[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]





                      ENSURING OPEN SCIENCE AT EPA

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

                                HEARING

                               BEFORE THE

                      SUBCOMMITTEE ON ENVIRONMENT

              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                               ----------                              

                           FEBRUARY 11, 2014

                               ----------                              

                           Serial No. 113-65

                               ----------                              

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





[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]






                      ENSURING OPEN SCIENCE AT EPA

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

                                HEARING

                               BEFORE THE

                      SUBCOMMITTEE ON ENVIRONMENT

              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 11, 2014

                               __________

                           Serial No. 113-65

                               __________

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





[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]





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






                               __________

                         U.S. GOVERNMENT PRINTING OFFICE 

88-135PDF                     WASHINGTON : 2014 
-----------------------------------------------------------------------
  For sale by the Superintendent of Documents, U.S. Government Printing 
  Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800 
         DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, 
                          Washington, DC 20402-0001














              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

                   HON. LAMAR S. SMITH, Texas, Chair
DANA ROHRABACHER, California         EDDIE BERNICE JOHNSON, Texas
RALPH M. HALL, Texas                 ZOE LOFGREN, California
F. JAMES SENSENBRENNER, JR.,         DANIEL LIPINSKI, Illinois
    Wisconsin                        DONNA F. EDWARDS, Maryland
FRANK D. LUCAS, Oklahoma             FREDERICA S. WILSON, Florida
RANDY NEUGEBAUER, Texas              SUZANNE BONAMICI, Oregon
MICHAEL T. McCAUL, Texas             ERIC SWALWELL, California
PAUL C. BROUN, Georgia               DAN MAFFEI, New York
STEVEN M. PALAZZO, Mississippi       ALAN GRAYSON, Florida
MO BROOKS, Alabama                   JOSEPH KENNEDY III, Massachusetts
RANDY HULTGREN, Illinois             SCOTT PETERS, California
LARRY BUCSHON, Indiana               DEREK KILMER, Washington
STEVE STOCKMAN, Texas                AMI BERA, California
BILL POSEY, Florida                  ELIZABETH ESTY, Connecticut
CYNTHIA LUMMIS, Wyoming              MARC VEASEY, Texas
DAVID SCHWEIKERT, Arizona            JULIA BROWNLEY, California
THOMAS MASSIE, Kentucky              MARK TAKANO, California
KEVIN CRAMER, North Dakota           ROBIN KELLY, Illinois
JIM BRIDENSTINE, Oklahoma
RANDY WEBER, Texas
CHRIS COLLINS, New York
VACANCY
                                 ------                                

                      Subcommittee on Environment

                 HON. DAVID SCHWEIKERT, Arizona, Chair
JIM BRIDENSTINE, Oklahoma            SUZANNE BONAMICI, Oregon
F. JAMES SENSENBRENNER, JR.,         JULIA BROWNLEY, California
    Wisconsin                        DONNA F. EDWARDS, Maryland
DANA ROHRABACHER, California         MARK TAKANO, California
RANDY NEUGEBAUER, Texas              ALAN GRAYSON, Florida
PAUL C. BROUN, Georgia               EDDIE BERNICE JOHNSON, Texas
RANDY WEBER, Texas
LAMAR S. SMITH, Texas






















                            C O N T E N T S

                           February 11, 2014

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

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

                           Opening Statements

Statement by Representative David Schweikert, Chairman, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology, U.S. House of Representatives......................    10
    Written Statement............................................    11

Statement by Representative Suzanne Bonamici, Ranking Minority 
  Member, Subcommittee on Environment, Committee on Science, 
  Space, and Technology, U.S. House of Representatives...........    11
    Written Statement............................................    13

Statement by Representative Lamar S. Smith, Chairman, Committee 
  on Science, Space, and Technology, U.S. House of 
  Representatives................................................    14
    Written Statement............................................    15

Statement by Representative Eddie Bernice Johnson, Ranking 
  Member, Committee on Science, Space, and Technology, U.S. House 
  of Representatives.............................................    16
    Written Statement............................................    17

                               Witnesses:

The Honorable John Graham, Dean, School of Public and 
  Environmental Affairs, Indiana University
    Oral Statement...............................................    19
    Written Statement............................................    21

Dr. Louis Anthony Cox, Jr., Chief Sciences Officer, Next Health 
  Technologies, Clinical Professor, Biostatistics and 
  Informatics, Colorado Health Sciences Center, and President, 
  Cox Associates
    Oral Statement...............................................    34
    Written Statement............................................    37

Dr. Ellen Silbergeld, Professor, Bloomberg School of Public 
  Health, Johns Hopkins University
    Oral Statement...............................................    44
    Written Statement............................................    46

Mr. Raymond Keating, Chief Economist, Small Business & 
  Entrepreneurship Council
    Oral Statement...............................................    67
    Written Statement............................................    69

Discussion.......................................................    78

             Appendix I: Answers to Post-Hearing Questions

The Honorable John Graham, Dean, School of Public and 
  Environmental Affairs, Indiana University......................   110

Dr. Louis Anthony Cox, Jr., Chief Sciences Officer, Next Health 
  Technologies, Clinical Professor, Biostatistics and 
  Informatics, Colorado Health Sciences Center, and President, 
  Cox Associates.................................................   117

Dr. Ellen Silbergeld, Professor, Bloomberg School of Public 
  Health, Johns Hopkins University...............................   122

Mr. Raymond Keating, Chief Economist, Small Business & 
  Entrepreneurship Council.......................................   201

            Appendix II: Additional Material for the Record

Letter from the American Lung Association, submitted by 
  Representative Suzanne Bonamici, Ranking Minority Member, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology.....................................................   208

Letter from the Center for Progressive Reform, submitted by 
  Representative Suzanne Bonamici, Ranking Minority Member, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology.....................................................   210

Letter from the Natural Resources Defense Council, submitted by 
  Representative Suzanne Bonamici, Ranking Minority Member, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology.....................................................   228

Letter from the Union of Concerned Scientists, submitted by 
  Representative Suzanne Bonamici, Ranking Minority Member, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology.....................................................   241

George Mason University Survey: Expert Opinion on Regulatory Risk 
  Assessment, submitted by Representative David Schweikert, 
  Chairman, Subcommittee on Environment, Committee on Science, 
  Space, and Technology..........................................   243

The Bipartisan Policy Center's The Science for Policy Project: 
  Improving the Use of Science in Regulatory Policy, submitted by 
  Representative David Schweikert, Chairman, Subcommittee on 
  Environment, Committee on Science, Space, and Technology.......   255

Recommendation from the Administrative Conference of The United 
  States, submitted by Representative David Schweikert, Chairman, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology.....................................................   325

Dr. Adrian G. Barnett, Institute of Health and Biomedical, 
  Innovation and School of Public Health, Queensland University 
  of Technology, Kelvin Grove, Queensland, Australia, letter to 
  the Editor in response to the article, ``Benefits of Publicly 
  Available Data,'' submitted by Representative David Schweikert, 
  Chairman, Subcommittee on Environment, Committee on Science, 
  Space, and Technology..........................................   332

Letter from the Halogenated Solvents Industry Alliance, Inc., 
  submitted by Representative David Schweikert, Chairman, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology.....................................................   334

 
                      ENSURING OPEN SCIENCE AT EPA

                              ----------                              


                      WEDNESDAY, FEBRUARY 11, 2014

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

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


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Chairman Schweikert. Let's have at it. The Subcommittee on 
Environment will come to order. And that was my gavel. Welcome 
to today's hearing ``Ensuring Open Science at EPA.'' In front 
of you are packets containing the written testimony, 
biographies, and truth-in-testimony disclosures for today's 
witnesses.
    This is also my very first hearing chairing this 
Subcommittee and so I was going to do something a little off 
the normal script. I first was going to turn to my soon-to-be 
very good friend from Oregon, Ranking Member Bonamici, and I 
have got to say thank you for your kindness. I am going to take 
a somewhat different tack than often happens at many of these. 
I actually have a fascination with the underlying science and 
want to try to do this as credibly as possible, you know, 
because this in some ways should be almost beyond the--
sometimes the right/left paradigm we engage in. This is 
hopefully about facts.
    On a philosophical level--and forgive me for going there--
for today's hearing how do you have a civil society with our 
public when our leaders, when the people around us, almost no 
one trusts our institutions anymore? You know, how do you have 
a society and hold it together when we don't trust our 
government, we don't trust our agencies, we don't trust so much 
around us? And my great hope is this being sort of a first step 
is a movement towards a level of transparency where I don't 
care whether you are a group from the right, left, or just 
someone from academia. The ability in today's world--when my 
laptop computer is now more powerful than the quad Xeon server 
I have at home, for all of us, our ability to actually--if you 
were crazy enough or were interested enough in your quant class 
to take the data, to understand it, to analyze it, to have an 
opinion, does that openness, does that transparency--and the 
President actually talked about this when he was first elected, 
that a transparent, open government develops hopefully a faith 
and trust with its population. Can we head that direction?
    And I know we get into certain things like I consider sort 
of red herrings, absurdities. There are ways to protect 
people's privacy. We do it every day. I come more from the 
financial side of the world having sat on Financial Services 
before, and data that was collected by CFPB and so many of the 
other agencies, they have systematic methodologies where they 
protect individuals' privacy.
    But I am--my great hope here as we sort of move forward on 
H.R. 4012, that we are sort of building a precedence of how do 
I build public data for public policy and public policy by sort 
of egalitarian public data where we all have the right to know 
what is underlying?
    And my last caveat for--and I have been thinking about this 
one a lot--and this is both for my friends on the right, the 
left, and our staff, you are going to have to step beyond sort 
of the confirmation bias. Let's say we are here a couple years 
from now and all of us have access to underlying baseline data 
and it is being used for regulatory or policy, don't think it 
is always going to say what you think it is going to say. There 
are going to be times when the data sets may say the agency 
isn't going far enough. There may be other times it turns 
around and says when you stress the data that we need to be 
going a very different approach, but at least it will be 
honest. And being fixated on sort of crowdsourcing of 
information, I believe the crowd does purify policy and I hope 
we are going that direction.
    [The prepared statement of Mr. Schweikert follows:]

           Prepared Statement of Subcommittee on Environment

                       Chairman David Schweikert
    I actually have fascination with the underlying science. And I want 
to try and do this as credibly as possible. Because this, in some ways 
this should be almost beyond the sometimes left right paradigm we 
engage in, this should be about facts.
    How do you have a civil society when our leaders, our public don't 
trust our institutions anymore? We don't trust our government, we don't 
trust our agencies, we don't trust so much around us. A transparent, 
open government develops, hopefully, a faith with its population.
    My great hope is, this being sort of a first step, is movement 
towards a level of transparency, where I don't care if you a group from 
the right or the left, or just someone from academia the ability in 
today's world . . . to take the data, to understand it, to have an 
opinion.
    A transparent, open government develops, hopefully, a faith with 
its population. Can we head that direction?There are ways to protect 
people's privacy, we do it every day.
    My great hope here is we sort of move forward on H.R. 4012, that we 
are sort of building a precedence on how do I build public data for 
public policy, and public policy by egalitarian public data, where we 
all have the right to know what is underlying.
    You are going to have to steep beyond confirmation bias. Don't 
think it (the data) is always going to say what you think it is going 
to say. There is bound to be times when the data sets may say the 
agency isn't going far enough. There may be other times it says when 
you stress the data, we need to be going with a different approach.
    I believe the crowd does purify policy, and I hope we are going in 
that direction.

    Chairman Schweikert. And for an opening statement, my 
friend, Ms. Bonamici, Ranking Member.
    Ms. Bonamici. Thank you very much, Chairman Schweikert.
    I want to start by saying welcome and to offer my sincere 
congratulations to you on becoming our new Subcommittee 
Chairman. I am looking forward to working with you. I am 
hopeful that we can find common ground and develop meaningful 
solutions to our Nation's important environmental challenges.
    And, I agree; improving transparency and public access, 
especially to federally funded research at the EPA or at any 
federal agency, is an important objective and one that I fully 
support. And although there may be disagreements about--among 
the Subcommittee Members about various actions that the EPA may 
be considering, I am confident that we all support increased 
transparency.
    Unfortunately, it appears that the language in the bill we 
are discussing today called the Secret Science Reform Act may 
actually prohibit EPA from increasing transparency. And I hope 
that this isn't an attempt to prevent or impede the EPA from 
promulgating regulations and performing its congressionally 
mandated priority objective of protecting human health and the 
environment.
    If implemented as written, this bill would actually prevent 
the EPA from using the best available science to inform its 
regulatory actions. The EPA relies on thousands of peer-
reviewed articles as part of their scientific review, and under 
this proposal, if for any reason all of the scientific and 
technical information associated with those articles was not 
publicly available, the EPA would have to proceed as if those 
studies did not exist. And that is not in the best interest of 
the American people who are our constituents. It is also not 
clear whether this proposal is retroactive. If so, then the 
legislation would essentially nullify all the progress we have 
made to date to improve the quality of the air our children and 
in fact all of our constituents breathe and the water that they 
drink.
    I am also concerned about the potential negative impacts 
that the bill could have on the scientific community. 
Researchers and organizations may be hesitant to conduct EPA-
funded research if they are required to disclose protected 
information like health records. Historically, researchers have 
been able to assure individuals participating in their studies 
that their personal information is safe, and that helps attract 
participants.
    Now, last year, this Committee took the unusual action of 
issuing a subpoena to acquire data that the EPA relied on when 
developing air quality regulations. This data, the basis of the 
Harvard 6 studies and the American Cancer Society study, 
contains personal health records of hundreds of thousands of 
Americans. And I presume that this is an example of the so-
called secret science that inspired this bill. But contrary to 
the assertion that the science behind those studies is secret, 
in fact, the legal owners of the data sets, Harvard University 
and the American Cancer Society, do allow legitimate 
researchers access to this information and they have procedures 
in place to protect it.
    So it is interesting this Committee did spend a significant 
amount of time scrutinizing HealthCare.gov and claiming that 
the website actually puts personal health records at risk. 
Frankly, I am a bit surprised that my colleagues do not now 
recognize the importance of protecting studies that actually do 
contain personal health information.
    But perhaps what is more troubling about this proposal--and 
I look forward to discussing it--is that it ignores the good 
work already done by this Committee. In 2010, this Committee 
reauthorized the America COMPETES Act, which requires the 
Office of Science and Technology Policy or OSTP to issue 
guidance to all federal agencies on the development of clear 
and coordinated policies to increase access to federally funded 
published research and digital scientific data. And it is my 
understanding that the EPA is currently in the process of 
developing policies pursuant to that guidance.
    This bill also seems to be inconsistent with the data and 
public access provisions included in the majority's FIRST Act. 
Although there are some open questions about specific 
provisions of the FIRST Act, the bill takes the more 
appropriate government-wide approach and requires consultation 
and input from the scientific and stakeholder community. It is 
worth having a real discussion--and again, we look forward to 
that--about how we can improve transparency and data access 
across the federal government.
    Additionally, as we have discussed, I hope we are able to 
have another hearing on this issue. I strongly encourage the 
participation of the EPA so that the Agency has an opportunity 
to appear before the Committee and provide on the record their 
analysis about the provisions of this bill. It would be 
logical--and I suggest this, Mr. Chairman--that we hold such a 
hearing in conjunction with our colleagues on the Research and 
Technology Subcommittee because they are also examining this 
issue very closely.
    Mr. Chairman, I truly hope we can work together to find a 
way to improve public access to federally funded research in a 
manner that does not compromise the EPA's mission to protect 
human health and the environment.
    Thank you again, and welcome to the Committee, Mr. 
Chairman, and I yield back the balance of my time.
    [The prepared statement of Ms. Bonamici follows:]

           Prepared Statement of Subcommittee on Environment

                Ranking Minority Member Suzanne Bonamici

    Thank you, Chairman Schweikert. I would like to start by saying 
welcome, and I offer sincere congratulations to you on becoming our new 
Subcommittee Chairman. I am looking forward to working with you and am 
hopeful that we can find common ground and develop meaningful solutions 
to our nation's important environmental challenges.
    Improving transparency and public access to federally funded 
research at EPA, or at any federal agency, is an important objective 
and one that I fully support. Although there may be disagreements among 
the Subcommittee Members about various actions that the EPA may be 
considering, I am confident that we all support increased transparency.
    Unfortunately, it appears the language in the bill we are 
discussing today, called the ``Secret Science Reform Act,'' may 
actually prohibit EPA from increasing transparency. I hope that this is 
not an attempt to prevent or impede the EPA from promulgating 
regulations and performing its Congressionally-mandated priority 
objective of protecting human health and the environment.
    If implemented, this bill would actually prevent the EPA from using 
the best available science to inform its regulatory actions. EPA relies 
on thousands of peer-reviewed articles as part of their scientific 
review. Under this proposal, if for any reason all of the scientific 
and technical information associated with those articles was not 
publicly available, EPA would have to proceed as if those studies did 
not exist. That is not in the best interest of the American people - 
our constituents.
    It is also not clear whether this proposal is retroactive. If so, 
then the legislation would essentially nullify all the progress we've 
made to date to improve the quality of the air our children--and all of 
our constituents for that matter--breathe and the water they drink.
    I am also concerned about the potential negative impacts that the 
bill could have on the scientific community. Researchers and 
organizations may be hesitant to conduct EPA-funded research if they 
are required to disclose protected information like health records. 
Historically, researchers have been able to assure individuals 
participating in their studies that their personal information is safe, 
and that helps attract participants.
    Last year, this Committee took the unusual action of issuing a 
subpoena to acquire data that the EPA relied on when developing air 
quality regulations. This data, the basis of the Harvard Six Cities 
study and the American Cancer Society study, contains the personal 
health records of hundreds of thousands of Americans. I presume that 
this is an example of the so-called ``secret science'' that inspired 
this bill.
    But contrary to the assertion that the science behind those studies 
is ``secret, in fact the legal owners of these data sets, Harvard 
University and the American Cancer Society, allow legitimate 
researchers access to this information and have procedures in place to 
protect it.
    It's interesting--this Committee spent a significant amount of time 
scrutinizing Healthcare.gov and claiming that the website puts personal 
health records of millions at risk; frankly I am a bit surprised that 
my colleagues do not now recognize the importance of protecting studies 
that actually do contain personal health information.
    But perhaps what is more troubling about this proposal is that it 
ignores the good work already done by this Committee. In 2010, this 
Committee reauthorized the America COMPETES Act, which requires the 
Office of Science and Technology Policy (OSTP) to issue guidance to all 
federal agencies on the development of clear and coordinated policies 
to increase access to federally funded published research and digital 
scientific data. It's my understanding that the EPA is in the process 
of developing policies pursuant to this guidance.
    This bill also seems to be inconsistent with the data and public 
access provisions included in the Majority's FIRST Act. Although there 
are some open questions about specific provisions of the FIRST Act, the 
bill takes the more appropriate government-wide approach and requires 
consultation and input from the scientific and stakeholder community.
    It is worth having a real discussion about how we can improve 
transparency and data access across the federal government. 
Additionally, as we have discussed, I hope we are able to have another 
hearing on this issue. I strongly encourage the participation of the 
EPA so that the agency has an opportunity to appear before the 
Committee and provide--on the record--their analysis about the 
provisions of this bill. It would be logical to hold such a hearing in 
conjunction with our colleagues on the Research and Technology 
Subcommittee because they have been examining this issue closely.
    Mr. Chairman, I hope that we can work together to find a way to 
improve public access to federally funded research in a manner that 
does not compromise the EPA's mission to protect human health and the 
environment.
    Thank you, Mr. Chairman and I yield back.

    Chairman Schweikert. Thank you, Ranking Member Bonamici.
    Now, I would like to turn to the Chairman of the full 
Committee, the gentleman--and I emphasize gentleman--from 
Texas, Mr. Smith, opening statement, please.
    Chairman Smith. Thank you, Mr. Chairman, and 
congratulations on chairing your first Subcommittee hearing.
    The Secret Science Reform Act of 2014 is a result of more 
than two years of investigative work on the part of the 
Science, Space, and Technology Committee. This work was 
initiated when the Environmental Protection Agency failed to 
live up to its public commitment to make the data that supports 
its most costly air regulations available to the public. In 
September 2011, then-Assistant Administrator Gina McCarthy 
committed to provide this Committee with the data EPA relied 
upon to justify its claims about air quality and health 
effects. In 2012, the President's own science advisor John 
Holdren testified that ``absolutely the data on which 
regulatory decisions are based should be made available to the 
Committee and should be made public.''
    The Committee sought this data for a simple reason: to see 
whether the science supports EPA's rules. An open and 
transparent government requires its disclosure. Through this 
process, we learned that much of the data either no longer 
exists or was never in the Agency's possession. Not only are 
EPA's claims not independently verifiable, the Agency cannot 
provide evidence to justify them. As a result, the American 
people have no way of knowing the truth.
    The EPA's mission is to protect public health and the 
environment, but the Agency's regulations impact all aspects of 
our economy. Sound public policy requires precise decision-
making that properly balances competing needs. While the Agency 
is charged with setting standards that are ``requisite to 
protect public health,'' those standards should be no more 
restrictive than necessary. Transparency and independent 
verification are basic tenets of science and must inform sound 
environmental policy. When the EPA does not follow these basic 
steps, it fails in its obligation to the American people and 
raises suspicions about whether its regulations can be 
justified.
    It is unfortunate that our Nation's environmental policy 
has become one of the most contentious issues in Washington, 
but a discussion about the merits of any particular regulation 
is meaningless if the public cannot trust the underlying 
science, and that is impossible if the information isn't even 
available.
    Everyone agrees that we need to protect the environment, 
but it should be done in a way that is transparent and honest. 
This bill encourages those principles. The Secret Science 
Reform Act of 2014 has two basic elements. One, it prohibits 
EPA from issuing regulations unless all scientific and 
technical information relied upon is specifically identified; 
and two, it requires that information to be publicly available 
in a manner that is sufficient for independent analysis and 
reproduction of research results.
    Americans impacted by EPA regulations have a right to see 
the data and determine for themselves if the Agency's actions 
are based on sound science or a partisan agenda. This bill 
ensures transparency and accountability. It is hard to imagine 
a single reason why anyone would oppose this basic principle 
that is consistent with the Administration's policies on 
transparency. James Madison may have explained this best when 
he said that ``a popular government without popular information 
or the means of acquiring it is but a prologue to a farce or a 
tragedy, or perhaps both. Knowledge will forever govern 
ignorance, and a people who need to be their own governors must 
arm themselves with the power knowledge gives.''
    Given the EPA's aggressive agenda and its willingness to 
play fast and loose with the law, the Agency should be forced 
to live up to the claims of transparency it so readily 
espouses. The American people deserve the facts and so does 
good policy.
    Thank you, Mr. Chairman. I yield back.
    [The prepared statement of Mr. Smith follows:]

      Prepared Statement of Full Committee Chairman Lamar S. Smith

    The Secret Science Reform Act of 2014 is the result of more than 
two years of investigative work on the part of the Science, Space, and 
Technology Committee. This work was initiated when the Environmental 
Protection Agency (EPA) failed to live up to its public commitment to 
make the data that supports its most costly air regulations available 
to the public.
    In September 2011, then-Assistant Administrator Gina McCarthy 
committed to provide this Committee with the data EPA relied upon to 
justify its claims about air quality and health effects. In 2012, the 
President's Science Advisor, John Holdren, testified that, 
``Absolutely, the data on which regulatory decisions.are based should 
be made available to the Committee and should be made public.''
    The Committee sought this data for a simple reason: to see whether 
the science supports EPA's rules. An open and transparent government 
requires its disclosure. Through this process, we learned that much of 
the data either no longer exists or was never in the agency's 
possession. Not only are EPA's claims not independently verifiable, the 
agency cannot provide evidence to justify them.
    As a result, the American people have no way of knowing the truth. 
EPA's mission is to protect public health and the environment. But the 
agency's regulations impact all aspects of our economy.
    Sound public policy requires precise decision-making that properly 
balances competing needs. While the agency is charged with setting 
standards that are ``requisite to protect public health,'' those 
standards should be no more restrictive than necessary.
    Transparency and independent verification are basic tenants of 
science and must inform sound environmental policy. When the EPA does 
not follow these basic steps, it fails in its obligation to the 
American people and raises suspicions about whether its regulations can 
be justified.
    It's unfortunate that our nation's environmental policy has become 
one of the most contentious issues in Washington. But a discussion 
about the merits of any particular regulation is meaningless if the 
public cannot trust the underlying science. And that's impossible if 
the information isn't even available.
    Everyone agrees that we need to protect the environment. But it 
should be done in a way that is transparent and honest. This bill 
encourages those principles.
    The Secret Science Reform Act of 2014 has two basic elements:

      1) It prohibits EPA from issuing regulations unless all 
scientific and technical information relied upon is specifically 
identified; and,

      2) It requires that information to be publicly available in a 
manner that is sufficient for independent analysis and reproduction of 
research results.

    Americans impacted by EPA regulations have a right to see the data 
and determine for themselves if the agency's actions are based on sound 
science or a partisan agenda. This bill ensures transparency and 
accountability.
    It's hard to imagine a single reason why anyone would oppose this 
basic principle that is consistent with the Administration's policies 
on transparency.
    James Madison may have explained this best when he said that, ``A 
popular government without popular information or the means of 
acquiring it, is but a Prologue to a Farce or a Tragedy--or perhaps 
both. Knowledge will forever govern ignorance, and a people who mean to 
be their own Governors must arm themselves with the power knowledge 
gives.''
    Given the EPA's aggressive agenda and its willingness to play fast 
and loose with the law, the agency should be forced to live up to the 
claims of transparency it so readily espouses. The American people 
deserve the facts. And so does good policy.

    Chairman Schweikert. Thank you, Chairman Smith.
    I now want to recognize my other bookend from Texas, the 
Ranking Member of the full Committee, Ms. Johnson.
    Ms. Johnson. Thank you very much, Mr. Chairman. And I would 
like to echo Ms. Bonamici in congratulating you on being named 
the Chair of the Subcommittee and look forward to working with 
you in this capacity and have been impressed with your 
particular statements, this meeting and others.
    Unfortunately, I regret that today's hearing might be a 
rough start in that regard. That is because the Secret Science 
Reform Act of 2014 continues to be one of the most regrettable 
sagas in the history of this esteemed Committee. Out of all the 
years I have served on this Committee, this term has been the 
worst experience.
    This saga began in the last Congress with majority requests 
for data associated with studies that the EPA relied on for 
certain clean air regulations. It continued in August of last 
year when the Chairman issued the first subpoena from this 
Committee in over 20 years to obtain that same data. And now, 
we are here today to discuss this misguided and mislabeled 
legislation.
    I want to be clear. The Secret Science Reform Act of 2014 
is built on a false premise. None of the science that have been 
in question during this two-year affair is secret. Is the data 
protected? Of course it is. The data contains the personally 
identifiable health information of hundreds of thousands of 
American citizens. Nonetheless, as the Democratic minority has 
repeatedly pointed out, legitimate researchers do have access 
to this data. So what is the problem? What legitimate 
researchers cannot already access this data?
    At the August 1, 2013, meeting to authorize a subpoena, the 
Chairman indicated Dr. James Enstrom could not access the 
American Cancer Society data. As I have pointed out before, Dr. 
Enstrom has a long history of conducting research and 
performing consultant work for the tobacco industry.
    Now, that brings us to today's hearing. Mr. Chairman, all 
three of the majority witnesses also have significant ties to 
the tobacco industry. First, we have Dr. John Graham. While he 
headed the Harvard Center for Risk Analysis, he personally 
solicited research funding from Philip Morris. Moreover, he 
invited Philip Morris public relation officials to review a 
draft chapter of his book on the subject of secondhand smoke. 
Dr. Graham's center ultimately received tens of thousands of 
dollars on grants from Philip Morris' subsidiary, Kraft General 
Foods.
    Next, we have Dr. Tony Cox, who has received numerous 
research grants from Philip Morris tobacco and has collaborated 
on research with internal Philip Morris scientists. In 
addition, Dr. Cox has served as a litigation consultant for the 
Philip Morris and R.J. Reynolds tobacco companies.
    Finally, we have Dr. Ray Keating. Dr. Keating's 
organization, the Small Business & Entrepreneurship Council, 
and its predecessor, the Small Business Survival Foundation, 
has solicited and received funding from tobacco companies. 
Moreover, documentation seems to suggest a large amount of 
collaboration with tobacco companies. For instance, in the mid-
'90s, Dr. Keating released a series of reports of FDA tobacco 
regulations and their negative effects on small business and 
also filed comments with the FDA on the same topic. These 
reports relied upon a study commissioned by Dr. Keating's 
organization and conducted by the American Economics Group. 
What Dr. Keating didn't mention in his reports or FDA comments 
is that the Small Business Survival Foundation was acting as a 
go-between for the tobacco industry. Tobacco companies' emails 
show that the study in question was jointly funded and 
organized by Philip Morris and R.J. Reynolds tobacco.
    The reason I highlight this, Mr. Chairman, is that EPA is a 
public health agency. I am a health professional. I find it 
deeply disturbing that the experts the majority seems to rely 
upon for advice in this arena of public health all have 
extensive ties to the tobacco industry. That is the same 
industry that was found by a federal court to have engaged in 
racketeering and wire fraud in order to subvert the public 
health of American people. And how did they accomplish this 
fraud? Through a well-documented history of funding researchers 
and third-party groups to cast doubt on the public health 
effects of tobacco.
    Mr. Chairman, this is a serious subject because ultimately 
this is about protecting public health of our citizens. It is 
about protecting the health of our neighbors and our friends 
and family. If the majority is serious about moving forward 
with this ill-advised legislation, then we need to hear from a 
credible set of witnesses. Our citizens deserve no less. I 
thank you and yield back.
    [The prepared statement of Ms. Johnson follows:]

                  Prepared Statement of Full Committee

                  Ranking Member Eddie Bernice Johnson

    Thank you Chairman Schweikert. I would like to echo Ms. Bonamici in 
congratulating you on being named Chair of the Subcommittee and look 
forward to working with you in this capacity. Unfortunately, I regret 
that today's hearing might be a rough start in that regard.
    That is because the ``Secret Science Reform Act of 2014'' continues 
one of the most regrettable sagas in the history of this esteemed 
Committee.
    This saga began in the last Congress with Majority requests for 
data associated with studies that the EPA relied upon for certain clean 
air regulations. It continued in August of last year when the Chairman 
issued the first subpoena from this Committee in over 20 years to 
obtain that same data. And now we are here today, to discuss this 
misguided and mislabeled legislation.
    I want to be clear, the ``Secret Science Reform Act of 2014'' is 
built on a false premise. None of the science that has been in question 
during this two year affair is ``secret.'' Is the data protected? Of 
course it is.
    The data contains the personally identifiable health information of 
hundreds of thousands of American citizens. Nonetheless, as the 
Democratic Minority has repeatedly pointed out, legitimate researchers 
do have access to this data.
    So what is the problem? What legitimate researchers cannot already 
access this data? At the August 1, 2013, meeting to authorize a 
subpoena, the Chairman indicated that Dr. James Enstrom could not 
access the American Cancer Society data. As I have pointed out before, 
Dr. Enstrom has a long history of conducting research and performing 
consulting work for the tobacco industry.
    And that brings us to today's hearing. Mr. Chairman, all three of 
the Majority's witnesses also have significant ties to the tobacco 
industry. First we have Dr. John Graham. While he headed the Harvard 
Center for Risk Analysis he personally solicited research funding from 
Philip Morris. Moreover, he invited Philip Morris public relations 
officials to review a draft chapter of his book on the subject of 
second-hand smoke. Dr. Graham's Center ultimately received tens of 
thousands of dollars in grants from Philip Morris subsidiary Kraft 
General Foods.
    Next we have Dr. Tony Cox, who has received numerous research 
grants from Philip Morris tobacco and has collaborated on research with 
internal Philip Morris scientists. In addition, Dr. Cox has served as a 
litigation consultant for the Philip Morris and RJR tobacco companies.
    Finally, we have Dr. Ray Keating. Dr. Keating's organization, the 
Small Business and Entrepreneurship Council, and its predecessor, the 
Small Business Survival Foundation has solicited and received funding 
from tobacco companies. Moreover, documentation seems to suggest a 
large amount of collaboration with tobacco companies. For instance, in 
the mid-1990's Dr. Keating released a series of reports on FDA tobacco 
regulations and their negative effects on small business and also filed 
comments with the FDA on the same topic. These reports relied upon a 
study commissioned by Dr. Keating's organization and conducted by the 
American Economics Group.
    What Dr. Keating didn't mention in his reports or FDA comments is 
that the Small Business Survival Foundation was acting as a go-between 
for the tobacco industry. Tobacco company emails show that the study in 
question was jointly funded and organized by Philip Morris and RJR 
tobacco.
    The reason I highlight this, Mr. Chairman, is that EPA is a public 
health agency. I find it deeply disturbing that the experts the 
Majority seems to rely upon for advice in the arena of public health 
all have extensive ties to the tobacco industry.
    That's the same industry that was found by a federal court to have 
engaged in racketeering and wire fraud in order to subvert the public 
health of the American people.
    And how did they accomplish this fraud? Through a well documented 
history of funding researchers and third party groups to cast doubt on 
the public health effects of tobacco.
    Mr. Chairman, this is a serious subject, because ultimately this is 
about protecting the public health of our citizens. It's about 
protecting the health of our neighbors, and friends, and family. If the 
Majority is serious about moving forward with this ill-advised 
legislation, then we need to hear from a credible set of witnesses. Our 
citizens deserve no less.
    I yield back.

    Chairman Schweikert. Thank you, Ranking Member Johnson.
    If there are any Members who wish to submit additional 
opening statements, your statements will be added to the record 
at this point.
    Chairman Schweikert. Our first witness, Hon. John Graham. 
Is it ultimately Professor or Doctor?
    Dr. Graham. Professor.
    Chairman Schweikert. Professor Graham, Dean of the School 
of Public and Environmental Affairs at Indiana University. In 
March 2001, President George H.W. Bush nominated Dr. Graham to 
serve as Administrator of the Office of Information and 
Regulatory Affairs at the Office of Management and Budget. He 
was confirmed by the Senate in July 2001 and served until 2006. 
Dr. Graham has also served as Dean of the Frederick Pardee RAND 
Graduate School, President of the Society of Risk Analysis, 
Professor of Policy and Decision Science at Harvard School of 
Public Health, and Founder and Director of the Harvard Center 
for Risk Analysis. Dr. Graham received his Ph.D. from Carnegie 
Mellon University. And one other just outlier, I think in my 
graduate school we used one of your books. Dr. Graham.

         TESTIMONY OF THE HONORABLE JOHN GRAHAM, DEAN,

          SCHOOL OF PUBLIC AND ENVIRONMENTAL AFFAIRS,

                       INDIANA UNIVERSITY

    Dr. Graham. Thank you, Mr. Chairman. You have my written 
remarks. I just want to use my brief time in the oral session 
to offer a case study of the value of transparency in data 
access from early in my career as an academic.
    In 1981-83 period, I was a doctoral student at Carnegie 
Mellon, as you mentioned. The question I was looking at was do 
automobile safety regulations save lives? The first federal 
regulations were 1966 to 1968 in all the cars. They addressed 
safety belts, padded dashboards, collapsible steering columns, 
and head restraints. They all came in at roughly the same time. 
The engineering estimates, based upon laboratory testing, were 
that these measures would reduce the risk of death in a crash 
by about 25 to 35 percent. The question is would those lives 
really be saved when they were introduced in cars in the real 
world?
    The first real-world valuation was published in 1975 by a 
professor named Sam Peltzman at the University of Chicago and 
he published it in one of the best peer-reviewed social science 
journals. What Peltzman did was is he assembled national safety 
data from 1947 to 1974. He compared the death rates in cars 
before regulation and after regulation. His results, which were 
surprising, were that the passenger death rates were down only 
about seven percent, not 25 to 35 percent as predicted. And the 
so-called nonoccupant deaths--think of pedestrians--were up 20 
percent. And as a result, the net of it all was he concluded 
that the regulations didn't save any lives. He then advanced 
the following theory for why this result had obtained. It is 
now called the theory of risk compensation. Drivers, sensing 
that they are in greater safety, drive faster or they are more 
likely to give their car to their teenage daughters or sons 
thinking they are safe.
    As a young graduate student at Carnegie Mellon, I was quite 
frankly skeptical of this whole study, both the empirical work 
and the theory that was behind it. So I went eagerly and 
reassembled all of Professor Peltzman's data sources from the 
documentation that he had in his paper. I then reassembled all 
of his original data set since this was all publicly available 
data. I then re-estimated his equations using the equations 
that were in his article. And I found that what he had a 
purported in his paper was in fact the result, given his 
assumptions. Then I did a reanalysis where I added three 
variables to his equation that he had not considered: the 
growth in the number of small cars in this country, which are 
more lethal than larger cars, the number of heavy trucks on the 
road and the traffic from heavy trucks, and the growth in the 
number of motorcycle registrations because he had included in 
nonoccupant deaths not just pedestrians but motorcyclists as 
well.
    I then reanalyzed the data using his procedure. I found 
that the passenger death rate was about 25 percent lower than 
would have occurred without the regulatory standards and the 
nonoccupant deaths had basically unchanged when you controlled 
for the growth in motorcycling. I concluded that this was a 
highly successful federal regulation that saved thousands of 
lives.
    With the help of my faculty advisor, we published this 
reanalysis in the peer-reviewed literature. It stimulated a 
whole bunch of debate, ten years of additional studies and so 
forth and so on, and I think it is fair to say today that most 
people would say reading this body of evidence that this 
regulation saved thousands of lives, maybe not as many as they 
originally projected, but a substantial number.
    The lessons I would like you to consider from this example, 
which I lived through for years, is that the process of 
reanalysis cannot proceed without transparency of what the data 
sources are and without access to the actual original data to 
reanalyze the problem. Second of all, the reanalysis process is 
not always antiregulation. It is not always antigovernment. In 
some cases, reanalysis shows that government regulations work, 
save lives, reduce injuries, and enhance the public good. So 
the underlying premises and assumptions of the bill that we are 
discussing today in my view are politically neutral and they 
will work for both sides of the argument.
    Final comment, when I served in OMB under President George 
W. Bush, we oftentimes had industry groups and environmental 
groups come to OMB with their data and analysis of why they 
wanted a regulation changed one way or the other. I think it 
would be a constructive thing if all of that information that 
they were required to give would satisfy these basic standards 
of transparency of what data sources were used and 
accessibility to the original data. That is a neutral--
politically neutral outcome that both sides of this debate 
should be subjected to.
    Thank you very much. I look forward to the questions.
    [The prepared statement of Hon. Graham follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Chairman Schweikert. Thank you, Professor Graham.
    Our next witness is Dr. Tony Cox, Chief Sciences Officer at 
Next Health Technologies, Clinical Professor of Biostatistics 
and Informatics at Colorado Health Sciences Center, and 
President of Cox Associates. Next Health Technologies offers 
advanced data analytics solutions to healthcare plans to reduce 
health, financial, and member attrition risks. Dr. Cox is also 
the current editor-in-chief of the journal Risk Analysis. In 
2012 he was inducted into the National Academy of Engineering 
and is a member of the National Academies Standing Committee on 
the use of public health data. Dr. Cox received his Ph.D. in 
risk analysis from MIT. Dr. Cox.

            TESTIMONY OF DR. LOUIS ANTHONY COX, JR.,

       CHIEF SCIENCES OFFICER, NEXT HEALTH TECHNOLOGIES,

       CLINICAL PROFESSOR, BIOSTATISTICS AND INFORMATICS,

                COLORADO HEALTH SCIENCES CENTER,

                 AND PRESIDENT, COX ASSOCIATES

    Dr. Cox. Thank you for inviting me today to discuss whether 
the data underpinning regulations should be made openly 
available. I am testifying on my own behalf today in support of 
the Secret Science Reform Act. I have provided the Committee 
the detailed CV describing my academic, publishing, and 
business affiliations.
    I am a risk analyst and I am happy to tell you why I think 
access to data is essential for high-quality analysis in the 
public interest. I can also tell you that it is not easy to get 
such access. Ms. Johnson or others with similar views might 
decide that researchers like me who have worked with cigarette 
manufacturers to quantify risks of smoking-associated diseases 
are not legitimate enough to deserve access to data, but 
without such access, we cannot correctly quantify what the 
risks are.
    We are discussing a key question for science and policy 
today. Is the public interest best served by requiring that 
data behind science-based environmental regulations be made 
available to those who want to see it? Many who argue yes 
believe that the very essence of trustworthy science is 
reproducibility of results and sharing of the data said to 
drive them. For example, over 2/3 of recently surveyed 
professionals involved in risk assessment said it was very 
important to have access to the underlying raw data so that 
they could independently analyze the results, but only about 1/
3 said that such access was usually the case. The proposed 
Secret Science Reform Act would help to close this gap.
    A concern about sharing of data is that it might prove 
burdensome for the original investigators, exerting a chilling 
effect on their research, but keeping well-organized records, 
data, and lab notebooks so that others can check methods and 
results is or should be part of the training of every good 
scientist. It imposes no extraordinary burdens and has many 
benefits. Scientific journals can also facilitate sharing of 
the data behind published conclusions.
    A second concern expressed by ALA and others is that making 
study data available might threaten the privacy of individuals. 
We have already heard that this morning. The technical issue of 
how to protect privacy while allowing valid statistical 
analysis is best addressed by technical solutions, and many 
excellent one such as multiple imputation are now available. 
They are already being used successfully at the Census Bureau 
and elsewhere. So I think this concern is a bit of a red 
herring. We can meet it by applying existing technical methods.
    But the most important concern I suspect is not technical. 
It is that bad people or people with agendas other than pure 
science and the public interest might delay good regulations by 
performing untrustworthy new analyses and reanalyses that would 
obscure the need for action. To address this concern, I think 
we must candidly assess how well our current scientific process 
delivers trustworthy results without much pressure from 
external reanalyses of data. It does not.
    We are living in an age of catastrophic failure in the 
reproducibility and trustworthiness of scientific results as 
evidenced by articles such as ``Why Most Published Research 
Articles Are False'' from 2005 and ``Trial and Error: Why 
Science Is Failing Us'' from 2011 or an editorial just last 
month on reproducibility in Science magazine. A common theme is 
that there is too much pressure on original investigators to 
use dubious statistical methods to publish results that are 
sensational but not necessarily correct and there is not enough 
encouragement for original investigators to do unbiased 
research knowing that others will soon be reanalyzing their 
data and claims. Fixing this critical problem requires more 
scrutiny and greater access to original data, not less.
    Let me end with two examples from my own experience in 
public health risk analysis. First, by applying causal analysis 
methods to the publicly available national mortality and 
morbidity air pollution study data, I recently discovered that 
air pollution levels are indeed correlated with mortality risks 
in 100 U.S. cities. This was already well known. For example, 
both were associated with cold winter days. But surprisingly, 
there was no evidence that reducing air pollution has caused 
any reductions in mortality rates. Open access to the data 
makes such unexpected discoveries possible and encourages 
others to check and possibly improve upon the results 
potentially informing important public policy.
    As a last example, Dublin, Ireland, recently extended bans 
on coal burning based on research claiming that banning coal 
burning immediately reduced mortality rates. That research was 
done and publicized in part by U.S. investigators who have 
prominently shaped U.S. EPA's science and claims about air 
pollution health effects. Yet a reexamination of the data last 
year funded by the Health Effects Institute revealed that its 
major conclusion was not true; mortality rates did not come 
down any faster where coal burning was banned from where it 
wasn't. European researchers had already pointed out years ago 
the fallacy of assuming that just because pollution levels in 
mortality rates had both declined, that suggested that one 
caused the other. But without access to the original data, they 
cannot quickly and easily prove that the original conclusions 
did not follow from the data. By the time the original U.S. 
investigators were funded to take another look at the data, 
Irish public policy had already been made. Only ready access to 
the data would have enabled others to fix the problem in time 
to inform policy decisions.
    We need not repeat such experiences here. We can choose to 
make data used to support regulatory decisions openly available 
for others to analyze and not wait until policy has been made 
and changes enacted before allowing the public to find out 
whether better analyses would have led to different results. I 
believe that doing so will promote sounder science and hence 
strongly promote the public interest.
    Thank you for your attention.
    [The prepared statement of Dr. Cox follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Chairman Schweikert. Thank you, Dr. Cox.
    To introduce our next witness I am going to turn to the 
Ranking Member Bonamici.
    Ms. Bonamici. Thank you, Mr. Chairman.
    I am pleased to introduce Dr. Ellen Silbergeld, a Professor 
of Environmental Health Science and Epidemiology at the Johns 
Hopkins Bloomberg School of Public Health. Dr. Silbergeld holds 
a Ph.D. in environmental engineering, completed postdoctoral 
fellowship in environmental medicine and neurosciences, and has 
more than 40 years of scientific research experience in fields 
related to environmental health. She has been an appointed 
expert to the EPA, the Department of Energy, and many other 
federal agencies. She is a MacArthur Genius Fellow among her 
many honors.
    Thank you so much for being here to testify today, Dr. 
Silbergeld.
    Chairman Schweikert. Dr. Silbergeld, five minutes.

         TESTIMONY OF DR. ELLEN SILBERGELD, PROFESSOR,

               BLOOMBERG SCHOOL OF PUBLIC HEALTH,

                    JOHNS HOPKINS UNIVERSITY

    Ms. Silbergeld. Thank you very much. I am appearing at your 
invitation to testify before the issues embodied in this bill 
and other issues that you have already alluded to, Mr. 
Chairman. And I have been a member, as indicated, of many 
expert panels involved in the evaluation of the scientific 
bases for regulation in the United States, the State of 
Maryland, and internationally. I also served as a member of the 
U.S. Delegation to the OECD during the development of the High 
Production Volume Chemicals Program which I would like to 
allude to.
    First, I want to join with you and others on this panel 
stating that the principles of openness and fairness are 
fundamental to science including toxicology, epidemiology, and 
basic research. And I agree with the statement of many at this 
hearing that there is an important need to reduce the secrecy 
that confounds public access to the basis for some EPA 
decisions specifically. However, with respect to my experience, 
the major driver of secrecy in EPA rulemaking is the deference 
given to industry in terms of shielding its studies from public 
view, and thus I am puzzled as to the uneven nature of the 
debate on this topic and I hope that your Committee can see to 
that balance.
    The problem of nondisclosure by industry in fact was a key 
issue in developing the High Production Volume Chemicals 
Challenge Program by the OECD during the time that I was a 
member of the U.S. Delegation. And frankly, I have been very 
proud of the leadership role of American industry in the 
success of this program through which information held by 
industry was in fact made publicly available. And the current 
website of the American Chemistry Council makes clear that the 
industry shares justifiable pride in its disclosures and 
adherence to greater transparency data.
    We need more information, and specifically, we need more 
information disclosure by industry. Information withheld is not 
informative. It--in fact, we can just look across the Potomac 
River to West Virginia and understand that if we had 
information, both the compulsion to produce it and to reveal 
it, how much better public health authorities and civic 
authorities and the public itself could respond to that event.
    I would like to also draw upon my experience as an editor-
in-chief of a major peer-reviewed journal and my experience 
over the past 18 years in terms of how science evaluates the 
quality of data that is published in the form of a scientific 
paper. The peer-review process requires the inclusion of 
scientific and technical information, including--as stated in 
your bill, sir--materials, data, and associated protocols 
necessary to understand, assess, and extend conclusions. The 
rest of the items in Section (2)(b)(3) of this bill, with 
respect, do not contribute to this goal in my opinion.
    We recognize that no study is perfect and frankly it is 
mostly protocol design and under-powering of studies rather 
than erroneous statistical approaches that have resulted in 
withdrawal of many papers in my experience, and this is why in 
science we rely on replication as the means of validating the 
findings and conclusions of any particular study. But 
replication is not the same as data reanalysis. Replication 
involves the design and conduct of a wholly independent study 
often with different methods to test the reliability of the 
same hypothesis that was first studied.
    Let me also reflect on my experience with data analysis as 
part of the EPA's process of reviewing science related to major 
regulation, as others have done on this panel. I was part of an 
expert panel advisory to the EPA under the Clean Air Act 
consideration of revising the National Ambient Air Quality 
Standards for lead. A reanalysis of the actual raw data was 
demanded by industry and it was accomplished in a 
nonadversarial way through third-party review undertaken by an 
acknowledged academic expert in biostatistics not connected 
with government, industry, or the original investigators.
    In conclusion, I would like to restate my strong 
philosophical support for increasing the transparency of 
information associated with government regulation. I suggest 
that we already have the tools to accomplish this goal and 
through the implementation certainly of the NIH covering data 
that is funded by that agency. I hope that your concerns can be 
reframed to apply to all sources of information in an effective 
and efficient manner because I know that some of my colleagues 
in industry have been vocal in calling for these steps. I call 
to them to tear down every wall--in the words of Ronald 
Reagan--that hides critically important information that is 
generated and held by industry.
    Thank you.
    [The prepared statement of Dr. Silbergeld follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Chairman Schweikert. Thank you, Dr. Silbergeld.
    Our last witness today is Mr. Raymond Keating, Chief 
Economist at the Small Business & Entrepreneurship Council. Mr. 
Keating has expertise on a wide range of issues affecting the 
entrepreneurial sector of the U.S. economy. He has written 
eight books, hundreds of articles, and writes for the Small 
Business & Entrepreneurship Council and the Center for 
Regulatory Solutions' online publication. Mr. Keating is also 
an Adjunct Professor at the Business School of Dowling College. 
He received his master's in economics from New York University 
and an MBA in banking and finance from--is it Hofstra?
    Mr. Keating. Hofstra.
    Chairman Schweikert. Hofstra University. Mr. Keating, five 
minutes.

       TESTIMONY OF MR. RAYMOND KEATING, CHIEF ECONOMIST,

           SMALL BUSINESS & ENTREPRENEURSHIP COUNCIL

    Mr. Keating. Thank you, Mr. Chairman and Members of the 
Committee, for holding this important hearing today.
    As you mentioned, I am Chief Economist with the Small 
Business & Entrepreneurship Council and I noticed 
Representative Johnson left but I wanted to thank her for 
upgrading me to a doctor. I tried to get away with that because 
I have two master's degrees, but nobody really lets me, so I 
have to thank her when I get a chance.
    I am going to take a little different tack from my 
colleagues and look at this issue from the small business 
perspective and also from the public's point of view of the 
regulatory process based on a survey that our group did 
recently. So just a few points that I want to highlight from my 
written testimony, number one, you know, just to kind of--from 
a small business perspective, the costs of regulation are very 
real and significant facts of economic life. Economics 101 
tells us that we should expect--what we should expect from 
increased regulation: higher costs for businesses and 
consumers, reduced market exchanges, and expanded political 
control, resources allocated based on political decisions and 
influences rather than via competition and consumer 
sovereignty, and that all wind up in the end diminishing 
economic growth.
    Number two, from a small business perspective, the SBA's 
Office of Advocacy has done a study. Several times I believe 
they have--I think they have done it three times. They have 
updated it a couple of times. Just looking at the costs of 
regulation, the costs of complying with regulation with an eye 
toward small business, those--just to throw out a few of those 
numbers, when you look at firms with less than 20 employees on 
a per-employee basis, the cost of complying with federal 
regulations are 42 percent higher than firms with 20 to 499 
employees and 36 percent higher than firms with 500 or more 
employees. On the environmental front in terms of environmental 
regulations, those disparities are even much, much higher.
    So the issue of transparency on the science being used to 
support regulation is not, you know, an esoteric academic or 
political point. It is very--has very real consequences in 
terms of the costs imposed on small businesses. And small 
business owners really want to know. They need to know what 
regulations quite frankly are legitimate and which ones that 
they are dealing with may not be so.
    You know, there is a lot going on at the EPA in terms of 
greenhouse gas regulations and there is more coming. When you 
look at the industries that are going to be directly affected 
and are directly affected, again, the majority of those 
businesses--the vast majority are small firms. When you look at 
manufacturing firms, manufacturing employer firms with less 
than 20 workers, that is 76 percent of those businesses. So 
they are small businesses. When you look at mining, quarry, oil 
and gas extraction, 85 percent of employer firms have less than 
20 workers. So this is a very real issue for small businesses 
across the board.
    Now, the poll that I want to mention we released it last 
month. It was a poll of American adults under the Center for 
Regulatory Solutions, our new organization, our new group if 
you will. And it was interesting what the public had to say on 
both the process and the cost of the effects of regulation. On 
the process, three numbers real quick: 68 percent said that 
government regulations on business are created by out-of-touch 
people who are trying to push a political agenda, 72 percent 
said that government regulations are created in a closed, 
secretive process, 64 percent said that government regulation 
on business was created in a way that does not consider the 
real-world impact. So that is the public view of the regulatory 
process.
    In terms of the effects, 53 percent agree that there are 
too many regulations on business, 61 percent believe that 
regulations on business are likely to do more harm to the 
economy by interfering with the market, preventing businesses 
from growing and hiring new employees and increasing prices for 
consumers. And small business owners would most assuredly agree 
with those assessments.
    One other one, you know, there is a whole host and I will 
be happy to get you the results of these--this survey, but 70 
percent of Americans said that regulations, they hurt the 
economy, 66 percent said they mostly hurt entrepreneurs and 
small businesses. Hurt consumers, 63 percent, mostly hurt 
American workers, 66 percent. You get the idea. The numbers are 
overwhelming in terms of how we are viewing--how the American 
public views this process.
    When you look at the economics of regulation, the impact of 
regulatory costs on small businesses, the views of the public 
on the regulatory process really should push government 
officials to be transparent in all aspects of regulation, 
including how regulations are created, the scientific reasons 
for regulation, the true cost of regulations. And it matters--
you know, it is--you don't want to have a situation where 
certain agencies or certain political points of view or certain 
political members are deciding who gets access and who doesn't.
    So I think when you look at the Secret Science and Reform 
Act, I think everybody in Congress on both sides of the aisle 
should be able to support it.
    Thank you.
    [The prepared statement of Mr. Keating follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Chairman Schweikert. Thank you, Mr. Keating.
    One of the joys of getting to sit in this chair, apparently 
I get to do the first question.
    Professor Graham, from what you have heard today and one of 
my premises is it goes far beyond just sort of us talking about 
the EPA so that the premise of sort of crowdsourcing of access 
to data and that the vetting of the confidence within--you 
know, the statistical confidence. Wouldn't most of the--well, 
from the regulatory community, the research community, even 
sort of the armchair statistician, does that really hurt 
environmental science or research or would it in some ways make 
it more robust?
    Dr. Graham. I certainly don't think it hurts it at all and 
there are lots of examples where it has helped with a more 
robust discussion.
    I do want to add though and underscore I think a useful 
distinction that Dr. Silbergeld made between independent 
studies that draw their own data and whether they verify other 
studies versus just reanalysis of existing information, and I 
agree with her that the independent studies sometimes are much 
more powerful and important. You do need to have a lot of 
clarity and transparency about how the original study was 
designed and its protocol in order to do that properly. So a 
lot of the requirement that is in the bill is necessary to do 
good independent studies. But I also think reanalysis is 
oftentimes a very useful type of work that adds new insights. 
And my example of the automobile safety regulation is one of 
those.
    Chairman Schweikert. Well, and almost to that premise--and 
maybe Dr. Cox would be appropriate for this, when looking at 
others' studies, the ability to take, you know, a study that 
may be a couple years old and take--you know, and stress it, 
see what is actually happening with the tails, sometimes bounce 
it against a more current study, you know, particularly in sort 
of a peer-reviewed world of--I--and, forgive me, but I don't 
know how much peer review is reading of the article and seeing 
if the general statistics work or actually sort of having the 
ability to look at the underlying data and bounce it against 
other studies that are around and say do I have a level of 
confidence? So there are two questions there. Tell me about how 
far into the raw data you think the peer-review world is going, 
particularly with government-funded studies, and how important 
it is to be able to constantly take studies and sort of bounce 
other models and other data against it.
    Dr. Cox. The current crisis in non-reproducibility of 
studies and in publication of results that turn out to be false 
is solidly grounded in the existing peer-review system. So when 
we look at papers like why most published research articles are 
wrong or if we look at last month's editorial on 
reproducibility in science, what is being referred to 
specifically is peer-reviewed studies. Typically, peer 
reviewers don't have the time or the opportunity to dig deeply 
into the original data. That is not the purpose of peer review. 
Peer review does add value by saying whether a paper makes 
sense, whether there are obvious methodological flaws. That is 
about as far as it usually goes. And again, the very severe 
problems with trustworthiness of published results and the 
excess of false positives in the environmental and medical 
literature, which has been well documented, are based on peer 
review.
    To your second question, having the opportunity to throw 
new models at old data I think is critical for making progress. 
For example, in this world of environmental health that we all 
care about today, the key question of do exposures cause health 
effects is one that requires methods that have not 
traditionally been used. It is a great opportunity but it 
requires access to data in order for the new methods and better 
methods to inform public policy.
    Chairman Schweikert. Dr. Graham, just because this is a 
level of personal curiosity, I am a little bit of a taleb fan, 
sort of the concept of if it is in the tail, you don't dismiss 
it because the catastrophic event can't happen. Is making data 
more egalitarian, will that actually provide us the opportunity 
to realize there is something, whether it be environmental or 
in my view of the world, you know, all sorts--to actually be 
able to identify those risk profiles?
    Dr. Graham. It is a good question. The commentary this 
morning about the Harvard and American Cancer Society procedure 
where they designate legitimate researchers and say that their 
data would be made available to legitimate researchers, I just 
want to make sure that everybody realizes--I say this as a 
former Harvard faculty member--this is not open access. This is 
not public access. So some people who may have some very good 
ideas and could do very good analysis may not look on the face 
of it like they are legitimate to Harvard or legitimate to the 
American Cancer Society.
    So, yes, it is very important that the principle of open 
access and public access provide everyone an opportunity to 
participate and they may find some results that are very 
unusual, that challenge conventional thinking, and they may 
never have been judged legitimate when they started that work 
so it is a very important advantage of true public access.
    Chairman Schweikert. All right. And thank you, Mr. Graham. 
I know I am over time but I have two others I just wanted to 
touch. And I don't think I have ever sat on a hearing where, 
when you look at the CVs of all of you, to quote my little 
brother, you are all freaky smart. And, forgive me, is it Dr. 
Silverberg?
    Ms. Silbergeld. Silbergeld.
    Chairman Schweikert. I actually got up very early this 
morning and actually read your ``Evidence-based Toxicology'' 
article, and I have got to compliment you. When a novice like 
myself could follow it, read it, and actually understand it, 
you are a terrific writer.
    I did want--there was just one thing in your conclusions 
and I appreciate the concerns so now I sort of want to sort of 
make the concept sort of move forward sort of public data for 
public policy. In your first couple paragraphs of your 
conclusion you actually sort of talk about requiring a 
framework to accommodate data from numerous types and that that 
may be sort of like the direction where--I know you were 
speaking of toxicology research goes. Do you actually see this 
happening sort of in the toxicology world where more and more 
data is becoming more and more accessible and a variety of 
researchers are analyzing it and weighting it and stressing it?
    Ms. Silbergeld. Thank you. If I may first respond to your 
concept of crowdsourcing science, I am not sure that is such a 
great idea and I think, with all due respect to my colleagues 
on this table, the record of the tobacco industry in--going 
beyond stressing data--I would say subjecting it to the Spanish 
Inquisition to twist it to say something that we now know it 
never said----
    Chairman Schweikert. Well, but----
    Ms. Silbergeld. --is something that is disturbing.
    Chairman Schweikert. But, Doctor, I appreciate that but 
crowdsourcing of the data is substantially a new phenomenon, 
not from 20 years ago, and the ability for me to have taken 
those data sets and said look what is happening--I am sorry. It 
is not ceteris paribus. You are talking two different time 
frames and two different technologies.
    Ms. Silbergeld. No.
    Chairman Schweikert. Yes, you are.
    Ms. Silbergeld. With respect, sir, that is why I am worried 
about the notion newly introduced of crowdsourcing because we 
have experience----
    Chairman Schweikert. Okay.
    Ms. Silbergeld. --of what has happened to access of data.
    Chairman Schweikert. Okay.
    Ms. Silbergeld. That is my comment. With respect to your 
question, sir, I--and with respect to the comments about peer 
review, as a journal editor I will take those blows----
    Chairman Schweikert. Well, that----
    Ms. Silbergeld. --and I understand them----
    Chairman Schweikert. --actually wasn't my question.
    Ms. Silbergeld. Yeah.
    Chairman Schweikert. My question was on your conclusion 
here where you talked about more accessibility to data. I think 
I am going to have to wait until the next round because I am 
now 3-1/2 minutes over time already. So let me turn to my 
Ranking Member. Maybe she can follow up where I was going.
    Ms. Bonamici. Thank you, Mr. Chairman.
    And before I begin my questions, I--two brief points. 
First, I don't want the lack of absence of Members on my side 
to be indicative of a lack of interest in this issue. There are 
several hearings and markups happening simultaneously, so 
please don't consider this as a lack of interest in the topic.
    Also, Mr. Chairman, we received and provided you with 
copies of letters from the American Lung Association, the 
American Thoracic Society, the Union of Concerned Scientists, 
the Center for Progressive Reform, and the Natural Resources 
Defense Council stating opposition to this bill, and I ask 
unanimous consent that they be submitted to the record.
    Chairman Schweikert. Any objections? So ordered.
    [The information appears in Appendix II]
    Ms. Bonamici. Thank you, Mr. Chairman.
    Dr. Silbergeld, under current law, because of the need to 
ensure that protected information like health records remains 
confidential, there are likely to be data that will not and 
should not become entirely available to the public. So should 
the EPA be precluded or any agency for that matter--but for the 
purposes of this hearing, should the EPA be precluded from 
considering studies that include health information if the 
studies are significant to determining the appropriate course 
of action? And if not, then how can we independently validate 
and verify such studies?
    Ms. Silbergeld. Thank you for the question. I think we have 
a model to go forward here. Which is really the model of 
evidence-based decision-making that first began in medicine, 
extended to healthcare, and now I count myself as one of the 
leaders in moving it into the field of toxicology in which we 
take the broadest possible look through the available--publicly 
available data and publications, including government reports, 
and attempt to synthesize those data using transparent and open 
processes of data access and evaluation. So I think we should 
always be committed to extending our view as wide as possible. 
Do we need to see raw data? I am not convinced that we do. I 
think in those instances where it has become of interest to do 
so, we have methods in place to accomplish that.
    And perhaps in response to the Chairman's question--and I 
apologize for using up your valuable time, sir--in fact, 
journals are increasingly soliciting and accommodating the 
production of much more extensive data, for example, on 
statistical models and protocols through the use of appendices. 
This is a somewhat new process in publication in which my own 
journal and others now encourage authors to submit this type of 
information which is publicly accessible through linkages in 
the paper and in any repository that has that paper that 
amplifies the kinds of information I think some of my 
colleagues would find particularly interesting.
    I also want to defend my reviewers by saying that they do a 
very exhaustive job of reviewing. And I agree with Dr. Cox that 
in fact I think some of the lack of reproducibility has come 
about through some failures in peer review.
    Ms. Bonamici. Thank you. And I am going to follow up on 
that because you state that requiring--in your article you 
state that requiring the disclosure of the raw data from every 
study that the EPA uses to support its regulatory assessment 
could actually preclude the EPA from using relevant research if 
the journal authors don't submit the raw data to the EPA. So 
could you talk a little bit--I know you touched on that, but 
could you talk about what would be the impact to the EPA of 
limiting the scope of those studies if they cannot consider 
those as part of their scientific review?
    Ms. Silbergeld. Well, for example, unless you can actually 
resolve the problems of protection of human subjects who appear 
in studies, this would then eliminate a great deal of the 
epidemiologic and clinical literature that could be available. 
And I know that we worry about this because in fact it was the 
tobacco industry who tried to bust open some repositories of 
confidential data that would have permitted identification of 
human subjects, and the rationale given by the industry was 
they wanted to interview some of those subjects and see if they 
gave the same answers that were reported in questionnaires used 
in studies. So this is a very disturbing aspect to the 
certainly of protection of people's autonomy, confidentiality, 
and the process of scientific research.
    Ms. Bonamici. Thank you. And I want--time for one question 
if I may, Mr. Chairman. I understand that the broad scientific 
community is engaged with the Office of Science and Technology 
Policy, or OSTP, and what representatives from academia, 
particularly the American Association of Universities and the 
Association of Public and Land-Grant Universities, is calling a 
thoughtful balanced process to increase public access to the 
results of federally funded research. And that is a type of 
government-wide approach to improving public access to 
federally funded R&D that is preferable to the legislation that 
specifically targets the EPA, especially in light of the fact 
the EPA generally relies on studies that are not funded by the 
Agency but other agencies like NSF and NIH.
    So could you please comment on the need to take a 
government-wide approach to improving public access? And if you 
could compare the bill we are considering today with OSTP 
approach and which would strike a better balance between the 
need for transparency in the regulatory process, balancing the 
rights of private citizens, and the need for the EPA to use the 
best science available.
    Ms. Silbergeld. Thank you. I think a comprehensive and 
consistent approach is certainly to be advocated. The fact, for 
example, is that a great deal of the evidence that the EPA 
would find and has found useful was in fact funded by other 
agencies such as the National Institutes of Health, which has 
set up an effective and functioning program, speaks to the need 
for a consistent policy.
    But I would like to restate my very great concern that I 
have a very great interest as a scientist to be able to see 
industry data and I would like to see industry behind the 
proactive stance and record of the American Chemical Council 
and others in terms of opening the doors on their data.
    Ms. Bonamici. Thank you. And my time is expired but I would 
be interested in hearing from the other witnesses about whether 
they would support the disclosure of the industry data as well.
    Thank you, Mr. Chairman, and I yield back.
    Chairman Schweikert. Thank you, Ranking Member.
    And, Mr. Bridenstine.
    Mr. Bridenstine. Thank you, Mr. Chairman. And I would like 
to say I am proud to support your bill, Mr. Schweikert, H.R. 
4012, the Secret Science Reform Act.
    I would like to bring up a slide if it is possible on the 
screen.
    [Slide]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Mr. Bridenstine. There it is. This is a quote from the 
President of the United States when he was campaigning. ``So if 
somebody wants to build a coal-fired power plant, they can. It 
is just that it will bankrupt them.'' That wasn't based on any 
kind of scientific data. That is a quote of the President of 
the United States. It is a campaign promise. He interviewed 
with the San Francisco Chronicle November 7, 2008. This is a 
promise that he has followed through with. There are two coal-
fired power plants in Oklahoma that are being shut down and the 
rates on my constituents are going up. The low estimate is 20 
percent, some say as high as 40 or 50 percent. Who does that 
affect? It affects the poor the most. This is President Obama's 
war on the poor. They spend the biggest part of their budgets 
on utilities, and so they are the ones being affected the 
worst.
    And here is the thing: The transparency of the data that 
they are using to create the rules and regulations that are 
shuttering these coal-fired power plants are not transparent. 
Transparency and verifiability are fundamental principles of 
any scientific endeavor and should certainly be required in 
those supported by taxpayers. The EPA continues to violate 
these principles by preventing independent researchers from 
examining the data and replicating the studies which ``support 
the Agency's rulemaking.'' My constituents in Oklahoma's 1st 
District are paying the price, quite literally paying the 
price, for the EPA's politicizing the regulatory process and 
its secret science charade.
    Mr. Chairman, I would like to spend a minute explaining how 
the EPA's secret science and groundless regulations will 
continue to needlessly harm my constituents and all Oklahomans. 
According to the Energy Information Administration (EIA), 
Oklahoma produces four percent of the country's crude oil and 
eight percent of its marketed natural gas. Oklahoma is leading 
the fracking revolution to provide cheaper energy to all 
Americans. Oklahoma is the 5th-largest shale gas-producing 
State, and 17 of the top 100 natural gas fields are located in 
Oklahoma. Mr. Chairman, the EPA's newest regulations on fossil 
fuel production and refining based on this secret science 
charade threaten my constituents with higher utility bills, 
less reliable electricity, and fewer jobs in Oklahoma's booming 
oil and gas industry.
    Can we bring up the second slide there?
    [Slide]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Mr. Bridenstine. The latest--can we bring up the slide 2?
    The latest EIA analysis shows that coal- and natural gas-
fired power plants provide about 90 percent, 90 percent of 
Oklahoma's electricity generation. My district has two 
petroleum refineries in Tulsa and four natural gas power 
plants, one in Coweta, one in Tulsa, and two in Jenks. Thanks 
for bringing up the next slide there.
    [Slide]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Mr. Bridenstine. We are talking about 155,000 barrels of 
refining capacity per day and 3,200 megawatts of production 
capacity.
    Can we bring up the next slide?
    [Slide]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Mr. Bridenstine. My 1st District constituents also use 
electricity produced by four coal-fired power plants, just--one 
just outside of my district in Oolagah, Muskogee, and Chouteau. 
That is another 4,300 megawatts of production that the EPA 
wants to shut down based on scientific data and models that it 
will not publicly release.
    Can I get the next slide, please?
    [Slide]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Mr. Bridenstine. Mr. Chairman, the EPA has put a bull's-eye 
on coal-fired power plants, a bull's-eye. This is the 
regulatory agenda here of the EPA. And once the EPA kills coal, 
let me be clear. They will come for natural gas. It is just a 
matter of time and we are already seeing that in the Obama 
Administration's war on fracking.
    Can we bring up the next slide, please?
    [Slide]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Mr. Bridenstine. In 2012, the Institute for Energy Research 
estimated that the EPA's MACT and Cross State Air Pollution 
Rules will take 33 gigawatts of national electricity generation 
off-line, 33 gigawatts, over twice the EPA's modeling 
prediction. That is ten percent of our country's coal capacity 
and also includes closing two natural gas-fired plants in 
Oklahoma, natural gas-fired plants in Oklahoma, one in Anadarko 
and one in Oklahoma City. The end result of the EPA's 
regulatory horror show is higher prices for consumers and 
industry, less economic growth, and fewer jobs.
    Next slide, please.
    [Slide]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Mr. Bridenstine. According to EIA, Oklahomans pay about 20 
percent less for residential, commercial, and industrial 
electricity than the U.S. average. Killing coal and eventually 
natural gas production in my State will saddle my constituents 
already struggling in this sluggish Obama economy with higher 
utility prices on par with those experienced in heavily 
regulated States such as California.
    Next slide.
    [Slide]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Mr. Bridenstine. Kentucky has already seen massive layoffs 
in the coal industry. When EPA uses secret science to justify 
new regulations, everyone is worse off except for EPA 
bureaucrats, as well as extreme environmentalists. Let me be 
clear. The EPA is now saying they are going to come after our 
woodstoves. Of course, a friend of mine, Thomas Massie from 
Kentucky, has gotten assurances from the EPA that if you like 
your woodstove, you can keep it.
    Let me ask one question for each of our panelists. Do any 
of you disagree with the principle that in the case of 
taxpayer-funded research or studies, the public should have 
access to the underlying data? Does anybody disagree with that?
    Yes, ma'am?
    Ms. Silbergeld. As stated in my testimony for the reasons 
given, I disagree with that, respectfully.
    Mr. Bridenstine. Noted. I yield back.
    Chairman Schweikert. Mr. Smith, Chairman of the full 
Committee.
    Chairman Smith. Thank you, Mr. Chairman.
    Mr. Keating, let me direct my first question to you, and I 
appreciate the poll that you mentioned earlier. I had not seen 
those results and they are very, very telling. And let me just 
highlight a couple of the results that you mentioned: 68 
percent said that the government regulations on business are 
created by out-of-touch people who are trying to push a 
political agenda; 72 percent said that the government 
regulations are created in a closed, secretive process; 70 
percent of Americans said the regulation mostly hurt the 
American economy. Those first two poll results that I mentioned 
and that you cited as well go to the heart of why we need the 
legislation at hand. And I really don't have a question for you 
other than to thank you for your testimony. If you want to add 
anything to your comments about why the legislation will have a 
positive effect, you are welcome to.
    Mr. Keating. Well, no, and there is a reason why I wanted 
to bring that here. I mean you talk about people being smart. 
These folks to my right here are far smarter than I am, but I 
want to bring the small business perspective and this survey 
that we had. And it is--you know, when we talk about the 
egalitarian access to data and the politicization of this 
process, those are very real things that are having, as the 
Vice Chair pointed out, very real effects on our economy in 
terms of jobs, small businesses, economic growth, all the way 
down the line.
    So I am a Madisonian on this. I love checks and balances. 
And the more checks and balances that we have, the more people 
we have looking at this, the more scientists, the more 
economists that we have looking at this, the better it is going 
to be for everybody because the ultimate point is not to 
politicize this. It is to get sound public policies. That is 
the bottom line.
    Chairman Smith. Thank you, Mr. Keating.
    Dr. Cox, as you know, some of the data that the EPA is 
relying upon to make rules and regulations is up to 30 years 
old. What are the disadvantages of using data that old when it 
comes to making decisions?
    Dr. Cox. There are trends and changes in the statistics of 
public health. Old patterns are not predictive necessarily of 
current events. More to the point, what regulators want to do 
is to intervene in the world as it is now to change it and make 
it better. To do that they often need to understand how the 
world works now with the current mix of pollutants, with the 
current configuration of industry. Staring hard into the 
rearview mirror does not necessarily provide that information. 
So I think the problem with old data is in part that it is old.
    The other thing that I will note is that basically 
regulations on results that depend on data that are not 
currently available does indeed allow the Agency to use the 
best-available information but it also allows Agency to use the 
worst-available information. Both are part of the published 
record. Without current access to current data, it is extremely 
difficult to distinguish between the best and the worst results 
in the past literature. So rather than looking at dead results 
and dead literature, I think it is important to keep the data 
alive and to allow current questions to be informed by current 
analyses of current data.
    Chairman Smith. Okay. Thank you, Dr. Cox.
    And, Dr. Graham, a two-part question, I guess. One, what is 
the advantage of making this data publicly available, if you 
can go into some detail; and secondly, is it really difficult 
to make this data available to the various scientific 
researchers?
    Dr. Graham. I don't think it is difficult. It is already 
done in most fields of science. The environmental health field 
is different because of its extensive reliance on some of the 
patient records we have been talking about, and therefore, 
there is going to be a meeting next month at the National 
Academy of Sciences where they discuss not whether these data 
should be released and shared but how to do so in a way that 
protects the privacy and confidentiality of those participants. 
And I have already encouraged the Committee staff to attend and 
learn from that discussion. And I think what you will find is 
most of the scientific community with the exception of the 
mental health field is already on board for this agenda. And so 
we do have a ways to go persuading the environmental health 
research community to be involved with the open access issue.
    Two other points just to respond to previous questions, 
this question of industry data, the way I read the Secret 
Science Reform Act, it applies to industry data. This 
legislation requires industry data to meet the same standards 
as academic data or other forms of data. The only thing I can 
think of that people were referring to is confidential business 
information, which would be held in the exception that is in 
the draft legislation. But I can tell you from my experience at 
OMB, 90, 95 percent of the industry information that they want 
to bring in is not covered by confidential business 
information.
    Chairman Smith. Okay.
    Dr. Graham. So this bill is going to cover industry data, 
as it should. Okay. Second point is should we have a 
government-wide approach, wait for all the agencies to agree 
that we should do open access or shall we do something that is 
focused on environmental health research? As I have mentioned, 
we already have open access in most fields of science already. 
You need a targeted approach that goes right at the domain of 
science where this problem exists and you need a solution 
obviously to the patient record issue to assure 
confidentiality. Thank you very much.
    Chairman Smith. Thank you, Dr. Graham. It is very helpful. 
I yield back.
    Chairman Schweikert. Thank you, Mr. Chairman.
    Ms. Edwards.
    Ms. Edwards. Thank you very much, Mr. Chairman, and I 
apologize for the shuffling, juggling a little markup in 
another Committee this morning.
    Dr. Silbergeld, as you know, it has been important to 
protect personal information of individuals participating in 
epidemiological studies and that there is a strict code of 
ethics among researchers as it relates to human subjects. As I 
understand it, researchers such as yourself are working on ways 
to disclose data from human studies so that individuals are 
protected but that others can use the data. However, in one of 
your articles you indicate that there are studies where the 
removal of all identifying data negates the scientific value of 
the data set. Can you elaborate on this statement in instances 
where the identifying data are necessary to the science? And 
also, can you discuss the importance of protecting the privacy 
of study participants and concerns that may arise if the 
potential study participants fear that their information will 
be exposed to the general public?
    Ms. Silbergeld. Thank you for that question. The clearest 
example and of greatest relevance to the subject of this 
Committee's hearing has to do with studies in which we are 
interested in the location of the subjects. And we have very 
sophisticated methods of determining this through spatial 
statistics, the use of GPS, and other data. That data--those 
data have to be absolutely protected because if those data 
become available, people can pretty much identify who 
participates in the studies. And I have conducted several 
studies in which we collected those data. That information has 
to be completely de-identified, which then of course means that 
no one else can exactly take those data and carry out the same 
analyses.
    I just want to reiterate that that to me as a scientist 
reanalyzing data is an uninteresting approach to science and 
unlikely to advance our confidence in the results of a specific 
study. What advances my confidence and should advance the 
confidence of everyone in this room in the results from one 
study is really what Dr. Cox alluded to, is whether or not the 
study can be replicated independently, not whether obtaining 
the data from the first study can be reanalyzed. That is 
relatively, frankly, trivial.
    And in fact the data that are now being called upon by 
journals and the NIH will allow one to determine whether 
protocols are appropriate and statistical models were 
appropriately selected in studies designed to meet the 
requirements of hypothesis testing. I also agree that there 
should be adequate funding given to public and private sector 
entities so that we can have the updated scientific findings 
that we all agree are important to us. Thank you.
    Ms. Edwards. But would you say that there are instances 
where the identifying data set--that those are very limited 
instances of research versus other kinds of research where you 
can have tons of data that it would be--you know, where it 
would be important to keep all of the data set available so 
that you could--I mean perhaps there could be an exclusion or 
some kind of a waiver or something that isn't the rule for more 
specialized identifying data sets where people's personal 
information is identifiable?
    Ms. Silbergeld. I would have to say from my experience and 
as someone who routinely goes through the rigors of obtaining 
approval from our Institutional Review Board, I cannot see that 
I have an ethical--I cannot ethically accept revealing 
information that would allow personal identification.
    I think that the most sophisticated approach to answering 
your questions and these difficult issues in addition to what 
Dr. Graham alluded to is really what is going on worldwide, 
probably first in the European Union because they are 
confronting it first, but we are looking at it now and that is 
looking at data from clinical trials. How do we get those data 
out there to restore the faith that has been pretty badly 
damaged by drug approval processes around the world and 
inadequate clinical trials but yet protect the identification 
of the persons who participate? And I think that is going to be 
a path forward that will be very informative for all of us.
    Ms. Edwards. Thank you. And I just have one question as my 
time is set to expire. Can you explain or describe rather what 
happens when, as Dr. Graham has said, the scientific culture at 
EPA is fragile and still in an early stage of development and 
that the political, legal, and engineering cultures are 
stronger and more certain than the culture of science and 
economics? You are the only scientist on this panel and someone 
who has worked on several expert groups convened by EPA. Do you 
want to comment on that position?
    Ms. Silbergeld. Thank you. I would like to defend the 
reputation and international standing of the EPA's scientific 
staff. They are widely recognized as among the best in the 
world. I even share the honor of a MacArthur Fellowship with a 
former EPA scientist. And while I am trained in engineering and 
I will accept his compliment, I think that the biological, 
ecological, and human health science at the EPA is 
extraordinary.
    Ms. Edwards. Great. Thank you very much.
    Thanks, Mr. Chairman.
    Chairman Schweikert. Thank you, Ms. Edwards.
    Dr. Broun.
    Mr. Broun. Mr. Chairman, before I start my questioning, I 
would like to take a point of personal privilege and just say 
that I am a physician; I am a scientist and we have seen 
throughout my medical career where there are reports and 
medical data that are not reproducible and where we have seen 
researchers promote an agenda and absolutely it is critical for 
us to have an open access to data so that we can reevaluate 
existing data of any study, as well as to reevaluate the 
findings by doing other studies that are likewise trying to 
study these same issues.
    Without having open access of data, it is absolutely 
impossible for a practicing physician such as myself to make a 
valid decision on drug use or whatever I am doing as a doctor 
to try to take care of my patient. So open access to all data 
is absolutely critical. And also, in medical research we have 
avenues of protecting that personal identifiable information 
and it is absolutely critical that we do so.
    So thank you, Mr. Chairman, for giving me access to a few 
minutes to vent here a little bit. And I appreciate your 
bringing this bill forward because I think it is absolutely 
critical.
    And we have seen in Georgia, just like Mr. Bridenstine is 
talking about in Oklahoma, we have seen the EPA bring forth 
regulations as closing down 15 power plants in the State of 
Georgia. And we cannot get the data that they have brought 
forward to really evaluate why they are making the regulatory 
burden so heavy. And it is going to hurt poor people. This EPA 
has an agenda that is hurting poor people and it is hurting 
senior citizens on a limited income. And having open access to 
the data is absolutely critical for us to be able to evaluate 
that.
    Now, having said that, Dr. Graham, in your view--I hope you 
will restore some time for me, Mr. Chairman. And, Dr. Graham, 
in your view does the Freedom of Information Act make this 
Secret Science Reform Act unnecessary?
    Dr. Graham. No, because oftentimes the government doesn't 
have the possession of the data that is sought.
    Mr. Broun. Well, I agree with that. Dr. Graham, you 
mentioned that the EPA chemical assessments under IRIS program 
is an example of the nonregulatory EPA determinations that have 
significant impacts and should be subject to transparency 
requirements. The IRIS program has been criticized by the 
National Academy of Sciences and others. Do you believe greater 
data access would improve the program?
    Dr. Graham. Yes.
    Mr. Broun. Do you think the IRIS program could comply with 
the provisions of this bill, the Secret Science Reform Act?
    Dr. Graham. Yes.
    Mr. Broun. Dr. Graham, the office you previously oversaw at 
OMB, the Office of Management and Budget, produces a report of 
cost and benefits of regulations across the federal government. 
According to the most recent draft of this report to Congress, 
the vast majority of the benefits for all regulations across 
the entire federal government, as high as 80 percent, are 
attributed to EPA Clean Air Act regulations and specifically 
reduced levels of fine particular matter. In your testimony you 
noted key uncertainties in EPA's science on this question. Do 
you find these numbers credible?
    Dr. Graham. They have uncertainties, particularly given 
that the data can only be given to ``legitimate researchers.'' 
And the people who were sponsoring all this research get to 
decide who the legitimate researchers are.
    Mr. Broun. And it is just up to them. So it is secret about 
them deciding who----
    Dr. Graham. It reminds me a little bit of the NFL 
concussion sort of debate we are having right now where the 
establishment community was saying there is no connection, 
there is no connection, there is no connection and then sort of 
the people who were trying to bring other kinds of science 
involved. If you let the established community have complete 
control over who the legitimate researchers are, you are not 
going to get unexpected and new insights.
    Mr. Broun. Mr. Keating, you mentioned forthcoming national 
EPA regulations on ozone, which could cost $90 billion per 
year. What kind of impact will this have on small businesses?
    Mr. Keating. Well, there is an assortment of impacts, 
first, the ones that you alluded to in terms of--think of a 
small business owner, small business as a consumer of 
electricity, power, so on and so on. So you are going to hit on 
that end in terms of the increased cost. But then as I 
mentioned in my testimony, all of these industries--and I love 
telling people this when I go out and speak to the public on 
all those issues. You know, if you look at the energy industry, 
pick the pharmaceutical industry, all the ones that people 
think of as big oil and big pharma and big this and big that. 
When you actually dig into the numbers, the population is 
overwhelmingly small firms, less than 20 employees depending on 
the industry we are talking about, 70, 80 percent. So from a 
small business perspective, you are getting hit on both sides. 
You are getting hit as a consumer and you are getting hit as 
being part of the industry, bottom line.
    Mr. Broun. Mr. Chairman, if I could, I just have another 
question for Mr. Keating to follow up on that.
    This President said that his energy policies will 
``necessarily skyrocket the cost of energy.'' This is what we 
are talking about as increasing the cost on small businesses. 
Who gets hurt most there? I believe it is poor people and 
senior citizens on limited income. Would you agree with that, 
Mr. Keating?
    Mr. Keating. I would agree with that but I certainly 
wouldn't limit it there. When you are talking about an economy 
that is struggling to create jobs for as long as we have been 
struggling, who are the job creators? You know, again, when you 
look at the numbers, small- and medium-sized firms are creating 
roughly 2/3 of the new jobs. There is a reason why we are 
suffering these days because--well, I know it could be a long 
list of things but I think they are all--they all go back to 
policy. And we look at regulatory issues, it creates an 
enormous amount of uncertainty for small businesses and it 
imposes an enormous amount of costs. Those are--you know, it 
is--again, the consumers--it is the small businesses themselves 
but it goes well beyond that in terms of people that are just 
looking to get a job and get back into the labor force.
    Mr. Broun. Thank you, Mr. Keating.
    Mr. Chairman, I thank you for your indulgence. I am just 
very concerned about the attack upon energy, particularly coal-
powered energy and fossil fuel energy that this Administration 
is utilizing the EPA to promote that attack, and it hurts poor 
people and senior citizens I think the most but it also hurts 
job creators and hurts our economy. Thank you. I yield back.
    Chairman Schweikert. Thank you, Dr. Broun.
    Mr. Weber.
    Mr. Weber. Gosh, I was going to let Dr. Broun keep going. I 
wasn't sure of my questions yet. I am just kidding.
    Chairman Schweikert. All right. Thank you, Mr. Weber.
    Mr. Weber. Next witness----
    Mr. Broun. I tried to take your time.
    Mr. Weber. Yeah. Yeah.
    I guess this is a question for all the panelists on the 
risk data, this data that is collected that we are discussing 
here today. And I will start with you, Dr. Graham. That is--by 
the EPA, for example, that is a public agency, right?
    Dr. Graham. Yes.
    Mr. Weber. Government-funded public agency, we would all 
agree with that?
    Dr. Graham. Yes.
    Mr. Weber. So I guess we would have to agree--anybody that 
disagrees with that? I guess we would have to agree that the 
money used to procure that data was public money. No?
    Dr. Graham. Well, the----
    Mr. Weber. Dr. Silbergeld, you are saying no.
    Dr. Graham. It is a mixture. Some of the studies have a 
mixture of public and private money.
    Mr. Weber. All right. Do we question the motives of those 
who provide that private money? We seem to be questioning the 
motives of those who testify.
    Dr. Graham. At this hearing you are in good shape unless 
you are the tobacco industry.
    Mr. Weber. Well, that is what I am saying. Personally, I 
think they are blowing smoke but we seem to be questioning 
people who are involved in this--I am an air-conditioning 
contractor and--from the State of Texas and we want somebody on 
that licensing board that understands the industry or somehow 
is involved. And I understand tobacco was a big lawsuit.
    The aim of science is to get to the truth and, Dr. 
Silbergeld, I was reading your personal statement here where 
you said, ``there is an urgent and important need to adopt an 
evidence-based approach to improve decision-making and increase 
public confidence in policy-making and enhancing the scientific 
basis of toxicology as well as its utility for other domains, 
including drug regulation,'' on and on and on. And then you 
continue. You say, ``through this process I think it is time--
it is now appropriate to draw together a workshop of 
stakeholders.'' Well, I would submit that we want people from 
industry, the energy industry, the coal industry, and we want 
the data to be accessible so that if--our aim is for the 
American public's health and its safety and we want--I mean is 
it not true that scientists want to get to the truth? Is that a 
truism? Or is it what Mark Twain said? All scientists are only 
sure of one thing and that is that every other scientist before 
them was wrong.
    Ms. Silbergeld. Well, actually, Mark Twain does express a 
certain tenent in science, which is what we call the 
falsifiability principle advocated by philosophers, which is 
that we start by doubting our own hypotheses.
    Mr. Weber. Okay. Well, yeah. Well, that is right. And so I 
just want to point out that we want those industry ties and we 
want people to be able to do that. I just find it appalling 
that we seem to have a disagreement over people in industry 
have a legitimate reason for getting involved. We question 
their motive in so many cases. And I think that we have the 
underlying premise--and you tell me if I am wrong--that somehow 
government employees are to be trusted more. The EPA, Science 
Advisory Policy Committee, whatever, are to be trusted more 
than those who have a vested interest in the very communities 
that they live in. And I want us to be open and honest.
    And I am going to be supporting your bill, Mr. Chairman, 
obviously, and I want us to be able to get the open and 
reviewable science and the methodology that was used. We are 
dealing on another issue on flood on FEMA where we are 
questioning their data. But I think that it would be a good 
thing for all scientists to be able to review the data or am I 
missing something here? Mr. Keating, I will start with you.
    Mr. Keating. I think you are spot on. And what is 
interesting about this, this is where public choice economists 
can help out a little bit here because they are the ones that 
point out what the incentives are in government, right? What 
are the political incentives? And free-market people, you know, 
we still have a certain skepticism, which I like, regarding 
what government does. So what you want to do when you are 
talking about science is clear that up as much as you can, 
dispel the idea that this is all politics, it is all driven by 
politics----
    Mr. Weber. And I apologize. I am running out of time. If I 
may go over----
    Mr. Keating. Yes.
    Mr. Weber. --to the good doctor next to you here. Same 
question. I think it is a good thing if most all of the studies 
were up for review by all scientists involved, don't you agree?
    Ms. Silbergeld. I think we have that process in place now, 
sir. And actually, if I may, in response--I am sorry Dr. Broun 
is not here because in fact his profession has driven what I 
think to be a model, which is the evidence-based approach. And 
physicians don't actually usually consult the underlying data. 
They look at systematic reviews----
    Mr. Weber. And, I am sorry. I need to move on. Dr. Cox?
    Dr. Cox. I think it is an excellent idea and I don't think 
that our current systems go far enough in the public interest.
    Mr. Weber. And, Dr. Graham, I think----
    Dr. Graham. I agree.
    Mr. Weber. Okay. Well, we want to be very--I know--I 
believe that all of our colleagues here want to be good 
stewards of the American tax dollars or taxpayers' money, and 
so the fact that we want to call in to question some of these 
policies by the EPA because they are killing jobs; it is just 
as pure and simple as you can make it. And if the scientific 
data is not absolutely concrete and 100 percent certain, then I 
think rather than have a war on coal, rather than have a war on 
fossil fuels--and I was on the Environmental Reg Committee in 
the Texas Legislature, and Texas does a good job of cleaning up 
their air. Now, there are federal government employees would 
like to think that they have to come in and riot herd on Texas 
to use an old Texas colloquialism. But leave it to the States 
for the most part because they do want a clean backyard.
    And, Mr. Chairman, I have gone on way too long and I will 
stop. Thank you very much.
    Chairman Schweikert. Thank you, Mr. Weber.
    Ms. Bonamici, do you ever feel that we are just surrounded 
by Texans on this Committee?
    Ms. Bonamici. Yes, indeed, Mr. Chairman.
    Chairman Schweikert. Would you like to do a closing 
statement or share some thoughts?
    Ms. Bonamici. Thank you very much, Mr. Chairman. I 
appreciate the opportunity. And thank you for your courtesy in 
allowing me to do this. But thank you to all the witnesses for 
being here today.
    Mr. Chairman, I know we share a common goal of transparency 
and I also--but the issue of course is how do we accomplish 
that? And I also know that we all want the EPA to be able to 
use the best science available and I look forward to further 
discussions about that.
    I also want to reiterate the need to hear from the EPA 
about this proposed legislation to get their input on how this 
would affect them, their work, their workload, and just to get 
a sense from them on the record and again working hopefully 
with the Subcommittee on Science and Technology. So I look 
forward to--the Subcommittee on Technology and Innovation. I 
look forward to working with you on this important issue, and 
as I said, we share the common goal of transparency. Let's 
figure out if there is a way we can get there. Thank you.
    Chairman Schweikert. Thank you, Ms. Bonamici.
    And this was one of those I have a particular personal 
interest in, so forgive me if sometimes--and I am hoping I get 
input from everyone, particularly those agencies that would be 
affected.
    There is a running joke in my family, what are the two 
times in life you think you know everything? When you are 14 
years old and the day after you get elected to Congress. It 
really is actually funny. And my concern is, you know, in part 
of this discussion, should data that is making regulatory 
policy, how egalitarian, how much should it be? And, you know, 
we all have this certain sort of folklore, experience in our 
lives. When I was a freshman in my statistics class, my 
professor at that time, she talked about how she had done all 
this modeling on what--you know, for a couple drug companies on 
what the different products for ulcers would be, but a couple 
years later she found out that the ulcers she had were actually 
caused by bacteria in the lining. So all this study over here 
on what was the best drug, it turns out they were looking at 
the wrong thing. They had it wrong.
    How often does that happen where the data sets, our current 
data belief, our current policy we believe today will be 
dramatically different a decade ago? It was only 10, 12 years 
ago if you and I sat in this room, we would have been hearing 
speakers, Members talking about Peak Oil, you know, the next 
incremental barrel of fossil fuels would be less. We screwed up 
somewhere the modeling on the understanding of technological 
curve, where we were at. We got it wrong but yet our tax 
policy, our environmental policy, our military policy was based 
on that data. And I am--so part of my embracing of the idea of 
lots of inputs is I am hoping somewhere there is the brilliance 
that helps us do what is best, and what is best for our country 
sometimes may have my ideological leaning and sometimes it 
might not, but at least it will be fact-based.
    So with that, I want to thank the witnesses here and I am 
very sincere. Having read all your CVs, you are all very, very 
unique individuals and very bright.
    The Members of the Committee will have--if they have 
additional questions for you, and I am almost sure there will 
be some coming towards you, we will ask you to respond in 
writing. The record will remain open for two weeks for 
additional comments and written questions from Members. And the 
witnesses are excused. Thank you for giving us some of your 
valuable time.
    [Whereupon, at 11:38 a.m., the Subcommittee was adjourned.]











                               Appendix I

                              ----------                              


                   Answers to Post-Hearing Questions




[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



                                 [all]
