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).

Deriving a water quality guideline for protection of aquatic communities exposed to triclosan in the Canadian environment.

Triclosan is an antibacterial and antifungal chemical used in a variety of consumer products, including soaps, detergents, moisturizers, and cosmetics. Aquatic ecosystems may be exposed to triclosan following the release of remaining residues in wastewater effluents and biosolids. In December 2017, Environment and Climate Change Canada (ECCC) released a federal environmental quality guideline (FEQG) report that contained a federal water quality guideline (FWQG) for triclosan. This guideline will be used as an adjunct to the risk assessment and risk management of priority chemicals identified under the Government of Canada's Chemicals Management Plan (CMP). The FWQG value for triclosan (0.47 µg/L) was derived by ECCC using a hazardous concentration for 5% of species (HC5) from a species sensitivity distribution (SSD). We recalculated the FWQG after performing an independent analysis and evaluation of the available aquatic toxicity data for triclosan and compared our results with the ECCC FWQG value. Our independent analysis of the available aquatic toxicity data entailed conducting a literature search of all available and relevant studies, evaluating the quality and reliability of all studies considered using thorough and consistent study evaluation criteria, and thereby generating a data set of high-quality toxicity values. The selected data set includes 22 species spanning 5 taxonomic groups. An SSD was developed using this data set following the ECCC approaches. The HC5 from the SSD derived based on our validated data set is 0.76 µg/L. This HC5 value is slightly greater (i.e., less sensitive) than the value presented in ECCC's final FWQG. Integr Environ Assess Manag 2018;14:437-441. © 2018 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

A refined ecological risk assessment for California red-legged frog, Delta smelt, and California tiger salamander exposed to malathion.

The California red-legged frog (CRLF), Delta smelt (DS), and California tiger salamander (CTS) are 3 species listed under the United States Federal Endangered Species Act (ESA), all of which inhabit aquatic ecosystems in California. The US Environmental Protection Agency (USEPA) has conducted deterministic screening-level risk assessments for these species potentially exposed to malathion, an organophosphorus insecticide and acaricide. Results from our screening-level analyses identified potential risk of direct effects to DS as well as indirect effects to all 3 species via reduction in prey. Accordingly, for those species and scenarios in which risk was identified at the screening level, we conducted a refined probabilistic risk assessment for CRLF, DS, and CTS. The refined ecological risk assessment (ERA) was conducted using best available data and approaches, as recommended by the 2013 National Research Council (NRC) report "Assessing Risks to Endangered and Threatened Species from Pesticides." Refined aquatic exposure models including the Pesticide Root Zone Model (PRZM), the Vegetative Filter Strip Modeling System (VFSMOD), the Variable Volume Water Model (VVWM), the Exposure Analysis Modeling System (EXAMS), and the Soil and Water Assessment Tool (SWAT) were used to generate estimated exposure concentrations (EECs) for malathion based on worst-case scenarios in California. Refined effects analyses involved developing concentration-response curves for fish and species sensitivity distributions (SSDs) for fish and aquatic invertebrates. Quantitative risk curves, field and mesocosm studies, surface-water monitoring data, and incident reports were considered in a weight-of-evidence approach. Currently, labeled uses of malathion are not expected to result in direct effects to CRLF, DS or CTS, or indirect effects due to effects on fish and invertebrate prey. Integr Environ Assess Manag 2018;14:224-239. © 2017 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

A probabilistic risk assessment for the Kirtland's warbler potentially exposed to chlorpyrifos and malathion during the breeding season and migration.

Two organophosphate pesticides, chlorpyrifos and malathion, are currently undergoing reregistration in the United States and were recently used by the US Environmental Protection Agency (USEPA) as case studies to develop a national procedure for evaluating risks to endangered species. One of the endangered bird species considered by the USEPA was the Kirtland's warbler (Setophaga kirtlandii). The Kirtland's warbler is an endangered migratory species that nests exclusively in young jack pine stands in Michigan and Wisconsin, and winters in the Bahamas. We developed probabilistic models to assess the risks of chlorpyrifos and malathion to Kirtland's warblers during the breeding season and the spring and fall migrations. The breeding area model simulates acute and chronic exposure and risk to each of 10 000 birds over a 60-d period following initial pesticide application. The model is highly species specific with regard to the foraging behavior of Kirtland's warblers during the breeding season. We simulated the maximum application rate and number of applications allowed on the labels for representative use patterns that could be found within 3 km of the breeding areas of Kirtland's warbler. The migration model simulates 10 000 birds during the course of their 12- to 23-d migration between their breeding area and the Bahamas. The model takes advantage of more than a century of observations of when, where, and for how long Kirtland's warblers forage in different habitats during the course of their migration. The data indicate that warblers only infrequently stop over in habitats that could be treated with chlorpyrifos and malathion. The breeding area and migration models resulted in predictions of very low acute and chronic risk for both pesticides to Kirtland's warblers. These results were expected, given that field observations indicate that the Kirtland's warbler has dramatically increased in abundance in recent decades. Integr Environ Assess Manag 2018;14:252-269. © 2017 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.

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.

Probabilistic risk-assessment model for birds exposed to granular pesticides.

For granular formulations of pesticides, direct consumption by birds is generally the most important route of exposure. A probabilistic exposure model was developed that estimates how many pesticide granules a bird ingests and, from that, the quantity of pesticide ingested. This model, referred to as the "granular pesticide avian risk assessment model" (GranPARAM), has input variables not included in current screening-level assessments for granular pesticides, such as proportion of time for which birds forage in the field, grit ingestion rates, attractiveness of pesticide granules compared with natural grit, and proportions of soil particles and pesticide granules in the size range consumed by birds. For input variables that are uncertain, variable, or both, distributions are used rather than point estimates. Monte Carlo analysis is then performed to propagate input variable uncertainties through the exposure model for granular pesticides. The outputs from the exposure portion of GranPARAM are estimated pesticide doses for each of 20 birds of a selected species on each of 1000 fields. The dose for each bird is compared with a randomly chosen dose from the dose-response curve for that species or an appropriate surrogate. If the exposure dose for a bird exceeds the randomly chosen effects dose, the bird is considered dead; otherwise, the bird is assumed to be alive. Thus, the risk output from GranPARAM is a bar chart showing the percentages of fields with 0/20 dead birds, 1/20 dead birds, 2/20 dead birds, and so forth.

Derivation of an ambient water quality criterion for mercury: taking account of site-specific conditions.

Mercury is considered to be a serious risk to wildlife. As a result, the Great Lakes Water Quality Initiative and others have developed ambient water quality criteria (AWQC) for the protection of wildlife. These AWQC have been controversial, however, because the AWQC were single values that did not account for site-specific conditions, derivation of the AWQC relied on a single no-observed-adverse-effect level, and the AWQC had an unknown level of conservatism because of reliance on both average and conservative assumptions and uncertainty factors. Rather than develop a single-value AWQC for total mercury, we derived an AWQC model that explicitly incorporates factors controlling bioavailability, methylation rates, and bioaccumulation in the aquatic environment (e.g., pH, dissolved organic carbon). To derive our AWQC model, field data were collected from 31 lakes in Ontario and an additional 10 lakes in Nova Scotia (North America). In the field study, levels of total and methylmercury in water and fish as well as levels of key water quality variables were determined. We conducted multiple-regression analysis to derive a model that estimates mercury levels in prey of mink. Mink are very sensitive to mercury exposure. An independent dataset consisting of 51 water bodies in the United States was then used to confirm the validity and robustness of the AWQC model. Next, we combined the results of chronic-feeding studies with similar protocols and endpoints in a meta-analysis to derive a dose-response curve for mink exposed to mercury in the diet. In the final step, we used a probabilistic risk model to estimate the concentrations of methylmercury in water that would lead to levels in fish sufficient for a 10% probability of exceeding the lethal dose affecting 5% of the mink population. The result is an AWQC equation for mercury for the protection of wildlife that can be used with a variety of site-specific conditions.