[House Hearing, 106 Congress] [From the U.S. Government Publishing Office] H.R. 88, REGARDING DATA AVAILABLE UNDER THE FREEDOM OF INFORMATION ACT ======================================================================= HEARING before the SUBCOMMITTEE ON GOVERNMENT MANAGEMENT, INFORMATION, AND TECHNOLOGY of the COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED SIXTH CONGRESS FIRST SESSION ON H.R. 88 TO AMEND THE TREASURY AND GENERAL GOVERNMENT APPROPRIATIONS ACT, 1999, TO REPEAL THE REQUIREMENT REGARDING DATA PRODUCED UNDER FEDERAL GRANTS AND AGREEMENTS AWARDED TO INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NONPROFIT ORGANIZATIONS __________ JULY 15, 1999 __________ Serial No. 106-107 __________ Printed for the use of the Committee on Government Reform Available via the World Wide Web: http://www.gpo.gov/congress/house http://www.house.gov/reform ______ U.S. GOVERNMENT PRINTING OFFICE 63-673 CC WASHINGTON : 2000 COMMITTEE ON GOVERNMENT REFORM DAN BURTON, Indiana, Chairman BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California CONSTANCE A. MORELLA, Maryland TOM LANTOS, California CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania JOHN L. MICA, Florida PATSY T. MINK, Hawaii THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington, MARK E. SOUDER, Indiana DC JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio Carolina ROD R. BLAGOJEVICH, Illinois BOB BARR, Georgia DANNY K. DAVIS, Illinois DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts ASA HUTCHINSON, Arkansas JIM TURNER, Texas LEE TERRY, Nebraska THOMAS H. ALLEN, Maine JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois DOUG OSE, California ------ PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont HELEN CHENOWETH, Idaho (Independent) DAVID VITTER, Louisiana Kevin Binger, Staff Director Daniel R. Moll, Deputy Staff Director David A. Kass, Deputy Counsel and Parliamentarian Carla J. Martin, Chief Clerk Phil Schiliro, Minority Staff Director Subcommittee on Government Management, Information, and Technology STEPHEN HORN, California, Chairman JUDY BIGGERT, Illinois JIM TURNER, Texas THOMAS M. DAVIS, Virginia PAUL E. KANJORSKI, Pennsylvania GREG WALDEN, Oregon MAJOR R. OWENS, New York DOUG OSE, California PATSY T. MINK, Hawaii PAUL RYAN, Wisconsin CAROLYN B. MALONEY, New York Ex Officio DAN BURTON, Indiana HENRY A. WAXMAN, California J. Russell George, Staff Director and Chief Counsel Matthew Ebert, Policy Advisor Grant Newman, Clerk Michelle Ash, Minority Counsel C O N T E N T S ---------- Page Hearing held on July 15, 1999.................................... 1 Text of H.R. 88.............................................. 2 Statement of: Hahn, Robert W., director, Joint Center for Regulatory Studies, AEI-Brookings..................................... 72 Holt, Hon. Rush D., a Representative in Congress from the State of New Jersey; James C. Miller III, counsel, Citizens for a Sound Economy and former Director of OMB; Harold E. Varmus, Director, National Institutes of Health; James T. O'Reilly, visiting professor, College of Law, University of Cincinnati; and Bruce Alberts, president, National Academy of Sciences................................................ 15 Kovacs, William L., vice president, Environment and Regulatory Affairs, U.S. Chamber of Commerce; Dr. Robert Shelton, vice provost for research, University of California and Association of American Universities, National Association of State Universities and Land Grant Colleges; Anthony Obadal, Washington counsel, Association of Equipment Distributors; Dr. George D. Thurston, associate professor, environmental medicine, New York University; Michael Gough, adjunct scholar, the Cato Institute; and Dr. Gary D. Bass, executive director, OMB Watch...................................................... 112 Letters, statements, et cetera, submitted for the record by: Alberts, Bruce, president, National Academy of Sciences: Letter dated April 5, 1999............................... 44 Prepared statement of.................................... 59 Bass, Dr. Gary D., executive director, OMB Watch, prepared statement of............................................... 199 Gough, Michael, adjunct scholar, the Cato Institute, prepared statement of............................................... 191 Hahn, Robert W., director, Joint Center for Regulatory Studies, AEI-Brookings, prepared statement of.............. 75 Holt, Hon. Rush D., a Representative in Congress from the State of New Jersey, prepared statement of................. 18 Horn, Hon. Stephen, a Representative in Congress from the State of California, prepared statement of................. 5 Kovacs, William L., vice president, Environment and Regulatory Affairs, U.S. Chamber of Commerce, prepared statement of............................................... 115 Miller James C., III, counsel, Citizens for a Sound Economy and former Director of OMB, prepared statement of.......... 22 Obadal, Anthony, Washington counsel, Association of Equipment Distributors, prepared statement of........................ 148 O'Reilly, James T., visiting professor, College of Law, University of Cincinnati: Letter dated July 17, 1999............................... 94 Prepared statement of.................................... 37 Shelton, Dr. Robert, vice provost for research, University of California and Association of American Universities, National Association of State Universities and Land Grant Colleges, prepared statement of............................ 135 Thurston, Dr. George D., associate professor, environmental medicine, New York University, prepared statement of....... 166 Turner, Hon. Jim, a Representative in Congress from the State of Texas, prepared statement of............................ 13 Varmus, Harold E., Director, National Institutes of Health, prepared statement of...................................... 29 Waxman, Hon. Henry A., a Representative in Congress from the State of California, prepared statement of................. 9 H.R. 88, REGARDING DATA AVAILABLE UNDER THE FREEDOM OF INFORMATION ACT ---------- THURSDAY, JULY 15, 1999 House of Representatives, Subcommittee on Government Management, Information, and Technology, Committee on Government Reform, Washington, DC. The subcommittee met, pursuant to notice, at 9:30 a.m., in room 2154 Rayburn House Office Building, Hon. Stephen Horn (chairman of the subcommittee) presiding. Present: Representatives Horn, Biggert, Ose, Ryan, and Turner. Staff present: J. Russell George, staff director and chief counsel; Matthew Ebert, policy advisor; Bonnie Heald, director of communications; Grant Newman, clerk; Chip Ahlswede, staff assistant; Justin Schlueter, Lauren Lefton, and Christina Steiner, interns; Phil Schiliro, minority staff director; Michelle Ash, minority counsel; Trey Henderson, minority professional staff member; and Jean Gosa, minority staff assistant. Mr. Horn. The Subcommittee on Government Management, Information, and Technology will come to order. We're here today to examine H.R. 88, a bill introduced by Representative George Brown of California, the ranking member on the House Committee on Science. [The text of H.R. 88 follows:] [GRAPHIC] [TIFF OMITTED] T3673.001 [GRAPHIC] [TIFF OMITTED] T3673.002 Mr. Horn. It would repeal the provision of the Emergency Supplemental Appropriations Act for fiscal year 1999. The provision introduced as an amendment by Senator Richard C. Shelby of Alabama enhances access to federally funded research data under the Freedom of Information Act. James Madison underscored the importance of maintaining an informed citizenry when he said, ``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 the Governors must arm themselves with the power knowledge gives.'' The Freedom of Information Act enacted in 1966 created the presumption that government records should be accessible to citizens. Before the law was approved, individuals who requested government documents were required to show a compelling reason for acquiring the information. The Freedom of Information Act shifted the burden of proof from the individual to the government, which now must justify why a citizen should not have the right to see the requested records. In its oversight capacity, this subcommittee is committed to ensuring that the intent of the Freedom of Information Act is upheld. However, in the case of federally funded research data, the concern is that one individual's right to government information may infringe upon another's right to privacy. Up to now, Federal agencies have had the discretion to withhold raw data collected during a federally funded research project from public scrutiny. Once the Shelby amendment is implemented, this information may be released to anyone who requests it through the Freedom of Information Act. Supporters of H.R. 88, which would repeal the Shelby amendment, are concerned that the Freedom of Information Act would not adequately protect the privacy of those who participate in federally funded research projects either as volunteers or as private researchers. They argue that this loss of privacy would be a strong disincentive to those who volunteer as subjects because their personal records might become accessible to the public. Similarly, private companies and other organizations would refrain from participating in these studies because public access to the data could result in the loss of proprietary information or trade secrets. Today we will examine H.R. 88 and other provisions affecting public access of federally funded research data in an attempt to determine a good and lasting public policy. We will hear from a stellar group of witnesses who hold differing views on this issue. I welcome our witnesses and I look forward to their testimony. [The prepared statement of Hon. Stephen Horn follows:] [GRAPHIC] [TIFF OMITTED] T3673.003 [GRAPHIC] [TIFF OMITTED] T3673.004 Mr. Horn. I now yield time to the gentleman from Texas, the ranking member on the subcommittee, Mr. Turner, and he will be followed by the ranking member on the full committee Mr. Waxman. Mr. Turner. Thank you, Mr. Chairman. I would like to yield first to the ranking member of the Government Reform Committee, Mr. Waxman. Mr. Waxman. Thank you very much for yielding to me and giving me this opportunity to make a statement before the hearing begins. Mr. Chairman, I want to thank you for holding this hearing on H.R. 88, which repeals the public access requirement regarding data produced under Federal grants and agreements awarded to institutions of higher education, hospitals, and other nonprofit organizations. I'm a strong supporter of H.R. 88 and am hopeful that this hearing will highlight the bill's numerous benefits. H.R. 88 is quite simple. It repeals Senator Shelby's amendment to the fiscal year 1999 Omnibus Consolidated and Emergency Supplemental Appropriations Act requiring public access to federally funded research data collected by nonprofit institutions. The Shelby amendment was added as a rider, so there was no opportunity for the appropriate authorizing committees to review whether or not there was a problem with regard to data availability. Senator Shelby's amendment is not good government legislation, as some will suggest. The amendment was simply an expression of opposition to the Environmental Protection Agency creating tighter restrictions under the Clean Air Act. In fact, one Internet website espousing support for the Shelby amendment explains that the amendment will ensure that agencies have a more difficult time imposing regulations on the business community. There are a number of technical defects with the Shelby amendment, including the fact that it was written with vague terms that are not defined, leaving open the definitions of data published and in developing policy and rules. However, I want to emphasize one particular defect: its unfairness. The Shelby amendment only applies to nonprofit grantees and not to contractors. Consequently, data collected by a private corporation under contract to the Federal Government would not be subjected to the FOIA, but data collected by a nonprofit under a grant from the Federal Government would be subject to the FOIA. And at a minimum I would hope that this committee considers having the Shelby language applied to both Federal contractors and nonprofit grantees. Mr. Chairman, there are also numerous substantive defects in the Shelby amendment. The amendment will hurt valuable research by placing patient confidentiality at risk, threatening intellectual property, increasing nonprofits' administrative burdens and costs, and increasing harassment of researchers. This only will lead to a reduction in the number of human subject volunteers, a reduction in the number of private public partnerships, and research no longer being conducted in certain research areas. I want to thank the Science Committee's distinguished ranking member, Representative George Brown, who cannot be with us today, for introducing H.R. 88. Repeal of the Shelby amendment is necessary to assure that scientific research continues to develop and grow. Thank you, Mr. Chairman. I yield my time to Mr. Turner, and want to explain to the witnesses that a conflict in my schedule prevents me from being here to hear all the testimony but I certainly will have a chance to review it. Thank you. [The prepared statement of Hon. Henry A. Waxman follows:] [GRAPHIC] [TIFF OMITTED] T3673.005 [GRAPHIC] [TIFF OMITTED] T3673.006 Mr. Horn. The gentleman from Texas, Mr. Turner. Mr. Turner. Thank you, Mr. Chairman. Appreciate you holding this hearing on H.R. 88 regarding the data available under the Freedom of Information Act. Included in the fiscal year Omnibus Consolidated and Emergency Supplemental Appropriations Act was the amendment introduced by Senator Shelby which requires public access to data produced under Federal grants and agreements awarded to institutions of higher education, hospitals, and other nonprofit organizations. This legislation before us, H.R. 88 introduced by Representative George Brown, would repeal the Shelby amendment. I am a strong supporter of ensuring openness and accountability in government. Government transparency helps enhance the public's trust and we all understand that. In addition, I support the sharing of scientific data. Free and open exchange of information helps us to understand science and such exchanges can promote scientific advancement and progress. However, it is imperative that we create data sharing. When we create these data sharing opportunities, we do not compromise the privacy of research participants or increase the potential for theft of intellectual property. We do not want human subject volunteers, who before gave information on the condition that their information would remain strictly confidential, to no longer be willing to release such information. Similarly, we should adhere to the principle that those who gather the data should have the opportunity to interpret it first. If data is available before the grant recipient has completed his research, there may be an opportunity for others to profit from that research. In addition I'm concerned that this amendment raises fairness issues. Shelby does not apply to Federal awards, to businesses or contractors, only to awards to nonprofits. Therefore, a small community nonprofit which receives a community development block grant from its State would be subject to the new Freedom of Information Act requirements, but a large defense contractor would not have to comply. The Shelby amendment has generated considerable interest. In fact, the Office the Management and Budget's recently published proposed regulation to comply with the Shelby amendment generated 40 times the average number of comments OBM usually--or OMB usually receives from a proposed regulation. A second comment period will commence at the end of this month with final rule due at the end of September. OMB, I understand, expects a similar response during the second comment period. One criticism with which I agree is the lack of a legislative record on this issue. The Shelby amendment was a rider to an appropriations bill and therefore the appropriate authorizing committees did not have the opportunity to thoroughly review the amendments's affects. In closing, I want to comment that I'm sorry that Ranking Member Brown, who has been most active on the issue, cannot be with us today because of health reasons. And I look forward to hearing from all of our witnesses on their thoughts as to whether there's a need for public access to data produced under Federal grants and agreements awarded to nonprofits. Thank you, Mr. Chairman. I look forward to hearing from all of our witnesses. [The prepared statement of Hon. Jim Turner follows:] [GRAPHIC] [TIFF OMITTED] T3673.007 [GRAPHIC] [TIFF OMITTED] T3673.008 Mr. Horn. Thank the gentleman. And we'll now proceed with the first panel. Let me describe our process here in terms of how it works. Some of you have been prior witnesses, some of you haven't. The fine statements you have presented to us have been read by staff and members prior to the hearing, and they will automatically go in the record when we call on you. We'll still use the agenda you have before you. It's carefully put together of pros and cons, everyone. So, there won't be a bunch of pros and there won't be a bunch of cons, but you'll hear combating arguments as you would in a court. Here we do swear in all witnesses, and this is an investigating subcommittee of the full Committee on Government Reform. We would like you not to read your testimony to us--we can read--but what we would like you to do is summarize it. We allow about 5 minutes. And we, you know, loosen that up a few minutes if we can. But, if we're to get through this panel-- there are three panels, I believe this morning--or two major panels. We need to get out of here before noon or we'll be swallowed up by another subcommittee holding a hearing. So if you can summarize it in 5 minutes, that will leave more chance for dialog between the members and the panels and within the panel. We believe in dialog. So it's been very helpful so far. So, if you would stand and raise your right hands and take the oath we can proceed. Is there anybody behind you that might be giving you advice, I might add? If so get them up. I only like the baptism once. [Witnesses sworn.] Mr. Horn. The clerk will note that six witnesses did that. Now, we will start with our colleague, Mr. Rush Holt, Member of Congress from New Jersey. And we're delighted to have you here. You have taken a lead in this area. And we look forward to hearing from you. STATEMENTS OF HON. RUSH D. HOLT, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY; JAMES C. MILLER III, COUNSEL, CITIZENS FOR A SOUND ECONOMY AND FORMER DIRECTOR OF OMB; HAROLD E. VARMUS, DIRECTOR, NATIONAL INSTITUTES OF HEALTH; JAMES T. O'REILLY, VISITING PROFESSOR, COLLEGE OF LAW, UNIVERSITY OF CINCINNATI; AND BRUCE ALBERTS, PRESIDENT, NATIONAL ACADEMY OF SCIENCES Mr. Holt. Thank you Chairman Horn. And I'm pleased to be here with these distinguished panelists and to address my colleagues, Mr. Ose, Mrs. Biggert, and Mr. Turner. As a cosponsor of H.R. 88, I'm sorry that our colleague George Brown can't be here today to speak on behalf of his bill. There is no one in Congress who has a better appreciation of the role of science and the process of science than George Brown. I think his bill is important, is very important. And that's why I've taken time to join you today. The provision was added in haste to last year's Omnibus appropriations bill to change Circular A-110. It has four major problems. I think it can force researchers to breach the confidentiality of their subjects, especially in medical studies; it's an infringement of intellectual property which could force release of data before researchers gain the benefits of the work; it creates an opportunity for harassment of science, of scientists and politicization of science; and it would impose a significant administrative burden on institutions and on scientists. As a representative of the district which is home to world class research, I strongly support H.R. 88. The 12th District of New Jersey is home to many researchers, particularly in the biotechnology and pharmaceutical fields, as well as in telecommunications, as well as at Princeton University, Monmouth University, Rider University, the College of New Jersey and neighboring Rutgers University. Federal research support and partnerships between public and private research are vital to the present and future economic success of my constituents as well as yours as those of the Nation. I support H.R. 88, because as a scientist I know that without the open exchange of information and ideas we could not have achieved the state of knowledge and the standard of living that we enjoy today. Without an open exchange of information and science, we will not maintain the progress of research, which is the source of new ideas to propel our economy. Contrary to the rhetoric that's been put forward by the proponents to change Circular A-110, this change in law will not make the scientific process more open and accessible either within the scientific community or to society as a whole. In fact, it will make certain lines of inquiry more difficult, if not impossible. The openness of scientific exchange which is so vital to the maintenance of scientific progress is not primarily a function of data access. It is dependent upon providing scientists with the opportunity to pursue all lines of inquiry and to freely and openly exchange their findings without fear of harassment or theft of their intellectual property by vested interests. Scientists have established means of sharing research through collaborations, conferences, publications, and peer review, all of which are essential to the process. As a representative of central New Jersey I'm greatly concerned about the possibility of harassment of scientists by groups with ulterior motives. They can seriously disrupt research. If research data are released prior to the completion of the academic review process, the public could come to rely on distorted interpretations and unfairly discredit the particular study and ultimately scientific inquiry in general. Also, ambiguity in determining which data might be subject to disclosure will make industries reluctant to continue or enter partnerships with federally funded researchers. Once data are commingled in a partnership it may be difficult to distinguish the data produced with Federal funds from those produced with other funds. The resulting reluctance of industry to participate in partnerships will significantly hurt the fast-paced pharmaceutical and biotech industries, I'm sure. As a scientist, I receive support for my work from the National Science Foundation, the Department of Energy, and indirectly from other Federal agencies. I never believed these Federal awards to be entitlements. As a grant recipient I knew that I had many responsibilities tied to the receipt of my award: a responsibility to manage the funds and conduct the research in accordance with my proposal and the terms of the general agreement, a responsibility to conduct my work in a thorough and careful manner and to communicate--to communicate my results to my colleagues and the public through presentations and publication in peer-reviewed publications that are publicly available in a manner inviting examination and replication, key to the scientific process. Scientists who do not make their findings public can have no expectation of further support. As a Member of Congress, I am concerned that Congress has hastily enacted legislation which is in direct contradiction to a Supreme Court decision which determined that data generated under Federal grants is not the property of the agency and not subject to the Freedom of Information Act. Any change to this decision deserves discussion with the parties affected. Finally, I support H.R. 88 because as a scientist and as a Member of Congress, I believe it was unfair, undemocratic, and unwise of Congress and the administration to enact a significant change in law without ever providing members of the academic scientific community and their private sector partners, representatives of research hospitals and other nonprofit organizations, an opportunity to participate in the process that directly impacted them. This is a sunshine provision enacted in the dark. The process now underway at the Office of Management and Budget--a mandatory rulemaking with predetermined outcome--is unwise, dangerous, and an inadequate substitute for an open, democratic legislative process such as we are engaged in this morning. The enactment of H.R. 88 would allow Congress to do what the public expects scientists to do: consider the views of all interested parties as we examine the nature and the scope of problems and to debate the merits of proposed solutions. As a society, we've enjoyed many benefits as a result of our decision to foster an open exploration of ideas. The public contract with science is critical to our society. Through Federal support of scientific research, we have created a powerful engine of social progress and economic growth. Let's not jeopardize this enterprise by hastily implementing a law that was crafted without the participation of all interested and affected parties. I thank you, Mr. Chairman, for the opportunity to speak with you this morning. [The prepared statement of Hon. Rush D. Holt follows:] [GRAPHIC] [TIFF OMITTED] T3673.009 [GRAPHIC] [TIFF OMITTED] T3673.010 Mr. Horn. Thank you very much. And we now move to the next witness, the Honorable James C. Miller III, former Director of the Budget, now the council for the Citizens for a Sound Economy. Welcome to this subcommittee. Mr. Miller. Thank you, Mr. Chairman. In addition to those qualifications and more pertinent to the hearing this morning, I was the first Administrator of the Office of Information and Regulatory Affairs at OMB. I have prepared a statement that I hope you will include in the record. Attached to that statement is a letter signed by all of my successors in the Reagan and Bush administrations, except for two who are now Federal judges and could not participate, though I suspect their private views are in accord. So all of the Reagan-Bush heads of that agency support the open language of the Shelby amendment and oppose H.R. 88. Now, why? Well, I think, No. 1, the taxpayer has paid for this information and it's theirs. They have a right of access to it. No. 2, I think that the notion of H.R. 88, or going against the Shelby-Aderholt language, places the notion of open accountable government on its head. What do I mean by that? Well, if agencies do not have to make available data on which they base reports that they cite as justification for rulemaking, for policymaking, then at best the public won't be informed about, or adequately informed about, the reasons for their decisions; and, at worst, you give the agencies an enormous license to play ``hide the ball'' and make decisions according to their own political preferences. Bear in mind that the language addressed here only covers reports that are published and are relied upon by agencies where the data collected was at public expense. Now, we hear criticisms of this language and support for H.R. 88. First, they say privacy would be invaded. I don't know of any reputable physical or social scientist that would maintain that you have to reveal the individual records of Aunt Jane's personal behavior in any report or web providing data. As we all know, when you do hypotheses testing, the specific records and details are masked; in fact, it is the aggregate data, the summary data, that is relevant. There is no need to find out whether Aunt Jane calls her nephew three times a week or not. More importantly, the Aderholt-Shelby language requires that the dissemination of such information go through Freedom of Information Act procedures. And FOIA procedures explicitly deny the release of data where it is on an individual record basis. So the revealing of personal data simply is not an issue. Second, you've heard criticism that Aderholt-Shelby will raise the cost of research. The answer is, yes, it will raise Federal costs a little bit. Why? Because under today's circumstances, researchers, not all, universities, not all, but some buy into research because they get the data base and can monopolize to some extent its use. But that's simply revealing that the real costs are higher than they should be. So, even if you had a little bit of an increase in the cost to the taxpayer of such research, it would represent a reduction in the total cost of research. Third, you hear the argument that there would be confiscation of property, of intellectual property or whatever. But FOIA procedures deny the release of data where it would compromise a proprietary interest. There's been a lot of research on how well FOIA has worked. There are glitches from time to time. But for the most part they are perceived to be working very, very well. Finally, I would raise the following. We have a larger issue here, and that is scientific method. And you don't progress unless you rely on scientific method. And scientific method doesn't work unless you have an opportunity for replication. What happens is that scientists or others will advance the ball by presenting new ideas, new perceptions, new hypotheses, and you advance the ball only by being able to replicate and check the validity of these allegations or these arguments. And if researchers hide the ball, if they don't release the data, you can't replicate. And so with respect to my colleagues here on this panel, I would probably venture to say they would agree that science is very important. I'm suggesting, recommending, that you not adopt H.R. 88 because, contrary to the view just expressed by the Congressman, I believe scientific method is enhanced by Aderholt-Shelby, and is not enhanced and in fact is compromised by H.R. 88. Thank you, Mr. Chairman. Mr. Horn. We thank you. [The prepared statement of Mr. Miller follows:] [GRAPHIC] [TIFF OMITTED] T3673.011 [GRAPHIC] [TIFF OMITTED] T3673.012 [GRAPHIC] [TIFF OMITTED] T3673.013 [GRAPHIC] [TIFF OMITTED] T3673.014 [GRAPHIC] [TIFF OMITTED] T3673.015 Mr. Horn. We now go to the distinguished Director of the Nation's National Institute of Health and a shared Nobel Prize with a colleague at the University of California, San Francisco--a very distinguished institution in our State--Dr. Varmus. Mr. Varmus. Thank you. Chairman Horn, Mr. Turner, other members, thank you for having this hearing and bringing this issue into the light. I am Harold Varmus, Director of the NIH, and I'm very happy to be here to support H.R. 88, a bill authored by your distinguished colleague, George Brown, ranking member of the Science Committee and a longtime advocate of openness in scientific research. I, too, am an advocate for openness in research. Exchanging ideas and sharing data are vital to the success of all research, including the research sponsored by the NIH. A true understanding of the breakthroughs we're making in genetics and clinical research and other realms of investigation could not be accomplished without the open sharing of methods and data. Openness has many virtues. It allows us to achieve trust in scientific outcomes and trust in the use of Federal dollars in biomedical research. It engenders faith that human subjects and animals are adequately protected in the research we do. And it sparks technical innovation. But a word of caution. I think it maybe a mistake to argue for opening all underlying scientific data to public scrutiny, simply because of the concept that openness is good. There are pitfalls in unrestrained openness, including unwarranted violations of privacy, potential harassment of scientific investigators, and a chilling effect on the free exchange of ideas and the entry of scientists into research. The widespread access to data envisioned by the A-110 amendment that H.R. 88 seeks to repeal could result in unforeseen abuses. In particular, patient privacy rights could be violated, and the willingness of scientists to speak openly about new ideas and take risks experimentally could be fettered by unrestricted data access. In addition, new requirements could undercut the ability of researchers to build private sector partnerships that now lead to the marketing of products. It's because of these concerns that we at the NIH have taken the position that while expanded access to scientific data should be encouraged, the A-110 amendment is a poor vehicle to achieve this. We are particularly concerned about the requirement that the Freedom of Information Act be the tool of regulatory implementation. FOIA is not designed to accommodate the confidentiality requirements of the most sensitive scientific data. Under FOIA, Federal agencies cannot place restrictions upon who obtains Federal records or on their intended use. Consequently, it might be possible for the privacy of patients to be compromised or for individual scientists to be harassed by selected interests opposed to their work for moral or for financial reasons. These intrusions could stop promising research in its tracks. Indeed, and perhaps even more importantly, the mere threat of such intrusions could impede the Nation's effort to recruit the best, most talented students into publicly supported research. As one example of the potential misfirings of the amendment to A-110, consider what would happen if HIV-infected patients thought that their condition might be revealed by someone using the new requirements to examine raw experimental data. Patients might not participate in clinical trials if they believed there was a chance that their infected status would be revealed. Progress toward treatment of the disease might thereby be curtailed. There are many aspects of the amendment to A-110 that trouble us, and many have already been mentioned. But I want to bring to your attention a particular provision that presents a new challenge to those who would want to make data accessible through this mechanism. I am thinking about the multiplicity of partnerships between public sector researchers, private companies, nonprofit organizations, even foreign governments that allow research to be conducted in many of our nonprofit organizations. Some of these partnerships make strict requirements on the researcher not to share data further. Without such agreements, investigators from private firms might not participate in these partnerships. Industry scientists are likely to avoid collaborations with publicly funded institutions, including universities, if they believe they can no longer protect their data from exposure. The A-110 amendment threatens those protections. I am aware that the administration is working to implement the A-110 amendment in the least intrusive manner possible, and I congratulate my colleagues at OMB for their efforts. However, it is my view that, on balance, you should support H.R. 88 and repeal the A-110 amendment. Taking such action will not, however, mean the end of data access. Instead, it will signal the beginning of efforts to establish a more responsible approach to data sharing, one that will protect the rights of individuals, recognize the proprietary interest of commercial enterprises, and consider the needs of our flourishing scientific community that has been built over a long period of time, with a great deal of thought and communal effort. I pledge to work with you and your colleagues in the efforts to expand data sharing and I would be happy to answer any questions you might have. Mr. Horn. Thank you very much for that presentation. [The prepared statement of Mr. Varmus follows:] [GRAPHIC] [TIFF OMITTED] T3673.016 [GRAPHIC] [TIFF OMITTED] T3673.017 [GRAPHIC] [TIFF OMITTED] T3673.018 [GRAPHIC] [TIFF OMITTED] T3673.019 [GRAPHIC] [TIFF OMITTED] T3673.020 [GRAPHIC] [TIFF OMITTED] T3673.021 Mr. Horn. Now we have a longtime expert on the FOIA Act, and that's Mr. James T. O'Reilly, visiting professor, College of Law, University of Cincinnati. I think you have been with us since the beginning. Mr. O'Reilly. It just feels that way. Thank you, Mr. Chairman, distinguished members and friends, thank you. I'm honored to be back in Congress talking about the Freedom of Information Act, as I have done numerous times before. For background, I have authored the national standard reference text that's going into its third edition next year, written dozens of articles and 25 books on related subjects. I have advised the Japanese, the English, the Canadians, on freedom of information. The message that you get from other countries is your infrastructure of dealing with information is remarkable and we wish in our country we had a similar infrastructure. From my studies for the Congressional Office of Compliance and my work for the Federal Administrative Conference, I have done a lot of background reading and thinking and writing on this subject. So I am here as a technical resource rather than advocate specific to H.R. 88. I want to offer four very specific facts: First, there is a viable infrastructure in the Freedom of Information Act. It's world recognized. The effect of the Shelby amendment was not to change that infrastructure and not to change the set of exemptions, but rather to expand the set or pool of information that's subject to that infrastructure. I also want to emphasize that the costs adopted as a result of the Shelby amendment will be transferred to requesters through the vehicles already present in the Freedom of Information Act of charging requesters for the costs of searching and processing data. Second, the Freedom of Information Act's exemptions for personal medical data, which I can say as a former participant in a Federal medical research project, are very sensitive. Those private information documents and data are protected under the (b)(6) amendment to the Freedom of Information Act. That exemption is not changed by Shelby. The third fact, the Freedom of Information Act exemption protecting persons who have interest in actual competition against the damage to their profit or proprietary interest is a very serious issue which agencies take very seriously in their protection of information--of that private commercially valuable, competitively valuable information. Executive Order 12600, the Supreme Court, and the most recent D.C. Circuit decision on June 25th, for example, have adequately safeguarded the profit and the proprietary desires of those persons subject to government grants and contracts. Shelby does not alter that protection. The experienced infrastructure is in place to manage that profit and competitive interest. The fourth fact is that Congress has been so protective of the public's accountability and sunshine interest that the Congress has declined to carve further exemptions into the Freedom of Information Act and none have been added to the act since 1976. If the Congress wished, it could take 1 of the 100 or more specific exempting statutes, as was done in the medical device research field, for example, and address that concern in a specific substantive statute for that type of information. If there is a specific articulated problem, then carve out that niche by an exemption for a specific program while leaving the Freedom of Information Act and indeed the Shelby amendment untouched. Historically, niche exemptions are the way to go, rather than trying to reconstruct or deconstruct the coverage of FOIA. To briefly explain, the Shelby amendment expands who the FOIA covers. It doesn't change what it exempts or how it operates. But the Forsham case in 1980 was poorly reasoned. I support the position of the dissent in that case. The Justices made a very good point in saying secret government would flourish if contract and grantee research, in that particular case for a diabetes drug, was not accessible. The Shelby action does not change the concept that the public has a right to know. It, rather, expands the pool of documents to which the Freedom of Information Act infrastructure and exemptions apply. I also want to point out as to costs the standard form Federal contracts and grants do provide that there be access by the agency to the specific records prepared under the grant or contract, and FOIA does pass the cost of the research, review and copying onto the requester. So recoupment of access costs will make this largely a user--funded process, though I recognize that will take time within the existing agency budgets and resources. Second, medical and mental health privacy is a very important topic, that I can say as a test subject in Federal research, I understand the sensitivity of this issue. The courts and the case law have very adequately protected this. I have had the misfortune of having to read every published freedom of information case from 1967 on to today--and that could have a mental effect on a person--but those protections are in place, and individual records are protected. Third, the patent and confidential information provisions are adequately protected. The infrastructure of Executive Order 12600 is in place. And, fourth, the advocates for change have a specific opportunity to pass specific laws that will cover their specific items. I want to compliment the American Society of Access Professionals, and those who are the front line people in government agencies handling FOIA requests. They do a great job of screening and protecting personal privacy and commercial privacy. I believe the track record is factually clear that the Freedom of Information Act infrastructure has worked, that the exemptions have worked, and that while there's misunderstanding about being put into the pool, the Freedom of Information Act is a viable accountability mechanism, and adding more documents to the pool is not going to change either the quality of the work done in screening those documents, or the access and privacy protection issues under FOIA. Thank you for the opportunity to participate and I look forward to your questions. Mr. Horn. Thank you very much. We appreciate your testimony. [The prepared statement of Mr. O'Reilly follows:] [GRAPHIC] [TIFF OMITTED] T3673.022 [GRAPHIC] [TIFF OMITTED] T3673.023 [GRAPHIC] [TIFF OMITTED] T3673.024 [GRAPHIC] [TIFF OMITTED] T3673.025 Mr. Horn. Dr. Bruce Alberts, very distinguished scholar and biology, an expert on the cell, and president of the National Academy of Sciences. We're glad to see you here again. Mr. Alberts. Mr. Chairman, thank you. It's a pleasure to be here, and I thank you for holding these important hearings. I want to start by saying the Academy and the scientists do not disagree with the basic objective of the Shelby amendment to the extent that it would make scientific data publicly available for reevaluation by other scientists. This is a very important aspect of science. The Academy has issued many reports stressing the importance of data sharing and openness for both science and Federal decisionmaking. I have quoted from one of them in my written testimony. I personally chaired a committee in 1987 for the Academy to ask whether there should be a project to map in sequence the human genome. That report published in 1988 set the stage for the very successful human genome project. And the central element of that project has been based on our recommendations to free access to all data that's been obtained. As you probably know, all sequence data is immediately put into the public data bases from that project and the Academy and scientists are very much interested in this kind of data sharing which is vital to the advance of science. However, there are numerous problems with the Shelby amendment that arise from three of its fundamental aspects. First, it relies solely on the Freedom of Information Act as a mechanism for disclosure, and we do not believe that this is the appropriate mechanism. Second, the Shelby amendment does not define the key phrase in the amendment, ``all data produced under award.'' And, third, the public data availability specified would not necessarily follow the completion of the researcher's scientific work as signaled by its publication in the scientific journal. I will deal briefly with each of these issues in turn. First, application of Freedom of Information Act to federally funded research grantees will be extremely burdensome and costly to researchers and research institutions. And we have not seen any evidence that the application of this new concept and its impact have been thoroughly thought through by Congress. In fact, as you know, this is the first hearing on the subject. We had legislation before any informing of Congress of the issues. A very unusual situation. We predict that the amendment will have a chilling effect on joint university industry research collaborations, something that--a very vital part of our economy and expanding part of our economy--and that it will be used by various special interest groups, of which there are many, to harass researchers doing research that these particular interest groups would like to stop. New, legislation will also be exploited by both foreign and domestic concerns as well as foreign military interests as a new tool for scientific espionage. As you know we're the clear leader in world science and technology. Many countries are already trying to do espionage; and what we're doing, this would give them a new avenue, a powerful new avenue that we don't reciprocally enjoy for their science. Well, the second fundamental problem with the Shelby amendment is understanding what the term ``data'' means in this legislation. We have suggested to OMB that it should mean research data as witnessed by the conversations on the Senate floor. On the other hand, OMB Circular A-110 does not define the term, ``research data.'' We have suggested that the research data contemplated by the Shelby amendment are the broad data that result from research observations and experiments under Federal grant awards. We also point out that the U.S. Supreme Court's decision, Feist Publications v. Rural Telephone Service Company, provides the legal definition of, ``raw data'' as uncopyrightable facts. We have thus suggested to OMB that research data should be defined to mean, ``facts, which are in the public domain and may not be copyrighted that result from scientific observation, experiment, or similar methods of research.'' We have also suggested to OMB that the definition of research data should contain a provision that, for research involving human subjects, would define research data in a way that would require that any information that would identify any specific individual be aggregated or redacted before this data is being sent to a government agency. This is not the case with FOIA. It's all sent to the government agency and thereafter the government agency decides what to do with it. The third fundamental problem with the Shelby amendment is that the Freedom of Information Act clearly does not protect the scientist's right to publish the result of the scientist's own research. Thus, federally funded research grantees now face a threat under the Shelby amendment of having their research data made public before the Freedom of Information Act--under the Freedom of Information Act, before they have had the opportunity to publish the results of their research. Publication of research results in peer-reviewed scientific journals is one of the most critical elements of the entire research process. It's what makes science so successful. It's the means by which new discoveries are communicated to others in the scientific community and to the public at large. Permitting the researcher who actually collected the data, worked for years to collect the data and to be the first to analyze and publish the conclusions concerning that data is an absolutely essential motivational aspect of all research. If you require public release of this data before publication, it would seriously short-circuit the entire scientific research progress that has been so effective in making the United States the world leader in science and technology. It would severely disadvantage federally funded research scientists while providing unreasonable advantages to all their competitors, both their competitors inside the United States and their international competitors. A premature release of research data before careful analysis of results, of course, would increase the risk of misleading conclusions being drawn from that data, no peer review would have been applied, and might create a loss of confidence in science on the part of the public because of the great unnecessary confusion that would arise. Any reasonable approach, in short, must make publication the triggering of that for application of legislation such as this Shelby amendment. I want to close by emphasizing that in my opinion FOIA is really fundamentally flawed as the mechanism here because it fails to require any evidence from the data requester that the disclose of the data in question is in the public interest. In other words, no prescreening of requests is involved. This actually invites harassment of scientists by those who don't like what particular scientists are doing. It will make the life of a scientist difficult. It will prevent us from attracting the very best people into scientific enterprise, a vital part of the success of our enterprise. In short, the Shelby amendment is throwing out the baby with the bath water. If I was one of our competitors looking with envy at the United States scientific enterprise and its driving of our economy, say I was from France, for example, I would say, Boy, this is a great thing for us; the United States is trying to stab themselves in the foot with this legislation. For this reason, I believe that Congress should hold additional hearings to gain a better understanding of the problems that would be created by the application of the Freedom of Information Act to the Federal grantee research data. Then Congress could craft specific legislation to provide for public access to federally funded research data, using a mechanism that balances the interest of the public in access to data with other important public interests. Of course, the National Academy of Sciences would be pleased to help in any way we can with that effort by Congress. I also offer for the record copies of two letters that I have sent to OMB concerning the Shelby amendment. Mr. Horn. Without objection. It will be in the record at this point, those letters. [The information referred to follows:] [GRAPHIC] [TIFF OMITTED] T3673.026 [GRAPHIC] [TIFF OMITTED] T3673.027 [GRAPHIC] [TIFF OMITTED] T3673.028 [GRAPHIC] [TIFF OMITTED] T3673.029 [GRAPHIC] [TIFF OMITTED] T3673.030 [GRAPHIC] [TIFF OMITTED] T3673.031 [GRAPHIC] [TIFF OMITTED] T3673.032 [GRAPHIC] [TIFF OMITTED] T3673.033 [GRAPHIC] [TIFF OMITTED] T3673.034 [GRAPHIC] [TIFF OMITTED] T3673.035 [GRAPHIC] [TIFF OMITTED] T3673.036 [GRAPHIC] [TIFF OMITTED] T3673.037 [GRAPHIC] [TIFF OMITTED] T3673.038 [GRAPHIC] [TIFF OMITTED] T3673.039 Mr. Alberts. Thank you. Mr. Horn. All right. If you would like, complete your statement. Mr. Alberts. Yes. Mr. Horn. That was the completion of it? Mr. Alberts. Yes. [The prepared statement of Mr. Alberts follows:] [GRAPHIC] [TIFF OMITTED] T3673.040 [GRAPHIC] [TIFF OMITTED] T3673.041 [GRAPHIC] [TIFF OMITTED] T3673.042 [GRAPHIC] [TIFF OMITTED] T3673.043 [GRAPHIC] [TIFF OMITTED] T3673.044 [GRAPHIC] [TIFF OMITTED] T3673.045 [GRAPHIC] [TIFF OMITTED] T3673.046 [GRAPHIC] [TIFF OMITTED] T3673.047 [GRAPHIC] [TIFF OMITTED] T3673.048 [GRAPHIC] [TIFF OMITTED] T3673.049 [GRAPHIC] [TIFF OMITTED] T3673.050 [GRAPHIC] [TIFF OMITTED] T3673.051 [GRAPHIC] [TIFF OMITTED] T3673.052 Mr. Horn. OK. Mr. Hahn, we haven't sworn you in yet so if you will stand and raise your right hand. [Witness sworn.] Mr. Horn. Mr. Hahn has been in a number of key institutions this year. You're in my path. We have followed each other over time. You were at Brookings and also involved with the American Enterprise Institute and also at the John F. Kennedy School. So we're delighted to have you here. And please proceed. You didn't hear--as we said earlier, we don't want the statements read, we want them summarized eyeball to eyeball, and that gives us more chance for dialog from here to there and among your colleagues. STATEMENT OF ROBERT W. HAHN, DIRECTOR, JOINT CENTER FOR REGULATORY STUDIES, AEI-BROOKINGS Mr. Hahn. Thank you, Mr. Chairman. Let me start out by saying that some of the concerns I've heard from the scientists here are a little overblown with respect to FOIA. I have had one experience with FOIA in my life where I couldn't get information out of a bureaucracy. It took about a year to get requests through all of their legal counsel, and I finally got a technical letter explaining why they couldn't give me some data. So I don't think the flood banks are going to open right away, but I'll defer to Mr. O'Reilly and others as to the legal complexities of that. I want to offer to you today a slightly different perspective than you've heard from some of the panel members, and one which may allow some room for compromise. It's based on some research I've done with Professor Linda Cohen at U.C. Irvine, and a short version of that research will be published in Science, hopefully in the next couple of weeks, and I'll look forward to the responses of my distinguished colleagues to my right here. You've asked me to offer views on H.R. 88, which would repeal the requirement to make data publicly available under Federal grants and agreements awarded to universities, the so- called Shelby or Aderholt-Shelby provision. To cut to the chase, my feeling is that the Shelby provision is not perfect, but it's something that we should work with and we should certainly try to build on its strengths. Thus, I don't support H.R. 88 or the Walsh-Price amendment, and I think Congress should work with the Executive to craft a regulation that builds on the strengths of the Shelby provisions. I want to discuss where we are now and make a couple of recommendations for your consideration. As you heard today, the scientific establishment, which we also have to view as an interest group--and I like to think of myself as a member of that establishment but we definitely are an interest group--is deeply---- Mr. Horn. Would you put that microphone a little closer to you? Mr. Hahn. Sure. The scientific establishment is deeply concerned over a proposed OMB regulation and the underlying law that would require data to be publicly available under FOIA or the Freedom of Information Act. Opponents of the regulation, and there are many, correctly point out that it is ambiguous in important respects and could be costly to scientists. I believe that's true. At the same time, I believe that the status quo fails to address a larger, more important problem, and we need to balance these competing costs and benefits. At present, as you are well aware, analyses used in policymaking are rarely checked carefully before big regulations are put into place. That was the whole genesis of the discussion of whether we should provide greater public access to data, which I'll talk about in a minute. So what I recommend is essentially allowing greater access to information that pertains to the formulation of big regulations. And I also propose, unrelated to this law but related to some other matters before Congress, that an agency be created to replicate key findings that are used to support regulations before they are finalized. I think that just conforms with common sense. As you know, one of the motivations for this law and the OMB regulation was the EPA regulation on ozone and particulate matter and, in particular, a Harvard study that suggested that reducing emissions of fine particles could lead to substantial reductions in premature mortality. I don't want to get into the merits of who should have given what to whom, but I want to introduce one point the Administrator of EPA, Carol Browner, suggested that this study was fine to use because it had been peer reviewed. And you have also heard two of the leading scientists on this panel suggest that peer review is a wonderful process. As one who participates in the peer review process, I think it is wonderful, but I don't think it's necessarily adequate when we're developing big regulations. I want to offer one example for you suggesting that the peer review process has serious flaws. There was a study, now famous, in the early 1980's that requested the data used in papers with statistical analyses published in a leading economics journal. And they sent the paper out and tried to get reviewers to replicate the results. The study authors found errors in nearly every paper that were sufficiently serious that the results could not be replicated. I repeat: could not be replicated. Well, that gives one pause for thinking about using such studies cavalierly in the development of huge regulations, when tens of billions, hundreds of billions of dollars are at stake in some of the regulations like particulate matter or, if we move toward regulating greenhouse gases or whatever. Those findings, in my view, cast serious doubt on the peer review process even for academic processes. I think it's noteworthy in this regard that some of the leading journals, such as Nature, Science, the American Economic Review, and others are now requiring data availability to editors and members of the scientific community. And I think the Aderholt-Shelby provision would take it further and I think that that provision is well advised, at least in the area of regulations. Now, why do I say that? Well, if all regulations that the Federal Government passed were great for society, no problem, right? But when you actually look at those regulations and apply rigorous--well, from an economist point of view, benefit- cost tests, I find in my research, based on the government's own analyses, that somewhere on the order of half of the government regulations would fail benefit-cost tests. That doesn't mean we shouldn't necessarily have these regulations but it gives one pause for reflection. To help weed out such bad regulations, it's important to have key data available in a timely manner so that policies can be analyzed before they are put in place. Because you and I know, once a regulation is put in place, it often takes on a life of its own. Let me move on to my recommendations briefly because I see that I am out of time. The first and most important one I have touched on is that the data access requirements should be restricted to economically significant regulations developed by all regulatory agencies. I think targeting such regulations meets some--in some ways meets some of the scientific concerns halfway--certainly not all of them, but I think it is a useful compromise. I would also urge Congress to consider creating an agency to replicate findings for economically significant regulations so that the public has some idea of what it's getting for the expenditures associated with these regulations. To conclude, Congress and the Executive are in a position to develop a sensible rule for promoting public access to data that is based on the strengths of the Aderholt-Shelby provision. The basic approach that I advocate is to proceed incrementally. Because I believe the biggest potential gains for society lie in providing greater access to major regulatory decisions, I have suggested that the OMB rule target proposed regulations that could have substantial economic impacts. Thank you very much. Mr. Horn. Well, we thank you. You and your colleagues' statements have been very helpful to us, a clash of ideas always does work. [The prepared statement of Mr. Hahn follows:] [GRAPHIC] [TIFF OMITTED] T3673.053 [GRAPHIC] [TIFF OMITTED] T3673.054 [GRAPHIC] [TIFF OMITTED] T3673.055 [GRAPHIC] [TIFF OMITTED] T3673.056 [GRAPHIC] [TIFF OMITTED] T3673.057 [GRAPHIC] [TIFF OMITTED] T3673.058 [GRAPHIC] [TIFF OMITTED] T3673.059 [GRAPHIC] [TIFF OMITTED] T3673.060 [GRAPHIC] [TIFF OMITTED] T3673.061 [GRAPHIC] [TIFF OMITTED] T3673.062 [GRAPHIC] [TIFF OMITTED] T3673.063 Mr. Horn. I now yield 5 minutes to the gentleman from Mr. California, Mr. Ose, to begin the questioning. Mr. Ose. Thank you, Mr. Chairman. I have but a few questions. I want to make sure I understand, Congressman Holt, you support H.R. 88? Mr. Holt. Yes. I'm a cosponsor. Mr. Ose. Mr. Miller, you oppose it. Mr. Miller. I oppose it. Mr. Horn. I might tell the gentleman that the way we have set up the panels is it goes supportive, oppose. Mr. Ose. Well, I got Dr. Varmus; I understand he supported. I'm sorry, but with Mr. O'Reilly and Mr. Alberts, I didn't quite understand. Mr. Alberts. Speaking for myself, Alberts, we support H.R. 88, with the idea that Congressmen do something in a more thorough fashion to meet what I see is a problem. But we have the wrong solution. Mr. O'Reilly. Individually, as a scholar I oppose it, not for any institution but for myself. Mr. Ose. That was the substance of my questioning. Thank you, Mr. Chairman. Mr. Horn. OK. We have one question on this side? OK. The vice chairwoman of the committee, Mrs. Biggert of Illinois. Mrs. Biggert. Thank you, Mr. Chairman. Not having been through this and having been here for very long, I hope that I understand what's going on. But some of the things that I've heard--let's take for an example a study or research project on a health issue, and a study is being conducted and it has to be--the data has to be given out. And let's say we have a study where there are two groups of individuals, one is the placebo, and then the other group that's receiving the medicine. Now, could the individual go by the Freedom of Information Act and receive a list of those that are participating in the study and whether they are receiving the placebo and whether they are receiving the proposed medicine? Mr. O'Reilly. Mr. O'Reilly. The answer is no. The citation is in the Food and Drug Administration's regulations at 21 CFR 20.63 and 20.-- I think it's 113. They specifically cover that and say that the individual names, identifications and the like, in clinical studies subject to the Food and Drug Administration's powers for drugs, vaccines, and medical devices are not disclosable. Mr. Varmus. Could I comment on that? Mr. O'Reilly is much more familiar with the details of FOIA than I am; however, there are some important things that I think were not included in his answer. First of all, our complaint is not that there shouldn't be access to data. Our concern is the use of FOIA in obtaining that data. We have other ways to ensure that a study of the kind you described is exposed so everyone can see what the grounds are for recommending that a drug should or should not be used. We're concerned that in a request for data of that kind through FOIA, the university scientists, for example, who did the study under an NIH grant, would have to supply unredacted information to the agency, where the redaction would occur. That by itself does a couple of things. First of all, it changes the delicate balance between nonprofit investigators in the academic sector and the government agency. In a sense, it turns the whole enterprise into a government agency. It means that the information comes to the NIH, where we have to count on accurate redaction, which may or may not occur, because information in a computer age may not be so easily manipulated to remove all personal indicators. The very fact that the information comes centrally, in my view, will cast a pall on the public's attitude toward participation in clinical trials, because that information is going to be traveling centrally. The possible reduction in our ability to attract people into those studies and to attract investigators to work on studies supported in that way might actually have the effect of driving more and more such research into the private sector where FOIA wouldn't apply. Thank you. Mrs. Biggert. Well, I know that the Freedom of Information Act is always thought of as sacrosanct. And even in school boards or public bodies, we're always, you know, very concerned. That is a good reason. But why--what is the compelling reason, then, that this information and the data should be given before it's published by the researchers? Mr. Miller. It's not. Mr. O'Reilly. Referring to the OMB proposal, it was published research, ma'am. Mrs. Biggert. But published means after--I think that Mr. Hahn said something about that they had taken the studies then and tried to do that, and there was something about peer pressure or peer review hadn't been done yet before this data was published. Mr. Alberts. That was me. Mr. Hahn. Well, two points. One is, as Mr. Miller said, the OMB regulation applies after a publication so you would only have to share it after your first publication. The point I was making about peer review was that while it's a useful process for helping to ensure quality, it has some serious defects. And when we're spending--or we're asking companies and individuals to spend billions of dollars on regulation, we may want to apply a higher quality standard than is typically applied in the peer review process. Mr. Horn. Dr. Alberts. Mr. Alberts. Let me just be clear, the Shelby amendment says nothing about publication. The OMB draft regulations bring in publication as a contributing element. My legal counsel sitting behind me, who would be happy to talk about this, does not think that the OMB regulations will stand up in court. It will certainly be challenged. So I think it's unwise of Congress to rely on the OMB interpretation of a law that says something different than what OMB in trying to improve the law has put in their regulations. Mr. Horn. Mr. Miller. Mr. Miller. Mr. Chairman and Congresswoman, let me followup on what Dr. Hahn was saying. The flagship journal of economics, a profession we both share--is the American Economic Review. And it contains a policy admonition to its authors that says, it's in my testimony, ``It is the policy of the American Economic Review to publish papers only if the data used and the analyses are clearly and precisely documented and are readily available to any researcher for purposes of replication.'' I know from personal experience, the American Economic Review is peer reviewed. I have published twice in that journal in my career, and I can tell you my pieces were peer reviewed. But the journal, in addition to having peer review, requires that the data be made available. Let me just suggest if there is a question, Mr. Chairman, members, of whether it's published data, then maybe you can clarify that. But I would not repeal the Shelby language. Modify it, perhaps. Mr. Hahn has some suggestions that personally I could live, though they would not necessarily be my choices, but if there are problems of that sort, it would seem to me appropriate to identify those problems and direct legislation to those, rather than repealing language when requiring published data, when data is--when reports are published and agencies act on those reports for policymaking or rulemaking purposes, the underlying data be made available. Mr. Horn. Dr. Varmus. Mr. Varmus. I'm concerned that we're pursuing a red herring here with respect to peer review. We all know that peer review is important. But also clearly fallible. The scientific community feels very strongly about replication in research. It is one of the credos of the way in which we operate. We all subscribe to that. The issue here is not whether peer review is a good thing; the issue is the proper way to gain access to data and to facilitate replication of studies to establish the truth. Our concern is that the scientific enterprise in this country, an incredibly productive, flourishing pillar of our society, is not served well by the Shelby amendment. Mrs. Biggert. Thank you, Mr. Chairman. Mr. Horn. The gentleman from Wisconsin, Mr. Ryan, 5 minutes for questioning. Mr. Ryan. Thank you, Mr. Chairman. Dr. Alberts, I would like to just start with a couple questions for you. My staff has showed me one or more of your later reports from the National Research Council, which is an arm of the National Academy of Sciences. It's a report of 1985, entitled, ``Sharing Research Data.'' and that included the following recommendation from this report: that data relevant to public policy should be shared as quickly and as widely as possible. I notice that a later 1997 National Research Council report, entitled, ``Bits of Power Issues in Global Access to Scientific Data,'' recommended that, ``data derived from publicly funded research are made available with as few restrictions as possible on a non-discriminatory basis for no more than the cost of reproduction and distribution.'' All right. Given this track record and given this clear position of the NAS on this issue, what steps has the NAS taken since 1985 to seek implementation of this type of policy? For instance, during this period has the NAS submitted principles to Congress, a plan for revealing this type of data on a timely basis, as was recommended in these reports? And up until the passage of this law, I'm concerned that we haven't seen much follow-through on this policy. Mr. Alberts. I will provide to you a letter that I wrote with the other two presidents of our organization, the president of the Institute of Medicine and the president of the National Academy of Engineering, I believe was 8 months ago, was sent to all scientific societies, widely distributed, expressing our worry that the openness that we all want is not adequately being provided for now and encouraging the scientific societies to take this very seriously. So, you know, we can't--through legislation we can only argue morally. My testimony also includes a quote from a major booklet we produce, called ``On Being a Scientist.'' It's being distributed in all graduate schools. It's used as a basis of teaching the practice of science, the ethics of science to young scientists, and it explicitly talks about the obligation and importance of scientists sharing data. So we don't make legislation. We try to get our colleagues to behave in the ways that we think is best for science. And I will be happy to provide you after this session with some of these letters and publications. Mr. Ryan. Dr. Hahn, I notice that comment got a little bit of a rise out of you. Would you care to comment? Mr. Hahn. It's great to ask scientists to do things, but when it's not in their immediate self-interest to do them, you're not going to get a lot of them to change their behavior. I think it is a fundamental problem in science. In spite of the fact that we have this norm or ethic of data sharing, there is not enough of it. What I have argued is that when we're developing public policies where billions of dollars are at stake, you deserve access to data that's been validated. Mr. Alberts. Let me say I do not disagree with Mr. Hahn's testimony. I think that in these cases we have an obligation to do more. And I think Congress has a role to play here. I just think Congress needs to think carefully about how to do it so it keeps the best aspects of the scientific enterprise, along with what you're trying to accomplish, which is making sure that you have access to the data you need. Mr. Ryan. Let me ask you this, Dr. Alberts. Given that FOIA currently applies to all research conducted by the Federal Government and other sensitive personal information is already protected under FOIA, we got 30 years of case law supporting privacy of rights and those type of concerns, do you believe that, you know, given the NAS publicly declared policy dating back to 1995, do you believe that the research community needs separate and distinctly different protections, such--different from those that the Federal Government currently has--or do you think that this is sort of a double standard opposing data access when the Federal Government direct research is already subject to these types of scrutinies and given the fact that the NAS since 1985 has, you know, quote, endorsed the fact that data relevant to public policy should be shared as quickly and as widely as possible? Mr. Alberts. Of course we're talking about data that is in the public domain because things have been published. The Shelby amendment does not talk about published or unpublished information, so by implication it covers all data, whether or not you have had a chance to publish it. As I said, the OMB draft regulations tried to fix that. But I don't think that's going to stand up in court. It will certainly be challenged. So we were not talking--and anything the Academy has put out about making data available to the public before you've had a chance to analyze it, we all know-- we all grew up with this little thing about the little red hen who was growing the wheat, making the flour and then making the bread and, you know, we all believe that people should profit from their very hard efforts and have a chance to use their own ingenuity to interpret their own data without having the obligation of making that public before they've had a chance to do so. And so I want to be very clear about the fact that we would support journal policies like that. We've heard, we all want journals to require of their people who publish in their journals, access to data as the Economics Journal does, as Nature and Science does, it's the kind of things we like. It's quite different than saying your data should be available at any time, even when you haven't had a chance to publish your results. Mr. Ryan. Rush, I notice you had your hand up there. Mr. Holt. Yes. As someone who is developing an expertise in the difference between science and politics, I would like to point out that the Freedom of Information Act is intended to ensure political openness. It is a very different tool. You ask, Do we need different procedures? And I would say, indeed, yes. And I see here a real assault on the scientific progress. You know, if Dr. Alberts hadn't mentioned it, I would have mentioned the National Academy's publication which was distributed to all societies, all universities, to get to all graduate students. It actually has been quite an effective piece. Indeed, young scientists and all practicing scientists do have a real motivation toward openness. They must abide by the general rules of publication and subjecting themselves to criticism, or their work to criticism, and to replication in order to continue. So there is a very strong motivation there. The problem is we end up--well, we're going off perhaps in a red herring in publish, because the Shelby amendment that we're talking about here doesn't talk about that. But even as implemented, we end up with real questions about at what stage is it published, what are the data, when are the data preliminary? Which parts of the data, of commingled data, are preliminary? Which parts of the data are publicly funded? So I think--and furthermore the FOIA exemption to protect-- going back to what Mrs. Biggert was talking about, she was concerned about protection of privacy and protection of individual information. Mr. Ryan. Let me---- Mr. Holt. FOIA's exemption is limited, but it does not protect communities and institutions. It would allow some, let's call it reverse engineering, that really could compromise personal privacy. Mr. Ryan. Let's put this in a little bit broader perspective. Let me ask you this question. Does it bother you-- now, I understand your background, but now that we are here as public stewards and that we have in essence about $700 billion a year through regulations that are imposed on our citizens, our constituents, does it bother you that at any level of government, often issues based on scientific data have not been reviewed by the government even before they're implemented, let alone by public and other scientists? For instance--and I have to just go back to one of the cases we've been talking about quite a bit, the ozone 2.5 the PM, particulate matter standard. It's my understanding is that the EPA could not even obtain the data for review. Does this make sense? If no one else can see the data, what kind of checks and balances exists if there is a mistake in the date and the data collection? And going back to the peer review point, isn't it true that most peer reviewers do not actually review the raw data and that they don't replicate the study? Mr. Holt. Well I don't know about the ozone data you're talking about. I'm not sure how it was published. Certainly in making public policy, we should rely on tested, accepted, scientific evidence, you know. But the emphasis has to be on data available for replication of the experiment, not data available for exposure of the people involved for exposure, including the scientists involved. It's--the whole point is to maintain the scientific process here. And that's what I think is threatened. Mr. Ryan. If I could, just 1 second, Mr. Miller. I noticed that that caused a rise out of you as well. But I guess what it really comes down to are we going to seek the truth in formulating laws and public policy that affect the very lives of everyone we represent? And that's really what it's coming down to. These are valid concerns, but sometimes these concerns seems like they're going overboard and they're actually contradictory with what the scientific community really seeks to achieve. But I notice, you know, Mr. Miller you had something you wanted to say. Mr. Miller. Mr. Ryan, I want to make two points. First, in response to your comment on regulation, I have experienced both on the regulatory budget side and on the fiscal side. We really have two kinds of budgets here, two kinds of Federal expenditures: those that are accommodated through direct outlays, and those that are accommodated through impressing people in the private sector to do things differently than they would have done otherwise. And the second is the regulatory budget side. In my judgment there is far more accountability and evidence on the fiscal side than there is on the regulatory side. If anything, you want to increase the accountability on the regulatory side. H.R. 88 would reduce accountability on the regulatory side. Then, second, an anecdote. One of the articles I published in the American Economic Review was coauthored with George Douglas. It was based on a book published by the venerable Brookings Institution. At both the AER and at Brookings, we went through extensive review, peer review. Yet, when the Civil Aeronautics Board in its assessment of the effects of airline regulation replicated our study, they found some mistakes. Nothing critical, but they found some mistakes. Mr. Horn. I will have to intervene at this point because we have a vote on the floor. We'll take a 20-minute recess now and get back to the questioning, because I haven't spoken yet and Mr. Turner, the ranking member has not been here yet. So please come back. [Recess.] Mr. Horn. The subcommittee will come to order. We were in the middle of questioning the various members, and we now have the ranking member returning from the Committee on Agriculture. Did you win that battle or didn't you---- Mr. Turner. We made progress. Mr. Horn. OK. Mr. Turner from Texas will question the witnesses; 5 minutes. Mr. Turner. Thank you, Mr. Chairman. One concern that I have about the Shelby amendment is the fact that it only applies to nonprofits, hospitals, et cetera. I might ask you, Mr. O'Reilly, what do you think about the wisdom of that narrow application of the amendment? Mr. O'Reilly. It is quite appropriate since Federal contractors have already been subject to a number of FOIA lawsuits and case decisions. Grantees have been protected since Forsham in 1980, but contractor data is extensively requested and extensively disclosed in current FOIA procedure, the most recent case being June 25 in the D.C. Circuit. McDonnell Douglas was the contractor, NASA was the agency, and NASA made a decision to disclose the contractor's data regarding a space or missile project. There the commercial confidentiality interests of McDonnell were not adequately considered by NASA, and Judge Silverman for the panel held strictly to the protection of that data of the contractor, and NASA was ordered to rethink its disclosure. The contractors have for years been involved in disputes, particularly about pricing and unit pricing. It is a very arcane area called ``Reverse Freedom of Information Act'' cases. The short answer to your question is, yes, grantees have not been covered until Shelby, so Shelby fits a narrow niche which previously had been exempt from the definition of an agency record that now will be covered. Mr. Turner. What about State and local government research that would be federally funded? They would not be subject to the same disclosure requirements, would it? Mr. O'Reilly. I'm sorry. What would you think of the State---- Mr. Turner. A grant from the Federal Government to a State government would not be subject to the same disclosure as required by Shelby for nonprofit groups. Mr. O'Reilly. That is really an area--the reason that I am hesitant is there are 50 different State laws. I believe six of the States specifically talk about this in their State laws. Some of the States are well ahead of the Federal Government requiring government-funded research to be disclosed. If I were to generalize, I would say in most States because the State is not subject to the definitions in Shelby, as I understand them, the State doing the research would not be covered unless it was covered by a State law. Mr. Horn. Excuse me, if I might. Suppose there was Federal money involved with the State? In 1954, I did a study for the National Science Foundation with several colleagues on State-conducted research. It was amazing what California had in the department of health. Les Breslow--a lot of you will remember him--one of the great public health officials, and Earl Warren would simply buy people off from the Federal Government, pay them a better salary and bring them to the sunshine. So there was a lot of research going on. Wouldn't that really follow then that the FOIA would go on if there was a Federal grant, or would it? Mr. O'Reilly. I would have to do a more specific analysis. This is one of those aspects of Shelby that, as you see, the OMB is struggling with at the moment. The short answer is, I don't know, but the California Open Records Act would probably not reach it, so Shelby might. Dr. Varmus. I am concerned about one comment that Mr. O'Reilly made that would suggest that we are making a narrow cut--addressing a very narrow issue. It would seem to me the opposite is true. On the one hand, we all agree that the government should have--and the Congress should have--its best shot at evaluating the scientific data on which it is going to base regulatory changes that have major economic impact. But, in fact, the NIH alone has 30,000 grants. NIH-supported investigators are doing a variety of things with additional support from the States, support from industry, support from other governments, support from private philanthropies. All of that comes under the risk of possibly threatening, possibly irrelevant FOIA requests that are not addressed to the core issue. That is why we feel strongly that we should go back to ground zero. We should start to address the problem in a more rational way and ask what it is we are trying to solve rather than use the very broad powers that we see embedded in A-110. We recognize that OMB is attempting to narrow those powers. We also recognize there is a very strong likelihood that that restriction is going to be subject to court challenge. Mr. O'Reilly. I would like to subsequently write to the subcommittee giving a more detailed response to your question. It is a good question. [The information referred to follows:] [GRAPHIC] [TIFF OMITTED] T3673.064 [GRAPHIC] [TIFF OMITTED] T3673.065 [GRAPHIC] [TIFF OMITTED] T3673.066 [GRAPHIC] [TIFF OMITTED] T3673.067 [GRAPHIC] [TIFF OMITTED] T3673.068 [GRAPHIC] [TIFF OMITTED] T3673.069 [GRAPHIC] [TIFF OMITTED] T3673.070 Mr. O'Reilly. I also want to point out that in Texas the governmental body owns the information or has a right of access to it. It becomes a public record under 552-002, Texas statute. So Texas is even broader than California's Open Records Act. Mr. Horn. I just thought that I would round it out, 5 minutes to Mr. Turner so that he can complete the questioning. Mr. Turner. So, Mr. O'Reilly, I take it that you are saying that you don't see any problems whatsoever with the Shelby language, that is even to the extent of the vagueness of the use of the words ``all data'' and ``work produced'' and those kinds of things that some have expressed concern about? Mr. O'Reilly. I would not grade this well if this were a law school exam paper. The wording has to be sharper, and ideally one would have had much longer statutory language and a much more detailed statutory exercise. Mr. Turner. You expressed the opinion earlier that any legitimate concern from the research community could be addressed by specific exemption. I guess--first of all, do you think there is a legitimate concern being expressed here from the research community, and if so, how do you think that could be addressed by a specific exemption? Mr. O'Reilly. Yes, it is legitimate for those who have never been familiar with or affected by the Freedom of Information Act to be concerned about it. I would respond to them, with education, to say that the infrastructure is in place, the exemptions are there and the system works and it is a model around the world. So it is OK to feel worried about it; but in fact, the more you look at it, the system will work. If there is a specific research problem, perhaps something involving the joint--we heard this morning about public-private partnerships. If there is something in that area, then I certainly support what is called a B3 exemption statute, a statute specific to these joint university and private research projects. That kind of a narrow statute would be quite adequate in dealing with this problem. Mr. Turner. Do you think there is any legitimacy to the complaints that some have levied against the use of the Freedom of Information Act just as a means of discovery in lieu of a lawsuit and the discovery procedures there, but using that act for those purposes? Mr. O'Reilly. I have got about 40 pages in the book on that topic so I will spare you that detail. Yes, discovery can be augmented by the Freedom of Information Act. No, the exemptions are a better protection for the public than are discovery exceptions. Rule 26 and the other exceptions from discovery in the Federal Rules of Civil Procedure give more access to data for specific litigants under protective orders than they would get from the Freedom of Information request. Mr. Turner. I have been told that there was a situation in Georgia where a cigarette manufacturer used the State Freedom of Information Act to get the names of children involved in a research study which looked at whether Joe Camel cigarette advertisements were directed to children. Is that a legitimate use of the Freedom of Information Act or is that a misuse of it? Mr. O'Reilly. If it were, in fact, disclosed, it would be a misuse. Mr. Miller. A violation. Mr. O'Reilly. It would probably go beyond the terms of Georgia Open Records Act. I would point out that Georgia is in the 11th Circuit and that is where the Farnsworth decision that held that the names of individual women in a medical research study done by the Centers for Disease Control had to be protected so they could not be disaggregated. At least in the Federal Freedom of Information Act and the Federal discovery rules, there is adequate protection. Mr. Turner. Mr. Holt suggested, I understand while I was gone, and made the comment that seemed to me to suggest that the Freedom of Information Act originally started out trying to be sure that those of us in public office and those of us who hold administrative positions did not withhold information that rightfully belonged to the public, but that when we look at independent scientific research, there are some other interests that should be protected. Do you agree with that? Mr. O'Reilly. There are adequate protections for those interests. I would point out that the Congress, in 1996, amended the purpose of the Freedom of Information Act so that the purpose language is now allowing any private reason for access. It amended the section of the act which said that the purpose of the Freedom of Information Act is to allow public access for the public review of what government was doing and now it is, ``for any purpose.'' So the Congress has amended the act's purposes. Specific to your question, it is very, very concerning to any medical research patient that your information, your specific information might be released. I, as a person subject to government, I would be concerned about it. But the answer is (b)(6), the Freedom of Information Act exemption, has worked very well in agencies around the government and is an adequate protection. Mr. Turner. Correct me if I am wrong, but I understand that the exemption with regard to disclosure of medical files, which says that disclosure is not required if the disclosure would clearly constitute unwarranted invasion of personal privacy, that that exemption is merely permissive with the agency rather than a required exemption. Am I correct on that? Mr. O'Reilly. On its face, you are correct. But it is tied in and has been tied in by the courts to 552a, the Privacy Act. The Privacy Act protects those documents and systems of records withheld by the agency. The agency loses its discretion about those personal and medical records that are kept in what is called a ``system of records'' under the Privacy Act. Mr. Turner. You mentioned that you thought there were other requirements of disclosure that applied to private contractors as opposed to nonprofit groups and hospitals. Give me the specifics on what exemptions exist or what requirements of disclosure exist that would, in effect, as you are suggesting, sort of equalize the requirements that the law places on nonprofits and on for-profit organizations. I am not sure that I understood that the parallel had actually been reached. Mr. O'Reilly. A government contractor who is providing the agency something under a specific contract is subject to Freedom of Information requests directed at the agency, typically by competitors. And those disclosure issues have been litigated in about seven appellate cases, I believe most of them in the D.C. Circuit. Grantees, the recipients of grants, have been exempted as a result of the majority opinion in the 1980 Supreme Court case Forsham v. Califano. The Shelby amendment reverses that 1980 decision and takes the position that the dissenters held in that case. Mr. Turner. It seems to me from your comments today that, as you say, you would not grade the Shelby amendment very highly if it were a law school exam, that this committee perhaps has the obligation to address the issue and try to resolve some of the uncertainties that OMB is struggling with in order to avoid a large volume of litigation that would appear to likely flow from the confusion that now exists. Mr. O'Reilly. The new statute I was speaking of, the specific statute, would have to be framed by the committee as you observed the working of Shelby--how does Shelby work in real practice after OMB is done with it, and then what needs to be protected. Mr. Holt. Mr. Turner, if I may, Mr. O'Reilly commented about the need for perhaps additional language to clear up the problems that might be caused with a private-public mix. In fact, this gets to the heart of it. What about the private- private mix? What about the mix of data that are part of the published paper, maybe mixed with data that were not part of that publication, data that are not ready for release? We really do the public a disservice if we allow the forced release of data that are in process, a real disservice. One of the things that scares me about how this will, I expect, be implemented, it provides an opportunity for back- door regulatory reform. And we should not underestimate the intensity and tactics that will be used by interest groups, political groups, companies who might be critical of results that would run counter to their perceived political or financial interests. Mr. Horn. I am going to have to shut off this question right now so that other members can question, if I might. Five minutes to Mr. Ose of California. Mr. Ose. Thank you, Mr. Chairman. Are we on the first round or second round? Am I reclaiming my time? Thank you, Mr. Chairman. I want to go back to a comment. I don't recall who said it. Something to the effect that regulatory reform--excuse me, there might be a back door to regulatory reform by opposing H.R. 88. I am not quite sure I got that right. But my primary concern here is that I want to make sure that the provisions of this bill only apply to government agencies. Am I correct on that? It does not apply to a private-private transaction? Mr. O'Reilly. Research paid for with Federal funds in whole or in part. Mr. Ose. The concern that I have--and I think it was Congressman Holt. The concern that I have is that the research, at least in California, where we tend to lead the States in regulatory rulings, oftentimes the research that is partially done leads to regulatory rulings that are based--in other words, the research isn't done, complete, I should say. But the edict comes out and all of a sudden farmers and small business people and home gardeners are impacted. What I am trying to get to is--I am looking for some guidance here. I have no doubt that you are smarter than I am, Congressman Holt, but given the difficulty that business faces if these regulatory edicts that are based in part or in whole on uncompleted data, how do small business owners, for instance, confront that dilemma where they didn't get to the underlying data? You come to me in my business and say that you have to do X, Y, and Z because we think this is an impact. I say to you, show me your data. All of a sudden, you say, I can't. Tell me how to get out of that dilemma. Mr. Holt. Mr. Ose, yes, I did use that phrase, back-door regulatory reform. First of all, I don't pretend to be smarter than any of you up there on the panel. Mr. Ose. I know you. You are smarter than I am. Mr. Holt. I have a somewhat of a different background. I do think that the disclosure of undigested partial data can create real problems and a real opportunity for disruption of the process, and as I mentioned earlier, harassment. You pointed out, as Mr. Ryan pointed out, a real problem of public policy if regulations are based on inappropriate or undigested or wrong scientific information or preliminary scientific information. But this should not be a fix for that. Certainly we want regulations promulgated following laws that we enact to be based on the best accepted understanding of relevant science. But this is something else. This is not a fix for that. And I will repeat what I said earlier, the Freedom of Information Act, even as amended, is intended for political openness. That is the intention of the bill. That is why--of that law. That is why it exists. We are talking about something else here. We are talking about scientific process. Mr. Ose. I appreciate your humility, but I know that you are smarter than me, first of all. Mr. Horn. Would the gentleman yield to me while you are figuring out who is smarter? I am just a country boy and I have to listen to all of this. I want to ask one question. How many of you were here in 1993 and 1994 in this town? You might remember this. In this room we, on a bipartisan basis, voted to elevate the Environmental Protection Agency to Cabinet status and the so-called Thurman--Democrat from Florida--Mica--Republican from Florida--addition was made to that. We had a majority. The majority in brief on this bipartisan Thurman-Mica, Mica-Thurman--two common-sense people, I might add, that are in my class, very fine legislators--they put in language that we would have to have unbiased science. The then-Democratic leader refused to bring the matter to the floor. He is still now the Democratic leader. But the fact is, what we are getting down to is the values that go behind social science research and policy research. This is not necessarily what you find in the chemical- biological-engineering areas, although we have had fraud at the highest levels, and a few handfuls of people that are just with the greed that comes with trying to get the Nobel Prize and all of the rest of it. Their colleagues caught them at that. That is what the whole replication process is in science. Now, when you get down to social science, and I am a political scientist; although my daughter, when asked at age 2 what her daddy did, she put her hands on her hips and said, he is a pitiful scientist. I come to you as a pitiful scientist, but I started my life in education for 30 years as a dean of research. So I have an interest in this. But when you get to social science matters, be it the Democrats sitting here or the Republicans sitting here, they can say, hey, was there some bias in this? They have already reached the conclusion rather than analyzed the problem. That is an understandable thing that people in public life would do. They want to know, hey, who are these people? Have they ever had any work in this area? Do they know anything about it, or just have axes to grind? A lot do on both sides. So it seems to me that is part of the motive of the Shelby amendment, to get it out on the table in terms of what are the values and what are they leading to, based on the values. Once you get a value set in there, hey, we can all predict the outcome. It doesn't take too many brains to figure that out, if you guys are still talking about brains. Anyhow, as I listen and think about it, over the last few years we have had a lot of unhappiness by members in both parties and the factions in both parties, depending on what comes out of that study that is used against them in a public policy debate. I think basically we have to face up to that--as to that. Now, in facing up to that, which I think is what probably motivates some of our colleagues, we don't want to have a problem where we hurt ``science,'' in America--medical science, health science, engineering science, and so forth. So maybe the exemption route is one way. I would like to hear comments from you. We are not going to close this record for a while. Feel free to write us. We will put it in the record at this point, without objection. But I would appreciate any wisdom that you have of my memory of the 1993-1994 argument. That is what it was all about. Nobody trusted the data that EPA was bringing in. If we were going to give it Cabinet status, we didn't want to have that continue. As I say, in this room Mr. Conyers was presiding, the Mica- Thurman, Thurman-Mica amendment was part of it. The result was that was the last that we ever saw of it. It is sitting somewhere over in the Capitol. Any wisdom that anybody has on this, the physical scientists and the social scientists? Dr. Varmus. Dr. Varmus. I agree with your notion that this needs to be narrowed. Watching my colleagues at OMB trying to write a narrowing of the proposal suggests how difficult it is to start from a flawed instrument and design a sharp tool that gets what you all desire--that is, public policy based on the best available evidence. That is why I support Representative Brown's proposal. I think we should start again. We recognize it as a problem, and we should have an open discussion of the best way to get at the relevant information in a way that serves public policy. Mr. Horn. Does anybody else want to comment on this? Mr. Miller. Mr. Miller. Well, if you start with the basic premise that the taxpayer pays for the information, it is theirs. You have to have a compelling reason to deny them access to that information. If need be, you might have some clarification that it refers only to published data, that it is data that is used as the basis for policymaking and for rulemaking. But to echo your concerns, Mr. Chairman, I think it is outrageous for an agency to be able to promulgate regulations in which they simply say, ``Trust me, we have a study that supports our point of view.'' That is so inconsistent with the goals established for open, accountable government, administrative procedures, and so forth. There also is a danger of delay, delay, delay. Obviously, the Shelby-Aderholt language has brought this issue to a head. If you were to back off now, my suspicion is that nothing would be done. Mr. Horn. Let me just say, if I might, Dr. Alberts, you have a lot of experience. We ask you for a lot of studies. We have asked you to do a number of studies, et cetera. How do you guard against the biases that can occur in social science research going back to 1863 or 1864 when you started? Mr. Alberts. In the early days, we weren't asked to do much of importance. Now we publish something like 200 reports a year, most of them for government. The studies are an art form. The first thing we do is set up a committee that contains a wide spectrum of expertise, people with opinions on both sides of the issue. And it is very important to that sort of a committee that brings in everybody's point of view. At the same time, we don't want anybody on the committee who is a public advocate for a position because they can't act as a scientist. They have to be paying attention to their political constituencies. So we limit the extremes of viewpoints to people who say in initial bias discussions that they are free to act as individuals and make their own judgments. I think we often succeed in getting people with quite diverse viewpoints to come to consensus views. That was the case of my human genome study where we started with two people who sat on opposite sides of the issue; either it was crazy or it was so obvious that we shouldn't even have a meeting. In the end, everybody agreed. The committee has to educate itself by bringing in all possible outside expertise. Then, after we have the report, we send it out to anonymous review. Now, the names of all the reviewers, as you know, are published along with the report, but not the opinions. I think there is a lot to be said for the kind of thing that Mr. Hahn was talking about, when you have legislation with great consequences based on a scientific set of findings that would be very serious about reviewing the science that underlines that regulation. I am very sympathetic to that point of view. I think Congress needs to do something about that. I don't think we are set up now to do that adequately. I do agree with my colleague, Dr. Varmus, that this very hastily written legislation, which has not had the benefit of any hearing or any normal process of Congress, is not the right way to do it. We have talked here about two different things in fact. We talked about the OMB regulations as if that is the law. But, in fact, the law is the Shelby amendment which, as I have said repeatedly, says nothing about publication, for example; and is, in my mind, fatally flawed. Congress needs to do something. I don't want this to all be settled in law courts. I think that is a waste of everybody's time. Mr. Horn. Let me just suggest, as I did a little earlier, that both Democratic and Republican staff will get together a series of questions; if we might send them to you--and we appreciate your thoughtfulness--just give us your best advice. Now, I want to finish out the panel for Mr. Ose; are you done? Ms. Biggert, the vice chair, how about it, do you want to let Mr. Ryan go ahead of you? Mrs. Biggert. Just one question. I'm sorry I had to leave. It might have been asked or not. When you were discussing the different exceptions or the different laws that would apply whether this data was supposed to be made public, who then is going--who decides? Is there anybody overall since this goes to many different agencies? Probably Mr. O'Reilly again. Mr. O'Reilly. The mechanics are relatively straightforward. The agency has a Freedom of Information office. Its people are career professionals, many of them with a science background in those scientific agencies. They receive the documents, screen them, and apply the agency's guidelines for personal medical information to be deleted, for aggregatable or disaggregatable information to be identified for commercial or proprietary claims. Then they use the Executive Order 12600 process to determine whether the information has a real commercial value, has been marked as such. They provide notice for making a disclosure of commercially valuable information. Then they make the decision, which is reviewed typically by the head of the staff of Freedom of Information officers in that agency. If the agency has a question, it will contact the person who made the submission, in this case, the researcher. The researcher has rights in some situations to appeal within the agency or have a discussion within the agency. In the ultimate case if there are so-called ``reverse'' Freedom of Information lawsuits, such as the McDonnell Douglas case of June 25, 1989, in which the agency can't agree with the company, in that case a government contractor, those mechanics are relatively simple. How it plays out, of course, depends on the quality, the resources and the staffing of each individual agency. Dr. Varmus. If I could make just one amendment to that. In attempts to solve a problem that you, Mr. Horn, have described very nicely for us, we are putting at risk the proper execution of all of these privacy provisions in enormous amounts of research information. The country is doing a tremendous amount of research in a wide range of fields, some of which includes very sensitive information--confidential information, proprietary information, private medical records--all of which is, in general, irrelevant to the major concern that Mr. Horn has described. We are opening the door to the possibility that in obtaining information from grantees, agencies get the information and could share it with other agencies. Depending upon people centrally in government to properly redact those records, you change the entire environment in which this very successful enterprise of federally funded research at our universities is carried out. Mrs. Biggert. Thank you. Thank you, Mr. Chairman. Mr. Horn. I yield now 5 minutes to the gentleman from Wisconsin, Mr. Ryan. Mr. Ryan. Thank you, Mr. Chairman. This has been a very enlightening panel. It's been a great discussion. A couple of issues have been coming up repeatedly that I would like to go at a little bit; that is, the published-- waiting until the data is published and the release of information data before the work is finished. I was hoping Mr. Holt would be here because he mentioned this quite a few times. Dr. Varmus, let me ask you. Right now, as it stands--and I just do not know the answer to this question--under current studies funded by the government or current government studies, is it--are researchers required to release the data before the work is finished? Dr. Varmus. Under the law that Mr. Shelby has proposed, that would be a requirement. OMB is trying to frame the regulations in such a way that would protect investigators from that kind of intrusion. As you have heard before, some are concerned that this is going to end up in court challenges to the OMB revision, and I don't know where it is going to come out. Mr. Ryan. If I recall from other testimony, the Shelby amendment didn't speak specifically to that issue. Dr. Varmus. It says data, all data. All data, of course, would include data obtained with Federal funds prior to or after publication. Mr. Miller. My understanding is, the Shelby language is an admonition in an appropriations bill for the OMB to do certain things. It does not establish a predicate for private litigation. Mr. Ryan. That is what I am trying to get at. It seems to me, it is an overreaching comment to suggest that this Shelby language in the bill does require the release of data before a work is completed. OMB is in charge of promulgating the regulation so that it is a workable piece of legislation. As somebody just said, they are going to promulgate this regulation so that it doesn't require the release of data before the work is actually completed. Dr. Varmus. That is one aspect of it, and there are many aspects of what the regulation has to achieve that I think present more problems, as in the issue of publication versus nonpublication. Mr. O'Reilly. I agree with your comment that this is not a self-implementing piece of legislation. This is a direct delegation to an expert administrative agency. In those circumstances, the agency, in this case OMB, would receive much more deference. Mr. Ryan. So OMB has more latitude to craft that---- Mr. O'Reilly. In the context of the Shelby amendment, yes. Mr. Ryan. On the published part, some testimony seemed--I just wanted to get at this a little bit more. There was concern that data would be released after a study is completed, but before a study is published. I noted some of the concern would be, fine, if you released it after it is published. But if you look back over years of data where work has been completed, but years have elapsed between the completion of work and the publishing of that work--and I think it is important to note the consequences of that kind of a system where you have years elapsing between it. I just had to go back to the National Cancer Institute's atomic fallout study. We just researched this in Congress last year, but we noticed the National Cancer Institute failed to publish a study that tracked the fallout from approximately 100 above-ground explosions in Nevada between 1951 and 1962. This study at the NCI suggested up to 75,000 additional thyroid cancers might result from these tests, mainly in young children exposed at the time. The study was drafted in 1992, so the study was completed in 1992, suggesting that there would possibly be an additional 75,000 cases of thyroid cancer for young children directly accountable to this testing; however, the study wasn't published until July 1997. This was only after substantial media hype and congressional oversight. There are literally lives at stake when we move the threshold to ``don't release the data until it has been published.'' if the data has been finished and you wait until it is published, you can see the types of consequences. I am from Wisconsin. In Wisconsin we had a study--I think it was Dr. White, if I recall, who did a study of our school choice program in Milwaukee. His study concluded, according to his results, that school choice didn't work. From his analysis, he concluded that it brought higher levels of parental involvement and satisfaction, but actually no academic gains. From 1990 to 1995, school choice opponents used that study quite extensively to defeat the school choice arguments. But upon review in 1996 by professors at Harvard and Princeton, they looked at his data and found from his data that the results were quite the opposite, that academic standards and performance actually increased. So we have found that substantial public policy has been on the line between the elapsed publish of the study and the completion of work and the ability to research the data. So it just seems to me kind of a specious argument to say, let's wait until this stuff is published, because if there is so much time between the publishing of the study and the actual completion of the work, you can see the dire consequences that are involved here. I would just like each of you to comment about that, if you think that we should wait until it is all published. Mr. Hahn. I think that you touch on an important issue, Congressman Ryan. Clearly most of us are researchers on this panel. We would be reluctant for a variety of reasons to share our data before a publication. One reason might be that the data set isn't clean. A second reason is, that we would like to get credit for our findings--for example, if we are interested in getting tenure. I think you have to strike a balance. But I also think that you need to ask yourself the following question as the legislators of the land. Do you want to be in the position of passing regulations or having the agencies that you oversee enact regulations costing hundreds of billions of dollars without exposing them to sunshine? That is why I had argued that in those cases it is absolutely imperative if the regulatory agency relies on a central study, like the Harvard study, that was one of the motivations for this hearing, that the data be made public if it is going to be relied on for the regulation. Mr. Ryan. I think this is getting closer to the heart of the issue, which is I clearly understand why the scientific researcher doesn't want it released until after the work is completed, but before it's published for those reasons you just outlined. That is eminently reasonable and within the self- interest of that individual. But those of us who have to conduct policy and those of us who have to watch out for the concerns of our constituents when we are evaluating promulgation of sweeping regulations have to look at that higher cost, have to look at that broader impact on the entire country. I think that is where these two goals clash. When you examine it in that light, clearly the higher priority should rest with the benefits to the public as a whole rather than that narrow self-interest. Dr. Varmus. I am not trying to hide behind this notion of publication. It is not a Holy Grail. In fact, the attempt to modify the Shelby amendment with the term ``publication'' is one that we at the NIH have criticized in dealing with OMB because the word ``publication'' itself means many different things. Scientists use websites, they give talks; there are many ways to make data public. The real issue is whether scientists have had a chance to look at the data. We don't want to confuse this with a failure to publish the radioactivity study, which we acknowledge should have appeared more quickly instead we should recognize the difficulty that we are having in trying to come to terms with an appropriate solution to a problem that I think we all agree about--that public policy should be based on the best available data that should be interpreted as best as possible without making a very broad threat to the entire scientific enterprise. Mr. Ryan. Let me ask you this, Dr. Varmus. I will just ask you an open-ended question. It sounds like everybody is pursuing the same goal albeit we have different routes. I agree with you, Mr. Miller, we wouldn't be here if this law hadn't passed; we wouldn't be moving on this if it hadn't passed. The NAS published a study in 1985 suggesting they wanted this to happen, but it is 1999. So it is a good thing that we are here talking about this. How would you craft data---- Mr. Horn. This will be the last question. Just answer that question and we will move on. Mr. Ryan. Thank you, Mr. Chairman. Dr. Varmus. I wouldn't presume to have an answer to a very difficult question like that, but I do think that some of us here and Members of Congress could, through a series of hearings like this one, come up with some ideas. In our own work at the NIH, for example, we have data- sharing policies that we use to guide our grantees, who then deposit all of their genomic sequence in a publicly available data base. They deposit their crystallographic information from protein structure studies in the public domain. It is publicly accessible. We have many other means, for example, to allow independent bodies to examine clinical trials information in a way that preserves confidentiality, builds confidence in the results, and allows us to alert physicians if a study is developing a conclusion that forms the basis for a public policy about health care. So there are ways to do it, but they should be ways that are appropriate to the kinds of solutions we are trying to achieve and not the kind of broad, potentially damaging law that is represented by the Shelby amendment. Mr. Ryan. It sounds like Mr. O'Reilly sort of answered that question, suggesting that the OMB does have a good degree of latitude in promulgating the regulation and that we are probably going down the right path already. I notice that my time has expired. I thank you, Mr. Chairman, for extending me great latitude. Mr. Horn. I would just ask the ranking member, Mr. Turner, if he has a few questions and then we will move to the second panel. Mr. Turner. Thank you, Mr. Chairman. I know we need to move along. We have had this panel before us for an extended period now. I guess after hearing all of you, I am left with the opinion that we do need to provide some mechanism to ensure that when there is research done with Federal dollars, at the time that research enters the public domain that the public has access to all of the underlying data it collects to support the conclusions of that research. I think that can be done and I think the assistance that each of you could give us would allow us to reach that goal. I personally think it is probably a responsibility that the Congress ought to take, rather than simply allowing it to be done by an administrative agency at the OMB. So with that, Mr. Chairman, this has been a very informative and helpful panel. Mr. Horn. I agree with my colleague. I wish that we could have another hour or two, because we have a lot of expertise this morning. We are going to have to get it down to writing, however, just to get the focus. Without objection, those responses would be put at this point in the record. Thank you for coming on short notice. You have really been an excellent panel. We don't always get that. I think we are going to get it also with the second panel. Would the second panel come forward, the university panel. We have Mr. Kovacs, Mr. Shelton, Mr. Obadal, Mr. Thurston, Mr. Gough, Mr. Bass. Gentlemen, I think you know, if you stand up and raise your right hands. If there is anybody advising you that is going to get into the record, please get them to stand up. [Witnesses sworn.] Mr. Horn. We have eight. The clerk will make sure that we have the names of all eight that have taken the oath. So we will start with Mr. William Kovacs, the vice president, Environmental and Regulatory Affairs for the U.S. Chamber of Commerce. Mr. Kovacs. STATEMENTS OF WILLIAM L. KOVACS, VICE PRESIDENT, ENVIRONMENT AND REGULATORY AFFAIRS, U.S. CHAMBER OF COMMERCE; DR. ROBERT SHELTON, VICE PROVOST FOR RESEARCH, UNIVERSITY OF CALIFORNIA AND ASSOCIATION OF AMERICAN UNIVERSITIES, NATIONAL ASSOCIATION OF STATE UNIVERSITIES AND LAND GRANT COLLEGES; ANTHONY OBADAL, WASHINGTON COUNSEL, ASSOCIATION OF EQUIPMENT DISTRIBUTORS; DR. GEORGE D. THURSTON, ASSOCIATE PROFESSOR, ENVIRONMENTAL MEDICINE, NEW YORK UNIVERSITY; MICHAEL GOUGH, ADJUNCT SCHOLAR, THE CATO INSTITUTE; AND DR. GARY D. BASS, EXECUTIVE DIRECTOR, OMB WATCH Mr. Kovacs. Thank you, Mr. Chairman. It is an honor to be here today to discuss this very significant regulatory reform issue, access to government funded information. The U.S. Chamber opposes H.R. 88, which would attempt to repeal the Shelby amendment. We have heard a lot of theoretical discussion today. I am probably going to put my comments more in terms of a practical setting. The Shelby amendment is a practical and reasonable extension of Federal law. Under Circular A-110, the Federal Government has the right to all of the data that is produced under government funded studies upon its first production. This data could be obtained by the Federal agencies today. Federal agencies have used their discretion not to obtain the data and, therefore, the practical need for the Shelby amendment, is that this information has been denied to the American public. Mr. O'Reilly made an excellent presentation of why FOIA is an appropriate mechanism. It has been around for 34 years. It is not only geared to providing information, but to protecting information. It incorporates numerous Federal statutes from technology transfer acts to the patent act to the copyright act. These protections are all incorporated into Circular A- 110. There is a long history on this issue. But the reason that the Chamber is here, I think was highlighted a little by Congressman Holt when he said that FOIA is a document about political openness. This is really the Chamber's position. When you look at the rules and regulations that we have in this country, a lot of these rules--and we refer to NAAQS, but that is not the only one--use this data to justify the imposition of regulations on business. Those regulations are the same as laws, but let's look at how many regulations there are. Every year the U.S. Federal Government through its agencies implements 4,000 regulations consisting of over 65,000 pages of text. The cost of these regulations, I believe it was Congressman Ose or Congressman Ryan who mentioned it, is $700 billion. Last year it was estimated to be $737 billion. This estimate is based on a Competitive Enterprise Study, ``The 10,000 Commandments,'' I had an intern add up all of the regulatory costs from 1977 to 1998. The cost totaled $14.2 trillion. This information puts the Shelby amendment in perspective. The cost of regulations is literally three times more than all of the corporate taxes paid in the United States on an annual basis. It equals all of the taxes that are paid by individuals in the United States and exceeds all of the corporate profits paid by all of the companies in the United States by $100 billion. Moreover, it has an effect on small business where the cost of regulation on a small company, 20 employees or less, is literally twice as high on large companies. So when you ask why we are concerned about this data, our concern is simply that it this is used to regulate business. As Mr. Hahn said, from Brookings, 50 percent of the regulations wouldn't pass a cost-benefit analysis. We are not sitting here saying that it is cost-benefit, but resources are precious. If we are going to spend $1 on a regulation that doesn't have an important effect, then we are not spending $1 on something that does have an important health effect. That is really crucial. The reason why the private sector is so concerned about the Shelby provision is that there is really no way to check on the Federal regulatory agencies. They have unbridled discretion. If agencies don't ask for the documents, the private sector has no way of getting them from the record. Several years ago Congress passed the Congressional Review Act, and it was to get regulations before they became effective so that it could review them. Since that time, 8,600 regulations have been sent to Congress, and in not one instance has Congress sent a regulation to the floor for a vote. The private sector, the regulated community, along with the State and local governments, are really the only checks that are left on these regulators, other than congressional oversight. So without getting into the issues of transparency in government or democracy, a lot of the issues that we raise and you made in your opening statement on Madison, are in the record. I want to make two final points. One is that the data access actually strengthens--and I want to underline the word ``strengthens''--the underpinnings of the regulatory process. And at the same time, the failure to provide data undercuts the underpinnings in the regulatory process. The NAAQS regulation is the best example. We could talk about a horror story where Carol Browner came here and talked about the number of lives saved, but she never released the data. She flip-flopped from $5 billion in cost and 40,000 in lives saved to $50 billion in cost and 10,000 lives saved. But no one has ever seen the life. The day after the D.C. Circuit ruled, the next day, another panel said, well, the same data was used in the NAAQS rulemaking so we are going to stay that case. We have done an analysis of 11 other rules of the agency. Every one of the rules that relies on the same data that the NAAQS standard relied on is now at risk. EPA has literally gutted its own regulatory program, which is really significant. My final point is that OMB really is the appropriate mechanism, not Congress. There were 9,200 comments. It is not that the comments came out 55 percent in favor of the Shelby amendment or 37 percent opposed to the Shelby amendment. What is crucial is that 55 percent of the comments were from individuals without a business organization or a business affiliation; 36 percent came from researchers of higher education. That means 91 percent of the 9,200 comments came from individuals. That is an incredible statement. If we are trying to involve people in democracy, this is what is going to do it because they want to know what is the basis for being regulated. We are strongly opposed to it. I guess that I want to end with a quote from one of those thousands of individuals. We don't know him and we are going to try to find out where he came from. The example follows the example Congressman Ose used where if you are a small business and a regulator walks in and says, here is your regulation, you have got to follow this, and the business owner says, give me your data. Mr. Long stated the following. He said, ``When I play poker, I am required to show my hand before I claim the pot. Bureaucrats should be held to the same standard.'' That is really all we are talking about. Tell us why we are being regulated so that we can begin to understand how we are governed. Thank you very much. [The prepared statement of Mr. Kovacs follows:] [GRAPHIC] [TIFF OMITTED] T3673.071 [GRAPHIC] [TIFF OMITTED] T3673.072 [GRAPHIC] [TIFF OMITTED] T3673.073 [GRAPHIC] [TIFF OMITTED] T3673.074 [GRAPHIC] [TIFF OMITTED] T3673.075 [GRAPHIC] [TIFF OMITTED] T3673.076 [GRAPHIC] [TIFF OMITTED] T3673.077 [GRAPHIC] [TIFF OMITTED] T3673.078 [GRAPHIC] [TIFF OMITTED] T3673.079 [GRAPHIC] [TIFF OMITTED] T3673.080 [GRAPHIC] [TIFF OMITTED] T3673.081 [GRAPHIC] [TIFF OMITTED] T3673.082 [GRAPHIC] [TIFF OMITTED] T3673.083 [GRAPHIC] [TIFF OMITTED] T3673.084 [GRAPHIC] [TIFF OMITTED] T3673.085 [GRAPHIC] [TIFF OMITTED] T3673.086 [GRAPHIC] [TIFF OMITTED] T3673.087 Mr. Horn. Thank you very much. I will use that analogy around here on a number of things. I now yield to my colleague, Mr. Ose from California, who is going to introduce our next witness. Mr. Ose. Thank you, Mr. Chairman. I am pleased today to have the opportunity or briefly to sit here and hear this testimony. One of those who has joined us today is Dr. Robert Shelton from the premier University of California at Davis, who also happens to be the vice provost in charge of research for the entire UC system. He is here to provide testimony, and we are certainly appreciative of him coming. Dr. Shelton is just one of the many examples of the fine upstanding people working and living in the Third Congressional District of California. He is a physicist---- Mr. Shelton. That's correct. Mr. Ose. As Congressman Holt is, I am sure he is smarter than I am, so I am looking forward to his testimony. Mr. Shelton. That is a topic that I will not get into. Thank you very much, Congressman Ose. Mr. Chairman, members of the subcommittee, I really appreciate the opportunity to talk about one university's perspective on H.R. 88 and, in particular, the use of FOIA to provide public access to research data. I have the honor of testifying today on behalf of the University of California, as you have heard, and I am also pleased to testify on behalf of the interests of NASULGC, an association of 203 public universities, and the AAU, which consists of the 62 leading North American research universities. What I will do is briefly summarize my written statement with some very specific examples from our professional experience at the University of California. We have three basic points that I want to make. First, the University of California supports H.R. 88 and we do so because, in our opinion, it is not meant to stop efforts to improve access to federally funded research. Rather, it is needed to ensure that these efforts do so in a careful and considered manner rather than in the context of rulemaking with a predetermined outcome. Second, I want to make clear, as you heard earlier, that universities do not oppose access to federally funded research data. Indeed, the University of California, like others, has policies that emphasize the criticality of publication by researchers and discourage limits on publication. It is anathema to our faculty, to our students, to our research staff to engage in research with restrictions on publication. Third, we applaud the use of scientific data in Federal policy rulemaking. We believe it is in the public interest that this process be open and informed. Our concern is that the use of FOIA as a mechanism for data access presents some serious potential problems. Let me try to be specific on that point from the perspective and experience of somebody in the University of California. First, the extension of FOIA to research data will provide an avenue to dissuade research on controversial issues. We heard earlier about some issues with animal rights. We certainly have a number of campaigns of harassment targeted at individual researchers involved in animal rights research, involved in tobacco research, involved in AIDS research. At the present, our campuses are able to moderate these situations and work with the requesters to limit the potential disruption through a negotiated process that would not exist under FOIA. Second, the extension of FOIA to research data may have inadvertent consequences for the university's ability to patent research discoveries. As you are aware, premature disclosure of research results can make it impossible to meet the stringent requirements for obtaining a patent. This is particularly true when you are talking about foreign patents and has implications for our global competitiveness for many of our cutting-edge research-based industries, not just in California but throughout the Nation. Third, the extension of FOIA on the research data may compromise university research partnerships with industry. While FOIA has an exemption for commercially valuable proprietary information, there is case law that suggests that this exemption may not cover information in the possession of not-for-profit institutions like the University of California. In the last decade, there has been an increasing number of cases where researchers working with data on a project sponsored by a Federal agency and by a private sector sponsor-- in fact, many of the programs initiated here through Congress and with the Federal agencies have encouraged such interactions as a way to get research results into the practical arena for the use by the public. I can tell you from personal experience in negotiating such contracts, there is an extreme sensitivity on the part of industry to intellectual property rights and to the privacy of those materials that they provide in these collaborations. Fourth, the extension of FOIA to research data may compromise human subject confidentiality. I won't say anything more about that because it's in my testimony and much was made of that by the earlier panel who have more experience than I do. Finally, we're concerned that the proposed revision could increase the costs to the universities, but I think this is a tertiary consideration. What we now face is the question of how to balance these substantive concerns with the needs for openness and research. I would respectfully suggest that Congress may wish to look at the safeguards provided in the California public records act and other State sunshine laws when dealing with legislation on data access. As a California public university, we are subject to this act which provides the mechanism for release of university records upon public request. Unlike FOIA, the Public Records Act provides important safeguards for the university in handling information. It enables us and other State agencies to reach a balance in determining whether public interest is best served by the release of the data. Perhaps critically it allows us, California, the University of California or the State agency, to negotiate directly with the requesting parties, as opposed to turning all of the data over to the agency that funded part of the work. In conclusion, the research partnership between the Federal Government and university serves the Nation in important ways. The direct investment in university-based research promotes the discovery of knowledge, it stimulates technical innovation, it educates our next generation and contributes directly to the Nation's economic prosperity and quality of life. We urge you to pass H.R. 88 and repeal the FOIA provision, not to bring to an end this discussion but in fact to allow it to take place in a considered legislative forum. We offer our assistance to the authorizing committees and OMB to begin a thoughtful process to review the practices, and I look forward to the question and answer period. Thank you very much. Mr. Horn. Thank you. [The prepared statement of Mr. Shelton follows:] [GRAPHIC] [TIFF OMITTED] T3673.088 [GRAPHIC] [TIFF OMITTED] T3673.089 [GRAPHIC] [TIFF OMITTED] T3673.090 [GRAPHIC] [TIFF OMITTED] T3673.091 [GRAPHIC] [TIFF OMITTED] T3673.092 [GRAPHIC] [TIFF OMITTED] T3673.093 [GRAPHIC] [TIFF OMITTED] T3673.094 [GRAPHIC] [TIFF OMITTED] T3673.095 [GRAPHIC] [TIFF OMITTED] T3673.096 [GRAPHIC] [TIFF OMITTED] T3673.097 [GRAPHIC] [TIFF OMITTED] T3673.098 Mr. Horn. And we're delighted to have Mr. Anthony Obadal, the Washington Council of the Associated Equipment Distributors. Mr. Obadal. Mr. Obadal. Thank you, Mr. Chairman. I am truly privileged to appear before this committee, and I want to thank you for the invitation. Mr. Horn. Now, remember you're under oath. Don't go too far. Mr. Obadal. And also the staff as well. I am--our statement contains not only the viewpoint of the Associated Equipment Distributors but also of the major private sector associations and unions engaged in the construction industry. We all belong to a group called the Transportation Construction Coalition, and that is a coalition of roughly 27 associations and three unions. We are united in our opposition to any attempt to repeal or delay the Shelby amendment. Our organizations support very strongly the principles of open government. We agree with Justices Marshall and Brennan in Forsham when they wrote that providing access to information enables an electorate to govern itself and that the openness required by the FOIA is ``vital to the proper operations of democracy.'' The Shelby amendment was generated by the refusal of the Environmental Protection Agency to make available--even though it possessed the power to obtain the data, it refused to do so. They prevented us from looking at the clean air standard regulations and the supporting documents and data that underlined it. Really, hundreds of communities have been affected by this regulation. We saw one estimate that there were 167 counties in 42 States which would be unable---- Mr. Horn. Would you repeat that sentence again--167? Mr. Obadal. 167 counties and in 42 states that would be unable to comply with EPA's new regulations. Reference has been made to the fact that the regulations already have been subject to some doubt because of the errors in estimating the health benefits and lives affected that was made by EPA when they considered these regulations. They were roughly I think 25 percent off in their estimates. It's not the amount. Every life is important. We all recognize that. It's the error. We think we're lucky to catch that error. What other errors exist in the underlying data that has not been subject to critical review by parties who were directly interested in it? Is it too much to ask that, as citizens, we be allowed to examine and criticize alleged facts and theories that underline governmental regulations? We think not. And we think there is agreement on this panel. I listened to the excellent questions this morning and the wonderful answers. I think everybody recognizes that this is an extremely important area to look at. Shelby has done a great service in closing this loophole. Marshall's--Brennan, Justice Marshall and Brennan predicted that if this loophole back in 1980 were allowed to exist, a bureaucracy desiring to keep its deliberations secret would begin to use outside sources ad nauseum to justify their decisions. And no one would be able to really criticize those sources. We are also concerned that the ozone mistake was not unique. For example, the Office of Research Integrity of the Public Health Service recently published a report describing its investigation of scientific misconduct between 1993 and 1997. The report focused on 150 cases. In half of them, misconduct was found involving falsification and involving fabrications of the data. The New York Times recently reported on a for-profit California research company that was engaged in over 170 studies. The investigation turned up the fact that there were fictitious patients, there were fabricated observations, there were substitution of blood and urine samples. In fact, blood and urine samples were kept in the refrigerator in the office and used as substitution. We think critical public review will help uncover this and will result not only in better regulation but better science. Now, most of the objections to Shelby concern the fear that the FIA provide--FOIA provides inadequate protection in matters of privacy and intellectual property. I think that was really dealt with extensively this morning. I would only point out that, with respect to privacy, the courts under the decisions cited in our statement to you engage in a balancing in which they can balance the individual's right of privacy against the preservation of the basic purposes of the Freedom of Information Act which is to open agency action to the light of public scrutiny. So what you're dealing with is a rule that decides these issues on a case-by-case basis. I very frankly think that that is the best kind of rule, because these issues are far too complex to provide simply a rigid standard. Justice requires looking at each individual case, and that's what we do. Last, the concern about researchers being beat to the publication table by someone who gets their data early, I think that's a very valid concern. However, I think that the Shelby amendment provides sufficient discretion in the OMB to deal with it and they have tried to with the word ``publish'' that they're using. Shelby, I notice there was some comment that there was no basis for the OMB latching onto that. I don't think that's correct. To the contrary. Shelby uses the word produce. All data produced under an award. What does that word mean? Well, when you take a look at Webster's and in Oxford and in Black's Law dictionary and start looking at cases, you mean--it means bringing forth for scrutiny, bringing forth for review. I think until those--the report is brought forth, that the documents can be kept secret. I know I'm running over my time. But I wanted to thank this committee. Mr. Horn. Thank you. We appreciate it. [The prepared statement of Mr. Obadal follows:] [GRAPHIC] [TIFF OMITTED] T3673.099 [GRAPHIC] [TIFF OMITTED] T3673.100 [GRAPHIC] [TIFF OMITTED] T3673.101 [GRAPHIC] [TIFF OMITTED] T3673.102 [GRAPHIC] [TIFF OMITTED] T3673.103 [GRAPHIC] [TIFF OMITTED] T3673.104 [GRAPHIC] [TIFF OMITTED] T3673.105 [GRAPHIC] [TIFF OMITTED] T3673.106 [GRAPHIC] [TIFF OMITTED] T3673.107 [GRAPHIC] [TIFF OMITTED] T3673.108 [GRAPHIC] [TIFF OMITTED] T3673.109 [GRAPHIC] [TIFF OMITTED] T3673.110 [GRAPHIC] [TIFF OMITTED] T3673.111 [GRAPHIC] [TIFF OMITTED] T3673.112 Mr. Horn. Dr. Thurston. Dr. George D. Thurston is associate professor, Environmental Medicine, New York University. Glad to have you here. Mr. Thurston. Thank you. I'm here today to discuss the many negative consequences of the recent changes made to Circular A-110 provisions regarding the mandated release of government-funded research data. The Shelby amendments are insidious in that they seem at first glance to be in the public's interest, but they are not. The amendment's stated goal is to make all data from federally funded scientific research readily available to the public, but this new provision will instead most likely be employed by powerful and wealthy special interests in order to squelch government-funded public research results and information that they do not welcome. Thus, the recent revisions will actually hurt the American's public right to know, not enhance it. Among the specific harms that will be caused by these new regulations and that can be avoided by the passage of H.R. 88 include compromised patient confidentiality. As Mr. O'Reilly earlier stated, the Shelby provision doesn't change the rules of FOIA. Instead, it just adds these to the group that can be FOIA'd. But the rules were not designed to deal with the research data of this type. This is--FOIA is inappropriate for this application. Another fact is higher research costs, a slowing of scientific progress, and regulatory delay. As Mr. Hahn wrote in his paper, the release of data could slow the development of data and delay the publication of results. If you look at the Harvard six-city study that's been bantered about here, and misrepresented I might say, there are over 100 publications that have come from that study, not 1. And if all that data were released after the first publication, that would have been a taking of property from those researchers who did all the work, decades of work. They would have had to give up that data, and other researchers would have had open access to that. So they would have lost, basically, their property. Their intellectual property and academic freedom is really infringed. So Mr. Miller's danger of delay is really applied to delay of regulation. The Chamber of Commerce on their webpage points out that agencies will have a much harder time imposing regulations on the business community as a result of Circular A-110. This Circular A-110 provision is not going to speed things up. It's going to, as the Chamber of Commerce points out, delay regulations. This isn't regulatory reform. This is much more than that. It's regulatory annihilation, I think, in some cases. They're just going to be able to take regulations and stop them in their tracks, at will. Researcher harassment is another problem. By making research data subject to inquiries, vested interests can easily tie up researchers' time and energy by filing endless requests for data. Additionally, once they have the data in hand, past experience with State open records and Freedom of Information Act laws indicates that vested interests will aim to discredit the data and/or its analysis, irrespective of its merits. Based on my investigation into this issue, I conclude that it will be impossible to craft limitations that can overcome the inherent flaw of using FOIA procedures to achieve broader access to Federal funded research data. As Mr. Miller said in the last panel, it's the summary of the data that's important. But the Shelby provision sets no such limit. As was discussed, the OMB regulations will likely be thrown out in court. So we're really dealing with what's in the law, which has no limits. Thus, FOIA is not an appropriate mechanism for assuring the proper sharing and testing of scientific data. But let me discuss how I came to these conclusions. In late 1997, I was asked to write an article for the Tulane Environmental Law Journal on the issue of the forcing of scientists to give unrestricted release of their health research data. As I started out the research I, like most people, first thought a requirement for the release of data from government-funded research was not unreasonable. However, as I investigated the past history of cases in which data had been released to special interests, my eyes were opened to the intractable problems and grave dangers of such a requirement. In my article, I summarize the case of Dr. Herb Needleman and his research on adverse effects of lead exposures on children. As part of a government lawsuit against polluters, Dr. Needleman had to make his research records available for examination by the lead industry. While the case was eventually settled out of court, a lengthy document accusing Dr. Needleman of scientific misconduct was forwarded to the NIH based on these data. After an NIH hearing, Dr. Needleman was finally cleared. But he concluded, ``If my case illuminates anything, it shows that the Federal investigative process can be rather easily exploited by commercial interests to cloud the consensus about a toxicant's dangers, can slow the regulatory pace, can damage an investigator's credibility, and can keep him tied up almost to the exclusion of any scientific output for long stretches of time while defending himself.'' Another case is that of Dr. Paul Fisher, who investigated the effects of tobacco company advertising on children. RJ Reynolds responded to his research by hiring consultants to analyze the studies and subpoenaed the research data. Because of State open records regulations, the Medical College of Georgia turned over the documents. Consultants to the cigarette industry then started criticizing his research, even though his research results were later independently confirmed. Dr. Fisher resigned in disgust and entered private practice in medicine. So researchers can be driven out of this practice by these freedom of information rules. Ironically, documents uncovered, in the Attorney General's tobacco settlement clearly shows that the tobacco industry had specifically designed their advertising to get kids smoking, just what Dr. Fisher had said years before. As recently noted by Deyo and colleagues in an article in the New England Journal of Medicine on this issue using yet other cases, ``the common theme in these examples is an attack through marketing, professional, media, legal, administrative or political channels on scientific results that ran counter to financial interests and strong beliefs. Freedom of Information requests, subpoenas and complaints to the Office of Research Integrity were analogous to SLAPP suits.'' Thus, policies as democratic and important as the Freedom of Information requirements can be and have been employed as mechanisms for vested interests to attack the messenger when the message is financially or politically unwelcome to the interest group involved. It's inevitable that the same things will happen if the Shelby amendment is allowed to be implemented. The amendment purports to be a public right-to-know provision, but it is in fact quite the opposite. The Shelby Circular A-110 provisions will open the gate to special interests to destroy government funded research in the United States at will. This will allow them to once again set the research agenda by controlling publicly funded research the way they have controlled and hidden their own industry research from the public in the past, such as asbestos and lead effects. Before the Federal Government started doing research into these areas, the public never knew. Industry did their research, they knew of their effects, they put it in a file drawer and locked it. And now we have federally funded research to let people know. This will give industry special interests the chance to undermine federally funded research that informs people about the adverse effects of pollutants and other hazards in their lives. If the Congress passes---- Mr. Horn. I am going to have to interrupt on that. Mr. Thurston. I'm almost done. Mr. Horn. What do you mean undermine? Explain it to me. Mr. Thurston. Well, you won't be able to use it, and people won't be able to do their research. Because they'll raise questions. It will come up for regulation. They'll get the data. They'll raise questions. You won't be able to go forward with the regulatory process. And, meanwhile, the researchers won't be doing any research because they'll be spending all their time---- Mr. Horn. Isn't that the way the scientific method operates anyhow? You have colleagues that review the data see if they can replicate it? Mr. Thurston. No, that isn't really exactly how it works. Other researchers generate their own data, and they see if they can replicate the results. There are situations, such as the Harvard data, where they did give up their data. I don't know what all this talk is about that they won't give up their data. EPA did request their data. They did give their data up to the Health Effects Institute in an agreement, and the Health Effects Institute reviewed that data and redid their analysis and confirmed every aspect, as far as I know, of the results of that study. That's an excellent example for showing how the Circular A- 110 provisions aren't needed, not the other way around. Everybody seems to be using this Harvard six-city study as an example. It's an excellent study. It was also subject of an OSI investigation a number of years ago. As I reported in my paper, the OSI came out and said not only did they do the things right, this is almost a textbook case of the way one should do a study. So this is an excellent study in that they have provided their data. They just didn't want to hand it over because patient confidentiality is crucial, and that was what they stood on. Mr. Horn. I think we all agree on that. Mr. Thurston. Thank you. So I feel that Congress, if it passes H.R. 88, will be properly acting to protect the public's primary source of unbiased scientific information, government- funded, peer-reviewed research. And, last, I would just like to say that if you have any questions about this Harvard study, I do work in that field so I am familiar with what has happened with that, and with these air pollution regulations, which no one has been damaged by. They haven't been implemented. I mean, the way the administration wrote it, there is over a decade before the States really have to implement it. So no one has been harmed by that regulation. And the error that Mr. Obadal was talking about it, was by EPA. They misread the paper. When someone went through and carefully read the paper, they found that the EPA had used median value and interpreted that as a mean. But when they carefully read the paper, it was all right there. There was no reason to request the data. The correct information was included in the paper. EPA just merely failed to read the paper correctly. Mr. Horn. Thank you very much. [The prepared statement of Mr. Thurston follows:] [GRAPHIC] [TIFF OMITTED] T3673.113 [GRAPHIC] [TIFF OMITTED] T3673.114 [GRAPHIC] [TIFF OMITTED] T3673.115 [GRAPHIC] [TIFF OMITTED] T3673.116 [GRAPHIC] [TIFF OMITTED] T3673.117 [GRAPHIC] [TIFF OMITTED] T3673.118 [GRAPHIC] [TIFF OMITTED] T3673.119 [GRAPHIC] [TIFF OMITTED] T3673.120 [GRAPHIC] [TIFF OMITTED] T3673.121 [GRAPHIC] [TIFF OMITTED] T3673.122 [GRAPHIC] [TIFF OMITTED] T3673.123 [GRAPHIC] [TIFF OMITTED] T3673.124 [GRAPHIC] [TIFF OMITTED] T3673.125 [GRAPHIC] [TIFF OMITTED] T3673.126 [GRAPHIC] [TIFF OMITTED] T3673.127 [GRAPHIC] [TIFF OMITTED] T3673.128 [GRAPHIC] [TIFF OMITTED] T3673.129 [GRAPHIC] [TIFF OMITTED] T3673.130 [GRAPHIC] [TIFF OMITTED] T3673.131 [GRAPHIC] [TIFF OMITTED] T3673.132 [GRAPHIC] [TIFF OMITTED] T3673.133 [GRAPHIC] [TIFF OMITTED] T3673.134 [GRAPHIC] [TIFF OMITTED] T3673.135 Mr. Horn. Mr. Gough is an adjunct scholar at the Cato Institute. Welcome. Mr. Gough. Thank you, Mr. Horn and members of the committee for the opportunity to address you. In my written testimony I comment on the importance of review and attempted replication of data for the advancement of science. I will limit my oral testimony to scientific data used for the development of laws, rules, regulations, risk assessments and other government guidance documents; and I will divide those data into two types. Laboratory experiments and replication of laboratory data can be attempted in other laboratories and access to experimental data isn't so important as information about how the experiments were done. Significantly, I do not include data from routine toxicity tests when I say experimental data. Those tests can cost millions of dollars, take years to complete, produce thousands of tissue samples and result in reams of data. Such tests are often the basis of Federal action, and access to the data from them is fundamental to understanding what the tests mean. Epidemiologic studies to examine the health of a population of people cannot be replicated. The data are collected on a unique set of people, circumstances, and time. In large part we are here today because of such a study. C.A. Pope and others who wrote a paper which is a primary basis for EPA's air pollution regulations initially refused a congressional request to release their data. After much pressure they released the data only to a committee of the jointly industry-EPA-funded Health Effects Institute. In May, Steve Malloy and I wrote the EPA and requested the Pope study data which are also the basis for EPA's proposed tier 2 gasoline sulfur regulations. EPA replied in a letter, ``We are not providing the health survey date you seek because these data are not in the Agency's possession. The data you seek are contained in a data base that is proprietary with the American Cancer Society. The EPA has never had access to this data base.'' Evidently it's not only critics of EPA's regulations who have not seen the data, not even EPA has seen them. I question whether billions of dollars in regulatory costs should be heaped on American industry, cities and consumers on the basis of data that have not been examined by the regulatory agency. Pope and his colleagues objected to releasing their data because they said it would compromise the privacy of individuals in the study. That is an overblown concern. For 5 years I chaired the committee that advised the U.S. Air Force's study of the health of the 1,200 Air Force personnel who sprayed 90 percent of the Agent Orange used in Vietnam. There are few more newsworthy or politically sensitive epidemiology studies. In 1990 or 1991, Air Force scientists told the advisory committee that they had received some requests for data. After a few minutes' conversation about whether access to the data should be restricted in any way, we agreed to make the data--we agreed to make the data available to anyone who requested it. The data were scrubbed of all personal identifiers and released. Scrubbing isn't a trivial exercise, but it can be done. My final examples concern the most widely used herbicide in this country, 2,4-D. EPA has declared that there is no evidence to support even the possibility that 2,4-D causes cancer, but the National Cancer Institute has made several epidemiologic investigations of it. Those investigations have been marred by mistakes that came to light only when the NCI data were independently reviewed. One NCI study included a table that indicated exposure to 2,4-D increased the risk of cancer. Inspection of the data showed that NCI scientists had never asked a question about 2,4-D use. Instead, they asked questions about all herbicides. The origin of the mistake that transformed herbicides into 2,4- D is not known. Subsequently, NCI scientists failed to report a survey of farm workers in Iowa and Minnesota that showed no association between 2,4-D and cancer. NCI published a study which received a great deal of publicity that associated cancer in dogs with 2,4-D. Although the dog owners' names had been removed from the data, NCI continued to stonewall release of data from the study for more than 18 months because it was concerned that industry would use information about the breeds of dogs and zip codes to track down and harass the dog owners. When NCI did release the data, independent analysis revealed flaws in it, in the study. Correction of those flaws eliminated the association between 2,4-D and cancer. The 2,4-D saga shows the importance of citizens having access to data to check on the work of government scientists and their grantees. The science used to support regulation and taxes must be based on publicly available data. Otherwise, government, simply by calling any collection of data, conclusions, and conjecture science and refusing to let others see the data, has a free hand to impose taxes and regulations. Regulations always generate antagonisms. People in organizations that stand to gain or lose stature or resources or money will look most seriously at those data. They are the ones most interested. Their involvement in review of data is a quicker way to get to the truth than the use of non-biased or ``philosopher-king agencies'' of the government. Thank you. Mr. Horn. Thank you. [The prepared statement of Mr. Gough follows:] [GRAPHIC] [TIFF OMITTED] T3673.136 [GRAPHIC] [TIFF OMITTED] T3673.137 [GRAPHIC] [TIFF OMITTED] T3673.138 [GRAPHIC] [TIFF OMITTED] T3673.139 [GRAPHIC] [TIFF OMITTED] T3673.140 [GRAPHIC] [TIFF OMITTED] T3673.141 Mr. Horn. And we turn to our last witness, which is Dr. Gary D. Bass, the executive director of OMB Watch. Mr. Bass. Thank you, Mr. Chairman. I guess it's helpful to go last because you get to hear all the commentary beforehand. Let me just say that OMB Watch has as its primary mission public access to government information. In fact, OMB Watch has testified before this committee repeatedly on electronic FOIA issues; and we also worked back in the early 1990's on the EPA Cabinet-level bill with both Mr. Horton and Mr. Conyers to put a right-to-know provision, which also didn't go through, and have worked all the way into the early 1980's on right to know. With that background, it is striking that OMB Watch concludes that the Shelby amendment is the wrong way--wrong way to proceed in making information available that grantees have. I would like to highlight five points in coming to that conclusion. First, since the passage of the Shelby bill--or Shelby amendment--and all the way through this hearing today, I am still uncertain what the problem is we're trying to resolve. I thought we were dealing with open government and public access. On the other hand, in listening to the panelists today, I'm somewhat like the magistrate from Casablanca saying to Humphrey Bogart, ``I'm shocked, absolutely shocked.'' It's now about reg reform, it isn't just simply the Chamber of Commerce website that has it about reg reform--and by the way, I'll add to Dr. Thurston's comment. The issues that are highlighted on that website are clean air, environmental justice, ergonomic regulations, secondhand smoke, breast implants. These are public protections that we rely on. No, it's not just simply that. It's not about open government. It's now become a partisan attack. How do we get these comments that came into OMB that Mr. Kovacs referred to? I went to another website called junkscience.org. You can win an award if you send to OMB your comments. There are five awards that were going to be given if you could get your comments in about how problematic the existing system is and how good the Shelby amendment is. Well, let me say that I am still uncertain what we're trying to fix. Once I better understand it, then I would like to engage in a serious discussion about fixing it. The second point I would make consistent with that which you pointed out and others have pointed out in this panel, there were no hearings. There were no hearings on a major substantive piece of legislation. And I thank you, Mr. Chairman, for having these de facto hearings on the subject, even though it's really about H.R. 88. The third point I would make is this really was a back-door amendment to the Freedom of Information Act. Mr. O'Reilly testified that the scope of FOIA has been expanded. That is a back-door amendment to FOIA. We now have a greater coverage of who is included. The Shelby amendment, by the way, says ``procedures of FOIA.'' Now, I don't know what that means. I'm assuming that Mr. O'Reilly is correct that the exemptions under FOIA would then apply and, therefore, the confidentiality issue, exemption 6, would apply. But then again, does predecisional exemptions apply? The Freedom of Information Act, as you know, in terms of agencies, allows for agency communications to be exempt from FOIA. Are we going to apply that to nonprofit grantees, to the Federal grantees? Where does the exemption list go and how far does it extend? Well, more importantly, what we have just done, by-passing the Shelby amendment without any hearings, is reverse 20 years of case law including, as Mr. O'Reilly pointed out, the Forsham case. Fourth point I would make, if there is a problem, if there is a problem, why would we fit it in the manner of the Shelby amendment? It has already been said by Mr. Kovacs that OMB's Circular A-110 provides for the opportunity for the agency to request this type of information. Section 53(d) specifically allows an agency to do that. In addition, section 36(c) allows for the agency to not only collect but to reuse that information. My fifth point: there are many substantive concerns that we have with the Shelby amendment, not the least of which is it does not deal solely with research. It deals with ``all data.'' That means that all Federal grantees, including those that provide services, whether it be institutions or homes with disabled kids, you name it, whatever the service provision is, this applies to them. The second concern I have is, really, this is an attack reminiscent of the attack on the advocacy voice of nonprofits. This does not cover, critically, money that goes to contractors, nor that which goes to State and local governments. If you will refer to page 8 of my testimony, there is a graphic, a chart that demonstrates exactly that State and local governments as well as contractor funding is roughly about eight times the scope of grants that would be covered under the Shelby amendment. One last point I would make under substantive concerns and that is the hefty discussion that has occurred not only on this panel but the previous panel about privacy. Clearly exemption 6 applies, according to Mr. O'Reilly. The issue isn't exactly that. The issue is more complex. It really gets to data quality and to the researcher capability. In today's era it is possible to take a small data set--and I'll take hypothetically research dealing with kids with AIDS. Hypothetically, it is quite possible to redact all the names. And because it's done in a small community or because it's a small subset of a population, computer matching would provide the capability, the possibility of identifying who those people are. In such a case, the researcher must make sure that the human subject pool is aware that the potential exists. That puts in a situation that you may not get the subject pool that you originally deemed possible. And let me say, Mr. Chairman, you had commented on your prior life as a dean of research, I will be committing heresy, but there may be no truth in research. There is often a lot of politics surrounding the research. And so it is with that I conclude that I think the Shelby amendment is unwarranted, unnecessary, and unwise and we strongly support H.R. 88. Thank you. Mr. Horn. Thank you very much. [The prepared statement of Mr. Bass follows:] [GRAPHIC] [TIFF OMITTED] T3673.142 [GRAPHIC] [TIFF OMITTED] T3673.143 [GRAPHIC] [TIFF OMITTED] T3673.144 [GRAPHIC] [TIFF OMITTED] T3673.145 [GRAPHIC] [TIFF OMITTED] T3673.146 [GRAPHIC] [TIFF OMITTED] T3673.147 [GRAPHIC] [TIFF OMITTED] T3673.148 [GRAPHIC] [TIFF OMITTED] T3673.149 [GRAPHIC] [TIFF OMITTED] T3673.150 [GRAPHIC] [TIFF OMITTED] T3673.151 Mr. Horn. I now yield 5 minutes to the gentleman from Texas, Mr. Turner, the ranking member. And after him we'll welcome Mrs. Biggert, the vice chair; and she'll adjourn the meeting. I have to be somewhere at 1, and I'm sorry about that. But the previous panel took a little more time than we thought. But I thank you all for coming. Mr. Turner. Mr. Turner. Thank you, Mr. Chairman. Obviously we've heard a diversity of opinion today, have been very helpful. The resolution before us simply repeals the Shelby amendment, and I guess it would be appropriate to ask even those of you who oppose the Shelby amendment whether or not you think it would be possible to craft some language that would appropriately address the concerns that have been expressed about access to data which in my opinion should be accessed after the research enters the public domain so as not to have a chilling effect upon academic freedom and inquiry. But, Dr. Bass, would you have a suggestion that you could offer us that would allow us to address the issue but to do it in a more responsible way? Mr. Bass. If the issue is solely as you just described it, Congressman, of gaining access to data from selected research that was used in hypothetically a particular case, OMB's Circular A-110 already provides the ability to make that happen. As Mr. Kovacs pointed out earlier, agencies are not utilizing that to the maximum effect. That would suggest, as Congress, your oversight responsibility may prove even more useful through that route of identifying where you believe that agency should be collecting the underlying data. I'm yet to be--I'm yet to be convinced that new legislation is needed. If legislation were needed, I would not use--I would not attempt to use FOIA in this manner. In some respects the Shelby amendment is like a caveman using the tools of that time to do brain surgery today. It is the wrong vehicle to achieve what you're saying. Mr. Turner. Maybe I misunderstood what the current law is, but, as I understand it, agencies, you're telling us agencies have access to this data. Mr. Bass. What I'm saying is the existing--the administrative requirements which are authored under Circular A-110 prescriptively state that the agency may request certain data from the Federal grantee. Not only does it state that, it also states that the Federal agency cannot only use it but reuse it and give it to others. Mr. Turner. Well, I thought that the proponents of the Shelby amendment here were trying to ensure that third parties who may be affected by the recommendations of the research also had access to the underlying data. It would appear to me that they do not under the current law. Mr. Bass. Under Circular A-110 if the agency chose to put under its grant agreement with the Federal grantee the exercise of that authority of taking the data, it then becomes an agency record which would then be potentially subject to FOIA and go through the process that Mr. O'Reilly described, in the last panel, of the procedures established within the agency for review to determine whether it should be made publicly available. In other words, we already have in place a structure for addressing some of these issues. The problem, if it is dealing with academic research, is that Circular A-110 does not prescriptively deal with the words ``Federal research data.'' And there may be more work that needs to be done in modifying A-110 to deal with that specific concern. Mr. Turner. I notice Mr. O'Reilly shaking his head. Mr. O'Reilly. I concur. Mr. Turner. So you're saying that it is true that under current law that third parties do have access. Mr. O'Reilly. Let me clarify. Third parties who have access to the agency record once it's in the agency can use the Freedom of Information Act. The Shelby amendment afforded an opportunity for a third party to have the agency bring into the agency, pieces of data that the agency did not currently possess, and which the agency on its own would not have taken into its control. Mr. Turner. And, Dr. Bass, you oppose. Mr. Bass. My point is that the ability to bring in the data and to make it a record as Mr. O'Reilly just described, already there are tools in place for the agency to seek that, to make that occur under the existing A-110. However, there may need to be some greater modification to A-110 to deal specifically with the research data that has been talked about today. Mr. Turner. So you are saying to us you have no objection to a third party requiring disclosure of the underlying data. Mr. Bass. No, that is not what I'm saying. What I am saying is that I have no problem with the government collecting the information that it deems necessary; and, therefore, that data does become subject to the Freedom of Information if the Federal agency has already collected it. I do not agree to extend the Freedom of Information Act to nonprofit organizations or to Federal grantees. I think that would be an incredible burden. It will be used in a way to harass agencies dealing with everything from smoking to reproductive grants, to you name it. There is always an opposite side on every issue, and the opposite side will use every vehicle possible. Mr. Turner. Would it be helpful if there was some limitation on when that data was available to those third parties? Mr. Bass. Absolutely. That needs to be considered. Mr. Turner. Would that remedy your objection if you required access to be limited to a time after publication? Mr. Thurston. After which publication? I mean, the Harvard six-city study actually has 100 publications. If those data were released after the first one, those researchers would have lost all those publications. Other researchers like me would have scarfed up their data and published it for them. That's a taking of property. There isn't just one publication. You look at the Framingham study: many, many publications. You know what's going to happen is that they'll say, OK, we won't publish that first paper. We'll wait 10 years until we get all of our publications ready, and then we'll put them out the door. Because I want tenure. I want to protect my rights to these data. So we won't publish that first paper. It will cause delay. People will protect their property, and they won't publish that first paper because they won't want to give it all away. And they certainly wouldn't want to open themselves up to the kinds of attacks Dr. Needleman has had. But in answer to your question, I guess your question really is, if we don't do the Circular A-110 revisions Mr. Shelby has done, what should we do? But I'm left to reiterate Dr. Bass' question, what's the problem? Why do we have to do something about this? The research we do, represents tens of billions of dollars of federally funded research every year. Mr. Obadal's research says in over 5 years there were 150 scientific misconduct cases out of all of that money, half of them were groundless. Quality research is coming out of this. If there is a problem, it's with privately funded research. The example he gives of West Coast Research Co., that's private research. And the New York Times--I can put this in the record. The New York Times had an article yesterday that U.S. officials are examining clinical trials, ones run by private companies. This is the problem. It says that problems exist in the recruitment practices in research sponsored by the drug industry and the system of oversight used to detect possible fraud. These examinations come on the heel of drastic changes in the clinical trial system which, in just the last decade, was largely based in the academic medical institutions doing like this federally funded research and conducted by professional researchers. But now it's become a multi-billion-dollar industry with hundreds of testing and drug companies working with thousands of private doctors who mine their patient lists for test subjects. You want a problem, look into this private research--but what we're talking about here, federally funded, peer-reviewed research, this is what the American people need. They don't need it to be subjected to these kind of unneeded regulations. There is no need for this regulation I agree with Dr. Bass. Mr. Turner. I think my time is up, Mr. Chairman, but if you would like to allow us---- Mrs. Biggert [presiding]. Why don't you have--Mr. Gough would you like to address that issue. Mr. Gough. A couple of comments. Well over 50 percent of the research in this country is funded by private sources in industry. To demean it all and toss it all in the wastebasket, I don't think is an advantage to anybody's interest. The Pope study became important not when it was first published, but when it was the basis of EPA regulations. That's what opened the doors to the questions. And the questions are pretty straightforward. It depends on a survey of volunteers by the American Cancer Society, how well was that done, how were the questions asked, so forth. Those are legitimate research questions. And that's--to respond to Mr. Bass--or Dr. Bass's issue, I mean, that's what nobody's been able to obtain. I think that's strictly public information, and it should be obtained by people who are going to be affected by the regulation either positively or negatively. Mr. Bass. Could I just add to that? Dr. Gough raised the issue of public versus private research. In passage of the Shelby amendment there was a colloquy involving several of the major players on the Senate side. Senator Nighthorse Campbell had stated, quote, the amended circular shall apply to all federally funded research regardless of the level of funding or whether the award recipient is also using non-Federal funds. This is the discussion that occurred in the last panel about commingling of funds. Will private research dollars be willing to be commingled with Federal dollars if potentially their data is suddenly going to be made public? There are a lot of concerns that the Shelby amendment raises in this regard that could be quite problematic. Mr. Turner. Thank you. Mrs. Biggert. Thank you. I have just one question, and I'm afraid we're going to have to adjourn since we're an hour and a half over our time limit. And you have all been very patient. Since neither the Shelby amendment nor the proposed revisions to the Office of Management and Budget Circular A-110 addressed the mechanism for Federal grant and award recipients to offset the administrative cost of the policy change, how would they be reimbursed for the cost of collecting the data? Does anybody have an answer to that? Mr. Shelton. Could I speak to that? I think the simple answer is that there probably would not be a mechanism. You know that the indirect cost for administrative purposes at universities is capped at I think 26 percent. One can argue up and down about indirect costs, as many of you have. But this would fall clearly under an administrative responsibility. And since all of the major research universities are already collecting that 26 percent for the administrative components of their indirect cost base, I don't see how it could be accommodated. Mrs. Biggert. So that would have to be. Mr. Shelton. That is a factor, and I mention that. But I think more critically--if I'm getting a take-home message-- because I've learned a lot today as well--more critically what we're seeing here is just how complex this issue is. You've got the issue of private and public funds coming together. And that's increasing. If you look at the University of California we have huge growth in the area of private sector funding of our projects, and very often that's combined with Federal funds simply because it's a very important problem that is of interest to both the public and the private sector. That factor could be harmed irreparably if we go this route of the Shelby amendment. There are other issues of harassment. You have heard issues of patents. What this tells me at these hearings is that this matter is sufficiently complex that we all need to take a very serious look at it before implementing the Shelby amendment. And that's why we favor H.R. 88 because--not because it eliminates the problem or eliminates our ability to discuss, but in fact the opposite. It gives us an opportunity in the sunshine of the day to go and discuss, as we have today, the pros and cons and come up with something that's both workable and gets at the real needs. Mrs. Biggert. Thank you. Mr. Obadal. Mr. Obadal. Yes, the costs of accumulating the data are currently covered by the current FOIA which could require parties to pay for those costs. And indeed I have been in a number of instances which we've had to do that. Second, the importance of the regulations and their impact on our society I think transcends the objections that we've been hearing today, many of which I believe are without merit. So if this committee is going to consider some sort of legislation, we certainly would urge you not in the interim to suspend the Shelby amendment or the OMB action under the Shelby amendment, which is sorely needed. I put a proviso to that, unless you're willing to freeze all regulation during the process until you come out with a solution. Mrs. Biggert. Thank you. Mr. Kovacs. Mr. Kovacs. It's been interesting going last and listening because I want to address the cost issue. One, I don't think you've heard anyone from the pro-Shelby side in any way state that they didn't want to reimburse the costs. That, No. 1, it is in FOIA; and, two, OMB, from what I am hearing, is going to have a cost reimbursement provision. That is not an issue. The second issue is, as part of the process, we need to move away from the academic to the practical world. In the practical world the FOIA request is made to the agency, not to the researcher. This idea of being harassed, is not the issue. The request is going to go to the agency. The agency is going to ask for the data. Under existing A-110 this data has to be managed anyway. So it's already in some form to be provided to the Federal Government. And to turn to Mr. Turner for a second, because, Congressman, when you had asked the question, what does Shelby really do, the reason Shelby was important was not because under existing law the agencies can't get title to the information, they can, and that is fully provided. They intentionally did not get it. So that this data was not available. Our central contention is that when the government implements a rule or a regulation, the data needs to be provided in ample time so that the public can analyze what the impact of the rule is going to be on them. And that's why, finally, OMB is so important, because OMB is taking these 9,100 or 9,200 comments and it's beginning to narrow them in a practical way. It's beginning to develop in definitions of what is ``published,'' what is ``data,'' and what does it apply to. It applies to a rule or regulation. So a lot of the stuff that you're hearing about is really theoretical. No one is objecting to protecting private or confidential information. We represent the business community. We want the confidential information, the trade secrets, all of that, protected. So what you're hearing is a theoretical argument versus a practical. OMB and the rulemaking process is moving in a practical way to release information. Everything else is theoretical. Mr. Bass. Madam Chairman, could I respond to the cost issue? Mrs. Biggert. Yes, quickly. Mr. Bass. My understanding of the way this would be implemented is that a requester would not file a FOIA request to the nonprofit grantee. It would go to the agency. The agency in turn would go select or request the information from the grantee. The FOIA fees are the agency's costs that would have to be dealt with. That's why the Shelby amendment added an extra clause that there could be other fees that are levied. The problem in it is, as OMB drafted the rule, the nonprofit has no right to request reimbursement. Mrs. Biggert. Well, doesn't the--under FOIA the reimbursement under the cost for collecting the data goes to the Treasury? So there's the problem, is how would that recipient get the reimbursement. I think that probably OMB would contend that it would take a legislative fix for that. Mr. Bass. That's right. Mr. Thurston. So, if that's the case, this is an unfunded mandate. Mrs. Biggert. Well, we'll look at that. I would like to thank all of the panelists. I certainly agree with Mr. Shelton that this is a very complex issue. I don't know if it was diabolical or planned, but the way that the chairman set up the two panels in having more or less the pro and con, as I listened I thought, well, I like that and I like that, so I think I realized by having the way that the panels were set up, how complex an issue it is and how much study is necessary. I feel like we need to write a term paper on this to really have the time to sit down and really synthesize all of the information that you have all given us. I think that this is one of the best or the two panels that I have ever heard at one of these meetings, and really this substance that you have brought us I really appreciate. And, with that, this subcommittee hearing is adjourned. [Whereupon, at 1:10 p.m., the subcommittee was adjourned.] -