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.




Principles for Modelling Dose-response for the Risk Assessment of Chemicals


Book Description

"Published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organisation and the World Health Organization, and produced within the framework of the Inter-Organization Programme for the Sound Management of Chemicals."




Science and Judgment in Risk Assessment


Book Description

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.




Regulatory Toxicology


Book Description

This book will be written by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It is the updated and expanded version of a monograph published in German in 2004. Chemical safety is regulated on various levels including production, storage, transport, handling, disposal or labelling. This book deals comprehensively with the safety-ensuring methods and concepts employed by regulatory agencies, industry and academics. Toxicologists use experimental and scientific approaches for data collection, e.g. about chemical hazards, physicochemical features or toxicokinetics. The respective experimental methods are described in the book. Toxicologists also deal with much insecurity in the exposure and effect scenarios during risk assessment. To overcome these, they have different extrapolation methods and estimation procedures at their disposal. The book describes these methods in an accessible manner. Differing concepts from one regulation area to another are also covered. Reasons and consequences become evident when reading the book. Altogether, the book Regulatory Toxicology will serve as an excellent reference.




Phthalates and Cumulative Risk Assessment


Book Description

People are exposed to a variety of chemicals throughout their daily lives. To protect public health, regulators use risk assessments to examine the effects of chemical exposures. This book provides guidance for assessing the risk of phthalates, chemicals found in many consumer products that have been shown to affect the development of the male reproductive system of laboratory animals. Because people are exposed to multiple phthalates and other chemicals that affect male reproductive development, a cumulative risk assessment should be conducted that evaluates the combined effects of exposure to all these chemicals. The book suggests an approach for cumulative risk assessment that can serve as a model for evaluating the health risks of other types of chemicals.




Mixture Toxicity


Book Description

In the last decade and a half, great progress has been made in the development of concepts and models for mixture toxicity, both in human and environmental toxicology. However, due to their different protection goals, developments have often progressed in parallel but with little integration. Arguably the first book to clearly link ecotoxicology an




Drinking Water and Health, Volume 8


Book Description

Pharmacokinetics, the study of the movement of chemicals within the body, is a vital tool in assessing the risk of exposure to environmental chemicals. This bookâ€"a collection of papers authored by experts in academia, industry, and governmentâ€"reviews the progress of the risk-assessment process and discusses the role of pharmacokinetic principles in evaluating risk. In addition, the authors discuss software packages used to analyze data and to build models simulating biological phenomena. A summary chapter provides a view of trends in pharmacokinetic modeling and notes some prospective fields of study.




Toxicity Testing for Assessment of Environmental Agents


Book Description

Toxicity testing in laboratory animals provides much of the information used by the Environmental Protection Agency (EPA) to assess the hazards and risks associated with exposure to environmental agents that might harm public health or the environment. The data are used to establish maximum acceptable concentrations of environmental agents in drinking water, set permissible limits of exposure of workers, define labeling requirements, establish tolerances for pesticides residues on food, and set other kinds of limits on the basis of risk assessment. Because the number of regulations that require toxicity testing is growing, EPA called for a comprehensive review of established and emerging toxicity-testing methods and strategies. This interim report reviews current toxicity-testing methods and strategies and near-term improvements in toxicity-testing approaches proposed by EPA and others. It identifies several recurring themes and questions in the various reports reviewed. The final report will present a long-range vision and strategic plan to advance the practices of toxicity testing and human health assessment of environmental contaminants.




Chemical Carcinogenesis


Book Description

This volume will provide a contemporary account of advances in chemical carcinogenesis. It will promote the view that it is chemical alteration of the DNA that is a route cause of many cancers. The multi-stage model of chemical carcinogenesis, exposure to major classes of human carcinogens and their mode-of-action will be a focal point. The balance between metabolic activation to form biological reactive intermediates and their detoxification, ensuing DNA-lesions and their repair will be profiled. It will describe the chemical changes that occur in DNA that result from endogenous insults including epigenetic changes that lead to gene silencing. It will describe major mechanisms of mutagenesis, affects on tumor suppressor genes and proto-oncogenes, and how cell-cycle check points can be by-passed by the "stealth-like" properties of chemical carcinogens. Environmental agents that can promote tumor formation will be discussed. The monograph will have wide appeal as a knowledge base for graduate students, post-doctoral fellows and faculty interested in this aspect of cancer causation and research.




Principles and Methods for the Assessment of Risk from Essential Trace Elements


Book Description

The risk assessment approach described in this monograph applies only to essential trace elements (ETEs) involved in human health and not to non-essential elements. The purpose of this monograph is to provide the scientific principles that support the concept of an acceptable range of oral intake (AROI) which uses a homeostatic model for determining the range of dietary intakes for essential trace elements (ETEs) that meet the nutritional requirements of a healthy population and avoid excess intakes. To facilitate comparisons AROIs are discussed in relation to other risk assessment approaches. Although it includes examples this monograph is not a compendium of assessments on ETEs nor is it a textbook detailing the scientific basis of risk assessment of the derivation of dietary reference intakes. Described in the book is the process of risk assessment which begins with the selection of the database for a particular ETE. A weight-of-evidence approach is then used for hazard identification selecting relevant end-point of deficient and excess exposures. Next the probability of risk and the severity of various effects are quantified and critical effects are selected. The AROI is then established by balancing end-points of comparable health significance. At this time the exposure assessment is conducted. Finally a risk characterization enumerating the strengths and weaknesses of the databases is performed integrating the AROI and exposure assessment. ... The amount of work which is entailed in these volumes is very great and the low cost does not reflect the time of experts travelling nor even the hours expended UN staff in Geneva... This well informed book with its predecessors in the series is essential reading for biologists chemists and medical professionals concerned with essential trace elements. - The International Journal of Environmental Studies