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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
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ENVIRONMENTAL
DECISIONS
IN THE FACE OF
UNCERTAINTY

Committee on Decision Making Under Uncertainty

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
×

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 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.

International Standard Book Number-13: 978-0-309-13034-9
International Standard Book Number-10: 0-309-13034-4

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Copyright 2013 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Suggested citation: IOM (Institute of Medicine). 2013. Environmental decisions in the face of uncertainty. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
×

Knowing is not enough; we must apply.
Willing is not enough; we must do.

—Goethe

image

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
×

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

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
×

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

IOM Staff

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
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Reviewers

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

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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
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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.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
×
5-1 Definitions of Preliminary Graphical Representations of Uncertainty
5-2 Implementing Value-of-Information in a Business Context
5-3 Examples of Value-of-Information Measures
 
6-1 Strengths and Weaknesses of Numeric, Verbal, and Visual Communication of Risk
6-2 When Greater Attention to Reporting Uncertainties May Be Needed
 
7-1 Implications of Uncertainty Analysis for Decision Making

FIGURES

1-1 The Presidential/Congressional Commission on Risk Assessment and Risk Management’s framework for risk management decisions
1-2 Factors considered in EPA’s decisions
 
5-1a Framework for decision making
5-1b Considerations for each assessment during phase
5-2 Schematic illustrating the values that can be calculated in a value-of-information analysis
 
6-1 Nine displays for communicating uncertain estimates for the value of a single variable used in experiments
6-2 Examples of the most common graphical displays of uncertainty: (a) a probability density function, (b) a cumulative distribution function, and (c) a box-and-whisker plot
6-3 Graphic used by Krupnick et al. (2006) to display sources of uncertainty and to describe the impact of each source of uncertainty on estimates of expected net benefits in 2025

TABLES

1-1 Selected Statutory Requirements Related to Consideration of Factors Other Than Estimates of Human Health Risks
 
4-1 Assessment of Risks, Benefits, Other Decision-Making Factors and Uncertainty at Selected Public Health Agencies and Organizations
4-2 Estimates of Infected Cases of BSE in the 20 Years Following Introduction of 500 Infected Animals into the United States
 
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
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Preface

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

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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
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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

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
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Abbreviations and Acronyms

ACIP

Advisory Committee on Immunization Priorities

AHRQ

Agency for Healthcare Research and Quality

ANRF

American Nonsmokers’ Rights Foundation

ATSDR

Agency for Toxic Substances and Disease Registry

 
BAT

best available technology economically achievable

B/C

benefit-to-cost

BCA

benefit–cost analysis

BCT

best conventional pollutant control technology

BMD

benchmark dose

BMR

benchmark response

BOD5

biochemical oxygen demand

BPT

best practicable control technology currently available

BSE

bovine spongiform encephalopathy

 
CAA

Clean Air Act

Cal EPA

California Environmental Protection Agency

CCSP

Climate Change Science Program

CDC

U.S. Centers for Disease Control and Prevention

CDER

Center for Drug Evaluation and Review

CDF

cumulative distribution function

CDRH

Center for Devices and Radiological Health

CEA

cost-effectiveness analysis

CERCLA

Comprehensive Environmental Response, Compensation, and Liability Act

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
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CFSAN

Center for Food Safety and Nutrition

CGE

computable general equilibrium

CIN

cervical intraepithelial neoplasia

CJD

Creutzfeldt-Jakob disease

C–R

concentration–response

CWA

Clean Water Act

 
EIA

economic impact analysis

EPA

U.S. Environmental Protection Agency

EVIU

expected value of including uncertainty

EVPI

expected value of perfect information

EVSI

expected value of sample information

 
FAO

Food and Agriculture Organization of the United Nations

FDA

U.S. Food and Drug Administration

FSIS

Food Safety and Inspection Service

 
GACT

generally available control technology

GAO

U.S. Government Accountability Office

GRADE

Grading of Recommendations Assessment, Development and Evaluation

 
HAP

hazardous air pollutant

HCRA

Harvard Center for Risk Analysis

HHS

U.S. Department of Health and Human Services

HPV

human papillomavirus

 
IARC

International Agency for Research on Cancer

IOM

Institute of Medicine

IPCC

Intergovernmental Panel on Climate Change

 
LOAEL

lowest-observed-adverse-effect level

 
MACT

maximum achievable control technology

MCL

maximum containment level

MCLG

maximum containment level goal

MEI

maximally exposed individual

 
NAAQS

National Ambient Air Quality Standards

NAS

National Academy of Sciences

NESHAPS

National Emission Standards for Hazardous Air Pollutants

NOAEL

no-observed-adverse-effect level

NPV

net present value

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Environmental Decisions in the Face of Uncertainty. Washington, DC: The National Academies Press. doi: 10.17226/12568.
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NRC

National Research Council

NTP

National Toxicology Program

 
OMB

Office of Management and Budget

OSHA

Occupational Safety and Health Administration

OSTP

Office of Science and Technology Policy

 
PDF

probability density function

POD

point of departure

 
QALY

quality-adjusted life-year

 
RCRA

Resource Conservation and Recovery Act

RfC

reference concentration

RfD

reference dose

RTE

ready to eat

 
SAB

Science Advisory Board of the EPA

SDWA

Safe Drinking Water Act

SHS

secondhand smoke

SSRI

selective serotonin reuptake inhibitor

 
TCE

trichloroethylene

TDI

tolerable daily intake

TSE

transmissible spongiform encephalopathy

 
UF

uncertainty factor

USDA

U.S. Department of Agriculture

USPSTF

U.S. Preventive Services Task Force

 
VOI

value of information

VSL

value of statistical lives

 
WHO

World Health Organization

WTP

willingness to pay

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The U.S. Environmental Protection Agency (EPA) is one of several federal agencies responsible for protecting Americans against significant risks to human health and the environment. As part of that mission, EPA estimates the nature, magnitude, and likelihood of risks to human health and the environment; identifies the potential regulatory actions that will mitigate those risks and protect public health1 and the environment; and uses that information to decide on appropriate regulatory action. Uncertainties, both qualitative and quantitative, in the data and analyses on which these decisions are based enter into the process at each step. As a result, the informed identification and use of the uncertainties inherent in the process is an essential feature of environmental decision making.

EPA requested that the Institute of Medicine (IOM) convene a committee to provide guidance to its decision makers and their partners in states and localities on approaches to managing risk in different contexts when uncertainty is present. It also sought guidance on how information on uncertainty should be presented to help risk managers make sound decisions and to increase transparency in its communications with the public about those decisions. Given that its charge is not limited to human health risk assessment and includes broad questions about managing risks and decision making, in this report the committee examines the analysis of uncertainty in those other areas in addition to human health risks. Environmental Decisions in the Face of Uncertainty explains the statement of task and summarizes the findings of the committee.

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