LAUSR

Agencies responsible for environmental protection are tasked with developing regulatory guidance that is based on the best available scientific evidence. Histopathology is a common endpoint in toxicologic bioassays; however, because of the subjective nature of this endpoint, and the advanced level of specialized training required for its effective utilization, the reliability of histopathology data can be inconsistent. Consequently, mechanisms for evaluating such data on a case-by-case basis are needed. The purposes of the present review are to describe a methodology that can be used to evaluate the credibility of histopathology findings and to discuss the results of such assessments as applied to real-world data collected from the scientific literature. A key outcome of these efforts was the finding that only 54% of the studies examined contained histopathology data that were considered to be either highly credible or credible, whereas data in 46% of those studies were of equivocal, dubious, or no credibility. In addition, the results indicated that the quality of the data examined tended to decline during the past 15 yr. The ultimate goals of the present review are to draw attention to reliability issues that can affect histopathology results, provide recommendations to improve the quality of this endpoint, and suggest an approach for the expeditious and judicious use of histopathology data in the weight-of-evidence determinations required for hazard and/or risk assessment. This exercise was conducted initially as part of a SETAC Pellston Workshop™ entitled "Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Chemicals (EHRA): Developing Technical Guidance Based on Case Studies to Support Decision Making" that was held in Pensacola, Florida (USA) from 31 January to 5 February 2016. Environ Toxicol Chem 2017;36:601-611. © 2016 SETAC.