Publications : 2022

LaPlaca SB, Heintz MM, Wikoff D, Haws LC. Multi-step integration of ecotoxicological study reliability in ecological risk assessment. Poster at Society of Environmental Toxicology and Chemistry SETAC North America 43rd Annual Meeting, Philadelphia, PA, November 2022.

Abstract

Evaluation of study reliability is a critical component of toxicity value development, as well as in the overall risk assessment process. As approaches vary and are evolving with the use of systematic review, the objective herein was two-fold: (1) to conduct a survey of how ecotoxicology study reliability is assessed by authoritative bodies globally, and (2) to propose a workflow to objectively integrate study quality considerations in the development of PNEC values for use in ecological risk assessment. The survey demonstrated that many regulatory agencies use Klimisch or Criteria for Reporting and Evaluating Ecotoxicity Data (CRED) methodologies; in practice, however, these frameworks are frequently modified and are utilized in differing capacities in the risk assessment process. In addition, different offices within the USEPA have their own guidance and approaches. Unique and overlapping criteria were identified in each study quality tool; these attributes were subsequently utilized in the proposed workflow. Specifically, we propose a tiered assessment of study reliability which involves a first step of assessment of minimum reporting and conduct standards to be considered for inclusion (e.g., test substance identification), similar to that employed by the USEPA for the ECOTOX database. Second, critical appraisal of reliability using a refined technique in which CRED criteria were modified to better incorporate systematic review principles. The proposed tool is modeled after the National Toxicology Program (NTP) Office of Health Assessment and Translation (OHAT) guidance, created to place emphasis on key criteria and formulation of an overall tier for reliability in toxicity value derivation. Key categories given the most weight that are incorporated into this tool include: i) are appropriate control groups tested and their performance reported? ii) is the performance of the exposed test species evaluated, including observations for toxicity? iii) is the exposure method, route, frequency of administration, and length of treatment period reported and consistent across study groups? This workflow and revised critical appraisal tool incorporates existing evaluation methods used across regulatory agencies in addition to systematic review principles, providing a thorough and transparent study quality review process that can be universally applied in assessing studies for toxicity value development and use in risk assessment for ecotoxicological endpoints.