    [House Hearing, 112 Congress]
    [From the U.S. Government Publishing Office]

                              EPA'S IRIS PROGRAM:
                       EVALUATING THE SCIENCE AND PROCESS
                        BEHIND CHEMICAL RISK ASSESSMENT

    =======================================================================

                                    HEARING

                                   BEFORE THE

                       SUBCOMMITTEE ON INVESTIGATIONS AND
                                   OVERSIGHT

                  COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
                            HOUSE OF REPRESENTATIVES

                          ONE HUNDRED TWELFTH CONGRESS

                                 FIRST SESSION

                                   __________

                            THURSDAY, JULY 14, 2011

                                   __________

                               Serial No. 112-30

                                   __________

     Printed for the use of the Committee on Science, Space, and Technology

           Available via the World Wide Web: http://science.house.gov

    EPA'S IRIS PROGRAM: EVALUATING THE SCIENCE AND PROCESS BEHIND CHEMICAL
                                RISK ASSESSMENT

                              EPA'S IRIS PROGRAM:
                       EVALUATING THE SCIENCE AND PROCESS
                        BEHIND CHEMICAL RISK ASSESSMENT

    =======================================================================

                                    HEARING

                                   BEFORE THE

                       SUBCOMMITTEE ON INVESTIGATIONS AND
                                   OVERSIGHT

                  COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
                            HOUSE OF REPRESENTATIVES

                          ONE HUNDRED TWELFTH CONGRESS

                                 FIRST SESSION

                                   __________

                            THURSDAY, JULY 14, 2011

                                   __________

                               Serial No. 112-30

                                   __________

     Printed for the use of the Committee on Science, Space, and Technology

           Available via the World Wide Web: http://science.house.gov

                                   ----------

                             U.S. GOVERNMENT PRINTING OFFICE

    67-255 PDF                       WASHINGTON : 2011

    For sale by the Superintendent of Documents, U.S. Government Printing
    Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800;
    DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC,
    Washington, DC 20402-0001

                  COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

                        HON. RALPH M. HALL, Texas, Chair
    F. JAMES SENSENBRENNER, JR.,         EDDIE BERNICE JOHNSON, Texas
        Wisconsin                        JERRY F. COSTELLO, Illinois
    LAMAR S. SMITH, Texas                LYNN C. WOOLSEY, California
    DANA ROHRABACHER, California         ZOE LOFGREN, California
    ROSCOE G. BARTLETT, Maryland         DAVID WU, Oregon
    FRANK D. LUCAS, Oklahoma             BRAD MILLER, North Carolina
    JUDY BIGGERT, Illinois               DANIEL LIPINSKI, Illinois
    W. TODD AKIN, Missouri               GABRIELLE GIFFORDS, Arizona
    RANDY NEUGEBAUER, Texas              DONNA F. EDWARDS, Maryland
    MICHAEL T. McCAUL, Texas             MARCIA L. FUDGE, Ohio
    PAUL C. BROUN, Georgia               BEN R. LUJAN, New Mexico
    SANDY ADAMS, Florida                 PAUL D. TONKO, New York
    BENJAMIN QUAYLE, Arizona             JERRY McNERNEY, California
    CHARLES J. ``CHUCK'' FLEISCHMANN,    JOHN P. SARBANES, Maryland
        Tennessee                        TERRI A. SEWELL, Alabama
    E. SCOTT RIGELL, Virginia            FREDERICA S. WILSON, Florida
    STEVEN M. PALAZZO, Mississippi       HANSEN CLARKE, Michigan
    MO BROOKS, Alabama
    ANDY HARRIS, Maryland
    RANDY HULTGREN, Illinois
    CHIP CRAVAACK, Minnesota
    LARRY BUCSHON, Indiana
    DAN BENISHEK, Michigan
    VACANCY
                                     ------

                  Subcommittee on Investigations and Oversight

                       HON. PAUL C. BROUN, Georgia, Chair
    F. JAMES SENSENBRENNER, JR.,         DONNA F. EDWARDS, Maryland
        Wisconsin                        ZOE LOFGREN, California
    SANDY ADAMS, Florida                 BRAD MILLER, North Carolina
    RANDY HULTGREN, Illinois             JERRY McNERNEY, California
    LARRY BUCSHON, Indiana
    DAN BENISHEK, Michigan
    VACANCY
    RALPH M. HALL, Texas                 EDDIE BERNICE JOHNSON, Texas
                                C O N T E N T S

                           Wednesday, April 13, 2011

                                                                       Page
    Witness List.....................................................     2

    Hearing Charter..................................................     3

                               Opening Statements

    Statement by Representative Paul C. Broun, Chairman, Subcommittee
      on Investigations and Oversight, Committee on Science, Space,
      and Technology, U.S. House of Representatives..................    17
        Written Statement............................................    18

    Statement by Representative Donna F. Edwards, Ranking Minority
      Member, Subcommittee on Investigations and Oversight, Committee
      on Science, Space, and Technology, U.S. House of
      Representatives................................................    19
        Written Statement............................................    21

                               Witnesses: Panel I

    The Honorable Paul Anastas, Assistant Administrator, Office of
      Research and Development, U.S. Environmental Protection Agency
        Oral Statement...............................................    23
        Written Statement............................................    25

    Mr. David Trimble, Director, Natural Resources and Environment,
      U.S. Government Accountability Office
        Oral Statement...............................................    28
        Written Statement............................................    30

    Dr. Jonathan M. Samet, MD, MS, Professor and Flora L. Thornton
      Chair, Department of Preventive Medicine, Keck School of
      Medicine, University of Southern California; and Chair,
      Committee to Review EPA's Draft IRIS Assessment of
      Formaldehyde, National Research Council, The National Academies
        Oral Statement...............................................    40
        Written Statement............................................    36

                              Witnesses: Panel II

    The Honorable Calvin Dooley, President and Chief Executive
      Officer, American Chemistry Council
        Oral Statement...............................................    62
        Written Statement............................................    63

    Ms. Rena Steinzor, Professor, University of Maryland School of
      Law, and President, Center for Progressive Reform
        Oral Statement...............................................    66
        Written Statement............................................    67

    Dr. Gail Charnley, Principal, HealthRisk Strategies
        Oral Statement...............................................   124
        Written Statement............................................   125

    The Honorable J. Christian Bollwage, Mayor, City of Elizabeth,
      New Jersey
        Oral Statement...............................................   127
        Written Statement............................................   128

                 Appendix I: Answers to Post-Hearing Questions

    The Honorable Paul Anastas, Assistant Administrator, Office of
      Research and Development, U.S. Environmental Protection Agency.   144

    Mr. David Trimble, Director, Natural Resources and Environment,
      U.S. Government Accountability Office..........................   166

    Dr. Jonathan M. Samet, MD, MS, Professor and Flora L. Thornton
      Chair, Department of Preventive Medicine, Keck School of
      Medicine, University of Southern California; and Chair,
      Committee to Review EPA's Draft IRIS Assessment of
      Formaldehyde, National Research Council, The National Academies   171

    The Honorable Calvin Dooley, President and Chief Executive
      Officer, American Chemistry Council............................   176

    Dr. Gail Charnley, Principal, HealthRisk Strategies..............   262

    The Honorable J. Christian Bollwage, Mayor, City of Elizabeth,
      New Jersey.....................................................   285

                Appendix II: Additional Material for the Record

    Representative Larry Bucshon, Subcommittee on Investigations and
      Oversight, Committee on Science, Space, and Technology, U.S.
      House of Representatives.......................................   306

                              EPA'S IRIS PROGRAM:
                       EVALUATING THE SCIENCE AND PROCESS
                        BEHIND CHEMICAL RISK ASSESSMENT

                                  ----------

                            THURSDAY, JULY 14, 2011

                      House of Representatives,
          Subcommittee on Investigations and Oversight,
                   Committee on Science, Space, and Technology,
                                                        Washington, DC.

        The Subcommittee met, pursuant to call, at 10:04 a.m., in
    Room 2318 of the Rayburn House Office Building, Hon. Paul C.
    Broun [Chairman of the Subcommittee] presiding.

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                                hearing charter

                  COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

                         U.S. HOUSE OF REPRESENTATIVES

                   SUBCOMMITTEE ON INVESTIGATIONS & OVERSIGHT

                   EPA's IRIS Program: Evaluating the Science

                  and Process Behind Chemical Risk Assessment

                            thursday, july 14, 2011
                            10:00 a.m. to 12:00 p.m.
                       2318 rayburn house office building

    Purpose

        On July 14, 2011, the Subcommittee on Investigations and Oversight
    will hold a hearing on the U.S. Environmental Protection Agency's (EPA)
    Integrated Risk Information System (IRIS). There will be two panels at
    the hearing; the first panel will comprise of witnesses from EPA, the
    U.S. Government Accountability Office (GAO), and the National
    Academies' National Research Council. The second panel will include
    individuals and experts who will talk about their perspectives on IRIS.
        In March of 2008, GAO reported that ``the IRIS database was at
    serious risk of becoming obsolete because EPA had not been able to
    routinely complete timely, credible assessments. After subsequent
    reports, in January 2009 [GAO] added EPA's processes for assessing and
    controlling toxic chemicals to [its] list of areas at high risk for
    waste, fraud, abuse, and mismanagement or in need of broad-based
    transformation.'' \1\
    ---------------------------------------------------------------------------
        \1\ David Trimble, Director, Natural Resources and Environment,
    Testimony before the Subcommittee on Investigations and Oversight,
    Committee on Science, Space, and Technology, July 14, 2011
    ---------------------------------------------------------------------------
        As a result, the Subcommittee held several hearings on this
    subject. On May 21, 2008, the Subcommittee took testimony from Dr.
    George Gray, the then-Assistant Administrator for Research and
    Development at EPA, and Ms. Susan Dudley, the then-Administrator of the
    Office of Information and Regulatory Affairs (OIRA). Additionally, Mr.
    John Stephenson of GAO testified on findings regarding the lack of
    productivity in the IRIS process.
        On June 12, 2008, the Subcommittee received testimony from Mr.
    Jerry Ensminger (U.S.M.C., retired), Mr. Lenny Seigel (Executive
    Director, Center for Public Environmental Oversight), and Dr. Linda
    Greer (Director of the Health Program at the Natural Resources Defense
    Council).
        In 2009, the Subcommittee heard from Mr. John Stephenson again, and
    Dr. Kevin Teichman, the Deputy Assistant Administrator for Science at
    EPA's Office of Research and Development. They testified about the
    current IRIS process announced by EPA Administrator Lisa Jackson on May
    21, 2009.
        These prior IRIS hearings focused on the IRIS interagency review
    process, and delved into the role of the White House and other
    agencies, to determine the extent of their involvement in IRIS'
    chemical risk assessments. Today's hearing, prompted in part by the
    National Academies' National Research Council report on EPA's
    formaldehyde assessment, focuses on the process EPA uses to initially
    develop draft IRIS assessments, which is separate from the overall
    process that includes the multiple layers of review. The National
    Academy of Sciences' (NAS) report dedicated an entire chapter that
    reiterated several previous criticisms of EPA's IRIS process. In light
    of those criticisms, and recognizing that this is not the first time
    NAS has articulated them, the committee's goal is to better understand
    the process behind the development of IRIS' chemical risk assessments,
    whether EPA plans on adopting the NAS' recommendations, and whether or
    not EPA assessments are based on the best available evidence and
    evaluated in accordance with established protocols.

    Background

        IRIS was established in the 1980s as an internal EPA database to
    provide a single source of information on the risks associated with
    exposure to chemicals. The IRIS database provides a hazard
    identification and dose-response analysis, scientific information that
    when combined with estimates of exposure allow regulatory agencies to
    produce a risk assessment. Historically, entries to the database were
    the result of extensive in-house development by the science staff at
    EPA, peer review processes with experts from outside the agency, and
    opportunities for public input and comment.
        By the early 1990s, the chemical database contained information on
    roughly 500 chemicals. However, as IRIS grew and gained more influence,
    EPA decided to restructure the IRIS process, which unfortunately led to
    the demise of the heretofore successful collaborative platform. This
    restructuring ultimately led to several reorganizations of the IRIS
    process (see Appendix B), with the most recent one announced by EPA
    Administrator Lisa Jackson on May 21, 2009.
        In 2009, GAO testified before this Subcommittee that EPA ``has not
    been able to complete timely, credible chemical assessments or decrease
    its backlog of 70 [as of 2008] ongoing assessments.'' \2\ Further, GAO
    reported, ``because EPA staff time was dedicated to completing
    assessments in the backlog, EPA's ability to both keep the more than
    540 existing assessments up to date and initiate new assessments was
    limited. We found that 48 of the 70 assessments being conducted as of
    December 2007 had been in process for more than 5 years-and 12 of
    those, for more than nine years. These time frames have lengthened.
    Currently, of those 70 assessments, 58 have now been ongoing for more
    than 5 years-and 31 of those for more than 9 years.'' \3\
    ---------------------------------------------------------------------------
        \2\ John B. Stephenson, Director, Natural Resources and
    Environment, Testimony before the Subcommittee on Investigations and
    Oversight, Committee on Science and Technology, June 11, 2009
        \3\ Ibid.
    ---------------------------------------------------------------------------
        The IRIS database currently includes 554 chemicals. Since GAO last
    reported, EPA completed six assessments in 2009 and ten assessments in
    2010. These numbers are far below the twenty assessments EPA planned to
    finalize in 2010. \4\ Moreover, 70 chemicals continue to remain in
    various stages of review.
    ---------------------------------------------------------------------------
        \4\ ``Update on Integrated Risk Information System (IRIS) Program
    Activities,'' EPA, Office of Research and Development, National Center
    for Environmental Assessment (NCEA) (hereinafter NCEA IRIS document)
    ---------------------------------------------------------------------------
        Further compounding the problem, EPA line offices are no longer
    required to concur with IRIS assessments and internal EPA comments are
    still not transparent. The quality of assessments being produced also
    continues to be an issue. Since 2005, five assessments have been
    referred to the National Academies' for evaluation. All of the NAS
    reviews have severely criticized EPA's assessments, and offered
    numerous recommendations, which EPA has yet to implement.

    Issues

       NAS: ``Review of the Environmental Protection Agency's Draft IRIS
                          Assessment of Formaldehyde''
        On April 8 of this year, NAS published its long-awaited study on
    EPA's formaldehyde assessment. While NAS ``strongly questioned EPA
    claims that exposure to formaldehyde can result in increased risk of a
    leukemia and other cancers that had not previously been associated with
    formaldehyde, asthma, and reproductive toxicity,'' \5\ that is not the
    most compelling part of the document for the purposes of this hearing.
    Of interest is that the NAS panel ``strongly faulted EPA's methodology
    in crafting its draft assessment, warning of a pattern of problems in
    how the agency crafts assessments for its Integrated Risk Information
    System (IRIS) database that could continue to hamper future risk
    studies. `The committee is concerned about the persistence of problems
    encountered with IRIS assessments over the years, especially given the
    multiple groups that have highlighted them . . . If the methodologic
    issues are not addressed, future assessments may still have the same
    general and avoidable problems that are highlighted here.'' \6\
    ---------------------------------------------------------------------------
        \5\ Maria Hegstad, ``NAS Sets Back EPA Proposal For Strict
    Formaldehyde Risk Assessment,'' Environmental NewsStand, April 8, 2011
        \6\ Ibid.
    ---------------------------------------------------------------------------
        In the summary of the report, the panel commented on the
    similarities in some of the problems with the IRIS assessment on
    formaldehyde, and those identified in other reports published by
    previous NAS panels:

      ``Overall, the committee noted some recurring methodologic problems
    in the draft IRIS assessment of formaldehyde. Many of the problems are
    similar to those which have been reported over the last decade by other
    NRC committees tasked with reviewing EPA's IRIS assessments for other
    chemicals. Problems with clarity and transparency of the methods appear
    to be a repeating theme over the years, even though the documents
    appear to have grown considerably in length. In the roughly 1,000-page
    draft reviewed by the present committee, little beyond a brief
    introductory chapter could be found on the methods for conducting the
    assessment. Numerous EPA guidelines are cited, but their role in the
    preparation of the assessment is not clear. In general, the committee
    found that the draft was not prepared in a consistent fashion; it lacks
    clear links to an underlying conceptual framework; and it does not
    contain sufficient documentation on methods and criteria for
    identifying evidence from epidemiologic and experimental studies, for
    critically evaluating individual studies, for assessing the weight of
    evidence, and for selecting studies for derivation of the RfCs and unit
    risk estimates.'' \7\
    ---------------------------------------------------------------------------
        \7\ ``Review of the Environmental Protection Agency`s Draft IRIS
    Assessment of Formaldehyde,'' National Research Council of the National
    Academies, April 8, 2011 (hereinafter NAS Formaldehyde Report)

        Please see Appendix A for detailed recommendations from the NAS
    ---------------------------------------------------------------------------
    report.

         NAS: ``Science and Decisions: Advancing Risk Assessment'' \8\
    ---------------------------------------------------------------------------
        \8\ ``Science and Decisions: Advancing Risk Assessment,'' National
    Research Council of the National Academies, 2009
    ---------------------------------------------------------------------------
        Dr. Thomas Burke, associate dean of The Johns Hopkins Bloomberg
    School of Public Health, recently chaired an NAS panel on ``ways to
    improve EPA risk assessments.'' \9\ At a joint meeting of EPA's Science
    Advisory Board and EPA's Board of Scientific Counselors, Dr. Burke
    said, ``The sleeping giant is that EPA science is on the rocks . . . if
    you fail, you become irrelevant, and that is kind of a crisis.'' \10\
    Referring to EPA's risk assessment process as the agency's ``Achilles
    heel,'' \11\ Dr. Burke's NAS panel suggested steps on how EPA could
    improve that process in a 2009 report titled, ``Science and Decisions:
    Advancing Risk Assessment.'' This report carries added weight in light
    of the NAS report on formaldehyde issued earlier this year with its
    chapter critical of EPA's IRIS process.
    ---------------------------------------------------------------------------
        \9\ ``Key Advisor Warns EPA to Improve Agency Science or Face a --
    Crisis,'' InsideEPA.com, July 8, 2011
        \10\ Ibid.
        \11\ Ibid.

                                   NTP's RoC
        The Department of Health and Human Services' (HHS) National
    Toxicology Program (NTP) publishes a report every Congress called the
    Report on Carcinogens (RoC). \12\ On June 10 of this year, the Twelfth
    RoC was released, and it elevated its classification of formaldehyde
    from `reasonably anticipated to be a human carcinogen' to `known to be
    a human carcinogen.' The report was published despite the NAS review.
    This is important because according to an analytic paper, NTP has:
    ---------------------------------------------------------------------------
        \12\ Maria Hegstad, ``NAS Critique of EPA Formaldehyde Study
    Hampers HHS --Cancer` Report,'' Environmental NewsStand, April 26,
    2011. ``Congress directed the program to prepare the report every other
    year, but due to concerns over the review process for the document, the
    last RoC was published in 2005. The RoC provides information on
    chemicals that NTP deems carcinogenic or reasonably anticipates to be
    human carcinogens, along with people's potential for exposure to
    them.''

      ``been reviewing the scientific data for formaldehyde in preparation
    for a listing decision in the 12th Report on Carcinogens (RoC). EPA and
    the NTP have had available, reviewed and relied upon the same studies,
    reports and underlying data in conducting their respective hazard
    evaluations of the possible relationship between formaldehyde exposure
    and leukemia and other lymphohematopoietic malignancies. Therefore, the
    NRC committee's review of and conclusions concerning the draft EPA IRIS
    report are, with respect to lymphohematopoietic malignancies (including
    myeloid leukemia), directly applicable to the NTP's own review and
    conclusions--precisely because the draft EPA and NTP reports involve
    the same studies and data sets.'' \13\
    ---------------------------------------------------------------------------
        \13\ ``National Research Council Report on Scientific Evidence
    Pertaining to the Relationship Between Formaldehyde Exposure and
    Leukemia: Implications for the National Toxicology Program's Listing of
    Formaldehyde in the 12th Report on Carcinogens,'' Environ International
    Corporation, April 22, 2011 (emphasis in original text)

    ---------------------------------------------------------------------------
    Further:

      ``The NRC committee's opinion was that EPA's review of the scientific
    literature as presented in the draft IRIS assessment does not provide a
    sufficient scientific basis for concluding that there is a causal link
    between formaldehyde exposure and leukemia. The NRC committee's
    conclusions concerning EPA's assessment of leukemia apply as well to
    application of the `listing criteria' for formaldehyde in the NTP's
    12th RoC. In particular, there is no reasonable basis for the NTP to
    conclude that formaldehyde should be listed in the 12th RoC as being
    either `known' or `reasonably anticipated' to cause myeloid leukemia or
    any other lymphohematopoietic malignancy.'' \14\
    ---------------------------------------------------------------------------
        \14\ Ibid. (emphasis in original text)

        The RoC's more serious listing of formaldehyde could possibly
    influence EPA's own assessment relating to formaldehyde and leukemia,
    despite NAS' comments. Conversely, if EPA reassesses its formaldehyde
    review and comes to a different conclusion, then that raises questions
    about conflicting information from two different government entities,
    which may cause confusion downstream as risk managers and regulators
    ---------------------------------------------------------------------------
    try to understand which determination is more reliable.

                                   EPA's SAB
        Under the current process, EPA's Science Advisory Board (SAB) is
    responsible for peer reviewing EPA's IRIS assessments. However, ``there
    have been questions in the past, including some raised by [EPA's]
    Inspector General about the independence of the SAB panels.'' \15\
    (Second footnote from passage) \16\The charge questions that lead SAB
    peer reviews are ``written by the EPA office requesting the review and
    which industry says can narrow the focus of the reviews. Sources also
    say the panels do not include a broad-enough roster of experts. For
    example, the SAB panel that recently reviewed EPA's IRIS assessment for
    inorganic arsenic* * *did not include a statistician or a cancer
    modeling expert and only one epidemiologist.'' \17\
    ---------------------------------------------------------------------------
        \15\ Aaron Lovell, ``Rebuffed by EPA, Industry Asks OMB, GOP to Fix
    Chemical Study Process,'' Environmental NewsStand.com, June 22, 2011
    (hereinafter Lovell Article)
        \16\ U.S. EPA Office of Inspector General, ``EPA can Improve its
    Process for Establishing Peer Review Panels,'' Evaluation Report No.
    09-P-0147, April 29, 2009
        \17\ Lovell Article, supra, note 11

            IRIS Assessments are not Insulated from Risk Management
        In the NAS' 1983 report, ``Risk Assessment in the Federal
    Government: Managing the Process,'' the National Research Council panel
    identified four components of a complete risk assessment:

          hazard identification;

          dose-response evaluation;

          exposure assessment; and

          risk characterization. \18\
    ---------------------------------------------------------------------------
        \18\ National Research Council, National Academy of Sciences,
    ``Risk Assessment in the Federal Government: Managing the Process,''
    1983

        IRIS reflects science that addresses the first two conditions. In
    discussing the difference between risk assessment and risk management,
    ---------------------------------------------------------------------------
    the Academy panel wrote:

      ``Risk assessment is the use of the factual base to define the health
    effects of exposure of individuals or populations to hazardous
    materials and situations. Risk management is the process of weighing
    policy alternatives and selecting the most appropriate regulatory
    action, integrating the results of risk assessment with engineering
    data and with social, economic and political concerns to reach a
    decision.'' \19\
    ---------------------------------------------------------------------------
        \19\ Ibid.

        This distinction is commonly cited when IRIS assessments are
    criticized. When assessments make determinations that safe levels are
    below background levels, the IRIS program can reasonably claim that
    such factors can be weighed later in the risk management process. In
    reality, IRIS assessments are usually adopted with no further
    consideration. ``[S]ome customers use IRIS because it is a useful
    source of information; while for other customers IRIS is mandatory, and
    those customers include state agencies. Customers who use IRIS for
    general information often rely upon other databases to complement an
    IRIS assessment. Other databases exist, which can provide some help,
    but for domestic regulatory purposes there is no satisfactory
    alternative to IRIS. And using an IRIS file as the scientific basis for
    a regulatory decision is expected and seldom challenged.'' \20\
    ---------------------------------------------------------------------------
        \20\ Jim Solyst, 11Eyeballing IRIS,'' The Environmental Forum,
    March/April 2009, Vol 26, No. 2

    ---------------------------------------------------------------------------
    Witnesses

                                    Panel 1

          The Honorable Paul Anastas, Assistant Administrator,
    Office of Research and Development, U.S. Environmental Protection
    Agency. Dr. Anastas will talk about EPA's efforts to implement the most
    recent revised IRIS process, provide a status of assessments, and
    discuss EPA's efforts to implement NAS' and GAO's recommendations.

          Mr. David Trimble, Director, Natural Resources and
    Environment, U.S. Government Accountability Office. Mr. Trimble will
    provide an overview of IRIS, highlight previous GAO work on IRIS, and
    evaluate EPA's efforts to implement GAO's recommendations.

          Dr. Jonathan M. Samet, MD, MS, Professor and Flora L.
    Thornton Chair, Department of Preventive Medicine, Keck School of
    Medicine, University of Southern California; and Chair, Committee to
    Review EPA's Draft IRIS Assessment of Formaldehyde, National Research
    Council, The National Academies. Dr. Samet will highlight the NAS'
    recent work on IRIS, and detail NAS' recommendations contained in
    chapter seven of their recently release report on formaldehyde.

                                    Panel 2

          The Honorable Calvin Dooley, President and Chief
    Executive Officer, American Chemistry Council. Mr. Dooley will talk
    about IRIS and industry's perspective on the IRIS process.

          Ms. Rena Steinzor, Professor, University of Maryland
    School of Law, and President, Center for Progressive Reform. Ms.
    Steinzor will talk about IRIS, and offer suggestions on how to improve
    it and remove it from GAO's high risk series.

          Dr. Gail Charnley, Principal, HealthRisk Strategies. Dr.
    Charnley will talk about IRIS, offer suggestions on how to improve it
    and remove it from GAO's high risk series, and discuss the NAS'
    recommendations.

          The Honorable J. Christian Bollwage, Mayor, City of
    Elizabeth, New Jersey. Mayor Bollwage will talk about how IRIS
    assessments impact local communities, particularly Elizabeth, New
    Jersey.

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Chairman Broun. The Subcommittee on Investigations and
    Oversight will come to order. Good morning, everyone. Welcome
    to today's hearing titled EPA's IRIS Program: Evaluating the
    Science and Process Behind Chemical Risk Assessment. You will
    find in front of you packets containing our witnesses'--our
    witness panels' written testimony, biographies, and truth in
    testimony disclosure.
        I recognize myself for five minutes for an opening
    statement.
        Good morning. I want to welcome our witnesses here today.
        This hearing continues the committee's work on EPA's
    Integrated Risk Information System or IRIS. The committee has
    held a number of hearings over the last few years on IRIS's
    ability to produce risk assessments associated with exposure to
    chemicals. In 2009, GAO placed the program on its High Risk
    Series because EPA was unable to complete timely, credible
    chemical assessments or decrease its backlog of ongoing
    assessments.
        Over the last decade, the IRIS Program has gone through a
    number of changes, particularly to the process by which its
    assessments are reviewed. These changes were meant to address
    the inappropriate influence of the White House, regulated
    agencies, and industry on the IRIS process; the argument being
    that these entities were preventing assessments from being
    finalized. Despite these changes, the process implemented by
    EPA in 2009 still allows for White House input, and the program
    still has a backlog of over 70 assessments, unchanged from the
    previous Administration.
        While EPA seems to be taking steps to adopt the
    recommendations of GAO regarding outside review, they have
    uniformly ignored the recommendations of another body, the
    National Academy of Sciences. For several years now they, too,
    have offered recommendations related to IRIS. These
    recommendations, however, did not focus on the review process
    but rather on how EPA develops the draft assessments in the
    first place. Time and time again, draft assessments were sent
    to the NAS for review, only to be severely criticized. Rather
    than adopting the recommendations of the Academy and updating
    their processes, EPA continued to churn out assessments that
    were summarily rebuked.
        As I stated at our 2009 hearing, ``The competing priorities
    of issuing assessments in a timely manner and producing
    assessments that are scientifically credible are central to the
    problems we face today.'' That statement remains just as true
    today as it did two years ago. Up until now, EPA has blamed
    outside forces for the failures of the program. In reality,
    they, too, are to blame. The program's credibility is
    threatened when it continually puts forth assessments that fail
    to address fundamental issues raised by reviewers. If, as the
    old adage goes, the definition of insanity is doing the same
    thing over and over and expecting a different result, then this
    program needs some therapy.
        Adopting the NAS recommendations is the first step to
    restoring the program's credibility. EPA's announcement 2 days
    ago is a step in the right direction, but the program's success
    hinges on its implementation. As the Academy noted in its
    formaldehyde report, many of the concepts and approaches they
    recommended are elementary and already exist in EPA's
    guidelines. They went on to state, ``The current state of the
    formaldehyde draft IRIS assessment suggests that there might be
    a problem with the practical implementation of the guidelines
    in completing the IRIS assessments.''
        Following through is the key here. It is up to the EPA to
    not only adopt the NAS recommendations but to also follow its
    own existing guidelines. This committee will continue its
    oversight of the IRIS program to ensure that EPA not only
    adopts the NAS recommendations, but that it follows guidelines
    already in existence and continuously seeks to employ the most
    modern, credible methods and protocols to assess chemical
    risks.
        I have a lot of questions about this program and where it
    is headed. As GAO stated in their testimony in 2009, ``EPA
    needs to hold itself more accountable to the public and
    Congress for carrying out this important component of its
    mission, especially since the IRIS program is discretionary.''
        As a physician myself, I understand the stakes that we are
    dealing with, particularly for sensitive populations such as
    children, pregnant women, and the elderly. I want to make sure
    that they are protected from undue harm. I also am aware of the
    damage caused by overly-conservative measures that scare our
    citizens without reason, ultimately doing nothing to advance
    safety. The opening line of the NAS's report titled, ``Science
    and Decisions,'' stated, ``Virtually every aspect of life
    involves risk.'' It is how we assess and manage that risk that
    ensures our safety.
        [The prepared statement of Mr. Broun follows:]
                   Prepared Statement of Chairman Paul Broun
        Good morning. I want to welcome our witnesses here today.
        This hearing continues the committee's work on the EPA's Integrated
    Risk Information System, or ``IRIS.'' The Committee has held a number
    of hearings over the last few years on IRIS's ability to produce risk
    assessments associated with exposure to chemicals. In 2009, GAO placed
    the program on its High Risk Series because EPA was unable to complete
    timely, credible chemical assessments or decrease its backlog of
    ongoing assessments.
        Over the last decade, the IRIS program has gone through a number of
    changes--particularly to the process by which its assessments are
    reviewed. These changes were meant to address the inappropriate
    influence of the White House, regulated agencies, and industry on the
    IRIS process-- the argument being that these entities were preventing
    assessments from being finalized. Despite these changes, the process
    implemented by EPA in 2009 still allows for White House input, and the
    program still has a backlog of over 70 assessments--unchanged from the
    previous administration.
        While EPA seems to be taking steps to adopt the recommendations of
    GAO regarding outside review, they have uniformly ignored the
    recommendations of another body - the National Academy of Sciences. For
    several years now, they too have offered recommendations related to
    IRIS. These recommendations, however, did not focus on the review
    process, but rather on how EPA develops the draft assessments in the
    first place. Time-and-time-again, draft assessments were sent to the
    NAS for review, only to be severely criticized. Rather than adopting
    the recommendations of the Academy, and updating their processes, EPA
    continued to churn out assessments that were summarily rebuked.
        As I stated at our 2009 hearing, ``[t]he competing priorities of
    issuing assessments in a timely manner and producing assessments that
    are scientifically credible are central to the problems we face
    today.'' That statement remains just as true today as it did two years
    ago. Up until now, EPA has blamed outside forces for the failures of
    the program. In reality, they too are to blame. The program's
    credibility is threatened when it continually puts forth assessments
    that fail to address fundamental issues raised by reviewers. If, as the
    old adage goes, the definition of insanity is doing the same thing over
    and over and expecting a different result, then this program needs some
    therapy.
        Adopting the NAS recommendations is the first step to restoring the
    program's credibility. EPA's announcement two days ago is a step in the
    right direction, but the program's success hinges on its
    implementation. As the Academy noted in its formaldehyde report, many
    of the concepts and approaches they recommended are elementary and
    already exist in EPA's guidelines. They went on to state ``the current
    state of the formaldehyde draft IRIS assessment suggests that there
    might be a problem with the practical implementation of the guidelines
    in completing the IRIS assessments.''
        Following through is the key here. It is up to the EPA to not only
    adopt the NAS recommendations, but to also follow its own existing
    guidelines. This Committee will continue its oversight of the IRIS
    program to ensure that EPA not only adopts the NAS recommendations, but
    that it follows guidelines already in existence, and continuously seeks
    to employ the most modern, credible methods and protocols to assess
    chemical risks.
        I have a lot of questions about this program and where it is
    headed. As GAO stated in their testimony in 2009, ``EPA needs to hold
    itself more accountable to the public and Congress for carrying out
    this important component of its mission, especially since the IRIS
    program is discretionary.''
        As a physician myself, I understand the stakes we are dealing
    with--particularly for sensitive populations such as children, pregnant
    women, and the elderly. I want to make sure they are protected from
    undue harm. I also am aware of the damage caused by overly conservative
    measures that scare our citizens without reason, ultimately doing
    nothing to advance safety. The opening line of the NAS's report titled
    Science and Decisions stated, ``[v]irtually every aspect of life
    involves risk.'' It is how we assess and manage that risk that ensures
    our safety.
        I now recognize the Ranking Member from Maryland for her opening
    statement.

        Chairman Broun. Now I recognize the Ranking Member from
    Maryland for her opening statement. I recognize Ms. Edwards for
    five minutes.
        Ms. Edwards. Good morning, and thank you, Mr. Chairman.
        For 50 years the tobacco industry has waged an organized
    campaign to cast doubt on the health risks of smoking
    cigarettes. They invented the effort to use science to fight
    science, to harness industry-funded research and public
    relations efforts, and to use friendly, public officials and
    FORA to point to these manufactured uncertainties in opposing
    any effort to protect the public.
        During that entire time public health experts have known
    absolutely that smoking causes cancer and that smoking remains
    in the words of the surgeon general, ``the single most
    important preventable cause of death in our society.'' This
    model of industry-funded science is being used to generate
    uncertainty and postpone even minor regulatory steps,
    regardless of the effects on public health and repeated with
    gusto by other industries.
        A similar campaign is being waged by the fossil fuel
    industry to cast doubt on the science of climate change, and
    today we are going to see some of this unfolding, surrounding
    EPA's science-based efforts to develop risk assessments related
    to health consequences of chemicals that Americans are exposed
    to commonly.
        Industry tends to push for two things in the realm of
    science and regulation. First they demand that we must have
    certainty before any action can be taken, and second, they
    point to studies that suggest there is uncertainty. What they
    don't mention quite so prominently is that the industry funds
    the production of studies designed to so doubt. That
    manufactured doubt is then used to justify inaction because
    obviously, there is no certainty. The result is gridlock. The
    country ends up in an endless loop of science, research,
    science, research that is expensive and counterproductive and
    making it almost impossible to ever make a statement about the
    harm of anything.
        With enough money and enough willing researchers, there is
    always money and there are always willing payees. Industry can
    be certain that there is always another study just around the
    corner, no matter the chemical or the consensus regarding its
    harm with the industry, generally hoping that the study will
    show no harm.
        In this world the scientists being paid say 325 bucks an
    hour, by the way, who work for industry, are not working to
    understand a problem but to provide answers that their clients
    want to use for their public relations campaigns. In 1983, the
    National Academy of Science has issued a red book on risk
    assessment. For almost 3 decades that has been the Bible on how
    to conduct a risk assessment. The report was motivated in part
    by a desire to try to set the science of assessing risk outside
    the political environment that surrounded decisions about what
    to do about those risks.
        But deep pockets readily use the report to see science as a
    fertile ground for fighting regulation. Industry learned that
    they can forestall any movement out of the realm of risk
    assessment and into the realm of risk management by
    manufacturing doubt, a process institutionalized by the NAS
    book. Not by NAS but by those who used it.
        Now the Academy has marched again into a situation that
    they may not have fully anticipated. The NAS report on EPA's
    draft formaldehyde assessment contains a very useful roadmap
    for how EPA should undertake reorganizing their IRIS
    assessments to make them more comprehensible and transparent,
    and though Dr. Anastas has embraced those recommendations,
    embraced the recommendations, the industries that most worry
    about IRIS assessments has seized on the language of the NAS
    report to try to claim that EPA cannot be trusted to do the
    science. That is not the message of the NAS report not the
    intention of the Academy panel.
        Under the Bush Administration that so crippled the EPA
    through a broken program with interference by OMB, that agency
    was able to finalize only a couple of IRIS assessments a year.
    EPA Administrator Lisa Jackson put in place a new process that
    severely cut back on OMB and polluting agency interference.
        So today we are going to hear from industry prescribers
    that go back to this kind of OMB-dominated system in which
    there is a suggestion that no assessment can ever be finalized
    without the Academy peer review of the draft assessment and
    then another peer review of the redrafted assessment.
        Instead I suggest that we follow the National Academy's
    advice. All the EPA the time to institute the kind of changes
    proposed in the formaldehyde review. Dr. Anastas has already
    proposed an initiative tied to the Academy roadmap that appears
    to be responsive and robust. It seems clear to me that to allow
    EPA to do their job with the advice from the Academy and not
    get captured by the endless science of the doubt machine is the
    direction that we should go.
        I look forward to hearing from our witnesses today to cast
    light on this process and to ensure that we have agencies that
    are actually working in the public interest and not in the
    private interest.
        Thank you, and I yield.
        [The prepared statement of Ms. Edwards follows:]
             Prepared Statement of Ranking Member Donna F. Edwards
        For fifty years the tobacco industry has fought a campaign to cast
    doubt on the health risks of smoking cigarettes. They invented the
    effort to use ``science'' to fight science; to harness industry-funded
    research for public relations campaigns; and to use friendly public
    officials to point to these manufactured uncertainties in opposing any
    effort to protect the public.
        And during that entire time, public health experts have absolutely
    known that smoking causes cancer, and that smoking remains--in the
    words of the Surgeon General--``the single most important preventable
    cause of death in our society.''
        That model of industry-funded science being used to generate
    uncertainty and postpone even minor regulatory steps--regardless of the
    effects on public health--has been taken up with gusto by other
    industries. A similar campaign is being waged by the fossil fuel
    industry to cast doubt on the science of climate change. And today we
    are going to see some of this unfold surrounding EPA's science-based
    efforts to develop risk assessments of the health consequences of
    chemicals to which Americans are commonly exposed.
        Industry tends to push for two things in the realm of science and
    regulation: first they demand that we must have certainty before any
    action can be taken, and, second, they point to studies that suggest
    there is uncertainty. What they don't mention quite so prominently is
    that they fund the production of studies designed to create doubt. That
    manufactured doubt is then used to justify inaction because, obviously,
    there is no certainty.
        The country ends up in an endless science loop that makes it almost
    impossible to ever make a statement about the harm of anything. If an
    agency tries to take a position, industry argues that there is
    ``another study'' just around the bend for which the agency should
    wait. With enough money and willing researchers, industry can guarantee
    that there is always another study just around the corner no matter the
    evidence regarding its harm.
        Of course the science that industry funds is specifically aimed at
    producing studies that show no harm from their products. In this world,
    the scientists who work for industry are not working to honestly
    understand a problem, but to provide answers that their clients want to
    use for their public relations campaigns. And make no mistake, no one
    pays you $325 an hour to produce science that isn't useful to their
    interests.
        The National Academy of Sciences has not been blind to this
    development in America's science and regulatory landscape. In 1983, the
    National Academy of Sciences issued the ``red book'' on Risk
    Assessment. For almost three decades that has been the bible on how to
    conduct a risk assessment. The report was motivated, in part, by a
    desire to try to set the science of assessing risks outside the
    political environment that surrounded decisions about what to do about
    those risks--a process they labeled risk management. The Academy,
    perhaps naively, hoped that all the struggles over regulatory decisions
    would be focused on risk management.
        What the Academy did not anticipate was how readily those with deep
    pockets would see science as fertile ground for fighting regulation.
    Industry learned that they can stall any movement out of the realm of
    risk assessment by manufacturing doubt, and the NAS red book helped
    institutionalize this system.
        And now the Academy has again marched into a situation that they
    may not have fully anticipated. The NAS report on EPA's draft
    formaldehyde assessment contains a very useful ``roadmap'' for how EPA
    should undertake reorganizing their IRIS assessments to make them more
    comprehensible and transparent. To his credit, Dr. Anastas has embraced
    those recommendations. But the industries that most worry about IRIS
    assessments have seized on the language of the NAS report to try to
    claim that EPA cannot be trusted to do science.
        That is not the message of the NAS report nor the intention of the
    Academy panel.

          If the Academy panel thought EPA could not institute
    effective changes, they would not have suggested EPA undertake them.

          If the NAS panel did not think IRIS assessments were
    needed or could be produced to a high quality, they would not have
    advised EPA to continue to put out those assessments even as they work
    to incorporate changes to that process as recommended by the Academy.

          If the panel did not trust EPA's ability to make
    appropriate changes to the draft-formaldehyde assessment, they could
    have recommended that EPA return to the Academy for a second review of
    that assessment. They did not make such a recommendation.

        Yet we will have testimony today from an industry-funded scientist
    that goes so far as to say that in light of the Academy study, the IRIS
    program should be killed.
        The IRIS program was a broken program during the Bush
    Administration. By 2006-2007, interference by OMB and endless science
    challenges by industry and polluting agencies that did not want to
    clean-up their messes--such as those documented at Camp LeJeune--had so
    crippled EPA that they were able to finalize only a couple of IRIS
    assessments a year.
        Pressure from this Subcommittee helped inspire GAO to put IRIS on
    their high risk watch list and inspired the new Administrator of EPA,
    Lisa Jackson, to put in place a new process that severely cut back on
    the opportunities for OMB and polluting agencies to interfere with
    EPA's production of IRIS assessments.
        It is too soon to know whether these steps will bear fruit, but we
    do know this: every IRIS assessment that the Academy has reviewed in
    the last half-dozen years, including the formaldehyde assessment, was
    largely a result of that broken process whereby OMB dictated to EPA
    much of the content and organization of those assessments. I would
    suggest that if the reports lacked coherence or clear communications
    perhaps it is because they were heavily interfered with by these non-
    EPA parties who insisted on new chapters, new sections, new issues and
    new articles being added.
        And the cure that industry prescribes for improving IRIS reports?
    Why, go back to the OMB-dominated system that produced them in the
    first place! Mr. Dooley sent a letter making just such a suggestion to
    Jack Lew. They further advocate that no assessment ever be finalized
    without an Academy peer review of the draft assessment and then another
    peer review of the redrafted assessment.
        Could the intent to slow roll action be any more transparent? And
    in the years between Academy reviews, just imagine how many new
    industry-funded studies might be created to throw up ever more science
    chaff in the path of EPA? These are not cures that will heal the IRIS
    program, but are designed to bleed it to death.
        Instead, I suggest that we follow the National Academy's advice.
    Allow EPA the time to institute the kinds of changes proposed in the
    formaldehyde review. Dr. Anastas has already proposed an initiative
    tied to the Academy roadmap that appears responsive and robust. And
    there is a new director of the IRIS program, Dr. Cogliano, who has been
    recruited to do for IRIS what he did for the International Agency for
    Research on Cancer risk process.
        We have good people in place and good advice from the Academy. Let
    us allow them to do their job and not get captured by the endless
    science doubt machine.

        Chairman Broun. Thank you, Ms. Edwards. If there are
    Members who wish to submit additional opening statements, your
    statements will be added to the record at this point.
        Now, before we begin, let me note that, again, testimony
    from the EPA was not received within the timeframe established
    in our committee rules. Testimony was not received until 2:47
    p.m. yesterday, with additional supplements trickling in at
    5:45 p.m. yesterday.
        Committee rule 7(B)(1) states that, ``Insofar as is
    practicable, no later than 48 hours in advance of his or her
    appearance each witness who is to appear before the committee
    shall file in printed copy and in electronic form a written
    statement of his or her proposed testimony and the curriculum
    vitae. Late testimony inhibits the committee's ability to fully
    evaluate the matter before it. Late delivery of testimony could
    set the stage for the committee to refuse to accept the written
    testimony of or hear from a witness.''
        In this instance it is imperative that EPA testify, but EPA
    has once again obstructed the committee's ability to conduct
    legitimate oversight. EPA provided late testimony to the fiscal
    year 2012 budget hearing on March 10, late testimony to the May
    11 hearing on hydraulic fracturing, and late testimony for the
    E-15 hearing on July the 7th .
        Additionally, questions for the record from the fiscal year
    2012 budget hearing were due on March 24, yet the committee
    only received responses 2 days ago, almost 4 months late.
        This is intolerable. The committee provided EPA a heads up
    on this hearing almost 2 months ago, providing ample time for
    OMB to review EPA's testimony. Dr. Anastas, this is
    unacceptable, and I expect EPA's testimony to be on time so
    that this committee can execute its responsibilities, and I
    hope in the future that we can count on you to do so and other
    officials with EPA to do so, and I would appreciate a very
    prompt response to our request.
        At this time I would like to introduce our first panel of
    witnesses. Dr. Paul Anastas, Assistant Administrator for the
    Office of Research and Development at the U.S. Environmental
    Protection Agency. Mr. David Trimble is the Director of Natural
    Resources and Environment at the U.S. Government Accountability
    Office. Dr. Jonathan Samet, is that correct? Samet. Okay.
    Samet, MD, served as Chair of the National Research Council's
    committee to review EPA's draft IRIS assessment of
    formaldehyde. Dr. Samet also previously chaired the National
    Research Council's Board on Environmental Studies and
    Toxicology, where he evaluated the EPA's reassessment of dioxin
    and related compounds.
        As our witnesses should know, spoken testimony is limited
    to five minutes each, after which the Members of the committee
    will have five minutes each to ask questions. Your written
    testimony will be included in the record of the hearing. It is
    the practice of the Subcommittee on Investigations and
    Oversight to receive testimony under oath. Do any of you have
    any objection to taking an oath?
        Let the record reflect that all witnesses are willing to
    take an oath. They indicated that by shaking their head from
    side to side, even though we heard no rattles. I saw it.
        You all may also be represented by counsel. Do any of y'all
    have counsel here today? Y'all is Southern for you all.
        Let the record reflect that none of the witnesses have
    counsel. They again indicated by the shake of their head,
    indicating no. If all of you would please stand now and raise
    your right hand, do you solemnly swear or affirm to tell whole
    truth and nothing but the truth, so help you God?
        Let the record reflect that all witnesses participating
    have taken the oath. Please take your seat.
        Now I recognize our first witness, Dr. Anastas.

                TESTIMONY OF THE HONORABLE PAUL ANASTAS,

              ASSISTANT ADMINISTRATOR, OFFICE OF RESEARCH

         AND DEVELOPMENT, U.S. ENVIRONMENTAL PROTECTION AGENCY

        Dr. Anastas. Good morning, Chairman Broun, Ranking Member
    Edwards, and other Members of the committee. I am Paul Anastas.
    I am the Assistant Administrator for the Office of Research and
    Development at the U.S. Environmental Protection Agency and the
    Agency's Science Advisor.
        Before I begin let me make a personal statement to this
    committee, and I think this committee appreciates the amount of
    respect that I have for this committee, and I want to give a
    personal apology to this for the tardiness of today's
    testimony. I do believe it was prepared promptly, and my
    apologies for the clearance process that may have delayed that.
    So that is something that I think is important and that I take
    seriously personally.
        Chairman Broun. Accepted and I greatly appreciate that. We
    look forward to having the testimony presented in a timely
    manner in the future. Thank you, and I am going to expect that,
    and I think you are a man of your word, and I appreciate that
    assurance that we can have that. Thank you.
        Dr. Anastas. Thank you, and thank you for the opportunity
    to be with you here today to discuss the EPA Integrated Risk
    Information System, otherwise known as IRIS. EPA plays a
    critical role in providing high quality health information on
    chemicals of concern. The agency's IRIS Assessment Program is a
    key part of this effort. It includes human health assessments
    on more than 540 chemical substances. These assessments provide
    the sound scientific basis for EPA decisions and are widely
    used by risk assessors, health professionals, state and local
    governments, as well as international governments.
        EPA is committed to upholding the highest standard of
    scientific integrity in all of its activities. This means
    constantly seeking to improve, strengthen, and enhance our
    scientific work to reflect the best available information.
    Continuous improvement of the IRIS Program is an important part
    of this effort.
        The EPA recently announced changes to the IRIS Program that
    will ensure we continue to use the best and most transparent
    science to pursue our mission of protecting human health and
    the environment. The new changes build upon the significant
    improvements initiated by Administrator Lisa Jackson in 2009.
        For example, since 2009, EPA has completed 16 IRIS
    assessments, more than the total number of assessments that
    were completed in the previous four years. We have cut down the
    average timeframe for completing assessments from between 3 and
    four years to within two years, and reduced the backlog of
    assessments in the pipeline, and yes, new assessments have been
    added to that pipeline, so that may be why the number looks to
    be the same.
        These improvements have been accompanied by a strong and
    continued emphasis on independent peer review of the IRIS
    Program. In April of this year EPA received a report from the
    National Academy of Sciences on their review of EPA's draft
    IRIS assessment on formaldehyde. EPA welcomes and accepts the
    recommendations of the NAS on the formaldehyde assessment and
    will incorporate these recommendations in the revision of the
    assessment.
        In the report the NAS also suggested ways to improve the
    IRIS process in two primary areas; accessibility and
    transparency. Because EPA is constantly seeking feedback from
    credible, independent scientific sources, we welcome these
    suggestions and are incorporating them fully into the IRIS
    Program.
        The new IRIS assessment documents will be shorter, clearer,
    more concise, and more transparent. IRIS users can expect to
    see a reduced volume of text and increased clarity and
    transparency of data, methods, and decision criteria. IRIS
    documents will rigorously be edited to eliminate any
    inconsistencies and redundancies and will include more
    graphical and tabular representations of the data.
        Related discussions will be consolidated into concise,
    narrative descriptions, and references to all studies used in
    the assessment development will be posted online. To make the
    scientific rationale of IRIS assessments as transparent as
    possible, the EPA will evaluate the strengths and weaknesses of
    critical studies in a more uniform way. We will also clearly
    indicate which criteria were most influential in weighing
    scientific evidence, supporting its choice of toxicity values.
    EPA is working closely with the Agency's Science Advisory Board
    to focus its expertise on how to best respond to the NAS
    suggestions.
        In addition, we continue to be committed to full
    consultation with scientists throughout the government and
    carefully consider and respond to their input. We will add a
    peer consultation step to the early stages of major IRIS
    assessments to assure that the scientific community can provide
    input as we make critical design decisions for individual
    assessments.
        These changes will be implemented over the coming months in
    a tiered approach, with the most extensive changes applied to
    those assessments in the earlier stages of development. These
    improvements are part of the natural evolution that accompanies
    all rigorous scientific work. We will continue to consider
    information and perspectives from independent scientific
    sources and pursue improvements in an ongoing basis.
        Thank you. I will be happy to answer any questions at the
    appropriate time as the chair directs.
        [The prepared statement of Mr. Anastas follows:]
          Prepared Statement of The Honorable Paul Anastas, Assistant
     Administrator, Office of Research and Development, U.S. Environmental
                               Protection Agency
        Good morning Chairman Broun, Ranking Member Edwards and other
    Members of the Committee. My name is Paul Anastas. I am the Assistant
    Administrator for Research and Development (ORD) at the Environmental
    Protection Agency and the Agency's Science Advisor. It is a pleasure to
    be here with you this morning to discuss EPA's Integrated Risk
    Information System (IRIS).

    Background and Description of IRIS Program

        EPA recognizes the critical role we play in disseminating timely,
    high-quality and accessible human health risk information on
    environmental contaminants that may endanger the health of the American
    public. Central to this aspect of EPA's mission is its Integrated Risk
    Information System, commonly called the IRIS program, which provides
    health effects information on chemicals to which the public may be
    exposed from releases to air, water, and land and through the use and
    disposal of products. IRIS assessments provide a scientific foundation
    for EPA decisions to protect public health across EPA's programs and
    regions under an array of environmental laws. While not regulations,
    IRIS assessments are critical to many Agency decisions. IRIS is also a
    resource for risk assessors and environmental and health professionals
    in state and local governments and other countries. After becoming
    Administrator in early 2009, Administrator Jackson reviewed the IRIS
    program and asked the Office of Research and Development (ORD) in May
    2009 to implement a new IRIS process that would revitalize the program
    and make it more responsive to the needs of the Agency. The aim of the
    new process was to ensure the highest level of scientific quality,
    integrity, transparency, and timeliness.

    EPA's Actions to Implement the 2009 IRIS Process

        EPA undertook several actions to implement the new IRIS process in
    2009. EPA regularly solicits public comments on the IRIS agenda, and
    ORD works directly with program and regional offices to ensure that
    IRIS assessments meet their needs. To ensure that IRIS assessments are
    focused on the highest priority needs, EPA expanded the role of the
    program and regional offices in nominating and prioritizing chemicals
    for assessment.
        EPA also has increased efforts to work with other agencies to share
    data and avoid duplication of effort. For example, ORD has a new
    Memoranda of Understanding with the California Environmental Protection
    Agency's Office of Environmental Health Hazard Assessment in addition
    to an existing Memoranda of Understanding with the Agency for Toxic
    Substances and Disease Registry. These efforts help to increase
    efficiency and assessment output. The Agency is also working closely
    with its Science Advisory Board on how to bring to bear its expertise
    on an ongoing basis to focus on the quality, transparency, and
    scientific rigor of IRIS assessments and guide EPA's response to the
    NAS recommendations. We will add a peer consultation step to the early
    stages of major IRIS assessments to assure that the scientific
    community can provide input as we make critical design decisions for
    individual assessments. The Agency also created an IRIS logistics team
    to coordinate all administrative support to improve efficiency and
    place increased emphasis on the scientific quality of assessments by
    allowing scientific staff to focus on the science. In addition, EPA
    developed the Health and Environmental Research Online database,
    referred to as HERO, which promotes transparency in risk assessments by
    capturing the literature used in EPA's health and environmental
    assessments and making the scientific studies used to develop
    assessments available to the public. The HERO database is web-based and
    accessible to everyone.
        These actions, collectively, have led to improved results in the
    IRIS process. Specifically, EPA has completed 16 assessments since
    2009, more than the number of assessments that were completed in the
    previous four years. EPA has reduced the IRIS backlog and is currently
    working on over 70 assessments. In 2010, EPA released nine assessments,
    seven of which were major assessments, for external peer review and
    public comment. Overall the new 2009 process resulted in greater
    involvement of EPA scientists and the public in the process.
        In summary, there have been many improvements to the IRIS program
    since 2009 to provide high quality assessments in a timely fashion.
    Assessment development time was shortened to 23 months for most
    assessments, which will speed the availability of IRIS assessments for
    use by the risk assessment community and public. The IRIS program is
    now entirely managed by EPA and EPA strives to ensure that all of its
    science assessments undergo rigorous, open and independent external
    peer review and that multiple opportunities exist for public review and
    comment. Additionally, changes in IRIS assessments that occur during
    the interagency and public process are documented and explained,
    ensuring a transparent final product.

    IRIS Process and the NAS Review

        In April 2011, the NAS released its review report of EPA's draft
    IRIS risk assessment of formaldehyde and included comments and
    recommendations to improve the IRIS process. EPA welcomes those
    recommendations and will be addressing all of them in a phased-in
    fashion. We note that the NAS specifically focused their comments on
    the development of draft IRIS assessments and did not recommend changes
    to the steps that occur later in the process. Additionally, the NAS
    recognized that EPA's implementation of their suggested changes would
    require a multiyear process. A summary of the NAS overall
    recommendations and EPA's responses to them are described below. \1\
    ---------------------------------------------------------------------------
        \1\ 1 Full text from p. 152 of the final published NAS report.

        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        1.  NAS recommended that EPA rigorously edit documents to reduce
    the text volume and address redundancies and inconsistencies.
          To respond to this recommendation, EPA is rigorously editing our
    assessment documents to substantially reduce the volume of text and
    address redundancies and inconsistencies; building on the existing IRIS
    guidelines and process to enhance the clarity and transparency of data
    evaluation and the presentation of findings and conclusions;
    consolidating related discussions to eliminate redundancies; increasing
    the use of tables and figures to improve communication of information;
    and providing reference information on the IRIS website for all studies
    considered.

        2.  NAS recommended that EPA include a fuller discussion of methods
    and develop concise statements of the criteria used to exclude, include
    and advance studies for hazard evaluation and derivation of toxicity
    values.
          In response to this recommendation, EPA is providing a fuller
    discussion of the methods used in our assessments, along with concise
    statements of the criteria used to exclude, include, and focus on the
    highest quality studies for hazard assessment and for derivation of
    toxicity values.

        3.  NAS recommended standardized evidence tables for all health
    outcomes.
          EPA is working towards replacing text descriptions of the studies
    with standardized evidence tables that provide the methods and results
    of each study for all health outcomes; and including text that will
    accompany evidence tables to present the criteria used to include or
    exclude studies.

        4.  NAS recommended that EPA provide a clearer articulation of the
    rationale and criteria for screening studies.
          To accomplish this, EPA is enhancing our sequential approach for
    progressively focusing on the most pertinent information, including:
    searching the literature, identifying the pertinent studies, and
    evaluating study characteristics; evaluating the overall weight of
    evidence for each health outcome; identifying plausible approaches for
    developing toxicity values; selecting the most pertinent data and
    developing toxicity values for each health hazard; and portraying
    toxicity information graphically.

        5.  NAS recommended that EPA use uniform approaches to thoroughly
    evaluate the strengths and weaknesses of critical studies, summarize
    findings in tables, and clearly articulate the rationale for the
    studies used to calculate toxicity values.
          To respond to these two suggestions EPA is streamlining IRIS
    assessment documents and more fully document our approach for
    assembling and evaluating the range of scientific data. As the NAS
    report indicated, we have already made similar changes to how we
    present the scientific evidence on the criteria air pollutants in our
    Integrated Science Assessments, and we are confident we can make
    comparable improvements in how we present our analysis of health study
    findings for chemicals evaluated in the IRIS program. EPA is also
    implementing a more uniform approach to our evaluation of the strengths
    and weaknesses of critical studies to increase the clarity of the
    rationale for selecting the studies used to calculate toxicity values.
    Lastly, we are increasing the use of evidence tables that summarize the
    factual details of pertinent studies for each health hazard and
    developing standardized language to describe study strengths and
    limitations.

        6.  NAS recommended that EPA provide descriptions to indicate
    various determinants of weight of evidence to promote understanding of
    what elements were emphasized in synthesizing the evidence.
          In response, EPA is augmenting its current analysis of data to
    indicate which criteria were most influential in evaluating the weight
    of evidence.

    Timeline for Responding to NAS Recommendations

        EPA's overarching goal is to continually improve our IRIS
    assessments, recognizing that these improvements will have a greater
    impact on our new assessments as opposed to those already in the
    pipeline. It is important to note that the NAS report viewed the
    implementation of their recommendations as a multi-year process. For
    example, the NAS stated `it is not recommending that EPA delay the
    revision of the formaldehyde assessment to implement a new approach.''
    To that end, EPA is doing the following:

          Assessments that have already been peer-reviewed or
    released for peer review: We are revising these assessments to address
    peer review comments, especially those that call for increased
    transparency of study selection and evidence evaluation.

          Assessments currently under development but not yet
    released for peer review: We are re-examining these assessments to
    ensure that the rationale for study selection and evidence evaluation
    is clear. These assessments will also be edited to reduce redundancy.

          New assessments that have not yet been started: We will
    fully implement the NAS recommendations for new assessments, including
    a tighter document structure, evidence tables to summarize details from
    pertinent studies, greater transparency in study selection and
    evaluation criteria, and greater emphasis on clear analysis and
    synthesis.

        The standards to which IRIS assessments are held, including the
    rigorous independent external peer review of every draft IRIS
    assessment, are among the best in the federal government and the
    scientific community. Over the coming months, the IRIS program will
    fully implement the NAS recommendations and continue to improve the
    IRIS process to reflect the highest standards of scientific integrity
    and credibility. Strengthening and streamlining the IRIS process is a
    continuing and ongoing priority for EPA. Thank you for the invitation
    to share my thoughts on this important topic. I will gladly answer any
    questions you have.

        Chairman Broun. Thank you, Dr. Anastas.
        I now recognize our next witness, Mr. Trimble.

                      TESTIMONY OF DAVID TRIMBLE,

              DIRECTOR, NATURAL RESOURCES AND ENVIRONMENT,

                 U.S. GOVERNMENT ACCOUNTABILITY OFFICE

        Mr. Trimble. Chairman Broun, Ranking Member Edwards, and
    Members of the Subcommittee, I am pleased to be here today to
    discuss our prior work and recommendations on EPA's Integrated
    Risk Information System. As you know, the IRIS database
    contains EPA's scientific position on the potential human
    health effects of exposure to more than 540 chemicals in the
    environment. IRIS assessments are a critical component of EPA's
    capacity to support scientifically-sound risk management
    decisions, policies, and regulations.
        In March 2008, we reported that the IRIS Program was at
    serious risk of becoming obsolete because the Agency has not
    been able to complete timely, credible chemical assessments or
    decrease its backlog of 70 ongoing assessments. We found that
    the timeframes for completing assessments were unacceptably
    long, often taking over a decade. In many cases assessments
    became obsolete before they could be finalized and were stuck
    in an endless loop of assessment and reassessment.
        In April 2008, EPA revised the IRIS process, but the
    changes made were not responsive to our recommendations. The
    new process was actually worse than the one it replaced,
    institutionalizing a process that resulted in frequent delays
    by enabling OMB to determine when an IRIS assessment could move
    forward. Further, this process effectively excluded the content
    of OMB's comments to EPA and those from the other interested
    federal agencies from the public record.
        Concerned with these problems and the agency's lack of
    responsiveness, we added EPA's process for assessing and
    controlling toxic chemicals to our January, 2009, report on
    government-wide high-risk areas in need of increased attention
    by executive agencies and Congress.
        In May 2009, the EPA made significant changes to the IRIS
    process. In June of that year we testified before this
    Subcommittee that these changes, if implemented and managed
    effectively, would be largely responsive to the recommendations
    we made in our March 2008 report. Let me highlight three of
    these key changes.
        First, the IRIS process would be managed by EPA rather than
    OMB as the former process was, restoring independence to EPA.
    Second, it required that all written comments provided by OMB
    and other federal agencies on draft IRIS assessments be part of
    the public record, adding transparency and credibility to the
    process. Third, the new process consolidated and eliminated
    steps, streamlining the process.
        Notably, the new process eliminated the step under which
    other federal agencies could have IRIS assessments suspended
    indefinitely to conduct additional research. As we have
    reported, we understand that there may be exceptional
    circumstances under which it may be appropriate to wait for the
    results of an important ongoing study. However, as a general
    rule, we believe the IRIS assessments that are based on the
    best available science is a standard that would best support
    the goal of completing assessments within reasonable time
    periods and minimizing the need to conduct wasteful rework.
        While the May, 2009 IRIS process changes reflect a
    significant improvement that can help EPA restore the integrity
    and productivity of the IRIS Program, EPA still faces
    significant management challenges as it seeks to complete
    timely, credible IRIS assessments.
        First, the EPA must continue to balance the need for using
    the best available science with completing IRIS assessments in
    a timely manner. As we have reported, even one delay can have a
    domino affect, requiring the process to essentially be repeated
    to incorporate changing science.
        Second, EPA faces long-standing difficulties in completing
    assessments of chemicals of key concerns; those that are both
    widespread and likely to cause significant health issues. We
    believe that EPA must continue to focus on the best available
    science, attaining credible expert review and finalizing IRIS
    assessments.
        Third, EPA must be disciplined in keeping to timelines,
    even in the absence of statutory deadlines for completing IRIS
    assessments.
        Lastly, we believe that to produce timely, credible IRIS
    assessments over a sustained period of time, it will be
    imperative for EPA to maintain a stable consistent process
    going forward.
        We are currently reviewing EPA's implementation of its
    revised 2009 IRIS assessment process and its response to our
    previous recommendations. As part of this review, we will be
    examining EPA's response to NAS's recommendations for
    improvements to the IRIS process. We plan to issue a report
    later this year.
        That concludes the summary of my statement. I will be happy
    to answer any questions that you or the Members of the
    committee may have.
        [The prepared statement of Mr. Trimble follows:]
     Prepared Statement of Mr. David Trimble, Director, Natural Resources
             and Environment, U.S. Government Accountability Office

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Chairman Broun. Thank you, Mr. Trimble.
        I know recognize for five minutes our next witness, Dr.
    Samet.

                TESTIMONY OF JONATHAN M. SAMET, MD, MS,

                 PROFESSOR AND FLORA L. THORNTON CHAIR,

                  DEPARTMENT OF PREVENTATIVE MEDICINE,

            KECK SCHOOL OF MEDICINE, UNIVERSITY OF SOUTHERN

               CALIFORNIA, AND CHAIR, COMMITTEE TO REVIEW

              EPA'S DRAFT IRIS ASSESSMENT OF FORMALDEHYDE,

           NATIONAL RESEARCH COUNCIL, THE NATIONAL ACADEMIES.

        Dr. Samet. Good morning, Mr. Chairman and Members of the
    Subcommittee. I am Jonathan Samet from the University of
    Southern California. As noted, I chaired the National Research
    Council committee that reviewed the EPA's draft IRIS
    formaldehyde assessment. I also currently chair the Clean Air
    Scientific Advisory Committee of the Agency.
        The draft, our review of the draft assessment was written
    by a 15-member committee that had a wide range of scientific
    expertise needed for the task. Our charge focused primarily on
    specific questions related to the Agency's approach to the IRIS
    assessment. But beyond these charge questions, the committee
    assessed the processes underlying the development of the draft
    and made suggestions about the process generally followed by
    EPA in developing the IRIS assessments. We were not charged or
    constituted to carry out an independent review of the evidence
    on formaldehyde.
        To do its job we reviewed the 1,000 page, approximately,
    draft assessment and key literature and determined whether
    EPA's conclusions were supported on the basis of that
    assessment and the literature reviewed. Much of our report is
    directed at providing constructive comments and recommendations
    on improving this draft specifically following our charge.
        That said, we felt that we could not address our charge
    without considering the methods and structure of the document
    as a whole and in responding to its charge questions, the
    committee found some recurring methodological problems that are
    cut across components of its charge.
        Consequently, we commented on the general methodology of
    the assessment in our second chapter and offered general
    suggestions in chapter seven with regard to the processes used
    by EPA. The general problems that we identified were not unique
    and have been reported by other committees. I think those
    problems have already received some comment. We found
    relatively little documentation of methods and insufficient
    clarity and transparency in how the evidence reviewed in the
    report was related back to the weight of evidence guidelines.
        We offered six specific recommendations with regard to how
    the present draft could be completed and moved forward
    satisfactorily. I will not go through these. They are listed in
    chapter seven of our report. They are straightforward and could
    be followed to bring the report to completion.
        I will turn to our general comments and suggestions on
    IRIS. As noted, we found general problems that we thought had
    been persistent in looking at NRC reviews of other IRIS
    reports. On the basis of lessons learned from the formaldehyde
    assessment, we offered our suggestions for changes in the IRIS
    development process that might help EPA improve its approach.
    We recognized that EPA had already implemented the plan
    discussed, released, and covered in the memorandum of 2009 from
    Administrator Jackson.
        We put together our own view of the underlying development
    process and offered a several-page roadmap for changes in the
    development process. The term roadmap was used because the
    topics that need to be addressed are set out, but we did not
    give detailed guidance. Each topic, in fact, would speak--would
    need to be developed in further detail.
        For each of the critical steps in the roadmaps there are
    underlying processes that would need to be examined and
    reconsidered. Our report provides further detail. We think that
    change in the IRIS development process, the process by which
    the drafts are developed, is feasible. We note as one example
    of the largely-successful overhaul of the process used for the
    National Ambient Air Quality Standards as an example. I have
    personally watched the revision of that process and noted its
    benefits.
        In conclusion, thank you for the opportunity to speak with
    you today, and I look forward to answering your questions.
        [The prepared statement of Dr. Samet follows:]
      Prepared Statement of Dr. Jonathan M. Samet, MD, MS, Professor and
    Flora L. Thornton Chair, Department of Preventive Medicine, Keck School
    of Medicine, University of Southern California; and Chair, Committee to
     Review EPA's Draft IRIS Assessment of Formaldehyde, National Research
                        Council, The National Academies

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Chairman Broun. I want to thank the panel, all of you.
        Reminding Members the committee rules limit questioning to
    five minutes each. The chair at this point will open the round
    of questions.
        The chair recognizes himself for five minutes.
        EPA announced changes to the IRIS process 2 days ago. In
    that announcement EPA indicated that it signed an MOU with the
    California Environmental Protection Agency's Office of
    Environmental Health Hazard Assessment to--in order to
    cooperate in the development of health assessments to encourage
    data sharing, avoid duplication of effort.
        Dr. Anastas, as a Georgian why should I be subject to
    California's risk assessments? If states are doing this work,
    why do we need IRIS? If IRIS assessments are better than state
    assessment, why have California do assessments for EPA? If IRIS
    isn't sufficient, why not rely on one own state assessment. Why
    just rely on one own state assessment? Please explain this to
    me why this isn't a backdoor attempt to implement California's
    risk assessment policies on the rest of the Nation.
        Dr. Anastas.
        Dr. Anastas. Thank you very much, Mr. Chairman. I am very
    happy that you asked that question because it gives the
    opportunity to explain some misconceptions about what IRIS is.
        IRIS assessments are not risk assessments. They are not
    risk management actions. They are not regulations. They are
    scientific assessments to understand the hazard, the underlying
    toxicity of substances. So the information that would be being
    shared between California and EPA is simply the underlying
    scientific basis, the assessments that are done by using the
    open scientific literature that is the basis of the science,
    but in no way would these assessments be risk assessments,
    California risk assessments, California regulations. These are
    only the underlying scientific bases that would be shared and
    the basis of these health hazard assessments.
        Chairman Broun. Well, I have got some follow-up questions
    to that that I will give you in writing to go forward, but just
    in the sake of time, Dr. Samet, as chair of the National
    Research Council committee that reviewed the EPA's draft IRIS
    assessment on formaldehyde, the committee decided to devote an
    entire chapter entitled, ``Roadmap for Revision.'' That
    highlighted specific changes to improve the formaldehyde IRIS
    assessment but also went a step further and offered
    recommendation for improving the IRIS process in general.
        Why did the committee decide to offer additional
    recommendations to improve the IRIS process? What letter grade
    would you give EPA for its formaldehyde assessment, A being
    excellent and F being a failure? And how about for the four
    other assessments that NAS has reviewed since 2005?
        Dr. Samet. The committee in its chapter seven wanted to
    give very specific guidance to the Agency on how to bring the
    formaldehyde assessment to completion. That was the six
    recommendations. The document, the draft assessment involves a
    number of underlying processes that have a generality to them,
    pulling together all the evidence, reviewing it, and evaluating
    it. And as we looked at the assessment, we found weaknesses
    which we documented in how those processes had been put into
    place and carried out.
        We felt that it was important to give the specific
    suggestions but also to provide general guidance on what needed
    to be done to help improve not only this IRIS assessment but
    hopefully future ones. As you noted, the National Research
    Council has reviewed other major IRIS assessments in the last
    decade and have found deficiencies in those documents.
        Now, I will say the committee was not asked to give a
    letter grade. I certainly couldn't give an A. I probably would
    be, Paul, sorry, a little pressed to give a B, and let us say
    we would certainly give--we will give a passing grade here, and
    I am not sure, and if I give a too-low grade, I know they will
    come back and ask me to revise it.
        Chairman Broun. Okay. Thank you, Dr. Samet.
        My time has just about expired, so I will recognize Ms.
    Edwards for five minutes.
        Ms. Edwards. Thank you, Mr. Chairman, and thank you to our
    witnesses this morning.
        Dr. Samet, your panel laid out certain challenges for EPA
    to take up to make the formaldehyde assessment stronger. Your
    panel did not recommend, however, that EPA bring that revised
    assessment back to the Academy for another round of review but
    to finish it and finalize it.
        Do you have confidence that EPA can successfully address
    the issues raised by your panel regarding how to strengthen and
    clarify the formaldehyde assessment?
        Dr. Samet. As a first comment, of course, an Academy panel
    can't recommend that something be brought back to the Academy,
    and I think however the document is revised I suspect that EPA
    will undertake further review. I think we were careful in
    chapter seven to say specifically what should be done. These
    changes as I noted in my testimony should be feasible, and they
    are changes that--and revisions that the agency should be able
    to make successfully.
        Ms. Edwards. And Dr. Anastas, do you have confidence that
    you will be able to make that assessment given the analysis by
    the Academy?
        Dr. Anastas. Yes. I think the important thing is we seek
    out the type of input that we received from the National
    Academy, we seek out from scientific experts, and we are very
    confident that getting the kind of input, the kind of
    recommendations, that we are able to follow through and
    incorporate those suggestions.
        Ms. Edwards. Thank you, and to follow on then, Dr. Samet,
    the Subcommittee has received some testimony for this hearing
    that suggests that the Academy should review every IRIS
    assessment, then review every revised assessment after changes
    are made following the NAS report. Would this be a difficult
    thing for the Academy to take on, and what effort would it
    require to review 20 IRIS assessments a year?
        Dr. Samet. Well, I, you know, certainly I am now speaking
    as chair of the committee and not in general with the Academy,
    which I can't do. I think there are many ways to have
    successful peer review. The Science Advisory Board of the EPA,
    which I serve on, being one. The Academy being another. I will
    say that now speaking individually, the effort involved in
    completing this review was substantial as I have mentioned. A
    15-member committee of volunteers working in four meetings in 8
    months and producing a, you know, a report over 100 pages.
        So substantial effort would be involved, and I think if the
    full load of peer review were somehow placed before the
    Academy, I am certain that that would stress the community of
    scientists who carry out such reviews.
        Ms. Edwards. Yes. I suspect that would be pretty
    impracticable.
        I wonder, Dr. Samet, you also provided a roadmap for EPA on
    how you think the IRIS process could be improved, and your
    panel apparently believed that EPA is actually capable of
    implementing those changes that the agency decides make sense.
        As chair of the Clean Air Science Advisory Committee at EPA
    you have had such changes take place and then I will just use
    the acronym, in the NAAQS process, and also as chair of CASAC
    and those assessment processes, are there lessons that might be
    learned here for IRIS?
        Dr. Samet. Well, I think if you look at chapter seven of
    our report we provided a case study of the revisions that were
    made, and having participated in reviews of NAAQS standards now
    for several decades and I think the process has become much
    clearer, must more transparent, and much more efficient, and I
    think it has worked. It took some time on the part of the
    Agency and some interactions with CASAC, but I think an
    improved process resulted.
        Ms. Edwards. And I just want to be clear. Your report
    contained examples of where your panel felt that the EPA got
    the science wrong or failed to adequately communicate how they
    evaluated studies and came to conclusions, but I couldn't find
    anyplace where you imply that EPA purposely distorted the
    science or their findings. Did you find any evidence at all of
    purposeful deception or intentional manipulation on the part of
    EPA?
        Dr. Samet. Well, certainly as we addressed our charge, we
    look carefully at how studies were selected and reviewed. I
    think we certainly found many examples where we felt that EPA
    had not communicated well or we could not follow their
    methodology but nothing that I would regard as purposeful to
    use your words.
        Ms. Edwards. Thank you, and then lastly, we will hear
    testimony today that argues that the Science Advisory Board
    lacks independence because it depends on EPA staff. Doesn't the
    CASAC also depend on EPA staff for its work?
        Dr. Samet. Well, EPA, I am sorry, CASAC certainly is
    supported by EPA staff. Our deliberations and discussions are
    fully public, and I certainly don't see them as influenced by
    EPA staff as we carry them out in the complete open.
        Ms. Edwards. Does either CASAC or the Science Advisory
    Board have, do you have any reason to believe that they lack
    any kind of independence because they rely somewhat on EPA
    staff?
        Dr. Samet. Not in my experience. No.
        Ms. Edwards. Thank you very much, and with that I yield.
        Mr. Hultgren. [Presiding] I am going to yield myself five
    minutes for some questions as well. So, Mr. Trimble, if I could
    start with you, what would it take to remove the IRIS Program
    from GAO's high-risk series?
        Mr. Trimble. That is a challenging question. We are in the
    process of working with the agency and OMB to discuss what sort
    of steps we would like to see along that process. I think there
    is no simple answer that is X and Y and Z. I think that we have
    got a little bit more work to figure out all the steps.
        Clearly from our prior work some of the steps they have
    taken has moved the ball along in terms of restoring
    independence, adding some transparency to the process, but
    clearly a lot of work needs to be done in terms of being able
    to address the large backlog that still remains, as well as to
    be able to move ongoing assessments forward in a timely manner.
        I think there is also the issue that is still lurking out
    there regarding sort of the pent-up backlog of IRIS assessments
    that the Office of Water and other parts of the EPA have not
    put in requests because they know there is such a logjam
    currently. So there are a lot of other hidden issues that we
    haven't addressed yet, but we are in the process of planning
    work.
        Mr. Hultgren. Do you have any estimate on the timeline on
    that?
        Mr. Trimble. Well, we have meetings scheduled I believe
    this fall with the Agency and OMB to sort of do a status
    report, and you know, I am not, I don't have a timeline at this
    stage.
        Mr. Hultgren. Dr. Anastas, let me read one part of Dr.
    Samet's testimony where he says, ``In the roughly 1,000 page
    formaldehyde draft reviewed by the present committee, little
    beyond a brief two-page introductory chapter could be found on
    the methods for conducting the assessment. In fact, the
    introductory chapter of formaldehyde is nearly identical to
    that used in the IRIS assessments. Numerous EPA guidelines are
    cited, but their role in the preparation of the assessment is
    not clear. In general, the committee found that the draft was
    not prepared in a consistent fashion. It lacked clear links to
    an underlying conceptual framework, and it does not contain
    sufficient documentation on methods and criteria for
    identifying evidence from epidemiologic and experimental
    studies for critically evaluating individual studies for
    assessing the weight of evidence and for selecting studies for
    derivation of the RFCs and unit risk estimates. The critical
    summary sections that synthesized the evidence are variable and
    too often brief or not present, and strength of evidence is not
    characterized with standardized descriptors.''
        How do you respond to that?
        Dr. Anastas. The reason that the Environmental Protection
    Agency seeks out the type of peer review, expert peer review
    from whether it is our Science Advisory Board or the National
    Academies is to get that exact type of review, that exact type
    of input. We take those recommendations extremely seriously. We
    think that those improvements are absolutely essential to
    improving and finalizing this draft assessment. That is why we
    seek it out. That is why we fully accept them. That is why we
    are integrating them into our revision of the formaldehyde
    assessment.
        Mr. Hultgren. So what is your intention, I guess, with, I
    mean, this is pretty significant what they have said, you know,
    that it sounds like there was a pretty significant failure here
    in the processes. What will happen to address those recognized
    failures?
        Dr. Anastas. I guess I look at it a little bit differently.
    I view that as a success in the process. We seek out this exact
    type of peer review in order to continuously improve this draft
    document. When we write a draft document, we want that type of
    input so that the final version that gets posted and is
    available to the American public and beyond is of the highest
    quality. That is why we accept those recommendations, and that
    is why we will build them into our revision.
        Mr. Hultgren. Okay. Dr. Samet, with my last remaining
    minute here, in her testimony Ms. Steinzor takes exception to
    your scolding of EPA staff in the April formaldehyde report by
    saying, ``I wish that the NRC Committee had not adopted such a
    haughty tone in scolding EPA staff.''
        In responding to her observation can you provide us with
    some context of how many reviews the Academy has done of other
    IRIS assessments and how often you or other chairs repeated the
    suggestions and recommendations that ultimately led to chapter
    seven of the formaldehyde report?
        Dr. Samet. Well, I guess I had not read the testimony or
    seen the term, scolding. I think that our comments in chapter
    seven are provided as recommendations and as positive help to
    the Agency in trying to improve the process as Dr. Anastas
    mentioned. I think probably, and I can look to my left and get
    a little help, but this is probably the fifth review in the
    last decade by a National Research Council committee of an IRIS
    assessment. These have been the larger, more complicated
    assessments, and I think in all of them there have been one or
    more general comments about methodology and some specific
    chapters on aspects of methodology with concerns expressed.
        Mr. Hultgren. Thank you. My time is up.
        I yield five minutes to Mr. McNerney.
        Mr. McNerney. Thank you, Mr. Chairman. I thank the panel
    for stepping forward this morning. I appreciate, Dr. Anastas,
    the attitude that you have about looking for input from
    independent sources. That is very important. As a scientist I
    appreciate that, and I understand that the Office of Research
    and Development relies on a board of scientific counselors to
    help provide an independent evaluation of your programs. That
    board did an assessment in 2008, and then again in 2010.
        Later this morning we are going to hear that the IRIS
    assessments are considered irrelevant and the department weak
    in science. Can you tell us a little bit about the board and
    what sort of people serve on it, their independence, and
    summarize their observations for us, please?
        Dr. Anastas. Yes. A number of years ago we sought to
    establish the Board of Scientific Counselors to give us
    independent reviews of our general performance, how we are
    performing on the wide range of activities that the Office of
    Research and Development undertakes. Specifically we asked them
    to review the IRIS process, and these Members who are of the
    highest quality from industry, academia, a broad spectrum of
    people, looked at the IRIS Program and gave us tremendous
    feedback, both constructive recommendations, as well as
    recognizing the strengths.
        Some of the quotes from the Board of Scientific Counselors
    include, ``Internationally IRIS assessments are considered to
    be of the highest quality and reliability.'' Another quote is,
    ``IRIS assessments are among the most heavily-peer-reviewed
    documents produced by scientists anywhere.''
        So there are tremendous strengths to the IRIS Program, but
    we also need to recognize that even strong programs can and
    must improve. I come from Boston where the Boston Red Sox
    happen to be in first place right now, but they are always
    seeking to improve. We will always engage in continuous
    improvement because that is what scientists do.
        Mr. McNerney. Was the Board's recommendations or are their
    recommendations aligned more or less with the recommendations
    from the National Academy?
        Dr. Anastas. Yes.
        Mr. McNerney. Thank you. Dr. Samet, why did the National
    Academy undertake the assessment in the first place, and who
    paid for that effort?
        Dr. Samet. Well, the National Research Council was asked by
    the Agency to carry out this review. I think there is a
    somewhat long and complicated history about that request that
    you are likely aware of, but the support for the review to the
    Academies came from the Environmental Protection Agency.
        Mr. McNerney. Did the National Academy feel that their
    recommendations or that your recommendations should be
    mandatory and enacted by the end of this year? Was that the
    intent?
        Dr. Samet. Well, the Academy, of course, makes--our report
    provides its recommendations. These have no binding
    requirements for the Agency. They are really peer review and
    suggestions and comments that we make in the spirit that we
    hope they will prove to be useful to the Agency as it revises
    the document or if it chooses to undertake revisions to the
    IRIS process itself.
        Mr. McNerney. So, I mean, they weren't initially given as,
    hey, you need to do this by the end of this year, or this is a
    big problem. That wasn't the intent then, was it?
        Dr. Samet. Well, an Academy committee would not make
    recommendations in that spirit. I mean, again, the Academy is
    an advisory to the government.
        Mr. McNerney. Thank you. Mr. Trimble, you reported this
    morning that the assessment, the IRIS assessment was
    unresponsive. I think that is the word I heard a number of
    times. What do you believe is the underlying cause for that
    assessment for your unresponsive assessment?
        Mr. Trimble. I believe the unresponsiveness I was referring
    to was in response to our 2008 report where we made
    recommendations to improve the process and then later in 2008,
    they made changes formalizing the process which was essentially
    no change. They institutionalized the things we had identified
    as problematic. That process was then changed in 2009.
        So the lack of responsiveness is to our prior
    recommendations and one of the reasons we put the area on our
    high-risk list.
        Mr. McNerney. I mean, you didn't answer my question. What
    do you think the underlying causes of that unresponsiveness?
        Mr. Trimble. Well, at that time I believe OMB and the EPA
    were committed to the procedures they had in place, and they
    were--their position was that the OMB's comments and other
    agencies' comments were deliberative and should not be put in
    the public domain.
        Mr. McNerney. Okay. My time has expired, but you never
    really answered the question. Thank you.
        Mr. Hultgren. I recognize Dr. Benishek for five minutes.
        Dr. Benishek. Thank you, Mr. Chairman. Distinguished
    Members of the panel, thank you for your time today. I know we
    are here to talk about chemicals, and as a physician I have a
    bit of experience with chemicals.
        I would like to talk today about a chemical called
    acrylonitrile or AN. It kind of has a funny name, and you
    probably never heard of it, but we all come in contact with it.
    As a physician I really haven't been aware that I was using the
    compound, but it is around in medicine a lot. It is found in
    everything from dialysis tubing to cell phones to computers and
    golf clubs.
        Recently the EPA released an IRIS assessment for AN with a
    60-day comment period, and based on initial review of the draft
    it doesn't seem to have a comprehensive objective review of the
    science. The draft completely ignores many of the articles
    published in reputable peer review journals, many with opposing
    views.
        I am concerned that the assessment will lead to burdensome
    regulations in a variety of industries, you know, especially in
    my district, plastics and boating industry, medical equipment.
    I find it troubling that the Agency seems to spend a lot of
    time and money accusing us in Congress to not--to ignoring
    science but fails to follow some of its own advice.
        Is the EPA's objective to review all critical published
    scientific information when preparing these assessments,
    whether or not the Agency agrees with the position? Dr.
    Anastas.
        Dr. Anastas. Thank you very much for the question. The
    short answer to your question is yes. We--an essential part of
    all of our analyses, speaking generally across all of the IRIS
    assessments, is understanding the relevant, credible scientific
    information and composing its assessments. Those assessments,
    and I am speaking specifically to acrylonitrile right now, go
    into an external peer review process where we get the reaction
    to this draft assessment.
        So if there are concerns about particular studies that may
    not have been identified, considered, that those are caught
    during this period in the peer review process.
        Dr. Benishek. Well, the reason I am asking this is, you
    know, apparently what this is, acrylonitrile review, there is
    no mention of several other publications. I am looking at one
    here. The International Agency for Research on Cancer, part of
    the World Health Organization published a review that wasn't
    cited. There is a review on AN in North Carolina Scientific
    Advisory Board that wasn't cited. There was a review by an
    independent peer review panel organized by TERA, the Toxicology
    for Excellence and Risk Assessment. There are several
    conflicting sources of information that aren't cited in the
    review and I just want to understand how the committee decides
    which studies to include in the review and which studies not to
    include.
        I mean----
        Dr. Anastas. That is an excellent question. The process by
    which studies are selected based on their relevance, their
    credibility is something that as we have spoken about, is
    always something that we are seeking to make clear, transparent
    with these public meetings, with this public external peer
    review. All of these comments are considered. That is why this
    draft is going out for this public peer review.
        I do want to clarify one thing that I mentioned earlier.
    These assessments are not regulations. These assessments are
    not risk assessments. These are the underlying scientific
    characterization of the hazard.
        Dr. Benishek. Well, it doesn't seem to me to, you know, I
    have read the papers where you may have like 100 citations, and
    just not having all the citations that are available doesn't
    seem to make any sense to me. You know what I mean? Why some
    are not listed I just don't get it, because, I mean, you just
    put another citation in there. It makes sense to have comments
    on both sides of the issue.
        Dr. Anastas. Absolutely and that is why we have these
    public sessions to consider all scientifically-sound, credible
    information be part of these assessments.
        Dr. Benishek. And yet these things that I cited weren't
    included. So I just don't understand why not.
        Dr. Anastas. If there were any scientific, credible,
    independent studies that were not included, then this is the
    process to ensure that all of them are included. This is why we
    go to the external public peer review.
        Dr. Benishek. So then are we going to include these studies
    that I had mentioned to you in the future or reevaluate the
    situation or what?
        Dr. Anastas. Any literature, any study that is relevant,
    sound, independent, scientifically credible. Anything that is--
    that meets those criteria would certainly be included.
        Dr. Benishek. Well, great. Then we will have the committee
    forward these studies to you, but maybe they can be included in
    your evaluation.
        Dr. Anastas. And the timing is excellent, because this is
    the external peer review and public assessment comment.
        Dr. Benishek. All right. Thanks.
        I yield back my time.
        Chairman Broun. The gentleman's time is expired.
        Now I recognize Mr. Miller for five minutes.
        Mr. Miller. Thank you. This is an issue, the IRIS System,
    that this Subcommittee considered when I was chair of the
    Subcommittee. We have thousands of chemicals that are in
    widespread use. We really do not know what the public health
    consequences are of exposure to those chemicals. We have about
    700 new chemicals entering the marketplace every year. We have
    no idea what most of those do to anybody. We have got cancer
    clusters and clusters of birth defects all over the country we
    know have got to be the result of exposure to something, and we
    don't know what, and the IRIS System is supposed to be how we
    assess the risk of exposure to chemicals.
        But despite all that because of the system that was in
    place there are only about three new or revised assessments
    being issued a year, and there was ample evidence of political
    interference and a great deal of influence by the industries
    that made those chemicals or use those chemicals.
        I have three charts I would like to show, and I believe
    somebody is, yes, standing by, and I hope the witnesses can see
    these.
        [Chart]
        This is actually a schematic of the process that the Bush
    Administration inherited from the Clinton Administration. Well,
    I believe it was in effect for most of the Bush Administration,
    and then a step or supposedly this was streamlined.
        Can we show the second?
        [Chart]
        Yeah. That is the streamlined version. Now, at the time I
    said that I was reminded of Chico Marx quote, ``Who are you
    going to believe, me or your own eyes,'' that that was a
    streamlined version of the process that had existed before.
    What that did, however, was put OIRA in the middle of the whole
    process.
        Now, Dr. Anastas, when Chairman Broun scolded you for not
    getting your testimony in on time, he said you had completed
    it, but you had to get it reviewed. Was that a review by OMB?
        Dr. Anastas. All testimony is reviewed by OMB.
        Mr. Miller. Okay, and that is where the holdup was? Well, I
    know you don't want to criticize OMB. Is OIRA a part of OMB?
        Dr. Anastas. Yes.
        Mr. Miller. Okay. Thank you, and that is the system that
    slowed it, that appeared to slowed it down greatly. Now, Mr.
    Trimble, the GAO has been in--very involved in all this in
    reviewing the IRIS System, and you were not suggesting--well,
    let us now go to the third slide.
        [Slide]
        And that is the slide that supposedly is streamlined, and
    actually it appears that you could believe your own eyes that
    that is streamlined. You are not suggesting we go from that
    back to the previous system, are you?
        Mr. Trimble. No, sir. The opposite.
        Mr. Miller. Okay. The opposite. All right.
        Dr. Samet, you reviewed a lot of OIRA's assessments. You
    looked at, let us see, formaldehyde, perchlorate, dioxin,
    trichloroethylene. I am not on of the committee's doctors. And
    tetrachloroethylene.
        Which of those systems were those assessments done under?
        Dr. Samet. I would, I can't exactly answer that. I mean, I
    would have to look at the timing of each of those and when they
    were done. They were mostly done over the last 5 or six years,
    so I guess that would be back with your 2004, 2008 slide.
        Mr. Miller. Well, Dr. Anastas, can you answer that
    question? Were any of these assessments that the academies have
    found fault with been performed under that system?
        Dr. Anastas. No.
        Mr. Miller. They were all under the previous systems?
        Dr. Anastas. Correct.
        Mr. Miller. The streamlined previous systems?
        Dr. Anastas. Correct.
        Mr. Miller. All right, and, again, although Susan Dudley,
    who headed OIRA at the time, sat right there, raised her hand,
    right hand, took the same oath that you all had, and said that
    there was never any--they never really substituted their
    judgment on science for EPA. There was a huge amount of
    evidence that that happened routinely.
        The impression from that period and from our hearings
    before is that the work EPA was doing to get a risk assessment
    through this streamlined process was one performed under fire,
    under hostile fire from the industries that produced the
    chemicals and from the industries and the agencies of
    government that used the chemicals. Is that correct?
        Dr. Anastas. Was that the characterization?
        Mr. Miller. Yes, sir.
        Dr. Anastas. That was the characterization.
        Mr. Miller. Okay, and is it possible that some of the fault
    that the academies have found with EPA's work in this is the
    result of the fact that the people performing the work felt
    they were under fire and were trying to anticipate every
    possible criticism?
        Dr. Anastas. There are those who have characterized that
    that way. Yes.
        Mr. Miller. Okay. Would you be one of those who
    characterizes it that way?
        Dr. Anastas. I think the excellent scientists who dedicate
    their professional lives to this have felt under a tremendous
    amount of pressure from different sources. Correct.
        Mr. Miller. Okay. My time has expired, Mr. Chairman.
        Chairman Broun. Thank you, Mr. Miller. Nice seeing you stay
    within five minutes. No, I said that in all sincerity.
        Now the Chairman recognizes Mr. Rohrabacher for five
    minutes.
        Mr. Rohrabacher. Thank you very much, Mr. Chairman.
        Yeah. I guess we have seen lots of examples where
    scientists have been put under pressure, especially during this
    investigation of global warming and such issues where our
    scientists were denied grants because they did not believe in
    global warming's theory, which we heard reports of across the
    board for years in this committee.
        So we know that there are certain advocacy elements within
    the scientific community that are willing to pressure other
    people within the scientific community. It is sort of like
    tenure in college for the college professors, of course, would
    never think about trying to control what type of people are
    hired onto their departments, but we all know that happens,
    don't we?
        I would like to ask in terms of how this affects the
    scientific questions that we are dealing with today, is--and I
    certainly would--I will take you, I will address you, you are
    the head man. Are the scientists who are involved with this
    risk assessment program, are they--are steps taken to make sure
    that they have not been part of advocacy groups prior to their
    involvement with this program?
        Dr. Anastas. I can't say that I do not investigate the
    backgrounds of scientists.
        Mr. Rohrabacher. Okay. So there is no background check to
    see if a scientist has been involved with an advocacy program
    or actually been hired, perhaps, by an advocacy organization
    prior to him getting involved and his decision making being
    trusted by your organization?
        Dr. Anastas. The only background check that would be done
    is for the scientific excellence.
        Mr. Rohrabacher. Okay. So you could have someone who is
    very etiological, very, very etiological and even being hired
    by groups that are just adamant about what they believe, and
    that person could still be someone who you are relying on for
    their judgment not to be impaired.
        Dr. Anastas. I can only say that we hire people for their
    excellence in science, that demonstrated excellence in science.
        Mr. Rohrabacher. Uh-huh, and you don't take into
    consideration if that person had been involved in an
    organization that perhaps that organization is so committed to
    a position that it reflects anyone who could associate. You
    know, there are certain groups that have a position, whether
    they are against what you believe or for what you believe, but
    they are so adamant that we know that that might indicate the
    person doesn't have an open mind towards certain issues.
        But that is not taken into consideration for hiring
    someone?
        Dr. Anastas. You raise an excellent point, Congressman,
    because at the essence of scientific excellence is objectivity.
        Mr. Rohrabacher. Correct.
        Dr. Anastas. And so when I use the words, scientific
    excellence, embedded in that definition would be objectivity.
        Mr. Rohrabacher. Okay, and however, someone's affiliation
    with certain advocacy groups is not something that you would
    look at to determine their objectivity?
        Dr. Anastas. If a person skewed their science in order to
    meet ideological ends, that would be antithetical to scientific
    excellence.
        Mr. Rohrabacher. And there is no organizations that you
    believe that just an association with that organization would
    say, well, maybe that person is just too much involved with
    advocating a position to be able to come on board?
        Dr. Anastas. I would only say that we need to evaluate the
    scientific excellence and the objectivity and other litmus
    tests, background checks----
        Mr. Rohrabacher. Right.
        Dr. Anastas. --or----
        Mr. Rohrabacher. Now, what we have seen too much of is
    scientific excellence is dependent on whether someone agrees
    with me or not, and that is what we have seen over and over and
    over again by the liberal establishment here in this city in
    dealing with scientific issues. And I certainly would think
    that if we have certain people that are committed to a position
    and they are involved with organizations that are committed,
    that that should be taken into consideration when giving them
    responsibility to assess whether or not something is
    scientifically viable or not.
        Let me ask you another thing.
        Chairman Broun. The Chairman's time has expired.
        Mr. Rohrabacher. Oh. Pardon me.
        Chairman Broun. Thank you, Mr. Rohrabacher.
        I now recognize Mr. Clarke for five minutes.
        Mr. Clarke. Thank you, Mr. Chairman. My question is more
    than likely for Dr. Anastas abut anyone else could feel free to
    answer. It is really a basic one.
        I just wanted to get clarification again between the
    difference between an IRIS scientific assessment and a complete
    risk assessment, if there are certain elements in a risk
    assessment that the IRIS assessment does not address. And then
    ultimately how you would compare the IRIS assessment in time
    development and in substance to the ultimate regulatory
    proposal that is issue?
        Dr. Anastas. Certainly and thank you very much for the
    question.
        The information that is provided in an IRIS assessment is
    an essential and key part that feeds into a risk assessment.
    However, there is the hazard characterization. In order to come
    up with the risk assessment, the risk probability, you need
    exposure data. So the exposure of an individual to the
    substance through a variety of roots, whether it is children,
    it is breathing in air, it is ingested in the water, that--
    those components coming together are part of the risk
    assessment process, which then feeds into the risk management
    alternatives. Those are the regulatory determinations that are
    carried out by our program offices, our Office of Water, our
    Office of Air, to take into account a wide variety of other
    factors, including everything from socio, economic, other
    considerations, technological feasibility of various risk
    management options.
        And so while the IRIS assessments and the information they
    provide is a critical piece, it is significantly removed from
    the regulatory process.
        Chairman Broun. Thank you, Mr. Clarke.
        Now recognize the full committee Chairman, Mr. Hall, for
    five minutes.
        Chairman Hall. Thank you, Mr. Chairman. Inasmuch as I don't
    know what questions have been asked or answers elicited and as
    much as I probably wouldn't believe anything any of the three
    of you say, I will yield back my time.
        Chairman Broun. I can't believe it. Okay.
        Mr. Sarbanes is still down there. I yield Mr. Sarbanes five
    minutes.
        Mr. Sarbanes. Thank you, Mr. Chairman. I appreciate it.
    Thank your for your testimony.
        I always start these hearings, these hearings being ones
    that are about chemicals and the risks that chemicals pose out
    there and our efforts to try to get a handle on that and get
    more information by observing it, if the average member of the
    public understood how little information and knowledge we have
    about the chemicals that are being put out there in the stream
    of commerce, in the natural streams, and so forth, they would
    be amazed and appalled. I think they have the expectation that
    our level of knowledge is much, much higher than it is, and a
    lot of the delay that we see in the kind of regulation and
    oversight and assessment is something they wouldn't imagine
    would be happening in the United States of America in the 21st
    century. So I don't know who is watching this hearing out there
    in the public, but I hope they spread the word on this.
        I was looking at this silver book, as it is so called, and
    on the back it talks about how risk assessment has become a
    dominant public policy tool for making choices based on limited
    resources to protect public health and the environment. So we
    talked a lot about that.
        However, risk assessment is at a crossroads, it says.
    Despite advances in the field risk assessment faces a number of
    significant challenges including lengthy delays in completing
    complex risk assessments, lack of data leading to significant
    uncertainty in risk assessments, and many chemicals in the
    marketplace that have not been evaluated, and emerging agents
    requiring assessment, which is a pretty good encapsulation of
    the testimony and exchange that we have been having here this
    morning.
        I think you all recognize that, and I see the three of you
    working in concert to try to improve the process, improve the
    reliability of the risk assessment process, and Dr. Anastas, I
    appreciate your lack of defensiveness with respect to the
    assessments and evaluations that have been done that you invite
    in terms of the IRIS process, and you are getting some good
    constructive input.
        Then commenting on the silver book, this--the back flap
    here says, ``Science and decisions,'' which is the name of the
    silver book, ``makes practical scientific and technical
    recommendations to address these challenges,'' i.e., the ones
    just referred to.
        Can you speak to the value of this? This is a follow up on
    an earlier framework known as the red book, as I understand it
    it complements it, but can you speak to the value of this, and
    then Dr. Samet, I would like to get your perspective on it as
    well. Thank you.
        Dr. Anastas. Thank you very much, Congressman, for the
    question because the so-called silver book was carried out by
    the National Research Council and chaired by a very well-
    respected professor at Johns Hopkins University named Tom Burke
    and provided some excellent framework for how we need to
    continuously improve our risk assessment processes, how we need
    to think more broadly if we are going to ensure that the risk
    framework is as strong as it needs to be.
        As Science Advisor of the Agency, I have the honor of
    chairing the Science Technology and Policy Council. Adopting
    the recommendations in the science book is something that is
    going on in real time, moving ahead so that across the Agency
    the findings of the silver book are able to be incorporated.
        Mr. Sarbanes. Thank you. Dr. Samet.
        Dr. Samet. I think the silver book was an important
    updating and broadening of the concepts that were in the so-
    called red book.
        I would also bring your attention to one other report that
    came out from the National Research Council around the same
    time, Toxicity Testing for the 21st Century, which laid out, I
    am sorry to use the word again, but a roadmap or a blueprint
    for how to address the problem highlighted in the comments on
    the back of the silver book. We need to have a way to test with
    validity the many chemicals coming into the marketplace. And
    the proposal in that document is how do we use our new science
    to try and address this question with some certainty, dealing
    with the hundreds of chemicals whose risks we are uncertain
    about as they come into the marketplace, using the best science
    possible.
        So I think that together those two reports do set out a,
    hopefully a new approach for the future.
        Mr. Sarbanes. Thank you. I yield back.
        Chairman Broun. The gentleman's time has expired. Thank you
    so much, Mr. Sarbanes.
        I want to thank the panel for you all's testimony and your
    answering questions, particularly in an expeditious manner, and
    I want to thank the committee Members for also asking their
    questions in an expeditious manner.
        You will be excused. Members may desire to submit written
    questions, and I trust that we will get replies in a timely
    manner from you all, so you all are excused, and thank you for
    your testimony today.
        And if the second panel will expeditiously also take their
    seats.
        At this time I would like to welcome and introduce our
    final panel of witnesses. First is the Honorable Calvin Dooley.
    He is President and CEO of the American Chemistry Council.
    Congressman Dooley previously represented the 20th
    Congressional District in California. We have Ms. Rena
    Steinzor, who is Professor at the University of Maryland School
    of Law and Founder and President of the Center for Progressive
    Reform. We have Dr. Gail Charnley, is Principal at HealthRisk
    Strategies. Dr. Charnley is an internationally-recognized
    scientist who has served on several advisory committees,
    including peer review panels for the EPA and FDA, the
    Presidential Congressional Commission on Risk Assessment and
    Risk Management, and is currently on the National Academy of
    Sciences Board on Environmental Studies in Toxicology. The
    Honorable Chris Bollwage is Mayor for the City of Elizabeth,
    New Jersey, a position he has held for the past 18 years. I am
    sorry. You have got one of the hardest jobs in politics. Mayor
    Bollwage also serves as Chair of the Conference of Mayors
    Brownfields Task Force.
        As our witnesses should know, spoken testimony is limited
    to five minutes each, and please try to maintain that five
    minutes. After which Members of the committee will have five
    minutes to ask each questions. I ask the committee Members to
    please be mindful of the time. Your written testimony will be
    included in the record of the hearing. It is the practice of
    the Subcommittee on Investigations and Oversight to receive
    testimony under oath. Do any of you have objections to taking
    an oath?
        Let the record reflect that all witnesses are willing to
    take an oath.
        You also may be represented by counsel. Do any of you have
    counsel here today?
        Let the record reflect that none of the witnesses have
    counsel. I think Congressman Dooley, you indicated you do not.
    Okay. That is great. If all of you would please now stand and
    raise your right hand. Do you solemnly swear or affirm to tell
    the whole truth and nothing but the truth, so help you God?
        Thank you, and you may be seated. Let the record reflect
    that all the witnesses participating have taken the oath.
        I now recognize our first witness, Congressman Dooley, for
    five minutes.

                      TESTIMONY OF CALVIN DOOLEY,

                 PRESIDENT AND CHIEF EXECUTIVE OFFICER,

                       AMERICAN CHEMISTRY COUNCIL

        Mr. Dooley. Good morning Mr. Chairman and Members of the
    committee. I appreciate the opportunity to be here today to
    speak to the pressing need to fix the Environmental Protection
    Agency's Integrated Risk Information System or IRIS.
        IRIS is one of the most important programs that EPA uses to
    assess the safety of chemicals. But in recent years, IRIS
    frequently has been criticized for failing to meet high
    standards of scientific inquiry, transparency, and quality.
        I have outlined several examples of flawed IRIS assessments
    in my written testimony, but the recent peer review of
    formaldehyde is perhaps the most telling. After EPA's draft
    IRIS review of formaldehyde was scrutinized, EPA asked the
    independent experts at the National Academy of Sciences, NAS,
    to review its findings.
        The NAS review questioned the evidence IRIS used to support
    its conclusions that a link exists between the exposure to
    formaldehyde and certain types of leukemia, stating,
    ``Conclusions appear to be based on a subjective view of the
    overall data, and the absence of a causal framework for these
    cancers is particularly problematic given the inconsistencies
    in the epidemiologic data, the weak animal data, and the lack
    of mechanistic data.''
        The NAS report also devoted an entire chapter to needed
    program improvements. NAS summed it up by saying, ``The
    committee is concerned about the persistence of problems
    encountered with IRIS assessments over the years, especially
    given the multiple groups that have highlighted them. If the
    methodologic issues are not addressed, future assessments may
    still have the same general and avoidable problems that they
    highlighted in their report.''
        While IRIS is a complex program that examines complex
    issues, the problems can be boiled down to two things. First,
    IRIS does not reflect modern scientific methods or 21st century
    knowledge about how chemicals interact in the body at different
    levels of exposure. Rather, IRIS continues to rely too heavily
    on outdated assumptions that were formulated in the 1970s.
        Second, there is little independence in the program's peer
    review process. EPA controls each step of the review process
    and ultimately decides which recommendations from peer review
    groups to act upon and which to ignore.
        IRIS needs a comprehensive overhaul to ensure that
    assessments are based on proven scientific data and modern
    scientific understanding. The peer review process must be
    enhanced so there is an honest broker to ensure that IRIS
    assessments are reviewed independently and recommendations from
    peer reviews and public comments are adequately incorporated.
        While EPA announced some process changes earlier this week
    and we are pleased that EPA has done so and that they recognize
    the program must be reformed, we remain concerned about the
    lack of a truly independent peer review process. ACC continues
    to believe that NAS should review all pending IRIS assessments
    to ensure their quality until the systematic problems with the
    program are fixed. And I will stress that. Until we have the
    confidence that the systematic problems are fixed.
        If the improvements announced this week are effective, that
    will validate--be validated by NAS reviews. Anyone who looks at
    the evidence, whether you are a state regulator, a public
    health official, or a furniture maker can see that the IRIS
    Program is broken. Getting it right is in the interest of us
    all. The current deficiencies and the lack of confidence in the
    program cause delays and unnecessary costs. Flawed assessments
    create public confusion, unwarranted alarm, unnecessary product
    de-selection, and litigation, all of which can put jobs and
    innovation at risk without a sound scientific basis.
        By making needed changes to IRIS we can minimize delays and
    provide answers to the public, public health professionals, and
    industry in a far-more credible and timely way.
        Thank you very much for the opportunity to testify, and I
    look forward to taking your questions.
        [The prepared statement of Mr. Dooley follows:]
    Prepared Statement of The Honorable Calvin Dooley, President and Chief
                 Executive Officer, American Chemistry Council
        Mr. Chairman and Members of the Committee. I am Cal Dooley,
    president and CEO of the American Chemistry Council. I appreciate the
    opportunity to be here today to speak to the pressing need to fix the
    Environmental Protection Agency's (EPA) Integrated Risk Information
    System, or IRIS.
        Shortly after taking office, President Obama committed that science
    and the scientific process would guide decisions of his Administration.
    We at the American Chemistry Council (ACC) welcomed this pledge,
    because we agree that credible, accurate, modern science must form the
    foundation of regulatory decisions.
        Three years later, though, our confidence in the Administration's
    commitment to scientific integrity in the regulatory process has
    eroded. This is in large part due to troubling inconsistencies,
    inefficiencies and lack of transparency in the federal system for
    assessing the safety of chemicals.
        IRIS is one of the most important programs EPA uses to assess
    chemical safety. It serves as a leading source of health risk
    information for other federal, state, and international regulatory
    bodies. But over the years, the program has been repeatedly criticized
    for failing to consistently meet high standards of scientific inquiry,
    transparency and quality.
        It is time to fix the IRIS program to protect health, safety and
    the environment and preserve the ability of American industry to
    innovate, compete and create jobs.

    Several examples illustrate the shortcomings of the IRIS program:

    Formaldehyde

        Perhaps the most telling example can be found in the recent case of
    formaldehyde. Formaldehyde has been the subject of scientific study for
    years. Numerous organizations including the World Health Organization
    have concluded that a large body of evidence shows that the levels of
    formaldehyde most people encounter do not cause adverse health effects.
    Despite this, EPA completed its IRIS review of formaldehyde in 2010,
    asserting that a link exists between exposure to formaldehyde and
    certain types of leukemia. EPA's conclusions quickly came under
    scrutiny. To provide clarity, EPA asked the National Academies of
    Science (NAS) to convene an expert Committee to review its findings.
        The NAS Committee issued its report earlier this spring and in it,
    they questioned the evidence EPA used to support its conclusion. In the
    report NAS stated:

          ``Conclusions appear to be based on a subjective view of the
    overall data, and the absence of a causal framework for these cancers
    is particularly problematic given the inconsistencies in the
    epidemiologic data, the weak animal data and the lack of mechanistic
    data.''

        In the report, the NAS Committee also offered a harsh critique of
    the IRIS program in general. In fact, the expert committee felt so
    strongly that they included an entire chapter devoted to the program
    improvements that they saw as ``critical for the development of a
    scientifically sound IRIS assessment.'' The NAS report stated:

          ``The committee is concerned about the persistence of problems
    encountered with IRIS assessments over the years, especially given the
    multiple groups that have highlighted them. If the methodologic issues
    are not addressed, future assessments may still have the same general
    and avoidable problems that are highlighted here.''

    Hexavalent Chromium

        In 2009, industry undertook a multi-million dollar mode-of-action
    research program to develop new data that EPA could use to assess the
    risk that Cr6 poses from low-level, environmentally-relevant exposure
    through drinking water. The research was directly responsive to the
    data needs of the Agency, and EPA staff was consulted during the
    process of developing the research plan.
        Despite the pending research, due later this year, the agency
    significantly accelerated its timetable for the hexavalent chromium
    IRIS assessment, publishing a draft in late 2010. EPA's independent
    peer review group expressed significant concerns about the scientific
    quality of the draft assessment, citing knowledge gaps, including those
    that could be filled by the industry research. EPA still intends to
    finalize the IRIS assessment by the end of September, about the same
    time that the new research should be completed.
        With this intensive schedule, we are concerned that EPA will not
    fully incorporate the extensive comments from EPA's peer review group.
    Failure to address the peer review comments and include the new
    research findings will result in a risk assessment that will be out-
    dated and inaccurate as soon as it is released.

    Dioxin

        The IRIS program first published its draft assessment of dioxin in
    the mid nineteen-eighties, but it remains a point of contention today.
    Specifically, both EPA's own Science Advisory Board (SAB) and the NAS
    criticized the model that EPA used in the IRIS assessment to evaluate
    cancer risk.
        In 1995, the Scientific Advisory Board told the IRIS program that
    it was inappropriate to extrapolate using a linear low dose method to
    estimate cancer risk to humans. EPA revised the assessment, but failed
    to follow the SAB directive.
        In 2006, after reviewing EPA's 2003 reassessment of dioxin, the NAS
    concluded--unanimously--that a non-linear method (as opposed to a
    linear dose-response model) should be used to extrapolate for
    estimating cancer risk to humans.
        Despite the National Academy's 2006 recommendation, EPA's
    reanalysis of key issues in the dioxin assessment again used a linear
    dose-response model.
        Sixteen years after EPA was given a clear recommendation by the SAB
    peer review to use a model that reflects knowledge of mode of action in
    the dioxin IRIS assessment, IRIS continues to push an out-dated risk
    assessment model for dioxin. Based on the expert review in 1995 and
    2006, IRIS has no scientific justification for doing so.

    Inorganic Arsenic

        In a case similar to dioxin, EPA defaulted to a linear no-threshold
    model in its draft IRIS assessment of inorganic arsenic, disregarding
    the 2005 EPA peer review panel recommendation to consider a threshold
    model. This is critical because applying the proposed model would
    result in naturally occurring levels in many soil and water supplies
    around the country being considered ``unacceptable'' by EPA guidelines.
        If this draft IRIS assessment stands, it could lead to confusion,
    undue concern and unnecessary costly modifications to water treatment
    systems, the abandonment of water sources, and the forced
    identification of alternative water supplies. And it could create the
    impression that typical arsenic levels in foodstuffs such as rice,
    fish, grapes, and other common foods could be cancer-causing.

        These examples clearly demonstrate that IRIS has failed to evolve
    with the significant progress that has been made in the science and
    technology of chemical risk assessment.
        Over the years, researchers and health professionals have gained a
    greater scientific understanding of the human body; the ways chemicals
    can interact with the body at different levels of exposures; and how
    that knowledge applies to determine the safety of chemical uses.
    However, IRIS risk assessments lag behind these advances and rely too
    heavily on outdated assumptions formulated in the 1970s.
        For example, IRIS assessments of carcinogenic responses in high-
    dose animal studies typically take the most conservative default
    approach, rather than applying relevant mode of action and real world
    exposure information to more accurately show the risk to humans.
        In effect, IRIS has clung to risk assessment approaches that assume
    that there is no safe dose or threshold--even when experts tell the
    program otherwise--as was the case with dioxin and inorganic arsenic.
    IRIS's failure to integrate this information into program decisions
    undermines the development of new science-based risk assessment
    practices, wastes investments in research and undercuts effective
    public health science policy.
        Not only has IRIS failed to keep pace with modern science, the
    program lacks the scientific accountability needed to be considered
    objective and credible.
        There is little independence in the IRIS program's standard peer
    review process: the IRIS office controls the development of the
    assessment, the design of the peer review charge questions, and the
    evaluation of the peer review findings. Ultimately, the IRIS program
    itself decides which recommendations from peer review groups to act
    upon and which to ignore. As we have seen in the case of dioxin, the
    IRIS office has exhibited steadfast reluctance to upgrade the
    assessments in response to the demands of independent peer reviewers.
        To restore credibility to the program, there must be an honest
    broker to ensure that EPA adequately considers and incorporates changes
    from peer reviews and public comments. That is why ACC has called for
    the NAS to review all pending IRIS assessments. Unfortunately, EPA
    dismissed this suggestion saying, ``IRIS is a model for openness,
    transparency, scientific integrity and scientific quality.''
        Anyone who looks at the evidence, whether you are a state
    regulator, a public health official or a furniture maker, can see that
    the IRIS program is broken and fails to effectively support EPA's
    mission to protect public health and the environment.

        EPA's refusal to fully acknowledge and rectify the many problems
    with the IRIS program calls for Congress to step in.
        EPA must be required to take immediate steps that will ensure
    pending IRIS assessments meet the highest standards of accuracy and
    scientific integrity:

          IRIS assessments in progress should incorporate the
    recommendations described in Chapter 7 of the NAS panel formaldehyde
    scientific peer review report where they are applicable;

          IRIS assessments that are currently in draft form (or
    that will be issued as draft for public comment and peer review in 2011
    and 2012) should be submitted to the NAS for independent scientific
    peer review; and,

          Revised IRIS assessments developed by the Agency must be
    evaluated (preferably by the same NAS panel that conducted the initial
    peer review) to ensure that the peer review panel's findings and
    recommendations have been adequately and transparently addressed.

        While NAS review of pending assessments will help improve the
    program in the interim, EPA must also initiate a comprehensive overhaul
    of the program to make IRIS effective and efficient in the future:

          Assessments must rely on proven scientific data instead
    of outdated assumptions;

          EPA must establish consistent data evaluation methods;

          EPA must adopt a consistent weight of evidence framework,
    based on transparent, rigorous evaluation methods, so that all
    available data can be taken into account, with the best and most
    relevant science given the greatest weight;

          Assessments should be based on 21st century knowledge of
    how chemicals interact with the human body;

          EPA must adopt proven approaches for evaluating cause,
    effect and uncertainty as part of IRIS assessments; and,

          EPA must enhance public comment and independent
    scientific peer review processes.

        The IRIS program is a critical part of our chemical regulatory
    system, and it must be improved. The current deficiencies and lack of
    confidence in the program are resulting in delays and unnecessary costs
    as the frequent shortcomings in draft assessments are addressed. Flawed
    assessments have significant consequences in and of themselves. They
    create public confusion, unwarranted alarm, unnecessary product de-
    selection and litigation, all of which ultimately can put jobs at risk
    without sound scientific basis.
        To be clear, ACC is not suggesting that IRIS assessments be
    suspended or delayed. We are proposing concrete ways to make pending
    and future reviews more accurate and more credible. Making the
    necessary changes will ensure that the program completes assessments
    more efficiently and provides answers to the public, public health
    professionals and industry in a far more timely way. Thank you very
    much for the opportunity to testify. I look forward to taking your
    questions.

        Chairman Broun. Thank you, Congressman.
        Now I now recognize our next witness, Ms. Steinzor. You are
    recognized for five minutes.

                      TESTIMONY OF RENA STEINZOR,

                PROFESSOR, UNIVERSITY OF MARYLAND SCHOOL

          OF LAW AND PRESIDENT, CENTER FOR PROGRESSIVE REFORM

        Ms. Steinzor. I appreciate the opportunity to testify on
    one of EPA's most important and foundational programs. These
    days the more important a public health program, the more
    likely it is to be the subject of relentless, intemperate, and
    unjustified attacks. IRIS is no exception. The program is a
    serious, well-informed, and carefully-conducted scientific
    effort to synthesize existing research in order to set
    reference doses for the worst toxic chemicals. But industry
    lobbyists have mischaracterized it as an anti-scientific effort
    to demonize such ostensibly benign substances as arsenic,
    formaldehyde, and dioxin. Arsenic, formaldehyde, dioxin.
    Really?
        Without IRIS EPA would be hard pressed to develop standards
    for the control of emissions of toxic chemicals that cause
    brain damage, cardiovascular illness, reproductive dysfunction,
    cancer, and a range of other diseases. Delaying IRIS profiles
    has and will endanger public health, an intolerable outcome
    that this committee must not allow to happen.
        The simple fact is that everyone attending this hearing
    would be hard pressed to come up with more than a handful of
    toxic chemicals that were exonerated by additional research.
    The overwhelmingly powerful historical trend moves in the
    opposite direction. As the research accumulates, chemicals
    prove to be more toxic than we first imagined, often by several
    orders of magnitude.
        From the American public's perspective the central and
    urgent problem with IRIS is not that it rushes to judgment on
    toxic chemicals. Far from it. The problem is that repeated
    rounds of redundant peer review and interagency comment allow,
    in fact, invite chemical manufacturers to slow the program to a
    crawl. Because of these delays IRIS is woefully incomplete.
        Profiles are missing for at least 255 high-priority
    chemicals. The 2008 GAO report warned that the Bush
    Administration's approach to IRIS left the database at risk of
    becoming obsolete. To its credit, the Obama Administration
    reviewed IRIS in an effort to speed the production of
    assessments. Although these changes are a definite improvement,
    the rate of production is still slow enough that EPA will not
    catch up with its existing backlog for another 55 years.
        Chemical manufacturers and their allies, most notably
    federal agencies like the Department of Defense and NASA, have
    targeted IRIS as a chokepoint for regulation. Anyone who has
    followed the IRIS Program closely for many years cannot help
    but find their recent denunciations of the program disingenuous
    and surreal. They have been in the thick of the action since
    IRIS began, making their case to IRIS staff, more senior EPA
    officials, sympathetic federal agencies and departments, and
    the White House Office of Information and Regulatory Affairs.
    In fact, the reason why IRIS profiles have ballooned into
    unmanageable length is the reaction of EPA staff to constant
    harassment by industry participants.
        The remedies proposed by the chemical industry will make
    these problems worse, not better. One of the most intemperate
    proposals is that OIRA increase its oversight of the program.
    OIRA is staffed almost exclusively by economists who have no
    better idea of what constitutes a good RfD than any other
    layperson.
        A second demand is that the NRDC be brought in to review--
    NRD be brought in to review all IRIS assessments. The academic
    scientists who serve on NRC review committees receive
    compensation that does not nearly pay for their time. Instead,
    they are motivated by a commitment to public service and the
    prestige of serving on a panel to consider cutting-edge
    scientific issues. Using NRC to run around double-checking
    routine government work would disrupt this delicate balance,
    damaging the National Academies as well as EPA.
        The final example of overreaction is the rider proposed for
    EPA's appropriations bill that would bar EPA from moving
    forward with future assessments until all existing assessments
    had been revised to conform to the NRC's advice about the
    formaldehyde assessment. This proposal would paralyze the IRIS
    Program for the foreseeable future by forcing its staff to
    engage in a massive round of paper shuffling.
        The chemicals we are talking about here are the worst of
    the worst, produced in amounts of millions of pounds annually.
    The victims of further IRIS delays are neither the companies
    that makes these chemicals, nor the scientists engaged in the
    endless research, but rather Americans and their health.
        Thank you.
        [The prepared statement of Ms. Steinzor follows:]
       Prepared Statement of Ms. Rena Steinzor, Professor, University of
      Maryland School of Law, and President, Center for Progressive Reform
        Mr. Chairman, Ranking Member Edwards, and Members of the
    Subcommittee, I appreciate the opportunity to testify before you today
    on one of the Environmental Protection Agency's (EPA) most important
    and foundational programs, the Integrated Risk Information System
    (IRIS). Let me get straight to the point. These days, the more
    important a public health program, the more likely it is to be the
    subject of relentless, intemperate, and unjustified attacks. IRIS is no
    exception. What is in fact a sober, well-informed, and carefully
    conducted scientific effort to synthesize existing research in order to
    set reference doses for the most toxic chemicals is portrayed by
    industry lobbyists as an anti-scientific effort to ``demonize'' such
    ostensibly benign substances as arsenic, formaldehyde, and dioxin. This
    deliberate misreading of the science by industry lobbyists is intended
    to prolong Americans' exposure to dangerous substances in the service
    of corporate profit, while at the same time immobilizing the federal
    agency best qualified to protect public health, the EPA.
        The truth is that everyone attending this hearing would be hard-
    pressed to come up with more than a dozen examples of toxic chemicals
    that have been found to be significantly less harmful than we
    originally thought when additional research was done. The powerful
    historic trend moves strongly in the opposite direction: as the
    research has accumulated, chemicals like dioxin, arsenic, formaldehyde,
    cadmium, mercury, and lead prove to be more toxic than we first
    imagined. Endless efforts to deconstruct individual studies should not
    obscure this trend, as the chemical industry was well aware until the
    current backlash against regulation offered it new opportunities to
    defeat safeguards that protect public health by distorting EPA's track
    record.
        IRIS started as an internal EPA database used to develop
    toxicological profiles for common chemicals. These profiles set the
    reference dose, or RfD, for a given chemical on the basis of existing
    scientific literature. An RfD is the amount below which human exposure
    is deemed unlikely to cause adverse health effects. Over time, IRIS has
    become an invaluable resource: It receives some 2,000 internet visits a
    day, testament to its importance as among the best, most comprehensive
    databases for this kind of baseline information. And, although IRIS
    itself most definitely is not a regulatory program, it provides a
    strong scientific foundation for much of the rest of the agency's work.
    Without the scientific determinations IRIS contains, EPA would be hard-
    pressed to develop standards for the control of emissions of toxic
    chemicals that cause brain damage, cardiovascular illness, reproductive
    dysfunction, cancer, and a range of other diseases. Delaying the
    production of IRIS profiles costs lives and endangers public health, an
    intolerable outcome that this Committee must not allow to happen.

    My testimony today makes four points about the future of the IRIS
    program:

          From the American public's perspective, the central and
    urgent problem with IRIS is not that it rushes to judgment on toxic
    chemicals. Far from it. The problem is that repeated rounds of
    redundant ``peer review'' and interagency comment allow--in fact,
    invite -chemical manufacturers, the Department of Defense, and other
    self-interested parties to slow the program to a crawl. Because these
    delays help to ensure that dangerous chemicals are left in commerce for
    years longer than necessary, people suffer avoidable diseases and
    irrevocable neurological and reproductive damage. The Government
    Accountability Office (GAO) has repeatedly warned Congress about the
    negative implications of these delays. See, e.g., GAO-08-6743T, EPA's
    New Assessment Process Will Increase Challenges EPA Faces in Evaluating
    and Regulating Chemicals (April 29, 2008) and GAO-09-271, HIGH-RISK
    SERIES, An Update (January 2009). GAO has placed the EPA chemicals
    program in the ``high risk'' category reserved for a small number of
    the most troubled programs in government. It made this important
    decision in part because IRIS updates are so slow that the data base
    risks becoming obsolete. It did not make any reference to the distorted
    critique of EPA science that the chemical industry has developed.

          Given that IRIS is constantly struggling to avoid capture
    by the chemical industry and, if anything, gives manufacturers far too
    many opportunities to befuddle final assessments, the chemical
    industry's sudden discovery of its flaws is as opportunistic as it is
    incredible.

          The National Research Council's (NRC) report on
    formaldehyde does not justify the radical changes sought by the
    industry. In fact, the NRC explicitly endorsed the program's
    continuation and improvement. Its critique of the formaldehyde
    assessment constitutes robust peer review, not an outright condemnation
    of the program and EPA science as industry witnesses would have you
    believe. I wish that the NRC committee had not adopted such a haughty
    tone in scolding EPA staff. But that tone was the product of political
    naivet regarding how its report would be exploited in the existing
    political climate. It cannot fairly be characterized as a
    recommendation that IRIS stop-or even slow-its critical work.

          The remedies sought by the American Chemistry Council
    (ACC) are designed to run IRIS off the road, further undermining EPA's
    mission to protect public health. I urge the Committee to side with the
    public, not the manufacturers of toxic chemicals long overdue for
    assessment and control.

        I am a law professor at the University of Maryland School of Law
    and the President of the Center for Progressive Reform (CPR) (http://
    www.progressivereform.org/). Founded in 2002, CPR is a 501(c)(3)
    nonprofit research and educational organization comprising a network of
    sixty scholars across the nation who are dedicated to protecting
    health, safety, and the environment through analysis and commentary. I
    joined academia mid-career, after seven years as an attorney at the
    Federal Trade Commission, five years as staff counsel to the House
    Energy and Commerce Committee, and seven years representing small and
    mid-sized electric utilities. My work on environmental regulation
    includes four books, and over twenty-seven articles (as author or co-
    author). My most recent book, published by the University of Chicago
    Press, is The People's Agents and the Battle to Protect the American
    Public: Special Interests, Government, and Threats to Health, Safety,
    and the Environment, which I co-authored with Professor Sidney Shapiro
    of Wake Forest University's School of Law, analyzes the state of the
    regulatory system that protects public health, worker and consumer
    safety, and natural resources, concluding that these agencies are
    under-funded, lack adequate legal authority, and are undermined by
    political pressure motivated by special interests. I have served as a
    consultant to EPA and have testified previously before Congress on
    regulatory subjects on numerous occasions.

    Saving IRIS

        Since 2005, Member Scholars at the Center for Progressive Reform
    (CPR) have researched and written five white papers regarding IRIS and
    the need to streamline the process for developing toxicological
    profiles and several letters to decision makers concerned about the
    program's future. They are available here: http://
    www.progressivereform.org/IRIS.cfm, and I have attached the two most
    recent reports, Corrective Lenses for IRIS and Setting Priorities for
    IRIS to this testimony. Our key findings include:

        1.  IRIS is woefully incomplete. EPA is many years behind in
    completing profiles of at least 255 chemicals. Some 109 chemical
    profiles that EPA was required by the Clean Air Act Amendments of 1990
    to have completed by 2008 are either included in IRIS but missing
    critical elements, or entirely absent from the database. A similarly
    sad situation afflicts the agency's efforts to carry out the statutory
    mandates of the Safe Drinking Water Act. Every five years, EPA
    generates a new Contaminant Candidate List (CCL). The lists contain
    recommendations both for chemicals and microbiological contaminants.
    Since 1996, EPA has published three CCLs that contain 156 distinct
    chemical substances. IRIS profiles are missing for 64 (41 percent) of
    these substances.

        2.  So severe are the delays in the IRIS process that a 2008 GAO
    report warned that the Bush Administration's approach to IRIS, which
    resulted in just two completed profiles per year, left the database at
    risk of becoming obsolete. (The report is available at http://
    www.gao.gov/new.items/d08743t.pdf.) To its credit, the Obama
    Administration revised the IRIS process in an effort to speed the
    production of assessments, and has managed to increase the number of
    completed profiles to nine annually. But although this performance is a
    definite improvement, the rate of production is still slow enough that,
    if nothing else is done to improve the pace of IRIS, EPA will not catch
    up with its existing backlog for another 55 years.

        3.  One area of particular concern is that the Obama
    Administration's new IRIS process left in place many of the roadblocks
    GAO had previously identified, including interagency review of
    individual assessments, multiple reviews by outside science panels, and
    prioritization of a few high-profile assessments at the expense of
    faster assessments. Potentially regulated parties, including other
    federal agencies like the Department of Defense and National
    Aeronautics and Space Administration, have targeted IRIS as a choke
    point for regulation. The labyrinthine process they have demanded,
    diagrammed on page 9 of the Corrective Lenses report, contains multiple
    rounds of peer review, public comment, and interagency review that are
    as redundant as they are time-consuming. In effect, the program suffers
    from the problem of ``information capture''-a phenomenon where
    potentially regulated industries and their federal agency clients
    submit so much irrelevant data to EPA, and do so with such frequency,
    that new assessments become mired in never-ending controversy.

        4.  To close data gaps and reestablish IRIS's credibility as a
    cutting-edge database, EPA needs to make four changes. First, EPA
    should reduce the procedural burdens that were formalized during the
    Bush administration. Second, EPA must articulate clear, statute-driven
    priorities about which assessments to complete to ensure that data gaps
    in statutory mandates would be more quickly addressed. Third, the IRIS
    process must be restructured to allow for timely assessments to be
    written on the basis of the weight of available evidence at the time an
    assessment is undertaken. Fourth, EPA must have adequate resources-and
    use those resources efficiently--to complete a much larger number of
    assessments.

        One additional point is worth making. The chemicals we are talking
    about here are the worst of the worst, produced in amounts of millions
    of pounds annually. As just one example, chromium compounds, which are
    categorized in the worst ten percent of all toxic chemicals and are
    among the hazardous air pollutants missing from IRIS, are emitted in
    amounts exceeding 58 million pounds annually. Unsafe exposure to
    chromium compounds causes cancer, suppresses immune systems, and harms
    kidney and respiratory functions. Over the last several years, industry
    has sponsored several studies of chromium. When a study documents
    adverse effects at common levels of exposure, the sponsors commission a
    second study designed to rip apart the first. Unfortunately, the
    victims of this endless treadmill are neither the sponsors, nor the
    scientists engaged in chasing each other's tails, but rather the
    public's health.

    Industry Influence over IRIS

        Anyone who has observed IRIS for many years cannot help but find
    the chemical industry's recent denunciations of the program
    disingenuous, even surreal. Far from being helpless bystanders in the
    process, industry Members have been in the thick of the action since
    the database was initiated, submitting the research they think most
    important and repeatedly advocating their view of the research to IRIS
    staff, more senior EPA officials, sympathetic federal agencies and
    departments, and the White House Office of Information and Regulatory
    Affairs (OIRA). To whatever extent that IRIS science is flawed, the
    people complaining about those flaws are full partners in its
    development. In fact, one reason why IRIS profiles have ballooned into
    unmanageable length is the reaction of EPA staff to constant harassment
    by industry participants.

    The Formaldehyde Review

        The NRC conducted a robust peer review of the draft IRIS
    formaldehyde assessment. The report is written in the detailed language
    of one group of scientists giving another group of scientists an
    unvarnished assessment of how a scientific finding could be revised and
    bolstered. Its work will undoubtedly improve the IRIS process, and EPA
    is already taking its recommendations to heart.
        Unfortunately, the NRC reviewers also succumbed to the fatal
    attraction of reiterating their professional superiority, using tough,
    even haughty language to critique EPA's work, and exhibiting a
    remarkable level of insensitivity to how their comments would be
    interpreted in the over-heated political atmosphere that afflicts the
    nation's Capitol these days. Clearly, the NRC committee was trying to
    help IRIS staff to do better, not to immobilize the program. Consider
    the following direct quotes from the NRC report:

          The draft IRIS assessment correctly concludes that formaldehyde
    is a genotoxic (DNA-reactive) chemical that causes cytogenetic effects,
    such as mutations. (emphasis added) (p. 4)

          The committee recognizes that revision of the approach will
    involve an extensive effort by EPA staff and others, and it is not
    recommending that EPA delay the revision of the formaldehyde assessment
    to implement a new approach. However, models for conducting IRIS
    assessments more effectively and efficiently are available, and the
    committee provides several examples in the present report. Thus, EPA
    might be able to make changes in its process relatively quickly by
    selecting and adapting existing approaches. (emphasis added) (p. 11)

        As a person who teaches for a living, I would urge future NRC
    panels to keep in mind how much self-important scolding can interfere
    with a student's learning process-we all know that truth in our
    academic lives but may forget it when we enter the policymaking world.
    Regardless, Congress would make a grave error if, at the behest of
    self-interested chemical manufacturers, it ignored the stated goals of
    the NRC's review.

    Excessive Remedies

        The remedies proposed by the chemical industry representatives here
    today confuse and distort the core purposes of IRIS. For example, one
    of the most intemperate proposals advanced by the American Chemistry
    Council is that the OIRA increase its oversight of the program. OIRA is
    the division within the White House that checks agency cost-benefit
    analyses. It is staffed almost exclusively by economists who have no
    better idea of what constitutes a good RfD than any other lay person.
    Two scientists work at OIRA, in comparison to the dozens of well-
    qualified scientists representing multiple disciplines who work at EPA.
    The recommendation that OIRA be put in charge of IRIS is not designed
    to improve the program's scientific validity, but rather is intended to
    give chemical manufacturers a sympathetic forum where they can tie IRIS
    in knots more easily.
        A second industry demand voiced by ACC is that NRC be brought in to
    review all IRIS assessments. NRC is the gold standard for peer review
    and, as I mentioned earlier, its critiques are always interesting. On
    the other hand, the academic scientists who serve on NRC review
    committees receive compensation that does not nearly pay for their
    time. Instead, they are motivated by a commitment to public service,
    the pleasure of engaging with bright and sophisticated colleagues, and
    the prestige of serving by invitation on a panel convened by the finest
    scientific institution in the nation. Using NRC to run around double-
    checking government work would corrode this delicate balance,
    ultimately rendering it unworkable. Not incidentally, it would also add
    unreasonable delay to an already dangerously slow process. I hope that
    the NRC recognizes the insidious implications of this recommendation
    and strongly opposes it.
        The invocation of NRC, and the National Academies as a whole, has
    become a common practice for potentially regulated parties who hope to
    slow down EPA decision making. The little-recognized hypocrisy of this
    practice is that when NRC ratifies EPA's judgments without
    qualification, aggrieved industry participants simply ignore its
    findings and proceed with their campaign against the agency. So, for
    example, NRC issued a report on mercury that was fully supportive of
    the RfD that EPA had set for the substance. (The NRC report is
    available at http://www.nap.edu/openbook.php?isbn=0309071402.) The
    electric utilities fighting EPA's regulatory efforts simply ignored the
    NRC report as if it had never been completed, continuing their attacks
    on the research underlying the agency's decision. Far from serving as
    an umpire in heated disputes, NRC was exploited as a tool to delay
    final action and then promptly cast aside.
        The final, penultimate example of overreaction that will endanger
    public health is the rider now pending in the House Appropriations
    Committee. It would bar EPA from moving forward with future assessments
    until all existing assessments had been revised to conform to the NRC's
    advice about the formaldehyde assessment. This proposal would paralyze
    the IRIS program for the foreseeable future by forcing its staff to
    engage in a massive round of paper shuffling.
        In a surprisingly successful effort to obscure the real motivations
    behind these radical suggestions, regulated industries have portrayed
    them as essential to job creation, and therefore of direct benefit to
    the average American. Fundamental to this set of claims is the notion
    that regulatory excesses in these times of economic recession have hit
    industry so hard that its Members cannot afford to expand their
    businesses and put people back to work. But some quick research on the
    percentage increase in profits from 2009 to 2010 for some of the ACC's
    largest Members yielded surprising results.

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Rules to protect public health and the environment most definitely
    do not have the effect of sweeping money into a pile and setting it on
    fire. Rather, they save the lives of millions of people, prevent many
    more millions from getting sick or becoming sicker, and preserve the
    irreplaceable natural resources without which human life would be
    impossible.
        For example, Clean Air Act regulations are uniformly recognized as
    a wonderful economic bargain by honest experts from all points on the
    political spectrum. According to EPA's very conservative numbers, which
    dramatically understate benefits and overstate costs, clean air rules
    saved 164,300 adult lives in 2010, and will save 237,000 lives annually
    by 2020. EPA estimates that the economic value of Clean Air Act
    regulatory controls will be $2 trillion annually by 2020; costs of
    compliance in that year will be $65 billion. Air pollution controls
    saved 13 million days of work loss and 3.2 million days of school loss
    in 2010. By 2020, they will save 17 million work loss days and 5.4
    million school loss days. I emphasize that EPA's cost estimates are
    based on extraordinarily conservative assumptions regarding regulatory
    benefits. For example, EPA says that a non-fatal heart attack in a
    person 0-24 years old is worth only $84,000 and that an emergency room
    visit to treat an asthma attack is worth only $363 per incident-
    hospitals don't give you a plastic ID bracelet for that little.
        And according to OIRA, which houses the staff of economists so
    embraced by ACC, ``the estimated annual benefits of major federal
    regulations are in the aggregate between $132 billion and $655 billion,
    while the estimated annual costs are in the aggregate between $44
    billion and $62 billion.'' (See http://www.whitehouse.gov/sites/
    default/files/omb/inforeg/2011--cb/2011--cba--report.pdf.)
        Thank you, Mr. Chairman and Ranking Member Edwards. I would be
    happy to answer any questions you may have.

    Attachments:
    1.  CPR Report, Corrective Lenses for IRIS
    2.  CPR Report, Setting Priorities for IRIS

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Chairman Broun. Thank you, Ms. Steinzor.
        I now recognize our next witness, Dr. Charnley, for five
    minutes. Dr. Charnley.

      TESTIMONY OF GAIL CHARNLEY, PRINCIPAL, HEALTHRISK STRATEGIES

        Dr. Charnley. Thank you, and good morning. I am a
    toxicologist, a human health risk analyst, and a toxicology
    consultant who has relied for many years on the information
    contained in the IRIS database for my work. I am speaking on
    the basis of my 30-year career as a scientist evaluating the
    relationship between chemical exposures and human health
    effects, and I am not representing any organization today.
        The role and purpose of IRIS are good and well-intentioned,
    but over the years IRIS has lost its way, straying from science
    and veering towards advocacy. As a result it no longer has much
    scientific credibility outside the agency or, importantly,
    within the agency itself.
        IRIS started out as a good idea, an advisory group of
    scientists that assessed chemical toxicity for the rest of EPA.
    The reach of IRIS goes way beyond EPA, however, as other
    federal agencies, state and local governments, both within the
    United States and in other countries, lacking their own
    resources to generate toxicity values, chemical toxicity
    values, have come to rely on those generated by IRIS. Because
    the influence of IRIS is so broad, the scientific quality and
    integrity of its reviews are critically important.
        The problem is that IRIS toxicity evaluations do not follow
    a rigorous, objective, transparent, scientific weight of
    evidence process, instead, relying on what--in the absence of
    such a process--appears to be cherry-picking data in support of
    policy preferences as needed.
        A true weight of evidence analysis should explicitly
    present the criteria for inclusion and exclusion of studies so
    that all relevant information is included and so that biases
    towards the inclusion of certain outcomes are avoided.
        IRIS assessments fail to use a weight of evidence process
    despite the explicit direction to do so provided by EPA's own
    risk assessment guidance and repeatedly by various National
    Academy of Sciences committees. My written statement details
    some of the large body of EPA documentation stating that it is
    EPA policy to perform balanced weight of evidence analysis as
    part of chemical risk assessment, a policy that is clearly
    being ignored by IRIS.
        I think the solution is not to try once more to tweak or
    revamp the existing process but to start over. Public health is
    not served by a broken, cumbersome, controversial process that
    lacks a rigorous scientific foundation and a transparent,
    replicable weight of evidence framework. Setting up a more
    effective process should follow the recommendations of a
    National Academy of Sciences committee convened for that
    purpose and should follow a weight of evidence procedure
    recommended by the Academy.
        Chapter seven of the Academy's formaldehyde report provides
    helpful but general guidance toward that end, and, no, I am not
    advocating that NAS review all IRIS reviews.
        EPA's recently proposed IRIS redesign relies on EPA's
    Science Advisory Board for, ``independent review and
    oversight,'' instead of the Academy. However, the SAB is not
    independent. EPA officials select SAB Members, formulate charge
    questions, provide staff support for the review process, and
    oversee SAB deliberations and report drafting.
        In contrast, the NAS process for selecting scientific panel
    Members and conducting reviews assures independence and
    objectivity along with appropriate expertise for which they are
    not compensated in any way.
        Truly independent peer review is the only way to give
    stakeholders confidence in the credibility of the outcome.
    Stakeholders are likely to accept the outcome of an independent
    Academy committee and unlikely to accept the outcome of an EPA-
    administered committee.
        In conclusion, the IRIS process is dysfunctional and
    attempts to tweak it have not resulted in meaningful
    improvements. Changes proposed this week are promising, but I
    believe that implementing those changes and implementing an
    improved, scientifically-based, transparent IRIS process would
    benefit greatly from National Academy of Science's guidance.
    The NAS is in a unique position to provide unbiased, credible,
    expert advise that, sadly, is so critically needed at this
    point if we are to move IRIS into a 21st century approach to
    assessing chemical toxicity effectively.
        Thank you.
        [The prepared statement of Ms. Charnley follows:]
        Prepared Statement of Dr. Gail Charnley, Principal, HealthRisk
                                   Strategies
        Good morning. I am speaking today as a toxicologist with a Ph.D.
    from MIT, as a human health risk analyst, and as a toxicology
    consultant to private clients who has relied for many years on the
    information contained in the IRIS database for my work. I am speaking
    on the basis of my 30-year career studying the relationship between
    chemical exposures and human health effects, as executive director of
    the bipartisan Presidential/Congressional Commission on Risk Assessment
    and Risk Management, as a member of the National Toxicology Program's
    Report on Carcinogens Committee, as a former senior program officer in
    the National Academy of Sciences' Toxicology and Risk Program, as a
    member of National Academy of Sciences committees, and as a member of
    the National Academy of Sciences Board on Environmental Studies and
    Toxicology. I am not representing any organization today, however, or
    being paid for my testimony.
        The role and purpose of IRIS are good and well-intentioned, but
    over the years IRIS has lost its way. IRIS started out as a good idea-a
    scientific advisory group that assesses chemical toxicity for the rest
    of EPA so as to avoid every office having to do it themselves and
    generating potentially conflicting toxicity values. The reach of IRIS
    goes far beyond EPA, however, as other federal agencies and state and
    local governments in the U.S. and other countries lacking their own
    resources for generating chemical toxicity values have come to rely on
    those generated by IRIS. IRIS assessment can thus become a de facto
    component of regulatory decision-making without benefit of appropriate
    administrative process. Because the influence of IRIS is so broad, the
    scientific quality and integrity of its reviews are critically
    important.
        Unfortunately, over time the IRIS process has become politicized
    and, as a result, it no longer has much scientific credibility outside
    the agency or, importantly, even within the agency. The process has
    strayed from science and veered towards advocacy. As you have heard
    from other speakers this morning, IRIS toxicity evaluations do not
    follow a rigorous, objective, transparent, scientific weight-of-
    evidence process, instead relying on cherry-picking data as needed to
    support policy preferences. Indeed, many of IRIS' recent conclusions
    appear to be based on what my colleagues and I refer to as ``magical
    modes of action'', that is, highly speculative biological explanations
    for toxicity.
        IRIS assessments fail to evaluate potential human cancer and
    noncancer effects of chemical exposures using a weight-of-evidence
    analysis despite the direction to do so provided by EPA's own risk
    assessment guidance documents and, repeatedly, by various National
    Academy of Sciences committees. For example, EPA's Information Quality
    Guidelines state that when EPA develops ``influential'' scientific risk
    assessments, it intends to use all relevant information and reach a
    position based on careful consideration of all such information, a
    process typically referred to as the ``weight-of-evidence'' approach.
    \2\ EPA's Assessment Factors Handbook \3\ states that a weight-of-
    evidence approach generally considers all relevant information in an
    integrative assessment and explains how the various types of evidence
    fit together. EPA's Risk Assessment Principles & Practices
    documentation asserts that risk assessment involves consideration of
    the weight of evidence provided by all available scientific data. \4\
    My point is that there is a large body of EPA documentation stating
    that it is EPA policy to perform balanced weight-of-evidence analysis
    as part of chemical risk assessment that is clearly being ignored-a
    glaring omission in light of EPA's own guidelines, policies, and NAS
    recommendations.
    ---------------------------------------------------------------------------
        \1\ EPA (2002) Guidelines for Ensuring and Maximizing the Quality,
    Objectivity, Utility, and Integrity of Information Disseminated by the
    Environmental Protection Agency. EPA/260R-02-008. Office of
    Environmental Information, Washington, DC
        \3\ EPA (2003) A Summary of General Assessment Factors for
    Evaluating the Quality of Scientific and Technical Information. EPA
    100/B-03/001. Science Policy Council, Washington, DC
        \4\ EPA (2004) Risk Assessment Principles and Practices. EPA/100/B-
    04/001. Office of the Science Advisor, Washington, DC
    ---------------------------------------------------------------------------
        A weight-of-evidence analysis for any potential health effects,
    whether cancer or noncancer, should be more than a matter of describing
    a set of available studies with an array of results and then announcing
    one's overall subjective judgment. Because judgments made about
    potential risk will usually not be definitive, it is important to
    present the strengths and weaknesses of alternative judgments that
    could be made, giving the reader a picture of how strongly one or
    another interpretation is supported vis- . . . -vis alternative
    possible explanations. Instead, IRIS assessments preclude a weight-of-
    evidence analysis by selecting almost solely for studies that
    demonstrate a positive result and a dose-response relationship,
    typically excluding studies that demonstrate no effect and thereby
    effectively preventing a balanced consideration of available evidence
    supporting or refuting the biological plausibility and likelihood of
    effects.
        A true weight-of-evidence analysis should explicitly present the
    criteria for inclusion and exclusion of studies so that all relevant
    information is included and so that biases toward inclusion of certain
    outcomes-such as only positive outcomes-are avoided. The goal should be
    to interpret possible reasons for disagreement, not to select the
    ``best'' study and rely on it even if it is contradicted by other study
    results. Omitting endpoints or studies that do not show a dose-response
    relationship in the direction EPA favors discounts valuable
    information, particularly information that could inform mode of action
    as well as dose-response.
        I think the solution is not to try once more to tweak or revamp the
    existing process but to get rid of it entirely and start over. Public
    health is not served by a broken, cumbersome, controversial process
    that lacks a rigorous scientific foundation and a transparent,
    replicable weight-of-evidence framework. Setting up a more effective
    process should follow the recommendations of a National Academy of
    Sciences committee convened for that purpose and should follow a
    weight-of-evidence procedure recommended by the Academy. Chapter 7 of
    the Academy's formaldehyde report provides helpful guidance to that
    end. \5\
    ---------------------------------------------------------------------------
        \5\ National Academy of Sciences/National Research Council. 2011.
    Review of the Environmental Protection Agency's Draft IRIS Assessment
    of Formaldehyde. National Academy Press. Washington, DC
    ---------------------------------------------------------------------------
        Some have proposed that IRIS rely on EPA's Science Advisory Board
    for independent external review and oversight instead of the Academy.
    However, the SAB review process is not independent. EPA officials
    select SAB Members, formulate the charge questions, provide staff
    support for the review process, and observe SAB deliberations and
    report drafting. According to the SAB web site, ``The Staff Office
    manages EPA requests for scientific and technical advice and peer
    review. The Staff Office also provides policy, technical and
    administrative assistance to advisory committees in conducting meetings
    and preparing reports. The SAB Staff Office oversees the formation of
    advisory committees and panels . . .'' and so forth. In contrast, the
    NAS process for selecting scientific panel Members and conducting
    reviews assures independence and objectivity along with appropriate
    expertise. Truly independent peer review is the only way to give
    stakeholders confidence in the credibility of the outcome. Stakeholders
    are likely to accept the outcome of an independent Academy peer review
    and unlikely to accept the outcome of an EPA-administered peer review.
    Then there's the problem of delay. Most of the recent controversial
    IRIS assessments reviewed by the NAS had already been reviewed by the
    SAB, but ended up at the Academy anyway.
        In conclusion, the IRIS process is dysfunctional and attempts to
    tweak it have not resulted in meaningful improvements. Developing an
    improved, scientifically based, transparent IRIS process would benefit
    greatly from National Academy of Sciences guidance. The NAS is in a
    unique position to provide unbiased, expert advice that, sadly, is so
    critically needed at this point if we are to move IRIS to a 21st
    century approach to assessing chemical toxicity effectively.

        Chairman Broun. Exactly five minutes. Exactly.
        Mayor Bollwage, you are now recognized for five minutes.

     TESTIMONY OF J. CHRISTIAN BOLLWAGE, MAYOR, CITY OF ELIZABETH,
                               NEW JERSEY

        Mr. Bollwage. Thank you very much, Mr. Chairman and Members
    of the committee. I just want to say upfront that I am a mayor.
    I am not a scientist, so I talk about trying to create jobs,
    economic development. We work with our city councils, our
    department managers. We make decisions on the ground every day,
    but risk management is one of those areas where local elected
    officials must make decisions, and we always like to have the
    best available tools.
        The IRIS System is a mix of scientific measure, expert
    guesswork, and surrounded by a high level of uncertainty with
    what might happen to humans if they are exposed to chemical
    substances. In the end from my position it is a tool, and we
    have learned through the experience of governing city that when
    you use a tool to guide decision making, you want to use the
    right tool, applied to the right problem, and use the tool in
    the right way. And the IRIS method has to yield the result that
    makes commonsense.
        I have worked closely with the Conference of Mayors for 15
    years in convincing the EPA and the Congress that not all
    contaminated sites in communities are the same. There are
    grossly contaminated sites called Superfund, but there are
    hundreds of thousands throughout our country less contaminated
    brownfield sites. I am very concerned with the public health in
    my community, and if that health threat can be dealt with and
    brownfield sites properly redeveloped, then it is a win-win for
    the community. Brownfield legislation has helped us remove that
    public health threat. We put these lands back to productive use
    creating jobs, urban redevelopment, new sources of revenues
    that are used to support public safety, public health, and
    maintain our physical infrastructure.
        One of the greatest impediments to this type of progress
    was the way that the EPA and the press have over-characterized
    the risk to the public. This attached an unpardonable stigma to
    any site whether the contamination was serious or negligible.
    Generally the risk has been overplayed, and it has become
    difficult from my position to educate the public about the
    difference between a brownfield site and a Superfund site.
        This was the case even after the EPA Administrator Browner
    released over 30,000 sites that were on the CERCLIS list, and
    these were not contaminated enough to warrant any further EPA
    action.
        I have a Superfund site in the City of Elizabeth. It is
    severely contaminated and way too costly to ever clean up. I
    also have brownfield sites. I am proud to report we developed
    many of those, IKEA Super Center, Jersey Gardens on a 166-acre
    former landfill. Has four hotels as well as 2 million square
    feet of retail space. They are thriving, and they have created
    hundreds of jobs, promoted redevelopment, and has been an
    enormous success for our community.
        I have submitted to the committee a report prepared by the
    Conference of Mayors that shows brownfield redevelopment in
    cities across the Nation have had the same positive impact
    because of local government's decisions.
        EPA's dioxin reassessment will converge with the IRIS
    System, and this combination will impact a wide range of policy
    decisions. The Conference of Mayors believes this tool as
    applied to brownfield sites could bring back the stigma of a
    Superfund site. And as a tool the IRIS System relies on
    toxicity values that are established with a very wide margin of
    error that is intended to allow for uncertainty.
        So when the IRIS System is used to inform risk management
    decisions, it must be noted that the compound effect of overly-
    conservative toxicity values with overly-conservative exposure
    scenarios can yield a very distorted characterization of risk.
        For example, when EPA proposed to lower the dioxin soil
    concentration for a contaminated site remediation, they
    proposed to lower the existing guideline from one point--one
    part per billion to 76 parts per trillion or even 3.7 parts per
    trillion.
        So not only is the exposure scenario unrealistic, but at
    3.7 parts per trillion of dioxin, the soil in every urban
    center in this country would pose an unacceptable risk because
    background levels are normally two to four times higher than
    that.
        So here is what troubles the mayors. People get 95 percent
    of dioxin from the foods they eat, not from a contaminated
    brownfield site. EPA continues to rely on a worst-case exposure
    scenario. So I have doubts about how this IRIS tool can be
    applied with any certainty.
        So I would like to make some following suggestions. The EPA
    can continue to improve the IRIS and the information based on
    toxicity and exposure assessment. The exposure assessment is
    something that should be evaluated by the National Academies of
    Science to determine if more realistic assumptions are
    appropriate.
        For example, it would be helpful to have actual
    measurements of a most-likely-case scenario in addition to a
    worst-case scenario.
        IRIS should be a tool to advise decisions, not mandate
    them. Mayors need the best tools available to help us make
    sound decisions. Our goals for our cities are to protect the
    public health and the environment while encouraging economic
    vitality.
        I want to thank you, Mr. Chairman, for this time, and thank
    Members of the committee as well.
        [The prepared statement of Mr. Bollwage follows:]
    Prepared Statement of The Honorable J. Christian Bollwage, Mayor, City
                            of Elizabeth, New Jersey
        My name is J. Christian Bollwage, and I am Mayor of the City of
    Elizabeth, New Jersey and Chair of the Conference of Mayors Brownfields
    Task Force for the past 15 years. I appreciate this opportunity to
    provide comments to the House Science Committee and I thank the
    Chairman for extending the invitation to participate in this panel.
        I am here representing The United States Conference of Mayors which
    is the non-partisan organization that represents cities with
    populations of 30,000 or more through their chief elected official, the
    Mayor. There are over 1,200 cities throughout the United States.
        I want to emphasize that I am a Mayor, not a scientist and
    therefore I am not accustomed to participating in scientific and
    technical discussions. However, I was asked to come before you today to
    provide comments on the real-world impacts of applying scientific
    assessment tools at the community level, and this I have done since
    becoming a locally-elected official.
        I am certainly not an expert on the IRIS system, but for want of a
    better tool, my staff are users of the IRIS system approach to hazard
    and human exposure assessment.
        Mayors, with their City Councils and Department Managers, have to
    make decisions on the ground every day to run a city. While many of
    these decisions require the careful application of common sense, some
    are more complicated, and these types of decisions require the use of
    more sophisticated decision-making tools.
        Risk management is one of those areas where local elected officials
    must make decisions, and we like to have the best tools available to
    assist us with our efforts.
        The IRIS system is not some sort of ``sacred tool'' that should
    never be questioned or evaluated. It does seem, however, that it is
    shrouded in a mix of scientific measurement, expert guesswork, and
    deals with a high level of uncertainty.
        I have been told that the IRIS method is one that combines
    measurement precision and a lot of guesswork about what might happen in
    humans if they are exposed to chemical substances. But, in the end, it
    is just a tool used by decision-makers.
        I have learned through the experience of governing a city for
    nearly 2 decades that when you use a tool to guide decision-making, you
    want the right tool, applied to the right problem. And you want to use
    that tool the right way.
        So, even though the IRIS method has some valid scientific
    components, it still has to yield a result that makes sense, even to
    the laypeople in the community.
        That is what I want to comment on here today.
        I worked closely with the Conference of Mayors starting 15 years
    ago to convince the EPA and Congress that not all contaminated sites in
    communities are the same.
        There are grossly contaminated sites that are Superfund sites with
    New Jersey having more than its fair share. But there are hundreds of
    thousands of less contaminated sites, known as brownfields that could
    be a potential public health threat but could also be cleaned up and
    turned into property that contributes to the well-being of that
    community. As a Mayor, the public health in my community is a paramount
    consideration. I am seriously concerned about the health of our
    children, our pregnant women, our average citizens and our city
    employees. However, I also don't want to unnecessarily cordon off
    pieces of property that should be properly evaluated, cleaned up, and
    reclaimed.
        That is why I worked so hard with the Conference of Mayors to get
    Congress and the Administration to establish Brownfield redevelopment
    policies.
        Brownfield legislation has helped us remove the public health
    threat, and we have put these lands back into productive use creating
    jobs, urban redevelopment and new sources of revenues that are used to
    support public safety, public health and maintain our physical
    infrastructure.
        One of the greatest impediments to this type of progress was the
    way EPA and the popular press characterized contaminated land in the
    1980s. EPA was, in our opinion, `less than careful' about how they
    originally characterized the risk to the public. In public hearings in
    many communities across the nation there was an unpardonable stigma
    attached to any site with contamination whether the contamination was
    serious or negligible. The popular press played an important role in
    fanning the flames of fear among the public. This made it virtually
    impossible to redevelop these properties. Developers wouldn't touch
    them, banks wouldn't lend money, and instead we had the abandonment of
    previously developed sites in favor of greenfields which contributed to
    urban sprawl.
        Generally, the risk was so over-played that it became a burdensome
    task to educate Congress and the public about the difference between a
    brownfield site and a Superfund site. This was the case even after EPA
    Administrator Carol Browner released over 30,000 sites that were on the
    CERCLIS list and said that these were not contaminated enough to
    warrant any further EPA action.
        I have a Superfund site in Elizabeth New Jersey. It is severely
    contaminated, and would pose a public health problem if it were not
    cordoned off properly- which it is. This site will likely plague the
    city for the next century because it was determined that it will cost
    too much money to clean it up.
        I also have quite a few brownfield sites in Elizabeth. I am proud
    to report that we have redeveloped many of them including the IKEA
    Super Center and the Jersey Gardens, an economically thriving shopping
    center that has created hundreds of jobs, promoted redevelopment and
    has been an enormous help to the city's economy.
        I am submitting to the Committee a report prepared by the
    Conference of Mayors that shows that brownfield redevelopment in cities
    across the nation have had the same positive impact because local
    government made the decision to clean these sites up, remove the
    potential public health threat and returned the land to productive use.
        But once again I am in Washington on the topic of not stigmatizing
    the redevelopment of brownfields unnecessarily. EPA's dioxin
    reassessment will converge with the IRIS system, and this combination
    will impact a wide range of policy decisions, including Preliminary
    Remediation Goals (PRGs) for dioxin levels in soil. The Conference of
    Mayors' believes this could have a severe impact on brownfields and
    other urban and suburban development.
        The U.S. Conference of Mayors is concerned that EPA's toxicity and
    exposure assumptions would drive dioxin PRG values down to levels that
    are below average concentrations in U.S. cities, and perhaps below
    current background levels in urban and suburban soils.
        As a tool, the IRIS system relies on toxicity values that
    established with a very wide margin of error built in that is intended
    to allow for uncertainty. The system also relies on exposure assessment
    calculations that rely on substantial exaggeration on risk.
        When the IRIS system is used to inform risk management decisions it
    must be noted that the compound effect of overly conservative toxicity
    values with overly conservative exposure scenarios yield a very
    distorted characterization of risk.
        This type of calibration of the different parts of the tool leaves
    local decision-makers with a risk analysis that is not realistic.
        For example, when EPA proposed to lower the dioxin soil
    concentrations for contaminated site remediation they intended to lower
    the existing guideline from 1 part per billion to 76 parts per trillion
    or even 3.7 parts per trillion. These lower standards were based on
    EPA's overly conservative approach to estimating dioxin toxicity in
    combination with assumptions about exposed children wallowing in the
    contaminated site soils.
        Not only is the exposure scenario unrealistic, but at 3.7 parts per
    trillion of dioxin, the soil in every urban and suburban area would
    pose an unacceptable risk because background levels are normally two to
    four times higher than 3.7 parts per trillion.
        Even lowering the dioxin standard in soil to 76 parts per trillion
    is lowering the so-called danger point to where the public will
    question their safety.
        What is troubling about those proposals for a Mayor is two
    important facts:

        1.  All of our citizens are getting 95 percent of their dioxin from
    the foods they eat, not from a contaminated brownfield site, and,

        2.  Rather than rely on worst-case exposure scenarios, the
    University of Michigan published a study that looks at actual dioxin
    levels in people reports:

              People who live on contaminated soil and have
    contaminated household dust do not have higher levels of dioxins in
    their blood. A study involving direct human measurement included 21
    people who lived on soil contaminated at 1,000 to 11,200 ppt TEQ of
    dioxins.

              The study authors stated that they believe their
    results apply to populations whose soil is contaminated in this range.

        EPA exposure assumptions are predominantly determined by policy
    judgments that are so overwhelmingly reliant on worst-case scenarios
    that they do not at all reflect the realities of potential human
    exposure
        So, I have doubts about how this IRIS tool can be applied with any
    certainty. And I am very concerned that it is the wrong tool for making
    local decisions.
        Our August 2010 Policy Paper highlights that these dioxin standards
    ``at or below background levels and if implemented will have an
    immediate chilling effect on the successes achieved over the last two
    decades to clean-up [brownfields] sites and return these properties to
    productive use.''
        So using this tool with its distortion of risk does not pass the
    reasonable-sense test at the local level.
        On the other hand, I understand the need for the EPA to develop
    assessment tools to help local decision-makers, so I would like to make
    the following suggestions.

        1.  The EPA should continue to improve IRIS and the information
    base on toxicity and exposure assessment

        2.  The exposure assessment assumptions should be evaluated by the
    National Academies of Science

              I think we are too smart in today's world to rely on
    one-size-fits-all assumptions in risk management when the stakes are so
    high

              Instead of EPA focusing on ``worst case scenarios'',
    they should also look at the ``most likely case''. This would be more
    useful to decision-makers to better understand the true risk of their
    decisions.

        3.  The EPA should not force local officials to rely on the IRIS
    system to make local decisions until the Agency improves the toxicity
    and exposure assessment methods to better reflect reality

              In particular, EPA should not force state regulators
    to base brownfield site clean-up decisions on the IRIS system

        Mayors need the best tools available to help us make sound
    decisions. Our goals for our cities are to protect the public health
    and the environment while encouraging the economic vitality. We need
    tools that are based in reality and common sense.
        I want to thank the Chairman and this Committee for the opportunity
    to give a Mayor's perspective on this important issue.

        Chairman Broun. Thank you, Mr. Mayor. I thank you all for
    your testimony today.
        Reminding Members that committee rules limit questioning to
    five minutes. The chair will at this point open the round of
    questions.
        The chair recognizes himself for five minutes.
        Dr. Charnley, to your knowledge does the IRIS Program
    reflect the framework outlined in the report, ``Risk Assessment
    and Risk Management in Regulatory Decision Making,'' developed
    by the Presidential Congressional Commission on risk assessment
    and risk management?
        Can you briefly outline the key aspects of the framework
    that should be reflected in IRIS risk assessments, and what
    does it mean to understand the context of a risk problem as
    discussed in the framework?
        Dr. Charnley. Well, what the risk commission framework does
    is emphasizes the importance of figuring out what the problem
    is you are trying to address before you address it, to clarify
    what your risk management goals are, and use those as a guide
    to risk assessment. As Dr. Anastas pointed out, however, the
    IRIS Program does not perform risk assessments. It generates
    safety values. It generates toxicity values that then a risk
    assessment would take, would use and compare to exposure values
    to come up with some understanding of what a human health risk
    might actually be.
        So what the IRIS Program does is provide some of the
    information that could be used in risk management but doesn't,
    it doesn't have the same context.
        Chairman Broun. Okay. Congressman Dooley, 2 days ago Dr.
    Anastas participated in a press conference and offered some
    insight on a new and improved IRIS process that will allegedly
    incorporate the Academy's recommendations from April, while
    building upon the 2009 revisions proffered by Administrator
    Jackson.
        Can you comment on the Agency's announcement?
        Mr. Dooley. Yes.
        Chairman Broun. Congressman, press the button so we can
    hear you, please, sir.
        Mr. Dooley. Yeah. We commend the EPA and Dr. Anastas on
    some of their recent actions. I think that whatever stakeholder
    you might be here, whether you are a member of Congress, a
    mayor, whether you are representing consumer interest groups or
    environmental groups or if you are part of the industry, we
    want to have an IRIS Process that meets a gold standard. We
    heard Dr. Samet say today that he would barely give it a
    passing grade on the formaldehyde IRIS assessment. I don't
    think any of us think that that is adequate.
        And so what we have been suggesting is that we are looking
    forward to the reforms that EPA is administering or enacting
    now to improve their program. I think we would all have a
    greater confidence that they were getting it right if for the
    next period of time that the next IRIS assessments that are
    coming out under these new reforms, that we would submit them
    to NAS just to make sure that we would have a double check on
    it to understand: did they enact the best processes, to ensure
    that we are using the best scientific process, that standards
    that ensure that the weight of evidence on the scientific
    research was adequate, that we had a peer review process that
    provided appropriate levels of transparency and independence.
        That is what we are suggesting when the industry, as we
    were characterized, is asking for NAS to play a major role in
    reviewing the IRIS assessments that could be issued in the next
    few months under the new and improved guidelines. We would all
    benefit and have greater confidence if we had NAS, you know,
    taking a review, making sure they got it right.
        Chairman Broun. Thank you, Congressman.
        Mayor Bollwage, I have got 1 minute left, so please answer
    quickly. Can you give us an idea of what sort of actions that
    you would need to consider as mayor if EPA proceeds with its
    proposed dioxin PRG, which as you note is at or below
    background levels, and what would it mean to your city, your
    constituents, your economy, your jobs, et cetera? What would be
    the positive outcomes of such a low dioxin PRG? That is, how
    would it affect safety?
        Mr. Bollwage. Thank you. Mr. Chairman, I can only explain
    it real quickly with we had an outdated plastics facility, and
    we wanted to convert it to Little League fields. We scraped
    away 3 inches of dirt and we mediated that and converted it
    into two healthy Little League fields.
        If the levels are lowered, we are going to wind up scraping
    away, what, 8 inches, 10 inches, 12 inches, a lot more of the
    dirt in order to make that area safe for Little League.
        You make the cost of a municipality increase substantially,
    and I don't know of any kids who are rolling around in the
    brownfields who have caught dioxin.
        Chairman Broun. My time has expired.
        Now I recognize Ms. Edwards for five minutes.
        Ms. Edwards. Thank you, Mr. Chairman, and thank you to our
    witnesses today.
        I just want to start out by noting that I do share Mr.
    Rohrabacher's view that it is important for us to know who is
    before us and who is influencing a process but merely working
    in an industry or working at an organization that advocates for
    a certain position is not a reason to exclude either that
    testimony or information.
        Nonetheless, I think it is also important that we have the
    same kind of transparency and accountability that we are
    demanding of the EPA and other agencies and their process is
    the same kind of transparency and accountability that we want
    in those who seek to influence or advocate in the process
    because it could otherwise operate to the detriment of the
    public health.
        Dr. Charnley, I have looked at your resume. It is very
    impressive, and I note that you are currently serving on the
    National Academy of Sciences Board of Environmental Science and
    Toxicology. Your appointment began in 2009. Is that correct?
        Dr. Charnley. Yes.
        Ms. Edwards. Thank you, and when you joined the--I also
    note in your testimony you indicated that you participated on
    numerous peer review panels convened by the EPA. You say that
    in your participation you acted independently. Isn't that
    correct?
        Dr. Charnley. Correct.
        Ms. Edwards. Thank you, and when you joined the National
    Academy of Science Board on Environmental Science and
    Toxicology, we have been told that you would occasionally maybe
    once or some number of times recuse yourself from board
    discussions of formaldehyde. Is that right?
        Dr. Charnley. That is correct.
        Ms. Edwards. And why did you feel a need to or were you
    required to recuse yourself, and in addition, who was paying
    you at the time, and what were you being paid to do that
    required your recusal?
        Dr. Charnley. Nobody was paying me at the time but before I
    joined the board I had given some advice to the Formaldehyde
    Council on how the National Academy of Sciences process works,
    and so when I served on the board, although the Academy does
    not believe that previous employment counts as a conflict, I
    felt that from an optics point of view, from a perception point
    of view that it would make sense to recuse myself from any
    discussions on formaldehyde just so that----
        Ms. Edwards. Thank you.
        Dr. Charnley. Yeah.
        Ms. Edwards. Well, let us not talk about optics. Let me
    just ask were you specifically in your--previous to your--prior
    to your appointment, were you paid to advise the Formaldehyde
    Council about ways in which they could use the NAS process to,
    you know, to thwart the assessment process through IRIS?
        Dr. Charnley. Of course not.
        Ms. Edwards. And so I am just curious, were you paid by
    them to advise you on how to get an Academy study on the EPA's
    IRIS draft assessment for formaldehyde?
        Dr. Charnley. I was not.
        Ms. Edwards. Okay. So what we will do is perhaps ask you
    some questions, specific questions on the record and also the
    Academy about the recusal process and about your work for the
    Formaldehyde Council and whether that had any impact on its
    work.
        Mr. Dooley, when we go to the Formaldehyde Council's
    webpage right now, and I have it, we are directed to a page
    that has the ACC logo on it. And then both organizations are
    shown to reside at the same address in Arlington, Virginia.
    What do you say about that?
        Mr. Dooley. The Formaldehyde Council, just earlier this
    year, I guess about 6 months ago, moved from being an
    independent agency to become one of among 50 different specific
    product panels that we have under ACC. So they are a self-
    funded group that is operated under the umbrella of the
    American Chemistry Council.
        Ms. Edwards. So I am--maybe I am confused, but--so what we
    have here today is we have an organization that has taken on
    the work of the Formaldehyde Council, an expert who advised the
    Formaldehyde Council, in my view, I think, to just use its
    power to get the NAS study started. And then we are also aware,
    I know I am, that Dr. Anastas's appointment was held up in the
    Senate by Senator Vitter until EPA would agree to fund the NAS
    formaldehyde review. And then we have one of the people who was
    advising the Formaldehyde Council on how to get a report
    requested of the Academy, I believe, and that report is now
    being misused to excuse or cripple EPA's assessment process.
        And so, as far as I am aware, none of that is--and--or
    those relationships have been disclosed to the committee, but
    it certainly puts your testimony in an informative light. Thank
    you very much, and I yield.
        Chairman Broun. Thank you, Ms. Edwards. The Chairman now
    recognizes Dr. Benishek for five minutes.
        Dr. Benishek. Thank you, Mr. Chairman. I find this all kind
    of scary because we have limited resources to deal with these
    risks, and when you hear conflicting testimony as to the
    accuracy and broadness of the investigation concerning a
    chemical risk, you want to spend your resources toward the
    chemical that has the most risk. And to not have that risk be
    politicized so you are wasting your resources on something that
    is not where you should be spending your resources.
        Dr. Charnley, do you have these same concerns that I do
    about this process? I am concerned about the Scientific
    Advisory Board for the EPA being open and not being biased. I
    find in different areas of the EPA the Scientific Advisory
    Boards don't have the experts on the panel that they should
    have, that have enough knowledge of the thing that they are
    actually judging the scientific validity of the people there,
    and not the experts in the field. Do you have any information
    about that that you can relate to us here?
        Dr. Charnley. Well, I think that is probably correct. I
    think that the difference with the Academy process is that a
    committee is convened of scientists to specifically address the
    substance or subject under consideration so that their
    expertise does directly inform whatever the subject matter is.
    And I do agree with you that putting resources towards
    substances that do not pose big public health impacts directs
    us away from issues and substances that do, and I don't think
    that is appropriate.
        Dr. Benishek. I so much agree with you. Mr. Dooley, let me
    ask you a question. Do you think that the people in the
    formaldehyde business want trouble with formaldehyde?
        Mr. Dooley. No, absolutely not. I mean--but this, again,
    comes to the essence of what this hearing is all about, how do
    we establish an IRIS assessment process that has the confidence
    of the NGO community or industry, that we are ensuring that it
    is using the best science and the best scientific process? When
    the NAS reviewed the IRIS review of formaldehyde, they found it
    was significantly flawed. That doesn't serve anyone's purpose.
        Formaldehyde is a building block chemical. But, even this
    IRIS assessment, it has consequences. The EPA was proposing
    there was an assessment level for formaldehyde, in terms of
    where it could be a concern for cancer, that they set a
    reference dose level that was .008 parts per billion. That was
    the level that they said consumers should be concerned about a
    risk of exposure. The World Health Organization had also done
    an assessment and concluded that the average person's breath
    contains up to 8 parts per billion. So, you back up and you
    say, is this IRIS risk assessment providing information that is
    really informing public health concerns, when by their own
    action level--or reference is 1,000 times greater than the
    formaldehyde in the air that we exhale.
        And that is where we think that we have got to step back
    and understand is how are we going to establish an IRIS process
    that is assessing--or considering hazard and exposure to some
    degree that actually can provide information that allows them
    there to make the responsible decision, that allows State
    regulators also to impose actions, and informs other Federal
    regulatory actions that emanate from this IRIS risk assessment.
    It needs to be done right. And what we are suggesting is until
    we have the confidence that it is right, we ought to allow NAS
    to review the IRIS assessment. And hopefully the reforms that
    Dr. Anastas spoke about this week will give us that positive
    outcome.
        Dr. Benishek. Appreciate it. I yield back my time. Thank
    you.
        Acting Chairman Bushon. I recognize the gentleman from
    North Carolina, Mr. Miller.
        Mr. Miller. Thank you, Mr. Chairman. My questions are
    similar to Ms. Edwards. Dr. Charnley, you testified that you
    were not testifying on behalf of anyone. Your disclosure
    statement says simply that you are not testifying on behalf of
    anyone. I assume that means nobody is paying you for sitting
    here today. I haven't asked you a question yet. But our
    research that our staff did shows that you have, in the past,
    worked for the Tobacco Institute, Phillip-Morris, Covenant and
    Burling, a law firm that presumably--representing industry,
    Chlorine Chemical Council, which is part of the American
    Chemistry Council, American Chemistry Council, Crop Life
    America, which is a pesticide manufacturer, Food Industry
    Dioxin Working Group, coal companies, and then a long list of
    groups that are funded by those industry groups. You have
    written papers or testified about perchlorate, dioxin, mercury.
    You have produced papers and editorial correspondence to
    learned journals, challenging the idea that children should get
    any extra measure of protection in regulatory science.
        You spoke of optics. Do you think the optics here would not
    have required that you tell the--this committee some of your--
    the work that you have done for industry?
        Dr. Charnley. Well, I think I stated clearly that I am a
    toxicology consultant. In my written testimony I state that
    work for--I consult to private entities, and it is, you know,
    you found who I work for, so, I mean, I--it is not like--that I
    am not disclosing that. I would be happy to--I have a list here
    of a lot of the organizations that I have worked for, and I
    will----
        Mr. Miller. Could you provide that to the----
        Dr. Charnley. Absolutely.
        Mr. Miller. --and could you also provide the issues that
    you have worked for on them?
        Dr. Charnley. Sure.
        Mr. Miller. Worked on them for them.
        Dr. Charnley. I would be happy to.
        Mr. Miller. Okay. That would----
        Dr. Charnley. Most of the work I do is pro bono, by the
    way.
        Mr. Miller. Pro bono?
        Dr. Charnley. Yes.
        Mr. Miller. Okay. Well, we--actually, our able committee
    staff also found an invoice that you had done a couple years
    ago that showed your billing rate was $325 an hour. So you do--
    also do some work for pay?
        Dr. Charnley. I do. I do----
        Mr. Miller. Okay.
        Dr. Charnley. --both.
        Mr. Miller. Okay. You spoke earlier of recusing yourself
    from a peer review panel when formaldehyde came up, which is
    admirable. I applaud that. If you have got an apparent
    conflict, then you should recuse yourself. But was that before
    or after you wrote a letter to--what is the name of the--the
    Health--Environmental Health Perspectives, that did not
    disclose that your--the research that you referred to in the
    letter was funded by the chlorine industry?
        Dr. Charnley. I have never failed to disclose the source of
    my funding in anything I have published.
        Mr. Miller. Okay. Did you write a letter to the
    Environmental Health Perspectives?
        Dr. Charnley. Yes.
        Mr. Miller. Did it have to do with chlorine?
        Dr. Charnley. I don't remember which one you are referring
    to, I am sorry----
        Mr. Miller. Okay. Do you----
        Dr. Charnley. --at the moment.
        Mr. Miller. You don't----
        Dr. Charnley. But I----
        Mr. Miller. You don't recall a controversy in which--
    Environmental Health Perspectives I assume is a learned
    journal? A peer reviewed learned journal?
        Dr. Charnley. It is a peer reviewed journal, yes.
        Mr. Miller. Okay. You don't recall that they changed their
    disclosure requirements as a result of a controversy about a
    letter that you wrote?
        Dr. Charnley. No. I recall that I said to the editor that I
    did not believe that I had a conflict because I no longer
    worked for the organization that had funded this similar work
    earlier. And according to the National Academy of Science's
    definition of conflict, which would apply to current
    employment, I did not have a conflict. However, I voluntarily
    disclosed that I had worked for such an entity in the past.
        Mr. Miller. Okay. It sounds like this whole issue is coming
    back to you now.
        Dr. Charnley. No--well, go ahead.
        Mr. Miller. Sorry. No, that is all right, I--Mr. Chairman,
    I have no further questions, but this remains a frustration in
    witnesses before this committee, who simply fill out this--and
    I had a discussion in the committee when our rules were adopted
    that substantially limited the disclosure statement--disclosure
    requirements, in which I was assured that if a witness had
    substantial economic interests, those would be disclosed. And
    we have seen repeatedly witnesses appear before this committee
    and appear and testify simply as public-spirited, disinterested
    citizens, and it appears their entire livelihood has come from
    the industry whose interests are at stake in the committee
    hearing. I would certainly hope that we could do better in the
    future.
        Acting Chairman Bushon. Thank you. I will take that up with
    the full committee Chairman. Thanks for your comments. I will
    now recognize myself for some questions, and assure the panel
    that I won't spend my entire time trying to defame all of your
    character.
        First I want to make a few brief comments about the--what I
    am hearing today. As a new member of Congress, I think the
    American people, if they were hearing this hearing today about
    EPA, and about the assessment they are making on chemicals, the
    American people would feel they are not getting a good bang for
    their buck. Just remind everyone that the budget of the EPA in
    2008 was $7.6 billion. The budget was 10.3 billion in 2010.
    And, believe it or not, the EPA received $7.2 billion in
    stimulus money, and yet we are at a hearing today discussing
    the fact that we have the inability to properly assess
    chemicals at the EPA, and that is not my opinion. Let me read
    from--the GAO testified before the Subcommittee that--in 2009
    that EPA has not been able to complete timely credible chemical
    assessments or decrease its backlog of 70, as of 2008, ongoing
    assessments, even though they received 7--well, I think 7--
    around 7.2 billion in stimulus money.
        And it says further, because the EPA staff time was
    dedicated to completing assessments in the backlog, EPA's
    ability to both keep the more than 540 existing assessments up
    to date and initiate new assessments was limited. So I think,
    from my perspective, this calls into question a lot of the
    rules that the EPA is currently putting out across the economic
    spectrum that is hurting our economy. And it is becoming pretty
    clear to me we don't have solid scientific evidence to back
    that up. So what I want to do is direct my questions, first to
    Congressman Dooley, about a couple of areas. Do you see that
    the assessment ability of IRIS, as being adequate? And I think
    you have stated before that you don't think it is. And based on
    that, do you see that there are longstanding economic impacts
    of their decision-making process, based on this information,
    that is hurting our job creation in our country?
        Mr. Dooley. First off is that the American Chemistry
    Council is very supportive of the suggestions that the NAS made
    to EPA for reforms. You know, we are encouraged that the EPA
    has indicated that they are going to try to enact some of those
    reforms. It is not mutually exclusive to have an IRIS risk
    assessment that is being operated in a manner that is
    consistent with what NAS has recommended and be a more
    efficient, and result in quicker IRIS assessments being done.
    And there shouldn't be any disagreement among any of us on that
    issue.
        When I was in Congress, I represented a district in the
    central valley of California. It was the fifth lowest per
    capita GDP district in the nation, out of 435. And the actions
    that IRIS could take to establish reference doses that are
    below those that pose any public health safety impact at
    expected levels of exposure, whether it is formaldehyde or
    dioxin, or whether it is arsenic, and that goes below what are
    background levels existing naturally, is that that has not only
    public health impacts, but it has public welfare impacts.
        If you require a lot of the low income communities in my
    district to comply with what is now a new arsenic standard that
    goes below what is naturally occurring, is that they have to
    allocate resources to water treatment systems that then aren't
    available for public health or education or, other public
    benefits, just as I said with dioxin. It also has an impact on
    private sector investments. If we have to divert revenues to
    achieve a higher level of remediation, or change processes that
    go to achieve an IRIS assessment that is below background
    levels, you are taking capital that could otherwise be invested
    in a new manufacturing capacity, creating jobs, that is going
    for a use that has very little benefit, and very little public
    health benefit.
        Acting Chairman Bushon. I think the answer is yes, it is
    having a significant impact, and at this time I will yield the
    rest of my time. And recognize the gentleman from Michigan, Mr.
    Clarke.
        Mr. Clarke. Thank you, Mr. Chair. In addition to IRIS,
    which is located in the EPA, there are other programs that
    conduct assessments of chemical risks that are located in other
    agencies and departments. And this question's to anyone here.
    To what degree have these assessments provided conflicting
    guidance or conclusions, and to what degree have these
    different programs provided--really been duplicating work? And
    if you found any conflicts or duplication, what proposals do
    you have to better coordinate and reduce the likelihood of
    conflicts and reduce the cause of duplication?
        Ms. Steinzor. If I could respond to that? IRIS is the
    premiere international source of reference dose information,
    which is the level below which exposure is acceptable and above
    which exposure is not acceptable. So it really measures
    whether--if we fed you dioxin on a spoon, what the level would
    be that would cause problems. As has been said repeatedly here,
    it is not a risk assessment process. It doesn't make a
    determination. IRIS itself is a scientific database that
    doesn't make a determination about what to do about the risk.
    It simply talks about what the reference dose is. It receives
    2,000 visits a day on the Internet from all over the world.
    That is a pretty high number for a database that is this
    technical. And, if anything, it needs to be bigger, better and
    stronger, not abolished, not paralyzed, because without it
    people would really not know what a toxicological profile--what
    the reference dose was for chemicals. So it really is unique,
    and it provides a tremendous service, I would say.
        Mr. Dooley. Maybe, as Ms. Steinzor mentioned, the IRIS
    reference dose is a standard which is not acceptable. And so I
    go back, and I will use the formaldehyde example, where you had
    the World Health Organization said the breath that you exhale
    has eight parts per billion. IRIS said a reference dose of
    .0008 parts per billion. You can also use the example of
    arsenic, where you have a little bit of a difference in
    standards internally, where you had an IRIS a risk assessment
    level of 1.4 parts per billion. But then you also have, in the
    safe drinking water standard, 10 parts per billion for drinking
    water. So there is some inconsistencies among various
    organizations there.
        So I think that is where we made a suggestion from ACC that
    there ought to be a role for OMB to play in this whole re-
    evaluation of the risk assessment. And what we are driving at
    here is because you have got multiple agencies--you have got
    FDA that is involved with some chemicals, whether it is food
    contact notification or assisting it, you have the Agency For
    Toxic Substance And Disease Registry, you have the National
    Toxicology Program, that does the report on carcinogens, you
    have EPA and IRIS--is that there needs to be a quarterback.
    That someone should not make determinations and evaluate
    necessarily the risk assessment, but that there is a common
    scientific process being utilized that is ensuring that we are
    incorporating the best laboratory practices, and that we are
    using the best weight of evidence practices, to reach
    conclusions. And that ought to be consistent across all these
    multiple agencies. And that is where we suggest that there is
    an appropriate role for OMB to play, to ensure that you have
    that consistency so that you don't have disparity and
    conclusions in action levels across various organizations that
    are maybe addressing the same chemical.
        Ms. Steinzor. Can I just add one point? My son, who is 20,
    is sitting behind me, and one of the most distressing things I
    have heard today is that he had formaldehyde in his body and
    exhales it at levels that are much higher than the reference
    dose set by the EPA database. That didn't happen because he is
    walking through a natural paradise on the Chesapeake Bay,
    although I wish that were true. It is because the air is
    polluted. We live in a non-attainment area that is awash in
    toxics and all sorts of other problems, and that is why that
    has happened. I also want to just say for the record there are
    two scientists, two, who work at OIRA. So making them the
    quarterback of anything would be a strange football game
    indeed.
        Acting Chairman Bushon. The gentleman's time has----
        Mr. Clarke. If I can just respond to the formaldehyde?
        Acting Chairman Bushon. The gentleman's time has expired.
    We will get--we will try to get back to you.
        Mr. Clarke. Thanks.
        Acting Chairman Bushon. I would like to recognize the
    gentleman from Maryland, Mr. Sarbanes.
        Mr. Sarbanes. Thank you, Mr. Chairman. Thank the panel.
    Congressman Dooley, I wanted to--you said a lot of nice things
    about the National Academy of Sciences, and I guess that is the
    basis for your proposal that they come in and review the risk
    assessments that IRIS is performing for some period of time.
    And you have also responded positively to changes that the EPA
    has said they are going to make in response to the National
    Academy of Science recommendations and so forth. On that basis,
    I assume you have pretty good feelings about this silver book,
    because that is a product of the National Academy of Science on
    the very topic that we are discussing here today, so I wanted
    to get your reactions to whether this is a constructive
    resource.
        Mr. Dooley. We think it is a very constructive resource. It
    is not that we agree with every element in it, but we think
    that it really does set a road map that has a lot that we can
    all learn from and incorporate into our government processes of
    assessing safety of chemicals.
        Mr. Sarbanes. I haven't read it from front to back.
    Actually, I have just read the back, as you may have seen. But
    from what I understand, I am assuming it is proposing
    recommendations that would allow the EPA and IRIS to operate in
    a way that would not require a kind of constant follow up
    assessment by NAS with respect to each specific chemical or
    toxic substance that was being assessed. And I am nervous about
    your recommendation on that, because I am worried that you are
    proposing adding more steps into a process, with the potential
    to kind of just drag the whole thing down and further
    contribute to the delay that is so frustrating for so many
    people, particularly when it comes to the issue of the worst of
    the worst.
        I mean, I keep hearing this phrase, I heard it in the other
    committee I served on in the last term, when we were looking at
    the Toxic Substances Control Act. I think, actually, you
    testified--some of those hearings. The worst, the worst. We
    can't seem to get even the worst of the worst--the place where
    we don't have to fear those substances anymore. And a lot of it
    has to do with this kind of, well, we need another study. We
    need to get the OMB in here as a quarterback, you know, OIRA
    and so forth and so on. We need to get moving on this stuff.
    And I think what this is attempting to do is propose how you
    can get the process and the framework that EPA uses to a place
    where it is working pretty well, and I am worried about that
    sort of getting off track.
        And then, Dr. Charnley, in the time I had, you had talked
    about your own view, that the changes proposed this week are
    promising ones, and I think has--have also said that you regard
    the National Academy of Science recommendations as helpful and
    constructive. I don't see how that jives with your suggestion
    that we should ``start over'' with the process that we
    currently have. I think that would be a mistake. Maybe you can
    clarify how you reconcile those two perspectives.
        Dr. Charnley. Sure. I did not mean stop IRIS. I did not
    mean disband IRIS. I meant that past efforts to modify the
    process have not produced meaningful improvements, apparently,
    because the Academy keeps coming back and making the same
    recommendations they have made for years. And for that reason I
    think that, in order to implement the changes recommended in
    Chapter 7 of the formaldehyde report, that implementation would
    itself benefit from guidance from the National Academy of
    Sciences, from a group of unbiased experts who can--who have
    been thinking about this problem for a long time and can
    provide helpful guidance.
        Mr. Sarbanes. Well, I think--thank you. I think that
    guidance is there. I think it is constructive, and I think the
    EPA is ready to move forward and keep this process of improving
    on a, you know, on a positive track. Let us not get off that
    track. Let us keep this process moving. With that, I yield
    back, Mr. Chairman.
        Acting Chairman Bushon. Thank you. At this point I would
    like to ask unanimous consent to add a number of documents to
    the record that have already been shared with the minority, and
    I understand they wish to add the records as well. Hearing no
    objection, so ordered.

    [The information appears in Appendix II:]

        Acting Chairman Bushon. I would like to thank the witnesses
    for their valuable testimony and the Members for their
    questions. The Members of the Subcommittee may have additional
    questions for the witnesses, and we will ask you to respond to
    those in writing. The record will remain open for two weeks for
    additional comments from Members. The witnesses are excused,
    and the hearing is now adjourned.
        [Whereupon, at 12:24 p.m., the Subcommittee was adjourned.]
                                  Appendix I:

                                  ----------

                       Answers to Post-Hearing Questions

                       Answers to Post-Hearing Questions
    Responses by The Honorable Paul Anastas, Assistant Administrator,
    Office of Research and Development, U.S. Environmental Protection
            Agency

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Responses by Mr. David Trimble, Director, Natural Resources and
            Environment,
    U.S. Government Accountability Office

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Responses by Dr. Jonathan M. Samet, MD, MS, Professor and Flora L.
            Thornton
    Chair, Department of Preventive Medicine, Keck School of Medicine,
            University of
    Southern California; and Chair, Committee to Review EPA's Draft IRIS
    Assessment of Formaldehyde, National Research Council, The National
            Academies

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Responses by The Honorable Calvin Dooley, President and Chief Executive
            Officer,
    American Chemistry Council

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Responses by Dr. Gail Charnley, Principal, HealthRisk Strategies

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Responses by The Honorable J. Christian Bollwage,
    Mayor, City of Elizabeth, New Jersey

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                                  Appendix II

                                  ----------

                 Additional Materials Submitted for the Record

               Material Submitted by Representative Larry Bucshon

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]