Review of California’s
Risk-Assessment Process for
PESTICIDES
Committee to Review California’s
Risk-Assessment Process for Pesticides
Board on Environmental Studies and Toxicology
Division on Earth and Life Studies
NATIONAL RESEARCH COUNCIL
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COMMITTEE TO REVIEW CALIFORNIA’S
RISK-ASSESSMENT PROCESS FOR PESTICIDES
Members
MARION F. EHRICH (Chair), Virginia–Maryland College of Veterinary Medicine, Blacksburg, VA
BRENDA ESKENAZI, University of California, Berkeley, CA
ROBERTA L. GRANT, Texas Commission on Environmental Quality, Austin, TX
ROBERT M. HOLLINGWORTH, Michigan State University, East Lansing, MI
MATTHEW C. KEIFER, National Farm Medicine Center, Marshfield Clinic, Marshfield, WI
CHENSHENG (ALEX) LU, Harvard School of Public Health, Boston, MA
JOSEPH V. RODRICKS, ENVIRON International Corporation, Arlington, VA
DAVID L. STONE, Oregon State University, Corvallis, OR
JEFFREY D. WOLT, Iowa State University, Ames, IA
Staff
SUSAN N.J. MARTEL, Project Director
CAMILLA ABLES, Program Officer
NORMAN GROSSBLATT, Senior Editor
MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center
RADIAH ROSE, Manager, Editorial Projects
TAMARA DAWSON, Program Associate
Sponsor
California Department of Pesticide Regulation
BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY
Members
ROGENE F. HENDERSON (Chair), Lovelace Respiratory Research Institute, Albuquerque, NM
PRAVEEN AMAR, Independent Consultant, Lexington, MA
RICHARD A. BECKER, American Chemistry Council, Washington, DC
MICHAEL J. BRADLEY, M.J. Bradley & Associates, Concord, MA
JONATHAN Z. CANNON, University of Virginia, Charlottesville
DOMINIC M. DI TORO, University of Delaware Newark, DE
DAVID C. DORMAN, Department of Molecular Biomedical Sciences, Raleigh, NC
CHARLES T. DRISCOLL, JR., Syracuse University, New York
GAIL CHARNLEY ELLIOTT, HealthRisk Strategies, Washington, DC
WILLIAM H. FARLAND, Colorado State University, Fort Collins, CO
LYNN R. GOLDMAN, George Washington University, Washington, DC
LINDA E. GREER, Natural Resources Defense Council, Washington, DC
WILLIAM E. HALPERIN, Rutgers University, Newark, NJ
STEVEN P. HAMBURG, Environmental Defense Fund, New York, NY
ROBERT A. HIATT, University of California, San Francisco
PHILIP K. HOPKE, Clarkson University, Potsdam, NY
SAMUEL KACEW, University of Ottawa, Ontario
H. SCOTT MATTHEWS, Carnegie Mellon University, Pittsburgh, PA
THOMAS E. MCKONE, University of California, Berkeley
TERRY L. MEDLEY, E.I. du Pont de Nemours & Company, Wilmington, DE
JANA MILFORD, University of Colorado at Boulder, Boulder
MARK A. RATNER, Northwestern University, Evanston, IL
JOAN B. ROSE, Michigan State University, East Lansing, MI
GINA M. SOLOMON, California Environmental Protection Agency, Sacramento, CA
PETER S. THORNE, University of Iowa, Iowa City, IA
JOYCE S. TSUJI, Exponent, Bellevue, WA
Senior Staff
JAMES J. REISA, Senior Director
ELLEN K. MANTUS, Scholar and Director of Risk Assessment
RAYMOND A. WASSEL, Scholar and Director of Environmental Studies
DAVID J. POLICANSKY, Scholar
SUSAN N.J. MARTEL, Senior Program Officer for Toxicology
MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center
RADIAH ROSE, Manager, Editorial Projects
OTHER REPORTS OF THE
BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY
Sustainability in Decision Making: Tools and Approaches for U.S. EPA (2014)
Rethinking the Components, Coordination, and Management of the US Environmental Protection Agency Laboratories (2014)
Sustainability Concepts in Decision-Making, Tools and Approaches for the US Environmental Protection Agency (2014)
Review of the Styrene Assessment in the National Toxicology Program 12th Report on Carcinogens (2014)
Review of the Formaldehyde Assessment in the National Toxicology Program 12th Report on Carcinogens (2014)
Review of EPA’s Integrated Risk Information System (IRIS) Process (2014)
Review of the Environmental Protection Agency’s State-of-the-Science Evaluation of Nonmonotonic Dose–Response Relationships as They Apply to Endocrine Disruptors (2014)
Assessing Risks to Endangered and Threatened Species from Pesticides (2013)
Science for Environmental Protection: The Road Ahead (2012)
Exposure Science in the 21st Century: A Vision and A Strategy (2012)
A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials (2012)
Macondo Well–Deepwater Horizon Blowout: Lessons for Improving Offshore Drilling Safety (2012)
Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops (2011)
Improving Health in the United States: The Role of Health Impact Assessment (2011)
A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011)
Review of the Environmental Protection Agency’s Draft IRIS Assessment of Formaldehyde (2011)
Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change (2010)
The Use of Title 42 Authority at the U.S. Environmental Protection Agency (2010)
Review of the Environmental Protection Agency’s Draft IRIS Assessment of Tetrachloroethylene (2010)
Hidden Costs of Energy: Unpriced Consequences of Energy Production and Use (2009)
Contaminated Water Supplies at Camp Lejeune—Assessing Potential Health Effects (2009)
Review of the Federal Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (2009)
Science and Decisions: Advancing Risk Assessment (2009)
Phthalates and Cumulative Risk Assessment: The Tasks Ahead (2008)
Estimating Mortality Risk Reduction and Economic Benefits from Controlling Ozone Air Pollution (2008)
Respiratory Diseases Research at NIOSH (2008)
Evaluating Research Efficiency in the U.S. Environmental Protection Agency (2008)
Hydrology, Ecology, and Fishes of the Klamath River Basin (2008)
Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment (2007)
Models in Environmental Regulatory Decision Making (2007)
Toxicity Testing in the Twenty-first Century: A Vision and a Strategy (2007)
Sediment Dredging at Superfund Megasites: Assessing the Effectiveness (2007)
Environmental Impacts of Wind-Energy Projects (2007)
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007)
Assessing the Human Health Risks of Trichloroethylene: Key Scientific Issues (2006)
New Source Review for Stationary Sources of Air Pollution (2006)
Human Biomonitoring for Environmental Chemicals (2006)
Health Risks from Dioxin and Related Compounds: Evaluation of the EPA Reassessment (2006)
Fluoride in Drinking Water: A Scientific Review of EPA’s Standards (2006)
State and Federal Standards for Mobile-Source Emissions (2006)
Superfund and Mining Megasites—Lessons from the Coeur d’Alene River Basin (2005)
Health Implications of Perchlorate Ingestion (2005)
Air Quality Management in the United States (2004)
Endangered and Threatened Species of the Platte River (2004)
Atlantic Salmon in Maine (2004)
Endangered and Threatened Fishes in the Klamath River Basin (2004)
Cumulative Environmental Effects of Alaska North Slope Oil and Gas Development (2003)
Estimating the Public Health Benefits of Proposed Air Pollution Regulations (2002)
Biosolids Applied to Land: Advancing Standards and Practices (2002)
The Airliner Cabin Environment and Health of Passengers and Crew (2002)
Arsenic in Drinking Water: 2001 Update (2001)
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)
Acute Exposure Guideline Levels for Selected Airborne Chemicals (18 volumes, 2000–2014)
Toxicological Effects of Methylmercury (2000)
Strengthening Science at the U.S. Environmental Protection Agency (2000)
Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000)
Ecological Indicators for the Nation (2000)
Waste Incineration and Public Health (2000)
Hormonally Active Agents in the Environment (1999)
Research Priorities for Airborne Particulate Matter (four volumes, 1998–2004)
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 (five volumes, 1989–1995)
Science and Judgment in Risk Assessment (1994)
Pesticides in the Diets of Infants and Children (1993)
Dolphins and the Tuna Industry (1992)
Science and the National Parks (1992)
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 ordered from the National Academies Press
(800) 624-6242 or (202) 334-3313
www.nap.edu
Preface
The California Department of Pesticide Regulation (DPR) conducts risk assessments as part of its mission to protect human health and the environment by regulating pesticide sales and use in the state. Premarket evaluation of pesticide products that have been approved by the US Environmental Protection Agency (EPA) is used to determine whether a product can be used safely in California. Risk assessments are also undertaken by DPR during the re-evaluation of registered pesticides or if an important health hazard resulting from exposure to a pesticide is identified. To ensure that DPR’s assessments use the best scientific information and current methods, DPR arranged for an independent peer review of the agency’s risk-assessment practices. Because the National Research Council has produced several important reports outlining improvements in the practice of risk assessment, DPR asked it to review whether DPR’s risk-assessment practices are scientifically and technically credible and to identify ways to improve the agency’s efficiency and productivity.
In response to DPR’s request, the National Research Council convened the Committee to Review California’s Risk-Assessment Process for Pesticides, which prepared this report. The members of the committee were selected for their expertise in toxicology, epidemiology, agronomy, occupational health, exposure assessment, and risk assessment. Appendix A has biographic information on the members.
The committee held public meetings to collect information on DPR’s risk-assessment process, to clarify relevant information about EPA’s pesticide program, and to get input from stakeholder groups. The committee thanks Sheryl Beauvais, Svetlana Koshlukova, Brian Leahy, Gary Patterson, Andrew Rubin, Randy Segawa, and Marylou Verder-Carlos, of DPR, for their presentations and assistance with providing background information on DPR’s risk-assessment practices. The committee also thanks the following for their presentations and other input: William Jordan, EPA; Anne Katten, California Rural Legal Assistance Foundation; and Arthur Lawyer, Technology Sciences Group.
The committee’s 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 the 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 of 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 thank the following for their review of the report: Steven Bradbury, Steven Bradbury and Associates; Robert Brent, Thomas Jefferson University; Thomas Cline, University of California, Berkeley; Richard Jackson, University of California, Los Angeles; Susan Kegley, Pesticide Research Institute; Timothy Pastoor, Syngenta Crop Protection, Inc.; Nu-May Ruby Reed, Davis, CA; Diane Rohlman, University of Iowa; Larry Sheets, Bayer CropScience; and Mae Wu, Natural Resources Defense Council.
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 the report was overseen by Deborah Cory-Slechta, University of Rochester, and David Savitz, Brown University. Appointed by the National Research Council, they were responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report rests entirely with the author committee and the institution.
The committee is grateful for the assistance of National Research Council staff in preparing the report. It particularly wishes to acknowledge the support of project director Susan Martel, who coordinated the project and contributed to the committee’s report. Other staff members who contributed to this effort are Camilla Ables, program officer in the Board on Agriculture and Natural Resources; James Reisa, director of the Board on Environmental Studies and Toxicology; Tamara Dawson, program associate; Norman Grossblatt, senior editor; and Mirsada Karalic-Loncarevic, manager of the Technical Information Center.
Finally, I thank all the members of the committee for their efforts throughout the development of this report.
Marion F. Ehrich, PhD
Chair, Committee to Review California’s
Risk-Assessment Process for Pesticides
Abbreviations
ADI | acceptable daily intake |
AEAP | Adverse Effects Advisory Panel |
AI | active ingredient |
ARB | Air Resources Board |
BMD | benchmark dose |
CalEPA | California Environmental Protection Agency |
CDPH | California Department of Public Health |
CSFII | US Department of Agriculture Continuing Survey of Food Intake by Individuals |
DFROII | Doctor’s First Report of Occupational Illness and Injury |
DPR | Department of Pesticide Regulation |
EPA | US Environmental Protection Agency |
IRIS | EPA’s Integrated Risk Information System |
MOE | margin of exposure |
NHANES | National Health and Nutrition Examination Survey |
NOAEL | no-observed-adverse-effect level |
NOEL | no-observed-effect level |
NRC | National Research Council |
OEHHA | Office of Environmental Health Hazard Assessment |
PBPK | physiologically based pharmacokinetic |
PHED | Pesticide Handler Exposure Database |
PISP | Pesticide Illness Surveillance Program |
PREC | Pesticide Registration and Evaluation Committee |
PUR | Pesticide Use Reporting |
RAPWG | Risk Assessment Prioritization Work Group |
RCD | risk-characterization document |
RfC | reference concentration |
RfD | reference dose |
TAC | toxic air contaminant |
USDA | US Department of Agriculture |
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Contents
The Committee’s Task and Approach
2 SETTING PRIORITIES AMONG PESTICIDES FOR RISK ASSESSMENT
California’s Priority-Setting Process
3 RISK-ASSESSMENT PRACTICES FOR PESTICIDES
Best Practices in Risk Assessment
California’s Risk-Assessment Practices
4 CALIFORNIA DATA TO INFORM PRIORITY-SETTING AND RISK ASSESSMENT OF PESTICIDES
Pesticide-Exposure Information
A BIOSKETCHES OF THE COMMITTEE TO REVIEW CALIFORNIA’S RISK-ASSESSMENT PROCESS FOR PESTICIDES
B DEPARTMENT OF PESTICIDE REGULATION RISK-ASSESSMENT GUIDANCE DOCUMENTS
C TECHNICAL RECOMMENDATIONS FOR DEPARTMENT OF PESTICIDE REGULATION RISK ASSESSMENTS
BOXES AND FIGURES
BOXES
2-1 DPR’s Candidate Selection and Priority-Setting Process for Pesticides
2-2 Summary of Criteria Used by DPR to Set Priorities
3-1 Cancer Assessments of Carbaryl Performed by Different Organizations
FIGURES
3-1 A framework for risk-based decision-making that maximizes the utility of risk assessment
3-2 Systematic review in the context of EPA’s Integrated Risk Information System process