EPA’S IRIS PROGRAM: EVALUATING THE SCIENCE AND PROCESS BEHIND CHEMICAL RISK ASSESSMENT HEARING BEFORE THE SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY HOUSE OF REPRESENTATIVES ONE HUNDRED TWELFTH CONGRESS FIRST SESSION THURSDAY, JULY 14, 2011 Serial No. 112–30 Printed for the use of the Committee on Science, Space, and Technology ( Available via the World Wide Web: http://science.house.gov U.S. GOVERNMENT PRINTING OFFICE 67–255PDF WASHINGTON : 2011 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001 EPA’S IRIS PROGRAM: EVALUATING THE SCIENCE AND PROCESS BEHIND CHEMICAL RISK ASSESSMENT EPA’S IRIS PROGRAM: EVALUATING THE SCIENCE AND PROCESS BEHIND CHEMICAL RISK ASSESSMENT HEARING BEFORE THE SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY HOUSE OF REPRESENTATIVES ONE HUNDRED TWELFTH CONGRESS FIRST SESSION THURSDAY, JULY 14, 2011 Serial No. 112–30 Printed for the use of the Committee on Science, Space, and Technology ( Available via the World Wide Web: http://science.house.gov U.S. GOVERNMENT PRINTING OFFICE 67–255PDF WASHINGTON : 2011 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001 COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY HON. RALPH M. HALL, Texas, Chair F. JAMES SENSENBRENNER, JR., EDDIE BERNICE JOHNSON, Texas Wisconsin JERRY F. COSTELLO, Illinois LAMAR S. SMITH, Texas LYNN C. WOOLSEY, California DANA ROHRABACHER, California ZOE LOFGREN, California ROSCOE G. BARTLETT, Maryland DAVID WU, Oregon FRANK D. LUCAS, Oklahoma BRAD MILLER, North Carolina JUDY BIGGERT, Illinois DANIEL LIPINSKI, Illinois W. TODD AKIN, Missouri GABRIELLE GIFFORDS, Arizona RANDY NEUGEBAUER, Texas DONNA F. EDWARDS, Maryland MICHAEL T. MCCAUL, Texas MARCIA L. FUDGE, Ohio PAUL C. BROUN, Georgia BEN R. LUJA´ N, New Mexico SANDY ADAMS, Florida PAUL D. TONKO, New York BENJAMIN QUAYLE, Arizona JERRY MCNERNEY, California CHARLES J. ‘‘CHUCK’’ FLEISCHMANN, JOHN P. SARBANES, Maryland Tennessee TERRI A. SEWELL, Alabama E. SCOTT RIGELL, Virginia FREDERICA S. WILSON, Florida STEVEN M. PALAZZO, Mississippi HANSEN CLARKE, Michigan MO BROOKS, Alabama ANDY HARRIS, Maryland RANDY HULTGREN, Illinois CHIP CRAVAACK, Minnesota LARRY BUCSHON, Indiana DAN BENISHEK, Michigan VACANCY SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT HON. PAUL C. BROUN, Georgia, Chair F. JAMES SENSENBRENNER, JR., DONNA F. EDWARDS, Maryland Wisconsin ZOE LOFGREN, California SANDY ADAMS, Florida BRAD MILLER, North Carolina RANDY HULTGREN, Illinois JERRY MCNERNEY, California LARRY BUCSHON, Indiana DAN BENISHEK, Michigan VACANCY RALPH M. HALL, Texas EDDIE BERNICE JOHNSON, Texas (IV) C O N T E N T S Wednesday, April 13, 2011 Page Witness List ............................................................................................................. 2 Hearing Charter ...................................................................................................... 3 Opening Statements Statement by Representative Paul C. Broun, Chairman, Subcommittee on Investigations and Oversight, Committee on Science, Space, and Tech- nology, U.S. House of Representatives ............................................................... 17 Written Statement ............................................................................................ 18 Statement by Representative Donna F. Edwards, Ranking Minority Member, Subcommittee on Investigations and Oversight, Committee on Science, Space, and Technology, U.S. House of Representatives .................................... 19 Written Statement ............................................................................................ 21 Witnesses: Panel I The Honorable Paul Anastas, Assistant Administrator, Office of Research and Development, U.S. Environmental Protection Agency Oral Statement ................................................................................................. 23 Written Statement ............................................................................................ 25 Mr. David Trimble, Director, Natural Resources and Environment, U.S. Gov- ernment Accountability Office Oral Statement ................................................................................................. 28 Written Statement ............................................................................................ 30 Dr. Jonathan M. Samet, MD, MS, Professor and Flora L. Thornton Chair, Department of Preventive Medicine, Keck School of Medicine, University of Southern California; and Chair, Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, National Research Council, The National Academies Oral Statement ................................................................................................. 40 Written Statement ............................................................................................ 36 Witnesses: Panel II The Honorable Calvin Dooley, President and Chief Executive Officer, Amer- ican Chemistry Council Oral Statement ................................................................................................. 62 Written Statement ............................................................................................ 63 Ms. Rena Steinzor, Professor, University of Maryland School of Law, and President, Center for Progressive Reform Oral Statement ................................................................................................. 66 Written Statement ............................................................................................ 67 Dr. Gail Charnley, Principal, HealthRisk Strategies Oral Statement ................................................................................................. 124 Written Statement ............................................................................................ 125 The Honorable J. Christian Bollwage, Mayor, City of Elizabeth, New Jersey Oral Statement ................................................................................................. 127 Written Statement ............................................................................................ 128 (V) VI Page Appendix I: Answers to Post-Hearing Questions The Honorable Paul Anastas, Assistant Administrator, Office of Research and Development, U.S. Environmental Protection Agency .............................. 144 Mr. David Trimble, Director, Natural Resources and Environment, U.S. Gov- ernment Accountability Office ............................................................................. 166 Dr. Jonathan M. Samet, MD, MS, Professor and Flora L. Thornton Chair, Department of Preventive Medicine, Keck School of Medicine, University of Southern California; and Chair, Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, National Research Council, The National Academies ............................................................................................................. 171 The Honorable Calvin Dooley, President and Chief Executive Officer, Amer- ican Chemistry Council ....................................................................................... 176 Dr. Gail Charnley, Principal, HealthRisk Strategies ........................................... 262 The Honorable J. Christian Bollwage, Mayor, City of Elizabeth, New Jersey ... 285 Appendix II: Additional Material for the Record Representative Larry Bucshon, Subcommittee on Investigations and Over- sight, Committee on Science, Space, and Technology, U.S. House of Rep- resentatives ........................................................................................................... 306 EPA’S IRIS PROGRAM: EVALUATING THE SCIENCE AND PROCESS BEHIND CHEMICAL RISK ASSESSMENT THURSDAY, JULY 14, 2011 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT, COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY, Washington, DC. The Subcommittee met, pursuant to call, at 10:04 a.m., in Room 2318 of the Rayburn House Office Building, Hon. Paul C. Broun [Chairman of the Subcommittee] presiding. (1) 2 3 HEARING CHARTER COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY U.S. HOUSE OF REPRESENTATIVES SUBCOMMITTEE ON INVESTIGATIONS & OVERSIGHT EPA’s IRIS Program: Evaluating the Science and Process Behind Chemical Risk Assessment THURSDAY, JULY 14, 2011 10:00 A.M. TO 12:00 P.M. 2318 RAYBURN HOUSE OFFICE BUILDING Purpose On July 14, 2011, the Subcommittee on Investigations and Oversight will hold a hearing on the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Infor- mation System (IRIS). There will be two panels at the hearing; the first panel will comprise of witnesses from EPA, the U.S. Government Accountability Office (GAO), and the National Academies’ National Research Council. The second panel will in- clude individuals and experts who will talk about their perspectives on IRIS. In March of 2008, GAO reported that ‘‘the IRIS database was at serious risk of becoming obsolete because EPA had not been able to routinely complete timely, credible assessments. After subsequent reports, in January 2009 [GAO] added EPA’s processes for assessing and controlling toxic chemicals to [its] list of areas at high risk for waste, fraud, abuse, and mismanagement or in need