Considerations for refining the risk assessment process for formaldehyde: Results from an interdisciplinary workshop

Melvin E. Andersen, P. Robinan Gentry, James A. Swenberg, Kenneth A. Mundt, Kimberly W. White, Chad Thompson, James Bus, James H. Sherman, Helmut Greim, Hermann Bolt, Gary M. Marsh, Harvey Checkoway, David Coggon, Harvey J. Clewell

Research output: Contribution to journalArticlepeer-review

19 Scopus citations


Anticipating the need to evaluate and integrate scientific evidence to inform new risk assessments or to update existing risk assessments, the Formaldehyde Panel of the American Chemistry Council (ACC), in collaboration with the University of North Carolina, convened a workshop: “Understanding Potential Human Health Cancer Risk - From Data Integration to Risk Evaluation” in October 2017. Twenty-four (24)invited-experts participated with expertise in epidemiology, toxicology, science integration and risk evaluation. Including members of the organizing committee, there were 29 participants. The meeting included eleven presentations encompassing an introduction and three sessions: (1)“integrating the formaldehyde science on nasal/nasopharyngeal carcinogenicity and potential for causality”; (2)“integrating the formaldehyde science on lymphohematopoietic cancer and potential for causality; and, (3)“formaldehyde research-data suitable for risk assessment”. Here we describe key points from the presentations on epidemiology, toxicology and mechanistic studies that should inform decisions about the potential carcinogenicity of formaldehyde in humans and the discussions about approaches for structuring an integrated, comprehensive risk assessment for formaldehyde. We also note challenges expected when attempting to reconcile divergent results observed from research conducted within and across different scientific disciplines - especially toxicology and epidemiology - and in integrating diverse, multi-disciplinary mechanistic evidence.

Original languageEnglish
Pages (from-to)210-223
Number of pages14
JournalRegulatory Toxicology and Pharmacology
StatePublished - Aug 2019
Externally publishedYes


  • Evidence integration
  • Formaldehyde
  • Inconsistent human epidemiology
  • Integrating data streams
  • Mode-of-action in animal studies
  • Reconciling conflicting conclusions


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