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OCR for page R1
METHYL BROM'DE RISK
CHARA~ERI~TION
~ N CAL ~ F O R N ~ A
Subcommittee for the Review of the Risk Assessment
of Methyl Bromide
Committee on Toxicology
Board on Environmental Studies and Toxicology
Commission on Life Sciences
National Research Council
NATIONAL ACADEMY PRESS
Washington, D.C.
OCR for page R2
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 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 Agreement No. 98-0316 between the National Academy of
Sciences and the California Department of Pesticide Regulation. 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.
International Standard Book Number 0-309-07087-2
Additional copies of this report are available from:
National Academy Press
2101 Constitution Ave., NW
Box 285
Washington, DC 20055
800-624-6242
202-334-33 13 (in the Washington metropolitan area)
http://www.nap.edu
Copyright 2000 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
OCR for page R3
~~ ~~:
:~U
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.
William 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. William A. Wulf are chairman and vice chairman, respectively, of the
National Research Council.
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SUBCOMMITTEE ON METHYL BROMIDE
CHARLES H. HOBBS (Chair), Lovelace Respiratory Research Institute, Albuquerque, New
Mexico
JANICE E. CHAMBERS, Mississippi State University, College of Veterinary Medicine, Mississippi
State, Mississippi
FRANK N. DOST, Professor Emeritus, Oregon State University, Corvallis, Oregon
DALE B. HATTIS, Clark University, Worcester, Massachusetts
MATTHEW C. KEIFER, University of Washington, Seattle, Washington
UCRIKE LUDERER, University of California-Irvine, Irvine, California
GLENN C. MILLER, University of Nevada, Reno, Nevada
SYLVIA S. TALMAGE, Oak Ridge National Laboratory, Oak Ridge, Tennessee
Staff
ROBERTA M. WEDGE, Project Director
EILEEN N. ABT, Research Associate
ROBERT J. CROSSGROVE, Editor
Lucy V. Fusco, Project Assistant
MIRSADA KARALIC-LONCAREVIC, ~ nformation Specialist
IV
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SUBCOMMITTEE ON METHYL BROMIDE
CHARLES H. HOBBS (Chair), Lovelace Respiratory Research Institute, Albuquerque,
New Mexico
JANICE E. CHAMBERS, Mississippi State University, College of Veterinary
Medicine, Mississippi State, Mississippi
FRANK N. DOST, Professor Emeritus, Oregon State University, Corvallis, Oregon
DALE B. HATTIS, Clark University, Worcester, Massachusetts
MATTHEW C. KEIFER, University of Washington, Seattle, Washington
UERIKE LUDERER, University of California-Irvine, Irvine, California
GLENN C. MILLER, University of Nevada, Reno, Nevada
SYLVIA S. TALMAGE, Oak Ridge National Laboratory, Oak Ridge, Tennessee
Stay
ROBERTA M. WEDGE, Project Director
EILEEN N. ABT, Research Associate
ROBERT J. CROSSGROVE, Editor
MIRSADA KARALIC-LONCAREVIC, Information Specialist
LUCY V. Fusco, Project Assistant
Sponsor
CALIFORNIA DEPARTMENT OF PESTICIDE REGULATION
v
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COMMITTEE ON TOXICOLOGY
BAILUS WALKER, JR. (Chair), Howard University Medical Center, Washington,
D.C.
MELVIN E. ANDERSEN, Colorado State University, Fort Collins, Colorado
GERMAINE M. BUCK, State University of New York at Buffalo
GARY P. CARLSON, Purdue University, West Lafayette, Indiana
JACK H. DEAN, Sallow Pharmaceuticals, Inc., Malverne, Pennsylvania
ROBERT E. FORSTER II, University of Pennsylvania, Philadelphia, Pennsylvania
PAUL M.D. FOSTER, Chemical Industry Institute of Toxicology, Research Triangle
Park, North Carolina
DAVID W. GAYLOR, U S. Food and Drug Administration, Jefferson, Arkansas
JUDITH A. GRAHAM, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina
SIDNEY GREEN, Howard University, Washington, D.C.
WILLIAM E. HALPERIN, National Institute for Occupational Safety and Health,
Cincinnati, Ohio
CHARLES H. HOBBS, Lovelace Respiratory Research Institute and Lovelace
Biomedical and Environmental Research Institute, Albuquerque, New Mexico
FLORENCE K. KINOSHITA, Hercules Incorporated, Wilmington, Delaware
MICHAEL J. KOSNETT, University of Colorado Health Sciences Center, Denver,
Colorado
MORTON LIPPMANN, New York University School of Medicine, Tuxedo, New York
THOMAS E. MCKONE, University of California, Berkeley, California
ERNEST E. MCCONNELL, ToxPath, Inc., Raleigh, North Carolina
DAVID H. MOORE, Battelle Memorial Institute, Bet Air, Maryland
GUNTER OBERDORSTER, University of Rochester, Rochester, New York
JOHN L. O'DONOGHUE, Eastman Kodak Company, Rochester, New York
GEORGE M. RUSCH, AlliedSignal, Inc., Morristown, New Jersey
MARY E. YORE, University of Kentucky, Lexington, Kentucky
ANNETTA P. WATSON, Oak Ridge National Laboratory, Oak Ridge, Tennessee
Stay
KULBIR S. BAKSHI, Program Director
SUSAN N.J. PANG, Program Officer
ABIGAIE STACK, Program Officer
RUTH E. CROSSGROVE, Publications Manager
KATHRINE J. IVERSON, Manager, Toxicology Information Center
LUCY V. Fusco, Project Assistant
LEAH PROBST, Project Assistant
Vl
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BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY
GORDON ORGANS (Chair), University of Washington, Seattle, Washington
DONALD MATTISON ~ Vice Chair), March of Dimes, White Plains, New York
DAVID ALLEN, University of Texas, Austin, Texas
INGRID C. BURKE, Colorado State University, Fort Collins, Colorado
WILLIAM L. CHAMEIDES, Georgia Institute of Technology, Atlanta, Georgia
JOHN Douse, University of Kansas Medical Center, Kansas City, Kansas
CHRISTOPHER B. FIELD, Carnegie Institute of Washington, Stanford, California
JOHN GERHART, University of California, Berkeley, California
J. PAUL OILMAN, Celera Genomics, Rockville, Maryland
BRUCE D. HAMMOCK, University of California, Davis, California
MARK HARWELL, University of Miami, Miami, Florida
ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque, New
Mexico
CAROL HENRY, Chemical Manufacturers Association, Arlington, Virginia
BARBARA HULKA, University of North Carolina, Chapel Hill, North Carolina
JAMES F. KITCHELL, University of Wisconsin, Madison, Wisconsin
DANIEL KREWSKI, University of Ottawa, Ottawa, Ontario
JAMES A. MACMAHON, Utah State University, Logan, Utah
MARIO J. MOLINA, Massachusetts Institute of Technology, Cambridge,
Massachusetts
CHARLES O'MELIA, Johns Hopkins University, Baltimore, Maryland
WILLEM F. PASSCHIER, Health Council of the Netherlands
KIRK SMITH, University of California, Berkeley, California
MARGARET STRAND, Oppenheimer Wolff Donnelly & Bayh, LLP, Washington,
D.C.
TERRY F. YOSIE, Chemical Manufacturers Association, Arlington, Virginia
Senior Staff
JAMES J. REISA, Director
DAVID J. POLICA~SKY, Associate Director and Senior Program Director for Applied
Ecology
CAROL A. MACZKA, Senior Program Director for Toxicology and Risk Assessment
RAYMOND A. WASSEL, Senior Program Director for Environmental Sciences and
~ · .
Engineering
KULBIR BAKSHI, Program Director for the Committee on Toxicology
LEE R. PAULSON, Program Director for Resource Management
ROBERTA M. WEDGE, Program Director for Risk Analysis
v''
. .
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COMMISSION ON LIFE SCIENCES
MICHAEL T. CLEGG (Chair), University of California, Riverside, California
PAUL BERG (Vice Chairg, Stanford University, Stanford, California
FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, D.C.
JOANNA BURGER, Rutgers University, Piscataway, New Jersey
JAMES E. CLEAVER, University of California, San Francisco, California
DAVID S. EISENBERG, University of California, Los Angeles, California
JOHN L. EMMERSON, Fishers, Indiana
NEAL L. FIRST, University of Wisconsin, Madison, Wisconsin
DAVID J. GALAS, Keck Graduate Institute of Applied Life Science, Claremont,
California
DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, California
ARTURO GOMEZ-POMPA, University of California, Riverside, California
COREY S. GOODMAN, University of California, Berkeley, California
JON W. GORDON, Mount Sinai School of Medicine, New York, New York
DAVID G. HOEL, Medical University of South Carolina, Charleston, South Carolina
BARBARA S. HULKA, University of North Carolina, Chapel Hill, North Carolina
CYNTHIA J. KENYON, University of California, San Francisco, California
BRUCE R. LEVIN, Emory University, Atlanta, Georgia
DAVID M. LIVINGSTON, Dana-Farber Cancer Institute, Boston, Massachusetts
DONALD R. MATTISON, March of Dimes, White Plains, New York
ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena, California
ROBERT T. PAINE, University of Washington, Seattle, Washington
RONALD R. SEDEROFF, North Carolina State University, Raleigh, North Carolina
ROBERT R. SOKAL, State University of New York, Stony Brook, New York
CHARLES F. STEVENS, The Salk Institute for Biological Studies, La Jolla, California
SHIRLEY M. TILGHMAN, Princeton University, Princeton, New Jersey
RAYMOND L. WHITE, University of Utah, Salt Lake City, Utah
Staff
WARREN R. MUIR, Executive Director
JACQUELINE K. PRINCE, Financial Officer
BARBARA B. SMITH, Administrative Associate
LAURA T. HOLLIDAY, Senior Program Assistant
. . .
v'''
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OTHER REPORTS OF THE
BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY
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)
Ozone-Forming Potential of Reformulated Gasoline (1999)
Risk-Based Waste Classification in California (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)
Toxicologic Assessment of the Army's Zinc Cadmium Sulfide Dispersion Tests
(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)
Ranking Hazardous Waste Sites for Remedial Action (1994)
Pesticides in the Diets of Infants and Children (1993)
Issues in Risk Assessment (1993)
Setting Priorities for Land Conservation (1993)
Protecting Visibility in National Parks and Wilderness Areas (1993)
Dolphins and the Tuna Industry (1992)
Hazardous Materials on the Public Lands ~ 1992)
Science and the National Parks (1992)
Animals as Sentinels of Environmental Health Hazards (1991)
Assessment of the U.S. Outer Continental Shelf Environmental Studies Program,
Volumes I-IV (1991-1993)
Human Exposure Assessment for Airborne Pollutants (1991)
Monitoring Human Tissues for Toxic Substances (1991)
Rethinking the Ozone Problem in Urban and Regional Air Pollution ~ 1991
Decline ofthe Sea Turtles (1990)
Copies of these reports may be orderedfrom the National Academy Press
(800) 624-6242 or (202) 334-3313
www.nap.edu
IX
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PREFACE
information gathered at a public meeting held in Irvine, California, on October 4, ~ 999. The
subcommittee wishes to thank the following members of the California Department of Pesticide
Regulation Paul Gosselin, Acting Chief Deputy Director, Lori Lim, and Thomas
Thongsinthusak—for providing the subcommittee with information on methyl bromide toxicology
and exposure data and models, for their presentation at the public meeting, and for responding
to follow up requests from the subcommittee members. We also gratefully acknowledge
Vincent J. Piccirillo, NPC, Inc., Bill Walker, Environmental Working Group, and Amy Kyle,
Consulting Scientist, for providing background information and for making presentations to the
subcommittee, and Jodi Kuhn, Methyl Bromide Industry Pane! of the Chemical Manufacturers
Association, for providing background materials as well.
This report has been reviewed in draft form by individuals chosen for their diverse
perspectives and technical expertise, in accordance with procedures for reviewing NRC reports
approved by the NRC's Report Review Committee. The purpose of this independent review is
to provide candid and critical comments that will assist NRC in making the 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 content of the final report is the
responsibility of NRC and the study subcommittee, and not the responsibility of the reviewers.
The review comments and draft manuscript remain confidential to protect the integrity of the
deliberative process. We wish to thank the following individuals, who are neither officials nor
employees of NRC, for their participation in the review of the report: Dana Barr, Centers for
Disease Control and Prevention; David Dorman, Chemical Industry Institute of Toxicology;
David Gaylor, National Center for Toxicological Research; Craig Harris, University of Michigan;
John Morris, University of Connecticut; and P. Barry Ryan, Emory University. These reviewers
have provided many constructive comments and suggestions; it must be emphasized, however,
that responsibility for the final content of this report rests entirely with the authoring
subcommittee and NRC.
~ am also grateful for the assistance of NRC staff in the preparation of this report. In
particular, the subcommittee wishes to acknowledge Roberta Wedge, staff officer for the
subcommittee, and Eileen Abt, research associate, with the Board on Environmental Studies
and Toxicology. Other staff members who contributed to this effort are Robert Crossgrove,
editor, Lucy Fusco, project assistant, and Kulbir Bakshi, program director for the Committee on
Toxicology.
Finally, ~ would like to thank the members of the subcommittee for their valuable
expertise and dedicated efforts throughout the preparation of this report. Their efforts are much
appreciated.
Charles H. Hobbs, D.V.M.
Chair, Subcommittee on the Review of the
Risk Assessment for Methyl Bromide
x
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Preface
One of the most widely used pesticides in California is methyl bromide, a gas-
eous fumigant that is used on a variety of crops primarily as a preplan" soil
insecticide, on post-harvest commodities, and in some residences as a fumi-
gant. Although methyl bromide is a recognized stratospheric ozone depleter
and is scheduled to be phased out completely by 2005 under the United Na-
tions Montreal Protocol, it continues to be of concern for the health of agricul-
tural workers and exposed residents.
The California Department of Pesticide Regulation (DPR) is responsible
for the development of regulations that determine the site-specific permit con-
ditions for the application of pesticides in the state. California is currently in
the process of proposing new regulations for issuing methyl bromide permits
that require submission of a worksite plan by the property operator, provide
extra protection for children in nearby schools, establish minimum buffer
zones around application sites, require that nearby residents receive prior noti-
fication of the application of methyl bromide, and set new limits on hours that
fumigation employees may work. To develop these regulations, the DPR pre-
pared a risk-characterization document to evaluate the toxicity and exposure
potential for workers and residents resulting from the inhalation of this pesti-
cide.
Under Section 57004 of the California Health and Safety Code, the scien-
tific basis of the proposed regulations is subject to external peer review by the
National Academy of Sciences, the University of California, or other similar
institution of higher learning or group of scientists. This report addresses that
regulatory requirement by reviewing the DPR risk-characterization document
that supports the proposed regulations.
The National Research Council (NRC), the operating arm of The National
Academies, assigned the task of preparing this report to its Committee on
Toxicology, which convened the subcommittee for the review of the risk as-
Xl
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XI ! PREFA CE
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PREFA CE Xl l ~
~ am also grateful for the assistance of NRC staff in the preparation of this
report. In particular, the subcommittee wishes to acknowledge Roberta
Wedge, staff officer for the subcommittee, and Eileen Abt, research associate,
with the Board on Environmental Studies and Toxicology. Other staff mem-
bers who contributed to this effort are Robert Crossgrove, editor, Lucy Fusco,
project assistant, and Kulbir Bakshi, program director for the Committee on
Toxicology.
Finally, T would like to thank the members of the subcommittee for their
valuable expertise and dedicated efforts throughout the preparation of this re-
port. Their efforts are much appreciated.
Charles H. Hobbs, D.V.M.
Chair, Subcommittee on the Review of
the Risk Assessment for Methyl Bromide
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Contents
EXECUTIVE SUMMARY
1 INTRODUCTION
Background, ~
California Regulations, 9
The Subcommittee's Task, 10
Organization of the Report, 11
2 TOXICOLOGY AND HAZARD IDENTIFICATION
Pharmacokinetics, 13
Genotoxicity, 16
Acute Toxicity, 17
Subchronic Toxicity, 1 8
Chronic Inhalation and Oncogenicity, 20
Reproductive Toxicity, 23
Developmental Toxicity, 27
Neurotoxicity, 3 1
Selection of Critical Effects for Acute Toxicity, 32
3 EXPOSURE ASSESSMENT .....
Background, 35
Likely Exposure Scenarios, 36
Quality of Data Available for Characterizing Exposures, 39
Accuracy and Appropriateness of Available Modeling Tools, 46
Summary, 54
xv
......... 12
.. 35
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1
xvi CONTENTS
4 RISK CHARACTERIZATION .....
Risk Characterization Goals, 56
Hazard identification, 57
Exposure Assessment, 60
Margin-of-Exposure Analysis, 64
Uncertainty Issues, 66
Summary, 69
5 CONCLUSIONS AND RECOMMENDATIONS
Toxicological Information, 70
Exposure Assessment, 72
Risk Characterization, 74
REFERENCES
APPENDIX A
Biographical Information on the Subcommittee for the
Review of the Risk Assessment of Methyl Bromide . .
APPENDIX B
Public Access Materials .......
APPENDIX C
Calculation of Air Exchange Rates
.... 56
..... 70
76
........ 84
.. 87
90
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Methyl Bromide
Risk Characterization
in California
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