Applicability of the fish embryo acute toxicity (FET) test (OECD 236) in the regulatory context of Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH).

In 2013 the Organisation for Economic Co-operation and Development (OECD) test guideline (236) for fish embryo acute toxicity (FET) was adopted. It determines the acute toxicity of chemicals to embryonic fish. Previous studies show a good correlation of FET with the standard acute fish toxicity (AFT) test; however, the potential of the FET test to predict AFT, which is required by the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation (EC 1907/2006) and the Classification, Labelling and Packaging (CLP) Regulation (EC 1272/2008), has not yet been fully clarified. In 2015 the European Chemicals Agency (ECHA) requested that a consultant perform a scientific analysis of the applicability of FET to predict AFT. The purpose was to compare the toxicity of substances to fish embryos and to adult fish, and to investigate whether certain factors (e.g., physicochemical properties, modes of action, or chemical structures) could be used to define the applicability boundaries of the FET test. Given the limited data availability, the analysis focused on organic substances. The present critical review summarizes the main findings and discusses regulatory application of the FET test under REACH. Given some limitations (e.g., neurotoxic mode of action) and/or remaining uncertainties (e.g., deviation of some narcotic substances), it has been found that the FET test alone is currently not sufficient to meet the essential information on AFT as required by the REACH regulation. However, the test may be used within weight-of-evidence approaches together with other independent, relevant, and reliable sources of information. The present review also discusses further research needs that may overcome the remaining uncertainties and help to increase acceptance of FET as a replacement for AFT in the future. For example, an increase in the availability of data generated according to OECD test guideline 236 may provide evidence of a higher predictive power of the test. Environ Toxicol Chem 2018;37:657-670. © 2017 SETAC.

The possibilities for the EU-wide use of similar ecological risk-based soil contamination assessment tools.

Soil degradation, e.g. due to soil contamination, is a serious problem in Europe. Therefore, the European Commission believes that a comprehensive EU strategy for soil protection is required. With the purpose of supporting the European soil policy, the possibilities for a common approach in the EU-wide use of ecological risks assessment methodologies are explored. For over ten years now, ecological procedures used in different countries have been discussed in international fora. More recently, within the framework of the HERACLES network a review of ecological risk assessment tools was performed, among other things. From this study it can be concluded that the inclusion of ecological risk assessment in soil quality standards shows an increasing interest in many EU Member States. The study also shows that there are many procedures for ecological risk assessment readily available in several EU countries and will be readily available in even more Member States in the nearby future. Besides, this study clearly shows quite some variation in the ecological risk assessment tools and in the resulting soil quality standards in the different countries. Therefore, an effort was made to look for potential harmonisation of these tools within the European Union. Risk assessment tools used in soil quality assessment include both political and scientific elements, which are often interwoven. Insofar differences in the existing tools originate from geographical or cultural differences between Member States or from political choices, harmonisation is not at all regarded an option. Nevertheless, several differences between existing ecological risk assessment tools have been identified, that merely originate from scientific or technical aspects. These tools could be standardized, which means that there could be a uniform tool to be used everywhere throughout the EU. The development of these harmonised risk assessment tools will imply an intensive international cooperation, with the purpose of at least making the existing differences between those tools from the Member States transparent and to investigate the possibilities for coming to similar tools from a scientific/technical perspective.

A spatial risk assessment methodology to support the remediation of contaminated land.

When soil and groundwater contaminations occur over large areas, remediation measures should be spatially prioritized on the basis of the risk posed to human health and in compliance with technological and budget constraints. Within this scope, the application of human health risk assessment algorithms in a spatially resolved environment raises a number of methodological and technical complexities. In this paper, a methodology is proposed and applied in a case study to support the entire formulation process of remediation plans, encompassing hazard assessment, exposure assessment, risk characterisation, uncertainty assessment and allocation of risk reduction measures. In the hazard assessment, it supports the selection of Contaminants of Concern (CoC) with regard to both their average concentrations and peak concentrations, i.e. hot spots. In the exposure assessment, it provides a zoning of the site based on the geostatistical mapping of contaminant. In the risk characterisation, it generates vector maps of Risk Factors on the basis of the risk posed by multiple substances and allows the interrogation of most relevant CoC and exposure pathways for each zone of the site. It also supports the Monte Carlo based probabilistic estimation of the Risk Factors and generates maps of the associated uncertainty. In the risk reduction phase, it supports the formulation of remediation plans based on the stepwise spatial allocation of remediation interventions and the on-time simulation of risk reduction performances. The application of this methodology is fully supported by an easy-to-use and customized Geographical Information System and does not require high expertise for interpretation. The proposed methodology is the core module of a Decision Support System (DSS) that was implemented in the DESYRE software aimed at supporting the risk-based remediation of megasites.

DESYRE: DEcision Support sYstem for the REhabilitation of contaminated megasites.

DESYRE (DEcision Support sYstem for the REqualification of contaminated sites) is a GIS-based decision support system (DSS) specifically developed to address the integrated management and remediation of contaminated megasites (i.e., large contaminated areas or impacted areas characterized by multiple site owners and multiple stakeholders). In the DESYRE conceptual design and development the main aspects pertaining to a remediation process--analysis of social and economic benefits and constrains, site characterization, risk assessment, selection of best available technologies, creation of sets of technologies to be applied, analysis of the residual risk, and comparison of different remediation scenarios--were included. The DESYRE DSS is a GIS-based software composed of 6 interconnected modules. In the characterization module, chemical and hydrogeological data are organized in a relational database and contaminants' distributions are mapped by using geostatistic tools. The socioeconomic module addresses the socioeconomic constraints though a fuzzy logic analysis to select the best land use. The risk assessment module is divided into 2 phases. In the preremediation phase, an original procedure allows assessing and representing the spatial distribution of risks posed by contaminants in soil and groundwater, providing a risk-based zoning of the site. Then, in the technology assessment module, a selection of suitable technologies and creation of different technology sets, taking into account both technical requirements and site-specific features, are performed by experts supported by multicriteria decision analysis tools. In the postremediation risk assessment, a simulation of applied technologies provides residual risk maps with related uncertainty maps. Finally, in the decision module, alternative remediation scenarios are described by a set of indices and can be compared and ranked by interested stakeholders using multicriteria decision analysis methodologies. The paper highlights original procedural steps and functionalities of DESYRE nd analyzes its main points of strength and potentialities, as well as limits.

Development of a site-specific Ecological Risk Assessment for contaminated sites: part II. A multi-criteria based system for the selection of bioavailability assessment tools.

A comparison procedure based on Multi-Criteria Decision Analysis (MCDA) and expert judgment was developed in order to allow the comparison of bioavailability tests to implement the chemical Line of Evidence (LoE) within a TRIAD based site-specific Ecological Risk Assessment framework including three tires of investigation. The proposed methodology was included in the Module 1 of the Decision Support System DSS-ERAMANIA and the obtained rank supported the selection of a suitable set of available tests to be applied to the case study. A simplified application of the proposed procedure is described and results obtained by the system software are discussed.

Decision support-oriented selection of remediation technologies to rehabilitate contaminated sites.

A methodology for selecting remediation technologies is presented as part of a decision support system for the rehabilitation of contaminated sites. It includes 2 steps: In the 1st step, a pool of suitable technologies is selected within a technologies database according to their applicability to site-specific conditions; in the 2nd step, the selected technologies: are ranked according to a multicriteria decision analysis (MCDA) approach. The MCDA was applied to allow for a transparent procedure and for the integration of expert analyses. The methodology was implemented in a previously developed georeferenced information system-based decision support system for the rehabilitation of contaminated sites and then applied to a case study (Porto Marghera, Venice, Italy). On the basis of the obtained results, the proposed methodology appeared suitable to select remediation technologies according to both technical features and requirements of available technologies, as well as site-specific environmental conditions of the site of concern, such as chemical contamination levels and remediation objectives.

Screening ecological risk assessment for the benthic community in the Venice lagoon (Italy).

According to the risk hypothesis: the sediment as source of potential risk for the benthic community, an Ecological Risk Assessment (ERA) based on the quotient method was undertaken. The exposure of the benthic community to different classes of pollutants (metals, chlorinated organic compounds and polynuclear aromatic hydrocarbons) was inferred by estimating the pollutant stocks in the top 15-cm sediment of the whole Venice lagoon, after application of geostatistic techniques. The risk was calculated by comparing the sediment exposure profiles with the ecotoxicological benchmarks for benthic organisms. Kriging based maps of the spatial distribution of the estimated risk for the benthic community over the whole lagoon were obtained. The highest risk, found in the areas nearest to the sources of contamination (e.g., the industrial district of Porto Marghera and the river mouths), was posed by mercury (40% of the sampling stations showed exposure levels higher than the Probable Effect Level), arsenic and nickel (75% of the sampling stations exceeded the Threshold Effect Level).

A method for risk assessment for three contaminated sites in northern Italy.

A stepwise human health risk assessment procedure carried out using American Society for Testing and Materials methodology was applied to three contaminated sites located in northern Italy: an uncontrolled landfill, an abandoned industrial site and an industrial waste contaminated land. Two different tiers of analysis were performed by means of the analytical model RBCA Tool Kit and the numerical model API-DSS, respectively. The latter was applied according to both a deterministic and a probabilistic risk analysis. The comparison of the two approaches highlighted the great benefit provided by probabilistic analysis for the risk assessment based on site specific parameters and more complex models, in particular for groundwater exposure route. Finally, the risk-based site specific target levels were compared to the generic regulatory threshold limits fixed by the Italian regulation. The comparison showed the regulatory limits generally too restrictive for non-carcinogenic substances but less protective for carcinogenic chemicals, outlining the need of a site-specific risk assessment especially for carcinogenic substances.

Ecological risk assessment of persistent toxic substances for the clam Tapes philipinarum in the Lagoon of Venice, Italy.

Because of contamination of sediments of the Lagoon of Venice, Italy, by inorganic pollutants (e.g., arsenic, cadmium, chromium, copper, lead, mercury, nickel, and zinc) and organic pollutants (e.g., polychlorobiphenyls), as well as the ecological and economical relevance of the edible clam Tapes philipinarum, an ecological risk assessment was undertaken to ascertain the extent of bioaccumulation that would pose a significant risk. Risk was estimated by means of toxic units and hazard quotient approaches, by comparing the exposure concentration with the effect concentration. Clam exposure was estimated by applying previous results based on bioaccumulation spatial regression models. In addition, a comparison was made between sum of dioxin-like polychlorinated biphenyl (PCB) congeners and total PCB bioaccumulation provided by spatial regression models and by a partitioning model. The effect concentrations were calculated as tissue screening concentrations, as the product of pollutant sediment quality criteria and the bioaccumulation factor. Finally, the cumulative risk posed by selected inorganic pollutants and total PCBs was estimated and a map of risk was drawn. The resulting chemicals of potential ecological concern were mercury, cadmium, arsenic, and nickel, as well as, to a lesser extent, total PCBs.

Effect of a contaminated site (the San Giuliano landfill, Venice, Italy) on the interaction between water bodies in a coastal aquifer system.

A complex multiple aquifer system affected by a contaminated site and exposed to tidal effects was investigated to develop the hydrogeological conceptual model of the study case. Two water bodies were identified, from top to down: a surface aquifer unaffected by tidal events, and a semiconfined aquifer partly communicating with the brackish lagoon waters. By using the Cl(-)/SO4(2-) ratio and the DOC (Dissolved Organic Carbon) concentration, as well as by applying the kriking to the piezometric levels results, the groundwater flow directions and the hydraulic gradients within the investigated aquifers were also identified. Based on the overall results, a schematic of the conceptual model for the whole aquifer system was provided which allows to visualize the communication between the different water bodies.

Characterization of contaminated soil and groundwater surrounding an illegal landfill (S. Giuliano, Venice, Italy) by principal component analysis and kriging.

The characterization of a hydrologically complex contaminated site bordering the lagoon of Venice (Italy) was undertaken by investigating soils and groundwaters affected by the chemical contaminants originated by the wastes dumped into an illegal landfill. Statistical tools such as principal components analysis and geostatistical techniques were applied to obtain the spatial distribution of chemical contaminants. Dissolved organic carbon (DOC), SO4(2-) and Cl- were used to trace the migration of the contaminants from the top soil to the underlying groundwaters. The chemical and hydrogeological available information was assembled to obtain the schematic of the conceptual model of the contaminated site capable to support the formulation of major exposure scenarios, which are also provided.