Systematic evidence map (SEM) template: Report format and methods used for the US EPA Integrated Risk Information System (IRIS) program, Provisional Peer Reviewed Toxicity Value (PPRTV) program, and other “fit for purpose” literature-based human health analyses

Thayer, Kristina A.; Angrish, Michelle; Arzuaga, Xabier; Carlson, Laura M.; Davis, Allen P.; Dishaw, Laura; Druwe, Ingrid; Gibbons, Catherine F.; Glenn, Barbara; Jones, Ryan; Kaiser, Jonas; Keshava, Channa; Keshava, Nagalakshmi; Kraft, Andrew D.; Lizarraga, Lucina E.; Persad, Amanda S.; Radke, Elizabeth G.; Rice, Glenn; Schulz, Brittany; Shaffer, Rachel M.; Shannon, Teresa; Shapiro, Andrew J.; Thacker, Shane; Vulimiri, Suryanarayana V.; Williams, Antony; Woodall, George M.; Yost, Erin E.; Blain, Robyn; Duke, Katherine; Goldstone, Alexandra E.; Hartman, Pam; Hobbie, Kevin A.; Ingle, Brandall; Lemeris, Courtney; Lin, Cynthia J.; Lindahl, Alex; McKinley, Kristen; Soleymani, Parnian; Vetter, Nicole

doi:10.1016/j.envint.2022.107468

Cited by 5 publications

(6 citation statements)

References 21 publications

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“…This is a thumbnail image of the interactive visual ( https://hawc.epa.gov/summary/visual/assessment/100500256/Animal-SQE-Heatmap_nonECHA/ ) accessed on 3 November 2023. 67 The study evaluation approach follows standard methods that are used in systematic evidence maps developed by the US EPA 27 , 28 , 32 and have only been adjusted, where appropriate, for the specific needs of this SEM. A full download of detailed evaluation summaries is available through HAWC, or in Excel Table S11.…”

Section: Resultsmentioning

confidence: 99%

“…The Office of Research and Development (ORD) Staff Handbook for Developing IRIS Assessments (referred to as the “IRIS Handbook”) 27 and a published evidence map template 28 , 29 outlines the systematic review methods used to develop the evidence map. The methods reproduced below are taken directly from our earlier SEMs on

PFAS, 12 , 30 because this SEM is a continuation of that work.…”

Section: Methodsmentioning

confidence: 99%

“… Note: The definitions in the table follow standard template language that is used in systematic evidence maps developed by the US EPA 27 , 28 , 32 and have only been adjusted, where appropriate, for the specific needs of this SEM. CASRN, Chemical Abstract Service registry number; DTXSID, DSSTox substance identifier; PECO, Populations Exposures Comparators Outcomes; PFAS, per- and polyfluoroalkyl substances; SEM, Systematic Evidence Map.…”

Section: Methodsmentioning

confidence: 99%

“… Note: “Potentially relevant” supplemental material are studies that do not meet the PECO criteria but may still contain information of interest that was tracked during screening. The definitions in the table follow standard template language that is used in systematic evidence maps developed by the US EPA 27 , 28 , 32 and have only been adjusted, where appropriate, for the specific needs of this SEM. ADME, absorption, distribution, metabolism, and excretion; ECHA, European Chemicals Agency; PBPK, physiologically-based pharmacokinetic; PK, pharmacokinetic; SEM, Systematic Evidence Map.…”

Section: Methodsmentioning

confidence: 99%

“…The ratings, which reflect a consensus judgment between reviewers, are defined in the IRIS Handbook. 27 The definitions below follow standard template language that is used in systematic evidence maps developed by the US EPA 28 , 32 and have only been adjusted, where appropriate, for the specific needs of this SEM. High: A well-conducted study with no notable deficiencies or concerns identified for the outcome(s) of interest; the potential for bias is unlikely or minimal, and the study used sensitive methodology.…”

Section: Methodsmentioning

confidence: 99%

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Expanded Systematic Evidence Map for Hundreds of Per- and Polyfluoroalkyl Substances (PFAS) and Comprehensive PFAS Human Health Dashboard

Shirke,

Radke,

Lin

et al. 2024

Environ Health Perspect

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Background: Per- and polyfluoroalkyl substances (PFAS) encompass a class of chemically and structurally diverse compounds that are extensively used in industry and detected in the environment. The US Environmental Protection Agency (US EPA) 2021 PFAS Strategic Roadmap describes national research plans to address the challenge of PFAS. Objectives: Systematic Evidence Map (SEM) methods were used to survey and summarize available epidemiological and mammalian bioassay evidence that could inform human health hazard identification for a set of 345 PFAS that were identified by the US EPA’s Center for Computational Toxicology and Exposure (CCTE) for in vitro toxicity and toxicokinetic assay testing and through interagency discussions on PFAS of interest. This work builds from the 2022 evidence map that collated evidence on a separate set of PFAS. Like our previous work, this SEM does not include PFAS that are the subject of ongoing or completed assessments at the US EPA. Methods: SEM methods were used to search, screen, and inventory mammalian bioassay and epidemiological literature from peer-reviewed and gray literature sources using manual review and machine-learning software. For each included study, study design details and health end points examined were summarized in interactive web-based literature inventories. Some included studies also underwent study evaluation and detailed extraction of health end point data. All underlying data is publicly available online as interactive visuals with downloadable metadata. Results: More than 13,000 studies were identified from scientific databases. Screening processes identified 121 mammalian bioassay and 111 epidemiological studies that met screening criteria. Epidemiological evidence (available for 12 PFAS) mostly assessed the reproductive, endocrine, developmental, metabolic, cardiovascular, and immune systems. Mammalian bioassay evidence (available for 30 PFAS) commonly assessed effects in the reproductive, whole-body, nervous, and hepatic systems. Overall, 41 PFAS had evidence across mammalian bioassay and epidemiology data streams (roughly 11% of searched chemicals). Discussion: No epidemiological and/or mammalian bioassay evidence were identified for most of the PFAS included in our search. Results from this SEM, our 2022 SEM on PFAS, and other PFAS assessment products from the US EPA are compiled into a comprehensive PFAS dashboard that provides researchers and regulators an overview of the current PFAS human health landscape including data gaps and can serve as a scoping tool to facilitate prioritization of PFAS-related research and/or risk assessment activities. https://doi.org/10.1289/EHP13423

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Section: Resultsmentioning

confidence: 99%

PFAS, 12 , 30 because this SEM is a continuation of that work.…”

Section: Methodsmentioning

confidence: 99%