SCIENTIFIC REVIEW OF THE PROPOSED RISK ASSESSMENT BULLETIN FROM THE OFFICE OF MANAGEMENT AND BUDGET

Committee to Review the OMB Risk Assessment Bulletin

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



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page R1
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 Committee to Review the OMB Risk Assessment Bulletin 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

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget 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, the U.S. Department of Agriculture, the U.S. Department of Defense, the U.S. Department of Energy, the U.S. Department of Health and Human Services, the U.S. Department of Labor, and the National Aeronautics and Space Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-10477-7 International Standard Book Number-10: 0-309-10477-7 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

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget 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. Wm. A. Wulf 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. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget This page intentionally left blank.

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget COMMITTEE TO REVIEW THE OMB RISK ASSESSMENT BULLETIN Members JOHN F. AHEARNE (Chair), Sigma Xi, Research Triangle Park, NC GEORGE V. ALEXEEFF, California Environmental Protection Agency, Oakland GREGORY B. BAECHER, University of Maryland, College Park A. JOHN BAILER, Miami University, Oxford, OH ROGER M. COOKE, Resources for the Future, Washington, DC CHARLES E. FEIGLEY, University of South Carolina, Columbia BARUCH FISCHHOFF, Carnegie Mellon University, Pittsburgh, PA CHARLES P. GERBA, University of Arizona, Tucson ROSE H. GOLDMAN, Harvard Medical School, Cambridge, MA ROBERT HAVEMAN, University of Wisconsin-Madison, Madison WILLIAM E. KASTENBERG, University of California, Berkeley SALLY KATZEN, George Mason University Law School, Arlington, VA EDUARDO MIRANDA, Stanford University, Stanford, CA MICHAEL NEWMAN, The College of William and Mary, Gloucester Point, VA DOROTHY E. PATTON, Retired, Chicago, IL CHARLES POOLE, University of North Carolina, Chapel Hill DANNY D. REIBLE, University of Texas at Austin JOSEPH V. RODRICKS, ENVIRON International Corporation, Arlington, VA Staff ELLEN K. MANTUS, Project Director JENNIFER SAUNDERS, Associate Program Officer NORMAN GROSSBLATT, Senior Editor MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center JOHN BROWN, Program Associate Sponsors U.S. ENVIRONMENTAL PROTECTION AGENCY U.S. DEPARTMENT OF AGRICULTURE U.S. DEPARTMENT OF DEFENSE U.S. DEPARTMENT OF ENERGY U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S. DEPARTMENT OF LABOR NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget 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 1 This study was planned, overseen, and supported by the Board on Environmental Studies and Toxicology.

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget 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 SUZANNE VAN DRUNICK, Senior Program Officer STEVEN K. GIBB, Program Officer for Strategic Communications RUTH E. CROSSGROVE, Senior Editor

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY 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

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget Preface In an effort to improve the overall practice of risk assessment in the federal government, the Office of Management and Budget (OMB) released its Proposed Risk Assessment Bulletin on January 9, 2006, with a stated objective to “enhance the technical quality and objectivity of risk assessments prepared by federal agencies.” The bulletin presents specific standards for risk assessments disseminated by federal agencies. OMB and the sponsoring agencies (Environmental Protection Agency, U.S. Department of Agriculture, Department of Defense, Department of Energy, Department of Health and Human Services, Department of Labor, and National Aeronautics and Space Administration) requested that the National Research Council (NRC) conduct a scientific review of the bulletin. In this report, the NRC’s Committee to Review the OMB Risk Assessment Bulletin provides its assessment of the OMB bulletin. The committee evaluates the standards presented in the bulletin, comments on the impact of the bulletin on the practice of risk assessment in the federal government, identifies critical elements missing from the bulletin, evaluates the consistency of the bulletin with previous reports of NRC and other organizations, and determines whether the draft bulletin has met OMB’s stated objective. This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by NRC’s 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: Lawrence Barnthouse, LWB Environmental Services, Inc.; Robert J. Budnitz, Lawrence Livermore National Laboratory; David Gaylor, Gaylor and Associates; J. Paul Gilman, Oak Ridge Center for Advanced Studies; Daniel Krewski, University of Ottawa; Jonathan Levy, Harvard School of Public Health; Roger O. McClellan, Albuquerque, New Mexico; Ali Mosleh,

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget University of Maryland; Gilbert Omenn, University of Michigan Medical School; and Paul Slovic, Decision Research. 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 B. John Garrick, Laguna Beach, California, and John C. Bailar, III, University of Chicago. Appointed by 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 gratefully acknowledges the following for making presentations to the committee: Linda Abbott, U.S. Department of Agriculture; Nancy Beck, Office of Management and Budget; Al Cobb, U.S. Department of Energy; Shannon Cunniff, U.S. Department of Defense; Homayoon Dezfuli, National Aeronautics and Space Administration; Steve Galson, Christopher Portier, and Christine Sofge, U.S. Department of Health and Human Services; John Graham, RAND Graduate School; Judith Graham, American Chemistry Council; George Gray, U.S. Environmental Protection Agency; Stephen Heinig, Association of American Medical Colleges; Alan Krupnick, Resources for the Future; Gilbert Omenn, University of Michigan Medical School; William Perry, U.S. Department of Labor; Lorenz Rhomberg, Gradient Corporation; Jennifer Sass, Natural Resources Defense Council; and Robert Shull, OMB Watch. The committee is also grateful for the assistance of the NRC staff in preparing this report. Staff members who contributed to this effort are Jennifer Saunders, associate program officer; Norman Grossblatt, senior editor; John Brown, program associate; Radiah Rose, senior editorial assistant; and James J. Reisa, director of the Board on Environmental Studies and Toxicology. Primary among the staff was Ellen K. Mantus, project director, whose knowledge, careful working with the committee, and extreme diligence brought this report to completion. I would especially like to thank the members of the committee for their efforts throughout the development of this report. John F. Ahearne, Chair Committee to Review the OMB Risk Assessment Bulletin

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget Contents     SUMMARY   1 1   INTRODUCTION   9      The Office of Management and Budget,   9      The Bulletin and Supplementary Information,   10      Committee’s Task and Approach,   11      Organization of the Report,   12      References,   13 2   CONSISTENCY WITH NATIONAL RESEARCH COUCIL AND OTHER REPORTS   15      Themes and Recommendations from Cited Studies,   16      Influence of the Cited Studies,   20      The Office of Management and Budget Bulletin: Consistency with Major Themes and Recommendations,   21      References,   25 3   RISK ASSESSMENT DEFINITION AND GOALS   26      Definition of Risk Assessment,   26      Goals,   30      References,   34 4   STANDARDS FOR RISK ASSESSMENT   35      Different Levels of Standards,   35      Range of Risk Estimates and Central Estimates,   36      Uncertainty,   43      Adverse Effects,   54      Risk Comparisons,   59      Summary of Committee Comments on Individual Standards,   61      References,   70

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget 5   OMISSIONS FROM THE BULLETIN   78      Engineered Systems,   78      Sensitive Subpopulations,   79      Exemptions, Waivers, and Deferrals,   80      The Role of Risk Assessment Policy and Default Options,   82      Externally Generated Risk Assessments,   83      Risk Communication,   85      Impacts,   87      References,   87 6   IMPACT ON THE PRACTICE OF RISK ASSESSMENT IN THE FEDERAL GOVERNMENT   88      The Absence of Information to Evaluate the Impact of the Bulletin on Agency Risk Assessment Practices,   89      Benefits,   90      Costs,   93      Are the Goals of Enhancing Technical Quality and Objectivity of Risk Assessment Met by the Proposed Bulletin?   103      References,   104 7   CONCLUSIONS AND RECOMMENDATIONS   105      Conclusions,   107      Recommendations,   110      References,   111     APPENDIX A: BIOGRAPHICAL INFORMATION ON THE COMMITTEE TO REVIEW THE OMB RISK ASSESSMENT BULLETIN   113     APPENDIX B: OMB PROPOSED RISK ASSESSMENT BULLETIN   122     APPENDIX C: STATEMENT OF TASK   149     APPENDIX D: PUBLIC MEETING AGENDA   151     APPENDIX E: QUESTIONS FOR FEDERAL AGENCIES FROM THE COMMITTEE AND AGENCY RESPONSES TO QUESTIONS   155      Agency Responses to Questions,   157      Consumer Product Safety Commission,   163      Department of Defense,   169      Department of Energy,   183      Department of Health and Human Services,   192      Department of Housing and Urban Development,   219      Department of Interior,   223      Department of Labor,   235

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget      Department of Transportation,   243      Environmental Protection Agency,   253      National Aeronautics and Space Administration,   271      Office of Management and Budget,   283 BOXES 1-1   Types of Risk Assessment   13 4-1   Principles and Objectives of a PRA Standard   48 TABLES 3-1   Goals for Risk Assessment as Stated in Bulletin and Clarified in Supplementary Information   31 4-1   Summary of Bulletin and Supplementary Information on Range of Risk Estimates and Central Estimates   38 4-2   Previous NRC Reports Addressing Issues of Uncertainty and Central Risk Estimates   40 4-3   Technical and Scientific Circumstances That Prevent the Current Applicability of the Bulletin   62

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget This page intentionally left blank.

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget SCIENTIFIC REVIEW OF THE PRPPOSED RISK ASSESSMENT BULLETIN FROM THE OFFICE OF MANAGEMENT AND BUDGET

OCR for page R1
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget This page intentionally left blank.