Are standard aquatic test species and methods adequate surrogates for use in environmental risk assessment of pesticides in tropical environments?

In regulatory risk assessment, surrogate species of fish, aquatic invertebrates, and primary producers are tested to assess toxicity and subsequently the risk of pesticides to freshwater biota. This study evaluates whether the standard, surrogate test species (mostly temperate in latitudinal distribution) used in many parts of the world are suitable surrogates for first-tier risk assessments involving tropical freshwater biota. Data for the toxicity of pesticides to tropical fish, invertebrates, and primary producer species were extracted from the USEPA ECOTOX database and peer-reviewed literature. For each pesticide, the most sensitive regulatory endpoint extracted from the US Environmental Protection Agency (USEPA) and European Food Safety Authority (EFSA) dossiers for freshwater fish, invertebrates, and primary producers was selected. The ratios of the endpoint for tropical species and for the most sensitive regulatory endpoint for the appropriate taxonomic group were determined. A value >1 indicates that the tropical species is less sensitive than the respective standard regulatory species. Tropical fish species were less sensitive than standard fish species in 84% of the comparisons, and in 93.5% of the comparisons, tropical fish were less or similarly sensitive (within a factor of 5). For aquatic invertebrates, 78.1% of the evaluated tropical species were less sensitive than standard species and 93.3% of tropical invertebrates species were less or similarly sensitive. For primary producers, 96% of tropical species were less sensitive than standard test species. Overall, standard species used globally were more sensitive or similarly sensitive compared to tropical species in more than 93% of the cases. In conclusion, the data show that freshwater toxicity data for pesticides from tests using standard test species, tested according to international accepted guidelines, are appropriate for use in first-tier risk assessments for tropical environments. Integr Environ Assess Manag 2023;19:202-212. © 2022 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

A pulsed-dose study evaluating chronic toxicity of chlorothalonil to fish: A case study for environmental risk assessment.

Chlorothalonil is a fungicide which is highly toxic to aquatic organisms. However, in natural aquatic environments, it is very rapidly degraded, with a half-life typically in hours, reducing exposure of aquatic organisms and the potential for effects. In standard regulatory studies looking at the chronic toxicity of chlorothalonil to fathead minnow, the most sensitive endpoint was fecundity. A standard fish full-life cycle study, where chlorothalonil concentrations were maintained constant throughout, resulted in a no-observed-effect concentration (NOEC) of 1.4 µg/L. Comparing peak modeled exposure concentrations to this NOEC can result in the chronic risk to fish being considered unacceptable. The present study investigated the effect on fecundity in fathead minnow using a fish short-term reproduction assay. Five different exposure profiles were employed with time-varying concentrations based on realistic worst-case modeled environmental exposure profiles, multiplied by an assessment factor of 10, which resulted in maximum measured concentrations up to 15.5 µg/L. There were no effects on fecundity from any of the exposure profiles tested. Therefore, based on these more realistic exposure profiles, the chronic risk to fish could be considered acceptable if these exposures were deemed to be representative of the worst case. Environ Toxicol Chem 2019;38:1549-1559. © 2019 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC.

Risk assessment considerations for plant protection products and terrestrial life-stages of amphibians.

Some amphibians occur in agricultural landscapes during certain periods of their life cycle and consequently might be exposed to plant protection products (PPPs). While the sensitivity of aquatic life-stages is considered to be covered by the standard assessment for aquatic organisms (especially fish), the situation is less clear for terrestrial amphibian life-stages. In this paper, considerations are presented on how a risk assessment for PPPs and terrestrial life-stages of amphibians could be conducted. It discusses available information concerning the toxicity of PPPs to terrestrial amphibians, and their potential exposure to PPPs in consideration of aspects of amphibian biology. The emphasis is on avoiding additional vertebrate testing as much as possible by using exposure-driven approaches and by making use of existing vertebrate toxicity data, where appropriate. Options for toxicity testing and risk assessment are presented in a flowchart as a tiered approach, progressing from a non-testing approach, to simple worst-case laboratory testing, to extended laboratory testing, to semi-field enclosure tests and ultimately to full-scale field testing and monitoring. Suggestions are made for triggers to progress to higher tiers. Also, mitigation options to reduce the potential for exposure of terrestrial life-stages of amphibians to PPPs, if a risk were identified, are discussed. Finally, remaining uncertainties and research needs are considered by proposing a way forward (road map) for generating additional information to inform terrestrial amphibian risk assessment.

Prospective aquatic risk assessment for chemical mixtures in agricultural landscapes.

Environmental risk assessment of chemical mixtures is challenging because of the multitude of possible combinations that may occur. Aquatic risk from chemical mixtures in an agricultural landscape was evaluated prospectively in 2 exposure scenario case studies: at field scale for a program of 13 plant-protection products applied annually for 20 yr and at a watershed scale for a mixed land-use scenario over 30 yr with 12 plant-protection products and 2 veterinary pharmaceuticals used for beef cattle. Risk quotients were calculated from regulatory exposure models with typical real-world use patterns and regulatory acceptable concentrations for individual chemicals. The results could differentiate situations when there was concern associated with single chemicals from those when concern was associated with a mixture (based on concentration addition) with no single chemical triggering concern. Potential mixture risk was identified on 0.02 to 7.07% of the total days modeled, depending on the scenario, the taxa, and whether considering acute or chronic risk. Taxa at risk were influenced by receiving water body characteristics along with chemical use profiles and associated properties. The present study demonstrates that a scenario-based approach can be used to determine whether mixtures of chemicals pose risks over and above any identified using existing approaches for single chemicals, how often and to what magnitude, and ultimately which mixtures (and dominant chemicals) cause greatest concern. Environ Toxicol Chem 2018;37:674-689. © 2017 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC.

Toward the definition of specific protection goals for the environmental risk assessment of chemicals: A perspective on environmental regulation in Europe.

This critical review examines the definition and implementation of environmental protection goals for chemicals in current European Union (EU) legislation, guidelines, and international agreements to which EU countries are party. The European chemical industry is highly regulated, and prospective environmental risk assessments (ERAs) are tailored for different classes of chemical, according to their specific hazards, uses, and environmental exposure profiles. However, environmental protection goals are often highly generic, requiring the prevention of "unacceptable" or "adverse" impacts on "biodiversity" and "ecosystems" or the "environment as a whole." This review aims to highlight working examples, challenges, solutions, and best practices for defining specific protection goals (SPGs), which are seen to be essential for refining and improving ERA. Specific protection goals hinge on discerning acceptable versus unacceptable adverse effects on the key attributes of relevant, sensitive ecological entities (ranging from organisms to ecosystems). Some isolated examples of SPGs for terrestrial and aquatic biota can be found in prospective ERA guidance for plant protection products (PPPs). However, SPGs are generally limited to environmental or nature legislation that requires environmental monitoring and retrospective ERA. This limitation is due mainly to the availability of baselines, which define acceptable versus unacceptable environmental effects on the key attributes of sentinel species, populations and/or communities, such as reproductive status, abundance, or diversity. Nevertheless, very few regulatory case examples exist in which SPGs incorporate effect magnitude, spatial extent, and temporal duration. We conclude that more holistic approaches are needed for defining SPGs, particularly with respect to protecting population sustainability, ecosystem function, and integrity, which are implicit in generic protection goals and explicit in the International Programme for Chemical Safety (IPCS) definition of "adverse effect." A possible solution, which the chemical industry is currently assessing, is wider application of the ecosystem services approach proposed by the European Food Safety Authority (EFSA) for the risk assessment of PPPs. Integr Environ Assess Manag 2017;13:17-37. © 2016 SETAC.

Genetically modified crops and aquatic ecosystems: considerations for environmental risk assessment and non-target organism testing.

Environmental risk assessments (ERA) support regulatory decisions for the commercial cultivation of genetically modified (GM) crops. The ERA for terrestrial agroecosystems is well-developed, whereas guidance for ERA of GM crops in aquatic ecosystems is not as well-defined. The purpose of this document is to demonstrate how comprehensive problem formulation can be used to develop a conceptual model and to identify potential exposure pathways, using Bacillus thuringiensis (Bt) maize as a case study. Within problem formulation, the insecticidal trait, the crop, the receiving environment, and protection goals were characterized, and a conceptual model was developed to identify routes through which aquatic organisms may be exposed to insecticidal proteins in maize tissue. Following a tiered approach for exposure assessment, worst-case exposures were estimated using standardized models, and factors mitigating exposure were described. Based on exposure estimates, shredders were identified as the functional group most likely to be exposed to insecticidal proteins. However, even using worst-case assumptions, the exposure of shredders to Bt maize was low and studies supporting the current risk assessments were deemed adequate. Determining if early tier toxicity studies are necessary to inform the risk assessment for a specific GM crop should be done on a case by case basis, and should be guided by thorough problem formulation and exposure assessment. The processes used to develop the Bt maize case study are intended to serve as a model for performing risk assessments on future traits and crops.

Framework for traits-based assessment in ecotoxicology.

A key challenge in ecotoxicology is to assess the potential risks of chemicals to the wide range of species in the environment on the basis of laboratory toxicity data derived from a limited number of species. These species are then assumed to be suitable surrogates for a wider class of related taxa. For example, Daphnia spp. are used as the indicator species for freshwater aquatic invertebrates. Extrapolation from these datasets to natural communities poses a challenge because the extent to which test species are representative of their various taxonomic groups is often largely unknown, and different taxonomic groups and chemicals are variously represented in the available datasets. Moreover, it has been recognized that physiological and ecological factors can each be powerful determinants of vulnerability to chemical stress, thus differentially influencing toxicant effects at the population and community level. Recently it was proposed that detailed study of species traits might eventually permit better understanding, and thus prediction, of the potential for adverse effects of chemicals to a wider range of organisms than those amenable for study in the laboratory. This line of inquiry stems in part from the ecology literature, in which species traits are being used for improved understanding of how communities are constructed, as well as how communities might respond to, and recover from, disturbance (see other articles in this issue). In the present work, we develop a framework for the application of traits-based assessment. The framework is based on the population vulnerability conceptual model of Van Straalen in which vulnerability is determined by traits that can be grouped into 3 major categories, i.e., external exposure, intrinsic sensitivity, and population sustainability. Within each of these major categories, we evaluate specific traits as well as how they could contribute to the assessment of the potential effects of a toxicant on an organism. We then develop an example considering bioavailability to explore how traits could be used mechanistically to estimate vulnerability. A preliminary inventory of traits for use in ecotoxicology is included; this also identifies the availability of data to quantify those traits, in addition to an indication of the strength of linkage between the trait and the affected process. Finally, we propose a way forward for the further development of traits-based approaches in ecotoxicology.