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 

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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 

( 

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

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

HON. LAMAR S. SMITH, Texas, Chair 

DANA ROHRABACHER, California 

RALPH M. HALL, Texas 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

FRANK D. LUCAS, Oklahoma 

RANDY NEUGEBAUER, Texas 

MICHAEL T. MCCAUL, Texas 

PAUL C. BROUN, Georgia 

STEVEN M. PALAZZO, Mississippi 

MO BROOKS, Alabama 

RANDY HULTGREN, Illinois 

LARRY BUCSHON, Indiana 

STEVE STOCKMAN, Texas 

BILL POSEY, Florida 

CYNTHIA LUMMIS, Wyoming 

DAVID SCHWEIKERT, Arizona 

THOMAS MASSIE, Kentucky 

KEVIN CRAMER, North Dakota 

JIM BRIDENSTINE, Oklahoma 

RANDY WEBER, Texas 

CHRIS COLLINS, New York 

VACANCY 

EDDIE BERNICE JOHNSON, Texas 

ZOE LOFGREN, California 

DANIEL LIPINSKI, Illinois 

DONNA F. EDWARDS, Maryland 

FREDERICA S. WILSON, Florida 

SUZANNE BONAMICI, Oregon 

ERIC SWALWELL, California 

DAN MAFFEI, New York 

ALAN GRAYSON, Florida 

JOSEPH KENNEDY III, Massachusetts 

SCOTT PETERS, California 

DEREK KILMER, Washington 

AMI BERA, California 

ELIZABETH ESTY, Connecticut 

MARC VEASEY, Texas 

JULIA BROWNLEY, California 

MARK TAKANO, California 

ROBIN KELLY, Illinois 

SUBCOMMITTEE ON ENVIRONMENT

HON. DAVID SCHWEIKERT, Arizona, Chair 

JIM BRIDENSTINE, Oklahoma 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

DANA ROHRABACHER, California 

RANDY NEUGEBAUER, Texas 

PAUL C. BROUN, Georgia 

RANDY WEBER, Texas 

LAMAR S. SMITH, Texas 

SUZANNE BONAMICI, Oregon 

JULIA BROWNLEY, California 

DONNA F. EDWARDS, Maryland 

MARK TAKANO, California 

ALAN GRAYSON, Florida 

EDDIE BERNICE JOHNSON, Texas 
(III) 

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 
Page

IV 

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 
(1) 

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. 
2 
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4 
5 
6 
7 
8 
9 
10 

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, 
11 

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 
12 

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 
13 

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 peerreviewed 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 
14 

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. 
15 

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, 
16 

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. 
17 

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. 
18 

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. 
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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 
20 

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:] 
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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-inchief 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 
35 

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 
36 

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:] 
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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 
45 

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-inchief 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:] 
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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 
68 

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:] 
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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 peerreview 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 
79 

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 
80 

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 
81 

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 evidencebased 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 
82 

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 governmentwide 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] 
83 
84 

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] 
85 
86 

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] 
87 
88 

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] 
89 
90 

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] 
91 
92 

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] 
93 
94 

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] 
95 
96 

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] 
97 
98 

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? 
99 

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 
100 

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 
101 

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 
102 

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 re-
103 

searchers 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. 
104 

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, 
105 

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. 
106 

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. 
107 

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.] 

(109) 

Appendix I 

ANSWERS TO POST-HEARING QUESTIONS
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ANSWERS TO POST-HEARING QUESTIONS

Responses by The Honorable John Graham 
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Responses by Cox Dr. Louis Anthony Cox, Jr. 
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Responses by Dr. Ellen Silbergeld 
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Appendix II 

ADDITIONAL MATERIAL FOR THE RECORD
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THE FOLLOWING DOCUMENTS WERE SUBMITTED FOR THE RECORD BY

REPRESENTATIVE SUZANNE BONAMICI
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THE FOLLOWING DOCUMENTS WERE SUBMITTED FOR THE RECORD BY

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