U.S. GOVERNMENT PRINTING OFFICE

63–673 CC WASHINGTON : 2000

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

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

HELEN CHENOWETH, Idaho

DAVID VITTER, Louisiana

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

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

THOMAS M. DAVIS, Virginia

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

JIM TURNER, Texas

PAUL E. KANJORSKI, Pennsylvania

MAJOR R. OWENS, New York

PATSY T. MINK, Hawaii

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

(III)

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, AEIBrookings ....................................................................................................... 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, AEIBrookings, 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

Page

IV

Letters, statements, et cetera, submitted for the record by—Continued

Waxman, Hon. Henry A., a Representative in Congress from the State

of California, prepared statement of ........................................................... 9

(1)

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:]

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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:]

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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

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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:]

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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

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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:]

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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 researchVerDate 11-MAY-2000 12:52 Jul 26, 2000 Jkt 000000 PO 00000 Frm 00019 Fmt 6633 Sfmt 6633 C:\DOCS\63673.TXT HGOVREF1 PsN: HGOVREF1
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ers 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

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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:]

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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 proceVerDate 11-MAY-2000 12:52 Jul 26, 2000 Jkt 000000 PO 00000 Frm 00024 Fmt 6633 Sfmt 6633 C:\DOCS\63673.TXT HGOVREF1 PsN: HGOVREF1
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dures 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.

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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

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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.

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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

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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,

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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

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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.

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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

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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,

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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

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tion, 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 regulaVerDate 11-MAY-2000 12:52 Jul 26, 2000 Jkt 000000 PO 00000 Frm 00094 Fmt 6633 Sfmt 6633 C:\DOCS\63673.TXT HGOVREF1 PsN: HGOVREF1
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tions 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.

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[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 governmentfunded 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

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Government, pay them a better salary and bring them to the sunshine. So there was a lot of research going on.

Wouldn’t that really follow then that the FOIA would go on if

there was a Federal grant, or would it?

Mr. O’REILLY. I would have to do a more specific analysis. This

is one of those aspects of Shelby that, as you see, the OMB is struggling with at the moment. The short answer is, I don’t know, but

the California Open Records Act would probably not reach it, so

Shelby might.

Dr. VARMUS. I am concerned about one comment that Mr.

O’Reilly made that would suggest that we are making a narrow

cut—addressing a very narrow issue. It would seem to me the opposite is true.

On the one hand, we all agree that the government should

have—and the Congress should have—its best shot at evaluating

the scientific data on which it is going to base regulatory changes

that have major economic impact. But, in fact, the NIH alone has

30,000 grants. NIH-supported investigators are doing a variety of

things with additional support from the States, support from industry, support from other governments, support from private philanthropies. All of that comes under the risk of possibly threatening,

possibly irrelevant FOIA requests that are not addressed to the

core issue. That is why we feel strongly that we should go back to

ground zero.

We should start to address the problem in a more rational way

and ask what it is we are trying to solve rather than use the very

broad powers that we see embedded in A–110. We recognize that

OMB is attempting to narrow those powers. We also recognize

there is a very strong likelihood that that restriction is going to be

subject to court challenge.

Mr. O’REILLY. I would like to subsequently write to the subcommittee giving a more detailed response to your question. It is

a good question.

[The information referred to follows:]

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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?

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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.

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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

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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 tryVerDate 11-MAY-2000 12:52 Jul 26, 2000 Jkt 000000 PO 00000 Frm 00108 Fmt 6633 Sfmt 6633 C:\DOCS\63673.TXT HGOVREF1 PsN: HGOVREF1
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ing 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.

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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

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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 socalled ‘‘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.

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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 selfimplementing 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

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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

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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 selfinterest.

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

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posit 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.

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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 prob- ably 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

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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

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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

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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

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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.

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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

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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.’’

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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.

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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, peerreviewed 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

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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 Cabinetlevel bill with both Mr. Horton and Mr. Conyers to put a right-toknow 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, alVerDate 11-MAY-2000 12:52 Jul 26, 2000 Jkt 000000 PO 00000 Frm 00201 Fmt 6633 Sfmt 6633 C:\DOCS\63673.TXT HGOVREF1 PsN: HGOVREF1
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lows 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.

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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.

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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,

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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

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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

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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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