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rose
Drinking
ally In
-aver
Subcommittee to Update the 1999 Arsenic in Drinking Water Report
Committee on Toxicology
Board on Environmental Studies and Toxicology
Division on Earth and Life Studies
National Research Council
NATIONAL ACADEMY PRESS
Washington, D.C.
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NATIONAL ACADEMY PRESS
2101 Constitution Ave., N.W.
Washington,D.C. 20418
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 Engineenug, 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 prod ect was supported by Cooperative Agreement No. X-82899401 -0
between the National Academy of Sciences and the U.S. Environmental
Protection Agency. Any opinions, findings, conclusions, or recommendations
expressed in this publication are those of the authoress and do not necessarily
reflect the view of the organizations or agencies that provided support for this
project.
Library of Congress Catalog Card Number: 2001097317
International Standard Book Number: 0-309-07629-3
Additional copies of this report are available from:
National Academy Press
2101 Constitution Ave., NW
Box 285
Washington, DC 20055
800-624-6242
202-334-3313 (in the Washington metropolitan area)
http://www.nap.edu
Copyright 2001 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
OCR for page R3
National Academy of Sciences
National Academy of Engineering
Institute of Medicine
National Research Council
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. Bruce M.
Alberts 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. Kenneth I. Shine 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chairman and vice chairman,
respectively, of the National Research Council.
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SUBCOMMITTEE TO UPDATE THE
1999 ARSENIC IN DRINKING WATER REPORT
ROBERT A. GOYER (Chair9, (emeritus) University of Western Ontario, London,
Ont., Canada
KENNETH P. CANTOR, National Cancer Institute, Bethesda, Maryland
DAVID L. EATON, University of Washington, Seattle, Washington
ROGENE F. HENDERSON, Lovelace Respiratory Research Institute, Albuquerque,
New Mexico
MICHAEL J. KOSNETT, University of Colorado Health Sciences Center, Denver,
Colorado
LOUISE M. RYAN, Harvard School of Public Health, Boston, Massachusetts
KIMBERLY M. THOMPSON, Harvard School of Public Health, Boston,
Massachusetts
MARIE E. VAHTER, Karolinska Institutet, Stockholm, Sweden
BOGUS WALKER, JR., Howard University Medical Center, Washington, D.C.
Staff
MICHELLE C. CATKIN, Project Director
ROBERTA M. WEDGE, Senior Program Officer
KULBIR BAKSHI, Senior Program Officer
RUTH E. CROSSGROVE, Editor
MIRSADA KARALIC-LONCAREVIC, Research Assistant
BRYAN P. SHIPLEY, Project Assistant
KELLY A. CLARK, Editorial Assistant
Sponsor
U.S. ENVIRONMENTAL PROTECTION AGENCY
v
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COMMITTEE ON TOXICOLOGY
BAILUSWALKER,JR. (Chair), Howard University Medical Center, Washington, D.C.
MELVIN E. ANDERSEN, Colorado State University, Fort Collins, Colorado
GERMANE M. BUCK, National Institute of Health, Washington, D.C.
ROBERT E. FORSTER II, University of Pennsylvania, Philadelphia, Pennsylvania
WILLIAM E. HALPERIN, New Jersey Medical School, Newark, New Jersey
CHARLES H. HOBBS, Lovelace Respiratory Research Institute and Lovelace
Biomedical and Environmental Research Institute, Albuquerque, New Mexico
SAMUEL KACEW, University of Ottawa, Ottawa, Ontario
NANCY KERKVLIET, Oregon State University, Corvallis, Oregon
MICHAEL J. KOSNETT, University of Colorado Health Sciences Center, Denver,
Colorado
MORTON LIPPMANN, New York University School of Medicine, Tuxedo, New York
ERNEST E. MCCONNELL, ToxPath, Inc., Raleigh, Norm Carolina
THOMAS E. MCKONE, Lawrence Berkeley National Laboratory and University of
California, Berkeley, California
HAR1HARA MEHENDALE, University of Louisiana at Monroe, Monroe, Louisiana
DAVID H. MooRE, Battelle Memorial Institute, Bet Air, Maryland
LAUREN ZEISE, California Environmental Protection Agency, Oakland, California
Stay
KUEBIR S. BAKSHI, Program Director
SUSAN N.J. MARTEE, Program Officer
ABIGAIL E. STACK, Program Officer
AIDA NEEL, Acl~ninistradve Assistant
JESSICA BROCK, Project Assistant
Al
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BoARD ON ENVIRONMENTAL STUDIES AND TOMCOLOGY]
GORDON ORIANS (Chair), University of Washington, Seattle, Washington
JOHN Douse ~ vice Chair),University of Kansas Medical Center, Kansas City,
Kansas
DAVID ALLEN, University of Texas, Austin, Texas
INGRID C. BURKE, Colorado State University, Fort Collins, Colorado
THOMAS BURKE, Johns Hopkins University, Baltimore, Maryland
GLEN R. CASS, Georgia Institute of Technology, Atlanta, Georgia
WIGWAM L. CHAMEIDES, Georgia Institute of Technology, Atlanta, Georgia
CHRISTOPHER B. FIELD, Carnegie Institute of Washington, Stanford, California
JOHN GERHART, University of California, Berkeley, California
J. PAUL OILMAN, Celera Genomics, Rockville, Maryland
DANIEL S. GREENBAUM, Health Effects Institute, Cambridge, Massachusetts
BRUCE D. HAMMOCK, University of California, Davis, California
ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque,
New Mexico
CAROL HENRY, American Chemistry Council, Arlington, Virginia
ROBERT HUGGETT, Michigan State University, East Lansing, Michigan
JAMES F. KrrcHELL, University of Wisconsin, Madison, Wisconsin
DANIEL KREWSKI, University of Ottawa, Ottawa, Ontario
JAMES A. MACMAHON, Utah State University, Logan, Utah
CHARLES O'MELIA, Johns Hopkins University, Baltimore, Maryland
WILLEM F. PASSCHIER, Health Council of the Netherlands, The Hague
ANN POWERS, Pace University School of Law, White Plains, New York
KIRK SMITH, University of California, Berkeley, California
Senior Staff
JAMES J. REISA, Director
DAVID J. POLICANSKY, Associate Director and Senior Program Director for
Applied Ecology
RAYMOND A. WASSEL, Senior Program Director for Environmental Sciences and
~ . .
~ngmeenng
KULBIR BAKSHI, Program Director for Committee on Toxicology
ROBERTA M. WEDGE, Program Director for Risk Analysis
K. JOHN HOLMES, Senior Staff Officer
RUTH E. CROSSGROVE, Managing Editor
'This study was planned, overseen, and supported by the Board on Environmental Studies and
Toxicology.
· .
V11
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OTHER REPORTS OF THE
BOARD ON ENVIRONMENTAL STUDIES AND TOMCOLOGY
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)
Toxicological Effects of Methylmercury (2000)
Strengthening Science at the U.S. Environmental Protection Agency: Research-
Management and Peer-Review Practices (2000)
Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000)
Modeling Mobile-Source Emissions (2000)
Copper in Drinking Water (2000)
Ecological Indicators for the Nation (2000)
Waste Incineration and Public Health (1999)
Hormonally Active Agents in the Environment (1999)
Research Priorities for Airborne Particulate Matter: I. Immediate Priorities and a
Long-Range Research Portfolio (1998~; II. Evaluating Research Progress and
- Updating the Portfolio (1999~; III. Early Research Progress (2001)
Ozone-Fo~'~ing Potential of Reformulated Gasoline (1999)
Arsenic in Drinking Water (1999)
Brucellosis in the Greater Yellowstone Area (1998)
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 (5 reports, 1989-1995)
Review of EPA's Environmental Monitoring and Assessment Program (3 reports,
1994-1995)
Science and Judgment in Risk Assessment (1994)
Pesticides in the Diets of Infants and Children (1993)
Setting Priorities for Land Conservation (1993)
Protecting Visibility in National Parks and Wilderness Areas (1993)
Dolphins and the Tuna Industry (1992)
Science and the National Parks (1992)
Assessment of the U.S. Outer Continental Shelf Environmental Studies Program,
Volumes I-IV (1991-1993)
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 orderedfrom
the National Academy Press
(800) 624-6242
(202) 334-3313
w~w.nap.edu
. . .
V111
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Preface
Under the Safe Drinking Water Act of 1976, the U.S. Environmental Protec-
tion Agency (EPA) adopted an interim maximum contaminant level (MCL)
for arsenic in drinking water of 50 micrograms per liter (,ug/L) as part of the
National Interim Primary Drinking Water Standards; that standard was orig~-
nally set in 1942. EPA conducted a risk assessment for arsenic in Mining
water in 1988. In 1996, the National Research Council (NRC) was asked to
review independently the scientific database and evaluate the validity of that
risk assessment. The NRC's 1999 report Arsenic in Drinking Water, con-
cluded that "the current EPA MCL for arsenic in drinking water of 50 ~g/L
does not achieve EPA's goal for public health protection and therefore re-
quires downward revision as promptly as possible." On January 22, 2001,
EPA issued a pending standard MCL of 10 Egg. Then on March 23,2001,
EPA delayed the effective date of the arsenic rule until further studies were
conducted. In April, EPA's Office of Water requested that the NRC update
its ~ 999 Arsenic in Drinking Water report.
In this report, the NRC's Subcommittee to Update the 1999 Arsenic in
Drinking Water Report reviews the available toxicological, epidemiological,
and risk assessment literature that has been published since the 1999 report.
The subcommittee reviewed data for dose-response assessment and risk esti-
mation; assessed whether the most recent EPA analysis is adequate for esti-
mating an effective dose for a ~ TO response; determined whether EPA' s analy-
sis appropriately considers and characterizes the available data on the mode
IX
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x PREFACE
of action of arsenic and the information on dose-response and uncertainties
when assessing the public-health impacts; and determined whether EPA' s risk
estimates for 3, 5, 10, and 20 ~g/L of arsenic are consistent with available
scientific information, including information from new studies.
This report has been reviewed in Raft form by individuals chosen for their
diverse perspectives and technical expertise, in accordance with procedures
approved by the NRC's Report Review Committee. The purpose ofthis inde-
pendent 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 manu-
script remain confidential to protect the integrity of the deliberative process.
We wish to thank the following individuals for their review of this report:
Bruce N. Ames, University of California, Berkeley; H. Vasken Aposhian,
University of Arizona; Andrew A. Benson, University of California, San
Diego; Kenneth G. Brown, Kenneth G. Brown, Inc.; Yvonne Dragan, Ohio
State University; Marsha Ford, Carolinas Medical Center; Joshua W. Ham~-
ton, Yarmouth College; Bruce P. Lanphear, University of Cincinnati; Denise
Lewis, U.S. Department of Agriculture; Roger O. McClellan, Chemical Indus-
try Institute of Toxicology; Mitchell Small, Carnegie Mellon University; Alian
H. Smith, University of California, Berkeley; and Ronald Wyzga, Electric
Power Research Institute. 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 Gilbert S.
Omenn, University of Michigan, and Frank H. Stillinger, Princeton University.
Appointed by the 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 consid-
ered. Responsibility for the final content of this report rests entirely with the
authonug committee and the institution.
The subcommittee gratefully acknowledges the following individuals for
providing background information and for making presentations to the sub-
committee: Christine Todd Whitman, Ephraim King, Diane Regas, lames
Taft, and Nanette Wiltse, EPA; Richard Bull, EPA's Science Advisory Board
Drinking Water Committee; Lawrence Bazel, Western Coalition of Arid
States; Erik Olson, Natural Resources Defense Council; Allan Smith, Univer-
sity of California, Berkeley; Gerhard Stohrer, Risk Policy Center; Janice
Yager, Electric Power Research Institute; Gunther Craun, City of Albuquer-
que; Kevin Bromberg, U.S. Small Business Administration; Bob Fensterheim,
OCR for page R11
PREFACE Xi
Environmental Arsenic Council; Angela Logomasini, Competitive Enterprise
Institute; Steven Lamm, Consultants in Epidemiology and Occupational
Health, Inc.; Richard Nelson, Nebraska Department of Health and Human
Services; and Tom Richichi, American Wood Preservers Institute. In addition,
the subcommittee wants to give special thanks to individuals who provided
data, further analysis, statistical analysis programs, and background informa-
tion to the subcommittee: John Bennett, Andrew Schulman, Irene Dooley, and
Charles Abernathy, EPA; Knashawn Morales, Harvard School of Public
Health; Ming-Hui Chen, Worcester Polytechnic Institute; Claudia Hopenhayn-
Rich, University of Kentucky; Michael Bates, University of California, Berke-
ley; and John Potter, Fred Hutchison Cancer Research Center.
The subcommittee is grateful for the assistance of the NRC staff for pre-
paring the report. Staff members who contributed to this effort are Michelle
Catlin, project director; James I. Reisa, director ofthe Board on Environmen-
tal Studies and Toxicology; Roberta M. Wedge, program director for risk
analysis; KuTbir Bakshi, program director for the Committee on Toxicology;
Ruth E. Crossgrove, managing editor; Mirsada Karalic-Loncarev~c, informa-
tion specialist; and Bryan P. Shipley, project assistant. Other staff members
who contributed to this effort are Ellen Mantus, Abigail Stack, and Susan
Martel, program of ricers; LeahProbst, Lucy Fusco, and Jessica Parker, project
assistants; and Kelly Clark editorial assistant.
Finally, ~ would especially like to thank all the members of the subcom-
mittee for their exceptional efforts throughout the development of this report.
The subcommittee members have gone above and beyond the call of duty to
complete this report within a very short time frame.
Robert A. Coyer, M.D.
Chair, Subcommittee to
Update the 1999 Arsenic Report
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Contents
Recommendations, 133
References, 135
5 Quantitative Evaluation of Risks Using Modeling Approaches
Overview of the Science Underlying EPA's 2001 Proposed Regulation, 141
Overview of the SAB's Report on the 2001 Risk Assessment, 148
The Subcommittee's Evaluation, 151
Summary and Conclusions, 1 73
Recommendations, 174
References, 175
6 Conclusions.~ ~ ~.~ ~ ~ ~ ~ ~.~
Findings of the Subcommittee, 180
Comparisons of Results of Dose-Response Assessments, 181
Plausibility of Cancer Risk Estimates, 185
Summary and Conclusions, 188
References, 188
· ~
X11
.. 141
... 180
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Contents
Summary ....
1
Introduction . . ............ ~ 5
Summary of NRC's ~ 999 Arsenic in Drinking Water Report, ~ 6
Policy Background, ~7
Charge to the Subcommittee, 20
Organization of this Report, 21
References, 22
2 Human Health Effects 24
Summary of Human Health Effects Discussed in the ~ 999 Report, 24
Recent Studies of Noncancer Effects in Humans, 25
Recent Studies of Cancer Effects in Humans, 37
Latency Period, 6
Essentiality, 65
Summary and Conclusions, 65
Recommendations, 68
References, 69
3 ExperimentalStudies 75
Summary of Experimental Studies Discussed in the 1999 Report, 75
Toxicokinetics, 77
. . .
x'''
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XiV CONTEN75
Animal Toxicity Studies, 86
Mechanisms of Toxicity, 91
Summary and Conclusions, 120
Recommendations, 121
References, 122
4 Variability and Uncertainty ........
.... 133
Variability Versus Uncertainty, 133
Variability and Uncertainties Discussed in the ~ 999 Report, ~ 34
Sources of Variability, 135
Sources of Uncertainty, 150
Value-of-Information Approach, 159
Summary and Conclusions, 160
Recommendations, 161
References, 162
5 Quantitative Assessment of Risks Using Modeling Approaches ~ 69
Overview of the Science Underlying EPA's 200 ~ Proposed
Regulation, 169
Overview of the SAB's Report on the 200 ~ Risk Assessment, 177
The Subcommittee's Evaluation, 180
Summary and Conclusions, 207
Recommendations, 209
References, 209
6 Hazard Assessment .............
Findings of the Subcommittee, 214
Comparisons of Results of Dose-Response Assessments, 216
Plausibility of Cancer Risk Estimates, 221
Summary and Conclusions, 223
References, 224
...... 214
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Arsenic in Drinking Water
2001 Update
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