[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:]

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    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:]

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    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:]

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    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:]

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    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:]

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    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:]

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    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.
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    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:]

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    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:]

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    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:]

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    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:]

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    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:]

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    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:]

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    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.]

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