ASSESSING RISKS TO

Endangered and
Threatened Species

FROM

PESTICIDES

Committee on Ecological Risk Assessment under FIFRA and ESA

Board on Environmental Studies and Toxicology

Division on Earth and Life Studies

National Research Council

NATIONAL RESEARCH COUNCIL
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

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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.

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, 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.

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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.

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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. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

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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

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)

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)

Preface

Under the US Endangered Species Act (ESA), the Fish and Wildlife Service (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 Insecticide, Fungicide, and Rodenticide Act (FIFRA), the US Environmental Protection 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 associated 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, 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 this report: Steven Bartell, Cardno ENTRIX; May Berenbaum, University of Illinois; Nancy Bryson, Holland & Hart, LLP; Francesca Dominici, Harvard School of Public Health; Scott Ferson, Applied Biomathematics; Robert Gilliom, National Water Quality Assessment Program, USGS; Tilghman Hall, Bayer CropScience; Jeffrey Jenkins, Oregon State University; Andreas Kortenkamp, Brunel University; Bernalyn McGaughey, Compliance Services International; Anke Mueller-Solger, California 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 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 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. However, 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 presentations 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 University; Steve Mashuda, Earthjustice; Bernalyn McGaughey, Compliance Services 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 questions throughout the study process. It especially thanks Jim Cowles, formerly of the Washington State Department of Agriculture, and Scott McMurry, Oklahoma State University, for their useful input in the early deliberations of this study.

The committee is grateful for the assistance of the National Research Council staff in preparing this report. Staff members who contributed to the effort 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 throughout 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 Environmental 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 member of this committee. The committee and the NRC are grateful for his service and his contributions.

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Contents

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