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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
PREPUBLICATION COPY,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. 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 081between 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 conclu. sions 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. Library of Congress Control Number,International Standard Book Number. Additional copies of this report are available from. The National Academies Press,500 Fifth Street NW,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,Prepublication Copy. The National Academy of Sciences is a private nonprofit self perpetuating society of distinguished scholars engaged in scien. tific 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 Engi. neering 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 mem. bers of appropriate professions in the examination of policy matters pertaining to the health of the public The Institute acts un. der the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal gov. ernment and upon its own initiative to identify issues of medical care research and education Dr Harvey V Fineberg is presi. dent 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 Function. ing 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. www national academies org,Prepublication Copy, COMMITTEE ON MODELS IN THE REGULATORY DECISION PROCESS. 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. 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,U S ENVIRONMENTAL PROTECTION AGENCY. U S DEPARTMENT OF TRANSPORTATION,Prepublication Copy v. BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY1, JONATHAN M SAMET Chair Johns Hopkins University Baltimore MD. RAMO N 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, This study was planned overseen and supported by the Board on Environmental Studies and Toxicology. vi Prepublication Copy,OTHER REPORTS OF THE,BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY. 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. 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,Prepublication Copy vii. 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. Prepublication Copy ix,x Prepublication Copy Preface. Although the reviewers listed above have provided many constructive comments and suggestions. they were not asked to endorse the conclusions or recommendations nor 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. Preface Prepublication Copy xi,Kenneth Reckhow Duke University. Paul Gilman Oak Ridge Center for Advanced Studies, 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,1 STUDY BACKGROUND 11,Early Environmental Models 11. Trends in Environmental Regulatory Model Use 12,Model Limitations and Assumptions 15. Origin of Study and Charge to Committee 16,Committee Approach to the Charge 18. Report Contents 24, 2 MODEL USE IN THE ENVIRONMENTAL REGULATORY DECISION PROCESS 25. Regulating Without Computational Models 25,Regulatory Model Classifications 27. Congressional and Executive Branch Influences 38, Oversight Processes Governing Regulatory Models at EPA 42. The Challenges of Modeling in a Regulatory Environment 48. 3 MODEL DEVELOPMENT 51,Introduction 51,Alternative Model Development Paths 51. Overview of Model Development 52, Interdependence of Models and Data from Measurements 54. Model Development Phases 56,Recommendations 62,4 MODEL EVALUATION 64. Introduction 64,Essential Objectives for Model Evaluation 66. Elements of Model Evaluation 69, Model Evaluation at the Problem Identification Stage 70. Evaluation at the Conceptual Model Stage 71,Evaluation at the Computational Model Stage 72. Evaluation at the Model Application Stage 82,Management of the Evaluation Process 88. Recommendations 97,Prepublication Copy xiii,xiv Prepublication Copy Contents. 5 MODEL SELECTION USE 103,Issues in Model Selection and Application 103. Proprietary Models 111,Recommendations 114,6 FUTURE MODELING ISSUES 115. Expansion of Measurement Systems 115, Improvements in Model Methods and Technologies 116. Changes in Perspectives on Model Use in Regulatory Decision Making 117. In Closing 118,Epilogue 119,REFERENCES 121,GLOSSARY 136. APPENDIXES, A Biographical Information on the Committee on Models in the Regulatory Decision. Process 144, B Public Workshop Presentations to the Committee on Models in the Regulatory Decision. Process 147, C Categories of Environmental Regulatory Models 150.