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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.
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 Alberts is president of the National Academy of Sciences.
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COMMITTEE ON RISK-BASED CRITERIA FOR NON-RCRA HAZARDOUS WASTE
ROGENE HENDERSON (Chair),
Lovelace Respiratory Research Institute, Albuquerque, New Mexico
MARK W. BELL,
Parsons Brinckerhoff Energy Services, Denver, Colorado
JOSEPH F. BORZELLECA,
Virginia Commonwealth University, Richmond, Virginia
EDWIN H. CLARK, II,
Clean Sites, Washington, DC
EDMUND A.C. CROUCH,
Cambridge Environmental Inc., Cambridge, Massachusetts
JOHN P. GIESY,
Michigan State University, East Lansing, Michigan
P. BARRY RYAN,
Emory University, Atlanta, Georgia
JAMES N. SEIBER,
U.S. Department of Agriculture, Albany, California
CURTIS C. TRAVIS,
Project Performance Corporation, Knoxville, Tennessee
Staff
RAYMOND A. WASSEL, Program Director
ROBERTA WEDGE, Staff Officer
ROBERT J. CROSSGROVE, Editor
MIRSADA KARALIC-LONCAREVIC, Information Specialist
RUTH DANOFF, Senior Program Assistant
LUCY V. FUSCO, Project Assistant
Sponsor
Department of Toxic Substances Control, California Environmental Protection Agency
BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY
GORDON ORIANS (Chair),
University of Washington, Seattle, Washington
DONALD MATTISON (Vice Chair),
March of Dimes, White Plains, New York
DAVID ALLEN,
University of Texas, Austin, Texas
MAY R. BERENBAUM,
University of Illinois, Urbana, Illinois
EULA BINGHAM,
University of Cincinnati, Cincinnati, Ohio
PAUL BUSCH,
Malcolm Pirnie, Inc., White Plains, New York
PETER L. DEFUR,
Virginia Commonwealth University, Richmond, Virginia
DAVID L. EATON,
University of Washington, Seattle, Washington
ROBERT A. FROSCH,
Harvard University, Cambridge, Massachusetts
JOHN GERHART,
University of California, Berkeley, 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
DANIEL KREWSKI,
Health Canada and 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
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. POLICANSKY, 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
COMMISSION ON LIFE SCIENCES
MICHAEL T. CLEGG (Chair),
University of California, Riverside, California
PAUL BERG (Vice Chair),
Stanford University, Stanford, California
FREDERICK R. ANDERSON,
Cadwalader, Wickersham & Taft, Washington, D.C.
JOHN C. BAILAR III,
University of Chicago, Chicago, Illinois
JOANNA BURGER,
Rutgers University, Piscataway, New Jersey
SHARON L. DUNWOODY,
University of Wisconsin, Madison, Wisconsin
DAVID EISENBERG,
University of California, Los Angeles, California
JOHN EMMERSON,
Portland, Oregon
NEAL FIRST,
University of Wisconsin, Madison, Wisconsin
DAVID J. GALAS,
Keck Graduate Institute of Applied 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
HENRY HEIKKINEN,
University of Northern Colorado, Greeley, Colorado
BARBARA S. HULKA,
University of North Carolina, Chapel Hill, North Carolina
HANS J. KENDE,
Michigan State University, East Lansing, Michigan
CYNTHIA KENYON,
University of California, San Francisco, California
MARGARET G. KIDWELL,
University of Arizona, Tucson, Arizona
BRUCE R. LEVIN,
Emory University, Atlanta, Georgia
OLGA F. LINARES,
Smithsonian Tropical Research Institute, Miami, Florida
DAVID 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, La Jolla, California
SHIRLEY M. TILGHMAN,
Princeton University, Princeton, New Jersey
JOHN L. VANDEBERG,
Southwest Foundation for Biomedical Research, San Antonio, Texas
RAYMOND L. WHITE,
University of Utah, Salt Lake City, Utah
WARREN R. MUIR, Executive Director
OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY
Research Priorities for Airborne Particulate Matter: I. Immediate Priorities and a Long-Range Research Portfolio (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: A Comparison of Naturally Occurring and Synthetic Substances (1996)
Upstream: Salmon and Society in the Pacific Northwest (1996)
Science and the Endangered Species Act (1995)
Wetlands: Characteristics and Boundaries (1995)
Biologic Markers [Urinary Toxicology (1995), Immunotoxicology (1992), Environmental Neurotoxicology (1992), Pulmonary Toxicology (1989), Reproductive Toxicology (1989)]
Review of EPA's Environmental Monitoring and Assessment Program (three 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 of the Sea Turtles (1990)
Tracking Toxic Substances at industrial Facilities (1990)
Copies of these reports may be ordered from the National Academy Press (800) 624-6242 or (202) 334-3313 www.nap.edu
Preface
The Department of Toxic Substances Control (DTSC) of the State of California Environmental Protection Agency is in the process of complying with the Regulatory Structure Update. The Regulatory Structure Update is a comprehensive review and refocusing of California's system for identifying and regulating management of hazardous wastes. As part of this effort, the DTSC proposes to change its current waste classification system that categorizes wastes as hazardous or nonhazardous based on their toxicity. Under the proposed system there would be two risk-based thresholds rather than the single toxicity threshold currently used to distinguish between the wastes. Wastes that contain specific chemicals at concentrations that exceed the upper threshold will be designated as hazardous; those below the lower threshold will be nonhazardous; and those with chemical concentrations between the two thresholds will be "special" wastes and subject to variances for management and disposal. The proposed DTSC system combines toxicity information with short or long-term exposure information to determine the risks associated with the chemicals.
Under section 57004 of the California Health and Safety Code, the scientific basis of the proposed waste classification system is subject to external scientific 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.
This report is intended to assist the DTSC in determining whether the proposed waste classification method will be scientifically well
grounded and protective of human health and the environment. It identifies areas where the proposed DTSC approach is appropriate, as well as areas where the DTSC documentation is not sufficient. The report indicates where and what type of improvements could be made to clarify both the presentation of the approach and the goals of the classification system.
To prepare the report, the committee reviewed the materials supplied to it by the DTSC, additional supporting materials received from DTSC and other individuals and organizations, and the information gathered at two public meetings held in Irvine, California on September 10, and November 20, 1998. The committee wishes to thank the following members of the California Environmental Protection Agency's Department of Toxic Substances Control: Jesse Huff, Director, Robert Borzelleri, Chief Deputy Director, Dr. Robert Stephens, Deputy Director, David Nunenkamp, Daniel Weingarten, and Drs. James Carlisle, Edward Butler, Bart Simmons, and John Christopher; and Dr. Lauren Zeise of the Office of Environmental Health Hazard Assessment for providing the committee with information on the models and framework for the risk methodology, for their presentations at the public meetings, and for their responses to written questions from committee members. We also gratefully acknowledge Barnes Johnson, U.S. Environmental Protection Agency, Office of Solid Waste and Emergency Response; Jane Williams, California Communities Against Toxics; Michael Lakin and Michael Easter, ICF Kaiser International (representing the Western States Petroleum Association); Linda M. Shandler and Brent C. Perry, County Sanitation Districts of Los Angeles County; Paul W. Abernathy, representing Mercury Technologies International/Advanced Environmental Recycling Corporation; Victor Hanna, City of Los Angeles, Bureau of Sanitation; Aspet Chater, Hugo Neu-Proler Company; Kirk T. Larson, representing San Diego Industrial Environmental Association; David Kay, Southern California Edison Company; and Charles A. White, Waste Management, Inc., for providing background information and for making presentations to the committee.
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 the 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 the NRC and the study committee, 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 the NRC, for their participation in the review of this report: John C. Bailar, University of Chicago; Karen Florini, Environmental Defense Fund; Rolf Hartung, University of Michigan; Carol Henry, American Petroleum Institute; Donald M. Mackay, Trent University; Donald Mattison, March of Dimes Birth Defects Foundation; Glenn Paulson, Paulson and Cooper, Inc.; Emil Pfitzer, Ramsey, NJ; and Kenneth W. Sexton, University of Minnesota. 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 committee and the NRC.
I am also grateful for the assistance of the NRC staff in the preparation of this report. In particular, the committee wishes to acknowledge Roberta Wedge, staff officer for the committee and Raymond A. Wassel, senior program director with the Board on Environmental Studies and Toxicology. Other staff members who contributed to this effort are Robert J. Crossgrove, editor; Ruth Danoff, senior program assistant; and Lucy V. Fusco, project assistant.
Finally, I would like to thank the members of the committee for their valuable expertise and dedicated efforts throughout the preparation of this report. Their efforts in preparing this report within a very short time frame are much appreciated.
ROGENE F. HENDERSON, PH.D.
CHAIR, COMMITTEE ON RISK-BASED CRITERIA FOR NON-RCRA HAZARDOUS WASTE
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Abbreviations
ADOM
acid deposition and oxidant model
AWQC
ambient water quality criteria
Cal/EPA
California Environmental Protection Agency
CAM
California Assessment Manual
CCR
California Code of Regulations
CFR
Code of Federal Regulations
CUPA
Certified Unified Program Agencies
CV
coefficient of variation
DAF
dilution attenuation factor
DDT
dichloro diphenyl trichloroethane
DTSC
Department of Toxic Substances Control
EFH
Exposure Factors Handbook
EP
extraction procedure
EPA
U.S. Environmental Protection Agency
EQL
estimated quantitation level
FDM
fugitive dust model
HWIR
Hazardous Waste Identification Rule
ISC
industrial source complex dispersion model
IWMB
Integrated Waste Management Board
LC
lethal concentration
LD
lethal dose
LOD
limit of detection
LOQ
limit of quantitation
MCL
maximum contaminant level
MSWL
municipal solid waste leachate
NAAQS
National Ambient Air Quality Standards
NIOSH
National Institute for Occupational Safety and Health
NRC
National Research Council
OSHA
Occupational Safety and Health Administration
PEA
preliminary endangerment assessment (model)
RAGS
Risk Assessment Guidance for Superfund
RCRA
Resource Conservation and Recovery Act
RSU
regulatory structure update
SD
standard deviation
SERT
soluble or extractable regulatory threshold
STLC
soluble threshold limit concentration
SWRCB
State Water Resources Control Board
TCDD
2,3,7,8-tetrachloro-dibenzo-p-dioxin
TCE
trichloroethylene
TCLP
toxicity characteristic leaching procedure
TTLC
total threshold limit concentration
WET
waste extraction test
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