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Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
×

Models in Environmental Regulatory Decision Making

Committee on Models in the Regulatory Decision Process

Board on Environmental Studies and Toxicology

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
×

THE NATIONAL ACADEMIES PRESS

500 Fifth Street, NW Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This project was supported by Contract No. 68-C-03-081 between the National Academy of Sciences and the U.S. Environmental Protection Agency. Additional support was provided by the U.S. Department of Transportation. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

International Standard Book Number-13: 978-0-309-11000-6

International Standard Book Number-10: 0-309-11000-9

Additional copies of this report are available from

The National Academies Press

500 Fifth Street, NW Box 285 Washington, DC 20055 800-624-6242 202-334-3313 (in the Washington metropolitan area) http://www.nap.edu

Copyright 2007 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America.

Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine


The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.


The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.


The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.


The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.


www.national-academies.org

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COMMITTEE ON MODELS IN THE REGULATORY DECISION PROCESS

Members

CHRIS G. WHIPPLE (Chair),

ENVIRON, Inc., Emeryville, CA

M. BRUCE BECK,

University of Georgia, Warnell School of Forest Resources, Athens

CLAYTON J. CLARK II,

University of Florida, Gainesville

ROBERT T. CLEMEN,

Duke University, Fuqua School of Business, Durham, NC

JUDITH A. GRAHAM,

American Chemistry Council, Arlington, VA

LOUIS J. GROSS,

University of Tennessee, Institute for Environmental Modeling, Knoxville

WINSTON HARRINGTON,

Resources for the Future, Washington, DC

PHILIP HOWARD,

Syracuse Research Corporation, Environmental Science Center, Syracuse, NY

KIMBERLY L. JONES,

Howard University, Washington, DC

THOMAS E. MCKONE,

University of California, Berkeley, and the Lawrence Berkeley National Laboratory, Berkeley, CA

NAOMI ORESKES,

University of California, San Diego

SPYROS N. PANDIS,

University of Patras, Patra, Greece

LOUISE M. RYAN,

Harvard School of Public Health, Department of Biostatistics, Boston, MA

MICHAEL L. STEIN,

University of Chicago, Statistics Department, Chicago, IL

WENDY E. WAGNER,

University of Texas School of Law, Austin

Staff

K. JOHN HOLMES, Project Director

MATTHEW RUSSELL, Associate Staff Officer

RUTH E. CROSSGROVE, Senior Editor

MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center

RADIAH A. ROSE, Senior Editorial Assistant

Sponsor

U.S. ENVIRONMENTAL PROTECTION AGENCY

U.S. DEPARTMENT OF TRANSPORTATION

Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
×

BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY1

Members

JONATHAN M. SAMET (Chair),

Johns Hopkins University, Baltimore, MD

RAMÓN ALVAREZ,

Environmental Defense, Austin, TX

JOHN M. BALBUS,

Environmental Defense, Washington, DC

DALLAS BURTRAW,

Resources for the Future, Washington, DC

JAMES S. BUS,

Dow Chemical Company, Midland, MI

COSTEL D. DENSON,

University of Delaware, Newark

E. DONALD ELLIOTT,

Willkie, Farr & Gallagher LLP, Washington, DC

MARY R. ENGLISH,

University of Tennessee, Knoxville

J. PAUL GILMAN,

Oak Ridge Center for Advanced Studies, Oak Ridge, TN

SHERRI W. GOODMAN,

Center for Naval Analyses, Alexandria, VA

JUDITH A. GRAHAM,

American Chemistry Council, Arlington, VA

WILLIAM P. HORN,

Birch, Horton, Bittner and Cherot, Washington, DC

JAMES H. JOHNSON, JR.,

Howard University, Washington, DC

WILLIAM M. LEWIS, JR.,

University of Colorado, Boulder

JUDITH L. MEYER,

University of Georgia, Athens

DENNIS D. MURPHY,

University of Nevada, Reno

PATRICK Y. O’BRIEN,

ChevronTexaco Energy Technology Company, Richmond, CA

DOROTHY E. PATTON (retired),

Chicago, IL

DANNY D. REIBLE,

University of Texas, Austin

JOSEPH V. RODRICKS,

ENVIRON International Corporation, Arlington, VA

ARMISTEAD G. RUSSELL,

Georgia Institute of Technology, Atlanta

ROBERT F. SAWYER,

University of California, Berkeley

LISA SPEER,

Natural Resources Defense Council, New York, NY

KIMBERLY M. THOMPSON,

Massachusetts Institute of Technology, Cambridge

MONICA G. TURNER,

University of Wisconsin, Madison

MARK J. UTELL,

University of Rochester Medical Center, Rochester, NY

CHRIS G. WHIPPLE,

ENVIRON International Corporation, Emeryville, CA

LAUREN ZEISE,

California Environmental Protection Agency, Oakland

Senior Staff

JAMES J. REISA, Director

DAVID J. POLICANSKY, Scholar

RAYMOND A. WASSEL, Senior Program Officer for Environmental Sciences and Engineering

KULBIR BAKSHI, Senior Program Officer for Toxicology

EILEEN N. ABT, Senior Program Officer for Risk Analysis

KARL E. GUSTAVSON, Senior Program Officer

K. JOHN HOLMES, Senior Program Officer

ELLEN K. MANTUS, Senior Program Officer

SUSAN N.J. MARTEL, Senior Program Officer

STEVEN K. GIBB, Program Officer for Strategic Communications

RUTH E. CROSSGROVE, Senior Editor

1

This study was planned, overseen, and supported by the Board on Environmental Studies and Toxicology.

Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
×

OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY

Toxicity Testing in the Twenty-first Century: A Vision and a Strategy (2007)

Sediment Dredging at Superfund Megasites: Assessing the Effectiveness (2007)

Environmental Impacts of Wind-Energy Projects (2007)

Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007)

Assessing the Human Health Risks of Trichloroethylene: Key Scientific Issues (2006)

New Source Review for Stationary Sources of Air Pollution (2006)

Human Biomonitoring for Environmental Chemicals (2006)

Health Risks from Dioxin and Related Compounds: Evaluation of the EPA Reassessment (2006)

Fluoride in Drinking Water: A Scientific Review of EPA’s Standards (2006)

State and Federal Standards for Mobile-Source Emissions (2006)

Superfund and Mining Megasites—Lessons from the Coeur d’Alene River Basin (2005)

Health Implications of Perchlorate Ingestion (2005)

Air Quality Management in the United States (2004)

Endangered and Threatened Species of the Platte River (2004)

Atlantic Salmon in Maine (2004)

Endangered and Threatened Fishes in the Klamath River Basin (2004)

Cumulative Environmental Effects of Alaska North Slope Oil and Gas Development (2003)

Estimating the Public Health Benefits of Proposed Air Pollution Regulations (2002)

Biosolids Applied to Land: Advancing Standards and Practices (2002)

The Airliner Cabin Environment and Health of Passengers and Crew (2002)

Arsenic in Drinking Water: 2001 Update (2001)

Evaluating Vehicle Emissions Inspection and Maintenance Programs (2001)

Compensating for Wetland Losses Under the Clean Water Act (2001)

A Risk-Management Strategy for PCB-Contaminated Sediments (2001)

Acute Exposure Guideline Levels for Selected Airborne Chemicals (five volumes, 2000-2007)

Toxicological Effects of Methylmercury (2000)

Strengthening Science at the U.S. Environmental Protection Agency (2000)

Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000)

Ecological Indicators for the Nation (2000)

Waste Incineration and Public Health (2000)

Hormonally Active Agents in the Environment (1999)

Research Priorities for Airborne Particulate Matter (four volumes, 1998-2004)

The National Research Council’s Committee on Toxicology: The First 50 Years (1997)

Carcinogens and Anticarcinogens in the Human Diet (1996)

Upstream: Salmon and Society in the Pacific Northwest (1996)

Science and the Endangered Species Act (1995)

Wetlands: Characteristics and Boundaries (1995)

Biologic Markers (five volumes, 1989-1995)

Review of EPA’s Environmental Monitoring and Assessment Program (three volumes, 1994-1995)

Science and Judgment in Risk Assessment (1994)

Pesticides in the Diets of Infants and Children (1993)

Page viii Cite
Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
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Dolphins and the Tuna Industry (1992)

Science and the National Parks (1992)

Human Exposure Assessment for Airborne Pollutants (1991)

Rethinking the Ozone Problem in Urban and Regional Air Pollution (1991)

Decline of the Sea Turtles (1990)


Copies of these reports may be ordered from the National Academies Press

(800) 624-6242 or (202) 334-3313

www.nap.edu

Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
×

PREFACE

The use of computational models is an essential element of the environmental regulatory process. The complex relationship between environmental emissions, the quality of the environment, and human and ecological impacts are linked by modeling in the regulatory process. The U.S. Environmental Protection Agency (EPA) may make a scientific determination of basic environmental goals, such as how clean our air and water need to be to protect human health and the environment. But determining how those goals can be met while simultaneously allowing for basic economic services, such as transportation, energy, and agriculture, requires that we examine the links, for example, between the auto emission standards and the attainment of ambient air quality standards or between the point sources of water pollution and the quality of water. The spatial and temporal scales on which environmental controls and environmental quality are linked generally do not allow for an observational approach to understand the links between economic activity and environmental quality. These linkages are made by modeling.

The task undertaken by this committee for the National Academies was to assess evolving scientific and technical issues related to the development, selection, and use of computational and statistical models in the regulatory process at EPA. In this report, the committee provides advice concerning management, evaluation, and use of models at the agency. Through public workshops and other means, the committee has considered cross-discipline issues related to model development and use, performance evaluation, peer review, uncertainty, and quality assurance–quality control. The committee assessed scientific and technical criteria that should be considered in deciding whether a model and its results could serve as a reasonable basis for environmental regulatory activities. It also examined case studies of model development, evaluation, and application as a basis for arriving at guiding principles.

This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by National Research Council (NRC) Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following for their review of this report: George V. Alexeeff, California EPA; Eula Bingham, University of Cincinnati; John Bredehoeft, the Hydrodynamics Group; E. Donald Elliott, Willkie, Farr & Gallagher, LLP; Paul Gilman, Oak Ridge Center for Advanced Studies; James Hammitt, Harvard Center for Risk Analysis; Michael Koerber, Lake Michigan Air Directors Consortium; Charles Lucas, American International Group, Inc. (retired); Virginia McConnell, Resources for the Future, Inc.; Jana Milford, University of Colorado and Environmental Defense; Lee Mulkey, University of Georgia; Kenneth Reckhow, Duke University; and Scott Zeger, Johns Hopkins University.

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor

Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
×

did they see the final draft of the report before its release. The review of this report was overseen by John Bailar, University of Chicago (retired), and David Allen, University of Texas. Appointed by the NRC, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the committee and the institution.

The committee received oral and written presentations from the following individuals:

Gary Foley, U.S. Environmental Protection Agency

Tom Voltaggio, U.S. Environmental Protection Agency

Albert McGartland, U.S. Environmental Protection Agency

S.T. Rao, U.S. Environmental Protection Agency

Joseph Merenda, U.S. Environmental Protection Agency

Jim Weaver, U.S. Environmental Protection Agency

David Burden, U.S. Environmental Protection Agency

Tim Wool, U.S. Environmental Protection Agency

Leslie Shoemaker, Tetra Tech, Inc.

Jim George, Maryland Department of the Environment

Cecilia Ho, Federal Highway Administration

Harry Kitch, U.S. Environmental Protection Agency

Timothy Miller, U.S. Geological Survey

Jennifer Sass, Natural Resources Defense Council

Scott Slaughter, Center for Regulatory Effectiveness

Adam Finkel, University of Medicine and Dentistry of New Jersey and Princeton University

Gene Tierney, U.S. Environmental Protection Agency

H. Christopher Frey, North Carolina State University

Margo Schwab, Office of Management and Budget

John Graham, Rand Graduate School

Rob Howard, Bechtel-SAIC, LLC

Sheila Jasanoff, Harvard University

Daniel Krewski, McLaughlin Centre for Population Health Risk Assessment

Jan M. Zielinski, McLaughlin Centre for Population Health Risk Assessment

Tim Ramsay, McLaughlin Centre for Population Health Risk Assessment

Richard T. Burnett, McLaughlin Centre for Population Health Risk Assessment

George Leavesley, U.S. Geological Survey

Sam Napolitano, U.S. Environmental Protection Agency

Elliot Lieberman, U.S. Environmental Protection Agency

M. Granger Morgan, Carnegie Mellon University

Pasky Pascual, U.S. Environmental Protection Agency

Barbara Petersen, Exponent, Inc. and Durango Software, LLC

James D. Schaub, U.S. Department of Agriculture

Woodrow Setzer, U.S. Environmental Protection Agency

Harvey Clewell, Centers for Health Research

Rory Conolly, U.S. Environmental Protection Agency

Richard Morgenstern, Resources for the Future

Robert Perciasepe, Audubon Society

Kenneth Reckhow, Duke University

Paul Gilman, Oak Ridge Center for Advanced Studies

Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
×

The committee and I thank all of these individuals for their contributions. A complete list of dates, titles, and presenter names can be found in Appendix B.

The committee and I are also grateful for the assistance of the NRC staff in the preparation of this report. K. John Holmes played a key role in preparing this report as project director. We also thank Raymond Wassel, senior program director of environmental sciences and engineering in the Board on Environmental Studies and Toxicology (BEST), and the other staff members contributing to this report: James Reisa, director of BEST; Steven Gibb, program officer for strategic communications; Ruth Crossgrove, senior editor; Matthew Russell, associate staff officer; Mirsada Karalic-Loncarevic, manager of the Technical Information Center; and Radiah Rose, senior editorial assistant.

As chair, I thank all the members of the committee for their expertise and dedicated effort throughout the study.

Chris Whipple, Chair

Committee on Models in the Regulatory

Decision Process

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CONTENTS

Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
×

FIGURES

1-1

 

Appendix J curve,

 

22

1-2

 

Typical EKMA diagram,

 

22

1-3

 

An orrery or physical model of the solar system,

 

33

1-4

 

The use of a mouse model for estimating human health risks,

 

34

1-5

 

Examples of dose-response models for estimating lifetime risk for male bladder cancers due to arsenic in drinking water for various exposed populations,

 

35

1-6

 

Components and functional arrangements of the IEUBK model that predict blood lead levels in children,

 

36

2-1

 

Basic modeling elements relating human activities and natural systems to environmental impacts,

 

46

2-2

 

Basic elements of risk assessment from the National Research Council’s Red Book,

 

52

2-3

 

Elements of advanced mechanistic approaches to health risk assessment,

 

55

2-4

 

Sources of information for setting various NAAQS,

 

67

2-5

 

Flow chart of general regulatory requirements for models used at the regulatory design and promulgation stage,

 

70

Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
×

3-1

 

Iterative steps in model development proposed by Jakeman et al. (2006),

 

88

3-2

 

Conceptual model for assessing eutrophication in the European seas linking nutrient enrichments and its direct and indirect effects in the ecosystem,

 

97

4-1

 

Stages of a model’s life cycle,

 

107

4-2

 

Range of probabilities that people assign to different words absent any specific context,

 

133

4-3

 

(a) Hypothetical distribution representing uncertainty in number of lives saved by a policy; (b) distribution representing uncertainty in value of a statistical life,

 

139

4-4

 

Unconditional posterior distribution for net benefit of policy,

 

139

4-5

 

Conditional distributions of net benefit assuming different amounts for the value of a statistical life,

 

140

5-1

 

(a) Individual dose-response models, and (b) overall dose-response model fitted using the Bayesian model averaging approach,

 

175

TABLES

2-1

 

Examples of EPA’s Web Sites Containing Model Descriptions for Individual Programs,

 

45

2-2

 

Examples of Major EPA Documents That Incorporate a Substantial Amount of Computational Modeling Activities,

 

47

2-3

 

Examples of Substantive Legislative Directions for EPA Models,

 

63

3-1

 

MOBILE Model Revisions,

 

86

4-1

 

QA/QC Checks for Model Code,

 

120

BOXES

S-1

 

Task Statement,

 

16

1-1

 

Ozone Modeling and the Irregular Swings Between Policy and Science,

 

21

2-1

 

Incorporating Human Behavior into Environmental Models,

 

50

2-2

 

Risk Assessment for Arsenic in Drinking Water,

 

53

2-3

 

The Development of the Requirement for Regulatory Impact Analysis for Major Federal Rules,

 

67

2-4

 

Elements of External Peer Review for Environmental Regulatory Models,

 

72

2-5

 

The Different Types of Science Advisory Panels at EPA,

 

74

3-1

 

Basic Steps in Modeling Development Process,

 

89

3-2

 

Interdependence of Models and Data from Measurements,

 

91

4-1

 

Attributes That Foster Accuracy, Precision, Parsimony, and Transparency in Models,

 

110

4-2

 

Individual Elements of Model Evaluation,

 

114

4-3

 

To Calibrate or Not To Calibrate,

 

124

4-5

 

Life-Cycle Evaluation of Models for Assessing Persistence and Long-Range Transport Potential,

 

151

4-6

 

Retrospective Analysis of Model Predictions,

 

158

Suggested Citation:"Front Matter." National Research Council. 2007. Models in Environmental Regulatory Decision Making. Washington, DC: The National Academies Press. doi: 10.17226/11972.
×

5-1

 

Example of a Generic Model for Application to Specific Settings,

 

171

5-2

 

Appendix W: EPA’s Guidelines on Air Quality Models,

 

173

5-3

 

Arsenic in Drinking Water: Model Selection,

 

174

5-4

 

Use of Multiple Models of Varying Complexity for Estimating Mercury in Fish,

 

176

5-5

 

Model Training and Support,

 

177

5-6

 

Confidence Building in Models Through Transparency,

 

178

5-7

 

Proprietary Components of Environmental Models,

 

186

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Models in Environmental Regulatory Decision Making

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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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