Science and Decisions


Book Description

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.







Hayes' Principles and Methods of Toxicology


Book Description

Hayes’ Principles and Methods of Toxicology has long been established as a reliable and informative reference for the concepts, methodologies, and assessments integral to toxicology. The new edition contains updated and new chapters with the addition of new authors while maintaining the same high standards that have made this book a benchmark resource in the field. Key Features: The comprehensive yet concise coverage of various aspects of fundamental and applied toxicology makes this book a valuable resource for educators, students, and professionals. Questions provided at the end of each chapter allow readers to test their knowledge and understanding of the material covered. All chapters have been updated and over 60 new authors have been added to reflect the dynamic nature of toxicological sciences New topics in this edition include Safety Assessment of Cosmetics and Personal Care Products, The Importance of the Dose/Rate Response, Novel Approaches and Alternative Models, Epigenetic Toxicology, and an Expanded Glossary. The volume is divided into 4 major sections, addressing fundamental principles of toxicology (Section I. "Principles of Toxicology"), major classes of established chemical hazards (Section II. "Agents"), current methods used for the assessment of various endpoints indicative of chemical toxicity (Section III. "Methods"), as well as toxicology of specific target systems and organs (Section IV. "Organ- and System-Specific Toxicology"). This volume will be a valuable tool for the audience that wishes to broaden their understanding of hazards and mechanisms of toxicity and to stay on top of the emerging methods and concepts of the rapidly advancing field of toxicology and risk assessment.




Critical Aspects of EPA's IRIS Assessment of Inorganic Arsenic


Book Description

The US Environmental Protection Agency (EPA) Integrated Risk Information System (IRIS) program develops toxicologic assessments of environmental contaminants. IRIS assessments provide hazard identification and dose-response assessment information. The information is then used in conjunction with exposure information to characterize risks to public health and may be used in risk-based decisionmaking, in regulatory actions, and for other risk-management purposes. Since the middle 1990s, EPA has been in the process of updating the IRIS assessment of inorganic arsenic. In response to a congressional mandate for an independent review of the IRIS assessment of inorganic arsenic, EPA requested that the National Research Council convene a committee to conduct a two-phase study. Critical Aspects of EPA's IRIS Assessment of Inorganic Arsenic is the report of the first phase of that study. This report evaluates critical scientific issues in assessing cancer and noncancer effects of oral exposure to inorganic arsenic and offers recommendations on how the issues could be addressed in EPA's IRIS assessment.







Pediatric Non-Clinical Drug Testing


Book Description

This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.




Translational Toxicology and Therapeutics


Book Description

Written by leading research scientists, this book integrates current knowledge of toxicology and human health through coverage of environmental toxicants, genetic / epigenetic mechanisms, and carcinogenicity. Provides information on lifestyle choices that can reduce cancer risk Offers a systematic approach to identify mutagenic, developmental and reproductive toxicants Helps readers develop new animal models and tests to assess toxic impacts of mutation and cancer on human health Explains specific cellular and molecular targets of known toxicants operating through genetic and epigenetic mechanisms




Risk Assessment for Chemicals in Drinking Water


Book Description

A comprehensive reference on state-of-the-art risk assessment methodologies for drinking water Risk Assessment for Chemicals in Drinking Water discusses the major steps and goals in risk assessments and suggests ways to improve the methodologies and accuracy, while consolidating up-to-date information on the current principles and practices in one authoritative reference. After an enlightening overview of risk assessment practices and regulatory guidelines, it: Includes descriptions of the use of variability analysis, exposure analysis, physiologically based pharmacokinetics, and modeling for both cancer and non-cancer endpoints Describes the practices of major organizations, including the U.S. EPA, Health Canada, World Health Organization, and California Office of Environmental Health Hazard Assessment Includes complete chapters on risk assessment for essential nutrients, arsenic, chloroform, and perchlorate Explains how to address susceptible sub-populations, including the elderly and infants and children, in risk assessments Covers the potential of using genomic and proteomic screens Addresses recent advances, emerging issues, and future challenges With contributions and perspectives from leading scientists, this is the definitive resource for health and environmental scientists, toxicologists, risk assessors and managers, regulators, consultants, and other professionals responsible for the safety of drinking water.




Connecting to the Living History of Radiation Exposure


Book Description

This book highlights the multiple ways of telling stories of radiation exposure; they include stories about Japan, Australia, the United States, the Canadian Arctic, and more, and they probe the framing of major incidents such as Three Mile Island, Chernobyl, and Fukushima. All the chapters in this book are written by authors who participated in our work at Oregon State University and have benefited from hearing not only from scientists but also from those whose lives were directly affected by the history of radiation exposure. The question ‘What is at stake when researching and narrating the histories of radiation exposure?’ is discussed, but the book does not reinforce existing frameworks, such as legal decisions or government policies, but rather highlights what narrative framings accomplish and commit by scrutinizing them with rigorous research, varied approaches, and, above all, listening to those whose lives were most affected by exposure. Previously published in Journal of the History of Biology Volume 54, issue 1, April 2021