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‘ U.S.CONGRESS ' ..
| OFFICE OF .
TECHNOLOGY ~ |
ASSESSMENT |
‘Technology Assessment Board of the 103d Congress
EDWARD M. KENNEDY, Massachusetts, Chairman
DON SUNDQUIST, Tennessee, Vice Chairman
SENATE HOUSE
ERNEST F. HOLLINGS, South Carolina GEORGE E. BROWN, JR., California
CLAIBORNE PELL, Rhode Island JOHN D. DINGELL, Michigan
ORRIN G. HATCH, Utah JIM McDERMOTT, Washington
CHARLES E. GRASSLEY, Iowa rN( Od s (@1ULC] nO) \ Pa( nna Core
DYNA = 910) 5)= 1)\| =)= n (Cl= a Pam\ye lnaoe! MICHAEL G. OXLEY, Ohio
ROGER C. HERDMAN
Technology Assessment Advisory Council
NEIL E. HARL, Chairman MAX LENNON
Charles F. Curtiss Distinguished Professor President, Clemson University
Iowa State University Clemson, South Carolina
Ames, lowa
THOMAS J. PERKINS
JAMES C. HUNT, Vice Chairman General Partner
Distinguished Professor, Health Sciences Center Kleiner, Perkins, Caufield and Byers
; University of Tennessee San Francisco, California
Memphis, Tennessee
CHASE N. PETERSON
CHARLES A. BOWSHER President Emeritus and Professor
Comptroller General of the United States University of Utah
Salt Lake City, Utah
Washington, D.C.
LEWIS M. BRANSCOMB WILLIAM H. ROBINSON
Director, Science, Technology & Public Acting Director, Congressional Research Service
Policy Program, Harvard University The Library of Congress
Washington, D.C.
Cambridge, Massachusetts
Be HERBERT (TED) DOAN JOHN F.M. SIMS
._. President (Ret.), The Dow Chemical Company Vice President, Marketing
: Midland, Michigan Usibelli Coal Mine, Inc.
Fairbanks, Alaska
JOSHUA LEDERBERG
MARINA v.N. WHITMAN
Professor, Rockefeller University
Professor, Institute of Public Policy Studies
. New York, New York
University of Michigan
Ann Arbor, Michigan
The Technology Assessment Board approves the release of this report. The views expressed in this report
are not necessarily those of the Board, OTA Advisory Council, or individual members thereof.
ML
22501864284
NKTOWOINLNIDSOIWWLN OOdUI ANS
U.S. CONGRESS
INFORM?" CENTRE
ere ne or
TECHNOLOGY
vi 12 OFT 1994 540:
ASSESSMENT ——
Wellcome Ce: uical Science
F erates
Recommended Citation:
U.S. Congress, Office of Technology Assessment, Researching Health Risks,
OTA-BBS-570 (Washington, DC: U.S. Government Printing Office, November
1993).
a ae eA Ry i) ee a Pe el A a
For sale by the U.S. Government Printing Office ¢
Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328
ISBN 0-16-043021-6
oreword
n everyday life, we evaluate the risks associated with various activities and make
choices, considering such things as benefits, costs, convenience, and past
experience. As a society, we must make similar choices. The process of health risk
assessment can help guide the decisions necessary for living in a world full of
chemicals, radiation, and fibers, both natural and manufactured.
Risk assessment illuminates the hazards that result from exposure to a substance
and the magnitude of the risk associated with different levels of exposure. Results of
health risk assessments are used as one of the inputs in formulating regulatory decisions.
Those decisions affect expenditures for regulatory compliance or treating exposure-
related diseases that can total billions of dollars.
Because of the public health and economic implications of risk assessments,
Congress has grown increasingly interested in the accuracy and scientific underpinning
of risk assessment. An indication of this interest was the request by the House Energy
and Commerce Committee and the House Science, Space, and Technology Committee
to the Office of Technology Assessment (OTA) to analyze the nature, organization, and
management of federally supported research on health risk assessment. This focus is
important because such research provides the scientific foundation for health risk
assessments.
In this report, OTA describes the Federal Government’s research activities that are
intended to improve health risk assessments. One of the findings of this Report is that
the attention and resources allotted to health risk assessment research are not
commensurate with its national impact. A particular problem is that research is
fragmented within and across the Federal agencies, greatly complicating setting research
priorities. Consequently, the agencies are not focusing on areas of research likely to have
the most far-reaching effect on policy—especially risk assessment methodology—and
they are unable to harness fully the rapid advances in the basic biological and biomedical
sciences.
Many individuals and institutions contributed their time and expertise to this
project. Experts from government, industry and academia served on the project’s
advisory panel and workshop on research structure and organization and reviewed drafts
of chapters and the full report. OTA gratefully acknowledges their contributions and
assistance. As with all OTA analysis, however, responsibility for the content is OTA’s
alone.
PI GLO
Roger C. Herdman, Director
Avisos Panel
Ronald W. Estabrook, Panel Chair
The University of Texas Southwestern Medical Center
Dallas, Texas
Eula Bingham Colin N. Park
University of Cincinnati _ The Dow Chemical Co.
Cincinnati, OH Midland, MI
Thomas A. Burke David P. Rall
The Johns Hopkins University Washington, DC
Baltimore, MD
Joseph V. Rodricks
Adam M. Finkel ENVIRON Corp.
Resources for the Future Arlington, VA
Washington, DC
Curtis C. Travis
Joseph H. Guth Oak Ridge National Laboratory
Natural Resources Defense Council, Inc. Oak Ridge, TN
New York, NY
James D. Wilson
Oliver Hankinson Monsanto Co.
University of California, Los Angeles St. Louis, MO
Los Angeles, CA
Lauren Zeise
David Lilienfeld California Environmental Protection Agency
EMMES Berkeley, CA
Potomac, MD
Rae Zimmerman
Gilbert S. Omenn New York University
University of Washington New York, NY
Seattle, WA
NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the advisory panel members. The panel
does not, however, necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the report and the accuracy
of its contents.
iv /
roject Staff
Clyde J. Behney PRINCIPAL STAFF ADMINISTRATIVE STAFF
Assistant Director
DALTON PAXMAN Cecile Parker
Health, Life Sciences,
Project Director Office Administrator
and the Environment
Margaret McLaughlin Linda Journiette-Rayford
Michael Gough Project Director! PC Specialist
Program Manager
Margaret Chu Jene Lewis
Biological and Behavioral Sciences
Senior Science Fellow (EPA) Administrative Secretary
Ginger Roehrig
PUBLISHING STAFF
Research Assistant
CONTRACTORS
Mary Lou Higgs
Kerry Conroy Manager, Publishing Services
Leah Mazade
Intern?
Editor Denise Felix
Washington, DC
Production Editor
John Hall
Miriam Davis Intern* Cheryl Davis
Washington, DC Typographer
Terri Smith
George Gray Susan Hoffmeyer
Harvard University Intern Graphic Designer
Boston, MA
CONTRIBUTORS
William Pease
University of California Hugh L. Spitzer
Berkeley, CA International Life Sciences
Institute
Sandy Weiner
Risk Sciences Institute
Massachusetts Institute
for Technology Jill S. Litt
1Through May 1992.
Cambridge, MA International Life Sciences
?Through May 1993.
Institute 3Through August 1993.
Risk Sciences Institute Through March 1993.
orkshop Participants
Thomas Burke, Workshop Co-chair lra Raskin
Department of Health Policy and Management Center for Medical Effectiveness Research
The Johns Hopkins University U.S. Department of Health and Human Services
Baltimore, MD Rockville, MD
Rae Zimmerman, Workshop Co-chair John Vandenberg
Robert F. Wagner Graduate School of Public Service Health Effects Research Laboratory
New York University U.S. Environmental Protection Agency
New York, NY Research Triangle Park, NC
Marvin Cassman Dan Vandermeer
National Institute of General Medical Sciences National Institute of Environmental Health Sciences
National Institutes of Health U.S. Department of Health and Human Services
Bethesda, MD Research Triangle Park, NC
Irwin Feller Jeanette Wiltse
Graduate School of Public Policy and Adminstration Office of Health Effects Assessment
The Pennsylvania State University U.S. Environmental Protection Agency
University Park, PA Washington, DC |
Carolyn Fulco Frank E. Young
National Academy of Sciences U.S. Department of Health and Human Services
Washington, DC Washington, DC
Bryan Hardin
National Institute for Occupational Safety and Health
U.S. Department of Health and Human Services
Washington, DC ~
NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the workshop participants. The
participants do not, however, necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the report and the
accuracy of its contents.
Vi yi
ontents
1 Summary, Issues and Options 1
Health Risk Assessment Research at Federal Agencies 3
Linking Health Risk Research to Decisionmaking 12
Prospects for the Future 19
Introduction to Issues and Options 20
Issues in Health Risk Research, Structure and Funding 22
Issues in Linking Research to Decisionmaking
(Radon as a Case Study) 36
2 An Introduction to Health Risk Assessment and
Its Research Base 45
Research Data for Health Risk Assessment 48
The Health Risk Assessment Process 50
Issues in Health Risk Assessment 54
Why Conduct Risk Assessment Research? 60
Summary 63
Chapter 2 References 63
3 Federal Research in Health Risk Assessment 67
Research at the Federal Agencies 67
Trends and Gaps _ 81
Summary 83
Chapter 3 References 83
4 Setting Priorities for Risk Assessment Research 87
Categorizing Health Risk Assessment Research 88
Federal Resources for Health Risk Assessment Research 93
National Research Priorities 98
Agency Priorities 102
Programmatic Priorities and Program Management 108
Administrative Tools for Priority-Setting 109
Findings and Conclusions 112
Chapter 4 References 115
vii
5 Research and Decisionmaking 119
Impact of Research on Risk Assessment Guidelines and
Decisionmaking 120
The Interdependency of Research and Decisionmaking 130
The Limits of Science in Social Decisions 133 ,
Linking Health Risk Research to Decisionmaking 137
Summary 140
Chapter 5 References 141
6 Indoor Radon: A Case Study in Decisionmaking 145
How Large Is the Waterborne Radon Problem? 146
Radon, Mining, and Indoor Exposures 146
Epidemiologic Studies of Radon-Related Lung Cancer 149
Policy 154
The Future 165
Chapter 6 References 167
7 Structuring the Future of Health Risk
Assessment Research 171
Structuring a High-Quality Research Program 172
Prospects for Research 174
Fostering Research Linkages 181
Summary and Conclusions 183
Chapter 7 References 184
APPENDIXES
A International Risk Assessment 187
B Department of Health and Human Services
Organization Chart 211
C Federal Obligations for Health R&D by Source
or Performer 212
D FY 1992 Estimates of Funding Support by
DHHS Agencies 214
List of Abbreviations 216
Acknowlegments 220
INDEX 225
Vili
