[House Hearing, 113 Congress] [From the U.S. Government Publishing Office] ENSURING OPEN SCIENCE AT EPA ======================================================================= HEARING BEFORE THE SUBCOMMITTEE ON ENVIRONMENT COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY HOUSE OF REPRESENTATIVES ONE HUNDRED THIRTEENTH CONGRESS SECOND SESSION ---------- FEBRUARY 11, 2014 ---------- Serial No. 113-65 ---------- Printed for the use of the Committee on Science, Space, and Technology [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] ENSURING OPEN SCIENCE AT EPA ======================================================================= HEARING BEFORE THE SUBCOMMITTEE ON ENVIRONMENT COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY HOUSE OF REPRESENTATIVES ONE HUNDRED THIRTEENTH CONGRESS SECOND SESSION __________ FEBRUARY 11, 2014 __________ Serial No. 113-65 __________ Printed for the use of the Committee on Science, Space, and Technology [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Available via the World Wide Web: http://science.house.gov __________ U.S. GOVERNMENT PRINTING OFFICE 88-135PDF WASHINGTON : 2014 ----------------------------------------------------------------------- For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800 DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, Washington, DC 20402-0001 COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY HON. LAMAR S. SMITH, Texas, Chair DANA ROHRABACHER, California EDDIE BERNICE JOHNSON, Texas RALPH M. HALL, Texas ZOE LOFGREN, California F. JAMES SENSENBRENNER, JR., DANIEL LIPINSKI, Illinois Wisconsin DONNA F. EDWARDS, Maryland FRANK D. LUCAS, Oklahoma FREDERICA S. WILSON, Florida RANDY NEUGEBAUER, Texas SUZANNE BONAMICI, Oregon MICHAEL T. McCAUL, Texas ERIC SWALWELL, California PAUL C. BROUN, Georgia DAN MAFFEI, New York STEVEN M. PALAZZO, Mississippi ALAN GRAYSON, Florida MO BROOKS, Alabama JOSEPH KENNEDY III, Massachusetts RANDY HULTGREN, Illinois SCOTT PETERS, California LARRY BUCSHON, Indiana DEREK KILMER, Washington STEVE STOCKMAN, Texas AMI BERA, California BILL POSEY, Florida ELIZABETH ESTY, Connecticut CYNTHIA LUMMIS, Wyoming MARC VEASEY, Texas DAVID SCHWEIKERT, Arizona JULIA BROWNLEY, California THOMAS MASSIE, Kentucky MARK TAKANO, California KEVIN CRAMER, North Dakota ROBIN KELLY, Illinois JIM BRIDENSTINE, Oklahoma RANDY WEBER, Texas CHRIS COLLINS, New York VACANCY ------ Subcommittee on Environment HON. DAVID SCHWEIKERT, Arizona, Chair JIM BRIDENSTINE, Oklahoma SUZANNE BONAMICI, Oregon F. JAMES SENSENBRENNER, JR., JULIA BROWNLEY, California Wisconsin DONNA F. EDWARDS, Maryland DANA ROHRABACHER, California MARK TAKANO, California RANDY NEUGEBAUER, Texas ALAN GRAYSON, Florida PAUL C. BROUN, Georgia EDDIE BERNICE JOHNSON, Texas RANDY WEBER, Texas LAMAR S. SMITH, Texas C O N T E N T S February 11, 2014 Page Witness List..................................................... 2 Hearing Charter.................................................. 3 Opening Statements Statement by Representative David Schweikert, Chairman, Subcommittee on Environment, Committee on Science, Space, and Technology, U.S. House of Representatives...................... 10 Written Statement............................................ 11 Statement by Representative Suzanne Bonamici, Ranking Minority Member, Subcommittee on Environment, Committee on Science, Space, and Technology, U.S. House of Representatives........... 11 Written Statement............................................ 13 Statement by Representative Lamar S. Smith, Chairman, Committee on Science, Space, and Technology, U.S. House of Representatives................................................ 14 Written Statement............................................ 15 Statement by Representative Eddie Bernice Johnson, Ranking Member, Committee on Science, Space, and Technology, U.S. House of Representatives............................................. 16 Written Statement............................................ 17 Witnesses: The Honorable John Graham, Dean, School of Public and Environmental Affairs, Indiana University Oral Statement............................................... 19 Written Statement............................................ 21 Dr. Louis Anthony Cox, Jr., Chief Sciences Officer, Next Health Technologies, Clinical Professor, Biostatistics and Informatics, Colorado Health Sciences Center, and President, Cox Associates Oral Statement............................................... 34 Written Statement............................................ 37 Dr. Ellen Silbergeld, Professor, Bloomberg School of Public Health, Johns Hopkins University Oral Statement............................................... 44 Written Statement............................................ 46 Mr. Raymond Keating, Chief Economist, Small Business & Entrepreneurship Council Oral Statement............................................... 67 Written Statement............................................ 69 Discussion....................................................... 78 Appendix I: Answers to Post-Hearing Questions The Honorable John Graham, Dean, School of Public and Environmental Affairs, Indiana University...................... 110 Dr. Louis Anthony Cox, Jr., Chief Sciences Officer, Next Health Technologies, Clinical Professor, Biostatistics and Informatics, Colorado Health Sciences Center, and President, Cox Associates................................................. 117 Dr. Ellen Silbergeld, Professor, Bloomberg School of Public Health, Johns Hopkins University............................... 122 Mr. Raymond Keating, Chief Economist, Small Business & Entrepreneurship Council....................................... 201 Appendix II: Additional Material for the Record Letter from the American Lung Association, submitted by Representative Suzanne Bonamici, Ranking Minority Member, Subcommittee on Environment, Committee on Science, Space, and Technology..................................................... 208 Letter from the Center for Progressive Reform, submitted by Representative Suzanne Bonamici, Ranking Minority Member, Subcommittee on Environment, Committee on Science, Space, and Technology..................................................... 210 Letter from the Natural Resources Defense Council, submitted by Representative Suzanne Bonamici, Ranking Minority Member, Subcommittee on Environment, Committee on Science, Space, and Technology..................................................... 228 Letter from the Union of Concerned Scientists, submitted by Representative Suzanne Bonamici, Ranking Minority Member, Subcommittee on Environment, Committee on Science, Space, and Technology..................................................... 241 George Mason University Survey: Expert Opinion on Regulatory Risk Assessment, submitted by Representative David Schweikert, Chairman, Subcommittee on Environment, Committee on Science, Space, and Technology.......................................... 243 The Bipartisan Policy Center's The Science for Policy Project: Improving the Use of Science in Regulatory Policy, submitted by Representative David Schweikert, Chairman, Subcommittee on Environment, Committee on Science, Space, and Technology....... 255 Recommendation from the Administrative Conference of The United States, submitted by Representative David Schweikert, Chairman, Subcommittee on Environment, Committee on Science, Space, and Technology..................................................... 325 Dr. Adrian G. Barnett, Institute of Health and Biomedical, Innovation and School of Public Health, Queensland University of Technology, Kelvin Grove, Queensland, Australia, letter to the Editor in response to the article, ``Benefits of Publicly Available Data,'' submitted by Representative David Schweikert, Chairman, Subcommittee on Environment, Committee on Science, Space, and Technology.......................................... 332 Letter from the Halogenated Solvents Industry Alliance, Inc., submitted by Representative David Schweikert, Chairman, Subcommittee on Environment, Committee on Science, Space, and Technology..................................................... 334 ENSURING OPEN SCIENCE AT EPA ---------- WEDNESDAY, FEBRUARY 11, 2014 House of Representatives, Subcommittee on Environment, Committee on Science, Space, and Technology, Washington, D.C. The Subcommittee met, pursuant to call, at 10:04 a.m., in Room 2318 of the Rayburn House Office Building, Hon. David Schweikert [Chairman of the Subcommittee] presiding. [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Schweikert. Let's have at it. The Subcommittee on Environment will come to order. And that was my gavel. Welcome to today's hearing ``Ensuring Open Science at EPA.'' In front of you are packets containing the written testimony, biographies, and truth-in-testimony disclosures for today's witnesses. This is also my very first hearing chairing this Subcommittee and so I was going to do something a little off the normal script. I first was going to turn to my soon-to-be very good friend from Oregon, Ranking Member Bonamici, and I have got to say thank you for your kindness. I am going to take a somewhat different tack than often happens at many of these. I actually have a fascination with the underlying science and want to try to do this as credibly as possible, you know, because this in some ways should be almost beyond the-- sometimes the right/left paradigm we engage in. This is hopefully about facts. On a philosophical level--and forgive me for going there-- for today's hearing how do you have a civil society with our public when our leaders, when the people around us, almost no one trusts our institutions anymore? You know, how do you have a society and hold it together when we don't trust our government, we don't trust our agencies, we don't trust so much around us? And my great hope is this being sort of a first step is a movement towards a level of transparency where I don't care whether you are a group from the right, left, or just someone from academia. The ability in today's world--when my laptop computer is now more powerful than the quad Xeon server I have at home, for all of us, our ability to actually--if you were crazy enough or were interested enough in your quant class to take the data, to understand it, to analyze it, to have an opinion, does that openness, does that transparency--and the President actually talked about this when he was first elected, that a transparent, open government develops hopefully a faith and trust with its population. Can we head that direction? And I know we get into certain things like I consider sort of red herrings, absurdities. There are ways to protect people's privacy. We do it every day. I come more from the financial side of the world having sat on Financial Services before, and data that was collected by CFPB and so many of the other agencies, they have systematic methodologies where they protect individuals' privacy. But I am--my great hope here as we sort of move forward on H.R. 4012, that we are sort of building a precedence of how do I build public data for public policy and public policy by sort of egalitarian public data where we all have the right to know what is underlying? And my last caveat for--and I have been thinking about this one a lot--and this is both for my friends on the right, the left, and our staff, you are going to have to step beyond sort of the confirmation bias. Let's say we are here a couple years from now and all of us have access to underlying baseline data and it is being used for regulatory or policy, don't think it is always going to say what you think it is going to say. There are going to be times when the data sets may say the agency isn't going far enough. There may be other times it turns around and says when you stress the data that we need to be going a very different approach, but at least it will be honest. And being fixated on sort of crowdsourcing of information, I believe the crowd does purify policy and I hope we are going that direction. [The prepared statement of Mr. Schweikert follows:] Prepared Statement of Subcommittee on Environment Chairman David Schweikert I actually have fascination with the underlying science. And I want to try and do this as credibly as possible. Because this, in some ways this should be almost beyond the sometimes left right paradigm we engage in, this should be about facts. How do you have a civil society when our leaders, our public don't trust our institutions anymore? We don't trust our government, we don't trust our agencies, we don't trust so much around us. A transparent, open government develops, hopefully, a faith with its population. My great hope is, this being sort of a first step, is movement towards a level of transparency, where I don't care if you a group from the right or the left, or just someone from academia the ability in today's world . . . to take the data, to understand it, to have an opinion. A transparent, open government develops, hopefully, a faith with its population. Can we head that direction?There are ways to protect people's privacy, we do it every day. My great hope here is we sort of move forward on H.R. 4012, that we are sort of building a precedence on how do I build public data for public policy, and public policy by egalitarian public data, where we all have the right to know what is underlying. You are going to have to steep beyond confirmation bias. Don't think it (the data) is always going to say what you think it is going to say. There is bound to be times when the data sets may say the agency isn't going far enough. There may be other times it says when you stress the data, we need to be going with a different approach. I believe the crowd does purify policy, and I hope we are going in that direction. Chairman Schweikert. And for an opening statement, my friend, Ms. Bonamici, Ranking Member. Ms. Bonamici. Thank you very much, Chairman Schweikert. I want to start by saying welcome and to offer my sincere congratulations to you on becoming our new Subcommittee Chairman. I am looking forward to working with you. I am hopeful that we can find common ground and develop meaningful solutions to our Nation's important environmental challenges. And, I agree; improving transparency and public access, especially to federally funded research at the EPA or at any federal agency, is an important objective and one that I fully support. And although there may be disagreements about--among the Subcommittee Members about various actions that the EPA may be considering, I am confident that we all support increased transparency. Unfortunately, it appears that the language in the bill we are discussing today called the Secret Science Reform Act may actually prohibit EPA from increasing transparency. And I hope that this isn't an attempt to prevent or impede the EPA from promulgating regulations and performing its congressionally mandated priority objective of protecting human health and the environment. If implemented as written, this bill would actually prevent the EPA from using the best available science to inform its regulatory actions. The EPA relies on thousands of peer- reviewed articles as part of their scientific review, and under this proposal, if for any reason all of the scientific and technical information associated with those articles was not publicly available, the EPA would have to proceed as if those studies did not exist. And that is not in the best interest of the American people who are our constituents. It is also not clear whether this proposal is retroactive. If so, then the legislation would essentially nullify all the progress we have made to date to improve the quality of the air our children and in fact all of our constituents breathe and the water that they drink. I am also concerned about the potential negative impacts that the bill could have on the scientific community. Researchers and organizations may be hesitant to conduct EPA- funded research if they are required to disclose protected information like health records. Historically, researchers have been able to assure individuals participating in their studies that their personal information is safe, and that helps attract participants. Now, last year, this Committee took the unusual action of issuing a subpoena to acquire data that the EPA relied on when developing air quality regulations. This data, the basis of the Harvard 6 studies and the American Cancer Society study, contains personal health records of hundreds of thousands of Americans. And I presume that this is an example of the so- called secret science that inspired this bill. But contrary to the assertion that the science behind those studies is secret, in fact, the legal owners of the data sets, Harvard University and the American Cancer Society, do allow legitimate researchers access to this information and they have procedures in place to protect it. So it is interesting this Committee did spend a significant amount of time scrutinizing HealthCare.gov and claiming that the website actually puts personal health records at risk. Frankly, I am a bit surprised that my colleagues do not now recognize the importance of protecting studies that actually do contain personal health information. But perhaps what is more troubling about this proposal--and I look forward to discussing it--is that it ignores the good work already done by this Committee. In 2010, this Committee reauthorized the America COMPETES Act, which requires the Office of Science and Technology Policy or OSTP to issue guidance to all federal agencies on the development of clear and coordinated policies to increase access to federally funded published research and digital scientific data. And it is my understanding that the EPA is currently in the process of developing policies pursuant to that guidance. This bill also seems to be inconsistent with the data and public access provisions included in the majority's FIRST Act. Although there are some open questions about specific provisions of the FIRST Act, the bill takes the more appropriate government-wide approach and requires consultation and input from the scientific and stakeholder community. It is worth having a real discussion--and again, we look forward to that--about how we can improve transparency and data access across the federal government. Additionally, as we have discussed, I hope we are able to have another hearing on this issue. I strongly encourage the participation of the EPA so that the Agency has an opportunity to appear before the Committee and provide on the record their analysis about the provisions of this bill. It would be logical--and I suggest this, Mr. Chairman--that we hold such a hearing in conjunction with our colleagues on the Research and Technology Subcommittee because they are also examining this issue very closely. Mr. Chairman, I truly hope we can work together to find a way to improve public access to federally funded research in a manner that does not compromise the EPA's mission to protect human health and the environment. Thank you again, and welcome to the Committee, Mr. Chairman, and I yield back the balance of my time. [The prepared statement of Ms. Bonamici follows:] Prepared Statement of Subcommittee on Environment Ranking Minority Member Suzanne Bonamici Thank you, Chairman Schweikert. I would like to start by saying welcome, and I offer sincere congratulations to you on becoming our new Subcommittee Chairman. I am looking forward to working with you and am hopeful that we can find common ground and develop meaningful solutions to our nation's important environmental challenges. Improving transparency and public access to federally funded research at EPA, or at any federal agency, is an important objective and one that I fully support. Although there may be disagreements among the Subcommittee Members about various actions that the EPA may be considering, I am confident that we all support increased transparency. Unfortunately, it appears the language in the bill we are discussing today, called the ``Secret Science Reform Act,'' may actually prohibit EPA from increasing transparency. I hope that this is not an attempt to prevent or impede the EPA from promulgating regulations and performing its Congressionally-mandated priority objective of protecting human health and the environment. If implemented, this bill would actually prevent the EPA from using the best available science to inform its regulatory actions. EPA relies on thousands of peer-reviewed articles as part of their scientific review. Under this proposal, if for any reason all of the scientific and technical information associated with those articles was not publicly available, EPA would have to proceed as if those studies did not exist. That is not in the best interest of the American people - our constituents. It is also not clear whether this proposal is retroactive. If so, then the legislation would essentially nullify all the progress we've made to date to improve the quality of the air our children--and all of our constituents for that matter--breathe and the water they drink. I am also concerned about the potential negative impacts that the bill could have on the scientific community. Researchers and organizations may be hesitant to conduct EPA-funded research if they are required to disclose protected information like health records. Historically, researchers have been able to assure individuals participating in their studies that their personal information is safe, and that helps attract participants. Last year, this Committee took the unusual action of issuing a subpoena to acquire data that the EPA relied on when developing air quality regulations. This data, the basis of the Harvard Six Cities study and the American Cancer Society study, contains the personal health records of hundreds of thousands of Americans. I presume that this is an example of the so-called ``secret science'' that inspired this bill. But contrary to the assertion that the science behind those studies is ``secret, in fact the legal owners of these data sets, Harvard University and the American Cancer Society, allow legitimate researchers access to this information and have procedures in place to protect it. It's interesting--this Committee spent a significant amount of time scrutinizing Healthcare.gov and claiming that the website puts personal health records of millions at risk; frankly I am a bit surprised that my colleagues do not now recognize the importance of protecting studies that actually do contain personal health information. But perhaps what is more troubling about this proposal is that it ignores the good work already done by this Committee. In 2010, this Committee reauthorized the America COMPETES Act, which requires the Office of Science and Technology Policy (OSTP) to issue guidance to all federal agencies on the development of clear and coordinated policies to increase access to federally funded published research and digital scientific data. It's my understanding that the EPA is in the process of developing policies pursuant to this guidance. This bill also seems to be inconsistent with the data and public access provisions included in the Majority's FIRST Act. Although there are some open questions about specific provisions of the FIRST Act, the bill takes the more appropriate government-wide approach and requires consultation and input from the scientific and stakeholder community. It is worth having a real discussion about how we can improve transparency and data access across the federal government. Additionally, as we have discussed, I hope we are able to have another hearing on this issue. I strongly encourage the participation of the EPA so that the agency has an opportunity to appear before the Committee and provide--on the record--their analysis about the provisions of this bill. It would be logical to hold such a hearing in conjunction with our colleagues on the Research and Technology Subcommittee because they have been examining this issue closely. Mr. Chairman, I hope that we can work together to find a way to improve public access to federally funded research in a manner that does not compromise the EPA's mission to protect human health and the environment. Thank you, Mr. Chairman and I yield back. Chairman Schweikert. Thank you, Ranking Member Bonamici. Now, I would like to turn to the Chairman of the full Committee, the gentleman--and I emphasize gentleman--from Texas, Mr. Smith, opening statement, please. Chairman Smith. Thank you, Mr. Chairman, and congratulations on chairing your first Subcommittee hearing. The Secret Science Reform Act of 2014 is a result of more than two years of investigative work on the part of the Science, Space, and Technology Committee. This work was initiated when the Environmental Protection Agency failed to live up to its public commitment to make the data that supports its most costly air regulations available to the public. In September 2011, then-Assistant Administrator Gina McCarthy committed to provide this Committee with the data EPA relied upon to justify its claims about air quality and health effects. In 2012, the President's own science advisor John Holdren testified that ``absolutely the data on which regulatory decisions are based should be made available to the Committee and should be made public.'' The Committee sought this data for a simple reason: to see whether the science supports EPA's rules. An open and transparent government requires its disclosure. Through this process, we learned that much of the data either no longer exists or was never in the Agency's possession. Not only are EPA's claims not independently verifiable, the Agency cannot provide evidence to justify them. As a result, the American people have no way of knowing the truth. The EPA's mission is to protect public health and the environment, but the Agency's regulations impact all aspects of our economy. Sound public policy requires precise decision- making that properly balances competing needs. While the Agency is charged with setting standards that are ``requisite to protect public health,'' those standards should be no more restrictive than necessary. Transparency and independent verification are basic tenets of science and must inform sound environmental policy. When the EPA does not follow these basic steps, it fails in its obligation to the American people and raises suspicions about whether its regulations can be justified. It is unfortunate that our Nation's environmental policy has become one of the most contentious issues in Washington, but a discussion about the merits of any particular regulation is meaningless if the public cannot trust the underlying science, and that is impossible if the information isn't even available. Everyone agrees that we need to protect the environment, but it should be done in a way that is transparent and honest. This bill encourages those principles. The Secret Science Reform Act of 2014 has two basic elements. One, it prohibits EPA from issuing regulations unless all scientific and technical information relied upon is specifically identified; and two, it requires that information to be publicly available in a manner that is sufficient for independent analysis and reproduction of research results. Americans impacted by EPA regulations have a right to see the data and determine for themselves if the Agency's actions are based on sound science or a partisan agenda. This bill ensures transparency and accountability. It is hard to imagine a single reason why anyone would oppose this basic principle that is consistent with the Administration's policies on transparency. James Madison may have explained this best when he said that ``a popular government without popular information or the means of acquiring it is but a prologue to a farce or a tragedy, or perhaps both. Knowledge will forever govern ignorance, and a people who need to be their own governors must arm themselves with the power knowledge gives.'' Given the EPA's aggressive agenda and its willingness to play fast and loose with the law, the Agency should be forced to live up to the claims of transparency it so readily espouses. The American people deserve the facts and so does good policy. Thank you, Mr. Chairman. I yield back. [The prepared statement of Mr. Smith follows:] Prepared Statement of Full Committee Chairman Lamar S. Smith The Secret Science Reform Act of 2014 is the result of more than two years of investigative work on the part of the Science, Space, and Technology Committee. This work was initiated when the Environmental Protection Agency (EPA) failed to live up to its public commitment to make the data that supports its most costly air regulations available to the public. In September 2011, then-Assistant Administrator Gina McCarthy committed to provide this Committee with the data EPA relied upon to justify its claims about air quality and health effects. In 2012, the President's Science Advisor, John Holdren, testified that, ``Absolutely, the data on which regulatory decisions.are based should be made available to the Committee and should be made public.'' The Committee sought this data for a simple reason: to see whether the science supports EPA's rules. An open and transparent government requires its disclosure. Through this process, we learned that much of the data either no longer exists or was never in the agency's possession. Not only are EPA's claims not independently verifiable, the agency cannot provide evidence to justify them. As a result, the American people have no way of knowing the truth. EPA's mission is to protect public health and the environment. But the agency's regulations impact all aspects of our economy. Sound public policy requires precise decision-making that properly balances competing needs. While the agency is charged with setting standards that are ``requisite to protect public health,'' those standards should be no more restrictive than necessary. Transparency and independent verification are basic tenants of science and must inform sound environmental policy. When the EPA does not follow these basic steps, it fails in its obligation to the American people and raises suspicions about whether its regulations can be justified. It's unfortunate that our nation's environmental policy has become one of the most contentious issues in Washington. But a discussion about the merits of any particular regulation is meaningless if the public cannot trust the underlying science. And that's impossible if the information isn't even available. Everyone agrees that we need to protect the environment. But it should be done in a way that is transparent and honest. This bill encourages those principles. The Secret Science Reform Act of 2014 has two basic elements: 1) It prohibits EPA from issuing regulations unless all scientific and technical information relied upon is specifically identified; and, 2) It requires that information to be publicly available in a manner that is sufficient for independent analysis and reproduction of research results. Americans impacted by EPA regulations have a right to see the data and determine for themselves if the agency's actions are based on sound science or a partisan agenda. This bill ensures transparency and accountability. It's hard to imagine a single reason why anyone would oppose this basic principle that is consistent with the Administration's policies on transparency. James Madison may have explained this best when he said that, ``A popular government without popular information or the means of acquiring it, is but a Prologue to a Farce or a Tragedy--or perhaps both. Knowledge will forever govern ignorance, and a people who mean to be their own Governors must arm themselves with the power knowledge gives.'' Given the EPA's aggressive agenda and its willingness to play fast and loose with the law, the agency should be forced to live up to the claims of transparency it so readily espouses. The American people deserve the facts. And so does good policy. Chairman Schweikert. Thank you, Chairman Smith. I now want to recognize my other bookend from Texas, the Ranking Member of the full Committee, Ms. Johnson. Ms. Johnson. Thank you very much, Mr. Chairman. And I would like to echo Ms. Bonamici in congratulating you on being named the Chair of the Subcommittee and look forward to working with you in this capacity and have been impressed with your particular statements, this meeting and others. Unfortunately, I regret that today's hearing might be a rough start in that regard. That is because the Secret Science Reform Act of 2014 continues to be one of the most regrettable sagas in the history of this esteemed Committee. Out of all the years I have served on this Committee, this term has been the worst experience. This saga began in the last Congress with majority requests for data associated with studies that the EPA relied on for certain clean air regulations. It continued in August of last year when the Chairman issued the first subpoena from this Committee in over 20 years to obtain that same data. And now, we are here today to discuss this misguided and mislabeled legislation. I want to be clear. The Secret Science Reform Act of 2014 is built on a false premise. None of the science that have been in question during this two-year affair is secret. Is the data protected? Of course it is. The data contains the personally identifiable health information of hundreds of thousands of American citizens. Nonetheless, as the Democratic minority has repeatedly pointed out, legitimate researchers do have access to this data. So what is the problem? What legitimate researchers cannot already access this data? At the August 1, 2013, meeting to authorize a subpoena, the Chairman indicated Dr. James Enstrom could not access the American Cancer Society data. As I have pointed out before, Dr. Enstrom has a long history of conducting research and performing consultant work for the tobacco industry. Now, that brings us to today's hearing. Mr. Chairman, all three of the majority witnesses also have significant ties to the tobacco industry. First, we have Dr. John Graham. While he headed the Harvard Center for Risk Analysis, he personally solicited research funding from Philip Morris. Moreover, he invited Philip Morris public relation officials to review a draft chapter of his book on the subject of secondhand smoke. Dr. Graham's center ultimately received tens of thousands of dollars on grants from Philip Morris' subsidiary, Kraft General Foods. Next, we have Dr. Tony Cox, who has received numerous research grants from Philip Morris tobacco and has collaborated on research with internal Philip Morris scientists. In addition, Dr. Cox has served as a litigation consultant for the Philip Morris and R.J. Reynolds tobacco companies. Finally, we have Dr. Ray Keating. Dr. Keating's organization, the Small Business & Entrepreneurship Council, and its predecessor, the Small Business Survival Foundation, has solicited and received funding from tobacco companies. Moreover, documentation seems to suggest a large amount of collaboration with tobacco companies. For instance, in the mid- '90s, Dr. Keating released a series of reports of FDA tobacco regulations and their negative effects on small business and also filed comments with the FDA on the same topic. These reports relied upon a study commissioned by Dr. Keating's organization and conducted by the American Economics Group. What Dr. Keating didn't mention in his reports or FDA comments is that the Small Business Survival Foundation was acting as a go-between for the tobacco industry. Tobacco companies' emails show that the study in question was jointly funded and organized by Philip Morris and R.J. Reynolds tobacco. The reason I highlight this, Mr. Chairman, is that EPA is a public health agency. I am a health professional. I find it deeply disturbing that the experts the majority seems to rely upon for advice in this arena of public health all have extensive ties to the tobacco industry. That is the same industry that was found by a federal court to have engaged in racketeering and wire fraud in order to subvert the public health of American people. And how did they accomplish this fraud? Through a well-documented history of funding researchers and third-party groups to cast doubt on the public health effects of tobacco. Mr. Chairman, this is a serious subject because ultimately this is about protecting public health of our citizens. It is about protecting the health of our neighbors and our friends and family. If the majority is serious about moving forward with this ill-advised legislation, then we need to hear from a credible set of witnesses. Our citizens deserve no less. I thank you and yield back. [The prepared statement of Ms. Johnson follows:] Prepared Statement of Full Committee Ranking Member Eddie Bernice Johnson Thank you Chairman Schweikert. I would like to echo Ms. Bonamici in congratulating you on being named Chair of the Subcommittee and look forward to working with you in this capacity. Unfortunately, I regret that today's hearing might be a rough start in that regard. That is because the ``Secret Science Reform Act of 2014'' continues one of the most regrettable sagas in the history of this esteemed Committee. This saga began in the last Congress with Majority requests for data associated with studies that the EPA relied upon for certain clean air regulations. It continued in August of last year when the Chairman issued the first subpoena from this Committee in over 20 years to obtain that same data. And now we are here today, to discuss this misguided and mislabeled legislation. I want to be clear, the ``Secret Science Reform Act of 2014'' is built on a false premise. None of the science that has been in question during this two year affair is ``secret.'' Is the data protected? Of course it is. The data contains the personally identifiable health information of hundreds of thousands of American citizens. Nonetheless, as the Democratic Minority has repeatedly pointed out, legitimate researchers do have access to this data. So what is the problem? What legitimate researchers cannot already access this data? At the August 1, 2013, meeting to authorize a subpoena, the Chairman indicated that Dr. James Enstrom could not access the American Cancer Society data. As I have pointed out before, Dr. Enstrom has a long history of conducting research and performing consulting work for the tobacco industry. And that brings us to today's hearing. Mr. Chairman, all three of the Majority's witnesses also have significant ties to the tobacco industry. First we have Dr. John Graham. While he headed the Harvard Center for Risk Analysis he personally solicited research funding from Philip Morris. Moreover, he invited Philip Morris public relations officials to review a draft chapter of his book on the subject of second-hand smoke. Dr. Graham's Center ultimately received tens of thousands of dollars in grants from Philip Morris subsidiary Kraft General Foods. Next we have Dr. Tony Cox, who has received numerous research grants from Philip Morris tobacco and has collaborated on research with internal Philip Morris scientists. In addition, Dr. Cox has served as a litigation consultant for the Philip Morris and RJR tobacco companies. Finally, we have Dr. Ray Keating. Dr. Keating's organization, the Small Business and Entrepreneurship Council, and its predecessor, the Small Business Survival Foundation has solicited and received funding from tobacco companies. Moreover, documentation seems to suggest a large amount of collaboration with tobacco companies. For instance, in the mid-1990's Dr. Keating released a series of reports on FDA tobacco regulations and their negative effects on small business and also filed comments with the FDA on the same topic. These reports relied upon a study commissioned by Dr. Keating's organization and conducted by the American Economics Group. What Dr. Keating didn't mention in his reports or FDA comments is that the Small Business Survival Foundation was acting as a go-between for the tobacco industry. Tobacco company emails show that the study in question was jointly funded and organized by Philip Morris and RJR tobacco. The reason I highlight this, Mr. Chairman, is that EPA is a public health agency. I find it deeply disturbing that the experts the Majority seems to rely upon for advice in the arena of public health all have extensive ties to the tobacco industry. That's the same industry that was found by a federal court to have engaged in racketeering and wire fraud in order to subvert the public health of the American people. And how did they accomplish this fraud? Through a well documented history of funding researchers and third party groups to cast doubt on the public health effects of tobacco. Mr. Chairman, this is a serious subject, because ultimately this is about protecting the public health of our citizens. It's about protecting the health of our neighbors, and friends, and family. If the Majority is serious about moving forward with this ill-advised legislation, then we need to hear from a credible set of witnesses. Our citizens deserve no less. I yield back. Chairman Schweikert. Thank you, Ranking Member Johnson. If there are any Members who wish to submit additional opening statements, your statements will be added to the record at this point. Chairman Schweikert. Our first witness, Hon. John Graham. Is it ultimately Professor or Doctor? Dr. Graham. Professor. Chairman Schweikert. Professor Graham, Dean of the School of Public and Environmental Affairs at Indiana University. In March 2001, President George H.W. Bush nominated Dr. Graham to serve as Administrator of the Office of Information and Regulatory Affairs at the Office of Management and Budget. He was confirmed by the Senate in July 2001 and served until 2006. Dr. Graham has also served as Dean of the Frederick Pardee RAND Graduate School, President of the Society of Risk Analysis, Professor of Policy and Decision Science at Harvard School of Public Health, and Founder and Director of the Harvard Center for Risk Analysis. Dr. Graham received his Ph.D. from Carnegie Mellon University. And one other just outlier, I think in my graduate school we used one of your books. Dr. Graham. TESTIMONY OF THE HONORABLE JOHN GRAHAM, DEAN, SCHOOL OF PUBLIC AND ENVIRONMENTAL AFFAIRS, INDIANA UNIVERSITY Dr. Graham. Thank you, Mr. Chairman. You have my written remarks. I just want to use my brief time in the oral session to offer a case study of the value of transparency in data access from early in my career as an academic. In 1981-83 period, I was a doctoral student at Carnegie Mellon, as you mentioned. The question I was looking at was do automobile safety regulations save lives? The first federal regulations were 1966 to 1968 in all the cars. They addressed safety belts, padded dashboards, collapsible steering columns, and head restraints. They all came in at roughly the same time. The engineering estimates, based upon laboratory testing, were that these measures would reduce the risk of death in a crash by about 25 to 35 percent. The question is would those lives really be saved when they were introduced in cars in the real world? The first real-world valuation was published in 1975 by a professor named Sam Peltzman at the University of Chicago and he published it in one of the best peer-reviewed social science journals. What Peltzman did was is he assembled national safety data from 1947 to 1974. He compared the death rates in cars before regulation and after regulation. His results, which were surprising, were that the passenger death rates were down only about seven percent, not 25 to 35 percent as predicted. And the so-called nonoccupant deaths--think of pedestrians--were up 20 percent. And as a result, the net of it all was he concluded that the regulations didn't save any lives. He then advanced the following theory for why this result had obtained. It is now called the theory of risk compensation. Drivers, sensing that they are in greater safety, drive faster or they are more likely to give their car to their teenage daughters or sons thinking they are safe. As a young graduate student at Carnegie Mellon, I was quite frankly skeptical of this whole study, both the empirical work and the theory that was behind it. So I went eagerly and reassembled all of Professor Peltzman's data sources from the documentation that he had in his paper. I then reassembled all of his original data set since this was all publicly available data. I then re-estimated his equations using the equations that were in his article. And I found that what he had a purported in his paper was in fact the result, given his assumptions. Then I did a reanalysis where I added three variables to his equation that he had not considered: the growth in the number of small cars in this country, which are more lethal than larger cars, the number of heavy trucks on the road and the traffic from heavy trucks, and the growth in the number of motorcycle registrations because he had included in nonoccupant deaths not just pedestrians but motorcyclists as well. I then reanalyzed the data using his procedure. I found that the passenger death rate was about 25 percent lower than would have occurred without the regulatory standards and the nonoccupant deaths had basically unchanged when you controlled for the growth in motorcycling. I concluded that this was a highly successful federal regulation that saved thousands of lives. With the help of my faculty advisor, we published this reanalysis in the peer-reviewed literature. It stimulated a whole bunch of debate, ten years of additional studies and so forth and so on, and I think it is fair to say today that most people would say reading this body of evidence that this regulation saved thousands of lives, maybe not as many as they originally projected, but a substantial number. The lessons I would like you to consider from this example, which I lived through for years, is that the process of reanalysis cannot proceed without transparency of what the data sources are and without access to the actual original data to reanalyze the problem. Second of all, the reanalysis process is not always antiregulation. It is not always antigovernment. In some cases, reanalysis shows that government regulations work, save lives, reduce injuries, and enhance the public good. So the underlying premises and assumptions of the bill that we are discussing today in my view are politically neutral and they will work for both sides of the argument. Final comment, when I served in OMB under President George W. Bush, we oftentimes had industry groups and environmental groups come to OMB with their data and analysis of why they wanted a regulation changed one way or the other. I think it would be a constructive thing if all of that information that they were required to give would satisfy these basic standards of transparency of what data sources were used and accessibility to the original data. That is a neutral-- politically neutral outcome that both sides of this debate should be subjected to. Thank you very much. I look forward to the questions. [The prepared statement of Hon. Graham follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Schweikert. Thank you, Professor Graham. Our next witness is Dr. Tony Cox, Chief Sciences Officer at Next Health Technologies, Clinical Professor of Biostatistics and Informatics at Colorado Health Sciences Center, and President of Cox Associates. Next Health Technologies offers advanced data analytics solutions to healthcare plans to reduce health, financial, and member attrition risks. Dr. Cox is also the current editor-in-chief of the journal Risk Analysis. In 2012 he was inducted into the National Academy of Engineering and is a member of the National Academies Standing Committee on the use of public health data. Dr. Cox received his Ph.D. in risk analysis from MIT. Dr. Cox. TESTIMONY OF DR. LOUIS ANTHONY COX, JR., CHIEF SCIENCES OFFICER, NEXT HEALTH TECHNOLOGIES, CLINICAL PROFESSOR, BIOSTATISTICS AND INFORMATICS, COLORADO HEALTH SCIENCES CENTER, AND PRESIDENT, COX ASSOCIATES Dr. Cox. Thank you for inviting me today to discuss whether the data underpinning regulations should be made openly available. I am testifying on my own behalf today in support of the Secret Science Reform Act. I have provided the Committee the detailed CV describing my academic, publishing, and business affiliations. I am a risk analyst and I am happy to tell you why I think access to data is essential for high-quality analysis in the public interest. I can also tell you that it is not easy to get such access. Ms. Johnson or others with similar views might decide that researchers like me who have worked with cigarette manufacturers to quantify risks of smoking-associated diseases are not legitimate enough to deserve access to data, but without such access, we cannot correctly quantify what the risks are. We are discussing a key question for science and policy today. Is the public interest best served by requiring that data behind science-based environmental regulations be made available to those who want to see it? Many who argue yes believe that the very essence of trustworthy science is reproducibility of results and sharing of the data said to drive them. For example, over 2/3 of recently surveyed professionals involved in risk assessment said it was very important to have access to the underlying raw data so that they could independently analyze the results, but only about 1/ 3 said that such access was usually the case. The proposed Secret Science Reform Act would help to close this gap. A concern about sharing of data is that it might prove burdensome for the original investigators, exerting a chilling effect on their research, but keeping well-organized records, data, and lab notebooks so that others can check methods and results is or should be part of the training of every good scientist. It imposes no extraordinary burdens and has many benefits. Scientific journals can also facilitate sharing of the data behind published conclusions. A second concern expressed by ALA and others is that making study data available might threaten the privacy of individuals. We have already heard that this morning. The technical issue of how to protect privacy while allowing valid statistical analysis is best addressed by technical solutions, and many excellent one such as multiple imputation are now available. They are already being used successfully at the Census Bureau and elsewhere. So I think this concern is a bit of a red herring. We can meet it by applying existing technical methods. But the most important concern I suspect is not technical. It is that bad people or people with agendas other than pure science and the public interest might delay good regulations by performing untrustworthy new analyses and reanalyses that would obscure the need for action. To address this concern, I think we must candidly assess how well our current scientific process delivers trustworthy results without much pressure from external reanalyses of data. It does not. We are living in an age of catastrophic failure in the reproducibility and trustworthiness of scientific results as evidenced by articles such as ``Why Most Published Research Articles Are False'' from 2005 and ``Trial and Error: Why Science Is Failing Us'' from 2011 or an editorial just last month on reproducibility in Science magazine. A common theme is that there is too much pressure on original investigators to use dubious statistical methods to publish results that are sensational but not necessarily correct and there is not enough encouragement for original investigators to do unbiased research knowing that others will soon be reanalyzing their data and claims. Fixing this critical problem requires more scrutiny and greater access to original data, not less. Let me end with two examples from my own experience in public health risk analysis. First, by applying causal analysis methods to the publicly available national mortality and morbidity air pollution study data, I recently discovered that air pollution levels are indeed correlated with mortality risks in 100 U.S. cities. This was already well known. For example, both were associated with cold winter days. But surprisingly, there was no evidence that reducing air pollution has caused any reductions in mortality rates. Open access to the data makes such unexpected discoveries possible and encourages others to check and possibly improve upon the results potentially informing important public policy. As a last example, Dublin, Ireland, recently extended bans on coal burning based on research claiming that banning coal burning immediately reduced mortality rates. That research was done and publicized in part by U.S. investigators who have prominently shaped U.S. EPA's science and claims about air pollution health effects. Yet a reexamination of the data last year funded by the Health Effects Institute revealed that its major conclusion was not true; mortality rates did not come down any faster where coal burning was banned from where it wasn't. European researchers had already pointed out years ago the fallacy of assuming that just because pollution levels in mortality rates had both declined, that suggested that one caused the other. But without access to the original data, they cannot quickly and easily prove that the original conclusions did not follow from the data. By the time the original U.S. investigators were funded to take another look at the data, Irish public policy had already been made. Only ready access to the data would have enabled others to fix the problem in time to inform policy decisions. We need not repeat such experiences here. We can choose to make data used to support regulatory decisions openly available for others to analyze and not wait until policy has been made and changes enacted before allowing the public to find out whether better analyses would have led to different results. I believe that doing so will promote sounder science and hence strongly promote the public interest. Thank you for your attention. [The prepared statement of Dr. Cox follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Schweikert. Thank you, Dr. Cox. To introduce our next witness I am going to turn to the Ranking Member Bonamici. Ms. Bonamici. Thank you, Mr. Chairman. I am pleased to introduce Dr. Ellen Silbergeld, a Professor of Environmental Health Science and Epidemiology at the Johns Hopkins Bloomberg School of Public Health. Dr. Silbergeld holds a Ph.D. in environmental engineering, completed postdoctoral fellowship in environmental medicine and neurosciences, and has more than 40 years of scientific research experience in fields related to environmental health. She has been an appointed expert to the EPA, the Department of Energy, and many other federal agencies. She is a MacArthur Genius Fellow among her many honors. Thank you so much for being here to testify today, Dr. Silbergeld. Chairman Schweikert. Dr. Silbergeld, five minutes. TESTIMONY OF DR. ELLEN SILBERGELD, PROFESSOR, BLOOMBERG SCHOOL OF PUBLIC HEALTH, JOHNS HOPKINS UNIVERSITY Ms. Silbergeld. Thank you very much. I am appearing at your invitation to testify before the issues embodied in this bill and other issues that you have already alluded to, Mr. Chairman. And I have been a member, as indicated, of many expert panels involved in the evaluation of the scientific bases for regulation in the United States, the State of Maryland, and internationally. I also served as a member of the U.S. Delegation to the OECD during the development of the High Production Volume Chemicals Program which I would like to allude to. First, I want to join with you and others on this panel stating that the principles of openness and fairness are fundamental to science including toxicology, epidemiology, and basic research. And I agree with the statement of many at this hearing that there is an important need to reduce the secrecy that confounds public access to the basis for some EPA decisions specifically. However, with respect to my experience, the major driver of secrecy in EPA rulemaking is the deference given to industry in terms of shielding its studies from public view, and thus I am puzzled as to the uneven nature of the debate on this topic and I hope that your Committee can see to that balance. The problem of nondisclosure by industry in fact was a key issue in developing the High Production Volume Chemicals Challenge Program by the OECD during the time that I was a member of the U.S. Delegation. And frankly, I have been very proud of the leadership role of American industry in the success of this program through which information held by industry was in fact made publicly available. And the current website of the American Chemistry Council makes clear that the industry shares justifiable pride in its disclosures and adherence to greater transparency data. We need more information, and specifically, we need more information disclosure by industry. Information withheld is not informative. It--in fact, we can just look across the Potomac River to West Virginia and understand that if we had information, both the compulsion to produce it and to reveal it, how much better public health authorities and civic authorities and the public itself could respond to that event. I would like to also draw upon my experience as an editor- in-chief of a major peer-reviewed journal and my experience over the past 18 years in terms of how science evaluates the quality of data that is published in the form of a scientific paper. The peer-review process requires the inclusion of scientific and technical information, including--as stated in your bill, sir--materials, data, and associated protocols necessary to understand, assess, and extend conclusions. The rest of the items in Section (2)(b)(3) of this bill, with respect, do not contribute to this goal in my opinion. We recognize that no study is perfect and frankly it is mostly protocol design and under-powering of studies rather than erroneous statistical approaches that have resulted in withdrawal of many papers in my experience, and this is why in science we rely on replication as the means of validating the findings and conclusions of any particular study. But replication is not the same as data reanalysis. Replication involves the design and conduct of a wholly independent study often with different methods to test the reliability of the same hypothesis that was first studied. Let me also reflect on my experience with data analysis as part of the EPA's process of reviewing science related to major regulation, as others have done on this panel. I was part of an expert panel advisory to the EPA under the Clean Air Act consideration of revising the National Ambient Air Quality Standards for lead. A reanalysis of the actual raw data was demanded by industry and it was accomplished in a nonadversarial way through third-party review undertaken by an acknowledged academic expert in biostatistics not connected with government, industry, or the original investigators. In conclusion, I would like to restate my strong philosophical support for increasing the transparency of information associated with government regulation. I suggest that we already have the tools to accomplish this goal and through the implementation certainly of the NIH covering data that is funded by that agency. I hope that your concerns can be reframed to apply to all sources of information in an effective and efficient manner because I know that some of my colleagues in industry have been vocal in calling for these steps. I call to them to tear down every wall--in the words of Ronald Reagan--that hides critically important information that is generated and held by industry. Thank you. [The prepared statement of Dr. Silbergeld follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Schweikert. Thank you, Dr. Silbergeld. Our last witness today is Mr. Raymond Keating, Chief Economist at the Small Business & Entrepreneurship Council. Mr. Keating has expertise on a wide range of issues affecting the entrepreneurial sector of the U.S. economy. He has written eight books, hundreds of articles, and writes for the Small Business & Entrepreneurship Council and the Center for Regulatory Solutions' online publication. Mr. Keating is also an Adjunct Professor at the Business School of Dowling College. He received his master's in economics from New York University and an MBA in banking and finance from--is it Hofstra? Mr. Keating. Hofstra. Chairman Schweikert. Hofstra University. Mr. Keating, five minutes. TESTIMONY OF MR. RAYMOND KEATING, CHIEF ECONOMIST, SMALL BUSINESS & ENTREPRENEURSHIP COUNCIL Mr. Keating. Thank you, Mr. Chairman and Members of the Committee, for holding this important hearing today. As you mentioned, I am Chief Economist with the Small Business & Entrepreneurship Council and I noticed Representative Johnson left but I wanted to thank her for upgrading me to a doctor. I tried to get away with that because I have two master's degrees, but nobody really lets me, so I have to thank her when I get a chance. I am going to take a little different tack from my colleagues and look at this issue from the small business perspective and also from the public's point of view of the regulatory process based on a survey that our group did recently. So just a few points that I want to highlight from my written testimony, number one, you know, just to kind of--from a small business perspective, the costs of regulation are very real and significant facts of economic life. Economics 101 tells us that we should expect--what we should expect from increased regulation: higher costs for businesses and consumers, reduced market exchanges, and expanded political control, resources allocated based on political decisions and influences rather than via competition and consumer sovereignty, and that all wind up in the end diminishing economic growth. Number two, from a small business perspective, the SBA's Office of Advocacy has done a study. Several times I believe they have--I think they have done it three times. They have updated it a couple of times. Just looking at the costs of regulation, the costs of complying with regulation with an eye toward small business, those--just to throw out a few of those numbers, when you look at firms with less than 20 employees on a per-employee basis, the cost of complying with federal regulations are 42 percent higher than firms with 20 to 499 employees and 36 percent higher than firms with 500 or more employees. On the environmental front in terms of environmental regulations, those disparities are even much, much higher. So the issue of transparency on the science being used to support regulation is not, you know, an esoteric academic or political point. It is very--has very real consequences in terms of the costs imposed on small businesses. And small business owners really want to know. They need to know what regulations quite frankly are legitimate and which ones that they are dealing with may not be so. You know, there is a lot going on at the EPA in terms of greenhouse gas regulations and there is more coming. When you look at the industries that are going to be directly affected and are directly affected, again, the majority of those businesses--the vast majority are small firms. When you look at manufacturing firms, manufacturing employer firms with less than 20 workers, that is 76 percent of those businesses. So they are small businesses. When you look at mining, quarry, oil and gas extraction, 85 percent of employer firms have less than 20 workers. So this is a very real issue for small businesses across the board. Now, the poll that I want to mention we released it last month. It was a poll of American adults under the Center for Regulatory Solutions, our new organization, our new group if you will. And it was interesting what the public had to say on both the process and the cost of the effects of regulation. On the process, three numbers real quick: 68 percent said that government regulations on business are created by out-of-touch people who are trying to push a political agenda, 72 percent said that government regulations are created in a closed, secretive process, 64 percent said that government regulation on business was created in a way that does not consider the real-world impact. So that is the public view of the regulatory process. In terms of the effects, 53 percent agree that there are too many regulations on business, 61 percent believe that regulations on business are likely to do more harm to the economy by interfering with the market, preventing businesses from growing and hiring new employees and increasing prices for consumers. And small business owners would most assuredly agree with those assessments. One other one, you know, there is a whole host and I will be happy to get you the results of these--this survey, but 70 percent of Americans said that regulations, they hurt the economy, 66 percent said they mostly hurt entrepreneurs and small businesses. Hurt consumers, 63 percent, mostly hurt American workers, 66 percent. You get the idea. The numbers are overwhelming in terms of how we are viewing--how the American public views this process. When you look at the economics of regulation, the impact of regulatory costs on small businesses, the views of the public on the regulatory process really should push government officials to be transparent in all aspects of regulation, including how regulations are created, the scientific reasons for regulation, the true cost of regulations. And it matters-- you know, it is--you don't want to have a situation where certain agencies or certain political points of view or certain political members are deciding who gets access and who doesn't. So I think when you look at the Secret Science and Reform Act, I think everybody in Congress on both sides of the aisle should be able to support it. Thank you. [The prepared statement of Mr. Keating follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Schweikert. Thank you, Mr. Keating. One of the joys of getting to sit in this chair, apparently I get to do the first question. Professor Graham, from what you have heard today and one of my premises is it goes far beyond just sort of us talking about the EPA so that the premise of sort of crowdsourcing of access to data and that the vetting of the confidence within--you know, the statistical confidence. Wouldn't most of the--well, from the regulatory community, the research community, even sort of the armchair statistician, does that really hurt environmental science or research or would it in some ways make it more robust? Dr. Graham. I certainly don't think it hurts it at all and there are lots of examples where it has helped with a more robust discussion. I do want to add though and underscore I think a useful distinction that Dr. Silbergeld made between independent studies that draw their own data and whether they verify other studies versus just reanalysis of existing information, and I agree with her that the independent studies sometimes are much more powerful and important. You do need to have a lot of clarity and transparency about how the original study was designed and its protocol in order to do that properly. So a lot of the requirement that is in the bill is necessary to do good independent studies. But I also think reanalysis is oftentimes a very useful type of work that adds new insights. And my example of the automobile safety regulation is one of those. Chairman Schweikert. Well, and almost to that premise--and maybe Dr. Cox would be appropriate for this, when looking at others' studies, the ability to take, you know, a study that may be a couple years old and take--you know, and stress it, see what is actually happening with the tails, sometimes bounce it against a more current study, you know, particularly in sort of a peer-reviewed world of--I--and, forgive me, but I don't know how much peer review is reading of the article and seeing if the general statistics work or actually sort of having the ability to look at the underlying data and bounce it against other studies that are around and say do I have a level of confidence? So there are two questions there. Tell me about how far into the raw data you think the peer-review world is going, particularly with government-funded studies, and how important it is to be able to constantly take studies and sort of bounce other models and other data against it. Dr. Cox. The current crisis in non-reproducibility of studies and in publication of results that turn out to be false is solidly grounded in the existing peer-review system. So when we look at papers like why most published research articles are wrong or if we look at last month's editorial on reproducibility in science, what is being referred to specifically is peer-reviewed studies. Typically, peer reviewers don't have the time or the opportunity to dig deeply into the original data. That is not the purpose of peer review. Peer review does add value by saying whether a paper makes sense, whether there are obvious methodological flaws. That is about as far as it usually goes. And again, the very severe problems with trustworthiness of published results and the excess of false positives in the environmental and medical literature, which has been well documented, are based on peer review. To your second question, having the opportunity to throw new models at old data I think is critical for making progress. For example, in this world of environmental health that we all care about today, the key question of do exposures cause health effects is one that requires methods that have not traditionally been used. It is a great opportunity but it requires access to data in order for the new methods and better methods to inform public policy. Chairman Schweikert. Dr. Graham, just because this is a level of personal curiosity, I am a little bit of a taleb fan, sort of the concept of if it is in the tail, you don't dismiss it because the catastrophic event can't happen. Is making data more egalitarian, will that actually provide us the opportunity to realize there is something, whether it be environmental or in my view of the world, you know, all sorts--to actually be able to identify those risk profiles? Dr. Graham. It is a good question. The commentary this morning about the Harvard and American Cancer Society procedure where they designate legitimate researchers and say that their data would be made available to legitimate researchers, I just want to make sure that everybody realizes--I say this as a former Harvard faculty member--this is not open access. This is not public access. So some people who may have some very good ideas and could do very good analysis may not look on the face of it like they are legitimate to Harvard or legitimate to the American Cancer Society. So, yes, it is very important that the principle of open access and public access provide everyone an opportunity to participate and they may find some results that are very unusual, that challenge conventional thinking, and they may never have been judged legitimate when they started that work so it is a very important advantage of true public access. Chairman Schweikert. All right. And thank you, Mr. Graham. I know I am over time but I have two others I just wanted to touch. And I don't think I have ever sat on a hearing where, when you look at the CVs of all of you, to quote my little brother, you are all freaky smart. And, forgive me, is it Dr. Silverberg? Ms. Silbergeld. Silbergeld. Chairman Schweikert. I actually got up very early this morning and actually read your ``Evidence-based Toxicology'' article, and I have got to compliment you. When a novice like myself could follow it, read it, and actually understand it, you are a terrific writer. I did want--there was just one thing in your conclusions and I appreciate the concerns so now I sort of want to sort of make the concept sort of move forward sort of public data for public policy. In your first couple paragraphs of your conclusion you actually sort of talk about requiring a framework to accommodate data from numerous types and that that may be sort of like the direction where--I know you were speaking of toxicology research goes. Do you actually see this happening sort of in the toxicology world where more and more data is becoming more and more accessible and a variety of researchers are analyzing it and weighting it and stressing it? Ms. Silbergeld. Thank you. If I may first respond to your concept of crowdsourcing science, I am not sure that is such a great idea and I think, with all due respect to my colleagues on this table, the record of the tobacco industry in--going beyond stressing data--I would say subjecting it to the Spanish Inquisition to twist it to say something that we now know it never said---- Chairman Schweikert. Well, but---- Ms. Silbergeld. --is something that is disturbing. Chairman Schweikert. But, Doctor, I appreciate that but crowdsourcing of the data is substantially a new phenomenon, not from 20 years ago, and the ability for me to have taken those data sets and said look what is happening--I am sorry. It is not ceteris paribus. You are talking two different time frames and two different technologies. Ms. Silbergeld. No. Chairman Schweikert. Yes, you are. Ms. Silbergeld. With respect, sir, that is why I am worried about the notion newly introduced of crowdsourcing because we have experience---- Chairman Schweikert. Okay. Ms. Silbergeld. --of what has happened to access of data. Chairman Schweikert. Okay. Ms. Silbergeld. That is my comment. With respect to your question, sir, I--and with respect to the comments about peer review, as a journal editor I will take those blows---- Chairman Schweikert. Well, that---- Ms. Silbergeld. --and I understand them---- Chairman Schweikert. --actually wasn't my question. Ms. Silbergeld. Yeah. Chairman Schweikert. My question was on your conclusion here where you talked about more accessibility to data. I think I am going to have to wait until the next round because I am now 3-1/2 minutes over time already. So let me turn to my Ranking Member. Maybe she can follow up where I was going. Ms. Bonamici. Thank you, Mr. Chairman. And before I begin my questions, I--two brief points. First, I don't want the lack of absence of Members on my side to be indicative of a lack of interest in this issue. There are several hearings and markups happening simultaneously, so please don't consider this as a lack of interest in the topic. Also, Mr. Chairman, we received and provided you with copies of letters from the American Lung Association, the American Thoracic Society, the Union of Concerned Scientists, the Center for Progressive Reform, and the Natural Resources Defense Council stating opposition to this bill, and I ask unanimous consent that they be submitted to the record. Chairman Schweikert. Any objections? So ordered. [The information appears in Appendix II] Ms. Bonamici. Thank you, Mr. Chairman. Dr. Silbergeld, under current law, because of the need to ensure that protected information like health records remains confidential, there are likely to be data that will not and should not become entirely available to the public. So should the EPA be precluded or any agency for that matter--but for the purposes of this hearing, should the EPA be precluded from considering studies that include health information if the studies are significant to determining the appropriate course of action? And if not, then how can we independently validate and verify such studies? Ms. Silbergeld. Thank you for the question. I think we have a model to go forward here. Which is really the model of evidence-based decision-making that first began in medicine, extended to healthcare, and now I count myself as one of the leaders in moving it into the field of toxicology in which we take the broadest possible look through the available--publicly available data and publications, including government reports, and attempt to synthesize those data using transparent and open processes of data access and evaluation. So I think we should always be committed to extending our view as wide as possible. Do we need to see raw data? I am not convinced that we do. I think in those instances where it has become of interest to do so, we have methods in place to accomplish that. And perhaps in response to the Chairman's question--and I apologize for using up your valuable time, sir--in fact, journals are increasingly soliciting and accommodating the production of much more extensive data, for example, on statistical models and protocols through the use of appendices. This is a somewhat new process in publication in which my own journal and others now encourage authors to submit this type of information which is publicly accessible through linkages in the paper and in any repository that has that paper that amplifies the kinds of information I think some of my colleagues would find particularly interesting. I also want to defend my reviewers by saying that they do a very exhaustive job of reviewing. And I agree with Dr. Cox that in fact I think some of the lack of reproducibility has come about through some failures in peer review. Ms. Bonamici. Thank you. And I am going to follow up on that because you state that requiring--in your article you state that requiring the disclosure of the raw data from every study that the EPA uses to support its regulatory assessment could actually preclude the EPA from using relevant research if the journal authors don't submit the raw data to the EPA. So could you talk a little bit--I know you touched on that, but could you talk about what would be the impact to the EPA of limiting the scope of those studies if they cannot consider those as part of their scientific review? Ms. Silbergeld. Well, for example, unless you can actually resolve the problems of protection of human subjects who appear in studies, this would then eliminate a great deal of the epidemiologic and clinical literature that could be available. And I know that we worry about this because in fact it was the tobacco industry who tried to bust open some repositories of confidential data that would have permitted identification of human subjects, and the rationale given by the industry was they wanted to interview some of those subjects and see if they gave the same answers that were reported in questionnaires used in studies. So this is a very disturbing aspect to the certainly of protection of people's autonomy, confidentiality, and the process of scientific research. Ms. Bonamici. Thank you. And I want--time for one question if I may, Mr. Chairman. I understand that the broad scientific community is engaged with the Office of Science and Technology Policy, or OSTP, and what representatives from academia, particularly the American Association of Universities and the Association of Public and Land-Grant Universities, is calling a thoughtful balanced process to increase public access to the results of federally funded research. And that is a type of government-wide approach to improving public access to federally funded R&D that is preferable to the legislation that specifically targets the EPA, especially in light of the fact the EPA generally relies on studies that are not funded by the Agency but other agencies like NSF and NIH. So could you please comment on the need to take a government-wide approach to improving public access? And if you could compare the bill we are considering today with OSTP approach and which would strike a better balance between the need for transparency in the regulatory process, balancing the rights of private citizens, and the need for the EPA to use the best science available. Ms. Silbergeld. Thank you. I think a comprehensive and consistent approach is certainly to be advocated. The fact, for example, is that a great deal of the evidence that the EPA would find and has found useful was in fact funded by other agencies such as the National Institutes of Health, which has set up an effective and functioning program, speaks to the need for a consistent policy. But I would like to restate my very great concern that I have a very great interest as a scientist to be able to see industry data and I would like to see industry behind the proactive stance and record of the American Chemical Council and others in terms of opening the doors on their data. Ms. Bonamici. Thank you. And my time is expired but I would be interested in hearing from the other witnesses about whether they would support the disclosure of the industry data as well. Thank you, Mr. Chairman, and I yield back. Chairman Schweikert. Thank you, Ranking Member. And, Mr. Bridenstine. Mr. Bridenstine. Thank you, Mr. Chairman. And I would like to say I am proud to support your bill, Mr. Schweikert, H.R. 4012, the Secret Science Reform Act. I would like to bring up a slide if it is possible on the screen. [Slide] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Bridenstine. There it is. This is a quote from the President of the United States when he was campaigning. ``So if somebody wants to build a coal-fired power plant, they can. It is just that it will bankrupt them.'' That wasn't based on any kind of scientific data. That is a quote of the President of the United States. It is a campaign promise. He interviewed with the San Francisco Chronicle November 7, 2008. This is a promise that he has followed through with. There are two coal- fired power plants in Oklahoma that are being shut down and the rates on my constituents are going up. The low estimate is 20 percent, some say as high as 40 or 50 percent. Who does that affect? It affects the poor the most. This is President Obama's war on the poor. They spend the biggest part of their budgets on utilities, and so they are the ones being affected the worst. And here is the thing: The transparency of the data that they are using to create the rules and regulations that are shuttering these coal-fired power plants are not transparent. Transparency and verifiability are fundamental principles of any scientific endeavor and should certainly be required in those supported by taxpayers. The EPA continues to violate these principles by preventing independent researchers from examining the data and replicating the studies which ``support the Agency's rulemaking.'' My constituents in Oklahoma's 1st District are paying the price, quite literally paying the price, for the EPA's politicizing the regulatory process and its secret science charade. Mr. Chairman, I would like to spend a minute explaining how the EPA's secret science and groundless regulations will continue to needlessly harm my constituents and all Oklahomans. According to the Energy Information Administration (EIA), Oklahoma produces four percent of the country's crude oil and eight percent of its marketed natural gas. Oklahoma is leading the fracking revolution to provide cheaper energy to all Americans. Oklahoma is the 5th-largest shale gas-producing State, and 17 of the top 100 natural gas fields are located in Oklahoma. Mr. Chairman, the EPA's newest regulations on fossil fuel production and refining based on this secret science charade threaten my constituents with higher utility bills, less reliable electricity, and fewer jobs in Oklahoma's booming oil and gas industry. Can we bring up the second slide there? [Slide] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Bridenstine. The latest--can we bring up the slide 2? The latest EIA analysis shows that coal- and natural gas- fired power plants provide about 90 percent, 90 percent of Oklahoma's electricity generation. My district has two petroleum refineries in Tulsa and four natural gas power plants, one in Coweta, one in Tulsa, and two in Jenks. Thanks for bringing up the next slide there. [Slide] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Bridenstine. We are talking about 155,000 barrels of refining capacity per day and 3,200 megawatts of production capacity. Can we bring up the next slide? [Slide] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Bridenstine. My 1st District constituents also use electricity produced by four coal-fired power plants, just--one just outside of my district in Oolagah, Muskogee, and Chouteau. That is another 4,300 megawatts of production that the EPA wants to shut down based on scientific data and models that it will not publicly release. Can I get the next slide, please? [Slide] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Bridenstine. Mr. Chairman, the EPA has put a bull's-eye on coal-fired power plants, a bull's-eye. This is the regulatory agenda here of the EPA. And once the EPA kills coal, let me be clear. They will come for natural gas. It is just a matter of time and we are already seeing that in the Obama Administration's war on fracking. Can we bring up the next slide, please? [Slide] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Bridenstine. In 2012, the Institute for Energy Research estimated that the EPA's MACT and Cross State Air Pollution Rules will take 33 gigawatts of national electricity generation off-line, 33 gigawatts, over twice the EPA's modeling prediction. That is ten percent of our country's coal capacity and also includes closing two natural gas-fired plants in Oklahoma, natural gas-fired plants in Oklahoma, one in Anadarko and one in Oklahoma City. The end result of the EPA's regulatory horror show is higher prices for consumers and industry, less economic growth, and fewer jobs. Next slide, please. [Slide] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Bridenstine. According to EIA, Oklahomans pay about 20 percent less for residential, commercial, and industrial electricity than the U.S. average. Killing coal and eventually natural gas production in my State will saddle my constituents already struggling in this sluggish Obama economy with higher utility prices on par with those experienced in heavily regulated States such as California. Next slide. [Slide] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Bridenstine. Kentucky has already seen massive layoffs in the coal industry. When EPA uses secret science to justify new regulations, everyone is worse off except for EPA bureaucrats, as well as extreme environmentalists. Let me be clear. The EPA is now saying they are going to come after our woodstoves. Of course, a friend of mine, Thomas Massie from Kentucky, has gotten assurances from the EPA that if you like your woodstove, you can keep it. Let me ask one question for each of our panelists. Do any of you disagree with the principle that in the case of taxpayer-funded research or studies, the public should have access to the underlying data? Does anybody disagree with that? Yes, ma'am? Ms. Silbergeld. As stated in my testimony for the reasons given, I disagree with that, respectfully. Mr. Bridenstine. Noted. I yield back. Chairman Schweikert. Mr. Smith, Chairman of the full Committee. Chairman Smith. Thank you, Mr. Chairman. Mr. Keating, let me direct my first question to you, and I appreciate the poll that you mentioned earlier. I had not seen those results and they are very, very telling. And let me just highlight a couple of the results that you mentioned: 68 percent said that the government regulations on business are created by out-of-touch people who are trying to push a political agenda; 72 percent said that the government regulations are created in a closed, secretive process; 70 percent of Americans said the regulation mostly hurt the American economy. Those first two poll results that I mentioned and that you cited as well go to the heart of why we need the legislation at hand. And I really don't have a question for you other than to thank you for your testimony. If you want to add anything to your comments about why the legislation will have a positive effect, you are welcome to. Mr. Keating. Well, no, and there is a reason why I wanted to bring that here. I mean you talk about people being smart. These folks to my right here are far smarter than I am, but I want to bring the small business perspective and this survey that we had. And it is--you know, when we talk about the egalitarian access to data and the politicization of this process, those are very real things that are having, as the Vice Chair pointed out, very real effects on our economy in terms of jobs, small businesses, economic growth, all the way down the line. So I am a Madisonian on this. I love checks and balances. And the more checks and balances that we have, the more people we have looking at this, the more scientists, the more economists that we have looking at this, the better it is going to be for everybody because the ultimate point is not to politicize this. It is to get sound public policies. That is the bottom line. Chairman Smith. Thank you, Mr. Keating. Dr. Cox, as you know, some of the data that the EPA is relying upon to make rules and regulations is up to 30 years old. What are the disadvantages of using data that old when it comes to making decisions? Dr. Cox. There are trends and changes in the statistics of public health. Old patterns are not predictive necessarily of current events. More to the point, what regulators want to do is to intervene in the world as it is now to change it and make it better. To do that they often need to understand how the world works now with the current mix of pollutants, with the current configuration of industry. Staring hard into the rearview mirror does not necessarily provide that information. So I think the problem with old data is in part that it is old. The other thing that I will note is that basically regulations on results that depend on data that are not currently available does indeed allow the Agency to use the best-available information but it also allows Agency to use the worst-available information. Both are part of the published record. Without current access to current data, it is extremely difficult to distinguish between the best and the worst results in the past literature. So rather than looking at dead results and dead literature, I think it is important to keep the data alive and to allow current questions to be informed by current analyses of current data. Chairman Smith. Okay. Thank you, Dr. Cox. And, Dr. Graham, a two-part question, I guess. One, what is the advantage of making this data publicly available, if you can go into some detail; and secondly, is it really difficult to make this data available to the various scientific researchers? Dr. Graham. I don't think it is difficult. It is already done in most fields of science. The environmental health field is different because of its extensive reliance on some of the patient records we have been talking about, and therefore, there is going to be a meeting next month at the National Academy of Sciences where they discuss not whether these data should be released and shared but how to do so in a way that protects the privacy and confidentiality of those participants. And I have already encouraged the Committee staff to attend and learn from that discussion. And I think what you will find is most of the scientific community with the exception of the mental health field is already on board for this agenda. And so we do have a ways to go persuading the environmental health research community to be involved with the open access issue. Two other points just to respond to previous questions, this question of industry data, the way I read the Secret Science Reform Act, it applies to industry data. This legislation requires industry data to meet the same standards as academic data or other forms of data. The only thing I can think of that people were referring to is confidential business information, which would be held in the exception that is in the draft legislation. But I can tell you from my experience at OMB, 90, 95 percent of the industry information that they want to bring in is not covered by confidential business information. Chairman Smith. Okay. Dr. Graham. So this bill is going to cover industry data, as it should. Okay. Second point is should we have a government-wide approach, wait for all the agencies to agree that we should do open access or shall we do something that is focused on environmental health research? As I have mentioned, we already have open access in most fields of science already. You need a targeted approach that goes right at the domain of science where this problem exists and you need a solution obviously to the patient record issue to assure confidentiality. Thank you very much. Chairman Smith. Thank you, Dr. Graham. It is very helpful. I yield back. Chairman Schweikert. Thank you, Mr. Chairman. Ms. Edwards. Ms. Edwards. Thank you very much, Mr. Chairman, and I apologize for the shuffling, juggling a little markup in another Committee this morning. Dr. Silbergeld, as you know, it has been important to protect personal information of individuals participating in epidemiological studies and that there is a strict code of ethics among researchers as it relates to human subjects. As I understand it, researchers such as yourself are working on ways to disclose data from human studies so that individuals are protected but that others can use the data. However, in one of your articles you indicate that there are studies where the removal of all identifying data negates the scientific value of the data set. Can you elaborate on this statement in instances where the identifying data are necessary to the science? And also, can you discuss the importance of protecting the privacy of study participants and concerns that may arise if the potential study participants fear that their information will be exposed to the general public? Ms. Silbergeld. Thank you for that question. The clearest example and of greatest relevance to the subject of this Committee's hearing has to do with studies in which we are interested in the location of the subjects. And we have very sophisticated methods of determining this through spatial statistics, the use of GPS, and other data. That data--those data have to be absolutely protected because if those data become available, people can pretty much identify who participates in the studies. And I have conducted several studies in which we collected those data. That information has to be completely de-identified, which then of course means that no one else can exactly take those data and carry out the same analyses. I just want to reiterate that that to me as a scientist reanalyzing data is an uninteresting approach to science and unlikely to advance our confidence in the results of a specific study. What advances my confidence and should advance the confidence of everyone in this room in the results from one study is really what Dr. Cox alluded to, is whether or not the study can be replicated independently, not whether obtaining the data from the first study can be reanalyzed. That is relatively, frankly, trivial. And in fact the data that are now being called upon by journals and the NIH will allow one to determine whether protocols are appropriate and statistical models were appropriately selected in studies designed to meet the requirements of hypothesis testing. I also agree that there should be adequate funding given to public and private sector entities so that we can have the updated scientific findings that we all agree are important to us. Thank you. Ms. Edwards. But would you say that there are instances where the identifying data set--that those are very limited instances of research versus other kinds of research where you can have tons of data that it would be--you know, where it would be important to keep all of the data set available so that you could--I mean perhaps there could be an exclusion or some kind of a waiver or something that isn't the rule for more specialized identifying data sets where people's personal information is identifiable? Ms. Silbergeld. I would have to say from my experience and as someone who routinely goes through the rigors of obtaining approval from our Institutional Review Board, I cannot see that I have an ethical--I cannot ethically accept revealing information that would allow personal identification. I think that the most sophisticated approach to answering your questions and these difficult issues in addition to what Dr. Graham alluded to is really what is going on worldwide, probably first in the European Union because they are confronting it first, but we are looking at it now and that is looking at data from clinical trials. How do we get those data out there to restore the faith that has been pretty badly damaged by drug approval processes around the world and inadequate clinical trials but yet protect the identification of the persons who participate? And I think that is going to be a path forward that will be very informative for all of us. Ms. Edwards. Thank you. And I just have one question as my time is set to expire. Can you explain or describe rather what happens when, as Dr. Graham has said, the scientific culture at EPA is fragile and still in an early stage of development and that the political, legal, and engineering cultures are stronger and more certain than the culture of science and economics? You are the only scientist on this panel and someone who has worked on several expert groups convened by EPA. Do you want to comment on that position? Ms. Silbergeld. Thank you. I would like to defend the reputation and international standing of the EPA's scientific staff. They are widely recognized as among the best in the world. I even share the honor of a MacArthur Fellowship with a former EPA scientist. And while I am trained in engineering and I will accept his compliment, I think that the biological, ecological, and human health science at the EPA is extraordinary. Ms. Edwards. Great. Thank you very much. Thanks, Mr. Chairman. Chairman Schweikert. Thank you, Ms. Edwards. Dr. Broun. Mr. Broun. Mr. Chairman, before I start my questioning, I would like to take a point of personal privilege and just say that I am a physician; I am a scientist and we have seen throughout my medical career where there are reports and medical data that are not reproducible and where we have seen researchers promote an agenda and absolutely it is critical for us to have an open access to data so that we can reevaluate existing data of any study, as well as to reevaluate the findings by doing other studies that are likewise trying to study these same issues. Without having open access of data, it is absolutely impossible for a practicing physician such as myself to make a valid decision on drug use or whatever I am doing as a doctor to try to take care of my patient. So open access to all data is absolutely critical. And also, in medical research we have avenues of protecting that personal identifiable information and it is absolutely critical that we do so. So thank you, Mr. Chairman, for giving me access to a few minutes to vent here a little bit. And I appreciate your bringing this bill forward because I think it is absolutely critical. And we have seen in Georgia, just like Mr. Bridenstine is talking about in Oklahoma, we have seen the EPA bring forth regulations as closing down 15 power plants in the State of Georgia. And we cannot get the data that they have brought forward to really evaluate why they are making the regulatory burden so heavy. And it is going to hurt poor people. This EPA has an agenda that is hurting poor people and it is hurting senior citizens on a limited income. And having open access to the data is absolutely critical for us to be able to evaluate that. Now, having said that, Dr. Graham, in your view--I hope you will restore some time for me, Mr. Chairman. And, Dr. Graham, in your view does the Freedom of Information Act make this Secret Science Reform Act unnecessary? Dr. Graham. No, because oftentimes the government doesn't have the possession of the data that is sought. Mr. Broun. Well, I agree with that. Dr. Graham, you mentioned that the EPA chemical assessments under IRIS program is an example of the nonregulatory EPA determinations that have significant impacts and should be subject to transparency requirements. The IRIS program has been criticized by the National Academy of Sciences and others. Do you believe greater data access would improve the program? Dr. Graham. Yes. Mr. Broun. Do you think the IRIS program could comply with the provisions of this bill, the Secret Science Reform Act? Dr. Graham. Yes. Mr. Broun. Dr. Graham, the office you previously oversaw at OMB, the Office of Management and Budget, produces a report of cost and benefits of regulations across the federal government. According to the most recent draft of this report to Congress, the vast majority of the benefits for all regulations across the entire federal government, as high as 80 percent, are attributed to EPA Clean Air Act regulations and specifically reduced levels of fine particular matter. In your testimony you noted key uncertainties in EPA's science on this question. Do you find these numbers credible? Dr. Graham. They have uncertainties, particularly given that the data can only be given to ``legitimate researchers.'' And the people who were sponsoring all this research get to decide who the legitimate researchers are. Mr. Broun. And it is just up to them. So it is secret about them deciding who---- Dr. Graham. It reminds me a little bit of the NFL concussion sort of debate we are having right now where the establishment community was saying there is no connection, there is no connection, there is no connection and then sort of the people who were trying to bring other kinds of science involved. If you let the established community have complete control over who the legitimate researchers are, you are not going to get unexpected and new insights. Mr. Broun. Mr. Keating, you mentioned forthcoming national EPA regulations on ozone, which could cost $90 billion per year. What kind of impact will this have on small businesses? Mr. Keating. Well, there is an assortment of impacts, first, the ones that you alluded to in terms of--think of a small business owner, small business as a consumer of electricity, power, so on and so on. So you are going to hit on that end in terms of the increased cost. But then as I mentioned in my testimony, all of these industries--and I love telling people this when I go out and speak to the public on all those issues. You know, if you look at the energy industry, pick the pharmaceutical industry, all the ones that people think of as big oil and big pharma and big this and big that. When you actually dig into the numbers, the population is overwhelmingly small firms, less than 20 employees depending on the industry we are talking about, 70, 80 percent. So from a small business perspective, you are getting hit on both sides. You are getting hit as a consumer and you are getting hit as being part of the industry, bottom line. Mr. Broun. Mr. Chairman, if I could, I just have another question for Mr. Keating to follow up on that. This President said that his energy policies will ``necessarily skyrocket the cost of energy.'' This is what we are talking about as increasing the cost on small businesses. Who gets hurt most there? I believe it is poor people and senior citizens on limited income. Would you agree with that, Mr. Keating? Mr. Keating. I would agree with that but I certainly wouldn't limit it there. When you are talking about an economy that is struggling to create jobs for as long as we have been struggling, who are the job creators? You know, again, when you look at the numbers, small- and medium-sized firms are creating roughly 2/3 of the new jobs. There is a reason why we are suffering these days because--well, I know it could be a long list of things but I think they are all--they all go back to policy. And we look at regulatory issues, it creates an enormous amount of uncertainty for small businesses and it imposes an enormous amount of costs. Those are--you know, it is--again, the consumers--it is the small businesses themselves but it goes well beyond that in terms of people that are just looking to get a job and get back into the labor force. Mr. Broun. Thank you, Mr. Keating. Mr. Chairman, I thank you for your indulgence. I am just very concerned about the attack upon energy, particularly coal- powered energy and fossil fuel energy that this Administration is utilizing the EPA to promote that attack, and it hurts poor people and senior citizens I think the most but it also hurts job creators and hurts our economy. Thank you. I yield back. Chairman Schweikert. Thank you, Dr. Broun. Mr. Weber. Mr. Weber. Gosh, I was going to let Dr. Broun keep going. I wasn't sure of my questions yet. I am just kidding. Chairman Schweikert. All right. Thank you, Mr. Weber. Mr. Weber. Next witness---- Mr. Broun. I tried to take your time. Mr. Weber. Yeah. Yeah. I guess this is a question for all the panelists on the risk data, this data that is collected that we are discussing here today. And I will start with you, Dr. Graham. That is--by the EPA, for example, that is a public agency, right? Dr. Graham. Yes. Mr. Weber. Government-funded public agency, we would all agree with that? Dr. Graham. Yes. Mr. Weber. So I guess we would have to agree--anybody that disagrees with that? I guess we would have to agree that the money used to procure that data was public money. No? Dr. Graham. Well, the---- Mr. Weber. Dr. Silbergeld, you are saying no. Dr. Graham. It is a mixture. Some of the studies have a mixture of public and private money. Mr. Weber. All right. Do we question the motives of those who provide that private money? We seem to be questioning the motives of those who testify. Dr. Graham. At this hearing you are in good shape unless you are the tobacco industry. Mr. Weber. Well, that is what I am saying. Personally, I think they are blowing smoke but we seem to be questioning people who are involved in this--I am an air-conditioning contractor and--from the State of Texas and we want somebody on that licensing board that understands the industry or somehow is involved. And I understand tobacco was a big lawsuit. The aim of science is to get to the truth and, Dr. Silbergeld, I was reading your personal statement here where you said, ``there is an urgent and important need to adopt an evidence-based approach to improve decision-making and increase public confidence in policy-making and enhancing the scientific basis of toxicology as well as its utility for other domains, including drug regulation,'' on and on and on. And then you continue. You say, ``through this process I think it is time-- it is now appropriate to draw together a workshop of stakeholders.'' Well, I would submit that we want people from industry, the energy industry, the coal industry, and we want the data to be accessible so that if--our aim is for the American public's health and its safety and we want--I mean is it not true that scientists want to get to the truth? Is that a truism? Or is it what Mark Twain said? All scientists are only sure of one thing and that is that every other scientist before them was wrong. Ms. Silbergeld. Well, actually, Mark Twain does express a certain tenent in science, which is what we call the falsifiability principle advocated by philosophers, which is that we start by doubting our own hypotheses. Mr. Weber. Okay. Well, yeah. Well, that is right. And so I just want to point out that we want those industry ties and we want people to be able to do that. I just find it appalling that we seem to have a disagreement over people in industry have a legitimate reason for getting involved. We question their motive in so many cases. And I think that we have the underlying premise--and you tell me if I am wrong--that somehow government employees are to be trusted more. The EPA, Science Advisory Policy Committee, whatever, are to be trusted more than those who have a vested interest in the very communities that they live in. And I want us to be open and honest. And I am going to be supporting your bill, Mr. Chairman, obviously, and I want us to be able to get the open and reviewable science and the methodology that was used. We are dealing on another issue on flood on FEMA where we are questioning their data. But I think that it would be a good thing for all scientists to be able to review the data or am I missing something here? Mr. Keating, I will start with you. Mr. Keating. I think you are spot on. And what is interesting about this, this is where public choice economists can help out a little bit here because they are the ones that point out what the incentives are in government, right? What are the political incentives? And free-market people, you know, we still have a certain skepticism, which I like, regarding what government does. So what you want to do when you are talking about science is clear that up as much as you can, dispel the idea that this is all politics, it is all driven by politics---- Mr. Weber. And I apologize. I am running out of time. If I may go over---- Mr. Keating. Yes. Mr. Weber. --to the good doctor next to you here. Same question. I think it is a good thing if most all of the studies were up for review by all scientists involved, don't you agree? Ms. Silbergeld. I think we have that process in place now, sir. And actually, if I may, in response--I am sorry Dr. Broun is not here because in fact his profession has driven what I think to be a model, which is the evidence-based approach. And physicians don't actually usually consult the underlying data. They look at systematic reviews---- Mr. Weber. And, I am sorry. I need to move on. Dr. Cox? Dr. Cox. I think it is an excellent idea and I don't think that our current systems go far enough in the public interest. Mr. Weber. And, Dr. Graham, I think---- Dr. Graham. I agree. Mr. Weber. Okay. Well, we want to be very--I know--I believe that all of our colleagues here want to be good stewards of the American tax dollars or taxpayers' money, and so the fact that we want to call in to question some of these policies by the EPA because they are killing jobs; it is just as pure and simple as you can make it. And if the scientific data is not absolutely concrete and 100 percent certain, then I think rather than have a war on coal, rather than have a war on fossil fuels--and I was on the Environmental Reg Committee in the Texas Legislature, and Texas does a good job of cleaning up their air. Now, there are federal government employees would like to think that they have to come in and riot herd on Texas to use an old Texas colloquialism. But leave it to the States for the most part because they do want a clean backyard. And, Mr. Chairman, I have gone on way too long and I will stop. Thank you very much. Chairman Schweikert. Thank you, Mr. Weber. Ms. Bonamici, do you ever feel that we are just surrounded by Texans on this Committee? Ms. Bonamici. Yes, indeed, Mr. Chairman. Chairman Schweikert. Would you like to do a closing statement or share some thoughts? Ms. Bonamici. Thank you very much, Mr. Chairman. I appreciate the opportunity. And thank you for your courtesy in allowing me to do this. But thank you to all the witnesses for being here today. Mr. Chairman, I know we share a common goal of transparency and I also--but the issue of course is how do we accomplish that? And I also know that we all want the EPA to be able to use the best science available and I look forward to further discussions about that. I also want to reiterate the need to hear from the EPA about this proposed legislation to get their input on how this would affect them, their work, their workload, and just to get a sense from them on the record and again working hopefully with the Subcommittee on Science and Technology. So I look forward to--the Subcommittee on Technology and Innovation. I look forward to working with you on this important issue, and as I said, we share the common goal of transparency. Let's figure out if there is a way we can get there. Thank you. Chairman Schweikert. Thank you, Ms. Bonamici. And this was one of those I have a particular personal interest in, so forgive me if sometimes--and I am hoping I get input from everyone, particularly those agencies that would be affected. There is a running joke in my family, what are the two times in life you think you know everything? When you are 14 years old and the day after you get elected to Congress. It really is actually funny. And my concern is, you know, in part of this discussion, should data that is making regulatory policy, how egalitarian, how much should it be? And, you know, we all have this certain sort of folklore, experience in our lives. When I was a freshman in my statistics class, my professor at that time, she talked about how she had done all this modeling on what--you know, for a couple drug companies on what the different products for ulcers would be, but a couple years later she found out that the ulcers she had were actually caused by bacteria in the lining. So all this study over here on what was the best drug, it turns out they were looking at the wrong thing. They had it wrong. How often does that happen where the data sets, our current data belief, our current policy we believe today will be dramatically different a decade ago? It was only 10, 12 years ago if you and I sat in this room, we would have been hearing speakers, Members talking about Peak Oil, you know, the next incremental barrel of fossil fuels would be less. We screwed up somewhere the modeling on the understanding of technological curve, where we were at. We got it wrong but yet our tax policy, our environmental policy, our military policy was based on that data. And I am--so part of my embracing of the idea of lots of inputs is I am hoping somewhere there is the brilliance that helps us do what is best, and what is best for our country sometimes may have my ideological leaning and sometimes it might not, but at least it will be fact-based. So with that, I want to thank the witnesses here and I am very sincere. Having read all your CVs, you are all very, very unique individuals and very bright. The Members of the Committee will have--if they have additional questions for you, and I am almost sure there will be some coming towards you, we will ask you to respond in writing. The record will remain open for two weeks for additional comments and written questions from Members. And the witnesses are excused. Thank you for giving us some of your valuable time. [Whereupon, at 11:38 a.m., the Subcommittee was adjourned.] Appendix I ---------- Answers to Post-Hearing Questions [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] [all]