PAHs, PCBs, pesticides) and inorganic contaminants. There is no limitation for temporal scale, and the combination of different model boxes allow to cover different spatial scales. Moreover, MERLIN-Expo incorporates advanced functionalities for uncertainty and sensitivity analysis. MERLIN-Expo is demonstrated on a case study in the Lagoon of Venice, aimed at estimating environmental and human exposure to different congeners of PCBs. Specifically, the modelling framework combines bioaccumulation modelling in aquatic species, human intake modelling through the diet, together with PBPK modelling of internal exposure. Past PCB concentration trends reconstructed from dated sediment cores are used as inputs to model the time-dependent bioaccumulation in selected aquatic organisms. Then lifetime dietary intakes from contaminated fish and seafood, as well as other food items collected from literature data, are used to estimate PCB internal exposure for local population. Modelling results are compared to available monitoring data on chemical concentrations in edible aquatic species and concentrations in serum of adult men in Venice area to assess the reliability and applicability of the proposed tool to real complex scenarios. Different outcomes of MERLIN-Expo can be used for regulatory purposes. For example, chemical concentrations in environmental media and biota can be compared with Environmental Quality Standards, human daily intake can be compared with given regulatory threshold for human health (e.g. Reference Dose) and internal exposure estimates can be evaluated against Biomonitoring Equivalents or other thresholds defined by risk assessors. This makes the tool interesting and promising for potential applications in different regulatory domains.