Using emerging science to inform risk characterizations for wildlife within current regulatory frameworks.

Many jurisdictions have regulatory frameworks that seek to reduce the effects of environmental exposures of anthropogenic chemicals on terrestrial wildlife (i.e., mammals, birds, reptiles, and amphibians). The frameworks apply for new and existing chemicals, including pesticides (prospective assessments), and to environmental contamination from releases (retrospective risk assessments). Relatively recently, there have been many scientific advances that could improve risk estimates for wildlife. Here, we briefly describe current regulations from North America (United States and Canada) and from Europe that include risk assessments for wildlife to ascertain whether they are conducive to the use of emerging science and new methods. We also provide examples where new and emerging science may be used to improve wildlife risk characterization and identify areas in need of future research. Integr Environ Assess Manag 2024;20:765-779. © 2024 His Majesty the King in Right of Canada and The Authors. Integrated Environmental Assessment and Management © 2024 Society of Environmental Toxicology & Chemistry (SETAC). Reproduced with the permission of the Minister of Environment and Climate Change Canada. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.

Advancing exposure assessment approaches to improve wildlife risk assessment.

The exposure assessment component of a Wildlife Ecological Risk Assessment aims to estimate the magnitude, frequency, and duration of exposure to a chemical or environmental contaminant, along with characteristics of the exposed population. This can be challenging in wildlife as there is often high uncertainty and error caused by broad-based, interspecific extrapolation and assumptions often because of a lack of data. Both the US Environmental Protection Agency (USEPA) and European Food Safety Authority (EFSA) have broadly directed exposure assessments to include estimates of the quantity (dose or concentration), frequency, and duration of exposure to a contaminant of interest while considering "all relevant factors." This ambiguity in the inclusion or exclusion of specific factors (e.g., individual and species-specific biology, diet, or proportion time in treated or contaminated area) can significantly influence the overall risk characterization. In this review, we identify four discrete categories of complexity that should be considered in an exposure assessment-chemical, environmental, organismal, and ecological. These may require more data, but a degree of inclusion at all stages of the risk assessment is critical to moving beyond screening-level methods that have a high degree of uncertainty and suffer from conservatism and a lack of realism. We demonstrate that there are many existing and emerging scientific tools and cross-cutting solutions for tackling exposure complexity. To foster greater application of these methods in wildlife exposure assessments, we present a new framework for risk assessors to construct an "exposure matrix." Using three case studies, we illustrate how the matrix can better inform, integrate, and more transparently communicate the important elements of complexity and realism in exposure assessments for wildlife. Modernizing wildlife exposure assessments is long overdue and will require improved collaboration, data sharing, application of standardized exposure scenarios, better communication of assumptions and uncertainty, and postregulatory tracking. Integr Environ Assess Manag 2024;20:674-698. © 2023 SETAC.

Challenges with the current methodology for conducting Endangered Species Act risk assessments for pesticides in the United States.

The US Environmental Protection Agency (USEPA or the Agency) is responsible for administering the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency is also required to assess the potential risks of pesticides undergoing registration or re-registration to threatened and endangered (i.e., listed) species to ensure compliance with the Endangered Species Act. To assess potential risks to listed species, a screening-level risk assessment in the form of a biological evaluation (BE) is undertaken by the Agency for each pesticide. Given the large number of registration actions handled by the USEPA annually, efficient tools for conducting BEs are desirable. However, the "Revised Method" that is the basis for the USEPA's BE process has been ineffective at filtering out listed species and critical habitats that are at de minimis risk to pesticides. In the USEPA's BEs, the Magnitude of Effect Tool (MAGtool) has been used to determine potential risks to listed species that potentially co-occur with pesticide footprints. The MAGtool is a highly prescriptive, high-throughput compilation of existing FIFRA screening-level models with a geospatial interface. The tool has been a significant contributor to risk inflation and ultimately process inefficiency. The ineffectiveness of the tool stems from compounding conservatism, unrealistic and unreasonable assumptions regarding usage, limited application of species-specific data, lack of consideration of multiple lines of evidence, and inability to integrate higher-tier data. Here, we briefly describe the MAGtool and the critical deficiencies that impair its effectiveness, thus undermining its intention. Case studies are presented to highlight the deficiencies and solutions are recommended for improving listed species assessments in the future. Integr Environ Assess Manag 2023;19:817-829. © 2022 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

ESASeedPARAM: A seed treatment model for threatened and endangered bird species in the United States.

The USEPA, National Marine Fisheries Service, and Fish and Wildlife Service are required to assess the risks of pesticides undergoing registration or reregistration to threatened and endangered (i.e., listed) species. Currently, the USEPA lacks a refined model to assess the risks of seed treatments to listed bird species. We developed the Endangered Species Assessment Seed Treatment Probabilistic Avian Risk Assessment Model (ESASeedPARAM) to incorporate species-specific diets, body weights, and food ingestion rates for potentially exposed listed bird species. The model also incorporates information on dissipation of seed residues after planting, and metabolism and elimination by birds during exposure. The ESASeedPARAM estimates hourly intake from ingestion of treated seeds for up to 50 days after planting. For each simulated bird, maximum retained dose (= body burden) and maximum rolling average total daily intake are estimated for acute and chronic exposure, respectively. The model is probabilistic and estimates exposure and risk for 20 birds on each of 1000 fields. The model accounts for interfield variation in the amount of waste grain on the soil surface in tilled, reduced till, and untilled fields. To estimate the fate of each bird from acute exposure, a random value is selected from the appropriate dose-response relationship and compared with the maximum retained dose. If acute exposure exceeds the randomly chosen effects value, mortality is assumed. For chronic risk, the most sensitive No Observed Adverse Effects Level (NOAEL) and Lowest Observed Adverse Effects Level (LOAEL) for an apical endpoint (survival, growth, reproduction) are compared with maximum rolling average total daily intake. In this article, we describe a case study conducted with the ESASeedPARAM for imidacloprid used as a seed treatment on wheat and soybean. Integr Environ Assess Manag 2023;19:527-546. © 2022 SETAC.

Utility of the avian sub-acute dietary toxicity test in ecological risk assessment and a path forward to reduce animal use.

The United States Environmental Protection Agency (USEPA) has long required both avian sub-acute dietary and acute oral studies to inform risk assessments for pesticides. Recently, the USEPA collaborated with People for the Ethical Treatment of Animals to determine whether the results of the acute oral avian toxicity test or the sub-acute dietary toxicity test consistently generated the greatest risk predictions in USEPA tier 1 assessments for pesticides first registered between 1998 and 2017. Their study concluded that in 99% of the cases, risk conclusions were driven by the acute oral study (OPPTS 850.2100, OCSPP 850.2100, or similar) because using these data results in higher risk quotients than sub-acute dietary data. Shortly after publishing these results, the USEPA released a formal memorandum providing guidance for waiving the sub-acute dietary study for most pesticides. The USEPA will, however, retain the option to require sub-acute dietary studies for pesticides with certain chemical properties. However, as the avian sub-acute dietary study has an exposure regimen that is often more representative of how birds are exposed to pesticides under actual use conditions than does the acute oral study (i.e., as part of a dietary item eaten over the course of a day and not a bolus dose), this study can provide useful context for risk assessment on a case-by-case basis. Decision criteria are needed to determine a path forward that both minimizes vertebrate animal testing and positions the avian sub-acute dietary data as an option for risk refinement. Decision criteria are proposed here with recommendations for refining the design of avian sub-acute dietary studies to ensure that the data generated are optimized to support a science-based acute avian risk assessment, supported by a case study demonstrating when and how sub-acute dietary studies may be used in a higher-tier risk assessment. Integr Environ Assess Manag 2022;18:1629-1638. © 2022 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

A field spray drift study to determine the downwind effects of isoxaflutole herbicide to nontarget plants.

Spray drift buffers are often required on herbicide labels to prevent potential drift effects to nontarget plants. Buffers are typically derived by determining the distance at which predicted exposure from spray drift equals the ecotoxicology threshold for sensitive plant species determined in greenhouse tests. Field studies performed under realistic conditions have demonstrated, however, that this approach is far more conservative than necessary. In 2016, the US Environmental Protection Agency estimated that isoxaflutole (IFT), a herbicide used to control grass and broadleaf weeds, could adversely affect downwind nontarget dicot plants at distances of ≥304 m from the edge of the treated field due to spray drift. This prediction implies that a buffer of at least 304 m is required to protect nontarget plants. To refine the predicted buffer distance for IFT, we conducted a field study in which sensitive nontarget plants (lettuce and navy bean, two to four leaf stage) were placed at various distances downwind from previously harvested soybean fields sprayed with Balance® Flexx Herbicide. The test plants were then transported to a greenhouse for grow out following the standard vegetative vigor test protocol. There were three trials. One had vegetation in the downwind deposition area (i.e., test plants placed in mowed grass; typical exposure scenario) and two had bare ground deposition areas (worst-case exposure scenario). For both plant species in bare ground deposition areas, effects on shoot height and weight were observed at 1.52 m but not at downwind distances of ≥9.14 m from the edge of the treated area. No effects were observed at any distance for plants placed in the vegetated deposition area. The field study demonstrated that a buffer of 9.14 m protects nontarget terrestrial plants exposed to IFT via spray drift even under worst-case conditions. Integr Environ Assess Manag 2022;18:757-769. © 2021 Bayer. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Ecological risk assessment for aquatic invertebrate communities exposed to imidacloprid as a result of labeled agricultural and nonagricultural uses in the United States.

A probabilistic ecological risk assessment (ERA) was conducted to determine the potential effects of acute and chronic exposure of aquatic invertebrate communities to imidacloprid arising from labeled agricultural and nonagricultural uses in the United States. Aquatic exposure estimates were derived using a higher-tier refined modeling approach that accounts for realistic variability in environmental and agronomic factors. Toxicity was assessed using refined acute and chronic community-level effect metrics for aquatic invertebrates (i.e., species or taxon sensitivity distributions) developed using the best available data. Acute and chronic probabilistic risk estimates were derived by integrating the exposure distributions for different use patterns with the applicable species or taxon sensitivity distributions to generate risk curves, which plot cumulative probability of exceedance versus the magnitude of effect. Overall, the results of this assessment indicated that the aquatic invertebrate community is unlikely to be adversely affected by acute or chronic exposure to imidacloprid resulting from currently registered uses of imidacloprid in the United States. Environ Toxicol Chem 2017;36:1375-1388. © 2016 SETAC.

Ecological risk assessment for Pacific salmon exposed to dimethoate in California.

A probabilistic risk assessment of the potential direct and indirect effects of acute dimethoate exposure to salmon populations of concern was conducted for 3 evolutionarily significant units (ESUs) of Pacific salmon in California. These ESUs were the Sacramento River winter-run chinook, the California Central Valley spring-run chinook, and the California Central Valley steelhead. Refined acute exposures were estimated using the Soil and Water Assessment Tool, a river basin-scale model developed to quantify the impact of land-management practices in large, complex watersheds. Both direct effects (i.e., inhibition of brain acetylcholinesterase activity) and indirect effects (i.e., altered availability of aquatic invertebrate prey) were assessed. Risk to salmon and their aquatic invertebrate prey items was determined to be de minimis. Therefore, dimethoate is not expected to have direct or indirect adverse effects on Pacific salmon in these 3 ESUs. Environ Toxicol Chem 2017;36:532-543. © 2016 SETAC.

Ecological risk assessment for mink and short-tailed shrew exposed to PCBs, dioxins, and furans in the Housatonic River area.

A probabilistic risk assessment was conducted to characterize risks to a representative piscivorous mammal (mink, Mustela vison) and a representative carnivorous mammal (short-tailed shrew, Blarina brevicauda) exposed to PCBs, dioxins, and furans in the Housatonic River area downstream of the General Electric (GE) facility in Pittsfield, Massachusetts. Contaminant exposure was estimated using a probabilistic total daily intake model and parameterized using life history information of each species and concentrations of PCBs, dioxins, and furans in prey collected in the Housatonic River study area. The effects assessment preferentially relied on dose-response curves but defaulted to benchmarks or other estimates of effect when there were insufficient toxicity data. The risk characterization used a weight of evidence approach. Up to 3 lines of evidence were used to estimate risks to the selected mammal species: 1) probabilistic exposure and effects modeling, 2) field surveys, and 3) species-specific feeding or field studies. The weight of evidence assessment indicated a high risk for mink and an intermediate risk for short-tailed shrew.

Risk assessment considerations with regard to the potential impacts of pesticides on endangered species.

Simple, deterministic screening-level assessments that are highly conservative by design facilitate a rapid initial screening to determine whether a pesticide active ingredient has the potential to adversely affect threatened or endangered species. If a worst-case estimate of pesticide exposure is below a very conservative effects metric (e.g., the no observed effects concentration of the most sensitive tested surrogate species) then the potential risks are considered de minimis and unlikely to jeopardize the existence of a threatened or endangered species. Thus by design, such compounded layers of conservatism are intended to minimize potential Type II errors (failure to reject a false null hypothesis of de minimus risk), but correspondingly increase Type I errors (falsely reject a null hypothesis of de minimus risk). Because of the conservatism inherent in screening-level risk assessments, higher-tier scientific information and analyses that provide additional environmental realism can be applied in cases where a potential risk has been identified. This information includes community-level effects data, environmental fate and exposure data, monitoring data, geospatial location and proximity data, species biology data, and probabilistic exposure and population models. Given that the definition of "risk" includes likelihood and magnitude of effect, higher-tier risk assessments should use probabilistic techniques that more accurately and realistically characterize risk. Moreover, where possible and appropriate, risk assessments should focus on effects at the population and community levels of organization rather than the more traditional focus on the organism level. This document provides a review of some types of higher-tier data and assessment refinements available to more accurately and realistically evaluate potential risks of pesticide use to threatened and endangered species.

Refined avian risk assessment for chlorpyrifos in the United States.

Refined risk assessments for birds exposed to flowable and granular formulations ofCPY were conducted for a range of current use patterns in the United States. Overall,the collective evidence from the modeling and field study lines of evidence indicate that flowable and granular CPY do not pose significant risks to the bird communities foraging in agro-ecosystems in the United States. The available information indicates that avian incidents resulting from the legal, registered uses of CPY have been very infrequent since 2002 (see SI Appendix 3). The small number of recent incidents suggests that the current labels for CPY are generally protective of birds.However, incident data are uncertain because of the difficulties associated with finding dead birds in the field and linking any mortality observed to CPY.Plowable CPY is registered for a variety of crops in the United States including alfalfa, brassica vegetables, citrus, corn, cotton, grape, mint, onion, peanut, pome and stone fruits, soybean, sugar beet, sunflower, sweet potato, tree nuts, and wheat under the trade name Lorsban Advanced. The major routes of exposure for birds to flowable CPY were consumption of treated dietary items and drinking water. The Liquid Pesticide Avian Risk Assessment Model (Liquid PARAM) was used to simulate avian ingestion of CPY by these routes of exposure. For acute exposure,Liquid PARAM estimated the maximum retained dose in each of 20 birds on each of1,000 fields that were treated with CPY over the 60-d period following initial application.The model used a 1-h time step. For species lacking acceptable acute oral toxicity data (all focal species except northern bobwhite (C. virginianus) and redwinged blackbird (A. phoeniceus)), a species sensitivity distribution (SSD) approach was used to generate hypothetical dose-response curves assuming high, median and low sensitivity to CPY. For acute risk, risk curves were generated for each use pattern and exposure scenario. The risk curves show the relationship between exceedence probability and percent mortality. The results of the Liquid PARAM modeling exercise indicate that flow able CPY poses an acute risk to some bird species, particularly those species that are highly sensitive and that forage extensively in crops with high maximum application rates (e.g., grapefruit, orange). Overall, most bird species would not experience significant mortality as a result of exposure to flowable CPY.The results of a number of field studies conducted at application rates comparable to those on the Lorsban Advanced label indicate that flowable CPY rarely causes avian mortality. The results of the field studies suggest that Liquid PARAM is likely over-estimating acute risk to birds for flowable CPY.For chronic exposure, Liquid PARAM estimated the maximum total daily intake (TDI) over a user-specified exposure duration (28-d in the case of CPY).The maximum average TDI was compared to the chronic NOEL and LOEL from the most sensitive species tested for CPY, the mallard. This comparison was done for each of the 20 birds in each of the 1000 fields simulated in Liquid PARAM.The outpu· ~ are estimates of the probabilities of exceeding the NOEL and LOEL.Liquid PAkAM did not predict significant adverse effects resulting from chronic exposure to flowable CPY. The small number of incidents (2) involving CPY reported since 2002 suggests that the current labels for CPY are generally protective of birds.Granular CPY is registered for a wide variety of crops including brassica vegetables, corn, onion, peanut, sugar beet, sunflower, and tobacco under the trade name Lorsban 15G. Consumption of grit is required by many birds to aid in digestion of hard dietary items such as seeds and insects. Because CPY granules are in the same size range as natural grit particles consumed by birds, there is a potential for birds to mistakenly ingest granular CPY instead of natural grit. We developed the Granular Pesticide Avian Risk Model (GranPARAM) to simulate grit ingestion behavior by birds. The model accounts for proportion of time that birds forage for grit in treated fields, relative proportions of natural grit versus pesticide granules onthe surface of treated fields, rates of ingestion of grit, attractiveness of pesticide granules relative to natural grit and so on. For CPY, each model simulation included20 birds on each of 1,000 fields to capture variability in rates of ingestion of grit and for aging behavior between birds within a focal species, and variability in soil composition between fields for the selected use pattern. The estimated dose for each birdwas compared with randomly chosen doses from relevant dose-response curves forCPY. Our analysis for a wide variety of use patterns on the Lorsban 15G label found that granular CPY poses little risk of causing mortality to bird species that frequent treated fields immediately after application. The predictions of the model have been confirmed in several avian field studies conducted with Lorsban 15G at application rates similar to or exceeding maximum application rates on the Lorsban 15G label.

Risks of carbamate and organophosphate pesticide mixtures to salmon in the Pacific Northwest.

Salmon populations in the Pacific Northwest are being affected by a variety of environmental stressors including intense fishing pressure, parasites and disease, climatic variability and change, land development, hatchery production, hydropower operations, stormwater runoff, and exposure to toxic contaminants. In recent years, there has been much concern that mixtures of pesticides are causing toxic effects to Pacific salmon. In this study, we compared measured stream water concentrations from 2 monitoring studies conducted in the Pacific Northwest with concentration-response curves derived for inhibition of brain acetylcholinesterase activity in juvenile coho salmon (Oncorhynchus kisutch) for mixtures of organophosphate (OPs) and carbamate (CBs) pesticides. In the first monitoring study, samples were collected from 2003 to 2007 in salmonid-bearing waters of 5 urban or agricultural watersheds in Washington State. This study was targeted to areas of high pesticide use and generally involved weekly sampling during the pesticide use season. The second monitoring study was the United States Geological Survey National Water Quality Assessment that included samples taken from 2003 to 2010 in California, Idaho, Oregon, and Washington. OPs and CBs were frequently detected in both studies. The available monitoring data collected since 2003, however, demonstrates that mixtures of OPs and CBs in surface waters rarely occur at levels capable of producing significant physiological and behavioral effects in Pacific salmon. The observed mixtures never reached concentrations capable of causing mortality. We conclude that mixtures of organophosphates and carbamates do not pose a significant direct risk to Pacific salmon.

Baseline ecological risk assessment of the Calcasieu Estuary, Louisiana: Part 1. Overview and problem formulation.

A remedial investigation/feasibility study (RI/FS) of the Calcasieu Estuary cooperative site was initiated in 1998. This site, which is located in the southwestern portion of Louisiana in the vicinity of Lake Charles, includes the portion of the estuary from the saltwater barrier on the Calcasieu River to Moss Lake. As part of the RI/FS, a baseline ecological risk assessment (BERA) was conducted to assess the risks to aquatic organisms and aquatic-dependent wildlife exposed to environmental contaminants. The purpose of the BERA was to determine if adverse effects on ecological receptors are occurring in the estuary; to evaluate the nature, severity, and areal extent of any such effects; and to identify the substances that are causing or substantially contributing to effects on ecological receptors. This article describes the environmental setting and site history, identifies the chemicals of potential concern, presents the exposure scenarios and conceptual model for the site, and summarizes the assessment and measurement endpoints that were used in the investigation. Two additional articles in this series describe the results of an evaluation of effects-based sediment-quality guidelines as well as an assessment of risks to benthic invertebrates associated with exposure to contaminated sediment.

Refined avian risk assessment for aldicarb in the United States.

Aldicarb was recently reviewed by the US Environmental Protection Agency (USEPA) for re-registration eligibility. In this paper, we describe a refined avian risk assessment for aldicarb that was conducted to build upon the screening-level methods used by USEPA. The goal of the refined ERA was to characterize and understand better the risks posed by aldicarb to birds in areas where the pesticide is applied. Aldicarb is a systemic insecticide sold in granular form under the trade name Temik. It is applied directly to soil and is used to control mites, nematodes, and aphids on a variety of crops (e.g., cotton, potatoes, peanuts). Consumption of grit is necessary for proper digestion in many bird species, particularly for granivores and insectivores. Thus, aldicarb granules may be mistaken for grit by birds. The Granular Pesticide Avian Risk Assessment Model (GranPARAM) is described in a companion paper and was used to estimate the probability and magnitude of effects to flocks of birds that frequent aldicarb-treated fields. One hundred thirty-five exposure scenarios were modeled that together include a range of bird species, crops, application methods and rates, and regions in the United States. The results indicated that, even for the most sensitive bird species, the risks associated with the agricultural use of granular aldicarb are negligible to low. There are several reasons for the limited risk: 1) the Temik formulation includes a gypsum core and a graphite coating and is black in color, all of which have been shown to be unattractive to birds, and 2) the pesticide is applied subsurface and rapidly dissolves following contact with water. The fact that no bird kill incidents involving appropriate label uses of aldicarb have been conclusively documented in the United States over its 38 years of use supports the results of this refined risk assessment.

Refined aquatic risk assessment for aldicarb in the United States.

Aldicarb is a systemic insecticide applied directly to soil and to control mites, nematodes, and aphids on a variety of crops (e.g., cotton, potatoes, peanuts). It is highly soluble in water (6,000 mg/L) and mobile in soils (K(oc) = 100). As a result, aldicarb has the potential to be transported to aquatic systems close to treated fields. The US Environmental Protection Agency (USEPA) recently conducted an aquatic screening-level ERA for aldicarb as part of the re-registration review process. We conducted a refined risk assessment for aldicarb to characterize better the risks posed by aldicarb to fish and invertebrates inhabiting small freshwater ponds near agricultural areas. For the exposure assessment, tier II PRZM/EXAMS (Predicted Root Zone Model [PRZM] and Exposure Analysis Modelling System [EXAMS]) modelling was conducted to estimate 30-y distributions of peak concentrations of aldicarb and the carbamate metabolites (aldicarb sulfoxide, aldicarb sulfone) in surface waters of a standard pond arising from different uses of aldicarb. The effects assessment was performed using a species sensitivity distribution (SSD) approach. The resulting risk curves as well as available incident reports suggest that risks to freshwater fish and invertebrates from exposure to aldicarb are minor. The available monitoring data did not provide conclusive evidence about risks to aquatic biota.

Dietary exposure of mink (Mustela vison) to fish from the housatonic river, Berkshire County, Massachusetts, USA: effects on reproduction, kit growth, and survival.

We evaluated the effects of feeding farm-raised mink (Mustela vison) diets containing polychlorinated biphenyl (PCB)-contaminated fish from the Housatonic River (HR; Berkshire County, MA, USA) on adult reproductive performance and kit growth and survival. Diets contained 0.22-3.54% HR fish, providing 0.34-3.7 microg total PCBs (TPCB)/g feed wet wt (3.5-68.5 pg toxic equivalence [TEQ]/g). Female mink were fed diets before breeding through weaning of kits. Twelve kits from each treatment were maintained on their respective diets for an additional 180 d. Dietary PCBs had no effect on the number of offspring produced, gestation period, or other measures of adult reproductive performance. Mink kits exposed to 3.7 microg TPCB/g feed (68.5 pg TEQ/ g) in utero and during lactation had reduced survivability between three and six weeks of age. The lethal concentrations to 10 and 20% of the population (LC10 and LC20, respectively) were estimated to be 0.231 and 0.984 microg TPCB/g feed, respectively. Because inclusion of PCB-contaminated fish that composed approximately 1% of the diet would reduce mink kit survival by 20% or more, it is likely that consumption of up to 30-fold that quantity of HR fish, as could be expected for wild mink, would have an adverse effect on wild mink populations.

A comparison of model performance for six quantitative structure-activity relationship packages that predict acute toxicity to fish.

Some regulatory programs rely on quantitative structure-activity relationship (QSAR) models to predict toxic effects to biota. Many currently existing QSAR models can predict the effects of a wide range of substances to biota, particularly aquatic biota. The difficulty for regulatory programs is in choosing the appropriate QSAR model or models for application in their new and existing substances programs. We evaluated model performance of six QSAR modeling packages: Ecological Structure Activity Relationship (ECOSAR), TOPKAT, a Probabilistic Neural Network (PNN), a Computational Neural Network (CNN), the QSAR components of the Assessment Tools for the Evaluation of Risk (ASTER) system, and the Optimized Approach Based on Structural Indices Set (OASIS) system. Using a testing data set of 130 substances that had not been included in the training data sets of the QSAR models under consideration, we compared model predictions for 96-h median lethal concentrations (LC50s) to fathead minnows to the corresponding measured toxicity values available in the AQUIRE database. The testing data set was heavily weighted with neutral organics of low molecular weight and functionality. Many of the testing data set substances also had a nonpolar narcosis mode of action and/or were chlorinated. A variety of statistical measures (correlation coefficient, slope and intercept from a linear regression analysis, mean absolute and squared difference between log prediction and log measured toxicity, and the percentage of predictions within factors of 2, 5, 10, 100, and 1,000 of measured toxicity values) indicated that the PNN model had the best model performance for the full testing data set of 130 substances. The rank order of the remainder of the models depended on the statistical measure employed. TOPKAT also had excellent model performance for substances within its optimum prediction space. Only 37% of the substances in the testing data set, however, fell within this optimum prediction space.

Evaluation of probabilistic risk assessment of pesticides in the UK: chlorpyrifos use on top fruit.

The use of probabilistic risk assessment (PRA) for examining chemical impacts has become an important area of debate within the European Union. This paper describes a case study on probabilistic techniques to assess pesticide risks in the UK aquatic environment. The main aim of this paper is to demonstrate both the potential strengths and weaknesses of PRA for assessing pesticides when compared with the conventional deterministic approach, and to examine whether PRA is useful within the European regulatory context. The organophosphate insecticide, chlorpyrifos, was selected as a model compound and toxicity exposure ratios calculated using Monte Carlo analysis and different distributions of spray drift and toxicity values following application to top fruit. Chlorpyrifos is highly toxic to arthropods but less toxic to fishes. Species sensitivity followed a log-normal distribution when fitted to all toxicity data. Toxicity data quantity had little influence on species sensitivity distribution model parameters when n was greater than 10 species. Below this, estimates were less accurate and precise, possibly because of the inclusion of data from many different sources. Estimates of chlorpyrifos exposure derived from the standard spray drift model differed substantially from measurements of chlorpyrifos in European surface waters. When a distribution based on measured concentrations was used in a PRA, the risk of acute fish mortality was low, and the risk of acute arthropod mortality was lower than in other scenarios, although not negligible. If PRA is used to assess pesticides, risk managers need further guidance on how to conduct a PRA and what constitutes 'unacceptable risk' under EC Directive 91/414/EEC, as judgement is required when simple trigger values are no longer used.