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Regulating Toxic SubstancesA Philosophy of Science and the Law$
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Carl F. Cranor

Print publication date: 1993

Print ISBN-13: 9780195074369

Published to Oxford Scholarship Online: October 2011

DOI: 10.1093/acprof:oso/9780195074369.001.0001

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The Scientific Background

The Scientific Background

(p.12) 1 The Scientific Background
Regulating Toxic Substances

Kristin Shrader-frechette General

Oxford University Press

This chapter provides some scientific background of risk assessment and sets up some of the institutional questions concerning the appropriate evidentiary standards needed within torts and administrative law to establish the requisite harms or risks of harm. The discussion here focuses on animal bioassays and human epidemiological studies, two aspects of carcinogen risk assessment relied upon in regulatory institutions to ascertain risks to human beings. The best evidence that proves that a substance causes cancer to human beings is provided by well-done epidemiological studies with large samples and sufficient follow-up. However, the chapter begins by considering animal studies, which is the evidence much more frequently relied upon by regulatory agencies, although it is less typically used in tort law and some jurisdictions give it little credence. There are uncertainties in animal bioassays which are large enough such that two different researchers using exactly the same data points from an animal study can come to much different conclusions.

Keywords:   animal bioassays, epidemiological studies, torts, carcinogen risk assessment, animal study

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