An introduction to Criteria for Reporting and Evaluating Exposure Datasets (CREED) for use in environmental assessments.

Risks posed by environmental exposure to chemicals are routinely assessed to inform activities ranging from environmental status reporting to authorization and registration of chemicals for commercial uses. Environmental risk assessment generally relies on two key values generated from exposure data and ecotoxicity data. Data sets of measured concentrations of chemicals in environmental matrices, referred to here as exposure data, are widely used to support environmental risk management, decision-making, and reporting, such as for chemical screening, ecological or human health risk assessments, and establishment of guidelines. Practitioners have developed schemes to determine the suitability of ecotoxicity data for specific purposes, focused on evaluating reliability and relevance, but analogous schemes are not available for exposure data. Moreover, regulatory guidance arguably provides less resolution on reporting and evaluating exposure data sets compared to ecotoxicity data. The evaluation of exposure data sets is subject to limitations from variable or unreported data quality objectives and/or from differences in expert judgments, potentially introducing bias and leading to decisions based on flawed and/or inconsistent information. Exposure data sets should be evaluated for reliability and relevance prior to use in environmental assessments. This paper is the first of a four-paper series detailing the outcomes of a Society of Environmental Toxicology and Chemistry technical workshop that has developed Criteria for Reporting and Evaluating Exposure Datasets (CREED). The workshop participants developed practical, systematic criteria for consistent and transparent evaluation of the reliability (quality) and relevance (fitness for purpose) of exposure data. This guidance should apply to many different (unspecified) purposes of assessment. CREED can be used to evaluate existing data sets, but can also inform data generators interested in improving their data collection and reporting to maximize data utility to other users. This first paper details existing frameworks for the evaluation of exposure data sets and demonstrates the need for CREED, drawing from different regulatory assessments, and describes the technical workshop. Integr Environ Assess Manag 2024;00:1-6. © 2024 SETAC.

Following the evidence and using the appropriate regulatory tools: A European-wide risk assessment of copper in freshwaters.

The ecological risks of copper (Cu) in freshwaters have been the focus of regulatory assessments for several decades. Recently, it has been suggested by the European Commission that Cu represents a continent-wide risk to freshwaters. We assessed to what extent this suggestion is supported by the available evidence if Cu bioavailability is considered in the assessment of risk. We used several evidence-driven metrics to assess the continental-wide risks of Cu to European freshwaters. Such an approach is recommended and readily applicable where comprehensive data sets are available. We confirmed the validity of a bioavailability-based Environmental Quality Standard of 1 µg L-1 for Cu and used this to characterize the risks of Cu in 286 185 regulatory monitoring samples from 17 307 sites across 19 European countries between 2006 and 2021. These data show that risks, based on site averages and accounting for bioavailability, were identified in only two countries (Spain and Portugal). Investigation of these risks showed them to be highly localized to a single region in Spain and not reflective of the country-wide risks for either country. The 95th percentile of all the risk quotients for the continent-wide data set is 0.35. The relatively low levels of risk associated with Cu are supported by long-term trend data from sites on two large European rivers (Rhine and Meuse), where highly significant (p < 0.001) decreases in Cu concentrations over the last 40 years can be observed. We conclude that it is critical to consider metal bioavailability in both effects and exposures in assessments of potential risk to ensure ecological relevance. Integr Environ Assess Manag 2023;19:1570-1580. © 2023 WCA Environment Ltd. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Updating the Chronic Freshwater Ecotoxicity Database and Biotic Ligand Model for Nickel for Regulatory Applications in Europe.

Bioavailability has been taken into account in the regulation of nickel in freshwater ecosystems in Europe for over a decade; during that time a significant amount of new information has become available covering both the sensitivity of aquatic organisms to nickel toxicity and bioavailability normalization. The ecotoxicity database for chronic nickel toxicity to freshwater organisms has been updated and now includes 358 individual data points covering a total of 53 different species, all of which are suitable for bioavailability normalization to different water chemistry conditions. The bioavailability normalization procedure has also been updated to include updates to the bioavailability models that enable more sensitive water chemistry conditions to be covered by the model predictions. The updated database and bioavailability normalization procedure are applicable to more than 95% of regulated European surface water conditions and have been used to calculate site-specific criteria for a variety of different water chemistry scenarios, to provide an indication of how the sensitivity to nickel varies between different water types. The hazardous concentration for 5% of a species (HC5) values for this diverse selection of water types range from 1.6 to 36 µg L-1 , clearly demonstrating the importance of accounting for nickel bioavailability in freshwaters. This updated database and bioavailability normalization procedure provide a robust basis for the derivation of regulatory thresholds for chronic nickel toxicity in freshwaters such as predicted no-effect concentrations and Environmental Quality Standards and are protective of the results of several mesocosm studies. Environ Toxicol Chem 2023;42:566-580. © 2023 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

Sources of copper into the European aquatic environment.

Chemical contamination from point source discharges in developed (resource-rich) countries has been widely regulated and studied for decades; however, diffuse sources are largely unregulated and widespread. In the European Union (EU), large dischargers report releases of some chemicals, yet little is known of total emissions (point and diffuse) and their relative significance. We estimated copper loadings from all significant sources including industry, sewage treatment plants, surface runoff (from traffic, architecture, and atmospheric deposition), septic tanks, agriculture, mariculture, marine transport (antifoulant leaching), and natural processes. A combination of European datasets, literature, and industry data were used to generate export coefficients. These were then multiplied by activity rates to derive loads. A total of approximately 8 kt of copper per annum (ktpa) is estimated to enter freshwaters in the EU, and another 3.5 ktpa enters transitional and coastal waters. The main inputs to freshwater are natural processes (3.7 ktpa), agriculture (1.8 ktpa), and runoff (1.8 ktpa). Agricultural emissions are dominated by copper-based plant protection products and farmyard manure. Urban runoff is influenced by copper use in architecture and by vehicle brake linings. Antifoulant leaching from boats (3.2 ktpa) dominates saline water loads of copper. It is noteworthy that most of the emissions originate in a limited number of copper uses where environmental exposure and pathways exist, compared with the bulk of copper use within electrical and electronic equipment and infrastructure that has no environmental pathway during its use. A sensitivity analysis indicated significant uncertainty in data from abandoned mines and urban runoff load estimates. This study provided for the first time a methodology and comprehensive metal load apportionment to European aquatic systems, identifying data gaps and uncertainties, which may be refined over time. Source apportionments using this methodology can inform more cost-effective environmental risk assessment and management. Integr Environ Assess Manag 2023;19:1031-1047. © 2022 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Assessing the Extent of Environmental Risks From Nickel in European Freshwaters: A Critical Reflection of the European Commission's Current Approach.

Nickel (Ni) has a been a Priority Substance under the European Water Framework Directive since 2008. As such it is deemed to present an European Union-wide risk to surface waters. Since 2013, the Ni Environmental Quality Standard (EQS) has been bioavailability-based, and new European Guidance supports accounting for bioavailability in assessing Ni compliance with the EQS. The European Commission has developed an approach to determine whether Priority Substances present a sufficient European Union-wide risk to justify an ongoing statutory monitoring programme, effectively to deselect a substance. This is a key step to ensure that finite monitoring resources are targeted at delivering environmental benefit, when there is an ever-growing burden of determinands to measure for all regulators. When the European Commission performed this exercise for Ni without accounting for bioavailability, they concluded that Ni should not be deselected, and Ni is an European Union-wide risk. Performing this same exercise with the same methodology, using regulatory monitoring data for over 300 000 samples, from more than 19 000 sites across Europe, and accounting for bioavailability, as detailed in the Directive, >99% of sites comply with the Ni EQS. Nickel shows very low risks for all of the criteria identified by the European Commission that need to be met for deselection. Accounting for bioavailability is key in the assessment of Ni risks in surface waters to deliver ecologically relevant outcomes. Environ Toxicol Chem 2022;41:1604-1612. © 2022 NiPERA. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

Development of a bioavailability-based risk assessment framework for nickel in Southeast Asia and Melanesia.

Nickel laterite ore deposits are becoming increasingly important sources of Ni for the global marketplace and are found mainly in tropical and subtropical regions, including Indonesia, the Philippines, Papua New Guinea, Cuba, and New Caledonia. There are few legislatively derived standards or guidelines for the protection of aquatic life for Ni in many of these tropical regions, and bioavailability-based environmental risk assessment (ERA) approaches for metals have mainly been developed and tested in temperate regions, such as the United States and Europe. This paper reports on a multi-institutional, 5-y testing program to evaluate Ni exposure, effects, and risk characterization in the Southeast Asia and Melanesia (SEAM) region, which includes New Caledonia, Papua New Guinea, the Philippines, and Indonesia. Further, we have developed an approach to determine if the individual components of classical ERA, including effects assessments, exposure assessments, and risk characterization methodologies (which include bioavailability normalization), are applicable in this region. A main conclusion of this research program is that although ecosystems and exposures may be different in tropical systems, ERA paradigms are constant. A large chronic ecotoxicity data set for Ni is now available for tropical species, and the data developed suggest that tropical ecosystems are not uniquely sensitive to Ni exposure; hence, scientific support exists for combining tropical and temperate data sets to develop tropical environmental quality standards (EQSs). The generic tropical database and tropical exposure scenarios generated can be used as a starting point to examine the unique biotic and abiotic characteristics of specific tropical ecosystems in the SEAM region. Integr Environ Assess Manag 2021;17:802-813. © 2021 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Empirical Bioavailability Corrections for Nickel in Freshwaters for Australia and New Zealand Water Quality Guideline Development.

Bioavailability-based approaches have been developed for the regulation of metals in freshwaters in several countries. Empirical multiple linear regression (MLR) models have been developed for nickel that can be applied to aquatic organisms. The MLR models have been compared against the use of previously developed biotic ligand models (BLMs) for the normalization of an ecotoxicity dataset compiled for the derivation of a water quality guideline value that could be applied in Australia and New Zealand. The MLR models were developed from data for a number of specific species and were validated independently to confirm their reliability. An MLR modeling approach using different models for algae, plants, invertebrates, and vertebrates performed better than either a pooled MLR model for all taxa or the BLMs, in terms of its ability to correctly predict the results of the tests in the ecotoxicity database based on their water chemistry and a fitted species-specific sensitivity parameter. The present study demonstrates that MLR approaches can be developed and validated to predict chronic nickel toxicity to freshwater ecosystems from existing datasets. The MLR approaches provide a viable alternative to the use of BLMs for taking account of nickel bioavailability in freshwaters for regulatory purposes. Environ Toxicol Chem 2021;40:113-126. © 2020 SETAC.

Application of Bioavailability Models to Derive Chronic Guideline Values for Nickel in Freshwaters of Australia and New Zealand.

There has been an increased emphasis on incorporating bioavailability-based approaches into freshwater guideline value derivations for metals in the Australian and New Zealand water quality guidelines. Four bioavailability models were compared: the existing European biotic ligand model (European Union BLM) and a softwater BLM, together with 2 newly developed multiple linear regressions (MLRs)-a trophic level-specific MLR and a pooled MLR. Each of the 4 models was used to normalize a nickel ecotoxicity dataset (combined tropical and temperate data) to an index condition of pH 7.5, 6 mg Ca/L, 4 mg Mg/L, (i.e., approximately 30 mg CaCO3 /L hardness), and 0.5 mg DOC/L. The trophic level-specific MLR outperformed the other 3 models, with 79% of the predicted 10% effect concentration (EC10) values within a factor of 2 of the observed EC10 values. All 4 models gave similar normalized species sensitivity distributions and similar estimates of protective concentrations (PCs). Based on the index condition water chemistry proposed as the basis of the national guideline value, a protective concentration for 95% of species (PC95) of 3 µg Ni/L was derived. This guideline value can be adjusted up and down to account for site-specific water chemistries. Predictions of PC95 values for 20 different typical water chemistries for Australia and New Zealand varied by >40-fold, which confirmed that correction for nickel bioavailability is critical for the derivation of site-specific guideline values. Environ Toxicol Chem 2021;40:100-112. © 2020 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

Deriving a bioavailability-based zinc environmental quality standard for France.

National Environmental Quality Standards (EQS) for zinc used for the assessment of ecological status in freshwaters have been shown to vary by over two orders of magnitude across 25 European countries. Such variability is unlikely to reflect consistent ecological protection or environmental relevance. Recent European technical guidance on EQS derivation gives an opportunity to derive protective metrics for zinc that are relevant to national water chemistry conditions. To derive a zinc EQS relevant to national water chemistry conditions and account for bioavailability, the new technical guidance requires high-quality spatial and temporal monitoring data. These data must be of water samples with concurrent measures of pH, dissolved organic carbon (DOC) and calcium, the parameters that most influence zinc bioavailability in freshwaters. A national bioavailability-based zinc EQS for France has been derived from Biotic Ligand Model calculations undertaken for freshwaters samples from 4645 sites (22,000 samples with concurrent measures of pH, DOC, calcium) in 96 regions. An EQS of 11.3 µg Zn L-1 was derived based on sensitive waters from the Bretagne region typically of circumneutral pH and relatively low DOC and low dissolved calcium. The least sensitive waters to zinc exposures in France are found in the Hauts-De-France, higher pH values than those in Bretagne, similar dissolved organic carbon and higher dissolved calcium. An indicative assessment of compliance showed that across France, 2% of the sites would exceed this bioavailability-based EQS.

Perspectives on Relevancy Assessment for Non-Standard Ecotoxicity Data in Environment Quality Standard derivation: Examples for Diclofenac.

A key step in deriving an Environmental Quality Standard (EQS) is assessing the reliability and relevance of the underpinning ecotoxicity data. While the assessment of data reliability is relatively well established, the detailed evaluation of data relevancy is a more recent development. We applied broadly accepted relevancy criteria to a series of non-standard ecotoxicity studies on diclofenac, focusing on some aspects that should be accounted for in studies used in EQS derivation. Specific relevancy issues include potential experimental bias, claimed 'significant effects' that are indistinguishable from controls, or within the range of normal, and lack of environmental applicability. We highlight that rigorous, comprehensive and, where necessary, specialist assessment of data relevancy for studies potentially applicable for EQS setting is critical if studies are to be appropriately used regulatory decision-making. We provide recommendations for researchers and environmental practitioners to ensure robust accounting of relevancy in non-standard studies is undertaken.

Demonstrating the Reliability of bio-met for Determining Compliance with Environmental Quality Standards for Metals in Europe.

The importance of considering the bioavailability of metals in understanding and assessing their toxicity in freshwaters has been recognized for many years. Currently, biotic ligand models (BLMs) are being applied for the derivation and implementation of environmental quality standards (EQS) for metals under the Water Framework Directive in Europe. bio-met is a simplified tool that was developed for implementing bioavailability-based EQS for metals in European freshwaters. We demonstrate the reliability of the relationship between the full BLM predictions and the thresholds (hazardous concentration affecting 5% of species [HC5] values) predicted by bio-met in 3 stages, for the metals copper, nickel, and zinc. First, ecotoxicity data for specific species from laboratory tests in natural waters are compared with predictions by the individual species BLMs included in the full BLMs. Second, the site-specific HC5 values predicted by bio-met for the natural waters used for ecotoxicity testing are compared with those provided by the full BLMs. The reliability of both relationships is demonstrated for all 3 metals, with more than 80% of individual species BLM predictions being within a factor of 3 of the experimental results, and 99% of bio-met local HC5 predictions being within a factor of 2 of the full BLM result. Third, using a larger set of European natural waters in addition demonstrates the reliability of bio-met over a broad range of water chemistry conditions. bio-met is therefore an appropriate tool for performing compliance assessments against EQS values in Europe, due to the demonstrated consistency with the toxicity test data. Environ Toxicol Chem 2020;39:2361-2377. © 2020 SETAC.

Best Practices for Derivation and Application of Thresholds for Metals Using Bioavailability-Based Approaches.

The primary goal of the present study is to provide a broad view of best practices for evaluating bioavailability models for metals for use in the protection of aquatic life. We describe the state of the science regarding 1) the evaluation and selection of ecotoxicity data, 2) the selection of bioavailability models for use in normalization, and 3) subsequent application of bioavailability models. Although many examples of normalization steps exist worldwide, a scheme is proposed to evaluate and select a model that takes account of its representativeness (water chemistry and taxonomic coverage of the ecotoxicity data set) and validation performance. Important considerations for a suitable model are the quantity of inputs needed, accuracy, and ease of use, all of which are needed to set protective values for aquatic life and to use these values to evaluate potential risks to organisms in receiving waters. Although the end results of different model application approaches may be broadly similar, the differences in these application frameworks ultimately come down to a series of trade-offs between who needs to collect the data and use the bioavailability model, the different requirements of spatial scales involved (e.g., regional vs site-specific values), and model predictiveness and protectiveness. Ultimately, understanding the limits and consequences of these trade-offs allows for selection of the most appropriate model and application framework to best provide the intended levels of aquatic life protection. Environ Toxicol Chem 2019;39:118-130. © 2019 SETAC.

Comparison of the Chronic Toxicity of Nickel to Temperate and Tropical Freshwater Species.

Reliable ecotoxicity data are required to derive thresholds protective for aquatic life that are scientifically defensible and practically implementable as environmental risk assessment and management tools. Much of the data that have been used to derive thresholds for environmental quality have been collected for temperate species. There are concerns that due to a lack of data for the different species present in tropical ecosystems, they may not be adequately protected by thresholds derived from temperate species. In the present study, chronic ecotoxicity data for nickel and freshwater species from different climatic regions have been collated. Comparisons were performed between tropical and temperate datasets on the basis of the threshold values and overall distributions of the ecotoxicity data, as well as between groups of species and closely related species from different climatic regions. The analysis indicated that the sensitivities of tropical and temperate species cover similar ranges. An approach based on the inclusion of as diverse a range of taxa as possible is recommended to ensure the protection of sensitive species in both temperate and tropical ecosystems. Environ Toxicol Chem 2019;38:1211-1220. © 2019 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC.

Assessing Compliance of European Fresh Waters for Copper: Accounting for Bioavailability.

This study determines the levels of compliance of European fresh waters with a bioavailability-based copper Environmental Quality Standard (EQS). A tiered approach for compliance assessment is used at which the first tier compares the dissolved metal concentration to a threshold, estimated using either regional or continental water chemistry data. At the second tier, the bioavailable metal concentration is calculated using the chemistry of the water body, and compared to the EQSbioavailable for copper. The thresholds at Tier 1 must be set at a level to ensure adequate protection of sensitive environments and to ensure efficient use of regulatory resources. Compliance of 99.3% is observed where bioavailability-based thresholds are used for the implementation derived from regionally relevant water chemistry data. Sites where elevated ambient background levels of copper are combined with high bioavailability (waters with low dissolved organic carbon) are those most likely to be at risk from copper exposures.

Validation of the nickel biotic ligand model for locally relevant species in Australian freshwaters.

Australian freshwaters have relatively low water hardness and different calcium (Ca) to magnesium (Mg) ratios compared with those in Europe. The hardness values of a substantial proportion of Australian freshwaters fall below the application boundary of the existing European nickel biotic ligand models (Ni BLMs) of 2 mg Ca/L. Toxicity testing was undertaken using Hydra viridissima to assess the predictive ability of the existing Ni BLM for this species in extremely soft waters. This testing revealed an increased competitive effect of Ca and Mg with Ni for binding to the biotic ligand in soft water (<10 mg CaCO3 /L) than at higher water hardness. Modifications were made to the Ni BLM by increasing the binding constants for Ca and Mg at the biotic ligand to account for softer waters encountered in Australia and the more important competitive effect of Ca and Mg on Ni toxicity. To validate the modified Ni BLM, ecotoxicity testing was performed on 5 Australian test species in 5 different natural Australian waters. Overall, no single water chemistry parameter was able to indicate the trends in toxicity to all of the test species. The modified Ni BLMs were able to predict the toxicity of Ni to the test species in the validation studies in natural waters better than the existing Ni BLMs. The present study suggests that the overarching mechanisms defining Ni bioavailability to freshwater species are globally similar and that Ni BLMs can be used in all freshwater systems with minor modifications. Environ Toxicol Chem 2018;37:2566-2574. © 2018 SETAC.