National Academies Press: OpenBook
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×

Review of U.S. EPA’s ORD Staff Handbook
for Developing IRIS Assessments

2020 Version

Committee to Review EPA’S IRIS Assessment Handbook

Board on Environmental Studies and Toxicology

Division on Earth and Life Studies

A Consensus Study Report of

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×

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

This activity was supported by Contract No. 68HERC19D0011 between the National Academy of Sciences and the U. S. Environmental Protection Agency. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-09088-9
International Standard Book Number-10: 0-309-09088-1
Digital Object Identifier: https://doi.org/10.17226/26289

Additional copies of this publication are available 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 2022 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2022. A Review of U.S. EPA’s ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. https://doi.org/10.17226/26289.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×

Image

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president.

The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.

The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.

Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×

Image

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×

COMMITTEE TO REVIEW EPA’S IRIS ASSESSMENT HANDBOOK

Members

Lisa A. Bero (Chair), Colorado School of Public Health, Aurora

Hugh A. Barton, Consultant, Mystic, CT

Weihsueh A. Chiu, Texas A&M University, College Station

Gary L. Ginsberg, New York State Department of Health, Albany

Julie B. Herbstman, Columbia University, New York, NY

Jessica L. Myers, Texas Commission on Environmental Quality, Austin

Heather B. Patisaul, North Carolina State University, Raleigh

David B. Richardson, University of California, Irvine

Paul Whaley, Lancaster University, Lancaster, United Kingdom

Kristine L. Willett, University of Mississippi, University

Corwin M. Zigler, University of Texas, Austin

Staff

Raymond Wassel, Scholar

Clifford S. Duke, Director, Board on Environmental Studies and Toxicology

Kathryn Guyton, Senior Program Officer

Leslie Beauchamp, Program Assistant

Melissa Franks, Senior Program Officer (until May 14, 2021)

Sponsor

U.S. Environmental Protection Agency

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×

BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY

Members

William H. Farland (Chair), Colorado State University, Fort Collins

Dana Boyd Barr, Emory University, Atlanta, GA

Ann M. Bartuska, U.S. Department of Agriculture (retired), Washington, DC

E. William Colglazier, American Association for the Advancement of Science, Washington, DC

Francesca Dominici, Harvard University, Boston, MA

George Gray, The George Washington University, Washington, DC

R. Jeffrey Lewis, ExxonMobil Biomedical Sciences, Inc., Annandale, NJ

Germaine M. Buck Louis, George Mason University, Fairfax, VA

Linsey C. Marr, Virginia Polytechnic Institute and State University, Blacksburg

R. Craig Postlewaite, U.S. Department of Defense, Burke, VA

Reza J. Rasoulpour, Corteva Agriscience, Indianapolis, IN

Ivan Rusyn, Texas A&M University, College Station

Joshua Tewksbury, Future Earth, Boulder, CO

Sacoby M. Wilson, University of Maryland, College Park

Staff

Clifford S. Duke, Director

Raymond Wassel, Scholar

Kathryn Guyton, Senior Program Officer

Marilee Shelton-Davenport, Senior Program Officer

Kaley Beins, Associate Program Officer

Laura Llanos, Finance Business Partner

Tamara Dawson, Program Coordinator

Leslie Beauchamp, Program Assistant

Thomasina Lyles, Program Assistant

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×

Acknowledgments

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, 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 individuals for their review of this report:

HARVEY CLEWELL, Ramboll US Consulting, Inc.

PENNY FENNER-CRISP, private consultant

SUE JINKS-ROBERTSON (NAS), Duke University

JULEEN LAM, California State University East Bay

JENNIFER McPARTLAND, Environmental Defense Fund

MOSHE OREN (NAS/NAM), Weizmann Institute of Science

KAREN ROBINSON, Johns Hopkins University

ANDREW ROONEY, National Institute of Environmental Health Sciences

KAN SHAO, Indiana University

KIM TRUONG, California Environmental Protection Agency

LAURA VANDENBERG, University of Massachusetts – Amherst

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by JOEL KAUFMAN, University of Washington and LYNN GOLDMAN (NAM), the George Washington University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×

Abbreviations and Acronyms

ADME Absorption, Distribution, Metabolism, Excretion
BMR Benchmark Response
CRO Contract Research Organization
EPA U.S. Environmental Protection Agency
GRADE Grading of Recommendations, Assessment, Development and Evaluation
HAWC Health Assessment Workspace Collaborative
IAP IRIS Assessment Plan
IRIS Integrated Risk Information System
KC Key Characteristics
LOAEL Lowest-observed-adverse-effect Level
MOA Mode of Action
NAMs New Approach Methods/Methodologies
OHAT Office of Health Assessment and Translation
OPPT U.S. Environmental Protection Agency Office of Pollution Prevention and Toxics
ORD U.S. Environmental Protection Agency Office of Research and Development
PBPK Physiologically Based Pharmacokinetic
PECO Population, Exposure, Comparator, Outcome
PK Pharmacokinetic
PODs Points of Departure
RfC Reference Concentration
RfD Reference Dose
ROBINS-E Risk of Bias in Non-randomized Studies of Exposures
ROBINS-I Risk of Bias in Non-randomized Studies of Interventions
TACIT Tool for Addressing Conflicts of Interest in Trials
TK Toxicokinetics
TSCA Toxic Substances Control Act
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R1
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R2
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R3
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R4
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R5
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R6
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R7
Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R8
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R9
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R10
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R11
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Review of U.S. EPA's ORD Staff Handbook for Developing IRIS Assessments: 2020 Version. Washington, DC: The National Academies Press. doi: 10.17226/26289.
×
Page R12
Next: Summary »
  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!