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.

Restoration of impaired ecosystems: An ounce of prevention or a pound of cure? Introduction, overview, and key messages from a SETAC-SER workshop.

A workshop on Restoration of Impaired Ecosystems was held in Jackson, Wyoming, in June 2014. Experts from Australia, Canada, Mexico, the United Kingdom, and the United States in ecotoxicology, restoration, and related fields from both the Society of Environmental Toxicology and Chemistry and the Society for Ecological Restoration convened to advance the practice of restoring ecosystems that have been contaminated or impaired from industrial activities. The overall goal of this workshop was to provide a forum for ecotoxicologists and restoration ecologists to define the best scientific practices to achieve ecological restoration while addressing contaminant concerns. To meet this goal, participants addressed 5 areas: 1) links between ecological risk assessment and ecological restoration, 2) restoration goals, 3) restoration design, 4) monitoring for restoration effectiveness and 5) recognizing opportunities and challenges. Definitions are provided to establish a common language across the varied disciplines. The current practice for addressing restoration of impaired ecosystems tends to be done sequentially to remediate contaminants, then to restore ecological structure and function. A better approach would anticipate or plan for restoration throughout the process. By bringing goals to the forefront, we may avoid intrusive remediation activities that close off options for the desired restoration. Participants realized that perceived limitations in the site assessment process hinder consideration of restoration goals; contaminant presence will influence restoration goal choices; social, economic, and cultural concerns can factor into goal setting; restoration options and design should be considered early during site assessment and management; restoration of both structure and function is encouraged; creative solutions can overcome limitations; a regional focus is imperative; monitoring must occur throughout the restoration process; and reciprocal transfer of knowledge is needed among theorists, practitioners, and stakeholders and among varied disciplines.

Opportunities and challenges of integrating ecological restoration into assessment and management of contaminated ecosystems.

Ecosystem restoration planning near the beginning of the site assessment and management process ("early integration") involves consideration of restoration goals from the outset in developing solutions for contaminated ecosystems. There are limitations to integration that stem from institutional barriers, few successful precedents, and limited availability of guidance. Challenges occur in integrating expertise from various disciplines and multiple, sometimes divergent interests and goals. The more complex process can result in timing, capacity, communication, and collaboration challenges. On the other hand, integrating the 2 approaches presents new and creative opportunities. For example, integration allows early planning for expanding ecosystem services on or near contaminated lands or waters that might otherwise have been unaddressed by remediation alone. Integrated plans can explicitly pursue ecosystem services that have market value, which can add to funds for long-term monitoring and management. Early integration presents opportunities for improved and productive collaboration and coordination between ecosystem restoration and contaminant assessment and management. Examples exist where early integration facilitates liability resolution and generates positive public relations. Restoration planning and implementation before the completion of the contaminated site assessment, remediation, or management process ("early restoration") can facilitate coordination with offsite restoration options and a regional approach to restoration of contaminated environments. Integration of performance monitoring, for both remedial and restoration actions, can save resources and expand the interpretive power of results. Early integration may aid experimentation, which may be more feasible on contaminated lands than in many other situations. The potential application of concepts and tools from adaptive management is discussed as a way of avoiding pitfalls and achieving benefits in early integration. In any case, there will be challenges with early integration of restoration concepts for contaminated ecosystems, but the benefits are likely to outweigh them.

Recommendations for the development and application of wildlife toxicity reference values.

Toxicity reference values (TRVs) are essential in models used in the prediction of the potential for adverse impacts of environmental contaminants to avian and mammalian wildlife; however, issues in their derivation and application continue to result in inconsistent hazard and risk assessments that present a challenge to site managers and regulatory agencies. Currently, the available science does not support several common practices in TRV derivation and application. Key issues include inappropriate use of hazard quotients and the inability to define the probability of adverse outcomes. Other common problems include the continued use of no-observed- and lowest-observed-adverse-effect levels (NOAELs and LOAELs), the use of allometric scaling for interspecific extrapolation of chronic TRVs, inappropriate extrapolation across classes when data are limited, and extrapolation of chronic TRVs from acute data without scientific basis. Recommendations for future TRV derivation focus on using all available qualified toxicity data to include measures of variation associated with those data. This can be achieved by deriving effective dose (EDx)-based TRVs where x refers to an acceptable (as defined in a problem formulation) reduction in endpoint performance relative to the negative control instead of relying on NOAELs and LOAELs. Recommendations for moving past the use of hazard quotients and dealing with the uncertainty in the TRVs are also provided.

Sequential analysis of lines of evidence--an advanced weight-of-evidence approach for ecological risk assessment.

Weight-of-evidence (WOE) approaches have been used in ecological risk assessment (ERA) for many years. The approaches integrate various types of data (e.g., from chemistry, bioassay, and field studies) to make an overall conclusion of risk. However, the current practice of WOE has several important difficulties, including a lack of transparency related to how each line of evidence is weighted or integrated into the overall weight-of-evidence conclusion. Therefore, a sequential analysis of lines of evidence (SALE) approach has been developed that advances the practice of WOE. It was developed for an ERA of chemical stressors but also can be used for nonchemical stressors and is equally applicable to the aquatic and terrestrial environments. The sequential aspect of the SALE process is a significant advancement and is based on 2 primary ideas. First, risks can be ruled out with the use of certain lines of evidence, including modeled hazard quotients (HQs) and comparisons of soil, water, or sediment quality with conservative soil, water or sediment quality guidelines. Thus, the SALE process recognizes that HQs are most useful in ruling out risk rather than predicting risk to ecological populations or communities. Second, the SALE process provides several opportunities to exit the risk assessment process, not only when risks are ruled out, but also when magnitude of effect is acceptable or when little or no evidence exists that associations between stressors and effects may be causal. Thus, the SALE approach explicitly includes interaction between assessors and managers. It illustrates to risk managers how risk management can go beyond the simple derivation of risk-based concentrations of chemicals of concern to risk management goals based on ecological metrics (e.g., species diversity). It also can be used to stimulate discussion of the limitations of the ERA science, and how scientists deal with uncertainty. It should assist risk managers by allowing their decisions to be based on a sequential, flexible, and transparent process that includes direct toxicity risks, indirect risks (via changes in habitat suitability), and the spatial and temporal factors that can influence the risk assessment.