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

Abstract

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.

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

“…United States-Emerging science has assisted in refining and more accurately characterizing toxicity (Bean et al, 2023;Rattner et al, 2023) exposure (Sample et al, 2022) and ultimately risk, particularly for assessing contaminated sites. Stable isotope analysis and bioelution testing for wildlife have been used to more accurately define exposures and sources for toxicants at contaminated sites (Morrissey et al, 2023;Post, 2002;Ruby et al, 1993).…”

Integrating emerging science to improve estimates of risk to wildlife from chemical exposure: What are the challenges?

“…Challenge: Working within constrained regulatory frameworks. The steps taken during problem formulation are guided by specifications set out in the relevant guidance documents for the jurisdiction, although often little focus is provided for wildlife per se (Sample et al, 2022). Some of these specifications are based on legal precedent or outdated science that no longer provide meaningful guidance on the problem formulation process.…”

“…Alternative lines of evidence can be used to help reduce uncertainty associated with traditional approaches, and new methods and tools can have current, direct applicability to them. The problem formulation work group's article (Sample et al, 2022) describes these opportunities for integration of new tools and methods, and the associated challenges.…”

“…Specific statements are required to document the issues, questions (hypotheses), and levels of protection. Those statements must inform decision-making, while being considered relative to the data and collection methods (Sample et al, 2022). As the science has advanced in a variety of areas (Bean et al, 2023;Morrissey et al, 2023;Rattner et al, 2023), there are many emerging technologies available to risk assessors to understand and quantify the extent and magnitude of risks to wildlife.…”

“…To address this impasse, the idea of organizing a workshop was conceived, which then led to work groups whose members coalesced in online meetings over time. That process resulted in a series of five reviews, each of which addressed a specific component of the risk-assessment process: problem formulation (Sample et al, 2022), effect assessment (Bean et al, 2023;Rattner et al, 2023), exposure assessment (Morrissey et al, 2023), and risk characterization (Johnson et al, 2024). The purpose of the present overview, the sixth article, is to provide the context for the various group recommendations for improving wildlife risk assessment across various regulatory regimes, by describing the perceived problems with current wildlife ecological risk assessment (WERA) practices and summarizing prospective advances.…”