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Science and Decisions

Science and Decisions
Author: National Research Council
Publisher: National Academies Press
Total Pages: 422
Release: 2009-03-24
Genre: Political Science
ISBN: 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.


Science and Judgment in Risk Assessment

Science and Judgment in Risk Assessment
Author: National Research Council
Publisher: National Academies Press
Total Pages: 668
Release: 1994-01-01
Genre: Science
ISBN: 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.


Risk Assessment in the Federal Government

Risk Assessment in the Federal Government
Author: National Research Council
Publisher: National Academies Press
Total Pages: 206
Release: 1983-02-01
Genre: Medical
ISBN: 0309033497

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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 Analysis and Governance in EU Policy Making and Regulation

Risk Analysis and Governance in EU Policy Making and Regulation
Author: Bernardo Delogu
Publisher: Springer
Total Pages: 298
Release: 2016-05-02
Genre: Political Science
ISBN: 331930822X

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This book provides an easy, but comprehensive and rigorous access to the main concepts, terminology, methods and procedures of risk analysis intended for all those involved in the EU policy and regulatory decision making on risks. It establishes a common ground of knowledge which enables a more informed dialogue on risks, a closer collaboration between decision makers and scientists and a better appraisal of the potential and limits of risk science. The book also brings together in an accessible way much multidisciplinary knowledge which had been dispersed over many technical documents and specialist books. The EU is in the front line of health, safety and environmental risk management. GMOs, food safety, hazardous chemicals, climate change, radiation hazards, are just a few of the popular risk issues addressed by the EU through policy and regulatory measures. The risk analysis paradigm, including risk assessment, management and communication has been at the core of the EU decision making for a long time already. EU Institutions strive for a science-based approach to risk management. Nevertheless, the dialogue and collaboration on risk issues between policy makers, stakeholders and scientists are still difficult and the potential and limits of science in support of decision making, as well as the basic concepts of risk analysis are not fully understood outside the narrow specialist circles.


Uncertainty in Risk Assessment, Risk Management, and Decision Making

Uncertainty in Risk Assessment, Risk Management, and Decision Making
Author: V.T. Covello
Publisher: Springer Science & Business Media
Total Pages: 523
Release: 2013-03-08
Genre: Technology & Engineering
ISBN: 1468453173

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The subject of this volume--uncertainties in risk assessment and management--reflects an important theme in health, safety, and environ mental decision making. MOst technological hazards are characterized by substantial uncertainty. Recent examples include nuclear waste disposal, acid rain, asbestos in schools, carcinogens in food, and hazardous waste. realing with such uncertainty is arguably the most difficult and challeng ing task facing risk assessors and managers today. Four primary sources of uncertainty in risk assessment and management can be identified: (1) uncertainties about definitions; (2) uncertainties about scientific facts; (3) uncertainties about risk perceptions and atti tudes; and (4) uncertainties about values. Uncertainties about definitions derive primarily from disagreements about the meaning and interpretation of key concepts, such as probability. Uncertainties about scientific facts derive primarily from disagreements about failure modes, the probability and magnitude of adverse health or environmental consequences, cause and effect relationships, dose-response relationships, and exposure patterns. Uncertainties about risk perceptions and attitudes derive primarily from disagreements about what constitutes a significant or acceptable level of risk. Uncertainties about values derive primarily from disagreements about the desirability or worth of alternative risk management actions or conse quences. The papers in this volume address each of these sources of uncertainty from a variety of perspectives. Reflecting the broad scope of risk assess ment and risk management research, the papers include contributions from safety engineers, epidemiologists, toxicologists, chemists, biostatisticians, biologists, decision analysts, economists, psychologists, political scien tists, sociologists, ethicists, and lawyers.


Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 292
Release: 2012-07-30
Genre: Medical
ISBN: 0309218160

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An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.