Science and Decisions
Science and Decisions

Author: National Research Council

Publisher: National Academies Press

Published: 2009-03-24

Total Pages: 422

ISBN-13: 0309120462

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Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.

Outdoor Air Pollution
Outdoor Air Pollution

Author: IARC Working Group on the Evaluation of Carcinogenic Risks to Humans

Publisher: IARC Monographs on the Evaluat

Published: 2016

Total Pages: 0

ISBN-13: 9789283201472

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"This publication represents the views and expert opinions of an IARC Working Group on the Evaluation of Carcinogenic Risk to Humans, which met in Lyon, 8-15 October 2013."

Risk Analysis
Risk Analysis

Author: John J. Cohrssen

Publisher: DIANE Publishing

Published: 1999-05

Total Pages: 420

ISBN-13: 0788149989

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Designed for consumers of risk information, this book offers a balance between the technical and nontechnical literature. The discipline of risk analysis has developed into an organized body of knowledge and methods only within the past 20 years. The passage of federal laws to protect public health and the environment has generated rapid growth in risk analysis in numerous fields. Statements of risk need to be understood to be useful to the public and environmental managers. This guidebook provides a tool for understanding risk analysis. Chapters: overview of risk analysis; hazard identification; risk assessment; and risk communication.

Science and Judgment in Risk Assessment
Science and Judgment in Risk Assessment

Author: National Research Council

Publisher: National Academies Press

Published: 1994-01-01

Total Pages: 668

ISBN-13: 030904894X

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The public depends on competent risk assessment from the federal government and the scientific community to grapple with the threat of pollution. When risk reports turn out to be overblownâ€"or when risks are overlookedâ€"public skepticism abounds. This comprehensive and readable book explores how the U.S. Environmental Protection Agency (EPA) can improve its risk assessment practices, with a focus on implementation of the 1990 Clean Air Act Amendments. With a wealth of detailed information, pertinent examples, and revealing analysis, the volume explores the "default option" and other basic concepts. It offers two views of EPA operations: The first examines how EPA currently assesses exposure to hazardous air pollutants, evaluates the toxicity of a substance, and characterizes the risk to the public. The second, more holistic, view explores how EPA can improve in several critical areas of risk assessment by focusing on cross-cutting themes and incorporating more scientific judgment. This comprehensive volume will be important to the EPA and other agencies, risk managers, environmental advocates, scientists, faculty, students, and concerned individuals.

Mutagenic Impurities
Mutagenic Impurities

Author: Andrew Teasdale

Publisher: John Wiley & Sons

Published: 2022-02-15

Total Pages: 548

ISBN-13: 1119551218

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Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.