SCIENTIFIC REVIEW OF THE PROPOSED RISK ASSESSMENT BULLETIN FROM THE OFFICE OF MANAGEMENT AND BUDGET
THE NATIONAL ACADEMIES PRESS
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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.
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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.
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
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
SUZANNE VAN DRUNICK, Senior Program Officer
STEVEN K. GIBB, Program Officer for Strategic Communications
RUTH E. CROSSGROVE, Senior Editor
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
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,
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
BOXES
TABLES
3-1 |
Goals for Risk Assessment as Stated in Bulletin and Clarified in Supplementary Information |
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4-1 |
Summary of Bulletin and Supplementary Information on Range of Risk Estimates and Central Estimates |
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4-2 |
Previous NRC Reports Addressing Issues of Uncertainty and Central Risk Estimates |
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4-3 |
Technical and Scientific Circumstances That Prevent the Current Applicability of the Bulletin |