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Related Experiment Videos

Comparing toxicologic and epidemiologic studies: methylene chloride--a case study

L T Stayner1, A J Bailer

  • 1Risk Assessment Program, National Institute for Occupational Safety and Health, Cincinnati, Ohio 45226.

Risk Analysis : an Official Publication of the Society for Risk Analysis
|December 1, 1993
PubMed
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Methylene chloride exposure may cause cancer. A study of Kodak workers found cancer risks consistent with Occupational Safety and Health Administration (OSHA) predictions, suggesting animal models may not always align with human occupational exposure risks.

Area of Science:

  • Toxicology and Occupational Health
  • Cancer Risk Assessment
  • Epidemiology

Background:

  • Methylene chloride is a known carcinogen in mice, forming the basis for human cancer risk assessments.
  • Epidemiologic studies on methylene chloride-exposed workers show mixed results regarding increased cancer risk.
  • Previous analyses of the Kodak worker study yielded conflicting conclusions on the validity of EPA risk assessment models.

Purpose of the Study:

  • To evaluate the consistency between Occupational Safety and Health Administration (OSHA) cancer risk predictions and observed mortality data from a study of Kodak workers exposed to methylene chloride.
  • To assess whether negative epidemiologic findings in occupationally exposed populations are reconcilable with established animal-based risk assessment models.

Main Methods:

Related Experiment Videos

  • Comparison of confidence intervals for standardized mortality ratios (SMRs) from the Kodak worker study with predicted confidence intervals from OSHA's multistage cancer risk models.
  • Inclusion of adjustments for the 'healthy worker effect,' variations in follow-up duration, and interspecies dosimetry differences in the comparative analysis.
  • Utilizing a negative epidemiologic study (Kodak workers) to test and validate occupational cancer risk predictions.

    • Main Results:

    • The standardized mortality ratios (SMRs) observed in the Kodak worker study were found to be not inconsistent with the confidence intervals predicted by OSHA's multistage risk assessment models for liver and lung cancer.
    • Adjustments for confounding factors did not alter the conclusion of consistency between the epidemiologic data and the OSHA model predictions.
    • The negative findings in the Kodak study align with the predictions derived from OSHA's risk assessment framework when appropriate adjustments are applied.

    Conclusions:

    • The negative cancer risk findings in the Kodak worker study are reconcilable with the predictions generated by OSHA's multistage cancer risk models.
    • This suggests that OSHA's risk assessment models, when accounting for factors like the healthy worker effect and dosimetry, can be consistent with negative occupational epidemiology.
    • The study supports the utility of OSHA's models in evaluating occupational cancer risks, even in the presence of seemingly negative human study results.