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Standard Methods for Development of EPA Transcriptomic Assessment Products (ETAPs)

online resource

posted on 2024-03-11, 13:04 authored by Amanda Brennan, Daniel Chang, John Cowden, Sarah Davidson-Fritz, Jeffry Dean, Michael Devito, Jermaine Ford, Logan Everett, Alison Harrill, Susan Hester, Michael Hughes, Jason Lambert, Lucina Lizarraga, Roman Mezencev, Denise MacMillan, Grace Patlewicz, Kris Thayer, Russell Thomas, Kelsey Vitense, Leah Wehmas, Aero Renyer, Scott Auerbach, Warren Casey, Reeder Sams, Sid Hunter, Wayne Cascio, Kay Holt, Samantha Jones, Ravi Subramaniam, Glenn E. Rice, John Bucher, Timothy Buckley, Peter Egeghy, Katie Paul Friedman, Joshua Harrill, Kristin Isaacs, Richard Judson, Jonathan Kaiser, Scott V. Masten, Fred Parham, Dan Petersen, Allison Phillips, Jon Sobus, Dan Villeneuve, Paul White, Antony Williams, George M. Woodall, Jay Zhao

EPA Transcriptomic Assessment Products (ETAPs) are developed by the Office of Research and Development (ORD), United States Environmental Protection Agency (EPA) to provide transcriptomic-based reference values (TRV). To the extent possible based on the currently available evidence, the objective of this human health assessment is to provide a TRV with the level of confidence and caveats outlined in the Standard Methods for Development of EPA Transcriptomic Assessment Products (ETAPs). The TRV is defined as an estimate of a daily oral dose that is likely to be without appreciable risk of adverse effects following chronic exposure. The TRV is meant to protect both the exposed individual and population from effects other than cancer or related to cancer if a necessary key precursor event does not occur below a specific exposure level. While a TRV is expressly presented as a chronic value in an ETAP, it may also be applicable across other exposure durations of interest including short-term and subchronic. This approach has been previously used by EPA in certain risk assessment applications (e.g., Provisional Peer-Reviewed Toxicity Value [PPRTV] assessments) wherein a chronic non-cancer reference value has been adopted as a conservative estimate for a subchronic non-cancer reference value when data quality and/or lack of duration-relevant hazard and dose-response data preclude direct derivation.

The ETAP is intended to be applied to data poor substances with no existing or publicly accessible repeat dose toxicity studies or suitable human evidence. The assessment is not intended to represent a comprehensive treatise on the chemical. ETAP assessments may be updated to incorporate new data or methodologies that might impact the toxicity values, or, retired if traditional toxicity studies and an associated human health assessment are published. The general methods associated with conducting the systematic literature survey and animal study are provided in Standard Methods for Development of EPA Transcriptomic Assessment Products (ETAPs).

Science Inventory, CCTE products: https://cfpub.epa.gov/si/si_public_search_results.cfm?advSearch=true&showCriteria=2&keyword=CCTE&TIMSType=&TIMSSubTypeID=&epaNumber=&ombCat=Any&dateBeginPublishedPresented=07/01/2017&dateEndPublishedPresented=&dateBeginUpdated=&dateEndUpdated=&DEID=&personName=&personID=&role=Any&journalName=&journalID=&publisherName=&publisherID=&sortBy=pubDate&count=25