Review of California's Risk-Assessment Process for Pesticides (2015)

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
                              OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu

THE NATIONAL ACADEMIES PRESS     500 Fifth Street, NW     Washington, DC 20001

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 13-C0026 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 authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

International Standard Book Number-13: 978-0-309-36775-2
International Standard Book Number-10: 0-309-36775-1

Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu/.

Copyright 2015 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America.

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

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. Ralph J. Cicerone 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. C. D. Mote, Jr., 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. Victor J. Dzau 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. Ralph J. Cicerone and Dr. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

This page intentionally left blank.

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

This page intentionally left blank.

Contents

SUMMARY

1 INTRODUCTION

The Committee’s Task and Approach

Organization of This Report

References

2 SETTING PRIORITIES AMONG PESTICIDES FOR RISK ASSESSMENT

California’s Priority-Setting Process

Committee’s Evaluation

Findings and Recommendations

References

3 RISK-ASSESSMENT PRACTICES FOR PESTICIDES

Best Practices in Risk Assessment

California’s Risk-Assessment Practices

Findings and Recommendations

References

4 CALIFORNIA DATA TO INFORM PRIORITY-SETTING AND RISK ASSESSMENT OF PESTICIDES

Pesticide-Exposure Information

Findings and Recommendations

References

APPENDIXES

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

D PESTICIDE TOXICITY ESTIMATES OF THE DEPARTMENT OF PESTICIDE REGULATION AND THE US ENVIRONMENTAL PROTECTION AGENCY USED TO GENERATE BOTTOM HISTOGRAM OF FIGURE 3-3

BOXES AND FIGURES

BOXES

1-1 Statement of Task

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

3-3 Comparison of reference values derived by EPA and DPR for the same active ingredients over three periods: before 1996, in 2004–2009, and in 2010–2014