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Using human data to protect the public's health.
M L Dourson1, M E Andersen, L S Erdreich
1Toxicology Excellence for Risk Assessment, 1757 Chase Avenue, Cincinnati, OH 45223, USA. Dourson@tera.org
Regulatory Toxicology and Pharmacology : RTP
|May 15, 2001
Summary
Human data is crucial for accurate risk assessment, often yielding lower safety thresholds than animal data. Utilizing human studies and pharmacokinetic modeling enhances public health protection policies.
Area of Science:
- Toxicology and Risk Assessment
- Environmental Health Sciences
- Pharmacokinetics and Human Studies
Background:
- The use of human data in risk assessment for environmental contaminants, drugs, and chemicals has a long history.
- Recent discussions within the Environmental Protection Agency (EPA) have raised questions about the reliance on human data for risk assessment.
- Existing risk assessment frameworks often rely on experimental animal data to derive safety values.
Purpose of the Study:
- To evaluate the differences between risk assessment values derived from human data versus experimental animal data.
- To assess the availability and appropriateness of animal data for deriving risk assessment values.
- To highlight the importance of human pharmacokinetic and mechanistic data in risk management decisions.
Main Methods:
- Comparison of reference doses (RfDs) and reference concentrations (RfCs) derived from human data (Integrated Risk Information System - IRIS) with those estimated from animal data.
- Inclusion of minimal risk levels from the Agency for Toxic Substances and Disease Registry (ATSDR) and tolerable intakes from Health Canada in the comparison.
- Analysis of human pharmacokinetic data from volunteer studies and in vitro mechanistic studies.
- Application of physiologically based pharmacokinetic (PBPK) modeling to assess interindividual variability.
Main Results:
- Human-based RfDs were over threefold lower than animal-based RfDs in 23% of comparisons.
- Human-based RfDs or RfCs were lower than animal-based ones in 36% of all comparisons.
- For 10 out of 43 comparisons, experimental animal data were insufficient or inappropriate for deriving RfDs or RfCs.
Conclusions:
- Direct use and interpretation of human data, alongside animal data, are essential for robust public health protection.
- Human pharmacokinetic and mechanistic data are critical for understanding variability and identifying at-risk populations.
- Policies encouraging the integrated use of human and animal data in risk assessment should be promoted.
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