Committee on the Institutional Means for Assessment of Risks to Public Health's Books

Risk Assessment in the Federal Government

Managing the Process

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Committee on the Institutional Means for Assessment of Risks to Public Health

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Risk Assessment in the Federal Government

Managing the Process

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Committee on the Institutional Means for Assessment of Risks to Public Health

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.

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206

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National Academies Press

Published Date

ISBN 10

0309033497

ISBN 13

9780309033497

Science and Judgment in Risk Assessment

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Commission on Life Sciences,Committee on Risk Assessment of Hazardous Air Pollutants

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Science and Judgment in Risk Assessment

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Commission on Life Sciences,Committee on Risk Assessment of Hazardous Air Pollutants

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.

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668

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National Academies Press

Published Date

ISBN 10

030904894X

ISBN 13

9780309048941

Risk Assessment in the Federal Government

Managing the Process

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Committee on the Institutional Means for Assessment of Risks to Public Health

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Risk Assessment in the Federal Government

Managing the Process

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Committee on the Institutional Means for Assessment of Risks to Public Health

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206

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National Academies Press

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ISBN 10

0309033497

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9780309033497

Poultry Inspection

The Basis for a Risk-Assessment Approach

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Food and Nutrition Board,Committee on Public Health Risk Assessment of Poultry Inspection Programs

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Poultry Inspection

The Basis for a Risk-Assessment Approach

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Food and Nutrition Board,Committee on Public Health Risk Assessment of Poultry Inspection Programs

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.

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177

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National Academies Press

Published Date

ISBN 10

0309037433

ISBN 13

9780309037433

Post-Vietnam Dioxin Exposure in Agent Orange-Contaminated C-123 Aircraft

By: Institute of Medicine,Board on the Health of Select Populations,Committee to Evaluate the Potential Exposure to Agent Orange/TCDD Residue and Level of Risk of Adverse Health Effects for Aircrew of Post-Vietnam C-123 Aircraft

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Post-Vietnam Dioxin Exposure in Agent Orange-Contaminated C-123 Aircraft

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.

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110

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National Academies Press

Published Date

ISBN 10

0309308933

ISBN 13

9780309308939

Assessment of the Possible Health Effects of Ground Wave Emergency Network

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Board on Radiation Effects Research,Committee on Assessment of the Possible Health Effects of Ground Wave Emergency Network (GWEN)

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Assessment of the Possible Health Effects of Ground Wave Emergency Network

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.

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183

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National Academies Press

Published Date

ISBN 10

0309047773

ISBN 13

9780309047777

Enhancing Food Safety

The Role of the Food and Drug Administration

By: National Research Council,Institute of Medicine,Board on Agriculture and Natural Resources,Food and Nutrition Board,Committee on the Review of the Food and Drug Administration's Role in Ensuring Safe Food

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Enhancing Food Safety

The Role of the Food and Drug Administration

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.

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588

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National Academies Press

Published Date

ISBN 10

0309152739

ISBN 13

9780309152730

Uses of Risk Analysis to Achieve Balanced Safety in Building Design and Operations

By: National Research Council,Division on Engineering and Physical Sciences,Commission on Engineering and Technical Systems,Committee on Risk Appraisal in the Development of Facilities Design Criteria

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Uses of Risk Analysis to Achieve Balanced Safety in Building Design and Operations

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.

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National Academies Press

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ISBN 10

0309046807

ISBN 13

9780309046800

Toxicity-Pathway-Based Risk Assessment

Preparing for Paradigm Change: A Symposium Summary

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Standing Committee on Risk Analysis Issues and Reviews

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Toxicity-Pathway-Based Risk Assessment

Preparing for Paradigm Change: A Symposium Summary

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Standing Committee on Risk Analysis Issues and Reviews

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.

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134

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National Academies Press

Published Date

ISBN 10

0309154227

ISBN 13

9780309154222

Science and Decisions

Advancing Risk Assessment

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Improving Risk Analysis Approaches Used by the U.S. EPA

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Science and Decisions

Advancing Risk Assessment

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Improving Risk Analysis Approaches Used by the U.S. EPA

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.

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422

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National Academies Press

Published Date

ISBN 10

0309120462

ISBN 13

9780309120463

Asbestiform Fibers

Nonoccupational Health Risks

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Board on Toxicology and Environmental Health Hazards,Committee on Nonoccupational Health Risks of Asbestiform Fibers

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Asbestiform Fibers

Nonoccupational Health Risks

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.

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350

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National Academies Press

Published Date

ISBN 10

0309078520

ISBN 13

9780309078528

Decision Making for the Environment

Social and Behavioral Science Research Priorities

By: National Research Council,Division of Behavioral and Social Sciences and Education,Center for Economic, Governance, and International Studies,Committee on the Human Dimensions of Global Change,Panel on Social and Behavioral Science Research Priorities for Environmental Decision Making

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Decision Making for the Environment

Social and Behavioral Science Research Priorities

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.

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296

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National Academies Press

Published Date

ISBN 10

0309165393

ISBN 13

9780309165396

Controlled Human Inhalation-Exposure Studies at EPA

By: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants

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Controlled Human Inhalation-Exposure Studies at EPA

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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159

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National Academies Press

Published Date

ISBN 10

030945252X

ISBN 13

9780309452526

Review of the Army Non-Stockpile Chemical Materiel Disposal Program

Disposal of Chemical Agent Identification Sets

By: National Research Council,Division on Engineering and Physical Sciences,Commission on Engineering and Technical Systems,Board on Army Science and Technology,Committee on Review and Evaluation of the Army Non-Stockpile Chemical Materiel Disposal Program

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Review of the Army Non-Stockpile Chemical Materiel Disposal Program

Disposal of Chemical Agent Identification Sets

This study is a review and evaluation of the U.S. Army's Report to Congress on Alternative Approaches for the Treatment and Disposal of Chemical Agent Identification Sets (CAIS). CAIS are test kits that were used to train soldiers from 1928 to 1969 in defensive responses to a chemical attack. They contain samples of chemicals that had been or might have been used by opponents as chemical warfare agents. The Army's baseline approach for treating and disposing of CAIS has been to develop a mobile treatment system, called the Rapid Response System (RRS), which can be carried by several large over-the-road trailers.

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149

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National Academies Press

Published Date

ISBN 10

0309068797

ISBN 13

9780309068796

Intentional Human Dosing Studies for EPA Regulatory Purposes

Scientific and Ethical Issues

By: National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants

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Intentional Human Dosing Studies for EPA Regulatory Purposes

Scientific and Ethical Issues

By: National Research Council,Policy and Global Affairs,Science, Technology, and Law Program,Committee on the Use of Third Party Toxicity Research with Human Research Participants

The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.

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226

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National Academies Press

Published Date

ISBN 10

0309091721

ISBN 13

9780309091725

Developing New Contraceptives

Obstacles and Opportunities

By: National Research Council and Institute of Medicine,Division of Behavioral and Social Sciences and Education,Commission on Behavioral and Social Sciences and Education,Committee on Contraceptive Development

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Developing New Contraceptives

Obstacles and Opportunities

There are numerous reasons to hasten the introduction of new and improved contraceptivesâ€"from health concerns about the pill to the continuing medical liability crisis. Yet, U.S. organizations are far from taking a leadership position in funding, researching, and introducing new contraceptivesâ€"in fact, the United States lags behind Europe and even some developing countries in this field. Why is research and development of contraceptives stagnating? What must the nation do to energize this critical arena? This book presents an overall examination of contraceptive development in the United Statesâ€"covering research, funding, regulation, product liability, and the effect of public opinion. The distinguished authoring committee presents a blueprint for substantial change, with specific policy recommendations that promise to gain the attention of specialists, the media, and the American public. The highly readable and well-organized volume will quickly become basic reading for legislators, government agencies, the pharmaceutical industry, private organizations, legal professionals, and researchersâ€"everyone concerned about family planning, reproductive health, and the impact of the liability and regulatory systems on scientific innovations.

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206

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National Academies Press

Published Date

ISBN 10

0309041473

ISBN 13

9780309041478

The Health Hazard Evaluation Program at NIOSH

Reviews of Research Programs of the National Institute for Occupational Safety and Health

By: Institute of Medicine,National Research Council,Division on Earth and Life Studies,Committee to Review the NIOSH Health Hazard Evaluation Program

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The Health Hazard Evaluation Program at NIOSH

Reviews of Research Programs of the National Institute for Occupational Safety and Health

By: Institute of Medicine,National Research Council,Division on Earth and Life Studies,Committee to Review the NIOSH Health Hazard Evaluation Program

It is the unique mission of the Health Hazard Evaluation Program within the National Institute for Occupational Safety and Health (NIOSH) to respond to requests to investigate potential occupational health hazards. In contrast to other NIOSH programs, the Health Hazard Evaluation Program is not primarily a research program. Rather, it investigates and provides advice to workplaces in response to requests from employers, employees and their representatives, and federal agencies. The National Research Council was charged with evaluating the NIOSH Health Hazard Evaluation Program and determining whether program activities resulted in improvements in workplace practices and decreases in hazardous exposures that cause occupational illnesses. The program was found to play a key role in addressing existing widespread or emerging occupational health issues. This book makes several recommendations that could improve a very strong program including more systematic use of surveillance data to facilitate priority setting, and greater interaction with a broader array of workers, industries, and other government agencies.

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226

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National Academies Press

Published Date

ISBN 10

0309126479

ISBN 13

9780309126472

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