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Extrapolation by proximate inference
1Psychobiology Laboratory, Harvard University School of Medicine, Boston, MA 02116-6078.
Neuroscience and Biobehavioral Reviews
|January 1, 1991
Summary
Scientists must differentiate scientific extrapolation from regulatory safety assessments. Misapplying scientific methods to legal questions hinders establishing acceptable agent safety levels.
Area of Science:
- Regulatory Science
- Risk Assessment
- Scientific Methodology
Background:
- Distinguishing between scientific extrapolation (e.g., astronomy) and legal/regulatory extrapolation is crucial.
- Legal and regulatory extrapolation aims to establish acceptably safe levels of agents.
Purpose of the Study:
- To highlight the critical differences between scientific and regulatory extrapolation.
- To explain why scientists' attempts at purely scientific extrapolation fail in legal/regulatory contexts.
Main Methods:
- Conceptual analysis of extrapolation methodologies.
- Review of scientific and technological information requirements in regulatory science.
Main Results:
- Scientific extrapolation relies on theoretical models and observations.
- Regulatory extrapolation requires integrating scientific data with legal and policy considerations.
- Scientists often fail to contribute effectively when applying purely scientific extrapolation to regulatory questions.
Conclusions:
- Effective regulatory extrapolation necessitates a distinct approach beyond pure scientific methods.
- Scientists need to understand the specific requirements of legal and regulatory contexts to contribute meaningfully to safety assessments.
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