Classification schemes for carcinogenicity based on hazard-identification have become outmoded and serve neither science nor society

Alan R. Boobis, Samuel M. Cohen, Vicki L. Dellarco, John E. Doe, Penelope A. Fenner-Crisp, Angelo Moretto, Timothy P. Pastoor, Rita S. Schoeny, Jennifer G. Seed, Douglas C. Wolf

Research output: Contribution to journalComment/debatepeer-review

57 Scopus citations


Classification schemes for carcinogenicity based solely on hazard-identification such as the IARC monograph process and the UN system adopted in the EU have become outmoded. They are based on a concept developed in the 1970s that chemicals could be divided into two classes: carcinogens and non-carcinogens. Categorization in this way places into the same category chemicals and agents with widely differing potencies and modes of action. This is how eating processed meat can fall into the same category as sulfur mustard gas. Approaches based on hazard and risk characterization present an integrated and balanced picture of hazard, dose response and exposure and allow informed risk management decisions to be taken. Because a risk-based decision framework fully considers hazard in the context of dose, potency, and exposure the unintended downsides of a hazard only approach are avoided, e.g., health scares, unnecessary economic costs, loss of beneficial products, adoption of strategies with greater health costs, and the diversion of public funds into unnecessary research. An initiative to agree upon a standardized, internationally acceptable methodology for carcinogen assessment is needed now. The approach should incorporate principles and concepts of existing international consensus-based frameworks including the WHO IPCS mode of action framework.

Original languageEnglish (US)
Pages (from-to)158-166
Number of pages9
JournalRegulatory Toxicology and Pharmacology
StatePublished - Dec 1 2016


  • Carcinogenicity
  • Classification
  • GHS
  • Hazard characterization
  • IARC
  • Risk assessment

ASJC Scopus subject areas

  • Toxicology


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