Understanding Risk addresses a central dilemma of risk decisionmaking in a democracy: detailed scientific and technical information is essential for making decisions, but the people who make and live with those decisions are not scientists. The key task of risk characterization is to provide needed and appropriate information to decisionmakers and the public. This important new volume illustrates that making risks understandable to the public involves much more than translating scientific knowledge. The volume also draws conclusions about what society should expect from risk characterization and offers clear guidelines and principles for informing the wide variety of risk decisions that face our increasingly technological society. Frames fundamental questions about what risk characterization means. Reviews traditional definitions and explores new conceptual and practical approaches. Explores how risk characterization should inform decisionmakers and the public. Looks at risk characterization in the context of the entire decisionmaking process. Understanding Risk discusses how risk characterization has fallen short in many recent controversial decisions. Throughout the text, examples and case studiesâ€"such as planning for the long-term ecological health of the Everglades or deciding on the operation of a waste incineratorâ€"bring key concepts to life. Understanding Risk will be important to anyone involved in risk issues: federal, state, and local policymakers and regulators; risk managers; scientists; industrialists; researchers; 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.
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.
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.
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.
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 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 overblown--or when risks are overlooked--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.
Over the last decade, several large-scale United States and international programs have been initiated to incorporate advances in molecular and cellular biology, -omics technologies, analytical methods, bioinformatics, and computational tools and methods into the field of toxicology. Similar efforts are being pursued in the field of exposure science with the goals of obtaining more accurate and complete exposure data on individuals and populations for thousands of chemicals over the lifespan; predicting exposures from use data and chemical-property information; and translating exposures between test systems and humans. Using 21st Century Science to Improve Risk-Related Evaluations makes recommendations for integrating new scientific approaches into risk-based evaluations. This study considers the scientific advances that have occurred following the publication of the NRC reports Toxicity Testing in the 21st Century: A Vision and a Strategy and Exposure Science in the 21st Century: A Vision and a Strategy. Given the various ongoing lines of investigation and new data streams that have emerged, this publication proposes how best to integrate and use the emerging results in evaluating chemical risk. Using 21st Century Science to Improve Risk-Related Evaluations considers whether a new paradigm is needed for data validation, how to integrate the divergent data streams, how uncertainty might need to be characterized, and how best to communicate the new approaches so that they are understandable to various stakeholders.
The events of September 11, 2001 changed perceptions, rearranged national priorities, and produced significant new government entities, including the U.S. Department of Homeland Security (DHS) created in 2003. While the principal mission of DHS is to lead efforts to secure the nation against those forces that wish to do harm, the department also has responsibilities in regard to preparation for and response to other hazards and disasters, such as floods, earthquakes, and other "natural" disasters. Whether in the context of preparedness, response or recovery from terrorism, illegal entry to the country, or natural disasters, DHS is committed to processes and methods that feature risk assessment as a critical component for making better-informed decisions. Review of the Department of Homeland Security's Approach to Risk Analysis explores how DHS is building its capabilities in risk analysis to inform decision making. The department uses risk analysis to inform decisions ranging from high-level policy choices to fine-scale protocols that guide the minute-by-minute actions of DHS employees. Although DHS is responsible for mitigating a range of threats, natural disasters, and pandemics, its risk analysis efforts are weighted heavily toward terrorism. In addition to assessing the capability of DHS risk analysis methods to support decision-making, the book evaluates the quality of the current approach to estimating risk and discusses how to improve current risk analysis procedures. Review of the Department of Homeland Security's Approach to Risk Analysis recommends that DHS continue to build its integrated risk management framework. It also suggests that the department improve the way models are developed and used and follow time-tested scientific practices, among other recommendations.
The mission of Department of Homeland Security Bioterrorism Risk Assessment: A Call for Change, the book published in December 2008, is to independently and scientifically review the methodology that led to the 2006 Department of Homeland Security report, Bioterrorism Risk Assessment (BTRA) and provide a foundation for future updates. This book identifies a number of fundamental concerns with the BTRA of 2006, ranging from mathematical and statistical mistakes that have corrupted results, to unnecessarily complicated probability models and models with fidelity far exceeding existing data, to more basic questions about how terrorist behavior should be modeled. Rather than merely criticizing what was done in the BTRA of 2006, this new NRC book consults outside experts and collects a number of proposed alternatives that could improve DHS's ability to assess potential terrorist behavior as a key element of risk-informed decision making, and it explains these alternatives in the specific context of the BTRA and the bioterrorism threat.
Toxicogenomics is a discipline that combines expertise in toxicology, genetics, molecular biology, and environmental health to help understand the response of living organisms to stressful environments. The National Research Council convened a workshop to discuss how toxicogenomic data could be applied to improve risk assessments, particularly cancer risk from environmental exposure to chemicals. Risk assessments serve as the basis of many public-health decisions in environmental, occupational, and consumer protection from chemicals. The workshop provided a forum for communities of experts, including those working in "-omics" and those in the policy arena, to discuss where their fields intersect, and how toxicogenomics could address critical knowledge gaps in risk assessments.
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.
Tetrachloroethylene is a volatile, chlorinated organic hydrocarbon that is widely used as a solvent in the dry-cleaning and textile-processing industries and as an agent for degreasing metal parts. It is an environmental contaminant that has been detected in the air, groundwater, surface waters, and soil. In June 2008, the U.S. Environmental Protection Agency released its draft Toxicological Review of Tetrachloroethylene (Perchloroethylene) (CAS No. 127-18-4) in Support of Summary Information on the Integrated Risk Information System (IRIS). The draft IRIS assessment provides quantitative estimates of cancer and noncancer effects of exposure to tetrachloreothylene, which will be used to establish airquality and water-quality standards to protect public health and to set cleanup standards for hazardous waste sites. At the request of EPA, the National Research Council conducted an independent scientific review of the draft IRIS assessment of tetrachloroethylene from toxicologic, epidemiologic, and human clinical perspectives. The resulting book evaluates the adequacy of the EPA assessment, the data and methods used for deriving the noncancer values for inhalation and oral exposures and the oral and inhalation cancer unit risks posed by tetrachloroethylene; evaluates whether the key studies underlying the draft IRIS assessment are of requisite quality, reliability, and relevance to support the derivation of the reference values and cancer risks; evaluates whether the uncertainties in EPA's risk assessment were adequately described and, where possible, quantified; and identifies research that could reduce the uncertainty in the current understanding of human health effects associated with tetrachloroethylene exposure.
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 overblown--or when risks are overlooked--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 US Fish and Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS) are responsible for protecting species that are listed as endangered or threatened under the Endangered Species Act (ESA) and for protecting habitats that are critical for their survival. The US Environmental Protection Agency (EPA) is responsible for registering or reregistering pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and must ensure that pesticide use does not cause any unreasonable adverse effects on the environment, which is interpreted to include listed species and their critical habitats. The agencies have developed their own approaches to evaluating environmental risk, and their approaches differ because their legal mandates, responsibilities, institutional cultures, and expertise differ. Over the years, the agencies have tried to resolve their differences but have been unsuccessful in reaching a consensus regarding their assessment approaches. As a result, FWS, NMFS, EPA, and the US Department of Agriculture asked the National Research Council (NRC) to examine scientific and technical issues related to determining risks posed to listed species by pesticides. Specifically, the NRC was asked to evaluate methods for identifying the best scientific data available; to evaluate approaches for developing modeling assumptions; to identify authoritative geospatial information that might be used in risk assessments; to review approaches for characterizing sublethal, indirect, and cumulative effects; to assess the scientific information available for estimating effects of mixtures and inert ingredients; and to consider the use of uncertainty factors to account for gaps in data. Assessing Risks to Endangered and Threatened Species from Pesticides, which was prepared by the NRC Committee on Ecological Risk Assessment under FIFRA and ESA, is the response to that request.
The Safe Drinking Water Act directs the U.S. Environmental Protection Agency (EPA) to regulate the quality of drinking water, including its concentration of radon, an acknowledged carcinogen. This book presents a valuable synthesis of information about the total inhalation and ingestion risks posed by radon in public drinking water, including comprehensive reviews of data on the transfer of radon from water to indoor air and on outdoor levels of radon in the United States. It also presents a new analysis of a biokinetic model developed to determine the risks posed by ingestion of radon and reviews inhalation risks and the carcinogenesis process. The volume includes scenarios for quantifying the reduction in health risk that might be achieved by a program to reduce public exposure to radon. Risk Assessment of Radon in Drinking Water, reflecting research and analysis mandated by 1996 amendments to the Safe Drinking Water Act, provides comment on a variety of methods to reduce radon entry into homes and to reduce the concentrations of radon in indoor air and in water. The models, analysis, and reviews of literature contained in this book are intended to provide information that EPA will need to set a new maximum contaminant level, as it is required to do in 2000.
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