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

                         HOW THE REPORT ON CARCINOGENS
                       USES SCIENCE TO MEET ITS STATUTORY
                          OBLIGATIONS, AND ITS IMPACT
                             ON SMALL BUSINESS JOBS

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

                                    HEARING

                                   BEFORE THE

                         SUBCOMMITTEE ON INVESTIGATIONS
                                 AND OVERSIGHT

                  COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

                                 JOINT WITH THE
                   SUBCOMMITTEE ON HEALTH CARE AND TECHNOLOGY

                          COMMITTEE ON SMALL BUSINESS
                            HOUSE OF REPRESENTATIVES

                          ONE HUNDRED TWELFTH CONGRESS

                                 SECOND SESSION

                                   __________

                           WEDNESDAY, APRIL 25, 2012

                                   __________

                               Serial No. 112-79

                                   __________

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

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

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                  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         BRAD MILLER, North Carolina
    FRANK D. LUCAS, Oklahoma             DANIEL LIPINSKI, Illinois
    JUDY BIGGERT, Illinois               DONNA F. EDWARDS, Maryland
    W. TODD AKIN, Missouri               BEN R. LUJAN, New Mexico
    RANDY NEUGEBAUER, Texas              PAUL D. TONKO, New York
    MICHAEL T. McCAUL, Texas             JERRY McNERNEY, California
    PAUL C. BROUN, Georgia               TERRI A. SEWELL, Alabama
    SANDY ADAMS, Florida                 FREDERICA S. WILSON, Florida
    BENJAMIN QUAYLE, Arizona             HANSEN CLARKE, Michigan
    CHARLES J. ``CHUCK'' FLEISCHMANN,    SUZANNE BONAMICI, Oregon
        Tennessee                        VACANCY
    E. SCOTT RIGELL, Virginia            VACANCY
    STEVEN M. PALAZZO, Mississippi       VACANCY
    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.,         PAUL TONKO, New York
        Wisconsin                        ZOE LOFGREN, California
    SANDY ADAMS, Florida                 BRAD MILLER, North Carolina
    RANDY HULTGREN, Illinois
    LARRY BUCSHON, Indiana               EDDIE BERNICE JOHNSON, Texas
    DAN BENISHEK, Michigan
    VACANCY
    RALPH M. HALL, Texas
                          COMMITTEE ON SMALL BUSINESS

                        HON. SAM GRAVES, Missouri, Chair
                           ROSCOE BARTLETT, Maryland
                               STEVE CHABOT, Ohio
                                STEVE KING, Iowa
                             MIKE COFFMAN, Colorado
                         MICK MULVANEY, South Carolina
                             SCOTT TIPTON, Colorado
                             JEFF LANDRY Louisiana
                       JAIME HERRERA BEUTLER, Washington
                              ALLEN WEST, Florida
                         RENEE ELLMERS, North Carolina
                              JOE WALSH, Illinois
                           LOU BARLETTA, Pennsylvania
                            RICHARD HANNA, New York
                           ROBERT SCHILLING, Illinois
                   NYDIA VELAZQUEZ, New York, Ranking Member
                             KURT SCHRADER, Oregon
                            MARK CRITZ, Pennsylvania
                          JASON ALTMIRE, Pennsylvania
                             YVETTE CLARK, New York
                              JUDY CHU, California
                         DAVID CICILLINE, Rhode Island
                           CEDRIC RICHMOND, Louisiana
                            JANICE HAHN, California
                             GARY PETERS, Michigan
                              BILL OWENS, New York
                          BILL KEATING, Massachusetts
                                C O N T E N T S

                           Wednesday, April 25, 2012

                                                                       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..................    26
        Written Statement............................................    28

    Statement by Representative Renee Ellmers, Chairman, Subcommittee
      on Health Care and Technology, Committee on Small Business,
      U.S. House of Representatives..................................    30
        Written Statement............................................    32

    Statement by Representative Paul D. Tonko, Ranking Member,
      Subcommittee on Investigation and Oversight, Committee on
      Science, Space, and Technology, U.S. House of Representatives..    34
        Written Statement............................................    36

    Statement by Representative Cedric Richmond, Subcommittee on
      Investigation and Oversight, Committee on Small Business, U.S.
      House of Representatives.......................................    38

                                   Witnesses:

    Dr. Linda S. Birnbaum, Director, National Institute of
      Environmental Health Sciences and National Toxicology Program,
      U.S. Department of Health and Human Services
        Oral Statement...............................................    40
        Written Statement............................................    43

    Mr. Charles A. Maresca, Director of Interagency Affairs, Office
      of Advocacy, U.S. Small Business Administration
        Oral Statement...............................................    49
        Written Statement............................................    51

    Discussion                                                           59

    Dr. James S. Bus, Director of External Technology, Toxicology and
      Environmental Research and Consulting, The Dow Chemical Company
        Oral Statement...............................................    70
        Written Statement............................................    72
    Dr. L. Faye Grimsley, Associate Professor, Tulane School of
      Public Health and Tropical Medicine, Department of Global
      Environmental Health Sciences
        Oral Statement...............................................    87
        Written Statement............................................    89

    Ms. Bonnie Webster, Vice President, Monroe Industries, Inc.
        Oral Statement...............................................    96
        Written Statement............................................    98

    Ms. Ally LaTourelle, Esq., Vice President, Governmental Affairs,
      Bioamber, Inc.
        Oral Statement...............................................   101
        Written Statement............................................   103

    Mr. John E. Barker, Corporate Manager, Environmental Affairs,
      Safety and Loss Prevention, Strongwell Corporation
        Oral Statement...............................................   108
        Written Statement............................................   110

    Dr. Richard B. Belzer, President, Regulatory Checkbook
        Oral Statement...............................................   114
        Written Statement............................................   116

    Discussion                                                          127

                  Appendix: Answers to Post-Hearing Questions

    Dr. Linda S. Birnbaum, Director, National Institute of
      Environmental Health Sciences and National Toxicology Program,
      U.S. Department of Health and Human Services (questions
      submitted by Members; no answers were received)................   139

    Mr. Charles A. Maresca, Director of Interagency Affairs, Office
      of Advocacy, U.S. Small Business Administration................   149

    Dr. James S. Bus, Director of External Technology, Toxicology and
      Environmental Research and Consulting, The Dow Chemical Company   163

    Dr. L. Faye Grimsley, Associate Professor, Tulane School of
      Public Health and Tropical Medicine, Department of Global
      Environmental Health Sciences..................................   177

    Ms. Bonnie Webster, Vice President, Monroe Industries, Inc.......   184

    Ms. Ally LaTourelle, Esq., Vice President, Governmental Affairs,
      Bioamber, Inc..................................................   195

    Mr. John E. Barker, Corporate Manager, Environmental Affairs,
      Safety and Loss Prevention, Strongwell Corporation.............   222

    Dr. Richard B. Belzer, President, Regulatory Checkbook...........   245

                 Appendix 2: Additional Material for the Record

    Letters Submitted by Subcommittee Chairman Paul Broun, House
      Committeeon Science, Space and Technology......................   268

    Letters Submitted by Subcommittee Chairman Renee Ellmers,
      HouseCommittee on Small Business...............................   281

                         HOW THE REPORT ON CARCINOGENS

                       USES SCIENCE TO MEET ITS STATUTORY

                          OBLIGATIONS, AND ITS IMPACT

                             ON SMALL BUSINESS JOBS

                                  ----------

                           WEDNESDAY, APRIL 25, 2012

                      House of Representatives,
          Subcommittee on Investigations and Oversight,
                   Committee on Science, Space, and Technology,
                                         joint with the
             Subcommittee on Healthcare and Technology,
                                   Committee on Small Business,
                                                        Washington, DC.
        The Subcommittees met, pursuant to call, at 10:01 a.m., in
    Room 2318 of the Rayburn House Office Building, Hon. Paul Broun
    [Chairman of the Investigations and Oversight Subcommittee]
    presiding.

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        Chairman Broun. Committee on Science, Space, and
    Technology, Subcommittee on Investigations and Oversight, and
    the Committee on Small Business, Subcommittee on Healthcare and
    Technology will come to order. Good morning, everyone. Welcome
    to today's joint hearing entitled, ``How the Report on
    Carcinogens Uses Science to Meet Its Statutory Obligations and
    Its Impact on Small Business Jobs.''
        In front of you are packets containing the written
    testimony, biographies, and truth in testimony disclosures for
    both of today's witness panels. Before we get started, since
    this is a two-panel joint hearing involving two House
    Committees, Subcommittees, I want to explain how we will
    operate procedurally so that all Members understand how the
    question-and-answer period will be handled. We will take
    testimony from the first panel and then proceed with a
    question-and-answer period. During the question-and-answer
    period, we will alternate between the two Committees, starting
    with the Science Committee majority and then the Science
    Committee minority. We will then call on the Small Business
    Committee majority, followed by the Small Business minority. If
    there is not a Member of one of these Committees present, we
    will continue to alternate between the majority and minority
    Members and allow all Members an opportunity for questioning
    before recognizing a Member for a second round of questions, if
    we get to a second round.
        We will recognize those Members of either Subcommittee
    present at the gavel in order of seniority on their respective
    Committee, and those coming in after the gavel will be
    recognized in their order of arrival.
        After the first panel has been excused, we will take
    testimony from the second panel and then undertake a question-
    and-answer period in the same fashion as with the first panel.
        I now recognize myself for five minutes for an opening
    statement.
        I would like to extend a strong, warm welcome to my
    colleagues from the Small Business Committee and thank them for
    their participation in this joint hearing today.
        The Science, Space, and Technology Committee has a history
    of conducting oversight hearings on agencies and programs that
    produce chemical assessments. While we have delved into the
    work performed by the Agency for Toxic Substances and Disease
    Registry and the EPA's IRIS Program on more than one occasion,
    this is the first time I have had the opportunity to hearing
    from the director of HHS's National Toxicology Program on the
    subject of the Report on Carcinogens, also known as the RoC.
        I view today's hearing as a learning opportunity for our
    Committees so that we may better understand the work performed
    by NTP as it publishes its report on carcinogens.
        As a legislator, I am very concerned with protecting public
    health and safety. I can think of few greater responsibilities
    that we have as public servants. As a physician, I take this
    responsibility even more seriously. When substances are found
    to be harmful, we should make every effort to minimize the
    public's exposure. We also have a responsibility to ensure that
    these determinations are appropriate and not arbitrary or
    capricious and are communicated correctly.
        While taking the most cautious and precautionary approach
    to making these determinations may seem like the right thing to
    do, this method may actually do more harm than good. When
    concerns and fear are promoted with little actual risk,
    commerce, small businesses, and everyday citizens are impacted
    with no appreciable benefit to their safety.
        It is often repeated that RoC does not assess risk, just
    hazards, and it is not a regulatory action, and therefore, it
    is not required to meet more rigorous standards. While this may
    be true, it unfortunately is not the whole story. These
    assessments are highly influential scientific assessments that
    influence regulatory actions at the earliest stages. When the
    law that established the RoC was passed, its stated intent was,
    ``to be a first step in regulation.''
        Because the RoC has such great import, it is critical that
    these reports reflect the best available science. The recent
    release of the 12th RoC demonstrates how confusing this process
    can be. In a report published last April on the EPA IRIS
    assessment of formaldehyde, the National Academy of Sciences
    stated, ``strongly question EPA's claims that exposure to
    formaldehyde can result in increased risk of leukemia and other
    cancers that had not previously been associated with
    formaldehyde, asthma, and reproductive toxicity.''
        Yet two months after the Academy's reports, the NTP issued
    the 12th RoC with an upgrade in the listing of formaldehydes to
    a known carcinogen, based in part on claims similar to those
    made by EPA and dismissed the Academy's report in an addendum.
    Since then, concerns have been raised about how the RoC is
    developed and how its findings are communicated.
        Last winter, the Small Business Administration's Office of
    Advocacy sent a letter to HHS, as well as to NTP, urging HHS,
    ``to review and evaluate the RoC's purpose and objectives and
    to consider whether, if substantial changes cannot be made, the
    RoC should continue to play a role in the Federal Government's
    Chemical Risk Assessment Program.''
        This is a surprisingly forthright comment and one that
    Congress should not take lightly. Separately, in the Omnibus
    Appropriations Bill passed last December, Congress directed the
    Academies to review the 12th RoC's listing of two of its
    substances, and I look forward to reading that report when it
    is published, hopefully soon.
        Although the RoC is not a regulation, by its own admission,
    ``the RoC can be used by regulatory agencies and others for
    decision making.'' That makes this a very influential document,
    because a RoC listing has real-world implications, and we will
    hear about some of those implications from the small business
    witnesses on our second panel.
        Ultimately, we have to ensure that the public has the best
    information possible in order to protect their health.
        [The prepared statement of Mr. Broun follows:]
        [GRAPHIC] [TIFF OMITTED] 74059.025

        [GRAPHIC] [TIFF OMITTED] 74059.026

        Chairman Broun. Now, I ask unanimous consent that we add a
    number of letters from various groups to the record. These have
    been shared with the minority in advance of the hearing.
        Without objection, so ordered.
        [The information may be found in Appendix 2.]
        Chairman Broun. I now recognize the Chair of the Committee
    on Small Business, Subcommittee on Health and Technology, for
    five minutes and her opening statement. Mrs. Ellmers.
        Chairwoman Ellmers. Good morning, and I thank Chairman
    Broun for working with me and my staff on this very important
    issue. I thank all of our witnesses for being here today, and I
    am looking very much forward to your testimony.
        We are here today to learn about the Report on Carcinogens
    and the impact it has on small businesses across America.
    According to the National Toxicology Program, this report is
    intended to be a science-based, public health communication
    tool. However, the Report on Carcinogens has been used by
    federal and State agencies as a regulatory document, using its
    listing of substances as a basis for regulatory and legislative
    action.
        Each year, small businesses with less than 20 employees are
    burdened with compliance regulations that cost them 36 percent
    more per employee than their larger counterparts. Despite the
    economic downturn, the regulatory burden on small businesses
    continues to grow. Increasing regulations mean small businesses
    must dedicate more money, time, and resources by complying with
    regulations instead of doing what they do best, creating jobs
    and innovating new products.
        The Federal Government has an important duty in researching
    and identifying substances that could cause harm and hazards in
    the public health. But at the same time, our government must
    recognize the adverse consequences of requiring businesses to
    call a substance a human carcinogen without definitive
    evidence. It is irresponsible and could lead to unnecessary
    strain for small businesses. The regulatory uncertainty this is
    causing has already resulted in small businesses delaying
    hiring new employees and is causing many small businesses to
    hold off on making important investment decisions.
        Scientists, small businesses, and their representatives are
    now raising concerns about the quality of this analysis and the
    process used to list these substances in the Report on
    Carcinogens. Specifically, questions have been raised regarding
    the peer review process. Reports have shown that this process
    has failed to meet the independent and objective standards that
    would justify the overbearing burdens being placed on local
    economies and businesses, not to mention the insufficient
    public comment procedures that remain lacking.
        The Report on Carcinogens was originally mandated by
    Congress in 1978, to help aid the research and prevention of
    many cancers. Although there have been many major breakthroughs
    in the scientific understanding of cancers and its causes, the
    process that the National Toxicology Program currently uses to
    identify carcinogens has not kept up with the pace of
    scientific developments. Despite warnings that the National
    Toxicology Program review process for the report must be
    improved, there are new concerns that the process for the next
    report has made only minor substantive changes and is merely a
    rearranging of the deck chairs.
        Small businesses continue to fear the ramifications of this
    report. When the government publishes scientific information
    that negatively impacts private businesses, the government has
    the duty and responsibility to ensure that the information is
    the product of an objective and scientifically sound process.
        Again, I want to thank each one of our witnesses today for
    their participation, as well as Chairman Broun and the Science
    Committee for hosting us today. I look forward to working with
    all of you on this very important issue.
        Mr. Chairman, I would like to take a moment to say that I
    have included one letter from a small business in my district
    as well as a letter to the Office of Advocacy, November 22,
    2011, to the letter of Department of Health and Human Services
    as part of my opening statement for the record.
        I yield back.
        [The prepared statement of Mrs. Ellmers follows:]
        [GRAPHIC] [TIFF OMITTED] 74059.027

        [GRAPHIC] [TIFF OMITTED] 74059.028

        Chairman Broun. Without objection, they will be entered
    into the record at this point.
        [The information may be found in Appendix 2.]
        Chairman Broun. The Chair now recognizes my good friend
    from New York, Mr. Tonko, for an opening statement. You are
    recognized for five minutes.
        Mr. Tonko. Thank you, Mr. Chair, and welcome to our
    witnesses.
        Usually I begin my statement by thanking you for having the
    Subcommittee examine a topic of importance and for inviting
    witnesses who bring a variety of perspectives and expertise to
    the subject at hand.
        Unfortunately, I am sorry that I am unable to do that
    today. We did not agree in all particulars of the last
    Subcommittee hearing, but I compliment you for inviting a
    balanced slate of witnesses to inform us on renewable energy
    tax provisions. When the Subcommittee is in a learning mode,
    such balance reflects well on the Subcommittee and highlights
    that we are truly interested in coming to a complete
    understanding of a policy issue.
        Today's hearing is very disappointing. In theory, we are
    examining the National Toxicology Program's 12th Report on
    Carcinogens. In reality, we are hearing the objections of one
    industry to the listing of one chemical. There is virtually no
    balance here today, in my opinion. Five of the six witnesses
    invited by the majority are aligned closely with the styrene
    industry and the American Composite Manufacturers Association.
        Certainly we should hear from the businesses with an
    interest in this report. Their concerns about the implications
    of the report for their businesses are legitimate issues for us
    to, indeed, consider. But in this matter, I would also expect
    us to bring other concerned voices into the room to ensure that
    we have a complete, complete picture of how the report and this
    program are viewed by all interested parties.
        If we were going to fully examine the deep issues this
    hearing purports to tackle, I would have expected to hear from
    veterans' groups, environmental justice groups, workers, and
    distinguished public health experts with intimate knowledge of
    the NTP and the Report on Carcinogens. No such individuals were
    called by the majority. To the degree there is any divergent
    voice heard today, it is because of the minorities' sense of
    obligation to try to provide some balance.
        I could have recommended witnesses such as retired Marine
    Corps Master Sergeant Jerry Amsfinger and Ms. Erin Brockovich,
    who worked with veterans and communities that have been harmed
    by chemical exposure and fought for years to get toxicity
    information into the public policy arena. I could have
    recommended a fleet of distinguished science policy experts,
    such as Dr. Phil Landrigan of Mount Sinai Medical College, or
    you could stay with the beltway, within the beltway and invite
    Dr. Lynn Goldman, Dean of the George Washington University
    School of Public Health and Dr. Jennifer Sass of the Natural
    Resources Defense Council.
        In addition, the structure of this hearing suggests that
    small businesses are hurt uniformly and primarily by documents
    such as the RoC. The picture is far more complicated than that.
    I could have recommended a host of small business leaders who
    would have made it clear that their business is expanding and
    taking market share away from petrochemical manufacturers
    because public tastes are, indeed, changing.
        The shift away from substances that cannot be easily
    recycled or composted is a process that gained a full head of
    steam long before the 12th Report on Carcinogens was drafted. I
    am attaching to my statement letters we have received from a
    wide variety of groups asking that this Subcommittee examine
    the claims of the styrene industry with a critical eye and that
    we understand how important the work of the NIEHS is to
    protecting public health.
        Out of fairness, I want to ask you, Mr. Chair, to commit to
    a second hearing that would expand the scope of the voices we
    hear on this important matter. The issues are too important to
    treat in such an imbalanced way. The Investigations and
    Oversights Subcommittee must be viewed as impartial and
    thorough and should build a complete record that includes more
    than allegations into lawsuit the styrene industry has brought
    against NIEHS. A second hearing would allow us to correct the
    impression that we will dance to any single-interest tune. I
    stand ready to work with you to shape such a hearing at your
    earliest convenience.
        There is one final issue I want to raise. Because the
    government is subject to an ongoing lawsuit in which Dr.
    Birnbaum as the director of NIEHS has a direct role, she may
    not be able to answer some questions here today. It would be
    grossly unfair for Members to try to use this forum to build
    the record to assist the industry in its lawsuit against the
    government by asking questions of Dr. Birnbaum that she cannot
    answer and then treating her as if she is trying to be evasive.
        So I ask that you be especially sensitive to the legal
    implications of this hearing and protect Dr. Birnbaum in
    situations where she has been counseled not to comment. Last
    week's joint hearing was marred by abusive conduct towards a
    witness. I know you found the behavior distasteful, and I find
    it unacceptable. Tough questions are fair game, but we should
    stand together to ensure that things do not move from being
    tough and probing to being personally abusive. I don't know
    whether the NIEHS or the styrene industry is right or wrong on
    the matters before us. I do not believe we have done enough
    work on this matter, nor invited a diverse enough set of
    witnesses to reach any meaningful conclusions today.
        The letters I am attaching to my statement asks us to
    believe that the styrene industry is wrong, and the Committee
    is biased in its approach. They may or may not be right on the
    first issue, but their second criticism is valid. To restore
    the perception of our independence and objectivity, we
    desperately need another hearing and a different set of
    witnesses. I hope we can work together on that hearing, Mr.
    Chair, and then we can bring, begin to come to a fuller
    understanding of the complex questions that are, indeed, before
    us.
        I yield back.
        [The prepared statement of Mr. Tonko follows:]
        [GRAPHIC] [TIFF OMITTED] 74059.029

        [GRAPHIC] [TIFF OMITTED] 74059.030

        Chairman Broun. Thank you, Mr. Tonko. I want to remind my
    good friend from New York that of the letters that you just
    asked to be admitted into the record, we have already admitted
    those into the record from our side all except for, I think but
    one of those, and we just have so many people, and this is
    about process and not about any given entity or chemical. It is
    about how the process goes on.
        Thank you, sir. I appreciate that.
        The Chair now recognizes my good friend from Louisiana, Mr.
    Richmond, for an opening statement. Sir, you are recognized for
    five minutes.
        Mr. Richmond. Thank you, Mr. Chairman.
        It is undisputed that chemicals are a part of our daily
    lives from the food that we eat, the products in our homes, and
    in our children's toys. In a great majority of their uses, they
    improve our lives.
        However, in a few instances they can be dangerous. To
    address this, the National Toxicology Program issues a Report
    on Carcinogens which lists substances that may cause cancer.
    The report now identifies 240 substances that are either known
    or are likely human carcinogens. For consumers, this gives them
    information they can use to make informed decisions. For
    employers, it can help them to protect the workers. For all of
    us, this report can lead to cleaner air and water. By
    identifying substances that may heighten the risk of cancer,
    the public is made aware of potentially life-threatening
    chemicals in our everyday lives.
        As new chemicals are created and additional uses are found
    for existing ones, companies are able to make their products
    stronger, more durable, and a better value for the consumer. As
    this process evolves, it remains a top priority to understand
    not only what is in them but how they may affect us, our
    children, and the environment.
        The rapid pace of scientific discovery in the United States
    makes doing so even more important. With this degree of
    innovation also comes a strong sense of corporate
    responsibility that we are fortunate to have in this country.
    It is important to remember that no business wants to put its
    employees or the public in danger. Safe products and a hazard-
    free work environment are in a company's own self-interest and
    simply make good business sense.
        With that in mind, the report's designation of substances
    as a carcinogen can only significantly impact small businesses.
    For some firms, listing a chemical that they use, even in
    minimal amounts, has the potential to stigmatize their products
    and their business. Unlike their large counterparts, small
    firms rarely have teams of attorneys and research personnel in
    house to mitigate the impact of such a listing. Instead they
    must hire expensive outside consultants or shift resources from
    production to regulatory compliance, slowing growth and job
    creation.
        Given these concerns there is a need to examine the report
    and how it is prepared. During today's hearing, I hope to
    examine how rigorous the listing process is and how open it is
    to external critique. Sound scientific analysis and methods, as
    well as public comment and peer review, are key to the
    legitimacy of the report.
        Transparency is also essential for businesses affected by a
    listing. They should have an opportunity to give their input
    throughout the process, especially at those points which try
    final listing decisions.
        I am also looking forward to hearing testimony on the
    revised process for the 13th report, which HHS recently issued
    in January. These procedures are at the heart of many of the
    issues that we will examine today. It is my hope that we can
    explore whether or not this new process increases transparency
    in public input.
        The Report on Carcinogens is an important source of
    information on substances that may cause cancer in humans. It
    remains vital for consumers, businesses, and government alike.
    The listing of these substances gives the public and decision
    makers a necessary resource to evaluate the safety of where we
    live, work, and our children play. Ensuring that this is the
    most credible scientific approaches and uses, processes that
    are open and clear, is essential not only to our Nation's
    public health but also to the economic viability of many small
    businesses.
        I would just say as a Member whose new footprint represents
    the largest petrochemical footprint in the United States
    Congress, that the concerns go both ways, and I think that the
    more information you have, the more knowledge that you have,
    the better that we can protect our citizens, our families, our
    children.
        So with that, Mr. Chairman, I would yield back.
        [The prepared statement of Mr. Richmond is not available.]
        Chairman Broun. Thank you, Mr. Richmond.
        I would like to remind my colleagues on both sides at
    today's hearing we have invited two Administration witnesses
    and two witnesses suggested by the minority. Our committee
    rules only require one minority witness. We thought it was
    important to allow a variety of opinions. Half the witnesses
    that are here today either represent the Administration or were
    invited by the minority. We are trying to be very candid and
    fair with, again, this is about process and not about any
    individual entity.
        If there----
        Mr. Tonko. Mr. Chair, I understand that there is only one
    Administrative representative here, and that would be Dr.
    Birnbaum. Thank you.
        Chairman Broun. There is a small business advocacy witness
    from Small Business Administration.
        Mr. Tonko. With their testimony reviewed by the leadership
    of that agency, I believe. Is that correct? It is an
    independent office.
        Chairman Broun. Thank you. Let us go ahead. If there are
    Members who wish to submit additional opening statements, your
    statements will be added to the record at this point.
        At this time I would like to introduce our witnesses. First
    is Dr. Linda Birnbaum, the Director of National Institute of
    Environmental Health Science and National Toxicology Program at
    the U.S. Department of Health and Human Services.
        Madam Chairwoman, would you like to introduce our other
    witness?
        Chairwoman Ellmers. Yes. Thank you, Mr. Chairman. I am
    going to introduce Mr. Charles Maresca. He is the Director of
    Interagency Affairs in the Small Business Administration's
    Office of Advocacy. The Office of Advocacy monitors federal
    agencies' compliance with the Regulatory Flexibility Act or
    RFA, as amended by the Small Business Regulatory Enforcement
    Fairness Act and represents the views and interests of small
    businesses before federal agencies.
        Mr. Maresca, I am looking forward to your testimony.
        Chairman Broun. Thank you, Mrs. Ellmers. I would like to
    thank the Chairwoman for being here and us doing this together.
        We will now begin hearing from our witnesses. 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.
        It is the practice of the Subcommittee on Investigations
    and Oversight to receive testimony under oath, and we will use
    that practice today here as well.
        Do any of you have--either of you have any objections to
    taking an oath?
        Okay. Let the record reflect that both witnesses are
    willing to take the oath by shaking their head in a normal
    fashion, side to side. You also may be represented by counsel.
    Do either of you have counsel here today?
        Let the record reflect that neither has counsel here today.
        Now, if you will please both stand and raise your right
    hand. Do you solemnly swear to affirm and tell the whole truth
    and nothing but the truth, so help you God?
        Be seated, please. Let the record reflect that both
    witnesses have taken the oath.
        Dr. Birnbaum, you are now recognized for five minutes.

             STATEMENT OF DR. LINDA S. BIRNBAUM, DIRECTOR,

          NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

                    AND NATIONAL TOXICOLOGY PROGRAM,

              U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

        Dr. Birnbaum. Good morning. I am Linda Birnbaum, Director
    of the National Institute of Environmental Health Sciences,
    part of the National Institutes of Health, and I am also
    Director of the National Toxicology Program, also known as the
    NTP. It is my pleasure to appear before you today to discuss
    the Report on Carcinogens.
        The report is required by biennially under the Public
    Health Service Act and issued by the Secretary of Health and
    Human Services. The Secretary has delegated responsibility for
    preparing the report to the NTP.
        In the United States, approximately one in two men and one
    in three women will develop cancer in their lifetime. We have
    both a legal and a moral obligation to identify substances in
    our environment that are cancer hazards and to communicate this
    information to ensure that people can choose to live and work
    in safe environments.
        The Report on Carcinogens is a science-based, public health
    document that provides information about the relationship
    between the environment and cancer. The report lists a wide
    range of substances, including metals, pesticides, drugs,
    natural and synthetic chemicals, and biological agents that are
    considered cancer hazards for people in the United States.
        A listing in the report indicates a potential hazard for
    cancer. Many factors, including the amount and duration of
    exposure and an individual's susceptibility to a substance
    affect whether a person will develop cancer. The Report on
    Carcinogens is not a risk assessment document. It is not a
    regulatory document.
        However, the report does provide decision makers and the
    public with information they can use to make decisions about
    exposures to cancer-causing substances. The Public Health
    Service Act stipulates that the report lists substances in one
    of two categories.
        The first is known to be carcinogens. The second category
    is reasonably anticipated to be carcinogens. These categories
    are based on criteria approved by the HHS secretary in 1996
    that was a product of a thorough and public review.
        For a substance to be listed in the known category, there
    must be sufficient evidence from studies in humans that
    indicates a causal relationship between the substance and human
    cancer. Briefly, for a substance to be listed in the reasonably
    anticipated category, any one of three scenarios may apply.
    One, limited evidence of cancer from human studies, or two,
    sufficient evidence of cancer from animal studies, or three,
    evidence that the substance is in a class of substances already
    listed in the report or that it causes biological effects known
    to lead to cancer in humans.
        The decision by the NTP to list a substance in the Report
    on Carcinogens is based on scientific judgment with
    consideration of all relevant research data and input from
    advisory groups and the public. For each listing, the report
    includes a substance profile with information on cancer studies
    that justifies the listing. The profile also provides
    information about use, production, potential sources of
    exposure, and any current federal regulations to limit
    exposures.
        Each edition of the report is cumulative and includes
    substances newly reviewed, along with those listed in all
    previous editions. The first report was released in 1980. The
    most recent 12th report in June, 2011. Anyone may nominate a
    substance for listing in or removal from the report. The
    multistep process to prepare the 12th report included expert
    advisory reviews, independent external peer review, and drew
    upon the science expertise of federal agencies including NIH,
    CDC, FDA, EPA, OSHA, and the Consumer Product Safety
    Commission.
        The process also increased opportunity for public review
    and input. In fact, public comments were solicited on six
    separate occasions.
        The NTP is now moving forward with preparation of the 13th
    report. We have changed some elements to enhance transparency
    and efficiency in the process but still maintain rigorous,
    independent, external peer review, and multiple opportunities
    for public input. Among the changes to enhance transparency, we
    will now prepare a single literature review document that
    systematically assesses all relevant literature and explains
    how the entity reaches its conclusions for its proposed listing
    recommendation. This document will be disseminated for public
    comment prior to public external scientific peer review.
        We believe that the Report on Carcinogens is and will
    remain an important public health document that improves the
    public and decision makers, provides, and empowers the public
    and decision makers with information about cancer hazards.
        I appreciate this opportunity to discuss the report and
    would be happy to answer any questions. Thank you.
        [The prepared statement of Dr. Birnbaum follows:]
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        Chairman Broun. Thank you, Dr. Birnbaum.
        Mr. Maresca, you are now recognized for five minutes.

                  STATEMENT OF MR. CHARLES A. MARESCA,

                    DIRECTOR OF INTERAGENCY AFFAIRS,

                          OFFICE OF ADVOCACY,

                   U.S. SMALL BUSINESS ADMINISTRATION

        Mr. Maresca. Chairman Broun, Ranking Member--Chairwoman
    Ellmers, Ranking Member Tonko, Ranking Member Richmond, Members
    of the Committees, good morning. Thank you for the opportunity
    to appear before you today to discuss small business concerns
    with the Department of Health and Human Services Report on
    Carcinogens.
        As Director of Interagency Affairs at the Office of
    Advocacy at the U.S. Small Business Administration, I manage a
    team of attorneys that works with small businesses and Federal
    Government agencies during the rulemaking process to reduce
    regulatory burdens on small business.
        Chief Counsel for Advocacy Winslow Sergeant wrote in a
    letter to HHS on November 22, 2011, that small businesses have
    two primarily concerns with the report, that substances have
    been listed in the RoC based on potentially inaccurate
    scientific information and that the peer review and public
    comment processes should be improved.
        Accurate and credible scientific assessments are vital for
    small businesses. Listing a substance in the report has the
    potential to curtail the use of the substance. This may lead to
    substantial adverse economic impacts for small businesses that
    use that substance, including increased costs of insurance and
    Workers' Compensation premiums.
        Further, when the Federal Government incorrectly lists a
    substance as a carcinogen or as a potential carcinogen, small
    businesses may experience lasting negative economic impacts.
        Also, technical labels can be misinterpreted and confuse
    the public about the true lead to questions about the true
    nature of the risk to health and safety. For example, although
    the report lists substances as reasonably anticipated to be a
    human carcinogen or known to be a human carcinogen, the caveat
    states that the listing of substances in the report only
    indicates a potential hazard and does not establish the
    exposure conditions that would pose cancer risks to individuals
    in their daily lives. The important distinction between hazard
    and risk is not understood by most consumers. Consumers and
    small businesses are likely to be more aware of whether the
    substance is listed than of the caveat.
        Small businesses are concerned with the soundness of the
    science underlying listing decisions. First, because it is a
    hazard-based listing, not a risk-based listing, the report has
    little value for estimating actual cancer risk to the general
    public even though the listings appear to indicate that there
    is a cancer risk. Second, NTP's weight-of-evidence analysis
    does not appear to account for inconsistent or contradictory
    data.
        A more robust weight-of-evidence analysis would consider
    all scientific data, including contradictory or inconsistent
    data.
        Small businesses are also concerned with the report's
    preparation process. The 12th RoC process did not provide
    sufficient opportunity for meaningful peer review or public
    comment. The peer reviewer process did not include adequate
    dialogue between NTP and the peer reviewers, nor did NTP
    provide adequate response to peer review or public comments.
        Although on paper the 12th RoC preparation process included
    several opportunities for public comment, small businesses
    found that NTP did not respond meaningfully to their comments.
    Because public comment is the primary method by which small
    businesses can contribute to the report's preparation process,
    it is important that such opportunities be meaningful.
        Finally, Advocacy is concerned with NTP's recent review of
    the 12th RoC preparation process for three reasons. First, the
    review process needs improvement. Second, the review of the
    12th RoC preparation process was a process-based review only
    and did not address substantive scientific concerns, and,
    third, the new preparation process for the upcoming 13th RoC
    should bolster opportunity for peer review or require NTP
    response to peer review and public comment.
        Advocacy commends two positive changes that resulted from
    the 12th RoC review process, including an additional
    opportunity for public comment and two additional opportunities
    for interagency comment.
        Small business relies on credible and reliable science.
    NTP's review of the 12th RoC demonstrates that it is aware that
    there are concerns with the RoC. However, NTP needs to make
    further improvements in order to ease concerns. To the extent
    that NTP can improve the scientific reliability as well as the
    peer review and public comment processes for the report, there
    will be a measurable burden reduction on small businesses.
        I would like to thank you once again for inviting me to
    speak to you today. I commend the Committee's interest in
    improving and fostering legitimacy in the report's listings,
    and I would be happy to respond to questions.
        [The prepared statement of Mr. Maresca follows:]
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        [GRAPHIC] [TIFF OMITTED] 74059.044

        Chairman Broun. Thank you, Mr. Maresca. We are going to
    give you that opportunity in just a second. I thank you all for
    your testimony.
        Reminding Members that Committee rules limit questions to
    five minutes. The Chair will, at this point, open the first
    round of questions, and I recognize myself for five minutes.
        Dr. Birnbaum, NAS's review of the 12th RoC listing of
    styrene and formaldehyde regarding that, last year Congress
    directed HHS to contract with the National Academies to review
    two of the 12th RoC's determinations. What is the status of
    this review, and when will HHS direct NAS to move forward with
    the review?
        Dr. Birnbaum. The Office of the Assistant Secretary of
    Health was charged with that, with contracting with NAS. I
    understand they are in the process of developing that contract
    with the Academy. They expect it to be in place by the fall.
        Chairman Broun. Okay. So can we be assured that it will be
    in place by the fall?
        Dr. Birnbaum. This is the responsibility for the Assistant
    Secretary of Health. They are working on it. They are doing
    everything they can to complete it by the end of this fiscal
    year, September 30.
        Chairman Broun. Very good. Thank you so much. I certainly
    look forward to that being completed.
        Mr. Maresca, is the RoC a highly influential scientific
    assessment?
        Mr. Maresca. The RoC is the first step in regulations that
    depend on science. Yes.
        Chairman Broun. The written testimony submitted by
    witnesses on the second panel have indicated that roughly
    250,000 jobs are associated with just one substance. OMB
    considered the scientific assessment to be, ``highly
    influential if it could impact public or private sector by more
    than $500 million in one year,'' or is, ``novel, controversial,
    or precedent setting or has significant interagency
    interests.''
        Do you consider the RoC to be a highly influential
    statement in those regards?
        Mr. Maresca. Mr. Chairman, I do not know how it would be,
    how the impact would be calculated. I do know that it is
    influential among, within the agencies.
        Chairman Broun. Okay. Very good. Again, Dr. Birnbaum, the
    13th RoC will contain a new category called candidate
    substances. Stakeholders are already concerned that a listing
    as reasonably anticipated inappropriately stigmatized
    substances without sufficient evidence as evidenced by the
    attention RoC has received over the past year.
        How will HHS prevent substances from being stigmatized
    simply by adding to this lower-level category without any
    justification or review?
        Dr. Birnbaum. I am sorry, Mr. Broun, but I am not aware of
    our adding any additional categories. The Congress in its
    wisdom gave us two categories, known and reasonably
    anticipated. Candidate substances are these chemicals or the
    substances or the biological agents that may be considered
    under the RoC. A candidate substance is not a category of
    carcinogen.
        Chairman Broun. Okay, but will this be published with the
    RoC, or is it going to be an interagency or within the agency
    as a--just a process of looking at potential substances?
        Dr. Birnbaum. Anyone can nominate candidate substances for
    evaluation in the Report on Carcinogens process. The first step
    in that nomination will be that candidate substances will be,
    information will be gathered on them and an expert group will
    review that nomination to decide whether there is enough
    information, and that will also include public comments at that
    point in time to go forward with a full-scale evaluation.
        Chairman Broun. Okay. Very good. Dr. Birnbaum, what action
    should consumers take in response to a substance listing in the
    RoC?
        Dr. Birnbaum. Reducing exposure to cancer-causing agents is
    important to public health and the Report on Carcinogens
    provides important information on substances that might pose a
    potential cancer risk, and individual's knowledge is power, and
    individuals can make decisions about what hazards that they can
    or are willing to be exposed to.
        Chairman Broun. One of the substances that are proposed for
    consideration in the 13th RoC is shiftwork involved light,
    involving light at night. Does this mean that people who work
    the third shift, including those in 24-hour places like a
    police station, the hospital should perhaps start thinking
    about limiting their exposure to the substances listed in this
    report?
        Dr. Birnbaum. There is always a balance between risk and
    benefit, and there is growing new scientific information that
    indicates that shift work may, in fact, have health
    consequences, including cancer.
        Chairman Broun. So we are going to outlaw working at night,
    I guess, if somebody takes that tact.
        My time has expired.
        Now I will recognize Mr. Tonko for five minutes.
        Mr. Tonko. Thank you, Mr. Chair.
        Now, I care about businesses in America, as I am certain
    everyone on the panel does, and I am also deeply concerned,
    however, about the impact of carcinogens on the lives of
    children, workers, sailors, soldiers, our veteran's community,
    and the public health professionals who work with them. Those
    voices are missing from today's hearing, as I earlier stated.
        Dr. Birnbaum, if you could give us insight into the other
    stakeholders in the work of the National Toxicology Program
    that we should be hearing from and why they would care about
    the information and the data you assemble.
        Dr. Birnbaum. Thank you, Mr. Tonko. I think it would be
    very important that we heard from some of the expert scientists
    who actually were involved in the conduct of these studies. I
    think that their expert, unconflicted advice would be very
    important to understanding the impacts that some of these
    compounds may have, have the potential to have on human health.
    I think the general population, public health experts, workers,
    but to me, I think it would be very important that you heard
    from the scientists who actually were involved in these
    studies.
        Mr. Tonko. We highlighted some of those in that stakeholder
    category. Beyond what I made mention, are there others you
    would list that might be included as stakeholders?
        Dr. Birnbaum. The National Toxicology Programs reporting
    carcinogens is intended as a public health document, and so it
    informs all stakeholders. I think it is very important, and
    many small businesses, in fact, are very interested in making
    sure that their workers are safe.
        Mr. Tonko. Uh-huh, and today we are hearing allegations
    that the process used for the 12th RoC was not transparent. Can
    you briefly explain how public comments and public input were
    considered during the listing process?
        Dr. Birnbaum. So public comments were taken six times
    during the preparation of the 12th Report on Carcinogens. There
    were four opportunities for written comments. All those written
    comments were not only posted on the Web for information, they
    were all provided to the different expert panels each time for
    their consideration. There were also two opportunities for oral
    public comment, both at different public meetings that were
    held to discuss the RoC. All the public comments were looked
    at. The peer panels and the expert panels discussed those
    public comments, and the NTP took them all into consideration
    in its final determination.
        Mr. Tonko. Now, I also believe there may be some confusion
    about what the Report on Carcinogens is and what the Report on
    Carcinogens is not. Do you consider the RoC to be a regulatory
    document? And if not, why not?
        Dr. Birnbaum. The RoC is not a regulatory document. It is a
    hazard assessment document. It looks at all the information,
    and I think that is important to state. It looks at all the
    information, both positive and negative, that is all evaluated
    and then the information which supports the determination of
    whether the compound has the potential to cause cancer, either
    as a known or reasonably anticipated carcinogen, is compiled to
    make the public health document, which is the substance profile
    part of the Report on Carcinogens. All of the information,
    however, positive and negative and all the discussion about it
    are available on the Website.
        Mr. Tonko. And do you think the general consensus out there
    is that it, indeed, is not regulatory? Do you hear from groups
    or individuals?
        Dr. Birnbaum. Yes. I think that it is understood by the
    scientific experts and most of the community that it is not a
    regulatory document.
        Mr. Tonko. Okay. Again, I think that as you have indicated
    with your comments here, the balance that we need to strike as
    a Subcommittee in order to have an in-depth and fair and
    balanced review would require that we hear from these other
    stakeholders and then and only then can we come up with a
    meaningful assessment of the NTP and the RoC.
        And so I appreciate your input, and Mr. Chair, I will yield
    back with, again, the request that we put together the efforts
    to host yet another hearing that would provide additional
    parties so as to strike with a full balance.
        Chairman Broun. Well, thank you, Mr. Tonko. I want to
    remind my good friend that this is about the process, not about
    the evaluation of any specific substance, and we have included
    in the record six, I think, of the seven letters that you have
    indicated, and so they are part of this record, and we are just
    trying to look at the process in this hearing, not whether a
    given substance should be included or not included. We are just
    looking at the process and what, how that process affects any
    given entity.
        So I thank you, and we will just, you and I can work
    together as we go forward.
        Mr. Tonko. Mr. Chair, if I might just suggest that
    developing the comments of those who have presented letters,
    many of us, having them more fully develop their thought on the
    process would be, indeed, helpful.
        Chairman Broun. Well, thank you, Mr. Tonko, and I want to
    remind you that I am a physician, and I am concerned about
    these, and Mrs. Ellmers is also a registered nurse, and she is
    concerned. She has been in the health care field for a long
    period of time.
        So both of us as Chairs are really interested not only in
    this process but also in protecting my patients and her
    patients also.
        Mr. Tonko. Well, for us non-health care professionals on
    the panel, as for us engineers, we want data and be able to
    assemble data and problem solve as engineers do.
        Chairman Broun. Again, sir, this is about the process of
    developing the RoC.
        Now recognize Chairman Ellmers for five minutes.
        Chairwoman Ellmers. Thank you, Mr. Chairman.
        I would like to start, Mr. Maresca, just for clarification
    purposes, to be clear, the Office of Advocacy is part of the
    U.S. Small Business Administration, a federal agency. Is this
    correct?
        Mr. Maresca. That is correct.
        Chairwoman Ellmers. Okay. The federal agency or the chief
    counsel for the federal agency who heads the Office is an
    appointee of President Obama. Is that correct?
        Mr. Maresca. That is correct.
        Chairwoman Ellmers. Thank you. Mr. Maresca, starting with
    the questions that I have for you on this issue, why did the
    Office of Advocacy decide to send a comment letter to the
    National Toxicology Program regarding the Report on
    Carcinogens?
        Mr. Maresca. We did hear from a number of small businesses
    and their representatives that there was a problem with the
    12th RoC. When we looked into it, we realized that there was
    going to be an impact on small business as a result of the
    listing of those substances, and as a result we sent that
    letter.
        Chairwoman Ellmers. All right. What does Advocacy think the
    National Toxicology Program can do to improve the Report on
    Carcinogens? What would be your input on that?
        Mr. Maresca. Well, as we said in our letter, we think that
    they can do a weight-of-evidence analysis during the process,
    looking more completely at the contradictory data as well as
    the data that supports the listing. We think that they can also
    improve the peer review and public comment process by including
    in those stages some response to the public comment and to the
    peer review.
        Chairwoman Ellmers. Thank you, Mr. Maresca, and Dr.
    Birnbaum, on that last response from Mr. Maresca, what do you
    do with the public comments? Do you respond to all the public
    comments, and to what point in the process does this occur?
    Before or after the Report on Carcinogens is published?
        Dr. Birnbaum. Thank you for the question, Mrs. Ellmers. The
    public comments come at different stages as I said before, and
    we listen to them, we consider them. They often lead to changes
    in what we determine or modifications in how we do things. For
    the 12th report, we did respond to all the public comments at
    the time that the document was released. For the 13th report,
    we intend to have the public comments actually discussed at the
    expert peer review meeting.
        Chairwoman Ellmers. Now, as the NTP develops the 13th
    edition of the Report on Carcinogens, do you think that the
    potential regulatory consequences of listing a substance should
    be considered? Now, I know, you know, as you have pointed out
    that this is a hazard assessment document, but because
    sometimes it seems to be used as this, do you think that this
    might improve it if we did look at the potential regulatory
    consequences?
        Dr. Birnbaum. Our charge from the Congress is to evaluate
    the potential for compounds to be a known carcinogen or
    reasonably anticipated carcinogen. Our charge is not to
    consider regulatory consequences.
        Chairwoman Ellmers. Okay. When new studies are published
    that provide additional scientific information regarding a
    substance already listed as a known carcinogen or reasonably
    anticipated to be a carcinogen, does the NTP review the new
    information and reexamine the listing decision?
        Dr. Birnbaum. If new information becomes available that
    might question the listing or cause a change in the listing,
    NTP will, if it is nominated to us or we self-nominate, we will
    begin to the process of evaluating and it can alter the listing
    about whether something can actually be removed from the list
    or downgraded or revised.
        Chairwoman Ellmers. With your response, one of the issues
    that has been raised is the timeframe that we are talking
    about. How quickly does the NTP review and reexamine the
    listing decisions, and does it take months or years?
        Dr. Birnbaum. It would depend upon the topic and the
    compound and the amount of new data that becomes available and
    how important that new data is. But I can tell you that even at
    the times of the external peer review and response to public
    comments can have an impact on how we might list or not list a
    compound.
        Chairwoman Ellmers. Thank you very much to both of you for
    your responses, and I yield back the remainder of my time.
        Chairman Broun. Thank you, Mrs. Ellmers.
        I now recognize my good friend from Louisiana, Mr.
    Richmond. I sure hope that the crawfish never get on the RoC.
    Mr. Richmond, you are recognized for five minutes.
        Mr. Richmond. Well, we certainly have an interest in
    formaldehyde considering the tens of thousands of trailers that
    contain formaldehyde that our people in Louisiana lived in
    after the storm.
        Dr. Birnbaum, the specific--and I want to just give you a
    chance to respond to the specific concerns which the 12th RoC
    process did not provide sufficient opportunity for meaningful
    peer review, and there was inadequate dialogue between NTP and
    the peer reviewers, lack of peer reviewer access to public
    comments, inadequate time and resources to perform the review
    and inadequate NTP responses to peer review comments.
        Dr. Birnbaum. I am sorry that you have had some
    misinformation if you heard that there was inadequate time for
    peer review, that the peer reviewers did not receive the public
    comments. All that was--is not true. In fact, the information
    was provided to all of them. There was extensive time for great
    peer review of all of the information. We held a special expert
    panel dealing with the issue of formaldehyde carcinogenesis.
        Mr. Richmond. And Mr. Maresca, before I get to you, Dr.
    Birnbaum, and I am trying to apply this to, you know, sometimes
    we speak in theory up here and sometimes I try to get it to
    reality. I remember growing up and my grandfather and all of
    his brothers owned funeral homes, which are, you know, the very
    basic of small businesses, and I noticed after he passed and
    years when I went back, I noticed that the embalming room, the
    door to the embalming room now has a big sign that says wear
    protective gear and formaldehyde may cause cancer.
        Well, my brother and all of his--I mean, my grandfather and
    all of his brothers who owned funeral homes and who were
    embalmers all developed a sense of cancer. Is this something
    that would come from NTP or at least a warning sign, or is that
    what we are talking about here? Yes.
        Dr. Birnbaum. NTP does not provide the warning signs.
        Mr. Richmond. Right.
        Dr. Birnbaum. It provides some of the information. NTP
    first listed formaldehyde as reasonably anticipated to be a
    human carcinogen in 1980. It then updated it in the 12th report
    to known carcinogen based upon a series of epidemiology studies
    in people, looking at thousands of workers in different
    occupations. Embalmers were one of those occupations.
    Embalmers, garment workers, and chemical workers and in all
    cases there was a relationship between the extent of the
    exposure, the duration of the exposure, how high the exposure
    was to formaldehyde, and the carcinogenic response, which
    appeared to be myeloid leukemia in those studies.
        Mr. Richmond. And just taking those examples and wearing my
    lawyer hat and small business side and all the other hats, it
    would seem to me that that information gives everybody an
    opportunity to act. It gives employers the ability to warn
    employees, it gives the chemical manufacturer the ability to
    warn suppliers and people who are going to use it, and or take
    necessary action to cover themselves from unnecessary liability
    and to protect the public at the same time.
        Is that the goal of what we are trying to do here?
        Dr. Birnbaum. Again, we are providing the information that
    decision makers and the public can use to protect health, and
    OSHA does take the NTP information and requires, for example,
    that if something is reasonably anticipated to be a human
    carcinogen, it does require labeling information, and it
    requires that to be on their material safety data sheets.
        Mr. Richmond. Mr. Maresca, now I will give you the same
    opportunity to respond to the critiques of the 12th report if
    you want to do that.
        Mr. Maresca. The--well, our response to the critiques is
    that we do believe the science could be improved and that the
    peer review process and public comment process could be
    improved. We do know that OSHA, that a listing in the RoC would
    require changes, a new listing to the RoC would require changes
    to manufacturers' safety data sheets.
        Mr. Richmond. And I guess the ultimate question, at some
    point a decision is going to have to be made one way or the
    other no matter how much peer review you have and no matter how
    much, you know, it is almost like being a judge and listening
    to two dozen experts on each side who are both advocating
    opposite positions, and at some point someone has to make a
    decision.
        How much do we allow for the back and forth until we are
    satisfied that the people who are charged with making a
    decision have to make a decision?
        Mr. Maresca. Well, I think more than what we have now is
    the quick answer to your question. A little bit more response
    to peer reviews, for example, more dialogue between the Agency
    and the public, more dialogue among the peer reviewers.
        Mr. Richmond. Thank you, Mr. Chairman. I see that I am out
    of time. I yield back.
        Chairman Broun. Thank you, Mr. Richmond.
        I now recognize Mr. Miller for five minutes.
        Mr. Miller. Thank you, Mr. Chairman. I do know Dr.
    Birnbaum. She--I don't think she lives in my district. She
    lives in my area, and I have seen her on many occasions, and I
    know her reputation, which is excellent, and I know the
    reputation of the scientific work done at NIEHS, and that is
    excellent, and I have relied upon her judgment on some
    occasions and have always found her judgment to be sound.
        Mr. Maresca.
        Mr. Maresca. Uh-huh.
        Mr. Miller. In my 20s I spent a year at University, as they
    would say, in London. I am not a gifted natural athlete. I
    think I am on the right slope of the athleticism bell curve,
    but the curve is still really fat where I am. But I like
    playing pick-up basketball, and a buddy I went to school with,
    the buddy I was at University with, played pick-up basketball,
    but I heard about a pick-up game among Americans living in
    London at an American school on Sunday afternoons. I showed up,
    and they let me play, but it quickly became apparent that I was
    just way, way out of my depth. And between the games I overhead
    the conversations, and everyone else in the game was actually
    living in Europe because they were playing European pro ball.
        Mr. Maresca, that is probably how you should feel sitting
    today beside Dr. Birnbaum in talking about the subject that is
    before us. Dr. Birnbaum has her Master's and her Ph.D. in
    microbiology. She has published 700--more than 700 peer
    reviewed publications, book chapters, abstracts, reports. They
    appear--her own original research is entirely in the area of
    public health effects of chemical exposures. She is an adjunct
    faculty member both in public health, toxicology, environmental
    sciences at the University of North Carolina, Chapel Hill, my
    alma mater, an excellent institution as well as a nearby
    university of lesser reputation. And you are a lawyer. Isn't
    that right?
        Mr. Maresca. That is correct.
        Mr. Miller. And the agency that you head, the office that
    you head is not a science policy office, and you are not a
    scientist. Isn't that right?
        Mr. Maresca. That is correct.
        Mr. Miller. Okay, and it is not the task of your agency to
    protect public health or the quality of the environment,
    environmental quality. Isn't that right?
        Mr. Maresca. That is correct.
        Mr. Miller. Okay. Do you have scientists who performed an
    independent assessment of the claims of the styrene industry
    about the evaluation of the scientific literature and any
    irregularities in the scientific process?
        Mr. Maresca. We do not.
        Mr. Miller. Okay. Is there anything that you have said in
    your testimony today that--we know the styrene industry has
    spent close to $1 million dollars in lobbying in just the last
    two years on this issue. Is there anything that you said in
    your testimony today that differs in any detail from the
    criticisms of the styrene industry?
        Mr. Maresca. I am not as familiar with the, all of the
    criticisms of the styrene industry. They were among the small
    businesses who did come to our office to suggest that there
    were problems with the 12th RoC.
        Mr. Miller. Okay. So your testimony today, your criticisms
    have come to you from the styrene industry. Is that correct?
        Mr. Maresca. In part. Yes.
        Mr. Miller. Okay, and you--according to your newsletter and
    actually the styrene industry's lobbying arms newsletter,
    claimed credit for this hearing today, for having obtained this
    hearing.
        But your newsletter said that you had a round table
    discussion of NIHES--NIEHS Report on Carcinogens and that
    representatives from the American Chemistry Council and
    Regulatory Checkbook were there. Was anyone from NIEHS there?
        Mr. Maresca. I do not believe so.
        Mr. Miller. Okay. Was Dr. Belzer, who will testify on the
    next hearing, was he at that----
        Mr. Maresca. I believe he was.
        Mr. Miller. Okay, and Mr. Tonko's statement today
    includes--he added to it a small business owner's statement
    that they actually manufacture, I wouldn't have thought of the
    styrene industry as being a small business, but there is
    someone who is developing another form of packing material from
    mushrooms, and he says that actually what you are advocating
    for today is hurting their interests. Were they included in the
    round table?
        Mr. Maresca. I am not familiar with that letter, so I
    couldn't tell you.
        Mr. Miller. Okay. Mr. Chairman, I will yield back my last
    11 seconds.
        Chairman Broun. Glory be. Thank you so much, Mr. Miller. By
    the way, I did not know that Dr. Birnbaum was a professional
    basketball player in Europe, and I appreciate you bringing that
    to our attention, and I would also like to remind my friend if
    you had looked at the second panel, there is Dr. Bus, who is a
    toxicologist, who will be presenting to us today also.
        So now I recognize my good friend, Mr. McNerney, for five
    minutes.
        Mr. McNerney. Thank you, Mr. Chairman, and I thank you for
    holding a hearing that is not specifically designed to bash the
    Administration.
        Dr. Birnbaum, can you tell us what evidence the National
    Toxicology Program used in listing styrene as a reasonably
    anticipated to be a carcinogen?
        Dr. Birnbaum. There were over, between 400 and 500 papers
    that were----
        Chairman Broun. Dr. Birnbaum, your microphone.
        Dr. Birnbaum. Sorry. There were over 400 to 500 papers or
    more that were looked at in the background document that were
    involved in assessing the health effects of styrene. There were
    many--there were three groups of expert witnesses who reviewed
    it, plus our Board of Scientific Counselors. There were votes
    taken at all of the expert groups, and of the 32 votes, 30 were
    for listing styrene. Thirty-one of the 32 were for listing
    styrene, and of those 31 there were actually several votes for
    listing it as a known carcinogen.
        Mr. McNerney. So you wouldn't consider that to be a
    controversial issue within the review groups?
        Dr. Birnbaum. I think not. I think the only discussion
    among one of the review groups was should it be listed as known
    or reasonably anticipated.
        Mr. McNerney. Well, the Report on Carcinogens lists many
    different substances that are known to be human carcinogens or
    reasonably anticipated to be human carcinogens. Why do you
    believe that the styrene and the formaldehyde in particular
    have generated so much controversy? If I may ask.
        Dr. Birnbaum. I think these are high-volume use compounds,
    but we have had controversy on some of our listings in the past
    as well.
        Mr. McNerney. Thank you. One of the things that I hear
    complaining from the industry groups is that there were public
    comments, and there were no response to those comments. How
    many public comments were there? Would it have overwhelmed the
    resources of your department to try to respond to each one of
    those comments?
        Dr. Birnbaum. Yes.
        Mr. McNerney. Thank you. Mr. Maresca claims, and this is
    still for Dr. Birnbaum, that several studies refute your
    listing of styrene as a reasonably anticipated to be a human
    carcinogen. Can you explain the discrepancies between the
    studies, your studies and the studies of the other side?
        Dr. Birnbaum. We looked at all of the studies, both the
    studies that demonstrated an association in humans for styrene
    and where some of the negative studies. Our conclusions were
    that the evidence in humans was limited. We also, though, found
    that styrene is a carcinogens in experimental animals by two
    routes of exposure by both oral and inhalation, and we also
    found that styrene is well known to be metabolized to a
    chemical called styrene oxide, and that can be found
    circulating in the blood of workers who are using styrene, and
    we have also found chromosomal aberrations. Those are genetic
    problems in the blood of workers who are exposed to styrene.
        So listing it as reasonably anticipated was based not on
    one of the three potential criteria to put it in that category
    but upon all three.
        Mr. McNerney. Does this listing apply to public use of
    styrene or to workers in styrene production or both?
        Dr. Birnbaum. All the human studies involve highly exposed
    workers.
        Mr. McNerney. So using a styrene cup is not really going to
    expose you to unnecessary cancer risks.
        Dr. Birnbaum. We are not concerned about any styrene that
    might leak from a polystyrene cup.
        Mr. McNerney. Thank you for your direct answers, and I
    yield back.
        Chairman Broun. Thank you, Mr. McNerney.
        I want to thank the witnesses for you all's valuable
    testimony and the Members for your questions. The Members of
    this, of either Committee may have additional questions for
    either of you, and we will ask you to respond to those
    questions in writing as expeditiously as you possibly can.
        Mr. Tonko. Mr. Chair. Point of clarification.
        Chairman Broun. Certainly.
        Mr. Tonko. I am just wanting to clarify, and I am doing
    this via the document from the Office of Advocacy from the SBA,
    and in their coversheet with testimony, they offer a letter to
    Secretary Sebelius at HHS, indicating that as Advocacy, as an
    independent body within the United States Small Business
    Administration, the views expressed by Advocacy do not
    necessarily reflect either the position of the Administration
    or the SBA.
        So I think that is important to clarify, and also in----
        Chairman Broun. I think that letter, I think you already
    have----
        Mr. Tonko. Right.
        Chairman Broun. It is submitted, and so you can ask any
    further questions by writing if you don't mind because we need
    to forge ahead.
        The record will remain open for two weeks for additional
    comments from Members, not to cut you off, but it will remain
    open so that you can make other comments. Witnesses are
    excused. We will move to our second panel. Thank you so much
    for participating today.
        And if the second panel will take your seats very quickly,
    we would appreciate it.
        While they are being seated, at this time I would like to
    introduce our second panel. First is Dr. James S. Bus. He is
    the Director of External Technology, Toxicology, and
    Environmental Research and Consulting for the Dow Chemical
    Company. Ms. Ally LaTourelle, Esquire, is the Vice President
    for Government Affairs at Bioamber, Incorporated, and Dr.
    Richard Belzer is the President of Regulatory Checkbook.
        And I recognize Chairwoman Ellmers for introducing the
    remaining witnesses.
        Chairwoman Ellmers. Thank you, Mr. Chairman.
        I would like to introduce Dr. Grimsley, who was invited to
    testify by my colleague, Ranking Member Richmond. She is a
    Certified Industrial Hygienist. She is currently on special
    leave from Tulane University School of Public Health and
    Tropical Medicine, where she is an Associate Professor.
        Chairman Broun. Thank you, Mrs. Ellmers.
        As our witnesses should know. Oh, I am sorry.
        Chairwoman Ellmers. I apologize.
        Chairman Broun. Go right ahead. I thought you had finished.
        Chairwoman Ellmers. This process is a little different than
    what we have in Small Business, so I----
        Chairman Broun. That is quite all right.
        Chairwoman Ellmers. I would also like to introduce Bonnie
    Webster, who is the Vice President of Monroe Industries in
    Avon, New York. Monroe Industries is a cast polymer company
    that manufactures high-end custom showers and vanity tops and
    has seven employees.
        I would also like to introduce John Barker. He is Corporate
    Manager of Environmental Affairs, Safety and Loss Prevention
    for Strongwell Corporation, which is headquartered in Bristol,
    Virginia. Strongwell Corporation manufactures ballistics panels
    and bridge beams and platforms and employees 465 people in
    their three facilities.
        Dr. Grimsley, Ms. Webster, and Dr. Barker, we very much
    look forward to your testimony today, and I yield back now, Mr.
    Chairman.
        Chairman Broun. Thank you, Mrs. Ellmers.
        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.
        As I noted before, it is the practice of the Subcommittee
    on Investigations and Oversight to receive testimony under
    oath, and we will use that practice here today.
        Do any of you have an objection to taking an oath?
        Okay. Very good. Let the record reflect that all witnesses
    are willing to take the oath. You also may be represented by
    legal counsel. Do any of you have counsel here today?
        Okay. Let the record reflect that none of the witnesses
    have counsel.
        Now, if you would each would please stand and raise your
    right hand. Do each of you solemnly swear and affirm to tell
    the whole truth and nothing but the truth, so help you God?
        Okay. Please be seated. Let the record reflect that all
    witnesses have taken the oath.
        I now recognize Dr. Bus for five minutes.

                     STATEMENT OF DR. JAMES S. BUS,

              DIRECTOR OF EXTERNAL TECHNOLOGY, TOXICOLOGY,

               AND ENVIRONMENTAL RESEARCH AND CONSULTING,

                        THE DOW CHEMICAL COMPANY

        Dr. Bus. Good morning. My name is Dr. James Bus. Over my
    career as a toxicologist, I have served as the President of the
    Society of Toxicology and served on science advisory bodies of
    the National Academy of Sciences, the EPA, the FDA, and the
    NTP. I am here today as a concerned scientist and represent the
    Styrene Information and Research Center, of which my employer,
    the Dow Chemical Company, is a founding member.
        I, Dow, and the styrene industry are keenly interested in
    protecting the health and safety of workers, customers, and the
    public. Objective, evidence-based reviews of the scientific
    research are essential elements in our decision making about
    products and facilities.
        The NTP is globally recognized as an authoritative body.
    Chemical classifications in its RoC carry significant
    consequences for businesses, large and small, including
    regulatory actions and commercial impacts.
        Thus, it is essential that the RoC classifications
    represent the highest quality scientific evaluations. My
    comments today focus on three shortcomings of the NTP's RoC
    process and are based in part on issues revealed in recent RoC
    evaluations, including styrene.
        First, the RoC process is almost entirely ad hoc and lacks
    explicit criteria necessary to assure consistency and
    transparency. Importantly, NTP's RoC process is completely
    silent about criteria needed to guide scientific evaluations at
    several key process stages.
        For example, draft monographs provide the primary rationale
    for RoC classifications. Yet the recently updated RoC process
    states that monograph reviews only include, ``external
    scientific input as needed, for example, consultants, ad hoc
    presentations, expert panels.''
        A 2011 NAS assessment of the EPA review of formaldehyde
    details a number of scientific best practices for assessments
    of chemicals in general and points out that ad hoc review
    processes cannot be relied on to produce scientifically valid
    assessments.
        Indeed, evidence-based approaches are now being used by
    other institutions such as the Institute of Medicine.
        Second, the RoC process lacks adequate checks and balances,
    including peer review and addressing outside or conflicting
    data. NTP's new process limits review by its Board of
    Scientific Counselors to NTP's initial draft concept document,
    which is akin to an outline of what the NTP's review intends to
    examine. Peer review of the critical draft monographs by
    external panels is left entirely to the discretion of the NTP,
    including the key steps of expert panel member selection and
    identification of review charge questions.
        In addition, interagency review of draft monographs is
    reduced to providing inputs that will only be considered at the
    discretion of the NTP and are not further shared with the
    expert panels or the public.
        Finally, draft monographs are presented to the NTP Board of
    Scientific Counselors for information only, denying this senior
    advisory panel any meaningful peer review. This is not
    transparent or credible peer review.
        Finally, the RoC fails to employ scientific best practices,
    relies on outdated approaches, and has not adopted recent NAS
    recommendations. The NAS has specifically outlined several
    fundamental best practices necessary to assure that the
    processes for toxicology-related assessments of chemicals are
    evidence based, objective, and scientifically credit. The
    process used to prepare the RoC falls considerably short of
    those objectives.
        For example, NTP has previously stated that RoC reviews are
    based on strength of evidence as compared to the more
    comprehensive weight of evidence analyses used by groups such
    as the Institute of Medicine. The RoC heavily favors finding
    supporting NTP's proposed listing position while contrary
    findings are seldom given much weight.
        Although external public comment is solicited, NTP has
    stated as a matter of policy it will no longer offer any
    written response, thereby masking the existence of different
    scientific views.
        In summary, the current RoC process falls well short of
    producing evidence-based decisions. I urge Congress to oversee
    a thorough assessment of the RoC, ideally through an NAS
    review, to ensure that any future RoC listings are evidence
    based, provide accurate public health information, and reflect
    the highest scientific standards in its processes and to begin
    to determine the RoC's fundamental relevancy going forward.
    This will increase the public's and industry's confidence in
    the RoC listings and their applications to science-informed
    decision making.
        Thank you.
        [The prepared statement of Dr. Bus follows:]
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        Chairwoman Ellmers [presiding]. Thank you, Dr. Bus.
        I would now like to introduce Dr. Grimsley for five
    minutes. Thank you.

                   TESTIMONY OF DR. L. FAYE GRIMSLEY,

                 ASSOCIATE PROFESSOR, TULANE SCHOOL OF

                  PUBLIC HEALTH AND TROPICAL MEDICINE,

           DEPARTMENT OF GLOBAL ENVIRONMENTAL HEALTH SCIENCES

        Dr. Grimsley. Good morning. My name is Faye Grimsley. I am
    Associate Professor of Global Environmental Sciences, Tulane
    University. I am currently on special leave as a Yerby Visiting
    Associate Professor, Department of Environmental Health,
    Harvard School of Public Health. My testimony today will focus
    on the process of the NTP Program's RoC, the impact of the
    Report on Carcinogens on jobs, and why the National Toxicology
    Program is important.
        First of all, the process involves a number of peer reviews
    first by Expert Panel; second, by Interagency Scientific Review
    Group; third, the NIEHS/NTP Scientific Review Group; and
    finally, review by the NTP Board of Scientific Counselors.
    Comments from the public are solicited during steps one through
    three of the process. When the Expert Panel meets to review the
    background documents and NTP Board of Scientific Counselors
    meets to review draft substance profiles, the public is invited
    to attend. Closed meetings are held when listing or removal
    status recommendations are made for selected substances.
    Although there are a number of closed meetings to discuss and
    recommend listing status of specific substances, the review
    process is transparent and open to the public for criticisms
    and opinions during the review process.
        The impact of the NTP RoC process on jobs. We know that
    according to NIOSH it is well documented that associations
    between occupational exposures and cancer exists. From an
    environmental health scientist point of view and an industrial
    hygienist, the NTP process is a valuable resource of
    information and is often cited and referred when carcinogenic
    information is needed. Any chemical substance listed by the RoC
    will impact the health of workers and the public. The review
    process should consider what impact this will have on
    businesses of all sizes. Whenever new regulations or standards
    are introduced, use of state-of-the-art technologies and
    practices to protect worker health may be beyond resources of
    small businesses. Small entities often have limited resources.
    Agencies charged with health and safety of the public and
    workers should anticipate and provide assistance and resources
    to these entities to relieve any additional strain of
    compliance.
        Most health and safety personnel, regardless of company
    size, would agree that additional requirements are involved
    when new chemicals are designated as a carcinogen or potential
    carcinogenic agent, but the benefits of knowing that readily
    available lists of carcinogenic chemicals relieve some of the
    burden of identifying one category of toxic substances which
    workers have a potential for exposures and adverse health
    effects if needed.
        Why the NTP is important to public health: with more and
    more chemicals being developed and used by society and in the
    workplace, databases that contain toxicity and health and
    safety information developed by the NTP process, and others
    will continue to be used by a number of companies,
    organizations, and agencies for toxicity assessment and
    decision making to address public health issues. Development of
    exposure limits and carcinogenic classifications is even, is a
    challenge.
        When workers and community members are unaware of the
    potential toxic health hazards in their work environment and
    communities, this makes them more vulnerable to injury and
    diseases. It is important to provide them with information and
    references to assist in anticipating and recognizing hazards
    and the health effects associated with carcinogens in the
    workplace and the community. If a chemical or agent lacks
    toxicological and carcinogenic data, it is difficult to conduct
    exposure assessment in public health and worker populations,
    which makes it difficult to respond to affected populations
    concerns and fears of long-term health effects.
        For example, in the aftermath of Hurricane Katrina, the
    public was very concerned about the copious amounts of mold
    exposure and potential health effects. The NTP played an
    instrumental role in gathering knowledge and coordinating
    potential research questions that could help address the impact
    of mold and mycotoxin and exposures and health effects.
        Potential exposures to chemicals occur in homes and
    communities. Scientists have the daunting task of combining and
    assessing data from laboratory studies and information from
    human population epidemiologic studies to determine a
    substance's cancer causing ability. Systematic processes are
    needed to assess toxicity and hazards associated with these
    chemicals. Given the limitations of oversight sometimes placed
    on federal agencies, the NTP is uniquely positioned to lead
    various types of reviews and investigations of chemicals that
    are of concern across different aspects of public health.
        Thank you.
        [The prepared statement of Dr. Grimsley follows:]
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        Chairwoman Ellmers. Thank you, Dr. Grimsley.
        I will now introduce Ms. Webster for five minutes. Thank
    you.

                    TESTIMONY OF MS. BONNIE WEBSTER,

                            VICE PRESIDENT,

                    MONROE INDUSTRIES, INCORPORATED

        Ms. Webster. Thank you, Chairman Broun, Chairwoman Ellmers,
    Ranking Member Tonko and Ranking Member Richmond for the
    opportunity to testify before you today. My name is Bonnie
    Webster, and I am the Vice President of Monroe Industries in
    Avon, New York. My husband, John, is here with me today and
    together we run the company. We have seven employees but often
    hire two to three more seasonally to meet demand. We are a cast
    polymer company and use styrene-based resin to manufacture
    high-end custom showers and vanity tops.
        We are a small operation, but we do go to great lengths to
    reach the highest level of safety. In 1999, we built a new
    facility away from residential areas because styrene, like any
    chemical, has the potential to be harmful when misused. We
    ensure that every employee uses a respirator and other safety
    equipment. Unlike larger companies we do not have the ability
    to employ a full-time occupational safety staff, however, we
    bring in consultants annually to address OSHA matters and
    ensure that even with small resources we are compliant and
    safe.
        Our company works hard to lessen the environmental impact
    of our production. We have created Robal Glass, a product that
    uses half the amount of resin. Robal Glass uses a bio-based
    resin and recycled glass for which we have won an EPA
    Environmental Quality Award. Our products have a life cycle of
    well over 20 years and are designed to last the duration of the
    home.
        Despite our hard work to be on the cutting edge of the
    composites industry, we are very concerned that the listing of
    styrene in the 12th Report on Carcinogens make it very
    difficult for us to stay in business.
        Currently there is only one company that will insure us.
    Should we be dropped by that company, like other composite
    companies whose coverage has been terminated by long-term
    carriers, it will be impossible for us to continue to make an
    affordable product. Today's mentality when it comes to
    liability lawsuits is who can we sue next. We cannot afford to
    be next and remain in business. If the poor science that
    informed the RoC listing begins to inform the EPA or OSHA
    regulations, our concerns will only worsen.
        Our worries are not unique only to Monroe. Many state air
    pollution regulatory programs will look at the RoC listing and
    set styrene ground level exposure limits based on a presumption
    of carcinogens, and this will make it impossible for composite
    manufacturers in these states to get or renew operating
    permits.
        In light of the uncertainty presented by the styrene
    listing in the RoC, we have no plans to expand our production
    or increase our number of employees. We hope with this economy
    we will be able to maintain the business that we have now.
    Compared to many other companies in the cast polymer subset of
    the composite's industry, we are in a better position than most
    because our products are totally customized and therefore, very
    difficult to import.
        The current environment has made it nearly impossible for
    high-production cast polymer fabricators to compete.
    Surrounding countries do not have the regulations and
    additional costs that we have here. Unlike larger composite
    manufacturers who do not have the luxury, if you can call it
    that, of moving production offshore, if this trend continues,
    we will have no choice but to liquidate our companies.
        There is a significant environmental benefit to using our
    engineered composite products over natural stone products and
    other materials that should be considered. Granite, for
    example, is mined in South America and often shipped to China
    to be polished before shipping, being shipped back to the U.S.
    to be fabricated. The environmental impact of the
    transportation aspect alone is considerable. The fact that our
    engineered surfaces are fully manufacturable in the United
    States, in addition to being partially constituted of recycle
    components, makes them a very green product.
        The RoC has hidden in the shadows pretending only to be
    harmless input to the public health agencies. It has been
    largely unsupervised by the Congress, unreachable by the
    Courts, and not carefully supervised by senior officials in
    their respective agencies. Yet its actions have every bit as
    much of an impact as regulations which in contrast are subject
    to the Administration Procedure Act.
        Our industry is asking that Congress reform the way the
    Federal Government analyzes the risk of chemicals to make it a
    more transparent, inclusive, and scientific process. Please
    consider these reforms that will ensure that federal programs
    like the Report on Carcinogens leads to valuable assessments
    that help rather than harm American business and the American
    worker.
        Thank you very much for your time.
        [The prepared statement of Ms. Webster follows:]
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        Chairwoman Ellmers. Thank you, Ms. Webster.
        I would like to introduce Ms. LaTourelle now for five
    minutes. Thank you.

               TESTIMONY OF MS. ALLY LATOURELLE, ESQUIRE,

                   VICE PRESIDENT GOVERNMENT AFFAIRS,

                         BIOAMBER, INCORPORATED

        Ms. LaTourelle. Thank you, Mrs. Chairman. Chairman Broun,
    Chairwoman Ellmers, Members of the Committee, Ranking Member
    Tonko, and Ranking Member Richmond, thank you for the
    invitation to speak today. This is the first time I have been
    before a committee, so I would like to, if I may, enter my
    written testimony into the record and summarize those points
    here for you today.
        Chairwoman Ellmers. Without objection.
        Ms. LaTourelle. Thank you. My name is Ally LaTourelle. I am
    the Vice President of Government Affairs for a company called
    Bioamber. We are a renewable chemical company. My work with
    Bioamber includes renewable chemical manufacturing project
    finance, federal, State, and local financial incentive
    analysis, renewable chemical and economic policy development,
    and I currently head global sustainability. It is a start-up.
        I am also a former investment advisor, both for private
    individuals on private companies in the clean tech sector and
    for public companies. So my perspective is a little bit
    different than the other members of the panel.
        Bioamber, just to start, is a next-generation chemicals
    company. We have a proven proprietary process that uses
    economically viable, sustainable feedstocks rather than oil and
    coal and natural gas to produce platform chemicals. These
    chemicals are used for a diverse range of applications.
        For example, we produce a non-toxic, bio-based succinic
    acid. This is used in many applications from food additives to
    fabrics, and we do so at lower cost.
        We have also developed bio-based butanediol, a technology
    that will be deployed at our first commercial scale facility in
    Ontario, Canada, along with the succinic acid. Now, in
    combination these two chemicals put together make what is
    called a modified polybutylene succinic, and this is a resin
    similar to what we just heard about.
        This--I did bring some samples here I would just like to
    show so that we can get a practical feel for what we produce.
    This is the modified PBS as it comes out. It goes into
    extrusion machines. This type of plastic is stamped into very
    familiar objects, coffee cup lids, and our technology is
    special because it gives heat resistance. Not only is it
    biodegradable within 90 days, but you also have heat
    resistance, which is a very difficult property to engineer.
        Respectfully, I would like to present a few different
    reactions to the issues of concern before the Committee today,
    from the perspective of a renewable chemistry company. Like Dr.
    Bus, I, too, question the fundamental relevancy of the RoC to
    small business, but from a different perspective, and my next
    statement is in no way challenging the science or the
    importance of the RoC itself. We find ongoing reporting of
    carcinogens has a negligible impact on competition in the face
    of industry-wide 21st century business concerns.
        The ad hoc nature of global chemical regulations is not
    detrimental to our small business, and it is not a shock. I
    would like to just remind you that the World Health
    Organization in its International Agency for Research on Cancer
    moved styrene, for example, from not classifiable to possibly
    carcinogen to humans in 1987. So the impacts of this
    information should have already come to the floor. They
    reviewed that assessment in 1994 and in 2002, and came up with
    the same conclusions. The U.S. Agency for Toxic Substances and
    Disease Registry pointed to that report in 2007, and the EPA
    has regulated styrene already in drinking water where it has
    been found.
        To be fair, Canada has found styrene to be non-toxic.
    However, I would like to point out that this in no way, even
    though we make a direct substitution for styrene, has in no way
    impacted our decision to commercialize, to get to commercial
    scale in Canada. Last year in California, for example, a total
    ban of styrene was considered.
        These regulations are essentially ongoing discussions, but
    they really take a backseat to the larger concerns of the 21st
    century. We have cost concerns related to energy supply price
    increases. We have shipping and supply chain costs mentioned by
    Ms. Webster associated with radical swings in the price of oil.
    We have increased demands for transparency, and the chemical
    industry is bringing science and innovation to design products
    that avoid these concerns, as well as toxicity. Our chemical
    process design takes 51 percent less energy to run than the
    incumbent petrochemical players. That means there is a 205
    percent energy efficiency that occurs pound for pound. In our
    adipic acid technology, for example, it takes 205 percent more
    energy to create a petrochemical adipic acid.
        Chairman Broun. Ms. LaTourelle, if you would, your time has
    expired, so if you would wrap up quickly, I would appreciate
    it.
        Ms. LaTourelle. Oh, yes. I am sorry.
        Chairman Broun. We would appreciate it.
        Ms. LaTourelle. My apologies.
        Just to wrap up, I would also like to suggest that
    regulations themselves lead to innovation. If we cannot
    identify the problems and if we do not have access to
    information, we cannot find the solutions. Large chemical
    partners also support a shift in this industry to safer
    alternatives. Familiar names from our strategic and innovation
    partner list are Dupont, Cargill, Lanxess, Mitsubishi Chemical,
    Mistui.
        I would also like to point out that retail regulation and
    consumer drive is a bigger concern to us than any of the other
    things mentioned.
        In conclusion, the environmental concerns, the 21st century
    concerns are quantifiable. Something like the RoC really takes
    a backseat in terms of small business to competitive answers
    that are readily available.
        Thank you for your time.
        [The prepared statement of Ms. LaTourelle follows:]
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        Chairman Broun. Thank you, Ms. LaTourelle.
        Mr. Barker, you are recognized for five minutes.

                    STATEMENT OF MR. JOHN E. BARKER,

               CORPORATE MANAGER, ENVIRONMENTAL AFFAIRS,

           SAFETY AND LOSS PREVENTION, STRONGWELL CORPORATION

        Mr. Barker. Thank you, Chairman Broun, Chairwoman Ellmers,
    Ranking Member Tonko, and Ranking Member Richmond, for the
    opportunity to testify before you today. My name is John
    Barker. I am Corporate Manager of Environmental Affairs at
    Strongwell Corporation. And I would also like to introduce my
    colleague, David Ring, who is with us from Strongwell.
        Strongwell employs 465 people with facilities in Bristol,
    Virginia; Abingdon, Virginia; and Chatfield, Minnesota. Our
    primary raw materials are styrene, resins, and reinforcements,
    which we use to make many products, including ballistic panels,
    having shipped over 150,000 to protect American troops and
    soldiers in Iraq and Afghanistan. We also manufacture bridge
    beams, platforms being used increasingly to reduce the
    lifecycle cost and improve sustainability of infrastructure.

        Like any chemical such as styrene, it is critical to follow
    the safety guidelines. At Strongwell, we pride ourselves in our
    proactive safety programs. Each facility has a Plant Safety
    Committee and an excellent safety record. Our employees are
    trained periodically on each chemical that we use, with all
    employees being retrained at least annually. We ensure that all
    employees have both the protective equipment and knowledge they
    need to safely use the chemicals that are a part of our
    production.
        By nearly every count, when following the proper safety
    guidelines, styrene is a safe chemical. Many studies from both
    the private and public sectors alike speak to the absence of a
    threat of cancer when using styrene. And regardless, the
    National Toxicology Program listed styrene as a reasonably
    anticipated carcinogen in the 12th Report on Carcinogens. The
    listing of styrene in the RoC is of significant concern to
    Strongwell and the composites industry in general. For one
    thing, the idea of ``reasonably anticipated'' has caused great
    confusion among our employees, their families, and members of
    our communities.
        We have taken a very proactive approach of informing
    employees about the ruling and other studies about styrene
    toxicity. We have gone over this matter in depth with city
    councils of both Bristol, Virginia, and Bristol, Tennessee, and
    have taken community leaders on tours of our facilities to
    fully explain our safety practices. We have spent millions of
    dollars on emissions reductions and have pushed toward direct
    injection molding, which lessens the exposure of workers to
    styrene.
        And Dr. Bus has explained the scientific problems behind
    the listing of styrene in the Report on Carcinogens. Let me
    tell you about some of the problems it is causing to business.
    As a company, Strongwell has gone to great lengths for many
    years to have a strong and positive relationship with our
    community. For example, we assist the local fire department in
    their annual training and we provide assistance in maintaining
    their equipment. Lately, we have been receiving anonymous phone
    calls saying things like, ``you do know that styrene causes
    cancer, don't you?'' This tells us that people believe the
    flawed science used in the assessment of styrene and it makes
    it difficult to maintain an open and fair relationship with our
    community.
        A Google search of styrene toxic tort returns a list of
    many law firms that now claim to specialize in styrene injury
    suits. Styrene was not a business opportunity for these law
    firms a year ago. Because we self-insure, styrene--or
    Strongwell has had to place a significant amount of money into
    reserves to protect ourselves against potential liability
    lawsuits. The money that we must reserve for liability purposes
    could be used for investment and job creation and expansion if
    it weren't for this listing.
        As I mentioned previously, Strongwell manufactures many
    important products and these are just a small example of the
    thousands of applications of composite products. Styrene is an
    essential chemical component of this manufacturing for which
    there is no reasonable replacement. Resins based on other
    chemicals do exist but they are usually far more expensive and
    not nearly as well understood in terms of health effects on
    humans.
        Likewise, we are very concerned about the potential
    regulatory burden that could be placed on our operations should
    the RoC listing form the basis of regulatory changes. Changes
    to the regulations already in effect by OSHA and EPA could
    cause the cost of compliance to increase substantially.
    Further, focusing on a matter that should be of no concern will
    make it harder for employees to get full attention to the
    safety issues that are important.
        Because there is no legitimate substitute for styrene and
    because the cost of liability and compliance could increase
    astronomically, there is a concern that the federal treatment
    of styrene could draft composites jobs offshore. And by the
    way, this is not just a concern for Strongwell but for the
    entire industry that employs over 250,000 people.
        Chairman Broun. Mr. Barker, if you could wrap up very
    quickly. You have overstated your five minutes, so please
    finish quickly.
        Mr. Barker. Okay. We do have international competition and
    we support reforms with the RoC process. And finally, I would
    like to say that while I am speaking here today, we have got 50
    second-graders from a local elementary school touring our plant
    in Bristol, Virginia, and if we believed that styrene posed any
    threat of cancer, we would never allow those children from our
    community to our facility.
        Thank you very much for the opportunity to provide these
    comments.
        [The prepared statement of Mr. Barker follows:]
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        Chairman Broun. Thank you, Mr. Barker.
        And now, I will recognize Dr. Belzer for five minutes.

                  STATEMENT OF DR. RICHARD B. BELZER,

                    PRESIDENT, REGULATORY CHECKBOOK

        Dr. Belzer. Thank you, Chairman Broun. I thank you for the
    opportunity to testify again today. I am Richard Belzer,
    President of Regulatory Checkbook, a nonpartisan, nonprofit
    organization whose mission includes the promotion of quality
    improvements in science, economics, and information quality.
        In August of 2011, I was asked by the Competitive
    Enterprise Institute to conduct a short study trying to explain
    why the RoC had become so intensely controversial. Regulatory
    Checkbook received an honorarium of $5,000 for a completed
    published paper. CEI put no substantive constraints on my work.
    Subsequently, Regulatory Checkbook supplied an additional
    $5,000 of unrestricted resources.
        My research shows that the RoC is not a high-quality
    scientific work product and there are two fundamental reasons
    why. This may be a little harder for you to see than I had
    anticipated. I apologize. When Congress wrote the RoC's
    authorizing legislation in 1978, it asked for a scientific
    compendium of substances carcinogenic to humans but did not ask
    for this in a scientific language. This you may or may not be
    able to quite read. The task was to list all substances which
    are either known to be carcinogens or may reasonably be
    anticipated to be carcinogens. And I will get to the second
    item in a moment.
        But science does not know or reasonably anticipate things.
    Science cannot tell you whether a number is significant. These
    are not scientific words; they are the words of lawyers. Given
    the opportunity, therefore, the NTP has exchanged its white lab
    coat of science for something of a bureaucratic imperative of
    maximizing the number of substances listed. The NTP has
    achieved this by maximizing its flexibility to use or reject
    scientific information however it sees fit. Thus, while the
    NTP's listing determinations have scientific content, they are
    not scientific determinations.
        The NTP defines a known human carcinogen as follows--and
    this is an actual verbatim description of it. A lot of
    attention has been focused on this--the footnote. I want to
    focus on something different. I want to focus on a comma midway
    through the first sentence. And the comma is important, because
    in English grammar everything that follows this comma is called
    a parenthetical element. It can be removed from the sentence
    without changing the sentence's meaning. Therefore, the NTP's
    definition for a known human carcinogen can be shown much more
    succinctly as follows, which is ``there is sufficient evidence
    of carcinogenicity from studies in humans.'' Everything else is
    subordinate to that.
        This definition is tautological and utterly opaque. It is
    tautological because it must be true. It goes without saying
    that for every substance defined as a known human carcinogen by
    the NTP, the evidence was at least sufficient in the judgment
    of the NTP. It is utterly opaque, however, because no one
    outside the NTP knows what makes evidence sufficient.
        Now, a similar story can be told regarding the definition
    of ``reasonably expected'' human carcinogen. A comma is located
    in the same place. Everything that follows that comma can be
    eliminated without altering the meaning of the criterion or the
    sentence.
        So we have ``sufficient evidence,'' we have ``limited
    evidence,'' we have in one case ``less than sufficient
    evidence.'' All these terms used by the NTP are legal terms.
    They are not scientific terms. So while the Congress seems to
    have asked for a scientific compendium, what the NTP appears to
    produce is legislative determinations and it does this in a way
    that makes it look like they are scientific. Biology words are
    often used, for example. But the determinations themselves
    cannot be scientific because the definitions are themselves not
    scientific.
        Now, return with me for just a moment to the--an earlier
    slide. There is a second clause, ii, and it is part of the
    definition of what the statute requires for a substance to be
    listed and that is that the substance has to meet the first
    test of being known or reasonably anticipated. It also has to
    be a substance to which a significant number of persons
    residing in the United States are exposed. That is in the law.
    To the best of my knowledge and reading through the listing
    decisions, the NTP does not do this. It doesn't actually
    fulfill that second prong of the requirement for a listing.
        There are ways of going about that. The NTP could define a
    significant number of persons residing in the United States. It
    could then define a de minimis cancer risk, and then it would
    have to go about a scientific task of estimating the number of
    persons exposed. Now, I don't believe that the NTP has done any
    of these three steps. The first two are strictly policy
    related. Science again can't speak to whether a number is
    significant or it can't speak to what constitutes de minimis
    cancer risk. But science can be used to estimate the number of
    persons exposed.
        Chairman Broun. Dr. Belzer, if you could go ahead and wrap
    up, please, sir.
        Mr. Belzer. I am sorry. I apologize.
        What can be done--I provided in my written testimony a
    number of different reforms that Congress could consider that
    would improve the scientific content of RoC and make it more
    useful for public policy purposes, for small businesses, for
    big business, for consumers, for anyone. The problem with the
    RoC now is that it stands as a document that does not actually
    have the scientific content that Congress had intended 35 years
    ago when it wrote the law.
        Thank you very much.
        [The prepared statement of Dr. Belzer follows:]
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        Chairman Broun. Thank you, Dr. Belzer.
        I appreciate you all's testimony. For you all that are not
    southern, y'all is plural for all y'all.
        I remind Members that Committee rules limit questioning to
    five minutes. The Chair at this point will open the first round
    of questions and I recognize myself for five minutes.
        Now, my first question is to Dr. Bus and Dr. Belzer.
    Written testimony submitted for this hearing indicates that
    roughly 250,000 jobs are associated with just one substance.
    OMB considers the scientific assessment ``highly influential''
    if it could impact the public or private sector by more than
    $500 million in one year or is ``novel, controversial, or
    precedent setting or has significant interagency interest.'' Do
    you consider the RoC to be a highly influential scientific
    assessment, Dr. Bus?
        Dr. Bus. Yes, indeed. In fact, as I pointed out in my
    testimony, the outputs from the report on carcinogens are
    directly translated in some regulatory environment such as
    California and other locations around the globe in terms of
    moving forward with regulatory action. So although they are not
    regulatory actions themselves, they serve as the foundation for
    it.
        Chairman Broun. And bring about regulations? Okay. Dr.
    Belzer.
        Dr. Belzer. It is--I have not looked at the economic
    consequences of the RoC in any way. I have looked at the amount
    of intense energy devoted to attempting to get good quality
    science out of the RoC. Based on that, I would draw the
    inference it is highly influential.
        Chairman Broun. Very good. Dr. Bus, you argue that the NTP
    does not apply a weight of the evidence review of substances,
    yet I understand that the Assistant Director of NTP at the
    December 15, 2011, meeting of the Board of Scientific Council
    has made it clear that NTP has always considered the full body
    of evidence for every chemical and that all the studies are
    listed in the background document. Are you really saying that
    you just disagree with how they weighed those studies?
        Dr. Bus. Absolutely not. In fact, the testimony as
    presented by Dr. Bucher indicated that, yes, they do perhaps
    consider all the evidence but really what is more important is
    the process by which the evidence is evaluated. So, for
    instance, in the recent NAS review of the formaldehyde
    document, that is where the National Academy of Sciences really
    outlined a roadmap for how scientific data should be evaluated
    with respect to assessments of the toxicology of chemicals. And
    they really emphasize that they should take a weight-of-
    evidence approach, which is not just a recitation of the
    numbers of studies that are out there but really a broad-based
    critical analysis of how you identify the studies, how those
    studies are used, how they are to be interpreted, and where
    they are to be employed. So there is a dramatic difference
    between a weight-of-the-evidence approach versus just simply
    listing the numbers of studies that are out there.
        Chairman Broun. Very good. Hopefully, we will have that
    contract put in place and the Academy can go forward.
        Dr. Belzer, in your testimony you state that the risks'
    descriptors ``known'' and ``reasonably anticipated'' are
    confusing. Can you tell us why this legal language which
    appears in the statute is confusing and is not appropriate for
    use in describing the cancer risk that a substance may possess
    or pose?
        Dr. Belzer. Well, as I noted in my oral testimony, the term
    ``known'' or the phrase ``reasonably anticipated,'' these are
    just not terms that scientists use. Scientists deal with
    theories and with hypotheses and they test them. But to say
    that something is known in science is very difficult. I am not
    sure what level of confidence Congress intended in 1978 for
    this idea of ``known human carcinogen.'' One possible
    interpretation that Congress intended would be like ```beyond a
    reasonable doubt,'' something like that. And it would be useful
    to know if that is the standard the NTP is using. The NTP
    doesn't--has not, to the best of my knowledge, disclosed how it
    interprets this language. What is the likelihood that a
    chemical is a human carcinogen? What is enough to be
    ``reasonably anticipated?'' Scientists can't answer that
    question but the NTP is making policy decisions. Presumably,
    they should be able to answer that question.
        Chairman Broun. Thank you, Dr. Belzer.
        Dr. Bus and Dr. Belzer, do you believe that the RoC truly
    reflects the intent of the law that created it? Dr. Bus.
        Dr. Bus. I believe with the status of ``reasonably
    anticipated'' and ``known,'' the intent clearly is to identify
    chemicals that the public should in fact take direct attention
    to. And if--with that degree of significance associated with
    those classifications, I believe the public is best served if,
    in fact, it has confidence that the scientific evaluations that
    underpin those classifications are based upon the highest
    quality scientific evaluation that can be done. And those
    principles have been outlined, as I have mentioned before, are
    really centered on evidence-based approaches to evaluation of
    the data, which really promotes a structured, organized way of
    looking at the data that gives you a consistent evaluation of
    the data from the chemical and that builds assurance with the
    public that, in fact, the evaluations that are put forward by
    the Report on Carcinogens in fact can be trustworthy and used
    for science-informed decision making.
        Chairman Broun. Thank you, Dr. Bus. I am not sure that that
    truly answered whether it follows the intent of the law. And
    Dr. Belzer, my time is expired, so if you would just include
    that in your written answers.
        So now, I recognize Mr. Tonko, my friend, for five minutes.
        Mr. Tonko. Thank you, Mr. Chair.
        Ms. LaTourelle and all of our witnesses, thank you for
    joining us today. But to Ms. LaTourelle, recently I toured a
    company started by a couple of graduates of Rensselaer
    Polytechnic Institute in my district, and they invented a
    process with the help of the campus incubator to use mushrooms
    and agricultural byproduct to grow packing material to replace
    polystyrene. They are enjoying real success and finding
    interested partners in old line businesses that welcome these
    products to reduce their own carbon footprint and meet customer
    preferences. It seems to me that consumers are ahead of some
    companies about what they want in products. As important as the
    Report on Carcinogens may be to some, it is irrelevant to the
    preexisting surge in demand to move away from petrochemical-
    based products. Could you elaborate a little on consumer demand
    as a driver for the change in these given areas?
        Ms. LaTourelle. Certainly. Consumer demand basically picks
    up where government regulations leave off or where government
    regulation is absent. The move toward greener--however you
    categorize that, essentially products that have more
    environmental benefit, use less energy, are nontoxic, and use
    renewable resources--are so in demand that companies like
    DuPont, for example, in 2010 surveyed 800 of their customers
    globally and DuPont's customer base is--it spans food and
    agriculture, transportation, chemicals, manufacturing,
    plastics--they understand that there is a long-term demand for
    these products and alternatives because of the larger drivers
    on the business and they look to their customers to be sure
    that there is going to be a ready market.
        Eight-nine percent of the 800 customers surveyed said that
    delivering products with environmental benefits is a long-term
    market opportunity, and those are the customers that sell
    products directly to consumers. Ninety-five percent of those
    surveyed reported customer demand is a key driver for
    developing products.
        I would also like to point out that there is such an
    incredible shift in the marketplace to these types of
    alternatives that companies like SC Johnson have created their
    own metrics through which they screen chemicals to use in their
    products. Theirs is called a Green Screen. Staples has been
    actively dialoguing with their suppliers. They have goals
    regarding how much renewable products they sell and they are
    working with their suppliers to find ways in which products can
    be less toxic and less harmful to the environment. Wal-Mart is
    a great example. They have reduced their packaging and found
    that essentially what it did is it made their shipments almost
    double in size because the reduction in packaging allowed them
    to ship more, and this has saved them millions of dollars in
    transportation costs.
        Mr. Tonko. Thank you. Now, you heard the testimony of the
    Office of Advocacy from SBA, and it struck me that they are
    very aggressive intervention into this case based on lobbying
    from the styrene industry amounts to a government office
    picking winners and losers in the market. Based on what you
    have learned, does it appear that they are working in the
    interest of green chemistry firms?
        Ms. LaTourelle. No. Clearly, green chemistry is--let me put
    it this way. The ship has sailed. Green chemistry is here. The
    alternatives are here. For governments to be determining what
    is going to happen in the green chemistry industry, it is too
    late. We certainly advocate for more incentives to get to
    commercial scale so that our respected colleagues on this panel
    can supply customers with these products. We are seeing more
    job creation coming out of green chemistry. For government to
    be inserting itself and disputing the process of a document
    like the RoC to me is disruptive to the larger issues of the
    availability of toxicology in general. Consumers get their
    information from many different sources, this being just one of
    them. Yes, it is influential. It influences the customer base,
    but we are already well beyond concerns of a document like
    this.
        Mr. Tonko. Thank you so much. I yield back, Mr. Chair.
        Chairman Broun. Thank you, Mr. Tonko.
        Now, I recognize Chairman Ellmers for five minutes.
        Chairwoman Ellmers. Thank you, Mr. Chairman.
        My first question is for Ms. Webster. If your company had
    to replace styrene with another substance, would you still be
    able to sell your products at a competitive price and how would
    that impact your bottom line?
        Ms. Webster. No, I would not be able to be competitive. It
    would make it easier----
        Chairman Broun. Microphone, please, ma'am.
        Ms. Webster. It would make it definitely easier for
    imported products to come into the United States. I do have a
    bio-based resin that I do use. That has actually gotten us more
    business. People do like the aspects of us going green, but no,
    the cost of the other resins that do not have styrene are very
    cost-prohibitive. And we have looked at vinyl esters and
    epoxies and things like that. It is just not cost-effective. It
    will increase imports.
        Chairwoman Ellmers. It will increase imports and then,
    obviously, if you were to--and this is just me throwing this
    out there--if you were to use another product, obviously that
    cost would be passed on to the consumer.
        Ms. Webster. Absolutely.
        Chairwoman Ellmers. My other question for you is you had
    mentioned in your testimony that you, you know, obviously as a
    small business you don't have the resources for a Regulatory
    Compliance Officer, is that correct?
        Ms. Webster. Yes.
        Chairwoman Ellmers. Okay. So who in your company is the
    person that is responsible to be complying with the federal
    regulatory process?
        Ms. Webster. We hire a company to come in, they do a
    walkthrough, they do training, they do training on the
    forklifts and things like that. Once a year, they come in and
    go through the plant, they let us know if there is any issues,
    they pat us on the back, and knock on wood, we haven't had any
    problems. So we hire somebody to come in to do that.
        Chairwoman Ellmers. My next question--thank you, Ms.
    Webster. I do want to add one last thing and you may not feel
    comfortable answering this and if you don't, that is fine. Is
    that a very costly endeavor, having someone have to actually
    come in and help you in that process?
        Ms. Webster. It runs--it is going up every year----
        Chairwoman Ellmers. Um-hum.
        Ms. Webster [continuing]. But it runs--it is just under
    $1,000 but I think it is based on how many employees you have.
        Chairwoman Ellmers. I see. Thank you. Thank you for that,
    Ms. Webster.
        For Mr. Barker, I have a couple questions for you. Do you
    feel that the Report on Carcinogens is helping or hindering you
    in creating a safer workplace?
        Mr. Barker. At this time I would have to say that it is a
    hindrance, although I think at this point not as great as it is
    likely to be. And from that hindrance it distracts our
    employees from the real concerns that they should be dealing
    with on a day-to-day basis, wearing the proper protective
    equipment, being concerned about the physical hazards they work
    with, and they are distracted because of the concern about
    getting cancer from styrene that the NTP has said is reasonably
    anticipated to be a carcinogen. So they are concerned about
    that. And we are concerned that the further we go with this as
    awareness grows, the more distracted they will become.
        Chairwoman Ellmers. And my last question for you is, now,
    it is our understanding that Strongwell participated in a
    public comment process of the 12th RoC. Is that correct?
        Mr. Barker. That is correct.
        Chairwoman Ellmers. Can you tell us whether or not your
    comments were responded to by the NTP?
        Mr. Barker. Our comments as far as I know were not
    responded to.
        Chairwoman Ellmers. Okay. And I would like to just, for the
    record, point out--and there again, in the previous panel, Dr.
    Birnbaum had stated to the best of her knowledge that all
    comments had been responded to. But I do have an additional
    question--thank you, Mr. Barker--for Dr. Belzer. In your
    testimony, you noted that the NTP completely ignores exposure
    or dose in making its determinations. And why is it important
    for exposure or dose to be considered when providing
    information to the public about substances that have the
    potential to cause cancer? I am sorry. Dr. Belzer.
        Dr. Belzer. Sorry, it wasn't clear who you were addressing.
        Chairwoman Ellmers. I am sorry, no. I apologize.
        Dr. Belzer. The public has an obvious need for information
    on chemicals or substances that could cause cancer but the dose
    at which those substances might cause cancer is very important.
    If it is something that happens at extraordinarily high doses
    and it happens in animals under laboratory conditions, that is
    an important fact but that is very different than happening at
    environmental exposure levels. This is the type of thing that
    people ought to have access to. I think that improving the
    targeting of the information so that--well, in 1978 I think
    there was a general notion that either a substance caused
    cancer or it didn't and that seemed to be the prevailing state
    of knowledge at the time. But that is not correct. Things are
    more far more complicated than that. And the NTP is quite
    capable of being more discriminating and to provide information
    that is more dose-relevant so that people have that information
    as well as the current worst-case scenario.
        Chairwoman Ellmers. Great. Thank you so much. Thank you for
    all of your comments and your testimony. Thank you.
        I yield back.
        Chairman Broun. Thank you, Mrs. Ellmers.
        I now recognize Mr. Richmond for five minutes.
        Mr. Richmond. Thank you, Mr. Chairman. It appears to me now
    that this is a styrene hearing. And with that, let me just
    start with--I have heard a lot of testimony about--that there
    is no legitimate substitute, the benefits of it, and I guess my
    question--I will start with you, Ms. Webster. Let us assume
    that NTP is right and styrene is a carcinogen. Now what?
        Ms. Webster. My company will most likely liquidate, and I
    will have to find another job.
        Mr. Richmond. So if it is in fact--if it in fact causes
    cancer, would--with substantial exposure, then it pretty much
    kills your business?
        Ms. Webster. The risk of liability that we would be faced
    with, I wouldn't be able to sleep at night. I go to work every
    day feeling good about what I do and if this comes out as
    listed as an anticipated carcinogen, I am not going to feel
    good about what I do.
        Mr. Richmond. And I guess my question is what if they are
    right? What if it does cause cancer?
        Ms. Webster. I guess I would like to see the scientific
    data. The research papers that I have seen and read is not
    showing that.
        Mr. Richmond. And Mr. Barker, I guess I would pose the same
    question to you. What if they are right and a high level
    exposure to it could cause cancer?
        Mr. Barker. Well, first of all, let me say that we are
    genuinely concerned about our employees and about our
    community, and we do not want our employees to get cancer from
    exposure to styrene. But I think this is part of the problem
    that Dr. Belzer was talking about. So they are right. To what
    degree? What is the risk? And that to me is the whole crux of
    the problem. Here the NTP has said that styrene is reasonably
    anticipated to be a carcinogen.
        Mr. Richmond. Um-hum.
        Mr. Barker. So how much exposure do you have to have to get
    cancer? Is it 50 parts per million for 10 years, 20 years? Is
    it 500 parts per million for eight hours? None of that has been
    discussed. And so that is--our problem right now is our
    employees, all they hear is this stuff causes cancer and there
    is a great deal of uncertainty. And we feel like there is just
    not a need for that uncertainty at this point. Now, if they
    were to come back and say, you know, something quantitative
    like, you know, there is pretty high risk you are going to get
    cancer if you work in this environment at 50 parts per million
    for 10 years, then, you know, we wouldn't--that would be
    unacceptable. Then we would start looking at engineering
    alternatives and possibly, you know, other materials.
        Mr. Richmond. And I guess my major concern and it is before
    my day and--but it reminds me, at least as I did a little
    research on it of the argument over asbestos or lead in paint
    and gas----
        Mr. Barker. Sure.
        Mr. Richmond [continuing]. And all of those things and
    effects on it, and now we are down the road and we still have
    asbestos in a number of things because we just didn't stop or
    recognize it early enough. But I ask and defer to Dr. Grimsley,
    I know that with BP and the chemicals we use to treat the oil
    spill, the dispersants, they are doing some sort of a study to
    see--and they are using exposure. So how can exposure be
    included and do you think that is a necessary first step in
    just saying it is likely to or could lead to cancer?
        Dr. Grimsley. Yes. I am serving on the Scientific Advisory
    Board for the NIEHS in the Gulf Worker study and they are
    looking at different types of exposures, some of the
    dispersants and some of the hydrocarbons that were related to
    that. The exposure component is a very important piece that the
    NIEHS is actually looking at. It is always one of the first
    steps that you want to do in exposure assessments is to
    actually have good data and to have good estimates about the
    exposures. And so they are going through and doing that
    important step in order to identify if you are going to
    actually have some type of health outcome that is related to
    any particular type of exposure--if it is a low exposure, if it
    is a medium exposure, if it is a high exposure.
        Mr. Richmond. And can that be done with styrene? Or where
    are we in the process of that?
        Dr. Grimsley. Well, I think, Ms. LaTourelle, she has
    already alluded to the point that some of the other agencies
    have already listed styrene as a carcinogenic agent. I used to
    work as an industrial hygienist at Texaco. I used to work as an
    industrial hygienist at International Paper and at bigger
    companies and smaller companies, we try to encourage what we
    call the ALARA, As Low As Reasonably Achievable. If you have
    exposure limits, you avoid exceeding the exposure limits, but
    most definitely try to keep the exposures down as low as
    possible, then, that is one of the things we strive for.
        Chairman Broun. The gentleman's time has expired.
        Mr. Richmond. Mr. Chairman, I see that my time has expired
    and, Mr. Chairman, if you will allow me, I just wanted to
    recognize that Dow is in my district and they are doing a
    wonderful job and they are expanding. And I went and watched
    their first responders and their safety mechanisms so I am not
    implying that anybody is not concerned about the health of
    their employees, but the question becomes what if NTP is right
    and other people are wrong? And I yield back.
        Chairman Broun. Thank you, Mr. Richmond.
        As much as my colleagues on the Democrat side would like to
    make this a hearing about styrene, holding a hearing on the RoC
    process, which is what this hearing is all about without
    discussing substances recently listed would be totally
    irresponsible and we need to fully evaluate the process. And
    that is what this is all about and specific substances just
    serve as case studies. They are not--this is not about styrene
    as much as my colleagues on the Democratic side would like to
    make it be. This is about the process. The title of this
    hearing is ``How the Report on Carcinogens Uses Science to Meet
    its Statutory Obligations, and its Impact on Small Business
    Jobs.'' So that is the reason that folks are here.
        So now I recognize Mr. Miller for five minutes.
        Mr. Miller. I thank the Chairman for that clarification,
    but the styrene industry's lobbyists do take credit for having
    scheduled this hearing.
        Mr. Barker and Ms. Webster, you have both said in your
    testimony that insurance costs might go up, policies might be
    canceled for firms that use styrene-based products or use
    styrene in their processes. Is that something you are supposing
    might happen or do you actually know of any instances where
    companies have in fact lost coverage or been charged more in
    premiums because of--they--because they used styrene either in
    their products or in their processes so we could check with
    those companies and the insurance companies directly for more
    information about that?
        Ms. Webster. I was on a conference call about six weeks
    ago. There was a woman--John Schweitzer might be able to get me
    her name--I think her name was Laurie who was--she was dropped
    by her insurance carrier and the next carrier that picked her
    up, the costs were quadruple.
        Mr. Miller. Okay. Can you get--I mean, Laurie is not enough
    to go on.
        Ms. Webster. Yeah, I know. The call was about six weeks
    ago.
        Mr. Miller. Mr. Barker, do you have--do you know personally
    of any companies that have in fact been dropped or had their
    premiums raised?
        Mr. Barker. I am aware of the same company I think that Ms.
    Webster is talking about.
        Mr. Miller. Okay. Can you get us Laurie's last name and----
        Mr. Barker. Yes.
        Mr. Miller [continuing]. Contact information----
        Mr. Barker. Sure.
        Mr. Miller [continuing]. As well? And I would hope that we
    could get from her the names of the companies----
        Mr. Barker. Sure.
        Mr. Miller [continuing]. Or rather the names of the
    insurance companies.
        Mr. Barker, in your testimony you said that you had done a
    Google search for styrene toxic tort and there were 12 firms
    that had been--that were advertising to handle styrene toxic
    torts since the 12th RoC came out. Our staff did the same
    research and found that actually only one of those mentioned
    the RoC in--on their Website, and I actually called some of
    those firms and it appeared that all but one--or maybe all of
    them had actually been doing styrene toxic torts well before
    the RoC. There were plenty of people in the scientific
    community including toxicologists who--public health experts
    who believe that styrene was a carcinogen before it was
    recognized--before the RoC. Are you aware that actually there
    were lawyers who were handling styrene toxic torts before the
    RoC, and in fact the RoC does not appear to have changed that?
        Mr. Barker. Yes.
        Mr. Miller. Okay. You were aware that that has been going
    on right along?
        Mr. Barker. Yes.
        Mr. Miller. Okay. Not new, not because of RoC, right along?
        Mr. Barker. Right.
        Mr. Miller. Okay. And finally, Mr. Barker, I know that
    there was a miscommunication between our staff--our Democratic
    staff and you yesterday. They sent a request for information in
    two emails to the address that had--to which your invitation to
    appear had been sent and did not get a response. Will you
    provide the information that they asked for for the record? And
    could you also just kind of tell us what happened now for the
    record?
        Mr. Barker. Well, I was on my way here----
        Mr. Miller. Okay.
        Mr. Barker [continuing). And didn't have access to email.
        Mr. Miller. All right. But you will provide us that
    information?
        Mr. Barker. Yes.
        Mr. Miller. All right. Well, Mr. Chairman, I think you said
    glory be before when I yielded back 12 seconds. I will yield
    back a minute and 20 now.
        Chairman Broun. Hallelujah. As Mr. Miller knows, I have
    always tried to be very liberal with you, as well as other
    Members of our Committee and have enjoyed serving----
        Mr. Miller. A tendency that does not show up in many other
    areas.
        Chairman Broun. Well, I try to be very lenient with
    everybody. But I also want to remind Mr. Miller that this
    Committee is not responsible for what outside entities state.
    This is still about process. This is not trying to exonerate or
    vilify any particular entity or industry and this is about the
    process. That is what I would hope to be as a scientist, as a
    physician, I am very concerned for my patients and for all
    Americans about potential exposure to anything that may cause
    people harm. And so I share my Democratic colleagues' concern
    about the health of all Americans and this is not to try to
    hold up any industry in either regard as to exonerate them. It
    is about process and it is not to try to vilify anybody. So
    thank you, Mr. Miller. I appreciate it.
        Now, I recognize my friend, Mr. McNerney, for five minutes.
        Mr. McNerney. Thank you. And I do thank the witnesses for
    coming forth today. It is not easy.
        Ms. LaTourelle, you have significant experience with green
    chemistry businesses, and jobs are, of course, a big deal to us
    here in Congress. Would you address job creation and the green
    chemistry production as opposed to the traditional
    petrochemical production businesses?
        Ms. LaTourelle. I would be happy to. And I would like to
    recommend the source from which the statistics that I am about
    to share are derived, that is the economic benefits of a green
    chemical industry in the United States, renewing manufacturing
    jobs while protecting health and the environment. I think that
    is something we can all get behind. This is a report by the
    BlueGreen Alliance, which is an organization that has
    environmental concerns and also labor concerns.
        It states that using similar input-output analysis, they
    estimate that spending a million dollars on traditional
    plastics production would generate 4.3 jobs while spending a
    million dollars on bioplastics would generate an estimated 6.9
    jobs. It is a pretty significant impact. The American
    Sustainable Business Council represents 120,000 sustainable
    businesses. They represent 200,000 sustainable business leaders
    and they are also a ready source for job creation. They have
    access to many green businesses, if you would like to know
    more.
        Mr. McNerney. Thank you. Nice answer.
        I understand from your testimony--think I understand from
    your testimony--I am going to ask for your verification that
    21st century businesses--for 21st century businesses, the RoC
    should have a little impact. Was that what you intended, and is
    it because of energy efficiency, public perceptions and so on?
    What are the sort of reasons for that, if I am correct?
        Ms. LaTourelle. Well, first, 21st century businesses have
    much larger concerns than a report like the RoC. I mean as I
    said before--sorry to mention styrene again--has been
    identified since 1987. These are concerns that businesses
    should have already vetted. They are not assessing the risk
    appropriately. I am not saying that the RoC has no place for
    us. It is clearly an important document. However, its impact on
    small business is questionable because, in any event, these
    types of documents should be drivers of innovation to find
    solutions----
        Mr. McNerney. That is great. That leads to my next
    question. I only have a limited amount of time.
        Ms. LaTourelle. Sorry.
        Mr. McNerney. You say that regulations spur innovation, and
    I have heard that from other witnesses in other hearings, and I
    just want to direct the next question to Mr. Barker. Would you
    say that the 12th RoC, which may lead to regulations, has led
    to innovation at Strongwell?
        Mr. Barker. Not the RoC at this point, but I would agree to
    some extent that some regulation can lead to innovation, yes.
        Mr. McNerney. Thank you.
        Dr. Grimsley, would you address the controversy between
    strength of evidence and weight of evidence?
        Dr. Grimsley. I am not quite sure what some of the
    procedures that are associated with the evidence, the weight of
    evidence and the strength of evidence, especially how some of
    the agencies go about looking at those, if they have a
    systematic process. I know they have a systematic process. The
    American Conference of Governmental Industrial Hygienists, the
    EPA, the NTP, when they go through and they actually look at
    the data that is available, I do know they have some type of
    system but I can't speak to exactly what--is it high, medium,
    low and to what extent those strengths of evidence are.
        Mr. McNerney. All right. Dr. Bus, let me just ask you a
    simple question. Was your objective today to throw down on the
    validity of the 12th RoC and 13th RoC? Is that your basic
    objective here today?
        Dr. Bus. My objective is to make sure that we have the
    highest quality science evaluation supporting these very
    important decisions such as classifications of carcinogens. And
    I strongly believe as a result of our experiences with styrene
    and other chemicals that what we have witnessed--that there is
    a significant need for refinement of the RoC process. And if
    those processes are considered and, we believe, as I proposed,
    a review by the National Academy of Sciences to conduct a
    review of those processes, in the end we will result--we have a
    process that will deliver classification decisions that we can
    have far greater confidence in not only as an industry but also
    as the public, which is the ultimate recipient of that
    information.
        So I am a strong believer that, yes, in fact the examples
    of some of the chemicals that have gone through the RoC reveal
    significant flaws in the process that can be solved. And
    certainly with the advice of the NAS or other advisory bodies,
    we could end up with a process which delivers science that
    truly is useful for informing decision making.
        Chairman Broun. The gentleman's----
        Mr. McNerney. So in other words this----
        Chairman Broun [continuing]. Time is expired and so we will
    go forward.
        And I thank you all for--all you all for you all's
    testimony here today. Members of either Committee may have
    additional questions for you all, and we ask for you to please
    respond very expeditiously in writing. The record will remain
    open for two weeks for additional comments from Members. You
    all are excused. I appreciate you all's participation.
        The hearing is now adjourned.
        [Whereupon, at 12:25 p.m., the Subcommittees were
    adjourned.]

                       Answers to Post-Hearing Questions

                       Answers to Post-Hearing Questions
    Responses from Dr. Linda S. Birnbaum were not submitted.

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                                   Appendix 2

                                  ----------

                       Additional Material for the Record

    Letters Submitted by Subcommittee Chairman Paul Broun, House Committee
                        on Science, Space and Technology

        Letters Submitted by Subcommittee Chairman Renee Ellmers, House
                          Committee on Small Business