Guidelines for Carcinogen Risk Assessment

Guidelines for Carcinogen Risk Assessment

March 2005 | Risk Assessment Forum, U.S. Environmental Protection Agency
The document provides guidelines for carcinogen risk assessment, emphasizing critical analysis of available information, mode of action, weight of evidence, dose-response assessment, and susceptibility to different populations and life stages. It outlines the organization and application of the guidelines, focusing on hazard assessment, exposure assessment, and risk characterization. The guidelines aim to protect human health while adhering to sound scientific principles, using peer-reviewed data and default options when necessary. Key features include: 1. **Critical Analysis of Available Information**: Starting point for evaluation, emphasizing the importance of critical analysis of all relevant data. 2. **Mode of Action**: Central to understanding carcinogenic processes, with a focus on identifying key events and processes leading to cancer. 3. **Weight of Evidence Narrative**: Integrating all evidence to conclude on the human carcinogenic potential of agents. 4. **Dose-Response Assessment**: Evaluating potential risks at specific exposure levels, including extrapolation to lower doses. 5. **Susceptible Populations and Life Stages**: Identifying and addressing risks to specific populations and life stages, particularly children. 6. **Evaluating Risks from Childhood Exposures**: Special attention to early-life exposures, recognizing higher susceptibility and the need for specific assessments. The guidelines are designed to be flexible, incorporating new scientific knowledge and evolving research methods, while maintaining scientific credibility and responsiveness to decision-makers. They are intended to guide EPA staff in developing and using risk assessments and to provide the public with information on the Agency's risk assessment methods.The document provides guidelines for carcinogen risk assessment, emphasizing critical analysis of available information, mode of action, weight of evidence, dose-response assessment, and susceptibility to different populations and life stages. It outlines the organization and application of the guidelines, focusing on hazard assessment, exposure assessment, and risk characterization. The guidelines aim to protect human health while adhering to sound scientific principles, using peer-reviewed data and default options when necessary. Key features include: 1. **Critical Analysis of Available Information**: Starting point for evaluation, emphasizing the importance of critical analysis of all relevant data. 2. **Mode of Action**: Central to understanding carcinogenic processes, with a focus on identifying key events and processes leading to cancer. 3. **Weight of Evidence Narrative**: Integrating all evidence to conclude on the human carcinogenic potential of agents. 4. **Dose-Response Assessment**: Evaluating potential risks at specific exposure levels, including extrapolation to lower doses. 5. **Susceptible Populations and Life Stages**: Identifying and addressing risks to specific populations and life stages, particularly children. 6. **Evaluating Risks from Childhood Exposures**: Special attention to early-life exposures, recognizing higher susceptibility and the need for specific assessments. The guidelines are designed to be flexible, incorporating new scientific knowledge and evolving research methods, while maintaining scientific credibility and responsiveness to decision-makers. They are intended to guide EPA staff in developing and using risk assessments and to provide the public with information on the Agency's risk assessment methods.
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