    [House Hearing, 116 Congress]
    [From the U.S. Government Publishing Office]

                           STRENGTHENING TRANSPARENCY
                             OR SILENCING SCIENCE?
                    THE FUTURE OF SCIENCE IN EPA RULEMAKING

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

                                    HEARING

                                   BEFORE THE

                          COMMITTEE ON SCIENCE, SPACE,
                                 AND TECHNOLOGY
                            HOUSE OF REPRESENTATIVES

                         ONE HUNDRED SIXTEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                               NOVEMBER 13, 2019

                                   __________

                               Serial No. 116-53

                                   __________

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

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

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

                              ______

                 U.S. GOVERNMENT PUBLISHING OFFICE
     38-271 PDF          WASHINGTON : 2020

                  COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

                 HON. EDDIE BERNICE JOHNSON, Texas, Chairwoman
    ZOE LOFGREN, California              FRANK D. LUCAS, Oklahoma,
    DANIEL LIPINSKI, Illinois                Ranking Member
    SUZANNE BONAMICI, Oregon             MO BROOKS, Alabama
    AMI BERA, California,                BILL POSEY, Florida
        Vice Chair                       RANDY WEBER, Texas
    CONOR LAMB, Pennsylvania             BRIAN BABIN, Texas
    LIZZIE FLETCHER, Texas               ANDY BIGGS, Arizona
    HALEY STEVENS, Michigan              ROGER MARSHALL, Kansas
    KENDRA HORN, Oklahoma                RALPH NORMAN, South Carolina
    MIKIE SHERRILL, New Jersey           MICHAEL CLOUD, Texas
    BRAD SHERMAN, California             TROY BALDERSON, Ohio
    STEVE COHEN, Tennessee               PETE OLSON, Texas
    JERRY McNERNEY, California           ANTHONY GONZALEZ, Ohio
    ED PERLMUTTER, Colorado              MICHAEL WALTZ, Florida
    PAUL TONKO, New York                 JIM BAIRD, Indiana
    BILL FOSTER, Illinois                JAIME HERRERA BEUTLER, Washington
    DON BEYER, Virginia                  FRANCIS ROONEY, Florida
    CHARLIE CRIST, Florida               GREGORY F. MURPHY, North Carolina
    SEAN CASTEN, Illinois
    BEN McADAMS, Utah
    JENNIFER WEXTON, Virginia
    VACANCY

                             C  O  N  T  E  N  T  S

                               November 13, 2019

                                                                       Page

    Hearing Charter..................................................     2

                               Opening Statements

    Statement by Representative Eddie Bernice Johnson, Chairwoman,
      Committee on Science, Space, and Technology, U.S. House of
      Representatives................................................     9
        Written statement............................................    10

    Statement by Representative Frank Lucas, Ranking Member,
      Committee on Science, Space, and Technology, U.S. House of
      Representatives................................................    10
        Written statement............................................    12

                                   Witnesses:

    Panel 1:

    Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant
      Administrator for Science, EPA Office of Research and
      Development (ORD); EPA Science Advisor
        Oral Statement...............................................    13
        Written Statement............................................    16

    Discussion.......................................................    22

    Panel 2:

    Dr. Linda S. Birnbaum, Scientist Emeritus, National Institute of
      Environmental Health Sciences (NIEHS); Director of NIEHS, 2009-
      2019
        Oral Statement...............................................    47
        Written Statement............................................    49

    Dr. Mary B. Rice, Assistant Professor of Medicine, Harvard
      Medical School; Pulmonary and Critical Care Physician, Beth
      Israel Deaconess Medical Center
        Oral Statement...............................................    54
        Written Statement............................................    56

    Dr. David Allison, Dean, School of Public Health, Indiana
      University-Bloomington; Member, ``Reproducibility and
      Replicability in Science'' Committee, the National Academies of
      Sciences, Engineering and Medicine
        Oral Statement...............................................    63
        Written Statement............................................    65

    Dr. Brian Nosek, Co-Founder and Executive Director, Center for
      Open Science
        Oral Statement...............................................    79
        Written Statement............................................    81

    Dr. Todd Sherer, CEO, the Michael J. Fox Foundation for
      Parkinson's Research
        Oral Statement...............................................    86
        Written Statement............................................    88

    Discussion.......................................................    96

                 Appendix I: Answers to Post-Hearing Questions

    Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant
      Administrator for Science, EPA Office of Research and
      Development (ORD); EPA Science Advisor.........................   108

    Dr. Mary B. Rice, Assistant Professor of Medicine, Harvard
      Medical School; Pulmonary and Critical Care Physician, Beth
      Israel Deaconess Medical Center................................   109

    Dr. Todd Sherer, CEO, the Michael J. Fox Foundation for
      Parkinson's Research...........................................   110

                Appendix II: Additional Material for the Record

    Letter submitted by Representative Eddie Bernice Johnson,
      Chairwoman, Committee on Science, Space, and Technology, U.S.
      House of Representatives.......................................   114

    Article submitted by Representative Suzanne Bonamici, Committee
      on Science, Space, and Technology, U.S. House of
      Representatives................................................   116

    News release submitted by Representatives Suzanne Bonamici and
      Brian Babin, Committee on Science, Space, and Technology, U.S.
      House of Representatives.......................................   118

    Letters submitted by Representative Lizzie Fletcher, Committee on
      Science, Space, and Technology, U.S. House of Representatives..   121

    Letter submitted by Representative Haley Stevens, Committee on
      Science, Space, and Technology, U.S. House of Representatives..   128

    Letter submitted by Representative Paul Tonko, Committee on
      Science, Space, and Technology, U.S. House of Representatives..   130

    Memorandum submitted by Representative Sean Casten, Committee on
      Science, Space, and Technology, U.S. House of Representatives..   132

    Documents submitted by Representative Dr. Mary Rice, Assistant
      Professor of Medicine, Harvard Medical School; Pulmonary and
      Critical Care Physician, Beth Israel Deaconess Medical Center..   138

                           STRENGTHENING TRANSPARENCY

                             OR SILENCING SCIENCE?

                             THE FUTURE OF SCIENCE

                               IN EPA RULEMAKING

                                  ----------

                          WEDNESDAY, NOVEMBER 13, 2019

                              House of Representatives,
                   Committee on Science, Space, and Technology,
                                                       Washington, D.C.

        The Committee met, pursuant to notice, at 10:02 a.m., in
    room 2318 of the Rayburn House Office Building, Hon. Eddie
    Bernice Johnson [Chairwoman of the Committee] presiding.

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Chairwoman Johnson. The hearing will come to order. And
    without objection, the Chair is authorized to declare a recess
    at any time.
        Good morning, and let me welcome our witnesses today,
    ``Strengthening Transparency or Silencing Science? The Future
    of Science in EPA Rulemaking.'' We're here today to discuss a
    proposed rule that EPA (Environmental Protection Agency)
    released last year, entitled, ``Strengthening Transparency in
    Regulatory Science.''
        This is not a new issue for this Committee. Between 2014
    and 2017, we saw three markups of legislation mirroring the so-
    called transparency principles of the proposed rule. The Secret
    Science Reform Act, the HONEST Act, and now the ``Strengthening
    Transparency in Regulatory Science'' rule have all been met
    with the same passionate negative response from the scientific
    community. This rule makes dangerous, sweeping assertions about
    what does and does not count as good science.
        With the public availability of data as the determining
    factor, EPA will eliminate many fundamental public health
    studies from consideration, effectively gutting health-
    protective regulations that keep our air and water clean.
        I am attaching to my statement a letter from over 60 public
    health groups, including the Michael J. Fox Foundation and the
    Center for Open Science, both represented on our second panel,
    where they express serious concerns about this proposed rule's
    impact on public health.
        No one in this room is against the principles of
    transparency in science or in our government. However, this
    rule warps the noble goal of transparency into a misleading,
    black-or-white test of the legitimacy of individual studies.
    I've said it many times in this very hearing room: The
    requirement for data to be publicly available is nothing more
    than an attempt to undercut EPA's mandate to use the best
    available science. I believe this is part of an effort to
    destroy regulations that protect public health but are opposed
    by some regulated industries.
        The public comment period for this rule was remarkable.
    Around 600,000 comments were filed, the vast majority of which
    were highly critical. Commenters panned the harmful
    consequences of the rule for public health and the dubious
    legal justification for the rule. Because EPA neglected to
    offer definitions for some of the fundamental terms it
    describes, terms like ``reproducible'' and even ``data,'' many
    comments wondered what parts of the rule even mean.
        In his September appearance before this Committee,
    Administrator Wheeler announced that a supplementary rule would
    be issued in early 2020. I think today's hearing is critically
    important to the Committee Members, as well as our
    distinguished second panel of scientists that will express our
    concerns before the rule is finalized. I am very worried that
    EPA is ignoring its mission to protect human health and the
    environment in an effort to make it easier for regulated
    industry.
        However, I am hopeful that the Agency takes to heart what
    our esteemed panel of scientists has to say about the rule as
    it works to finalize a supplemental proposal. Thank you.
        [The prepared statement of Chairwoman Johnson follows:]

        Good morning. I would like to welcome our witnesses to
    today's hearing -- ``Strengthening Transparency or Silencing
    Science? The Future of Science in EPA Rulemaking.''
        We are here today to discuss a proposed rule that EPA
    released last year, entitled ``Strengthening Transparency in
    Regulatory Science.'' This is not a new issue for this
    Committee. Between 2014 through 2017, we saw three markups of
    legislation mirroring the so-called ``transparency'' principles
    of the proposed rule. The Secret Science Reform Acts, the
    HONEST Act, and now the ``Strengthening Transparency in
    Regulatory Science'' rule have all been met with the same
    passionate negative response from the scientific community.
        This rule makes dangerous, sweeping assertions about what
    does and does not count as good science. With the public
    availability of data as the determining factor, EPA will
    eliminate many foundational public health studies from
    consideration, effectively gutting health-protective
    regulations that keep our air and water clean. I am attaching
    to my statement a letter from over 60 public health groups -
    including the Michael J. Fox Foundation and the Center for Open
    Science, both represented on our second panel - where they
    express serious concerns about this proposed rule's impact on
    public health.
        No one in this room is against the principle of
    transparency in science or in our government. However, this
    rule warps the noble goal of transparency into a misleading,
    black-or-white test of the legitimacy of individual studies.
    I've said it many times in this very hearing room: The
    requirement for data to be publicly available is nothing more
    than an attempt to undercut EPA's mandate to use the best
    available science. I believe this is part of an effort to
    destroy regulations that protect public health but are opposed
    by some regulated industries.
        The public comment period for this rule was remarkable.
    Around 600,000 comments were filed, the vast majority of which
    were highly critical. Commenters panned the harmful
    consequences of the rule for public health and the dubious
    legal justification for the rule. Because EPA neglectedto offer
    definitions for some of the fundamental terms it describes -
    terms like ``reproducible'' and even ``data'' - many commenters
    wondered what parts of the rule even mean.
        In his September appearance before this Committee,
    Administrator Wheeler announced that a supplemental rule would
    be issued in early 2020. I think today's hearing is critically
    important so that Committee Members, as well as our
    distinguished second panel of scientists, can express our
    concerns before the rule is finalized.
        I am very worried that EPA is ignoring its mission to
    protect human health and the environment in an effort to make
    life easier for regulated industry. However, I am hopeful that
    the Agency takes to heart what our esteemed panel of scientists
    has to say about this rule as it works to finalize a
    supplemental proposal.Thank you.

        Chairwoman Johnson. I now would recognize our Ranking
    Member, Mr. Lucas, for an opening statement.
        Mr. Lucas. Thank you, Madam Chairwoman, and thank you to
    our witnesses for being here today.
        Transparency and reproducibility are an important part of
    ensuring the quality of the science that supports Federal
    regulations. By providing access to research data, scientists
    can replicate previous results to assure validity, relevance,
    and accuracy. We all want Federal agencies to rely on the best
    available science when making policy. I believe that we need a
    broader conversation on the best way for the Federal Government
    to conduct and to use transparent science that can be
    independently verified.
        Unfortunately, this hearing is narrowly focused on one
    proposed rule from one agency. This is about attacking the EPA
    under the current Administration, not about improving
    transparency and scientific integrity. I believe this is a
    missed opportunity to have a more holistic, productive
    discussion on an important topic.
        Ensuring that government research is transparent and can be
    independently verified is not a new goal. The Obama
    Administration issued memos on the need to promote public
    access to scientific information and include the underlying
    data for policy decisions. So in 2018, the EPA issued
    ``Strengthening Transparency in Regulatory Science,'' a rule
    that would prioritize those efforts.
        I think this is a laudable goal. After all, if taxpayers
    are expected to follow costly regulations, they should be able
    to trust that they stem from the best available science that
    can be independently verified. If Federal agencies are relying
    on data that can't be used for future research, it's impossible
    to know if the initial results were obtained by accurate
    science or simply by chance.
        I believe the EPA's proposed rule is well-intended, but
    there's still work to be done. That's why I was pleased to hear
    Administrator Wheeler confirm that the Agency is currently
    working on a supplemental rule for this topic. And while
    today's hearing will focus on the proposed rule, which was
    issued by the previous EPA administrator, we already know this
    won't be the final proposal from the Agency. So why are we
    holding a hearing on the original proposed rule that will be
    irrelevant in just a month or so?
        What's worse, Dr. Jennifer Orme-Zavaleta, and from now on,
    Doc, I'll refer to you as ``Dr.'' if you don't mind, who joins
    us from the EPA today, will be unable to comment on the
    development of the proposed rule, as she did not serve in the
    relevant office at the time it was issued. And because the
    supplemental rule is currently in the drafting process, the
    Doctor is also unable to comment on its specific requirements
    or details. It is my understanding that, once it's released,
    the supplemental rule will receive its own comment period and
    then move through the regular implementation process.
        I can't help but think this hearing would be more
    productive if we had waited for the supplemental rule to be
    published and then provided our comments and direction on the
    most current proposal.
        In closing, I'd like to emphasize that I think we could
    have a much more productive hearing if we had a broader
    discussion about the best way to improve reproducibility and
    transparency. I also want to say that if we can't improve the
    transparency of underlying data, then Congress should do our
    job and authorize the funding necessary to update and replicate
    vital research in a more transparent manner.
        I'm hopeful that our second panel today can address the
    broader issues of transparency in science. I'm particularly
    interested in the testimony from Dr. David Allison on behalf of
    the National Academies of Science, who currently completed a
    study on reproducibility initiated by the Committee.
        I'm also pleased to welcome Dr. Brian Nosek, who joins us
    from the Center for Open Science, and is currently exploring
    ways to facilitate and encourage transparency in the research
    community from the ground up. I look forward to hearing about
    constructive ideas on how policymakers and agencies can balance
    the reproducibility and the need to protect individual privacy
    and maintain data security.
        I thank our witnesses for taking the time to appear before
    us. I hope we can have an open and productive conversation on
    the broad issue of transparency in science.
        With that, I yield back, Madam Chair.
        [The prepared statement of Mr. Lucas follows:]

        Thank you, Madam Chairwoman, and thank you to our witnesses
    for being here today.
        Transparency and reproducibility are an important part of
    ensuring the quality of the science that supports federal
    regulations. By providing access to research data, scientists
    can replicate previous results to assure validity, relevance,
    and accuracy.
        We all want federal agencies to rely on the best available
    science when making policy. And I believe that we need a
    broader conversation on the best way for the federal government
    to conduct and use transparent science that can be
    independently validated.
        Unfortunately, this hearing is narrowly focused on one
    proposed rule from one agency.
        This is about attacking the EPA under the current
    administration-not about improving transparency and scientific
    integrity. I believe this is a missed opportunity to have a
    more holistic, productive discussion on an important topic.
        Ensuring that government research is transparent and can be
    independently verified is not a new goal. The Obama
    Administration issued memos on the need to promote public
    access to scientific information and include the underlying
    data for policy decisions.
        So in 2018, the EPA issued ``Strengthening Transparency in
    Regulatory Science,'' a rule that would prioritize these
    efforts.
        I think this is a laudable goal. After all, if taxpayers
    are expected to follow costly regulations, they should be able
    to trust that they stem from the best available science that
    can be independently verified.
        If federal agencies are relying on data that can't be used
    for future research, it's impossible to know if the initial
    results were obtained by accurate science or simply by chance.
        I believe the EPA's proposed rule is well-intentioned, but
    there is still work to be done. That's why I was pleased to
    hear Administrator Wheeler confirm that the agency is currently
    working on a supplemental rule for this topic.
        And while today's hearing will focus on the proposed rule,
    which was issued by the previous EPA Administrator, we already
    know this won't be the final proposal from the agency.
        So why are we holding a hearing on the original proposed
    rule that will be irrelevant in just a month or so?
        What's worse, Dr. Jennifer Orme-Zavaleta, who joins us from
    the EPA today, will be unable to comment on the development of
    the proposed rule, as she did not serve in the relevant office
    at the time it was issued. And because the supplemental rule is
    currently in the drafting process, Dr. Orme-Zavaleta is also
    unable to comment on its specific requirements, or details.
        It is my understanding that once it's released, the
    supplemental rule will receive its own comment period, and then
    move through the regular implementation process.
        I can't help but think this hearing would be more
    productive if we had waited for the supplemental rule to be
    published, and then provided our comments and direction on the
    most current proposal.
        In closing, I'd like to again emphasize that I think we
    could have a much more productive hearing if we had a broader
    discussion about the best way to improve reproducibility and
    transparency.
        I also want to say that if we can't improve the
    transparency of underlying data, then Congress should do our
    job and authorize the funding necessary to update and replicate
    vital research in a more transparent manner.
        I'm hopeful that our second panel today can address the
    broader issue of transparency in science. I am particularly
    interested in testimony from Dr. David Allison on behalf of the
    National Academies of Science, who recently completed a study
    on reproducibility initiated by this Committee.
        I'm also pleased to welcome Dr. Brian Nosek, who joins us
    from the Center for Open Science, and is currently exploring
    ways to facilitate and encourage transparency in the research
    community from the ground up.
        I look forward to hearing about constructive ideas on how
    policymakers and agencies can balance reproducibility with the
    need to protect individual privacy and maintain data security.
        I thank our witnesses for taking the time to appear before
    us today and I hope we can have an open and productive
    conversation on the broad issue of transparency in science. I
    yield back, Madam Chair.

        Chairwoman Johnson. Thank you, Mr. Lucas.
        If there are Members who wish to submit additional opening
    statements, your statements will be added to the record at this
    point.
        And at this time I'd like to introduce the witness for our
    first panel. Dr. Jennifer Orme-Zavaleta is the Principal Deputy
    Assistant Administrator for Science with the Office of Research
    and Development (ORD) and the Science Advisor for the
    Environmental Protection Agency. This is her second time
    testifying before this Committee during the 116th Congress. I
    welcome you back and thank you for your time.
        You will have 5 minutes for your spoken testimony. Your
    written testimony will be included in the record for the
    hearing. And when you have completed your spoken testimony, we
    will begin with questions. Each Member will have 5 minutes for
    questions.
        You now may proceed, and thank you for being here.

                TESTIMONY OF DR. JENNIFER ORME-ZAVALETA,

                PRINCIPAL DEPUTY ASSISTANT ADMINISTRATOR

                    FOR SCIENCE, OFFICE OF RESEARCH

                 AND DEVELOPMENT, AND SCIENCE ADVISOR,

                    ENVIRONMENTAL PROTECTION AGENCY

        Dr. Orme-Zavaleta. Good morning, and thank you.
        Madam Chairwoman Johnson and Ranking Member Lucas, as
    noted, my name is Jennifer Orme-Zavaleta, please call me
    Jennifer. I'm the Principal Deputy Assistant Administrator for
    Science in the U.S. Environmental Protection Agency's Office of
    Research and Development, and I also act as the Agency's
    Science Advisor. My responsibility as the career lead for ORD
    is to ensure that we provide solid and robust science to inform
    Agency decisions. I have worked at EPA since 1981, and of the
    38 years I've been with EPA, I've spent 25 years in ORD.
        I appreciate the opportunity to talk with you today about
    EPA's proposed rule to strengthen transparency in regulatory
    science.
        EPA is committed to transparency and giving public access
    to its data and research, and we have made great strides on
    this. EPA's efforts span administrations, from 2013 OSTP
    (Office of Science and Technology Policy) memo to increase
    access to federally funded research, to the Evidence-Based
    Policymaking Act of 2018 and to OMB's (Office of Management and
    Budget's) 2019 memo on improving the Information Quality Act.
    For example, EPA's plan to increase access to results of EPA-
    funded scientific research was finalized in 2016. Since then,
    EPA has implemented all three phases outlined in the plan. This
    includes working to ensure EPA's own research publications and
    the underlying data for these publications are publicly
    accessible, as well as working to increase access to EPA-funded
    research. These efforts are more outlined on some of our
    websites.
        In addition to these efforts, EPA initiated a rulemaking
    process in 2018 to increase transparency and public access to
    scientific data. EPA's proposed rule, `Strengthening
    Transparency in Regulatory Science,' seeks to ensure that the
    science underlying EPA's actions is publicly available in a
    manner sufficient for independent validation.
        The proposed rule would require that data and models
    underlying studies to support significant EPA regulatory
    actions, regardless of who generated or funded them, be made
    publicly available. EPA intends to release a supplemental
    proposed rule for public comment in early 2020 to provide
    clarifications on certain terms and aspects of the proposed
    rule.
        While EPA believes that maximizing transparency is
    important, the Agency understands that there may be instances
    in which data and models cannot be made available. Thus, the
    proposed rule states that the EPA Administrator may grant an
    exception if it is not practicable to ensure that data and
    models are publicly available.
        EPA issued the proposed rule on April 30, 2018 and held a
    public hearing that summer, in which some of you participated,
    and provided comment. The public comment period was extended
    after request from the public and from Congress, and it closed
    on August 16, 2018. During that time, we received nearly
    600,000 comments. More than 9,200 of these were unique
    comments, many of which raised very complex issues.
        Comments were submitted by professional organizations,
    States, tribes, industry, environmental groups, health groups,
    universities, the general public, and more. Almost all
    commenters supported the goal of greater transparency even if
    they disagreed with the approach in the proposed rule. And
    these comments covered many complex topics, and EPA is
    currently working hard to address these issues.
        EPA also solicited feedback from the Science Advisory Board
    (SAB) on personally identifiable information or PII and
    confidential business information, CBI. EPA received these
    comments in September, and the comments are publicly available
    and are being considered as we develop the final rule. The SAB
    is also providing comments on the entire rule, and we
    anticipate receiving those comments soon.
        EPA has just sent a supplemental rule to OMB for
    interagency review. The supplemental rule was developed because
    we received so many public comments, and we wanted to provide
    clarifications on certain terms and aspects of that proposed
    rule. We are committed to ensuring adequate time for public
    review of the supplemental rule, and we anticipate releasing it
    for public comment in early 2020.
        Since the supplemental rule is not yet public and is still
    undergoing review, I cannot speak to particular details, but
    once we get further in the process, I'd be happy to offer
    briefings on the supplemental rule.
        As you know, an older draft version of the supplemental
    rule leaked to The New York Times, and I would like to clarify
    a few things. First, the version that was published in The New
    York Times was an outdated version and is not what was sent to
    OMB for interagency review. Second, the supplemental rule is a
    supplement to the proposed rule. It is not a new rule or a new
    draft of the proposed rule. Rather, it's a supplement that
    contains clarifications, modifications, and additions to
    certain provisions in the proposed rule.
        And last, the proposed rule applies prospectively to
    regulations. It does not apply to already-established rules and
    regulations. The proposed rule does apply to dose-response data
    and models that inform significant rules made in the future,
    including data and models that were previously developed. The
    supplemental rule will be available for public comment, as I
    noted, in early 2020, and we anticipate finalizing the proposed
    rule next year.
        So EPA is committed to greater transparency, protecting PII
    and CBI, following all applicable laws and regulations, and
    continuing to protect public health and the environment. Thank
    you again for the opportunity to appear before you today, and
    I'm happy to answer any questions.
    [The prepared statement of Dr. Orme-Zavaleta follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Chairwoman Johnson. Thank you very much. We will now begin
    our questioning period. And I will yield to myself 5 minutes.
        Doctor, the EPA cannot carry out its mission to protect
    public health and the environment without considering the best
    available science. Congress requires that the Agency's
    decisions be informed by the latest, most accurate scientific
    data. By preventing EPA from considering critical scientific
    studies, the proposed rule would exclude the best available
    science and endanger the public. Does the Agency consider it
    reasonable or wise to categorically eliminate studies, for
    example, all human epidemiology studies based on that one
    factor?
        Dr. Orme-Zavaleta. So the Agency is committed to using the
    best available science in its decisions while also providing
    greater transparency to help the public understand how those
    science informations were used in reaching those decisions.
    This is a point that we received a number of comments on and
    also what's contributing to the supplemental rule because we
    need to seek further information before we make decisions on
    that final rule.
        Chairwoman Johnson. Now, tell me then, how can EPA meet the
    statutory obligations to use the best available science in laws
    such as the Safe Drinking Water Act and the Toxic Substances
    Control Act if the rule would prevent it from considering
    certain studies even if they are considered definitive by the
    research community?
        Dr. Orme-Zavaleta. So the issue of science and public
    trust, there's a couple of aspects to keep in mind. When
    looking at good science, there are other tenets that weigh
    heavily in looking at how well studies were conducted, their
    quality assurance, what type of external peer review they went
    through, and overarching scientific integrity. And that's what
    contributes to good science.
        The idea with the transparency rule is to provide the data
    available to the public so they understand how that science was
    used in making decisions.
        Chairwoman Johnson. The rule has a provision wherein the
    Administrator can unilaterally exempt a study from the rule.
    Would EPA scientists, including yourself, consider it
    appropriate for a political appointee to have this arbitrary
    power over EPA's science?
        Dr. Orme-Zavaleta. So this is also a topic that we received
    a number of comments on from a variety of different sectors,
    and that's something that we're weighing very heavily as we
    look through in developing the final rule.
        Chairwoman Johnson. OK. In your nearly 40 years at EPA, can
    you personally recall any instance in which considering less
    science led to a better policy decision by the Agency?
        Dr. Orme-Zavaleta. So my time at EPA has been in a variety
    of different facets, some involving some rulemaking, but,
    again--so I can't speak to that specifically from my own
    experience. But we are working hard to ensure that the Agency
    is evaluating the best available science while meeting all of
    the other requirements for providing the public information so
    that they can understand how we made the decisions that we
    made.
        Chairwoman Johnson. Thank you very much. I'll now recognize
    Mr. Lucas.
        Mr. Lucas. Thank you, Madam Chair.
        Jennifer, and you said I could call you Jennifer----
        Dr. Orme-Zavaleta. Indeed.
        Mr. Lucas [continuing]. You addressed it in your testimony,
    and I think all of us read some of the news media, so it's no
    secret that a version of the supplemental rule was leaked and
    reported by The New York Times. And, by the way, for the record
    I happen to have a copy of the document that was used in that
    story. And just for note again to repeat one more time, is this
    the most recent version of the supplemental rule?
        Dr. Orme-Zavaleta. That is not the most current version.
    That is an older version, and that was not what was submitted
    to OMB last Friday.
        Mr. Lucas. Thank you. Now, I ask, because, as I said in my
    opening statement, it seems like this hearing is premature and
    that it would be more productive if we waited for the
    supplemental rule to be published, not leaked, and provide our
    comments and direction on the most current proposal. Can you
    confirm that the supplemental rule is still in the drafting
    process?
        Dr. Orme-Zavaleta. So the supplemental rule was submitted
    to OMB, and it's now part of the interagency review process. We
    will see what comments come back from that review. We'll work
    to finalize the supplemental rule and then issue it for public
    comment early next year.
        Mr. Lucas. Do you agree that a productive hearing would
    result from conversations based on a published rule, not a
    leaked version?
        Dr. Orme-Zavaleta. So we are happy to be here today to
    answer questions that you may have. What input we receive today
    we will add into all the other comments that we have for
    consideration. We're happy to provide further briefings as more
    information becomes available.
        Mr. Lucas. In The New York Times article the reporter
    stated, ``The new version does not appear to have taken any of
    the opposition into consideration.'' It's my understanding that
    once it's released the supplemental rule will also be open for
    public comment and then move through the regular implementation
    process. Is that correct and consistent with the rulemaking
    process?
        Dr. Orme-Zavaleta. That's part of the rulemaking process.
    And I would note that the reason that we have a supplemental
    rule is actually because of the number of comments that were
    raised and some of the complex issues and the need for
    clarification. And so it's because of that input we felt it
    necessary for a supplement to clarify terms, to seek comment on
    further aspects and help us with our consideration in going
    through the rulemaking process.
        Mr. Lucas. It would seem that the process is working.
        With that, Madam Chair, I yield back the balance of my
    time.
        Chairwoman Johnson. Thank you very much. Ms. Bonamici.
        Ms. Bonamici. Thank you, Chairwoman Johnson.
        Thank you to our witness for being here today.
        Chairwoman Johnson, I request unanimous consent to submit
    for the record a copy of The New York Times article from
    November 11, 2019, titled, ``EPA to Limit Science Used to Write
    Public Health Rules'' and also the EPA press release in
    response to that article from November 12, 2019.
        Chairwoman Johnson. Without objection.
        Ms. Bonamici. Thank you. The EPA's proposed rule titled
    ``Strengthening Transparency in Regulatory Science'' isn't
    about transparency. It's an attack on sound science. We've had
    this conversation in this hearing room many times. Transparency
    is a laudable goal, and it can be accomplished through
    collaboration with and input from the scientific community.
    This rule, unfortunately, will detrimentally limit the science
    that EPA can rely on in regulatory decisionmaking and, if
    implemented, will have negative consequences for the EPA and
    its mission to protect public health and the environment and
    for every person who benefits from clean air and clean water.
        In his testimony before this Committee in September,
    Administrator Wheeler stated, ``We intend to issue a
    supplemental proposed rule to our science transparency
    regulation early next year.'' According to the record, I then
    asked if the supplemental rule would be published prior to
    2020. The Administrator clearly stated, ``I'm told early next
    year.''
        And then earlier this week The New York Times reported that
    the EPA draft supplemental proposed rule is currently headed
    for White House review. The EPA press release yesterday then
    stated that the final text has been submitted to the Office of
    Management and Budget for interagency review. And, Dr. Orme-
    Zavaleta, you just confirmed that.
        Dr. Orme-Zavaleta. Yes.
        Ms. Bonamici. I'm concerned that the EPA was not
    transparent with Congress during this process. The OMB review
    of the proposed rule took only 4 days in the past, so assuming
    that the timing is similar, the supplemental proposed rule
    could very well be ready to publish before 2020. At best, the
    Administrator's testimony was misleading and at worst it was
    deliberately deceptive, and either is unacceptable.
        So Dr. Orme-Zavaleta--did I get that right?
        Dr. Orme-Zavaleta. You're doing great.
        Ms. Bonamici. Close?
        Dr. Orme-Zavaleta. You're----
        Ms. Bonamici. Please answer yes or no. Are you aware of the
    Administrator's testimony from when he was here in September?
        Dr. Orme-Zavaleta. Yes.
        Ms. Bonamici. And the timing in these press reports
    indicates that the final agency review (FAR) meeting has
    already taken place. So when Administrator Wheeler testified
    before the Committee on September 19, had the final agency
    review meeting already been scheduled?
        Dr. Orme-Zavaleta. So I'm not sure I'm entirely
    understanding final agency review.
        Ms. Bonamici. The final agency review meeting, had that
    already been scheduled?
        Dr. Orme-Zavaleta. So you're talking about the FAR process?
        Ms. Bonamici. Yes.
        Dr. Orme-Zavaleta. So we were in the--I think we hadn't
    even initiated--by the time of his testimony, I think it might
    have just--just been initiated in that FAR process, but we
    didn't resolve that until late last week, then--and then
    getting the draft supplemental to OMB.
        Ms. Bonamici. Well, the Administrator was here on September
    19.
        Dr. Orme-Zavaleta. So the FAR is completed now.
        Ms. Bonamici. Well, it's my understanding that the final
    agency review meeting was on September 30, 2019.
        Dr. Orme-Zavaleta. And I'm checking to see--yes.
        Ms. Bonamici. OK. So when the Administrator was here on
    September 19 it's reasonable to assume that he knew about the
    meeting that was scheduled on September 30. Is that correct?
        Dr. Orme-Zavaleta. I don't know that he knew that it was
    actually scheduled at that point in time, so I can't speak, but
    we can get further clarification from him regarding that
    particular testimony.
        Ms. Bonamici. Thank you.
        Dr. Orme-Zavaleta. But the FAR didn't complete until the
    week after.
        Ms. Bonamici. And I want to get another topic in. In light
    of the submission of the supplemental rule to OMB, please
    clarify the timeline for us. Will the supplemental rule be
    published prior to 2020?
        Dr. Orme-Zavaleta. I am not aware that it'll be published
    prior to 2020. We are anticipating after the beginning of the
    new year. The OMB process can vary in time, and the typical
    process can be anywhere from 90 days. So I can't say whether
    they'll have that completed prior to that.
        Ms. Bonamici. I also want to clarify, you mentioned
    something in your oral testimony that's not in your written
    testimony about retroactive application. In response to one of
    my questions during his testimony, Administrator Wheeler
    stated, ``Our proposal did not retroactively apply.'' Those
    were his words. But according to the news reports, the draft
    supplemental rule states that the rule would apply to all data
    and models, regardless of when the data and models were
    generated. The EPA press release states, ``The proposal and
    supplemental will not apply to any regulations already in
    place.''
        So please clarify for the record, even if, as the EPA
    stated yesterday, the proposal and supplemental will not apply
    to regulations already in place, does the language in the
    supplemental rule suggests that the EPA is still considering
    some type of retroactive application? And if so, what does that
    mean?
        Dr. Orme-Zavaleta. So the proposed rule--and this is the
    thing that we wanted to clarify with The New York Times article
    because I think it did get confused. So the supplement, you
    know, it does not apply to already-established rules and
    regulations. It does apply to dose-response data and models
    that could inform significant rules made in the future,
    including the data and models that were previously developed.
        Ms. Bonamici. Thank you for that clarification, which I
    find very concerning. The proposed rule and its implications on
    the EPA's statutory obligations warrant further consideration
    and scrutiny. So today I'm sending a letter requesting that the
    National Academy of Sciences, as an authoritative, independent,
    nonpartisan scientific organization work with the EPA to review
    the proposed rule.
        I yield back the balance of my time.
        Chairwoman Johnson. Thank you very much. Mr. Posey.
        Mr. Posey. Thank you, Madam Chair, for holding this hearing
    today on transparency, and I appreciate your attendance, Dr.--
    --
        Dr. Orme-Zavaleta. Jennifer.
        Mr. Posey [continuing]. Orme-Zavaleta.
        Dr. Orme-Zavaleta. Yes, you're----
        Mr. Posey [continuing]. And I'm glad to see that the Agency
    is moving more toward better transparency. And I'm sad that it
    has been maligned by the media and others.
        In the past, EPA has relied upon ``secret studies'' to move
    forward with a particular political agenda. These studies were
    used to justify regulations that would have negatively affected
    thousands of people. For example, the EPA sought to regulate
    fine particulate matter or airborne dirt. This would have
    particularly hurt the agriculture business, which is the
    second-largest industry in the State of Florida. There would be
    no way to test the data used to make the regulation because it
    was secret. I have a problem with that obviously, and I believe
    we should have transparency. And any study funded with taxpayer
    funds should be made public.
        How do you believe the transparency and reproducibility
    will improve the quality and return on investment on federally
    funded scientific research?
        Dr. Orme-Zavaleta. So I think that as we look at federally
    funded scientific research, we are already making that
    information publicly available. Our published articles are made
    available through the NIH (National Institutes of Health)
    PubMed Central. Our data are made publicly available, so that's
    a provision that we are already doing.
        Mr. Posey. OK. Thank you. Has the EPA's Office of Research
    and Development incorporated reproducibility and transparency
    in federally funded research? And how has your office
    incorporated those measures?
        Dr. Orme-Zavaleta. So we provide the information, the data
    that we generate. We make that publicly available. And so
    that's where we're currently at. This particular rule is not
    final, and we're not implementing the rule as it has been
    proposed. But again, we're working hard to make sure that the
    data that we generate, the research that we conduct and
    implementing the--that particular provision, it's--also
    includes our external grants, as well as the rest of the
    Agency. So any research or any publication that the Agency
    generates, we make those publications available. We make the
    underlying data available. And that provision is now expected
    of our grantees as well.
        Mr. Posey. Well, thank you.
        Dr. Orme-Zavaleta. The main thing that I do want to
    highlight here, though, is that in doing so, we're going to
    continue to follow the applicable laws that protect PII and
    CBI.
        Mr. Posey. Thank you. I appreciate your forthrightness.
    I've had problems with the Agency in the past getting
    forthright answers from them. Suppose now I wanted to get a
    copy of a study that was previously deemed ``secret'' to make a
    law or rule, a law made by unelected, unaccountable,
    unrecallable bureaucrats. Would I now be able to get a copy of
    that secret study having any identification or personal
    information redacted of course? Would I be able to get a copy
    of the study now that they denied someone to see, say, 4 years
    ago?
        Dr. Orme-Zavaleta. I think I'd have to know some of the
    specifics, but I think we would work hard--if the study is
    published and available, we can provide that particular study
    and the underlying data that are highlighted in that particular
    study.
        Mr. Posey. Yes. If it was used to promulgate a rule, then
    it would probably be accessible now to the public even though
    it were not in the past?
        Dr. Orme-Zavaleta. So we're looking at regulations going
    forward, so a previously conducted study and the previous
    regulation, that record stands, but we're looking at
    regulations going forward. So this particular rule applies
    prospectively.
        Mr. Posey. So I still can't get a copy of a publicly paid-
    for study that was used to promulgate a rule in the past?
        Dr. Orme-Zavaleta. It depends on how far past, but the
    docket that supports that rulemaking, that's what's publicly
    available now.
        Mr. Posey. I thank you. I yield back the balance of my
    time.
        Chairwoman Johnson. Thank you very much. Ms. Stevens.
        Ms. Stevens. Thank you, Madam Chair. I'd like to submit a
    letter for the record from Dr. Mona Hanna-Attisha, Founder and
    Director of the Michigan State University Hurley Pediatric
    Public Health Initiative. Dr. Hanna-Attisha also works as a
    pediatrician in Flint, Michigan.
        It's also worth teasing out some of what Dr. Hanna-Attisha
    has written before I get into my questions. Dr. Hanna-Attisha
    wrote that, quote, ``I know from my work as a pediatrician in
    Flint that when the EPA succeeds, people are protected, and
    when the EPA fails, people get sick. This is especially true
    for our most vulnerable communities and most desperately for
    our children both here in Flint and around the State. Let the
    story of the Flint water crisis serve as a tragic reminder of
    the consequences of undermining science, not only the science
    of water treatment but also the science of lead's
    neurotoxicity.''
        Quote, ``Unfortunately, the newly revised EPA proposal
    `Strengthening Transparency in Regulatory Science' undermines
    essential protections and established science-based
    decisionmaking processes. Shockingly, it does so to an even
    greater extent than the original proposed rule would have,
    despite overwhelming public opposition.''
        Dr. Orme-Zavaleta, do you acknowledge that the proposed
    rule would preclude the use of many types of studies that the
    EPA has used in the past to address environmental threats that
    disproportionately affect children, low-income populations, or
    both?
        Dr. Orme-Zavaleta. If I could please get some clarification
    because it sounds like Dr. Hanna was referring to the
    supplemental rule that leaked versus the proposed rule, and so
    is your question specific to the proposal or to the
    supplemental?
        Ms. Stevens. Well, it's to both frankly.
        Dr. Orme-Zavaleta. So I can't speak to the supplemental----
        Ms. Stevens. Yes.
        Dr. Orme-Zavaleta [continuing]. At this point in time, but
    again, you know, these echo many of the comments that we
    received, and it's because of some of these issues that we are
    going out with a supplemental to get further input and to
    provide some clarifications as we move forward.
        Ms. Stevens. Yes. While we here on the Science Committee
    protect and support transparency, so I appreciate your response
    and also wanted to ask, did the EPA consult the Office of
    Children's Health Protection before it wrote that the proposed
    rule could ignore the Executive Order 12898 or with the Office
    of Environmental Justice before it wrote the rule to ignore the
    E.O.? And the E.O., just for those in the audience, directs the
    EPA to identify and address disproportionately high and adverse
    human health or environmental effects.
        Dr. Orme-Zavaleta. So I was not part of the development of
    the proposed rule, and I can't really speak to which all--which
    programs were all engaged in----
        Ms. Stevens. OK. So we'll submit that for the record and
    get back. How can the EPA in part--how is this legally
    justified in terms of its decision to not perform an assessment
    on the proposed rule's adverse impacts on vulnerable
    populations? Is there an ability for you guys to provide legal
    justification, or is that something else we should submit for
    the record?
        Dr. Orme-Zavaleta. I think that would be better to submit
    for the record.
        Ms. Stevens. OK. And so then going forward with the
    supplemental draft, you know, if you could provide any specific
    opportunities or insights and ways in which you've engaged
    minority populations and children's health advocates to
    participate in the further rulemaking process, is that
    something that you can speak to at this time?
        Dr. Orme-Zavaleta. So in developing the supplemental, we
    did utilize an agency workgroup, which had representation
    across the Agency. I don't believe the Office of Children's
    Health identified a person to take part, but we did get cross-
    agency input in reviewing all of the comments and determining
    where we needed further clarifications, further comment, as
    well as offering what we are--certain clarifications of terms
    and aspects. So that's what's going to be coming forward.
        Ms. Stevens. Well, I'd certainly like to recommend that the
    Agency gets in touch with Dr. Hanna-Attisha and her associates
    given that the largest public health crisis of our time, those
    voices would certainly be valued and recommended.
        And I'd also like to commend you, Dr. Orme-Zavaleta, for
    your very lengthy career in civil service at the EPA as a
    scientist. Thank you for being here with us today.
        Dr. Orme-Zavaleta. Thank you.
        Ms. Stevens. I yield back my time.
        Chairwoman Johnson. Thank you very much. Mr. Baird.
        Mr. Baird. Thank you, Madam Chair. I appreciate the witness
    being here today and your background and experience.
        You already mentioned The New York Times article, and I
    understand your address to that, you cannot probably comment on
    the supplemental rule, but I guess I'm wondering about, is
    there any scenario where whatever the version of the rule that
    might be finalized, this transparency rule would somehow
    invalidate the existing regulations?
        And you mentioned something about not going back or
    whatever the previous decision was based on that might not
    change previous decisions, and can you elaborate on any kind of
    a situation where that might invalidate existing rules? I guess
    what I'm trying to say is after you've made a rule and then,
    you know, your colleagues and so on do the research and
    reproducibility and replicability end up being validations. So
    if you had additional research that proved what the previous
    rule and decision was maybe in error, can you adjust that
    rulemaking----
        Dr. Orme-Zavaleta. So, again, this--this particular rule,
    once it's finalized, would apply prospectively to future rules
    and regulations. It would not undo existing rules and
    regulations. It's only looking forward. And I think in the case
    of some statutes, whether it's NAAQS (National Ambient Air
    Quality Standards) or a 6-year review of drinking water
    regulations, that would be an opportunity where new information
    can be considered in updating those particular activities, if
    that gets to what you're looking for.
        Mr. Baird. We're getting close. You're on the right track.
    My question is sometimes these rules end up impacting
    businesses and so on. The airborne rule for agriculture was one
    of those. I guess my question is, how fast can you make
    adjustments in the rule? I'm wondering if the process doesn't
    inhibit or----
        Dr. Orme-Zavaleta. Well, the Agency follows the statutory
    requirements in developing its different rules and regulations.
    But the other thing to keep in mind is, first and foremost, we
    are about protecting public health and the environment. And we
    want to make sure that our decisions are sound and will meet
    the mission of the Agency.
        Mr. Baird. So I understand, and maybe I'll rephrase this,
    once the rule is finalized and it's put in place, but then if
    new data was available or became available that made you want
    to modify that rule, how long would it take to make a change in
    the rule?
        Dr. Orme-Zavaleta. It would depend on----
        Mr. Baird. It would have to go back clear through the whole
    process?
        Dr. Orme-Zavaleta. So that would be in the policy side of
    EPA, and each would follow their statutory schedule of
    rulemaking and looking at the contaminants that they control
    under the different authorities. So it would follow that
    schedule. There wouldn't be any sort of increased schedule.
        Mr. Baird. So that could take a year or 2 years or what to
    make a----
        Dr. Orme-Zavaleta. It depends on----
        Mr. Baird. Whatever that policy is?
        Dr. Orme-Zavaleta. It depends on the particular--whether
    it's under the Clean Air Act, Clean Water Act, Safe Drinking
    Water Act, what have you. It would be that schedule that this
    rule would apply.
        Mr. Baird. OK.
        Dr. Orme-Zavaleta. OK.
        Mr. Baird. Thank you. I yield back.
        Chairwoman Johnson. Thank you very much. Mr. McNerney.
        Mr. McNerney. Well, I thank the Chairwoman, and I thank
    you, Dr. Orme-Zavaleta, for appearing today. I know you're in
    for some tough questions.
        The EPA cannot unilaterally decide to completely transform
    the way it uses science in its rulemaking. It needs to receive
    the authority from Congress, and it needs to justify the use of
    that authority. If the Agency cannot do that, the rule is not
    valid.
        In its May 2018 notice extending the public comment period,
    the EPA cited 5 U.S. Code 301. According to The New York Times,
    this is now the sole authority being cited by the Agency. Dr.
    Orme-Zavaleta, are you familiar with the notice that the EPA
    published in May 2018 which extended the public comment period
    and announced a public hearing on the proposed rule, and cited
    EPA's supposed authority under 5 U.S.C. 301?
        Dr. Orme-Zavaleta. So I'm aware that we extended the public
    comment period from the end of May until the middle of August,
    yes.
        Mr. McNerney. What about citing the EPA's supposed
    authority under that code?
        Dr. Orme-Zavaleta. So I'm going to have to defer that to
    our legal counsel if that's something you want to submit for
    the record, then we can respond that way.
        Mr. McNerney. Well, thank you. In reference to the proposed
    rule, let's talk about 5 U.S.C. 301. It's a two-sentence law
    that called the Federal Housekeeping Statute that was enacted 4
    years before the EPA was created. Are you aware of any
    executive department that has relied on this housekeeping
    statute to fundamentally overhaul its regulatory process?
        Dr. Orme-Zavaleta. So, again, I would have to defer to our
    general counsel.
        Mr. McNerney. Well, I have to advise you that the Committee
    staff made it clear to the EPA that you should be able to
    answer all questions on the proposed rule.
        Dr. Orme-Zavaleta. I cover a lot of topics, but I am not a
    lawyer.
        Mr. McNerney. Well, if the EPA's position is that it
    already has the authority to carry out this rule under 5 U.S.C.
    301, why is it promulgating the new rule now?
        Dr. Orme-Zavaleta. Again, I think that's something we'll
    have to follow up on.
        Mr. McNerney. OK. Well, I'm curious about how far the
    Agency could push the authority that it claims under this
    statute. Could the EPA invoke 5 U.S.C. 301 to consider only
    science published by industry?
        Dr. Orme-Zavaleta. Again, I'll have to defer that comment.
        Mr. McNerney. Could the EPA invoke 5 U.S.C. 301 to consider
    science differently in enforcing clean-air regulations within
    different States based on whether the State voted for or
    against President Trump?
        Dr. Orme-Zavaleta. Again, I think that's something that
    we'll have to follow up with you.
        Mr. McNerney. Will the EPA at least knowledge that 5 U.S.C.
    301 does not convey any authority under the rule that conflicts
    with existing statutory enforcement obligations?
        Dr. Orme-Zavaleta. And I'll have to defer that as well. So
    anything on the authority, sir, I'm not going to be able to
    address.
        Mr. McNerney. Well----
        Dr. Orme-Zavaleta. That's not my area of expertise.
        Mr. McNerney [continuing]. The EPA was notified that you
    today would have to answer all these questions.
        Dr. Orme-Zavaleta. I apologize if that was a
    misunderstanding, but that's beyond my particular expertise.
        Mr. McNerney. All right. Well, I'm going to have to yield
    back. Thank you.
        Chairwoman Johnson. Thank you very much. Mr. Murphy.
        Mr. Murphy. Thank you, Madam Chairman. And thank you,
    Doctor, for your service. It's a testament to dedication in
    science that we have great people in government that have
    dedicated their lives to that, so thank you very much.
        I've been in medicine for 30 years and done a different
    type of dedication, and I've read and continue to read many,
    many medical journals, as I'm sure you do. And I think it's
    important that people know that when you and I read journals,
    we look at articles, we look at studies with a very, very
    discerning eye. I personally don't believe anything in the
    literature until I believe it. And I think that's the way our
    scientists have pointed out.
        And so it bothers me to think or imply that folks would
    think that the people in the EPA would do anything less. I
    think scientists, we hold ourselves to a different standard,
    that we look for the true objective facts, and we base that
    upon that. So I thank you for the work that you're doing in
    that.
        I will ask one question. Have you by any chance had a
    chance to review the news release from the EPA yesterday?
        Dr. Orme-Zavaleta. Yes, I saw it after it came out.
        Mr. Murphy. OK. In quick summary, it talks about The New
    York Times and several glaring inaccuracies of their article.
    And I think, to be very honest with you, it's just seemingly a
    theme that goes on around here about reckless reporting,
    inaccurate reporting, and flat out lying.
        And so I wondered, you know, since you have read this, it
    talks about false information being stated, things that are bad
    reporting, things that are not true. I wondered if you might
    have a comment for the Committee about this news release and
    how you feel. Is this an accurate depiction of the inaccuracies
    put out by The New York Times?
        Dr. Orme-Zavaleta. Well, I think the key clarification from
    the press release, again, is just to highlight that this is a
    supplement. It's not a new rule. It is a supplement to what was
    proposed, and the Agency wanted to clarify terms. We wanted to
    also get additional comment as we continue our deliberations in
    finalizing the rule. I think that was one of the key pieces of
    clarification.
        The other key clarification, again, was to note that this
    rule applies prospectively to new rules and regulations, not to
    the past rules and regulations.
        Mr. Murphy. Yes, thank you. Do you think there's anybody at
    the EPA that does not have the interest of the American people
    at heart?
        Dr. Orme-Zavaleta. I have not come across anyone at EPA--
    the thing that is remarkable about all of the Agency employees
    is their dedication to the mission of the Agency and protecting
    public health and the environment.
        Mr. Murphy. Thank you. I think that we owe a great debt to
    the EPA for keeping the country safe, keeping our waterways
    safe, keeping what we take in safe. We're not perfect in this
    regard, and there are a lot of times that we go back and look
    at things that we could've done differently. So I appreciate
    that.
        You know, you talked about in your prepared testimony how
    the rulemaking was just one step in a long effort to improve
    scientific integrity and transparency. Can you expand upon that
    a little bit? Has this been a bipartisan effort? Tell me a
    little bit more or tell us a little bit more about how this
    process really has been one of collectiveness.
        Dr. Orme-Zavaleta. Well, again, I think, as I noted
    earlier, as science has come across increased scrutiny, we have
    been working hard to build public trust in the quality of our
    science, and we do that primarily through strong quality
    assurance, strong, independent expert peer review of our work,
    as well as a strong scientific integrity program.
        Combined with that, building public trust is also helping
    to enable the public to understand what information was used in
    the decisions the Agency makes. So if they choose, they can go
    back and try to understand how we came to the conclusions that
    we came to. And that's where the transparency piece comes in.
        Mr. Murphy. Thank you. Just one final question. Is non-
    government-funded research currently subjected to the same
    transparency requirements that the EPA's intramural research
    and extramural grants have?
        Dr. Orme-Zavaleta. So this particular rule--the proposed
    rule applies only to EPA.
        Mr. Murphy. OK. All right. Thank you, Madam Chair. I'll
    yield back my time.
        Chairwoman Johnson. Thank you very much. Mr. Tonko.
        Mr. Tonko. Thank you, Madam Chair, and thank you, Dr. Orme-
    Zavaleta, for joining us.
        For 5 years, I have fought against these deceptively named
    science transparency proposals. I said this when we were
    debating the Secret Science and HONEST Acts, and it's still
    true today. These efforts pay cheap lip-service to improving
    scientific integrity and transparency, but their true purpose
    is to undermine the decades of sound science on which EPA
    relies to protect our air, water, and the health and safety of
    the American people. Any form of this rule, any form
    essentially guarantees that political agendas are given more
    weight than science in EPA rulemaking.
        I asked EPA to withdraw this rule at the summer 2018 public
    comment session. I and others pointed out that its effect would
    be to undermine necessary science and endanger public health.
    When the supplemental rulemaking came to light, I hoped this
    meant that EPA was re-evaluating. But based on reports, this
    EPA is going down that same path and will endanger the health
    and safety of millions of Americans for many generations to
    come.
        So, Dr. Orme-Zavaleta, the proposed rule tracks closely
    with the Secret Science Reform Act of 2015, legislation
    previously debated by this Committee. In fact, the language is
    virtually identical. Congress has repeatedly considered this
    legislation, and time and time again we have declined to move
    it forward.
        Out of the Secret Science Reform Act of 2014, of 2015, or
    the HONEST Act of 2017, how many ever became law?
        Dr. Orme-Zavaleta. I guess I'm not sure--of those
    particular that you just cited, I don't believe Congress passed
    a law----
        Mr. Tonko. OK. So the answer is zero. To your knowledge,
    were EPA officials aware that Congress had already rejected the
    Secret Science and HONEST Acts?
        Dr. Orme-Zavaleta. I would assume so, but I don't know for
    a fact.
        Mr. Tonko. How many comments were issued with concerns
    about the rule?
        Dr. Orme-Zavaleta. So, again, we received nearly 600,000
    comments, about 9,200 which were unique. And, as I noted
    earlier, you know, I think many of the comments supported the
    concept of transparency, and where they differed was in the way
    that we approach that.
        Mr. Tonko. OK. And did any comments raise the issue that
    this rule would endanger the health and safety of Americans?
        Dr. Orme-Zavaleta. We received a number of comments from
    all sectors, a variety of different topics, and so those were
    similar to some of the comments that we received.
        Mr. Tonko. That they did raise the concern of health and
    safety of Americans?
        Dr. Orme-Zavaleta. Yes.
        Mr. Tonko. Thank you. Have any EPA officials expressed
    concern that this rule would endanger the health and safety of
    Americans?
        Dr. Orme-Zavaleta. I don't believe we've come into that
    conversation yet. I mean, Administrator Wheeler has asked that
    we continue to proceed with the development of this rule.
        Mr. Tonko. But do you know of any officials at EPA that
    expressed concerns?
        Dr. Orme-Zavaleta. I do not know, no.
        Mr. Tonko. You do not know. Have career staff expressed
    concerns about being left out of the process of drafting the
    proposed rule?
        Dr. Orme-Zavaleta. I haven't heard about specific comments
    related to the drafting, but when we were asked to take up that
    proposed rule and move it forward through the process, we are
    ensuring that career staff are engaged in our workgroup process
    so that we can go through the comments and go through the
    clarifications and the decisions moving forward.
        Mr. Tonko. Right. To be involved but you then again do not
    know of any staff that expressed concerns about being left out?
        Dr. Orme-Zavaleta. Personally, no.
        Mr. Tonko. When was the decision made to write a
    supplemental proposed rule? When did you learn about it, and
    how many career staff are now involved in drafting it,
    including yourself?
        Dr. Orme-Zavaleta. So, again, as we worked through from the
    public comment period, we've had a career-led effort in looking
    at the comments and trying to understand some of the complex
    issues that were raised. Many of these issues led us to
    recommend to the Administrator the benefit of a supplemental to
    provide clarifications and further discussion of the certain
    aspects of the rule. The Administrator agreed that it would be
    important to do that. So we're moving forward, and we'll be
    looking to get further comment on that rule when it goes out.
        Mr. Tonko. Thank you. And many people fear that this rule
    will endanger the health and safety of Americans. If Americans
    are sickened as a result of this rule, does EPA have a plan to
    provide care?
        Dr. Orme-Zavaleta. So, again, EPA is looking to protect
    public health and the environment.
        Mr. Tonko. But Americans are sickened as a result of this
    rule, do they have a plan to provide care?
        Dr. Orme-Zavaleta. We've got a ways to go to see what the
    final rule is going to look like. We have lots of information
    that we are considering. Decisions have not been made what that
    final rule will look like.
        Mr. Tonko. So I assume they don't have a plan. And if
    Americans are sickened or die as a result of this rule, who
    will be held accountable?
        Dr. Orme-Zavaleta. Yes, I--you know, it's----
        Mr. Tonko. Who would be----
        Dr. Orme-Zavaleta. It's hard to say.
        Mr. Tonko [continuing]. Held accountable?
        Dr. Orme-Zavaleta. It's hard to say. Again, we don't know
    what the final rule is going to look like.
        Mr. Tonko. Who's the top political EPA appointee overseeing
    the drafting of the supplemental proposed rule?
        Dr. Orme-Zavaleta. Well, the Administrator is the top
    official.
        Mr. Tonko. Thank you. With that, Madam Chair, I yield back.
        Chairwoman Johnson. Thank you very much. Mr. Babin.
        Mr. Babin. Yes, ma'am. Thank you very much, Madam Chair.
        Dr. Orme-Zavaleta, thank you for being here today, and I
    thank you for your professional career. I appreciate it.
        I'd like to continue this same line that Dr. Murphy had
    started a while ago. As several of my colleagues have already
    mentioned, our discussion here today is overshadowed by the
    recent New York Times article that provided a long list of
    comments and a leaked copy of an earlier draft of the
    supplemental rule.
        I have to say that I'm very disappointed that we're
    allowing the work of one reporter to characterize our
    discussion here today, particularly when we have yourself,
    followed by a panel of expert witnesses, to talk about the
    broader issue of improving scientific transparency.
        But since we've decided to make a New York Times article
    the centerpiece of our discussion, I think it's only fair that
    we include the EPA's rebuttal to that article, which Dr. Murphy
    had already brought up. And without objection, if it's not
    already done, I'd like to enter that into the record if that's
    OK, Madam Chair.
        Chairwoman Johnson. Without objection.
        Mr. Babin. Thank you.
        I know you've already mentioned it, and I'd like for you to
    elaborate a little bit more. Do you think that The New York
    Times article accurately portrayed the draft supplemental rule
    that was leaked?
        Dr. Orme-Zavaleta. So I think the article confused a few
    aspects.
        Mr. Babin. OK. All right. Thank you. Do you think this
    Committee would be better served if we, as you suggested in
    your prepared testimony, received briefings on the supplemental
    rule once it is published through the appropriate channels
    instead of wasting our time debating an outdated version?
        Dr. Orme-Zavaleta. So, again, I'm happy to be here today to
    help answer questions related to the proposed rule, and we're
    happy to follow up with briefings once the supplemental is
    publicly available.
        Mr. Babin. OK. Well, will you commit today to work to
    schedule those briefings as soon as the supplemental rule is
    published?
        Dr. Orme-Zavaleta. I'll defer to our congressional affairs
    staff, and they'll follow up.
        Mr. Babin. OK. And do you have any reason to believe that
    the proposed or draft supplemental rule would somehow make it
    more difficult for the EPA to carry out its regulatory mission?
        Dr. Orme-Zavaleta. So just to note, the supplemental is a
    supplement----
        Mr. Babin. Right.
        Dr. Orme-Zavaleta [continuing]. To the proposed rule
    seeking additional clarifications and modifications to the rule
    and getting comment back on that.
        Mr. Babin. OK. Well, The New York Times article said just
    the opposite, so will this supplemental make it more difficult
    to----
        Dr. Orme-Zavaleta. So that's one of the clarifications that
    we wanted to provide, that this is not a new rule. It is a
    supplement to what was proposed where we are seeking some
    clarification of terms and other aspects of the rule and
    getting further comment back from the public.
        Mr. Babin. Well, when I read The New York Times article, it
    didn't come across like that at all. Madam Chair, I'm going to
    yield back. That's all I have. Thank you. Thank you very much.
        Chairwoman Johnson. Thank you very much. Mr. Casten.
        Mr. Casten. Thank you. Dr. Orme-Zavaleta, thank you so much
    for coming today and for your decades of service to the EPA.
        If my cell phone is any predictor, this is not the
    Committee hearing that most of the country is watching today.
    But I want to suggest there's a parallel. Our colleagues over
    in the Intelligence Committee right now are defending the
    Constitution from the White House. And I sit here watching this
    and thinking we are right now defending the enlightenment from
    the White House. And I'm not being hyperbolic. When we
    politicize the Constitution, we put our republic at jeopardy,
    and when we politicize science, we put our species in jeopardy.
        You cannot be happy that you're here. You cannot be happy
    that your leadership has put you in a position to defend an
    anti-scientific history. But make no mistake, Union of
    Concerned Scientists has reported that the idea behind this
    rule came from a 1996 memo from Chris Horner to R.J. Reynolds--
    Chris Horner, who was part of Trump's transition team at EPA;
    Chris Horner, who is a tinfoil-hat-wearing climate denier. And
    he wrote in his memo in 1996, ``Because there is virtually no
    chance of affecting change if the focus is environmental
    tobacco smoke, our approach is one of addressing process as
    opposed to scientific substance.'' He then went through and
    recommended essentially what you're proposing here today, what
    your Agency is proposing here today.
        Madam Chair, I'd like unanimous consent to enter this memo
    into the record.
        Now, in The New York Times report, it said that the
    supplemental proposed rule is considering applying the policy
    retroactively so that all past scientific research could be
    excluded by EPA unless the underlying data is made publicly
    available. The EPA response to this--which you've been talking
    about--largely dodges the important points.
        So, number one, EPA said in a release that, quote, ``The
    proposal and supplemental will not apply to any regulations
    already in place.'' Yes or no, is it within EPA's authority to
    review and update existing regulations at its own discretion?
        Dr. Orme-Zavaleta. I believe they follow the statutory
    schedule.
        Mr. Casten. So it's a yes?
        Dr. Orme-Zavaleta. It's a maybe.
        Mr. Casten. You have that discretion. Aren't there mandated
    timelines to update certain existing regulations like those
    issued under the National Ambient Air Quality Standards?
        Dr. Orme-Zavaleta. I believe the statutes do require a
    regular schedule for updating.
        Mr. Casten. OK. So given that EPA can reconsider any
    regulations it deems necessary and the mandatory
    reconsiderations--is it safe to say that any existing
    regulation can be ultimately rewritten within the bounds of
    this proposed rule should it be finalized?
        Dr. Orme-Zavaleta. Should this rule be finalized, then it
    will apply prospectively to new rules and regulations.
        Mr. Casten. But those old rules are going to come up for
    renewal under what we just talked about, so it's fundamentally
    disingenuous to assert, as EPA has, that the rule will not be
    applied retroactively to existing regulations. And----
        Dr. Orme-Zavaleta. It's still applying prospectively.
        Mr. Casten. But all those rules are coming up for renewal.
    This----
        Dr. Orme-Zavaleta. And the Agency may decide to update--a
    lot of it is driven by what new information becomes available.
        Mr. Casten. And we are asked to trust that people led by
    science deniers are going to make that decision right. Look,
    this is painful. And we are sitting at a moment where none of
    this assault on science happens if people in your shoes stand
    up. If and when you stand up, we've got your back, but please
    stand up.
        Dr. Orme-Zavaleta. Thank you.
        Mr. Casten. Thank you. I yield back.
        Chairwoman Johnson. Thank you very much. Mr. Balderson.
        Mr. Balderson. Thank you, Madam Chair. And, Doctor, thank
    you very much.
        Doctor, it's my understanding that the EPA currently has
    transparency rules in place for internal research in EPA
    grants. Can you elaborate on what those requirements are today?
        Dr. Orme-Zavaleta. So related to public access, which is
    different from a transparency rule, but it's public access to
    information. And, so, yes, that's currently in place where our
    research and the publications from that research are made
    publicly available, along with the underlying data for that,
    that's now extended across the Agency, as well as applying to
    our external grants community.
        Mr. Balderson. OK. Thank you. A follow-up, are there
    policies to ensure the protection of personal or sensitive data
    within these transparency requirements?
        Dr. Orme-Zavaleta. The Agency does have laws and
    regulations that do provide for the protection of PII and CBI.
        Mr. Balderson. OK. Thank you. Is there any reason that non-
    government-funded research could not also be subject to similar
    transparency requirements?
        Dr. Orme-Zavaleta. So the public access information applies
    more broadly. This particular transparency rule applies just to
    EPA.
        Mr. Balderson. OK. Thank you. When finalizing the science
    transparency rule will the EPA ensure the all-important studies
    underlying significant regulatory actions at the EPA regardless
    of their source are subject to a transparent review by a
    qualified scientist?
        Dr. Orme-Zavaleta. So we go through the scientific process,
    and our information that we develop, the science that we use,
    we look for external peer review to help ensure the quality of
    that science. In agency decisionmaking and rulemaking process,
    it does go through a public notice and comment period.
        Mr. Balderson. Doctor, thank you for your time. And, Madam
    Chair, I yield back my remaining time.
        Chairwoman Johnson. Thank you very much. Mr. Foster.
        Mr. Foster. Thank you, Madam Chair, and thank you, Dr.
    Orme-Zavaleta, for everything. You know, I read some interview
    you had online, and you talked about growing up I think in the
    Cleveland area.
        Dr. Orme-Zavaleta. I did.
        Mr. Foster. And I got my Ph.D. in the salt mine under
    Mentor Harbor, and we'd go swimming in the lake. And you
    probably know what a Tittabawassee trout is from----
        Dr. Orme-Zavaleta. Actually, I don't.
        Mr. Foster. You don't, OK. All right. There's a song about
    it I think having to do with ``burn on big river''----
        Dr. Orme-Zavaleta. Oh, yes.
        Mr. Foster [continuing]. Which you're probably familiar
    with. Yes.
        I thank you for your career.
        I'd like some clarification if I could on the prospective
    nature of the proposed rule. So under the proposed rule change,
    might it be possible that during a rule update, scientific
    studies that had previously been accepted as valid scientific
    input for the original rule might be rejected for the purposes
    of the rule update?
        Dr. Orme-Zavaleta. So that's also part of the kinds of
    comments that we received, and that's currently what's being
    discussed and debated. So we'll have to see how all of this
    weighs as we work toward finalizing that rule and what that
    final rule----
        Mr. Foster. So the answer is possibly yes with the current
    state of deliberation?
        Dr. Orme-Zavaleta. I think it's one of a number of comments
    that we're still working through.
        Mr. Foster. OK. So something as simple as a change in the
    data retention requirements between the time it was originally
    published and current data retention requirements might--
    might--cause the science to be rejected?
        Dr. Orme-Zavaleta. Yes, I don't know about the data
    retention. That's a little more detailed than I think----
        Mr. Foster. Yes, well, the general issue that we've been
    wrestling with, you know, for the last several years is this
    whole narrative about secret science and honest science and so
    on, you know, to my mind represents a deliberate blurring
    between--and of distinctions between science that's
    irreproducible due to, you know, statistical or procedural
    errors or science that is not reproducible because it's based
    on confidential PII or CBI that really shouldn't be made
    public. Science that's based on natural experiments, things
    that just happen naturally, volcano eruptions, you know, things
    like that, and also manmade ones such as, say, the BP blowout
    that, you know, where very valid science was extracted using an
    experiment that probably should not be repeated.
        And, finally, valid experiments that have been performed
    and research that's been performed in the past at a time when
    the data retention requirements were different, you know, I
    very much appreciate when you read Science Magazine these days
    there's backup information that you can see at the end of the
    article.
        And it's good that we've moved that way, but some of the
    best science, things like the Harvard Six Cities studies, if
    that is at risk, then people's lives are at risk. And I think
    to the extent that you're even involved in the final decisions
    over this, I urge you to stick up for retaining science, the
    best available science.
        And, you know, as was mentioned, you know, Congress has
    considered and rejected a lot of these, you know, secret
    science and honest science proposals for good reasons. Can you
    understand why we might not be comfortable with having the
    final call on these being made by an coal lobbyist?
        Dr. Orme-Zavaleta. So, again, I think what you raise I
    think highlights a number of the comments that we received.
    There's a lot of confusion about what some of these terms
    meant, and that's part of the reason that we are looking to a
    supplemental to provide some clarification, provide some
    modifications, and seek comment on additional aspects of this.
        We're going to go through the rulemaking process. We're
    currently at the interagency review of the supplement. The
    information that comes in from that, we will then take into
    consideration as we work through developing. So these are
    comments that we are all grappling with right now.
        Mr. Foster. Yes. Now, would you characterize the
    formulation of the draft rule, which has been, you know,
    discussed, as something that is bottom-up where the scientific
    staff, the career people in the EPA have come up with the first
    drafts and then these are looked over and approved by the top?
    Or would you characterize it as top-down where the political
    appointees consult with whoever they consult with, come up with
    a draft, and then you're at best asked to comment on----
        Dr. Orme-Zavaleta. So, again, I was not engaged in the
    drafting of the proposed rule.
        Mr. Foster. So that happened at a level above you in the
    EPA?
        Dr. Orme-Zavaleta. Or outside of me, yes.
        Mr. Foster. Or outside of you. And so above you in the org
    chart are all political appointees at this point?
        Dr. Orme-Zavaleta. I report to the Acting Deputy
    Administrator.
        Mr. Foster. So everyone above yo--is the people involved in
    drafting a----
        Dr. Orme-Zavaleta. You know, we'd be happy to follow up if
    you'd like more information on the development of the proposal.
    We can follow up with you on that.
        Mr. Foster. OK. Thank you. I'm out of time and yield back.
        Dr. Orme-Zavaleta. Yes.
        Chairwoman Johnson. Thank you very much. Mrs. Fletcher.
        Mrs. Fletcher. Thank you, Chairwoman Johnson.
        And, Dr. Orme-Zavaleta, thank you for being here again
    before this Committee.
        Many scientific, academic, and public health and nonprofit
    organizations have formally expressed concern or opposition to
    the proposed rule, including, among others, the American Heart
    Association, the American Lung Association, the American
    Academy of Pediatrics, Children's Environmental Health Network,
    American Association for the Advancement of Science, the
    National Academies, the American Medical Association, the
    Association of American Medical Colleges, which has expressed
    its concern in writing. And I would like unanimous consent to
    enter their letter expressing objection into the record.
        The list goes on and on and on. And so I want to ask you a
    few questions about the comments that you've received from
    these institutions. You've worked at the EPA for 40 years, and
    over the course of your career I assume that you've encountered
    these groups or groups like them and worked with them on many
    occasions. Do you believe that they are good-faith advocates
    for scientific research and public health?
        Dr. Orme-Zavaleta. I think many of the people that
    submitted comments, whether they are professional associations
    or others, all submitted those in good faith.
        Mrs. Fletcher. And we can agree that the organizations with
    which you're familiar and referencing, they perform worthwhile
    work in this area?
        Dr. Orme-Zavaleta. For some of those professional
    associations, yes.
        Mrs. Fletcher. So some of their concerns about the rule,
    two of the quotations that I've seen repeatedly are that they
    restrict the use of the best available science, that that was
    one outcome of the rule, and that it will adversely affect
    decisionmaking processes. Are they wrong in that assessment?
        Dr. Orme-Zavaleta. So they raised a number of points, and
    we are looking at those very closely, very carefully as we
    consider, you know, the future development, future steps of the
    rulemaking process.
        Mrs. Fletcher. So later this morning in the next panel the
    CEO of the Michael J. Fox Foundation will testify about that
    foundation's concerns regarding the rule. And based on the
    written testimony that he submitted, he'll say that the rule
    puts individuals at great risk of having their Parkinson's or
    other diagnoses exposed if they participate in clinical
    studies. Now, certainly, that is a concern for my constituents.
    It's a concern for the researchers. We want to encourage these
    kinds of studies, and that concern is something that I think
    Americans share.
        And on another issue, you know, as I'm sure you're aware,
    the EPA may be working on setting a maximum contaminant level
    for PFAS in the near future, and studies to date have revealed
    serious concerns and serious health problems associated with
    these chemicals. But the majority of what we know about PFAS
    contamination and the adverse health effects comes from studies
    that rely on personal information and health information of
    individuals.
        So, currently, the scientists don't share that data for
    ethical and legal reasons.
        Dr. Orme-Zavaleta. Right.
        Mrs. Fletcher. Shouldn't the EPA reconsider the rule that
    would threaten to expose the personal information and could
    have a chilling impact both on participation and on research
    overall?
        Dr. Orme-Zavaleta. Yes, so we appreciate all the comments
    that we received on this, and we took that very topic to our
    Science Advisory Board for review. They provided some comments
    through that consultation process on how the Agency can
    continue to protect PII, as well as CBI, and how we can use
    that information in our decisionmaking process. So all of this
    is now coming in for our consideration as we go forward.
        Mrs. Fletcher. And are those protections for PII and CBI
    contained in the supplement to the rule?
        Dr. Orme-Zavaleta. So, again, I can't speak to the
    particulars of what's in the supplement at this point in time.
    Again, the supplement is something that we're looking to help
    clarify terms, as well as talk through additional modifications
    and gaining further input.
        Mrs. Fletcher. So with these principal concerns about
    participation, about PII, CBI, about getting the best possible
    science, are you also aware that, in addition to the diverse
    organizations and the other folks who have weighed in on these
    issues, that the CBO, working on the Secret Science Reform Act
    of 2015, discussed by my colleague Mr. Tonko earlier, that that
    would cost EPA approximately $250 million a year for several
    years going forward? And given the concerns of the scientific
    community, the concerns about the expense of complying with
    this rule, what is the likelihood or the possibility that EPA
    will abandon this rule in its entirety?
        Dr. Orme-Zavaleta. So I don't believe the--so we received a
    number of comments related to potential costs, and I'm aware
    that there's been some earlier conversations. Again, all of
    that is going to be coming into our deliberations and our
    discussions as we finalize the rule. I don't believe that the
    committee's workgroup has gotten to that particular issue just
    yet, but that's something that will be weighed as we go
    forward.
        Mrs. Fletcher. Thank you very much. I've gone over my time,
    so, Madam Chairwoman, I yield back.
        Chairwoman Johnson. Thank you very much. Ms. Wexton.
        Ms. Wexton. Thank you, Madam Chair. Thank you, Doctor, for
    joining us again today.
        I want to return to the question of the statutory authority
    that EPA is citing in support of its proposed rule,
    specifically 5 U.S.C. 301, which we are putting on the board.
    So that section applies to the head of an executive department
    or military department may prescribe regulations and so on and
    so on. So is the EPA an executive department or a military
    department?
        Dr. Orme-Zavaleta. So EPA is in the executive branch.
        Ms. Wexton. OK.
        Dr. Orme-Zavaleta. It's an independent agency in the
    executive branch.
        Ms. Wexton. All right. Were you aware that 5 USC 301 also
    specifically outlines the executive departments that are
    included under that statute?
        Dr. Orme-Zavaleta. Yes, so similar to the earlier
    questions, I'm going to have to defer any questions related to
    the statutory authority because that's beyond my area of
    expertise, but we can follow up with you on that.
        Ms. Wexton. But we can agree that the EPA is not a military
    department?
        Dr. Orme-Zavaleta. Not that I am aware of.
        Ms. Wexton. OK. And then do we have the graphic of 101? So
    these are the executive departments that are specifically
    outlined as pertaining to 301's requirements. Can you show me
    where on there we have anything about the EPA?
        Dr. Orme-Zavaleta. So I think you raise a good point, and
    that's something that we'll consider going forward and we'll
    have our general counsel review that.
        Ms. Wexton. OK. It's concerning to me that the EPA is using
    this particular statute to justify this rulemaking and don't
    even have a shred of other authority in support of it. This is
    a basic housekeeping rule. It's really intended for internal
    operations for certain agencies, not for outward-facing big
    things like this proposed rule. So if they're planning to cite
    this again, I would suggest that they come up with something
    better.
        Dr. Orme-Zavaleta. Well, thank you. I appreciate the
    comment.
        Ms. Wexton. So switching gears just a little bit right now,
    the proposed rule has a provision that would allow the
    Administrator to provide case-by-case unilateral exemptions to
    the rule. Is that correct?
        Dr. Orme-Zavaleta. So that's in the proposed rule, yes.
        Ms. Wexton. OK. Does that cause you any concern at all?
        Dr. Orme-Zavaleta. Well, it's a topic that we heard a
    number of comments on, and that's something that's currently
    being discussed further.
        Ms. Wexton. What sort of guardrails or regulations or rules
    are there for that case-by-case exemptions?
        Dr. Orme-Zavaleta. I don't know of existing ones now, but I
    will note that in the Agency's rulemaking process, you know,
    there is a briefing. There are decisions that are made by the
    EPA Administrator, so the EPA Administrator already makes a
    number of decisions related to----
        Ms. Wexton. But this exemption provision for the proposed
    rule would apply only to the EPA Administrator, who would be
    able to exempt studies and science from the rule. Is that
    correct?
        Dr. Orme-Zavaleta. That's what's in the proposed rule, yes.
        Ms. Wexton. OK. And the EPA Administrator is a political
    appointee, is that correct?
        Dr. Orme-Zavaleta. And Senate-confirmed, yes.
        Ms. Wexton. And how long have you served with this EPA? How
    long have you been----
        Dr. Orme-Zavaleta. Thirty-eight years.
        Ms. Wexton. OK. And in your 38 years at the EPA, have you
    ever seen any instance where an EPA administrator was given
    this kind of authority to overrule career staff's decision to
    consider a particular study during the rulemaking process?
        Dr. Orme-Zavaleta. I haven't been involved in all of those
    types of decisions with administrators over all that time.
        Ms. Wexton. With the understanding that you have not been
    involved in every decision that's been made over the last 38
    years, can you recall a time that that the Administrator has
    been allowed to overrule----
        Dr. Orme-Zavaleta. Yes, I can't really speak to that
    because I haven't been engaged in that.
        Ms. Wexton. But can you cite an example?
        Dr. Orme-Zavaleta. Not that I'm aware of.
        Ms. Wexton. OK. Very good. As a career scientist, how would
    you feel personally if a political appointee told you that you
    could arbitrarily consider some scientific research in your
    work but not other scientific research?
        Dr. Orme-Zavaleta. As a career scientist, I would have a
    conversation and make the case, but the Administrator makes the
    policy decision.
        Ms. Wexton. OK. Thank you very much. I have no further
    questions. I'll yield back.
        Chairwoman Johnson. Thank you very much. Ms. Sherrill.
        Ms. Sherrill. Thank you. And, Dr. Orme-Zavaleta, our
    soldiers and their families make great sacrifices on our
    behalf, and we have a duty to take care of them. Military
    operations and facilities present unique environmental
    challenges, as I'm sure you know. And the Department of Defense
    (DOD) funds a great deal of important public health research
    relevant to its operations. Are you aware that the DOD was one
    of the 600,000 public commenters in response to the proposed
    rule?
        Dr. Orme-Zavaleta. Yes.
        Ms. Sherrill. And are you aware that in its public comment
    the DOD criticized the fundamental premise of the rule by
    saying, quote, ``We do not believe that failure of the Agency
    to obtain a publications underlying data from an author
    external to the Agency should negate its use,'' quote?
        Dr. Orme-Zavaleta. So I have not read all 600,000 comments
    that came in. I'm aware that they submitted comments, but I
    think those are the types of comments that our workgroup is
    going through right now.
        Ms. Sherrill. So does it concern you that the DOD thinks
    the EPA's position is incorrect?
        Dr. Orme-Zavaleta. I think it's one of many comments that
    we'll be going through. We heard from a wide variety of
    different sectors, and those are things that we will be looking
    at seriously going forward.
        Ms. Sherrill. And the DOD also wrote that the EPA should
    not apply the rule retroactively. Why is the EPA even
    considering retroactive application in the face of DOD's
    opposition?
        Dr. Orme-Zavaleta. So, again, to be clear, this rule does
    not apply retroactively. It applies prospectively to future
    rulemakings.
        Ms. Sherrill. But it does appear you won't be using some
    prior studies in future rulemakings, so it will----
        Dr. Orme-Zavaleta. We don't know that at this point.
        Ms. Sherrill. And so the DOD wrote in its comments that,
    quote, ``It appears as if the EPA may have overlooked the
    advancement of science through open publication as a compelling
    interest,'' end quote. Can you walk me through why the EPA sees
    it fit to disregard the importance of open science, as laid out
    by the Defense Department in its public comment?
        Dr. Orme-Zavaleta. So I think, again, I don't know the
    specifics of what DOD raised. I would note that, however, in
    the rulemaking process, there is an interagency review step of
    which DOD is one of those agencies that has a chance to review
    and comment during that time.
        Ms. Sherrill. I would implore you to look carefully and
    listen carefully to what they say.
        Can you explain why it seems that the DOD is concerned with
    protecting the health and wellness of our Nation's soldiers and
    families, and yet it appears from some of what we're seeing
    from this rule that the EPA is not as concerned with that?
        Dr. Orme-Zavaleta. So EPA's mission, again, is to protect
    public health and the environment, and that applies for
    civilian and military.
        Ms. Sherrill. So it is a huge concern, I would think, that
    the DOD has some real concerns with this proposed rule. Dr.
    Orme-Zavaleta, can you confirm that the EPA will fairly
    consider any further comments submitted by the DOD about the
    supplemental proposed rule? Because our soldiers and families
    really deserve nothing less.
        Dr. Orme-Zavaleta. Yes, we are looking seriously at all the
    comments that we received, and so additional comments that come
    in, we are weighing very carefully.
        Ms. Sherrill. Thank you, and I yield back.
        Chairwoman Johnson. Thank you very much. Ms. Horn.
        Ms. Horn. Thank you, Dr. Orme-Zavaleta, for your dedication
    and your work.
        We've had some important questions I think raised today. I
    want to dig in a little bit more about the processes that are
    currently in place and the ability to understand and interpret
    the data. As a scientist, you've no doubt gone through years of
    training to understand the data that comes in front of you and
    to be able to make use of it, correct?
        Dr. Orme-Zavaleta. Yes.
        Ms. Horn. And would you say that on average regular members
    of the public could take raw data and correctly interpret that
    information without proper training or insight?
        Dr. Orme-Zavaleta. So, again, these were similar to some of
    the comments that we've received in trying to get better
    clarification of data.
        Ms. Horn. So I'm going to take that as a no.
        And it's correct to say that the EPA, throughout its
    history and to this day, possesses time-tested methods that
    look at the scientific data, that have peer-reviewed processes
    of other individuals who have experience and expertise in those
    areas to interpret the data?
        Dr. Orme-Zavaleta. We do rely heavily on independent expert
    peer review----
        Ms. Horn. So the EPA doesn't just take the assertions of a
    study and put it out without a peer-review process before it
    does anything with them?
        Dr. Orme-Zavaleta. Many of the studies already go through
    an independent peer-review process as part of the journal
    publication, for example, but how EPA might use that
    information may also go through additional peer review, as well
    as public comment if it's used in the decisionmaking process.
        Ms. Horn. So as a scientist, you've no doubt been through
    this peer-review process. In your personal experience, have you
    seen this as effective in assessing the validity of the data?
        Dr. Orme-Zavaleta. We rely on it heavily.
        Ms. Horn. And EPA has a number of advisory boards such as
    SAB and CASAC (Clean Air Scientific Advisory Committee) and
    other boards that evaluate the data and the science that comes
    before the EPA to evaluate or to set policies, correct?
        Dr. Orme-Zavaleta. Yes.
        Ms. Horn. And this has been used throughout the history of
    the EPA to address, as you said, public health and
    environmental issues. These are no doubt critical to our whole
    communities from our Nation's security, our soldiers, sailors,
    the water that we drink, the air that we breathe. And would you
    say that the peer-review process and analysis by these advisory
    boards are a critical component to providing necessary checks
    and balances on the validity of the data without endangering
    the personally identifiable and very important health
    information that is needed to get to the heart of these
    problems?
        Dr. Orme-Zavaleta. All right. So peer review is a core
    tenet of how we ensure good science, and the particular
    question you've raised about PII and CBI is in fact one that we
    took to our Science Advisory Board.
        Ms. Horn. So, bottom line, we do have processes in place to
    ensure that the studies that are being conducted are
    scientifically valid, and there are checks in the process by
    individuals who understand the science and the data?
        Dr. Orme-Zavaleta. Yes.
        Ms. Horn. OK. Thank you. I yield back.
        Chairwoman Johnson. Thank you very much. Mr. Lamb.
        Mr. Lamb. Thank you, Madam Chairwoman.
        Dr. Orme-Zavaleta, are you familiar with the application of
    cost-benefit analysis to an EPA rulemaking?
        Dr. Orme-Zavaleta. I am familiar with it, but I have not
    conducted that personally.
        Mr. Lamb. Administrator Wheeler emphasizes the importance
    of cost-benefit analysis as part of his administration,
    correct?
        Dr. Orme-Zavaleta. I don't know for sure.
        Mr. Lamb. On May 13, 2019 of this year he sent an agency-
    wide memo in which he endorsed a sound, transparent, and
    consistent approach to evaluating benefits and costs. Do you
    remember that?
        Dr. Orme-Zavaleta. Right offhand, no.
        Mr. Lamb. OK. Was a cost-benefit analysis done for this
    proposed rule?
        Dr. Orme-Zavaleta. I'm not aware that one was done.
        Mr. Lamb. OK. Do you know that it was not done?
        Dr. Orme-Zavaleta. We could follow up with you and provide
    you that information.
        Mr. Lamb. So you don't know whether it was done or not?
        Dr. Orme-Zavaleta. No, because I was not involved in
    developing the proposed rule.
        Mr. Lamb. OK. Do you know if any cost-benefit analysis is
    planned for the future of this proposed rule or supplemental?
        Dr. Orme-Zavaleta. We will be looking at the number of
    comments that came in related to cost as we go forward in
    developing a final rule. So I think that will come into play,
    but it hasn't been part of the conversation yet.
        Mr. Lamb. Do you know if they will do a formal cost-benefit
    analysis?
        Dr. Orme-Zavaleta. We don't know yet.
        Mr. Lamb. You don't know. Will you commit that if one has
    already been done or if one is done, you will share the cost-
    benefit analysis with this Committee?
        Dr. Orme-Zavaleta. I will have to follow up with you on
    that.
        Mr. Lamb. OK. Behind you, your assistant is nodding her
    head yes----
        Dr. Orme-Zavaleta. OK.
        Mr. Lamb [continuing]. So can you confirm----
        Dr. Orme-Zavaleta. No, she's not confirming. We're not
    there yet in those kinds of discussions.
        Mr. Lamb. Is there any reason why you would not share a
    cost-benefit analysis with this Committee?
        Dr. Orme-Zavaleta. If we conduct one and it's going to be
    part of the final rule, then that will be shared with everyone.
        Mr. Lamb. If you conduct one and as part of the final rule,
    you will share it with this Committee, is that correct? Yes?
        Dr. Orme-Zavaleta. Yes.
        Mr. Lamb. OK. Thank you. Have you ever heard of something
    called the Health Effects Institute (HEI)?
        Dr. Orme-Zavaleta. Yes.
        Mr. Lamb. And is it correct to say that the Health Effects
    Institute is a collaboration equally funded between the motor
    vehicle industry and the EPA for research purposes?
        Dr. Orme-Zavaleta. Yes, and in fact from EPA both Office of
    Research and Development and Office of Air and Radiation
    support the Health Effects Institute.
        Mr. Lamb. And in 2000, the Health Effects Institute did a
    re-analysis of the Harvard Six Cities study and the American
    Cancer Society study and confirmed the findings of those
    original studies. Are you aware of that?
        Dr. Orme-Zavaleta. Yes.
        Mr. Lamb. So, in other words, the auto industry paid half
    the cost, along with the EPA, of confirming that those two Six
    Cities air quality studies were accurate. Is that correct?
        Dr. Orme-Zavaleta. So both the authors of the Harvard Six
    Cities study and the author of the American Cancer Society
    study requested--given a lot of the scrutiny and questions
    placed on their studies, requested that the Health Effects
    Institute do a reanalysis, and that's how that played out.
        Mr. Lamb. And the result of that playing out was that they
    confirmed the finding of those studies, correct?
        Dr. Orme-Zavaleta. Correct, yes.
        Mr. Lamb. So, again, in other words, the auto industry
    helped to pay for the effort to confirm those two studies,
    correct?
        Dr. Orme-Zavaleta. Well, they paid for the Health Effects
    Institute. I can't say exactly what resources were used to
    support the reanalysis.
        Mr. Lamb. OK. Would you agree with Dr. Rice on our next
    panel that using the HEI to vet results like this is a
    practical and proven approach to the concerns about
    transparency specifically without compromising the health data
    privacy of study participants?
        Dr. Orme-Zavaleta. So the way the HEI approached this is
    they formed an independent panel that conducted analysis, and
    then there was a separate peer review of that analysis that was
    performed.
        Mr. Lamb. So the auto industry, through this process, was
    able to confirm the results of a study without releasing the
    health data publicly, correct?
        Dr. Orme-Zavaleta. So the auto industry supports HEI.
        Mr. Lamb. Which confirmed the results of this study without
    publicly releasing the health data, correct?
        Dr. Orme-Zavaleta. Yes.
        Mr. Lamb. Thank you. Madam Chairwoman, I yield back.
        Chairwoman Johnson. Thank you very much. That concludes our
    questioning for this panelist witness. And let me thank you,
    Dr. Orme-Zavaleta, for coming, and you're dismissed.
        Dr. Orme-Zavaleta. Thank you very much.
        Chairwoman Johnson. We will have a short recess just to let
    the second panel be set up.
        [Recess.]
        Chairwoman Johnson. Welcome back at this time. And I'd like
    to introduce our second panel of witnesses. First, we have Dr.
    Linda Birnbaum. Dr. Birnbaum served as Director of the National
    Institute of Environmental Health Sciences from 2009 to 2019,
    and she is speaking today as a private citizen.
        Dr. Mary Rice is an Assistant Professor of Medicine at
    Harvard Medical School and a Pulmonary and Critical Care
    Physician at Beth Israel Deaconess Medical Center in Boston,
    Massachusetts.
        And third, we have Dr. David Allison. Dr. Allison is the
    Dean of Indiana University's Bloomington School of Public
    Health. He has served on the Replicability in Science Committee
    at the National Academies of Sciences, Engineering, and
    Medicine.
        And Dr. Brian Nosek. Dr. Nosek is Professor of Psychology
    at the University of Virginia and the Co-Founder and Executive
    Director of the Center for Open Science in Charlottesville,
    Virginia.
        And last but not least Dr. Todd Sherer, the CEO of the
    Michael J. Fox Foundation for Parkinson's Research.
        As with our first panel, you each will have 5 minutes for
    your spoken testimony. Your written testimony will be included
    in the record for the hearing. And when all of you have
    completed your spoken testimony, we will begin the round of
    questions. Each Member will have 5 minutes to question the
    panel.
        We will begin now with Dr. Linda Birnbaum.

                   TESTIMONY OF DR. LINDA S. BIRNBAUM,

                 FORMER DIRECTOR, NATIONAL INSTITUTE OF

                ENVIRONMENTAL HEALTH SCIENCES, 2009-2019

        Dr. Birnbaum. Good morning, Chairwoman Johnson, Ranking
    Member Lucas, and distinguished Members of the Committee. I'm
    Linda Birnbaum, recently retired after 40 years of Federal
    service. I was Director of NIH's (National Institute of
    Health's) National Institute of Environmental Health Sciences
    (NIEHS) and with HHS' (Department of Health and Human Services)
    National Toxicology Program for the past 10 years. Prior to
    that, I spent 19 years at EPA for most of it directing the
    Agency's largest health research division. I've conducted
    scientific research to better understand how the environment
    impacts our health and have published over 800 peer-reviewed
    papers, book chapters, and reports.
        I'm a member of the National Academy of Medicine, the
    recipient of the North Carolina Governor's Award for Science,
    the former President of the Society of Toxicology, the Vice
    President of the International Union of Toxicology, Chair of
    the Toxicology Division of the American Society of Pharmacology
    and Experimental Therapeutics, and the recipient of multiple
    honorary degrees and awards.
        I've always been involved in the conduct of research, much
    of which has been used in making policy decisions. My work and
    that which I have overseen has involved basic biomedical
    research, toxicology, and public health. I've never been a
    regulator myself.
        My comments today are those of a private citizen and do not
    reflect the views of NIEHS, NIH, or HHS.
        I want to focus on three basic issues. The first is the
    core values of scientific studies, which involve people.
    Because it is unethical to intentionally expose people to
    chemicals of concern, observational human studies compare
    populations who have different exposures. People provide
    personal information such as medical information, as well as
    behaviors in confidence that their own data will not be openly
    shared.
        Human studies require confidentiality to be conducted. It
    is unethical to reveal individual human data. In many
    epidemiology studies, scientists and subjects work closely
    together in design, conduct, interpretation, and communication
    of the findings. Thus, the second point is that the impact of
    EPA's proposed transparency rule will not only make it more
    difficult for human studies to be conducted ethically but in
    many cases will make it impossible to use any information
    collected not only prospectively but looking back at the vast
    treasure trove of existing investigations.
        The third point involves EPA's mandate to use the best
    available science to protect the environment and public health.
    Scientific knowledge is constantly evolving. While a given
    experiment may answer one question, it invariably raises
    others. There is always some uncertainty in science, but that
    does not mean that decisions cannot be made, which is why it is
    so important to use all the data.
        While I am a toxicologist, that does not mean I prefer
    using animal data when data from people exists. Nature is
    inherently conservative, and studies in various animal models
    can inform us about the potential for human risk. We can
    investigate, observe the effects mechanistically in animal and
    cell culture models, and then ask whether the same mechanisms
    exist in humans. Such approaches all provide biological
    plausibility to human observational studies.
        When we have several epidemiology studies in different
    populations conducted by various investigators and achieve the
    same results and they're supporting animal and mechanistic
    evidence, why would we think that we can't believe the
    findings? Why would we want to rely solely on 20th-century
    methodologies in the 21st century? Good laboratory practice
    only assures that we know what was done, not that the right
    question was asked.
        The same can be said of some guideline studies, which may
    be inappropriate when you're looking for effects of
    pharmaceuticals in an individual rather than effects of
    environmental exposures on a population. Small effects may not
    be measurable in an individual but may have large impacts on a
    population. For example, developmental exposure to lead results
    in the loss of several IQ points in a population, which has
    significant economic and societal costs, but you can't know
    whether each of us would be a little smarter if we hadn't been
    exposed to lead.
        Today, we have systematic review of the lead data which
    confirm that there is no safe level for lead. In fact, the more
    we look at population data, there is no threshold for many
    exposures, including arsenic, mercury, and air pollution.
    Thresholds are often a function of analytical methodology. Why
    would EPA want to enshrine threshold approaches in regulation?
        EPA's proposed transparency rule in fact will block the use
    of the best science. It will prevent EPA from using the best
    available science in making policy. In fact, it will
    practically lead to the elimination of science from
    decisionmaking. EPA's current proposal would silence science
    and block its ability to meet its mission of protecting human
    health and the environment.
        Thank you, and I welcome your questions.
        [The prepared statement of Dr. Birnbaum follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Chairwoman Johnson. Thank you very much. Dr. Rice.

                     TESTIMONY OF DR. MARY B. RICE,

                    ASSISTANT PROFESSOR OF MEDICINE,

               HARVARD MEDICAL SCHOOL, AND PULMONARY AND

                        CRITICAL CARE PHYSICIAN,

                  BETH ISRAEL DEACONESS MEDICAL CENTER

        Dr. Rice. Madam Chairwoman, Ranking Member, and Members of
    the Science Committee, thank you for the opportunity to speak
    today. I'm a Pulmonary and Critical Care Physician at Beth
    Israel Deaconess Medical Center at Harvard Med School where I
    treat patients with lung disease and study the effects of air
    pollution on lung health.
        I am speaking on behalf of the American Thoracic Society
    (ATS). We are a 16,000-member medical professional organization
    dedicated to the prevention of lung disease, and we treat
    patients with illnesses such as asthma, COPD (chronic
    obstructive pulmonary disease), or lung cancer that are caused
    or worsened by air pollution. We have serious concerns about
    the EPA's proposal and what it means for our patients and the
    health of Americans, especially children and the elderly, who
    are especially susceptible to pollution.
        Our major objection to this proposal is that by excluding
    studies whose underlying data cannot be shared with the public,
    it would effectively block EPA from considering critical
    studies that involve real people living in the real world and
    exposed to day-to-day levels of pollution. These epidemiology
    studies provide the most relevant information to protect the
    health of the American public. They have repeatedly shown that
    pollution is linked to premature death in older adults due to
    heart attacks and respiratory causes, to worse lung function
    and asthma attacks among kids and adults.
        There are multiple mechanisms for data-sharing and
    resolution of controversy in research, but this proposal is not
    about improving transparency. It is a strategy to block sound
    science. I'll explain how this proposal introduces a process
    barrier.
        Before a health study can begin, investigators must
    complete a rigorous review by an institutional review board to
    ensure that the risks of participating in the study are as low
    as possible, including risks to privacy. Study participants
    sign a consent form that details how their private data will be
    protected. Researchers cannot share publicly data about
    people's medical problems, hospitalizations, or deaths or the
    addresses of their homes and schools. So under this rule, EPA
    would disregard such studies in its rulemaking because the
    demand for public data sharing cannot be met.
        Ignoring medical research in regulatory decisionmaking is
    the opposite of progress, and it's not in the interest of human
    health. As a doctor, I would do my patients a disservice if I
    ignored a huge chunk of the scientific literature in making my
    medical decisions. And the same would be true for EPA if it
    ignored evidence in making decisions about toxins in our
    environment.
        It's naive to argue that de-identification will fully
    protect the privacy of study participants in today's era of big
    data. For example, a recent study in California took the HIPAA
    (Health Insurance Portability and Accountability Act)-compliant
    de-identified data from an air pollution study and, using
    publicly available databases and programs, the investigators
    re-identified one in four study participants. Now, imagine the
    long-term consequences of leaking private health and address
    information as a result of this proposal. Would you be willing
    to enroll yourself or your child in a study about toxins in the
    water, air, or food if you knew EPA would take your data and
    share it with the world?
        Second, I want to emphasize that this process barrier is a
    familiar and sneaky strategy to discredit science that was
    pushed by big tobacco in the 1990s. As mentioned earlier,
    there's an internal memo that I've included with my testimony
    from 1996 by tobacco lawyer Chris Horner that lays out a
    detailed strategy for how the tobacco industry can discredit
    scientific findings that it doesn't like.
        Mr. Horner advised big tobacco to focus on process as
    opposed to scientific substance because attacking the substance
    of the science that secondhand smoke is bad for health would be
    a public relations nightmare. He advised big tobacco to lobby
    for the construction of, quote, ``explicit procedural hurdles
    the EPA must follow in issuing scientific reports.'' The memo
    used the same terms of, quote, ``transparency'' and, quote,
    ``sound science'' that the EPA is now using in its proposal.
        The American Thoracic Society is not fooled. This proposal
    is not about transparency; it's about discrediting or ignoring
    science about the harmful effects of toxic exposures to our
    kids and all adults.
        And one final point, this proposal gives broad discretion
    to the EPA Administrator to, quote, ``exempt significant
    regulatory decisions on a case-by-case basis.'' And the ATS is
    concerned that this grants excessive authority to the
    Administrator, without accountability to the public to cherry-
    pick studies that support political objectives and ignores
    studies, no matter how robust, that have inconvenient results.
    This flies in the face of any transparent scientific process.
        Our patients with lung disease and all Americans depend on
    the EPA to make well-informed decisions based on the best
    available evidence to set environmental standards that protect
    their health.
        On behalf of the ATS, I implore this Committee and Congress
    to prevent EPA from adopting process proposals that block peer-
    reviewed research from being considered in its rulemaking, and
    I look forward to your questions. Thank you.
        [The prepared statement of Dr. Rice follows:]

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          Ms. Bonamici [presiding]. Thank you for your testimony.
        I now recognize Dr. Allison for 5 minutes for your
    testimony.

                     TESTIMONY OF DR. DAVID ALLISON,

                     DEAN, SCHOOL OF PUBLIC HEALTH,

              INDIANA UNIVERSITY-BLOOMINGTON, AND MEMBER,

            ``REPRODUCIBILITY AND REPLICABILITY IN SCIENCE''

             COMMITTEE, THE NATIONAL ACADEMIES OF SCIENCES,

                       ENGINEERING, AND MEDICINE

        Dr. Allison. OK. Good morning, Ms. Bonamici, Ranking Member
    Lucas, and Members of the Committee. Thank you for the
    opportunity to speak with you today. My name is David Allison,
    and I have the privilege of serving as the Dean of the School
    of Public Health at Indiana University Bloomington, although
    today I am not speaking on behalf of Indiana University but as
    a member of the National Academies' Committee on
    Reproducibility and Replicability in Science. I've dedicated my
    career to the pursuit of knowledge through rigorous science and
    its truthful communication.
        My written testimony provides background on the National
    Academies' Committee, a copy of the executive summary of the
    committee's report, and an expanded version of my remarks here.
        Science is a method to discover and share knowledge about
    the world. In science, three things are vital: The data, the
    methods used to collect the data which give them their
    probative value, and the logic connecting the data and methods
    to conclusions. These are the substrates of science.
        The data, methods, and logic used to inform conclusions
    need to be thoroughly and transparently described so that
    others may understand what was done and thereby judge the
    probative value of the data for the conclusions. As we all
    heard from our middle school mathematics teachers, show all
    your work. That is, it is not enough to provide an answer. One
    must show us how one got the answer. Transparency has value.
        I will now address the questions posed by you and conclude
    my testimony with my own perspectives on the EPA proposed rule.
    The first question posed to me was what is the definition of
    reproducibility? The Academies' study defined reproducibility
    as obtaining consistent results using the same input data,
    computational steps, methods and codes, and conditions of
    analysis.
        Another important concept is scientific rigor. Rigor can be
    defined as the diligent application of scientific procedures
    that, based on principles and theories of science, would be
    expected in probability to offer successively ever-better
    approximations to the truth.
        The remaining questions on my invitation to testify focused
    on the risks of both a strict interpretation of the proposed
    EPA rule and the establishment of reproducibility standard
    within its regulatory process. And they ask how rigor and
    reproducibility are related.
        Were reproducibility to become the sole and essential
    criteria for inclusion of data, some sound research would
    likely be excluded from EPA environmental and public health
    regulations. Reproducibility by itself is neither necessary nor
    sufficient for determining the validity of a study. In general,
    a rule that strongly encourages and incentivizes making science
    transparent and reproducible would be good. In contrast, a rule
    which made transparency and reproducibility jointly necessary
    or jointly sufficient for the admissibility of a study could
    result in the exclusion of high-quality studies that, for
    legitimate reasons, cannot be made fully transparent and
    reproducible.
        At the other extreme, studies may be transparent and
    reproducible but contain flaws leading to incorrect
    conclusions. Transparency contributes to rigor, but additional
    aspects of rigor are vitally important, including
    appropriateness of study design, sampling procedures,
    measurements, and statistical analyses.
        The 2018 proposed EPA rule allows for exceptions. What is
    unclear is how exceptions will be adjudicated and whether the
    adjudication process will lead to the exclusion of rigorous
    studies, potential bias in terms of which studies and data sets
    are used in rulemaking, and ultimately diminish public trust.
        Finally, it is not obvious that a rule addressing the
    admissibility of studies in rulemaking would serve EPA's goals
    of promoting transparency and rigor in science better than
    would a statement of principles on the valuing and weighting of
    evidence, especially with so many likely and necessary
    exceptions built into the rule.
        In summation, the National Academies' Study Committee and
    I, as an individual scientist, are strong proponents of
    reproducibility and replicability of transparency and science
    and, more importantly, of the utmost rigor in the execution of
    and the unvarnished truthful communication of scientific
    research. To the extent that EPA can enact procedures that
    promote these practices, that is all to the good. Yet there
    must be flexibility to allow for research lacking complete
    transparency or reproducibility but otherwise shown to be
    rigorous to inform rulemaking.
        Just as other scientific communities and government
    regulatory bodies relying on scientific information must do, I
    advocate that we consider all relevant scientific information,
    while providing the most weight to the best information. As
    scientists drawing conclusions about whether propositions have
    been demonstrated to be true, we might withhold a conclusion
    unless research meeting some specified condition is available.
    But as a society engaged in prudent decisionmaking, we must
    make our decisions on the best information available. Thank
    you.
        [The prepared statement of Dr. Allison follows:]

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        Ms. Bonamici. Thank you for your testimony.
        I now recognize Dr. Nosek for 5 minutes for your testimony.

                      TESTIMONY OF DR. BRIAN NOSEK,

                   CO-FOUNDER AND EXECUTIVE DIRECTOR,

                        CENTER FOR OPEN SCIENCE

        Dr. Nosek. Chairwoman Johnson, Ranking Member Lucas, and
    Members of the Committee, thank you for this opportunity to
    discuss the role of transparency and reproducibility for
    maximizing the return on research investments.
        In 2013 Jeff Spies and I launched the Center for Open
    Science or COS out of my lab at the University of Virginia as a
    nonprofit technology and culture-change organization. COS has a
    mission to increase transparency, integrity, and
    reproducibility of research. To advance that mission, we
    maintain the free and open-source, open-science framework, a
    cloud-based collaborative management service used by more than
    180,000 researchers to improve the rigor and transparency of
    their research.
        COS is also working to change the incentives landscape in
    academic science with a policy framework that promotes
    transparency called the TOP (Transparency and Openness
    Promotion) Guidelines and initiatives that promote the
    visibility of open practices and shift publication criteria
    toward rewarding asking important questions and using rigorous
    methodologies rather than demanding exciting results.
        Finally, COS conducts meta-science, research on the
    research process, to identify inefficiencies in discovery and
    to evaluate whether the intervention is to reduce those
    inefficiencies are effective. Lack of transparency creates
    friction in the pace of discovery and reduces the return on
    investment of research dollars. We can increase the returns by
    promoting greater transparency of a variety of research
    outputs.
        Ideally, you would have transparency of my research plans,
    what I thought I was doing in advance, so that you can compare
    the studies that ended up published with the studies that I did
    that were not published and what my plans were to do at the
    outset versus what I discovered after the fact. Transparency of
    my materials would allow others to examine how it is I got to
    the conclusions that I got to and then re-use those materials
    for other purposes. Transparency of my data will make it easier
    for others to replicate or extend or evaluate the rigor of the
    conclusions that I draw, and transparency of the outcomes makes
    sure that all of our research investments are available in
    terms of what we learned from these investments in science.
        There is a maturing infrastructure of tools and services
    that make it possible for researchers to do these behaviors.
    There's also a growing awareness and shifting norms within the
    research community about the importance of transparency. For
    example, the TOP Guidelines policy framework has been adopted
    by more than 1,000 scientific journals for authors and by some
    funders for their grantees. There is more work to do, but your
    continuing support for these efforts could have salutary
    effects on the research culture.
        Ultimately, COS believes that the biggest opportunity for
    reducing friction in the research process is setting the
    default to open, open plans, open materials, open data, and
    open outcomes. Flipping the default from closed to open will
    foster decisionmaking frameworks for the exceptions when other
    interests outweigh the goal of transparency.
        Two common occasions in which competing principles can
    dominate are protecting intellectual property and protecting
    participant confidentiality for sensitive human subjects
    research. Sensible policies for managing these competing
    interests will facilitate the culture shift that's already
    underway.
        There are also important considerations for how best to use
    scientific evidence in policymaking. The EPA rule that prompted
    this hearing had the positive qualities of identifying
    transparency and reproducibility but had the negative quality
    of suggesting that evidence failing to meet those principles
    should not be used. It is important to use the best available
    evidence for rulemaking. There will always be occasions in
    which the best available evidence is not fully transparent or
    has unknown reproducibility, and there are many potential
    solutions for assuring credibility of findings when underlying
    data cannot be fully transparent.
        There are many factors that affect the quality of research,
    the certainty of its conclusions, and its generalizability to
    the policy context. The goal should not be transparency or
    bust. The goal should be explicitly representing the
    uncertainty of evidence to help you as policymakers make better
    decisions. There are in fact federally funded research efforts
    underway to assist with this if you'd like to discuss that
    during Q&A.
        Thank you for your continuing support of science and for
    the opportunity to speak with you today.
        [The prepared statement of Dr. Nosek follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Ms. Bonamici. Thank you for your testimony.
        I now recognize Dr. Sherer for 5 minutes for your
    testimony.

                      TESTIMONY OF DR. TODD SHERER,

                   CEO, THE MICHAEL J. FOX FOUNDATION

                        FOR PARKINSON'S RESEARCH

        Dr. Sherer. Thank you, Madam Chairwoman, Ranking Member
    Lucas, my Representative Congresswoman Sherrill, and the other
    esteemed Members of the Committee. Thank you again for the
    opportunity to testify today.
        My name is Todd Sherer, and I'm a Ph.D.-trained
    neuroscientist and CEO of the Michael J. Fox Foundation for
    Parkinson's Research. Parkinson's disease is estimated to
    affect 1 million people in the United States, severely
    impacting quality-of-life for patients and their loved ones.
    This disease costs the U.S. Government and American families
    $52 billion each year, $25 billion of which comes from Medicare
    and Social Security. Our foundation strives to partner
    effectively with the government to leverage Federal research
    investments and help get more good ideas into clinical testing.
        It would be impossible to overstate the importance of
    increasing the flow of patients into these clinical studies.
    Encouraging research participation by more patients and
    families is a major focus for us. Since we were founded, we
    have funded more than $900 million in research to accelerate
    progress toward a cure. As Federal research funders do more, we
    can do more, and together we can accelerate real results to
    those living with this disease.
        Before I joined the foundation, I was a bench
    neuroscientist focused on the underlying causes of Parkinson's
    disease. Parkinson's is a neurodegenerative disorder. Symptoms
    include the more recognized movement aspects such as tremor and
    slowness but also memory and thinking problems, mood disorders,
    and sleep issues. There are no treatments to slow or stop the
    progression of the disease.
        Because the symptoms can develop slowly, people in the
    early stages of Parkinson's still go to work, engage with
    family and friends, and remain leaders in their communities.
    These individuals also want to participate in clinical studies
    toward better treatments and a cure. They have every right to
    keep their diagnosis private and still participate in research.
        But the EPA's proposed rule puts these individuals at great
    risk of having their Parkinson's diagnosis exposed. Such
    exposure could result in unfair job loss snowballing into a
    loss of income, insurance, and other life-altering
    consequences. It is vital that we protect patients' right to
    privacy.
        I do want to be clear, the Michael J. Fox Foundation
    believes that transparency is critical in research. Open data-
    sharing among the scientific community is a core value of our
    foundation to speed discovery and replication and to deepen the
    public's trust in findings. With the consent of its 1,500
    patient and control volunteers, our Parkinson's progression
    markers initiative makes all de-identified data available to
    the research community. Scientists around the world have
    downloaded this data nearly 5 million times and used it in more
    than 150 peer-reviewed published papers with the goal of
    improving the diagnosis and treatment of Parkinson's.
        Similarly, we encourage the thousands of researchers who've
    received grants from us to make data available based on the
    nature of the study and the feasibility of de-identification.
    Stripping data of personally identifiable information is
    critical in protecting privacy. There must be a balance between
    research transparency and protecting patient confidentiality.
    Major scientific journals follow a similar practice and only
    require data to made confidentially available to other
    researchers to reproduce or extend analyses.
        If the proposed rule were enacted, there are thousands of
    studies that would be excluded from the EPA's evaluation when
    it comes to determining standards, policies, and programs that
    keep us all safe. For example, epidemiological and population-
    based studies form the bedrock of knowledge for determining the
    environment's impact on human health. Data collected through
    these types of studies cannot always be adequately deidentified
    and therefore should be protected and not publicly shared.
        Under the EPA's proposed rule, findings from these studies
    could not be used by the Agency as it sets national
    environmental standards, but census data and epidemiological
    studies are critical to understanding the causes of Parkinson's
    disease. We believe most if not all Parkinson's cases are due
    to a combination of genetic and environmental factors.
        I want to share a story, with his permission, from Kevin
    Kwok of California. Kevin is 58 years old and was diagnosed
    with Parkinson's when he was 46. He spent his college summers
    hauling toxic waste drums at a well-known global chemical
    company and cleaning the insides of chemical reactors. Even
    with protective outerwear and following OSHA (Occupational
    Safety and Health Administration) safety guidelines, he had
    direct contact with chemical reagents every day for months.
    While we can't say with certainty that the job had a direct
    impact on Kevin's diagnosis, with more research, we may know in
    the future how these exposures contributed to his disease.
        Kevin is an avid research participant and hopes that his
    contributions can inform not only the science of Parkinson's
    but also the legislation that impacts people living with the
    disease who are at risk. For example, in addition to stories
    like Kevin's, there are dozens of studies linking Parkinson's
    disease to pesticide exposure, many of which would be not
    admissible under this proposed rule.
        The proposed rule will force EPA to make decisions based on
    less information, which compromises its core mission. Please
    ensure the EPA continues to balance the need for scientific
    integrity and transparency with its duty to protect the health
    of Americans. Thank you for the opportunity.
        [The prepared statement of Dr. Sherer follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Ms. Bonamici. Thank you for your testimony.
        At this point we will begin our first round of questions,
    and I recognize myself for 5 minutes for my questions.
        It's an honor to hear from such a distinguished panel of
    scientists. And this rule has inspired a lot of attention in
    the scientific community. And I'd like each panelist to answer
    very briefly, basically yes or no, do you support the
    ``Strengthening Transparency and Regulatory Science'' rule as
    written?
        Dr. Birnbaum. No.
        Dr. Rice. No.
        Dr. Allison. More information and clarification is needed.
        Dr. Nosek. Not as written.
        Dr. Sherer. No.
        Ms. Bonamici. Thank you very much. The EPA's proposed rule,
    which we've discussed in this Committee, the essence of it many
    times, undermines scientific integrity, jeopardizes bedrock
    public health and environmental standards, and endangers the
    EPA's ability to protect the American people. It's particularly
    troubling that the proposed rule appears to be inconsistent
    with the EPA's statutory obligation to use the best available
    science, as required in the Toxic Substances Control Act, the
    Safe Drinking Water Act, the Clean Water Act. And if finalized
    in its current form, the proposed rule would preclude the use
    of a range of scientific research that has long been used to
    safeguard the public.
        There's also tremendous uncertainty about how this proposed
    rule and supplemental would be applied and to what it would be
    applied, and regardless of how that question is ultimately
    answered, we know that the rule will severely undermine public
    health and environmental protections.
        I want to start with Dr. Birnbaum. In your testimony, you
    discuss the evolving nature of science and the importance of
    using all data. If finalized in its current form, how would
    application of the proposed rule affect the scientific
    foundation of the EPA's regulatory decisionmaking?
        Dr. Birnbaum. So all the available data would mean all the
    epidemiology studies if there are any clinical studies--and
    occasionally with air pollution work we've had some clinical
    studies done. It would include animal studies. It would include
    mechanistic studies. And the requirement for public
    availability of all the underlying human data would preclude
    the use of most of the epidemiological and clinical studies,
    which would mean that we would be forced to make our decisions
    based upon animal data only.
        Now, the animal data, the question is how much of that will
    be freely available as well because if some of the data is,
    say, conducted using chemicals which may have CBI information,
    that would not be able to be shared. So you lead to
    constriction of the databases that you can use to make your
    decision.
        Ms. Bonamici. Thank you very much.
        Dr. Allison, the National Academies have issued numerous
    reports to advise the EPA on opportunities to improve
    transparency on the collection and analysis of data. And I
    think everyone here supports transparency. Most recently, these
    reports have included reproducibility and replicability in
    science, open science by design, and fostering integrity in
    research. Does the proposed rule respond to impediments that
    reproducibility, as outlined in the Academies' Reproducibility
    and Replicability in Science report?
        Dr. Allison. The proposed rule has some provisions in it
    that respond to some of the issues in the reproducibility and
    replicability report, but I am not clear that it would take
    into account all of the comments on it. Clearly, more
    information in the proposed rule would be necessary to
    understand how it would be implemented and whether it would
    successfully accommodate the issues.
        Ms. Bonamici. Thank you. And I mentioned earlier today that
    I'm sending a letter requesting that the National Academies of
    Sciences, as an authoritative and independent nonpartisan
    scientific organization, work with the EPA to review the
    proposed rule. Last year, the presidents of the National
    Academies submitted public comments for the proposed rule and
    warned that it could pose a threat to the credibility of
    regulatory science at the EPA. The Academies urged the EPA to
    seek objective expert guidance on the rule and offered their
    own assistance in reviewing it.
        So as a member of the National Academy of Medicine--is that
    Dr. Rice? Dr. Birnbaum. As a member of the National Academy of
    Medicine, do you agree that the uncertainties in the proposed
    rule require the independent expert advice of the National
    Academies?
        Dr. Birnbaum. I think it's always useful to get the
    Academies' advice, but I think there is enough information out
    there that some of the problems with the rule require it to be
    redrafted. It would be good if they saw sought outside advice
    in doing that.
        Ms. Bonamici. Right. And, Dr. Allison, you as well I
    understand are a member of National Academy of Medicine. Do you
    agree that the uncertainties in the proposed rule require
    independent expert advice of the National Academies?
        Dr. Allison. The National Academies were established by the
    U.S. Government for the purpose of providing advice to other
    organizations on scientific matters and are pleased to do so
    when called upon.
        Ms. Bonamici. Thank you very much. And I see my time is
    expired. I just want to close with an appreciation for Dr.
    Sherer. As someone with a family member with Parkinson's, I
    appreciate your being here, but I also understand the
    sensitivity of sometimes people do not want to disclose their
    diagnosis but they still want to get the help and participate
    in studies, so your points are well taken.
        And I yield back, and I now recognize Mr. Lucas for 5
    minutes for your questions.
        Mr. Lucas. Thank you, Madam Chair.
        Dr. Nosek, in your prepared testimony you stated that the
    EPA rule had the positive qualities of identifying the
    importance of transparency and reproducibility of research but
    had the negative quality of suggesting that evidence failing to
    meet these principles should not be used in policymaking. I
    appreciate your effort to provide constructive input on this
    policy, as well as your work to better institutionalize
    transparency in the research community. Given your expertise,
    can you provide additional insights into what you would like to
    see in any science transparency policy both at the EPA and
    governmentwide to make it more practical for all policymakers
    and researchers?
        Dr. Nosek. Yes. Thank you for that question. So as I noted
    in the statements, a general hope for policymaking is that
    openness is the default assumption, is that part of the value
    and opportunity that we have, given the modern ability to share
    information very widely, is to provide tools and resources and
    services to make much more of the research process itself, not
    just the end conclusions, more available to all.
        In terms of implementation issues related to that policy,
    to the extent that there could be provisions that address the
    issues that have been raised by the whole panel on managing
    privacy, this would be a significant advantage for the
    applicability of the rule to maximize the availability and use
    of research evidence. So, for example, data enclaves that
    manage the preservation of data but still the privacy of that
    data for independent others to confirm its validity is a means
    of potentially promoting the credibility and overall
    reproducibility of findings while simultaneously managing that
    with privacy concerns.
        Mr. Lucas. Your research involves developing technology
    solutions to help researchers incorporate transparent
    mechanisms as they conduct their research. One example is the
    open science framework (OSF), an online data management tool
    that allows scientists to store their data privately as they
    conduct their research but then allows them to easily make the
    entire project publicly accessible once their work is
    completed. The OSF also allows individual researchers to set
    the parameters of disclosing data, establishing tiered and more
    limited access to data that may require additional controls
    such as personal, sensitive information. How could a Federal
    agency use OSF or similar technology to improve data
    transparency?
        Dr. Nosek. So some opportunities for using OSF and the many
    other tools and services that support similar aims would be
    building into grant requirements what the provisions are for
    the preservation of the research planning, the materials, the
    data, and the outcomes that were produced from that work and
    under what conditions that data must be preserved over a period
    of time and which parts of it can be made publicly accessible
    to the maximum extent possible.
        So many agencies that provide funding for Federal research
    already have been making advances for data management plans
    being an important part of the proposal process for grants. NIH
    just released some new plans for their data management
    planning, for example. Continuing to support those efforts
    would be very useful.
        Mr. Lucas. So along that line, a similar-tiered access
    approach could be useful in ensuring appropriate data
    protections for all Federal research?
        Dr. Nosek. Yes.
        Mr. Lucas. With that, Mr. Chairman, I yield back.
        Mr. Casten [presiding]. Mr. Tonko, you are recognized for 5
    minutes.
        Mr. Tonko. Thank you, Mr. Chair.
        I have here a letter, Mr. Chairman, that was sent to the
    Committee by esteemed organizations, including the
    Environmental Defense Fund, the Union of Concerned Scientists,
    Earth Justice, the Natural Resources Defense Council, the
    Environmental Protection Network, and the Clean Air Task Force,
    all requesting that this rule not move forward.
        The letter states that the rule has been criticized by,
    quote, ``leading scientific organizations and public health
    organizations with the editors of the Nation's leading
    scientific journals; Presidents of the National Academies of
    Sciences, Engineering, and Medicine; the President of Harvard
    University; nearly 100 leading Harvard scientists and medical
    experts; EPA's own Science Advisory Board, and other scientific
    experts have all voiced concerns about the proposed rule.''
        The letter concludes, and I quote, ``For the sake of the
    air and water, the EPA has been tasked with protecting and the
    millions of human lives that rely on these resources, EPA must
    not finalize this proposal,'' close quote.
        I share these concerns and move to enter the letter into
    the record.
        Mr. Casten. Without objection.
        Mr. Tonko. Thank you. In terms of public health, what
    consequences should we be most worried about if this rule moves
    forward, to anyone on the panel? Yes. Doctor?
        Dr. Rice. Thank you for that question. Let me give an
    example. So the EPA right now is looking at the National
    Ambient Air Quality Standard for particulate matter, and as
    part of that review, they just released their policy
    assessment. They looked at hundreds of studies about the health
    effects of particulate matter. And where the data are
    particularly robust is that long-term exposure of particulate
    matter is associated with premature mortality. There are many
    studies that have shown that. So just for this particular
    policy assessment, the EPA focused on 21 studies looking at
    particulate matter and total mortality, 14 on premature
    cardiovascular death, 10 on lung cancer, 7 on respiratory
    premature death.
        If this proposed rule were implemented now, the EPA would
    not be able to use those studies in deciding what level of
    particulate matter is safe because the studies could not meet
    the requirements for public data release. And so the EPA would
    be setting a health standard that affects the health of the
    entire country, all of us, on exposure that is clearly
    associated with mortality and just ignoring that science. And
    we are very concerned about what the long-term ramifications
    would be of setting standards without looking at the science.
        Mr. Tonko. Thank you, Dr. Rice.
        Anyone else on the panel? Yes.
        Dr. Allison. I think it's really the health of science
    that's the key question here, and I think that anything which
    serves to restrict access to useful information on the basis of
    a simplistic notion of looking at one indicator of the value of
    research is unwise and undermines the health of science and
    rationality in general. We need to consider the many aspects
    that provide science its probative value, not only
    reproducibility and transparency.
        Mr. Tonko. So that being said, to the panel again, the
    entire panel, how would this rule then affect the health of
    future generations?
        Dr. Birnbaum. So many of the exposures that we experience
    have effects on susceptible populations. And one of the most
    susceptible populations are the unborn and young children. And
    the effects that occur developmentally, the exposures that
    occur developmentally not only may have immediate effects but
    can have effects that will last the rest of your life. So the
    effects here could affect an entire generation.
        Mr. Tonko. Thank you, Dr. Birnbaum.
        Anyone else that wants to take a stab at answering how it
    would affect future generations? Dr. Rice?
        Dr. Rice. Yes, I, too, would echo that my greatest concern
    is our children, my own children. I have three kids. I have one
    of them who has respiratory problems. It is clear that--and I'm
    an air pollution scientist, so that's a pollutant I focus on.
    But air pollution exposure makes kids sicker and increases
    their----
        Mr. Tonko. In what ways? Addressing what types of diseases?
        Dr. Rice. So asthma attacks----
        Mr. Tonko. OK.
        Dr. Rice [continuing]. So children who have asthma are more
    likely to end up in the hospital or to use medications for
    their asthma. Studies in California and across the country have
    shown that exposure to pollution makes kids' lung function
    trajectory slow down, and they don't attain the level--the same
    level of peak lung function in adulthood that they might have
    if they were exposed to lower levels of pollution. So these are
    critical windows of exposure. And so exposure to our children
    today matters for the health that they attain for the rest of
    their lives.
        Mr. Tonko. So if this rule isn't supported by public health
    groups or scientific societies, then it forces us to ask why
    did the Administration go down this path?
        Dr. Rice. I can't answer that question, but in my oral
    testimony and my written testimony I want to draw attention to
    the fact that there's a history here and that there's a long
    precedent of using the terms transparency and reproducibility
    in science as a barrier for using science that's inconvenient.
        So let me give just one example. Back in the 1990s R.J.
    Reynolds used a law in Georgia to get the raw data from a study
    that a pediatrician that looking at Joe Camel, the cartoon
    character, and how it appealed to kids, and they recognized
    that he was associated with tobacco smoking more than they knew
    that Mickey Mouse was associated with Disney. And that wasn't
    the only study showing that. The Journal of the American
    Medical Association released multiple studies showing that that
    kind of marketing appealed to kids. So it wasn't really that
    controversial. But then when they got the raw data, they
    attacked the scientists, and they attacked the conclusions that
    he drew. And I worry that those are some of the motivations
    behind this effort.
        Mr. Tonko. Yes, it's tragic. With that, I yield back, Mr.
    Chair.
        Mr. Casten. Mr. Baird, you're recognized for 5 minutes.
        Mr. Baird. Thank you, Mr. Chair.
        And, Ranking Member Lucas, I appreciate the opportunity to
    ask questions. I really appreciate the opportunity to have
    comments from such a distinguished group of witnesses. That's
    very helpful and insightful for our Committee and the work that
    we're trying to do.
        I only have a certain amount of time, so, Dr. Allison,
    you're the one that I'm going to ask a couple of questions of.
    First off, though, I just wonder if you're aware that if you'd
    have just gone 2 more hours north when you came to Indiana from
    Alabama you'd have been at Purdue University.
        You know, in your testimony and all the work that you've
    done, what, over 600 scientific publications, you've edited
    five books, you serve as a member of the Committee on
    Reproducibility and Replicability from the National Academy of
    Sciences, so I think it's very appropriate to have you here to
    talk about the things that we're interested in today.
        And so my first question is that in your testimony you
    mentioned that perhaps a thorough statement of raw principles
    like what constitutes good scientific evidence and how to
    effectively weigh and evaluate evidence for drawing conclusions
    could be more useful than a single rulemaking transparency.
    Could you elaborate on that?
        Dr. Allison. Certainly. Let me say that these are my own
    opinions are not necessarily those of the committee that I was
    here to represent today since the committee didn't address the
    EPA rule per se.
        But it seems to me that EPA, to construct a simplistic rule
    that says information will be available or usable only if it's
    reproducible and transparent puts too much weight on one
    factor. It may allow things in that shouldn't come in, and it
    may exclude things that shouldn't be excluded, whereas there
    are other factors that need to be involved. It becomes
    reasonable only to the extent that exceptions are allowed. But
    those exceptions will likely be extensive and frequently
    necessary. Questions have already been raised about exactly how
    would those exceptions be made, and would the process of making
    those exceptions foster trust or distrust or optimal
    approaches?
        Better yet it seems to me would be to say multiple factors
    are important to weigh, including but not limited to
    reproducibility and transparency, replicability,
    generalizability of findings, and importantly, overall research
    rigor. This can be assessed on a case-by-case basis so that the
    overall evidence can be weighed, all evidence can be
    considered, but then ultimately decisions are based upon the
    weight of the evidence. This is the typical practice in much of
    science, as I wrote extensively in my written remarks about
    this, and is a practice generally used by other organizations,
    for example, like FDA (Food and Drug Administration).
        Mr. Baird. I found it especially interesting you mentioned
    that scientific research, you know, involves data and methods
    and logic in how you got there, but the application of rigor in
    the methods, I found that extremely useful and extremely
    relevant to making sound scientific decisions. So any further
    thoughts on that issue on rigor?
        Dr. Allison. Certainly. We know that a great deal of
    science varies tremendously in the degree of rigor. Some
    studies have stronger value than others in helping us determine
    the truth of propositions. We can only evaluate the strength of
    those studies to the extent that we really know what was done.
    So knowing what was done is very important, and that's partly
    where transparency comes in.
        So transparency is vital. We do want to promote it in all
    of science. As Dr. Nosek said, we are, as an entire scientific
    community, working on this, taking ever greater steps to make
    more and more science transparent. But, as Dr. Rice and others
    have pointed out, there will always be certain aspects of
    science that are not fully transparent for any number of
    reasons. These could include protection of patient privacy,
    fulfillment of the contract of informed consent, simple loss of
    information, and we should not make a dicto simpliciter out of
    the notion that we will only consider information that's
    transparent.
        Mr. Baird. Thank you. I've got a whole notebook here. I
    could spend the rest of the day with you, but they tell me I've
    got 5 minutes, so thank all of you for being here, and I yield
    back.
        Mr. Casten. Thank you. And I now recognize myself for 5
    minutes.
        Dr. Allison, are you familiar with the phrase p-hacking?
        Dr. Allison. Sadly, yes.
        Mr. Casten. Could you give us just a simple overview of
    what that means for the Committee and how that can be used to
    draw bad conclusions from good data sets?
        Dr. Allison. Certainly. P-hacking is a term that it broadly
    includes multiple practices in which one adaptively analyzes
    data with the intent of producing a particular result in terms
    of a p-value, a p-value being a particular statistic that tells
    one about what we refer to as the statistical significance of
    the data, very, very loosely speaking, getting a finding. And
    one can continually reanalyze the data, one can analyze only
    males and only females separately. One can analyze only young
    and old. One can throw out an outlier, include an outlier, and
    transform the data until eventually one gets the result one
    wants. And so the practice of p-hacking undermines the
    replicability and validity of analyses.
        Mr. Casten. So that is a brilliant job of summarizing at
    least 3 weeks of my college statistics class. I appreciate it.
        So in the supplemental rule that the EPA released, they
    said that their intent is to, quote, ``reanalyze data,'' which
    they defined as ``to analyze exactly the same data to see if
    the same result emerges from the analysis by using the same
    programs and statistical methodologies that were originally
    used to analyze the data.'' To my way of thinking, that sounds
    like a recipe for p-hacking. Would you share that concern?
        Dr. Allison. Again, these are my own comments, but I would
    not describe it as a recipe, but I would describe it as an
    opportunity. And I think that this is again where the issue of
    more information is needed. One would hope that in fact with
    respect to transparency, then if EPA is going to go down that
    road, it might want to propose additional plans whereby they
    engaged the services of Dr. Nosek or other people who do these
    sorts of things so that their plans also became transparent and
    so that their reanalysis plans became shots they called prior
    to looking at and analyzing the data. That might be something
    in an ideal world. Whether that would always be practicable is
    unclear. Of course, there would need to be exceptions but it
    would be helpful.
        Mr. Casten. Thank you for that clarification. I really was
    thinking in the context of because the reanalysis would only
    apply to results where the data was there, we are limiting this
    that we have. And so, you know, accepting your very good
    comments that reproducibility cannot be the sole basis of good
    science, it would seem to me that reanalysis, as they're
    describing, is not even synonymous precisely with
    reproducibility. Yes or no, do you agree with that?
        Dr. Allison. If reproducibility is defined as the National
    Academies of Science Committee that I served on defines it,
    then reanalysis is at most reproducibility if it runs the exact
    same analysis as was initially run.
        Mr. Casten. OK. Dr. Rice, I've got another easy one for
    you.
        Dr. Rice. I had a follow-up comment on that----
        Mr. Casten. Well, let me--because we're tight on time----
        Dr. Rice. OK.
        Mr. Casten [continuing]. I'm sure as a medical doctor
    you're familiar with pre-existing conditions.
        Dr. Rice. Absolutely.
        Mr. Casten. Purely as an individual, not any associations
    you're with, do you have complete confidence that Congress will
    never remove the protections to people with pre-existing
    conditions?
        Dr. Rice. I can't comment on that issue specifically, but I
    can talk about the kinds of conditions that we collect and
    research. You asked about----
        Mr. Casten. Well, I asked the question because if we have a
    concern that our data may not always be kept private and that
    it may limit our ability to get insurance, get medical
    coverage----
        Dr. Rice. Yes. Oh, I see where you're asking.
        Mr. Casten [continuing]. Is it reasonable to assume that
    the average American may not want their health data to be in a
    publicly searchable database?
        Dr. Rice. Well, that I agree with. I think that the average
    American probably does not want their data about their mental
    health, their alcohol use, their tobacco behavior, their income
    on a public database that could potentially be hacked. And for
    environmental health data, it may be especially easy to figure
    out who people are because it has to do where people are
    located.
        So, for example, in my research we adjust for community-
    level confounders, things like census-tracked income, census-
    tracked education level, things that are associated with where
    the person lives. And so if you had 10 or 15 of those variables
    which are data sets, too, you could pretty easily figure out
    where that person is located. So I think that's a real----
        Mr. Casten. I always hate interrupting because our time is
    so short here, but if you could just with a limited time left--
    --
        Dr. Rice. Yes.
        Mr. Casten [continuing]. In the supplemental rule that was
    revealed, EPA says that studies will be weighted not by
    scientific metrics but by the public availability of data and
    models. So can you just speak to what that weighting would do
    to the quality of data and, ultimately the ethics of----
        Dr. Rice. Yes.
        Mr. Casten [continuing]. Data collection, given what you
    just discussed?
        Dr. Rice. Certainly. That concerns me because environmental
    health research, we really need to adjust for those kinds of
    confounders that I just mentioned. Personal-level
    characteristics are really important so that we do the
    biostatistics right. So that would actually create a bias
    against research that really characterizes their study
    participants really well so that you can account for
    confounding. Those are the kinds of studies that are least
    likely to be able to meet this requirement.
        Mr. Casten. Thank you. And I have used up my time.
        Mr. Foster.
        Mr. Foster. Thank you, Mr. Chair. And I'd also actually
    like to start out by thanking the Ranking Member Lucas and the
    minority staff for the existence of Dr. Nosek on this panel.
    You know, for someone who's lived through the previous 5 years
    on this panel, seeing an entire panel, minority and majority,
    all with the dedication to getting the best science as the
    basis of public policy, it's thrilling.
        Now, to me, the privacy and PII are some of the toughest
    problems in everything that we're wrestling with here. So,
    first, what is the state-of-the-art on patient consent forms
    and data anonymization? Is there at least going forward a
    pretty good, you know, recipe for how you perform public health
    studies without making too many compromises?
        Dr. Birnbaum. So it's very difficult to completely protect
    privacy if you make the data fully available.
        Mr. Foster. Yes. But, for example, you know, does a typical
    consent form for a specific study allow that data to be used in
    a subsequent real scientific study----
        Dr. Birnbaum. Yes, so the types of terminology that goes
    into an IRB (institutional review board) protocol, a consent
    form, is that all attempts to maintain confidentiality will
    be--but you can't assure confidentiality.
        Dr. Sherer. Yes, just to jump in because I referenced one
    of the studies that we are supporting, there are ways to handle
    this in the consent process. And I think we have to be clear we
    don't just focus on what the scientists want to do. These are
    the volunteers that are participating and being transparent to
    them on what's happening with their data and that their data
    will be used for further research. And obviously there's always
    the risks, but people should be aware of the risks if they're
    participating.
        And one of the concerns that we have is that you can wind
    up biasing people who are involved in projects who don't want
    to participate if you put too much criteria on it, and then you
    don't have a full data set.
        Mr. Foster. Right. And presumably, if you ask them to
    consent to having their data used for multiple potentially
    unknown future studies, that's a much bigger ask than one
    specific study. You'll get drop-off that may or may not bias
    your patients and----
        Dr. Sherer. Yes, I think people are--you know, you have a
    pyramid of people who are willing to be involved at different
    levels, and it's just a matter of being transparent. I think in
    the case of some of the studies being discussed here that are
    using census data or medical record data, you're a lot further
    from that direct consent, and you have to be very careful about
    how that data is ultimately going to be shared.
        Mr. Foster. Now, in terms of data anonymization, I guess
    Dr. Rice mentioned the problem that if you just do a first-
    order anonymization, it can be undone with access to other data
    sets. This is something we're wrestling with on my other
    committee. I chair a task force on artificial intelligence, and
    we are wrestling with the fact that artificial intelligence
    works better with big data sets, you know, like big sets of
    medical records. And what you want to do is give access to lots
    of researchers, very large data sets. And one of our witnesses
    was promoting a technology that goes by the name of homomorphic
    encryption, which allows you to publish an encrypted data set
    and ask very detailed statistical questions about that without
    actually having access to it.
        And I guess, Dr. Nosek, is that an approach your familiar
    with?
        Dr. Nosek. I am familiar with the general approach, not the
    particulars of that one, but yes, this is a very interesting
    set of emerging technologies. Alfred P. Sloan Foundation has
    supported a number of efforts in this regard that perturb the
    data in such a way that you can't identify any individual data
    point, but it still maintains the overall structure of the data
    so you can draw confident conclusions.
        Mr. Foster. Yes, because it seems like that's something
    where some effort in that direction could really be
    transformative to--your ability to make fewer compromises in
    this pyramid of people willing to come into this.
        Dr. Sherer. Just to add, particularly in a chronic disease
    like Parkinson's disease where it's a late onset, people are
    older in their life, one additional concern is that some of the
    data collection may have started decades ago, and you can't
    really go back in time to re-consent and re-set up the rules
    about that data. So I think one of the concerns is you'd still
    want to be able to use that data if you're changing the rules
    going forward on what is required with sharing. You can't go
    back 30 years when you started collecting the data.
        Mr. Foster. Well, yes, over Veterans Day weekend there was
    a veteran with Parkinson's probably from Agent Orange. And the
    questions of the--just the validity of the data that was
    collected, and I guess there's automatic consent in the
    military, yes, there was another comment.
        Dr. Rice. Yes. Oh, I just wanted to describe the process by
    which--when a study participant enrolls in a study, we have to
    specify exactly how we're going to use their data and what
    protections are going to be in place to protect that data. So
    really the same point that--studies that have already
    completed, these participants have already signed those consent
    forms, and those consent forms specified how the data could be
    used, so this would really impose a major limit on the kind of
    research that could be used by the EPA.
        Mr. Foster. Now, going forward, do you believe there's a
    satisfactory set of options for there, or is that still a work
    in progress in trying to maximize acceptance of participation
    on the study versus, you know, ability of it to be used?
        Dr. Birnbaum. So what is done frequently now--and this
    started a number of years ago--is you would basically give
    people two or three choices, you know, I don't want my data
    used for anything else, my data can be used for everything, you
    have to come back and ask me. And those are kind of the three
    basic options that exist. And going forward, that can be done.
    And there are some studies for the past couple of years where
    that has already been done. But if you go back before a couple
    years ago, people were pretty much consented to do exactly one
    thing.
        Mr. Foster. Right. And then you have to track down that
    patient, which has got to be a nightmare in many circumstances.
        And so maybe I'll just close with a pitch for the repeal of
    the unique patient identifier ban that the medical world has
    been living under, which is something we successfully passed
    through the House this summer and is awaiting action on the
    Senate, could be transformative to the ability of researchers
    to actually, you know, go through and do things like re-
    contacting patients.
        Anyway, thank you, and yield back my time.
        Mr. Casten. Thank you.
        Before we bring today's hearing to a close, I really want
    to thank all our witnesses for coming before the Committee
    today and taking the time. Thank you very much.
        The record will remain open for 2 weeks for additional
    statements from the Members and for any additional questions
    the Committee may ask of the witnesses.
        The witnesses are excused, and the hearing is now
    adjourned.
        [Whereupon, at 12:36 p.m., the Committee was adjourned.]

                                   Appendix I

                                  ----------

                       Answers to Post-Hearing Questions

                       Answers to Post-Hearing Questions

    Responses by Dr. Jennifer Orme-Zavaleta

        [Despite repeated requests by the Committee over a period
    of ten months, EPA declined to submit any responses to the
    Questions for the Record put forth by Committee Members.]
    Responses by Dr. Mary B. Rice

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Responses by Dr. Todd Sherer

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                                  Appendix II

                                  ----------

                       Additional Material for the Record

            Letter submitted by Representative Eddie Bernice Johnson

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

              Article submitted by Representative Suzanne Bonamici

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

          News release submitted by Representatives Suzanne Bonamici
                                and Brian Babin

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

              Letters submitted by Representative Lizzie Fletcher

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                Letter submitted by Representative Haley Stevens

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                 Letter submitted by Representative Paul Tonko

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

               Memorandum submitted by Representative Sean Casten

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                      Documents submitted by Dr. Mary Rice

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]