    [Senate Hearing 115-18]
    [From the U.S. Government Publishing Office]

                                                             S. Hrg. 115-18

                    AGENCY USE OF SCIENCE IN THE RULEMAKING
        PROCESS: PROPOSALS FOR IMPROVING TRANSPARENCY AND ACCOUNTABILITY

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

                                    HEARING

                                   before the

                                SUBCOMMITTEE ON
                   REGULATORY AFFAIRS AND FEDERAL MANAGEMENT

                                     of the

                                  COMMITTEE ON
                             HOMELAND SECURITY AND
                              GOVERNMENTAL AFFAIRS
                              UNITED STATES SENATE

                         ONE HUNDRED FIFTEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                                 MARCH 9, 2017

                                   __________

                       Available via http://www.fdsys.gov

           Printed for the use of the Committee on Homeland Security
                            and Governmental Affairs

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                               ________

                    U.S. GOVERNMENT PUBLISHING OFFICE

     25-313 PDF                 WASHINGTON : 2017
    ____________________________________________________________________
     For sale by the Superintendent of Documents, U.S. Government Publishing Office,
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      Fax:(202) 512-2104 Mail:Stop IDCC,Washington,DC 20402-001

            COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS

                        RON JOHNSON, Wisconsin, Chairman
    JOHN McCAIN, Arizona                 CLAIRE McCASKILL, Missouri
    ROB PORTMAN, Ohio                    THOMAS R. CARPER, Delaware
    RAND PAUL, Kentucky                  JON TESTER, Montana
    JAMES LANKFORD, Oklahoma             HEIDI HEITKAMP, North Dakota
    MICHAEL B. ENZI, Wyoming             GARY C. PETERS, Michigan
    JOHN HOEVEN, North Dakota            MAGGIE HASSAN, New Hampshire
    STEVE DAINES, Montana                KAMALA D. HARRIS, California

                      Christopher R. Hixon, Staff Director
                   Margaret E. Daum, Minority Staff Director
                         Laura W. Kilbride, Chief Clerk

           SUBCOMMITTEE ON REGULATORY AFFAIRS AND FEDERAL MANAGEMENT

                       JAMES LANKFORD, Oklahoma, Chairman
    JOHN MCCAIN, Arizona                 HEIDI HEITKAMP, North Dakota
    ROB PORTMAN, Ohio                    THOMAS R. CARPER, Delaware
    MICHAEL B. ENZI, Wyoming             MAGGIE HASSAN, New Hampshire
    STEVE DAINES, Montana                KAMALA D. HARRIS, California
                         John Cuaderess, Staff Director
                     James Mann, Professional Staff Member
                      Eric Bursch, Minority Staff Director
                   Warren Flatau, Minority Legislative Fellow
         Katie Delacenserie, Subcommittee Clerk and Committee Archivist

                                C O N T E N T S

                                     ------
    Opening statement:
                                                                       Page
        Senator Lankford.............................................     1
        Senator Heitkamp.............................................     8
        Senator Hassan...............................................     9
        Senator Harris...............................................    11
        Senator Daines...............................................    16
        Senator Carper...............................................    23
    Prepared statement:
        Senator Lankford.............................................    35
        Senator Heitkamp.............................................    37

                                   WITNESSES
                            Thursday, March 9, 2017

    Susan Dudley, Director, Regulatory Studies Center, The George
      Washington University..........................................     3
    Andrew A. Rosenberg, Ph.D., Director, Center for Science and
      Democracy, Union of Concerned Scientists.......................     5
    Nancy Beck, Ph.D., Senior Director, Regulatory Science Policy,
      American Chemistry Council.....................................     7

                         Alphabetical List of Witnesses

    Beck, Nancy, Ph.D.:
        Testimony....................................................     7
        Prepared statement...........................................    56
    Dudley, Susan:
        Testimony....................................................     3
        Prepared statement...........................................    38
    Rosenberg, Andrew A., Ph.D.:
        Testimony....................................................     5
        Prepared statement...........................................    49

                                    APPENDIX

    Article submitted by Senator Harris..............................    74
    Responses to post-hearing questions for the Record from:
        Ms. Dudley...................................................    77
        Mr. Rosenberg................................................    81
        Ms. Beck.....................................................    85

                          AGENCY USE OF SCIENCE IN THE

                       RULEMAKING PROCESS: PROPOSALS FOR

                   IMPROVING TRANSPARENCY AND ACCOUNTABILITY

                                  ----------

                            THURSDAY, MARCH 9, 2017

                                     U.S. Senate,
                            Subcommittee on Regulatory,
                          Affairs and Federal Management,
                        of the Committee on Homeland Security
                                      and Governmental Affairs,
                                                        Washington, DC.
        The Committee met, pursuant to notice, at 10:15 a.m., in
    room 342, Dirksen Senate Office Building, Hon. James Lankford,
    Chairman of the Subcommittee, presiding.
        Present: Senators Lankford, Daines, Heitkamp, Carper,
    Hassan, and Harris.

                OPENING STATEMENT OF SENATOR LANKFORD\1\

        Senator Lankford. Good morning. Welcome to today's
    Subcommittee hearing entitled Agency Use of Science in the
    Rulemaking Process: Proposals for Improving Transparency and
    Accountability.
    ---------------------------------------------------------------------------
        \1\ The prepared statement of Senator Lankford appears in the
    Appendix on page 35.
    ---------------------------------------------------------------------------
        Over 2 years ago, this Subcommittee began an in-depth
    review of the rulemaking process, tackling subjects such as
    retrospective review, agency use of guidance, and issues
    surrounding small business' concerns when it comes to improving
    the regulatory outcomes. This morning we will continue our
    regulatory work by examining how agencies use scientific
    information to inform their regulatory decision making.
        American people should be confident that when agencies
    regulate they are relying on up-to-date, accurate, and unbiased
    information. To put it simply, agencies should rely on the best
    available information and make decisions based on the weight of
    that information.
        When determining whether scientific information is the best
    available, agencies should consider things like whether
    information has been peer-reviewed by an independent third
    party, whether the conclusions are verifiable and reproducible,
    whether the information's use is consistent with its intended
    purpose, and whether the data is transparent and publicly
    available.
        This is not a new idea. Presidents from both parties have
    stressed the importance of relying on sound science to inform
    regulatory decisions. Executive Order (EO) 12866, which has
    been in place since 1993, and endorsed by every President
    since, directs agencies to base decisions on the best
    reasonably obtainable, scientific and technical information.
    Eight years ago, President Obama went even further by issuing a
    memorandum to agency heads guaranteeing scientific integrity by
    following a list of principles that included consideration of
    well-established scientific processes and urging transparency
    to the public. And in 2011, President Obama issued Executive
    Order 13563, where he directed each agency to ensure the
    objectivity of any scientific and technical information used to
    support regulatory actions.
        Yet, despite these clear directives, agencies continue to
    use questionable science to support their regulatory decisions,
    or we do not know the background on science. For example, in
    2015, when the Environmental Protection Agency (EPA) proposed a
    ban on chlorpyrifos, an insecticide that farmers have been
    using successfully for decades, the agency based the regulation
    on a study that was discredited by their own scientific
    advisory panel and by the U.S. Department of Agriculture
    (USDA).
        I understand agencies often face difficult choices and not
    all studies come to the same conclusion, but it is very
    concerning when agencies are not open about why they chose to
    use a study with such significant criticism. When agencies hide
    information from both Congress and the American people, it is
    our job to question motives and methods as a part of oversight.
        Transparency is not an unreasonable request. In fact, it
    will go a long way in enforcing better regulations and heading
    off lawsuits in the future. When agencies issue regulations
    that place legally binding requirements on the American people,
    the data and methods or models the agency used should be
    publicly available for independent, third-party review.
        When many of the most costly Clean Air Act (CAA)
    regulations are based on a single Harvard study from 1993, EPA
    should not be able to hide behind the excuse they can't release
    the study because they do not own it, Harvard does, despite the
    fact that Harvard receives well over half a billion dollars in
    Federal awards.
        Examples like these call into question whether agencies are
    using best information because it is unknown, not because there
    is just a false accusation. We just don't know, and the
    American people do deserve to be able to know when these things
    impact their lives in such a significant way.
        Each administration has their own priorities, but the
    principles supporting regulatory decisions should remain
    constant, regardless of who occupies the White House. If past
    administrations' attempts to encourage agencies to base their
    regulatory decisions on transparent, sound science have failed,
    Congress should consider establishing new legal requirements.
        I look forward to discussing steps Congress can take to
    implement basic, fundamental requirements that have been
    endorsed by both Democrat and Republican administrations for
    decades.
        Senator Heitkamp is running a little bit behind, though I
    will always tease her and say the lady is never late, but I
    will recognize her for an opening statement if she chooses to
    give that orally, or to be able to put that into the permanent
    record if she does not choose to.
        With that I would like to recognize our witnesses. Let me
    introduce them all and then we will do a swearing-in, and then
    we will take your testimony.
        The Hon. Susan Dudley is the Director of the Regulatory
    Studies Center and Distinguished Professor of Practice in the
    Trachtenberg School of Public Policy and Public Administration,
    George Washington (GW) University. Before joining the faculty
    at GW, she served as the Administrator of the Office of
    Information and Regulatory Affairs (OIRA), from 2007 to 2009.
    Thanks for being here.
        Dr. Andrew Rosenberg is the Director of the Center for
    Science and Democracy at the Union of Concerned Scientists.
    Before joining the Union of Concerned Scientists, he served as
    the Northeast Regional Administrator of the National Marine
    Fisheries Service (NMFS) at the National Oceanic and
    Atmospheric Administration (NOAA). Thanks again.
        Dr. Nancy Beck is a senior director of Regulatory and
    Science Policy at the American Chemistry Council (ACC). Prior
    to joining the ACC she served as a toxicologist and science
    policy analyst at the Office of Management and Budget (OMB's)
    Office of Information and Regulatory Affairs from 2002 to 2012.
        I do thank all of the witnesses for appearing.
        It is our custom, as a Subcommittee and as a committee, to
    swear in all witnesses, so if you would all please rise and
    raise your right hand.
        Do you swear the testimony you will give before this
    committee will be the truth, the whole truth, and nothing but
    the truth, so help you, God?
        Ms. Dudley. I do.
        Mr. Rosenberg. I do.
        Ms. Beck. I do.
        Senator Lankford. Thank you. You may be seated. Let the
    record reflect the witnesses have all answered in the
    affirmative.
        We do use a timing system here. That would be a 5-minute
    time clock that will start in front of you, countdown for your
    opening statements. Obviously all of your written statements
    will go into the permanent record already, and so we are
    welcome to be able to receive your oral testimony.
        Susan Dudley, you are up first.

      TESTIMONY OF SUSAN DUDLEY,\1\ DIRECTOR, REGULATORY STUDIES
                CENTER, THE GEORGE WASHINGTON UNIVERSITY

        Ms. Dudley. Thank you very much, Chairman Lankford, and it
    is good to meet you, Senator Hassan.
    ---------------------------------------------------------------------------
        \1\ The prepared statement of Ms. Dudley appears in the Appendix on
    page 38.
    ---------------------------------------------------------------------------
        Effective regulatory policy that focuses resources on
    addressing real threats to public health and the environment
    depends on reliable scientific information and transparent
    policy choices, so your hearing is important.
        I do not think anyone wants science to be politicized, but
    no one is immune to the temptation to put a spin on science to
    advance a policy goal. Politicization can arise when political
    decisionmakers attempt to distort scientific findings, but also
    when scientists and others attempt to exert influence on policy
    decisions by how they present scientific information.
        My prepared testimony focuses on the second type of
    politicization. It identifies two problems that current
    regulatory institutions tend to aggravate. The first is when
    scientists, intentionally or not, insert but do not disclose
    their own policy preferences in the scientific advice they
    provide decisionmakers. I have called this ``hidden policy
    judgments'' and others have called it ``advocacy science'' or
    ``normative science.'' The second problem is the tendency to
    camouflage controversial policy decisions as science. For this
    I adopt Wendy Wagner's colorful term, a ``science charade.''
        Institutional arrangements tend to aggravate both the
    hidden policy judgments and science charades, which threaten
    the credibility of science and harm regulatory policy. Many of
    those involved in regulatory decisions have incentives to hide
    policy preferences, such as how to deal with uncertainty
    inherent in assessments of risk, and to dismiss, and even
    denigrate dissenting views. Key policy choices, disguised as
    science, too often rest with technical staff, while
    policymakers are able to avoid responsibility by claiming that
    their hands were tied by the science.
        In thinking about reforms to improve how science is used in
    regulation, clarifying which aspects of the decision are
    matters of science and which are matters of policy is essential
    to avoid both hidden policy judgments and the science charade.
    This was a key finding of a 2009 Bipartisan Policy Center (BPC)
    report, as well as a 1983 National Research Council (NRC) book.
        In a forthcoming paper, Marcus Peacock and I offer 10
    recommendations. I boiled those down to eight in my written
    testimony, and will trim them down to five for the remaining
    few minutes that I have.
        First, we must recognize that science is a positive
    discipline that can inform, but not decide, appropriate policy.
    In drafting authorizing legislation, Congress should not
    delegate decisions to agencies on the pretense that science
    alone can make the normative decision of what policy ought to
    be.
        Second, science advisory panels can provide a necessary and
    valuable source of information and peer review for agencies,
    but greater efforts should be made to restrict their advice to
    matters of science and not ask them to recommend policy.
    Further, a 2012 Keystone Center report emphasized all potential
    panelists on those science advisory boards will have conscious
    and unconscious biases, so it is important to select panelists
    with diverse perspectives and expertise, who are willing to
    engage in open discussion and are open to considering other
    views.
        Third, risk assessments necessarily involve assumptions and
    judgments as well as pure scientific inputs, yet they often
    generate precise-sounding predictions that hide not only
    considerable uncertainty about actual risk but hidden
    judgments. Greater transparency regarding the assumptions and
    policy rationales for choosing one set of assumption or models
    over another would encourage more openness and constructive
    discussion about science and policy.
        Fourth, reproducibility is important and it requires
    sharing of underlying data. I understand and appreciate
    concerns about disclosure of personally identifiable
    information (PII) and confidential information, but many
    Federal agencies have successful guidelines allowing access to
    data containing PII, using tiered approaches commensurate with
    the sensitivity of the information.
        And finally, the scientific method depends on falsifiable
    hypotheses, data gathering, replication, dissent, and
    challenge--Reforms that intentionally engage rather than avoid
    competing views and that subject scientific predictions to ex-
    post evaluation would go a long way toward improving underlying
    science and the decisions that depend on it.
        Legislation both Senators Lankford and Heitkamp have
    introduced, could be constructive. One bill that you introduced
    just yesterday would require advanced notices of proposed
    rulemaking for high-impact regulations, and one that you
    introduced together last session, would have required agencies
    to plan for ex-post review when proposing new rules, and that
    provides that feedback.
        So I will close there, and thank you again for inviting me.
        Senator Lankford. Thank you. Dr. Rosenberg.

     TESTIMONY OF ANDREW A. ROSENBERG, PH.D.,\1\ DIRECTOR, CENTER
        FOR SCIENCE AND DEMOCRACY, UNION OF CONCERNED SCIENTISTS

        Mr. Rosenberg. Chairman Lankford, Senator Hassan, Members
    of the Subcommittee, and Ranking Member Heitkamp, thank you for
    the opportunity to testify today on the important role of
    science and rulemaking process.
    ---------------------------------------------------------------------------
        \1\ The prepared statement of Mr. Rosenberg appears in the Appendix
    on page 49.
    ---------------------------------------------------------------------------
        I am Andrew Rosenberg, Director of the Center for Science
    and Democracy at the Union of Concerned Scientists, and I have
    more than 25 years of experience as a scientist in government
    service, academia, and the private sector. I have served as a
    scientist and regulator in Democratic and Republican
    administrations, including as Deputy Director of NOAA
    Fisheries, as you noted. And in academia, I was the Dean of
    Life Sciences and Agriculture at the University of New
    Hampshire.
        Independent science plays a critical role in the policy
    decisions made by the Federal Government that impact Americans'
    health and safety, and the science process consists of
    continuous and incremental discoveries in multiple fields of
    study, accumulating a weight of evidence and building toward
    broad acceptance of facts within the scientific community.
        Weight of evidence refers to the cumulative body of
    scientific research and analysis that pertains to a particular
    subject. Weight refers not only to the number of studies but
    also their importance, robustness, and credibility in drawing
    scientific inference. Credibility relates to the design of the
    study, analytical methods, methods of inference, as well as
    provenance of the work with regard to potential conflicts of
    interest, peer reviews conducted, and comparisons with other
    relevant studies.
        A valid and credible scientific process consists of a
    rigorous examination of ideas, review and critique by
    technically qualified peers, open exchange of ideas among
    colleagues, and protection against manipulation of results by
    vested interests.
        I serve as a regular reviewer for scientific journals, as a
    member of editorial boards, and as an independent reviewer for
    national and international reports. In this capacity, I
    consider the framing of the study, the methods, the results,
    the researchers' interpretation in light of my knowledge of the
    field, and relevant scientific literature. I may not agree with
    the conclusions drawn by the researchers, but if the
    aforementioned components are well-executed then the study
    contributes to the body of evidence, in my view.
        Every study is subtly different and should be judged by
    experts in the field on its merits, and in my view, best
    available science is research that is conducted in accordance
    with well-established scientific practices, including well-
    designed investigation, logical statistically rigorous
    analyses, clear documentation of data collection and analytical
    methods, careful peer review of results free from external
    influences seeking a particular policy outcome.
        I strongly believe that this process cannot be legislated
    without undermining innovation and unduly constraining the
    scientific information available to policymakers and to the
    public. If one were to legislate what should legally be
    considered best available science, it would prevent the
    innovation and flexibility that is inherent in the scientific
    process. This ability to innovate is essential for agencies as
    they address new discoveries, such as emerging public health
    threats.
        Public access to science that underlies regulatory
    decisions is important as part of our democracy and to ensure
    the rationale for decisions is clear, even if all do not agree
    with the final policy outcomes. On this point it is important
    to distinguish between data and science. The scientific
    information critical for an informed public concerns how
    studies are conducted, how information is interpreted, and
    inferences are drawn. This is not dissimilar from the
    information a peer reviewer like me considers in evaluating a
    study, albeit for the public in a non-technical form. Peer
    reviewers, in general, do not review raw data.
        Agency rulemaking must be informed by independent science
    advice that is free from political pressure. Twenty-four
    Federal agencies have developed scientific integrity policies
    that help ensure the independence of scientific advice. There
    is now legislation in both House and Senate that would codify
    scientific integrity policies into law, which I view as a
    positive step for protecting science-informed policymaking.
    Strengthening peer review policies in several agencies further
    safeguards government science.
        Best available science should be used to describe the
    weight of scientific evidence developed by a credible process
    for ensuring independence from political influence. Agency
    scientists supported by a commitment to independent science,
    scientific integrity policies, and appropriate transparency
    measures should be trusted to provide science advice to
    decisionmakers, and I agree it is advice. All Americans benefit
    when science is used to inform policy, and its integrity in the
    rulemaking process is imperative for a functional democracy and
    a safer, cleaner planet for all.
        Thank you Mr. Chairman, Ranking Member, and Members of the
    Committee. I appreciate the opportunity.
        Senator Lankford. Dr. Beck.

    TESTIMONY OF NANCY BECK, PH.D.,\1\ SENIOR DIRECTOR, REGULATORY
              SCIENCE POLICY, AMERICAN CHEMISTRY COUNCIL.

        Ms. Beck. Good morning, Chairman Lankford, Ranking Member
    Heitkamp, Senator Hassan, and Senator Harris. I am honored to
    be here today representing the American Chemistry Council. My
    name is Nancy Beck and I have spent over 15 years working at
    the intersection of science and policy.
    ---------------------------------------------------------------------------
        \1\ The prepared statement of Ms. Beck appears in the Appendix on
    page 56.
    ---------------------------------------------------------------------------
        The business of chemistry is a critical component for
    manufacturing safe, high-quality products. ACC member companies
    and the public rely on science to innovate, to advance product
    stewardship, and to prove the assessments of chemical risk. ACC
    members expect high-quality science and objective assessment
    processes to underpin regulatory decisions.
        Reliance on high-quality science is critical to ensuring
    public trust. Regrettably, that trust is eroding. In July 2016,
    almost 200 toxicologists signed an appeal for the integrity in
    science. They were expressing concerns that precautionary
    regulations and policies are being presented as objective
    science, when, in fact, they are not. Dr. Rosenberg recently
    stated, ``When science is sidelined from policy decisions, we
    all lose.'' The American Chemistry Council shares these
    concerns.
        Improving agency science should not be as challenging as it
    has been. As you have mentioned, Senator Lankford, government
    and non-governmental guidance already exists. In 2002, Federal
    agencies were directed through OMB's information quality
    guidelines to ensure the quality, objectivity, utility, and
    integrity of information which they disseminate to the public.
        Unfortunately, while most agencies have committed to
    meeting these standards, some agencies' scientific analyses
    falls short. Some examples of this are provided in the
    testimony ACC has provided in writing. These shortfalls are
    despite Federal guidance on risk assessment and peer review,
    and further guidance from organizations like the National
    Academy of Sciences (NAS), the Keystone Center, and the
    Bipartisan Policy Center.
        The bipartisan Lautenberg Chemical Safety Act (LCSA) now
    mandates that EPA apply high-quality, reliable, and relevant
    scientific information by using best available science and a
    weight of the evidence approach. To date, EPA appears to imply
    that business as usual is consistent with these standards.
    Rather than explicitly incorporating the best available science
    and the weight of the evidence standards into the draft
    framework rules it is developing to implement the act, the
    agency has suggested that it can simply rely on existing
    approaches and current practices. This is of great concern to
    the ACC.
        The peer review report from EPA's most recently released
    draft risk evaluation notes that EPA did not apply a weight of
    the evidence approach, nor did it use a systematic review
    process, which is a critical part of conducting a weight of the
    evidence evaluation. EPA simply chose the value that would
    provide the lowest allowable exposure, without transparently
    documenting the quality of the individual studies they
    considered.
        The good news here is that there are many potential
    solutions to improve agency science, and I am going to present
    just four.
        One, improving and clarifying scientific definitions. The
    intent of the scientific standard is to improve existing agency
    practices. Agencies should provide clear and specific
    definitions for terms like best available science and weight of
    the evidence. These definitions should address not only what
    agencies should consider when evaluating information, but also
    what information agencies should present in the evaluations,
    forcing the agencies to show their work and present their
    thought process in a clear and transparent manner.
        Two, there must be stronger oversight to ensure that
    existing guidance is actually followed. Existing guidance
    documents could be converted into agency checklists and agency
    staff could self-certify that their evaluations are consistent
    with these checklists. These checklists could also be used by
    stakeholders and peer reviewers.
        Third, as was mentioned before, the importance of improving
    peer review practices cannot be underestimated. Ensuring that
    peer review panels have the depth and breadth necessary to
    address scientific concerns while also ensuring that conflicts
    and biases are addressed is critical.
        And fourth, the government can play an important role in
    changing the incentives for grant funding such that decisions
    are not so heavily dependent on finding positive results, and
    the government standards for funding should ensure that
    research studies follow best scientific practices and are
    designed with the regulatory use in mind.
        In conclusion, ensuring that Federal decisionmaking is
    firmly based on the use of high-quality science can be achieved
    through common-sense reforms that will lead to a more efficient
    and effective regulatory process. ACC looks forward to working
    with Members of the Committee to enhance approaches to ensure
    that high-quality science is the foundation of regulatory
    decisionmaking.
        Thank you.
        Senator Lankford. Thank you. Before we move into our time
    of questions, as is our tradition on this committee, the
    Ranking Member and I will defer our questions at the end.
        Before we move to Senator Hassan, I want to recognize
    Senator Heitkamp for her opening statement.

                 OPENING STATEMENT OF SENATOR HEITKAMP

        Senator Heitkamp. Just a quick apology to our panel. I had
    a markup in the Banking Committee where a bill of mine was
    being considered, and I wanted to make sure it got across the
    finish line. So I had a chance to review your testimony and
    really appreciate your attendance, and I ask that the Chairman
    include my opening comments for the record.\1\
    ---------------------------------------------------------------------------
        \1\ The prepared statement of Senator Heitkamp appears in the
    Appendix on page 37.
    ---------------------------------------------------------------------------
        Senator Lankford. Absolutely. Without objection. So did you
    get your bill across the finish line?
        Senator Heitkamp. Well, I got it out of committee.
        Senator Lankford. OK. Out of the gate is a start.
    [Laughter.]
        So that is great.
        Senator Hassan, you are recognized.

                  OPENING STATEMENT OF SENATOR HASSAN

        Senator Hassan. Well, thank you, Mr. Chairman, and Ranking
    Member Heitkamp, and welcome to all of the witnesses today.
    Thank you all for being here.
        I wanted to start, Dr. Rosenberg, with a question to you.
    In your testimony you talk about the scientific community's
    view of what constitutes best available science, and you also
    state that generally accepted standards cannot clearly be
    legislated without jeopardizing the kind of scientific
    innovation that leads to some of our most important findings
    and discoveries.
        So I would ask you to take just a minute or so to elaborate
    a little bit more on what you see as the problem with
    legislating what should be considered the best available
    science.
        Mr. Rosenberg. Thank you, Senator. I think this is a really
    crucial point, of course, for the hearing, but in general as we
    think about the processes of bringing science into rulemaking.
        If you legislate best available science, I believe, from
    being an agency scientist and regulator, that is exactly what
    agencies will do and they will not deviate. And so even if
    there is clearly a better approach, even if there is new
    science that should be brought into the mix, agencies will say,
    ``My mandate is to do it this way. I will do it that way until
    the mandate changes.''
        I know that there is some rhetoric that agencies do things
    differently from their mandates. From my experience, you spend
    an awful lot of time saying, ``OK, what is the law telling us
    we need to do? '' and you really do not have very much time to
    do other things. If that guidance is given in statute for best
    available science, it will become very rigid in agency
    practice, and the danger there is that, science does actually
    evolve, quite dramatically sometimes. You want people to be
    able to include new information, new types of data collection
    that lead to new inference in their results and bring that to
    bear on the best policies for the Nation.
        Senator Hassan. Thank you. Another question for you, Dr.
    Rosenberg. You highlighted the significance of understanding
    scientific uncertainties, but also the importance of acting
    once the weight of evidence is compelling enough to justify a
    reasonable policy solution. For example, while there may be a
    degree of uncertainty as to some aspects of climate change,
    there is widespread agreement that global climate change caused
    by human activities is occurring now and it is a growing threat
    to society, and as somebody whose home in New Hampshire just
    ran out of power because of sudden extreme winds this morning,
    like many Americans I am acutely aware of this growing sense of
    extreme weather.
        So why does science have uncertainty, why is it OK for
    scientific uncertainty to exist, and how does uncertainty play
    into the decisionmaking process.
        Mr. Rosenberg. Well, again, thank you for the question.
    Uncertainty exists not only in science, of course, but
    unfortunately in life, but certainly scientific evidence will
    always have some degree of uncertainty. I think the importance
    is to characterize that uncertainty but think of it in terms
    of, from a policy perspective, then, what risks are we
    incurring?
        And so uncertainty comes in many forms. As a scientist you
    think about uncertainty in really four different ways. You
    think about measurement error, which is your ability to
    actually measure what is happening in the world; process error,
    which is your understanding of the processes by which things
    move forward; implementation error, your ability if you
    implement something to actually do it accurately; and model
    error, your ability to characterize a process in a model which
    is inherently going to leave some aspects out.
        Well, that is helpful for scientists to think about those
    types of uncertainty and they mean something different, but to
    a broader public, and usually to policymakers, uncertainty
    means you do not really know. It does not necessarily mean
    that. I mean, all of those types of uncertainty are different.
        So if you go back to your climate change example, I would
    say it is not so much that there is a level of agreement among
    scientists as there is a very large weight of evidence, and if
    you look at that weight of evidence, it is quite compelling,
    any possible way you look at it. And sure, there may be people
    who say, ``Well, I can identify one piece of evidence that does
    not seem to fit,'' but the weight of evidence is entirely
    clear.
        Now you, as policymakers, are responsible for deciding how
    much risk we should take. That is not a science decision. I
    agree with Professor Dudley on that. We can say if you tell us
    something about risks that you believe society should incur,
    how the uncertainty that we have relates to those risks. Most
    people would say, if, in fact, climate is changing as rapidly
    as the evidence indicates, that the risks to many aspects of
    society are very high, so, therefore, you might want to take
    action with more uncertainty than, say, you would take in
    crossing the street.
        Senator Hassan. Right. Well, thank you, and that leads me
    to a question for the whole panel, a general one, and I have a
    little over a minute left. So I want to follow up on that,
    because Dr. Rosenberg just described the balance between
    uncertainty and risk to public. In New Hampshire, as you all
    know, like in many other States, we have a heroin and opioid
    epidemic that is devastating and it is a critical public health
    threat. And the threat, the scale of it is stunning, it is
    unprecedented, and we have been really working hard to get in
    place the prevention, treatment, recovery, and public safety
    measures needed to support those on the front lines of this
    epidemic.
        But sometimes those interventions and methods we are using
    are newer, and while we have evidence supporting our policies,
    we do not always have the kind of 100 percent certainty that we
    would like to have to approach this public health epidemic.
        So the real question is, does scientific uncertainty about
    something mean we should not take action at all when the risk
    is high, and what dangers do you think legislating a definition
    of best available science could pose to responding to this type
    of urgent crisis? Because I have only got like 10 seconds left,
    Dr. Dudley, I will start with you and then I will ask the
    others to submit a written answer to that.
        Ms. Dudley. Very briefly, no. Uncertainty does not mean act
    or do not act, but I agree with Dr. Rosenberg--it is a policy
    question. So scientists can tell you, ``Here is the
    uncertainty. Here is why we have this uncertainty,'' and it is
    policy officials' responsibility to say, ``Here is what action
    I would like to take,'' knowing that uncertainty.
        Senator Hassan. Thank you.
        Senator Lankford. Senator Harris.

                  OPENING STATEMENT OF SENATOR HARRIS

        Senator Harris. Thank you. Thank you all for your work. I
    have to tell you my mother was a scientist, an endocrinologist,
    and, in fact, one of my first jobs ever was cleaning pipettes.
    I was awful. She fired me. [Laughter.]
        But I do appreciate your work and the importance of the
    work, and particularly the importance of politics not playing
    into your mission and the very important role you play in
    advancing us, in terms of human health and also what we need to
    do in terms of really thinking about what we can do in terms of
    being innovative as a country.
        So, Dr. Rosenberg, I have a question for you. This morning
    on CNBC, EPA Administrator Scott Pruitt stated that carbon
    dioxide is not a primary contributor to global warming. He
    said, and I quote, ``I think that measuring with precision
    human activity on the climate is something very challenging to
    do, and there is tremendous disagreement about the degree of
    impact, so no, I would not agree that it is a primary
    contributor to global warming that we see.'' And then he went
    on to say, ``We need to continue the debate and continue to
    review and continue our analysis.''
        Separately, according to an article in the New Republic on
    March 7, the EPA's Office of Science and Technology, which has
    historically been in charge, of developing clean water
    standards for the States, had on its website that their
    standards were guided by science. Since January 30 of this
    year, the reference on their website to science-based standards
    has disappeared.
        So my question to you is that we are obviously talking a
    lot here, in this hearing, about sound science policy, yet one
    of the most important agencies that should consider science has
    removed the reference to science from their website. So can you
    talk a little bit about what you believe the role of science
    will play in the EPA and any other Federal agencies, and your
    concerns, if the importance and significance of science is
    diminished?
        Mr. Rosenberg. Thank you, Senator, for the question. I was
    not good at cleaning pipettes either, so I became a fisheries
    scientist instead of a Senator, I guess. [Laughter.]
        The statements that you read are very concerning. I can
    only tell you what I believe the role of science should be.
    Clearly, the weight of evidence as--in my response to Senator
    Hassan--on not only the occurrence of global warming but also
    the human role in global warming, is very strong. In fact, it
    has been looked at by multiple studies, multiple investigators.
    All of the data sets indicate that you cannot really explain
    the data without attribution to greenhouse gas emissions,
    including CO2, but not restricted to CO2.
        So it is very concerning to say that he does not believe
    that CO2 is a primary contributor, and equally, that the
    uncertainty is so high that we cannot act, and I think this
    goes back to Senator Hassan's question directly. Whether it be
    an opioid crisis, global warming, or many other issues, you
    really have to think about what is the risk. So it seems to me
    that the uncertainty is relatively low about whether global
    warming is occurring. There certainly is higher uncertainty
    about localized effects, but the risk of not taking action is
    quite high, and there are elements of understanding that risk
    that come from the science.
        For an agency like the EPA, which is fundamentally focused
    on public health and safety protections, which are largely
    identified by scientific work, to, in any way, diminish the
    role of science in the agency is extremely concerning because
    it is public health and safety, and that is what they were set
    up by Congress to do, and those are fundamentally science and
    technical questions. How you address them, of course, is both a
    policy decision for you and for the Administration, depending
    on which policies we are talking about, but I hope we would all
    agree that without a very strong science basis and recognition
    of that science, then we would be in serious trouble with
    regard to public health and safety across the country.
        I was asked what I make of the change in the website for
    the EPA Office of Science. I was very concerned about it
    because it referenced economically viable solutions as opposed
    to public health, and that certainly worries me. In my
    experience as a regulator, there is an awful lot of discussion
    about what is economically viable for whom, which part of an
    industry and which part of the public, and so on, but public
    health threats need to be front and center and predominant, and
    that is a science and technical exercise, by and large.
        Senator Harris. And so we have a lot of students in the
    hearing room, which always makes us happy. Can you explain to
    me and them, and the Committee, what you believe this might
    means in terms of the next couple of years, and what the
    diminishing of science has the potential to do, in terms of
    policy for the next couple of years, and any long-term impact
    as it relates to the health and well-being of our citizens?
        Mr. Rosenberg. Well, first of all, again, I hope that the
    EPA continues to do what they have done for the Nation since it
    was created, and that is continue to protect public health and
    safety. And sure, I understand that people can criticize from
    different perspective, but fundamentally we should realize
    where we have come over the last 40 to 50 years, in terms of
    public health and safety. I live in the Boston area. Look at
    Boston Harbor or the Charles River or the air in Los Angeles,
    or whatever you would like, to decide whether that is
    important. So I hope the agency refocuses on using science and
    technical information.
        I believe that there are many actions that have been
    proposed or called out or mentioned by Administrator Pruitt and
    others in the Administration that would dramatically slow the
    ability to address public health and safety concerns, and I
    think that that is truly problematic, because while we have
    come a long way in 40 years, there certainly are many issues
    that continue to arise. So I hope students are thinking, first
    of all, it is really important to be involved in science and
    technology, and I have quoted you a number of times, Senator
    Hassan, from when we met, that, everyone here agrees that
    Science, Technology, Engineering and Math (STEM) education is
    really important. I hope we listen to the STEM-educated.
        And so I hope the students here think about STEM education,
    and also are thinking fundamentally about what history has
    shown us about public health and safety changes in the country.
    They may not remember L.A. when you could not drive down the
    streets, but it did occur, and we have learned a lot from the
    history of agencies like the EPA, and we cannot let up now.
        Senator Harris. Thank you. And, Mr. Chairman, I have asked
    unanimous consent that the article be entered into the
    record.\1\
    ---------------------------------------------------------------------------
        \1\ The article referenced by Senator Harris appears in the
    Appendix on page 74.
    ---------------------------------------------------------------------------
        Senator Lankford. Without objection.
        Senator Harris. Thank you.
        Senator Lankford. Before I recognize Ranking Member
    Heitkamp, I would encourage dialogue with us. We have a bill
    dealing with sound science, and it is not a partisan bill. That
    is everything, and for everyone, for either side of this. And
    so I would appreciate just the dialogue on that ongoing.
        So, Senator Heitkamp.
        Senator Heitkamp. Thank you, Mr. Chairman, and thank you to
    all of the students here. I know this seems like it might be
    really boring, and not consistent with some fireworks that you
    see in other committee hearings, but I think that this
    discussion is so important to the future of our country. How do
    we take fact-based analysis, science-based analysis? And you
    will never separate facts from judgment.
        So we are going to have different judgments about different
    facts, and we are going to have to analyze those. But the
    problem is that frequently people have different sets of facts,
    and different visions of science, some of which you heard
    today. The challenge that we have right now regarding CO2--we
    can have this discussion, but frequently, on things like that,
    the world moves around us. Right? The Chief Executive Officers
    (CEOs) of major Fortune 500 companies move around us, and say,
    in their judgment, they have looked at it, they need to do
    things differently in their own contexts. The public moves
    around us.
        And that is always the challenge we have with science,
    because frequently, in Washington, D.C., it is politicized. We
    just have to put that out there, that science is in the eyes of
    the beholder, what is, in fact, scientific fact. And one of the
    things that I resist that we are doing a little bit today is we
    are just looking at one area, whether it is climate or whether
    it is, in fact, the EPA.
        This discussion goes beyond that, and I want to engage
    first with Ms. Dudley, because we have had long conversations
    about the application of fact-based analysis to rulemaking, and
    there is a challenge here because people look at rulemaking, or
    these challenges, through the lens of what they believe to be
    fact.
        I want to just give you an example. Recently--this is
    actually true--a basketball player suggested that the world was
    flat. That was in a tweet. I do not know if you saw it. And the
    response that someone gave was, ``Well, we should respect his
    opinion.'' And I'm thinking, maybe not, because I thought
    Galileo dealt with this and was imprisoned. The Earth goes
    around the Sun. The Earth is not flat.
        But yet there seems to be an acceptance in this country for
    a wide variety of reasons which say let's respect this. And so
    there is a widespread kind of narrowing of the lanes. You can
    have a difference of opinion within a narrow lane, but we
    cannot be swimming outside the lanes so that we accept or have
    a reasonable dialogue about the Earth being flat. I am just
    sorry. I am not going to do it.
        And so the reason why I raised that is, can we, in fact,
    legislate that lane in a way that really gets us back to using
    science, but also recognizes that judgment comes with science?
    And I would like to start with Susan.
        Ms. Dudley. I think that is a great way to look at it.
    There are some things that clearly we know, based on science.
    The world is not flat. There are other things where there is
    more uncertainty. As Dr. Rosenberg said, there is a lot of
    uncertainty. It is inherent in everything, not just science but
    in everything. And being able to differentiate what is pure
    science, what is pure policy, and what is in that trans-science
    area in the middle that we need to translate from pure science
    to policy, that is the trickiest thing. And if we can be more
    explicit about that, if scientists can say, ``Here is where the
    science ends and here is the uncertainty around it,'' if we
    could be more explicit about that, I think we would solve a lot
    of the problems that you are talking about, where we are
    arguing about science when we really are not.
        I will just quote briefly from The Bipartisan Policy
    Center. They had a report in 2009, on improving use of science
    in regulatory policy, and they concluded that ``a tendency to
    frame regulatory issues as debates solely about science,
    regardless of the actual subject in dispute, is at the root of
    the stalemate and acrimony all too present in the regulatory
    system.''
        Senator Heitkamp. Yes. Dr. Rosenberg.
        Mr. Rosenberg. So I agree. I mean, this is an absolutely
    critical point. I believe, certainly, in the process of
    policymaking we should give different people their due, based
    on expertise. I certainly have an opinion on pretty much
    everything, my wife will tell you.
        Senator Heitkamp. And you would agree with me, the world is
    not flat. [Laughter.]
        Mr. Rosenberg. I am quite certain that the evidence is
    overwhelming.
        Senator Lankford. Have you ever been to western Oklahoma?
    [Laughter.]
        Mr. Rosenberg. No, sir.
        Senator Heitkamp. Or the Red River Valley in North Dakotas.
        Mr. Rosenberg. So I recognize there is some uncertainty----
    [Laughter.]
        But I actually think that the scientific evidence and the
    inference that you draw from that evidence, and call science,
    should be done by people who are working through a scientific
    process, and, in fact, are scientists.
        By the same token, I certainly agree with Susan, that,
    everyone has an opinion and we need to try to be careful so
    that for me as a scientist to offer my opinion about, a policy
    matter and I am couching it clearly as this is my opinion about
    the policy matter, not that it is my science that dictates a
    particular policy matter. And so I often am in training for
    young scientists and students who will say it is important to
    distinguish--here is the evidence and here is what I think it
    means, in light of the body of scientific knowledge. Now if I
    want to say, ``Here is what I think you ought to do about it,
    Senator,'' that needs to be clearly separated.
        The difficulty in the current debate, of course, is that
    you have all kinds of people saying, ``Well, the science says
    this.'' ``No, it says that.'' Most of them seem to be non-
    scientists or observers, and I think they should offer their
    opinion, whether the world is flat or not, but I think we
    should weight it and not consider it scientific evidence. That
    is why I continually refer to the scientific process in my
    testimony.
        And I do not think that science is the sole deciding factor
    for most policies. It never is. You have an incredibly
    difficult job of making those societal choices. Those societal
    choices that you deal with every day are not a scientific
    decision. They are not part of the science process. All we can
    do is try to inform you of what the threats are, problems are,
    the opportunities, and certainly the consequences of certain
    decisions, based on the evidence that we have collected or have
    in hand.
        Senator Heitkamp. Well, let us talk to Dr. Beck.
        Ms. Beck. Yes. It is a great question. To me, it comes down
    to transparency. I do not want you to trust me because I am a
    scientist. I want you to trust me because you have looked at my
    analysis, and you have been able to evaluate, if it rigorous,
    did it follow the scientific method, did anyone peer-review it?
    Right? If we can be transparent about the quality of the
    science and the uncertainties that come along with the science,
    then we can have a real dialogue about what the policy should
    be.
        So, to me, the solution is in clarity in transparency and
    the strength of the science.
        Senator Heitkamp. Yes. I mean, I just think it is a big
    circle, and, there is consensus that this is the unknown in the
    middle. These are the variables in the middle. But there are
    scientific facts that do, in fact, establish and are widely
    accepted, in spite of what some person may say. Unfortunately,
    too often, we argue--let us take climate. For so many people,
    climate is not in the center. Climate is on the outside. This
    is known. And, in part, because I think it got politicized
    before there was ever an evaluation of the science. You see
    what I am saying? Because the public, and, I think, opinion-
    makers did not come to consensus on the science or on the
    variables before there was a lot of discussion about policy
    initiatives.
        And so it becomes a political issue as opposed to a
    scientific issue, and that is the challenge that we have, which
    is when does it cross the Rubicon? Can we achieve some kind of
    analysis? And Senator Lankford and I are struggling with this.
    How do we respect other opinions but also narrow the focus of
    what we consider scientific proof or sound science?
        And so with that, that is more rhetorical than anything
    else. I will allow Senator Daines to have a moment here.
        Senator Lankford. Yes. I recognize Senator Daines.

                  OPENING STATEMENT OF SENATOR DAINES

        Senator Daines. It has been a great discussion. Thank you,
    Mr. Chairman and Ranking Member Heitkamp.
        I just would submit, for the record, that Exhibit A and B
    for the flat Earth thought would be probably in North Dakota
    and Oklahoma---- [Laughter.]
        And I will bring the contrarian opinion here, being from
    the Rockies of Montana.
        Well, thank you for testifying before the Committee today.
    I guess if you want to have a fun fact this morning, I am the
    only chemical engineer that serves in Congress, out of 535 of
    us here on the Hill. There are several engineers. I get to hold
    down the chemical engineering caucus of one. So I truly have a
    fundamental appreciation for the proper role of science in the
    Federal rulemaking process, because it should, above all, be
    objective, meaning two things above all. One, data should be
    able to stand up to public scrutiny, and, two, it can be
    replicable.
        When I worked at Procter and Gamble--I spent 28 years in
    the private sector before I came here to this new day job,
    where I wear a tie every day--our company used science to meet
    the needs of the mass consumer market, ultimately studying the
    needs of our consumers and rigorously developing a solution to
    meet that need. That is what made our business successful. It
    was the best type of sound and objective peer review you could
    ask for.
        As Ms. Dudley mentioned in her testimony, science can only
    tell us what is but not what ought to be, and for that the
    rulemaking process requires human judgment, which has run amok,
    in my opinion, as regulators continue to conflate science with
    their own personal judgments.
        I know the issue of climate came up. I will give you an
    example of that. I was in a hearing last year where we had Gina
    McCarthy, the Director of the EPA, come and testify. We were
    talking about the Clean Power Plan. And the Clean Power Plan,
    those regulations were going to affect the State of Montana
    more than any other State in the United States. It was going to
    have a devastating effect on our jobs--studies done by the
    University of Montana--our jobs, tax revenues, economic
    activity, double the increases in utility rates.
        So I asked Gina, I said, ``Cato ran the regulations through
    an algorithm called Magic, where you take the regulation, it
    then determines what the projected reduction in CO2 would be,
    and then projects what the impact would be on global
    temperature, which ultimately these regulations were means to
    an end, in terms of trying to reduce CO2 and reduce the impact
    on temperature.
        And when Cato ran those numbers, the answer came back, 0.02
    degrees centigrade, which is negligible. It is a rounding
    error. And I challenged Gina on that. I said, ``Gina, I
    understand what we want to do with these regulations and we can
    quantify the impact on people. We can also quantify the impact
    on the science on climate.'' And I was hoping she would refute
    my data, and tell me why I was wrong and why she had other
    studies.
        But in this limited peer review I had, from one senator to
    an EPA director, she did not refute the data. In fact, she
    said, ``We need to do this because it is almost a moral
    obligation to show the world, and show China, and India, and
    other places, how we are leading in that effort,'' to which I
    responded, pragmatically, ``Well, if you we cede the leadership
    of technology for coal-fired plants to the Chinese and to
    India, we will not have a better outcome. We will have a worse
    outcome, environmentally speaking, because we do a better job
    in the United States of protecting our environment, and sure,
    we could develop clean coal technology, innovate it, and affect
    the entire world.''
        So I think this is an example, again, where we need to get
    into the science and not be afraid to debate the science,
    debate the facts and the figures here, to ensure that we have
    appropriate regulations and outcomes.
        Ms. Dudley, in your written testimony, you mentioned that
    Congress too often cedes power to regulators, allowing them to
    set policy objectives. An example you offered was the
    difference between the Clean Air Act and the Safe Drinking
    Water Act (SDWA), and how Congress required agencies to
    consider economic costs in the Safe Drinking Water Act.
        So my question is, would you say that agencies are
    currently compliant with statutory guardrails like requirements
    to consider economic costs and benefits?
        Ms. Dudley. Every President, going all of the way back to
    Carter, but more explicitly Reagan and Clinton, set in place
    standards that required agencies to look at the benefits and
    the costs of new regulations, and try to maximize the net
    benefits--get more benefits than cost, whenever possible. But
    it is subject to statutory constraints. The Safe Drinking Water
    Act is explicit and says you should look at the benefits and
    costs. The Clean Air Act, especially the ambient air quality
    standards, is not. In fact, it has been interpreted as saying
    that you cannot consider the costs of achieving the standard.
        This gets back to what I was saying to you, Senator,
    Heitkamp, regarding the blurring of the lines. In the Clean Air
    Act we pretend that we are making our decision purely based on
    public health, because we are not allowed to consider costs.
    But nobody really thinks that is true because we do not set the
    standards at zero. In the Safe Drinking Water Act, there is
    much less acrimony, much less argument over whether the science
    is biased or not, because we can be clear, here is what the
    science says; now let us do some tradeoffs in setting the
    policy. And I think, to the extent statutes can look more like
    the Safe Drinking Water Act, that allow us to be honest about
    where the science ends and where the policymaking begins, that
    would improve the analysis and also the decisions.
        Senator Daines. Yes. If Congress were to have established
    these economic guardrails for agencies over past Congresses, do
    you have any estimate of how much cost it would have saved the
    economy, or how many jobs, perhaps, would have been created?
        Ms. Dudley. There are just so few good estimates of the
    real impacts of regulation, either benefits or costs, but I
    could just give you an example. An EPA rule--not the Clean
    Power Plan but another rule that affected electric utilities,
    the Mercury and Air Toxics Rule--the Supreme Court sent that
    back to EPA because that statute set standards that are
    appropriate.
        Senator Daines. Yes.
        Ms. Dudley. And the Court said, ``It's not appropriate to
    have $9 billion in costs to achieve hundreds of thousands of
    dollars in risk reduction.'' So, in that case, the Supreme
    Court said, when the statutory language says appropriate, it
    does mean this balancing of benefits and costs.
        Senator Daines. Yes.
        Ms. Dudley. But yes, if Congress were more explicit, I
    think that $9 billion you would have been able to save.
        Senator Daines. Yes. That is a pretty good number. Well,
    and I think you mentioned the Clean Power Plan. Certainly a
    little over a year ago the Supreme Court intervened, as well,
    on that.
        I want to talk about the redacting PII. I think that came
    up for public access.
        Oh, I am out of time, I see, Mr. Chairman. Are you OK?
        Senator Lankford. I will ask for unanimous consent to give
    you 12 more seconds. [Laughter.]
        That is fine.
        Senator Daines. I am having so much fun here, I am looking
    at----
        Senator Lankford. It is all right. Go ahead.
        Senator Daines [continuing]. The red light was on here,
    Senator.
        Regarding redacting PII for public access, Mr. Rosenberg
    spoke in his testimony that the public should not have access
    to scientific information used for regulations in order to
    maintain confidentiality. We do not use reams of paper anymore.
    We do use Excel and other forms. Dr. Beck, cannot sensitive
    information be redacted, since most data is electronic?
        Ms. Beck. Yes. I think sensitive information can be
    redacted, as well as protecting confidential business
    information, trade secret information. There are ways to share
    the data without sharing these important details.
        Senator Daines. So it seems that researchers, can data
    mine, they can slice-and-dice numbers to perhaps draw their
    preferred conclusions. And back to that important point of peer
    review and scrutiny, do you believe there is wisdom in numbers
    on this one, and public scrutiny of scientific information
    could perhaps foster better regulatory rules and outcomes?
        Ms. Beck. Reproducibility, to me, is critical. Right? So
    often times you need the underlying data to actually reproduce
    the analysis. We have had situations at the American Chemistry
    Council where we did not understand an analysis that was
    presented by EPA, and at first we worked with the journal
    researchers, to try to get that data. We worked with the agency
    to try to get that data. Eventually--and this took years--we
    were able to get the data through a data transfer agreement
    with the National Institutes of Health (NIH), and they
    protected whatever information needed to be protected, and we
    were able to conduct a re-analysis of that data. And that re-
    analysis came out differently than the agency's analysis, so
    now we can actually have that important scientific dialogue to
    understand the data. So I think that access to information is
    really important.
        Senator Daines. Thank you.
        Senator Lankford. Thank you. So this whole conversation is
    the challenge that we have back and forth between, we want to
    get good information, whether it is science, or whether it is
    facts, or research, or whatever it may be, in any area, because
    the policymakers need that, and the agencies need that. So the
    conversation today is really all about how do we get that
    balance between getting good science, but understanding we are
    not asking the scientists to be the policymakers, and in a
    strange way, we ask the Federal Bureau of Investigation (FBI)
    to go research, to go get everything together, and then they
    give all of their information to the Department of Justice
    (DOJ), and the Department of Justice determines whether to
    prosecute. The two are kept separate, so you do not have the
    people doing all of the research and all of the gathering of
    information also making the final decision.
        In a strange way, science and policymakers are the same
    way. We ask folks in science, ``Do the research. Get the
    information.'' But we have to make some final decisions on this
    on how to be able to balance it, but we want to make sure that
    is done in the same in the agencies. So the challenge is, how
    do we pull this together?
        Professor Dudley, you made a comment that I would like to
    be able to highlight more. You did not talk about it much,
    during your oral testimony, but you did in your written
    testimony--about risk assessments, and getting multiple options
    and opportunities, knowing that science does not always agree
    on some things. So giving kind of a larger window view of that.
    Can you go into a little more depth on that?
        Ms. Dudley. Yes. I think that would be very important, and
    because the model----
        Senator Lankford. Describe what you mean by the risk
    assessments, and then take us through it.
        Not everyone in the room has read your written statement.
        Ms. Dudley. Well, you are missing something. [Laughter.]
        In developing, especially environmental and public health
    regulations, we go through a process where agencies assess the
    risk and then they try to manage the risk. And back in 1983,
    the National Academy of Sciences said, conceptually, we should
    think of those as two separate things-the risk assessment
    process and the risk management process, because the risk
    management process takes other factors into account--the
    economics, law, what other regulations are in effect, political
    goals--whereas the risk assessment is the scientific inputs.
    Again, risk assessment tells us what ``is'' versus what
    ``should be.''
        But I think we have all talked about this. It is important
    to recognize that even in that risk assessment phase, it is not
    as straightforward as ``the Earth is flat or not.'' There is a
    lot of uncertainty. There are different models that predict
    different things, different data available, different
    assumptions used to apply those data to the situation that we
    are concerned about. And that is where a lot of these hidden
    policy judgments can get hidden.
        So one of my recommendations--and this is not my
    recommendation but it comes from other people in this field--is
    that it would be better if the scientists were to lay out,
    using this set of assumptions, we get this number, a different
    set of assumptions provides different numbers. Lay that out,
    and then the policymaker can look at those different estimates,
    and that is the policymaker's job. I mean, it is your job. It
    is the head of EPA's job. Knowing this is a range of estimates,
    what is the right policy?
        Senator Lankford. You have worked with us before, at OIRA,
    and you are familiar with the process. What would that look
    like, as far as an executive action or a codification or--how
    would you consider something like that fitting into how we do
    our government?
        Ms. Dudley. That is a great question. It is so much harder
    to put it into a statute.
        Senator Lankford. Correct.
        Ms. Dudley. So in 2007, we issued--I forget what it was
    called--the Office of Science and Technology Policy and OIRA
    issued a joint paper that Ms. Beck was very involved in, on
    risk analysis in general. Not just the regulatory process. And
    that laid out some things that really had been based on a set
    of guidelines issued in the Clinton Administration. Those have
    withstood the test of time. I wonder whether that would be
    something that might be worth fleshing out a little bit more.
        Senator Lankford. OK. That is interesting to be able to
    note.
        Dr. Rosenberg, you have mentioned a couple of times that
    you feel like it will especially squash science and innovation
    if best available science is codified at some point. So I want
    to delve into that a little bit more, of the why, because as I
    read through it, my competitive nature says if it is the best
    available science and it is new science coming up, it would
    drive them to be able to show the validity of it, multiple
    locations to be able to see how it has been used, and to show
    this science, this technique, this modeling is better than that
    modeling, and to be able to push them toward that.
        You seem to imply that if we do best available science that
    will actually push all innovation out and only old science,
    that has been well-tested and has, as you have mentioned,
    weight of evidence from being used over and over again, will be
    the one that is used. How do we hit a balance on that, because
    this is not theory anymore? This is already being codified by
    Congress. It is in the Toxic Substances Control Act (TSCA) Bill
    already, of a standard for best available science. It has been
    in Executive Orders (EO) for a very long time.
        Mr. Rosenberg. Thank you, Mr. Chairman. I think in TSCA and
    in other bills, there is some description of process, but if
    you codify, and, particularly, then becomes judicially
    reviewable, then people will retreat back to what is the most
    cautious interpretation in many cases. That is what I believe
    agencies will do. They will be careful about the information
    that they consider as part of that weight of evidence, and that
    means that you would be less willing to consider new
    information or information coming from other sources that might
    be critically important.
        I believe that you can certainly, through your oversight
    responsibilities, hold agencies to account that they have used
    a very effective process. My concern is, in legislation, then
    it becomes a much more rigid vehicle. So it is not that I do
    not think that there is no such thing as best available
    science. I described what I think the hallmarks of best
    available science are in my testimony.
        I do not think it is as rigid, and if I can refer to
    Professor Dudley's comments on risk assessment, as there is a
    good example. The view of how you do risk assessment in
    different fields has, in many cases, changed through time. You
    could legislate exactly how you should perform a risk
    assessment, including how do you paramaterize the models, if
    you like. Now you are getting down deeply into how do you
    actually conduct the science.
        On the other hand, there may be much better ways to
    approach that problem that emerge next year, the year after, or
    in a different field, and you want to make sure that people are
    able to do that and not say, ``That is not how we do it.''
        In TSCA, it seems to me, and you are obviously an expert on
    TSCA, but there is an opportunity to use a structured system,
    but it does not apply across many other fields. Even the term
    ``replicable'' or ``reproducible''--what does that mean to me
    as a scientist who does field studies on marine biology?
        Senator Lankford. You have to wait for that same fish to
    swim by again, in the same spot. [Laughter.]
        Mr. Rosenberg. Yes. I would ask the fisherman to catch him
    again.
        Senator Lankford. Yes. We need to know--and I think the
    oversight portion of this feeds into what you just mentioned,
    that when people are looking at it, it is not just closest
    science, or the sciences in the cubicle next to you that was
    most convenient for the agency----
        Mr. Rosenberg. Absolutely.
        Senator Lankford [continuing]. Or it is someone that I
    graduated with, but there is an actual opening up to say, let
    us ask the broader question. Let us ask the entire science
    community. And going back to your comments earlier, about peer
    review--it seemed like you were very engaged in the issue of
    oversight on peer review process--to be able to ask the broader
    question, for us, as policymakers, to say, have we looked at a
    broader group of science? And just because you used them last
    year does not mean that this is the best available science this
    year. It could be someone besides your brother-in-law that has
    the best available science this year. Let us open this up.
        Mr. Rosenberg. I entirely agree that the mechanisms for
    ensuring that the science is not only best available but--and
    is independent, are critically important, and those are peer
    review, disclosure of conflicts of interest, ensuring that you
    are bringing in information from other fields, all of those
    things, that are done in understanding that all of this science
    is scrutinized through a public process as well.
        Senator Lankford. That is the ultimate peer review.
        Mr. Rosenberg. There are many aspects of peer review that
    occur in a regulatory process.
        Senator Lankford. But the question is, when you are going
    for best available science--and I am going to go to Senator
    Carper here in just a moment--but when you are going at best
    available science, our goal of that, and what I hope we can do,
    and what I hope we did in TSCA--TSCA was so well-received it
    was voice-voted here in the Senate, as putting in statute, for
    the first time, something that has been in executive action for
    a long time, to say let us look at how do we open this up to as
    many people in the science community as we can, and ask the
    EPA, in this setting, to be able to look specifically at who
    you have used, but is that the best method to use, and go
    research that out, and go ask the real questions of it, and
    then to be able to put that in that language, and also, as you
    have talked about before, the weight of evidence, which we will
    come back and talk about in a moment again. That becomes
    extremely important.
        What we are trying to figure out is, if this works in TSCA,
    does it work in other instances, to ask for the data, to ask
    for the method, to ask for the model, to do the transparency,
    to do, as you have just mentioned, for the public to be able to
    look at it and do the ultimate peer review, and to be able to
    evaluate and ask the hard questions that need to be asked, and
    know it is going to stand up, that the scientists are willing
    to be able to say, ``This is good science. We put our science
    out. Policymakers made their decisions based on that,'' but at
    the end of the day, people can look and review the science. And
    so if you disagree with a policymaker, you can also go back and
    ask them, ``Where did you get this thought to come from?'' and
    you can also go back and disagree with them, and argue through
    the facts as well.
        Mr. Rosenberg. All of those principles I agree with, but I
    would just add you also need to make it workable, because, of
    course, you cannot wait to make a decision about a toxic
    chemical, about a resource or anything else, until you have
    such broad engagement. And there always, of course, will be
    somebody with a contrarian view.
        Senator Lankford. Sure.
        Mr. Rosenberg. And so it does have to be a workable system
    that agencies can actually manage. Otherwise, they will not
    actually carry out their mandated results.
        Senator Lankford. I could not disagree more, but even in
    emergency situations, where we have seen agencies step in and
    say, ``This is so vitally important. We need to engage right
    now for public safety and health,'' there are mistakes even in
    that, and we need to allow for humanity to exist.
        One of the most obvious examples was recently, when
    agencies rushed in after the fertilizer plant explosion in West
    Texas, and it was immediately, we need to make these massive
    changes around the country, and then, 2 years later, the Bureau
    of Alcohol, Tobacco, Firearms and Explosives (ATF) finished
    their investigation and discovered that was not an accidental
    explosion. That was an intentionally set fire. Well, that
    changed everything on the premise, that for 2 years the
    agencies had run with a false premise.
        So I understand everyone makes mistakes in the process on
    that, but good oversight helps us in the process as well, and a
    good set of boundaries for it.
        We will come back to this. I want to recognize Senator
    Carper.

                  OPENING STATEMENT OF SENATOR CARPER

        Senator Carper. Thanks. Thanks so much, Mr. Chairman.
    Senator Heitkamp, good morning. Nice to see you. To our
    witnesses, Susan, welcome back. You have been here before. You
    should probably pay us by the appearance. [Laughter.]
        Dr. Rosenberg, Dr. Beck. I have a specific question for Dr.
    Beck. Before I do, I applaud our Chair and Ranking Member for
    holding this hearing. We are grateful to our witnesses for
    coming.
        I have a question for Dr. Beck, but before I do that I
    would just like to ask Susan if each of you just take maybe 30
    or 45 seconds, since I did not get to hear your testimony, and
    just maybe give me what you thought would be a point that we
    should really walk away from here with. Give us a good nugget
    or two.
        Ms. Dudley. For me, I think it is that science is essential
    for informing regulatory policy, but it cannot decide
    regulatory policy, or policy, in general, and that there are
    other disciplines that are also important. And so often, when
    people accuse others of politicizing science, they really are
    talking about decisions that science can inform, but not
    decide. And if we could do a better job of being clear where
    the science ends and where the policy begins, I think it would
    open up to much more rational debate on the policy side, and we
    would not impugn science inappropriately.
        Senator Carper. All right. Good. Thank you. Dr. Rosenberg.
        Mr. Rosenberg. I would actually agree with that. I would
    also say that we should--when we are talking about concepts
    such as best available science, we should really focus on the
    process of developing that science. It is not a matter that
    everyone goes and redoes the analysis, that it is the science
    through a credible process, contributes to a weight of
    evidence.
        And then there is a judgment call on a policymaker's side--
    is the weight of evidence enough to take action? But we should
    trust that there is a strong science process and continue to
    strengthen it with elements such as scientific integrity
    policies and transparency policies.
        Senator Carper. Good. Thank you. Dr. Beck same question.
        Ms. Beck. So I agree with Susan Dudley about--both of
    them--about the separation of science and policy, and I think
    this is why it is important that we be really transparent about
    the quality of science. And the confusion about whether or not
    to codify a definition is--I just do not understand it. I think
    that people should commit to using an approach--that uses a
    clear criteria to evaluate studies, to ensure they are peer-
    reviewed. It does not put the finger on the scale for any
    particular study, but ensures that at that period in time, you
    are looking at all of the evidence and using the best evidence
    to define the science. And then you move it to the policy
    arena.
        Senator Carper. Would it be safe to say that the three of
    you agree that we should not be blinded by science?
        I think everybody nods yes. Thank you. Thomas Dolby would
    appreciate you saying that.
        Dr. Beck, my colleague has been talking about Toxic
    Substance Control Act and his compadre from Oklahoma, Jim
    Inhofe, following David Vitter from Louisiana, Tom Udall,
    myself, and a bunch of others, worked for years to enact the
    full legislation. And I think if they ever remake the filmstrip
    or civics video about how a bill becomes a law, I would
    nominate TSCA for the Oscar, and say--it took a long time, but,
    in the end, it was just really nicely done.
        The reason it was important that Congress act last year,
    was that TSCA had been essentially a broken law since 1991. I
    think some would say even before that, where an industry, I
    think in 1991, successfully sued to overturn the Bush
    Administration's proposed ban on asbestos. And they were able
    to do that because the old law required EPA, as you may recall,
    to choose the ``less burdensome'' regulation for industry, and
    industry argued that the EPA had not evaluated the costs and
    the benefits of all possible alternatives to a ban, even though
    EPA had spent, I guess, a decade or so writing the rule and had
    prepared thousands of pages of analysis.
        The EPA concluded that TSCA was unusable, and for decades
    it could not regulate the safety of chemicals it knew to be
    dangerous.
        Would you agree that the requirement that EPA select the
    ``least burdensome'' regulation is a major part of why old TSCA
    was unusable and a major part of why we all worked so hard
    together to reform it, Ms. Beck?
        Ms. Beck. Yes, that language was very problematic.
        Senator Carper. If you want to say more that that language
    was very problematic, you can.
        Ms. Beck. Well, the language does not----
        Senator Carper. We do not charge you for testimony. We do
    not pay you either. [Laughter.]
        Ms. Beck. The language does not exist anymore, right? I
    think there was full agreement that the language confused the
    science and the policy. So now you have an unreasonable risk
    standard in the new Lautenberg Chemical Safety Act, which is
    based purely on the evaluation of the science. It looks at the
    hazards and the exposures under very specific exposure
    conditions, and then it makes a science determination. And then
    separate from that, there will be some risk management steps
    that consider costs and benefits, but there is no requirement
    on the agency to choose the least burdensome.
        Senator Carper. OK. When we wrote the new law over the last
    couple of years, we told EPA to--try to first figure out
    whether or not a chemical was dangerous, and then to consider
    the cost when the agency was deciding how to protect people
    from whatever risk the agency had identified. We did not tell
    EPA, though, that it had to study the costs and benefits of
    every possible regulation, and we did not tell EPA that it had
    to choose the cheapest option. We told EPA it had to protect
    the public against unsafe chemicals and consider costs when it
    did so.
        Let us just say, for a moment, that EPA proposes a
    regulation under TSCA that costs industry, we will say, a
    billion dollars. A lot of money. And industry tells EPA, during
    the required comment period, that there is an alternative that
    will protect people just as well, that costs only a million
    dollars. A million versus a billion. Is it not true that the
    Administrative Procedures Act (APA) requires EPA to consider
    and respond to industry's views on cost when they write the
    final rule? And that could be, again, you, Dr. Beck. Is it not
    true that the Administrative Procedures Act requires EPA to
    consider and respond to industry's views when EPA writes the
    final rule?
        Ms. Beck. So I am not an expert in the Administrative
    Procedures Act, but yes, the rulemaking process does require
    that the agency consider the public comments and provide
    responses to those comments. It does not require that the
    agency accept those comments but they have to consider them,
    discuss them, and explain how they were considered.
        Senator Carper. OK. Thanks.
        Ms. Beck. Yes.
        Senator Carper. Is it not also true that if EPA ignores
    that cheaper, equally protective measure in its final rule that
    industry could also sue and overturn the rule, under the
    Administrative Procedures Act? And if you do not know the
    answer to that question, maybe one of the other--your
    colleagues would. Dr. Rosenberg. Susan?
        Mr. Rosenberg. Well, it is probably more Susan's area than
    mine, but I would say that frequently happens with a claim that
    it is arbitrary and capricious, which is the language of the
    Administrative Procedures Act, and that was drummed into my
    head when I was a regulator, because that is in every challenge
    to a regulation--you have been arbitrary and capricious, which
    goes back to the role of science. So, yes, that is what APA
    does. It gives you that opportunity.
        Senator Carper. Yes. Susan? Same question.
        Ms. Dudley. Yes, that is right. Anybody could sue if the
    agency did not base their final regulation on the material in
    the docket, which would be comments from the public, the data
    they have, et cetera.
        Senator Carper. OK. Good. Who succeeded you at OIRA? Was it
    Cass Sunstein?
        [No audible response.]
        One of the things that President Obama asked him to do was
    to--I do not know if it had been done before, but I think they
    called it a look-back--to look back at regulations that had
    been adopted, in some cases many years ago, that may have
    served their purpose but did not anymore, and to see which ones
    should be saved, which ones modified, and which ones gotten rid
    of.
        I have read that that was a pretty successful endeavor. I
    believe it went on throughout the rest of the Obama
    Administration. Do you have any recollection of that?
        Ms. Dudley. You are right. It was actually something that
    every President since Carter has asked agencies to do.
        Senator Carper. Yes.
        Ms. Dudley. And yet they really do not do a good job of it,
    for several reasons. One is that the incentives are not there.
    It is much more interesting to look at the next problem to
    solve rather than looking back, and even regulated parties
    often are not interested, because--especially if there are
    investments they had to make, the last thing they want is for
    the agency to say, ``Oh, never mind. We should not have done
    that,'' because then their competitors will have an advantage.
        Senator Carper. Yes.
        Ms. Dudley. But it is also hard to do. So it is not----
        Senator Carper. Did you do it while you were running OIRA?
        Ms. Dudley. Yes, and so I was at OIRA for the last end of
    the Bush Administration----
        Senator Carper. Yes.
        Ms. Dudley [continuing]. So I was actually wrapping up
    things that had been begun before me, toward the end.
        Senator Carper. You were there on the clean-up?
        Ms. Dudley. I was there for the clean-up. I was finishing
    things.
        Senator Carper. Oh, that is good.
        Ms. Dudley. But one of the things that I think about
    retrospective review is that it is not just to see what does
    not work and to rescind and reduce costs. It is to find out
    whether our estimates of the risk reduction benefits were
    accurate. It is part of the scientific method that requires
    hypothesis testing, gathering data and testing your hypothesis.
        So I think it is very important. There was a bill that
    Senators Lankford and Heitkamp introduced last year that would
    have required agencies, when writing a new regulation, to plan
    for how they would review it, 5 or 10 years down the road.
    That, I think, would be huge for the science, the risk
    assessment that goes into regulation----
        Senator Carper. Right.
        Ms. Dudley [continuing]. Ex-ante as well as ex-post.
        Senator Carper. You are not just saying that because he is
    sitting here, are you?
        Ms. Dudley. No. Not because I am huge fan of both of yours,
    but no, that is not why.
        Senator Carper. Thank you. And the converse is true.
        Thanks so much for being here and for your help. Thanks.
    Thanks, Mr. Chairman.
        Senator Lankford. No, thank you, and can I finish up this
    conversation as well, when we were talking about finishing and
    closing and cleaning it up, and we will have about another 10
    minutes or so if you all are kind of wondering on time, unless
    we keep going, and then it goes until one. We will see.
        My question for you is this issue of retrospective review.
    How does that work in the science, and I am still thinking
    about the legislative side of this. Let us say you have a
    regulation that is a $100 million-plus regulation that comes
    out. Seven years later you go back and look at it. It is not
    accomplishing what you want. The science has moved, as Dr.
    Rosenberg, you have talked about often. The science continues
    to develop in research. You have better measurement tools and
    you figure out your hypothesis did not work. How do you do a
    retrospective review when there is also a scientific opinion
    that is sitting, that may, at that point, be 10 or 12 years
    old? Are you talking about a retrospective review that would
    also include re-evaluating the science again, or just looking
    at the numbers, or trying to evaluate that?
        Ms. Dudley. I actually think thats one of the under-
    appreciated advantages of doing better retrospective review
    would be evaluating whether our scientific predictions were
    right. So it is not just valuable for the regulations that we
    issued 10 years ago, because it may be too late to change
    those, but it helps us the next time we issue a regulation, we
    will know which of our assumptions maybe were not right. So I
    think it will improve the science if we could do a better job
    of it.
        Senator Lankford. Right. And it is the same thing whether
    it is economics or whether it is science of any type, that you
    get a chance to note, this is what we estimated, this is what
    we thought would happen, this is the model, and then we look at
    it 5 years later and say, is the model proving to be correct,
    and sometimes you have not had enough time to be able to
    evaluate it, and sometimes you have.
        Ms. Dudley. It is just an essential part of the scientific
    method.
        Senator Lankford. OK. I want to get into this issue of
    weight of evidence. Dr. Beck, you and Dr. Rosenberg both
    brought this up significantly, both in written comments and in
    oral comments as well, by dealing with the weight of evidence.
    Dr. Beck, you mentioned several spots that you had some
    frustration already with the EPA not looking at weight of
    evidence. I would like to get a chance to talk about that and
    figure out how we address that, because that is one of the
    things in TSCA, specifically in statutory language, that this
    Congress said, ``no, we want EPA to look at weight of evidence
    in this role, and to be able to figure out where that comes
    from.''
        So, Dr. Beck, if you want to talk about how you see that
    being applied right now and then let us try to figure out how
    we actually deal with this.
        Ms. Beck. Yes. So in the Congressional Record associated
    with the TSCA rulemaking, there is a definition for weight of
    evidence, and we would like to see the agency simply adopt that
    definition. It basically would commit them to looking at the
    studies and evaluating their strengths and limitations using a
    systematic review process which is a standardized process for
    essentially evaluating evidence, providing sort of the recipe
    for how you are going to bake your cake before you bake it.
    Everybody knows the criteria that you are going to use, the
    plans that you are going to use for analysis. You put that up
    front. You are clear about how you are going to collect your
    literature and evaluate your literature and do the analysis. So
    once you have evaluated the strength of the evidence, right,
    the individual strength of each individual studies, based on
    the quality of those studies, you weight it all and you make
    your determination.
        So that is the definition to us that seems so
    straightforward and so consistent with the scientific process,
    we think it should be adopted into the regulations that EPA is
    writing, to implement TSCA.
        Senator Lankford. OK. Are there other definitions out there
    for weight of evidence that you would recommend, other than
    what was done in the Congressional Record?
        Ms. Beck. The term has been confused over the years. Some
    people use a strength of evidence approach. That is very
    different and we do not support a strength of evidence. That is
    how many studies are positive, how many are negative----
        Senator Lankford. Right.
        Ms. Beck [continuing]. And oftentimes people discount the
    negative studies. We only think the negative studies should be
    discounted if they are of bad quality. If they are of high
    quality they should be considered equally.
        So, to me, the cleanest approach is to adopt the one that
    the Congressional drafters had, and there was support for that
    definition in the House language as well as in the Senate
    language.
        Senator Lankford. OK. Dr. Rosenberg, any comments about
    just the weight of evidence?
        Mr. Rosenberg. Well, I would just say that the weight of
    evidence is more than just tallying up the number of studies,
    and I do not think that you can equally weight every study. And
    so I do not disagree that there should be clear guidance from
    the agency, in terms of--so that people can understand how the
    agency will interpret information going forward. But I would
    caution against saying, well, if it is a credible study then
    everything gets equal weight, because that is not how you would
    do it as a scientist, certainly. You would consider the
    uncertainty. You would consider a lot of factors around the
    study and weight things appropriately.
        Senator Lankford. Back to the range of options, Dr. Beck,
    you had mentioned one of your proposals, grant funding not
    based on positive outcome.
        Ms. Beck. Yes. So, in the scientific world there is this
    concept of publish or perish, and that if you do not have a
    strong publication record you are not going to get promotions
    in academia and you are not going to get tenured positions. And
    in the journal world, there is an incentive to only publish
    data that are positive. People do not like to publish negative
    studies. People have talked about creating journals of negative
    data so that people are not reproducing the same studies that
    fail over and over again because the public does not know that
    they fail, because nobody is publishing them.
        So if there was a way to, at least within the Federal
    Government, to encourage the publication and the presentation
    of negative data, that would be extremely helpful.
        We are aware of cases, for instance, at the National
    Institute of Environmental Health Sciences (NIEHS), where they
    have done some studies that are actually negative, and we have
    been talking to them, can you please publish these data? These
    are important studies. And at this point in time there are not
    incentives to them to release negative data as much as there is
    to release positive data.
        Senator Lankford. But when you talk about grant funding
    based on it, the grant funding should be, at the beginning of
    it they do the study, not at the end of it. Somewhat this
    sounds like----
        Ms. Beck [continuing]. Yes----
        Senator Lankford [continuing]. You want to make sure your
    study ends up positive at the end if you have got grant
    dollars, if you want to get more grant dollars.
        Ms. Beck. If you want to get more grant dollars. That is
    correct. You have a 5-year grant and you want to get your grant
    renewed, or you want your center renewed, you want your center
    to have positive findings or it is not likely to get renewed by
    a Federal agency.
        Senator Lankford. So is it the fear that the science either
    gets limited--there were, for lack of better terms, 10 things
    we learned not to do, one thing we learned to do, and we only
    published the one because you want to show positive, or is your
    fear that the science is going to make sure that they try to
    push it and steer it toward something positive, regardless?
        Ms. Beck. Well, it is actually both. The official term is
    publication bias, and that is that what exists in the
    literature are mostly positive findings. So then when people go
    to evaluate all of the evidence in totality, they are going to
    have a lot more positive studies than negative studies, and
    then what you cannot evaluate does not get to inform your
    regulation, right, so the positive studies are then informing
    the regulation and the negative studies, which are not
    published, are not known.
        Senator Lankford. OK. Dr. Rosenberg.
        Mr. Rosenberg. Just very briefly, while I agree that
    occurs, it is not restricted to grant-funded research. Of
    course, industry does the same thing. Clinical trials are the
    classic example of that. You do not put forward the clinical
    trials that did not show the positive effect. And so there is a
    problem of those incentives. It is all across industry and it
    is also in academia.
        Senator Lankford. OK. Both of you also mentioned the issue
    about peer review, and if there is a legislative--in fact, Dr.
    Rosenberg, I think you said if there is an area to address in
    legislation that peer review process or trying to improve that
    was one of the areas. But regardless of whether it is
    legislative or not, what would be your recommendations on
    trying to deal with the peer review process, or how we label
    this, this is a peer-reviewed study, and still determine the
    quality of that?
        Mr. Rosenberg. Well, I think I said that both scientific
    integrity and peer review were important areas for progress. I
    think the independence of peer review is critical, where you
    are actually getting the peer reviewers, and the breadth of
    that peer review. This is actually not the same as a peer
    review you do for academic journals, where, there is a limited
    number of reviewers and then you can move forward with
    publication. Obviously, in regulatory work, you have to have a
    more intensive process, and that goes to the selection of peer
    reviewers and so forth.
        I think, from a legislative perspective, it is important
    that agencies be clear about what their peer review process is,
    and how they select reviewers. We should be careful that
    reviewers are not representatives of different interests, so
    the idea that has been in some quarters in science advisory
    boards, that you should have representational members. That is
    a bad idea for peer review. You should be there because of your
    expertise in particular areas and you contribute to the review.
    There are questions in regulatory review about whether it
    should be anonymous review or not. The most important thing is
    that there is a clear and transparent, process for how we are
    going to conduct peer review. People can know that we did it--
    --
        Senator Lankford. So let me press on that a little bit.
    When you are talking about representational review, do you have
    an issue, for instance, if you were doing--let us say we are
    testing safe drinking water, that EPA is both doing their own
    sample with their own agency folks. Industry that may be nearby
    that they know that they are suspect, should they be able to be
    at that site, be able to pull from that same--if you are going
    to pull 10 gallons of water out and be able to examine it, they
    pull a quart out of it as well, out of that same group, so they
    are able to run it through their lab? So you have multiple
    competing labs all checking it, because as you know well, there
    are some differences in all of the testing there. Do you have a
    problem with that type of peer review, where it is a group that
    could be affected by it, but they would have to be there onsite
    to be able to make sure their sample is consistent?
        Mr. Rosenberg. So I do not have any problem with having, as
    you describe, different entities involved in the sampling. What
    I would say is that if you are going to then apply peer review,
    which is independent, outside experts who look at the results,
    and look at the methodology, and do all of the things that you
    do in peer review--this is not, again, the raw data, but how it
    was done--that that be done not just for the agency analysis
    but it also be done then if the affected industry says, oh,
    well, we got different results----
        Senator Lankford. Show your data.
        Mr. Rosenberg [continuing]. It should have exactly the same
    peer review standards.
        Senator Lankford. Yes.
        Mr. Rosenberg. The difficulty I have had in regulatory
    settings is that I might go through, 20 public meetings on
    scientific analysis for, again, marine resources. I know you
    have many of those in Oklahoma. And someone else would stand up
    and say, ``Well, my results are different.'' You have
    absolutely no idea whether that has been reviewed or who has
    reviewed it. It is not meeting the same standard at all. So you
    have to compare like with like.
        Senator Lankford. Yes. You will be glad to know that
    Oklahoma has more fresh water shoreline than any other State in
    the union.
        Mr. Rosenberg. I am really happy to know that.
        Senator Lankford. We dig a lot of ponds. [Laughter.]
        So we do that. We know how to store our water.
        Let me ask for your quick response on that as well, and
    then I want to try to move on to a final question.
        Ms. Beck. Yes. Peer review is an area that I think could
    benefit from a lot of improvements. One of these issues
    relating to representative, equal review of all data is
    funding. I listened to a peer review panel where there was a
    very good study funded by industry, and when it came up one of
    the peer reviewers said, ``Wait. Was not that funded by
    industry? We are not going to consider that.'' It was just
    completely discounted, simply based on its funding, and there
    was no evaluation of the quality of the data.
        So, again, I think these peer-review panels, of course you
    need to address conflicts and biases, but you need the breadth
    and the depth and the expertise. If you are reviewing something
    about a manufacturing process and you have nobody that
    understands the manufacturing process, I do not think that peer
    review is going to end up being very good.
        In the FDA, they have ways of having experts that might
    have conflicts on panels to help educate the panels, but they
    do not vote. Senator Carper referred to the Oscar-winning TSCA
    rule. The TSCA legislation actually requires different
    representations on the review panel, and those representations
    include animal welfare, labor, industry. In putting that panel
    together for the industry representation, EPA has chosen two
    people from the pharmaceutical industry. These people do not
    understand the chemical manufacturing process and TSCA does not
    regulate pharmaceuticals.
        So I think you have to reach a point where you ensure that
    you have the right expertise and breadth to do a high-quality
    peer review.
        Senator Lankford. Yes, which makes it a challenge after the
    fact.
        Ms. Beck. Yes.
        Senator Lankford. The TSCA language on the science section,
    do any of the three of you have an issue with that, how it was
    written for that area, as much as you know the language? I am
    not going to ask you to know every word of it, but as much as
    you know. Dr. Beck.
        Ms. Beck. So I would just say that that language, it is
    consistent with what is in the information quality guidelines.
    It is very consistent with what is in the Safe Drinking Water
    Act. It should not be new to the agencies.
        Senator Lankford. No, it has been in existence for a long
    time----
        Ms. Beck. Yes.
        Senator Lankford [continuing]. As Executive Orders and
    other actions.
        Ms. Beck. It is not new. It is around, so it is actually
    nice to see it in there, and we hope that when EPA finalizes
    their framework rules under TSCA they will commit, to meeting
    those standards in their rules.
        Mr. Rosenberg. Chairman, I do not know the language in that
    little detail. I would just refer back to one comment that Dr.
    Beck made, about representation on a peer-review panel. That is
    exactly the problem of having people who are there to represent
    a particular interest. They are no longer peer reviewers. If
    they are there because they have particular expertise, I do not
    have a problem.
        Senator Lankford. Right.
        Mr. Rosenberg. But if you say, ``I am here as an industry
    reviewer. I am here to represent the interests of industry,''
    or non-governmental organizations (NGO's), then I have a real
    problem. That is not a peer review to me.
        Senator Lankford. Right.
        Ms. Beck. I agree with you. It should be expertise.
        Senator Lankford. Right. So let me ask this question. Is
    there an issue with trying to get the data, the models, and the
    methods out, so when an agency concludes their work, you can
    ask the practical question, ``You came to this conclusion as an
    agency head. You based it on this report. Can we see--with
    private information excluded, obviously, and redacted--the
    data, the models, and the methods'' to be able to come to that?
    Susan Dudley.
        Ms. Dudley. I think that is essential, and I will just read
    from Science magazine which requires that now for their
    articles. The editors, when they made the change to make data
    available, said that ``when the greatest number of creative and
    insightful minds can find access and understand the essential
    features that led to the collection of a data set, the data
    reached their highest potential.''
        So I think that is an essential element of the transparency
    that you mentioned in your opening statement.
        Senator Lankford. OK. Dr. Rosenberg.
        Mr. Rosenberg. I do not agree that the raw data is needed
    and I do not think that is what Science requires, in most
    cases. At least whenever I publish there they do not ask for
    the raw data. I think the confidentiality is not just for
    public health records. It is also confidential business
    information, intellectual property. It gets very complicated
    quickly.
        Again, for most studies, you are not reviewing the raw data
    but you are doing exactly what Susan said. You are looking at
    how was the data collected, what is the provenance of the
    study, models, and so on. Does that mean that we would never
    consider results from a proprietary model, including the magic
    model that one of your committee members cited? For evaluating
    the Clean Power Plan we should not consider that because that
    model is proprietary. So there is a whole range of information,
    not just public health information.
        I think that to the extent that data can be released, fine,
    but I do not think that that should be the requirement, and if
    you cannot do it, for multiple reasons, therefore, you do not
    move forward.
        Senator Lankford. How do we have transparency without
    knowing the data, or without knowing the process of how it was
    put together? Because as you know well, the variables within
    data and the assumptions that underlie that can vary
    dramatically.
        Mr. Rosenberg. I have absolutely no difficulty with
    describing, in detail, how the data was collected. The data
    collection process is part of something I review in every study
    that I look at. The modeling process is something that I review
    in every study that I look at, because I tend to mostly review
    modeling studies. I do not review the raw data.
        Now, sure, some people may want to do alternative analyses
    of that raw data. It is almost inevitably going to be for
    regulatory matters, industry. Nobody else would have the
    capability of doing that. But again, then, interpreting those
    results, unless they are put back into exactly the same peer
    review process that the agency used, is almost impossible, and
    the difficulty then is you have gotten into a very difficult,
    very long process of review with almost no end, because anyone
    putting in a new process starts a new round of peer review and
    you just stay in peer review forever.
        So I think you need to be realistic about what the
    information will be. The information to review is the details
    of that process of how that data was collected, certainly, and
    all of the other elements of the study, as I indicated in my
    testimony.
        Senator Lankford. OK. Dr. Beck.
        Ms. Beck. I noted this is in my testimony. The public trust
    is eroding in science. There are articles in the Washington
    Post about how 50 percent of the science that is published is,
    maybe false and not true. And I am not saying every study is
    unreliable, but if you want to have trust and confidence in
    your regulatory decisions, you need to be as transparent as you
    can absolutely be about that underlying data, so that everyone
    is on the same page and can have a scientific dialogue. It
    helps to build trust and confidence.
        So proprietary information, private information, all that
    needs to be protected. There are ways to protect proprietary
    information in models while letting other people look at those
    models. I think there are legal ways data-sharing can happen,
    and to the extent that the scientific community can improve
    that, the public confidence in the science will be greatly
    improved and confidence in regulatory decisions will be
    improved.
        Senator Lankford. Yes, that is a balance, obviously. We
    want people to be able to do their research, to be able to
    protect their data. They have paid for it, they have worked
    through the process, unless it is the Federal taxpayer that
    paid for it, and that is a whole different set of issues.
        But the challenge that we face is trying to trust it and to
    say ``how can we get a chance to do a good evaluation,'' even
    things that are given the tag ``it was in a journal,'' ``it was
    published,'' or ``it was peer-reviewed.''
        One of my favorites studies, when we were going through and
    doing the preparation for all this, and the research, was
    finding Dr. Bohanan's tests from Harvard, the biologist there,
    where he wanted to find out how the scientific journals went,
    and so he created a completely bogus study, with bogus modeling
    and everything else, and presented it to 300 different
    scientific journals, and 157 of them accepted it. And you
    think, OK, there is a challenge here, even within scientific
    journals, on how they accept what is fact and what is, at that
    point, completely bogus information. So we have to be able to
    guard that, and that is part of gaining public trust.
        The one thing I would like to do is be able to maintain
    this conversation. We are seeking a way to be able to solve
    this legislatively. We do not want to overreact and what it has
    done and able to squash the future of science, or to be able to
    compel people to not do research or to be able to put
    proprietary information that should not be put in the public
    domain not in there.
        I would tell you I serve on the Intelligence Committee as
    well. We deal with a tremendous amount of redacted information
    and a tremendous amount of research that can be put aside with
    private information. So I think there are ways to be able to
    accomplish some of this without putting people's private
    information or proprietary information at risk, so we can still
    gain trust.
        So I would appreciate your feedback as we walk through this
    process. The legislative process, as I can assure you, is a
    messy process, and I would appreciate it if you would join us
    in the mess, and any ideas that you have.
        Before we adjourn I do want to announce that on April 6,
    the Subcommittee intends to hold a hearing regarding our
    continuing efforts to address potential problems and solutions
    associated with the Federal workforce.
        This concludes today's hearing. I do, again, want to thank
    your witnesses for being here today. I appreciate knowing your
    work. We did not get to even 10 percent of what you each
    submitted in your written work as well, and I do bemoan that,
    but we are out of time.
        The hearing record will remain open for 15 days until the
    close of business on March 24, for the submission of statements
    and questions for the record.
        I thank all of you again. This hearing is adjourned.
        [Whereupon, at 11:59 a.m., the Subcommittee was adjourned.]

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