[Senate Hearing 115-410]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 115-410

 OVERSIGHT OF THE ENVIRONMENTAL PROTECTION AGENCY'S IMPLEMENTATION OF 
              SOUND AND TRANSPARENT SCIENCE IN REGULATION

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

                                HEARING

                               BEFORE THE

 SUBCOMMITTEE ON SUPERFUND, WASTE MANAGEMENT, AND REGULATORY OVERSIGHT

                                 OF THE

                              COMMITTEE ON
                      ENVIRONMENT AND PUBLIC WORKS
                          UNITED STATES SENATE

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                               ----------                              

                            OCTOBER 3, 2018

                               __________                            

  Printed for the use of the Committee on Environment and Public Works
  
  

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                      COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS

                     ONE HUNDRED FIFTEENTH CONGRESS
                             SECOND SESSION

                    JOHN BARRASSO, Wyoming, Chairman
JAMES M. INHOFE, Oklahoma            THOMAS R. CARPER, Delaware, 
SHELLEY MOORE CAPITO, West Virginia      Ranking Member
JOHN BOOZMAN, Arkansas               BENJAMIN L. CARDIN, Maryland
ROGER WICKER, Mississippi            BERNARD SANDERS, Vermont
DEB FISCHER, Nebraska                SHELDON WHITEHOUSE, Rhode Island
JERRY MORAN, Kansas                  JEFF MERKLEY, Oregon
MIKE ROUNDS, South Dakota            KIRSTEN GILLIBRAND, New York
JONI ERNST, Iowa                     CORY A. BOOKER, New Jersey
DAN SULLIVAN, Alaska                 EDWARD J. MARKEY, Massachusetts
RICHARD SHELBY, Alabama              TAMMY DUCKWORTH, Illinois
                                     CHRIS VAN HOLLEN, Maryland

              Richard M. Russell, Majority Staff Director
              Mary Frances Repko, Minority Staff Director
                              ----------                              

             Subcommittee on Superfund, Waste Management, 
                        and Regulatory Oversight

                  MIKE ROUNDS, South Dakota, Chairman
JERRY MORAN, Kansas                  CORY A. BOOKER, New Jersey, 
JONI ERNST, Iowa                         Ranking Member
DAN SULLIVAN, Alaska                 BERNARD SANDERS, Vermont
JOHN BARRASSO, Wyoming (ex officio)  CHRIS VAN HOLLEN, Maryland
                                     THOMAS R. CARPER, Delaware (ex 
                                         officio)
                            
                            C O N T E N T S

                              ----------                              
                                                                   Page

                            OCTOBER 3, 2018
                           OPENING STATEMENTS

Rounds, Hon. Mike, U.S. Senator from the State of South Dakota...     1
Booker, Hon. Cory A., U.S. Senator from the State of New Jersey..     3

                               WITNESSES

Calabrese, Edward J., Professor, University of Massachusetts at 
  Amherst School of Public Health and Health Sciences............     5
    Prepared statement...........................................     8
    Responses to additional questions from:
        Senator Markey...........................................    15
        Senator Sanders..........................................    18
Hahn, Robert, Visiting Professor, Oxford University Smith School 
  of Enterprise and the Environment..............................    20
    Prepared statement...........................................    22
    Responses to additional questions from Senator Sanders.......    29
Holt, Rush D., Chief Executive Officer, American Association for 
  the Advancement of Science.....................................    31
    Prepared statement...........................................    33
    Responses to additional questions from Senator Markey........    38

                          ADDITIONAL MATERIAL

Case-Control Study of Lung Cancer Risk From Residential Radon 
  Exposure in Worcester County, Massachusetts. Richard E. 
  Thompson et al., Health Physics Society. Manuscript accepted 
  August 29, 2007................................................   379
National Stone, Sand & Gravel Association, Statement for the 
  Record, October 3, 2018........................................   393

 
 OVERSIGHT OF THE ENVIRONMENTAL PROTECTION AGENCY'S IMPLEMENTATION OF 
              SOUND AND TRANSPARENT SCIENCE IN REGULATION

                              ----------                              


                       WEDNESDAY, OCTOBER 3, 2018

                               U.S. Senate,
         Committee on Environment and Public Works,
              Subcommittee on Superfund, Waste Management, 
                                  and Regulatory Oversight,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 2:20 p.m. in room 
406, Dirksen Senate Office Building, Hon. Mike Rounds (Chairman 
of the Subcommittee) presiding.
    Present: Senators Rounds, Booker, Barrasso, Carper, Ernst, 
Sullivan, Whitehouse, and Van Hollen.

            OPENING STATEMENT OF HON. MIKE ROUNDS, 
          U.S. SENATOR FROM THE STATE OF SOUTH DAKOTA

    Senator Rounds. Good afternoon, everyone.
    The Environment and Public Works Subcommittee on Superfund, 
Waste Management, and Regulatory Oversight is meeting today to 
conduct a hearing entitled Oversight of the Environmental 
Protection Agency's Implementation of Sound and Transparent 
Science in Regulation.
    Today we will hear testimony from experts and members of 
the scientific community in order to explore opportunities for 
greater transparency and the use of the best available science 
at the EPA. Regulations created by the EPA help to protect the 
American people from tainted water, dirty air, and chemical 
exposure. The essential work completed by the EPA should always 
have as its basis protecting human health and the environment.
    However, in the past, I have been concerned that the broad 
discretion and lack of transparency at the EPA has led the 
Agency to seek out the science that supports a predetermined 
policy outcome rather than relying upon the best available 
science before coming to conclusions. Failing to do so results 
in regulations that overly burden our economy without having a 
substantial impact on human health or environmental protection.
    On April 30th, 2018, the EPA published a proposed rule 
entitled ``Strengthening Transparency in Regulatory Science.'' 
This proposed rule would require the EPA to identify what 
science they used to come to regulatory decisions and to make 
those studies available to the public without compromising 
privacy protections.
    The proposed rule would also require the EPA to take into 
account high quality studies that challenge current scientific 
assumptions. The proposal seeks to accomplish this without 
excluding historically relied upon studies by allowing the EPA 
Administrator to waive certain data access requirements on a 
case by case basis.
    I thank the EPA for taking this important step, and I look 
forward to hearing from our witnesses today about the proposed 
rule.
    In addition, on September 12th, 2017, I introduced S. 1794, 
the Honest and Open New EPA Science Treatment Act, commonly 
referred to as the HONEST Act. Companion legislation, H.R. 
1430, was also introduced by Representative Lamar Smith. The 
HONEST Act passed the House of Representatives with bipartisan 
support on March 29th, 2017. Both bills have been referred to 
the Senate Committee on Environment and Public Works.
    The HONEST Act would prohibit the EPA from proposing, 
finalizing, or disseminating regulations or guidance unless all 
scientific and technical information relied on to support those 
actions is based on the best available science. The bill also 
requires this information to be specifically identified and 
publicly available in a manner sufficient for independent 
analysis and substantial reproduction of research results. 
Finally, the HONEST Act requires the EPA to redact sensitive 
information such as personally identifiable information, trade 
secrets, or commercial or financial information.
    It has been suggested by some that the EPA is incapable of 
providing greater scientific transparency because of privacy 
concerns. We have a responsibility to be sensitive to that 
issue, in part because we do not want to dissuade individuals 
from participating in environmental studies.
    I believe the EPA should use, as a model, the privacy 
protections already used by other Federal agencies, including 
the de-identification protocols employed by the Department of 
Health and Human Services.
    The EPA has a long history of creating burdensome, 
unnecessary regulations without giving the public an 
opportunity to fully vet the reasoning behind their decisions. 
We should all agree with providing greater transparency if it 
can be done without excluding legitimate scientific studies or 
compromising privacy. This is especially true if we can turn to 
other agencies, like the National Institutes of Health, for 
guidance on best practices.
    Sound, reliable science is vital to helping us make 
important policy decisions that impact not just the health of 
American families, but their livelihoods. We should welcome 
vigorous debate on the science the EPA relies upon. Doing so 
will result in regulations that have the greatest benefit to 
human health and the environment, while doing the least harm to 
the economy. It will also result in regulations that can 
withstand legal challenges, providing industry with a level of 
certainty that allows them to make long-term investment 
decisions.
    I would like to thank our witnesses for being here with us 
today, and I look forward to hearing your testimony.
    At this time, I would like to recognize Senator Booker for 
a 5-minute opening statement.
    Senator Booker.

           OPENING STATEMENT OF HON. CORY A. BOOKER, 
           U.S. SENATOR FROM THE STATE OF NEW JERSEY

    Senator Booker. Mr. Chairman, I am really grateful. Thank 
you for this opportunity and for calling the hearing.
    I just want to give a quick opening statement and will 
submit a lot more of my remarks for the record.
    One thing the Chairman and I agree with is how important it 
is for our regulatory agencies, including the EPA, to use the 
best available science to inform their decisionmaking. That is 
why so many of their Federal environmental laws include a best 
available science requirement, including TSCA, something that 
all of us worked well together on, which members of this 
Committee spent lots of time working on and came to an 
incredible bipartisan consensus on.
    I think we can also agree that transparency in agency 
decisionmaking is very important. So, I am glad to have the 
chance to have a discussion about the need for transparent, 
science based decisionmaking at the EPA.
    Unfortunately, the policy proposals that are the subject of 
today's hearing include the EPA's proposed rule to purportedly 
strengthen transparency and regulatory science. This rule is 
far more likely to hinder science based regulation than help 
it. In fact, the EPA did not even consult with its own 
scientific advisory board, which is charged with determining 
whether the best available science is being used as a basis for 
EPA regulatory actions, regarding this public rule. Instead, it 
has chosen to ignore fundamental concerns raised by its own 
advisory board members.
    I believe that the proposed rule put forth by the EPA and 
the legislation called the HONEST Act actually conflicts with 
the EPA's directive to use the best available science. Examples 
of this are common sense. If the EPA could not consider 
scientific studies unless the underlying data is made publicly 
available in a way that is sufficient for validation, the 
Agency would not be able to consider science gathered in the 
aftermath of environmental disasters, such as the Deepwater 
Horizon oil spill, which is not a scientifically replicable 
event.
    The Agency would not be able to consider studies that rely 
on private medical information or confidential business 
information because that data could not be made publicly 
available. Obviously, it would be unethical for anyone to 
attempt to replicate public health analyses that used data 
gathered from different exposures to certain populations and 
communities, exposures to lead, to PCBs, to mercury, or other 
chemical contaminants. We would not want anybody to replicate 
those studies and that suffering.
    For example, the EPA bases its standards for lead based 
paint hazards on long-term studies of children who were exposed 
to lead. Prohibiting the EPA from using these historical 
studies would cripple its ability to protect children and other 
vulnerable populations from lead, as one example.
    I am looking forward to this afternoon's conversation, but 
I want to emphasize that if the EPA was truly concerned about 
transparency, there are actually meaningful actions the EPA 
could be immediately taking.
    First, the EPA could release to the public the report that 
EPA completed more than 1 year ago regarding the cancer risks 
of formaldehyde, something we still have not released. Where is 
the transparency there?
    Second, the EPA could convene an independent science 
advisory panel to recommend best practices for ensuring 
transparency in developing public health and environmental 
regulations, not ignore their own science based advisory board.
    Finally, the EPA could immediately withdraw its May 2018 
proposed rule to modify the Risk Management Program amendments 
where EPA is now proposing to restrict the public's access to 
information about what chemicals are being stored in facilities 
in their communities and neighborhoods. The public has a right 
to know about dangerous chemicals. Why is the EPA withholding 
that information from them?
    So, I look forward to hearing from our witnesses. I will 
put more information for the record, but I again want to thank 
my colleague and friend for calling this important hearing 
having this discussion.
    Senator Rounds. Thank you, Senator Booker.
    Our witnesses joining us for today's hearing are Dr. Edward 
Calabrese, Professor, University of Massachusetts at Amherst 
School of Public Health and Health Sciences; Robert Hahn, 
Visiting Professor, Oxford University Smith School of 
Enterprise and the Environment; and Dr. Rush Holt, Chief 
Executive Officer, American Association for the Advancement of 
Science.
    Welcome to all of you.
    I would like to also, at this time, yield to Senator Booker 
to introduce Dr. Holt.
    Senator Booker. I could not let this moment go, Chairman, 
without trying to make Dr. Holt blush a little bit, because he 
is nothing short of a New Jersey treasure. He served eight 
terms in the House of Representatives and was the Congress's 
only legitimate rocket scientist who was in Congress. He has 
had an extraordinary career of public service even beyond his 
eight terms as a House member.
    Right now, he is a publisher of Science Family of Journals. 
In this role, Dr. Holt leads the largest multidisciplinary 
scientific and engineering membership organization. Prior to 
joining AAAS, Dr. Holt was not only a Congressperson, but he 
was probably one of the best well known leaders in his State of 
New Jersey because he was the most nerd-chic guy in our State.
    Dr. Holt has been named one of Scientific American 
magazine's 50 national visionaries contributing to a brighter 
technological future and a champion of science by the Science 
Coalition. From 1989 to 1998 Dr. Holt was Assistant Director of 
the Princeton Plasma Physics Laboratory, and he previously 
taught physics and public policy at Swarthmore College.
    And I just want to get rid of the rumor. In the TV show The 
Big Bang Theory, Sheldon's character was not based on Dr. Holt.
    [Laughter.]
    Senator Van Hollen. Mr. Chairman, if I could just briefly 
add to that.
    I want to welcome all the witnesses, but it is good to see 
my friend, Rush Holt. We served together for many years in the 
House, and everything that the Ranking Member said is 100 
percent true, but he left out a very important fact, which I 
believe you are the only Member of Congress who won Jeopardy or 
was a finalist on Jeopardy, as well.
    I apologize because I am going to have to leave, and I am 
going to try and come back, but I appreciate the opportunity. 
Thanks.
    Senator Rounds. Thank you.
    Once again, thank you, Senator Booker.
    Thank you to all of our witnesses for taking the time to 
participate today; we most certainly appreciate it.
    We will now turn to our first witness, Dr. Calabrese, for 5 
minutes.
    I would share with you all your opening statements will all 
be included, without objection, for the record. We would ask if 
you could try to limit your opening remarks to about 5 minutes; 
that would be greatly appreciated by the Committee as well.
    Dr. Calabrese, welcome, and you may begin.

  STATEMENT OF EDWARD J. CALABRESE, PROFESSOR, UNIVERSITY OF 
  MASSACHUSETTS AT AMHERST SCHOOL OF PUBLIC HEALTH AND HEALTH 
                            SCIENCES

    Mr. Calabrese. Thank you very much.
    Good afternoon, Chairman Rounds, Ranking Member Booker, and 
distinguished members of the Committee. My name is Edward 
Calabrese, and I am a Professor of Toxicology at the University 
of Massachusetts School of Public Health, Amherst, Mass. I am 
pleased to share with you my views on the EPA risk assessment 
transparency proposal.
    Briefly, I have been at UMass for 42 years, teaching and 
researching in the areas of toxicology and risk assessment. I 
have authored nearly 900 papers in the peer reviewed 
literature, about a dozen books, served on multiple National 
Academy committees such as the Safe Drinking Water Committee 
and the Air Cabin Safety Committee, which recommended to the 
FAA to eliminate smoking on commercial aircraft, a 
recommendation that was quickly adopted.
    For the past 20 years, I have been funded by the Air Force 
Office of Scientific Research to assess the nature of the dose 
response of toxic substances in the low dose zone in order to 
protect the health and the well-being of Air Force personnel. 
These activities have led to a major dose response revolution 
in the area of biology, medicine, toxicology, and risk 
assessment.
    The USEPA has proposed a general framework to strengthen 
its regulatory science procedures via enhancing transparency in 
multiple ways. I applaud EPA for this proposal as it is not 
only timely but requires scientific and administrative 
accountability. The proposal is broad, requiring the Agency to 
provide the scientific basis for proposed regulations, 
including underlying data. While this is an excellent start, 
the Agency should also commit to providing detailed 
explanations and public access to data that the Agency 
considered and decided not to use for regulation.
    In addition, most EPA scientific decisions are based on 
multiple assumptions, some of which are frequently hidden, 
obscured, and often silent drivers of regulatory action; for 
example, the use of highly susceptible and often poorly 
predictive animal models. These assumptions need to be fully 
described, documented, and justified. This process should also 
include the basis for why EPA chose not to adopt the use of 
other or different approaches and/or assumptions. Thus, EPA's 
transparency proposal is excellent as far as it goes, but it 
needs to be expanded; it also requires an explanation of what 
was considered, and why it was rejected.
    Multiple high profile controversies exist over the lack of 
availability of data sets used by EPA for regulatory decisions. 
While I have not been involved in Agency disputes over such 
data bases, I would like to note two personal examples that 
speak to data sharing with EPA and the scientific community, 
and the value offered to the Agency and the public. For 
example, in the 1980s I developed a data base of 6,000 dose 
responses concerning whether carcinogens could cause cancer 
with but a single dose. I made many presentations on this topic 
across the country, including several NAS Committees concerned 
with acute/short term exposures to toxic and carcinogenic 
agents in the aftermath of the 1984 Bhopal, India, disaster. 
Following these presentations, EPA asked me to provide it with 
a copy of the single exposure carcinogen data base. These 
presentations and the shared data base were intended to assist 
the NAS in guidance to EPA.
    Second, my group at the University of Massachusetts 
conducted multiple studies on soil ingestion in children and 
adults. Subsequently, EPA used these data for clean up 
standards of soil and dust contamination for the benefit of 
children and adults. Our group created a public Web site with 
all our data available for use by the EPA and the world, minus 
personal identifiers.
    These are examples to enhance improved science and 
transparency in regulatory activities. The EPA transparency 
proposal is crucial to enhance public health and should have 
been adopted in some form 20 or more years ago.
    With regards to risk assessment, ``data transparency'' 
should require the EPA to routinely receive and openly evaluate 
for accuracy any information that could significantly alter the 
key scientific assumptions underlying and dictating regulatory 
policy and practices. This current EPA proposal does just that 
by stating that EPA should no longer use the LNT, or linear 
non-threshold, model as the default in risk assessment.
    Movement away from LNT as the accepted default model is 
long overdue. It is compellingly supported by many peer 
reviewed scientific and historical studies and is badly needed 
to advance toward a more science based approach in assessments 
of human and ecological risks.
    Within this context, I have researched the nature of the 
dose response in the low dose zone for more than 30 years and 
have published about 500 papers on this topic in peer reviewed 
journals. I have organized and conducted international 
conferences on the topic for over 25 years and have created a 
professional journal called Dose Response, for which I am the 
editor in chief. I have also written chapters on dose response 
for some of the major textbooks.
    More recently, in the past decade I have exhaustively 
researched the historical origins and scientific foundations of 
EPA's LNT model and have found it sorely wanting. LNT is 
important because it is the model upon which all our cancer 
risk assessments and key health and ecological regulations are 
based. What I have learned was unexpected, and it has turned 
more than 30 years of my understanding of toxicology upside 
down. It has revealed that what I taught for so many years at 
UMass and have written about so ardently in my many articles 
and books was factually wrong. What I learned in this 
reevaluation of LNT was that the field of toxicology and our 
regulatory agencies, such as EPA, had made a serious error in 
their understanding of LNT and incorrectly applied it to the 
assessment of human and ecological risks.
    During my research and publication over a dozen peer 
reviewed journal articles on the scientific origins of LNT, I 
learned that the LNT dose response model which drives cancer 
risk assessment was based on flawed science, on ideological 
biases by leading radiation geneticists, on scientific 
misconduct by National Academy of Sciences genetics panel 
during the atomic radiation scares of the 1950s, and on a 40-
year mistaken assumption by yet another NAS committee.
    I learned that these flaws, biases, misconducts, and 
mistakes ultimately gave rise to the EPA model and were 
perpetuated down to the present day by subsequent committees of 
the NAS and EPA. What began for me as a routine academic 
exercise to affirm the scientific origins and credibility of 
LNT ironically ended as a remarkable repudiation of its 
scientific adequacy, challenging both the old guard and an EPA 
risk assessment process that is in need of significant 
revision.
    My findings show that the EPA adopted LNT for all the wrong 
reasons and built their flawed risk assessment edifice upon it, 
failing to perform due diligence expected by Congress and the 
public.
    Senator Rounds. If I could ask you to perhaps wrap it up. 
Everything will be included in the record.
    Mr. Calabrese. It is one paragraph more, Senator.
    Senator Rounds. Yes. Go ahead.
    Mr. Calabrese. Second, extensive research findings that 
contradict EPA's LNT model have now been documented in the 
scientific literature.
    With so many failed LNT predictions, EPA must not continue 
to use LNT as its default. A crusading EPA was young, 
impressionable, inexperienced, and somewhat blinded, and it 
adopted the flawed LNT model, believing that it would save the 
world. Not only was it wrong scientifically; the LNT in many 
ways has damaged public health and the economy, the worst of 
both worlds.
    The present EPA proposal to consider non-linear models for 
risk assessment is a critical, positive development. Thus, I 
believe that the EPA has made a bold and constructive proposal 
that is scientifically sound and should be strongly supported, 
approved, and implemented.
    Thank you very much.
    [The prepared statement of Mr. Calabrese follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Senator Rounds. Thank you, Mr. Calabrese.
    Now we will turn to Mr. Robert Hahn for your opening 
statement.

STATEMENT OF ROBERT HAHN, VISITING PROFESSOR, OXFORD UNIVERSITY 
         SMITH SCHOOL OF ENTERPRISE AND THE ENVIRONMENT

    Mr. Hahn. Thank you, Chairman Rounds, Ranking Member 
Booker, and distinguished members of the Committee.
    Most of you folks are probably old enough to remember the 
movie The Graduate with Dustin Hoffman. There was a scene early 
on in The Graduate where he is wandering around aimlessly by 
the swimming pool and a gentleman comes up to him and whispers 
the word plastics.
    Well, the word I want to whisper to you today, and Senator 
Booker and Senator Rounds touched on this in their opening 
remarks, is the importance of evidence. There is a virtual 
explosion going on in the Academy in which I work as an 
economist in developing evidence based policy.
    Just moving a little bit beyond the pros and cons of this 
legislation, which I will talk about in a minute and give my 
perspective on, I think there is a real opportunity politically 
to move forward in basing decisions that politicians and civil 
servants make about regulatory decisions and other programs, 
and basing them on evidence based policy, and that is where I 
would like to see us going. That is sort of my big ax to grind. 
So, if I run out of my 5 minutes, I have at least made my 
political statement, which is probably a good thing to do if I 
am going to run for President, which I am not.
    I want to make a few points and conclude with a short plea 
for breaking the political logjam.
    The first one is that I believe that the HONEST Act, as it 
is called, addresses a very important public policy issue, and 
it does so in a constructive way. That is not to say that it is 
perfect or can't be improved, but I am very sympathetic with 
the direction in which it and the EPA proposal is trying to 
move us.
    The second point is why simply apply this to EPA? There are 
a lot of regulatory agencies and programmatic agencies in 
Washington, DC. We might want to think about expanding the 
kinds of ideas that Senator Rounds and Senator Booker talked 
about.
    And the third point I want to make is the point I just made 
about better evidence decisionmaking related to a commission I 
served on that President Obama was instrumental in starting, 
along with Congressman Ryan and Senator Murray.
    So, point No. 1. The HONEST Act addresses an important 
public policy concern. I am just going to give you one example, 
so it is proof by anecdote. I have about 3 minutes.
    So, I ran a center for about 10 years between two think 
tanks in Washington, DC, the AEI Brookings Center on Regulatory 
Policy, or some such thing. I was doing a study with Ted Gayer, 
who is now at Brookings, trying to figure out what was going on 
with mercury emissions in a proposed regulation that EPA had on 
mercury emissions, and it took us a really long time to figure 
out what was going on because we didn't have easy access to the 
data or the models. We found, in our independent analysis, that 
that particular rule, as it was tailored, probably wouldn't 
pass a benefit-cost test, and we published our findings in 
science. But that is of secondary importance.
    What is of primary importance is the point that the Ranking 
Minority Member and the Chair pointed out, that we want to have 
these data made available and these models made available in a 
way that academics and other interested parties can check on 
the findings before they go into force.
    Let me move on to a second point under this, and it relates 
to my specific views on the strengthening transparency and 
regulatory science proposal that EPA had.
    There can be honest differences of opinion, but what would 
that proposal have done? It would have required the EPA to 
identify studies that are used in making regulatory decisions, 
it would have encouraged studies to be made publicly available 
to the extent practicable, and it would direct the EPA to 
clearly state and document assumptions made in regulatory 
analyses.
    Now, if I were grading an exam, say, at the Kennedy School, 
where I was on the faculty many years ago, and a student didn't 
do that, they probably would have gotten a C or less. In other 
words, these are things that make common sense, at least from 
my point of view.
    Here is what, in my view, the EPA rule wouldn't do: it 
wouldn't nullify existing environmental regs; it wouldn't 
disregard existing research, violate confidentiality 
protections, or jeopardize privacy.
    Let me move on to my conclusion, which is repeating my 
opening introduction.
    I think there is a real opportunity here for the Congress 
to move forward in promoting a new era in terms of getting 
people to acquire and use data more intelligently to improve 
decisions in government and in the private sector.
    For the government, I believe there is an opportunity to 
move things forward by promoting, as I said before, evidence 
based policy. It is pretty hard for a politician or an 
individual of any political persuasion to object to the idea of 
evidence and using better evidence in decisionmaking. I think 
that is really important.
    I think the HONEST Act represents a modest, albeit 
important, step in the direction of trying to move such policy, 
and I would urge legislators to move swiftly to consider this 
effort and other efforts that could vastly improve the quality 
of decisionmaking in government and thus improve the welfare of 
American citizens.
    Thank you.
    [The prepared statement of Mr. Hahn follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Senator Rounds. Thank you for your testimony, Mr. Hahn.
    We will now turn to our third witness, Dr. Holt.
    Dr. Holt, you may begin.

 STATEMENT OF RUSH D. HOLT, CHIEF EXECUTIVE OFFICER, AMERICAN 
           ASSOCIATION FOR THE ADVANCEMENT OF SCIENCE

    Mr. Holt. Thank you. And I do hope to stick to the evidence 
and to the topic at hand. Thank you.
    Chairman Rounds, Senator Booker, I appreciate the 
opportunity to testify before you today on behalf of the 
American Association for the Advancement of Science.
    The AAAS is the world's largest general scientific 
membership organization publisher of Science magazine, among 
other things, and our mission is to advance science, 
engineering, and innovation throughout the world for the 
benefit of all people. We also represent 250 affiliated 
societies.
    The transparency rule that you are considering is opposed 
by many, I think most, scientists and scientific organizations 
because, contrary to the stated purpose of the rule, the rule 
would result in the exclusion of valid and important scientific 
findings from the regulatory process, as Senator Booker has 
said.
    Transparency, openness, and peer review and regulatory 
science are essential ingredients of science, as espoused by 
AAAS since the founding in 1948. However, the so called 
transparency rule is an insidious dodge.
    Those who want to overturn the EPA procedures with this 
rule provide no good evidence that there is any deficiency in 
the scientific research that has been used up until now. 
Excluding the kinds of peer reviewed research that has been 
used is not justified.
    To put it bluntly, the initiative you consider today is not 
about transparency or sound science; it apparently is about 
reducing regulations. We know this because the architects and 
proponents present their proposals as part of a deregulatory 
agenda.
    But most important, whatever the ulterior purpose may or 
may not be, the effect of the rule would be a significant 
reduction in good, relevant science that could be used by EPA, 
and the change would likely result in harm to people and the 
environment.
    The proposed rule and its strict application would allow 
only research that is made completely public, and this 
demonstrates either a deep misunderstanding of how science 
works, and should work, or an intention to cherry pick evidence 
in the name of transparency.
    There are numerous examples of excellent peer reviewed 
research where some data cannot be published openly or where 
the experiment cannot be precisely repeated, and where 
redaction and anonymizing won't work. The most obvious examples 
are research projects that study human illness resulting from 
pollutants, for example.
    There are accepted procedures for testing results and 
verifying outcomes with methodologies that do not require 
access to all the raw data, so it doesn't need to be fixed. 
That is my point there.
    The U.S. Department of Defense has said the EPA 
transparency rule would be problematic. EPA's own Science 
Advisory Board questioned whether it would be possible to 
implement the rule as proposed. The current Deputy Assistant 
Administrator of EPA's Chemicals Office stated that ``such a 
requirement would be incredibly burdensome, not practical,'' 
and could justify all TSCA risk evaluations; not to mention the 
many, many scientists and scientific societies who see this 
rule as damaging.
    The proponents of the rule want to eliminate secret 
science. There is no secret science here. The only secret that 
I see is the deficiency that the authors of the transparency 
rule see in the existing research used by EPA. The open secret 
is that the proponents of the rule are not seeking a better 
scientific process; they appear to be seeking a way to cherry 
pick research in order to loosen regulations.
    So, I recommend that you scrap these initiatives and work 
with the science community and other stakeholders to increase 
the use of science in the regulatory process, not to find ways 
to decrease the science that can be used.
    I thank you for your time, and I will be happy to take any 
questions.
    [The prepared statement of Mr. Holt follows:]
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    Senator Rounds. Dr. Holt, thank you for coming and 
testifying today.
    Each of the Senators now has the opportunity for a 5-minute 
Q&A with you, and I will begin at this time.
    I would like to start with Mr. Hahn. I would just like to 
ask over a multi-period of time you have written extensively on 
the need for greater scientific transparency with regard to 
regulations that have an enormous impact on the economy and the 
quality of life for the American people. What do you believe 
has been the primary motivating factor behind not pursuing 
greater transparency prior to the current Administration?
    Mr. Hahn. I am not sure I have a 1-minute answer to that 
question, but I guess I think about it on a couple levels. 
Sometimes there is raw politics involved in particular issues 
where Congress may feel strongly about doing something, and it 
may not be in its own interest to necessarily get to the heart 
of the scientific matter.
    I think partly it is a matter that agencies don't always 
adapt to the latest technology, so we have the Internet now, we 
have easy ways of sharing things. It is worth, in my view, 
putting some resources into some of the issues that Dr. 
Calabrese mentioned earlier so that people can have access to 
the kinds of data bases that he developed, but I am thinking of 
the government, the models on which they are building things.
    So, for example, when we were writing the Administration's 
version of the Clean Air Act, EPA used a consultant that didn't 
share its model, and a lot of the Clean Air Act was being 
driven by the results of this model, in my opinion, and I don't 
think that was an appropriate way to conduct the development of 
that very important piece of legislation.
    Senator Rounds. Thank you.
    Dr. Calabrese, as a scientist, can you speak to the value 
of studies that can be replicated?
    Mr. Calabrese. Replication is a pretty complicated question 
because it is really--in many ways, replication is the gold 
standard, especially when you are dealing with low dose 
exposures. High dose exposures is one thing, where you kind of 
overwhelm systems with massive exposures, and you can see 
effects, but human exposures are going to be at much lower 
levels, and you really want to see if there are adverse effects 
that you are trying to prevent and you think might be 
occurring, then you want to be able--in your experimental 
systems, you want to be able to see if these findings are 
reproduceable or not.
    The problem with these types of things is that, especially 
with regards to epidemiologic data and to somewhat minor 
effects, a lot of times a study comes out positive in one and 
then can't be replicated in many other studies. So the gold 
standard is that we really have to hold the scientific 
researchers accountable for essentially providing reliable 
information to regulatory agencies and to society to give us 
confidence that the findings are sustainable and are 
believable, and this doesn't have to necessarily involve an 
exact replication, but would have to involve some type of 
confirmatory reliability that is substantial, that adds strong 
weight of evidence to any conclusion.
    Senator Rounds. Thank you.
    Dr. Holt, I am just curious. It would seem to me that for 
those of us that have to make decisions based upon 
recommendations from any type of an agency, in this case either 
Republican or Democrat, it seems to me the most data that we 
can get, and that which can be identified as being 
scientifically and peer reviewed, would be welcome by the 
scientific community, but you have expressed a real doubt about 
the intent of moving forward with that, and I am just curious. 
It seems as though the movement toward using sound science and 
one with as much transparency as possible would be a positive 
thing, and I am just curious.
    I have heard your opening statement, but I am kind of 
surprised that there wouldn't be more of a welcoming to a peer 
reviewed discussion with a number of different points of view 
that would be brought in, and I am missing something, I think, 
on it. Could you maybe elaborate a little bit, please?
    Mr. Holt. Yes, thank you. Surely, you do want verification. 
EPA is required to base their work on science, actually 
different from most regulatory agencies. It is written into the 
laws. In other words, you should be using current science. And 
the science is not just the collection of data; it is 
collection of data in a way that removes bias; it is assembly 
of the data that--I mean, it has to be empirical, based on 
experiment, observation, and then it has to be verified, and 
that is the key word.
    It is really a red herring to say replication is what is 
necessary. The verification can come in various ways: through 
repeating the experiment, if it is an experiment. But even most 
experiments are hard to repeat exactly, and certainly natural 
disasters. Senator Booker referred to the Gulf oil discharge. 
Let's hope that isn't repeatable. There are many circumstances 
where it can't be repeated in exactly the same way.
    But it can be verified through peer review, through 
independent verification, through confirmation of the studies 
by putting them in the context of other studies. That is the 
way science works. And it is science, this whole process that 
you want to be maximized in the regulatory process.
    Senator Rounds. Thank you.
    Senator Booker.
    Senator Booker. I am going to defer to my colleague and 
friend, Senator Carper.
    Senator Rounds. Senator Carper.
    Senator Carper. Thank you so much for deferring.
    A quick question of you, Dr. Holt. I am not going to ask a 
yes or no question of you, but anything that the other two 
witnesses said that you would say, yes, that is right, I agree 
with that? Have they said anything that you agree with?
    Mr. Holt. Well, yes. I mean, certainly that we need----
    Senator Carper. Briefly mention one of the things that you 
may heard.
    Mr. Holt. Yes. More evidence. Clearly, we always want more 
evidence in this day and age, when evidence, opinion, and 
ideology are considered interchangeable.
    Senator Carper. Good.
    Same question, Dr. Calabrese, of you and Mr. Hahn. Anything 
that Rush said that you agree with even a little bit?
    Mr. Calabrese. I would have to say I agree only a little 
bit with a couple of points that he made, and that is in many 
ways, I agree, the Agency is directed toward science based 
regulation. But the problems with science based regulation are 
the assumptions upon which the science essentially feeds into, 
and that is that we have national toxicology program studies 
that use very high doses, three doses at extremely high doses 
that may be 100,000-fold more than what people may be exposed 
to, and we have unverified----
    Senator Carper. I am going to stop right there. Thank you. 
We will ask you to continue to respond for the record, if you 
will. I have little time.
    Mr. Hahn, anything that he said that you actually agree 
with? If you could be very brief in stating.
    Mr. Hahn. The answer is yes, and I think we all agree that 
agencies should use the best science, and they should have a 
transparent process so people and experts can understand what 
we are getting. I think the point of disagreement is about 
whether the proposals before us, the proposed rule and the 
HONEST Act, whether they move the ball forward or whether they 
don't, and my reading is that they do move the ball forward.
    Senator Carper. OK. Thank you.
    A question, if I could, of Dr. Holt. I think it was in May 
of this year we learned that political appointees within EPA 
have stalled the release of EPA's formaldehyde risk assessment. 
The risk assessment reportedly concludes that formaldehyde 
causes cancer and leukemia. This health assessment has been 
years in the making and is ready to be peer reviewed, but EPA's 
political folks are insisting on keeping it under lock and key 
in response to industry pressure.
    My question of you, Dr. Holt, is how would you respond to 
the concern that EPA is keeping its own formaldehyde science 
secret, while simultaneously claiming that it needs a new rule 
to ``strengthen the transparency of EPA's regulatory science''?
    Mr. Holt. Senator Booker pointed out the irony in this. 
There does seem to a double standard there. I am not expert on 
the formaldehyde study per se, and in fact, much of it is not 
available for examination.
    Senator Carper. All right.
    Let me try another question, if I could, Dr. Holt. EPA's 23 
Federal advisory committees were established, I believe, to 
advise the Agency on environmental science, on public health 
safety, and other subjects that are central and critical to 
EPA's work.
    Last year EPA announced that it would prohibit scientists 
who receive EPA grants from serving on its Federal advisory 
committees. In 1999 a Federal appellate court rejected a nearly 
identical approach at HHS, reasoning that members of these 
committees are ``selected because they are experts in that 
field'' and therefore, it is not surprising that HHS would also 
fund their research.
    My question: Given that EPA's advisory committees should 
include the best scientists, shouldn't EPA eliminate its 
seemingly unlawful effort to exclude anyone with an EPA grant 
from serving on them?
    Mr. Holt. Senator, I would refer you to a statement that we 
made, our organization made some months ago. I won't take much 
time from this hearing because that is somewhat apart from the 
subject of this hearing, but in EPA in particular, the science 
advisory process is essential. And I don't want to get into how 
much or if it is being degraded, but it is important to defend 
that scientific advisory process in the EPA.
    Senator Carper. All right.
    One last question, Dr. Holt. Given that the rulemaking 
process, rewriting a rule or litigating a rule, are costly 
endeavors, shouldn't EPA either withdraw the rule entirely or 
perhaps remedy all the problems before finalizing it?
    Mr. Holt. That is what I was trying to get at when I said I 
don't see the reason to change this. If there is deficiency in 
how it has worked up to now, then we can talk about what 
changes might be needed. But I don't see the deficiencies.
    Now, some people have said, for example, the six cities 
Harvard study that found deadly effects of small particulates 
was a flawed study, but most people don't think it was a flawed 
study, and in fact, it has been verified in a variety of ways. 
And yet that has been the example that has been used for why we 
need a change in transparency, a change in procedures at EPA.
    So, unless I am convinced that what has been done is wrong 
and needs to be changed, I don't see why we should have this or 
any variation on it.
    Senator Carper. Mr. Chairman, thanks for allowing Dr. Holt 
to answer that question, and my thanks to Senator Booker for 
yielding his time to me. Thank you.
    Senator Rounds. Thank you, sir.
    At this time, I will turn to the full Committee Chairman, 
Senator Barrasso.
    Senator Barrasso. Thank you, Senator Rounds. Thanks for 
holding this important hearing.
    Mr. Hahn, I was wondering. President Obama issued an 
executive order 7, 8 years ago, I think 2011, stating, he said 
regulations ``must be based on the best available science.'' 
Does the EPA's current proposed rule to strengthen the 
transparency of the Agency's use of regulatory science, does 
this align with what President Obama asked for in 2011?
    Mr. Hahn. I don't know exactly the text of what President 
Obama said, but to me, we all agree, there is consensus, that 
rules should be based on the best available science. And I 
would even go further and say we should roll rules out slowly 
so we can learn about what works and what doesn't work, and do 
pilot studies and feed that back into our knowledge.
    The real issue is what is happening on the ground at 
agencies like EPA, HHS, independent agencies like the Federal 
Communications Commission, and that is kind of my wheelhouse, 
where we do benefit-cost analyses. We see that some of the 
regulations that come out of these agencies are incredibly 
beneficial, like seatbelt regulations, like the smoking 
regulation you talked about earlier, and some of them are not 
so beneficial, they are very expensive and actually don't 
improve overall consumer welfare.
    So the short answer is yes, this rule, in my view, promotes 
the best available science, but I would like to see Congress 
more generally pushing in the direction of promoting evidence 
based policy.
    Senator Barrasso. Dr. Calabrese, your testimony notes a lot 
of health models currently used to inform regulatory decisions 
are based on data gathered 60 years ago. These models also use 
scientific assumption developed during that era.
    How have the advances in science and technology improved 
the scientific community's ability to produce more accurate 
results and research?
    Mr. Calabrese. There has been a wealth of scientific 
development since the first proposal for the use of LNT for 
cancer risk assessment back in 1956, and essentially what we 
have had since the 1950s to the present time is really policy 
driving science. But we have such substantial scientific 
development that really has to be switched around, and science 
has to now drive policy. And my understanding of the dose 
response relationships in great detail is that the simplistic 
linearized model of the 1950s did not take into account the 
plethora of biology that we have today, and the regulatory 
agencies need to be flexible to the science and let science 
drive policy, rather than the other way around.
    Senator Barrasso. Mr. Hahn, EPA's proposal allows the 
Administrator to grant case by case waivers to use scientific 
studies which may not be able to meet the new transparency 
studies. Do you believe that the proposal's waiver is an 
appropriate method to provide flexibility, while maintaining 
the strong transparency standards that we are looking for?
    Mr. Hahn. The short answer to your question is yes, but I 
haven't thought carefully about other ways of doing that that 
could potentially be better.
    Senator Barrasso. Dr. Calabrese, your testimony also states 
that hidden assumptions in the EPA's secret science are often 
kind of silent drivers of regulatory action. Could you please 
describe how secret science can bias decisions made from a 
regulatory standpoint?
    Mr. Calabrese. Yes. The so called what I call the secret 
type sciences is essentially you might have really excellent 
studies that deal with an animal model that has very little 
relevance to a human population, yet we assume that the human 
population is responding exactly like the information provided 
by the animal. So, the science can be great, but the relevance 
of a human population can be pretty much nil, and yet that is 
what the belief systems are based on, and regulations are based 
on, and there are a whole series of other specific examples 
like that.
    Senator Barrasso. Thank you very much.
    Thank you, Mr. Chairman.
    Senator Rounds. Senator Booker.
    Senator Booker. I just want you to know, Mr. Chairman, I am 
not intimidated at all by going after the Chairman. He and I 
have a lot in common. He has a degree in science, biology, 
chemistry. I have a degree in science as well, political 
science.
    [Laughter.]
    Senator Barrasso. And we are both left handed, as are 
several of the panelists today. It is a big day.
    Senator Booker. Yes.
    Senator Barrasso. What about you, Carper? We have three 
left handers here and a couple left handers there.
    Senator Booker. That is pretty good. That is pretty good.
    Dr. Holt, Mr. Hahn used a football analogy which was an 
appeal to my more baser qualifications for the job I am in, as 
a former football player, where he talked about moving the ball 
up the field or not. He said that is what this is about.
    Clearly, you want transparency. Clearly, you have talked 
about the urgency for transparency, the urgency for good 
science. But I just don't think what is being clearly stated is 
that this very great tune of saying, hey, we want more 
transparency actually doesn't move the ball forward; it 
actually is going to move the ball back and hurt, potentially, 
the health and well-being of folks.
    Could you succinctly explain one more time why such a 
proposed rule and the legislation actually could devastatingly 
hurt the safety and security of the American public?
    Mr. Holt. The rule excludes the use of some kinds of 
research, and there are long lists of actual research or 
potentially relevant research that would be eliminated by any 
likely interpretation or application of this rule. I would 
direct the Senators to a letter I believe is available to you, 
I can certainly make it available to you, from the Emmett 
Environmental Law and Policy Clinic at Harvard Law School about 
the transparency rule. It is signed by presidents of hospitals 
and universities. They have a long list of valid research that 
they believe by any reasonable interpretation of this rule 
would be unusable in making regulatory policy.
    And as I said in my prepared remarks, if you don't use all 
the good relevant science, people will be hurt.
    Senator Booker. Right. And so the fact that the majority of 
your membership organization has spoken out against this; the 
EPA's own Science Advisory Board has spoken out against this; 
you have universities and other science folks saying don't do 
this because you are going to exclude relevant science, you are 
going to undermine the safety of individuals because much of 
this is not replicable; all these things should scream to us 
that there is something wrong, even though the buzz words sound 
really good.
    I want to bring your attention to a strategy that was used 
by those industries that were trying to prevent health and 
safety standards that we take for example, cigarette smoking 
has been brought up. The EPA's proposed rule sounds so much 
similar. This secret science rhetoric that was used by the 
tobacco industry is the same rhetoric that is being used right 
now.
    At the time, the tobacco industry lobbyists sought to 
create process based hurdles that would make it harder for 
agencies to establish guidelines and safeguards for secondhand 
smoke exposure. Rumored proposals would have prohibited the EPA 
from using a study unless it was considered replicable and all 
the underlying data in that study was released to the public.
    This is deja vu all over again, as another New Jerseyan 
once said.
    So here is industry--and this is the irony of this moment 
for me--is that you have industry working really hard to stop 
the transparency on things like the methane rule, on what we 
are seeing right now with the methylene chloride, and then on 
other areas they are trying to stop us regulating things just 
like we did with the tobacco industry.
    You have been, obviously, down here for 16 years of your 
career. Do you see this double standard and hypocrisy being 
used to try to do things that hurt the public health when it 
benefits industry, and doing things that undermine science?
    Mr. Holt. Well, in my testimony I talked about a likely 
motivation of the people who are proposing this because they 
are proposing it as part of a deregulatory regime, but I wanted 
to get beyond that because really what I wanted to talk about 
is not whether it is a double standard and what the motivation 
is, but what would the effect be. And this is not just me 
saying this; I mentioned this Environmental Law Clinic, but the 
Thoracic Medical Society, the American Geophysical Union, the 
American Chemical Society; many, many organizations and even 
far more individual scientists are saying the effect would be 
that science that we know to be good science would likely be 
excluded.
    Senator Booker. And just to make this last comment, exactly 
what you said is the issue with the methylene chloride, which 
people are dying from in the United States of America. It has 
been responsible for dozens of deaths. Under the TSCA law, 
bipartisan TSCA law, the EPA proposed a ban on methylene 
chloride in paint strippers in 2017, and in 2018 the Agency 
said it would finalize a rule, yet they haven't acted. The 
scientific basis for the proposed ban on methylene chloride 
comes from an Agency risk assessment that received extensive 
interagency review and external peer review by independent 
scientists and relied on high quality studies but--and the 
point of here--the underlying case studies are not publicly 
available because of protecting information.
    So this is an example of what you are saying of how this 
would stop the banning of this chemical, which we know now 
needs to be banned; other nations have done it.
    So I would just like to submit for the record, Mr. 
Chairman, if I can ask unanimous consent to submit for the 
record comments and letters from the Boston University School 
of Public Health, the California Environmental Protection 
Agency, the Project on Government Oversight, the Environmental 
Defense Fund, the Natural Resource Defense Council, all 
demanding that the rule be withdrawn immediately, and the 
Ecological Society of America, which opposes the EPA's rule.
    Senator Rounds. Without objection.
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    Senator Rounds. Senator Ernst.
    Senator Ernst. Thank you to our witnesses today, and thanks 
for holding the hearing, Mr. Chair.
    Mr. Hahn, in your written testimony you stated that your 
research found that some of the EPA's environmental assessments 
were not always of high quality, and these assessments went on 
to form the basis for major regulations.
    Can you go into a little bit more detail on this or specify 
which regulations you found to be based on low quality 
environmental assessments?
    Mr. Hahn. So, I did that research about 10 years ago, and I 
can't give you a list of a top 10, and journalists often ask 
me, but I can give you some examples of what the problems were.
    Senator Ernst. OK. That would be helpful.
    Mr. Hahn. And some of these problems have been fixed. But 
you get a 200-page regulatory impact assessment, which is great 
for insomnia, on some chemical, and frequently the Agency 
doesn't summarize in a very clear way what their main findings 
are; they don't necessarily pay attention to the alternatives 
which they were supposed to think about in finding the best and 
cheapest way of achieving the result; they don't necessarily 
count all the benefits they should have.
    So, there were real deficiencies in the analytical rigor 
that was underlying these regulatory proposals. And some of the 
administrators at EPA and other agencies have tried to fix some 
of these things; I don't know how well they are doing.
    But what I would say generally--and I am sorry Senator 
Booker had to leave--I think it is a really good idea to be 
able to share data and models, because even at the highest 
level of academia, even with peer reviewed publications there 
are frequently errors.
    A couple of professors from Harvard, who shall remain 
nameless but everyone knows who they are, wrote a very 
influential book about how long it should take to recover after 
the last Great Recession, and it turns out there were some 
fundamental errors in their analysis that wouldn't have been 
uncovered but for the fact that their data was shared, which is 
a good idea. So, I think it is a really good idea to be 
thinking about sharing data.
    At the same time, I agree with you that we don't want to 
necessarily eliminate, by law or regulation, some very 
persuasive data that is published in peer reviewed journals, 
but my bugaboo is it is really important to share this data so 
other people can take a look at it in sunlight so that, when 
you are passing a regulation that is going to impose costs on 
people or make them lose their job, that you have the best 
available evidence upon which to make those decisions.
    Senator Ernst. No, I thank you for that.
    So, just going back and maybe repeating in different terms 
some of what you just said, it is possible, then, that some of 
those assessments were made, and they were the result of maybe 
shoddy work or perhaps errors; is that correct?
    Mr. Hahn. To use a phrase that my 3 year old niece used 
many years ago when I was doing this research, some of it was 
stinky.
    Senator Ernst. Well, that is a great way to describe it. Do 
you think that the EPA was trying to tailor the assessments to 
support the need for regulations in some of those cases, 
perhaps?
    Mr. Hahn. I think it is possible. It is something that is 
very hard to prove, but we all live in Washington, DC.
    Senator Ernst. Certainly. And that is why I think that 
having transparency and peer review is important; a little bit 
of sunlight there. If a regulation is truly needed, then you 
shouldn't be opposed to having other people take a look at the 
methodology there.
    Dr. Holt, this ties into this conversation as well. Some of 
those regulations turned out by various Federal agencies, 
including EPA, do pose economic threats to certain industries, 
and of course, a number of those communities that rely on those 
industries. If you were to be an employee of one of those 
industries or live in a community where a lot of that economic 
thrust is involved, shouldn't you want to know every bit of 
information or data that is being used by those different 
agencies to develop the regulation that might threaten your 
very job or even your entire community?
    Mr. Holt. Surely, there are regulations that don't work 
well, that are improper, that even should be removed, but the 
approach to making regulations is not to limit bad regulations 
by limiting the science that might lead to regulations, which 
is what is going on here. The full science should be available. 
And this is not to make science more available; the effect is 
to restrict the science that is available, because the whole 
rule is about removing some studies that cannot be used to make 
regulations. So, we should ask, are we throwing out some good 
science here. And the answer that is arrived at by science 
society after science society, science after scientist, is yes, 
it would be throwing out good research.
    Senator Ernst. Well, I certainly appreciate all of the 
different opinions here today.
    Thank you, Mr. Chair.
    Senator Rounds. Thank you.
    Senator Whitehouse.
    Senator Whitehouse. Thank you, Chairman. I appreciate this 
hearing.
    Dr. Holt, in a circumstance in which science discovers that 
a substance or a chemical is harmful to human health, and there 
is an industry involved in the manufacture or the distribution 
of that chemical or substance, and that industry wants to fight 
back against the science, what sort of an apparatus does such 
an industry have at its disposal to take on the enterprise of 
science?
    Mr. Holt. Well, let me stick to the subject at hand here. 
An approach that they might use is to say that their test 
results are proprietary. And under this rule, if it were in 
effect, the studies that might be available would not be 
available because they have a legitimate claim to keep their 
data proprietary, non-public; and therefore, some good science 
that had been verified in appropriate ways would not be 
available to the regulatory agency.
    Senator Whitehouse. Setting aside that question for a 
minute and back to my original question, does an industry in 
that predicament have access to an array of groups that have 
experience in trying to deprecate science and foment 
alternative views?
    Mr. Holt. Well, as I have heard you speak often, there is 
an imbalance in access to resources, access to media, and 
access to public persuasion, so the regulatory agencies are set 
up in order to try to restore that imbalance, to make sure that 
all parties have input to the regulatory process.
    Senator Whitehouse. The concern or a concern that I have 
about the very title of this hearing, Sound and Transparent 
Science--which in theory is a very good thing--goes back to a 
phrase that has been kicked around in this conversation called 
secret science, which I think is a highly misleading term. My 
understanding is that very often in public health, in order to 
get data, you look at people's public health records; you look 
at who got sick, who didn't. You look at the health records of 
human beings.
    The condition of getting access to those records is that 
you don't give that private information out publicly. People's 
families might not want to know about it; people might not want 
their employers to know about it. There might even be cases 
where they don't want their insurance companies to know about 
it.
    Will you agree with me that it should not be the price of 
having health records form the basis for scientific study that 
the individuals involved lose all their privacy with respect to 
their health records?
    Mr. Holt. Still directed at me?
    Senator Whitehouse. Yes.
    Mr. Holt. Yes. You are right. As I said earlier, there 
really is no secret science. There should be fully available 
science when it comes to making regulation, and that science--
--
    Senator Whitehouse. And the term ``secret'' really----
    Mr. Holt [continuing]. That science is not just the data. 
Some of the data must be kept non-public because of health 
records, because of legal proprietary information, because of a 
number of other things.
    Senator Whitehouse. But if you were an industry----
    Mr. Holt. But the science itself, the process of taking 
those data and verifying them should not be secret. But that is 
not what this rule or this legislation would deal with.
    Senator Whitehouse. If you were an industry that wanted 
strategically to knock down public health science so that the 
dangers of your product were not understood or made public, 
then this would be a pretty handy way to go about it, because 
you disable an entire field of legitimate public health science 
by calling secret science science that actually only depends on 
people's health records.
    Mr. Holt. I think it could be used that way.
    Senator Whitehouse. May I ask unanimous consent that a 
curriculum vitae for Dr. Calabrese dated August 2013 be put 
into the record? I don't know if it is in the record already, 
but it is a pretty good summary of some of his industry clients 
and how much they have paid him over the years, and I think 
that is important in judging the witness's conflicts of 
interest here. So, if I could add that to the record.
    Senator Rounds. Without objection.
    Senator Whitehouse. Thank you.
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    Senator Rounds. I am going to take just a little bit of 
liberty here. I really do appreciate the participation of all 
of our witnesses here today.
    I look back at the time in which I have had an opportunity 
to serve on this Subcommittee, and the idea on it is to be able 
to provide oversight, and part of that is to ask questions 
about how the determinations are made.
    Part of the discussion on that, and I think regardless of 
which side of the dais you sit on, you want sound science, and 
you want the opportunity to be able to look at it and to ask 
the same questions that you would as if we all had scientific 
background; what would we be asking with regard to how that 
determination is made, and what data is available,, and how is 
it come up with, as much to be able to support the regulatory 
processes and say, look, we may disagree with the regulatory 
outcome, but we understand the science that was used behind it, 
and we can dispute it, or we can agree with it, back and forth.
    It seems to me that there must be a way for an agency with 
regulatory oversight responsibilities to be able to share over 
a period of time a process that could be agreed upon very 
similar to, and I am thinking about the National Science 
Foundation, where, time and again, there are different projects 
that are looked at, they are peer reviewed, they are looked at 
objectively by outside groups who then discuss clearly how they 
come to a conclusion as to which way they work; what should be 
included, whether or not the projects meet the appropriate 
funding guidelines, and so forth.
    Speaking from experience as a former Governor who worked on 
a National Science Foundation, at that point we were looking at 
National Science Foundation work for an underground laboratory 
to be located in Lead, South Dakota. Matter of fact, Princeton 
was one of the universities which participated in a lot of 
work. And we went through an extended period of time in which 
there were peer review processes to determine whether or not 
this was one of the sites at which an underground laboratory 
looking for neutrinos would be built, and I found it 
fascinating that although there was constant discussion among 
the different science organizations who were working on 
different locations, there was an acceptance that the basic 
process of sound science would win out.
    Now, whether we use the terms of being able to replicate 
something or to be able to say that it is verifiable, become 
items that within the science community have clear and defined 
terms. But these are the types of discussions that we need to 
have if we are going to get to the point where, over a period 
of time, regardless of which Administration it is, they should 
be held accountable for using the appropriate science, year in, 
year out.
    And an oversight committee such as this, regardless of 
whether there are Republicans responsible for operating as a 
majority or Democrats, and regardless of whether the 
Administration is Republican or Democrat, there should be 
certain accepted standards that either Republican or Democrat 
administrations should be held to adhere to with regard to how 
the regulatory processes are determined, and the accepted facts 
that are being used in making those regulations. That is what 
this is all about.
    I don't think there is anything wrong with questioning the 
existing program which is out there, because most certainly 
there are questions that are raised on a regular basis. It does 
not mean that any one of the existing proposals is perfect, but 
most certainly I think the discussion that you all have held 
today, and the differing points of view that you have, has been 
very helpful to this Committee in trying to move forward, and I 
would just thank you all for your input today.
    Senator Whitehouse. Can I ask two more unanimous consents? 
One to put into the record a memorandum from the public 
relations firm of Bracewell and Patterson dating back to 1996 
for the R. J. Reynolds Tobacco Company, and the other an action 
plan called The Secret Science Action Plan, prepared for 
Phillip Morris.
    Senator Rounds. Without objection.
    Senator Whitehouse. Thank you, sir.
    Senator Rounds. Thank you.
    [The referenced information follows:]
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    Senator Rounds. With that, once again I want to thank all 
of our witnesses here today. You add to the discussion.
    I would also like to thank our colleagues who have attended 
this hearing for their thoughts and questions.
    The record will be open for 2 weeks, which brings us to 
Wednesday, October 17th.
    With that, this hearing is adjourned.
    [Whereupon, at 3:35 p.m. the Committee was adjourned.]
    [Additional material submitted for the record follows:]
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