Guidelines for Carcinogen Risk Assessment

By Environmental Protection Agency

Book Id: WPLBN0000126487
Format Type: PDF eBook
File Size: 0.2 MB
Reproduction Date: 2007

Title:	Guidelines for Carcinogen Risk Assessment
Author:	Environmental Protection Agency
Volume:
Language:	English
Subject:	Ecology, Natural resource issues, Environemtal protection
Collections:	Environmental Awareness Library Collection
Historic Publication Date:
Publisher:	United States Environmental Protection Agency


Citation APA MLA Chicago Agency, E. P. (n.d.). Guidelines for Carcinogen Risk Assessment. Retrieved from http://gutenberg.cc/

Description
Excerpt: This document has been reviewed in accordance with U.S. Environmental Protection Agency policy and approved for publication. Mention of trade names or commercial products does not constitute endorsement or recommendation for use.

Table of Contents
CONTENTS List of Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v Federal Register Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Part A: Guidelines for Carcinogen Risk Assessment I. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 II. Hazard Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 A. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 B. Elements of'Hazard Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1. Physical-Chemical Properties and Routes and Patterns of Exposure . . . . . . . . . . . . . 3 2. Structure-ActivityRelationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3. Metabolic and Pharmacokinetic Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4. Toxicologic Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 5. Short-TermTests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 6. Long-Term Animal Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 7. Human Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 C. Weight of Evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 D. Guidance for Dose-Response Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 E. Summary and Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 III. Dose-Response Assessment, Exposure Assessment, and Risk Characterization . . . . . . . . . 10 A. Dose-Response Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 1. Selection of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 2. Choice of'Mathematical Extrapolation Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 3. Equivalent Exposure Units Among Species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 B. Exposure Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 C. Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 1. Options for Numerical Risk Estimates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 2. Concurrent Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 3. Summary of Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 IV. EPA Classification System for Categorizing Weight of Evidence for Carcinogenicity from Human and Animal Studies (Adapted from IARC) . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 A. Assessment of Weight of' Evidence for Carcinogenicity from Studies in Humans . . . . 17