IN THE FACE OF
Committee on Decision Making Under Uncertainty
Board on Population Health and Public Health Practice
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
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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 study was supported by Contract No. EP-C-09-003, TO#6 between the National Academy of Sciences and the Environmental Protection Agency. 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.
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Suggested citation: IOM (Institute of Medicine). 2013. Environmental decisions in the face of uncertainty. Washington, DC: The National Academies Press.
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.
COMMITTEE ON DECISION MAKING UNDER UNCERTAINTY
FRANK A. SLOAN (Chair), J. Alexander McMahon Professor of Health and Management and Professor of Economics, Duke University, Durham, NC
JAMES S. HOYTE, Assistant to the President and Associate Vice President, Adjunct Lecturer on Public Policy, Harvard University, Boston, MA (Retired)
ROGER E. KASPERSON, Research Professor and Distinguished Scientist, Clark University, Worcester, MA
EMMETT B. KEELER, Senior Mathematician and Professor of Health Economics, Pardee RAND Graduate School, Santa Monica, CA
SARAH B. KOTCHIAN, Associate Director for Planning, University of New Mexico, Albuquerque (Retired)
JOSEPH V. RODRICKS, Principal, ENVIRON International Corporation, Arlington, VA
SUSAN L. SANTOS, Assistant Professor, University of Medicine and Dentistry of New Jersey, Piscataway
STEPHEN H. SCHNEIDER, 1 Melvin and Joan Lane Professor for Interdisciplinary Environmental Studies, Department of Biology, and Senior Fellow, Woods Institute for the Environment, Stanford University, CA
STEPHANIE TAI, Assistant Professor of Law, University of Wisconsin Law School, Madison
DETLOF VON WINTERFELDT, Professor of Industrial and Systems Engineering and Professor of Public Policy and Management, University of Southern California, Los Angeles
ROBERT B. WALLACE, Irene Ensminger Steecher Professor of Epidemiology and Internal Medicine, University of Iowa, Iowa City
MICHELLE C. CATLIN, Study Director (from September 2011)
KATHLEEN STRATTON, Study Director (through August 2011)
KRISTINA SHULKIN, Senior Project Assistant (until July 2008)
HOPE HARE, Administrative Assistant
ROSE MARIE MARTINEZ, Director, Board on Population Health and Public Health Practice
1 Deceased, July 2010.
This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’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 for 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 individuals for their review of this report:
Ann Bostrom, University of Washington
E. D. Elliott, Yale University School of Law
William H. Farland, Colorado State University
Adam M. Finkel, University of Medicine and Dentistry of New Jersey
Dennis G. Fryback, University of Wisconsin–Madison
Marianne Horinko, The Horinko Group
Ronald A. Howard, Stanford University
David O. Meltzer, University of Chicago
Kara Morgan, Food and Drug Administration
Richard D. Morgenstern, Resources for the Future
Mary D. Nichols, California Air Resources Board
Gregory M. Paoli, Risk Sciences International
Melissa J. Perry, George Washington University
David Spiegelhalter, Centre for Mathematical Sciences, Cambridge
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 Chris G. Whipple, ENVIRON, and Harold C. Sox, Geisel School of Medicine at Dartmouth. Appointed by the National Research Council and the Institute of Medicine, 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 authoring committee and the institution.
Boxes, Figures, and Tables
Multiple sources of uncertainty exist in any risk assessment including those conducted by the U.S. Environmental Protection Agency (EPA), the lead agency responsible for protecting Americans against significant risks to human health and the environment. The EPA asked the Institute of Medicine (IOM) to convene a committee to provide guidance for its decision makers and partners on approaches to manage risk in different contexts when uncertainty is present. To tackle this issue, the IOM assembled a committee of experts in the fields of risk assessment, public health, health economics, decision analysis, public policy, risk communication, and environmental and public health law. The committee met five times, including three open sessions during which committee members discussed relevant issues with outside experts and discussed the charge with the EPA.
In discussing its charge, the committee found it helpful to clarify the questions in its statement of task. When considering that question of “how … uncertainty influence[s] risk management under different public health policy scenarios,” the committee deliberated on how uncertainty can and should influence decisions and help decision makers, rather than focusing on how it currently influences such decisions. In addition, when considering tools and techniques from other areas of public health policy, the committee considered whether there are tools and techniques available from other decision-making settings of potential use to EPA decision making, what their benefits and drawbacks are, and whether and how those tools could be applied by EPA.
Uncertainty is a very broad topic with many potential implications for decision making; this presented a thorny challenge to the committee throughout its deliberations. That challenge was amplified by the broad range of
perspectives and diverse backgrounds committee members brought to the deliberations. The result was adoption of a broader approach to considering uncertainty than is typically taken for environmental decisions. In contrast, historically, much of the work related to uncertainty by EPA and others has focused on the uncertainty in the estimates of human health risks.
Despite a lengthy delay in completing this report, and after responding to excellent peer-review comments, in the end, I am proud of the work we have done and hope that the EPA and other decision makers will find the fundamental report message useful. In summary, that message is that EPA has made substantial technical progress in how it conducts uncertainty analyses in support of its human health risk assessments. However, because uncertainties pervade not only relationships between hazards and health outcomes, more emphasis is needed on the uncertainty in factors affecting EPA’s decisions in addition to estimates of uncertainties in how policies affect human health (e.g., uncertainty in economics and technological assessment that are used for regulatory purposes). Advances in accounting for these latter uncertainties are critical to more robust assessments and ultimately should lead to better decisions.
The committee would like to thank all of the individuals who contributed to the work of the committee, including those who presented to the committee (Appendix C), and the peer reviewers who gave the committee a careful assessment and a list of suggested changes that, when implemented, substantially improved the report. The committee also acknowledges the help of consultants Lynn Goldman and David Paltiel, who provided effective guidance at critical points in the Committee’s work. I would also like to acknowledge committee members Michael Taylor and Robert Perciasepe, who resigned from the committee upon being offered appointments at the FDA and EPA, respectively, Dorothy Patton, who also resigned from the committee, and Steven Schneider, who died in July 2010. All four members made early contributions to the committee’s deliberations but were not involved in the drafting and approval of the final report.
Finally, I would like to thank my colleagues on the committee for their efforts and perseverance throughout what turned out to be a lengthy process. They have argued their positions but also accommodated their colleagues and sought consensus. I would also like to acknowledge the contributions of a number of staff members from IOM, in particular Kathleen Stratton and Michelle Catlin, whose efforts were essential in information gathering, in report writing, in responding to reviewers’ comments, and in providing the committee with assistance and support. Many thanks to many other IOM staff, particularly Rose Marie Martinez, who made important contributions along the way to the final production of this report.
Frank A. Sloan, Chair
Committee on Decision Making Under Uncertainty
Advisory Committee on Immunization Priorities
Agency for Healthcare Research and Quality
American Nonsmokers’ Rights Foundation
Agency for Toxic Substances and Disease Registry
best available technology economically achievable
best conventional pollutant control technology
biochemical oxygen demand
best practicable control technology currently available
bovine spongiform encephalopathy
Clean Air Act
California Environmental Protection Agency
Climate Change Science Program
U.S. Centers for Disease Control and Prevention
Center for Drug Evaluation and Review
cumulative distribution function
Center for Devices and Radiological Health
Comprehensive Environmental Response, Compensation, and Liability Act
Center for Food Safety and Nutrition
computable general equilibrium
cervical intraepithelial neoplasia
Clean Water Act
economic impact analysis
U.S. Environmental Protection Agency
expected value of including uncertainty
expected value of perfect information
expected value of sample information
Food and Agriculture Organization of the United Nations
U.S. Food and Drug Administration
Food Safety and Inspection Service
generally available control technology
U.S. Government Accountability Office
Grading of Recommendations Assessment, Development and Evaluation
hazardous air pollutant
Harvard Center for Risk Analysis
U.S. Department of Health and Human Services
International Agency for Research on Cancer
Institute of Medicine
Intergovernmental Panel on Climate Change
maximum achievable control technology
maximum containment level
maximum containment level goal
maximally exposed individual
National Ambient Air Quality Standards
National Academy of Sciences
National Emission Standards for Hazardous Air Pollutants
net present value
National Research Council
National Toxicology Program
Office of Management and Budget
Occupational Safety and Health Administration
Office of Science and Technology Policy
probability density function
point of departure
Resource Conservation and Recovery Act
ready to eat
Science Advisory Board of the EPA
Safe Drinking Water Act
selective serotonin reuptake inhibitor
tolerable daily intake
transmissible spongiform encephalopathy
U.S. Department of Agriculture
U.S. Preventive Services Task Force
value of information
value of statistical lives
World Health Organization
willingness to pay