Biosolids Applied to Land

Advancing Standards and Practices

Committee on Toxicants and Pathogens in Biosolids Applied to Land

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



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Biosolids Applied to Land: Advancing Standards and Practices Biosolids Applied to Land Advancing Standards and Practices Committee on Toxicants and Pathogens in Biosolids Applied to Land 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

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Biosolids Applied to Land: Advancing Standards and Practices THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, D.C. 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 Grant No. X-82862501 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 author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number 0-309-08486-5 Library of Congress Control Number 2002112634 Cover photograph by Robert O’Dette, Synagro. 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 2002 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Biosolids Applied to Land: Advancing Standards and Practices 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. Bruce M.Alberts 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. Wm.A.Wulf 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. 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 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. Bruce M.Alberts and Dr. Wm.A.Wulf are chair and vice chair, respectively, of the National Research Council www.national-academies.org

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Biosolids Applied to Land: Advancing Standards and Practices COMMITTEE ON TOXICANTS AND PATHOGENS IN BIOSOLIDS APPLIED TO LAND Members THOMAS A.BURKE (Chair), Johns Hopkins University, Baltimore, Maryland LAWRENCE R.CURTIS, Oregon State University, Corvallis, Oregon CHARLES N.HAAS, Drexel University, Philadelphia, Pennsylvania ELLEN Z.HARRISON, Cornell University, Ithaca, New York WILLIAM E.HALPERIN, New Jersey Medical School, Newark, New Jersey JOHN B.KANEENE, Michigan State University, East Lansing, Michigan GREG KESTER, Wisconsin Department of Natural Resources, Madison, Wisconsin STEPHEN P.MCGRATH, Institute for Arable Crops Research, Rothamsted, England THOMAS E.MCKONE, University of California, Berkeley, California IAN L.PEPPER, University of Arizona, Tucson, Arizona SURESH D.PILLAI, Texas A&M University, College Station, Texas FREDERICK G.POHLAND, University of Pittsburgh, Pittsburgh, Pennsylvania ROBERT S.REIMERS, Tulane University, New Orleans, Louisiana ROSALIND A.SCHOOF, Gradient Corporation, Mercer Island, Washington DONALD L.SPARKS, University of Delaware, Newark, Delaware ROBERT C.SPEAR, University of California, Berkeley, California Staff SUSAN N.J.MARTEL, Study Director MARK C.GIBSON, Program Officer ROBERTA M.WEDGE, Program Director for Risk Analysis RUTH E.CROSSGROVE, Editor JESSICA BROCK, Senior Project Assistant MIRSADA KARALIC-LONCAREVIC, Research Assistant KELLY A.CLARK, Editorial Assistant

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Biosolids Applied to Land: Advancing Standards and Practices BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY1 Members GORDON ORIANS (Chair), University of Washington, Seattle JOHN DOULL (Vice Chair), University of Kansas Medical Center, Kansas City DAVID ALLEN, University of Texas, Austin INGRID C.BURKE, Colorado State University, Fort Collins THOMAS BURKE, Johns Hopkins University, Baltimore, Maryland WILLIAM L.CHAMEIDES, Georgia Institute of Technology, Atlanta CHRISTOPHER B.FIELD, Carnegie Institute of Washington, Stanford, California DANIEL S.GREENBAUM, Health Effects Institute, Cambridge, Massachusetts BRUCE D.HAMMOCK, University of California, Davis ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque, New Mexico CAROL HENRY, American Chemistry Council, Arlington, Virginia ROBERT HUGGETT, Michigan State University, East Lansing JAMES H.JOHNSON, Howard University, Washington, D.C. JAMES F.KITCHELL, University of Wisconsin, Madison DANIEL KREWSKI, University of Ottawa, Ottawa, Ontario JAMES A.MACMAHON, Utah State University, Logan WILLEM F.PASSCHIER, Health Council of the Netherlands, The Hague ANN POWERS, Pace University School of Law, White Plains, New York LOUISE M.RYAN, Harvard University, Boston, Massachusetts KIRK SMITH, University of California, Berkeley LISA SPEER, Natural Resources Defense Council, New York, New York Senior Staff JAMES J.REISA, Director DAVID J.POLICANSKY, Associate Director and Senior Program Director for Applied Ecology RAYMOND A.WASSEL, Senior Program Director for Environmental Sciences and Engineering KULBIR BAKSHI, Program Director for the Committee on Toxicology ROBERTA M.WEDGE, Program Director for Risk Analysis K.JOHN HOLMES, Senior Staff Officer SUSAN N.J.MARTEL, Senior Staff Officer SUZANNE VAN DRUNICK, Senior Staff Officer RUTH E.CROSSGROVE, Managing Editor 1   This study was planned, overseen, and supported by the Board on Environmental Studies and Toxicology.

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Biosolids Applied to Land: Advancing Standards and Practices WATER SCIENCE AND TECHNOLOGY BOARD Members RICHARD G.LUTHY (Chair), Stanford University, Stanford, California JOAN B.ROSE (Vice Chair), University of South Florida, St. Petersburg RICHELLE M.ALLEN-KING, Washington State University, Pullman GREGORY B.BAECHER, University of Maryland, College Park KENNETH R.BRADBURY, Wisconsin Geological and Natural History Survey, Madison JAMES CROOK, CH2M Hill, Boston, Massachusetts EFI FOUFOULA-GEORGIOU, University of Minnesota, Minneapolis PETER GLEICK, Pacific Institute for Studies in Development, Environment, and Security, Oakland, California STEVEN P.GLOSS, U.S. Geological Survey, Flagstaff, Arizona JOHN LETEY, JR., University of California, Riverside DIANE M.MCKNIGHT, University of Colorado, Boulder CHRISTINE L.MOE, Emory University, Atlanta, Georgia RUTHERFORD H.PLATT, University of Massachusetts, Amherst JERALD L.SCHNOOR, University of Iowa, Iowa City LEONARD SHABMAN, Virginia Polytechnic Institute and State University, Blacksburg R.RHODES TRUSSELL, Montgomery Watson, Pasadena, California Staff STEPHEN D.PARKER, Director LAURA J.EHLERS, Senior Staff Officer JEFFREY W.JACOBS, Senior Staff Officer WILLIAM S.LOGAN, Senior Staff Officer MARK C.GIBSON, Staff Officer M.JEANNE AQUILINO, Administrative Associate ELLEN A.DE GUZMAN, Research Associate PATRICIA JONES KERSHAW, Study/Research Associate ANITA A.HALL, Administrative Assistant ANIKE L.JOHNSON, Project Assistant JON Q.SANDERS, Project Assistant

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Biosolids Applied to Land: Advancing Standards and Practices OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY 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) Toxicological Effects of Methylmercury (2000) Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices (2000) Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000) Copper in Drinking Water (2000) Ecological Indicators for the Nation (2000) Waste Incineration and Public Health (1999) Hormonally Active Agents in the Environment (1999) Research Priorities for Airborne Particulate Matter (3 reports, 1998–2001) Ozone-Forming Potential of Reformulated Gasoline (1999) Risk-Based Waste Classification in California (1999) Arsenic in Drinking Water (1999) Brucellosis in the Greater Yellowstone Area (1998) 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 (5 reports, 1989–1995) Review of EPA’s Environmental Monitoring and Assessment Program (3 reports, 1994–1995) Science and Judgment in Risk Assessment (1994) Pesticides in the Diets of Infants and Children (1993) Setting Priorities for Land Conservation (1993) Protecting Visibility in National Parks and Wilderness Areas (1993) Dolphins and the Tuna Industry (1992) Science and the National Parks (1992) Assessment of the U.S. Outer Continental Shelf Environmental Studies Program, Volumes I–IV (1991–1993) 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 Academy Press (800) 624–6242 or (202) 334–3313 www.nap.edu

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Biosolids Applied to Land: Advancing Standards and Practices Preface In this report, biosolids are defined as sewage sludge that has been treated to meet the regulatory requirements for land application set out in the Code of Federal Regulations, Title 40 (Part 503). The U.S. Environmental Protection Agency (EPA) established the Part 503 rule and is responsible for overseeing the national biosolids program. The land-application requirements include concentration limits and loading rates for chemical pollutants, treatment and use requirements for controlling and reducing pathogens and the attraction of vectors, and management practices. The requirements are intended to protect public health and the environment from any reasonably anticipated adverse effects. Over the past decade, questions have been raised about the adequacy of the chemical and pathogen standards for protecting public health. To help address the questions and the requirement for periodic reassessment of the Part 503 rule, EPA asked the National Research Council (NRC) to independently review the technical basis of the chemical and pathogen regulations for biosolids, focusing only on human health. In this report, the NRC’s Committee on Toxicants and Pathogens in Biosolids Applied to Land (membership and biographical information provided in Appendix A) searched for evidence on human health effects related to biosolids exposure and the technical methods and approaches used by EPA to establish its human-health-based chemical and pathogen standards for biosolids. The NRC and the committee are aware that some interested parties were anticipating that this report might make a determination of whether EPA should continue to promote land application of biosolids. However, such a

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Biosolids Applied to Land: Advancing Standards and Practices determination was not part of the committee’s charge. The committee agrees that regulations must be adequate to protect human health and the environment and that they must be complied with and enforced. The committee was asked to focus its review on approaches for identifying human health hazards, for assessing exposure to those hazards, and for assessing risk from the exposures. This report offers numerous recommendations to update and strengthen the scientific credibility of the biosolids regulations and to ensure their consistent implementation. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures 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 institution in making its 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 review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Robert Cooper, BioVir Laboratories, Inc., Benicia, California; Alison Cullen, University of Washington, Seattle, Washington; Charles Henry, University of Washington, Seattle, Washington; Cecil Lue-Hing, Cecil Lue-Hing & Associates, Inc., Burr Ridge, Illinois; Philip Landrigan, Mount Sinai School of Medicine, New York, New York; Aaron Margolin, University of New Hampshire, Durham, New Hampshire; Penny Newman, Center for Community Action and Environmental Justice, Riverside, California; George O’Connor, University of Florida, Gainesville, Florida; Robert Southworth, Marshall, Virginia; Alan Stern, New Jersey Department of Environmental Protection, Trenton, New Jersey; Willy Verstraete, University of Gent, Gent, Belgium; and William Yanko, Big Bear City, California. 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 this report was overseen by Michael Kavanaugh, Malcolm Pirnie, Inc., Emeryville, California, and Ronald Estabrook, University of Texas Southwestern Medical Center, Dallas, Texas. Appointed by the NRC, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. The committee gratefully acknowledges the individuals who made presentations to the committee at its public meetings. A list of those individuals is

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Biosolids Applied to Land: Advancing Standards and Practices provided in Appendix B. The committee also wishes to thank EPA staff members Alan Hais, Robert Bastian, Alan Rubin, James Smith, and Charles White for their assistance in providing documents and information. The committee is grateful for the assistance of the NRC staff in preparing the report. It particularly wishes to acknowledge the contributions of Susan Martel, project director, who coordinated the project and contributed to the committee’s report. Other staff members who contributed to this effort are James J.Reisa, director of the Board on Environmental Studies and Toxicology; Roberta M.Wedge, program director for risk analysis; Mark Gibson, program officer (Water Science and Technology Board); Ruth E.Crossgrove, editor; Mirsada Karalic-Loncarevic, research assistant; and Jessica Brock, senior project assistant. Finally, I would especially like to thank all the members of the committee for their efforts throughout the development of this report. Thomas A.Burke, Ph.D. Chair, Committee on Toxicants and Pathogens in Biosolids Applied to Land

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Biosolids Applied to Land: Advancing Standards and Practices Contents     ABBREVIATIONS   xviii     SUMMARY   1 1   INTRODUCTION   17     Biosolids,   18     Human Health and Risk-Assessment Issues,   25     The Committee’s Task,   26     The Committee’s Approach,   27     Report Organization,   29     References,   29 2   BIOSOLIDS MANAGEMENT   31     Federal Biosolids Regulations and Current State of Program,   35     European Biosolids Management,   55     Pathogen Issues and Treatment Controls,   74     Pathogen Equivalency Committee,   80     Implementation and End-Use Practices,   82     Characterization of Biosolids,   91     Compliance Assistance and Enforcement,   95     Findings and Recommendations,   96     References,   99

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Biosolids Applied to Land: Advancing Standards and Practices 3   EPIDEMIOLOGICAL EVIDENCE OF HEALTH EFFECTS ASSOCIATED WITH BIOSOLIDS PRODUCTION AND APPLICATION   106     Description of the Literature,   107     Findings and Recommendations,   121     References,   122 4   ADVANCES IN RISK ASSESSMENT SINCE THE ESTABLISHMENT OF THE PART 503 RULE   126     The Risk-Assessment Process,   126     New Approaches and Considerations in Risk Assessment,   130     Changes in Risk-Assessment Approaches in EPA Offices,   147     Findings and Recommendations,   156     References,   158 5   EVALUATION OF EPA’S APPROACH TO SETTING CHEMICAL STANDARDS   164     Hazard Assessment and Chemical Selection,   165     Exposure Assessment,   178     Derivation of Risk-Based Standards,   205     Inorganic Chemicals,   207     Organic Chemicals,   219     Findings and Recommendations,   238     References,   242 6   EVALUATION OF EPA’S APPROACH TO SETTING PATHOGEN STANDARDS   257     Pathogen Standards,   257     Pathogens in Biosolids,   267     Exposure to Pathogens,   279     Host Factors,   287     Exposure to Workers,   289     Antibiotic Resistance,   290     Pathogen Risk Assessment,   291     Findings and Recommendations,   303     References,   306 7   INTEGRATION OF CHEMICAL AND PATHOGEN RISK ASSESSMENT   322     Agent-By-Agent Risk Assessment,   322     Secondary Transmission,   324

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Biosolids Applied to Land: Advancing Standards and Practices     Complex Mixtures,   327     Findings and Recommendations,   331     References,   333     GLOSSARY   335     APPENDIXES     A   Biographical Information on the Committee on Toxicants and Pathogens in Biosolids Applied to Land,   338 B   Participants at Public Sessions,   344

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Biosolids Applied to Land: Advancing Standards and Practices Abbreviations CFR Code of Federal Regulations CFU colony forming units CWA Clean Water Act EQ exceptional quality HEI highly exposed individual MEI most exposed individual MPN most probable number MT metric tons NIOSH National Institute for Occupational Safety and Health NRC National Research Council NSSS National Sewage Sludge Survey OIG EPA Office of Inspector General PCBs polychlorinated biphenyls PEC Pathogen Equivalency Committee PFRP process to further reduce pathogens PFU plaque-forming unit POTW publicly owned treatment works PSRP process to significantly reduce pathogens QMRA quantitative microbial risk assessment RME reasonable maximum exposure TEF toxicity equivalency factor TS total solids

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Biosolids Applied to Land: Advancing Standards and Practices Biosolids Applied to Land: Advancing Standards and Practices

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