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Committee on Ecological Risk Assessment under FIFRA and ESA

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Committee on Ecological Risk Assessment under FIFRA and ESA Board on Environmental Studies and Toxicology Division on Earth and Life Studies National Research Council

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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 Insti- tute 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 Contract EP-C-09-003 between the National Academy of Sciences and the U.S. Environmental Protection Agency. Any opinions, findings, conclu- sions, 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: 978-0-309-28583-4 International Standard Book Number-10: 0-309-28583-6 Additional copies of this report are available from The National Academies Press 500 Fifth Street, NW Box 285 Washington, DC 20055 800-624-6242 202-334-3313 (in the Washington metropolitan area) http://www.nap.edu Copyright 2013 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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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. Charles M. Vest 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 re- sponsibility 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. Harvey V. Fineberg 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 Nation- al 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. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON ECOLOGICAL RISK ASSESSMENT UNDER FIFRA AND ESA Members JUDITH E. MCDOWELL (Chair), Woods Hole Oceanographic Institution, MA H. RESIT AKCAKAYA, Stony Brook University, NY MARY JANE ANGELO, University of Florida PATRICK DURKIN, Syracuse Environmental Research Associates, Inc., NY ANNE FAIRBROTHER, Exponent, Inc., WA ERICA FLEISHMAN, University of California, Davis DANIEL GOODMAN, Montana State University WILLIAM L. GRAF, University of South Carolina PHILIP M. GSCHWEND, Massachusetts Institute of Technology BRUCE K. HOPE, CH2M HILL, OR GERALD A. LEBLANC, North Carolina State University THOMAS P. QUINN, University of Washington NU-MAY RUBY REED (retired), California Environmental Protection Agency Staff ELLEN K. MANTUS, Project Codirector DAVID POLICANSKY, Project Codirector KERI STOEVER, Research Associate NORMAN GROSSBLATT, Senior Editor MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center RADIAH ROSE, Manager, Editorial Projects CRAIG PHILIP, Senior Program Assistant Sponsors NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION U.S. DEPARTMENT OF AGRICULTURE U.S. ENVIRONMENTAL PROTECTION AGENCY U.S. FISH AND WILDLIFE SERVICE v

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BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY1 Members ROGENE F. HENDERSON (Chair), Lovelace Respiratory Research Institute, Albuquerque, NM PRAVEEN AMAR, Clean Air Task Force, Boston, MA MICHAEL J. BRADLEY, M.J. Bradley & Associates, Concord, MA JONATHAN Z. CANNON, University of Virginia, Charlottesville GAIL CHARNLEY, HealthRisk Strategies, Washington, DC FRANK W. DAVIS, University of California, Santa Barbara CHARLES T. DRISCOLL, JR., Syracuse University, New York LYNN R. GOLDMAN, George Washington University, Washington, DC LINDA E. GREER, Natural Resources Defense Council, Washington, DC WILLIAM E. HALPERIN, University of Medicine and Dentistry of New Jersey, Newark 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 RICHARD L. POIROT, Vermont Department of Environmental Conservation, Waterbury MARK A. RATNER, Northwestern University, Evanston, IL KATHRYN G. SESSIONS, Health and Environmental Funders Network, Bethesda, MD JOYCE S. TSUJI, Exponent Environmental Group, Bellevue, WA Senior Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Scholar RAYMOND A. WASSEL, Senior Program Officer for Environmental Studies ELLEN K. MANTUS, Senior Program Officer for Risk Analysis SUSAN N.J. MARTEL, Senior Program Officer for Toxicology EILEEN N. ABT, Senior Program Officer MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center RADIAH ROSE, Manager, Editorial Projects 1 This study was planned, overseen, and supported by the Board on Environmental Studies and Toxicology. vi

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OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY 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) vii

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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 (fourteen volumes, 2000-2013) 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 viii

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Preface Under the US Endangered Species Act (ESA), the Fish and Wildlife Ser- vice (FWS) and the National Marine Fisheries Service (NMFS) are responsible for designating species as endangered or threatened (that is, listing species) and determining whether federal actions might jeopardize the continued existence of a listed species or adversely affect its critical habitat. Under the Federal Insecti- cide, Fungicide, and Rodenticide Act (FIFRA), the US Environmental Protec- tion Agency (EPA) is responsible for registering pesticides and ensuring that pesticides do not cause unreasonable adverse effects on the environment, which includes listed species and their critical habitats. Over the years, EPA, FWS, and NMFS have struggled unsuccessfully to reach a consensus on approaches to assessing the risks to listed species. Consequently, EPA, FWS, NMFS, and the US Department of Agriculture (USDA) asked the National Research Council to examine scientific and technical issues related to determining risks to species that are listed under the ESA posed by pesticides that are registered under FIFRA. In this report, the Committee on Ecological Risk Assessment under FIFRA and ESA first provides a common approach that EPA, FWS, and NMFS could use to conduct assessments. It then discusses models, data, and uncertainties associat- ed with exposure analysis and addresses various issues associated with assessing the effects of pesticides on listed species, including evaluating sublethal, indirect, and cumulative effects; modeling population-level effects; considering the effects of chemical mixtures; and incorporating uncertainties into the effects analysis. The committee closes by discussing the risk-characterization process and the need to propagate uncertainty through all components of the assessment so that decision- makers are well informed regarding the risk estimates produced. The present 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 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, evi- dence, and responsiveness to the study charge. The review comments and draft ix

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x Preface manuscript remain confidential to protect the integrity of the deliberative pro- cess. We thank the following for their review of this report: Steven Bartell, Cardno ENTRIX; May Berenbaum, University of Illinois; Nancy Bryson, Hol- land & Hart, LLP; Francesca Dominici, Harvard School of Public Health; Scott Ferson, Applied Biomathematics; Robert Gilliom, National Water Quality As- sessment Program, USGS; Tilghman Hall, Bayer CropScience; Jeffrey Jenkins, Oregon State University; Andreas Kortenkamp, Brunel University; Bernalyn McGaughey, Compliance Services International; Anke Mueller-Solger, Califor- nia Delta Stewardship Council; Terrance Quinn, University of Alaska Fairbanks; Joseph Rodricks, ENVIRON; Kenneth Rose, Louisiana State University; and Janet Silbernagel, University of Wisconsin, Madison. 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 the review coordinator, Danny Reible, The University of Texas at Austin, and the review monitor, Michael Ladisch, Purdue University. Appointed by the National Research Council, they were re- sponsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review com- ments were carefully considered. Responsibility for the final content of the re- port rests entirely with the committee and the institution. One committee member, Daniel Goodman, disagreed with the committee on several points and prepared a dissenting statement that was included as an appendix in the draft report that was submitted to peer reviewers. The report has been substantially revised in response to reviewer comments, and many issues raised by Dr. Goodman have been addressed with changes to the report. Howev- er, Dr. Goodman passed away while the report was in review, so determining how he would have judged the revised report is not possible. Accordingly, his dissenting statement has not been included in this final report; however, it is available in the public access file. The committee gratefully acknowledges the following for their presenta- tions to the committee during open sessions: Ann Bartuska, David Epstein, and Harold Thistle, USDA; Steven Bradbury and Edward Odenkirchen, EPA; Aimee Code, Northwest Center for Alternatives to Pesticides; Nancy Golden, FWS; Christian Grue, University of Washington; Barbara Harper, Confederated Tribes of the Umatilla Indian Reservation; Scott Hecht and Nathaniel Scholz, National Oceanic and Atmospheric Administration; Jeffrey Jenkins, Oregon State Uni- versity; Steve Mashuda, Earthjustice; Bernalyn McGaughey, Compliance Ser- vices International; John Stark, Washington State University; and Mike Willett, Northwest Horticultural Council. The committee members also thank the staff of EPA, FWS, and NMFS for being so helpful in answering their numerous ques- tions throughout the study process. It especially thanks Jim Cowles, formerly of the Washington State Department of Agriculture, and Scott McMurry, Oklaho- ma State University, for their useful input in the early deliberations of this study.

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Preface xi The committee is grateful for the assistance of the National Research Council staff in preparing this report. Staff members who contributed to the ef- fort are Ellen Mantus and David Policansky, project codirectors; Keri Stoever, research associate; James Reisa, director of the Board on Environmental Studies and Toxicology; Norman Grossblatt, senior editor; Mirsada Karalic-Loncarevic, manager of the Technical Information Center; Radiah Rose, manager of editorial projects; and Craig Philip, senior program assistant. I especially thank the members of the committee for their efforts through- out the development of this report. Judith E. McDowell, Chair Committee on Ecological Risk Assessment Under FIFRA and ESA

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Dedication This report is dedicated to Dr. Daniel Goodman (1945-2012), who served on the committee that authored this report until November 14, 2012, when he passed away unexpectedly. Dr. Goodman was professor and director of the En- vironmental Statistics Group in the Department of Ecology at Montana State University in Bozeman, where he had been on the faculty since 1980. Dr. Goodman provided advice to several federal agencies, including NOAA and EPA, and had served as a report reviewer for the NRC before becoming a mem- ber of this committee. The committee and the NRC are grateful for his service and his contributions. xiii

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Contents SUMMARY ........................................................................................................ 3 1 INTRODUCTION .................................................................................. 16 The Federal Insecticide, Fungicide, and Rodenticide Act, 16 The Endangered Species Act, 20 The Relationship Between The Two Acts, 23 The Committee and Its Task, 25 The Committee’s Approach to Its Task, 25 Organization of the Report, 27 References, 27 2 A COMMON APPROACH AND OTHER OVERARCHING ISSUES .................................................................................................... 28 A Common Approach, 28 Coordination among Agencies, 34 Uncertainty, 37 Best Data Available, 39 Conclusions and Recommendations, 43 References, 45 3 EXPOSURE ANALYSIS ....................................................................... 49 Exposure-Modeling Practices, 49 Geospatial Data for Habitat Delineation and Exposure Modeling, 55 Uncertainties in Exposure Modeling and Parameter Inputs, 65 Conclusions and Recommendations, 79 References, 81 4 EFFECTS ANALYSIS ........................................................................... 91 Sublethal, Indirect, and Cumulative Effects, 92 Effects Models, 101 Mixtures, 108 Interspecies Extrapolations and Surrogate Species, 128 Other Uncertainties in Effects Analysis, 131 xv

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xvi Contents Conclusions and Recommendations, 132 References, 135 5 RISK CHARACTERIZATION .......................................................... 148 Concentration-Ratio Approach, 149 Probabilistic Approach, 150 Conclusions, 152 References, 152 APPENDIXES A SELECTED EXCERPTS FROM 40 CFR PART 158 – DATA REQURIMENTS FOR PESTICIDES .................................... 155 B BIOGRAPHICAL INFORMATION ON THE COMMITTEE ON ECOLOGICAL RISK ASSESSMENT UNDER FIFRA AND ESA ....................................... 171 BOXES, FIGURES, AND TABLES BOXES 1-1 Statement of Task, 26 2-1 Generic Outline for Reporting Ecological Risk-Assessment Results for Listed Species or Their Critical Habitats, 36 3-1 AgDRIFT Inputs, 71 4-1 Ecological Risk Assessment in Species That Have Complex Population Structure and Life History: Pacific Salmon and Trout, 96 FIGURES S-1 Relationship between the Endangered Species Act (ESA) process and the ecological risk assessment (ERA) process, 6 1-1 Consultation process under ESA Section 7 for a federal action that potentially could affect a listed species or critical habitat, 22 2-1 Relationship between the Endangered Species Act (ESA) Section 7 decision process and the ecological risk assessment (ERA) process for a chemical stressor, 30 3-1 Organic-carbon normalized sorption coefficients, Koc, values for atrazine plotted on a logarithmic scale, 72 3-2 Distribution of Koc values for atrazine in a 6.25 hectare field, showing a range of about a factor of 2, 73

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Contents xvii 3-3 Upper panels: Distribution of observed (pseudo-) first-order biodegradation rates (per day) of flumetsulam as reported for 21 test soils by Lehman et al. (1992) on linear (left) and logarithmic (right) scales. Lower panels: Distribution of observed bacterial- number-normalized biodegradation rates (L/organism-hour) of the butoxyethyl ester of 2,4-D as reported for 33 test surface waters by Paris et al. (1981) on linear (left) and logarithmic (right) scales, 76 4-1 The effect of pesticide exposure on a density-dependence function, 109 4-2 Concentration-response curve of a chemical in the presence and absence of a synergist, 115 4-3 Example derivations used to determine K values, 127 4-4 Species sensitivity distributions for 2,2’-dipyridyldisulfide derived by using a Bayesian statistical model, 131 TABLES S-1 Examples of Authoritative Sources of Geospatial Data, 11 2-1 Steps in the ESA Process as Related to Elements in the ERA Process for Pesticides, 31 3-1 Nested Hierarchy of Hydrologic Units, 60 3-2 Variability of Pesticide Degradation Rates in Soils, 74 3-3 Biodegradation Rate Coefficients and Other Physical-Chemical Data Used in PRZM/EXAMS Fate Modeling of the Ethylhexyl Ester of 2,4-D, 78 4-1 Example Dataset Used to Assess Exposure to and Effects of Cypermethrin, in Mixture with Several Other Chemicals, on the Sockeye Salmon, Oncorhynchus nerka, 126

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