UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C. 20460
OFFICE OF THE ADMINISTRATOR
SCIENCE ADVISORY BOARD
September 1, 2017
EPA-SAB-17-008
The Honorable E. Scott Pruitt
Administrator
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460
Subject: Science Advisory Board comments on EPA's response to recommendations
on the Integrated Risk Information System
Dear Administrator Pruitt:
The EPA Chartered Science Advisory Board (SAB) met on August 29-30, 2017 and, as part of
the meeting's agenda, received an update on the restructuring of the Integrated Risk Information
System (IRIS). The Board was particularly impressed and pleased with the rapid progress that
the Agency has made in responding to recommendations from the National Research Council of
the National Academies of Sciences (NAS) and the SAB, with particularly notable
improvements in the program over the past year. The SAB members in attendance voted
unanimously that I communicate to you their enthusiasm for the IRIS program's progress.
As you may know, the NAS criticized several aspects of the IRIS program in their 2011 review
of the formaldehyde assessment, recommending significant changes designed to make IRIS
assessments more systematic and transparent.1 The NAS recommended that the program
establish clearer guidelines for study selection, standardize the presentation of studies, use clear
weight-of-evidence guidelines, better describe and justify assumptions to determine points of
departure, explain modeling processes used to develop risk estimates, and better document the
conclusions and estimation of toxicity values. In its 2014 report, the NAS commended EPA for
significant progress toward implementing the recommendations of the 2011 report, although
there remained additional room for improvement.2
1	National Research Council. 2011. Review of the Environmental Protection Agency's Draft IRIS Assessment of
Formaldehyde. Washington, DC: The National Academies Press, https://doi.org/10.17226/13142.
2	National Research Council. 2014. Review of EPA's Integrated Risk Information System (IRIS) Process.
Washington, DC: The National Academies Press, https://doi.org/10.17226/18764.

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The SAB has observed significant enhancements in the IRIS program over the past few years,
with impactful changes over the past year, and marked progress over the past six months. The
changes are so extensive and positive that they constitute a virtual reinvention of IRIS. For
example, it is now standard practice for the program to engage stakeholders in an early scoping
and problem formulation phase, thereby allowing stakeholders to provide important input at the
very beginning of the process. The program has fully adopted the principles of systematic
review, and incorporated automation and publicly available software platforms to modernize the
process. Finally, the IRIS documents are now more modular and structured to enhance
transparency and readability.
The SAB notes that no other federal entity performs the IRIS functions, and that IRIS helps
ensure consistency in chemical assessments within the Agency and across the federal
government. IRIS serves the needs of regions, states and tribes, who often lack the ability to
perform their own chemical risk assessments. IRIS is also well-positioned to incorporate new
evidence streams such as cell-based screening and computational methods into risk assessment,
which will be a major advancement over the coming years. The Board commends the Agency for
making such significant improvements over a short period of time. We are optimistic that the
restructured IRIS program will strengthen the scientific foundations of risk assessment and
protect the health and safety of the American public.
Sincerely,
/s/
Dr. Peter S. Thorne, Chair
Science Advisory Board
Enclosure
(1) Roster of SAB Members
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NOTICE
This report has been written as part of the activities of the EPA Science Advisory Board (SAB), a public
advisory group providing extramural scientific information and advice to the Administrator and other
officials of the Environmental Protection Agency. The SAB is structured to provide balanced, expert
assessment of scientific matters related to problems facing the Agency. This report has not been reviewed
for approval by the Agency and, hence, the contents of this report do not necessarily represent the views
and policies of the Environmental Protection Agency, nor of other agencies in the Executive Branch of the
Federal government, nor does mention of trade names of commercial products constitute a
recommendation for use. Reports of the SAB are posted on the EPA Web site at http ://www. epa. gov/sab.
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U.S. Environmental Protection Agency
Science Advisory Board
BOARD
CHAIR
Dr. Peter S. Thorne, Professor and Head, Department of Occupational & Environmental Health, College
of Public Health, University of Iowa, Iowa City, IA
MEMBERS
Dr. Joseph Arvai, Max McGraw Professor of Sustainable Enterprise and Director, Erb Institute, School
of Natural Resources & Environment, University of Michigan, Ann Arbor, MI
Dr. Deborah Hall Bennett, Professor and Interim Chief, Environmental and Occupational Health
Division, Department of Public Health Sciences, School of Medicine, University of California, Davis,
Davis, CA
Dr. Kiros T. Berhane, Professor, Preventive Medicine, Keck School of Medicine, University of Southern
California, Los Angeles, CA
Dr. Sylvie M. Brouder, Professor and Wickersham Chair of Excellence in Agricultural Research,
Department of Agronomy, Purdue University, West Lafayette, IN
Dr. Joel G. Burken, Curator's Professor and Chair, Civil, Architectural, and Environmental Engineering,
College of Engineering and Computing, Missouri University of Science and Technology, Rolla, MO,
United States
Dr. Janice E. Chambers, William L. Giles Distinguished Professor and Director, Center for
Environmental Health and Sciences, College of Veterinary Medicine, Mississippi State University,
Starksville, MS
Dr. Alison C. Cullen, Professor, Daniel J. Evans School of Public Policy and Governance, University of
Washington, Seattle, WA
Dr. Ana V. Diez Roux, Dean, School of Public Health, Drexel University, Philadelphia, PA
Also Member: CASAC
Dr. Otto C. Doering III, Professor, Department of Agricultural Economics, Purdue University, W.
Lafayette, IN
Dr. Joel J. Ducoste, Professor, Department of Civil, Construction, and Environmental Engineering,
College of Engineering, North Carolina State University, Raleigh, NC
Dr. Susan P. Felter, Research Fellow, Global Product Stewardship, Procter & Gamble, Mason, OH
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Dr. R. William Field, Professor, Department of Occupational and Environmental Health and Department
of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA
Dr. H. Christopher Frey, Glenn E. Futrell Distinguished University Professor, Department of Civil,
Construction and Environmental Engineering, College of Engineering, North Carolina State University,
Raleigh, NC
Dr. Joseph A. Gardella, SUNY Distinguished Professor and John and Frances Larkin Professor of
Chemistry, Department of Chemistry, College of Arts and Sciences, University at Buffalo, Buffalo, NY
Dr. Steven P. Hamburg, Chief Scientist, Environmental Defense Fund, Boston, MA
Dr. Cynthia M. Harris, Director and Professor, Institute of Public Health, Florida A&M University,
Tallahassee, FL
Dr. Robert J. Johnston, Director of the George Perkins Marsh Institute and Professor, Department of
Economics, Clark University, Worcester, MA
Dr. Kimberly L. Jones, Professor and Chair, Department of Civil and Environmental Engineering,
Howard University, Washington, DC
Dr. Catherine J. Karr, Associate Professor - Pediatrics and Environmental and Occupational Health
Sciences and Director - NW Pediatric Environmental Health Specialty Unit, University of Washington,
Seattle, WA
Dr. Madhu Khanna, ACES Distinguished Professor in Environmental Economics, Director of Graduate
Admissions and Associate Director, Institute of Sustainability, Energy, and Environment, Department of
Agricultural and Consumer Economics, University of Illinois at Urbana-Champaign, Urbana, IL
Dr. Francine Laden, Professor of Environmental Epidemiology, Associate Chair Environmental Health
and Director of Exposure, Departments of Environmental Health and Epidemiology, Harvard T.H. Chan
School of Public Health, Boston, MA
Dr. Robert E. Mace, Deputy Executive Administrator, Water Science & Conservation, Texas Water
Development Board, Austin, TX
Dr. Clyde F. Martin, Horn Professor of Mathematics, Emeritus, Department of Mathematics and
Statistics, Texas Tech University, Crofton, MD
Dr. Sue Marty, Senior Toxicology Leader, Toxicology & Environmental Research, The Dow Chemical
Company, Midland, MI
Dr. Denise Mauzerall, Professor, Woodrow Wilson School of Public and International Affairs, and
Department of Civil and Environmental Engineering, Princeton University, Princeton, NJ
Dr. Kristina D. Mena, Associate Professor, Epidemiology, Human Genetics and Environmental Sciences,
School of Public Health, University of Texas Health Science Center at Houston, El Paso, TX
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Dr. Surabi Menon, Director of Research, ClimateWorks Foundation, San Francisco, CA
Dr. Kari Nadeau, Naddisy Family Foundation Professor of Medicine, Director, FARE Center of
Excellence at Stanford University, and Sean N. Parker Center for Allergy and Asthma Research at,
Stanford University School of Medicine, Stanford, CA
Dr. James Opaluch, Professor and Chair, Department of Environmental and Natural Resource
Economics, College of the Environment and Life Sciences, University of Rhode Island, Kingston, RI
Dr. Thomas F. Parkerton, Senior Environmental Associate, Toxicology & Environmental Science
Division, ExxonMobil Biomedical Science, Houston, TX
Mr. Richard L. Poirot, Independent Consultant, Burlington, VT
Dr. Kenneth M. Portier, Independent Consultant, Athens, GA
Dr. Kenneth Ramos, Associate Vice-President of Precision Health Sciences and Professor of Medicine,
Arizona Health Sciences Center, University of Arizona, Tucson, AZ
Dr. David B. Richardson, Associate Professor, Department of Epidemiology, School of Public Health,
University of North Carolina, Chapel Hill, NC
Dr. Tara L. Sabo-Attwood, Associate Professor and Chair, Department of Environmental and Global
Health, College of Public Health and Health Professionals, University of Florida, Gainesville, FL
Dr. William Schlesinger, President Emeritus, Cary Institute of Ecosystem Studies, Millbrook, NY
Dr. Gina Solomon, Deputy Secretary for Science and Health, Office of the Secretary, California
Environmental Protection Agency, Sacramento, CA
Dr. Daniel O. Stram, Professor, Department of Preventive Medicine, Division of Biostatistics, University
of Southern California, Los Angeles, CA
Dr. Jay Turner, Associate Professor and Vice Dean for Education, Department of Energy, Environmental
and Chemical Engineering, School of Engineering & Applied Science, Washington University, St. Louis,
MO
Dr. Edwin van Wijngaarden, Associate Professor, Department of Public Health Sciences, School of
Medicine and Dentistry, University of Rochester, Rochester, NY
Dr. Jeanne M. VanBriesen, Duquesne Light Company Professor of Civil and Environmental
Engineering, and Director, Center for Water Quality in Urban Environmental Systems (Water-QUEST),
Department of Civil and Environmental Engineering, Carnegie Mellon University, Pittsburgh, PA
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Dr. Elke Weber, Gerhard R. Andlinger Professor in Energy and the Environment, Professor of
Psychology and Public Affairs, Woodrow Wilson School of Public and International Affairs, Princeton
University, Princeton, NJ
Dr. Charles Werth, Professor and Bettie Margaret Smith Chair in Environmental Health Engineering,
Department of Civil, Architectural and Environmental Engineering, Cockrell School of Engineering,
University of Texas at Austin, Austin, TX
Dr. Peter J. Wilcoxen, Laura J. and L. Douglas Meredith Professor for Teaching Excellence, Director,
Center for Environmental Policy and Administration, The Maxwell School, Syracuse University,
Syracuse, NY
Dr. Robyn S. Wilson, Associate Professor, School of Environment and Natural Resources, Ohio State
University, Columbus, OH
SCIENCE ADVISORY BOARD STAFF
Mr. Thomas Carpenter, Designated Federal Officer, U.S. Environmental Protection Agency,
Washington, DC
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