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

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

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

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

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

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

Biosolids Applied to Land: Advancing Standards and Practices