Publications : 2017

Reddick Schaefer H, Myers J. Texas Commission on Environmental Quality Guidelines for Systematic Review: Ethylene glycol case study. Abstract 2821, Society of Toxicology 56th Annual Meeting, Baltimore, MD, 2017.

Abstract

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The Texas Commission on Environmental Quality (TCEQ) developed guidance to provide information on conducting systematic reviews during the development of chemical-specific toxicity factors. The framework supplements TCEQ’s 2015 published regulatory guidelines on deriving toxicity factors and were developed specifically for use by the TCEQ. We present a case study using ethylene glycol as an example of how systematic review methods can be applied during the development of chemical-specific toxicity factors. Building from existing methodologies, the TCEQ systematic review process includes six steps: 1) Problem Formulation; 2) Systematic Literature Review and Selection of Studies for Inclusion; 3) Data Extraction; 4) Study Quality and Risk of Bias Assessment; 5) Evidence Integration and Endpoint Determination; and 6) Rating the Confidence in the Body of Evidence. For ethylene glycol, publically available databases were searched using explicitly stated search criteria, which resulted in 106 references. The selected studies were imported into the Health Assessment Workspace Collaborative (HAWC) systematic literature review tool. Each title and abstract were reviewed for relevance and tagged for either inclusion (human, animal, or mechanistic) or exclusion (not a relevant/applicable study) based on predetermined criteria. The pool of available data was narrowed down to 18 included studies: 7 human studies, 6 animal studies, and 5 mechanistic/in vitro studies. Identified studies were reviewed in detail and the primary data was extracted for potential use in the development of the toxicity factor. Each study was also evaluated for study quality and risk of bias based on a number of attributes determined prior to the review. After addressing the study quality and risk of bias for each of the selected studies, the information from each of the data streams (human, animal, mechanistic) was compiled together and assessed for use as key, supporting, and informative studies. Using a qualitative ranking system of low, medium, or high confidence, the confidence and uncertainty for each aspect or element of the toxicity assessment was rated. Further case studies are necessary to confirm and clarify the utility of the TCEQ systematic review guidelines. Each step of the systematic literature review and evidence integration process plays an important role in improving confidence and transparency in the development of toxicity factors