Committee on Improving Risk Analysis Approaches Used by the U.S. EPA's Books

Science and Decisions:

Advancing Risk Assessment

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

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Science and Decisions:

Advancing Risk Assessment

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

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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424

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National Academies Press

Published Date

ISBN 10

0309388147

ISBN 13

9780309388146

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

Review of EPA's Integrated Risk Information System (IRIS) Process

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review the IRIS Process

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Review of EPA's Integrated Risk Information System (IRIS) Process

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review the IRIS Process

The Integrated Risk Information System (IRIS) is a program within the US Environmental Protection Agency (EPA) that is responsible for developing toxicologic assessments of environmental contaminants. An IRIS assessment contains hazard identifications and dose-response assessments of various chemicals related to cancer and noncancer outcomes. Although the program was created to increase consistency among toxicologic assessments within the agency, federal, state, and international agencies and other organizations have come to rely on IRIS assessments for setting regulatory standards, establishing exposure guidelines, and estimating risks to exposed populations. Over the last decade, the National Research Council (NRC) has been asked to review some of the more complex and challenging IRIS assessments, including those of formaldehyde, dioxin, and tetrachloroethylene. In 2011, an NRC committee released its review of the IRIS formaldehyde assessment. Like other NRC committees that had reviewed IRIS assessments, the formaldehyde committee identified deficiencies in the specific assessment and more broadly in some of EPA's general approaches and specific methods. Although the committee focused on evaluating the IRIS formaldehyde assessment, it provided suggestions for improving the IRIS process and a roadmap for its revision in case EPA decided to move forward with changes to the process. Congress directed EPA to implement the report's recommendations and then asked the National Research Council to review the changes that EPA was making (or proposing to make) in response to the recommendations. Review of EPA's Integrated Risk Information System (IRIS) Process provides an overview of some general issues associated with IRIS assessments. This report then addresses evidence identification and evaluation for IRIS assessments and discusses evidence integration for hazard evaluation and methods for calculating reference values and unit risks. The report makes recommendations and considerations for future directions. Overall, Review of EPA's Integrated Risk Information System Process finds that substantial improvements in the IRIS process have been made, and it is clear that EPA has embraced and is acting on the recommendations in the NRC formaldehyde report. The recommendations of this report should be seen as building on the progress that EPA has already made.

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227

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National Academies Press

Published Date

ISBN 10

0309304172

ISBN 13

9780309304177

Rethinking the Components, Coordination, and Management of the U.S. Environmental Protection Agency Laboratories

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Strengthening the US Environmental Protection Agency Laboratory Enterprise: Phase 1 Priority Needs, Guiding Principles, and Overall Goals

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Rethinking the Components, Coordination, and Management of the U.S. Environmental Protection Agency Laboratories

The Environmental Protection Agency (EPA) applies scientific results that have been provided by various parts of its own organization and by external organizations. The agency requires substantial high-quality inhouse scientific expertise and laboratory capabilities so that it can answer questions related to regulation, enforcement, and environmental effects of specific chemicals, activities, and processes. It is also usually faced with situations in which research or analytic work is time-critical, so it maintains dedicated laboratory staff and facilities that can respond quickly to such needs. In recent years, EPA has made several changes to improve the efficiency and effectiveness of its laboratories, such as the designation of national program directors to align the work of research laboratories with the needs of the agency's regulatory program offices. The agency is currently undertaking an integrated evaluation of it laboratories to enhance the management effectiveness and efficiency of its laboratory enterprise and to enhance its capabilities for research and other laboratory-based scientific and technical activities. The results of EPA's evaluation are expected to include options for colocation and consolidation of laboratory facilities. Rethinking the Components, Coordination, and Management of U.S. Environmental Protection Agency Laboratories assesses EPA's highest-priority needs for mission-relevant laboratory science and technical support, develops principles for the efficient and effective management of EPA's laboratory enterprise to meet the agency's mission needs and strategic goals, and develops guidance for enhancing efficiency and effectiveness now and during the next 10 years. EPA's laboratories play a vital role in the agency's work. The findings and recommendations of this report will help EPA to develop an implementation plan for the laboratory enterprise.

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Page Count

247

Publisher

National Academies Press

Published Date

ISBN 10

030931240X

ISBN 13

9780309312400

Evaluating Research Efficiency in the U.S. Environmental Protection Agency

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Policy and Global Affairs,Committee on Science, Engineering, and Public Policy,Committee on Evaluating the Efficiency of Research and Development Programs at the U.S. Environmental Protection Agency

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Evaluating Research Efficiency in the U.S. Environmental Protection Agency

A new book from the National Research Council recommends changes in how the federal government evaluates the efficiency of research at EPA and other agencies. Assessing efficiency should be considered only one part of gauging a program's quality, relevance, and effectiveness. The efficiency of research processes and that of investments should be evaluated using different approaches. Investment efficiency should examine whether an agency's R&D portfolio, including the budget, is relevant, of high quality, matches the agency's strategic plan. These evaluations require panels of experts. In contrast, process efficiency should focus on "inputs" (the people, funds, and facilities dedicated to research) and "outputs" (the services, grants, publications, monitoring, and new techniques produced by research), as well as their timelines and should be evaluated using quantitative measures. The committee recommends that the efficiency of EPA's research programs be evaluated according to the same standards used at other agencies. To ensure this, OMB should train and oversee its budget examiners so that the PART questionnaire is implemented consistently and equitably across agencies.

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Page Count

152

Publisher

National Academies Press

Published Date

ISBN 10

0309178193

ISBN 13

9780309178198

Science And Judgement In Risk Assessment

Student Edition

By: Kurt J Isselbacher

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Science And Judgement In Risk Assessment

Student Edition

By: Kurt J Isselbacher

This text explores how the US Environmental Protection Agency EPA can improve its risk assessment practices under the 1990 Clean Air Act Amendments and other regulatory statutes. It examines the assumptions made in risk analysis, how to deal with uncertainty, and other basic concepts, such as "inference assumptions", "default options", and the historical, social and regulatory contexts of risk assessment and risk management.

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337

Publisher

CRC Press

Published Date

ISBN 10

1560325895

ISBN 13

9781560325895

Improving the Nation's Water Security

Opportunities for Research

By: National Research Council,Division on Earth and Life Studies,Water Science and Technology Board,Committee on Water System Security Research

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Improving the Nation's Water Security

Opportunities for Research

By: National Research Council,Division on Earth and Life Studies,Water Science and Technology Board,Committee on Water System Security Research

Concern over terrorist attacks since 2001 has directed attention to potential vulnerabilities of the nation's water and wastewater systems. The Environmental Protection Agency (EPA), which leads federal efforts to protect the water sector, initiated a research program in 2002 to address immediate research and technical support needs. This report, conducted at EPA's request, evaluates research progress and provides a long-term vision for EPA's research program. The report recommends that EPA develop a strategic research plan, address gaps in expertise among EPA program managers and researchers, and improve its approaches to information dissemination. The report recommends several high-priority research topics for EPA, including conducting empirical research in behavioral science to better understand how to prepare people for water security incidents.

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170

Publisher

National Academies Press

Published Date

ISBN 10

0309105668

ISBN 13

9780309105668

Models in Environmental Regulatory Decision Making

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Models in the Regulatory Decision Process

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Models in Environmental Regulatory Decision Making

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Models in the Regulatory Decision Process

Many regulations issued by the U.S. Environmental Protection Agency (EPA) are based on the results of computer models. Models help EPA explain environmental phenomena in settings where direct observations are limited or unavailable, and anticipate the effects of agency policies on the environment, human health and the economy. Given the critical role played by models, the EPA asked the National Research Council to assess scientific issues related to the agency's selection and use of models in its decisions. The book recommends a series of guidelines and principles for improving agency models and decision-making processes. The centerpiece of the book's recommended vision is a life-cycle approach to model evaluation which includes peer review, corroboration of results, and other activities. This will enhance the agency's ability to respond to requirements from a 2001 law on information quality and improve policy development and implementation.

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286

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National Academies Press

Published Date

ISBN 10

0309178924

ISBN 13

9780309178921

Science for Environmental Protection

The Road Ahead

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Science for EPA's Future

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Science for Environmental Protection

The Road Ahead

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Science for EPA's Future

In anticipation of future environmental science and engineering challenges and technologic advances, EPA asked the National Research Council (NRC) to assess the overall capabilities of the agency to develop, obtain, and use the best available scientific and technologic information and tools to meet persistent, emerging, and future mission challenges and opportunities. Although the committee cannot predict with certainty what new environmental problems EPA will face in the next 10 years or more, it worked to identify some of the common drivers and common characteristics of problems that are likely to occur. Tensions inherent to the structure of EPA's work contribute to the current and persistent challenges faced by the agency, and meeting those challenges will require development of leading-edge scientific methods, tools, and technologies, and a more deliberate approach to systems thinking and interdisciplinary science. Science for Environmental Protection: The Road Ahead outlines a framework for building science for environmental protection in the 21st century and identified key areas where enhanced leadership and capacity can strengthen the agency's abilities to address current and emerging environmental challenges as well as take advantage of new tools and technologies to address them. The foundation of EPA science is strong, but the agency needs to continue to address numerous present and future challenges if it is to maintain its science leadership and meet its expanding mandates.

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188

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National Academies Press

Published Date

ISBN 10

0309264898

ISBN 13

9780309264891

Issues in Risk Assessment

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Committee on Risk Assessment Methodology

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Issues in Risk Assessment

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Committee on Risk Assessment Methodology

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.

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375

Publisher

National Academies Press

Published Date

ISBN 10

0309047862

ISBN 13

9780309047869

Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review the OMB Risk Assessment Bulletin

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Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review the OMB Risk Assessment Bulletin

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.

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Page Count

302

Publisher

National Academies Press

Published Date

ISBN 10

0309104777

ISBN 13

9780309104777

Science and Judgment in Risk Assessment

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

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Science and Judgment in Risk Assessment

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

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.

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Page Count

638

Publisher

National Academies Press

Published Date

ISBN 10

0309074908

ISBN 13

9780309074902

Review of the Department of Homeland Security's Approach to Risk Analysis

By: National Research Council,Committee to Review the Department of Homeland Security's Approach to Risk Analysis

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Review of the Department of Homeland Security's Approach to Risk Analysis

By: National Research Council,Committee to Review the Department of Homeland Security's Approach to Risk Analysis

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.

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Page Count

160

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National Academies Press

Published Date

ISBN 10

0309159245

ISBN 13

9780309159241

A Review of the Environmental Protection Agency's Science to Achieve Results Research Program

By: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on the Review of Environmental Protection Agency's Science to Achieve Results Research Grants Program

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A Review of the Environmental Protection Agency's Science to Achieve Results Research Program

Environmental research has driven landmark improvements that led to the protection of human and ecosystem health. Recognizing the value of knowledge generated by environmental research and the ingenuity within academic and nonprofit institutions, the US Environmental Protection Agency (EPA) created a program known as Science to Achieve Results, or STAR, in 1995. STAR is EPA's primary competitive extramural grants program. A Review of the Environmental Protection Agency's Science to Achieve Results Research Program assesses the program's scientific merit, public benefits, and overall contributions in the context of other relevant research and recommends ways to enhance those aspects of the program. This report also considers the conclusions and recommendations of a prior National Research Council review of the STAR program (2003), the STAR program's research priorities in light of the nation's environmental challenges, and the effects of recent STAR funding trends on obtaining scientific information needed to protect public health and the environment.

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114

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National Academies Press

Published Date

ISBN 10

0309458609

ISBN 13

9780309458603

Understanding Risk

Informing Decisions in a Democratic Society

By: National Research Council,Division of Behavioral and Social Sciences and Education,Board on Environmental Change and Society,Committee on Risk Characterization

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Understanding Risk

Informing Decisions in a Democratic Society

By: National Research Council,Division of Behavioral and Social Sciences and Education,Board on Environmental Change and Society,Committee on Risk Characterization

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.

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Page Count

263

Publisher

National Academies Press

Published Date

ISBN 10

0309133246

ISBN 13

9780309133241

Using 21st Century Science to Improve Risk-Related Evaluations

By: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Incorporating 21st Century Science into Risk-Based Evaluations

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Using 21st Century Science to Improve Risk-Related Evaluations

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.

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201

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National Academies Press

Published Date

ISBN 10

0309453488

ISBN 13

9780309453486

Book's by Committee on Improving Risk Analysis Approaches Used by the U.S. EPA

Science and Decisions:

Science and Decisions:

Science and Judgment in Risk Assessment

Science and Judgment in Risk Assessment

Review of EPA's Integrated Risk Information System (IRIS) Process

Review of EPA's Integrated Risk Information System (IRIS) Process

Rethinking the Components, Coordination, and Management of the U.S. Environmental Protection Agency Laboratories

Rethinking the Components, Coordination, and Management of the U.S. Environmental Protection Agency Laboratories

Evaluating Research Efficiency in the U.S. Environmental Protection Agency

Evaluating Research Efficiency in the U.S. Environmental Protection Agency

Science And Judgement In Risk Assessment

Science And Judgement In Risk Assessment

Improving the Nation's Water Security

Improving the Nation's Water Security

Models in Environmental Regulatory Decision Making

Models in Environmental Regulatory Decision Making

Science for Environmental Protection

Science for Environmental Protection

Issues in Risk Assessment

Issues in Risk Assessment

Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget

Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget

Science and Judgment in Risk Assessment

Science and Judgment in Risk Assessment

Review of the Department of Homeland Security's Approach to Risk Analysis

Review of the Department of Homeland Security's Approach to Risk Analysis

A Review of the Environmental Protection Agency's Science to Achieve Results Research Program

A Review of the Environmental Protection Agency's Science to Achieve Results Research Program

Understanding Risk

Understanding Risk

Using 21st Century Science to Improve Risk-Related Evaluations

Using 21st Century Science to Improve Risk-Related Evaluations

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