The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health.
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.
Risk assessments are often used by the federal government to estimate the risk the public may face from such things as exposure to a chemical or the potential failure of an engineered structure, and they underlie many regulatory decisions. Last January, the White House Office of Management and Budget (OMB) issued a draft bulletin for all federal agencies, which included a new definition of risk assessment and proposed standards aimed at improving federal risk assessments. This National Research Council report, written at the request of OMB, evaluates the draft bulletin and supports its overall goals of improving the quality of risk assessments. However, the report concludes that the draft bulletin is "fundamentally flawed" from a scientific and technical standpoint and should be withdrawn. Problems include an overly broad definition of risk assessment in conflict with long-established concepts and practices, and an overly narrow definition of adverse health effects-one that considers only clinically apparent effects to be adverse, ignoring other biological changes that could lead to health effects. The report also criticizes the draft bulletin for focusing mainly on human health risk assessments while neglecting assessments of technology and engineered structures.
The scientific basis, inference assumptions, regulatory uses, and research needs in risk assessment are considered in this two-part volume. The first part, Use of Maximum Tolerated Dose in Animal Bioassays for Carcinogenicity, focuses on whether the maximum tolerated dose should continue to be used in carcinogenesis bioassays. The committee considers several options for modifying current bioassay procedures. The second part, Two-Stage Models of Carcinogenesis, stems from efforts to identify improved means of cancer risk assessment that have resulted in the development of a mathematical dose-response model based on a paradigm for the biologic phenomena thought to be associated with carcinogenesis.
With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process. Consequently, FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration describes the proposed risk-characterization framework that can be used to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework presented in this report is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and recommendations.
In 2007, the National Research Council envisioned a new paradigm in which biologically important perturbations in key toxicity pathways would be evaluated with new methods in molecular biology, bioinformatics, computational toxicology, and a comprehensive array of in vitro tests based primarily on human biology. Although some considered the vision too optimistic with respect to the promise of the new science, no one can deny that a revolution in toxicity testing is under way. New approaches are being developed, and data are being generated. As a result, the U.S. Environmental Protection Agency (EPA) expects a large influx of data that will need to be evaluated. EPA also is faced with tens of thousands of chemicals on which toxicity information is incomplete and emerging chemicals and substances that will need risk assessment and possible regulation. Therefore, the agency asked the National Research Council to convene a symposium to stimulate discussion on the application of the new approaches and data in risk assessment. The symposium was held on May 11-13, 2009, in Washington, DC, and included presentations and discussion sessions on pathway-based approaches for hazard identification, applications of new approaches to mode-of-action analyses, the challenges to and opportunities for risk assessment in the changing paradigm, and future directions.
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.
The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health.
According to surveys, the public believes the chickens it is buying are wholesome. Poultry Inspection: The Basis for a Risk-Assessment Approach looks at current inspection procedures to determine how effective the Food Safety Inspection Service is in finding dangerous levels of contaminants and disease-producing microorganisms. The book first describes the history behind the current system, noting that the amount of poultry inspected has increased dramatically while techniques and regulations have remained constant since 1968. The steps involved in an inspection are then described, followed by a discussion of alternative and innovative inspection procedures. It then provides a risk-assessment model for poultry, including submodels for each stage of processing. Risk assessment is used to protect health, establish priorities, identify problems, and set acceptable levels of risk. The model is applied both to microbiological hazards and to chemical contaminants.
From 1972 to 1982, approximately 1,500-2,100 US Air Force Reserve personnel trained and worked on C-123 aircraft that had formerly been used to spray herbicides in Vietnam as part of Operation Ranch Hand. After becoming aware that some of the aircraft on which they had worked had previously served this purpose, some of these AF Reservists applied to the US Department of Veterans Affairs (VA) for compensatory coverage under the Agent Orange Act of 1991. The Act provides health care and disability coverage for health conditions that have been deemed presumptively service-related for herbicide exposure during the Vietnam War. The VA denied the applications on the basis that these veterans were ineligible because as non-Vietnam-era veterans or as Vietnam-era veterans without "boots on the ground" service in Vietnam, they were not covered. However, with the knowledge that some air and wipe samples taken between 1979 and 2009 from some of the C-123s used in Operation Ranch Hand showed the presence of agent orange residues, representatives of the C-123 Veterans Association began a concerted effort to reverse VA's position and obtain coverage. At the request of the VA, Post-Vietnam Dioxin Exposure in Agent Orange-Contaminated C-123 Aircraft evaluates whether or not service in these C-123s could have plausibly resulted in exposures detrimental to the health of these Air Force Reservists. The Institute of Medicine assembled an expert committee to address this question qualitatively, but in a scientific and evidence-based fashion. This report evaluates the reliability of the available information for establishing exposure and addresses and places in context whether any documented residues represent potentially harmful exposure by characterizing the amounts available and the degree to which absorption might be expected. Post-Vietnam Dioxin Exposure rejects the idea that the dioxin residues detected on interior surfaces of the C-123s were immobile and effectively inaccessible to the Reservists as a source of exposure. Accordingly, this report states with confidence that the Air Force Reservists were exposed when working in the Operation Ranch Hand C-123s and so experienced some increase in their risk of a variety of adverse responses.
Written at the request of the U.S. Air Force and Congress, this book evaluates the potential health effects associated with deployment of the Ground Wave Emergency Network (GWEN), a communications system to be used in case of a high-altitude detonation of a nuclear device. The committee, composed of experts in biophysics, physics, risk assessment, epidemiology, and cancer, examines data from laboratory and epidemiologic studies of effects from electromagnetic fields to determine the likelihood of health effects being caused by the operation of a fully implemented GWEN system.
Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
This volume considers engineering risk analysis applications to the field of building safety. Building codes and design criteria used by architects and engineersâ€"standards of good practice defined by industry consensusâ€"have made great strides in bringing the dangers of facilities under control, but the range of hazards (e.g., fire, indoor air pollutants, electrical malfunctions) is broad. Risk analysis offers improved overall safety of new and existing facilities without imposing unacceptable costs. Broad application of risk analysis will help facility professionals, policymakers, and facility users and owners to understand the risks, to determine what levels of risk are socially and economically tolerable, and to manage risk more effectively.
In 2007, the National Research Council envisioned a new paradigm in which biologically important perturbations in key toxicity pathways would be evaluated with new methods in molecular biology, bioinformatics, computational toxicology, and a comprehensive array of in vitro tests based primarily on human biology. Although some considered the vision too optimistic with respect to the promise of the new science, no one can deny that a revolution in toxicity testing is under way. New approaches are being developed, and data are being generated. As a result, the U.S. Environmental Protection Agency (EPA) expects a large influx of data that will need to be evaluated. EPA also is faced with tens of thousands of chemicals on which toxicity information is incomplete and emerging chemicals and substances that will need risk assessment and possible regulation. Therefore, the agency asked the National Research Council to convene a symposium to stimulate discussion on the application of the new approaches and data in risk assessment. The symposium was held on May 11-13, 2009, in Washington, DC, and included presentations and discussion sessions on pathway-based approaches for hazard identification, applications of new approaches to mode-of-action analyses, the challenges to and opportunities for risk assessment in the changing paradigm, and future directions.
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.
Much of the more than 30 million tons of asbestos used in the United States since 1900 is still present as insulation in offices and schools, as vinyl-asbestos flooring in homes, and in other common products. This volume presents a comprehensive evaluation of the relation of these fibers to specific diseases and the extent of nonoccupational risks associated with them. It covers sources of asbestiform fibers, properties of the fibers, and carcinogenic and fibrogenic risks they pose.
With the growing number, complexity, and importance of environmental problems come demands to include a full range of intellectual disciplines and scholarly traditions to help define and eventually manage such problems more effectively. Decision Making for the Environment: Social and Behavioral Science Research Priorities is the result of a 2-year effort by 12 social and behavioral scientists, scholars, and practitioners. The report sets research priorities for the social and behavioral sciences as they relate to several different kinds of environmental problems.
The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA's pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility.
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