Key challenges and developments in wildlife ecological risk assessment: Problem formulation.

Problem formulation (PF) is a critical initial step in planning risk assessments for chemical exposures to wildlife, used either explicitly or implicitly in various jurisdictions to include registration of new pesticides, evaluation of new and existing chemicals released to the environment, and characterization of impact when chemical releases have occurred. Despite improvements in our understanding of the environment, ecology, and biological sciences, few risk assessments have used this information to enhance their value and predictive capabilities. In addition to advances in organism-level mechanisms and methods, there have been substantive developments that focus on population- and systems-level processes. Although most of the advances have been recognized as being state-of-the-science for two decades or more, there is scant evidence that they have been incorporated into wildlife risk assessment or risk assessment in general. In this article, we identify opportunities to consider elevating the relevance of wildlife risk assessments by focusing on elements of the PF stage of risk assessment, especially in the construction of conceptual models and selection of assessment endpoints that target population- and system-level endpoints. Doing so will remain consistent with four established steps of existing guidance: (1) establish clear protection goals early in the process; (2) consider how data collection using new methods will affect decisions, given all possibilities, and develop a decision plan a priori; (3) engage all relevant stakeholders in creating a robust, holistic conceptual model that incorporates plausible stressors that could affect the targets defined in the protection goals; and (4) embrace the need for iteration throughout the PF steps (recognizing that multiple passes may be required before agreeing on a feasible plan for the rest of the risk assessment). Integr Environ Assess Manag 2022;00:1-16. © 2022 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC). This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.

Applying ecosystem services for pre-market environmental risk assessments of regulated stressors.

Ecosystem services (ES) are the benefits that people obtain from ecosystems. Investigating the environment through an ES framework has gained wide acceptance in the international scientific community and is applied by policymakers to protect biodiversity and safeguard the sustainability of ecosystems. This approach can enhance the ecological and societal relevance of pre-market/prospective environmental risk assessments (ERAs) of regulated stressors by: (1) informing the derivation of operational protection goals; (2) enabling the integration of environmental and human health risk assessments; (3) facilitating horizontal integration of policies and regulations; (4) leading to more comprehensive and consistent environmental protection; (5) articulating the utility of, and trade-offs involved in, environmental decisions; and (6) enhancing the transparency of risk assessment results and the decisions based upon them. Realisation of these advantages will require challenges that impede acceptance of an ES approach to be overcome. Particularly, there is concern that, if biodiversity only matters to the extent that it benefits humans, the intrinsic value of nature is ignored. Moreover, our understanding of linkages among ecological components and the processes that ultimately deliver ES is incomplete, valuing ES is complex, and there is no standard ES lexicon and limited familiarity with the approach. To help overcome these challenges, we encourage: (1) further research to establish biodiversity-ES relationships; (2) the development of approaches that (i) quantitatively translate responses to chemical stressors by organisms and groups of organisms to ES delivery across different spatial and temporal scales, (ii) measure cultural ES and ease their integration into ES valuations, and (iii) appropriately value changes in ES delivery so that trade-offs among different management options can be assessed; (3) the establishment of a standard ES lexicon; and (4) building capacity in ES science and how to apply ES to ERAs. These development needs should not prevent movement towards implementation of an ES approach in ERAs, as the advantages we perceive of using this approach render it more than worthwhile to tackle those challenges. Society and the environment stand to benefit from this shift in how we conduct the ERA of regulated stressors.

Rethinking Environmental Protection: Meeting the Challenges of a Changing World.

SUMMARY: From climate change to hydraulic fracturing, and from drinking water safety to wildfires, environmental challenges are changing. The United States has made substantial environmental protection progress based on media-specific and single pollutant risk-based frameworks. However, today's environmental problems are increasingly complex and new scientific approaches and tools are needed to achieve sustainable solutions to protect the environment and public health. In this article, we present examples of today's environmental challenges and offer an integrated systems approach to address them. We provide a strategic framework and recommendations for advancing the application of science for protecting the environment and public health. We posit that addressing 21st century challenges requires transdisciplinary and systems approaches, new data sources, and stakeholder partnerships. To address these challenges, we outline a process driven by problem formulation with the following steps: a) formulate the problem holistically, b) gather and synthesize diverse information, c) develop and assess options, and d) implement sustainable solutions. This process will require new skills and education in systems science, with an emphasis on science translation. A systems-based approach can transcend media- and receptor-specific bounds, integrate diverse information, and recognize the inextricable link between ecology and human health.

Ecosystem services in risk assessment and management.

The ecosystem services (ES) concept holds much promise for environmental decision making. Even so, the concept has yet to gain full traction in the decisions and policies of environmental agencies in the United States, Europe, and elsewhere. In this paper we examine the opportunities for and implications of including ES in risk assessments and the risk management decisions that they inform. We assert that use of ES will: 1) lead to more comprehensive environmental protection; 2) help to articulate the benefits of environmental decisions, policies, and actions; 3) better inform the derivation of environmental quality standards; 4) enable integration of human health and ecological risk assessment; and 5) facilitate horizontal integration of policies, regulations, and programs. We provide the technical basis and supporting rationale for each assertion, relying on examples taken from experiences in the United States and European Union. Specific recommendations are offered for use of ES in risk assessment and risk management, and issues and challenges to advancing use of ES are described together with some of the science needed to improve the value of the ES concept to environmental protection. Integr Environ Assess Manag 2017;13:62-73. © 2016 SETAC.

Toward a conceptual approach for assessing risks from chemical mixtures and other stressors to coastal ecosystem services.

Growth of human populations and increased human activity, particularly in coastal areas, increase pressure on coastal ecosystems and the ecosystem services (ES) they provide. As a means toward being able to assess the impact of multiple stressors on ES, in the present study we propose an 8-step conceptual approach for assessing effects of chemical mixtures and other stressors on ES in coastal areas: step A, identify the relevant problems and policy aims; step B, identify temporal and spatial boundaries; step C, identify relevant ES; step D, identify relevant stressors (e.g., chemicals); step E, translate impacts into ES units; step F, assess cumulative risk in ES units; step G, rank stressors based on their contribution to adverse effects on ES; and step H, implement regulation and management as appropriate and necessary. Two illustrative case studies (Swedish coastal waters and a coastal lagoon in Costa Rica) are provided; one focuses on chemicals that affect human food supply and the other addresses pesticide runoff and trade-offs among ES. The 2 cases are used to highlight challenges of such risk assessments, including use of standardized versus ES-relevant test species, data completeness, and trade-offs among ES. Lessons learned from the 2 case studies are discussed in relation to environmental risk assessment and management of chemical mixtures. Integr Environ Assess Manag 2017;13:376-386. © 2016 SETAC.

Ecosystem services in the Great Lakes.

A comprehensive inventory of ecosystem services across the entire Great Lakes basin is currently lacking and is needed to make informed management decisions. A greater appreciation and understanding of ecosystem services, including both use and non-use services, may have avoided misguided resource management decisions in the past that have resulted in legacies inherited by future generations. Given the interest in ecosystem services and lack of a coherent approach to addressing this topic in the Great Lakes, a summit was convened involving 28 experts working on various aspects of ecosystem services in the Great Lakes. The invited attendees spanned a variety of social and natural sciences. Given the unique status of the Great Lakes as the world's largest collective repository of surface freshwater, and the numerous stressors threatening this valuable resource, timing was propitious to examine ecosystem services. Several themes and recommendations emerged from the summit. There was general consensus that 1) a comprehensive inventory of ecosystem services throughout the Great Lakes is a desirable goal but would require considerable resources; 2) more spatially and temporally intensive data are needed to overcome our data gaps, but the arrangement of data networks and observatories must be well-coordinated; 3) trade-offs must be considered as part of ecosystem services analyses; and 4) formation of a Great Lakes Institute for Ecosystem Services, to provide a hub for research, meetings, and training is desirable. Several challenges also emerged during the summit, which are discussed in the paper.

Assessing and managing multiple risks in a changing world-The Roskilde recommendations.

Roskilde University (Denmark) hosted a November 2015 workshop, Environmental Risk-Assessing and Managing Multiple Risks in a Changing World. This Focus article presents the consensus recommendations of 30 attendees from 9 countries regarding implementation of a common currency (ecosystem services) for holistic environmental risk assessment and management; improvements to risk assessment and management in a complex, human-modified, and changing world; appropriate development of protection goals in a 2-stage process; dealing with societal issues; risk-management information needs; conducting risk assessment of risk management; and development of adaptive and flexible regulatory systems. The authors encourage both cross-disciplinary and interdisciplinary approaches to address their 10 recommendations: 1) adopt ecosystem services as a common currency for risk assessment and management; 2) consider cumulative stressors (chemical and nonchemical) and determine which dominate to best manage and restore ecosystem services; 3) fully integrate risk managers and communities of interest into the risk-assessment process; 4) fully integrate risk assessors and communities of interest into the risk-management process; 5) consider socioeconomics and increased transparency in both risk assessment and risk management; 6) recognize the ethical rights of humans and ecosystems to an adequate level of protection; 7) determine relevant reference conditions and the proper ecological context for assessments in human-modified systems; 8) assess risks and benefits to humans and the ecosystem and consider unintended consequences of management actions; 9) avoid excessive conservatism or possible underprotection resulting from sole reliance on binary, numerical benchmarks; and 10) develop adaptive risk-management and regulatory goals based on ranges of uncertainty. Environ Toxicol Chem 2017;36:7-16. © 2016 SETAC.

Ecosystem services as assessment endpoints for ecological risk assessment.

Ecosystem services are defined as the outputs of ecological processes that contribute to human welfare or have the potential to do so in the future. Those outputs include food and drinking water, clean air and water, and pollinated crops. The need to protect the services provided by natural systems has been recognized previously, but ecosystem services have not been formally incorporated into ecological risk assessment practice in a general way in the United States. Endpoints used conventionally in ecological risk assessment, derived directly from the state of the ecosystem (e.g., biophysical structure and processes), and endpoints based on ecosystem services serve different purposes. Conventional endpoints are ecologically important and susceptible entities and attributes that are protected under US laws and regulations. Ecosystem service endpoints are a conceptual and analytical step beyond conventional endpoints and are intended to complement conventional endpoints by linking and extending endpoints to goods and services with more obvious benefit to humans. Conventional endpoints can be related to ecosystem services even when the latter are not considered explicitly during problem formulation. To advance the use of ecosystem service endpoints in ecological risk assessment, the US Environmental Protection Agency's Risk Assessment Forum has added generic endpoints based on ecosystem services (ES-GEAE) to the original 2003 set of generic ecological assessment endpoints (GEAEs). Like conventional GEAEs, ES-GEAEs are defined by an entity and an attribute. Also like conventional GEAEs, ES-GEAEs are broadly described and will need to be made specific when applied to individual assessments. Adoption of ecosystem services as a type of assessment endpoint is intended to improve the value of risk assessment to environmental decision making, linking ecological risk to human well-being, and providing an improved means of communicating those risks. Integr Environ Assess Manag 2016;12:522-528. Published 2015 SETAC. This article is a US Government work and, as such, is in the public domain in the USA.

Toward a standard lexicon for ecosystem services.

The complex, widely dispersed, and cumulative environmental challenges currently facing society require holistic, transdisciplinary approaches to resolve. The concept of ecosystem services (ES) has become more widely accepted as a framework that fosters a broader systems perspective of sustainability and can make science more responsive to the needs of decision makers and the public. Successful transdisciplinary approaches require a common language and understanding of key concepts. Our primary objective is to encourage the ES research and policy communities to standardize terminology and definitions, to facilitate mutual understanding by multidisciplinary researchers and policy makers. As an important step toward standardization, we present a lexicon developed to inform ES research conducted by the US Environmental Protection Agency and its partners. We describe a straightforward conceptualization of the relationships among environmental decisions, their effects on ecological systems and the services they provide, and human well-being. This provides a framework for common understanding and use of ES terminology. We encourage challenges to these definitions and attempts to advance standardization of a lexicon in ways that might be more meaningful to our ultimate objective: informing environmental decisions in ways that promote the sustainability of the environment upon which we all depend.

Probability surveys, conditional probability, and ecological risk assessment.

We show that probability-based environmental resource monitoring programs, such as the U.S. Environmental Protection Agency's (U.S. EPA) Environmental Monitoring and Assessment Program, and conditional probability analysis can serve as a basis for estimating ecological risk over broad geographic areas. Under certain conditions (including appropriate stratification of the sampled population, sufficient density of samples, and sufficient range of exposure levels paired with concurrent response values), this empirical approach provides estimates of risk using extant field-derived monitoring data. The monitoring data were used to prescribe the exposure field and to model the exposure-response relationship. We illustrate this approach by estimating risks to benthic communities from low dissolved oxygen (DO) in freshwater streams of the mid-Atlantic region and in estuaries of the Virginian Biogeographical Province of the United States. In both cases, the estimates of risk are consistent with the U.S. EPA's ambient water quality criteria for DO.

A new process for organizing assessments of social, economic, and environmental outcomes: case study of wildland fire management in the USA.

Ecological risk assessments typically are organized using the processes of planning (a discussion among managers, stakeholders, and analysts to clarify ecosystem management goals and assessment scope) and problem formulation (evaluation of existing information to generate hypotheses about adverse ecological effects, select assessment endpoints, and develop an analysis plan). These processes require modification to be applicable for integrated assessments that evaluate ecosystem management alternatives in terms of their ecological, economic, and social consequences.We present 8 questions that define the steps of a new process we term integrated problem formulation (IPF), and we illustrate the use of IPF through a retrospective case study comparing 2 recent phases of development of the Fire Program Analysis (FPA) system, a planning and budgeting system for the management of wildland fire throughout publicly managed lands in the United States. IPF extends traditional planning and problem formulation by including the explicit comparison of management alternatives, the valuation of ecological, economic and social endpoints, and the combination or integration of those endpoints. The phase 1, limited prototype FPA system used a set of assessment endpoints of common form (i.e., probabilities of given flame heights over acres of selected land-resource types), which were specified and assigned relative weights at the local level in relation to a uniform national standard. This approach was chosen to permit system-wide optimization of fire management budget allocations according to a cost-effectiveness criterion. Before full development, however, the agencies abandoned this approach in favor of a phase 2 system that examined locally specified (rather than system-optimized) allocation alternatives and was more permissive as to endpoint form. We demonstrate how the IPF process illuminates the nature, rationale, and consequences of these differences, and argue that its early use for the FPA system may have enabled a smoother development path.

The Nexus between ecological risk assessment and natural resource damage assessment under CERCLA: introduction to a Society of Environmental Toxicology and ChemistryTechnical Workshop.

A SETAC Technical Workshop titled "The Nexus Between Ecological Risk Assessment and Natural Resource Damage Assessment Under CERCLA: Understanding and Improving the Common Scientific Underpinnings," was held 18-22 August 2008 in Gregson, Montana, USA, to examine the linkage, nexus, and overlap between ecological risk assessment (ERA) and natural resource damage assessment (NRDA) under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Experts from a broad range of relevant scientific, legal, and policy disciplines convened to 1) ascertain the potential for improved scientific harmonization of the processes of ERA and NRDA; 2) identify where statutory, regulatory, or scientific constraints might exist that would constrain or preclude the harmonization of the 2 processes; 3) determine approaches that might overcome these constraints; and 4) recommend research or potential changes in regulatory policies that might serve to improve both processes. This is the introduction to a series of 3 papers that describe the findings and conclusions of this workshop. Although unanimity was not achieved on all technical, legal, or policy questions posed to the participants, some consensus areas did arise. First, there appear to be few if any legal constraints to using the environmental data collected for ERA or NRDA for both processes. Second, although it is important to recognize and preserve the distinctions between ERA and NRDA, opportunities for data sharing exist, particularly for the characterization of environmental exposures and derivation of ecotoxicological information. Thus, effective coordination is not precluded by the underlying science. Where a cooperative, interactive process is involved among the response agencies, the natural resource trustees, and the responsible party(s), technical, legal or regulatory constraints can be minimized. Finally, one approach that might enhance the potential applicability of data collected for the ERA is to consider ecosystem services in the development of assessment endpoints. These points are explained in greater detail in the series of papers published herein.

Translating ecological risk to ecosystem service loss.

Hazardous site management in the United States includes remediation of contaminated environmental media and restoration of injured natural resources. Site remediation decisions are informed by ecological risk assessment (ERA), whereas restoration and compensation decisions are informed by the natural resource damage assessment (NRDA) process. Despite similarities in many of their data needs and the advantages of more closely linking their analyses, ERA and NRDA have been conducted largely independently of one another. This is the 4th in a series of papers reporting the results of a recent workshop that explored how ERA and NRDA data needs and assessment processes could be more closely linked. Our objective is to evaluate the technical underpinnings of recentmethods used to translate natural resource injuries into ecological service losses and to propose ways to enhance the usefulness of data obtained in ERAs to the NRDA process. Three aspects are addressed: 1) improving the linkage among ERA assessment endpoints and ecological services evaluated in the NRDA process, 2) enhancing ERA data collection and interpretation approaches to improve translation of ERA measurements in damage assessments, and 3) highlighting methods that can be used to aggregate service losses across contaminants and across natural resources. We propose that ERA and NRDA both would benefit by focusing ecological assessment endpoints on the ecosystem services that correspond most directly to restoration and damage compensation decisions, and we encourage development of generic ecosystem service assessment endpoints for application in hazardous site investigations. To facilitate their use in NRDA, ERA measurements should focus on natural resource species that affect the flow of ecosystem services most directly, should encompass levels of biological organization above organisms, and should be made with the use of experimental designs that support description of responses to contaminants as continuous (as opposed to discrete) variables. Application of a data quality objective process, involving input from ERA and NRDA practitioners and site decision makers alike, can facilitate identification of data collection and analysis approaches that will benefit both assessment processes. Because of their demonstrated relationships to a number of important ecosystem services, we recommend that measures of biodiversity be targeted as key measurement endpoints in ERA to support the translation between risk and service losses. Building from case studies of recent successes, suggestions are offered for aggregating service losses at sites involving combinations of chemicals and multiple natural resource groups. Recognizing that ERA and NRDA are conducted for different purposes, we conclude that their values to environmental decision making can be enhanced by more closely linking their data collection and analysis activities.

Integrating human and ecological risk assessment: application to the cyanobacterial harmful algal bloom problem.

Environmental and public health policy continues to evolve in response to new and complex social, economic and environmental drivers. Globalization and centralization of commerce, evolving patterns of land use (e.g., urbanization, deforestation), and technological advances in such areas as manufacturing and development of genetically modified foods have created new and complex classes of stressors and risks (e.g., climate change, emergent and opportunist disease, sprawl, genomic change). In recognition of these changes, environmental risk assessment and its use are changing from stressor-endpoint specific assessments used in command and control types of decisions to an integrated approach for application in community-based decisions. As a result, the process of risk assessment and supporting risk analyses are evolving to characterize the human-environment relationship. Integrating risk paradigms combine the process of risk estimation for humans, biota, and natural resources into one assessment to improve the information used in environmental decisions (Suter et al. 2003b). A benefit to this approach includes a broader, system-wide evaluation that considers the interacting effects of stressors on humans and the environment, as well the interactions between these entities. To improve our understanding of the linkages within complex systems, risk assessors will need to rely on a suite of techniques for conducting rigorous analyses characterizing the exposure and effects relationships between stressors and biological receptors. Many of the analytical techniques routinely employed are narrowly focused and unable to address the complexities of an integrated assessment. In this paper, we describe an approach to integrated risk assessment, and discuss qualitative community modeling and Probabilistic Relational Modeling techniques that address these limitations and evaluate their potential for use in an integrated risk assessment of cyanobacteria.

An integrated framework for health and ecological risk assessment.

The World Health Organization's (WHO's) International Program for Chemical Safety has developed a framework for performing risk assessments that integrate the assessment of risks to human health and risks to nonhuman organisms and ecosystems. The WHO's framework recognizes that stakeholders and risk managers have their own processes that are parallel to the scientific process of risk assessment and may interact with the risk assessment at various points, depending on the context. Integration of health and ecology provides consistent expressions of assessment results, incorporates the interdependence of humans and the environment, uses sentinel organisms, and improves the efficiency and quality of assessments relative to independent human health and ecological risk assessments. The advantage of the framework to toxicologists lies in the opportunity to use understanding of toxicokinetics and toxicodynamics to inform the integrated assessment of all exposed species.

An approach to predict risks to wildlife populations from mercury and other stressors.

Ecological risk assessments for mercury (Hg) require measured and modeled information on exposure and effects. While most of this special issue focuses on the former, i.e., distribution and fate of Hg within aquatic food webs, this paper describes an approach to predict the effects of dietary methylmercury (CH3Hg) on populations of piscivorous birds. To demonstrate this approach, the U.S. Environmental Protection Agency's National Health and Environmental Effects Research Laboratory (U.S. EPA NHEERL) is working cooperatively with environmental and conservation organizations to develop models to predict CH3Hg effects on populations of the common loon, Gavia immer. Specifically, a biologically-based toxicokinetic model is being used to extrapolate CH3Hg effects on the reproduction of a tested bird species, the American kestrel (Falco sparverius), to the loon. Population models are being used to incorporate stressor effects on survival and reproduction into projections of loon population effects. Finally, habitat and spatially-explicit population models are being used to project results spatially, assess the relative importance of CH3Hg and non-chemical stressors, and produce testable predictions of the effects of biologically-available Hg on loon populations. This stepwise process provides an integrated approach to estimate the impact on wildlife populations of regulations that limit atmospherically-distributed Hg, and to develop risk-based population-level regulatory criteria.