[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
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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
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Answers to Post-Hearing Questions
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