Environmental Risk Assessment Framework Research Articles

Progress in the environmental risk assessment of plant protection products in Brazil: An overview of birds and mammals and soil organisms proposals.

Since 2019, the Brazilian Institute of Environment and Renewable Natural Resources (IBAMA) has actively developed pesticide environmental risk assessment (ERA) frameworks adapted to Brazil's specific ecological contexts. This initiative, supported by funding from the Brazilian Ministry of Justice and in partnership with academic institutions, has led to a concerted effort to establish ERA protocols for various taxa, including birds and mammals, soil organisms, aquatic organisms, and reptiles and amphibians. The outcomes of this initiative were disseminated in two distinct workshops held in February and November of 2023, where the agency showcased its research to the technical-regulatory community. This article synthesizes the proposals for birds and mammals and soil organisms. First, we summarize the agency's proposals for both focal and generic species to be incorporated into the ERA and the methodologies for calculating exposure of these taxa to pesticides through agricultural practices, encompassing seed treatment and foliar applications. On this occasion, IBAMA also disclosed the risk assessment tool that the agency is developing for birds and mammals. IBAMA highlighted the knowledge gaps that must be bridged to progress from preliminary (lower-tier) to more comprehensive (higher-tier) assessments. Regarding soil organisms, during the workshop, the presenters shared findings on the most prevalent species of earthworms and enchytraeids in Brazil. They emphasized the need for additional data collection on a regional scale. The agency has also proposed methods for estimating soil organism exposure to pesticides at a screening level and identified specific data gaps that could be addressed to refine assessments at higher tiers. In summary, the workshop communicated the progress in establishing ERA guidelines, which we encapsulate here to benefit the technical-regulatory community. © 2024 The Author(s). Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Applying a tiered environmental risk assessment framework to estimate the risk of pesticides to soil organisms in Latin America.

This work investigates the application of a tiered risk assessment scheme for soil organisms based on the risk quotient (RQ) and the toxicity exposure ratio (TER). Forty-five pesticides registered in Latin America were chosen and the ecotoxicological endpoints for earthworms, Collembola, and microorganisms were collated. Tier I assessment was made on conservative assumptions in which no refinements were applied. There, 14 pesticides (31%) exceed the RQ regulatory trigger indicating unacceptable risk, whereas 27 (60%) indicate unacceptable risk on the TER approach. In a Tier II evaluation when refinement options such as foliar interception, field half-life, and the dissipation following the peak estimated environmental concentration are considered, eight (18%) pesticides indicate unacceptable risk based on the RQ, and 15 (33%) indicate unacceptable risk based on the TER. A nonmetric multidimensional scaling evaluation was performed to understand the relevant characteristics involved in how each pesticide poses a risk to soil organisms. Based on the outcome of this analysis, we observed that, for a given pesticide, the combination of high persistence, low or no crop interception, and high toxicity are likely to require higher tier risk assessment. Refinement options can consider either or both the exposure and/or the effect side of the framework. Exposure refinements are potentially simpler and can be conducted with data already available to risk assessors, whereas effect refinements involving further testing with the organisms potentially at risk are still under discussion for intermediate and higher tiers. A sensitive, simple, and logical environmental risk assessment framework can be used to adequately identify risks based on the relevant protection goals that, in turn, will help to protect the desired soil multifunctionality of the ecosystem. We encourage academia and industry to further investigate these topics to provide the most scientifically robust and evidence-based information to decision makers. Integr Environ Assess Manag 2023;19:446-460. © 2022 SETAC.

Towards ‘one substance-one assessment’: an analysis of European chemical registration and environmental risk assessment frameworks

BACKGROUND AND AIM The registration and risk assessment of chemicals on the European market is currently fragmented across different legal frameworks, dependent on the chemical's use. A ‘one-substance one-assessment’ (OS-OA) approach has been proposed in order to better protect human and environmental health, and increase harmonisation and consistency across these different legal frameworks. We reviewed the five main European chemical registration frameworks and their risk assessment procedures for the freshwater environment, covering 1) medicines for human use, 2) veterinary medicines, 3) pesticides, 4) biocides and 5) industrial chemicals in order to provide an understanding of the differences between these chemical legislations and analyse how a shift towards an OS-OA approach might be realised. RESULTS Overall, the function of the current frameworks is similar, but important differences exist between the frameworks' environmental protection goals and risk assessment strategies. These differences result in inconsistent assessment outcomes for similar chemicals. Chemicals are also registered under multiple frameworks due to their multiple uses, and chemicals that are not approved under one framework are in some instances allowed on the market under other frameworks. In contrast, an OS-OA will require a uniform hazard assessment between all different frameworks. In addition, we show that industrial chemicals are the least hazardous for the freshwater environment, whilst biocides seem the most toxic following current regulatory assessment schemes. Finally, in order to facilitate a successful move towards an OS-OA approach we recommend a) harmonisation of protection goals and risk assessment strategies, b) that emission, use and production data should be made publicly available and that data sharing becomes a priority, and c) an alignment of the criteria used to classify problematic substances. KEYWORDS EU chemical legislation, Regulatory risk assessment, Water pollution, Environmental risk assessment

Building a European Partnership for next generation, systems‐based Environmental Risk Assessment (PERA)

The European Partnership for next generation, systems-based Environmental Risk Assessment (PERA) is a strategic initiative launched by the European Food Safety Authority (EFSA). This initiative is in response to the recognition that the current ERA paradigm has “fallen out of step with scientific knowledge and progress” and the new policy and societal ambitions e.g. the EU Green Deal strategy to better safeguard the environment. As part of the initiative, EFSA commissioned the development of a roadmap to facilitate a transition to an integrated and cross-sectoral environmental risk assessment (ERA) approach. The PERA systems-based approach aims to connect relevant partners from various sectors across regulatory silos, promotes and facilitates the sharing of data and expertise, and improves efficiency and transparency of the risk assessment process. In this External Scientific Report, we present the PERA roadmap that comprises of a problem description (current state), a vision (future state) and a series of steps to move towards the vision (transition process). The PERA roadmap was developed after extensive desk research and multiple stakeholder interviews, that were used to identify partners, areas needing further development, challenges, blockers and collaboration opportunities. We designed a vision for next generation ERAs, initially focused on pesticides, based on the ideas of stakeholders and accounting for the identified strengths and weaknesses of the current ERA system. Workshops were held during which stakeholders were invited to comment on these draft concepts providing valuable feedback for further revision. The PERA vision is a visual framework for systems-based ERA, with a concentric circle model. Its core circle builds upon and strengthens current ERA processes by focusing on pesticide specific aspects useful for comparability and decreasing the assessment complexity of pesticides. The inner core circle is surrounded by a supportive circle of landscape scale ERA, that addresses ecosystems properties of generic relevance for all pesticides. These two ERA circles are in turn connected to surrounding circles representing the agricultural, ecological and production systems as well as the political, economic and social systems. To fully optimize the process these circles need to be interconnected with information feed-back loops. The vision and roadmap were designed to incorporate the strengths, knowledge and expertise of the current state into a new holistically framed systems-based ERA. Strategies for transition, as well as concrete projects to spark the transition process are proposed and include concrete and tangible steps in a holistic direction within the current regulatory framework.

A generic environmental risk assessment framework for deep-sea tailings placement

Deep-sea tailings placement (DSTP) involves the oceanic discharge of tailings at depth (usually >100 m), with the intent of ultimate deposition of tailings solids on the deep-sea bed (>1000 m), well below the euphotic zone. DSTP discharges consist of a slurry of mine tailings solids (finely crushed rock) and residual process liquor containing low concentrations of metals, metalloids, flotation agents and flocculants. This slurry can potentially affect both pelagic and benthic biota inhabiting coastal waters, the continental slope and the deep-sea bed. Building on a conceptual model of DSTP exposure pathways and receptors, we developed a stressor-driven environmental risk assessment (ERA) framework using causal pathways/causal networks for each of eight pelagic and benthic impact zones. For the risk characterisation, each link in each causal pathway in each zone was scored using four levels of likelihood (not possible, possible, likely and certain) and two levels of consequence (not material, material) to give final risk rankings of low, potential, high or very high risk. Of the 246 individual causal pathways scored, 11 and 18 pathways were considered to be of very high risk and high risk respectively. These were confined to the benthic zones in the mixing zone (continental slope) and the primary and secondary deposition zones. The new risk framework was then tested using a case study of the Batu Hijau copper mine in Indonesia, the largest DSTP operation globally. The major risk of DSTP is smothering of benthic biota, even outside the predicted deposition zones. Timescales for recovery are slow and may lead to different communities than those that existed prior to tailings deposition. We make several recommendations for monitoring programs for existing, proposed and legacy DSTP operations and illustrate how georeferenced causal networks are valuable tools for ERA in DSTP.

Specificity within bird–parasite–parasitoid food webs: A novel approach for evaluating potential biological control agents of the avian vampire fly

Abstract Quantitative food web analyses can provide insights into the specificity of consumers such as herbivores, parasites and parasitoids. Understanding such patterns can be useful in forecasting the potential benefits and risks of biological control agents being considered for introduction against invasive species. The avian vampire fly, Philornis downsi (Diptera: Muscidae), is a neotropical bird parasite that is invasive in the Galapagos Islands, where it is causing substantial mortality of endemic bird species. We used a novel in‐field experimental food web approach within the native range of P. downsi in Ecuador to test the hypotheses that pupal parasitoids known to attack P. downsi specialize on members of the genus Philornis, which occur only in bird nests. We deployed pupae of non‐Philornis fly species adjacent to bird nests to assess specificity of the parasitoids and used two indices to assess specificity: Resource Range (RR), which evaluates the breadth of host use, and Pair Difference Index (PDI), which evaluates interaction strength. The results revealed very strong compartmentalization within the guild of pupal fly parasitoids, with four species attacking only Philornis spp. Both specificity indices indicated significant levels of specificity towards the genus Philornis for two of these species: Conura annulifera and Trichopria sp. novus. We also assessed the specificity of the two dominant Philornis species attacking 11 bird species and preference of the two dominant parasitoid species for bird species. Although there was some significant preference for particular bird species by the Philornis spp., there was no indication that this drove specificity patterns by the parasitoids. Policy implications. Our results confirm previous laboratory studies indicating specificity by C. annulifera and support the hypothesis that this species would produce few, if any, nontarget impacts if released into Galapagos to suppress populations of the P. downsi. These results can inform an environmental risk assessment framework to guide governmental agencies in deliberation on potential field releases of parasitoids in the Galapagos Islands.

An integrated environmental risk assessment framework for coal-fired power plants: A fuzzy logic approach.

This study quantifies the environmental risk of a coal-fired thermal power plant during operation by using environmental monitoring data, site surveys, and documented evidence. The following criteria are assessed: emissions (CO, SO2 , NOx , PM10 ), impact on aquatic ecosystem (fish protection at cooling water intake and cooling water discharge temperature), and waste management (fly ash and bottom ash). Fuzzy sets were defined for each criterion, taking environmental regulatory context as an expert judgment. A survey was conducted with multiple stakeholders to determine the relative importance of risk factors. The survey results showed that the most concerned risks are SO2 and NOx emissions. The proposed method estimates the risk of each environmental criterion separately and then accumulates them into an environmental risk index (ERI). Accordingly, we assessed the Catalagzi coal-fired power plant, which has been in operation on the Black Sea coast in northwestern Turkey. For this case study, the ERI resulted in a value of 0.78 (on a scale of 0-1), showing high environmental risk to the facility. Moreover, the applicability of the proposed framework was tested in several existing coal-fired power plants using simultaneous measurements. All studied coal-fired power plants in Turkey have unacceptable pollutants (PM10 , SO2 , and NOx ) concentration levels indicating high health risk potential. The application of the integrated environmental risk assessment framework showed that new environmental regulations are needed in Turkey to specify more strict emission limits and to monitor CO2 , fine particulate matter emissions, cooling water discharge, and fish protection at cooling water intake.

Environmental quality assessment in a marine coastal area impacted by mining tailing using a geochemical multi-index and physical approach

Mining has been described as an important source of contaminants to the coastal zone worldwide, which is greatly intensified in the case of tailing dam ruptures. This study assessed the environmental quality of the marine coastal area impacted by a mining disaster (Fundão Mine dam collapse on 05 November 2015, Southeast Brazil) by applying a geochemical multi-index and physical approach over 18 months (from October 2018 to March 2020). Nutrients, metal(oid)s and Polycyclic Aromatic Hydrocarbons (PAHs) were integrated by quality indexes: Canadian Council of Ministers of the Environment Water Quality Index (CWQI) and the Pollution Load Index (PLI) for water quality; Sediment Quality Guideline Quotients (SQG-q metal(oid)s and SQG-q PAHs) for sediment quality. Three scenarios regarding river discharge and wave-heights (Hs) were considered: 2018/2019-wet, 2019-dry, 2019/2020-wet. An Environmental Risk Assessment framework was built to describe the overall environmental quality in regards to water and sediment quality indexes as well as physical conditions. Here we show that the worsening of environmental quality is highly associated with the decrease of water quality by metal(oid)s (total forms of As and Ni; dissolved forms of Co and Fe) during the 2019-dry scenario when river discharge was at the lowest and the highest Hs occurred. Resuspension of fine sediment and suspended Fe(III) oxy-hydroxide nanoparticles by waves seem to be the main processes for releasing metal(oid)s into the water column. CWQI and PLI showed marginal and polluted conditions for water quality, respectively, and SQG-q for metals and PAHs indicated moderate impact in the sediment during the 2019-dry period. Toxicity to pelagic and benthic fauna is expected to occur in those conditions. Recovery of environmental quality occurred during the 2019/2020-wet scenario, which could be explained by alongshore and offshore transport of sediment and the dilution of aqueous metal(oid)s by intense river discharge on the continental shelf.

Occurrence of antibiotic resistome in farmland soils near phosphorus chemical industrial area

Heavy metal pollution of soil surrounding phosphorus chemical industry has been a long-concerned problem; however, the occurrence of antibiotic resistance genes (ARGs) in farmland soils in its vicinity remains unexplored. In this study, variations of heavy metals, ARGs, mobile genetic elements (MGEs), and microbiome in surface soils of farmland along the prevailing downwind direction of a phosphorus chemical industrial zone were investigated. Cadmium (Cd) contents in soils close to the industrial zone (≤ 500 m away) were statistically higher than those at greater distances (1000 to 4000 m). A comparable ARG diversity was observed across soils, while the relative abundance of ARGs decreased markedly with increasing distance in the range of 1000 m. The soil in closest proximity to the industrial zone (20 m away) exhibited divergent compositions of ARGs, MGEs, and bacterial community from the other soils at farther locations (500 to 4000 m away). Variation partitioning analysis revealed that Cd and MGEs levels were the primary factors controlling ARG distribution. Structural equation modeling further indicated that the direct effect of Cd on ARG abundance was stronger than its indirect effect via affecting MGEs and microbiome. The observed prevalence of ARGs in farmland soils highlights the necessity of including resistome in the framework for environmental risk assessment of phosphorus chemical manufacturing.

Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU.

An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants.

An environmental risk assessment framework for enhanced oil recovery solutions from offshore oil and gas industry

Environmental risk assessments are necessary to understand the risk associated with enhanced oil recovery (EOR) solutions and to provide decision support for choosing the best technology and implementing risk-reducing measures. This study presents a review of potentially relevant environmental/ecological risk assessment (ERA) guidelines and, based on this review, proposes an initial suggestion of an ERA framework for understanding the environmental impacts from EOR solutions. We first shortlist the important elements necessary for conducting an ERA of EOR solutions from the selected guidelines. These elements are then used to build the suggested ERA framework for produced water discharges, drilling discharges and emissions to air from EOR solutions, which is the primary objective of the present study. Furthermore, the emphasis is placed on identifying the knowledge gaps that exist for conducting ERA of EOR processes. In order to link the framework with the current best environmental practices, a review of environmental policies applicable to the marine environment around the European Union (EU) was conducted. Finally, some major challenges in the application of ERA methods for novel EOR technologies, i.e. uncertainties in the ERA due to lack of data and aggregation of risk from different environmental impacts, are discussed in detail. The frameworks suggested in this study should be possible to use by relevant stakeholders to assess environmental risk from enhanced oil recovery solutions.

Economic optimization from fleets of aero-derivative gas turbines utilising flared associated gas

Abstract Associated gas is been wasted to flaring in some parts of the world. The use of these flared gases for both industrial and economic purposes would be very beneficial. This paper presents the development of a model for optimizing the economic return of fleets of gas turbines utilizing flared associated gas. The paper further analyzed the impact of gas turbine degradation on the optimized divestment times of the redundant engines and the economic use of associated gas. Hypothetical but realistic gas turbines were modeled using the Cranfield University performance simulation tool, TURBOMATCH. In furtherance with the investigation, the Techno-Economic and Environmental Risk Assessment (TERA) framework has been adopted for a broad and multi-dimensional optimization of the economic return from the fleets. The results were employed in three degradation scenarios (optimistic, medium, and pessimistic) within the TERA framework to generate economic models. Genetic Algorithm (GA) in MATLAB was used in carrying out optimization to maximize the economic benefit. The result showed that an increase of 1.0% and 1.6% in the energy and net present value (NPV) respectively of the optimized clean fleet as against the baseline were achieved. The economic performance of the fleets shows the optimized fleet (clean) having the highest NPV of $2.84 b and the pessimistic degraded fleet having the least NPV of $2.39 b. More results revealed that degradation reduced the NPV of the project by 4.0%,9.1%, and 15.8% for the three different degradation scenarios. This paper has proposed a model that can be used for the profitable economic utilization of associated gas which would be useful to gas turbine operators and investors.

Application of a standard risk assessment scheme to a North Africa contaminated site (Sfax, Tunisia) -Tier 1

Phosphorus is a critical element to agriculture, consequently global phosphate rock demand will remain rising to feed a growing world population. The beneficiation of phosphorous ore gives rise to several tons of a waste by-product [phosphogypsum (PG)] which valorisation is limited, within other reasons, by the risks posed to environment and human health. Although threatening, the accumulation in stacks is the only procedure so far practiced by several countries as a means to get rid of this industrial externality. As part of a NATO Science for Peace Project (SfP 983311) this study describes the application of an environmental risk assessment (ERA) framework, to assess the risks posed by a PG stack to the surrounding soils, in Sfax, Republic of Tunisia. The ERA followed a weight of evidence approach, supported by two lines of evidence (LoE): the chemical (ChemLoE) and the ecotoxicological (EcotoxLoE). Integrated risks point for risk values greater than 0.5 in soils collected in PG stack surrounding area. Soil salinization, has likely contributed to the exacerbation of risks, as well as to the lack of consistency between both LoEs. This study highlights the need of rethinking the weight given to each LoE in ERA, in areas where soil salinization is a reality.

A Mystery Tale: Nickel Is Fickle When Snails Fail-Investigating the Variability in Ni Toxicity to the Great Pond Snail.

Dissolved Ni concentrations inhibiting the growth of juvenile great pond snails (Lymnaea stagnalis) have been documented to vary from about 1 to 200 µg L-1 Ni. This variability makes L. stagnalis either a moderately sensitive or the most sensitive freshwater species to chronic Ni exposure tested to date. Given the role of sensitive species in environmental risk assessment frameworks, it is particularly important to understand this variability, i.e., to characterize the factors that modulate Ni toxicity and that may confound toxicity test outcomes when uncontrolled. In the present study, we tested if this variability was due to analytical (growth calculation: biomass versus growth rate), environmental (water quality), lab-specific practices, and/or snail population differences among earlier studies. Specifically, we reanalyzed previously published Ni toxicity data and conducted additional measurements of Ni aqueous speciation, short-term Ni uptake, and chronic Ni toxicity with test waters and snail cultures used in previous studies. Corrections for Ni bioavailability and growth calculations explained a large degree of variability in the published literature. However, a residual 16-fold difference remained puzzling between 2 studies: Niyogi et al. (2014) (low ECxs) and Crémazy et al. (2018) (high ECxs). Indeed, differences in metal bioavailability due to water chemistry, lab-specific practices, and snail population sensitivity could not explain the large variation in Ni toxicity in these 2 very similar studies. Other potentially important toxicity-modifying factors were not directly evaluated in the present work: test duration, diet, snail holding conditions, and snail age at onset of testing. The present analysis highlights the need for further studies to elucidate 1) the mechanisms of growth inhibition in Ni-exposed L. stagnalis and 2) the important abiotic and biotic factors affecting this biological response. Until these processes are understood, substantial uncertainties will remain about inclusion of this species in Ni environmental risk assessment. Integr Environ Assess Manag 2020;16:983-997. © 2020 SETAC.

Key principles and operational practices for improved nanotechnology environmental exposure assessment.

Nanotechnology is identified as a key enabling technology due to its potential to contribute to economic growth and societal well-being across industrial sectors. Sustainable nanotechnology requires a scientifically based and proportionate risk governance structure to support innovation, including a robust framework for environmental risk assessment (ERA) that ideally builds on methods established for conventional chemicals to ensure alignment and avoid duplication. Exposure assessment developed as a tiered approach is equally beneficial to nano-specific ERA as for other classes of chemicals. Here we present the developing knowledge, practical considerations and key principles need to support exposure assessment for engineered nanomaterials for regulatory and research applications.

In vitro toxicity of isolated strains and cyanobacterial bloom biomasses over Paramecium caudatum (ciliophora): Lessons from a non-metazoan model organism

Cyanobacteria have been considered a major global threat because of their widespread ability to proliferate and contaminate inland and marine waters with toxic metabolites. For this reason, to avoid risks to humans and environmental health, regulatory legislation and guidelines have been established based on extensive toxicological data. However, most of what is known in this field come from works on microcystin (MC) variants, which effects were almost exclusively tested in metazoan models. In this work, we used acute end-point toxicological assays and high-resolution hybrid quadrupole time-of-flight mass spectrometer coupled with electrospray ionization source (ESI-Q-TOF-MS) analyses to evaluate the deleterious impact of aqueous extracts prepared from cultures of cyanobacteria and environmental bloom biomasses over a non-metazoan model organism, the cosmopolitan fresh/brackish water unicellular microeukaryote, Paramecium caudatum (Ciliophora). Our data suggest that all extracts produced time-dependent effects on P. caudatum survival, irrespective of their metabolite profile; and that this ciliate is more sensitive to extracts containing microginins than to extracts with only MCs, stressing that more toxicological investigations should be performed on the environmental impact of neglected cyanotoxins. Further, our data provide evidence that P. caudatum may be more sensitive to cyanotoxins than vertebrates, indicating that guidelines values, set on metazoans are likely to be inaccurate to protect organisms from basal food web positions. Thus, we highly recommend the widespread use of microeukaryotes, such as ciliates in environmental risk assessment frameworks for the establishment of more reliable cyanotoxin monitoring guideline values.

Prospects for incorporation of epigenetic biomarkers in human health and environmental risk assessment of chemicals.

Epigenetic mechanisms have gained relevance in human health and environmental studies, due to their pivotal role in disease, gene × environment interactions and adaptation to environmental change and/or contamination. Epigenetic mechanisms are highly responsive to external stimuli and a wide range of chemicals has been shown to determine specific epigenetic patterns in several organisms. Furthermore, the mitotic/meiotic inheritance of such epigenetic marks as well as the resulting changes in gene expression and cell/organismal phenotypes has now been demonstrated. Therefore, epigenetic signatures are interesting candidates for linking environmental exposures to disease as well as informing on past exposures to stressors. Accordingly, epigenetic biomarkers could be useful tools in both prospective and retrospective risk assessment but epigenetic endpoints are currently not yet incorporated into risk assessments. Achieving a better understanding on this apparent impasse, as well as identifying routes to promote the application of epigenetic biomarkers within environmental risk assessment frameworks are the objectives of this review. We first compile evidence from human health studies supporting the use of epigenetic exposure-associated changes as reliable biomarkers of exposure. Then, specifically focusing on environmental science, we examine the potential and challenges of developing epigenetic biomarkers for environmental fields, and discuss useful organisms and appropriate sequencing techniques to foster their development in this context. Finally, we discuss the practical incorporation of epigenetic biomarkers in the environmental risk assessment of chemicals, highlighting critical data gaps and making key recommendations for future research within a regulatory context.

Environmental risk assessment of propranolol in the groundwater bodies of Europe

A growing concern for contamination due to pharmaceutical compounds in groundwater is expanding globally. The β-blocker propranolol is a β-adrenoceptors antagonist commonly detected in European groundwater bodies. The effect of propranolol on stygobiotic species (obligate groundwater dweller species) is compelling in the framework of environmental risk assessment (ERA) of groundwater ecosystems. In fact, in Europe, ERA procedures for pharmaceuticals in groundwater are based on data obtained with surrogate surface water species. The use of surrogates has aroused some concern in the scientific arena since the first ERA guideline for groundwater was issued. We performed an ecotoxicological and a behavioural experiment with the stygobiotic crustacean species Diacyclops belgicus (Copepopda) to estimate a realistic value of the Predicted No Effect Concentration (PNEC) of propranolol for groundwater ecosystems and we compared this value with the PNEC estimated based on EU ERA procedures. The results of this study showed that i) presently, propranolol does not pose a risk to groundwater bodies in Europe at the concentrations shown in this study and ii) the PNEC of propranolol estimated through the EU ERA procedures is very conservative and allows to adequately protect these delicate ecosystems and their dwelling fauna. The methodological approach and the results of this study represent a first contribution to the improvement of ERA of groundwater ecosystems.

Toward the Development and Application of an Environmental Risk Assessment Framework for Microplastic.

Emissions of plastic waste to the environment and the subsequent degradation into microplastic particles that have the potential to interact with biological organisms represent a concern for global society. Current understanding of the potential impacts on aquatic and terrestrial population stability and ecosystem structure and function associated with emissions of microplastic particles is limited and insufficient to fully assess environmental risks. Multistakeholder discussions can provide an important element in helping to identify and prioritize key knowledge gaps in assessing potential risks. In the present review, we summarize multistakeholder discussions from a 1‐d International Council of Chemical Associations–sponsored symposium, which involved 39 scientists from 8 countries with representatives from academia, industry, and government. Participants were asked to consider the following: discuss the scientific merits and limitations of applying a proposed conceptual environmental risk assessment (ERA) framework for microplastic particles and identify and prioritize major research needs in applying ERA tools for microplastic particles. Multistakeholder consensus was obtained with respect to the interpretation of the current state of the science related to effects and exposure to microplastic particles, which implies that it is unlikely that the presence of microplastic in the environment currently represents a risk. However, the quality and quantity of existing data require substantial improvement before conclusions regarding the potential risks and impacts of microplastic particles can be fully assessed. Research that directly addresses the development and application of methods that strengthen the quality of data should thus be given the highest priority. Activities aimed at supporting the development of and access to standardized reference material were identified as a key research need. Environ Toxicol Chem 2019;38:2087–2100. © 2019 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC.

Development of environmental risk assessment framework and methodology for consumer product chemicals in China.

Environmental risk assessment (ERA) methodologies for consumer product chemicals are well established in most developed regions including the United States, Canada, and the European Union. However, such methodologies are not yet fully developed for emerging economies, such as China. The objective of the present study was to develop an ERA framework involving an exposure methodology using conditions specific to China (i.e., physical setting, infrastructure, and consumers' habits and practice). Incorporated in this newly developed ERA framework for assessing consumer product chemicals were China's current regulatory screening and prioritization schemes as part of a tiered risk assessment approach. The framework started with tier 0, which utilized the existing Chinese regulatory qualitative method; tiers 1 and 2 were quantitative, and used deterministic and probabilistic methods that accounted for per capita residential water usage, wastewater treatment capability, and wastewater/in-stream dilution factors. Due to major differences in wastewater treatment infrastructure and water usage between urban versus rural regions in China, 2 scenarios were identified for quantitatively assessing environmental exposure: 1) urban with wastewater treatment, and 2) rural without wastewater treatment (i.e., direct discharge of wastewater). Our study presents the methodology of the framework with its technical rationale and the companion model Chera, and also provides an overview of the current status of ERA research in China. Environ Toxicol Chem 2019;38:250-261. © 2018 SETAC.