<DOC> [110th Congress House Hearings] [From the U.S. Government Printing Office via GPO Access] [DOCID: f:40941.wais] TOXIC TRAILERS: HAVE THE CENTERS FOR DISEASE CONTROL FAILED TO PROTECT PUBLIC HEALTH? ======================================================================= HEARING BEFORE THE SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT COMMITTEE ON SCIENCE AND TECHNOLOGY HOUSE OF REPRESENTATIVES ONE HUNDRED TENTH CONGRESS SECOND SESSION __________ APRIL 1, 2008 __________ Serial No. 110-88 __________ Printed for the use of the Committee on Science and Technology Available via the World Wide Web: http://www.science.house.gov U.S. GOVERNMENT PRINTING OFFICE 40-941 PDF WASHINGTON DC: 20087 --------------------------------------------------------------------- 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) 512-2250 Mail Stop SSOP, Washington, DC 20402-0001 ______ COMMITTEE ON SCIENCE AND TECHNOLOGY HON. BART GORDON, Tennessee, Chairman JERRY F. COSTELLO, Illinois RALPH M. HALL, Texas EDDIE BERNICE JOHNSON, Texas F. JAMES SENSENBRENNER JR., LYNN C. WOOLSEY, California Wisconsin MARK UDALL, Colorado LAMAR S. SMITH, Texas DAVID WU, Oregon DANA ROHRABACHER, California BRIAN BAIRD, Washington ROSCOE G. BARTLETT, Maryland BRAD MILLER, North Carolina VERNON J. EHLERS, Michigan DANIEL LIPINSKI, Illinois FRANK D. LUCAS, Oklahoma NICK LAMPSON, Texas JUDY BIGGERT, Illinois GABRIELLE GIFFORDS, Arizona W. TODD AKIN, Missouri JERRY MCNERNEY, California JO BONNER, Alabama LAURA RICHARDSON, California TOM FEENEY, Florida PAUL KANJORSKI, Pennsylvania RANDY NEUGEBAUER, Texas DARLENE HOOLEY, Oregon BOB INGLIS, South Carolina STEVEN R. ROTHMAN, New Jersey DAVID G. REICHERT, Washington JIM MATHESON, Utah MICHAEL T. MCCAUL, Texas MIKE ROSS, Arkansas MARIO DIAZ-BALART, Florida BEN CHANDLER, Kentucky PHIL GINGREY, Georgia RUSS CARNAHAN, Missouri BRIAN P. BILBRAY, California CHARLIE MELANCON, Louisiana ADRIAN SMITH, Nebraska BARON P. HILL, Indiana PAUL C. BROUN, Georgia HARRY E. MITCHELL, Arizona CHARLES A. WILSON, Ohio ------ Subcommittee on Investigations and Oversight HON. BRAD MILLER, North Carolina, Chairman JERRY F. COSTELLO, Illinois F. JAMES SENSENBRENNER JR., EDDIE BERNICE JOHNSON, Texas Wisconsin DARLENE HOOLEY, Oregon DANA ROHRABACHER, California STEVEN R. ROTHMAN, New Jersey DAVID G. REICHERT, Washington BRIAN BAIRD, Washington PAUL C. BROUN, Georgia BART GORDON, Tennessee RALPH M. HALL, Texas DAN PEARSON Subcommittee Staff Director EDITH HOLLEMAN Subcommittee Counsel JAMES PAUL Democratic Professional Staff Member DOUGLAS S. PASTERNAK Democratic Professional Staff Member KEN JACOBSON Democratic Professional Staff Member BART FORSYTH Republican Counsel TOM HAMMOND Republican Professional Staff Member STACEY STEEP Research Assistant C O N T E N T S April 1, 2008 Page Witness List..................................................... 2 Hearing Charter.................................................. 3 Opening Statements Prepared Statement by Representative Bart Gordon, Chairman, Committee on Science and Technology, U.S. House of Representatives................................................ 17 Statement by Representative Brad Miller, Chairman, Subcommittee on Investigations and Oversight, Committee on Science and Technology, U.S. House of Representatives...................... 9 Written Statement............................................ 11 Statement by Representative F. James Sensenbrenner Jr., Ranking Minority Member, Subcommittee on Investigations and Oversight, Committee on Science and Technology, U.S. House of Representatives................................................ 13 Written Statement............................................ 15 Prepared Statement by Representative Nick Lampson, Chairman, Subcommittee on Energy and Environment, Committee on Science and Technology, U.S. House of Representatives.................. 18 Panel I: Dr. Heidi Sinclair, Medical Director, Baton Rouge Children's Health Project; Assistant Professor, Department of Pediatrics, Louisiana State University Health Sciences Center Oral Statement............................................... 19 Written Statement............................................ 21 Biography.................................................... 25 Mrs. Lindsay Huckabee, Resident of FEMA-provided mobile home in Kiln, Mississippi, from October, 2005 to March, 2008 Oral Statement............................................... 28 Written Statement............................................ 29 Ms. Becky Gillette, Formaldehyde Campaign Director, Sierra Club Gulf Coast Environmental Restoration Task Force Oral Statement............................................... 32 Written Statement............................................ 34 Biography.................................................... 38 Discussion ATSDR Response to Sierra Club Tests............................ 38 Health Effects From Formaldehyde............................... 39 Tracking Trailer Residents' Long-term Health................... 40 Failings of ATSDR.............................................. 40 Dr. Sinclair's Experience in Her Trailer....................... 46 Obstacles to Safe Housing...................................... 47 More on Tracking Residents..................................... 48 Trivializing Health Concerns................................... 48 Health Care Costs.............................................. 49 Formaldehyde's Effects on Reproductive Health.................. 50 Population Size................................................ 50 Panel II: Dr. Meryl H. Karol, Professor Emerita, University of Pittsburgh Oral Statement............................................... 51 Written Statement............................................ 53 Dr. Christopher T. De Rosa, Assistant Director for Toxicology and Risk Assessment, National Center for Environmental Health/ Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services Oral Statement............................................... 56 Written Statement............................................ 58 Biography.................................................... 63 Discussion Safe Formaldehyde Exposure Levels.............................. 66 ATSDR Review Process........................................... 67 Dr. De Rosa's Performance Reviews.............................. 68 Consequences of Inaction: Health Effects of Additional Exposure 68 Protecting the Public.......................................... 69 More on Long-term Health Tracking.............................. 69 Dr. De Rosa Excluded From Past Reviews?........................ 70 ATSDR Emergency Health Evaluations............................. 70 More on Reproductive Health.................................... 71 Deficiencies in the February 2007 Health Consultation.......... 72 Panel III: Dr. Howard Frumkin, Director, and Dr. Thomas Sinks, Deputy Director, Agency for Toxic Substances and Disease Registry, and National Center for Environmental Health, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services Oral Statement............................................... 73 Written Statement............................................ 75 Biography.................................................... 83 Vice Admiral Harvey E. Johnson, Jr. (Ret.), Acting Deputy Administrator and Chief Operating Officer, Federal Emergency Management Agency, Department of Homeland Security Oral Statement............................................... 83 Written Statement............................................ 85 Biography.................................................... 91 Discussion Warning FEMA Employees About Formaldehyde...................... 92 February 2007 Health Assessment................................ 93 Dr. De Rosa's Concerns Over the Health Consultation............ 97 2005 Formaldehyde Testing...................................... 98 FEMA's Emergency Housing....................................... 98 Acute Formaldehyde Exposure Levels............................. 98 Tracking Former Trailer Occupants.............................. 99 Trailer Costs, Inventory, and Sales............................ 99 FEMA Outreach on Formaldehyde Health Effects................... 100 Drs. Frumkin and Sinks Health Consultation Review.............. 100 FEMA's Office of General Council's Involvement With the Health Consultation................................................. 103 Trailers at Maxwell Air Force Base............................. 104 Emergency Housing Alternatives................................. 104 How Will ATSDR Prevent Future Problems?........................ 105 More on Dr. De Rosa's Performance.............................. 106 Review of the Events Surrounding the Health Consultation....... 108 More on Obstacles to Safe Housing.............................. 109 Health Care Costs.............................................. 111 CDC Actions: May-July, 2007.................................... 111 Were Discussions Being Made By FEMA's Lawyers?................. 112 Appendix: Additional Material for the Record #1. ATSDR Health Consultations. 2/1/07-1/29/07................... 116 #2. Interim Findings on Formaldehyde Levels in FEMA-supplied Travel Trailers, Park Models, and Mobile Homes (CDC). 2/29/08.. 190 #3. Handwritten notes by Joseph D. Little, one of two authors on the February 2007 ATSDR Health Consultation--Formaldehyde Sampling of FEMA Temporary-Housing Trailers. 6/28/06-8/30/07... 211 #4. ATSDR Chronology. 2008....................................... 234 #5. OSHA fact sheet on ``Occupational Exposure to Formaldehyde.'' 1/1/95......................................................... 241 #6. E-mail from Bryan McCrear, Contracting Officer, FEMA to Guy Morgan, Morgan USA. Re: FEMA orders 10,000 handicapped travel trailers from Morgan USA. 9/2/95............................... 243 #7. News article: ``Couple Discovers High Levels of Formaldehyde in FEMA Trailer,'' WLOX-TV, Biloxi, MS. 3/17/06................ 244 #8. E-mail from Adrian Server to Mary Martinet, David Trissell, Edward Broyles, Jordan Fried, Cc: Martin Matzen. Re: Server to FEMA attorneys involved, ``Whatever testing we do, we better do it very quietly.'' 3/18/06..................................... 246 #9. E-mail from Bronson Brown to FEMA staff. Re: FEMA staff should not enter new trailers until they are ``off-gassed.'' 3/ 22/06.......................................................... 247 #10. E-mail from Stewart (ESF-8 1603 AFO NOLA) to Stephen De Blasio (FEMA), Barbara Russell (Fluor), Guy Bonomo (FEMA), and Larry Woodruff. Re: Warning on trailers: Health concerns. FEMA says to tell residents to air out trailers and keep temperature and humidity low. 4/5/06....................................... 248 #11. Evaluation of Formaldehyde Concentration in the Carlton and Dawn Sistrunk FEMA Trailer by Bonner Analytical Testing Company. Sistrunk trailer results from 0.9-2.4 ppm. 4/6/06..... 253 #12. E-mail from Frank Alamia, Office of General Counsel, the Department of Homeland Security, to Adrian Server. Re: Use NIOSH, not OSHA standard, for testing. 5/17/06................. 256 #13. E-mail chain with FEMA staff. Re: FEMA headquarters decides to only air out trailers residents are complaining about. 5/30/ 06............................................................. 258 #14. MEMO from Dr. William Ringo, FEMA Occupational Safety and Health Officer, stating that occupational exposure levels are too high as a reference. 6/2/06................................ 260 #15. E-mail chain with FEMA field staff. Re: FEMA's field staff was told if a TT has been cleared, FEMA is under ``no further obligation'' to put complainant in a hotel. 6/13/06............ 262 #16. E-mail chain with FEMA field staff. Re: FEMA continues to deny health claims from residents and resident manager for hotel programs says applicants have reported serious medical problems from formaldehyde, but has been told to deny hotel stays. 6/14/06................................................. 264 #17. E-mail from Peggy Phillips, FEMA Logistical Management Specialist. Re: ``OGC has advised that we do not do testing, which would imply FEMA's ownership of this issue.'' 6/16/06.... 266 #18. E-mail chain with message from Martin McNeese, FEMA Region VIII Emergency Management Program Specialist, to Patrick Preston, cc to David Chawaga and Kevin Souza. Re: McNeese, ``I think the [ATSDR] report gave us what we were looking for.'' 2/ 12/07.......................................................... 268 #19. E-mail from Patrick Preston to Margaret Ramos. Re: Preston tells another FEMA lawyer that FEMA ``has not identified any independent evidence of dangerous formaldehyde conditions in trailers.'' 2/27/07............................................ 270 #20. Letter to Patrick Preston from Mark Keim stating that the ATSDR Health Consultation has been ``completed without a policy review by our senior technical staff. I am concerned that this health consultation is incomplete and perhaps misleading.'' Notes there is no ``safe'' level of exposure. 3/17/07.......... 274 #21. E-mail from MHOPS Maintenance Coordinator to MHOPS Field Staff. Re: FEMA tells Mississippi housing office that ATSDR results indicate that formaldehyde levels in travel trailers would not cause ``physical discomfort to most people.'' FEMA is using ATSDR ``level of concern'' as a guide to our housing program. 3/22/07............................................... 276 #22. E-mail from Martin McNeese to Stephen Miller. Re: In response to concerns from GSA, FEMA says travel trailers are not being sold for housing but as recreational vehicles. 4/08/ 07............................................................. 278 #23. E-mail from David Chawaga to FEMA staff. Re: FEMA asks who determined 0.3 ppm was the ``level of health concern for sensitive individuals'' as there is not website providing that number. Refers to several sites listing 0.1 ppm or less as the level. 5/1/07.................................................. 282 #24. McNeese response to 5/1/07 e-mail from David Chawaga. Re: ``The .3 ppm reference is also out of the ATSDR report.'' 5/1/ 07............................................................. 284 #25. E-mail chain with message from Jeff Runge (FEMA) to Jerry Thomas (CDC). Re: After CBS report, Runge says ATSDR did study that showed ``conclusively'' that ventilating a new trailer obviated problems with formaldehyde. 5/17/07................... 288 #26. E-mail chain with message from Harvey Johnson to Jeff Runge. Re: Johnson tells Dr. Runge he wants a ``fresh look.'' 5/17/07. 293 #27. E-mail chain with message from Merritt Lake to William Lang. Re: Merritt Lake, DHS's expert on formaldehyde, tells Dr. Lang that 0.3 ppm is the exposure level for adults, but children are more sensitive. 5/17/07........................................ 295 #28. E-mail chain with message from Price Roe to FEMA staff. Re: DHS deputy secretary tells Runge to take the lead on medical issues. Runge reviews various standards; says none are ``germaine to 24-hr x 7 days/week exposure in a mobile home or trailer that child or stay-home parent may experience.'' 5/18/ 07............................................................. 298 #29. E-mail from Stephen Orsino to Jordan Fried. Orsino, FEMA attorney, notes that ACGIH level of 0.3 ppm used by ATSDR has a caveat attached that it should not be applied to non- occupational applications. 5/23/07............................. 306 #30. Formaldehyde Event DHS/OHA SITREP Draft #002. Re: FEMA draft statement: ATSDR said 0.3 ppm was level of concern, but Mississippi doctor is seeing upper respiratory illnesses in children living in trailers; need to re-look at the issue. 5/ 25/07.......................................................... 308 #31. E-mail chain with message from Mike McGeehin to William Lang, Paul Garbe, Gary Noonan. Re: McGeehin doubts that any study would allow CDC to ``define a level below which adverse effects do not occur.'' 5/29/07................................ 321 #32. E-mail chain with message from Lang to Garratt. Re: CDC ought to be able to say that 0.1 ppm is a reasonable short-term mitigation goal. 5/29/07....................................... 323 #33. E-mail from Jill Igert, Senior Counsel, Office of Chief Counsel, Louisiana Transitional Recovery Office. Re: FEMA conference call on formaldehyde. Decision made with CDC last year to ventilate isn't sufficient. ``It doesn't work in Louisiana or Mississippi during the summer time.'' 5/31/07..... 326 #34. E-mail chain with message from Vice Adm. Johnson. Re: Johnson says ``slow to roll any sales and/or provisions as opposed to a notice to suspend'' in response to question about whether FEMA should immediately suspend provision of travel trailers for disasters and sale to occupants. 6/1/07........... 330 #35. News article: ``Formaldehyde High In Trailers.'' Jackson Clarion Ledger. 6/4/07......................................... 332 #36. E-mail from Lang to Kevin Souza. Re: Current question is whether these trailers, under real-life conditions, provide safe and healthful environment. 6/4/07......................... 334 #37. E-mail from Lang to Garratt. Re: Who put out Gerberding letter without consulting FEMA? FEMA wants ``rapid answers.'' 6/5/07......................................................... 336 #38. Information Paper: Formaldehyde in FEMA Provided Temporary- use Travel Trailers. 7/16/07................................... 338 #39. E-mail chain with FEMA staff. Re: GSA makes DHS aware of health complaint about trailer surplused to military. 7/17/07.. 345 #40. FEMA Disaster Assistance Directorate. Discussions, Issues and Questions Paper: Formaldehyde Testing. Re: DHS OHA has recommended 0.1 ppm as ``interim formaldehyde baseline safety level.'' FEMA/CDC site visit to LA. 7/22/07.................... 348 #41. E-mail chain. Re: No study protocol and sampling plan for new testing. Lang reports on field trip to Louisiana. Cites ``major problem'' with HVAC systems in the trailers. ``There is not ventilation in the units. . . In addition, most of the units have gas stoves. . . Gas cooking is a potent source of formaldehyde.'' 7/24/07........................................ 354 #42. CDC Health Advisory on formaldehyde: admits that people can manifest symptoms at very low levels. ``Symptoms should lessen if the affected individual is removed from the area of exposure.'' 7/26/07............................................ 360 #43. E-mail chain with message from Gil Jamieson to FEMA staff. Re: Moratorium on sales is in place because TT are not built to HUD standards. 8/18/07......................................... 363 #44. E-mail from Michael Lapinski to Vice Admiral Johnson. Re: FEMA refers to ``long delay'' in getting signature from CDC on IAA. 9/23/07................................................... 366 #45. E-mail from Lapinski to Vice Admiral Johnson. Re: Johnson is told numbers ``out there'' are 0.1 ppm, which is the NASA, ASHRAE and California Air Resources Board standard. 0.1 ppm ``likely to become the defacto standard.'' Johnson wants to approve sampling plan. 10/22/07................................ 369 #46. E-mail from Heather Smith to FEMA staff. Re: Johnson does not want testing until there is an action plan. 10/31/07....... 372 #47. E-mail from Lang to Lapinski and Garratt. Re: New health consultation recommends level unachievable in almost any residential situation. Wants to scrap the Phase I study; move to Phase III; get people out of trailers. Only other alternative is to accept higher levels for disaster relief. 11/ 2/07........................................................... 373 #48. E-mail from Jeff Runge to Johnson, Paulison, David, Schneider. Re: ``I'd be ok with `higher levels (over 0.1)' or `relatively higher levels (0.1).' '' 11/15/07.................. 375 #49. Statement of Administrator Paulison. Re: Background document for FEMA Administrator Paulison's announcement of new testing states that testing was delayed because no agency was willing to ``establish guidance for residential indoor levels of formaldehyde.'' 12/07.......................................... 376 #50. E-mail from Sam Coleman to Donald Benken with Tom Sinks CC'd. RE: FEMA wants the CDC to help with trailer testing. 7/5/ 06............................................................. 379 #51. Letter from Patrick Preston to Scott Wright. RE: Test results and data from the FEMA trailer Formaldehyde testing conducted by EPA. 11/30/06..................................... 380 #52. E-mail from Sam Coleman to Joseph Little and Scott Wright with Howard Frumkin CC'd. RE: EPA Concerns that FEMA may not be properly interpreting the data from EPA testing. 12/1/06....... 381 #53. E-mail from Howard Frumkin to Joseph Little, Scott Wright, Sven Rodenbeck, and Phillip Allred with Tom Sinks CC'd. RE: Howard Frumkin asking for details on the ATSDR analysis of Formaldehyde in FEMA trailers. 12/4/06......................... 384 #54. E-mail from Joseph Little to Howard Frumkin with Tom Sinks, Scott Wright, and Chris De Rosa CC'd. RE: Summary of ATSDR involvement in the analysis of Formaldehyde in FEMA trailers and of conference calls with FEMA OGC and EPA. 12/4/06......... 385 #55. E-mail from Howard Frumkin to Chris De Rosa with Tom Sinks CC'd. RE: Howard Frumkin asking Chris De Rosa to keep him up- to-date on potentially controversial activities such as the ATSDR analysis of Formaldehyde in trailers. 12/5/06............ 387 #56. E-mail from Scott Wright to Richard Nickle and Gregory Zarus with John Florence and Joseph Little CC'd. RE: Joe and Scott instructed not to discuss or release any data outside of themselves and FEMA's Office of Chief Counsel 12/7/06.......... 388 #57. E-mail from Richard Nickle to James Holler with Gregory Zarus CC'd. RE: FEMA Trailers issue could warrant inquiry from outside the division. 12/26/06................................. 389 #58. E-mail from Mark Keim to Phillip Allred. RE: Formaldehyde health consultation to be presented to Howard Frumkin January 8th, 2007. 1/6/07.............................................. 391 #59. E-mail from Phillip Allred to Joseph Little and Scott Wright. RE: Formaldehyde health consultation to be presented to Howard Frumkin January 8th, 2007. 1/8/07....................... 392 #60. E-mail from Phillip Allred to Joseph Little and Scott Wright. RE: Howard Frumkin's reaction to the Formaldehyde health consult. 1/8/07......................................... 393 #61. Formaldehyde Sampling at FEMA Temporary Housing Units. Baton Rouge, Louisiana: Executive Summary. 1/16/07................... 394 #62. E-mail from Phillip Allred to Louise Williams. RE: Setting up a meeting to brief Tom on the Formaldehyde Consultation. 1/ 18/07.......................................................... 395 #63. E-mail from Louise Williams to Phillip Allred. RE: Time set up to brief Tom on the Formaldehyde Consultation. 1/19/07...... 396 #64. Letter from Mark Keim to Patrick Preston with Michael Allred, Joseph Little, and Scott Wright CC'd. RE: Delivery of ATSDR Health Consultation to FEMA. 2/1/07...................... 397 #65. E-mail from Phillip Allred to Phillip Allred. RE: Phillip spoke to Patrick Preston about the temporary housing issues. 2/ 15/07.......................................................... 399 #66. E-mail from Richard Nickle to (only key people listed) Chris De Rosa, Howard Frumkin, Joseph Little, Tom Sinks, and Scott Wright. RE: Health Consultation finalized and sent to FEMA-- Summary of findings are detailed in this e-mail. 2/2/07........ 400 #67. E-mail from Mark Keim and Phillip Allred. RE: Formaldehyde update to be presented at the Issues Management Meeting to Tom Sinks and Howard Frumkin. 3/2/07............................... 402 #68. E-mail from Chris De Rosa to Howard Frumkin and Tom Sinks. RE: Concerns regarding the Formaldehyde health consultation done for FEMA (Letter to Patrick Preston detailing concerns is attached). 3/8/07.............................................. 403 #69. E-mail from Chris De Rosa to Mark Keim and James Holler. RE: Concerns regarding the Formaldehyde health consultation done for FEMA (Letter to Patrick Preston detailing concerns is attached). 3/9/07.............................................. 405 #70. E-mail from Howard Frumkin to Mark Keim with Chris De Rosa and Tom Sinks CC'd. RE: Howard Frumkin acknowledges that the report should be corrected to include both acute and chronic toxicity. 3/9/07............................................... 408 #71. E-mail from Mark Keim to Howard Frumkin with Chris De Rosa and Tom Sinks CC'd. RE: Mark Keim acknowledges that he will make changes to the health consult. 3/9/07..................... 409 #72. E-mail from Chris De Rosa to Howard Frumkin and Tom Sinks. RE: History of FEMA not including cancer risks and asking ATSDR to not include long-term health effects of Formaldehyde and on amending the original Formaldehyde health assessment. 3/9/07... 410 #73. E-mail from Chris De Rosa to Howard Frumkin and Tom Sinks. RE: Concerns regarding the Formaldehyde health consultation done for FEMA (letter to Patrick Preston detailing concerns is attached). 2/27/07............................................. 412 #74. Letter from Mark Keim to Patrick Preston with Chris De Rosa and Howard Frumkin CC'd. RE: Concerns that the Formaldehyde Health Consultation didn't address long-term health effects including cancer. 3/17/07...................................... 414 #75. E-mail from Becky Gillette to James Durant. 2/27/07......... 416 #76. E-mail from Susan Metcalf to James Holler and Mary Jean Brown with James Durant CC'd. RE: Determining CDC's Response to the Sierra Club. 3/5/07........................................ 417 #77. E-mail from Becky Gillette to James Durant. RE: Second request for an ATSDR contact to investigate Formaldehyde in FEMA trailers. 5/7/07.......................................... 418 #78. E-mail from Sascha Fielding to Chris De Rosa. RE: Requesting Chris to look over the responses to Congress regarding FEMA trailers. 3/23/07.............................................. 419 #79. E-mail from Chris De Rosa to Sascha Fielding. RE: Concerns from the response to Congress regarding FEMA trailers. 3/27/07. 420 #80. E-mail from Angela Davis to Barbara Rogers and Sascha Fielding. RE: Non-disclosure request by FEMA Office of General Counsel of ATSDR Formaldehyde data discussed in Issue Management Meeting (typically for Dr. Frumkin and Dr. Sinks). 3/21/07........................................................ 421 #81. E-mail from Howard Frumkin to CDC All--NCHE/ATSDR. RE: Newsletter--Important point was CDC's response to Congressman Gene Taylor detailing that the CDC would not provide a health assessment of Formaldehyde exposure in FEMA trailers. 4/6/07... 422 #82. E-mail from Joseph Little to Dagny Olivares, Richard Nickle, Larry Cseh, and Phillip Allred with Mark Keim CC'd. RE: Joseph Little concurs with the content of a FEMA news release which does not include any long-term health effects (i.e., cancer). 5/3/07......................................................... 424 #83. E-mail from Dagny Olivares to Mark Keim and Phillip Allred. RE: CDC not undertaking a health assessment as no one has requested them to do so with regards to media requests on the CDC's response to people living in trailers. 5/17/07........... 432 #84. E-mail from Stanley Meiburg to Sascha Fielding, Jane Telfer, and Kenneth Rose. RE: Continued Formaldehyde discussions in Issues Management Meetings with regards to CBS News report. 5/ 21/07.......................................................... 433 #85. E-mail from Jane Telfer to William Cibulas, Stanley Meiburg, Sascha Fielding, and Kenneth Rose with Howard Frumkin CC'd. RE: Details on FEMA releasing the February Health Consultation without long-term health risks. 5/21/07........................ 434 #86. Letter from Congressman Gene Taylor to Julie Gerberding. RE: Asking CDC to Investigate the Formaldehyde in trailers. 2/22/07 436 #87. Letter from Julie Gerberding to Congressman Gene Taylor. RE: Information on Formaldehyde and CDC recommends ventilation of the units. 5/30/07............................................. 437 #88. E-mail from Howard Frumkin to Chris De Rosa and Tom Sinks. RE: Forwarding news article about Formaldehyde and Kids. 5/30/ 07............................................................. 443 #89. E-mail from Chris De Rosa to Howard Frumkin and Tom Sinks. RE: CDC should be cautious about the word ``safe'' in reference to formaldehyde since it is a carcinogen. 6/1/07............... 445 #90. E-mail from Scott Wright to Sascha Fielding with Joseph Little CC'd. RE: Basis of the 0.3 ppm level of concern used by ATSDR. 7/20/07................................................. 447 #91. E-mail from Howard Frumkin to Sascha Fielding, Mike McGeehin, William Cibulas, and Henry Falk. RE: 0.3 ppm level of concern has little or no operational meaning. 7/20/07.......... 448 #92. E-mail from Henry Falk to Howard Frumkin, Scott Wright, and others. RE: FEMA talking points on the ATSDR report and discussion of the 0.3 level of concern. 7/20/07................ 449 #93. E-mail from Howard Frumkin to Henry Falk, Scott Wright, and others. RE: Discussion of FEMA Talking Points. 7/20/07......... 450 #94. E-mail from Howard Frumkin to Scott Wright, Joseph Little, Henry Falk, and others. RE: Formaldehyde Exposure Levels. 7/21/ 07............................................................. 451 #95. E-mail from Scott Wright to Richard Nickle. RE: Scott helped draft Director Paulison with his Congressional testimony and helped with the new FEMA fact sheet. 7/24/07................... 453 #96. E-mail from William Cibulas to Howard Frumkin, Scott Wright, Henry Falk, Joseph Little, and others. RE: Mentions concern that they don't mention cancer with regards to Formaldehyde Exposure Levels. 7/24/07....................................... 454 #97. E-mail from Dagny Olivares to Howard Frumkin. RE: HAN Feedback from the Emergency Communications System. NOTE: Still no mention of cancer concerns in the attached document. 7/25/07 456 #98. E-mail from Chris De Rosa to Mike McGeehin, Henry Falk, Howard Frumkin, and Tom Sinks. RE: Discussions regarding ATSDR's approaches to the health consultations. 7/25/07........ 459 #99. E-mail from Chris De Rosa to Richard Weston. RE: No mention of long-term health effects and developmental toxicity in the Health Advisory. 7/26/07....................................... 463 #100. E-mail from Mike McGeehin to Howard Frumkin and others. RE: Discussion on language in the report prepared by ATSDR for the CDC website. 7/28/07........................................... 465 #101. E-mail from Dagny Olivares to Howard Frumkin and others. RE: Posting the report prepared by ATSDR for the CDC website. 7/30/07........................................................ 466 #102. E-mail from Sascha Fielding to Howard Frumkin and others. RE: Meeting to identify and review health issues related to living in the trailers. 7/30/07................................ 468 #103. E-mail from Anne Sowell to Mark Bashor with Tom Sinks CC'd. RE: Concerns regarding the ATSDR Formaldehyde consult. 8/8/07.. 470 #104. E-mail from Howard Frumkin to Henry Falk, Tom Sinks, and Mike McGeehin. RE: Reduced pressure on CDC if FEMA is moving people out of the trailers. 8/9/07............................. 472 #105. E-mail from Julie Gerberding to Henry Falk, Howard Frumkin, William Gimson, and Tom Sinks. RE: Speeding up the timeline for the study to relieve pressure. 8/10/07......................... 474 #106. E-mail from Chris De Rosa to Mike Groutt with Scott Wright and Joseph Little CC'd. RE: Comments on Chronology of FEMA Trailers to include details on senior policy and technical reviews. 8/10/07............................................... 476 #107. E-mail from Tom Sinks to Howard Frumkin, Henry Falk, and Louise Galaska. RE: Tom Sinks states that ATSDR leadership was unaware that this consult was done through the Council's office. 9/11/07................................................ 478 #108. E-mail from Alan Crawford to Tom Sinks. RE: Initial meeting between ATSDR, EPA, and FEMA and a request to Dr. Frumkin regarding Formaldehyde testing in June 2006. 9/13/07........... 479 #109. Letter to Howard Frumkin from Chris De Rosa. RE: Concerns regarding several critical public health issues and objections to limitation on Chris's ability to perform the duties contained in his position description. 9/21/07................. 480 #110. E-mail from Chris De Rosa to Tom Sinks, Howard Frumkin, Kenneth Rose, Jana Telfer, and Mark Basher with Henry Falk and Mark Kashdan CC'd. RE: Health alert regarding formaldehyde levels. 10/6/07................................................ 487 #111. E-mail from Tom Sinks to Chris De Rosa, Howard Frumkin, Kenneth Rose, Jana Telfer, and Mark Basher with Henry Falk and Mark Kashdan CC'd. RE: Health alert regarding formaldehyde levels. 10/7/07................................................ 488 #112. E-mail from Tom Sinks to Henry Falk, Tom Sinks, and others. RE: ATSDR leadership was unaware that their staff was working directly with FEMA lawyers. 10/12/07........................... 489 #113. Flyer: Formaldehyde Levels in FEMA-Supplied Trailers--Early Findings from the Centers for Disease Control and Prevention... 492 #114. Memo from NCEH/ATSDR--Howard Frumkin to Chris De Rosa. RE: 2007 Performance Assessment and Detail. 10/25/07............... 493 #115. Letter from Edward Murray. RE: Management Notification of Highly Sensitive Issues--Failure to notify OGC/CDC. 11/8/07.... 494 TOXIC TRAILERS: HAVE THE CENTERS FOR DISEASE CONTROL FAILED TO PROTECT PUBLIC HEALTH? ---------- TUESDAY, APRIL 1, 2008 House of Representatives, Subcommittee on Investigations and Oversight, Committee on Science and Technology, Washington, DC. The Subcommittee met, pursuant to call, at 9:37 a.m., in Room 2318 of the Rayburn House Office Building, Hon. Brad Miller [Chairman of the Subcommittee] presiding. <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> hearing charter SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT COMMITTEE ON SCIENCE AND TECHNOLOGY U.S. HOUSE OF REPRESENTATIVES Toxic Trailers: Have the Centers for Disease Control Failed to Protect Public Health? tuesday, april 1, 2008 9:30 a.m.-1:00 p.m. 2318 rayburn house office building Overview The mission of the Agency for Toxic Substances and Disease Registry (ATSDR), a sister agency of the Centers for Disease Control and Prevention (CDC), ``is to serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and disease related to toxic substances.'' Unfortunately, the agency failed to meet any of those objectives when it produced a Health Consultation on Formaldehyde Sampling of FEMA Temporary-Housing Trailers in February 2007. In almost every respect ATSDR failed to fulfill its mission to protect the public from exposure to formaldehyde at levels known to cause ill-health effects. The agency's handling of this issue and their inability to quickly and effectively correct it was the direct result of a collapse of senior management and leadership at the very top of the agency. The agency failed to translate scientific findings and facts into appropriate public health actions which would have resulted in properly informing and warning tens of thousands of Hurricanes Katrina and Rita survivors living in FEMA-provided trailers and mobile homes of the potential health risks they faced. The agency should have pushed to remove them from this circumstance as early as possible. Instead, they did virtually nothing. The Health Consultation, which was conducted at the request of the Federal Emergency Management Agency's (FEMA) Office of General Counsel was scientifically flawed and omitted critical health information. The report provided an illusion of safety that was used to drive FEMA policy of maintaining tens of thousands of Hurricanes Katrina and Rita families in FEMA-provided travel trailers. Rather than clearly warning occupants of the full-extent of potential health effects they could be exposed to the report determined that opening windows and vents would reduce the concentrations of formaldehyde in the trailers below levels of health concern. Opening windows and vents did substantially reduce the level of formaldehyde in the trailers, but the Health Consultation inappropriately relied on a ``level of concern'' regarding the health risks of formaldehyde of 0.3 parts per million (ppm), ten times higher than ATSDR's own Minimal Risk Level of up to one year of exposure (0.03 ppm) and three times higher than the level of exposure widely accepted by other federal agencies to cause health effects (0.1 ppm). It also neglected to mention the potential long-term effects of exposure to formaldehyde and possible cancer risks. Purpose The Subcommittee hearing will review how and why the Nation's public health agency failed to protect the public's health. The hearing will examine the direct involvement of the Director and Deputy Director of ATSDR in reviewing, vetting and approving the release of the agency's February 2007 Health Consultation on formaldehyde which was scientifically unsound and quickly dismissed by the agency's chief toxicologist after it had been forwarded to FEMA. Dr. Christopher De Rosa, ATSDR's chief toxicologist and then-Director of the Division of Toxicology and Environmental Medicine, immediately drafted a swift, sharp letter to FEMA pointing out many of the scientific faults with the report and said to release it as it was would be ``perhaps misleading.'' The Director of ATSDR finally had the letter sent to Mr. Rick Preston from FEMA's Office of General Counsel, who had requested the report in the first place, from a separate ATSDR office on March 17, 2007. Amazingly, Mr. Preston acknowledged in interviews with Subcommittee staff that he simply placed the letter in a file drawer and never shared it with anyone else. Without knowledge of the March letter, the February Health Consultation by itself led senior FEMA officials to believe that concentrations of formaldehyde in FEMA-provided temporary housing units did not present a public health hazard. That interpretation of ATSDR's Health Consultation and the astonishingly lackluster effort by ATSDR officials to correct public mis-statements by FEMA officials or to immediately revise their own flawed report in the Spring of 2007 led FEMA to maintain the status quo and keep tens of thousands of Hurricane Katrina and Rita survivors living in potentially formaldehyde-laden toxic trailers for at least one year longer than necessary or warranted. Apart from the March 17th letter ATSDR had no response at all. If they had, perhaps more than 30,000 families would not remain in these temporary housing units today. Among the key questions: <bullet> Why did the leadership of ATSDR take such halfhearted actions after the flawed report was issued and after they were informed--and agreed--that the report was fundamentally flawed and would be misleading if it was released? <bullet> Why did top officials of ATSDR fail to either publicly or privately correct mis-statements by the FEMA Administrator that formaldehyde in the trailers did not pose a threat to the inhabitants? <bullet> The preparation and dissemination of the February Health Consultation to FEMA was managed by the Office of the Director. The Director of ATSDR, Dr. Howard Frumkin, reviewed and commented on the report and his Deputy, Dr. Tom Sinks, reviewed, edited and approved the release of the report. Given their intimate involvement in the preparation of this report, why did Drs. Frumkin and Sinks both take concerted actions in the fall of 2007 to publicly scold the two authors of the report, reprimand their branch chief who was unaware of the report and demote and retaliate against Dr. Chris De Rosa, the agency's chief toxicologist, who appeared to be the one individual who repeatedly pushed the agency to do more and be more assertive in its response to the formaldehyde issue? <bullet> How can the public and Congress trust an agency to protect the public's health that treated one of the most important public health issues of the agency's recent past so wantonly, with so little urgency, insight, sound scientific advise or concern? Background Formaldehyde is a colorless, strong-smelling gas that is widely used in the building industry, as an adhesive in many consumer products, including plywood, particle board, carpet and upholstery. Travel trailers are widely composed of these products. Because of the materials used in their construction, mobile homes and travel trailers have long been known to contain higher levels of formaldehyde, particularly when they are new, and there is a lot of ``off-gassing'' of formaldehyde. Over time the levels of formaldehyde in these products normally decrease as ``off-gassing'' occurs. Still, some trailers have shown elevated levels of formaldehyde even after years of ``off- gassing.'' Hurricane Katrina made landfall on August 29, 2005. Less than one month later on September 24, 2005 Hurricane Rita struck the Gulf Coast. These hurricanes left tens of thousands of individuals and families homeless. In response, FEMA provided more than 140,000 mobile homes and travel trailers known as temporary housing units, to individuals and families across the Gulf Coast, but the potential threat of exposure to high levels of formaldehyde from this housing was soon recognized by at least some federal agencies. High levels of formaldehyde in the manufactured homes industry was no secret. Several health studies in the 1980s documented adverse health effects from individuals living in travel trailers and mobile homes. By October 2005, concerned about the health consequences of formaldehyde exposures to FEMA workers, the Occupational Safety and Health Administration (OSHA) began testing for formaldehyde in FEMA temporary housing staging areas and discovered high levels of formaldehyde. But no agencies conducted testing on the actual trailers families and individuals would be living in for extended periods of time. In November 2005, Dr. Howard Frumkin, who took over as Director of the Agency for Toxic Substances and Disease Registry (ATSDR) two months earlier, seemingly recognized the health risks from the toxic chemicals being unleashed into the environment in the wake of Hurricane Katrina, including formaldehyde. But Dr. Frumkin did not link the formaldehyde to trailers at the time, but said as a result of Hurricane Katrina people faced a number of environmental health risk factors. ``In many ways,'' Dr. Frumkin told the Knight Ridder Newspapers, ``this is the major environmental health disaster of our lifetime.'' \1\ Yet, the issue of formaldehyde exposure in travel trailers never seemed to galvanize or sustain Dr. Frumkin's attention or interest. --------------------------------------------------------------------------- \1\ Seth Borenstein and Chris Adams, ``Health problems abound months after Katrina roared ashore,'' Knight Ridder Washington Bureau, 30 November 2005. --------------------------------------------------------------------------- In April 2006, after hearing of a high level of formaldehyde in one trailer, the Sierra Club began testing other FEMA trailers. It conducted 52 tests between April and August, 2006 and found that 45 of the trailers it tested had levels of formaldehyde above 0.1 parts per million, the level at which potential health effects may begin to occur. In June 2006, a Louisiana man living in a trailer who had complained of formaldehyde died. This, in combination with the Sierra Club tests and the fact that FEMA was concerned about litigation regarding the presence of elevated levels of formaldehyde in these trailers, spurred FEMA to initiate environmental testing of the trailers for formaldehyde. In June 2006, FEMA and the Environmental Protection Agency (EPA) began developing protocols for the testing of trailers. Since the immediate aftermath of Hurricane Katrina the EPA had been working with ATSDR on emergency public health incidents, including oil fires and potentially contaminated sediment. Dr. Frumkin had implemented a streamlined procedure to respond to these sorts of emergency public health calls. Federal or State agencies would contact ATSDR's Office of Terrorism Preparedness and Emergency Response (OTPER) within the Office of the Director who would assign the specific tasks to subject matter experts within ATSDR or very often to the Emergency Response Team within the Division of Toxicology and Environmental Medicine (DTEM). In this instance, Sam Coleman, Director of EPA's Region 6 Superfund Division, who had worked in the past with the Emergency Response Team contacted Scott Wright, a member of the team about assisting FEMA in testing travel trailers for formaldehyde. Scott Wright, following the normal procedure established by Dr. Frumkin, contacted Don Benken who was then Acting Director of OTPER. The first of a long series of conference calls took place in late June between FEMA, EPA and ATSDR regarding the testing of FEMA trailers. Don Benken was present on the call as well as Scott Wright and Joseph Little, from the Emergency Response Team. The calls were normally directed by Rick Preston, a trial attorney from FEMA's Office of General Counsel who was handling FEMA's litigation on the formaldehyde issue. After this first call Don Benken says that he physically walked into Dr. Tom Sinks' office and informed him that FEMA arranged the call partly because they were concerned about litigation. Dr. Sinks said that they should offer assistance in any way that they could. In the end, the test protocols called for testing 96 ``unoccupied'' trailers for levels of formaldehyde. Testing ``occupied trailers'' was deemed too difficult because of confounding lifestyle issues, such as smoking. Tobacco contains formaldehyde and could have skewed the test results, some of the participants argued. In the tests, the EPA collected environmental samples in 96 new unoccupied travel trailers in order to access the levels of formaldehyde in closed trailers and under two ventilation methods: by running the air conditioning with the bathroom vents open and by opening the windows and vents. The tests were conducted in October 2006 and the data was provided to FEMA attorney Rick Preston, who provided a CD of the test results to Scott Wright at ATSDR in November. In the letter, received by Wright in early December, Preston said: ``Please review the data and provide to us a written report of your analysis of the results of these tests and any conclusions or recommendations that can be derived therefrom.'' Preston also asked that the information and their analysis be kept confidential. The role of ATSDR was to interpret and analyze the data, make recommendations regarding the best methods to reduce formaldehyde in the trailers and determine potential health implications. February 2007 Health Consultation On December 1, 2006, Sam Coleman from the EPA sent an e-mail to Joseph Little and Scott Wright at ATSDR and cc'd Dr. Frumkin and others at EPA on the e-mail. The e-mail thanked Joe and Scott for all of their help, but then warned: ``We at EPA are concerned that FEMA might not be properly interpreting the data. We urge CDC to complete its review as soon as possible to provide appropriate advice to FEMA.'' Dr. Frumkin sent an e-mail to Joe and Scott the following day saying ``I didn't know this was happening'' and asked who at ATSDR was handling this issue. Dr. Frumkin appeared so concerned about this issue at the time that he telephoned Scott Wright on his cell phone on Wright's day off. On December 4th, Joe Little sent an e-mail to Dr. Frumkin, Dr. Sinks, and others, including Dr. De Rosa, that clearly mentions they are working with Rick Preston from FEMA's Office of General Council. Scott and Joe's evaluation looked simply at ventilation methods to reduce formaldehyde in the trailers. Opening windows and vents did substantially reduce the level of formaldehyde in the trailers, but the Health Consultation also relied on a ``level of concern'' regarding the health risks of formaldehyde of 0.3 parts per million (ppm), ten times higher than ATSDR's own Minimal Risk Level of up to one year of exposure (0.03 ppm) and three times higher than the level of exposure widely accepted by other federal agencies, including EPA, OSHA and the Consumer Products Safety Commission and international organizations to cause health effects (0.1 ppm). These health effects can include irritation of the respiratory tract, watery eyes, burning sensations in the eyes, nose and throat, nausea, coughing, chest tightness, wheezing, skin rashes, and allergic reactions. Over the long-term exposure to elevated levels of formaldehyde may be linked to cancers of the nasal sinuses, brain and leukemia. On January 8, 2007, Mike Allred, Associate Director of the OTPER presented the ``draft'' Health Consultation at Director Frumkin's normal weekly Issues Management Meeting. Dr. Frumkin told Allred that he wanted an executive summary and some conclusions. Dr. Sinks recalls seeing and editing the document at least once, although Scott and Joe say the document went through four revisions with the Director's office. Mike Allred physically carried the document from Joe and Scott to Dr. Sinks for edits. Dr. Sinks does not recall making any significant changes or corrections to the document. On February 1, 2007, the Health Consultation was completed and sent to Rick Preston, the FEMA trial attorney. The transmittal letter to the Health Consultation said: ``In summary, the opening of windows and vents was effective in reducing formaldehyde concentrations below levels of health concern.'' On February 27, 2007, the Director of ATSDR's Division of Toxicology and Environmental Medicine, Dr. Chris De Rosa became aware of the report for the first time. He immediately informed the director of ATSDR and his deputy that the report was fundamentally flawed and he drafted--on his own volition--a letter to FEMA's Rick Preston that said the February Health Consultation failed to undergo ``a policy review by our senior technical staff'' and neglected to mention that formaldehyde was a ``probable'' carcinogen, that there was no safe levels of exposure and it omitted any reference to long-term exposure or cancer risks. It concluded: ``Failure to communicate this issue is possibly misleading, and a threat to public health.'' On Monday, March 5, 2007, ``Formaldehyde in FEMA trailers'' was one of the topics of discussion at the Director's Issues Management Meeting. These meetings are not attended by Division Directors, such as Dr. De Rosa. On March 8th, Dr. De Rosa sent a second e-mail to Dr. Sinks and Dr. Frumkin, since he had not heard anything from them on his Feb. 27th e- mail, and told them that he planned to send the letter to FEMA the following day if he received no objections from them. On Friday, March 9th, Dr. Frumkin did respond to Dr. De Rosa and said he agreed with his concerns but wanted the response to FEMA coming from the same ATSDR office that originated the initial health consultation to respond. On March 17, 2007, ATSDR finally sent a letter drafted by Dr. De Rosa, but signed by the new Associate Director of the OTPER, Dr. Mark Keim, to Rick Preston at FEMA. Rick Preston told Subcommittee staff that he simply took the letter and filed it away because he believed everyone at FEMA was well aware of the risks noted in the March letter. The letter, according to Preston, was never shared with anyone else. From March onward, Dr. De Rosa continued to raise the formaldehyde issue internally. He repeatedly pushed and prodded the agency to do more and to alert the residents of the trailers, the public and Congress to the true risks of formaldehyde exposure. At the same time, FEMA was publicly using the February Health Consultation to justify maintaining the status quo and keeping people in trailers. At a Congressional hearing in mid-May 2007, FEMA Administrator David Paulison said, referring to the February Health Consultation, ``We've been told that the formaldehyde does not present a health hazard.'' During the same time-frame the media was reporting on formaldehyde linked health problems in children and others living in trailers on the Gulf Coast. Yet, the leadership of ATSDR remained silent. They did not publicly or privately correct the record, seek a ``revised'' Health Consultation or take other appropriate actions. Both Dr. Frumkin and Dr. Sinks told Subcommittee staff that they were simply unaware of media, congressional or other attention to this issue between March and the summer of 2007. They say that they wish they had done more sooner. Yet, documents obtained by the Subcommittee show that the formaldehyde issue was brought up at the Director's Issues Management Meetings at least two other times after the March 17th letter was mailed. Once on March 21st and again on May 21st in response to a CBS News report on the formaldehyde issue in FEMA trailers. Meanwhile Dr. Chris De Rosa, continued to push the agency to become more engaged on the formaldehyde issue. On June 1, 2007, Dr. De Rosa again sends an e-mail to Director Frumkin, Deputy Director Sinks and others regarding the formaldehyde issue, warning them that there is no ``safe'' level of exposure to formaldehyde. Only after a second Congressional hearing on this topic in July 2007 and a severe public critique of ATSDR's February Health Consultation did ATSDR begin to respond. Even as the agency began to respond, Chris De Rosa kept pushing to do more. In August, Dr. Frumkin placed Dr. De Rosa in charge of re-writing the February Health Consultation. He was removed from this role in September. On September 21, 2007, Dr. De Rosa wrote a blistering letter to ATSDR Director Dr. Frumkin raising his concerns that ATSDR was failing to protect the public's health on the formaldehyde and other issues. The following month, as part of his annual review, Dr. De Rosa received an ``unsatisfactory'' performance evaluation and was removed as Director of the Division of Toxicology, a post he had held with distinction for the previous 16 years. The Subcommittee considers Dr. De Rosa a whistleblower. The agency did finally publish a ``revised'' (much more complete) Health Consultation in October 2007. But the fundamental failings of the agency revealed as a result of their work on the formaldehyde issue remains a serious issue of concern. Rather than articulating a clear, concise and scientifically sound response to the formaldehyde issue from the beginning ATSDR seems to be an agency marred by confusion, lack of clear guidance and poor science from the very top of the leadership pyramid to the bottom. In February 2007, an internal ATSDR summary of the February Health Consultation said: ``In summary, the opening of windows and vents was effective in reducing formaldehyde concentrations below levels of health concern.'' In April 2007, the Director of ATSDR, Dr. Howard Frumkin sent out a personal newsletter to all staff that mentioned ATSDR's role in accessing environmental samples of formaldehyde levels in trailers that resulted in the February report. ``These data indicate that in trailers with closed windows, formaldehyde levels are similar to those found in new conventional housing,'' he wrote. The day after Congressional hearings in July 2007 on this issue, one of the two primary authors of the February report wrote: ``ATSDR emphatically stated in the conclusions that the levels of formaldehyde seen in trailers was of a Health Concern!'' It appears clear that the agency's overall ``conclusions'' were not based in scientific fact, but seemed to wax and wane with the public and congressional interest in this matter. In February 2008, a full year after ATSDR completed its initial Health Consultation on formaldehyde, Dr. Julie Gerberding, the Director of the CDC held a press conference to announce the results of new formaldehyde tests on occupied trailers. Dr. Gerberding said the tests provided a snapshot of formaldehyde levels in FEMA trailers that helped the CDC ``understand and confirm what we suspected all along,'' she said, ``that in some of these situations the formaldehyde levels are high enough where there could be a health hazard to the people who are living there.'' Because formaldehyde levels are likely to rise in the summer as the heat and humidity increase the CDC made that those in trailers ``be relocated to safer, permanent housing as quickly as possible, and certainly before the warm summer months arrive, because we want people to be as safe as they can possibly be.'' At the same news conference, FEMA administrator David Paulison said, ``The real issue is not what it will cost but how fast we can move people out.'' Remarkably, seven months earlier, on July 24, 1007, Dr. De Rosa sent an e-mail addressed to ``colleagues'' at ATSDR, including Drs. Frumkin and Sinks and 15 other employees regarding FEMA's announcement that it intended to conduct formaldehyde testing in trailers. ``Colleagues,'' wrote De Rosa, ``While testing may be warranted, what immediate interventions are being pursued thru appropriate channels to interdict exposures? Or to mitigate health impacts? I am concerned that the reported clinical signs are the harbinger of a[n] impending public health disaster.'' But no one seemed to listen. Witnesses Panel I: <bullet> Dr. Heidi Sinclair, Assistant Professor of Pediatrics, Louisiana State University, Medical Director, Baton Rouge Children's Health Program <bullet> Mrs. Lindsay Huckabee, Resident of FEMA-provided mobile home in Kiln, Mississippi from October 2005-to-present, along with her husband and five children. <bullet> Ms. Becky Gillette, Formaldehyde Campaign Director, Sierra Club Gulf Coast Environmental Restoration Task Force Panel II: <bullet> Dr. Christopher De Rosa, Former Director, Division of Toxicology and Environment Medicine, Agency for Toxic Substances and Disease Registry (ATSDR) <bullet> Dr. Meryl Karol, Professor Emerita, University of Pittsburgh, Department of Environmental & Occupational Health Panel III: <bullet> Dr. Howard Frumkin, Director, Agency for Toxic Substances and Disease Registry (ATSDR) and National Center for Environmental Health, (NCEH) <bullet> Dr. Tom Sinks, Deputy Director, Agency for Toxic Substances and Disease Registry (ATSDR) and National Center for Environmental Health, (NCEH) <bullet> Vice Admiral (ret.) Harvey E. Johnson, Jr., Deputy Administrator, Federal Emergency Management Agency (FEMA) Chairman Miller. Good morning. This hearing will come to order. Today's hearing is Toxic Trailers: Have the Centers for Disease Control Failed to Protect Public Health? The Agency for Toxic Substances and Disease Registry, ATSDR, is a constituent agency of the Centers for Disease Control and Prevention, the CDC, it is to serve the public by using the best science, taking responsive public health actions and providing trusted health information to prevent harmful exposures and disease related to toxic substances. The staff of this subcommittee has engaged in more than 100 hours of interviews and read thousands of pages of documents in preparing this morning's hearing on this matter. The ATSDR failed in its mission in producing a health consultation for the Federal Emergency Management Agency, FEMA, on the possible health consequences of formaldehyde exposure in trailers provided by FEMA to survivors of Hurricanes Katrina and Rita. ATSDR failed in what it produced in the consultation, but ATSDR's greatest failings were in what it left undone. ATSDR's failings were not just in scholarship, in academic disputation in obscure learned journals. Tens of thousands of Katrina and Rita survivors economically and politically powerless, vulnerable people, were living in the FEMA trailers. ATSDR released the consultation to FEMA on February 1 last year. The consultation concluded that formaldehyde levels in the trailers would be ``below levels of concern'' so long as the doors and windows were left open to air out the trailers. The level of concern was established at 0.3 parts per million. We will hear this morning that is a level well above the level of exposure that would likely cause adverse health consequences in sensitive people. And the report was entirely silent on the risks associated with continuous, long-term exposure to formaldehyde. In short, ATSDR issued a scientifically flawed report and failed to correct the record when they knew that the report was significantly flawed. And the result of that failure was that thousands of Americans were exposed to unsafe levels of formaldehyde fumes for a full year after the ATSDR and FEMA knew or should have known the real health risks of the formaldehyde exposure. It was not until February 13 of this year that the head of CDC, Julie Gerberding, announced that CDC was encouraging people to be moved out of the trailers as rapidly as possible. This is not an instance of lower level employees acting without the knowledge of the leadership of ATSDR or CDC. The facts are these: The analysts who did this report were approved for this task by the Deputy Director of the Agency, Dr. Tom Sinks, in July of 2006. The analysts produced a report that was then sent directly to the emergency response officials in the Directors Office. On January 8, 2007, the draft report was briefed to the Director, the Deputy Director, and the senior staff of the Director, and the briefing did not include the Division Directors that possess the technical expertise to evaluate toxicological or epidemiological studies. The Director of ATSDR was given a copy of the draft report and told Committee staff that he cannot remember whether he ever read it in January of 2007. The Deputy Director was given a copy of the draft report and remembers reviewing it at least one time. The analysts believe that review processes went through four rounds, providing comments back to the analysts on what they needed to do to improve the report. There was no process in place to guarantee that anyone else between the two analysts and the Director and Deputy Director had a chance to review the report. There was no control sheet to indicate to the Director who else had reviewed it. In most agencies this is a standard form to guarantee that a document has received the proper clearances. This whole process for moving Katrina-related consultations was established at the personal direction of the Dr. Howard Frumkin, the Director of ATSDR. In sum, there was a failure of leadership to establish effective systems to guarantee that important health, public health documents were reviewed properly and based on the best science. There was also a stunning lack of concern for how important this consultation was to thousands of American families. It appears that this consultation was, received only a cursory review by the Director's office, by the Director himself, and the Deputy Director claims only the vaguest memories of any concerns regarding the report. Another director, another official at ATSDR had a very different reaction to the formaldehyde consultation when he saw it. After the report was reviewed and approved by the Director, ATSDR sent the report to FEMA. When it was then distributed within ATSDR and landed on the desk of Dr. Chris De Rosa, the head of the Department of Toxicology and Environmental Medicine, he was appalled. He immediately e-mailed Dr. Frumkin to urge that they send a letter, ATSDR send a letter to FEMA, effectively withdrawing the report. Now, when he didn't receive a response, Dr. De Rosa sent his letter again, sent a letter draft to Dr. Frumkin and said that he would assume that unless Dr. Frumkin got back to him by the end of the next day that Dr. Frumkin intended to do nothing, and Dr. De Rosa would send the letter himself. Dr. Frumkin then agreed to have ATSDR send the letter over the signature of an official from the responsible office, in this case an official in the Director's office. ATSDR finally sent that letter on March 17, 2007. That letter read, in relevant part, ``The health consultation has been completed without a policy review by our senior technical staff. I am concerned that this health consultation is incomplete and perhaps misleading.'' This letter, like the prior consultation, was sent to the Office of Chief Counsel at FEMA, to Mr. Rick Preston, an attorney there. Mr. Preston told our staff that he simply put the letter in his file and did not mention it to anyone else at FEMA. But with that letter of repudiation, the leadership of ATSDR washed their hands of the report until awkward questions came up at a hearing by Chairman Waxman last July. In the wake of that hearing, Dr. Frumkin ordered a revised consultation posted in October, 2007, and shifted the blame for the consultation, the failings of the consultation, arguing that Dr. De Rosa, who was the one who asked the questions, the awkward questions about the report, should be removed from his position because of the poor quality of the formaldehyde health consultation. I want to make it very clear to the management of CDC and ATSDR that this committee considers Dr. De Rosa to be a whistleblower. Much of our information about this came from Dr. De Rosa originally. I have joined Chairman Gordon and Chairman Lampson in signing a letter to Dr. Gerberding expressing that position very forcefully. I think I have made it very clear that there are officials at ATSDR who should be on a professional improvement plan, a PIP in the jargon of federal employees. It isn't Dr. De Rosa, and I want to emphasize that nothing should happen to Dr. De Rosa except that he be restored to his previous position. Think back to when you were a child and you were sick. The safest place was to be at home in bed. Here we have government providing families with homes that were making children sick. Where do those children go to be safe? Where do families turn for help? The ATSDR is mandated to intervene to protect the public health, public from adverse health consequences of toxic chemicals, but in this case we find the leadership at the very top level of the agency with little interest in the actual work that was required to do that. Take a look at the testimony, the testimony from ATSDR is inspiring. It is aspirational. They say all the right words of concern and commitment, but their actions and their inactions speak much louder than their words. The Nation needs much better leadership from ATSDR and the CDC. [The prepared statement of Chairman Miller follows:] Prepared Statement of Chairman Brad Miller The Agency for Toxic Substances and Disease Registry--ATSDR--is a constituent agency of the Centers for Disease Control and Prevention (CDC). Its mission is to ``serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and disease related to toxic substances.'' The staff of this subcommittee has engaged in more than a hundred hours of interviews and read thousands of pages of documents in preparing this morning's hearing on this matter. The ATSDR failed in its mission in producing a health consultation for the Federal Emergency Management Agency--FEMA--on the possible health consequences of formaldehyde exposure in trailers provided by FEMA to survivors of Hurricanes Katrina and Rita. ATSDR failed in what it did in producing the consultation, but ATSDR's greatest failings were in what it left undone. ATSDR's failures were not just in scholarship, in academic disputation in obscure learned journals. Tens of thousands of Katrina and Rita survivors were living in the trailers. ATSDR released the consultation to FEMA on February 1, 2007. The consultation concluded that formaldehyde levels in the trailers would be ``below levels of concern'' so long as the doors and windows were left open to air out the trailers. The ``level of concern'' was established at 0.3 parts per million. We will hear this morning that is a level well above the level of exposure that would likely cause adverse health reactions in sensitive people. And the report was entirely silent on risks associated with continuous, long-term exposure to formaldehyde. In short, ATSDR issued a scientifically flawed report and failed to correct the record when they knew that the report was significantly flawed. And the result of that failure was that thousands of Americans were exposed to unsafe levels of formaldehyde fumes for a full year after ATSDR and FEMA knew or should have known the real health risks. It was not until February 13, 2008 that Julie Gerberding announced that CDC encouraged people to be moved out of trailers as rapidly as possible. This was not an instance of lower level employees acting without the knowledge of the leadership of ATSDR or CDR. The facts are these: <bullet> The analysts who did this job were approved for this task by the Deputy Director of the agency, Dr. Tom Sinks, in July of 2006; <bullet> The analysts produced a report that was then sent directly to the emergency response officials in the Director's Office; <bullet> On January 8, 2007, the draft report was briefed to the Director, the Deputy Director and the senior staff of the Director--this briefing did not include the Division Directors that possess the technical expertise to evaluate toxicological or epidemiological studies; <bullet> The Director of ATSDR was given a copy of the draft report and told Committee staff that he cannot remember whether he ever read it or not in January of 2007; <bullet> The Deputy Director was given a copy of the draft report and remembers reviewing it at least one time--the analysts believe that review process went through four rounds providing comments back to the analysts on what they needed to do to improve the report; <bullet> There was no process in place to guarantee that anyone else between the two analysts and the Director and Deputy Director had a chance to review the report; There was no control sheet to indicate to the Director who else had reviewed it in most agency's this is a standard form to guarantee that a document has received the proper clearances; <bullet> This whole process for moving Katrina-related consultations was established at the personal direction of the Director of ATSDR, Dr. Howard Frumkin. In sum, there was a complete failure by leadership to establish effective systems to guarantee that important public health documents were properly reviewed and based on the best science. There was also a stunning lack of concern for how important this consultation was to thousands of American families. It appears that this consultation received only a cursory review in the Director's office by the Director himself and the Deputy Director claims only the vaguest memories of any concerns regarding the report. Another official at ATSDR had a very different reaction to this formaldehyde consultation when he saw it. After the report was reviewed and approved by the Director, ATSDR sent the report to FEMA. Then it was distributed to some within ATSDR. When it landed on the desk of Dr. Chris De Rosa, the head of the Division of Toxicology and Environmental Medicine, he was appalled. He immediately e-mailed Dr. Frumkin to urge that they send a letter to FEMA to effectively withdraw the report. When he didn't receive a response, De Rosa resent his letter draft and said that Dr. Frumkin would have to get back to him by close of business the next day or would assume Frumkin's silence implied support and Dr. De Rosa would send the letter to FEMA himself. Frumkin then agreed to have ATSDR send the letter over the signature of an official from the responsible office--in this case an official in the Director's office. ATSDR finally sent that letter on March 17, 2007. That letter read, in relevant part, ``the Health Consultation . . . has been completed without a policy review by our senior technical staff. I am concerned that this health consultation is incomplete and perhaps misleading.'' This letter--like the prior consultation--was sent to an attorney in the Office of Chief Counsel at FEMA, Mr. Rick Preston. Mr. Preston told our staff that he simply filed the letter and did not send it to anyone else at FEMA. With that letter of repudiation, the leadership of ATSDR washed their hands of the report until awkward questions were raised at a hearing by Chairman Waxman last July. In the wake of that hearing, Dr. Frumkin ordered a revised consultation--posted in October 2007, and shifted the blame for the consultation. Dr. Frumkin argued that Dr. De Rosa--who first questioned that report--should be removed due to the poor quality of the formaldehyde health consultation. I want to make it very clear to the management at CDC that the Committee considers Dr. De Rosa to be a whistleblower. I have joined Chairmen Gordon and Lampson in signing a letter to Dr. Gerberding expressing this position very forcefully. I think I have made it clear who at ATSDR I believe would most benefit from Professional Improvement Plan and it isn't Dr. De Rosa--who has been put on one by Drs. Frumkin and Sinks. I want to emphasize that we believe that nothing is to happen to Dr. De Rosa short of restoring him to his post. Think back to when you were a child and sick. The safest place to be was at home in bed. But here we have a situation where the government has provided families with homes that are making children sick. Where do those children go to be safe? Who do their families turn to for help? ATSDR is mandated to intervene to protect the public from the adverse health consequences of toxic chemicals. But in this case we find the leadership at the very top of that agency with no interest in the actual work it would take to carry out that role. Take a look at their testimony. In inspiring tones, they utter the right words of concern and commitment, but their actions and inactions speak much louder than their words. The Nation needs better leadership from ATSDR and the CDC. Chairman Miller. Now, I would like to recognize--I will recognize Mr. Sensenbrenner of Wisconsin. Mr. Sensenbrenner. Thank you, Mr. Chairman. Today's hearing touches on some of the core issues lawmakers face in implementing policy based on science. As the former Chairman of this Full Committee and the Ranking Member of the Subcommittee, as well as being the Ranking Member of the Select Committee on Global Warming, I probably have had more experience with this intersection than most of my colleagues. How do you rely on good science to make informed decisions in the public interest? First and foremost, good decisions require good science and good scientific recommendations. The Agency for Toxic Substances and Disease Registry, which I will refer to as the ATSDR as the Chairman has, has failed us on this count. ATSDR's mission is, ``To serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and disease-related toxic substances.'' This mission is intended to serve not only lawmakers and other federal agencies but also individuals like today's witnesses. Lindsay Huckabee. Ms. Huckabee's family experienced various health problems since moving into trailers provided by the Federal Emergency Management Agency. To date, too little has been communicated about what affect the formaldehyde levels on her FEMA-provided trailer have had on her family's health. After an extensive Subcommittee investigation it appears that one of the principle failings within ATSDR is its review process. I hope to hear testimony from agency officials about that review process and how it can be strengthened in the future to prevent situations like this from occurring. Regardless of the merits of an individual scientist, good scientists requires review and contribution from various perspectives. On at least two recent instances ATSDR has proven itself incapable of sufficient review. ATSDR recently released a report entitled, ``Public Health Implications of Hazard Subjects in the 26 U.S. Great Lakes Areas of Concern.'' ATSDR began work on that report in 2002, and largely completed it by 2004. The study was reviewed by external peer reviewers and cleared for release by ATSDR in July, 2007. Days before its slated release, ATSDR's leadership withheld the report's release because, according to the agency, significant scientific concerns had come to their attention. I am convinced that those concerns are legitimate. I am, therefore, confused as to how the report cleared ATSDR's review process. Watchdog agencies and Congressional committees are justifiably concerned when a report on public health is pulled with minimal explanation days before its release. If this report was fatally flawed, why were problems not uncovered during ATSDR's two years of review before the report was cleared for release? ATSDR's initial health consultation on formaldehyde levels in FEMA trailers similarly failed the public. That consultation titled, ``Formaldehyde Sampling at FEMA Temporary Housing Units,'' dated February 1, 2007, concluded that the average concentration of formaldehyde per day in ventilated trailers after the fourth day of sampling and for the remainder of the study was below the level of concern for sensitive individuals of 0.3 parts per million. That conclusion led FEMA to believe that concentrations of formaldehyde in FEMA-provided housing units did not present a public health hazard. That was not the message the report's authors intended to convey. A competent internal review process could have determined that the consultation was potentially misleading before it was ever transmitted to FEMA. First, competent review could have determined that there were potential problems with the report's stated level of concern. The consultation does not discuss why it chose this level, nor does it discuss the problems could occur at much lower levels. The stated level was three times higher than the level used by several other government agencies and, according to many experts, above the level where many individuals will experience negative health affects. While the consultation's authors had a strong argument for choosing this level, the level should have been subject to at least some degree of internal review. The health consultation also focused exclusively on the short-term effects and failed to mention the potential long-term effects of exposure to formaldehyde and the possible risk of cancer. Dr. Christopher De Rosa, then the ATSDR's Director of the Division of Toxicology and Environmental Medicine, first read the release nearly a month after it was transmitted to FEMA. He pointed out some of the consultation's flaws and argued that as written it was perhaps misleading. On March 17, 2007, ATSDR wrote to Rick Preston in FEMA's Office of General Counsel, who had originally requested the consultation and raised these concerns. Mr. Preston, however, did not share these concerns with other officials at FEMA. For its part ATSDR took no action to immediately revise its report, nor did it raise any protests as FEMA continued to rely on the health consultation as evidence of the trailers' acceptability. A month and a half after the report was transmitted to FEMA, the report was still flawed, and the public was still uninformed. As today's hearing will make clear, far too little is known about the effects of formaldehyde and about what level should be considered problematic. Clearly, risk managers have to accept exposure to some level of formaldehyde. Suggestions that there is, ``no safe level of formaldehyde'' are simply not helpful because formaldehyde is ubiquitous. Sitting in this hearing room today we are breathing in formaldehyde. It has long been know that these levels are higher in trailers and mobile homes, both because of the material that's used and the relatively poor air exchange. But exactly what level is unacceptable is not clear. A report dated February 29, 2008, from the Centers for Disease Control titled, ``Interim Findings on Formaldehyde Levels in FEMA-Supplied Travel Trailers, Park Models, and Mobile Homes,'' provided information about formaldehyde levels in FEMA-supplied, occupied travel trailers, park models, and mobile homes that were still being used as of January of this year. This report found that the average formaldehyde concentration of these units was 77 parts per billion, well above what it termed the typical U.S. background levels of ten to 30 parts per billion. The range of concentration in tested trailers was, however, extremely broad. The lowest tested trailer registered on 3 parts per billion, well below the U.S. average, while the highest concentration measured 590 parts per billion. The interim report recommended fast action, finding that its condition supported the need to move quickly before the weather in the region warms up, to relocate residents of the U.S. Gulf Coast Region displaced by Hurricanes Katrina and Rita who still live in travel trailers, park models, and mobile homes. This recommendation is broad, sweeping, and authoritative, but it raises as many questions as it provides answers. Does the CDC recommend relocating everyone in FEMA-provided trailers, even in those trailers with formaldehyde concentrations below the typical background norms in U.S. homes? If not, what level is the appropriate level of concern? Should Americans living in trailers and mobile homes not provided by FEMA be concerned about formaldehyde levels? Do we need wide-scale testing for formaldehyde concentrations? The public will not be served by drastic action based upon limited science. Relocating individuals who are experiencing health affects is an urgent priority, but causing a panic among individuals who are perfectly safe will only result in unnecessary expense and neglect those who are actually in need. We need a clearer understanding of formaldehyde and its effects on human health before we act more broadly. As the Ranking Member of the Global Warming Committee, I know too well how science intensified under constant media exposure can lead to paranoia that seems to require immediate, wide-scale, and admittedly well-intentioned action. As policy- makers we depend on agencies to product high-quality, thoroughly-reviewed science and to provide prudent objective advice. We haven't gotten it from ATSDR and as a result we are really operating in the blind in terms of what our response should be to this problem. And I thank the Chair for indulging me to speak for more than five minutes. [The prepared statement of Mr. Sensenbrenner follows:] Prepared Statement of Representative F. James Sensenbrenner Jr. Today's hearing touches some of the core issues lawmakers face in implementing policy based on science. As the former Chairman of the Science Committee, the Ranking Member on this subcommittee, and the Ranking Member on the Select Committee on Global Warming, I have had more experience with this intersection than most. How do you rely on good science to make informed decisions in the public's interest? First and foremost, good decisions require good science and good scientific recommendations. The Agency for Toxic Substances and Disease Registry (ATSDR) has failed us on this count. ATSDR's mission is ``to serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and disease related to toxic substances.'' This mission is intended to serve not only lawmakers and other Federal agencies, but also individuals like today's witness, Lindsay Huckabee. Ms. Huckabee's family has experienced various health problems since moving into trailers provided by the Federal Emergency Management Agency's (FEMA). To date, too little has been communicated about what affect the formaldehyde levels in her FEMA-provided trailer have had on her family's health. After an extensive Subcommittee investigation, it seems clear that one of the principle failings within ATSDR is its review process. I hope to hear testimony from agency officials about that review process and how it can be strengthened in the future. Regardless of the merits of an individual scientist, good science requires review and contribution from various perspectives. On at least two recent instances, ATSDR has proven incapable of sufficient review. ATSDR recently released a report titled, Public Health Implications of Hazardous Substances in the Twenty-Six U.S. Great Lakes Areas of Concern. ATSDR began work on that report in 2002 and largely completed it by 2004. The study was reviewed by external peer reviewers and cleared for release by ATSDR in July, 2007. Days before its slated release, ATSDR's leadership withheld the report's release because, according to the agency, significant scientific concerns had come to their attention. I am convinced that these concerns are legitimate. I am therefore confused as to how the report cleared ATSDR's review process. Watchdog agencies and Congressional Committees are justifiably concerned when a report on public health is pulled with minimal explanation days before its release. If this report was so fatally flawed, why were problems not uncovered during ATSDR's two years of review before the report was cleared for release? ATSDR's initial health consultation on formaldehyde levels in FEMA trailers similarly failed the public. That consultation titled, Formaldehyde Sampling at FEMA Temporary Housing Units, dated February 1, 2007, concluded that: The average concentration of formaldehyde per day in [ventilated trailers], after the fourth day of sampling and for the remainder of the study, was below the level of concern for sensitive individuals of 0.3 parts per million. That conclusion led FEMA to believe that concentrations of formaldehyde in FEMA-provided housing units did not present a public health hazard. This was not the message the report's authors intended to convey. A competent internal review process should have determined that the consultation was potentially misleading before it was ever transmitted to FEMA. First, competent review could have determined that there were potential problems with the report's stated ``level of concern.'' The consultation does not discuss why it chose this level, nor does it suggest that problems could occur at much lower levels. The stated level was three times higher than the level used by several other government agencies and, according to many experts, above the level where many individuals will experience negative health effects. While the consultation's authors had a strong argument for choosing this level, the level should have been subject to some degree of internal review. The health consultation also focused exclusively on short-term effects and failed to mention the potential long-term effects of exposure to formaldehyde and the possible risk of cancer. Dr. Christopher De Rosa, then ATSDR's Director of the Division of Toxicology and Environmental Medicine, first read the release nearly a month after it was transmitted to FEMA. He pointed out some of the consultation's flaws and argued that, as written, it was ``perhaps misleading.'' On March 17, 2007, ATSDR wrote to Rick Preston in FEMA's Office of the General Counsel, who had originally requested the consultation, and raised these concerns. Mr. Preston did not, however, share these concerns with other officials at FEMA. For its part, ATSDR took no action to immediately revise its report nor did it raise any protests as FEMA continued to rely on the Health Consultation as evidence of the trailer's acceptability. A month and half after the report was transmitted to FEMA, the report was still flawed and the public was still uninformed. As today's hearing will make clear, far too little is known about the effects of formaldehyde and about what levels should be considered problematic. Clearly, risk managers have to accept exposure to some level of formaldehyde. Suggestions that there is ``no safe level'' of formaldehyde are simply not helpful because formaldehyde is ubiquitous. Sitting in this hearing room today, we are breathing in formaldehyde. It has long been known that these levels are higher in trailers and mobile homes both because of the materials used and the relatively poor air exchange. But exactly what level is unacceptable is unclear. A report dated February 29, 2008 from the Centers for Disease Control (CDC), titled Interim Findings on Formaldehyde Levels in FEMA- Supplied Travel Trailers, Park Models, and Mobile Homes, provided information about formaldehyde levels in FEMA-supplied occupied travel trailers, park models, and mobile homes that were still being used as of January 2008. This report found that the average formaldehyde concentration of these units was 77 parts per billion, well above what it termed the typical U.S. background levels of 10-30 parts per billion. The range of concentrations in tested trailers was, however, extremely broad. The lowest tested trailer registering only three parts per billion, well below the U.S. average, and the highest concentration measured 590 parts per billion. The Interim Report recommended fast action. Finding that its conclusions ``support[ed] the need to move quickly, before weather in the region warms up, to relocate residents of the U.S. Gulf Coast region displaced by Hurricanes Katrina and Rita who still live in travel trailers, park models, and mobile homes.'' This recommendation is broad, sweeping, and authoritative, but it raises as many questions as it provides answers. Does CDC recommend relocating everyone in FEMA-provided trailers, even those in trailers with formaldehyde concentrations below the typical background norms in U.S. homes? If not, what level is the appropriate level of concern? Should Americans living in trailers and mobile homes not provided by FEMA be concerned about formaldehyde levels? Do we need wide-scale testing for formaldehyde concentrations? The public will not be served by drastic action based on limited science. Relocating individuals who are experiencing health effects is an urgent priority, but causing a panic among individuals who are perfectly safe will only result in unnecessary expense and neglect of those actually in need. We need a clearer understanding of formaldehyde and its effects on human health before we act more broadly. As Ranking Member on the Global Warming Committee, I know too well how science, intensified under constant media exposure, can lead to paranoia that seems to require immediate, wide-scale action. As policy-makers we depend on agencies to produce high quality, thoroughly reviewed science and to provide prudent, objective advice. Chairman Miller. I thank you, Mr. Sensenbrenner, and I appreciate your going more over your time than I went over my time, making me look better by comparison. I now ask unanimous consent that all the additional opening statements or any additional opening statements be included in the record. Without objection, it is so ordered. [The prepared statement of Chairman Gordon follows:] Prepared Statement of Chairman Bart Gordon The country depends on the Agency for Toxic Substances and Disease Registry to warn of health dangers that come with exposure to chemicals. In the wake of Hurricanes Katrina and Rita, hundreds of thousands of Americans found themselves placed in mobile homes and travel trailers as semi-permanent housing. Formaldehyde has historically been found at higher levels in this kind of manufactured housing than in traditional construction. It should come as no surprise then that within months of families being placed in these trailers, some complaints about sicknesses--nose bleeds and asthma-like symptoms most prominently--began to filter back to FEMA. The people in these trailers include the most vulnerable among us-- children, the elderly, the handicapped. Many of these are people who were really stuck in the trailers twenty-four hours a day, seven days a week. Children and babies breath faster than adults and are less able to process formaldehyde so it builds up in their bodies faster than in adults. These are the same populations that you might expect to be most sensitive to formaldehyde--lower levels of exposure triggering stronger health reactions. These are the very segments of the public that we most expect the government to act to protect. In the summer of 2006, ATSDR began working with the Environmental Protection Agency and FEMA to develop a test protocol to examine formaldehyde in trailers. The ATSDR leadership was aware of this effort. They did not assign their top formaldehyde or toxicology people to this task. Rather, they left it to two emergency response staff with no special training on formaldehyde. Those staffers then analyzed the data that came back from the EPA testing, and they produced a report that went directly to the Director and Deputy Director for review through the Director's Office of Terrorism Preparedness and Emergency Response. Apparently neither the Director nor Deputy Director asked any questions about how the report was produced or who else had seen it. Their memories of dealing with that report are vague on what they knew, what they saw, what they said or what they did. However, they must have approved the report because it went to FEMA on February 1, 2007. The report suggests that if people just open windows and doors of their trailers, they can keep formaldehyde levels below ``levels of concern'' regarding health effects. But as we know, another round of testing and more careful analysis by another office at the CDC, led to a very different conclusion from the same agency. In February of 2008 the CDC announced that people should be moved out of these trailers as quickly as possible. Getting it wrong in February of 2007 consigned tens of thousands of Americans to a year in unhealthful housing. That hardly sounds like the public health was well served. Our review of the way the original formaldehyde Health Consultation was handled demonstrates a complete managerial collapse at ATSDR. The wrong people were assigned to write it under the Katrina emergency consultation process set up by the Director. Then the wrong people reviewed the report--in this case those people consist solely of the Director and Deputy Director of the agency. When the mess is made apparent to the Director, he does virtually nothing to correct the situation. Only when the mess becomes more public do the leaders of the agency swing into action to issue a corrected consultation and shift blame to others. Among those blamed for the poor original consultation was Dr. Chris De Rosa. Ironically, it was Dr. De Rosa that first brought problems with the report to the attention of the Director of ATSDR, Dr. Frumkin. He continued to push on the health conditions in trailers and other matters throughout 2007. His reward for these efforts was to be blamed for the failed health consultation and removed from his post as director of the Division of Toxicology and Environmental Medicine--a job he had held for 16 years. The Science and Technology Committee consider Dr. De Rosa a whistleblower. He sought to repeatedly raise the alarm within the corridors of the CDC that a public health disaster was unraveling before them. I strongly believe that raising the alarm on a critical public health issue that has impacted thousands of individuals should be rewarded not punished. I trust that we will receive assurances today from Dr. Frumkin that retaliation against Dr. De Rosa will cease, and that he will be recognized for his efforts to fulfill the mission of ATSDR ``to serve the public'' by ``taking responsive public health actions [in order] to prevent harmful exposures and disease related to toxic substances.'' [The prepared statement of Mr. Lampson follows:] Prepared Statement of Representative Nick Lampson Science is not supposed to take politics or ``broad implications'' into account. It is supposed to provide us with reliable facts-- truths--about our environment. It is a sad day in this country when our government and its agencies and scientists let politics determine ``scientific'' results and guidelines. And it is a shame that our nation's scientists whom we entrust with public health and safety are more worried about politics more than science and the health of the people we are all sworn to protect. The victims of Hurricane Katrina suffered one tragedy at the mercy of mother nature and another at the mercy of their own government and of science--the one thing that should never provide tainted results or harm. The leaders of these agencies should swear allegiance first to the scientific process and secondly to whomever their bosses may be. Unfortunately only Dr. De Rosa upheld that standard in this situation, and we thank him for his unwavering commitment to the truth and honesty. Despite mounting evidence it seems that the agencies involved are still unwilling to accept the broader implications of their actions. The men and women and children that were in FEMA's care will suffer the rest of their lives, and maybe even their children and grandchildren will bear the burden of FEMA and the CDC's inaction and willingness to throw scientific fact out of the window. The way we are told societies should be judged is based on how they treat their most vulnerable. I for one am ashamed of how we have treated our fellow Americans in their greatest time of need. Chairman Miller. I also ask unanimous consent to enter into the record documents that have been collected by the Subcommittee during the course of work on this matter, and those documents have already been provided to the Minority. Without objection, so ordered. [The information appears in Appendix: Additional Material for the Record.] I now would like to introduce our witnesses, our first panel today. Our first witness is Dr. Heidi Sinclair. Dr. Sinclair is Assistant Professor of Pediatrics at Louisiana State University and is the Medical Director of the Baton Rouge Children's Health Program. Ms. Lindsay Huckabee lived with her husband and five children in a FEMA-provided mobile home in Kiln, Mississippi, from October, 2005, until just last month. Mr. Sensenbrenner. Will the gentleman yield? Chairman Miller. Yes. Mr. Sensenbrenner. We know all about Kiln, Mississippi, because of your favorite son. You tell him he ought to go back to work. That is Brett Farve. Chairman Miller. The Ranking Member agreed earlier that all sports analogies would be college basketball, but I think the early exit of the University of Wisconsin has changed his view. Our last witness is Ms. Becky Gillette, the Formaldehyde Campaign Manager for the Sierra Club Gulf Coast Environmental Restoration Task Force. Welcome to all of our witnesses. You will have five minutes for your spoken testimony. Your written testimony will be included in the record for the hearing. When you all complete your testimony, we will begin with questions, and each Member will have five minutes to question the panel. It is the practice of this subcommittee to take testimony under oath. Do any of you have any objection to being sworn in? If not, oh, you may also be represented by counsel. Is anyone here represented by counsel? Now, would you please stand and raise your right hand? [Witnesses sworn] Chairman Miller. All the witnesses affirmed that they would tell the truth. Dr. Sinclair, please begin. Panel I: STATEMENT OF DR. HEIDI SINCLAIR, MEDICAL DIRECTOR, BATON ROUGE CHILDREN'S HEALTH PROJECT; ASSISTANT PROFESSOR, DEPARTMENT OF PEDIATRICS, LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER Dr. Sinclair. Good morning. Thank you, Chairman Miller and Congressman Sensenbrenner, for inviting me to testify today. My name is Dr. Heidi Sinclair with the Louisiana State University Health Science Center (LSUHSC). The views expressed herein do not reflect the views and opinions of LSUHSC. I am here today as a community pediatrician and advocate for vulnerable children. I, too, was displaced by Hurricane Katrina. I relocated to Baton Rouge in June of 2006, to accept the position of Medical Director of the Baton Rouge Children's Health Project, established post-Katrina by the Children's Health Fund in collaboration with LSU pediatrics in Baton Rouge. Our project's mobile medical units have provided comprehensive medical and mental health care to over 400 children and families displaced to the Baton Rouge area. As FEMA trailer group sites were being established, a number of concerns were expressed regarding the safety and suitability of both the travel trailers and the group sites themselves. We were concerned then as we are now that people living in these trailers are continually being exposed to formaldehyde, which is most readily absorbed through the respiratory tract by breathing. Symptoms associated with formaldehyde exposure include sinus irritation, respiratory problems, skin rashes, eye irritation, nausea and stomach aches, as well as neurological problems such as headaches, fatigue, depression, insomnia, and difficulty concentrating. Since we began seeing patients at the FEMA trailer villages, presenting problems have included many symptoms consistent with formaldehyde exposure. While ATSDR lists 0.008 parts per million or eight parts per billion as minimal risk level for long-term formaldehyde exposure, it is important to emphasize that much remains unclear about formaldehyde. Most human studies have been limited to adult occupational exposure. Children, however, are more likely to be affected by even low- level exposure to formaldehyde in their living environment because they generally spend more time at home, have a higher respiratory rate, have a greater surface to mass ratio, are closer to the ground and formaldehyde concentrations are higher closer to the ground, and have immature metabolic systems that may not enable them to clear absorbed formaldehyde as quickly as adults. There are also concerns about possible long-term consequences of formaldehyde exposure, which include changes to the immune system that can increase allergic responsiveness in general, possible reproductive or developmental toxicity, an increased risk of nasal and nasal-pharyngeal carcinomas and possibly lung cancer, throat cancer, or blood disorders. Following reports in 2006 of elevated formaldehyde in the Mississippi Gulf Coast area travel trailers, I discussed concerns regarding formaldehyde in travel trailers in our area with colleagues at the Office of Public Health, the Children's Health Fund, and elsewhere. The Health Consultation, ``Formaldehyde Sampling at FEMA Temporary Housing Units, released by ATSDR in February of 2007, added confusion regarding what might be considered safe levels of formaldehyde. In this report, 0.3 parts per million or 300 parts per billion was chosen as the level of concern. This level, however, is nearly 40 times higher than what is established by the ATSDR as minimal risk level for long-term exposure. Misinterpretations of this study and other misconceptions may have served to minimize understanding of the possible exposure risks to those living in travel trailers in our area. In July, 2007, FEMA announced that they would work with CDC to test occupied travel trailers. I contacted the CDC and learned that the testing would be random, residents would not be able to request to have their trailer tested, it was unclear if individual results were going to be given to residents, and the actual study start date was unknown. The Sierra Club provided our project with a few test kits. All of the tests were elevated with seven of the eight trailers testing between 100 and 300 parts per billion, ten to 25 times above ATSDR's minimal risk level for long-term exposure and at least five times above levels often present in conventional homes. A summary of this testing sample was shared with persons with the Office of Public Health, the Children's Health Fund, and others. I was contacted in the summer and fall of 2007, by CDC representatives and participated in a phone conference with CDC representatives regarding their upcoming study on occupied travel trailers. ATSDR's October, 2007, update and revision seems to be an effort to clarify that their February FEMA consultation was not meant to imply that formaldehyde levels in the travel trailers were safe for long-term occupancy. This update also mentions concerns of CDC, NCEH, ATSDR, and EPA representatives as early as July, 2006, that the study requested by FEMA, ``could not be generalized and applied to occupied trailers in the Gulf Region.'' In summary, I would like to share my conclusions and recommendations. First, I am glad that FEMA acknowledged that travel trailers are designed for short-term recreational use and are not intended for housing. I recommend that FEMA more actively involve local government, non-profits, and family and child advocates in planning safe and appropriate housing options for displaced families. Second, I am surprised that the CDC did wait so long to initiate formaldehyde testing of occupied travel trailers given the stated concerns of some of their own representatives as early as July 2006, and given reports by ATSDR in February of 2007, that cited formaldehyde levels so greatly above their own defined minimal risk level for long-term exposure. Third, formaldehyde exposure is just one of many problems being faced by families displaced by Hurricanes Katrina and Rita. It is unacceptable that so many families must endure uncertainty and concerns regarding their exposure to elevated levels of formaldehyde in addition to daily anxieties and stresses of displacement. Fourth, as FEMA works with local agencies to find more appropriate and safe housing solutions for families, we recommend that coordinated efforts be made to prevent any further disruption and endangerment. Finally, I recommend that the CDC consider expanding their proposed child health study to a wider sample of children displaced, affected by Hurricane Katrina. I look forward to contributing to such a study in any way I might be able. Thank you. [The prepared statement of Dr. Sinclair follows:] Prepared Statement of Heidi Sinclair Good morning. Thank you for this opportunity to testify today before the Committee on Science and Technology. My name is Dr. Heidi Sinclair, Assistant Professor of Pediatrics with the Louisiana State University Health Sciences Center (LSUHSC) and Medical Director of the Baton Rouge Children's Health Project. I am here today at the request of the Committee on Science and Technology as a health care provider, community pediatrician, and advocate for vulnerable children. The views expressed herein do not reflect the views and opinions of LSUHSC. Background I was living in New Orleans at the time of Hurricane Katrina and relocated to Baton Rouge in June of 2006 to accept the position of Medical Director of the Baton Rouge Children's Health Project, a unique and innovative partnership of LSU Pediatrics in Baton Rouge and The Children's Health Fund. The Children's Health Fund is committed to providing health care to the Nation's most medically under-served children and their families through the development and support of primary care medical programs such as the Baton Rouge Children's Health Project. Our project, established the fall of 2006, has two professionally staffed mobile medical units, ``doctors' offices on wheels,'' providing comprehensive primary pediatric medical and mental health care through 4,968 encounters to over 400 children and families displaced to the Baton Rouge area. Services are provided weekly or bimonthly at a number of FEMA group sites. Prominent among these is Renaissance Village, the largest FEMA trailer village in Louisiana with nearly 600 travel trailers and estimates of 1,500 to 2,100 residents at peak. Formaldehyde Exposure and FEMA Trailer Sites As FEMA trailer group sites were established and families were moved into these travel trailers, a number of concerns were expressed regarding the safety and suitability of both the travel trailers and the group sites themselves. Regarding formaldehyde, a colleague initially raised concerns to the Children's Health Fund and to Louisiana congressional staff during a legislative visit in May of 2006. We were concerned then as we are now that people living in these trailers are continually being exposed to formaldehyde, which is most readily absorbed through the respiratory tract (by breathing), with most exposures occurring through inhalation, and skin or eye contact. Indoors, a major source of formaldehyde is off-gassing from particle board and urea-foam insulation. Symptoms The most common associated symptoms of formaldehyde exposure include neurological problems, such as headaches, depression, and insomnia as well as skin rashes, eye irritation, sinus problems, recurrent colds and nose-bleeds. Long-term consequences can include changes to the immune system and development of certain cancers. Since we began seeing patients at the FEMA trailer villages, the most common presenting problems have, in fact, included: skin rashes, sinus problems and recurrent colds, headaches, fatigue, depression, insomnia and attention deficits. Some patients also have recurrent nose-bleeds, stomach aches, nausea, eye irritation and respiratory problems. All of these symptoms are consistent with formaldehyde exposure. These symptoms admittedly are non-specific and not uncommonly encountered in a general pediatric population. However, formaldehyde cannot be ruled out as a contributing factor, even when considering the FEMA trailer park population's association with stress, poor nutrition, and exposure to other allergens such as mold or irritants. Exposure Levels While the Agency for Toxic Substances and Disease Registry (ATSDR) lists 0.008 ppm (8 ppb) as minimal risk level for long-term (>365 day) formaldehyde exposure, it is important to emphasize that much remains unclear about formaldehyde. Some persons, for example, will experience symptoms at levels as low as 0.05 ppm while others will have no symptoms even at much higher levels. Most studies of human exposure to formaldehyde have reviewed adult, acute high level or 8-10 hour occupational exposure--there have been fewer studies on health effects of elevated indoor air levels of formaldehyde in homes, and almost no studies of its effects on children. Formaldehyde and Children Nonetheless, children, particularly the youngest, are more likely to be affected by even low-level exposure to formaldehyde because they: <bullet> Spend more time at home; <bullet> Have a higher respiratory rate; <bullet> Have a greater surface to mass ratio (thus would be expected to absorb more formaldehyde); <bullet> Are closer to the ground (formaldehyde gas is heavier than air and thus at higher concentrations closer to the ground); and <bullet> Have an immature metabolic system that may not enable them to metabolize and clear absorbed formaldehyde as quickly as in adults. Therefore, when approaching these issues, it is probably best to say that there is NO acceptable level of formaldehyde exposure that is safe for children. Long-Term Exposure Beyond the immediate symptoms, there are concerns about possible long-term consequences of formaldehyde exposure. <bullet> Formaldehyde sensitization has been associated with changes to the immune system (increased IgE, altered T-cell cytokine secretion) that can increase allergic responsiveness in general; <bullet> Formaldehyde is genotoxic--causing rearrangement of chromosomes and breakage of sister chromatids; <bullet> Formaldehyde is listed as a carcinogen or probable carcinogen by a number of national and international organizations; and <bullet> Formaldehyde has most closely been correlated with increased risk of nasal and nasal-pharyngeal carcinomas but may also be associated with lung cancer or blood disorders. Homeland Security cites a study of mobile home residents exposed to formaldehyde above 0.10 ppm (100 ppb) for 10 years indicating a statistically significant increase in the risk of throat cancer. Timeline of Concern and Agency Contact In the summer and fall of 2006, I followed reports coming from the Mississippi Gulf Coast of families living in FEMA travel trailers who were experiencing more alarming adverse events such as daily profuse nose-bleeds, severe respiratory problems, and pet illnesses. In May 2006, the Sierra Club released a report of elevated levels of formaldehyde in 30 of 32 travel trailers they tested in the Gulf Coast. I felt it would be worthwhile to check the formaldehyde levels in some of the travel trailers in our area. I discussed my concerns informally with colleagues at the Office of Public Health and elsewhere. The general consensus was that formaldehyde off-gassing should only be a problem in new travel trailers. As our families had been occupying these travel trailers for over a year, it was assumed formaldehyde off-gassing should no longer be a problem. Secondly, the travel trailers at Renaissance Village were manufactured before Katrina. It was felt that they should not have the same problems with elevated levels of formaldehyde as those in the Mississippi Gulf Coast which were put together quickly after Katrina. The Health Consultation of Formaldehyde Sampling at FEMA Temporary Housing Units released by the ATSDR in February of 2007 only added to the confusion regarding what might be considered ``safe'' levels of formaldehyde in occupied travel trailers. In this report, 0.3 ppm (300 ppb) was chosen as the ``level of concern.'' This level (0.3 ppm) was reportedly selected as it is an effect level associated with acute narrowing of the bronchi in sensitive individuals. However, this level is nearly forty times higher than what is established by ATSDR as ``minimal risk level'' (0.008 ppm or 8 ppb) for long-term (> 365 days) exposure. At this time, community members felt that this was an issue for FEMA to investigate and accept accountability for. Every few months, when the formaldehyde issue reappeared in the media, rumors would circulate that FEMA would be testing the travel trailers. On these occasions, I contacted Mr. Manuel Broussard, FEMA Public Relations in Baton Rouge, who would clarify that FEMA was not planning to test occupied travel trailers. Mr. Broussard also put me in touch with Ms. Gail Tate, FEMA Interagency Coordinator, who affirmed that FEMA's plan was to continue working towards relocating trailer residents rather than to offer testing. After last year's Congressional hearings and FEMA's announcement in July of 2007 that it would work with the CDC to test occupied travel trailers, many trailer residents believed that this testing was imminent and they would be able to request to have their trailer tested. In fact, FEMA released a press statement in July 2007 that testing would begin on Tuesday, July 24, 2007. In order to better inform concerned patients, I contacted the CDC for clarification and learned that the CDC needed time to design a study and that the testing of the travel trailers would be random: residents would not be able to request to have their trailer tested; it was unclear if individual results were going to be given to those residents whose trailers were tested; and the study start date was unknown. There was a fear, warranted or not, among both residents and service providers, of possible reprisals from FEMA if people complained about formaldehyde or initiated testing of travel trailers independently. On my request, the Sierra Club provided our project with a few test kits and assisted me with installing and collecting these testers, following up with the families to review test results, and in advising families on measures they might take to reduce their exposure to formaldehyde. This sample of trailers tested approximately ten to twenty-five times above ATSDR's ``minimal risk level'' for long-term exposure and at least five times above levels often present in conventional homes.\1\ Only one of the eight measured less than 0.1 ppm--the other seven tested between 0.1-0.3 ppm (100-300 ppb). --------------------------------------------------------------------------- \1\ It is not unusual for conventional homes to have indoor formaldehyde concentration levels of 0.01 to 0.02 ppm (10-20 ppb). --------------------------------------------------------------------------- While maintaining confidentiality on the request of the families involved, the summary of this testing sample was shared with persons with the Office of Public Health, the Children's Health Fund and others. The Children's Health Fund has provided us with additional testers and we have recently been offering this testing to concerned families who have not yet had their trailers tested by the CDC or others. I was contacted first in late summer/early fall of 2007 by representatives from the CDC. One gentleman called me to give me the contact information for Allison Stock, Ph.D., MPH, Team Leader, Air Pollution Team, CDC/NCEH. I also spoke on a number of occasions with La Freta Dalton, Senior Health Communication Specialist, CDC/ATSDR, and participated in a phone conference with CDC representatives regarding their upcoming study. In the fall of 2007, Allison Stock and I exchanged a number of e-mails and attempted to arrange a phone conference regarding CDC's contract with FEMA to test occupied travel trailers but I do not believe we ever actually spoke in person. ATSDR's October 2007 Update and Revision of the February report on Formaldehyde Sampling of FEMA Temporary-Housing Trailers clarified that ``the exposure scenarios examined by the sampling were not intended to represent those that people living in trailers would experience,'' and concludes that ``long-term exposures, even at lower level increase the possibility of cancer or reproductive or developmental toxicity'' and removed language defining any set ``level of concern.'' This update also mentions concerns of CDC/NCEH, ATSDR and EPA representatives as early as July 2006 that the study requested by FEMA ``could not be generalized and applied to occupied trailers in the Gulf region.'' Conclusions The Committee asked me to address, ``what do (I) believe the Federal Government, particularly the ATSDR, could have or should have done regarding the formaldehyde issue.'' First, I am glad that FEMA acknowledged that recreational vehicles, such as the travel trailers used so extensively post-Katrina, are not regulated by HUD and are designed for short-term recreational use and are not intended for housing. FEMA has accordingly announced that it will no longer offer recreational vehicles as a temporary housing option after future disasters. I recommend that in the aftermath of future disasters, FEMA will more actively involve local government, non-profits, and family and child advocates in planning safe and appropriate housing options for displaced families. Second, I am surprised that the CDC waited so long to initiate formaldehyde testing of occupied travel trailers given the stated concerns of some of their own representatives as early as July 2006 and given the reports by ATSDR in February of 2007 that cited formaldehyde levels greatly above their own defined ``minimal risk level'' for long- term exposure. At the recent public forum in Baker, Louisiana, on CDC's recently released study, I was shocked by the statement of the representative present that the CDC was not aware there was a potential problem with elevated levels of formaldehyde in the travel trailers until July of 2007. Third, formaldehyde exposure is just one of the many problems being faced by families displaced by Hurricanes Katrina and Rita. People are still struggling with fractured support systems, loss of property, sense of self, income, community and loved ones, stigma, unstable living situations, transportation problems, and difficulty accessing quality health care and child care. It is unacceptable that many families must endure uncertainty and concerns regarding possible short and long-term effects of on-going exposure to elevated levels of formaldehyde in addition to the daily anxieties and stresses of displacement. Fourth, as FEMA works with local agencies to find more appropriate and safe housing solutions for families, we recommend that coordinated efforts be made to prevent any further disruption and endangerment of families. While priority is being placed on removing families from their potentially toxic living environment, consideration must also be given to families' very real educational, employment, child care, health care and transportation needs. Children and families must not be forced to move from one difficult environment to another. Finally, I recommend that the CDC consider expanding their proposed child health study to a wider sample of children displaced/affected by Hurricane Katrina and look forward to contributing to such a study in anyway I might be able. Thank you. References Agency for Toxic Substances and Disease Registry, Formaldehyde (HCHO) CAS 50-00-0; UN 1198, UN 2209 (formalin). Agency for Toxic Substances and Disease Registry, Health Consultation, Formaldehyde Sampling at FEMA Temporary Housing Units, Baton Rouge, LA, February 1, 2007. FEMA: Statement of Administrator R. David Paulison, HQ-No: 07-143, July 20, 2007. FEMA: Interim Direction on use of Temporary Housing Units, July 31, 2007. FEMA: CDC Releases Results of Formaldehyde Level Tests, Release Number: HQ-08-021, February 14, 2008. Flynn, Elizabeth, MD; Matz, Paul, MD; Woolf, Alan, MD; Wright, Robert, MD, MPH; Indoor Air Pollutants Affecting Child Health, American College of Medical Toxicology, November 2000. Homeland Security: Background Health Information on Formaldehyde, July 23, 2007. Mendell, M.J., Indoor residential chemical emissions as risk factors for respiratory and allergic effects in children: a review, Indoor Air 2007:17:259-277. Sierra Club: Testing By Sierra Club Shows Abnormal Levels of Formaldehyde in FEMA Trailers, May 16, 2006. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry, An Update and Revision of ATSDR's February 2007 Health Consultation: Formaldehyde Sampling of FEMA Temporary-Housing Trailers, Baton Rouge, LA, September-October, 2006, October 2007. Biography for Heidi Sinclair Post Graduate Medical Training Louisiana State University--July 2000-July 2004 New Orleans, LA Residency, Internal Medicine/Pediatrics Medical Education Tulane University School of Medicine--Aug. 1996-May 2000 New Orleans, LA MD Post Graduate Education Tulane University School of Public Health--June 1997-May 2000 and Tropical Medicine New Orleans, LA MPH, Tropical Medicine Undergraduate Education University of Pittsburgh--May 1993-May 1995 Pittsburgh, PA Post-Baccalaureate University of California, Berkeley--Aug. 1987-May 1990 Berkeley, CA BA, South Asian Studies Medical Licensure Louisiana State Board of Medical Examiners Medicine and Surgery L#025106 DEA #BS8964505 Board Certification Pediatrics--Oct. 2004 Board Certification Internal Medicine--Dec. 2006 Work Experience Louisiana State University--June 2006-present Health Sciences Center Baton Rouge, LA Department of Pediatrics Assistant Professor As Medical Director of the Baton Rouge Children's Health Project, responsible for direct clinical care of children and families served by the medical mobile unit as well as supervision of staff and coordinating mobile medical and mental health services as part of LSUHSC Department of Pediatrics and the Children's Health Fund's national network of mobile pediatric care providers. Louisiana State University--Aug. 2004-June 2006 Health Sciences Center New Orleans, LA Department of Pediatrics, Ambulatory Division Assistant Professor As Medical Director of Bridge City Center Youth, responsible for clinical care of youth in custody of Bridge City Center for Youth, supervision of 24 hour on-site clinical nursing services, supervision of on-site pharmaceutical and dental service and coordinating youth care with Office of Youth Development. Other clinical responsibilities have included providing clinical services and Pediatric resident and student supervision at UNO Student Health Clinic, New Orleans Adolescent Hospital and Level 1 Well-Baby Nursery at University Hospital, LSUHSC-New Orleans. Other administrative responsibilities have included assisting in developing lectures and rotations in conjunction with the Adolescent Medicine division. Louisiana State University School of Public Health--Oct. 2004-June 2006 New Orleans, LA Adjunct Assistant Professor Juvenile Justice Program Medical Director, Bridge City Center for Youth Participation in on-going program evaluation and monitoring, education and program development in conjunction with LSU Juvenile Justice Program. Americorps/VISTA--Aug. 1995-Aug. 1996 Beaumont, Texas Project Supervisor, Henry's Place Implemented community project to set-up drop-in day center for mentally-ill homeless, recruited, trained and managed volunteers, counseled and provided referrals to center guests, supervised daily activities of Henry's Place. University of Pittsburgh--1993-1994 Athletic Support Services Pittsburgh, PA Math and Science Tutor Caring Teachers, English Arts--1992-1993 Makuhari, Japan Developed curriculum, taught conversational English to children and adults using creative and interactive methods. Transworld Teachers--1991 San Francisco, CA Trainee, Student Teacher Volunteer Experience Common Ground Clinic--Oct. 2005-May 2006 Clinical Care Provider After hours clinical service and supervision of volunteer medical service providers: nurses, medical students and nurse practitioners. Covenant House Student Clinic--Aug. 2004-June 2005 Staff MD Oversight of LSU medical student volunteer adolescent medicine clinic in rotation with fellow LSUHSC Pediatric faculty. Community Medicine Interest Group--1997-2000 Co-Founder, Treasurer New Orleans, LA Sponsored talks by representatives from Department of Health and Human Services, Medicaid/Medicare, Health Care for the Homeless, St. Thomas Clinic, Adolescent Drop-in Center and on loan repayment, alternative medicine, midwifery, HIV, prison health care, and international medicine. Sierra Club, Inner City Outings--1996-1999 Trip Leader, Volunteer Recruitment New Orleans, LA Organized and led outdoor trips for urban youth in association with Gert-Town Resource Center and the Pediatric AIDS Program. Fundraising. New Orleans Center for Science and Math--1996-1997 Math and Science Tutor New Orleans, LA Participated in Saturday morning tutoring program for high school students from New Orleans Center for Science and Math. Western Psychiatric Institute and Clinic--1993-1994 Remedial Math Tutor Pittsburgh, PA Taught basic money management and math skills to clinic outpatients. Calcutta Rescue--1993/1988 Clinic Volunteer Calcutta, India General medical assistance. Research Experience Tulane Infectious Diseases Section--1997-1999 Student Researcher New Orleans, LA In association with Health Care for the Homeless: to document the prevalence of tuberculosis infection and active disease, the effectiveness of a centralized directly observed preventative treatment (DOPT) program and factors related to adherence to DOPT. University of Pittsburgh, Department of Biology--1994-1995 Student Researcher Pittsburgh, PA Research to identify genes involved in growth of Mycobacterium in order to provide new targets for anti-mycobacterial drug design. Publications Building Integrated Mental Health and Medical Programs for Vulnerable Populations Post-Disasters: Connecting Children and Families to a Medical Home, Pre Hospital Disaster Management, Jan. 2008. Directly observed preventative therapy at a TB clinic for the homeless (abstract). H. Sinclair; R.W. Little, MD; N.E. Hyslop, MD; R. Mera, Ph.D. Journal of Investigative Medicine 47, 111A, 1999. Honors/Awards Adopt-A Student Scholarship--1996-2000 MD/MPH Combined Degree Fellowship--1996-2000 Dean's Award for Excellence in Research and Presentation by a Medical Student--1998 Novartis Community Service Award--1997 Recent Training Center for Mind-Body Medicine--Jan. 2007 Language Fluency French, Spanish, Hindi, Japanese, American Sign Language Introductory level proficiency Chairman Miller. Thank you. Neither the Chair nor the Ranking Member set a good example in staying within the five minutes, and we will be somewhat indulgent, but we want to bear in mind that there is at least a five-minute suggestion of the limit of the oral testimony. Mrs. Huckabee. STATEMENT OF MRS. LINDSAY HUCKABEE, RESIDENT OF FEMA-PROVIDED MOBILE HOME IN KILN, MISSISSIPPI, FROM OCTOBER, 2005 TO MARCH, 2008 Mrs. Huckabee. I would first like to thank the Committee for bringing this up and Congress and holding somebody accountable for what has been going on. My name is Lindsay Huckabee. I am not an expert on formaldehyde. I am not a scientist. I am a woman, a wife, and a mother, who spent countless hours dealing firsthand with the effects of formaldehyde. On August 29 of 2005, our apartment was destroyed along with all its belongings. We contacted FEMA and were told that we qualified for their housing, temporary housing program. We received a trailer in December of 2005. It was a single-wide mobile home, not a travel trailer like many people believe. Whenever we first entered it, we noticed that there was a real strong, offensive smell. We had sinus issues going on. My six-year-old immediately started having nosebleeds, along with my four-year-old. In the 29 months since we received our first FEMA trailer, our family has suffered many health issues. Four of my five children have been treated for asthma. Four of them are currently on prescriptions for breathing treatments, none of which were asthmatic before we moved into the trailer. My husband and I have allergy symptoms, sinus symptoms, and we have been tested for allergies and nothing shows up on a test. My husband had a tumor in his soft pallet that was removed. It was considered non-cancerous but still malignant because of its rate of growth. Our ear, nose, throat doctor feels that formaldehyde could have been a contributing factor to this. While it cannot be proven, he said that he will make a note of it for further study. My daughter, Lelah, was four when we moved into the trailer. She is now six. She developed moderate asthma. She has had sinus infections severe enough to require two surgeries. Whenever I ask the ENT if these surgeries were really necessary because they were very invasive, he asked me if I could be out of that trailer in 30 days or less. I told him that, no, I had nowhere to go. He said, then she must be put through this because he fears that her nasal passages would not be wide enough to exchange air. We had formaldehyde tests done on our trailer in April of 2007. Our first trailer was a Fleetwood home built in November of 2005. The test came back at 0.18 parts per million, which is above the 0.1 believed to be harmful to humans. There is no way to know how high it was in the 16 months we lived there before having it tested. Since FEMA and the CDC suggests that opening windows will out-gas the fumes and lower the level, I have to believe it was much higher, since we did this repeatedly. We reported our findings to FEMA. We were told that we would be provided with a replacement unit that would be formaldehyde free. The second trailer was a 2005 model built by Destiny Homes. We had a formaldehyde test done on it before we moved into it, found that its levels were 0.018 parts per million. It was lower than the ones that we had received but in researching I found that 0.008 is what is considered safe for long-term use. This was still above that. Whenever I informed FEMA of our new findings, they said it is lower than the one you had before so we are good, right? I testified in a hearing in Washington, D.C. in July of 2007, regarding the FEMA and the formaldehyde issue. Whenever I got back, we received a pamphlet saying that they were working with the CDC to find safe levels. When I called FEMA to the help number they gave us, she told me I needed to call the CDC to find out what was a safe level of formaldehyde. We called the CDC number that was provided by FEMA. First we were told to call FEMA back, the CDC wasn't handling that. After insisting that I had already called FEMA and were told to call the CDC number, I was transferred to six different people, none of which were willing to give me a name or an employee ID number. Each one told us they knew nothing about formaldehyde, that they didn't know anything about any levels, and one of them even told us she didn't know anything about working with FEMA on this. So whenever we got off the phone we were just as confused as we were in the beginning. I was able to meet with some of the CDC directors or some of the CDC employees at a town meeting held. I was told by one of them they knew nothing about the formaldehyde until after the July, 2007, hearing. I find this really hard to believe considering my own pediatrician had spoken with the CDC about doing a child health study. We went back and forth with the CDC trying to get a safe number to find out, you know, we were running air purifiers, trying to find out if our trailer was, indeed, safe. We saw a decrease of symptoms once we had the air purifiers running. We were told that there is no safe level of formaldehyde for living in 24 hours a day. I feel like since the CDC and FEMA and the ATSDR all knew a year in advance from today about the formaldehyde in the trailers, I feel like essentially we were lab rats. We were put in this situation, we were exposed to this, and seeing as this large group of scientists knew about it, it seems like they should have at least been doing studies to find out what the effects were. This is not a new chemical. It has been around, used in everything for decades, if not longer. I think that it is a shame that this high-tech agency has no more information on this than they do have. [The prepared statement of Mrs. Huckabee follows:] Prepared Statement of Lindsay Huckabee I would like to start by thanking the Members of this Congressional Committee for taking the time to address this issue and for allowing me the honor of coming before you to speak. My name is Lindsay Huckabee and I currently am currently living in Diamondhead, Mississippi in a hotel with my husband and our five children. On August 29, 2005, our apartment and all of its contents were destroyed by Hurricane Katrina. We contacted the Federal Emergency Management Agency (FEMA) and were granted immediate assistance. In early October, we received a travel trailer to use as a temporary shelter. We were unable to stay in the travel trailer because of the many maintenance problems it had. After six weeks of no response from the maintenance department, we contacted FEMA about a replacement unit. We were told that we qualified for a single-wide mobile home because of our family size so we cleared a site and provided septic, water and power to the site at our expense. We met all of the requirements and the trailer was delivered December 14, 2005. We could smell something in the trailer as soon as we entered and it made our noses, eyes and throats burn, but we thought it was normal for a new trailer to smell this way. We had no idea that we were moving into a home that would be making our family sick. We aired out the trailer and, eventually we became accustomed to the smell and did not notice it unless we were gone for a day or more. In the twenty-nine months since we received our first FEMA trailer, our family has suffered many health issues. Four of my five children have been treated for asthma and all four of them have current prescriptions for breathing treatments. All five children, my husband and I have allergy and sinus symptoms with no positive allergen that shows up on a test. We all keep the ``allergic black eyes;'' that is what doctors call the purple circles under our eyes that give us a constant tired and sick look. My husband has been on a daily sinus and allergy medication, had a tumor removed from the soft pallet of his mouth, and been on antibiotics about every other month. Our Ear, Nose and Throat doctor (ENT) said that while he could not be sure that the formaldehyde caused the tumor, it was in a location he had never personally seen before and he would not rule it out as it is known to cause cancer of the nasal passages and lungs. My daughter Vicki is 13 years old and has had a sore throat off and on since moving into the first FEMA trailer. Vicki keeps mild congestion in her sinuses and has been on antibiotics several times, but has never been hospitalized. My daughter Caitlin will be nine this month, she has had sinus infections, pneumonia, asthmatic bronchitis, sore throat, nosebleeds, headaches and asthmatic symptoms. Caitlin is currently on a daily allergy medication and inhaled asthma medication as needed. Prior to living in the trailers Caitlin had never been treated for any breathing problems. Caitlin has had many x-rays and been on antibiotics again and again, but she has only been hospitalized once. Lelah is six years old and since moving in to our first FEMA trailer she has developed moderate asthma and has also had sinus infections severe enough to need an operation to widen her sinus passages. Lelah's doctor said that with the sinus tissue staying inflamed from the constant irritation, there was nowhere for the sinus fluid to drain. Lelah has had pneumonia, ear infections, throat infections, asthmatic bronchitis, nosebleeds, headaches, two MRIs and has been put under for surgery four times. Lelah is currently on three daily medications with two more as needed. In the past Lelah has been on as many as eight daily medications at one time and she has been hospitalized three times. Steven is four years old and has been pretty fortunate health-wise. Steven is on a daily allergy medication and he has had asthmatic bronchitis, pneumonia, sinus infections and nosebleeds. Steven has also been treated with breathing treatments for asthma. Prior to living in the FEMA trailers Steven had never had breathing problems of any kind. Steven has only been hospitalized once. Michael is two years old and he was born prematurely after we moved into our FEMA trailer. Michael has had sinus infections off and on since he was six days old; he has also had asthmatic bronchitis, pneumonia, laryngitis, only a few nosebleeds and undergone cardiac testing because he occasionally turns blue for an unknown reason. Michael is currently on two daily allergy medications, a nasal steroid, and antibiotics for the sixth strait week. Michael has been hospitalized three times. I have had migraine headaches, sinus infections, throat infections, bronchitis, and sleep deprived. My doctor has given me sleeping medication; muscle relaxers and we have spoken about anti depressants to handle the stress of taking care of sick children while I myself am sick too. I decided against the anti depressants because while I am stressed, I don't feel like I am depressed and I don't need anything that would alter my thinking. Were all these caused by formaldehyde? I believe that they were either caused by it or made worse by it. Everywhere I look for an answer I come up empty. No one seems to know enough about it to say for sure. We know that it CAN cause all these and many more health effects. I don't think that it is just by chance all my children were healthy in the years before the hurricane and once getting into trailers changed. We have no way of knowing what Michael's health would have been like were he not born into a FEMA trailer. I was told by our E.N.T. that we needed to get out of the trailer as soon as we could. He had many repeat patients with the same symptoms all living in FEMA trailers. He said that there were chemicals that could be making my children sick. Both Lelah and Michael have been to an Allergy and Asthma specialist. He has done allergy test and found nothing. He said that there must be exposure to some sort of irritant rather than an actual allergy to something. Then he asked if we were in a FEMA trailer. He too had seen an increase of patients with inactive or mild asthma having more severe problems upon moving into these trailers. . After months and months of office visits and phone calls, I was frustrated and upset. Before moving into the FEMA trailer, I can't remember going to the doctor other than for well-child checks and a few times with Lelah when she was very young. To date I am still at the doctor's office or calling just about every week. Our pediatrician, Dr. Needle, told me that there seemed to be a trend among patients in FEMA trailers and increased office visits with allergy-like symptoms. He had been doing some research and thought that formaldehyde may be our problem. It was through him that a Sierra Club member contacted me about a formaldehyde test to see if we were living in levels that could be dangerous. I really did not want this to be the answer, since we had nowhere else to go. We had a formaldehyde test done on our trailer in April of 2007. Our first trailer was a Fleetwood home built in November of 2005. The test came back as 0.18 ppm, which is well above the 0.10 ppm believed to be harmful to humans according to one agency. There is no way to know how high it was in the 16 months we lived in the trailer prior to having it tested. Since FEMA suggested that ``opening windows would out-gas the fumes and lower the level,'' I have to believe that the level was much higher when we moved in. When we told FEMA about the test, we met much opposition. FEMA representatives were rude when I called them. I was forced to call more than five different representatives, and my request for a new mobile home was lost twice before anything was done to help solve my problem. Finally, FEMA agreed to replace our mobile home. We were told that the new trailer would be ``formaldehyde free.'' It was supposed to be a used FEMA trailer built in 2005 by Destiny. We had a formaldehyde test done on the new FEMA trailer before we started to move anything into it. An inspector from FEMA saw the tester hanging and asked what it was. When I told him it was used to test for formaldehyde, he said that people were claiming to have high formaldehyde levels so they could get bigger and better trailers. When I asked if FEMA had done test to find this out, he said NO. The test on the new trailer came back at 0.108 ppm, which is still above the level believed to be harmful, but lower than the last trailer. When we called FEMA to tell them what the results were, the lady said, ``it is lower than the other trailer, so we are good, right?'' After returning from Washington DC in July of 2007, we received information from FEMA on formaldehyde. The information sheet gave a number for FEMA to call for more details on what levels were acceptable and what the long-term health effects would be. The number proved to be useless. After talking to the woman at FEMA about our symptoms and our concerns we were told that it did not sound like we had a problem with formaldehyde. We had already had a test done on our trailer so we knew what our problem was. We were told that we did not qualify for the formaldehyde-testing program. We then asked what level was considered safe for us to live in and her response was ``I don't know you have to call the CDC for that information.'' We called the CDC number we were given and it proved to be as useless as the FEMA number. First we were told to call FEMA. After insisting that we had already called them and been told to call the CDC number, we were transferred to six different desks of people in different departments and levels of management where the final answer we received was that we needed to talk to FEMA about our concerns. The CDC representatives said that they did not have information on levels of formaldehyde and what was safe and what was not. We were told that the employees could not give us their names or even an employee number therefore there was no way for us to follow up on the conversations or have anyone to hold accountable for the lack of information. I was able to meet with several CDC officers at a meeting held in Bay St. Louis, Mississippi on March 6th 2008. I found them very willing to answer our questions about the formaldehyde and possible effects on people. I was surprised to learn how little is known about formaldehyde and long-term effects. While searching for the magic ``safe'' level of formaldehyde, we found several different numbers through the Internet. The level of 0.1 ppm, the most commonly accepted safe limit, was not intended to gage how safe exposure was for children, people with breathing problems, or even healthy adults for longer than the average workday. According to the CDC representative I spoke with at the community meeting that was held to answer questions about formaldehyde, there is ``No safe level for exposure in a residence.'' I was told at the meeting that CDC was not aware of the issue until after the July 17th hearing last year. I personally find this hard to believe. It is my understanding that the ATSDR did the original testing for FEMA and OSHA when they wanted to know what the levels were for employees and how to bring them down. They reported the levels to FEMA and agreed to not share the information. They even sent a revised letter making sure the FEMA knew that there was no known SAFE level for people to live in since formaldehyde is a know carcinogen. ATSDR is a part of CDC. According to everything I can find on the CDC and ATSDR, both claim to exist to protect us from toxic substances--like formaldehyde. What I can't understand is, how an agency set in place to protect the people, failed to let the people know about this problem. I did not think it was there to help the government find out how much it messed up and then help them keep quiet about it. I know that at least one pediatrician contacted the CDC to find out about starting a study and researching what was going on down here with the kids in the FEMA travel trailers and mobile homes. There is now evidence that FEMA knew about the formaldehyde as early as December of 2005, which is the same time that I get my first mobile home. They covered up the problem, hid behind lawyers and made sure they could not be held responsible. FEMA made people feel like they were being picky, and ungrateful for mentioning the illnesses and requesting assistance. While FEMA was covering their behinds, my children were staying sick. I blamed myself for not doing enough to keep them well, but when FEMA took on the role of landlord for the thousands of people, they took on the responsibility to provide a safe and healthy living environment for these people. While no one should have been exposed to a toxin for over two years, I think that the CDC should take advantage of this disaster and learn everything they can about formaldehyde. It is bad enough that was question every symptom and the length of every illness wondering if we would have gotten sick in the first place, or why all the other kids that caught this cold at the same time have been done with it for weeks, but the fact that NO ONE can tell us how long the effects of formaldehyde will stay with us, is horrifying. This is not a new chemical. There should be more information on it. When the CDC and ATSDR first knew that people were living in these levels and there was even a possibility that they were getting sick, they should have stepped in and found out what was going on. Two years later, after so many people have moved on, some even died in these trailers, it may be too late to know the full extent of what effect formaldehyde has on people. There were people of every age, race, and economic status in these trailers. I fell like after it was fist known that the formaldehyde was a problem, we were lab rats subjected to the toxin, but no one wanted to record the results. Chairman Miller. Thank you, Mrs. Huckabee. Ms. Gillette. STATEMENT OF MS. BECKY GILLETTE, FORMALDEHYDE CAMPAIGN DIRECTOR, SIERRA CLUB GULF COAST ENVIRONMENTAL RESTORATION TASK FORCE Ms. Gillette. My name is Becky Gillette, and I am Formaldehyde Campaign Director for Sierra Club. After Katrina it became common knowledge that the FEMA trailers had serious air quality problems; people complained about burning eyes, respiratory problems, rashes, headaches, even bloody noses. Sierra Club began formaldehyde testing in April of 2004, and continued through 2007. What we found was that 61 out of our 69 tests, 88 percent, were over the 0.1 ppm limit that EPA had set. And when you use the much lower levels recommended by the ATSDR recommendations, not a single trailer was safe. We tested 17 different brands of trailers and all had at least one high test, and there were three deaths of people in the trailers that we tested that we believe could have been caused by the formaldehyde. Finally, in October of 2006, over a year after Katrina, many people had been in the trailers for over a year, EPA tested the trailers, but there was delay after delay in releasing the results of those. FEMA has asked ATSDR to reevaluate those test results. I also contacted ATSDR several times, and no one ever got back to me. When it was finally released, the ATSDR health consultation was a huge disappointment. The report said that formaldehyde averaged 1.2 parts per million at the beginning of the test and dropped to 0.3 ppm after four days of constant ventilation. This was shocking because 1.2 parts per million is extremely high, and I found it incredible that ATSDR could say 0.3 parts per million was below the level of health concern. At that level most people that walk into a trailer will experience immediate distress, and ATSDR's own standards were many magnitudes lower. ATSDR gave completely erroneous advice, covering up this problem with the health of tens of thousands of families at stake. Finally, in October of 2007, over two years after Katrina, a year after the EPA testing, ATSDR revised its health consultation to more accurately report the problem, but that was two years that women were living in these trailers, getting pregnant, having miscarriages, having still births, and losing babies to SIDS. Adults and children were getting cancer. People with asthma were literally finding it difficult to breathe, and mothers were getting up in the middle of the night to give breathing treatments to their children. I recall calling Earl Shorty to give him the results of their FEMA trailer testing. His wife, Desiree Collins, was coughing so bad in the background that it was painful to hear her. A few days later she passed away. One woman I tested, Theresa Coggins, a diabetic, went into a coma for eight days, running up a $100,000 hospital bill. Another woman, Christine Lawrence, told me that her head felt like a balloon that was about to burst. But did FEMA and ATSDR care? No. There was a callous disregard for the health of the trailer residents, and there was an appalling lack of urgency. But this negligence is only the tip of the iceberg. Contaminated communities often feel let down by ATSDR. Attorney Monique Harden, coauthor of a report that details the injustices of ATSDR in Mossville, Louisiana, says, ``Any help that you can provide in getting the Science and Technology Committee to connect the dots between ATSDR's role in the toxic FEMA trailers with its ``public health'' work in communities plagued by pollution would be greatly appreciated. The problem that we have is that ATSDR's conduct in the FEMA trailer crisis is not an aberration but is consistent with the way it has always worked.'' Sal Mier, who retired from the CDC as Director of the Division of Prevention in the Dallas Regional Office wrote, ``We strongly believe there is a national pattern in the manner in which ATSDR conducts their consultations and assessments and that this pattern could result in great risks to the public health of many communities. It is our perception that ATSDR embodies a philosophy and consequently a methodology and guidance this is designed towards the non-identification or trivialization of public health problems.'' Our tax dollars are being used to lie to us about the impact of toxic pollution. The harmful and inaccurate advice regarding formaldehyde in FEMA trailers is just the latest example. Congress could help by calling for an independent National Academies of Science investigation into the process by which health consultations are developed and communicated. Katrina was ``the perfect storm'' to expose formaldehyde poisoning that has been allowed in our buildings now for decades. FEMA just purchased what was available to sell for the general public. There are many other people other than disaster victims who are at risk here. The CDC needs to take immediate steps to do a nationwide health survey and consultation regarding formaldehyde and building materials. If there is one benefit that can come out of all the misery and death that has resulted from formaldehyde and FEMA trailers, let it be that the citizens of the U.S. are finally afforded the same protections that are provided under law in Europe, Japan, and even China. Thank you. [The prepared statement of Ms. Gillette follows:] Prepared Statement of Becky Gillette My name is Becky Gillette, Formaldehyde Campaign Director for Sierra Club. After Katrina, it soon became common knowledge that the FEMA trailers being used to house people who had lost their homes had serious air quality problems. People reported that being in the trailers caused burning eyes, respiratory problems, coughing, headaches, rashes and even bloody noses. Many people had what came to be known as ``trailer cough,'' a cough that wouldn't go away. After Paul and Melody Stewart of Bay St. Louis, MS, found high levels of formaldehyde in their FEMA trailer in early March 2006, Sierra Club funded work to test FEMA trailers to see how widespread the problem was. We began those tests in April of 2006 and continued testing later that year and again in 2007 because FEMA kept saying that all people had to do was ventilate the trailers and the problem would go away. What we found was very alarming. Overall, 61 out of 69 tests--or 88 percent--were over 0.1 ppm.\1\ OSHA, EPA and other agencies all agree that health effects from exposure to formaldehyde may begin at 0.1 ppm.\2\ When you use the lower limits recommended by the Agency for Toxic Substances & Disease Registry (ATSDR) for long-term exposure, not a single one of the trailers tested was in the safe range. The ATSDR Minimal Risk Levels is 0.04 ppm for 1-14 days exposure, 0.03 ppm for 14-364 days exposure and 0.008 ppm for 365 or more days exposure. --------------------------------------------------------------------------- \1\ Sierra Club Fact Sheet ``Toxic Trailers? Tests reveal high formaldehyde levels in FEMA trailers.'' \2\ National Cancer Institute Fact Sheet ``Formaldehyde and Cancer: Questions and Answers, http://www.cancer.gov/cancertopics/factsheet/ Risk/formaldehyde --------------------------------------------------------------------------- When we initiated testing, we suspected just a couple trailer brands had the problem. But out of 17 brands of trailers tested, all had at least one high test. And it was also alarming to us that there were three deaths of people in the trailers that we tested that we believe could have been caused by the formaldehyde. That is just the deaths we know of because it wasn't possible to keep up with all 69 families tested because FEMA trailer residents are very migratory. Sierra Club did everything possible to publicize the high formaldehyde levels in the trailers that were being used at one point to house more than 100,000 families. There were numerous articles and television news programs on the issue, but FEMA continued to deny there was a problem and said people just needed to open their windows and let the campers' air out. At the same time people were moving out of their FEMA trailers to live in tents, storage sheds and even their vehicles because the formaldehyde was so bad. People were experiencing numerous health problems such as repeated respiratory infections, migraine headaches and cancer. Finally in September to October 7, 2006--more than a year after Katrina--EPA undertook testing of the trailers for FEMA. We were very glad that more expensive, extensive testing was being done to evaluate the problem since FEMA had discounted the Sierra Club testing. But we were extremely disappointed when there was delay after delay in releasing the results of the EPA testing. When we asked why, FEMA said the results were sent to the Agency for Toxic Substances and Disease Registry (ATSDR) for evaluation. I knew the test results had to be bad or FEMA would have announced them immediately. Four months after EPA did that testing, I sent a Freedom of Information Act request to get the EPA testing results, and started sending e-mails to a contact at ATSDR.\3\ --------------------------------------------------------------------------- \3\ ATSDR e-mails between Becky Gillette and James Durant, February-May 2007. --------------------------------------------------------------------------- In an e-mail to James Durant, an environmental health scientist for the ATSDR, Feb. 27, 2007, I wrote: ``We have been very frustrated with the widespread poisoning of tens of thousands of people in FEMA trailers due to high levels of formaldehyde. FEMA and the (Mississippi) Health Dept. refuse to do anything about it. Would this be something we could request investigated by ATSDR? Any tips for us on how to do that?'' Mr. Durant responded: ``I am sorry that it has taken a while to get back to you. My supervisor and I have been trying to track down who in CDC/ATSDR has been heading up this issue. This was not as straight forward as we thought it would be. We have found the person heading this up, but she is out of the office. Hopefully, we will be able to get an answer to you on what is going on with the formaldehyde soon.'' I never heard anything back, and on May 7--seven months after the EPA testing was concluded--I once again wrote Mr. Durant and asked: ``Did you ever find out who is handling the FEMA request for information from ATSDR regarding formaldehyde in FEMA trailers? FEMA just put out a release showing their testing showed very high levels of formaldehyde even after ventilation. But FEMA says that is below the ATSDR threshold, which is several times higher than the EPA and American Lung (Association) guidelines. ``I just tested a family with .32 ppm . . . they have spent over $700 on medical bills related to the toxic exposure. It is very wrong to suggest these levels--so strong they make your eyes burn--are acceptable. ``Do you have a contact at ATSDR on this?'' Mr. Durant responded: ``So you are telling me that no one has contacted you regarding formaldehyde at all? When you contacted me, we attempted to have the person who is heading this up contact you. It was my understanding that you would be contacted. I will flag this issue and try to get someone to contact you that knows what is happening.'' My response was: ``No, I never heard from anyone. ATSDR, we have been told, has been asked to give recommendations to FEMA. Ventilation simply doesn't work here in the summer as it is too hot and humid. If you do ventilate, the humidity can actually make out-gassing worse.'' In early 2007 when I first contacted the ATSDR, the agency had already produced a Health Consultation. It was dated Feb. 1, 2007. But that information was not released to the public until months later and then the report went counter to the agency's own formaldehyde standards. When it was finally released, the ATSDR's Health Consultation was a huge disappointment. I'm quoting excerpts from a FEMA press release May 4, 2007 titled FEMA Study: Ventilating Travel Trailers Can Significantly Reduce Formaldehyde Emission Levels:\4\ --------------------------------------------------------------------------- \4\ http://www.fema.gov/news/newsrelease.fema?id=36010 ``FEMA said today that its study of air samples collected from travel trailers in the Gulf shows that formaldehyde emission levels in the units can be significantly reduced through adequate ventilation. The study involved collecting air samples from 96 new, unused travel trailers from Sept. 19 to Oct. 7, --------------------------------------------------------------------------- 2006, at a staging area in Baton Rouge, La. ``The baseline for concentrations of formaldehyde in the units averaged 1.2 ppm (parts per million) at the beginning of the test. . . .According to the evaluation report provided to FEMA by ATSDR, the average concentration of formaldehyde per day in the units using open window ventilation dropped below 0.3 ppm after four days of ventilation and remained low for the rest of the test period. The level for health concerns for sensitive individuals was referenced by ATSDR at 0.3 ppm and above.'' This is shocking because 1.2 ppm is extremely high. I found it incredible that ATSDR could say that 0.3 ppm was below the level of health concerns. At that level, most people experience extreme distress. It was far, far too high. ATSDR's own standards are many magnitudes lower at 0.04 ppm for 1-14 days exposure and far lower than that for long-term exposure. In a nutshell, the formaldehyde levels with ventilation went from astronomical to extremely toxic and the ADSDR told the public: No problem! ATSDR gave completely erroneous advice. What ATSDR did was criminal negligence covering up this problem when the health and lives of tens of thousands of Americans were at stake. Finally in October of 2007 the ATSDR revised the February Health Consultation to more accurately reflect the scope of the problem. But that means it was one year between the time ATSDR was asked to evaluate the EPA test results and when the agency delivered the second Health Consultation that more accurately described the risks. That was one year of time where tens of thousands of families were exposed to this toxic gas. It was one entire year when women were getting pregnant and sometimes having miscarriages, stillbirths or losing their children to Sudden Infant Death Syndrome (SIDS). Children and adults were getting cancer. And people with pre-existing conditions like asthma were finding it literally hard to catch a breath. Mothers were getting up in the middle of the night to give breathing treatments to children. I had no sense that there was any bureaucrat in Atlanta or Washington who even had a clue the amount of suffering and illness that was resulting from this long-term exposure to a toxic gas. I recall calling to give the bad news to Earl Shorty in Baker, La. about their trailer's high formaldehyde levels. His wife Desiree Collins was coughing so bad in the background it was painful to hear her. A short time later she passed away. One woman I tested, Theresa Coggins, a diabetic, had gone into a coma for eight days, running up a $100,000 hospital bill. Another woman whose trailer tested high, Christine Lawrence, told me her head felt like a balloon that was about to bust. FEMA and ATSDR showed an appalling lack of urgency. There was a callous disregard for the health of FEMA trailer residents. I didn't get the sense there was anyone in FEMA or ATSDR waking up in the middle of the night worrying about families being poisoned. Instead, all we got was a cover-up and denial of the problem. If it was possible to file a malpractice lawsuit against a federal agency, the ATSDR would not only end up owing millions of dollars for harming the health of people, but it would lose its license to practice medicine. Other concerns about ATSDR But the thousands of people who have suffered from this agency's negligence on formaldehyde are only the tip of the iceberg. For many years now the ATSDR has been called in when communities are concerned about health impacts from massive amounts of toxic pollution. Contaminated communities often feel let down by how little ATSDR studies can tell them about associations between millions of pounds of toxic releases and rampant illness and early death nearby. And they are frustrated by the long amount of time it takes for ATSDR to complete studies. I would like to introduce into the record a report that details the injustices of ATSDR in Mossville, LA.\5\ One of the authors of that report, attorney Monique Harden, wrote the following: --------------------------------------------------------------------------- \5\ ATSDR's Misinformation Campaign on Dioxin Exposures in Mossville, Louisiana, August 2007. ``Any help that you can provide in getting the Science & Technology Committee to connect the dots between ATSDR's role in the toxic FEMA trailers with its ``public health'' work in communities plagued by pollution would be greatly appreciated. The problem that we have is that ATSDR's conduct in the FEMA trailer crisis is not an aberration but is consistent with the --------------------------------------------------------------------------- way it has always worked.'' The ATSDR has also suppressed a report on Great Lakes health risks showing people living in polluted areas around the Great Lakes face higher rates of lung, breast and colon cancer. Sal Mier, a concerned grandparent in Midlothian, Texas, who retired from the CDC as Director of the Division of Prevention in the Dallas Regional Office, says: ``We strongly believe there is a national pattern in the manner in which ATSDR conducts their Consultations and Assessments and that this pattern could result in great risks to the public health of many U.S. communities. It is our perception that ATSDR embodies a philosophy and consequently a methodology and guidance that is designed toward the non- identification and/or trivialization of public health problems.'' \6\ --------------------------------------------------------------------------- \6\ Letter from Sal Mier to House Science and Technology Committee: ATSDR's Conduct with Public Health Consultations/Assessments, A Possible Systemic Nationwide Problem, Feb. 20, 2008. Mr. Mier says the most people who request Health Consultations end up wishing they hadn't. That is because ATSDR issues a report whitewashing any health impacts form the pollution, and it removes any leverage local communities had with the polluters. Mr. Mier says: ``It puts last nail in the coffin because it exonerates the polluter. I think there is a pattern nationally.'' The Olympic Environment Council (OEC) is another environmental group that regretted ever petitioning for the help of ATSDR to assess the link between 67 years of releases of dioxin, PCBs, phthalates, heavy metals, and other contaminants released from a local chlorine dependent pulp mill in Port Angeles, Washington, and high incidences of illness in the community. In a letter to the ATSDR, Darlene Schanfald, Ph.D., OEC Project Coordinator, Rayonier Hazardous Waste Site Cleanup, said: ``There are so many flaws in this report that rather than enumerating/citing each, the report can be summed up as a corruption of science. Maybe even a corporate corruption of science since it is evident the staff did not want to rule against the polluter when there was substantial evidence to do so.'' \7\ --------------------------------------------------------------------------- \7\ Letter to Julie L. Gerberding, ATSDR Administrator, RE: FINAL PUBLIC HEALTH ASSESSMENT FOR RAYONIER, INC. MILL, PORT ANGELES WA--EPA FACILITY ID WAD000-490169, from Darlene Schanfald, Ph.D., OEC Project Coordinator, Rayonier Hazardous Waste Site Cleanup, Oct. 22, 2004. Numerous flaws in the ATSDR consultation were detailed in a report prepared by Dr. Peter deFur.\8\ --------------------------------------------------------------------------- \8\ Comments of Dr. Peter L. deFur on behalf of the Olympic Environmental Council (OEC) on the Public Health Assessment for Rayonier Mill; Port Angeles, Clallam County, Washington; CERCLIS No. WAD000-490169, September 6, 2000. --------------------------------------------------------------------------- Even when the agency does find a link between pollution and health problems, it tries to shield industry. At case in point was an ATSDR investigation of DuPont Delisle on the Mississippi Gulf Coast, one of the largest sources of dioxin emissions in the country. After Katrina ATSDR did find dioxin levels in crabs can make them unsafe for consumption by girls and women of childbearing age. But ATSDR denied there was any link between the dioxin found in the crabs and DuPont, which is the only large industry on the Bay of St. Louis. Conclusions and Recommendations These cases are all clear evidence of a pattern of ATSDR betraying the public's trust when doing public Health Consultations. Our tax dollars are being used to lie about the impact of toxic pollution. The harmful and inaccurate advice regarding formaldehyde in FEMA trailers is just the latest egregious example. At the end of the press release for the first formaldehyde Health Consultation, it says: ``ATSDR serves the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and diseases related to toxic substances.'' This mission statement is contradictory to the advice given in the first formaldehyde Health Consultation. Congress could help address this problem by calling for an independent federal National Academy of Sciences investigation of the process by which Health Consultations are developed and communicated. Now that the scope of the formaldehyde problem is apparent, immediate steps need to be taken to provide health care to the many thousands of families who have been sickened. Many of these families lost everything in the storms, and don't have health insurance. The government needs to set up free health clinics and work diligently to help physicians and other health professionals determine the best methods to treat the wide variety of health problems that have resulted. The Children's Health Care Fund has studied the health of residents of the FEMA trailers and determined there is an urgent need for a health care ``Marshall Plan'' to respond to an emerging humanitarian crisis in Louisiana and Mississippi.\9\ Sierra Club endorses this recommendation. --------------------------------------------------------------------------- \9\ The Recovery Divide: Poverty and the Widening Gap among Mississippi Children and Families Affected by Hurricane Katrina, http:/ /www.childrenshealthfund.org/whatwedo/operation-assist/pdfs/ TheRecoveryDivide<INF>-</INF>Full%20Report.pdf, February 2007. --------------------------------------------------------------------------- The CDC has already announced a study monitoring the health of children who lived in the FEMA trailers that will eventually be expanded to a study of the health of adults. This is badly needed and these studies can't end in a few months because the health effects of this exposure can be expected for the lifetimes of those people exposed. The CDC also needs to study mental heath as some professionals suspect the high rates of depression and suicide on the Gulf Coast could be linked to the toxic exposure.\10\ --------------------------------------------------------------------------- \10\ Statement from Ph.D. Psychologist Dr. Lou Finkle of Gulfport, MS, March 24, 2007. --------------------------------------------------------------------------- Katrina was the largest natural disaster in our nation's history, and the formaldehyde in FEMA trailers was the second disaster that harmed the health of people far more than the original disaster. I strongly urge you to realize that the storm is not over. Katrina merely was a ``perfect storm'' to expose the formaldehyde poisoning that has been allowed in our buildings now for decades. ATSDR, FEMA and HUD are still not responding adequately to results that showed high levels of formaldehyde in RVs, trailers and other products that are sold to the general public. FEMA just purchased what was available for sale to the public. Manufacturers have said they didn't do anything different in manufacturing trailers for sale to FEMA than to the general public. The fact is that formaldehyde has been a big problem for many, many years. The CDC needs to take immediate steps to do a nationwide survey of how big the problem is not only in RVs and manufactured housing, but also in temporary classrooms that have tested high. We have even seen high formaldehyde levels in government office buildings such as one occupied by U.S. Rep. Diane Watson.\11\ --------------------------------------------------------------------------- \11\ U.S. Rep. Diane Watson statement at formaldehyde hearing before U.S. House Committee on Government Oversight and Reform, July 19, 2007. --------------------------------------------------------------------------- Many millions of Americans live in manufactured housing. A lot of people retire to live in a RV at least part of the year. With the declining economy, many people who are losing their homes are moving into trailers. At my blogsite www.toxictrailers.com many people have written about high formaldehyde levels in RVs, trailers, regular homes and offices. It isn't just victims of disaster who are at risk here. The CDC needs to immediately launch a nationwide investigation into formaldehyde levels in RVs, mobile homes, temporary classrooms and other housing that may be contaminated. It there is one benefit that can come from all the suffering resulting from formaldehyde in FEMA trailers, let it be that we finally get this toxic gas out of building materials providing the citizens of the U.S. the same protections provided under the law in Europe, Japan and even China. Biography for Becky Gillette Becky Gillette is a free-lance writer/photographer and an environmental activist currently living in Eureka Springs, AR. She was living on the Mississippi Gulf Coast when Hurricane Katrina hit. After repairing flood damages to her home, she became aware of problems with formaldehyde levels in FEMA trailers. She received a grant from Sierra Club to organize a testing program for the trailers and publicized the results which showed about 90 percent of FEMA trailers have excessive formaldehyde levels. She launched the web site www.toxictrailers.com to publicize the problems, and helped organize a Congressional hearing on the subject that led to FEMA halting the use of the travel trailers. In 2007 she received an Environmental Hero Award from Louisiana Environmental Action Network recognizing her formaldehyde work. She is currently Formaldehyde Campaign Director for Sierra Club's Gulf Coast Environmental Restoration Task Force. Gillette's writing and photography have been published in about 50 magazines and newspapers nationwide. Her article have appeared in Ladies Home Journal, Organic Gardening, Utne Reader, E, The Environmental Magazine, Builder, BioScience, In Business, Mississippi Business Journal, In Business and Furrow. Gillette was Chair of the Mississippi Chapter Sierra Club for five years, and in 2002 she received the National Conservation Achievement Award from National Wildlife Federation for communications. She has been named Mississippi 2008 Small Business Journalist of the Year by the Small Business Administration. She is currently Formaldehyde Campaign Chair for the Sierra Club Gulf Coast Environmental Restoration Task Force. Discussion ATSDR Response to Sierra Club Tests Chairman Miller. Thank you. We will now have our first round of questioning, and my hope is that this panel will be limited to one round of questioning because we have more to go. I can tell that none of you appear disappointed that there will only be one round of questioning from each of us. Ms. Gillette, you just testified about the Sierra Club's initial testing as early as April of 2006. You released those publicly, they were in the press. Did you get contacted by anyone at ATSDR, CDC, FEMA about the results of your test, about your test, and what they showed? Ms. Gillette. No. ATSDR, I just got the runaround from them. They kept saying on e-mail they would get back with me, and they never did. Finally over July, last July someone with NIOSH wrote and asked for the results of our testing, but we were never, you know, given the opportunity to tell them about the scope of the problem. And the thing that really bothered me is that I didn't feel like there was any bureaucrat that was actually coming and spending even 15 minutes in these trailers, let alone stay overnight in them and find out what it is really like to have to live with those kind of high formaldehyde levels. Health Effects From Formaldehyde Chairman Miller. Okay. Mrs. Huckabee, I think that Ms. Gillette just said that she thought that there was a trivialization of health consequences. The ATSDR health consultation in February of 2007, described that results below the 0.3 level, parts per million, as being a nuisance affect. Would you describe the effect on your family? Mrs. Huckabee. If you consider nosebleeds, sinus infections, asthma attacks, repeat hospitalizations for pneumonia, asthmatic bronchitis, tumors, if you consider all of these minor nuisances, then I guess you could agree with it. I mean, after all, it could be worse, I suppose. Chairman Miller. And advised by our able staff that that was not actually in the written report, but that is based upon, the nuisance effect is based upon interviews with staff. Dr. Sinclair, I know if you have tens of thousands of Americans over the course of a couple of years they are going to have bad things happen to them. You heard Ms. Gillette describe deaths in the trailers. Do you concur that the formaldehyde exposure may very well have been a contributing factor in some of those deaths? Dr. Sinclair. I would say it very well may have been a contributing factor. You cannot prove cause and effects, but many of the symptoms that our family's children exhibited while common in a general pediatric population, are also associated with formaldehyde exposure. Chairman Miller. You described in your testimony the affects that, the health affects that may come from formaldehyde exposure. What did you observe personally in your treatment in seeing families that lived in those trailers? Dr. Sinclair. The travel trailers in our area may not have had as high levels of formaldehyde as those in the Mississippi Gulf Coast because most of them were put together before Katrina and not put together as quickly after Katrina as those in the Mississippi Gulf Coast. The symptoms that many of my patients were exhibiting were not as dramatic as many of those reported by pediatricians and families in the Mississippi Gulf Coast area, however, they were persistent and difficult to treat. What I am more concerned about are the possible long-term health affects of these families' exposure to formaldehyde over the past two and one-half years. Tracking Trailer Residents' Long-term Health Chairman Miller. And what do you think should be the--what should we do to track the health of those folks who have been in the trailers for health consequences? Should there be a continuing effort to pay attention to their--what happens to them medically? Dr. Sinclair. I believe so. First of all, families should never have been put in these travel trailers to begin with. They are not meant for living. They are not up to electrical standards. They have stoves that would explode. They are not up to storm standards. They are very small, 200 square feet. That being said, now that people have lived in these travel trailers for a year, two years, two and one-half years, I think it would be very beneficial to create a data bank to track families and children and to follow their long-term health and so if there is certain concerning symptoms, that future health care providers could be alerted to the fact that they had lived in the travel trailers and maybe have a little bit higher level of concern that some of the symptoms might not just be your general cold, asthma, allergies but maybe a symptom of something more concerning. Chairman Miller. Ms. Gillette, what effort do you think there should be to follow the longer-term health of the people in the trailers? Ms. Gillette. Well, I actually think it is not enough to follow their health, but you need to provide free health care to people that have been poisoned by their own government, and the problem is that many of these people are still struggling to get their lives back together. They lost everything in the storm. There is no affordable housing that you can get into. Rental rates have doubled. The government needs to get some sort of formaldehyde swat team together that really bones up on how do you treat people that are exhibiting the symptoms of formaldehyde poisoning. Because a lot of the health care providers don't know, and they are actually in some cases giving treatment that we think may be doing more harm than good. So we really need this concerted effort on training people that are specialists in treating families that have been exposed to formaldehyde this long. After people have been exposed to high levels of it, they become more sensitive. Many of them make get multiple chemical sensitivity. So there really needs to be some free clinics provided for these people, and, again, as far as tracking, I will just say one thing. Some of these people have moved all over the U.S., and it is going to be difficult to track them. But definitely it needs to be done and not just for children but also for adults. Chairman Miller. Thank you. As an example to the other Members of the Committee, I will limit my five minutes of questioning to six and one-half minutes. Mr. Sensenbrenner. For five minutes more or less. Failings of ATSDR Mr. Sensenbrenner. It will be less. There are two aspects to this issue. One is the aspect of the fact that there have been people who have been exposed to unacceptably high levels of formaldehyde because the ATSDR did not do its job properly. The other issue to make sure that a catastrophe like this never happens again. And I think that this committee could probably be the most constructive in getting on the back of ATSDR to make sure that their medical and scientific review process passes the smell test. And this obviously did not pass that test because it certainly was not acceptable science and what is more problematical in my opinion is that the deficiencies in the ATSDR report should have been caught earlier on and were not. Now, this is not the only case where the ATSDR has not only dropped the ball but fumbled it in the end zone. And in my opening remarks I did refer to the issue of the public health implications of hazardous substances in 26 U.S. areas of concern in the Great Lakes. Let me say that there was a premature release of that report. The public health officials both in Wisconsin and Minnesota reviewed the prematurely- released report and have sent letters to Dr. Howard Frumkin, who is the director of the ATSDR, stating that his report failed. And this is a little bit closer to home for me than the Gulf Coast is, but it shows that the problems of inadequate and erroneous scientific review in the ATSDR are not limited to the issue of formaldehyde in the trailers that FEMA provided to people who were displaced by the two storms. In analyzing toxic substances and what I think is probably the greatest natural resource in the United States, and that is the Great Lakes, which are the largest body of fresh water in the world, I ask unanimous consent to include the letter from the State of Wisconsin, Division of Public Health, signed by the Chief Medical Officer, Henry Anderson, M.D., as well as a letter that was sent to Dr. Frumkin by the Minnesota Department of Public Health and specifically by John Link Stein, who is the Director of the Environmental Health Division in Minnesota. And I want to have the record be as complete in its indictment of how bad the ATSDR has been and how much they have opened up the population of this country to disease and serious medical conditions because they haven't done their job properly. And I would hope that this hearing at minimum would be a lesson to them that this should never happen again, and if it does happen again, if folks here from the ATSDR, the CDC think that today's price to pay is pretty high, to quote Ronald Reagan, ``You ain't seen nothing yet.'' I yield back the balance of my time to the Chairman. Chairman Miller. Thank you. Without objection the documents that Mr. Sensenbrenner has moved be entered into the record are so admitted. [The information follows:] <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> Chairman Miller. The Chair recognizes Ms. Hooley for five minutes of questioning. Dr. Sinclair's Experience in Her Trailer Ms. Hooley. Thank you, Mr. Chair. I will be rather brief. I have a couple of questions for Dr. Sinclair. First of all, I understand that your own mobile unit had high levels of formaldehyde in it. Did you experience any symptoms firsthand? Dr. Sinclair. First of all, as a displaced person I was actually living in a FEMA trailer in New Orleans for half the week while I was commuting back and forth the first year before I relocated to Baton Rouge, and I had headaches the whole time I was there. I had difficulty sleeping. This was before I knew anything about formaldehyde. I always kept my windows open and the doors open, and I assumed that my headaches were because I wasn't sleeping well. As far as our own medical mobile unit, when we come on in the mornings, especially in the hot weather, you do have--you notice the smell, and you do have burning eyes, and we run the air, we open the windows and vents, and by the time we start clinic, we are, you know, we are not noticing the effects of formaldehyde. One thing I would like to point out is that we retested the trailers, that, our medical mobile unit, for just eight hours, which is our workday. Ms. Hooley. Uh-huh. Dr. Sinclair. And it tested lower. It was still above what EPA recommends for an eight-hour workday exposure, which is 100 parts per billion but was less than what OSHA recommends for an eight-hour workday exposure, which is the 300 parts per billion. So this is where some of this confusion has come up is that the 0.3 parts per million or 300 parts per billion is considered an acceptable level by OSHA for an eight-hour workday exposure but not an acceptable level for long-term exposure in a living environment. Obstacles to Safe Housing Ms. Hooley. And when you found that you were having headaches and not sleeping well and all of that, and as you understood better what was going on, what did you do about getting people out of these mobile homes that had such high levels of formaldehyde? Dr. Sinclair. This is the real challenge because the cure is really to get out of the mobile, of the travel trailers. And Mayor Nagin's request that families be sent to their doctors and doctors give them advice about what to do about their formaldehyde exposure is frustrating for me as a health care provider because my advice is to get out of the travel trailers. So that is basically what we have been doing, is just advising people until you can get out, run the air conditioners, don't smoke inside, don't use---- Ms. Hooley. Did you work with other agencies, though, to find them other housing? I mean, if this was a high exposure, and how successful were you in getting them out of these travel trailers? Dr. Sinclair. The rental market in Baton Rouge is extremely tight right now, as is the rental market in New Orleans, and the list of housing that our case manager was able to find in the Baton Rouge area, we managed to find three apartments for about 300 families. We talked, she also talked with a FEMA case manager. They weren't much more successful. They had about five apartments. Catholic Charities has been very helpful in assisting families. They managed to place 367 families last fall, but it has been a real challenge. And so the other real issue here is the fact of the housing shortage. More on Tracking Residents Ms. Hooley. The question is that I am concerned about, two things, is one, that this never happen again, and two, what are you going to do to track all of those people that were living in these travel trailers that had the high level of formaldehyde? Dr. Sinclair. This has also been a great area of frustration for me because we want to keep track of our families as they move out so that we can continue providing care to them. What we do is we basically just let them know where we are, they have our phone numbers, but there has not been a data bank to keep track of families that have been in the travel trailers. Ms. Hooley. Don't you think that would be a good idea? Dr. Sinclair. I definitely think that would be a good idea. Ms. Hooley. What is it, what do you need to do to make that happen? Dr. Sinclair. FEMA, I talked to FEMA, and they said that they have only kept track of those families that they are still providing rental assistance to. Louisiana Family Recovery Corps is not keeping a list of families that have lived in the travel trailers. Ms. Hooley. Well, maybe all of you--excuse me for interrupting you. Dr. Sinclair. Yeah. Ms. Hooley. But it seems to me that you have got several agencies involved and that you might sit down and talk to one another and say, this is something that we really need to do and begin that process and who is in charge and who is going to do it, how are you going to do that in a concerted effort, because it is not okay to say, well, you know, this agency is doing this, this agency is doing that, and then when you end up nobody is really doing it. Dr. Sinclair. I agree. Ms. Hooley. Okay. I hope that happens. Do I have any time left? No. Dr. Sinclair. I agree, because it has been really difficult to find out where people are going and follow their health. Trivializing Health Concerns Ms. Hooley. Okay. But I think it is incumbent upon all the agencies that are involved to, in fact, do that. I just have a quick question for Ms. Gillette. Why do you think they have trivialized the health problems? I mean, that, you brought that up in your testimony. Ms. Gillette. I think there are a couple of things. One is I don't think that, I think it was hard for people to believe that this housing was as toxic as it was because it is stuff that is sold to the general public. And so then there was the issue, well, what do we do about it, and there aren't affordable housing out there. I know people who have loved ones who have died in the trailers they think were killed by the formaldehyde. They are still living in the trailers. They don't have anywhere else to go. Ms. Hooley. So what do you see the solution? Ms. Gillette. Well, the big--the one bigger solution is that you have to reform how the CDC works and so that it stops, you know, covering for big polluters. It is more interested really in corporate America than it is the health of the people. And that is a big problem. These health consultations that are done across the country almost never find any connection between huge amounts of pollution and people being sick and dying all around there. And so until you change that mindset that, oh, we really just can't prove that all that toxic pollution is causing these people to die, you know, it harms all of us. Because if you have pollution on the Gulf Coast that is not controlled because the ATSDR says there is no connection between the pollution and the health affects, well, guess where you get a lot of seafood from? People all over the U.S. are eating seafood that is contaminated by dioxin and other pollutants. Ms. Hooley. So I shouldn't eat seafood from the South? Ms. Gillette. Well, they don't want, you know, the South is not going to want you to say that, but especially the bigger fish you don't want, you know, that magnify the pollution. But my point is like when dioxin goes up in the air and it, you know, the whole population of the U.S. is overexposed to dioxin now. We are getting it in our food, we are getting it in our air, and we need to reduce our pollution, and we can't do that as long as we have a federal agency that keeps telling people that pollution doesn't matter, that it is not really harmful. Ms. Hooley. Mrs. Huckabee, I just have one thing. It is not really a question. I am so sorry this happened to your family and hopefully this won't happen in the future. Chairman Miller. Thank you, Ms. Hooley. The fact that things happen in the South doesn't mean that it wasn't Northerners doing it. Mr. Lampson for five minutes. Health Care Costs Mr. Lampson. Thank you, Mr. Chairman. I particularly want to thank you for letting me sit in on your committee, and I want to commend you and Ranking Member Sensenbrenner for the work that you have both done in bringing out these atrocities, and they are atrocities. It is hard to believe that something like this could happen in our country, particularly following a time when so many people have had trauma already. But I just, a couple of questions because most of what I wanted to ask has been put into the record, but let me start with Mrs. Huckabee. Many families have to bear the brunt of thousands of dollars of health care costs. I know that FEMA established a program to reimburse for many of the medical bills. Do you know about how much you have spent? Have you asked for that money back? Have you asked for a reimbursement, and have you received any reimbursement from FEMA at this point? Mrs. Huckabee. No. Absolutely no reimbursement. In fact, I heard a rumor that there was--that they were doing that. We faxed in all of our medical information, notes from our doctors, and heard absolutely nothing back from FEMA. So if they are, in fact, reimbursing people, that is brand new news to me. Mr. Lampson. Thank you. Do you think they should? Mrs. Huckabee. I believe so. I mean, if it is, you know, if you have got, you know, several doctors saying, look. This was if not 100 percent caused, it was definitely made worse, but I think FEMA is having enough problems coming up with the things that they have already said they are going to do as far as food vouchers and things like that. They haven't got a grasp on that yet either. Formaldehyde's Effects on Reproductive Health Mr. Lampson. Dr. Sinclair, do we know the long-term health affects of chronic formaldehyde exposure, and can the toxicity be passed on to future children and grandchildren of these residents? Dr. Sinclair. We do not know. There have been fairly convincing links to formaldehyde exposure to nasal-pharyngeal cancer and nasal cancers and probably throat cancer, lung cancer, and possibly blood disorders such as leukemias. There is conflicting evidence about affects on reproductive health. There are possible correlations from occupational studies that may have, may link formaldehyde to premature births and miscarriages, but, again, there haven't been long-term studies of exposure in living environments. There have been cell studies that show that formaldehyde at fairly low levels can be genotoxic and cause changes to chromosomes and breakage of sister chromatids and may be related to birth defects. But this isn't clear. Population Size Mr. Lampson. Do you know how many people have been involved with these trailers? Do we know that number? Dr. Sinclair. Tens of thousands have lived in the travel trailers. Mr. Lampson. We have got an approximate number. We don't know the number. Dr. Sinclair. FEMA has an exact number of families that have lived in the travel trailers. Voice. One hundred and forty thousand. Dr. Sinclair. Yeah. One hundred and forty thousand. Mr. Lampson. One hundred and forty thousand trailers. Dr. Sinclair. Families. Mr. Lampson. Families. Dr. Sinclair. Yeah. At Renaissance Village, which is the largest FEMA trailer village in Louisiana, there have been over 800 families that have moved in and out of Renaissance Village, and the peak population there, estimates range from 1,400, the official number, to about 2,500, the unofficial number, including friends and families that were living with others in the travel trailers. Mr. Lampson. I thank you very much, and I will yield back my time, Mr. Chairman. Chairman Miller. Thank you. And I thank this first panel. We will now take just a two-minute break and have our second panel. [Recess.] Panel II: Chairman Miller. I would now like to introduce our second panel. Dr. Meryl Karol is a Professor Emerita of Environmental and Occupational Health Sciences at the University of Pittsburgh. She is a former President of the Society of Toxicology and the former Secretary General of the International Union of Toxicologists. Dr. Christopher De Rosa is the former Director of the Division of Toxicology and Environmental Medicine at ATSDR, the former and his title is now a matter of dispute. As our witnesses should know, the, from having observed the previous panel and from what we have already told them, the oral testimony, the spoken testimony should be limited to five minutes each with some indulgence, after which the Members of the Committee will ask five minutes of questions each. It is, again, the practice of the Subcommittee to take testimony under oath. Do either of you have any objection to being sworn in, to be, swearing an oath? Okay. You also may be represented by counsel. Is, are either of you represented by counsel at this hearing today? If you would now please stand and raise your right hand. [Witnesses sworn] Chairman Miller. Both the witnesses have taken the oath. Dr. Karol, you may begin. STATEMENT OF DR. MERYL H. KAROL, PROFESSOR EMERITA, UNIVERSITY OF PITTSBURGH Dr. Karol. Chairman Miller, Mr. Sensenbrenner, Members of the Subcommittee, thank you for inviting me to testify today. In describing my background I am a former President of the Society of Toxicology. I was also the Secretary General of the International Union of Toxicologists. This is an association of toxicologists from all six continents. Academically I was Associate Dean for Research and Academic Affairs at the Graduate School of Public Health at the University of Pittsburgh, and currently I am Professor Emerita of Environmental and Occupational Health Sciences at the University. I wish to stress that my testimony today reflects only my opinions. As a toxicologist I have conducted research for 34 years on mechanism of chemically-induced lung and skin diseases. I have conducted research on formaldehyde, focusing on allergic sensitization following both skin and lung exposure. This research was supported by both the NIEHS and by NIOSH. I have published nearly 200 scientific articles, books, book chapters, and monographs. Particularly relevant is a 2007, monograph entitled, Improving Indoor Environmental Quality for Public Health, and that discusses effects of indoor environments on human health. In the brief time that I have available today, and it will be five minutes, I would like to comment on one of the major recommendations of the ATSDR February, 2007, health advisory. Specifically, that 0.3 ppm concentration of formaldehyde be designated a level of concern for sensitive individuals. The level of concern being defined as a level above which individuals with hypersensitivity to formaldehyde would suffer adverse health affects. In my opinion this level has to be lowered. In outdoor air formaldehyde is normally present in concentrations around 0.002 parts per million. Indoors the concentration is typically ten to 20 times higher, depending on various factors such as construction materials, furnishings, the age of the housing. With newer homes typically releasing more formaldehyde by off-gassing. Heat and ventilation also affect the formaldehyde concentration. Most people can detect the presence of 0.5 ppm formaldehyde by its odor. This and higher concentrations typically causes eye, nose, and throat irritation with symptoms of eye tearing or perhaps eye, nose, and throat burning, hoarseness, cough, difficulty in breathing. However, formaldehyde can be irritating at a concentration that is even lower. A percentage of the population develops eye irritation when exposed to a concentration below the odor threshold and around the 0.3 stated level of concern. Sensitive individuals may have adverse affects when exposed to yet lower concentrations. Such individuals would include those with hyperactive or twitchy airways, those with underlying disease or with a viral infection of the lungs, among other concerns. Infants and the elderly would reasonably be expected to be more responsive to irritants such as formaldehyde. Their narrower airways make children more susceptible than adults to agents such as irritants that cause airway constriction. The ATSDR proposal of February, 2007, suggests 0.3 ppm formaldehyde as a level of concern for sensitive individuals. The basis for this proposal was the OSHA guideline for acceptable workplace exposures, with a maximum of 0.7 ppm formaldehyde averaged over an eight-hour work shift. It must be emphasized that the OSHA permissible exposure is an occupational standard established for healthy adults expected to have only an eight-hour exposure. In order to apply this guideline to indoor environments that would be safe for the general population, one must lower their permissible concentration because the population is diverse, not only with respect to age but with respect to underlying health status and concurrent environmental exposures. And they may be exposed for 24 hours a day. Ten years ago a review was published that critically looked at 150 scientific articles on formaldehyde and concluded that eye irritation occurred at 0.24 ppm in about 20 percent of the population, and these are non-sensitive subjects. The authors of that article concluded that an indoor environment where exposures might occur 24 hours a day could maintain a concentration of formaldehyde below 0.1 ppm, and that would protect virtually all persons. In summary, to protect residents against adverse affects from formaldehyde inside their trailers, guidelines must take into consideration the diversity of the exposed population, as well as the diversity of the indoor environment, including the temperature, ventilation, furnishings, and other chemicals. Suggestion that 0.3 ppm be designated a level of concern for formaldehyde might protect non-sensitive individuals, but it would not protect those that are sensitive. The level of concern should be lowered and should not exceed 0.1 ppm. Uncertainty remains regarding the likelihood of chronic health affects resulting from continued formaldehyde exposure in trailers. And for this reason the level of concern have to be revisited periodically. [The prepared statement of Dr. Karol follows:] Prepared Statement of Meryl H. Karol Chairman Miller, Mr. Sensenbrenner, Members of the Subcommittee. Thank you for inviting me to testify today. In describing my background, I am a former President of the Society of Toxicology, USA, a professional organization of approximately 6,000 scientists from academia, government, and industry. I am also a former Secretary- General of the International Union of Toxicologists, an association comprised of 51 national societies of toxicology from all six continents. The goal of the International Union is to increase the knowledge base of toxicology and to extend this knowledge to other nations and societies. Academically, I am the former Associate Dean for Research and Academic Affairs at the Graduate School of Public Health at the University of Pittsburgh, in Pennsylvania. Currently, I am Professor Emerita of Environmental and Occupational Health Sciences at the University. I wish to stress that my testimony today reflects only my opinions. As a toxicologist, I have conducted research for 34 years on mechanisms of chemically-induced lung and skin diseases. This research has been supported by the NIEHS, NIOSH, USDA, and grants from industrial corporations and professional associations. I have published more than 170 refereed scientific articles that are focused on chemical toxicity and have authored and edited several books, book chapters and monographs. Particularly relevant is a monograph (of which I was an editor) entitled, Improving Indoor Environmental Quality for Public Health. The monograph (1), published in the June 2007 issue of Environmental Health Perspectives, is comprised of six articles by international experts in indoor air quality. It contains discussion of the effects of indoor environments on human health. I have lectured extensively, both nationally and internationally on indoor environmental quality, including meetings organized by the World Health Organization. I have taught graduate classes in environmental and occupational health, principals of toxicology, and methods in toxicology. I currently serve on the Scientific Advisory Board of the EPA, and on the National Research Council's (NRC) Committee on Toxicology. I chair the NRC Committee on Toxicologic and Radiologic Effects from Exposures to Depleted Uranium During and After Combat. Regarding my work with formaldehyde, I have conducted research that focused on the potential allergic sensitization from skin and pulmonary exposure to formaldehyde. This research, supported by both NIEHS and NIOSH, resulted in the development of an animal model of formaldehyde sensitization, and also led to the development an immunologic assay to detect the presence in serum of antibodies directed to formaldehyde (2). In the brief time I have available today, I would like to comment on the ATSDR's health advisory (issued February 2007) on formaldehyde levels in FEMA-provided trailers, and to specifically address one of its major recommendations, i.e., that a 0.3 ppm concentration of formaldehyde be designated a ``level of concern'' for sensitive individuals. A level of concern has been defined as the level above which individuals with hypersensitivity to formaldehyde would suffer adverse health effects. What is Formaldehyde Hypersensitivity? Formaldehyde is normally present in low concentrations, around 3mg/ m<SUP>3</SUP> (2.5 ppb), in the outdoor air. Indoor, the concentration is usually higher and may reach 25-50 ppb depending on numerous factors that include: the construction materials used, furnishings, the age of the housing (newer homes would be expected to release formaldehyde by off-gassing from materials). Other factors that also contribute to formaldehyde concentrations within homes include the heating and ventilation systems. Most people can detect the presence of 500 ppb (0.5 ppm) formaldehyde in the atmosphere by its characteristic odor. At this and higher concentrations, it typically causes eyes, nose and throat irritation with symptoms of eye tearing or perhaps eye, nose and throat burning, hoarseness, cough, or difficulty breathing. However, formaldehyde can be irritating, especially to the eyes when present in a concentration that is lower than this odor threshold. As I will discuss later, it is known that a considerable percentage of the population develops eye irritation when exposed to 0.24 ppm formaldehyde, a concentration considerably below its odor threshold (3) and the ``level of concern.'' There exist sensitive individuals, people who may have an adverse response when exposed to still lower concentrations of formaldehyde, i.e., concentrations that are below the level that causes health effects in the majority of people. Such individuals would include those with hyperreactive ``twitchy'' airways, those with underlying respiratory disease, with a viral infection of the lungs, among others. Infants and the elderly would reasonably be expected to be more responsive to irritants such as formaldehyde. Their narrower airways make children more susceptible than adults to agents such as irritants that cause airway constriction. The Formaldehyde ``Level of Concern'' The ATSDR Health Consultation of February 1, 2007 offers 0.3 ppm (369mg/m<SUP>3</SUP>) formaldehyde as a concentration associated with the narrowing of the lung bronchi in sensitive individuals (4). This statement implies that most individuals (i.e., those without sensitivity) would not be adversely affected upon exposure to 0.3 ppm formaldehyde. Unfortunately, the Consultation statement is contrary to published reports that provide evidence that 0.3 ppm is not a protective concentration even for the general population. It certainly would not be protective for the more susceptible persons, i.e., those described above. The basis for establishment of the 0.3 ppm level of concern is a 2001 ATSDR document (5) that lists OSHA permissible exposure limit (PEL) of 0.75 ppm formaldehyde (averaged over an eight-hour workshift) as a guideline for an acceptable exposure level. However, it must be emphasized that the PEL is an occupational standard, established for healthy adults, individuals expected to have only an eight-hour (workday) exposure. In order to use this guideline to set indoor environmental exposures that are safe for the general population, one must consider applying safety factors that would lower the permissible concentration of formaldehyde to make it appropriate for a population that is diverse with regard to age, underlying health status, concurrent environmental exposures, and may be exposed for 24 hr/day. October 2007 Revision of the Feb. 2007 ATSDR Health Consultation The October 2007 revision sought to address, among other items, the deficiency in the Feb. 2007 report regarding the insufficient discussion of the health implications resulting from formaldehyde exposure. It addressed the question, ``Are air formaldehyde levels in closed, unventilated trailers high enough to be associated with health effects in humans?'' When corrected, the air samples taken in closed trailers yielded an average value of 1.04 ppm formaldehyde (with some values extending to 3.5 ppm). Concentrations in air-conditioned trailers averaged 0.39 ppm, whereas concentrations in trailers with open windows were 0.09 ppm. The advisory correctly concluded that the levels in the air-conditioned trailers exceeded federal exposure guidelines. OSHA warns that ``Airborne concentrations of formaldehyde above 0.1 ppm can cause irritation of the respiratory tract'' (6). Guidelines for safe formaldehyde exposure What are the known effects of formaldehyde on humans? Which are the susceptible populations? What guidelines are appropriate to protect the health of human sub-populations? Irritation Formaldehyde is known to cause irritation of the eyes, nose, throat and respiratory tract. During the past 60 years, the Occupational Exposure Guideline for formaldehyde (to prevent irritation reactions in workers) has been revised downward from 10 ppm in 1947 to 0.3 ppm (as a ceiling value) in 1992. In 1997, a panel of experts critically reviewed 150 scientific articles related to formaldehyde to derive an occupational exposure limit that would prevent irritation (3). The panel found that eye irritation occurred at concentrations lower than those that caused nose/throat irritation and concluded that it was the most sensitive irritative effect. They found reports of eye irritation at 0.24 ppm (19 percent of 16 subjects) clearly indicating the variation that exists among humans with regard to this endpoint. The panel concluded that maintaining a formaldehyde concentration below 0.1 ppm in the indoor environment where exposures might occur 24 hour/day might avoid irritation in virtually all persons. In agreement, the current OSHA guideline states that between 0.1-0.5 ppm, irritation may occur in some individuals. Chronic airway disease Formaldehyde does not appear to pose a hazard for pulmonary emphysema or chronic obstructive pulmonary disease (COPD). Allergic sensitivity Formaldehyde has been associated with allergic skin sensitivity in humans and animals (2). It remains uncertain whether inhaled formaldehyde will or will not induce lung sensitization in humans (7) although controlled animal studies have failed to detect this response (2). Cancer Based on the reported concentration-dependent carcinogenic effect of formaldehyde in rats and mice, and on inadequate epidemiologic data on the cancer risk in humans, ACGIH (1989) recommended that workplace formaldehyde exposures be reduced to the ``lowest possible level.'' ACGIH has adopted the 0.3 ppm TLV-CV (ceiling value) for formaldehyde and lists it as an A2 suspected human carcinogen. There is considerable controversy regarding the conclusion that formaldehyde causes cancer in humans. In 2004, the International Agency for Research on Cancer (IARC) reclassified formaldehyde as a Group 1 carcinogen based largely on the results of the National Cancer Institute (NCI) study on nasopharyngeal cancer (NPC). However, the NPC findings in the NCI study were driven by a large excess in one plant (6 or 10 cases from that one plant). Nine other plants collectively had no NPC excess, nor was an NPC excess observed in two other cohort studies, one by NIOSH and one in the UK. The NCI nasal pharyngeal excess driven by one plant was the subject of several papers by the Marsh group. In a recent update (8), the investigators found that the large NPC excess in this plant appears to be due to prior employment in the metal working industries of the local area, where exposures to many agents known or suspected to cause upper respiratory cancers (e.g., sulfuric acid mists, mineral acid, metal dusts and heat) have occurred. The causal association of formaldehyde with leukemia has also been questioned. A reanalysis (9) of the data provided little evidence to support a causal association between formaldehyde exposure and mortality from leukemia. Summary and Recommendations The literature regarding the adverse effects from formaldehyde indicates the potential for both acute and chronic health effects. Guidelines for safe exposure to formaldehyde to protect against these effects have been established for the workplace. To protect residents against adverse effects from formaldehyde inside their trailers, guidelines must take into consideration the diversity of the exposed population (including age and underlying health conditions) as well the diversity of the indoor environment (including the temperature, ventilation, furnishings, other airborne chemicals). The suggestion that 0.3 ppm be designated a ``level of concern'' for formaldehyde would not protect sensitive or nonsensitive individuals from irritation reactions. The level of concern should be lowered and not exceed 0.1 ppm. Uncertainty remains regarding the likelihood of chronic adverse health effects resulting from continued formaldehyde exposure in trailer residences. References 1. Wu F., Jacobs D., Mitchell C., Miller D., Karol M.H. Improving indoor environmental quality for public health: impediments and policy recommendations. Environ Health Perspect 115:953-957, 2007. 2. Lee, H.K., Alarie, Y. and Karol, M.H. Induction of formaldehyde sensitivity in guinea pigs. Toxicol App Pharmacol 75:147-155, 1984. 3. Paustenbach D., Alarie Y., Kulle T., Schachter N., Smith R., Swenberg J., Witschi H., and Horowitz S. A recommended occupational exposure limit for formaldehyde based on irritation. J Toxicol Environ Health 50:217-263, 1997. 4. Agency for Toxic Substances and Disease Registry, Health Consultation, Formaldehyde sampling at FEMA temporary housing units, February 1, 2007. 5. Agency for Toxic Substances and Disease Registry, Managing Hazardous Materials Incidents, Medical Management Guidelines for Acute Chemical Exposures, Formaldehyde. Atlanta, ATSDR, 2001. 6. OSHA Fact Sheet 2002. 7. Kranke B. and Aberer W. Indoor exposure to formaldehyde and risk of allergy. Allergy 55:402-404, 2000. 8. Marsh G., Youk A.O., and Morfeld B. Mis-specified and non-robust mortality risk models for nasopharyngeal cancer in the National Cancer Institute formaldehyde worker cohort study. Regulatory Toxicol and Pharmacol 47:59-67, 2007. 9. Marsh G. and Youk A.O. Reevaluation of mortality risks from leukemia in the formaldehyde cohort study of the National Cancer Institute. Regulatory Toxicol and Pharmacol 40:113-124, 2004. Chairman Miller. Thank you, Dr. Karol. Dr. De Rosa. STATEMENT OF DR. CHRISTOPHER T. DE ROSA, ASSISTANT DIRECTOR FOR TOXICOLOGY AND RISK ASSESSMENT, NATIONAL CENTER FOR ENVIRONMENTAL HEALTH/AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dr. De Rosa. Good morning, Chairman Miller and Ranking Member, Mr. Sensenbrenner, and other distinguished Members of the Subcommittee. I am Chris De Rosa, and I have been working for the Federal Government for 28 years. Today I will respond to the issues posed in your letter of invitation dated February 27, 2008. I would like to note for the record that I am not here as a representative of ATSDR, but rather as an individual. I would also like to emphasize that my remarks today and other stated concerns should no way be construed as a reflection on many of the highly-talented and motivated, well-intentioned staff of my agency. I served as the Director for the Division of Toxicology and Environmental Medicine at ATSDR from 1991, until 2007. I have a degree in ecology, Master's degree, and a Ph.D. in biology from Miami University of Ohio and have held academic appointments at the Universities of Virginia and Maine over a period of 10 years. Before coming to ATSDR in '91, I worked for the EPA's Office of Research and Development for 10 years as Branch Chief and then Acting Director of the Environmental Criteria and Assessment Office. I am author or coauthor of over 200 peer-reviewed publications and have served on the editorial review committees of over ten professional journals. I have been a charter member of the World Health Organization Steering Group for Risk Assessment since 1994. I am a member of the American College of Toxicology and one of the 180 elected fellows of the Collegium Ramazzini. The mission of ATSDR is to serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and disease related to toxic substances. There are a range of activities that ATSDR undertakes as a response to the health mandates outlined in the CERCLA or Super Fund Legislation. Of these, one of these is a health consultation, developed as a formal response to time-sensitive issues as was the case in the aftermath of Hurricane Katrina. Following the Agency's initial response to this tragic event, ATSDR was also engaged in ongoing verbal and written evaluations and discussions for a wide range of information on behalf of EPA and FEMA. These included the evaluation of formaldehyde levels in the air of unoccupied FEMA trailers. In contrast to a health consultation, such evaluations are more informal, usually verbal, periodic discussions of available data as it emerges. Initial discussions regarding sampling protocols and data collection of formaldehyde in trailers used by EPA, used by FEMA, and analyzed by EPA began in June of 2006. Because of the sensitivity of emergency events and preparedness and other coordination activities, I began a series of weekly reports in 1999, for all senior staff including senior agency leadership. These reports summarized significant events in these often time-sensitive programmatic areas. The details that we provided regarding the work we did in support of EPA and FEMA were frequently included in these reports. In early December 2006, Dr. Howard Frumkin stated to me I had not kept him adequately informed of the fact that we were evaluating samples on behalf of FEMA that were collected by EPA. I advised Dr. Frumkin that this was a routine collaboration that has occurred between ATSDR and EPA over a period of 25 years, especially dealing with time-sensitive events of environmental contamination. Dr. Frumkin requested that his name be deleted from the mailing list for these weekly reports in September of 2007, because he found them to be unhelpful. In early December 2006, my division's Emergency Response Team, ERT, was asked to provide an evaluation of EPA's sampling data regarding the levels of formaldehyde in unoccupied trailers. Dr. Frumkin was aware of this evaluation as early as December 4, 2006. At the specific direction of FEMA, its attorney for the Office of Legal Counsel, my division's ERT did not share the evaluation through the usual division review and approval channels. Instead they provided the drafts of the consultation to the Director's Office of Preparedness, Terrorism, and Emergency Response, OPTER. This was done without my knowledge, and I was unaware of the role of Dr. Frumkin's office in the oversight of this effort until summer 2007. It was through this channel that Drs. Frumkin and Sinks provided review and comment on the draft. During the period between which--is this indicating my time is up, Mr. Chairman? Chairman Miller. No. Mr. De Rosa. Okay. Thank you. I appreciate that. This was done without my knowledge, and I was unaware of the role of Dr. Frumkin's office in the oversight of this effort until summer 2007. It was through this channel that Drs. Frumkin and Sinks provided review and comment on the draft consultation. During the period intervening between the point at which the sampling data was provided to my division's ERT and the release of the consultation to FEMA on February 1, 2007, Drs. Sinks and Frumkin provided review and comment on the draft consultation during this period. At no time did I have any contact regarding this effort with either FEMA or EPA. The health consultation was forwarded to FEMA February 1, 2007. I was unaware of this until receipt of the health consultation on February 27, when a copy of the report appeared upon my desk. After an initial review of the consultation, I immediately contacted Dr. Frumkin's office by telephone and e- mail to state my concerns regarding the limitations of the consultation. I stated the report failed to address longer-term health affects, especially the issue that formaldehyde is a carcinogen. That same day I sent a second e-mail transmitting a proposed amendment to the consult to address these longer-term health concerns. After repeated requests to issue an amendment to the original consult, I was directed by Dr. Frumkin to forward my proposed response to Dr. Mark Keim, then acting Director of OPTER. At this point I concluded that the lead for this effort resided solely within the Office of the Director, specifically the Office of Preparedness, Terrorism, and Emergency Response (OPTER). I had no further involvement with the FEMA consultation until late June 2007, when there was a briefing for Congressional Staff regarding this issue. However, in the interim I repeatedly cautioned Dr. Frumkin and other senior staff regarding the issues confronted by the agency in this matter. For example, on June 1 I wrote to Dr. Frumkin outlining my concerns in response to a request from FEMA to identify, ``safe levels of exposure to formaldehyde.'' I---- Chairman Miller. Dr. De Rosa, if you could summarize your testimony. Mr. De Rosa. Okay. So despite the repeated efforts to bring these issues to the attention of my management, we had very little constructive follow-up effort. I recommended that we use the Health Guidance Values in the toxicological profile for formaldehyde as a point of departure for any discussion regarding safe levels. This was after repeated requests from FEMA to restrict our evaluations to short-term exposures. I did state that as our efforts went forward that health interventions must be pursued to address the clinical manifestations of acute formaldehyde toxicity. I stated that such clinical signs were harbinger of a pending public health catastrophe that may be trans- generational in its impact. And I stressed the importance of alerting residents to the potential reproductive, developmental, and carcinogenic affects of formaldehyde. The response I received was that such matters should not be discussed in e-mails, since they might be misinterpreted. Chairman Miller. Thank you. If you have anything further-- -- Dr. De Rosa. I think I would simply close by saying that I know that this has been a complicated matter for everyone involved, that there are often no straightforward answers to complicated situations. However, I think that we need to invoke the maxim of public health practice articulated by Bernardino Ramazzini four centuries ago, that, ``It is better to prevent than cure.'' And that the precautionary principle should be invoked in matters of this nature. Thank you. [The prepared statement of Dr. De Rosa follows:] Prepared Statement of Christopher T. De Rosa INTRODUCTION Good Morning, Chairman Miller, and Ranking Minority Member Mr. Sensenbrenner other distinguished Members of the Subcommittee. I am Christopher De Rosa and I have worked for the Federal Government for 28 years. Today I will respond to the issues posed in your letter of invitation dated February 27, 2008. I would like to note for the record that I am not here as a representative of The Agency for Toxic Substances and Disease Registry (ATSDR) but as an individual scientist. I would also like to emphasize that my remarks today and other stated concerns should in no way be construed as a reflection on the highly talented, motivated and well intentioned staff at all levels of the ATSDR, as well as the Centers for Disease Control and Prevention (CDC). At present I serve as the Assistant Director for Toxicology and Risk Analysis at the National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention. Previously, I served as the Director, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry (ATSDR) from 1991 to 2007. Prior to my selection as Division Director, I was the Deputy Associate Administrator for Science, also at ATSDR. After receiving my Master's Degree in Ecology and Ph.D. in Biology from Miami University, Oxford, Ohio, I held academic appointments at the Universities of Virginia and Maine over a period of ten years. Before coming to ATSDR in 1991, I worked for the Environmental Protection Agency's Office of Research and Development (EPA/ORD) for ten years. With the EPA, I served as Branch Chief of the Chemical Mixtures Assessment Branch and Acting Director of the Environmental Criteria and Assessment Office (ORD). I have been the recipient of the U.S. EPA Bronze Medal four times and continue to serve on a number of EPA advisory committees. I have also served in a similar capacity for the Departments of Justice, Energy, and Defense and other federal agencies, the World Health Organization (WHO) and a range of foreign countries in Europe, Asia, South America and Africa. I am an author/co-author of over 200 peer- reviewed publications and have served on the editorial/review boards of over ten professional journals. I have been a charter member of the World Health Organizations' Steering Group for Risk Assessment since 1994, and I am a member of the American College of Toxicology, the American Association for the Advancement of Science, and the Research Society of North America and other professional organizations. I am one of 180 elected fellows of the Collegium Ramazzini in the world, a credentialed member of the Senior Biomedical Research Service (1998-2007) and now am classified as a ``Distinguished Consultant'' (ATSDR/CDC). The ATSDR is one of eight operational units within the Department of Health and Human Services, and is co-located with the CDC in Atlanta, Georgia. The mission of ATSDR is ``to serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and disease related to toxic substances.'' It is the primary federal agency that addresses the health mandates of the Comprehensive Emergency Response, Compensation and Liability Act (CERCLA) often referred to as Superfund. ATSDR's mission is remarkably congruent with my own personal mission statement that is ``to be an advocate for public health by translating science into public health service and policy.'' My opinions regarding the range of potential health affects to Formaldehyde exposure are those articulated in ATSDR's Toxicological Profile on this substance. ATSDR's Toxicological Profiles on priority chemicals are peered and publicly reviewed in accordance with the Superfund Authorization Reauthorization and Amendment Act (SARA 1994). There are a range of activities and programs that have been developed to fulfill CERCLA public health mandates. One of these is a ``Health Consultation,'' developed as a formal response to what may be time sensitive issues as was the case in the aftermath of Hurricane Katrina, which occurred in August 2005. Following the Agency's initial response to this tragic event, ATSDR was also engaged in ongoing verbal and written evaluations and discussions for a wide range of information on behalf of EPA and FEMA. This included the evaluation of formaldehyde levels in the air of unoccupied FEMA trailers. In contrast to a Health Consultation, such evaluations are more informal, usually verbal, periodic discussions of available data. Initial discussions regarding sampling protocols and data collection of formaldehyde in trailers used by the EPA began in late June of 2006. Because of the sensitivity of emergency event, preparedness and coordination activities, I began weekly reports in 1999 for all senior staff including senior Agency leadership. These reports summarized significant events in these often, time sensitive programmatic areas. The details regarding the work we did in support of EPA and FEMA were frequently reported in these reports. In early December of 2006, Dr. Howard Frumkin stated to me that I had not kept him adequately informed of the fact that we were evaluating air samples from FEMA trailers collected by EPA and in support of EPA's efforts following Hurricane Katrina. I advised Dr. Frumkin that this was the product of a routine collaboration between ATSDR and EPA for approximately 25 years for time sensitive events involving environmental contamination. These efforts had been reported frequently in the weekly reports to senior management. Dr. Frumkin requested that his name be deleted from the mailing list for these weekly reports in September of 2007 since he found them to be unhelpful. In early December 2006, two members of my division's Emergency Response Team (ERT) were asked to provide an evaluation of EPA's sampling data regarding the levels of formaldehyde in unoccupied trailers. Dr. Frumkin was aware of this evaluation as early as December 4, 2006. At the specific direction of FEMA's attorney, these two members of my division's ERT did not share the evaluation through the usual division review and approval channels. Instead they provided the drafts of the consultation to the Director's Office for Preparedness, Terrorism and Emergency Response (OPTER). However, this was done without my knowledge and I was unaware of the role of Dr. Frumkin's office in the oversight of this effort until summer 2007. It was through this channel that Drs. Frumkin and Sinks provided review and comment on the draft Health Consultation. During the period intervening between the point at which the sampling data was provided to my division's ERT by FEMA's Office of Legal Council (OLC) on December 4, 2006 and the release of the Health Consultation to FEMA on February 1, 2007, Drs. Sinks and Frumkin provided review and comment on the draft consultation. During this period, at no time did I have contact with either FEMA or EPA on this issue. This Health Consultation was forwarded to FEMA on February 1, 2007. I was unaware of this until the receipt of the Health Consultation on February 27, 2007, when a copy of the report appeared on my desk. After an initial review of the Health Consultation, I immediately contacted Dr. Frumkin's office by telephone and e-mail to state my concerns regarding the limitations of the Health Consultation. I stated that the report failed to address longer-term health effects especially the issue that formaldehyde is a carcinogen. That same day I sent a second e-mail transmitting a proposed amendment to the consult to address these longer-term health concerns. After repeated requests to issue an amendment to the original consult, I was directed by Dr. Frumkin to forward my proposed response to Dr. Mark Keim, acting Director of the Office of Preparedness, Terrorism and Emergency Response. This letter amending the February 1st consult was subsequently sent to FEMA over the signature of Dr. Mark Keim on March 17, 2007. At this point, I concluded that the lead for this effort resided solely within the Office of the Director. I had no further formal involvement with the FEMA consultation until late June, 2007, when an impromptu briefing for Congressional Staff occurred, regarding this issue. However, in the interim, I repeatedly cautioned Dr. Frumkin and other senior staff regarding the formaldehyde issue in FEMA trailers. For example, on June 1, 2007, I wrote to Dr. Frumkin outlining my concerns in response to a request from FEMA to identify ``safe levels of formaldehyde exposure.'' I cautioned that since formaldehyde is a carcinogen, it is a matter of U.S. Federal Government science policy, that there is technically no ``safe level'' of exposure. I wrote that the Department of Health and Human Services had classified formaldehyde as ``reasonably anticipated to be a human carcinogen.'' I also wrote that in 1995, the World Health Organization's (WHO), International Agency for Research on Carcinogens (IARC) had classified formaldehyde as ``probably carcinogenic to humans'' while EPA had determined that formaldehyde is a ``probable human carcinogen.'' I further cautioned that: <bullet> formaldehyde may be a reproductive and developmental toxicant; <bullet> it is a irritant as evidenced by the reported symptoms of the children in the trailers in Mississippi; and <bullet> that the overt symptoms would probably trigger sensitization in some proportion of the population, to varying degrees in children and others housed in the FEMA trailers. I also recommended that ATSDR's Health Guidance Values for short- term, intermediate and long-term exposures to formaldehyde be used in assessing the hazards posed by formaldehyde in the FEMA trailers. Dr. Frumkin concurred with my concerns with an e-mail response. Finally, I wrote that to my knowledge this was the third time that we had been approached by FEMA requesting that we provide health guidance on safe levels of exposure to formaldehyde and that we restrict our evaluation to short-term exposures. The first instance occurred in the Spring of 2006 when FEMA requested that I review a draft statement that encompassed only the short-term health information that had been abstracted from our Toxicological Profile. I indicated that FEMA had neglected to address longer-term exposures and indicated that failure to address longer-term health effects could be misleading. Subsequently, starting in the summer of 2007, particularly after Congressional hearings and reports in the media, I repeatedly requested that we initiate health interventions to interdict these exposures and mitigate health effects. This was based on reports of acute clinical signs consistent with formaldehyde toxicity and presented by residents of FEMA trailers. Most importantly, I pointed to the primal need to alert the trailer residents regarding all health hazards. In August 2007, ATSDR began to respond to Congressional requests for documents related to the FEMA trailers. It was during this time that I first became aware that the scope and content of the February 1st consult was specifically directed by Dr. Frumkin's office. Drs. Frumkin and Sinks and senior management of Dr. Frumkin's OPTER, had reviewed and/or had been made aware of the ongoing evaluation of sampling data on behalf of FEMA as early as December 2006. Mr. Don Benkin then Acting Director for OPTER, was involved from the beginning of this activity dating back to June 19, 2006. In discussing this issue at the weekly Senior Staff meeting on Aug. 29, 2007, Dr. Frumkin addressed the need for all staff to grasp the broader public health implications of any request we received from outside agencies. He indicated that it was a failure of my division's ERT to take into account the broader implications of the FEMA request by restricting the review to short-term exposures only (as directed by FEMA's Office of Legal Council), even though the ERT believed they were following the instructions issued by Dr. Frumkin's office. As our efforts in the Gulf Coast Region and elsewhere went forward, I repeatedly requested (albeit without success), that health interventions be pursued to address the clinical manifestations of acute formaldehyde toxicity presented in clinical settings by residents of the FEMA trailers. I stated that such clinical signs were a ``harbinger of a pending public health catastrophe'' that may be ``transgenerational'' in its impact. I stressed the importance of alerting the trailer residents to the potential reproductive, developmental and carcinogenic effects of formaldehyde exposure. The only response I received was that such matters should not be discussed in e-mails since they might be ``misinterpreted.'' In March of 2007, after I reviewed a draft of CDC Director, Dr. Julie Gerberding's proposed response to Congressman Taylor's letter, I responded that there was still no mention of carcinogenicity and that it was not appropriate to compare formaldehyde exposures in trailers to that of conventional housing. Based upon follow-up discussions with my ERT staff regarding the February Health Consultation it was clear to me, Drs. Frumkin and Sinks provided review and comment on multiple occasions prior to the development of the Health Consultation and that they must have been aware of the content and scope of the February 1st consult. I found this to be deeply troubling since the Emergency Response Team's efforts were now being identified as the primary basis for Congressional concerns about the scope and nature of the Agency's conclusions as stated in the first Health Consultation. Internally, Dr. Frumkin stated that the ERT should have been aware of the broader implications of the FEMA request particularly since it involved FEMA's Office of Legal Council. On August 10, 2007 Dr. Frumkin assigned to my division the lead to develop a revised Health Consultation based upon the sampling data provided by FEMA. On September 19, 2007, I forwarded a draft, but unedited, revised consultation, to Dr. Frumkin in response to his comments received the previous day. At that point the document had been completed to the satisfaction of three other divisions within ATSDR who had been involved in the review, data analysis and authorship of the revised consultation. The following day Dr. Frumkin reassigned the lead to his Office of Science. The resulting consultation that appeared in October was notable in that the executive summary was changed to read that health interventions to interdict exposures and or mitigate health effects should be ``identified'' as opposed to ``identified'' and ``implemented.'' Further, some of the references addressing reproductive and developmental effects were deleted. Based upon my concerns, as previously outlined, I wrote a letter on September 21st addressing these and other issues were based on important health findings were not being shared with the public. In this letter I requested a meeting with senior management to identify ``a constructive path forward.'' Drs. Falk, Frumkin, Sinks, and Louise Galaska met with me on October 5, 2007. At that meeting, I was asked what I proposed as a constructive path forward. In response to that question, I stated that it was my hope that they would provide such guidance, since I had already stated my concerns in my letter of September 21, 2007. In response, they stated that they had no guidance to provide. As a result, the meeting was adjourned within 15 minutes and I was told by Dr. Frumkin that he would provide a written response to my letter. After my September 21st letter to Dr. Frumkin, my evaluation, which was scheduled for October 4, 2007, was then deferred until October 22, 2007. The meeting was then rescheduled three different times. Originally it was scheduled to be at 7:30 AM, then at 4:00 PM and then finally at 3:00 PM. Drs. Frumkin and Sinks knew that I was preparing to leave on international travel within the next hour of the appointment scheduled 3:00 PM. The proposed evaluation of my performance was not presented to me for review five days in advance in accordance with Agency guidelines and policy. Due to complications in preparing for my travel, the evaluation was done telephonically, as it was done in the previous evaluation cycle. I was told that my evaluation was ``unsatisfactory.'' When I asked why, I was told that I was not a ``team player.'' Subsequently my written evaluation was presented to me by Dr. Frumkin three minutes before the beginning of the Ramazzini Award Ceremony and Presentation in Carpi, Italy. This was done in a public forum, in the presence of my father, who attended the meeting as my guest, as well as colleagues with whom I was seated near the front of the auditorium. At that same time, Dr. Frumkin also presented me with a memorandum stating that I was being removed from my position as Division Director. This memorandum stated that I was being reassigned to a position that had no job description until December 20, 2007. Since this was the first day of my annual holiday leave, I did not receive the written job description until January 7, 2008 when I returned to work. My office was moved in November 2007; in December 2007 and again in February 2008 involving three offices and two geographic locations. In summary, I was removed from my position after 16 years of superior performance and having met or exceeded 95 percent of all of my division's performance objectives in the past three years. In 2006, an independent year long external peer review of all division activities concluded that my former division was ``meeting an important national need,'' that our Division's consensus based ``goals and objectives'' were consistent with this ``national need and the mission of the Agency'' and was ``performing at a high level.'' As a voting member of the credentialing committee for the Senior Biomedical Research Service since 1998, one of 180 elected Fellows of the Collegium Ramazzini, and having served on the editorial boards for over 10 professional journals, I know that scientists can make mistakes. However, the only rationale provided to me at the time of my evaluation was that I was not a ``team player.'' There were no written narratives associated with the evaluation presented to me in Italy, addressing the rationale for the elements in my performance plan that were rated as unsatisfactory. As documented in my curriculum vitae, I have served as an expert witness on behalf of the U.S. Government on multiple occasions (in which the government prevailed). I currently serve on approximately 25 committees of national and international significance and have served as author or co-author on approximately 200 publications. I have made numerous invited and plenary presentations on behalf of multiple organizations, including: the National Academy of Sciences, the Institute of Medicine and the National Institutes of Health, The EPA, and the WHO. Nevertheless, in Dr. Frumkin's response to my September 21st letter, he maligned my technical ability, communication skills, managerial competence and my professional reputation. The issues addressed in my testimony today, as well as others conveyed in my September 21, 2007 memo to Dr. Frumkin presented me with a profound professional dilemma. In addressing this dilemma, I recalled a framed document entitled The Centers for Disease Control and Prevention's ``Pledges to the Citizens of the United States'' which was displayed in my former office. One of the five points in this pledge, that served as a key point in my own deliberative process was that ``We will place the benefit to society above the benefits to the institution.'' I also recalled the first time when I was undergoing the background investigation for top secret security clearance several years ago. The best advice I was given was to ``speak the truth even when it hurts.'' Finally, I recalled the central core of public health practice and environmental medicine first articulated by Bernardino Ramazzini four centuries ago. ``That it is better to prevent than cure.'' This is what I have attempted to do addressing the FEMA trailers issue. This is what I am continuing to pursue in this and other matters. In addition to the FEMA consultation, my letter of September 21, 2007 also addressed the Great Lakes Report and the presence of the carcinogen 1,4-Dioxane in baby shampoos, bubble bath and approximately 30 percent of cosmetic products. These were the three issues that were addressed in Dr. Frumkin's response to my letter, and that were used to justify my unsatisfactory rating. I pursued these issues because I believe important public health information, that had been vetted in accordance with all Agency review and clearance procedures, was being withheld from the public. Accordingly, it was not available to promote the best informed public health decisions by citizens, community leaders, health care professionals and those responsible for the oversight of public health more generally. Given the visibility of my former position within the Agency, and what had been viewed as a respected contribution to the Agency's goals and mission, my removal, which closely followed my attempt to speak the truth to authorities, sends a chilling message, not only to other Agency employees, but to all federal employees and more importantly those dependent upon support from our nation's federal agencies. Citizens of the United States who pay for the services provided by these agencies should benefit from the best possible scientific information in a timely, responsive, and responsible fashion. Because of my commitment to this concept, it is my ardent desire to be reinstated to my former position as Director of the Division of Toxicology and Environmental Medicine which has been the very heart of my professional career. I would like to express my sincere thanks to the Members and staff of this subcommittee for their time and attention concerning these matters. Biography for Christopher T. De Rosa Born: Cincinnati, Ohio, June 18, 1949. Married (28 years), four children (ages 27, 24, 21, 18). EDUCATION: B.A. Ohio Wesleyan University, Delaware, Ohio, 1971 (Pre-professional). M.S. Miami University, Oxford, Ohio, 1974 (Ecology). Ph.D. Miami University, Oxford, Ohio, 1976 (Biology). CERTIFICATION: Credentialed Distinguished Consultant (2007-present) Credentialed Member of the Senior Biomedical Research Service (SBRS). ATSDR/CDC (1997-2007) Security Clearance: Top Secret Elected Fellow of the Colloquium Ramazzini (1995-present) POSITIONS: 2005-Present Director, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, Atlanta, Georgia. Duties: As below and 1. Coordinates professional development programs across ATSDR and with external partners. 2. Develops educational materials in support of Environmental Medicine. 1992-2004 Director, Division of Toxicology, Agency for Toxic Substances and Disease Registry. Atlanta, Georgia. Duties: 1. Development and implementation of an integrated program of toxicology, encompassing the listing and prioritization of hazardous materials identified at National Priorities List Sites, a critical assessment of the available world literature on priority chemicals, and identification of priority data needs. 2. Supervise a scientific and technical support staff of 60 individuals in three Branches, two Sections and the Office of the Director, and 12 on site contractors. 3. Direction of strategic planning for implementation of applied research. 4. Coordination of programs with the EPA, NTP, WHO, IPCS, and NIEHS, the public, the private sector, and other interested parties. 5. Development and implementation of ATSDR's emergency response, preparedness, and prevention programs based upon peer review research findings and scientifically sound decision support methods. 6. Coordinates professional development programs across ATSDR and with external partners. 7. Develops educational materials in support of environmental medicine. Reason for leaving: Reorganization 1991-1992 Deputy Associate Administrator for Science and, Acting Director, Division of Toxicology, Agency for Toxic Substances and Disease Registry. Atlanta, Georgia. Duties: 1. Direct and manage the technical planning and implementation of a scientific health risk assessment and related methodology research program for the agency. 2. Provide leadership for the agency's determination of public health action levels. 3. Provide leadership and agency-wide coordination and evaluation of the agency's risk assessment activities. 4. Share with the Associate Administrator responsibility for developing and implementing research plans and science policy for the agency, including: interagency liaison (CDC/NIH/EPA), five-year research plans, liaison with WHO, United Nations, coordination of research with other relevant programs, quality assurance strategy for research activities, and management of the agency's Board of Scientific Counselors. 5. Serve as agency spokesperson in matters of science, especially regarding risk assessment and exposure action levels. Reason for leaving: Selection as Director, Division of Toxicology. Agency for Toxic Substances and Disease Registry, Atlanta, Georgia. 1989-1991 Acting Director, Environmental Criteria and Assessment Office. United States Environmental Protection Agency. Cincinnati, Ohio. Duties: 1. Responsible for the oversight of the technical planning and implementation of a scientific health risk assessment and related assessment methodology research program. This includes responsibility for the oversight of approximately 40 technical staff and an annual budget of five million dollars. 2. Provide leadership for the establishment and operation of the administrative/resource management/supervisory and scientific/technical support systems and office infrastructure necessary for the daily operation of the office. 3. Provide scientific leadership to the ECAO office, and also to the Office of Health and Environmental Assessment, Office of Research and Development, and other EPA offices in the area of health risk assessment and research to insure the technical quality of activities. 4. Function as a senior scientist, manager, and policy-making official of the Office of Health and Environmental assessment, Office of Research and Development, and EPA and represent these organizations in appropriate professional, scientific, regulatory, public health, and public policy-making activities. Reason for leaving: Growing Interest in Public Health Practice and Policy. 1986-1989 Branch Chief: Chemical Mixtures Assessment Branch, Environmental Criteria and Assessment Office. United States Environmental Protection Agency. Cincinnati, Ohio. Duties: 1. Planning and coordination of office activities in support of Superfund (CERCLA) and Solid Waste (RCRA) legislative mandates. 2. Group leader of ECAO scientists with the specific mission of providing scientific and technical expertise assessment of chemical mixtures. 3. Oversight of authorship, review of methods and technical reports in the fields of ecotoxicology and health effects assessment. 3. Provision of technical advice to public and private sector scientists. Reason for leaving: Promotion 1985-1986 Acting Branch Chief: Chemical Mixtures Assessment Branch, Environmental Criteria and Assessment Office. U.S. Environment Protection Agency. Cincinnati, Ohio. Duties: As above 1984-1985 Group Leader, Chemical Mixtures Assessment Group, Environmental Criteria and Assessment Office, U.S. Environmental Protection Agency, Cincinnati, Ohio. Duties: As above but without budgetary responsibility. Reason for leaving: Promotion 1982-1984 Assistant Professor of Botany/Zoology. University of Maine, Oromo, Maine. Duties: 1. Development of introductory biology lectures (enrollment 1,500 students/year, 20 graduate teaching assistants). 2. Development of introductory biology laboratories. 3. Participation in team taught courses and seminars for undergraduate and graduate students. 4. Design, implementation and funding procurement for research projects, publications in appropriate journals, presentations at professional meetings, and supervision of student research. Reason for leaving: Recognized impact of environmental programs on human health. 1980-1982 Environmental Health Scientist/Ecologist, Environmental Criteria and Assessment Office, U.S. Environmental Protection Agency, Cincinnati, Ohio. Duties: 1. Provide office expertise on health and ecological effects of environmental pollutants. 2. Document manager, contributor for 11 water qualifies criteria documents. 3. Preparation of other criteria documents, hazard profile summaries, scientific and technical assessment reports, risk assessment methods for single chemicals and complex mixtures, and special reports. 4. Project officer on contracts pertaining to the effects of environmental agents on health and the stability of exposed ecosystems; ensure the adequacy of extramural scientists' reviews and evaluations, review drafts for scientific and technical accuracy, assure conformance to agency policy, and make revisions and modifications as necessary. Reason for leaving: Interest in teaching and basic research. 1977-1980 Assistant Professor, Department of Biology, University of Virginia, Charlottesville, Virginia. Duties: 1. Development and delivery of introductory biology lectures (enrollment 1,000 students/year. 2. Development and delivery of additional courses in Genetics, Cell Physiology, and Biochemistry, Behavioral Ecology and Specialty Seminars for advanced students. 3. Design, implementation, and funding procurement for research projects, publications in appropriate journals, presentations at professional meetings and supervision of student research. Reason for leaving: A growing interest in applied aspects of ecological and environmental health research. 1976-1977 Instructor, Department of Biology, University of Virginia, Charlottesville, Virginia. Duties: 1. Lecturing in introductory biology. 2. Supervision, development, and coordination of undergraduate laboratories, including equipment, experiments, demonstration materials, organizational format and staff. 3. Initiation of personal research program in applied ecology. 4. Development of Advanced Placement (AP) Curriculum for High School Biology in State of Maine. Reason for leaving: Promotion. 1975-1976 National Science Foundation Research Fellowship, Department of Zoology, Miami University, Oxford, Ohio. Duties: Design and implementation of environmental research projects. These responsibilities included the development of equipment, definition of research aims, utilization of computer programs for statistical analysis of data, and publication of results. Reason for leaving: Graduation and faculty appointment at University of Virginia. 1973-1975 Teaching Assistantship, Department of Zoology, Miami University, Oxford, Ohio. Duties: Preparation and implementation of undergraduate and graduate biology laboratories in biochemistry, zoology, physiology, and ecology. Reason for leaving: Research appointment. 1972-1973 Laboratory Assistant, Laboratory Assistant, Miami University, Oxford, Ohio. Duties: Preparation of solutions and laboratory materials for use by students. Reason for leaving: Teaching appointment. HONORARY AND PROFESSIONAL ORGANIZATIONS: American Society of Integrative and Comparative Biology. American Association for the Advancement of Science. Animal Behavior Society. Ecological Society of America. Society of the Sigma Xi (Scientific Research Society of North America). Society for Risk Analysis. American College of Toxicology. Elected Fellow, Collegium Ramazzini. Credentialed Member of the Senior Biomedical Research Service, CDC/ ATSDR. New York Academy of Sciences. Society of Occupational and Environmental Health. Discussion Chairman Miller. Thank you, Dr. De Rosa. The Chair now recognizes himself for five minutes, and the Chair may call time, but the Chairman will try to do it more gently than to sound a horn to let either Members or witnesses know that their time has expired. Safe Formaldehyde Exposure Levels Dr. De Rosa, it does appear that there was testing at various points, first by the Sierra Club, then by FEMA, that there were different standards for safe exposure or concern from exposure, and that this particular exposure didn't fit neatly into some standard. But based upon the testing that had already occurred by February of 2007, and despite the fact that there wasn't a specific standard in existence for these particular circumstances, did you, do you think that the ATSDR and CDC knew enough in February 2007, to know that there was something to worry about? Dr. De Rosa. I think that the reports in the media and elsewhere were strikingly consistent with the health affects of formaldehyde. I felt that the level that had originally been used was not an appropriate level, that the levels I referred to just recently were many times lower than that, .008 parts per million. If people were going to be there for a period of a year or longer, less than that, perhaps .03 parts per million. Those would have been the values that I would have insisted be included in such a consultation as a point of departure looking at the other parameters that may govern exposures and the health effects of formaldehyde in the situation presented by the trailers. Chairman Miller. Dr. Karol, do you have anything to add on that topic? Dr. Karol. Yes. There are other agencies in other countries that have established guidelines for safe indoor air. One of them is the Canadian health concern, and they established 0.1 ppm as safe for indoor air, WHO recommends a level of .12 ppm, so these are all very consistent that this should have been the safe level and that this should have been measured in the trailers, see what the levels actually were. ATSDR Review Process Chairman Miller. Thank you. Dr. Frumkin, you said in your testimony that you were not here to--excuse me. Dr. De Rosa. You said in your testimony you were not here testifying on behalf of ATSDR. I do think that is abundantly clear. In the early stages of our investigation there was some suggestion that there was actually a conscious effort to exclude you from the review chain for the report, and your superiors adamantly deny because they knew what your position would be. Your superiors adamantly deny that is the case, and they say that they put into place expedited review procedures because of the urgency surrounding Katrina and Rita. And I certainly applaud the government trying to act quickly on its feet when circumstances require that. But were you part of, did you design the review procedures that excluded you, that did not include you in the review? Dr. De Rosa. I did not. Chairman Miller. Okay. Did you review, in fact, review this report? Dr. De Rosa. I did not review the February 1 consultation at all. Chairman Miller. Okay. And when did you first see it again? Dr. De Rosa. February 27. Chairman Miller. And how quickly after that did you, when did you do something, if ever? Dr. De Rosa. Upon reading the report I called the Office of the Director, I spoke with personnel there, and indicated that we had a significant issue with this document because it was incomplete and perhaps misleading. I followed that up with an e-mail to that effect. I then rapidly drafted a proposed amendment, pointing out that there was a concern regarding the longer-term health affects that same afternoon and that this was the letter that could be forwarded over my signature or forwarded over anyone's signature for that matter to amend our initial consult. Chairman Miller. I understand that your superiors both, at ATSDR both in their interviews with our staff and then their expected testimony later today, will say that you were responsible for the work of your team, even though it was not directly reviewed by you. Do you have a response to that? Dr. De Rosa. In fact, that was the reason I was most concerned in my initial review. I felt that our internal procedures governing the review of any division document had not been followed and that this was why the consult turned out as it did. I later learned that that was not the case. I later learned that this was being dealt with in the aftermath of Katrina, where staff were tasked as needed, independent of giving management chain to provide the needed input on a consultation or other evaluation. Typically, this would have gone through several levels of review prior to that. Not knowing the involvement of Dr. Frumkin and Sinks at the time, I did meet with my staff to reaffirm our standard operating procedures in clear terms and didn't learn about the other aspects of the review and clearance process prior to summer of 2007. Dr. De Rosa's Performance Reviews Chairman Miller. In the last few months it is apparent that your superiors at ATSDR have grown to view you as a problem employee, but I know that the Federal Employment System had incented bonuses for the best employees, to keep them in federal employment. Have you gotten one of those in the past? Dr. De Rosa. In 2006, I received a very substantial and generous bonus and salary raise based on my performance. Chairman Miller. And how much was that? Dr. De Rosa. It was five percent of my salary as an increase I believe, and 10 percent bonus. Chairman Miller. And that was the most recent review before the one at which you were found to be lacking? Dr. De Rosa. It was. Consequences of Inaction: Health Effects of Additional Exposure Chairman Miller. Okay. For both Dr. Karol--the Chair now warns himself that he is over his time. It does appear that the conduct of ATSDR in issuing the report in February of 2007, and then failing to act with some urgency when it was very clear that FEMA was continuing to tout that report as authority for their needing to do nothing more than what they were doing, may have delayed, may very well have delayed moving people out of the trailers for a year. Some people have been in the trailers for two and one-half years, some people much less. How much can we calculate or estimate what difference it might make for the families, for children, for pregnant mothers, for the older folks to have had an additional year of exposure to formaldehyde fumes? Dr. Karol. Dr. Karol. The important thing to do now is to track those people to get good records and to have a health assessment so that you have got good data to evaluate in the future, and it is difficult to evaluate what the effect might have been. But, you know, right now what you can do is to track the people, get them evaluated, and get the trailers evaluated as well. Chairman Miller. Dr. De Rosa. Dr. De Rosa. I would agree. I think that what we refer to as a health registry of those individuals who had been exposed throughout that period should be instituted to the extent that it can be so that the people can be followed through time. Because we know many of the affects that Dr. Karol referred to have a latency of 10 to 20 years. And so this is something that may not manifest itself for a period of time. We do know that people have already been clearly affected by the reports of sensitization and as well as the other classic signs of acute formaldehyde toxicity. Chairman Miller. The Chair's time has expired. The Chair now recognizes Ms. Eddie Bernice Johnson for five minutes. Protecting the Public Ms. Johnson. Thank you very much, Mr. Chairman. Dr. De Rosa, the mission of your agency is to be protective toward the public with scientific information, isn't it? Dr. De Rosa. Yes, ma'am. Ms. Johnson. Do you feel confident that your agency is fulfilling that mission? Dr. De Rosa. I believe that there are many ongoing efforts that meet that criteria of protecting the public's health. I believe in some areas, and again, I am speaking personally, not for my agency---- Ms. Johnson. Uh-huh. Dr. De Rosa.--that perhaps a more precautionary approach could be taken in dealing with the uncertainties that surround many of these types of unfortunate incidents that occur throughout our country and elsewhere. Ms. Johnson. Is there a procedure by which once information is gained and it is, it lends itself to being a rather negative about what is going on, how is it received by the leadership of the agency? Dr. De Rosa. There have been many instances in which such concerns have been raised and have resulted in the development of health alerts that are, again, developed in coordination with other agencies and placed on our website and duly noted. In other instances there seems sometimes I would suggest a reluctance to deal with things such as multiple chemical sensitivity. Ms. Johnson. Uh-huh. Dr. De Rosa. My own view is that we should be addressing this issue, agreeing on what we know, agreeing on what we don't know, and identifying how to deal with the latter. More on Long-term Health Tracking Ms. Johnson. When you arrive at a position that there is some question about the effects of an environment or whatever, and perhaps a person is exposed, need to be tracked, how is that handled? Dr. De Rosa. Generally speaking when we have a group of individuals that have been exposed, we will attempt to follow those individuals through time to identify subsequent health issues that they may experience. Ms. Johnson. Do you know whether or not this has been instituted with Katrina victims? Dr. De Rosa. To my knowledge it has not been, but I believe it is being considered, and I would think that it would be an appropriate path forward. Ms. Johnson. Well, thank you very much. Dr. Karol, being an expert on toxicology, I noticed that you just mentioned that some tracking would probably bring forth future information. Do you feel that your consultation with the ATSDR has been useful? Dr. Karol. Well, I think that there has to be a systematic approach in the future to document who is living in the trailers, what the conditions are, what are the other exposures in the trailer, and what are the health concerns. I, you know, I think that is absolutely essential to go forward. Ms. Johnson. Thank you, Mr. Chairman. Chairman Miller. Thank you, Ms. Johnson. The Chair now recognizes not a Member of this committee but the Chairman of the Environment and Energy Subcommittee, Mr. Lampson. Dr. De Rosa Excluded From Past Reviews? Mr. Lampson. Thank you, Mr. Chairman. Dr. De Rosa, have you been left out of reviews and other times, other circumstances do you recall? Dr. De Rosa. I have not had further involvement with the ongoing activities regarding formaldehyde in trailers issue, nor with what was referenced earlier as the report on the Great Lakes, 26 areas of concern. I have had very limited involvement since October with reviews of that nature. Mr. Lampson. What about before that? Were there other times that you were left out of a review? Dr. De Rosa. It is hard to know if one has been left out of a review, but, you know, it is certainly possible, you know. I would not be aware if I had been left out. Mr. Lampson. Generally, how have you been treated of late in the agency? Dr. De Rosa. My experiences in the last period of months since October have been complicated. I have been removed from my position as I mentioned as the Director of the Division of Toxicology and Environmental Medicine. I have limited opportunity to interact with my peers in terms of technical exchange due to my physical relocation on three different instances since October; October, December, and February. I have been put on a performance improvement plan as of February 21, as I recall, 90-day period, after which my performance will be evaluated. ATSDR Emergency Health Evaluations Mr. Lampson. I am at a loss of words to follow that comment, so let me switch. You indicate that you requested that health interventions be pursued to address the clinical symptoms that people were experiencing. Are you, are there protocols of ATSDR in place for dealing with emergency situations, situations where people are experiencing health effects and some intervention is needed immediately? Dr. De Rosa. There are, but I would have to point out that ATSDR is an advisory and not a regulatory agency, though we do serve in an advisory capacity to organizations such as FEMA and EPA. And there are things that have been done in the past, for example, providing alternative drinking water supplies to communities whose water has been contaminated. There are also a range of health education activities that can be pursued that people can readily invoke that represent relatively low-hanging fruit. And generally speaking when people are given appropriate information, they act in the interest of their health. Mr. Lampson. How typical, I guess that is what I am trying to understand, how typical the situation is that or has been at your agency? It seems poor science was converted to poor information that, and the result was inaction. And I would add that the process took far too long to provide an emergency response. So how do we fix this? Dr. De Rosa. The initial response of the agency was very proactive. We had individuals deployed in the field prior to Katrina. We had stood up the range of resources available to us and had participated extensively in some of the initial triaging of people that were affected by Hurricane Katrina. I think the issue becomes what happens in the longer-term aftermath of these events. What do we do to take into account that something that happens in a very short timeframe for a very--at an extended level of exposure, perhaps. How do we track those individuals longer-term to understand what the longer-term consequences might be? And what interventions might be pursued to minimize any consequences of those acute exposures? More on Reproductive Health Mr. Lampson. Are you aware of whether or not any of this can be passed onto future generations? Dr. De Rosa. Well, I did say that there were, potentially trans-generational impacts. That means in my mind that the developing fetus may well be affected by this, that there may well be reproductive developmental outcomes that would be evident in the children perhaps not yet born. That is an area in which there is some scientific debate. It is important to note that while the debate occurs that these reports have been described as inconsistent as opposed to contradictory, inconsistent means that because of the variable nature of the different studies that have been done, different findings will be reported by different studies at different points in time using different protocols. But the International Agency for Research on Carcinogens from a consult on occasion has indicated that the evidence in this case is suggestive but inconsistent. Mr. Lampson. My time has expired. I have other questions. I will submit them for the record, and I think that it would be-- I want to say that we appreciate the service that you have given to us and your willingness to stand up and speak about the things that you believe so strongly in. We need more people like you, not fewer. Thank you very much. I yield back my time. Deficiencies in the February 2007 Health Consultation Chairman Miller. Thank you. Just one question on clarification. Dr. Karol, the reason we have asked you to be a part of this panel is that you are obviously an expert in toxicology, and you were not involved in this in any way. And we are, we expect you to be a neutral witness. You don't have a dog in this fight except the public health generally. When you reviewed the February, 2007, health consultation, how much research, how much thought, how apparent was it to you was required, how much, how apparent was it to you that there was some deficiencies in that consultation? Dr. Karol. The best way to answer that was to, is to say that after I read that consultation, I immediately went into literature to see what else was known, because it seems insufficient as far as its coverage of long-term chronic effects. And as far as its coverage of sensitive, asthmatic individuals, hypersensitivity, allergic sensitivity so that, you know, I think it could have been done in a much more thorough manner. And it should have been done. There is a lot in the literature as far as reviews from the National Research Council, from the WHO, from numerous groups that have looked at formaldehyde as far as long-term consequences. And I don't think that is reflected adequately in the ATSDR document. Chairman Miller. Well, I still, I am not quite clear. Did you put the consultation down and say, well, that sounds right, but let me do a little research and see what the other literature says? Or did you put it down and say, and think to yourself, this just doesn't ring true? Dr. Karol. Well, parts of it I said, there has got to be more than this, and this isn't what sounds right to me, and that is why I went into the literature. Parts of it covering the acute effects, I think they tried hard to look at what was known but did not do a sufficient job. So I think it really falls down in the area of chronic effects, possible reproductive effects, possible carcinogens in someone. Chairman Miller. Dr. De Rosa, I want to join in--you can relax. I don't have any more questions, but I want to join in what Mr. Lampson has said. It is not second nature for many managers to value whistleblowers. There is some tendency to see them as insubordinate, as disloyal to their superiors. But the loyalty we expect is a loyalty to the mission of the agency, the loyalty to the mission to protect the public health, and we appreciate your willingness to step forward and say that when that, you think that the agency is not faithfully serving that mission. So we so value, we do appreciate whistleblowers, and would be deeply disappointed if you had adverse employment consequences as a result of blowing the whistle on conduct that we needed to know about. You may. You don't have to but you may. Dr. De Rosa. Just briefly I would comment that in struggling with what was a dilemma for me in pursuing this issue, I referred to a plaque that hung on my wall that was a pledge to the citizens of the United States by the CDC at that time in 1990. One of the elements, five elements was that we will put the benefits to society above the benefits to the institution, and so that is what I tried to do. Chairman Miller. Thank you, Doctor. This, we have now completed this panel. We will again take a two-minute break before beginning the next panel. Thank you. [Recess.] Panel III: Chairman Miller. I would now like to welcome our third panel, our final panel. Dr. Howard Frumkin is the Director of the National Center for Environmental Health in the Agency for Toxic Substances and Disease Registry, the Centers for Disease Control, the ATSDR. Dr. Frumkin is joined by Dr. Tom Sinks, the Deputy Director at the National Center for Environmental Health at the ATSDR, and our final witness is Vice Admiral Harvey Johnson, Jr., the Deputy Administrator of the Federal Emergency Management Agency, FEMA. You each have five minutes for your spoken testimony, your oral testimony. Your written testimony will be included in the record. When you complete your testimony, we will begin with questions, and each Member will have five minutes to question the panel. It is the practice of the Subcommittee to take testimony under oath. Do any of you have an objection to swearing an oath, being sworn in? You also may be represented by counsel. Do any of you have counsel in this hearing today? The witnesses have all said that they do not object to swearing an oath, and they have no counsel with them. Would you please all now stand and raise your right hand? [Witnesses sworn] Chairman Miller. Thank you. The witnesses have all entered into the oath. Dr. Frumkin, I understand that you will be reading a joint statement for yourself and Dr. Sinks. You may begin. STATEMENT OF DR. HOWARD FRUMKIN, DIRECTOR, AND DR. THOMAS SINKS, DEPUTY DIRECTOR, AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY, AND NATIONAL CENTER FOR ENVIRONMENTAL HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dr. Frumkin. Good morning, Chairman Miller, other distinguished Members of the Subcommittee. Thank you for the opportunity to be here today. I am Dr. Howard Frumkin, Director for the Centers for Disease Control and Prevention's National Center for Environmental Health and the Agency for Toxic Substances and Disease Registry. I am accompanied, as the Chairman said, by Dr. Thomas Sinks, Deputy Director of NCEH/ ATSDR. We share with the Committee a firm commitment to strong science, to public health protection, and to good government. We recognize the need to be accountable. Perhaps most importantly, we know that the tens of thousands of people throughout the Gulf Region who suffered through the 2005 hurricanes and then lived for too long in structures not intended for long-term residence deserve our very best. We have accomplished a great deal in protecting public health, and I welcome the opportunity to describe our work. I will do so in three parts. First, in our overall response to Hurricanes Katrina and Rita, we did a great deal to protect public health. Hundreds of CDC and ATSDR staff were deployed to the Gulf Region, and hundreds more back in Atlanta supported their work. Setting aside our general public health work and focusing on environmental health alone, we helped restore safe drinking water and safe food; we helped evaluate all superfund sites in the damage zone for hazardous conditions; we mapped and assessed industrial facilities to identify hazards; we protected the public from carbon monoxide poisoning linked with generator use; we investigated mold in buildings and protected the public from that hazard; we assessed hospitals, clinics, schools, and other facilities and cleared them for re-entry as appropriate; and we assessed dozens of sets of environmental sampling data for health risks. Our work was extraordinarily effective and successful in protecting public health. Second, with respect to the specific focus of today's hearing, formaldehyde exposure in FEMA-supplied trailers and mobile homes, as I have previously acknowledged, our initial work could have been better. In retrospect, there were indications of a formaldehyde problem as early as the first half of 2006, and we could have engaged the issue earlier and more aggressively. Our initial work product, our February 2007 report on formaldehyde in unoccupied trailers was narrowly focused, used an inappropriate level of concern, and did not deliver a sufficiently clear and complete public health message. The steps we took to rectify the report, while ultimately successful, took several months to complete, longer than they should have. Our initial formaldehyde work did not meet our own standards of excellence. We have carefully reviewed the factors that contributed, and we have taken concrete corrective actions. Some were immediate. For example, since irregular communication between FEMA and our agency contributed to the problem, we clarified with our own staff and with FEMA the appropriate channels of communication. Other corrective actions are ongoing, a review by our expert external Board of Scientific Counselors of our scientific clearance procedures, and an external review of our management procedures. I regret that our initial work on formaldehyde in trailers did not meet our own expectations. I am confident that we have learned important lessons, that we are acting on those lessons, and that we will be an even stronger, more effective agency moving forward. Third, I wish to update the Subcommittee of our ongoing work on formaldehyde in trailers. Our portfolio is broad and deep. Our study of 519 occupied trailers whose results are shown on the graphic provide the most solid evidence to date that formaldehyde levels were high. These data led to action, FEMA's decision to relocate trailer residents to more permanent housing and to discontinue the use of travel trailers. Our study of trailer structures with Lawrence Berkeley Laboratory is examining what features of trailers contribute to formaldehyde emissions. A remediation study with NASA is examining technologies that could lower formaldehyde levels. Our clinical record review of children in Mississippi will help clarify respiratory health implications of the hurricane aftermath including living in trailers. A long-term cohort study of children who resided in trailers will yield extensive data on the health implications of that experience. We will work with FEMA to create a registry of trailer registrants to facilitate follow-up and tracking over time as was discussed in the earlier panels. Our expert panel continues to meet to review our science and to advise us on our work. Our extensive communication effort continues our outreach to the public with health information. We are updating our toxicology profile on formaldehyde, and we have engaged other agencies to move toward long-term coordinated approaches to safe, healthy manufactured housing. This is a record of active, sustained, successful protection of public health. We share with the Members of the Subcommittee a common goal, to serve the public and to bring to bear the best science in doing so. As public servants, we are accountable for achieving this goal. I am very proud of our overall efforts to protect public health following Hurricanes Katrina and Rita, including our more recent efforts relating to formaldehyde. I recognize that in some respects we could and should have done better. We welcome the oversight of the Committee as we strive constantly to improve, and we stand ready to cooperate as we move forward. Thank you. [The prepared statement of Dr. Frumkin and Dr. Sink follows:] Prepared Statement of Howard Frumkin and Thomas Sinks Good morning Chairman Miller, Mr. Sensenbrenner, and other distinguished Members of the Subcommittee. Thank you for the opportunity to be here today. I am Dr. Howard Frumkin, Director of the Agency for Toxic Substances and Disease Registry (ATSDR) and the Centers for Disease Control and Prevention's (CDC's) National Center for Environmental Health (NCEH). ATSDR and CDC/NCEH are separate Department of Health and Human Services agencies that are managed jointly from an administrative perspective. I am accompanied by Dr. Thomas Sinks, Deputy Director of ATSDR and CDC/NCEH. I am a physician with 26 years of experience in environmental and occupational medicine and epidemiology. I have been Director of NCEH/ ATSDR since September 2005. Previously, I served as chairman of the Department of Environmental and Occupational Health at Emory University's Rollins School of Public Health and professor of medicine at Emory Medical School. Dr. Sinks is a career CDC epidemiologist, having served in scientific and leadership positions for more than 23 years. We share with the members of the Subcommittee a common goal--to serve the public, and to bring to bear the best science in doing so. As public servants, we are accountable for achieving this goal. I am very proud of our overall efforts to protect public health following Hurricanes Katrina and Rita, including our more recent efforts related to formaldehyde in Federal Emergency Management Agency (FEMA)-provided travel trailers, park and mobile homes (hereafter referred to as trailers). I recognize that in some respects we could and should have done better. There are key lessons to be learned, and we have taken important steps to ensure that our current and future work reflects those lessons we have learned. Our testimony will focus on three areas. First, I will provide an overview of NCEH/ATSDR activities and accomplishments related to Hurricane Katrina in general and formaldehyde and FEMA-provided trailers in particular. Next, I will discuss events leading to the original (2/07) ATSDR health consultation and management decisions during this period, and describe measures we have taken to ensure that as we move forward our work reflects lessons learned. Finally, I will summarize CDC/ATSDR ongoing and future scientific endeavors to further expand our understanding of, and ability to address, public health impacts of formaldehyde in FEMA-provided trailers. Overview: NCEH/ATSDR Accomplishments and Activities Regarding Hurricane Katrina, Formaldehyde, and Health Under the leadership of the CDC Director's Emergency Operations Center, CDC and ATSDR took a wide range of actions to protect the public against even greater health impacts from devastation caused by Hurricanes Katrina and Rita. Our Agencies' contribution to the broader disaster response included---- <bullet> Deploying hundreds of CDC and ATSDR staff to the Gulf Coast region to provide hands-on technical support. <bullet> Staffing emergency response operations with several hundred full-time staff to manage and triage requests for assistance from state and local health departments and other local partners. <bullet> Taking measures to ensure early detection of possible epidemics of infectious diseases and providing real-time guidance on how to control and prevent future outbreaks. <bullet> Monitoring the health needs of people in shelters and providing printed public health education information. <bullet> Protecting the health of emergency responders. <bullet> Evaluating vaccination needs and practices. <bullet> Supplying materials and medications through the National Pharmaceutical Stockpile. <bullet> Providing up-to-date communication materials to health professionals, the media, and the public. NCEH/ATSDR served as the CDC/ATSDR lead for environmental health aspects of the response to Hurricanes Katrina and Rita. The list below provides several examples of NCEH/ATSDR accomplishments and other contributions. <bullet> Supported federal, State and local officials in restoring environmental public health services (safe drinking water, food safety). <bullet> In coordination with the Environmental Protection Agency (EPA), evaluated all Superfund sites in the area for hazards and assessed industrial facilities to identify hazardous conditions related to hurricane damage. <bullet> Anticipated and assessed well established hazards in indoor environments related to carbon monoxide poisoning and mold. <bullet> Collaborated in assessing numerous community and individual facilities such as schools to clear them for re- entry. <bullet> Conducted state-of-the-art assessment of environmental sampling data for human health implications and made health recommendations to federal, State and local health and environmental officials. In May of 2007, CDC launched a formal program to address the formaldehyde health concerns in FEMA-provided trailers. The program is led by the Director of the Division of Environmental Hazards and Health Effects within NCEH, with oversight from Dr. Sinks and me. We also developed an interagency agreement with FEMA to support the NCEH activities. The program has several components, described below: <bullet> Expert Panel: We established an expert panel to obtain individual guidance in developing CDC's methods for studying aspects of formaldehyde exposure. <bullet> Study of Occupied Trailers: Through an Interagency Agreement with FEMA, CDC is conducting a formal study that included testing formaldehyde levels in 519 occupied FEMA- provided trailers in Mississippi and Louisiana. Interim results were announced on February 14, 2008. The formaldehyde levels in indoor air were higher than typical (based on recent data) levels of U.S. indoor exposure in single family homes and apartments.\1\ --------------------------------------------------------------------------- \1\ While this study was not designed to be nationally representative (for example 75 percent of homes did not have indoor carpet), these data represent some of the best available recent information. Results were presented in person to occupants of each of the 519 trailers that were tested as part of the study, with assistance of the United States Public Health Service Commissioned Corps. FEMA housing staff --------------------------------------------------------------------------- also participated in these visits. CDC/ATSDR recommended that individuals and families be relocated from FEMA-provided trailers in the Gulf Coast Region before warmer weather returns, based on these interim findings. We also provided guidance on setting priorities for relocation. On March 3, 2008, we released a more detailed interim report (available on our web site at http:// www.cdc.gov/Features/FEMAtrailersFindings/). The interim report provides additional findings, including formaldehyde levels by trailer type and manufacturer. We expect to issue a final report this Spring. This report will contain a more detailed analysis than in the interim report. <bullet> Communications: Our communication project team responded to more than 6,000 calls for information related to formaldehyde and/or FEMA-provided trailers since July 2007. More than 1,000 persons attended 15 public availability sessions in Louisiana and Mississippi to learn about the results of CDC's formaldehyde sampling of FEMA-provided trailers. Health education materials were aggressively distributed in locations frequented by residents of FEMA-provided trailers. New information has been released rapidly and made available on CDC's web site. <bullet> A chart review has been conducted of medical records of children living in Hancock County, Mississippi, in 2005- 2007, for respiratory illness, skin conditions, or gastrointestinal illnesses. The review is expected to be completed in the near future. <bullet> Studies of Unoccupied Trailers: CDC is assessing formaldehyde levels across different models and classes of unoccupied travel trailers and mobile homes used by FEMA as temporary housing. The purpose of this sampling is to identify factors that may predict high exposure scenarios inside the units, and to investigate cost effective solutions to reduce the formaldehyde concentrations. CDC is conducting additional work: With the Lawrence Berkeley National Laboratory, to test components of unoccupied trailers from FEMA's inventory for off-gassing of formaldehyde. With NASA, to evaluate potential methods to mitigate formaldehyde levels in trailers. To test unoccupied trailers to determine formaldehyde levels by manufacturer, time of day, and temperature. Retrospective Look at the ATSDR Health Consultation The information below reflects the facts and events as I currently understand them regarding the February 2007 ATSDR health consultation and measures we have taken to insure that our work moving forward reflects lessons learned. In July 2006, a representative of EPA contacted members of ATSDR's Division of Toxicology and Environmental Medicine (hereafter referred to as Division of Toxicology) requesting that ATSDR participate in a conference call with representatives of FEMA. The purpose of the call was to discuss EPA's sampling for formaldehyde in FEMA-provided unoccupied trailers. After the initial contact, the Acting Deputy Director of NCEH/ ATSDR's Office of Terrorism Preparedness and Emergency Response (hereafter referred to as Office of Emergency Response), who was also NCEH/ATSDR's coordinator for Hurricane Katrina-associated actions, informed Dr. Sinks of the request for ATSDR participation in discussion with EPA and FEMA regarding EPA sampling of formaldehyde. This request was handled by staff of ATSDR's Division of Toxicology who routinely handled emergency requests. At the time, the request for assistance appeared to be consistent with previous efforts to support EPA in the aftermath of Hurricanes Katrina and Rita, and Dr. Sinks encouraged agency involvement. During the next several months, staff of ATSDR's Division of Toxicology managed and handled ATSDR's involvement in regular communications with representatives of FEMA and EPA on this issue. Specifically, the staff participated in conference calls with EPA and FEMA concerning sampling plans for measuring formaldehyde levels in unoccupied trailers. The resulting sampling design involved 96 unoccupied travel trailers newly purchased by FEMA. The specific role of staff of the Division of Toxicology was to interpret the data generated by EPA sampling activities in order to: (1) evaluate levels of formaldehyde measured by EPA in closed, unoccupied trailers; and (2) determine whether two mitigation strategies (opening windows and running air conditioning) would substantially reduce formaldehyde levels. Staff of the Division of Toxicology regularly listed this project in their routine report of activities distributed through supervisory and management channels. EPA sampled the trailers in October 2006, and provided the data to FEMA on November 17, 2006. FEMA transmitted the data to staff of ATSDR's Division of Toxicology on December 1, 2006, for analysis. The data were accompanied by a cover letter from a FEMA attorney who had participated in the interagency conference calls regarding testing for formaldehyde in trailers. The letter did not restrict the scope of ATSDR's analysis or conclusions, nor am I aware of any communication from FEMA attempting to impose such a restriction. Upon completion of a draft of the report, Division of Toxicology staff provided a copy to the coordinating office for response activities related to Hurricanes Katrina and Rita, the Office of Emergency Response. Staff from that Office reported this status in early January 2007 at a routine meeting with Dr. Sinks and me. A follow-up e-mail from the Office of Emergency Response suggests that I looked at the draft report during the meeting and noted the absence of an executive summary and conclusions/recommendations. Following the meeting Dr. Sinks read the draft and provided handwritten comments on the hard copy. Those comments were relayed to the Division of Toxicology staff working on the project and they finalized the document. In his role as coordinator of our continued response to Hurricanes Katrina and Rita, the Acting Director of the Office of Emergency Response transmitted the health consultation to FEMA on February 1, 2007. As noted earlier, the focus of ATSDR's analysis was narrow. As stated in the health consultation, ``FEMA has not requested ATSDR to evaluate longer-term formaldehyde concentrations in trailers or health concerns related to potential exposures. ATSDR will be available to provide assistance if such data becomes available in the future.'' In late February 2007, Dr. Christopher De Rosa, Director of the Division of Toxicology, notified Dr. Sinks that he had only recently reviewed the health consultation. Although this project was listed in regular reports of work in his Division, he stated that he had not seen the document previously and that it failed to address the potential long-term health consequences related to chronic exposure to formaldehyde. The Director of the Division of Toxicology had not raised this concern to staff in his Division earlier, prior to release of the report. Regarding health consequences of long-term exposure, I concurred with this concern once it was raised to me. I encouraged the Division Director to draft a letter to FEMA highlighting ATSDR's concerns and clarifying the scope of the health consultation. The letter, dated March 17, 2007, states: ``I am concerned that this health consultation is incomplete and perhaps misleading. Formaldehyde is classified as `reasonably anticipated to be a human carcinogen.' As such, there is no recognized safe level of exposure. Thus any level of exposure to formaldehyde may pose a cancer risk regardless of duration. Failure to communicate this issue is possibly misleading and a threat to public health.'' During a hearing held by the House Committee on Oversight and Government Reform in July 2007, a witness questioned the ``level of concern'' referenced in the February 2007 ATSDR health consultation. This prompted a careful re-evaluation of the report. That re-evaluation revealed several issues. First, the report did not make sufficiently clear that the purpose of the health consultation was very narrow-- characterizing formaldehyde levels in closed unoccupied trailers and the effect of two mitigation strategies. Second, ATSDR's use of a ``level of concern'' provided a false impression of what constitutes an acceptable health risk, further contributing to misinterpretation. Third, the analysis had not examined how formaldehyde levels varied by manufacturer, time of day, or temperature. In August 2007, because of these and other issues, Dr. Sinks recommended that the data be reanalyzed and the report completely rewritten. I concurred and in October the revised report was released. Both the original report and the final report remain available on the ATSDR web site at: http://www.atsdr.cdc.gov/substances/formaldehyde/ public<INF>-</INF>assessment.html Lessons Learned CDC/ATSDR recognize that our agencies should have moved more forcefully to address the emerging concern related to formaldehyde levels in FEMA-provided trailers, particularly as it became apparent that people were living in them for longer periods of time, not as a short-term solution as they had been widely considered in the past. As Director of NCEH/ATSDR, I accept responsibility for shortfalls in our response, and for taking steps to prevent similar situations in the future. Issue: We addressed formaldehyde exposures too slowly and too narrowly. Issue: The initial health consultation fell short of our own standards. Lessons Learned/Actions Taken: Hurricane Katrina presented many scientific and organizational challenges. Through this experience, we identified gaps in how scientific work is assigned, supervised, and reviewed. We have taken responsibility ourselves and have directed all of our managers to implement several steps to address these issues. These include: <bullet> Triaging key assignments to appropriate scientific staff depending on the content of the request and staff expertise <bullet> Providing appropriate scientific and supervisory oversight of all staff <bullet> Applying consistent peer review across all divisions We have also requested that our Board of Scientific Counselors examine our review and clearance process for all scientific materials, and we have commissioned an external review of management procedures to identify opportunities for improvements. Finally, all of our staff have been asked to make sure that any contacts with other agencies are directed through the most appropriate channels to insure consistent and correct communication. Moving Forward CDC/ATSDR now recognize formaldehyde in FEMA-provided trailers as an important public health issue, and have made research in this area a high priority to which we are devoting a tremendous amount of effort and are making significant progress. Beginning in May of 2007, before the hearing that prompted us to revisit the health consultation and reissue the report in October 2007, and continuing today, NCEH's Division of Environmental Hazards and Health Effects has been proceeding with a broad set of formaldehyde-related activities. These activities are being conducted with the full support of the NCEH Division Director as well as Center, Coordinating Center and Agency- wide leadership. And, we have an extensive and transparent communication network through which we are keeping policy-makers and the public apprised of our activities and findings. CDC/ATSDR will continue to build the science base and to protect public health from formaldehyde exposures in indoor environments. To help clarify the health impacts of formaldehyde exposure, we are planning several additional activities, including: <bullet> A five-year study of children who resided in FEMA- supplied trailers in Alabama, Louisiana, Mississippi, and Texas is being initiated; the protocol currently is under review. <bullet> A broad and proactive approach to formaldehyde in manufactured structures. We have reached out to FEMA, HUD, and other partners, and will collaborate with them in addressing this multi-jurisdictional challenge. <bullet> A registry/census of current and former residents of FEMA-provided trailers, which would facilitate communication with them in the future. For example, this could facilitate conducting future studies. In summary, CDC/ATSDR remains firmly committed to building the science base and protecting public health from formaldehyde exposures in indoor environments, and more broadly, to helping assure safe, healthy indoor environments for all Americans. These are all important issues to assure that science and public health are fully addressed and CDC looks forward to the opportunity to work with the Committee on these important issues. Conclusion As we continue our ongoing research, we recognize fully our obligation to the American public, to Congress, and most importantly to residents of the travel trailers, to deliver the independent, credible science that helps inform good decision-making by the individuals who were displaced by Hurricanes Katrina and Rita. Thank you for the opportunity to present this information to you today. We would be happy to answer any questions. <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> Biography for Howard Frumkin Howard Frumkin is Director of the Agency for Toxic Substances and Disease Registry and also Director of the National Center for Environmental Health at the Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. NCEH/ATSDR works to maintain and improve the health of the American people by promoting a healthy environment and by preventing premature death and avoidable illness and disability caused by toxic substances and other environmental hazards. Dr. Frumkin is an internist, environmental and occupational medicine specialist, and epidemiologist. Before joining the CDC in September, 2005, he was Professor and Chair of the Department of Environmental and Occupational Health at the Rollins School of Public Health of Emory University, and Professor of Medicine at Emory Medical School, in Atlanta. At Emory he founded and directed the Environmental and Occupational Medicine Consultation Clinic, the Occupational Medicine Residency training program, and the Southeast Pediatric Environmental Health Specialty Unit. Dr. Frumkin previously served on the Board of Directors of Physicians for Social Responsibility (PSR), where he co-chaired the Environment Committee; as president of the Association of Occupational and Environmental Clinics (AOEC); as Chair of the Science Board of the American Public Health Association (APHA), as a member of EPA's Children's Health Protection Advisory Committee, where he chaired the Smart Growth and Climate Change work groups; and on the National Toxicology Program Board of Scientific Counselors. He currently serves on the Institute of Medicine Roundtable on Environmental Health Sciences, Research, and Medicine. In Georgia, he was a member of the state's Hazardous Waste Management Authority, the Department of Agriculture Pesticide Advisory Committee, and the Pollution Prevention Assistance Division Partnership Program Advisory Committee, and is a graduate of the Institute for Georgia Environmental Leadership. In Georgia's Clean Air Campaign, he served on the Board and chaired the Health/Technical Committee. He was named Environmental Professional of the Year by the Georgia Environmental Council in 2004. He has served as a consultant to several corporations, including Hewlett-Packard, Southwire, Georgia Power, and Polaroid, and to several unions, including the Chemical Workers Association and the Utility Workers Union. His research interests include public health aspects of urban sprawl and the built environment; air pollution; metal and PCB toxicity; climate change; health benefits of contact with nature; and environmental and occupational health policy, especially regarding minority workers and communities, and those in developing nations. He is the author or co-author of over 100 scientific journal articles and chapters, and his books include Urban Sprawl and Public Health (Island Press, 2004, co-authored with Larry Frank and Dick Jackson), Emerging Illness and Society (Johns Hopkins Press, 2004, co-edited with Randall Packard, Peter Brown, and Ruth Berkelman), Environmental Health: From Global to Local (Jossey-Bass, 2005), and Safe and Healthy School Environments (Oxford University Press, 2006, co-edited with Leslie Rubin and Robert Geller). Dr. Frumkin received his A.B. from Brown University, his M.D. from the University of Pennsylvania, his M.P.H. and Dr.P.H. from Harvard, his Internal Medicine training at the Hospital of the University of Pennsylvania and Cambridge Hospital, and his Occupational Medicine training at Harvard. He is Board-certified in both Internal Medicine and Occupational Medicine, and is a Fellow of the American College of Physicians and the American College of Occupational and Environmental Medicine. Dr. Frumkin was born in Poughkeepsie, New York. He is married to Beryl Ann Cowan, an attorney and child advocate. They live in Atlanta with their two children, Gabriel (age 18) and Amara (age 14). Chairman Miller. Thank you. Admiral Johnson. STATEMENT OF VICE ADMIRAL HARVEY E. JOHNSON, JR. (RET.), ACTING DEPUTY ADMINISTRATOR AND CHIEF OPERATING OFFICER, FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY Vice Admiral Johnson. Good morning, Chairman Miller, Congressman Lampson, Members of the Committee. I am Harvey Johnson, the Acting Deputy Administrator and Chief Operating Officer of FEMA within the Department of Homeland Security. I am here this morning, Mr. Chairman, to assure the Committee that FEMA is taking responsible steps to address the concerns regarding the presence of formaldehyde in temporary housing units. I would like to do this by making three principal points. First, the health and safety of temporary housing occupants is of paramount importance to FEMA. One of our primary missions is to provide individual citizens, disaster victims; and communities and members of the FEMA team, many of whom are disaster victims themselves, take this very seriously. Since March of 2006 to the present, we have investigated each instance where an occupant has reported concern due to formaldehyde, and we sought to find remedy by swapping out the housing unit or relocating the family to a rental housing unit. FEMA has been aggressive to search within communities to find available housing options which sometimes have been rare to offer current occupants mobile homes and travel trailers. We have seen in the population of households, the temporary units dropped from a peak of almost 143,000 units to now just over now 30,000. Since February 14th and the release of the preliminary findings, FEMA has prioritized relocation of those occupants who have expressed a health concern, those who are most susceptible to health risks such as elderly to households with young children and those with respiratory challenges. That category is comprised of just over 12,000 households. For current and future disasters, FEMA will test the level of formaldehyde in every unoccupied unit prior to deployment and provide the certified results to the state as well as to the occupant. FEMA will deliver the units that are determined acceptable by the state. FEMA has also updated specifications for purchases of new manufactured housing units and park models to be more stringent on air quality. Second, FEMA has been completely transparent on this issue. FEMA sought to ensure that the occupants of temporary housing units have access to all of the available information about formaldehyde. We have established and still maintain an open call center where callers can talk to FEMA or representatives from the Centers for Disease Control. We maintain a website that provides access to all current formaldehyde information, and we have distributed fliers to occupants on three separate occasions informing occupants of the symptoms of formaldehyde exposure and suggesting actions they can take to reduce formaldehyde levels based on guidance from public health officials at the time. FEMA has provided more than 20,000 pages of documents to Congress, including this subcommittee. We have provided similar information to the Government Accounting Office to the department's Office of Inspector General. Our staffs have met with Congressional staff and various investigators on numerous occasions. FEMA has hosted meetings and provided information on various advocacy groups to ensure transparency of FEMA's actions regarding formaldehyde. And finally, FEMA recognizes the importance and significance of this issue and is intent on becoming part of the solution. FEMA recognizes our limitations as well. We are not a public health agency, and frankly, we are not a long-term housing agency, either. We have sought medical and environmental assistance from the very beginning, engaging with the Environmental Protection Agency, the Department of Health and Human Services, the Centers for Disease Control, and the Office of Health Affairs within the Department of Homeland Security. Even today we engage in all or some of them every day in our shared desire to best meet the health and safety challenges of disaster victims. We have tried to be a smart consumer of their advice and have tried to implement that advice in the practical settings of a disaster site. We have made some mistakes along the way. All of us have. But it has occurred as the act has been in the service of providing assistance to disaster victims with the best of intentions, and we have all learned and gained a significant knowledge along the way. At no time has FEMA ever turned from the challenge because of concern for litigation or thought that we might be criticized for our actions. We have also tried to learn more from the challenges. For example, we are working right now with a temporary housing manufacturer and believe that our public/ private cooperation will lead to a temporary housing unit at extremely low levels of formaldehyde and that these new units will be available for the upcoming hurricane season. Importantly, Mr. Chairman, FEMA shares the objectives of this committee that our collective efforts to examine this complex issue will result in better policy and greater awareness and more consistent assurance to the public, more specifically to current and prospective disaster victims, that FEMA and our federal and state partners can better ensure their health and safety. I am pleased to answer any of your questions. [The prepared statement of Vice Admiral Johnson follows:] Prepared Statement of Harvey E. Johnson, Jr. Good morning Chairman Miller, Congressman Lampson, and Members of the Committee. I am Harvey Johnson, Acting Deputy Administrator and Chief Operating Officer for the Department of Homeland Security's Federal Emergency Management Agency (FEMA). Thank you for inviting me here and giving me an opportunity to assure this committee that FEMA is taking responsible steps to address the concerns regarding the presence of formaldehyde in temporary housing units provided to disaster assistance applicants. The health and safety of the residents of travel trailers provided to disaster victims is of paramount importance to FEMA. These are more than simple words, as they reflect an element of the ethos of FEMA-- providing effective assistance to communities and disaster victims. Today, I will briefly highlight actions FEMA took in 2006 and early 2007 regarding the issue of formaldehyde in temporary housing units. Second, I will address FEMA's agreement with the Centers for Disease Control and Prevention (CDC) under which CDC performed testing of more than 500 units in the Gulf Coast and the actions taken based on the preliminary results. Third, I will highlight the additional actions FEMA is taking to provide for the safety and well being of the residents of these travel trailers by finding them alternative housing. Finally, I will address the additional interim measures regarding the use of temporary housing units that FEMA has adopted as a precaution, and which FEMA will employ for all disaster housing operations until permanent indoor air quality standards related to formaldehyde are developed by appropriate health officials. 2006-2007 Actions Taken Regarding Formaldehyde Formaldehyde is a substance that is widespread in today's environment. Indeed, formaldehyde is commonly found in a wide-range of manufactured items, including materials used to construct manufactured items, including materials used to construct travel trailers and manufactured housing (also known as ``mobile homes''). The trailers purchased by FEMA are not unique in this regard. At higher levels, especially indoors, formaldehyde can be irritating to the respiratory system, and has been identified by the National Toxicology Program (NTP) as reasonably anticipated to be a human carcinogen. The issue of formaldehyde in travel trailers is complicated by the fact that, despite over 30 years of research, no federal agency has determined an acceptable level of formaldehyde in residential indoor air. There is no established or recognized standard or benchmark for formaldehyde exposure in indoor residential air-quality. Nor are there any government standards relating to formaldehyde levels in the types of travel trailers provided by FEMA to Gulf Coast housing applicants. FEMA began tracking formaldehyde-related concerns by Gulf Coast travel trailer occupants in early 2006. FEMA addressed applicant concerns on a case-by-case basis in the Gulf Coast. FEMA's response to complaints about formaldehyde levels included sending a housing staff employee to visit with the occupants of the units to discuss mitigation techniques for the units including: increased ventilation, keeping indoor air temperatures moderate, lowering the humidity, and not smoking in the unit. In instances when these mitigation efforts did not resolve the residents' concerns, FEMA also offered to provide residents with a different unit. As FEMA continued to monitor formaldehyde reports throughout spring 2006, FEMA became concerned that the complaints might not be isolated occurrences. As a result, FEMA began consulting with the Environmental Protection Agency (EPA), the Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services (HHS), and the manufactured home industry to gather information about the presence and effects of formaldehyde. We also began widespread distribution of information to travel trailer occupants across the Gulf Coast identifying potential sources of formaldehyde and explaining to applicants how they could mitigate the exposure to formaldehyde. Flyers capturing this information were hand delivered to all travel trailer occupants beginning in summer 2006. In September 2006, FEMA began a study to test formaldehyde levels in travel trailers, and to identify the most effective methods for reducing formaldehyde levels in travel trailers and manufactured housing (also known as ``mobile homes'') in use in the Gulf Coast region. Given the lack of alternative housing in the Gulf, finding alternative housing for all mobile home and trailer occupants from their temporary housing would have taken too long, and would have left residents with no way to address their concerns in the immediate term. We had to find a way to mitigate the levels immediately. The mitigation study involved collecting air samples from new, unused travel trailers that were ventilated in various ways during the months of September and October at a staging area in Baton Rouge, Louisiana. FEMA modified an Interagency Agreement with EPA to perform this sampling. In November 2006, EPA provided the data gathered during the sampling phase to FEMA for further analysis. A FEMA staff attorney forwarded the data to ATSDR emergency response staff for evaluation. ATSDR's Health Consultation, provided to that FEMA staff attorney in February 2007, confirmed that proper ventilation (i.e., opening all windows, rather than using air conditioning) could reduce the formaldehyde levels. FEMA believed that this guidance was based on the best available published studies and standards in light of the absence of standards directly relating to formaldehyde and indoor air quality. FEMA developed information and guidance based on the results of the study and provided this information and guidance to the residents of the travel trailers. Given the absence of applicable indoor air-quality standards, the initial consultation with ATSDR was intended to evaluate the effectiveness of formaldehyde-mitigation measures rather than the long- term health impacts associated with particular residential concentrations of formaldehyde. As is noted in the Health Consultation, ``FEMA has not requested ATSDR to evaluate long-term formaldehyde concentrations in trailers or health concerns related to potential exposures.'' In March 2007, the FEMA staff attorney who had requested the ATSDR analysis in November, and to whom ATSDR had sent its February Health Consultation, received a follow-up letter from ATSDR stating that the February 2007 Health Consultation was ``incomplete and perhaps misleading.'' Unfortunately, this letter only came to the attention of senior leadership several months later. Had the March 2007 follow-up letter from ATSDR been brought to senior leadership's attention when it was received, we would have sought clarification from ATSDR. ATSDR also subsequently revised its Health Consultation in October 2007 to include a number of caveats relating to potential health impacts of long-term exposure. At the time of the release of the revised report, FEMA was already moving ahead with CDC on more comprehensive testing, including for long-term effects. FEMA has always taken these health concerns seriously, which is why we initially reached out to EPA and CDC and continue to closely coordinate with appropriate agencies as we make policy decisions regarding the use of temporary housing units (travel trailers, park models and mobile homes). From early 2006 through May 2007, FEMA received approximately 130 complaints regarding formaldehyde, including 47 requests that a resident's unit be ``swapped-out'' for another unit. To put that number in context, during its response to Hurricanes Katrina and Rita, FEMA provided temporary housing units to more than 143,000 families across the Gulf Coast. In May 2007, renewed focus on the formaldehyde issue followed media reports of concerns by a doctor in Mississippi about health trends he believed he was seeing in residents of temporary housing. FEMA immediately engaged with the Department of Homeland Security's Office of Health Affairs (DHS OHA) as well as the experts from the CDC and ATSDR to better understand the potential health concerns associated with formaldehyde and determine the best scientifically valid approach to address this issue. On behalf of FEMA, DHS OHA officials met at the CDC headquarters in Atlanta with representatives of the National Center for Environmental Health and the ATSDR to develop a strategy to rapidly test actual indoor air quality conditions in occupied units, determine a scientifically valid target for air quality improvement, and further assess potential mitigating actions that could be taken to further reduce formaldehyde levels. This meeting eventually resulted in the Inter-Agency Agreement with CDC discussed below. In order to address the ongoing health and safety concerns of those still residing in temporary housing units while FEMA was working with the CDC and other health agencies, FEMA established a Formaldehyde Call Center for occupants living in travel trailers and mobile homes. All occupants who contact the help line with questions or concerns are offered an immediate move to a hotel or motel. Additionally, FEMA distributed a second formaldehyde and housing fact sheet to the occupants of every FEMA trailer across the Gulf Coast (70,000 flyers were distributed across the Gulf), as well as throughout the rest of the country. The fact sheet provided basic information about formaldehyde, including possible medical effects, ventilation techniques to reduce formaldehyde levels, and contact information for assistance. In addition to offering immediate housing options to current trailer occupants, the Agency issued an Interim Direction on the Use of Temporary Housing Units on July 31, 2007, which took the added step of temporarily suspending the installation, sale, transfer or donation of travel trailers or park model recreational vehicles while the agency worked with health and environmental experts to assess air quality and health-related concerns. Interagency Agreement With CDC In August 2007, FEMA and CDC entered into an Interagency Agreement to initiate and complete testing of a statistical sampling of occupied units and to provide technical assistance and public health guidance to FEMA to evaluate the indoor environmental air quality in temporary housing units and the associated health effects to residents. At FEMA's request, CDC is also conducting a health study of children who lived in FEMA-supplied temporary housing in Mississippi and Louisiana, as well as mitigation strategies for unoccupied units, focusing on components that off-gas and technologies that reduce off-gassing or accumulation. Testing of occupied units was to have begun in early November 2007, but did not begin until December 2007. However, because there are no federal standards for formaldehyde exposure in a residential setting, testing was delayed to allow for the necessary development of a consensus among public health experts as to how to interpret the testing results in order to provide health advice. This was necessary to have a basis to explain to the occupants what the test results would mean. FEMA wanted to make sure that the results of that testing would help occupants make informed decisions about their health concerns and permanent housing needs. I made the decision to delay this testing, and believe events have confirmed it as the right decision. While we would have preferred to initiate testing in November, please be assured that FEMA and the CDC were fully committed to this effort. It was, however, imperative that testing was conducted appropriately and intelligently such that it would yield scientifically valid and accurate results. Of equal importance was ensuring we could provide appropriate public health guidance to enable occupants to make an informed decision on the risks involved with continued exposure as compared to the range of alternative housing available to them. After public health guidance was developed, CDC began indoor air sampling of occupied temporary housing units in Mississippi and Louisiana in December 2007. On February 14, 2008, CDC released preliminary test results, and FEMA and CDC outlined the steps to be taken to provide for the safety and well being of the residents of temporary housing units. CDC's preliminary evaluation of a scientifically established random sample of 519 travel trailers and mobile homes tested between December 21, 2007 and January 23, 2008 found that, in many of the travel trailers and mobile homes tested, formaldehyde levels were higher than typical levels (based on recent sampling) of U.S. indoor exposure in single-family homes and apartments. The average level of formaldehyde was about 77 parts per billion (ppb), or .077 parts per million (ppm). In general formaldehyde levels in travel trailers were higher then levels found in manufactured homes. Following the completion of the testing, CDC and FEMA representatives visited all participants whose units were tested as part of the study to discuss the levels of formaldehyde measured in their temporary housing unit. All participants who had their unit tested were offered an immediate move to a hotel, motel, or apartment. 108 of the 519 participants accepted this offer (88 moved to alternate housing, 20 are in hotels/motels). In addition to these results-specific visits, CDC and FEMA distributed a third fact sheet on the preliminary results of formaldehyde levels to all temporary housing occupants between February 15 and 18, 2008. FEMA and CDC have jointly hosted several community availability sessions to provide information to residents who are concerned about the testing results, and to answer questions. Furthermore, for those residents that were not included in the initial testing, we have offered to test any occupied unit and provide those results to the occupant. FEMA awarded a contract for such additional testing to Bureau Veritas, the same testing company that was used by CDC for its testing in late 2007. Testing is currently underway, and is available to occupants living in FEMA-supplied temporary housing units nationwide. The test results will be provided to the occupant so they can make informed decisions about their housing options. As of March 25, 2008, 1,554 households have requested testing. The contractor has contacted 965 of those households and scheduled 479 tests. As of March 25, 2008, 291 tests have been completed. Alternative Housing Options for Residents of Temporary Housing Units Since early 2006, FEMA has offered immediate alternative housing to anyone who has requested to move out of their unit for any reason, including concerns about formaldehyde. FEMA has never believed that travel trailers are an acceptable long-term housing solution, and it is our desire to ensure that all residents move into more appropriate housing as soon as possible. FEMA is aggressively identifying alternate temporary and long-term housing and matching up housing occupants with available units as quickly as the occupants can accept the offer and move. Those occupants who have voiced a health concern in response to continued engagement from FEMA have all been afforded multiple options to relocate out of their travel trailer. FEMA previously announced a plan to close all group sites and relocate residents by June 1, 2008 and will continue this activity as part of our ongoing efforts. FEMA has already moved over 111,000 households out of temporary housing units as residents move into long- term housing solutions. However, the task is not complete, since as of March 25, 2008 there are 31,136 households occupying temporary housing units in the Gulf Coast. FEMA has begun to expedite the relocation of residents from temporary housing units to apartments or other alternative housing, including hotels, motels and ``Katrina cottages.'' The priority in relocation will be those occupants expressing a health concern and those most susceptible to health risk such as the elderly, households with young children and those with respiratory challenges. FEMA has implemented an aggressive outreach plan for these priority occupants. In addition to offering alternatives to all applicants that call the formaldehyde call centers, FEMA caseworkers are reaching out to occupants to explain the relocation and testing options available to them. In late February 2008, FEMA and CDC identified 14,266 households as a priority because the applicants expressed specific health concerns or may be more susceptible to health risks. As of March 25, 2008, 1,378 of these priority households have been relocated, and we continue to target the remaining 12,888 for relocation. In late February, FEMA also identified an additional 9,367 households as a priority for relocation because they are living in group or commercial sites, or they are pre- disaster renters living on private sites. As of March 25, 2008, 1,358 of these households have been relocated. From February 14 to March 25, 2008, FEMA caseworkers have offered 6,145 households an immediate move to a hotel or motel--644 have accepted the hotel/motel offer, while 5,502 households have refused that option. From February 14 to March 25, 2008, FEMA caseworkers have offered alternative housing resources (rental resources or Alternative Housing Pilot Program units) to 4,662 households--2,813 have accepted an alternative housing resource or their decision is pending, 1,842 have refused all options, and nine have decided to live with family or friends. These data include both calls from occupants to the formaldehyde call center and calls made by FEMA caseworkers to occupants. FEMA applicant services staff continue to identify and provide options and resources to remaining occupants while they make final decisions about their relocation alternatives. As part of the effort to provide occupants with alternate housing, FEMA is implementing new and expanded policies and executing contracts to: <bullet> Enter into direct contracts with hotels in order to obtain additional hotel/motel capacity if needed. <bullet> Utilize contract resources to support local relocation. <bullet> Provide food vouchers or stipends for households relocated to hotels without cooking facilities. <bullet> Enter into direct lease agreements with landlords. <bullet> Contract for temporary storage and/or shipping of household property. <bullet> Contract for the boarding and care of household pets for families relocated to hotels or apartments that do not allow pets. <bullet> Provide furniture for rental units by working with Voluntary Agencies where possible, or purchasing the furniture when necessary. <bullet> Contract for moving teams and equipment to assist in the movement of households with special medical needs. <bullet> Provide additional staff to our offices on the ground to facilitate and manage the expedited relocation of households. These efforts are in addition to several other initiatives FEMA already had in progress to provide additional housing options and reduce common barriers for the remaining disaster population. FEMA is providing more incentives to encourage landlords to offer and extend rental opportunities to those victims still seeking a long-term housing solution. FEMA has also taken steps to reduce or eliminate barriers that some families experience when trying to relocate to a rental unit, such as utility payments, deposits, and fees. These incentives and additional actions include: <bullet> Authorizing payment of rental assistance above the current Fair Market Rate; <bullet> Payment to landlords for utilities if included in the rent payment; <bullet> Payment to landlords for repairs to property damage made by disaster applicants; <bullet> Payment of security deposits, and processing fees for background checks required by some landlords; and, <bullet> Assistance with locating furniture and other necessities to meet basic living needs. In addition, in October 2007, FEMA established a reimbursement program that provides relocation assistance to disaster victims displaced by Hurricanes Katrina and Rita. This program reimburses relocation expenses up to $4,000 for applicants returning to their pre- disaster states. For those families that are already living in their pre-disaster state in FEMA-provided temporary housing, FEMA will pay moving expenses to a FEMA-funded rental resource anywhere in the continental United States, if the new location is greater than 50 miles from applicants' current location in the state. Relocation assistance is limited to travel costs, furniture transportation expenses, and moving services, and is subject to the applicant's overall cap of assistance under the IHP program. FEMA has assigned case workers to contact every applicant currently residing in a travel trailer, park model or mobile home in the Gulf Coast to make them aware of available housing resources, and we continue to provide case management services to applicants while they make final decisions about their housing alternatives. No occupant of a FEMA provided travel trailer has to wait for the results of air quality testing to take advantage of these alternative housing options--they are available now. It is important to note that nearly 80 percent of the remaining travel trailers and park models in use in the Gulf Coast are on private home sites. These households are, for the most part, making repairs so they can return to their pre-disaster dwelling. Additional Precautionary Measures On March 10, 2008, FEMA issued a revision to the July 31, 2007 Interim Direction on the Use of Temporary Housing Units based on the preliminary results of the testing conducted by CDC. FEMA will continue to utilize and offer manufactured housing (mobile homes) that meets or exceeds the Department of Housing and Urban Development (HUD) standards, as a temporary housing option. FEMA will not deploy, transfer or sell travel trailers. However, FEMA may continue to provide larger, better ventilated park models in support of future disasters, but only in accordance with the mandatory testing and State notification. Under the Interim Direction, FEMA will have the air quality of the unit independently tested to determine formaldehyde levels prior to allowing any disaster victim to occupy an existing manufactured home, park model or any new form of housing. FEMA will provide the certified results of such testing, as well as a compendium of formaldehyde risk and warning information to the State and the disaster assistance applicant, and will subsequently only deliver and provide units determined to be acceptable by the state. FEMA has entered into a contract with an approved Industrial Hygienist to conduct air quality testing on temporary housing units prior to allowing such units to be occupied by eligible disaster victims. The air quality testing will use a testing strategy appropriate to the conditions that follows the same NIOSH testing protocols that the CDC contractor used to test occupied units. FEMA has relied heavily upon the expertise of the officials from the DHS ORA in the development of the testing guidance. The same protocol will be used for all air quality testing, no matter where it takes place, whether at storage sites, staging areas or on private property. FEMA has initiated testing of mobile homes that will be utilized in response to the current disasters in Arkansas, Tennessee, California and Oregon. Mobile homes have been accepted and deployed in California and Oregon. FEMA will continue the testing process for mobile homes in Hope, Arkansas and Selma, Alabama. Once tested, these mobile homes will be offered to Arkansas and Tennessee for consideration to house disaster victims in response to the tornadoes that affected those states. FEMA has also implemented new requirements for future purchases of to-be-built manufactured homes, park models, and other new forms of alternative temporary housing that will ensure such units are specifically designed and constructed to emit (and tested to assure) the lowest possible levels of formaldehyde. FEMA has updated housing specifications for purchases of Uniform Federal Accessibility Standard (UFAS) and non-UFAS park models, as well as mobile homes. These units must meet the design and construction requirements established in Title 24 of the Code of Federal Regulations sections 3280.308-309. Units must include weather radios and manufacturers must not use materials which emit high levels of formaldehyde during production. FEMA has also offered to refund the purchase price of travel trailers or park models to all individuals who bought their unit between July 24, 2006 and July 23, 2007. This applies to units purchased directly from FEMA by disaster assistance applicants already occupying the unit, and to those who purchased units through the General Services Administration. As of March 13, 2008, two disaster assistance applicants who purchased their unit directly from FEMA had requested a refund and FEMA received 756 requests for refunds from those who purchased a unit through GSA auction sales. To put that number in perspective, it represents 7% of the 10,839 travel trailers and park models that were sold through GSA between July 2006 and July 2007. Since the suspension in the sale of travel trailers, FEMA has also continued to receive a significant number of inquiries requesting that we re-instate the sale of units. However, because of unresolved health concerns associated with the units, we will not transfer or sell travel trailers at this point in time. Summary In summary, we remain committed to assisting all residents of temporary housing units in finding permanent housing solutions. We continue to address the formaldehyde issue forthrightly: sharing information with temporary housing residents; testing occupied as well as new units and providing results to the occupants and the states; working with occupants to encourage alternative housing solutions; removing barriers for relocation to apartments; closing group sites; and providing case management services to assist all eligible households. Allegations have been made, and inferences drawn, from a limited review of a large number of e-mails FEMA produced to Congress in the spring and summer of 2007. These allegations include that the Agency suppressed or influenced formaldehyde reports because of fear of litigation and liability for injuries to occupants. Let me be clear, FEMA has not, nor will we condone any action that interferes with scientific experts conducting their work in a scientifically responsible manner. The health and safety of residents has been and continues to be our primary concern. FEMA has not and will not attempt to, nor will we condone any effort to, suppress or inappropriately influence any report from the CDC, or ATSDR or any report from any agency, including any report related to the effects of formaldehyde on residents in the direct housing program. Together, with our outstanding partners throughout the federal, State, local, private, and voluntary agency communities, we will continue to advance ideas and pursue housing assistance solutions that will effectively, and compassionately, help individuals and communities recover, re-establish, and reclaim their neighborhoods and communities. Thank you for the opportunity to testify. I would be pleased to answer any questions you may have. Biography for Harvey E. Johnson, Jr. Harvey E. Johnson, Jr. (USCG, retired Vice Admiral) is the Deputy Administrator and Chief Operating Officer of FEMA. He came to FEMA in April 2006 after serving as Commander, Pacific Area of the U.S. Coast Guard since June 2004. Mr. Johnson has a wealth of emergency and crisis management experience, including support to Admiral Thad Allen and the Coast Guard's Hurricane Katrina response efforts by coordinating and deploying West Coast resources. His operational experience includes various Coast Guard efforts, including search and rescue, freighter grounding, vessel break-up and pollution response for the motor vessel Selendang Ayu and the tank vessel Seabulk Pride in Alaskan waters. In addition, he participated in multiple Naval War College, Lead Shield and Rogue Vessel exercises in response to simulated maritime homeland security threats and the management of hundreds of Coast Guard law enforcement, search and rescue and pollution response cases in the Pacific. While serving as Commander, Pacific Area, Mr. Johnson led efforts that encompassed more than 73 million miles west of the Rocky Mountains and throughout the Pacific Basin to the Far East. Prior to this assignment, he was the Commander, Seventh Coast Guard District and served as the Director, Homeland Security Task Force-Southeast, where he directed Operation Able Sentry, the Department of Homeland Security's response to the crisis in Haiti. In addition to these duties, he served as the Executive Director of the Coast Guard's transition into the Department of Homeland Security, Director of Operations Capability and Director of Operations Policy. Prior to promotion to Flag rank in 2001, Mr. Johnson served as the Executive Assistant to the Commandant of the Coast Guard. Other assignments included: Commanding Officer of Air Station Brooklyn, and concurrently as Commanding Officer of Air Station San Diego and Commander, Activities San Diego. He also served as a fellow at the Chief of Naval Operations Strategic Studies Group in Newport, Rhode Island. Mr. Johnson began his career as a Deck Watch Officer aboard the Cutter Steadfast (WMEC-623). He then earned his Naval Aviator wings in 1977. He flew the HH-52A helicopter at Coast Guard Air Station Houston, the HH-3F at Coast Guard Air Station Kodiak, the HH-65A in Brooklyn and Corpus Christi and the HH-60J in San Diego. His staff assignments include: Aviation Assignment Officer in the Office of Personnel and Training; Program Reviewer and Analyst within the Office of the Chief of Staff; Deputy Chief, Programs Division within the Office of the Chief of Staff; and member of the Streamlining Team. His major decorations include the Legion of Merit (3), the Meritorious Service Medal (3), the Coast Guard Commendation Medal (2) and the Coast Guard Achievement Medal. Mr. Johnson received a Bachelor of Science degree at the U.S. Coast Guard Academy in 1975. He earned a Master of Science degree at the Naval Postgraduate School in 1983 and a Master of Science degree in Management as a Sloan Fellow at the Sloan School of Management at the Massachusetts Institute of Technology in 1993. Mr. Johnson is a native of Tampa, Florida. He is married to the former Janet L. Cronin of Boston, Massachusetts, and they have two children, Jennifer and Scott. Discussion Warning FEMA Employees About Formaldehyde Chairman Miller. The Chair now recognizes himself for five minutes for an initial round of questions. Admiral Johnson, this is not the only Committee or Subcommittee of Congress that has looked at the trailers provided by FEMA. In the documents produced to other Committees, either the Government Reform and Accountability Committee or the Homeland Security Committee, documents from FEMA show that FEMA employees were warned about formaldehyde in trailers. Is that correct? Vice Admiral Johnson. What is correct, sir, is that from 2005, Bechtel Corporation asked as a matter of routine to conduct assessments for formaldehyde in travel trailers. That was done in 2005. That was a Bechtel effort that was really not made aware to FEMA. Also in 2005, that was just a few months after Katrina where there were hundreds of thousands of families without any type of housing. And so we were still providing--in the initial stage of providing housing and that issue did not come to our attention. It did not seem--it did not rise to the level of the decision-makers' attention in 2005. In 2006, we became aware by the first reports in Mississippi by occupants who reported problems with formaldehyde, and at that point on I think--and without going through the timeline, I think you will see that FEMA reacted to every one of those reports. We began consulting with EPA, with CDC, and with others and we sought medical advice. I believe we have taken responsible actions based on that medical advice over the last two years. Chairman Miller. The documents included an e-mail, March 22, 2006, from Bronson Brown to Richard Sease, Owen Motter, and David Shawaga that said, staff are to be instructed that prior to entering the trailers there should be a period of time for off-gassing before conducting any work operations inside the trailers. Vice Admiral Johnson. That is correct. The gentleman who wrote the e-mail was our head of Occupational, Health, Safety in FEMA, and the trailers he was referring to were unoccupied trailers that had been closed and sealed for some amount of time. Those were not occupied trailers by disaster victims. And so it is, when those trailers have been sealed in the heat, we do want to make sure that our employees take the proper precautions to ventilate those units before they go into them. Chairman Miller. And how long would be the period of exposure by a FEMA employee entering a trailer to do some work? Vice Admiral Johnson. Well, those are typically--those are workers who in this case were either preparing trailers to be occupied or were preparing trailers to be sent back--had been already used and to be disposed of in some manner. So they would usually be in those for a short amount of time. February 2007 Health Assessment Chairman Miller. Dr. Frumkin, turning your attention to the February 2007 Health Assessment, do you know who it was at FEMA who requested that health assessment? Dr. Frumkin. My understanding it was Mr. Preston in the Counsel's Office. Chairman Miller. And do you know the purpose of the assessment? Dr. Frumkin. We understood that it was a request for a review of data in terms of its health implications, a fairly standard kind of request. Chairman Miller. Was it for purposes of acting to protect the safety of the occupants or was it tied to any pending liability? Dr. Frumkin. I am not aware of any liability issues at the time, although in retrospect, there have been documents that we have seen that demonstrate that concern. Chairman Miller. Well, there was an e-mail from Dr. Sinks on October 12 of last year, 2007, that said, unfortunately the request was generated by FEMA lawyers attempting to respond to legal actions against FEMA. Were you aware of that e-mail? Dr. Frumkin. I think in retrospect, one of the issues that we could have done better was to have recognized the significance of a request from an attorney that is an irregular form of a request, and we could have flagged concerns with that to the agency. Chairman Miller. Okay. Is it your practice to provide expertise to lawyers involved in litigation? Dr. Frumkin. No, it is our practice to provide expertise to sister agencies that request that expertise. We did not in this case recognize that this was a different sort of request from a sister agency than the usual one. Chairman Miller. Second round. The initial e-mail to you-- well, first of all, could you describe the chain of review for the February health consultation provided to FEMA, February 2007 health consultation provided? Were you in that chain? Who else was in that chain? Dr. Frumkin. The ordinary chain of review that prevailed at the time and that was used across all of our divisions was as follows. A product would be developed by staff in the division, it would move up through the division leadership, and then in some cases, usually on a discretionary basis, be brought to the attention of center leadership. There was also an accountability to the Emergency Response Office as Dr. De Rosa explained earlier, but that did not replace, that simply supplemented the standing line of review. Chairman Miller. I am sorry, was there a separate emergency response chain or were there different procedures for emergency responses? Dr. Frumkin. The baseline procedure was the one that usually prevails and that is that staff within a given division would move their documents, their work, through their division for clearance. In addition, because of the complexity of the Katrina work and the fact that all of our divisions were involved, we had created sort of a central point of information and contact in the Emergency Response Office so that documents were moved up the chain as well. Chairman Miller. Well, I am sorry. I am still not quite understanding. Which procedure was used with respect to the Health Assessment in 2007, February 2007? Dr. Frumkin. What we have learned in retrospect was that the clearance within the division did not occur as it ordinarily would and should have. So the staff went directly through the emergency response chain, and that was the only chain that they used. Chairman Miller. And you were part of that chain, that is correct, is it not? Dr. Frumkin. After the review in the Emergency Response Office, it came to the Office of the Director, yes. Chairman Miller. Okay. And when did you--I have an organizational chart that shows that the chain appears to consist of Marilyn DiSirio, Nabil Issa, Mark Keim, Gina Motrie, Linda Anderson, Tom Sinks, and you. Would those be the people in the chain? [The chart follows:] <GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT> Dr. Frumkin. No, sir. Those are various Associate Directors within the Office of the Director. The specific person who was part of the emergency response chain was Dr. Keim. He would report directly to Dr. Sinks and to me. Chairman Miller. Who would? Dr. Frumkin. Dr. Keim. Chairman Miller. Dr. Keim? Okay. And when did you learn that it had not gone by Dr. De Rosa for review? Dr. Frumkin. In late February when Dr. De Rosa contacted me with his concerns, I was surprised to realize that he had not had a role in overseeing his staff in preparing the report. Chairman Miller. You did not know before that time that he had not seen the review, the assessment? Dr. Frumkin. No. Chairman Miller. Dr. Sinks, you are in that chain as well. Did you know in February of 2007 that Dr. De Rosa was not in the link, in the chain? Dr. Sinks. Absolutely, I did not. Dr. De Rosa called me and stated that he was informed that his staff had been instructed not to share the document with him on orders from the Office of the Director. I commented to him at the time that that was-- those instructions never came from the Office of the Director. He then went back, spoke to his staff, and sent a second e-mail which included the letter that he recommended be sent forward to FEMA which about 10 days later we did send forward. Chairman Miller. Is your recollection now--well, Dr. Sinks and then Dr. Frumkin, the same question. Is your recollection now different from when you were interviewed by our staff about all of this? Dr. Sinks. My recollection is not. I think I have been very consistent in speaking to your staff for more than six hours on this issue, and I think I said this same information. Chairman Miller. Dr. Frumkin, is your recollection the same now as it was when you interviewed with our staff? Dr. Frumkin. If there is a disparity, I cannot recall it, no. Chairman Miller. Okay. And is it correct that the emergency response procedures would have gone directly from whatever employees were involved in developing this assessment to Dr. Keim, to Dr. Sinks, to you, and would not--the emergency response procedures did not include Dr. De Rosa. Dr. Sinks. I will try to handle that. There is a small group in Dr. De Rosa's division which is an emergency response team which under the National Contingency Plan, and Dr. De Rosa is our representative under the National Contingency Plan, does operate and operates independently of our emergency response group that coordinates things in our Office of the Director. They do report to a team lead, that team lead reports to a branch chief, and ultimately that branch chief reports to Dr. De Rosa. Those individuals were informing their chain of command of the work they were doing since June of 2006 and weekly updates. Dr. Frumkin became aware of the work they were doing in December 4th of 2006 and sent Dr. De Rosa an e-mail at that time specifically asking Dr. De Rosa to keep us informed and to update us routinely at our senior staff meeting which occurs once a week. Chairman Miller. I understand that the employees involved in preparing the assessment have told our staff in extensive interviews, probably every bit as extensive as yours, that the ordinary procedure for the emergency response--and they understood that this was subject to the emergency response procedures--went directly to Dr. Keim. Is that, that is different from what your understanding is? And that routinely with respect to emergency response, it did not go past Dr. De Rosa, it went directly to Dr. Keim to Dr. Sinks to Dr. Frumkin. Is their testimony incorrect? Or not testimonies, but what they have said incorrect? Dr. Sinks. Let me try to respond to this for you, Mr. Miller. I believe their testimony is correct in terms of what actually happened to the document. I do not believe Dr. De Rosa saw the document until three weeks after the document was issued. It was never our expectation that the division supervisors be excluded from the review. I do not believe there is any written e-mails to that effect or any type of information that would suggest that that was done. It may very well be that the individuals in his team had that perception, but it was not a perception that was given to them by us. Dr. De Rosa's Concerns Over the Health Consultation Chairman Miller. Dr. Sinks, I am also inclined to conclude when there is silence in e-mails, when that seems to be of the ordinary method of communication, that that means that it did not happen. Do you have an e-mail--this is to both Dr. Frumkin and Dr. Sinks--to support the testimony today that you encouraged Dr. De Rosa to prepare a response to the February 2007 Health Assessment to say that it was flawed, it had not gone through ordinary views, and there were scientific concerns about it and that it might be misleading? Dr. Frumkin. I don't recall e-mail communication on that point, Mr. Chairman, but I do recall very clearly that when Dr. De Rosa finally weighed in on the issue of the report several weeks after it was released, I recognized that his concerns were correct and indicated that we should act on them. Chairman Miller. Okay. When you said finally, do you have any basis to contradict what he said earlier which was that he acted as soon as he had a chance to read it? He immediately e- mailed you to express his concerns? Dr. Frumkin. Well, Dr. De Rosa's opportunity to be involved began in June of '06 when his staff began their involvement on the issue or certainly in December of '06 when I asked him to involve himself and keep me informed, but for reasons that are unclear to me, he didn't take that opportunity to be involved until much later. Chairman Miller. Well, the wording of his second e-mail to you would be very peculiar if in fact there were oral discussions during that period since his first e-mail he says, ``I am resending the previous e-mail which describes my concerns regarding the formaldehyde health consultation. If I receive no objections from you, I will send the attached letter to FEMA by COB.'' What is COB? Close of business. Excuse me. Friday, March 9. Had there been conversations apart from e-mail communications between the time of the first e-mail and second e-mail? I mean, it is certainly the tenor, the tone of this e- mail. The e-mail implies that he hadn't heard from you. Dr. Frumkin. I think that is correct. I had not seen his first e-mail until he resent it. Chairman Miller. Dr. Sinks, did you see the first e-mail? I think it was copied to you as well. Dr. Sinks. Dr. De Rosa sent the e-mail. I can't say that I did see the e-mail. I did not respond to the e-mail, and when Dr. De Rosa sent it about one week later, Dr. Frumkin responded to it. Chairman Miller. Thank you. But I am gloriously over. Mr. Lampson? 2005 Formaldehyde Testing Mr. Lampson. My apology, Mr. Chairman. I was waiting for you to give me time, and I didn't know you had recognized me. Please accept my apology. Thank you very much. Admiral Johnson, did you say a while ago--did I hear--maybe I heard something incorrect, but did you say that there had been some testing done in 2005? Vice Admiral Johnson. The report to us was that there was some testing of Bechtel Corporation who was the subcontractor-- a contractor for FEMA that had asked for some testing for formaldehyde in units that their employees were working. We were really unaware that that had taken place, but it did occur in 2005. FEMA's Emergency Housing Mr. Lampson. When FEMA proceeded, was it under some direction or the emergency housing that it provided, did you have a mandate to go forward with the knowledge that you had, indicating that the housing it was providing was safe and fit for short- and long-term housing? Vice Admiral Johnson. When we began, we had actually been using travel trailers and mobile homes for a number of years for disasters. It is a very common form of temporary housing, and when we used them in post-Katrina, it was a full expectation it would be suitable housing for all the disaster victims who would use them. Mr. Lampson. What would be temporary? Vice Admiral Johnson. Typically temporary in most disasters is going to be less than--perhaps less than six months. This is only the second time I think in our history that we have had a disaster that has gone beyond that and had people in travel trailers which was not typically duration expected of their stay. Acute Formaldehyde Exposure Levels Mr. Lampson. Why did FEMA, when requesting the ATSDR, provide health guidance on safe levels of exposure to formaldehyde as late as 2007, ask that the evaluation be restricted to short-term exposures? And why would FEMA request that when residents had already been living in those trailers for two years? Vice Admiral Johnson. The primary concern at that time again wouldn't--with knowledge, now we look back and wish we knew what we knew then. At the time that we were asked of that support, we were really trying to mitigate the effects from formaldehyde. At that time as well, sir, as I mentioned in my opening statement, there were up to--we were leading up to 143,000 families in travel trailers. We were still standing up new group sites at that time just a few months after the disaster. So we began to recognize that formaldehyde was causing issues with our occupants, so we were trying to figure out how can we do something about it, how can we mitigate the effects, and that was the primary effort of the first request for support. Tracking Former Trailer Occupants Mr. Lampson. As a part of that mitigation, did you--have you begun to keep a list of all of the people who have lived in these trailers and set up a plan for monitoring the effects on anybody who may suffer illnesses because of it? Vice Admiral Johnson. I say sort of yes and no to your question. Yes, we do have a record of all those who have lived in travel trailers and mobile homes, and at this point we are working with CDC to begin to establish a registry that would track those families. The registry doesn't exist now, but we are working with CDC to establish that registry. Trailer Costs, Inventory, and Sales Mr. Lampson. There was a FEMA and HUD press release on April 26th of 2007 and it announced that individuals in travel trailers would be able to purchase their trailers at a fair and equitable price. What would you pay for one of those trailers? Vice Admiral Johnson. Sir, I can tell you, we sold those on an average for about $300. Even today, with all of the media attention, the public attention, the government attention from formaldehyde, I was asked just yesterday, when will FEMA begin selling travel trailers again to the public. Mr. Lampson. How much did we pay for them? Vice Admiral Johnson. I think in travel trailers, I would be guessing, I think it is about $8,000--$8,000 to $10,000. Mr. Lampson. Did the manufacturers give us a break on the price because we were purchasing a large number of them? Vice Admiral Johnson. I am sure we got a good price. We bought a number of them. I would have to get back to the staff on the exact cost of the units. Mr. Lampson. Would you, please? Vice Admiral Johnson. Yes, sir. Mr. Lampson. I don't believe we know the actual number purchased and the price per item, giving us a total. That could be a pretty big number, couldn't it? Vice Admiral Johnson. Yes, sir. We still have--as of August last year, we stopped using travel trailers. We still have 3,500 travel trailers in our inventory that we are not using in current disasters today in Tennessee and Arkansas and other places around the Nation. Mr. Lampson. Do you know when we purchased those whether they had done--was it a bid process? Vice Admiral Johnson. Yes, sir. We bought--well, two things. First is that immediately when the disaster occurred, again, overwhelming catastrophic disaster, we used all of the units that were in our inventory. We actually went and bought thousands of units that were on the lots of manufacturers and their distributors, and then we went back to the manufacturer themselves and had a separate order. So there were actually sort of three phases of providing the temporary housing. Mr. Lampson. Do you know how many actual--how many of those living in trailers have actually chosen to purchase them? Vice Admiral Johnson. I think we sold about 900 units from FEMA, and then we worked through GSA and they sold I believe some number of 5,000 additional units. We can provide that specific data. But we sold many thousands of units to the public, some were occupants and some were just people who wanted to buy them for a recreational vehicle. FEMA Outreach on Formaldehyde Health Effects Mr. Lampson. And were they given the same instructions regarding potential health effects? Were they warned before they decided to purchase trailers about the formaldehyde levels? Vice Admiral Johnson. When we began to--I think July of '06 was our first flier that we sent out to all of the residents of mobile homes and travel trailers. Anything that we sold beyond that point when we recognized the situation as it was, we did provide full information, access to our website, copies of the fliers so that they were fully informed on their purchase. Mr. Lampson. I have a copy of a flier here, and the language that is used in this flier is fairly innocuous language. I would hope that there would be more detailed information given certainly by the time that we began to have all of this information. And Mr. Chairman, I have gone way over my time. Are we going to have a second round? Are we going to have a second round? I'll---- Chairman Miller. Yes. Mr. Lampson.--reopen my time right now and wait. Chairman Miller. Yes. Mr. Lampson. Then I yield back my time right now. Chairman Miller. Apparently I was not paying any closer attention to you than you were to me. Mr. Lampson. I will do better next time. Drs. Frumkin and Sinks Health Consultation Review Chairman Miller. All right. Thank you. Dr. Frumkin and Dr. Sinks, according to documents provided by ATSDR, in addition simply to this February health consultation being copied to you, routed to you, there was a briefing on it, an oral briefing that included both of you. Now, when you testified-- well, not testified but when you were interviewed by our staff, you said you really didn't remember much about that. Do you remember anything more about it now? Dr. Frumkin. The document was described to us in our regular weekly staff meeting, and there was a discussion about it fairly briefly as we have many items that we cover. I took a quick look at it at the time and asked for an executive summary and for some conclusions since I noticed that they were missing, and readers would have a hard time getting to the bottom line. Chairman Miller. Do you recall who was there? I assume that Dr. De Rosa wasn't there because the evidence is undisputed that he didn't know about it at that time. Dr. Frumkin. Yes, sir, he wasn't there. Chairman Miller. Was Dr. Keim, was he there? Dr. Frumkin. I don't recall. Dr. Sinks. It would have either been Dr. Keim or his deputy who would have presented to us in that issues management meeting. It is a weekly meeting. We go over many of the issues that we would be dealing with during that week, and it was presented probably in a couple of minutes as this is a document that has been prepared by the division. And at that point, I know I did take a look at the document following the meeting. We were never provided a briefing. A briefing I would describe as the principal investigators and their supervisors meeting with us to describe what the work was that they were doing, why they were making certain decisions. We do have those briefings on a large number of subjects that our agency is involved in. There was never a briefing provided to us by the staff or the division. Chairman Miller. Did you ever ask any questions? Do you recall asking any questions at that meeting? Dr. Sinks. I can't recall the meeting specifically. I did ask to see the document. I did sit down and read the document. Once I did provide some comments in the margins of the text and provided that back to probably Mr. Alred who provided that to us. Chairman Miller. And you don't recall whether there was any discussion of what the procedures were for reviewing it, whether it had been reviewed by Dr. De Rosa or who had reviewed it at the Division of Toxicology and Environmental Medicine? Dr. Sinks. There was no discussion about it. We had made the assumption, and apparently incorrectly, that it had been reviewed by the division. Chairman Miller. Okay. And was there any discussion of why it was being provided? Who had asked for it? Dr. Sinks. We knew that it was work that was going on. I can't tell you why it was presented to us at that time. If one of us had asked to see it or not, this was more than a year ago, but it was brought to us. I can tell you, sir, that in our policy, we do have a policy on review of health consultations, and it very clearly states that those health consultations are reviewed by various individuals in the divisions with the discretion to bring it to the Office of the Director. And whether that discretion is based on the division's recommendation or our recommendation, it can be either way. Chairman Miller. Do you recall the March 9 e-mail from Dr. De Rosa, and it is according to what it says. It was from Dr. De Rosa to both of you, or to each of you. Re, draft letter to FEMA. The consultation was developed, sent forward, and signed by DTE and staff. Now, the earlier e-mail had already said that he had not seen it. ``They indicated to me that they had been directed to not share the information further and not to address longer-term health effects. That is why IARC was cited repeatedly without reference to cancer and was not included in the literature cited. FEMA's initial contact came directly to me nine months ago on this issue. I reviewed the proposed statement and specified that they neglected to address longer- term risk including cancer. FEMA then came back to our OPTER''--I assume that is an acronym, obviously, it is--``with the same request, and this was assigned to DTE and staff. After the completion of the consultation, our staff sent their signed consultation directly to OPTER who sent out the letter. By separate e-mail, I shared the response with Mark Keim. If you wish for him to send it out, that is fine. Otherwise, I will send it at your direction. Either way is fine with me.'' So you obviously knew after this e-mail that he had not reviewed the letter, is that correct? Dr. Frumkin? Dr. Frumkin. Yes, I think there are several points in that e-mail on which we can agree. One is that we didn't adequately include consideration of longer-term health impacts in the original consultation. And the second is that our document review process which should have included Dr. De Rosa didn't function as well as it should have. We have been very careful about relooking at our document review process, looking for where things may have operated, not as well as they should have, an for opportunities to do better in the future. Chairman Miller. Is there a procedure that shows--is there a procedure for initialing I think it is called buck sheets? Anything like that at ATSDR to show who has seen a document? Dr. Frumkin. There is for correspondence and for certain kinds of documents, but generally not for the documents within divisions. Chairman Miller. Under your procedures, you would have no way of being able to look at the document, look at any document and know who has reviewed it, is that correct? Dr. Frumkin. The ways that we have of tracking documents across the agency are complex, and that is one of the things we have recognized the need to look at as we move toward improving in the future. Chairman Miller. This e-mail, again, they indicated to me-- these were the DTM staff and members involved in developing the consultation--that they had been directed not to share the information further and not to address longer-term health effects. That would appear to me to be a startling sentence in that e-mail that should have gotten a great deal of attention for what had happened and why it had happened. But there doesn't seem to be any response that matches up to my response which is to be startled that they had been told by FEMA what kind of report they wanted. Do you have any document--I mean, do you have e-mails that say that you wanted to get to the bottom of this? Dr. Sinks. Let me respond to that in two ways. First of all, in Dr. De Rosa's e-mail of the week before discussing this, he says that he has spoken to his staff and he has taken care of the issue of making sure that adequate clearance goes through his division. I believe that is the e-mail you mentioned the first time he sent a letter. I think our focus was actually on the content of his letter and what should be going forward which was an appropriate thing to be doing, and we embraced his coming forward and recommending that level; and Dr. Frumkin concurred, and we sent it forward. Chairman Miller. Even after the letter went out, not the one that Dr. De Rosa had drafted but someone else at your direction sent a letter to FEMA, a letter that apparently was placed in a file and not circulated at all at FEMA or given to anybody responsible for public health instead of liability, FEMA continued to tout ATSDR's assessment. It was in the press, it was in testimony before the Government Reform and Accountability Office, Accountability Committee here last summer. It did not always refer to ATSDR by name. It simply said scientific agency. When did you become aware that FEMA was continuing to tout ATSDR's flawed Health Assessment? Dr. Frumkin. We were not adequately aware of the way the assessment was being used or interpreted or misinterpreted during that several month period in early 2007. We focused on it much more intensively during the middle of 2007 when the media reports and the Congressional oversight drew our attention to it. But we don't routinely track media reports about what other agencies are doing. Dr. Sinks. Sir, if I may add to that---- Chairman Miller. Sure, Dr. Sinks. Dr. Sinks.--response, we also became much more heavily engaged in May, about the middle of May, when we were contacted by the Department of Homeland Security to become more engaged in the issue; and that is when we started to develop our plans for more robust response to the formaldehyde issue. FEMA's Office of General Council's Involvement With the Health Consultation Chairman Miller. Dr. Sinks, you did say a moment ago that you had in fact reviewed the letter, the Health Assessment? Dr. Sinks. Yes, I did see the Health Assessment. The first one, the first week of February, yes. Chairman Miller. Did you read the first sentence which reads, ``the ATSDR Emergency Response Program was requested by the Federal Emergency Management Agency, FEMA, Office of General Counsel, to review and provide an evaluation of analytical data related to a project involving formaldehyde sampling at FEMA temporary housing units/trailers located in Baton Rouge, Louisiana?'' Dr. Sinks. Sir, I would have read that statement and I believe there are actually earlier clues in the e-mails that would have indicated to me that the Office of General Counsel at FEMA had made that request of us. It was not something that caught my attention at the time. Chairman Miller. Okay. Well, the e-mail that you sent I think in October, in the fall of last year, that you were shocked to learn that it had been provided to a lawyer for presumably liability concerns, not based upon concerns about public health. Did you just not pay any attention? Do lawyers usually get involved in the public health considerations? Dr. Sinks. Occasionally lawyers do get involved in public health considerations. I think, Mr. Miller, I certainly had the opportunity to recognize that. All of us who did review the document or did read the document would have had that opportunity. There were also e-mails that had gone on before that would have given us that opportunity. It was simply something that did not catch my attention at the time. Chairman Miller. The second paragraph of that e-mail, unfortunately the request was generated by FEMA lawyers attempting to respond to legal actions against FEMA. You said that this request must not have seemed extraordinary to our staff, but it didn't seem extraordinary to you, either. Dr. Frumkin. Mr. Miller, I think in retrospect, we failed to recognize the import of a contact that came from an attorney rather than through typical technical channels. Please be assured that we are about protecting public health. We are not about litigation support. We undertook this work in a sincere effort to advance public health and in no way ever would compromise that mission. Chairman Miller. Just one moment, please. Actually, Mr. Lampson is recognized for another round of questions. Trailers at Maxwell Air Force Base Mr. Lampson. Thank you, Mr. Chairman. Mr. Johnson, is FEMA taking mobile homes to Maxwell Air Force Base for testing? Vice Admiral Johnson. I am not aware currently that we are taking them to Maxwell Air Force Base. Mr. Lampson. We have learned that there is a plan to take some trailers there, I don't know the number, heat them up, measure the formaldehyde content, and then send them to Tennessee. You can't clarify that in any way? Vice Admiral Johnson. Just what I would say is right now, as I mentioned before, if we provide a mobile home to any disaster site currently, which would be Tennessee, Arkansas, Oregon, those who have a current disaster, we developed protocol working with the Office of Health Affairs and DHS of how to test that unit so we can provide the test result to the state and to the potential occupant of that unit. Right now it is seven days of not heating up, and seven days of simulated actual situation which in most cases involves using the air- conditioner and climate control, humidity control. And so we have this standard protocol. We do test it. We use the same test company, the same protocol, the NIOSH protocol that was used by CDC, and we have actually done that successfully for the last probably 2 months. We provided housing units that tested very low in formaldehyde to Oregon, and we are currently prepared to provide mobile homes to Tennessee and Arkansas at levels where the state has accepted those units. Mr. Lampson. But you don't know for certain that that testing is going on at Maxwell Air Force---- Vice Admiral Johnson. Well, we are doing testing in Selma and in Hope, Arkansas. So I am not quite sure in Selma, if that is Maxwell Air Force Base but that is where we have a facility that exists now for mobile home storage. Emergency Housing Alternatives Mr. Lampson. Although I would like to believe that we won't have any more natural disasters that leave people homeless, we all know that it is probably going to happen at some time in the future. Is FEMA looking at alternatives for emergency housing? Can we use new green building materials to manufacture temporary housing that is healthier? What is your agency doing along these lines? And can you also tell me when FEMA anticipates that residents will be moved out of the trailers entirely? Vice Admiral Johnson. Yes, sir. Good question. We have a joint housing solutions group that we stood up about a year ago, and their job is to reach out to industry and identify potential alternatives to mobile homes and travel trailers; and they have actually tested--some are shipping containers, some are other modular homes, and they have actually looked at about 40 different alternatives that cost different amounts. Some take more set-up than others, and we are exploring different alternatives to mobile homes and travel trailers. Last year Congress appropriated $400 million for us to run an alternative housing pilot program in the Gulf Coast, and we currently have what are called Katrina cottages in Mississippi and there is a current program in Louisiana, Texas, Mississippi, all to look at alternatives to mobile homes and travel trailers. And so we are very attuned to the need to find a broader range of solutions. Within the Gulf Coast right now, it is our desire to move all the residents out of travel trailers into more permanent alternatives such as rental units, apartments, and the like. We want to have all out of group sites before hurricane season on the first of June, and we are working very hard every day to move an average of about 500 to 700 families a day to leave a mobile home or a travel trailer inside the Gulf Coast today, moving towards more permanent locations. In some cases, that is their house. They have a travel trailer that is in their driveway as they begin to repair a house post-Katrina, and so it ranges from moving back into their house, moving in with relatives, or moving actively into apartments and hotels and motels and other sorts of housing alternatives. Mr. Lampson. At 500 to 700 a day and you're looking at hopefully completing it by June? Vice Admiral Johnson. Well, we hope to get all the group sites--in some locations, and I think it came up in a prior panel, in Louisiana, there appears to be an almost adequate number of alternative housing apartments and rental units. In Mississippi, the local housing has not recovered nearly as quick. The issue with Mrs. Huckabee is in an area of Mississippi where there are not available rental units. In some parts, in other parishes and counties, very, very difficult to find alternatives; and so some people do feel in order to stay close to family, to school, to work, to church they are making the choice to stay where they are as opposed to moving to an alternative that we hope that we can provide to them. How Will ATSDR Prevent Future Problems? Mr. Lampson. Dr. Frumkin, your statement that we could and should have done better is an understatement. Your agency has failed to protect public health, failed to produce the best science. I still don't understand how your agency produced such a poor quality scientific report to FEMA, why you failed to improve or correct that report, and I also can't understand why you didn't personally communicate with your counterparts at CDC and FEMA when it was reported that trailer residents were experiencing clinical symptoms associated with formaldehyde exposure. In light of that incident, what changes have you instituted specifically at ATSDR to eliminate a recurrence of that situation? Dr. Frumkin. With respect, sir, we have done an awful lot of very effective public health protection, but I have to agree that we didn't do the job we would have liked to have done with regard to the trailers. The opportunities for improvement that we have identified are in several domains. One has to do with the clearance and review of scientific documents. The Board of Scientific Counselors, which is an external group, is reviewing our scientific clearance procedure to see whether there are ways to improve that. In the meantime, we have reinforced to the divisions the need to abide by standard existing procedures because that hadn't always been done and it wasn't done in this case. With regard to management issues, also a potential opportunity for improvement, we have commissioned an outside review of our management procedures, if we can identify opportunities for improvement there. And then as detailed in our written testimony, there is a series of short-term solutions or improvements that we have implemented, for example, clarifying communication channels within in between agencies. The ways that we are triaging and tracking the issues that we manage have been considerably strengthened. We have our weekly meetings both for issues management and senior staff, and we have clarified with all participants of the meetings the need to raise important issues and to raise them repeatedly if they remain active. We are tracking those actively now. So we have made some improvements internally. We have sought external oversight so that we can identify the very best opportunities for improvement as we move forward. More on Dr. De Rosa's Performance Mr. Lampson. A little while ago, Dr. De Rosa testified that he has been put on a 90-day notice that he must show personal improvement and must embark on a personal improvement program in order to do so. Yet, he is the one who helped identify shortcomings that were there. Is that fair? Dr. Sinks. Dr. Sinks. Let me try to respond to that. First of all, Dr. De Rosa did identify one of two key issues with the report that were relevant, the February 2007 report. He identified the lack of long-term health issues being identified. Unfortunately, he did not identify the fact that it was using an emergency medical guidance as a level of concern, and I wish that he had actually identified that. I heard him testify earlier that in fact he had mentioned this to us, but I never recall having heard him bring this up before; and in fact, the first time we became aware of the problem was in the hearing that was mentioned in July. And I believe this was something I had the opportunity to have seen and I missed, and I believe everybody who reviewed that document had the opportunity to see that, and we missed that. Going back to the performance improvement plan, and this is a standard document that is essentially an agreement that identifies the fundamental steps one should be taking in terms of their job to improve their performance, and that document was developed with several discussions with Dr. De Rosa about the types of activities that we thought his new position should be doing. What he wanted to do, he had significant input into that document. The elements in that document do relate to the type of work that he wished to do and I concurred with, and it is simply a document that identifies expectations for adequate performance. It is actually a document that is designed to help Dr. De Rosa to understand what the expectations are for his performance. Mr. Lampson. Are comparable steps being taken--level because were you not involved in the same level of failure? Dr. Frumkin. There is accountability across all levels of our organization, sir, from the Director's office, from myself, and Dr. Sinks to the Division Directors, to the Branch Chiefs, to the individual staff members. At every level of accountability, we take responsibility when we haven't performed well, and we work to make improvements. I need to emphasize that the reassignment of Dr. De Rosa was not in any way a retaliation for his actions in this case. His reassignment was a result of personnel actions that are best not discussed in a public forum like this. With regard to Dr. De Rosa's involvement in this particular situation, his major intervention during the one-year period between mid-'06 and mid-'07 was a suggestion that long-term health effects had been omitted from the report and it needed to be included; and that suggestion was gratefully accepted and acted on. So it is important to decouple the personnel action that occurred in late '07 from a review of the events we are talking about today. Mr. Lampson. Is his job at stake? Dr. Frumkin. There is absolutely no plan or no intention by me or anybody else I know to threaten his employment. His reassignment is at the same grade level, same seniority level, and I view it as a long-term reassignment. Mr. Lampson. Do you feel that he interprets any of these actions as related to this issue? Dr. Frumkin. That would be a question for him. Mr. Lampson. That was certainly the impression that came here. What steps exactly are you all taking, and if you can't discuss them in public, can you submit it to us, to the Committee? The steps are for anybody including yourselves as far as accountability is concerned. Dr. Frumkin. Yes, we can submit that in writing. Mr. Lampson. Okay. Thank you. Mr. Chairman, I yield back. Chairman Miller. Thank you, Mr. Lampson. I think we are getting close to the end. There are obviously many points of dispute in the testimony and in the interviews, but I think everyone involved is going to have many opportunities to testify under oath about these events in deposition and probably at trial as well. I respect, Dr. Frumkin, that you don't want to go into the personnel issues, but the memorandum of October 24 that you prepared, I want to read just an excerpt of that, that provided Dr. De Rosa with an unsatisfactory rating a year after being given a substantial bonus as an incentive to stay in federal employment. ``During the past year, he,'' Dr. De Rosa, ``was unaware of significant projects. His staff became involved in a project to assess formaldehyde levels in unoccupied FEMA trailers. In June 2006, his office took it upon themselves to engage in this long-term, non-emergency evaluation. They were technically unprepared to do the work. In addition, they took direction from a FEMA lawyer without consulting their supervisors. ATSDR consultation resulting from their work was of inadequate quality and has since been revised.'' Is that still your view? Dr. Frumkin. Yes. Review of the Events Surrounding the Health Consultation Chairman Miller. Okay. And again, I the e-mail that I earlier referred to and read from, Dr. Sinks; and that e-mail, you saw that e-mail, did you not, in October to all the staff at ATSDR about the levels of formaldehyde and the inadequacies of the work done to that point? Dr. Frumkin. I am sorry. I am not sure which e-mail you are referring to. Chairman Miller. It is dated October 12, 2007. It is from Dr. Sinks to all the CDC. The attachment is final outside contact procedures. Dr. Frumkin. Yes. Chairman Miller. And did you direct that he send that e- mail? Dr. Frumkin. I concurred with sending it. We decided together that it needed to be sent. Chairman Miller. Okay. And that says, unfortunately that request was generated by FEMA lawyers attempting to respond to legal actions against FEMA. Staff was asked to handle EPA generated data as confidential. Those were extraordinary--that was extraordinary, is that correct? Dr. Frumkin. It is a very irregular process for an interagency collaboration, yes. Chairman Miller. Okay. But again, the assessment itself in the first sentence says it was at the direction or at the request of FEMA's general counsel, isn't that right? Dr. Frumkin. In the previous document that you read? Chairman Miller. In the assessment, the February 2007 assessment. Dr. Frumkin. Yes. Chairman Miller. Dr. Sinks? Dr. Sinks. That is correct. Chairman Miller. And Dr. De Rosa's e-mail of March 9, 2007, said also that the staff at ATSDR who prepared the report said that they were directed not to share the information further and not to address longer-term health effects. Is that also not something that would--it would be very extraordinary? Dr. Sinks. I think half of that is certainly correct if you look at the incoming letter of transmittal to the data from the lawyer to the ATSDR staff, it does direct them not to share the data. It does not limit the scope of the evaluation, at least in my reading. Now, I don't believe Dr. De Rosa, Dr. Frumkin, or I were ever in a discussion with FEMA about this consult. So we don't know exactly what the discussions were verbally, but in the letter of transmittal, it does ask the staff to hold the data confidential, but it does not, at least in my read of it, restrict the scope of the work. Chairman Miller. But the e-mail from Dr. De Rosa, which apparently is based upon old discussions with those staff members, said that they were directed not to address longer- term health effects. Dr. Frumkin. That would be a claim that you would have to discuss with Dr. De Rosa. Certainly that direction to the best of my knowledge didn't come from FEMA, and I know that it didn't come from within our agency. Chairman Miller. I am sorry. So when you got this e-mail on March 9, 2007, about the Health Assessment that had just gone out the previous month, and it said that the employees involved were directed not to address longer-term health effects, you decided that what Dr. De Rosa said was wrong, that there was no such direction? Dr. Frumkin. Rather than correct that statement, I focused on getting a correction out to FEMA so that we could set the record straight. Chairman Miller. And I understand that a letter did go out, it went out to the lawyer who had asked for this in the first place and because of that, litigation had been resolved. He put it in his file. He didn't give it to anybody. But what is very hard to fathom is that with the first sentence of the Health Assessment which Dr. Sinks says he read, saying that the request came from a lawyer, with the lawyer for FEMA, with the e-mail saying that the staff involved had been told not to share the information, not to address longer-term health effects, apparently dictating what was to be considered and what was not, you did not feel some sense of urgency other than to send a letter. And even when FEMA continued to tout the ATSDR's assessment as being scientific support, that everything was fine, if you just open the windows and doors, you didn't feel any sense of urgency to call somebody and say, didn't you get our letter? Dr. Frumkin. The initial fix for the problem of too narrow a scope in the original health consultation was simply to broaden the scope. Rather than engage the assertion that there had been some limitation on the initial scope, we simply corrected it and set the record straight by sending the letter to FEMA. We did not follow up with FEMA to check on the implementation of the letter. And in retrospect, I think that we should have engaged during that first half of '07 more actively than we did. More on Obstacles to Safe Housing Chairman Miller. Admiral, I don't want you to feel left out. FEMA Administrator David Paulson testified before the House Homeland Security Committee in May of last year and testified, we have been told that the formaldehyde does not present a health hazard. However, we do encourage our occupants of those trailers to air them out, keep them open as much as possible to let the fumes out. Was there a basis--did anyone tell you besides ATSDR? Vice Admiral Johnson. If I can answer that question by correcting one issue, there seems to be a focus on dealing with the lawyer and on FEMA's desire to avoid litigation, and I would like to at least make the record clear that while we had a lawyer, Preston, who was primarily in communications with CDC, there were other people from other disaster assistant directors who were also involved and that FEMA's primary motivation was not to avoid litigation because we clearly went public with the information as soon as we received it. Our primary motivation was to get as much information as we could as non-medical people to do the best that we could to preserve the health and safety of the people who were living in these travel trailers. So I would like to make it clear that we were not trying to avoid litigation, and that wasn't our reason for going to CDC. When Administrator Paulson testified before Congress, I think it does reflect perhaps a misinterpretation of the report. It was our feeling at the time that based on the information that we had, both from EPA and CDC, that we didn't confront the health situation that we now know that we did. Chairman Miller. Mr. Lampson? Mr. Lampson. Let me get one point of clarification, Mr. Johnson. When I asked regarding the provision of safe and fit housing for a short- or long-term period, would you agree that your mandate is to provide safe and fit housing, whether it be long-term or short-term? Vice Admiral Johnson. That is correct. I agree with that. Mr. Lampson. And was FEMA acting under that mandate when it provided those trailers---- Vice Admiral Johnson. That is correct. Mr. Lampson.--for both short- and long-term? Vice Admiral Johnson. Yes, sir. Mr. Lampson. And is there a backup plan now adequate in your mind that if you come into another situation where you find that your step number one isn't working and you have to take emergency actions that there is a way that we are not going to have people in harm's way again? Vice Admiral Johnson. I think it would be nice to say clearly that the answer is yes, we have got this plan and it won't ever happen again. I think where we are is that while we are here, members of the manufacturing housing community are also watching; and we are working with them, as I indicated before. We have been able to identify what parts of a mobile home or a trailer actually present the greatest risk for formaldehyde. We worked with them recently to establish a unit that doesn't use urea insulation, it doesn't use vinyl gypsum board, and we have been able to reduce the level of formaldehyde to a much, much, much lower level now in one prototype unit than we have ever had before. We have just issued a contract to buy more of those units. And so it is our intent we think that we will need mobile homes in the future, and we want to be able to write a spec that requires significantly lower amounts of formaldehyde. We also have a range of options from sheltering to apartments and motels and hotels and other things that we try to do and we use them even now. But the situation in Greenburg, Kansas, where the town is exactly blown away by a tornado, there are no close options that meet the needs of the individuals unless they travel great distances to work and where they are home. And so we are working very hard to expand the range of options, look at things beyond mobile homes and travel trailers, that where we have mobile homes to have them significantly reflect lower formaldehyde. Health Care Costs Mr. Lampson. And then one last question. I brought up with--I can't think of her name right now, the lady from the trailer. Vice Admiral Johnson. Mrs. Huckabee. Mr. Lampson. The dollars in health care costs that she has faced and many others have faced, and I did understand that FEMA has established a program to reimburse families for these medical bills. If that is the case, how many people have applied for such reimbursements; and if FEMA has paid money out at this point, how much? Vice Admiral Johnson. Mr. Lampson, unfortunately, it is not the case. FEMA does not have authority, an order to reimburse medical expenses. It is not the policy of FEMA or the government at this point to reimburse medical expenses. Mr. Lampson. I yield back my time, Mr. Chairman. Vice Admiral Johnson. Let me just correct one number that I gave you. We are actually moving 1,000 households a week, not a day, out of travel trailers and mobile homes in the Gulf Coast, just to give you the right number. Mr. Lampson. Thank you. Thank you very much. CDC Actions: May-July, 2007 Chairman Miller. Dr. Frumkin, we have only talked about a couple e-mails, and in fact there have been a good many e-mails about this but one that Dr. De Rosa sent from his Blackberry on July 24 of last year, 2007, kind of late at night. ``Colleagues, while testing may be warranted, what immediate interventions are being pursued through appropriate channels to interdict exposures or to mitigate health impacts? I am concerned that the reported clinical signs are the harbinger of an impending public health disaster. We know based on data provided to us that levels are up to 80 times higher than peak occupational limits and up to 300 times higher than our health guidance values. I think we must be more proactive in protecting the people while assisting FEMA.'' Do you remember getting that e-mail? Dr. Frumkin. Yes. Chairman Miller. What did you do? Dr. Frumkin. There was a lot underway already. First, I have to say that I agree with the sentiments in that e-mail completely. We have to be proactive in protecting the people living in trailers. And it happens that at that point in time we were undertaking a large range of actions that would lead to exactly that goal. Beginning in May we undertook discussions with FEMA that launched all of the activities that are now under way that I described, the testing of occupied trailers, and that was a data set that we needed to determine exactly what the level of risk was. We couldn't extrapolate from the unoccupied trailers to the occupied trailers, so we needed solid data to help with that. The follow-up studies, the clinical reviews, and so on, all of those were under way or being planned at that point in time. But the sentiment behind Dr. De Rosa's e-mail, the concern for the well-being of people in the region was very much a shared concern, and there were, in fact, a lot of activities under way at that point to help protect their health. Chairman Miller. Did you do anything at that point to advise FEMA again other than that letter sent to the lawyer, and when Admiral Johnson said FEMA didn't know about it, at least one employee at FEMA knew about it. The February 2007 consultation, health assessment, was not one that they should be paying attention to, should be relied upon. It was flawed. I mean, you are very critical of it later. You are very critical of it in your evaluation of Dr. De Rosa, something that came out of his shop. But do you have anything in writing or can you recall an oral discussion with anyone at FEMA that made those same criticisms and said stop using that? Dr. Frumkin. At about that time in July, we were revisiting the original consultation with a lot more attention than it had gotten before; and at that point, we fully realized the limitations of that original consultation, and it was soon after that, I can't remember the exact date, when we made the decision to pull back the original consultation and reissue a more accurate document. Chairman Miller. October? Dr. Frumkin. October was when it was released, yes. Chairman Miller. Okay. It was retracted in October. This was in July? Dr. Frumkin. Yes, sir. Chairman Miller. Okay. Mr. Lampson. Mr. Chairman? Chairman Miller. Yes. Mr. Lampson. Are you about to wrap up? Chairman Miller. Yes. Mr. Lampson. Were Discussions Being Made By FEMA's Lawyers? Mr. Lampson. Unless someone wants to make a comment about it, let me just make a comment here I guess at the end. Admiral Johnson, because this hearing is focused probably more on the events of 2007, I am going to overlook I guess your several I think misleading statements about FEMA's response to the formaldehyde issue in 2006. Suffice it to say that FEMA spent most of that year telling trailer occupants that there was no problem and worrying about the impact of testing those trailers on FEMA's legal liability, in March of '06, FEMA's attorneys knew that EPA had determined that some people had negative reactions to formaldehyde at 0.1 parts per million and said any testing would have to be done quietly. But in May of '06, before it had done any investigation, FEMA issued a statement that there are ``no health concerns associated with formaldehyde inside out FEMA mobile homes and travel trailers. FEMA then delayed testing, even unoccupied trailers, because of the words of a FEMA attorney, ``testing would imply ownership of the issue.'' And your Office of General Counsel said that it didn't want the testing to determine what levels were unsafe but only how to ventilate the trailers. Then when ATSDR issued its seriously flawed health consultation which FEMA officials described as giving them what we were looking for, FEMA's lawyers directed ATSDR not to release the study publicly so it could be reviewed. We all know that there is plenty of blame to go around, but we sure want to be talking about this in '07. The lawyers were running the show. Vice Admiral Johnson. Mr. Lampson, respectfully I reject the notion that the lawyers were running the show. I reject the notion that FEMA made any decisions based on concern for litigation. What you see in e-mails is you see what occurs in many organizations, staff people talking with each other, raising pros and cons and concerns that should be considered by leadership but don't make decisions by leadership. Every action that FEMA took I think was responsible given the level of knowledge that we had at the time and what is clearly an insufficient sophistication about medical implications of formaldehyde. But the lawyers were advising, they were dealing litigation. We consistently made other options available to residents. We consistently put information on our website, twice. We hand-delivered 70,000 fliers to individual units. So I think if you judge us by our actions as opposed to the interaction between our lawyers, I believe that given the knowledge that we had at the time, I believe we took responsible steps. Mr. Lampson. At least the e-mails that we have been able to see up here, it seems that all of the decisions were being made by the lawyers. And that is a problem from here, as we see it. I voted against the creation of the Department of Homeland Security a number of years ago. I thought that it was going to create a horrible bureaucracy. I think it has, and I think that we are suffering a lot of effects because of our haste, because of our unwillingness to try to look and see what impact our decisions are going to have on the American people. Perhaps we have made too many decisions, Chairman Miller, on the political strengths of our parties, rather than the real needs of the people who are this country and our government. And I think that to some extent I am ashamed with the way we have reacted and the fact that people have had to come and tell us some of the stories that we have heard is embarrassing. To know that we have not followed typical protocol that you teach in basic science classes about how you go about trying to make good, reasonable decisions with only taking into consideration real science is hard for me to go back to my ninth grade physical science class that I taught in many years ago and show them that this government was acting in the best interests of its citizens when we took some of the steps that we did. It is a little disheartening, ladies and gentlemen, to have to sit up here and say these things or even think them or to have heard from some of the brave people that did take the time to come up, and I hope that we never, ever have to go through something like this again. Mr. Chairman, I yield back my time. And again, I thank you for the effort that you have made and this committee has made in keeping this issue to the forefront. Chairman Miller. I think this hearing is now concluded, although certainly not this matter. I think there will be a good deal more inquiry, both by perhaps other oversight committees, including perhaps this one, and certainly very possibly, very certainly in litigation as well, private litigation as well. Thank you for appearing. Under the rules of our committee, the record will be held open for two weeks for Members to submit additional statements and any additional questions they might have of the witnesses. This hearing is now adjourned. [Whereupon, at 12:56 p.m., the Subcommittee was adjourned.] Appendix: ---------- Additional Material for the Record <Graphics Not Available in Tiff Format>