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71–346PDF 2011

FOSTERING QUALITY SCIENCE AT EPA: 

PERSPECTIVES ON COMMON SENSE REFORM 

(PART I AND PART II) 

HEARING 

BEFORE THE

SUBCOMMITTEE ON ENERGY AND 

ENVIRONMENT 

COMMITTEE ON SCIENCE, SPACE, AND 

TECHNOLOGY 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TWELFTH CONGRESS 

FIRST & SECOND SESSION 

WEDNESDAY, NOVEMBER 30, 2011 

and 

FRIDAY, FEBRUARY 3, 2012 

Serial No. 112–54 

and 

Serial No. 112–59 

Printed for the use of the Committee on Science, Space, and Technology 

( 

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

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

HON. RALPH M. HALL, Texas, Chair 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

LAMAR S. SMITH, Texas 

DANA ROHRABACHER, California 

ROSCOE G. BARTLETT, Maryland 

FRANK D. LUCAS, Oklahoma 

JUDY BIGGERT, Illinois 

W. TODD AKIN, Missouri 

RANDY NEUGEBAUER, Texas 

MICHAEL T. MCCAUL, Texas 

PAUL C. BROUN, Georgia 

SANDY ADAMS, Florida 

BENJAMIN QUAYLE, Arizona 

CHARLES J. ‘‘CHUCK’’ FLEISCHMANN, 

Tennessee 

E. SCOTT RIGELL, Virginia 

STEVEN M. PALAZZO, Mississippi 

MO BROOKS, Alabama 

ANDY HARRIS, Maryland 

RANDY HULTGREN, Illinois 

CHIP CRAVAACK, Minnesota 

LARRY BUCSHON, Indiana 

DAN BENISHEK, Michigan 

VACANCY 

EDDIE BERNICE JOHNSON, Texas 

JERRY F. COSTELLO, Illinois 

LYNN C. WOOLSEY, California 

ZOE LOFGREN, California 

BRAD MILLER, North Carolina 

DANIEL LIPINSKI, Illinois 

GABRIELLE GIFFORDS, Arizona (Resigned 

from Congress on January 25, 2012) 

DONNA F. EDWARDS, Maryland 

MARCIA L. FUDGE, Ohio 

BEN R. LUJA ́ N, New Mexico 

PAUL D. TONKO, New York 

JERRY MCNERNEY, California 

JOHN P. SARBANES, Maryland 

TERRI A. SEWELL, Alabama 

FREDERICA S. WILSON, Florida 

HANSEN CLARKE, Michigan 

VACANCY 

SUBCOMMITTEE ON ENERGY AND ENVIRONMENT

HON. ANDY HARRIS, Maryland, Chair 

DANA ROHRABACHER, California 

ROSCOE G. BARTLETT, Maryland 

FRANK D. LUCAS, Oklahoma 

JUDY BIGGERT, Illinois 

W. TODD AKIN, Missouri 

RANDY NEUGEBAUER, Texas 

PAUL C. BROUN, Georgia 

CHARLES J. ‘‘CHUCK’’ FLEISCHMANN, 

Tennessee 

RALPH M. HALL, Texas 

BRAD MILLER, North Carolina 

LYNN C. WOOLSEY, California 

BEN R. LUJA ́ N, New Mexico 

PAUL D. TONKO, New York 

ZOE LOFGREN, California 

JERRY MCNERNEY, California 

EDDIE BERNICE JOHNSON, Texas 
(III) 

C O N T E N T S 

November 30, 2011 

Page 

Witness List ............................................................................................................. 2 

Hearing Charter ...................................................................................................... 3 

Opening Statements 

Statement by Representative Andy Harris, Chairman, Subcommittee on Energy and Environment, Committee on Science, Space, and Technology, U.S. 

House of Representatives .................................................................................... 9 

Written Statement ............................................................................................ 10 

Statement by Representative Brad Miller, Ranking Member, Subcommittee 

on Energy and Environment, Committee on Science, Space, and Technology, 

U.S. House of Representatives ............................................................................ 11 

Written Statement ............................................................................................ 12 

Witnesses: 

Ms. Susan Dudley, Director, Regulatory Studies Center, and Research Professor of Public Policy & Public Administration, The George Washington 

University 

Oral Statement ................................................................................................. 14 

Written Statement ............................................................................................ 15 

Dr. Alan Moghissi, President, Institute for Regulatory Science 

Oral Statement ................................................................................................. 19 

Written Statement ............................................................................................ 20 

Dr. Kenneth Green, Resident Scholar, American Enterprise Institute 

Oral Statement ................................................................................................. 26 

Written Statement ............................................................................................ 28 

Dr. Gary Marchant, Professor of Law and Executive Director, Center for 

Law, Science & Innovation, Arizona State University 

Oral Statement ................................................................................................. 31 

Written Statement ............................................................................................ 33 

Discussion 36 

Appendix I: Answers to Post-Hearing Questions 

Ms. Susan Dudley, Director, Regulatory Studies Center, and Research Professor of Public Policy & Public Administration, The George Washington 

University ............................................................................................................. 54 

Dr. Alan Moghissi, President, Institute for Regulatory Science .......................... 57 

Dr. Kenneth Green, Resident Scholar, American Enterprise Institute .............. 61 

Dr. Gary Marchant, Professor of Law and Executive Director, Center for 

Law, Science & Innovation, Arizona State University ...................................... 67 

C O N T E N T S 

February 3, 2012 

Page 

Witness List ............................................................................................................. 70 
Page

IV 

Hearing Charter ...................................................................................................... 71 

Opening Statements 

Statement by Representative Andy Harris, Chairman, Subcommittee on Energy and Environment, Committee on Science, Space, and Technology, U.S. 

House of Representatives .................................................................................... 76 

Written Statement ............................................................................................ 76 

Statement by Representative Brad Miller, Ranking Minority Member, Subcommittee on Energy and Environment, Committee on Science, Space, and 

Technology, U.S. House of Representatives ....................................................... 77 

Written Statement ............................................................................................ 78 

Witnesses: 

Mr. Daniel Greenbaum, President and Chief Executive Officer, Health Effects 

Institute 

Oral Statement ................................................................................................. 80 

Written Statement ............................................................................................ 81 

Dr. Deborah Swackhamer, Professor, Environmental Health Sciences, University of Minnesota, and Chairwoman, EPA Science Advisory Board 

Oral Statement ................................................................................................. 85 

Written Statement ............................................................................................ 86 

Mr. Michael Walls, Vice President, Regulatory and Technical Affairs, American Chemistry Council 

Oral Statement ................................................................................................. 88 

Written Statement ............................................................................................ 89 

Dr. Richard Belzer, President, Regulatory Checkbook 

Oral Statement ................................................................................................. 96 

Written Statement ............................................................................................ 98 

Dr. Jerald Schnoor, Allen S. Henry Chair in Engineering, Department of 

Civil and Environmental Engineering, University of Iowa 

Oral Statement ................................................................................................. 115 

Written Statement ............................................................................................ 116 

Dr. S. Stanley Young, Assistant Director for Bioinformatics, National Institute of Statistical Sciences 

Oral Statement ................................................................................................. 123 

Written Statement ............................................................................................ 124 

Discussion 125 

Appendix I: Answers to Post-Hearing Questions 

Mr. Daniel Greenbaum, President and Chief Executive Officer, Health Effects 

Institute ................................................................................................................ 140 

Dr. Deborah Swackhamer, Professor, Environmental Health Sciences, University of Minnesota, and Chairwoman, EPA Science Advisory Board ................ 144 

Mr. Michael Walls, Vice President, Regulatory and Technical Affairs, American Chemistry Council ....................................................................................... 147 

Dr. Richard Belzer, President, Regulatory Checkbook ......................................... 155 

Dr. Jerald Schnoor, Allen S. Henry Chair in Engineering, Department of 

Civil and Environmental Engineering, University of Iowa .............................. 179 

Dr. S. Stanley Young, Assistant Director for Bioinformatics, National Institute of Statistical Sciences .................................................................................. 188 

Appendix II: Additional Materials for the Record 

Reprint from American Journal of Entomology: ‘‘Reproducible Epidemiologic 

Research’’ .............................................................................................................. 194 

‘‘Deming, Data and Observational Studies’’: Article by S. Stanley Young and 

Alan Karr .............................................................................................................. 201 
(1) 

FOSTERING QUALITY SCIENCE AT EPA: 

PERSPECTIVES ON COMMON SENSE REFORM 

(PART I) 

WEDNESDAY, NOVEMBER 30, 2011 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON ENERGY AND ENVIRONMENT, COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY, Washington, D.C. 

The Subcommittee met, pursuant to call, at 2:13 p.m., in Room 

2318 of the Rayburn House Office Building, Hon. Andy Harris 

[Chairman of the Subcommittee] presiding. 
2 

MLPH 'f. "A~L. TEXAS 

C-lAIPMAN 

E~~'" 3,RNICE JOH~·S<)N. T,XAS 

US. HOUSE OF R:;:PRESENTATIVES 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

2321 ~AYjjl;Rr<. hUU::;E OFFICE BU,LDING 

WASHINGTON. DC 2001 "...{j3~1 

Subcommittee on Energy & Environment Heating 

Fostering Quuli1)' Science at EPA: Per.wectives on Common Sense Reform 

Wednesday, November 30, 2011 

2:00 p.m. to 4:00 p.m. 

2318 Rayburn House Office Building 

Ms. SUSIW Dudley, Directul", Roogulatory Studies Cciltcr, aud Research PruIooSlior of Public 

Policy & Public Admjnj~lTation. George WashillgLon "University 

Dr. AllIn Moghissi, President, Instimte for Regulatory Sci=e 

Dr. Kenneth Green, Resident Scholar, American Enterprise Instimic 

Dr. Gary Marchant, Professor of Law and Exe.cutive D:irccLor, Center for Law, Seience & 

Innovation, Arizona State l;nivel":sity 
3 

COMMITTEE ON SCIENCE AND TECHNOLOGY 

SUBCOMMITTEE ON ENERGY AND ENVIRONMENT 

U.S. HOUSE OF REPRESENTATIVES 

HEARING CHARTER 

Fostering Quality Science at EPA: Perspectives on Common Sense Reform 

PURPOSE 

Wednesday, November 30,2011 

2:00 p.m. to 4:00 p.m. 

2318 Rayburn House Office Building 

On Wednesday, November 30, 2011, the Subcommittee on Energy and Environment of the Committee 

on Science, Space, and Technology will hold a hearing to provide external perspectives on the need to 

reauthorize and reform science, research and development activities at the Environmental Protection 

Agency (EPA); explore the intersection of Agency-supported science and its regulatory mission; and 

receive focused recommendations to raise the level, quality, usefulness, and objectivity of EPA science, 

including any necessary changes to the Environmental Research, Development and Demonstration 

Authorization Act. 

WITNESSES 

Ms. Susan Dudley, Director, Regulatory Studies Center, and Research Professor of Public Policy & 

Public Administration, The George Washington University 

Dr. Alan Moghissi, President, Institute for Regulatory Science 

Dr. Kenneth Green, Resident Scholar, American Enterprise Institute 

Dr. Gary Marchant, Professor of Law and Executive Director, Center for Law, Science & Innovation, 

Arizona State University 

BACKGROUND 

The Environmental Research, Development, and Demonstration Authorization Act (ERDDA) authorizes 

research and scientific activities at the Environmental Protection Agency (EPA). Originally enacted in 

1976, Congress subsequently passed annual authorizations through fiscal year 1981. In addition to 

establishing annual authorization levels, these statutes also directed EPA policy in a variety of areas, 

including establishing the Office of Research and Development (ORD)l, requiring a 5-year 

environmental R&D plan, and creating EPA's Science Advisory Board (SAB). 

I Sec Appendix 1 for EPA organizational stmcturc. 
4 

Year Act Public Law Number 

1976 ERDDA 94-475 

1977 ERDDA of 1978 95-155 

1978 ERDDA of 1979 95-477 

1979 ERDDA of 1980 96-229 

1980 ERDDA of 1981 96-569 

Since 198 L there have been a number of bills introduced to reauthorize ERDDA that were not 

ultimately enacted into law.2 As a result, explicit authorization of EPA's environmental R&D ended at 

the end of fiscal year 1981. This failure to comprehensively reauthorize EPA research, development, 

and demonstration programs and activities illustrates a broader trend among expired environmental 

statutes. The Congressional Research Service notes this trend, stating "Although Congress somewhat 

recently has renewed the authorization of appropriations for certain EPA programs and activities 

through targeted amendments to various statutes, a more comprehensive reauthorization of many of the 

statutes that EPA administers has not been enacted for a number of years. "J 

In addition to ERDDA, EPA also dcrivcs authority for R&D activitics through other major 

environmental statutes. For example, under the Clean Air Act, the EPA Administrator must issue 

criteria that "accurately reflect the latest scientific knowledge useful in indicating the kind of extent of 

all identifiable effects on public health or welfare which may be expected from the presence of such 

pollutant in the ambient air.,,4 Through the Safe Drinking Water Act (SDWA), EPA sets standards 

based on "the best available, peer-reviewed science and supporting studies conducted in accordance with 

sound and objective scientific practices."s Similarly, the Clean Water Act (CWA) requires EPA to 

publish water quality infonnation "accurately reflecting the latest scientific knowledge.'" 

In many cases, these major regulatory statutes also authorize specific R&D programs and activities. For 

example, the Clear Air Act established a national research and development program for the prevention 

and control of air pollution including establishing technical advisory committees and research on air 

pollutant monitoring. The SOW A authorized the Administrator of EPA to conduct research and studies 

rclating to thc causcs, diagnosis, trcatment, control, and prcvention of physical or mental discascs 

resulting directly or indirectly from contaminants in the water including improved methods to identify 

and measure contaminants in drinking water and improved methods to identify and measure the health 

effects of contaminants in drinking water. The CW A directed the Administrator to establish national 

programs for the prevention, reduction, and elimination of pollution and as part of such programs to 

work in cooperation with other State and Federal agencies to coordinate and accelerate research, 

2 HR 3115 (1982), HR 2804 (1982), S. 1205 (1982), S. 2577 (1983), HR 2899 (1984), S. 1292 (1984), HR 2319 (1985), 

S. 2702 (1985). S. 1144 (1986). HR 2355 (1987), HR 1523 (1987). HR 2153 (1989), HR 4873 (1990), HR 2404 (1991), S. 

1655 (1991), HR 1994 (1993), S. 1545 (1993), HR 2405 (1995), HR Ig 14 (1995), HR 3322 (1996), HR 1276 (1997), HR 

1742 (1999), HR 1743 (1999) . 

.1 CongTessional ReseaTch Service, "Environmental Laws: SummaTies of Major Statutes Administered by the Environmental 

Protection Agency," RL3079R, August 11,2011. 

'42 U.S.c. 97408 (a)(2) (2000). 

542 U.S.c. §300g-l(b)(3)(A)(i). 

" 33 U.S.c. § 1314 (a)(I). 

2 
5 

invcstigation, cxpcrimcnts, dcmonstrations and studies relating to the causcs, cffccts, extcnt, prevcntion, 

reduction and elimination of pollution in the navigable waters of the U.S. 

The science enterprise at EPA is spread across program offices and regions. ORD is organized into 

three national labs (comprised of 18 separate labs) and four national centers (which have 19 divisions)7 

In addition to 18 labs within ORD, therc arc 9 labs split among sevcral program officcs and each of the 

10 regions has its own lab'" In FY2010, the appropriations level for EPA Science and Technology 

activities (S&T includes ORD and the other 19 labs) was $874.9 million. The appropriations level for 

FY2011 was 5840.3 million. The FY2012 House Committee-passed appropriations level is $777.6 

million and the FY2012 Senate Committee draft appropriations level is $809 million. 

The fragmented nature of EPA R&D presents a challenge to program management and coordination, 

and has complicated efforts to evaluate the effectiveness of these activities. Numerous studies 

conducted by the EPA Office of Inspector General, the Government Accountability Office, and others 

have cited significant concerns with the science activities of the Agency and the difficulties in 

evaluating the usefulness of the science to program needs. These studies have offered recommendations 

on how to improve the science enterprise at EPA, but many of these recommendations have not been 

implemented. 

7 See Appendix 2. 

1\ Sec Appendix 3. 
6 

SEPA l""~c ':::_M~ 

f ~,"C ~,",' f:" .,' "r:, 

U.S. EPA 

Organizational 

Chart 

Appendix 1 

Administrator 

Deputy Administrator 

AuistantAdministralor 

ror Air and Racli.ation 

Assistant Administrator 

tor Chemical Safety 

and PoIIWon Prevention 

AssistantAdministrator 

for International and 

TribollAffafrs 

I 

Office of the Chief 

FlnancialOfficer 

AssistantAdministrator 

tor Water 

AssistantAdministrator 

forResearchanc! 

Deviriopment 

AssistantAc:lmintstmor 

itlrErtYironrnental 

Information 

I 

Office of General 

Counsel 

I 

A$si$tant Administrator I for Solid Waste and 

Emergency Response 

A$sistantAdministrator 

fot' Enforcementand 

ComplianceAnllrance 

AssistantA!ministrator 

for Administration and 

Resources Management 

Office of Inspector 

General 

I Region 1 Region 2 Region 3. Region 4 Region 5 I I Boslon NewYorl< Philadelph" AIIanta Chicago i 

=r= I· ±~=L Region 6 

Dallas 

Region 1 

Kans.asClty 

4 

Region B Region 9 i Region 10 

Denver ! San Franciscol Seattle 
7 

&EPA I.i~::~~ 511t~s 

I 1,/, ')M,~'I1:<" 'r~:f::),;r 

iqeJl::'1 

~ionaIfIM!IIl.d 

Er.oI,,,,,,,,,,ot..:lThtI~ 

~u~tt. ~!lQ'JI.~~i 

1 

Appendix2 

ORO's Organization 

!mm!dimOffice 

oftheAs~f5tilntA.dminj&I.f310i 

Patti Anil$las. Assi5tantAd'1linfstmlf 

lek Kadth,Deputy Assis!am:AdminiltratorioJ Management 

Kevin T elehman. Oeptliy A"blant Administrator for Science 

RamonaTrI)VatD AssooateAssJstantAdmini:striaoJ 

/' ~?u;=!l~~t 

I

f .~ir,CI"'I,,"d"""!1 '$;aro~A~ &rs:.Ilr~IU\'l':Dr RiI:sc~rus 

• hmmH. '"~ Ik1!tnyC"",,,~~;'i'!"l 

·C~.I;~ISlloq.fD,~r"~ltr 

·~tnI~ IM/'J ~ISI!.Ann""rt 

'\ 

1 

\, .h~~"dSo.:oril'f ./ 

2 

Nr.I~": 

RS:t;~.~1l'1!r:I 

Rnact!..aborl:t:I'y 

3 

The bottom of this chart shows three nationClllabs and four national centers The three national labs are broken down in 

IIppendix 3. 
8 

Appendix3 

•••• ' •••••••• ',~! ••••••••••••••••••••••• , ••• ',L.!-: • • • • •• • • • • •• • .... ~...:..c~( :-:-: :-!.C;!7:t:-: :-:::: :-:::::::::::::::: :!.C;!~::: =.::: ::.!!:: ~:! :-: ~WI.IIII.IIIIII~IIIi ••• IIII •• IIIIII.IlIlIIi ••••••••• 1l1 ii~.:.-IIIi.II;Ii-IIM •• IIi-lliilllll;W-W.1I1I II "." 11.11 II "." "'.11" II.," 1111.11.",.," 1111.11.l1li.'" "II" ".1111"" '".1111" II II III .... II II. -II-If,II.IIII-III1,. 111.-11111 11=:11-111=.11 1!,1I~1I._,!.,.~1t 11.111 

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.......................... 

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""_"'11_" __ 11_"_11 "'_11 __ " "_III II "_11_"'_11" "_11_",_", II "" 11_" II" .. "'_II"". II""" .. "'. ~-~:!~III-IIII11-lIIlIIlIIlII ~-III'IiI ~-111111:111~~ 1II_~'111":~~~ ~_~ t ' .. , ... '''''.· ........ CI ...... .,.._I"S-....... ' .. IFer-...... ~ •• '!III,...,. .. ·_ 

Column 1 shows 10 regional bbs. Column 2 shows 9 program IJbs Column 3 shows 18 ORO l.1bs. 
9 

Chairman HARRIS. The Subcommittee on Energy and Environment will come to order. Good afternoon. Welcome to today’s hearing entitled ‘‘Fostering Quality Science at EPA: Perspectives on 

Commonsense Reform.’’ In front of you are packets containing the 

written testimony, biographies, and truth in testimony disclosures 

for today’s witness panel. 

I now recognize myself for five minutes for an opening statement. 

I want to welcome everyone to this afternoon’s hearing. This is 

the second in a series of hearings this Subcommittee will be conducting to provide ideas and guidance to reform science at EPA. 

Unfortunately, the Environmental Research, Development, and 

Demonstration Authorization Act or ERDDA, which is the statute 

authorizing R&D at EPA, as well as the Science Advisory Board, 

was last reauthorized for fiscal year 1981. Thirty years of Congressional neglect and the aggressive and unjustified regulatory train 

wreck being pursued by this Administration make the time right 

to evaluate reforms to environmental science at the agency. 

Many things have changed since 1981 that demand renewed 

Congressional attention. Funds appropriated to EPA science and 

technology account have more than tripled from 1981 to 2010, and 

the agency’s overall budget has ballooned to almost $9 billion. The 

agency now employs almost 18,000 people and maintains nearly 40 

laboratories. 

According to the Office of Management and Budget the overall 

effect of all major federal regulations in 1981, were a net cost savings of $1 billion. In contrast, in 2010, EPA’s major rules alone represented over 23 billion in costs, a figure itself that many believe 

is a significant underestimate, and there have been disagreements 

as to the real benefits of these regulations. 

There are also very pragmatic reasons for us to be keenly interested in reforming and reauthorizing science activities at the EPA. 

Given the dire fiscal straits that our country is facing, programs, 

activities, and agencies that are operating under expired or outdated authorizations will have targets on their backs as we seek 

to get our budgetary house in order. 

In light of this the right reforms to EPA R&D programs will not 

only improve trust in the science that informs regulatory decisions 

but will also provide a framework to prioritize the most important 

functions and reduce unnecessary and wasteful spending elsewhere. 

For instance, despite 1.2 million examples of successful hydraulically-fractured wells, the agency is moving forward with an unnecessary study in the area. 

Some basic questions need to be asked. What should the role of 

EPA be in conducting research? Should it be limited to fundamental research? Should R&D be limited to supporting the agency’s 

regulatory agenda? What is the relationship between EPA’s science 

and policymaking missions? And how do we prevent the politicizing 

of scientific activities? How can Congress best ensure regulatory 

science that is reliable, peer-reviewed, transparent, understandable, and objective? Are structural changes necessary to improve 

the quality and independence of the agency’s scientific advisory 

bodies? And do we have our environmental priorities right? And 

are we getting the most environmental bang for our buck? 
10 

This hearing follows up on testimony received two weeks ago 

from officials at the EPA’s Office of Research and Development, Office of the Inspector General, and the Government Accountability 

Office. 

Furthermore, in order to build a substantive record this is actually the ninth hearing on science and process at the EPA that this 

Committee has held so far in the 112th Congress. The Committee 

has also sent a series of letters to EPA and the Administration requesting further information about policies on transparency, cost 

benefit analysis, and peer review. Unfortunately, we are still waiting for responses to four letters sent since September. 

Reforming environmental science should not be a partisan issue, 

as the 2009 report by the Bipartisan Policy Center’s Science for 

Policy Project co-chaired by the former chair of the full Science 

Committee, Sherry Boehlert, explained, ‘‘A tendency to frame regulatory issues as debates solely about science, regardless of the actual subject in dispute, is at the root of the stalemate and acrimony 

all too present in the regulatory system today.’’ 

The report went on to recommend that Congress should include 

their recommendations, ‘‘In legislation as relevant programs are reauthorized,’’ including suggesting the studies used in developing 

regulations should be subject to data access requirements, agencies 

and advisory bodies should be transparent in their approach to 

evaluating weighing studies, and that agencies should explicitly 

differentiate between scientific judgments and policy judgments. 

These are reasonable core principles that I hope both sides can 

agree upon and which will advance fulfillment of the President’s 

executive order requiring that, ‘‘Our regulatory system must be 

based on the best available science.’’ 

The diverse set of witnesses with us today will offer their views 

on these and other EPA scientific reform ideas and offer recommendations for improving and clarifying environmental R&D 

priorities. I hope these suggestions will highlight some potential 

avenues for bipartisan cooperation as our Subcommittee continues 

its work on these issues. 

Again, I want to thank all the witnesses for appearing before the 

Subcommittee, and I look forward to a constructive discussion. 

[The prepared statement of Mr. Harris follows:] 

PREPARED STATEMENT OF CHAIRMAN ANDY HARRIS

I want to welcome everyone to this afternoon’s hearing on Fostering Quality 

Science at EPA: Perspectives on Common Sense Reform. 

This is the second in a series of hearings this Subcommittee will be conducting 

to provide ideas and guidance to reform science at EPA. Unfortunately, the Environmental Research, Development and Demonstration Authorization Act, or ERDDAA 

(ERDDA), which is the statute authorizing R&D at EPA as well as the Science Advisory Board, was last reauthorized for fiscal year 1981. Thirty years of Congressional 

neglect and the aggressive and unjustified regulatory train wreck being pursued by 

this administration make the time ripe to evaluate reforms to environmental science 

at the Agency. 

Many things have changed since 1981 that demand renewed Congressional attention. Funds appropriated to EPA’s science and technology account have more than 

tripled from 1981 to 2010, and the Agency’s overall budget has ballooned to almost 

$9 billion dollars. The Agency now employs almost 18,000 people, and maintains 

nearly 40 laboratories. According to the Office of Management and Budget, the overall effect of all major federal regulations in 1981 was a net cost savings of $1 billion. 

In contrast, in 2010, EPA’s major rules alone represented over $23 billion in costs— 
11 

a figure itself that many believe is a significant underestimate and there have been 

disagreements as to the real benefits of these regulations. 

There are also very pragmatic reasons for us to be keenly interested in reforming 

and reauthorizing science activities at the EPA. Given the dire fiscal straits that 

our country is facing, programs, activities, and agencies that are operating under 

expired or outdated authorizations will have targets on their backs as we seek to 

get our budgetary house in order. In light of this, the right reforms to EPA R&D 

programs will not only improve trust in the science that informs regulatory decisions, it will also provide a framework to prioritize the most important functions 

and reduce unnecessary and wasteful spending elsewhere. For instance, despite 1.2 

million examples of successful hydraulically-fractured wells, the Agency is moving 

forward with an unnecessary study in this area. 

Some basic questions need to be asked: What should be the role of EPA in conducting research? Should it be limited to fundamental research? Should R&D be 

limited to supporting the Agency’s regulatory agenda? What is the relationship between EPA’s science and policymaking mission, and how do we prevent the politicizing of scientific activities? How can Congress best ensure regulatory science that 

is reliable, peer reviewed, transparent, understandable, and objective? Are structural changes necessary to improve the quality and independence of the Agency’s 

scientific advisory bodies? And do we have our environmental priorities right, and 

are we getting the most environmental bang-for-our-buck? 

This hearing follows up on testimony received two weeks ago from officials from 

EPA’s Office of Research and Development, Office of the Inspector General, and the 

Government Accountability Office. Furthermore, in order to build a substantive 

record, this is actually the ninth hearing on science and process at the Environmental Protection Agency that this Committee has held so far in the 112th Congress. The Committee has also sent a series of letters to EPA and the Administration requesting further information about policies on transparency, cost-benefit 

analysis, and peer review. Unfortunately, we are still waiting for responses to four 

letters sent since September. 

Reforming environmental science should not be a partisan issue. As a 2009 report 

by the Bipartisan Policy Center’s Science for Policy Project, co-chaired by the former 

Chair of the full Science Committee, Sherry Boehlert, explained: ‘‘A tendency to 

frame regulatory issues as debates solely about science, regardless of the actual subject in dispute, is at the root of the stalemate and acrimony all too present in the 

regulatory system today.’’ The report went on to recommend that Congress should 

include their recommendations ‘‘in legislation as relevant programs are reauthorized,’’ including suggesting that studies used in developing regulations should be 

subject to data access requirements, agencies and advisory bodies should be transparent in their approach to evaluating and weighing studies, and that agencies 

should explicitly differentiate between scientific judgments and policy judgments. 

These are reasonable core principles that I hope both sides can agree on and 

which will advance fulfillment of the President’s executive order requiring that ‘‘Our 

regulatory system . . . must be based on the best available science.’’ 

The diverse set of witnesses with us today will offer their views on these and 

other EPA scientific reform ideas, and offer recommendations for improving and 

clarifying environmental R&D priorities. I hope these suggestions will highlight 

some potential avenues for bipartisan cooperation as our Subcommittee continues its 

work on these issues. 

I want to thank the witnesses for appearing before the Subcommittee and I look 

forward to a constructive discussion. 

Chairman HARRIS. The chair now recognizes Mr. Miller, the 

Ranking Member, for five minutes for an opening statement. 

Mr. MILLER. Thank you, Mr. Chairman. I appreciate your accommodating me by beginning slightly early this afternoon to allow me 

to cast votes in the Financial Services Committee, and I would also 

like to make this Committee’s efforts in rewriting the authorization 

statute to be a bipartisan effort. I appreciate your willingness to 

work with us to try to make future hearings more useful to the 

Committee in informing that important work. 

Today the Subcommittee meets again for part two of the EPA research and science, series of hearings. The first hearing two weeks 

ago was disappointing and a missed opportunity. The stated purpose of the hearing a couple weeks ago was to examine the ability 
12 

of EPA’s research enterprise to meet the agency’s mission to protect public health and the environment. 

However, many of my colleagues decided instead to use their 

time to focus on EPA’s hydraulic fracturing study rather than on 

that stated purpose. I believe the goal of this series of hearings 

should be to establish a useful Committee record to prepare the 

right legislation to reauthorize the Environmental Research, Development, and Demonstration Authorization Act, ERDDA. 

Today’s hearing does not appear to be any more likely to inform 

the Committee about structural and substantive concerns of stakeholders related to EPA’s research activities, and it is not a balanced, comprehensive, or even a helpful hearing. This hearing 

looks like what we are seeing on the House Floor this week, a platform for anti-regulation, anti-science talking points, and as I said 

a couple of weeks ago, I hope that my Republican counterparts are 

truly interested in reform that will lead to better research to enhance public health and protect the environment. 

Although we all agree that there are legitimate concerns related 

to EPA’s research enterprise, this hearing doesn’t really help us 

understand or address those issues. The agency’s scientific research 

is important as more complex environmental issues emerge and 

evolve that need to be understood and addressed. Scientific research knowledge and technical information are fundamental to 

EPA’s mission and inform its standard setting, regulatory compliance, and enforcement functions. That is why Congress saw fit to 

create advisory bodies at EPA like the Clean Air Scientific Advisory Committee, which was created to provide independent advice 

on the science and allow the Administrator to make regulatory decisions. 

I really hope today that we would have a productive conversation 

about how best to position EPA to perform that mission, protecting 

human health and the environment. And if we are really serious 

about working towards reauthorizing ERDDA, which does need to 

be done as the Chairman said, after 30 years perhaps it is wise to 

revisit that statute, we must establish a Committee record that will 

offer us a wide range of views on how best to draft legislation that 

would serve the agency better, as well as the people that we all 

represent. 

If that is the case, I hope that we can commit to working together after today to put together hearings and panels that will 

serve that purpose. 

And with that, Chairman Harris, I yield back. 

[The prepared statement of Mr. Miller follows:] 

PREPARED STATEMENT OF RANKING MEMBER BRAD MILLER

Thank you Chairman Harris. Today the Subcommittee meets again for part two 

of the EPA research and science series of hearings. The first hearing two weeks ago 

was pretty disappointing and a missed opportunity. The stated purpose of our hearing a couple of weeks ago was to examine the ability of EPA’s research enterprise 

to meet the agency’s mission to protect public health and the environment. However 

many of my colleagues on the other side of the aisle decided to use their time to 

focus on EPA’s hydraulic fracturing study rather than on that stated purpose. I believe the goal of this series of hearings is to establish a useful Committee record 

in preparation of writing legislation to reauthorize the Environmental Research, Development, and Demonstration Authorization Act (ERDDA). 
13 

Today’s hearing does not appear to be any more likely to inform the Committee 

about structural and substantive concerns of stakeholders related to EPA’s research 

activities. It is not balanced, comprehensive, or even helpful. This hearing looks just 

like what we are seeing on the House floor this week—the anti-regulation, antiscience talking points of the far right. As I said a couple of weeks ago, I hoped that 

my Republican counterparts were really interested in reform that will lead to better 

research to enhance public health and protect the environment. Although we all 

agree that there are legitimate concerns related to EPA’s research enterprise, this 

hearing doesn’t come close to helping us understand or address these issues. The 

agency’s scientific research is important as more complex environmental issues 

emerge and evolve that need to be understood and addressed. Scientific research, 

knowledge, and technical information are fundamental to EPA’s mission and inform 

its standard-setting, regulatory, compliance, and enforcement functions. That is why 

Congress saw fit to create advisory bodies at EPA, such as the Clean Air Scientific 

Advisory Committee (CASAC), which was created to provide independent advice on 

the science which allows the Administrator to make regulatory decisions. 

I really hoped that today we would have a productive conversation about how best 

to position the EPA to perform its mission of protecting human health and the environment. If we are really serious about working towards reauthorizing ERDDA, we 

must establish a Committee record that will offer us a wide-range of views on how 

best to draft legislation to better serve the agency as well as the people that we 

all represent. If that is the case, I hope that we can commit to working together 

after today in formulating hearings and panels that will serve that purpose. 

With that, Chairman Harris, I yield back. 

Chairman HARRIS. Thank you very much, Mr. Miller. 

If there are Members who wish to submit additional opening 

statements, your statements will be added to the record at this 

point. 

At this time I would like to introduce our witness panel. Again, 

I want to thank you for your patience. For the slightly delayed 

start. Our first witness today is the Honorable Susan Dudley, Director of the Regulatory Studies Center and Research Professor of 

Public Policy and Public Administration at the George Washington 

University. From April, 2007 through January, 2009, Professor 

Dudley served as the Presidentially-appointed Administrator of the 

Office of Information and Regulatory Affairs in the U.S. Office of 

Management and Budget. 

The next witness will be Dr. Alan Moghissi, the President of the 

Institute for Regulatory Science. Previously working for EPA Dr. 

Moghissi managed numerous programs, including the Bio-Environmental Radiological Program at the National Environmental Research Center in Las Vegas, the Health and Environmental Risk 

Analysis Program in Washington, DC. He was also the Principle 

Science Advisor for Radiation and Hazardous Materials and represented the Office of Research and Development in a number of 

work groups responsible for drafting environmental regulations. 

The next witness is Dr. Kenneth Green, a Resident Scholar at 

the American Enterprise Institute. Dr. Green has studied public 

policy and regulation at Free Enterprise Think Tanks across North 

America for nearly 20 years. An environmental scientist by training, Dr. Green focuses on policy and regulations involving energy 

and environmental health. 

And the final witness today is Dr. Gary Marchant, Professor of 

Law and Executive Director of the Center for Law, Science, and Innovation at Arizona State University. Prior to joining the ASU faculty in 1999, he was a partner in the Washington, DC, law firm, 

Kirkland & Ellis, where his practice focused on regulatory issues. 
14 

Thank you all for appearing before the Subcommittee today. As 

our witnesses should know, spoken testimony is limited to five minutes each, after which the Members of the Committee will have five 

minutes each to ask questions. 

I now recognize our first witness, Ms. Susan Dudley, Director of 

the Regulatory Studies Center and Research Professor of Public 

Policy and Public Administration at the George Washington University. 

Ms. Dudley. 

STATEMENT OF MS. SUSAN DUDLEY, DIRECTOR, 

REGULATORY STUDIES CENTER, AND RESEARCH PROFESSOR 

OF PUBLIC POLICY AND PUBLIC ADMINISTRATION, 

GEORGE WASHINGTON UNIVERSITY 

Ms. DUDLEY. Thank you, Chairman Harris, Ranking Member 

Miller, and Members of the Subcommittee. As you mentioned I am 

at G.W. but my remarks here today are my own. 

EPA regulations are often the subject of heated debate involving 

accusations of politicized science and advocacy science. While it is 

legitimate to be wary of policy officials and politicians trying to influence scientific studies, more often than not, these debates center 

on issues that science can inform but not decide. 

And I am actually going to read a quote from the Bipartisan Policy Center Report that the chairman mentioned. In fact, you read 

the same quote, but I am going to repeat it again. This is the Bipartisan Policy Center Report, ‘‘Improving the Use of Science and 

Regulatory Policy.’’ ‘‘ A tendency to frame regulatory issues as debates solely about science, regardless of the actual subject in dispute, is at the root of the stalemate and acrimony all too present 

in the regulatory system today.’’ 

And I do highly recommend that report. I think it does show that 

these issues are not partisan. Framing issues as debates solely 

about science is problematic for two reasons. 

First, while science is essential for understanding the positive 

question of what is, it is less helpful for the normative policy question of what should be. Sound policy decisions depend not only on 

scientific assessments of risk but also on other factors such as economics, ethics, law, and, yes, politics, the will of the people. 

Second, scientists will never have complete information to predict 

outcomes with absolute certainty, so even the risk assessment as 

opposed to the risk management phase of an analysis depend on 

assumptions and judgments that guide the use of scientific information. 

Policymakers and the public are often unaware of the influence 

of these risk assessment policy choices or the existence of alternative assessments that are equally plausible. Instead, assessments often generate precise-sounding predictions that hide considerable uncertainty about the actual risk and heavily are influenced 

by hidden judgments about what policies should look like. 

Institutional arrangements in the regulatory development process tend to aggravate these problems, perpetuating the charade 

that policies are based purely on science, insulating experts involved in a particular rulemaking from dissenting views, rein-
15 

forcing preconceptions and biases, and leading to regulatory policy 

decisions that are not at all transparent. 

As the Committee evaluates approaches to address perceived 

problems in the quality of EPA science, it is important to identify 

whether the source of the problem is politicians attempting to control science or the politicization of science, or scientists attempting 

to control policy, something that David Goldston, who was the Executive Director of the Bipartisan Policy Center Project on this and 

now at NRDC, calls that the scientification of policy. 

My own experience supports the Bipartisan Policy Center’s conclusion that the latter problem is behind much of the controversy 

related to science-based regulation. So with that in mind, let me 

offer three modest recommendations. 

One, recognize that science is a positive discipline that can inform but not decide appropriate policy. Avoid the temptation to delegate decisions to agencies on the pretense that science alone can 

make the normative decision of what the policy should be. I was 

going to quote again from the Bipartisan Policy Center report, but 

I won’t in the interest of time. 

My second recommendation to recognize that risk assessment 

necessarily involves assumptions and judgments as well as pure 

scientific inputs and establish procedures and incentives to make 

more transparent risk assessment inputs in the range of plausible 

outcomes. 

The National Academies of Science has offered numerous recommendations in this regard for improving the quality and transparency of the EPA risk assessment, including in its recent report 

earlier this year on the formaldehyde IRIS process. 

And my final recommendation is to increase the robustness of 

regulatory science by institutionalizing feedback mechanisms along 

with checks and balances. The scientific method depends on 

falsifiable hypotheses, data gathering, dissent, and challenge to ensure objective analysis to minimize bias in the interpretation of results. 

Now, no one is truly objective, so institutional reforms that engage and encourage competing views could go a long way to improve the clarity of the risk assessment process and the decisions 

that depend on scientific input. 

President Obama has taken some positive steps in this regard, 

reinforcing interagency review and calling for more open exchange 

with the public. 

Other successful reforms might involve pre-rulemaking disclosure of risk assessment information to engage broad public comment on the proper choice of studies, models, assumptions, et 

cetera, long before any policy decisions are framed and positions 

are set in stone. 

And with 1 second left I will stop. Thank you. 

[The prepared statement of Ms. Dudley follows:] 

PREPARED STATEMENT OF MS. SUSAN DUDLEY, DIRECTOR, 

REGULATORY STUDIES CENTER, AND RESEARCH PROFESSOR OF PUBLIC POLICY

& PUBLIC ADMINISTRATION, THE GEORGE WASHINGTON UNIVERSITY

Chairman Harris, Ranking Member Miller, and Members of the Subcommittee, 

thank you for inviting me to testify today on ‘‘Fostering Quality Science at EPA: 

Perspectives on Common Sense Reforms.’’ I am Director of the George Washington 
16 

1The George Washington University Regulatory Studies Center raises awareness of regulations’ effects with the goal of improving regulatory policy through research, education, and outreach. This statement reflects my views, and does not represent an official position of the GW 

Regulatory Studies Center or the George Washington University. 

University Regulatory Studies Center and Research Professor in the Trachtenberg 

School of Public Policy and Public Administration. 1

From April 2007 to January 2009, I oversaw the executive branch regulations of 

the federal government as Administrator of the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB). I have devoted my career to trying to improve both the framework for developing regulations 

and our understanding of regulations’ effects, and for over three decades have examined regulations from perspectives in government (as both a career civil servant and 

political appointee), academia, consulting, and the non-profit world. 

*** 

EPA regulations intended to address public health and environmental risks depend on scientific information. They are often the subject of heated debate involving 

accusations of ‘‘politicized science’’ and ‘‘advocacy science,’’ as everyone—including 

scientists and agency officials—wields scientific information in the service of advocacy. While it is legitimate to be wary of politicians or policy officials trying to influence scientific studies, more often than not, these debates center on issues that 

science can inform, but not decide. 

As the Bipartisan Policy Center, in its 2009 report, Improving the Use of Science 

in Regulatory Policy, observed: 

Political decision-makers should never dictate what scientific studies should conclude, and they should base policy on a thorough review of all relevant research 

and the provisions of the relevant statutes. But some disputes over the 

‘‘politicization’’ of science actually arise over differences about policy choices that 

science can inform, but not determine. (BPC 2009, 4) 

Science is rarely sufficient for making policy decisions for two reasons. First, 

while science is essential for understanding the positive question of what is, or predicting what outcomes might derive under different scenarios, it is less helpful for 

the normative (policy) decisions regarding what should be. Sound policy decisions 

depend not only on scientific assessments of risk, but also on other factors, such as 

economics, ethics, law, and politics—the will of the people. 

Second, scientists will never have complete information to predict outcomes with 

absolute certainty, so risk assessors use what the National Research Council (NRC 

1983) called ‘‘risk assessment policy’’—assumptions and rules of thumb—to guide 

the use of scientific information in analyses that inform policy in the face of uncertainty. 

In each step [of the risk assessment process], a number of decision points (components) occur where risk to human health can only be inferred from the available 

evidence. Both scientific judgments and policy choices may be involved in selecting 

from among possible inferential bridges, and we have used the term risk assessment policy to differentiate those judgments and choices from the broader social 

and economic policy issues that are inherent in risk management decisions. (NRC) 

Policymakers and the public are often unaware of the influence of these risk assessment policy choices or the existence of alternative assessments that are equally 

plausible. Instead, assessments often generate precise-sounding predictions that 

hide considerable uncertainty about the actual risk. Since EPA’s stated policy is to 

err on the side of overstating risk, it relies on one-sided policy choices at each node 

in the risk assessment process. Policy decisions that are reported as if they are 

based on science are heavily are influenced by these hidden staff judgments about 

what policies should be. 

While some judgment is necessary to translate scientific evidence into risk assessment, current risk assessment policies lead to distortions in risk estimates and false 

precision in the presentation of scientific information. This threatens the scientific 

credibility of the process, hiding rather than making transparent the uncertainty in 

assessments of risk, putting key policy choices in the hands of staff, and allowing 

policy makers to avoid making hard decisions. 

When questions involving policy judgment and values are falsely characterized as 

scientific, a small number of people have an effective monopoly on the information 

that is used and how it is characterized, leading to decisions that are not as accountable or as transparent as they should be. ‘‘When regulators purport to rely on 
17 

2 Institutions and Incentives in Regulatory Science, Lexington Books, Jason Johnston ed., 

forthcoming spring 2012. 

science as the sole basis for their policy choices, the real reasons justifying their 

choices remain hidden from public view.’’ (Coglianese 2009) This is exacerbated by 

the adversarial nature of rulemaking, and group dynamics that discourage differences of opinion and lead to poor decisions that mask uncertainty and give short 

shrift to important factors and perspectives. 

Institutional arrangements in the regulatory development process tend to aggravate these problems, perpetuating the charade that policies are based purely on 

science, insulating experts involved in a particular rulemaking from dissenting 

views, reinforcing preconceptions and biases, and leading to regulatory policy decisions that are not at all transparent. 

Statutory mandates, such as those directing EPA to set National Ambient Air 

Quality Standards (NAAQS) for ‘‘criteria pollutants’’ under the Clean Air Act, can 

make inevitable the ‘‘science charade,’’ where regulatory agencies ‘‘camouflag[e] controversial policy decisions as science.’’ (Wagner 1995, 1614) Congress directs EPA 

to set NAAQS at a level that is ‘‘requisite to protect public health with an adequate 

margin of safety,’’ but restricts the agency from considering key factors, establishing 

instead the pretense that science is sufficient to determine a single point concentration that is ‘‘requisite to protect public health.’’ The courts have reinforced a limited 

interpretation of the Act, as well as tight deadlines for issuing revised standards. 

Executive branch career and policy officials respond by developing scientific-sounding explanations to justify one standard over another. Analysts have an incentive 

to downplay rather than reveal the implications of key risk assessment policy 

choices, and decision makers point to science as either requiring a new standard or 

as being so uncertain that a new standard cannot be set. The interagency review 

process is often truncated by very short timeframes established by the statute and 

reviewing courts, and constrained by the limited range of options presented by EPA 

and its Clean Air Science Advisory Committee. Public interveners vigorously defend 

alternative standards based on their own interpretation of the science. 

This has evolved into an adversarial process, characterized by harsh rhetoric in 

which each party claims the science supports its recommended policy outcome and 

questions opponents’ credibility and motives, rather than a constructive discussion 

regarding appropriate assumptions and data and the reasonableness of the statutory goal. The real reasons for selecting a non-zero standard are not transparent. 

*** 

As the Subcommittee evaluates approaches to address perceived problems with 

the ‘‘quality, usefulness and objectivity of EPA science,’’ it is important to identify 

whether the source of the problem is: 

A. politicians attempting to control science (‘‘politicization of science’’), or 

B. scientists attempting to control policy (‘‘scientification of policy.’’) 

My own experience supports the BPC conclusion that this latter problem is behind 

much of the controversy related to science-based regulation, and is the main contributor to the science charade: 

A tendency to frame regulatory issues as debates solely about science, regardless 

of the actual subject in dispute, is at the root of the stalemate and acrimony all 

too present in the regulatory system today. (BPC 2009, 10) 

Current procedures for developing regulations addressing health and environmental risk blur the lines between science and policy, hindering not only public policy decisions, but development of scientific knowledge itself. Current institutions 

provide incentives to bury policy judgments in analyses that are presented as 

science, perpetuating the science charade. 

Altering these incentives is challenging, and I appreciate this Subcommittee’s interest in this subject. In a chapter of a forthcoming book, 2 my coauthor Professor 

George Gray and I offer modest suggestions aimed at increasing transparency in 

regulatory science, strengthening the checks and balances provided by different participants in the rulemaking process, and engaging a broad range of expertise and 

perspectives to counter the problems insular decision-making brings. Those suggestions are the basis for a few recommendations to the Subcommittee. 

1. Recognize that ‘‘science’’ is a positive discipline that can inform, but not decide, 

appropriate policy. Avoid the temptation to delegate decisions to agencies on the 
18 

pretense that ‘‘science’’ alone can make the normative determination of what 

policy should be. 

The BPC observed: 

The first impulse of those concerned with regulatory policy should not be to claim 

‘‘the science made me do it’’ or to dismiss or discount scientific results, but rather 

to publicly discuss the policies and values that legitimately affect how science gets 

applied in decision making. (BPC 2009, 4) 

Distinguishing between science and policy is not always easy or straightforward, 

and scientists may make choices based on values in the course of their work. Nonetheless, policy debate would be clarified and enhanced if a systematic effort were 

made to distinguish between questions that can be resolved through scientific judgments and those that involve judgments about values and other matters of policy 

when regulatory issues comprise both. This transparency would both help force values debates into the open and could limit spurious claims about, and attacks on 

science. (BPC 2009, 15) 

Legislators should also take care to limit the role of scientific advisory panels to 

advising on science, and not to embed their policy views in their scientific recommendations. The BPC recommended: 

In general, scientific advisory panels should not be asked to recommend specific 

regulatory policies. (BPC 2009, 5) 

2. Recognize that risk assessment necessarily involves assumptions and judgments 

as well as pure scientific inputs, and establish procedures and incentives to 

make more transparent risk assessment inputs and the range of plausible outcomes. 

Efforts to identify and characterize the uncertainty in scientific evidence by quantifying the range of outcomes of potential regulatory actions may provide useful data 

for improving risk assessment policy choices and increasing confidence in decisions. 

The BPC recommended: 

In presenting the conclusions of literature reviews, agencies and their scientific 

advisory committees need to be as open and precise as possible in discussing levels 

of risk and uncertainty. Policy makers should be wary of conclusions about risk that 

are expressed as a single number. (BPC 2009, 8) 

3. Increase the robustness of regulatory science by institutionalizing feedback 

mechanisms, checks, and balances. 

Greater transparency in the models, assumptions, and risk assessment policy 

choices could encourage more open, constructive debate on those choices. The scientific method depends on falsifiable hypotheses, data gathering, dissent, and challenge to ensure objective analysis to minimize bias in the interpretation of results. 

No one is truly objective. We all approach problems with our own ‘‘priors’’ and, 

particularly when faced with new or incomplete information, we tend to look to others in whom we trust to help form our opinions and make decisions. Cass Sunstein’s 

interesting research on ‘‘why groups go to extremes’’ shows that individuals form 

more extreme views when surrounded by others with similar perspectives. Institutional reforms that engage competing views could go a long way to improve the clarity of the risk assessment process and the decisions that depend on scientific input. 

President Obama has built on his predecessors’ efforts to provide for interagency 

review of different aspects of regulatory decisions, including the underlying science. 

He has directed agencies to encourage an ‘‘open exchange of information and perspectives among State, local, and tribal officials, experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole, including relevant scientific and technical findings.’’ 

Successful reforms might involve pre-rulemaking disclosure of risk assessment information, to engage broad public comment on the proper choice of studies, models, 

assumptions, etc. long before any policy decisions are framed, and ‘‘positions’’ established. 

*** 

I appreciate this Subcommittee’s interest in improving how science informs environmental regulation, and welcome opportunities to discuss the likely effects of different reforms. 
19 

*** 

References 

• Breyer, S. (1993). Breaking the vicious circle: toward effective risk regulation. 

Harvard Univ Pr. 

The Bipartisan Policy Center (2009). Improving the Use of Science in Regulatory 

Policy. http://www.bipartisanpolicy.org/library/report/science-policy-project-finalreport 

• Coglianese, C. U.S. House of Representatives, The Committee on Science and 

Technology (2009). Testimony on the role of science in regulatory reform. 

http://democrats.science.house.gov/Media/file/Commdocs/hearings/2009/ 

Oversight/30apr/Coglianese—Testimony.pdf 

• National Research Council (1983). Risk Assessment in the Federal Government: 

Managing the Process. National Academy Press. 

• Sunstein, C. (2009). Going to Extremes: How Like Minds Unite and Divide. Oxford University Pr. 

• Wagner, W.E. (1995). The science charade in toxic risk regulation. Columbia 

Law Review, 95(1613). 

Chairman HARRIS. Thank you very much. 

I now recognize our second witness, Dr. Alan Moghissi, the President of the Institute for Regulatory Science. 

STATEMENT OF DR. ALAN MOGHISSI, PRESIDENT, INSTITUTE 

FOR REGULATORY SCIENCE 

Dr. MOGHISSI. Chairman Dr. Harris, Ranking Member Miller, 

Members of the Subcommittee, as the chairman said my name is 

Alan Moghissi, and I am the President of Institute for Regulatory 

Science. We are not for profit organization established in 1985, and 

we are in Alexandria, Virginia. We are dedicated to the idea that 

societal decisions notably environmental regulations must be based 

on what we call best available science, and Mr. Chairman, you 

used that term, and that was music to my ear. 

And we define best available science if you go to our website at 

www.nars.org, you will find upon the description of BAS, my testimony to you is based on that, however, my—it is—what I am doing 

today is my personal interpretation of BAS rather than official pronouncement of the Institute for Regulatory Science. 

Although the term regulatory science is used extensively in the 

interest of transparency, let me define it again. Regulatory science 

consists of the scientific foundation of policy, notably regulatory decisions. It is the science part of the subject rather than societal implications of the regulatory side. 

Based on this definition the scientific activity of the EPA are 

overwhelmingly regulatory science. I appreciate the opportunity to 

testify before your Committee, and I am proposing the Congress to 

enact the Regulatory Science Sunshine Act, Regulatory Science 

Sunshine Act as a segment of the EPA Authorization Appropriation 

or as a separate act. 

My written testimony includes metrics for evaluation of regulatory science information and regulatory science ethics. My apologies that I cannot describe them because I needed more than 1 

hour to do so, and I have only five minutes. 

Please note that the regulatory science information at best in the 

metrics that I included partially reproducible evolving science and 

often at lower maturity going all the way to scadon to scientific 
20 

judgment or even speculation. A characteristic of the class I just 

described a partially reproducible evolving science is that although 

its foundation is proven science and uncontested, it often uses a 

macolic on the right side described, assumptions, judgment, default 

data, and values if the relevant data or values aren’t all available 

and most unfortunately as Mr. Chairman pointed out, on occasion 

it uses societal adjustments that are outside the purview of science. 

The proposed Regulatory Science Sunshine Act would require 

that within the R&D Program EPA makes a concerted effort to 

double up procedures, processes, and methods for each regulatory 

science, regulatory decision that is based on or includes science, 

one, identification of assumptions, judgment, default data, any 

other similar system used in the regulatory process, identification 

of potential alternatives, and how the conclusions would be different if an alternative assumption, judgment or similar parameters are used. 

Two, description of the content of all mathematical equations in 

words. 

Three, information identified above must be written in a language that is understandable to knowledgeable non-specialists or 

better yet to an average person. 

Clear and unambiguous justification for the inclusion of societal 

objectives in science rather than addressing societal objectives in 

the administrative decision process. 

And obligation of EPA to comply with ethical requirement of regulatory science. 

I am a proud member of the—proud charter member of the EPA 

and believe that EPA has done an outstanding job in protecting 

human health and the environment. However, I would be less than 

frank if I would not express my concern over certain decisions that 

have had adverse societal including environmental consequences. 

There are those in the regulatory science community who believe 

that members of the other scientific disciplines have settled the 

general public without difficulties understanding the complex nature of regular—of scientific—of regulations. They are wrong. They 

are dead wrong. 

Quoting Sir Thomas Jefferson as did my boss, Ruckelshaus, ‘‘If 

we think the people are not enlightened enough to exercise their 

control with a wholesome discretion, the remedy is not to take it 

away from them but to inform their discretion.’’ 

Thank you much. 

[The prepared statement of Mr. Moghissi follows:] 

PREPARED STATEMENT OF DR. ALAN MOGHISSI, PRESIDENT, INSTITUTE FOR

REGULATORY SCIENCE

Chairman Dr. Harris, Ranking Member Miller, and Members of the Subcommittee; I am A. Alan Moghissi, President of Institute for Regulatory Science 

(RSI). We were established in 1985 as a not-for-profit organization located in Alexandria, VA and. We are dedicated to the idea that societal decisions notably environmental regulations must be based on what we call ‘‘Best Available Science’’ or BAS. 

I am a proud charter member of the U.S. Environmental Protection Agency (EPA) 

and believe that EPA has done an outstanding job in protecting human health and 

the environment but I am less proud that EPA has missed some opportunities to 

use BAS in its decisions. I appreciate the opportunity to testify before your Committee and intend to suggest that the time has come for the EPA to substantially 

expand transparency in the scientific foundation of its regulatory activities. 
21 

Science at the EPA and the Establishment of Regulatory Science 

Looking back at the history when EPA was formed, although there were laws 

dealing with air, water, and food, the ability of government to adequately regulate 

emission of toxic agents was limited. For example, there was no law that provided 

government for regulating manufacturing of chemicals. During that period the Congress quickly passed a number of laws mandating promulgation of regulations at 

a rapid pace. Upon the formation of the EPA, the managers and scientists at that 

Agency were faced with the urgent need to promulgate a large number of regulations based on deadlines mandated by legislative actions or judicial decisions. This 

problem caused the EPA to rely upon the judgment of scientists, short cutting scientific issues, and use their best to meet the deadlines. During this initial phase 

of the EPA the phrase regulatory science appeared describing the scientific segments or parts of regulations. Meanwhile regulatory science is defined as follows: 

Regulatory science consists of the scientific foundation of policy notably regulatory 

decisions 

Regulatory science, sometimes called regulatory sciences, covers many disciplines 

(Moghissi et al, 2011). It includes regulatory toxicology, regulatory ecology, regulatory hydrology, and regulatory atmospheric sciences, to mention a few. It is no different than other disciplines such as chemistry discipline that covers, inorganic 

chemistry, organic chemistry, biochemistry, physical chemistry, chemical engineering, and medicinal chemistry, to mention a few. 

As expected virtually all regulatory agencies must deal with regulatory science in 

promulgating their regulations. For example the Food and Drug Administration 

(FDA) has not only used that term to describe its scientific objectives but also has 

devoted significant funds for R&D devoted to regulatory science in areas of its regulatory authority. Similarly, the EPA has an extensive regulatory science program 

both in its R&D and program offices, although that term is not always used in its 

pronouncements. 

With the maturity of the EPA’s regulatory process the EPA is provided significant 

funding for R&D. A discussion of relevancy of EPA’s R&D to its mission, the quality 

of science used in its regulatory process and related issues have been addressed numerous times and most recently, in testimonies before this Committee (Anastas 

2011, Trimble 2011, Elkins 2011). Therefore, this testimony will address the transparency issue, a subject that appears to have been insufficiently addressed. As stated above, during its initial phases of operation, EPA was facing deadlines and had 

to go through shortcuts. Meanwhile, the EPA has time to thoroughly evaluate the 

scientific foundation of its regulations. An example of these regulations is emission 

limits being considered for greenhouse gases. EPA did not face a deadline and based 

on its own desire undertook the laborious and highly contested decision to regulate 

greenhouse gases. 

Subsequent to the formulation of the term regulatory science, my colleagues and 

I tried to develop a systematic process for evaluation of regulatory science information. We had to identify fundamental principles not only for regulatory science but 

also for any scientific claim. We had also to address how does an organization including a regulatory agency assesses the reliability of a scientific claim regardless 

of its origin. We struggled for many years to address the level of maturity of scientific information. Finally, we had to address the issue of science vs. areas outside 

the purview of science. These efforts took over three decades and have reached sufficient maturity that can be described here. 

Metrics for Evaluation of Regulatory Science Information 

As stated above, the development of the BAS system and Metrics for Evaluation 

of Regulatory Science Information (MERSI) derived from BAS was the result of extensive efforts to systematically evaluate a number of issues addressing the needs 

of a large segment of the affected communities, notably regulatory science. The development of MERSI was the consequence of three previous publications. The first 

formal effort Best Available Science; Its Evolution, Taxonomy and Applications 

(Moghissi et al 2008) contained the fundamental concept of BAS. The next attempt 

led to the publication of the book: Best Available Science: Fundamental Metrics for 

Evaluation of Scientific Claims (Moghissi et al 2010) that in many respect, was the 

second edition of the first book. A new version of that book by Moghissi and 

Swetnam is in preparation. During all of these activities the dominant role of independent peer review in regulatory science was unambiguously described. Consequently, it was logical to prepare a book Peer Review and Scientific Assessment: 

A Handbook for Funding Organizations, Regulator Agencies and Editors (Moghissi 

et al, in press) with significant applicability to regulatory science. 
22 

Fundamental Principles of MERSI 

Open-Mindedness Principle: This principle implies that the regulatory science community and the general public must be willing to consider new knowledge and new 

scientific claims. 

Skepticism Principle: This principle requires that it is incumbent upon those who 

make a scientific claim to provide sufficient evidence supporting their claim. The 

Skepticism Principle provides balance and ensures that the Open-Mindedness principle is not misused. 

Universal Scientific Principles: The Universal Scientific Principles are a set of basic 

principles and standards that apply to virtually all of the scientific disciplines including regulatory sciences. 

Transparency Principle: Those who make a scientific claim have not only the intellectual but also the ethical obligation to identify the level of maturity and reliability 

of each segment, and if societal or other areas outside the purview of science are 

included in the claim. 

Reproducibility Principle: Reproducibility is the proof of validity of any scientific 

claim, and separates undisputed areas of science from those that include assumptions and interpretations. 

Pillar: Classification of Scientific Information 

It is well established that science evolves and that new discoveries, advancement 

of scientific knowledge, and numerous technologies result from the evolution of 

science. Therefore, it is necessary to classify scientific information (SI) in terms of 

its level of maturity and its reproducibility. 

Class I: Proven SI: This class consists of scientific laws (or principles) and their application. The scientific foundation of information included in this class is understood and meets the requirements of the Reproducibility Principle. Scientific laws 

or principles are predictable and reliable. As the majority of SI covered in regulatory 

sciences seldom qualifies as Proven SI, further discussion is not required. 

Class II: Evolving SI. The overwhelming majority of scientific advancements and 

virtually all regulatory science information are included in this class. 

Reproducible Evolving SI: Reliable and reproducible information dealing with a 

subject that is not completely understood constitutes the core of this class. Much 

of medical science provides a good example of Reproducible Evolving Science. Like 

Class I (Proven SI) information in this class meets the Reproducibility Principle. 

However unlike Proven SI, the scientific foundation of information in this class is 

often either unknown or the knowledge is incomplete. 

Partially Reproducible SI: Sometimes referred to as Rationalized SI or Scientific 

Extrapolation this class includes a large segment of regulatory science information 

including predictive models. Although it builds upon Proven or Reproducible Evolving SI, it uses assumptions, extrapolations, and default data to derive its results. 

An important characteristic of this class is its level of reproducibility. Whereas the 

scientific foundation of this class meets the Reproducibility Principle the choice of 

assumptions, mathematical processes, default data, and numerous other prerequisites are inherently arbitrary and thus are not necessarily reproducible. 

Correlation-Based SI: This class attempts to correlate systematic observations performed in accordance with Universal Scientific Principles to an effect. There is an 

extensive literature covering this class including a large segment of epidemiology. 

Experience shows that correlation does not necessarily imply causation and as expected, some correlations have correctly identified their cause but others have 

proven to be unrelated. A segment of evidence-based medicine belongs to this class. 

Hypothesized SI: An organized response to an observation, an idea, or any other 

initiating thought process constitutes the core of this class. This class seldom if 

ever has a scientific foundation. Obviously, this class does not comply with the Reproducibility Principle. 

SI based on Judgment: In the absence of scientific information, decision makers 

may call upon scientific experts to make an educated judgment. There is an accepted methodology for this process that involves asking multiple qualified and knowledgeable individuals to answer specific questions and statistically assessing the results. Even so, the results are still tantamount to an educated guess. 
23 

Speculation: Speculation does not meet the standards for any of the discussed 

classes of scientific information addressed above. It is based solely on the opinion 

and intuition of an individual. Often the objective of speculation is to initiate a research project or stimulate a scientific discussion. 

Fallacious Information: Most unfortunately, the scientific community and the general public are often provided fallacious information presented as science. Often 

called ‘‘junk science’’ or ‘‘pseudo science,’’ some of the information provided to the 

regulators by special interest groups qualifies as fallacious information. 

Pillar: Reliability of SI 

This Pillar requires a formal and generally acceptable process to categorize the 

reliability of SI. Consequently, SI is divided into several distinct categories in ascending level of reliability 

Category I: Personal Opinions. Expression of views by individuals regardless of 

their training, experience, and social agenda are seldom reliable. 

Category II: Gray Literature. Reports prepared by government agencies, advocacy 

groups, and others that have not been subjected to an independent peer review are 

included in this category. Gray Literature is often no more reliable that personal 

opinion. 

Category III: Peer-Reviewed SI. The acceptability of a scientific claim requires that 

it has been subjected to independent peer review and has passed the strict scrutiny 

by independent scientific peers. Peer review is a well established process and 

issued extensively in scientific publications and grant submission. Briefly, an acceptable peer reviewer is an individual who is capable of understanding and performing the project under review with little or no additional study. Furthermore, 

the reviewer must also be independent and without conflict of interest. Finally, 

(ASME/RSI2002) those who have a stake in the outcome of the review may not act 

as reviewers or participate in the selection of the reviewers. Despite its acknowledged shortcomings peer review is the only available mechanism to assess the validity of a scientific claim, aside from reproducing the actual claim. 

CategoryIV: Consensus-Processed SI. In the consensus process an expert panel, convened in a manner similar to that described for Review Panels, evaluates the proposed information. Since much of regulatory science falls into the Rationalized, 

Correlation-Based, or Hypothesized SI, it is not surprising that contradictory information can be found in peer-reviewed literature covering a specific subject. In such 

cases, the consensus process increases the likelihood that its outcome would be 

consistent with the information that will result from relevant future studies. 

Pillar: Outside the Purview of Science 

One of the most often violated requirements of regulatory science is the inclusion 

of societal objectives, ideology, beliefs, and numerous other non-scientific issues. On 

occasion, the regulators claim that they must include societal objectives in their scientific activities to be protective of human health, the ecosystem, and numerous 

other worthwhile goals. What is being overlooked is that all of these goals, as desirable as they might be, are outside the purview of science and must be addressed 

after the scientific issues have been resolved. The confirmation of this Pillar is provided by the Ruckelshaus Effect (Ruckelshaus 1983, Moghissi et al in press) which 

states that ‘‘ . . . all scientists must make it clear when they are speaking as scientists -ex cathedra-and when they are recommending policy they believe should 

flow from scientific information . . . ’’ 

Ethics of Regulatory Science 

One of the key issues needing the consideration of legislators and regulators is 

compliance with ethical principles of regulatory science. Only these principles were 

only recently formulated, they are readily derivable from ethical principles of virtually all professions notably scientific, engineering, and medical professions. 

Principle I: 

A scientific issue is settled when anyone with the necessary scientific skills, required 

equipment, and facilities can reproduce it. 

On more than one occasion proponents of an issue claim that ‘‘science has spoken’’ 

or ‘‘science is settled’’ or several other phrases indicating that the scientific part of 

a regulatory process has been clarified. In effect, those who make such a claim must 
24 

provide evidence that the science is reproducible and in the MERSI system, falls 

into Proven or Reproducible Evolving SI. 

Principle II: 

Those who prepare a regulatory science document must provide to the affected community assumptions, judgments, and similar parts in a language understandable to 

a knowledgeable non-specialist. 

This principle includes the consequences of using ‘‘assumptions, judgments, and 

similar parts,’’ the justification of using them, and potential alternatives that were 

not used. This principle is based on the MERSI principle on transparency. The regulated community, the scientists and their organizations, and the interested members 

of the public are entitled to know the regulatory science is used in a specific decision. 

Principle III: 

Regulatory science information must exclude societal objectives thus violation the 

MERSI Pillar ‘‘Areas Outside the Purview of Science.’’ 

During the initial phases of the EPA, the need for rapid promulgation of regulations 

led to ‘‘being protective’’ and included societal judgments in the scientific process. 

One can argue if during that period those actions were justified. However the inclusion of societal objectives or ant other subject that is included in ‘‘areas outside the 

purview of science’’ is not justified. 

Principle IV: 

Regulatory science information is only then acceptable if it has been subjected to 

independent peer review and the review criteria (questions provided to peer reviewers) 

include compliance with principles I, II, and III of regulatory science ethics. 

There is a consensus within the scientific community that peer review is a prerequisite for acceptability of scientific claims. However, the peer review of regulatory 

science information is particularly important because of the usage of ‘‘assumptions, 

judgments, and similar parts.’’ It is crucial to ensure that the selection of ‘‘assumptions, judgments, and similar parts’’ is not based on a preconceived desire of the regulatory science participants to promote a specific goal. Similarly, if societal objectives are included in regulatory science information, they should be not only identified but also justified. 

Proposed Roadmap for Fostering Quality Science at the EPA 

Before addressing the proposed roadmap, it is imperative to recognize that the establishment of the EPA and actions taken by that agency, resulted in a cleaner and 

healthier environment. It would not be constructive to evaluate the performance of 

the EPA with the objective to see if EPA could have done a better job. Instead, it 

is more productive to propose relevant R&D with the objective to improve EPA’s 

performance by enhancing the transparency of the regulatory science used by that 

agency. 

It is proposed to enact the Regulatory Science Sunshine Act as a segment of 

the EPA authorization/Appropriation or as a separate Act. The proposed Act would 

require that EPA develop processes, procedures, and methods for each regulatory 

decision that is based on or includes science: 

1. Identification of assumption judgments, default data, or other similar systems 

used in the regulatory process, identification potential alternatives, and how 

the conclusion would be different if alternative assumptions, judgments, and 

similar parameters were used. 

2. Description of the content of all mathematical formulations in words. 

3. The information identified above must be written in a language that is understandable to a knowledgeable non specialist or, better yet, to an average person. 

4. Clear and unambiguous justification for the inclusion of societal objectives in 

science rather than addressing societal objectives in the administrative decision process. 

5. Obligation of the EPA to comply with ethical requirements of regulatory 

science 

The Regulatory Science Sunshine Act would require that EPA makes a concerted effort to develop relevant processes, procedures, and methods to respond to 

the needs identified above. As many other regulatory agencies face the same problem, such an effort would also benefit numerous other agencies. 
25 

Consequences of Regulatory Science Sunshine Act 

The opposition to transparency in regulatory science is based on the following: 

1. There are those who believe that the ‘‘average citizen’’ is not educated enough 

or smart enough to appreciate the intricacies of regulatory science. 

2. Some of the staff members of regulatory agencies consider that items identified under Regulatory Science Sunshine Act to be burdensome. After all, 

whereas scientists in regulatory agencies have a unique competency, others 

do not have relevant experience and competency. 

3. The identification of potential uncertainties would result in the opposition of 

the public to the relevant regulation. It is being claimed that people would 

suggest that in view of these uncertainties no money should be spent to promulgate or comply with a specific regulation. 

4. Certain lobbyists with access to regulatory agencies prefer the current situation because they can impact the regulations without the remainder of the society having the ability to judge the foundation of decisions without significant efforts. 

5. Members of a variety of advocacy groups also prefer the current situation, as 

long as the political leadership is supporting them. 

6. There are numerous other individuals and groups who are either opposed to 

transparency or do not care one way or another. 

A closer look at the items identified indicates that the following issues are legitimate and must be addressed: 

Ability of the Public to Follow Regulatory Science: It is true that a segment of population will have difficulties following the intricacies of regulatory science. However, 

other segments are capable of comprehending the subject. In addition using as my 

former boss William Ruckelshaus quoted Thomas Jefferson ‘‘If we think [the people 

are] not enlightened enough to exercise their control with a wholesome discretion, 

the remedy is not to take it from them, but to inform their discretion.’’ 

Competency of Regulatory Agency Staff: There is ample evidence indicating that 

there are scientists outside the regulatory agency who are as competent or more 

competent in relevant areas of regulatory science than the staff members of the relevant agency. This subject is well recognized by reliance upon peer review. 

Decisions Based on Uncertain Scientific Information: By far the most critical issue 

in the proposed legislation in the legitimate issue of convincing the public that a 

decision is necessary in the interest of the society. It should be recognized that societal decisions based on incomplete and uncertain scientific information is more common than may appear. 

The example of meteorology can be used to demonstrate the point, a discipline 

that provides short term weather forecasting. Most cities rely upon forecasts on 

snow and its severity and use them to mobilize the necessary personnel and ensure 

availability of relevant equipment. Similarly, governmental agencies make decisions 

on both positive and negative consequences of the predicted rainfall. 

Let us use the example of Hurricane Irene to demonstrate the point. Events related to this hurricane started at about August 15, 2011 and a few days later, it 

became clear that Irene would impact the U.S. The pathway of Irene was modified 

as the hurricane moved closer and its severity was modified several times from category I to category II and Category III but as Irene landed it was largely category 

I. Many cities and communities had to make decisions based on the information 

they received at any given time in every case the information was uncertain and 

incomplete until Irene landed. Should the decision makers wait until they had complete and fully reliable information? No responsible decision maker would do so. 

Conversely, often the predicted weather proves to be wrong. How often a sunny day 

is predicted and how often rain or snow is predicted but the predictions prove to 

be wrong. 

The EPA and other regulatory agencies have the legal and ethical obligation to 

inform the public to the best of their ability the status of the science used in their 

regulatory decisions. The information must include assumptions, judgments, the inclusion of default data, and any other information that impacted the scientific aspects of their decision. 

Conclusions 

The Regulatory Science Sunshine Act would require a reorientation of the 

EPA’s R&D with the objective to develop processes, procedures, and methods for 
26 

transparency in regulatory decisions. EPA should be required to identify assumptions, judgments, default data, or other similar systems used in the regulatory process, identify potential alternatives, and how the conclusion would be different if alternative assumptions, judgments, and similar parameters were used. In addition, 

EPA should attempt to describe the content of all mathematical formulations in 

words. Furthermore, the Act should mandate that EPA makes a concerted effort to 

describe these activities in a language that is understandable to a knowledgeable 

non specialist or, better yet, to an average person. 

References 

Ananstas P. Written testimony before the U.S. House of Representatives; Committee 

on Science, Space and Technology; Subcommittee on Energy and Environment. (November 17) 2011 

ASME/RSI(American Society of Mechanical Engineers/Institute for Regulatory 

Science) Assessment of Technologies supported by the Office of Science and Technology Department of Energy; Results of peer review for fiscal year New 2002. York, 

NY, ASME 2002. 

Elkins Jr. AA. Fostering quality science at EPA. Statement before the Subcommittee 

on Energy and Environment, Committee on Science, Space and Technology; U.S. 

House of Representatives, (November 17) 2011. 

Moghissi AA, Straja SR, Love BR, McBride DK, Swentnam M. Best Available 

Science; its evolution, taxonomy, and application. Arlington, VA:Potomac Institute 

for Policy Studies; 2008 

Moghissi AA, Swentnam M, Love BR, Straja SR. Best Available Science; its evolution, taxonomy, and application, second edition. Arlington, VA: Potomac Institute 

Press; 2010 

Moghissi AA, McBrideDK, Amin MA. Regulatory Sciences: Description of the disciplines ,education, and ethics. Tokyo; Japan Science and Technology Agency, 2011 

Moghissi AA, Straja SR, Love BR. Peer review and scientific assessment: A handbook for funding organizations, regulatory agencies, and editors. Cambridge, UK 

Cambridge University Press (in press) 

Moghissi AA, Swetnam M. Best Available Science; A systematic process for the development and application of metrics for evaluation of scientific claims (in preparation) 

Ruckelshaus WD. Science, risk, and public policy. Science 221; 1026–1028: 1983 

Trimble DC. Environmental Protection Agency; Actions needed to improve planning, 

coordination, and leadership of EPA laboratories. Testimony before the Subcommittee on Energy and Environment, Committee on Science, Space and Technology; U.S. House of Representatives, (November 17) 2011. 

Chairman HARRIS. Thank you very much. 

I now recognize our third witness, Dr. Kenneth Green, a Resident Scholar at the American Enterprise Institute. 

STATEMENT OF DR. KENNETH GREEN, RESIDENT SCHOLAR, 

AMERICAN ENTERPRISE INSTITUTE 

Dr. GREEN. Thank you. Chairman Harris, Ranking Member Miller, Members of the Subcommittee, I thank you for inviting me to 

testify today. I am as the chairman said Kenneth Green, a Resident Scholar with the American Enterprise Institute. I am a biologist and environmental policy analyst by training, and I have studied public policy with a science component for about 20 years now, 

mostly in non-profit and non-partisan public policy research institutions across North America. 

My testimony represents only my views and should not be associated or construed as the official position of anybody else, and my 

spoken testimony is an abstract from the written testimony I sub-
27 

mitted, which is a little bit lengthier, and I wouldn’t have time for 

it today. 

For the sake of complete disclosure, I want to mention that verbally what I submitted in my truth in testimony form, I have 

served as a grant reviewer for the U.S. EPA on three or four occasions and was paid their customary per-diem for participating in 

such reviews in 2008, and 2009. Other than offering my judgment 

on the quality and soundness and relevance of potential grant proposals, I had no other involvement with the award process, nor any 

involvement to my knowledge of any grant recipients or applicants 

in any way. 

In fact, I would like to take a second to compliment EPA on the 

rigor of the process they use to evaluate these outside grant proposals and innovative grant requests. I was quite impressed with 

the level of rigor and discipline involved in analyzing the proposals, 

ranking them, discussing them, the knowledge ability of the panelists and so forth, and I commend that process. 

I wish I could say that all of EPA’s science-related activities were 

equally satisfying to think about, but unfortunately, I can’t. My 

own research, both my own research and reading in the literature 

suggests that EPA has serious problems in the way that it employs 

scientific information when it assesses both the potential benefits 

and potential costs of existing and proposed public policies. 

As is common in the public health community, EPA’s science culture seems highly risk averse, so much so that when confronted 

with a range of possible risks, they tend to accept assumptions and 

design protocols, analytical protocols and frameworks in ways that 

lead to ever-greater estimations of health risk from ever-lower levels of exposure to environmental pollutants. This is sometimes referred to simply as being conservative or precautionary. In a medical context that can be beneficial, and indeed, nobody wants the 

agency to blithely dismiss risks, but when such artificially-elevated 

risk estimates are translated into economic estimates of regulatory 

benefit and cost and used to prioritize agency efforts and activities, 

the product is increasingly costly regulations that do increasingly 

little good, or worse in some cases, actually impose costs to society 

greater than the benefits that they produce. 

That is where things diverge from a harmless precautionary exercise into poor public policy, and I think it is a serious problem. 

Without a sound understanding of the proposed benefits and costs 

of regulations, it is impossible to have a rational public policy development process. 

It is also difficult for agencies without that to determine their 

regulatory priorities. Thus, even where an agency’s proposals might 

do more harm than good, they can’t optimally bring their resources 

to bear where they can do benefit to secure the biggest bang for 

the regulatory dollar without wasting public revenues, public resources. 

My own experience with EPA is partly back in 1997, when I was 

looking at the National Ambient Air Quality Standards, and I noticed some of the problems with the way EPA handles risk assessment. While EPA on one hand was saying that, well, if we reduce— 

we want to stop the reduction of high-level ozone in the atmosphere 

because that ozone protects people from cataracts and skin cancer, 
28 

they did not want to account for that same phenomenon when they 

said they want to reduce ozone in lower levels of the atmosphere. 

And yet the reduction of ozone would have the same effect. 

So they didn’t want to net out the benefits and harm, possible 

harms of the regulation, and that was pointed out by others, and 

I think eventually was discussed in the Supreme Court, that you 

have to do a net assessment of health and risks and benefits. 

Others have documented bigger problems. Garrett Vaughn in 

2006 examined EPA’s claims about the benefits and costs of their 

air quality regulations and observed that EPA’s estimate of having 

saved the country some $22 trillion through public health protection from 1970 to 1990 would, if accurate, roughly equal the aggregate net worth of all U.S. households in 1990. Vaughn points out 

that by EPA claims net benefits equal to nearly three times the 

profits of all U.S. corporations and a return on capital by the EPA 

regulations of 500 percent, comparing to a seven percent rate return on investment in the private sector. 

Economist Anne Smith recently testified to this Committee, Subcommittee, one associated interesting effect of EPA’s benefits inflation is that the degree to which it makes the total number of 

deaths attributable to particulates implausible. EPA’s presumption 

that fully 320,000 deaths in the United States were due to particulate matter in 2005 represents over 13 percent of all deaths in the 

United States on average. And behind this average is the presumption that in large expanses of the Eastern U.S., between 16 and 22 

percent of all deaths in 2005 were due to particulate matter. 

The distortions go on, and I could continue, but I am running out 

of time. I am sure we all agree that protecting the environment is 

very important. Having grown up with asthma myself in the San 

Fernando Valley in California, smog capital of North America at 

the time, I am very aware of the role that poor air quality can play 

in determining one’s quality of life. 

But I hope we also agree there is no benefit in overprotection, 

and there is no benefit in misallocation of resources, and there is 

no benefit in the misdirection of attention to small risks at the expense of large risks, which we face elsewhere in the economy, and 

that getting the science right is important. 

EPA’s use of science tends to overestimate the risks humans face, 

I believe, and underestimate the cost of compliance and regulations, leading to poor public policy development. 

With that I look forward to your questions. Thank you very 

much. 

[The prepared statement of Mr. Green follows:] 

PREPARED STATEMENT OF DR. KENNETH GREEN, RESIDENT SCHOLAR, AMERICAN

ENTERPRISE INSTITUTE

The views expressed in this testimony are those of the author alone and 

do not necessarily represent those of the American Enterprise Institute. 

Chairman Harris, Ranking Member Miller, Members of the Subcommittee: 

Thank you for inviting me to testify today. I am Kenneth P. Green, a Resident 

Scholar at the American Enterprise Institute. 

I am a biologist and environmental policy analyst by training, and I have studied 

public policies with a science component for nearly 20 years now, mostly at nonprofit, non-partisan public policy research institutions across North America. I 

began career studying air quality regulations in California, and later expanded that 
29 

focus to national air quality policy, climate policy, and energy policy, which are inextricably related. 

My testimony represents my personal views only, and should not be construed as 

the official position any other persons or organizations with which I may be affiliated. 

For the sake of complete disclosure, I want to mention verbally what I submitted 

in my ‘‘Truth in Testimony’’ form: I have served as a grant reviewer for the United 

States Environmental Protection Agency on 3 or 4 occasions, and was paid their customary per-diem for participating in such reviews in 2008 and 2009. Other than offering my judgment on the quality, soundness, relevance, and potential of grant proposals, I had no other involvement with the award process, nor, to my knowledge, 

have I had any involvement with any grant recipient or applicant in any way. 

In fact, I would like to take this opportunity to compliment EPA on the rigor of 

the process employed for the reviews in which I participated, which involved assessing relatively low-cost research proposals by university researchers and small businesses in the area of environmental technology, energy technology, and related research. The level of professionalism I encountered in my review sessions was refreshing. The reviewers selected were clearly knowledgeable, diverse, and applied 

serious effort to the analysis of research proposals that sought taxpayer funding. 

These were satisfying exercises after which I felt confident that, if the EPA followed 

the conclusions of the reviewers, taxpayer money might provide some net social benefit. 

I wish I could say that all of EPA’s science-related exercises are equally satisfying 

to think about, but unfortunately, I cannot. Both my own research and reading in 

the literature suggests that EPA has serious problems in the way it employs scientific information when it assesses both the potential benefits, and potential costs 

of existing and proposed public policies. 

As is common in the Public Health community, EPA’s science-culture seems highly risk-averse, so much so that when confronted with a range of possible risks, they 

tend to accept assumptions and design analytical protocols and frameworks in ways 

that lead to ever-greater estimations of health risk from ever-lower levels of pollution exposure. This is sometimes referred to as being ‘‘conservative,’’ or ‘‘precautionary.’’ In a medical context, this can be beneficial, and indeed, nobody wants 

an agency to blithely dismiss proclaimed risks to the public health. 

However, when such artificially elevated risk estimates are translated into economic estimates of regulatory benefit and cost, the product is increasingly costly 

regulations that do increasingly little good, or worse, actually imposes costs greater 

than the benefits it produces. 

This is where things diverge from harmless (if excessive) ‘‘risk-aversion’’ into poor 

public policy, and it is, I think, a serious problem: having a sound understanding 

of the proposed benefits and costs of regulation is a pre-requisite for rational public 

policy development. 

Without rigorous benefit-cost estimates, it is impossible for an agency to determine regulatory priorities. Thus, even where an agency’s proposals might do more 

harm than good, they cannot optimally bring resources to bear to secure the biggest 

safety return-on-investment for regulatory investments potentially wasting scarce 

public tax resources. This applies between agencies as well. If agency A uses methodologies that inflate the risk posed by the things they regulate, they may well draw 

public resources away from agency B, which uses more scientifically accurate riskassessment methods. 

As researchers such as Anne E. Smith, Garrett A. Vaughn and others have observed, the tendency to overstate risk, leading to over-estimates of regulatory benefits have afflicted what many would consider EPA’s most important mission: ensuring that air quality is kept at a level that protects the public health with an adequate margin of safety. 

In my own research looking at the proposed 1997 revisions to the National Ambient Air Quality Standards, I noted similar problems. For example, while EPA was 

arguing that preserving ozone levels in the upper atmosphere offered protection 

against cataracts and skin cancer caused by UV exposure, they did not account for 

the fact that ozone anywhere in the atmosphere offers similar protections. Thus, 

they did not consider that lowering ozone levels would increase some risks while decreasing others. 

Others have documented even larger absurdities, and things have not improved 

over time. 

In 2006, Garrett A. Vaughn examined EPA’s claims about the benefits and costs 

of their air quality regulations. 
30 

1Garrett A. Vaughn (2006). ‘‘Regulatory Sleight of Hand: How the EPA’s Benefit-Cost Analyses Promote More Regulation and Burden Manufacturers. (VA: Manufacturers Alliance) 2 Anne E. Smith (2011). ‘‘Prepared Statement of Anne E. Smith, Ph.D. at a Hearing 

on’’Quality Science for Quality Air’’ by the Subcommittee on Energy and the Environment , 

Committee on Science, Space, and Technology, United States House of Representatives, Washington, DC, October 4, 2011 

Vaughn points out that the EPA’s estimate of having saved the country some $22 

trillion dollars through public health protection from 1970 to1990, ‘‘If accurate, that 

sum would equal ‘‘roughly the aggregate net worth of all U.S. households in 1990.’’ 

Vaughn points out that by EPA’s self-promoting calculations, ‘‘In 1990, for instance, 

the EPA claims net benefits equal to nearly three times the profits of all U.S. corporations.’’ Given how little EPA claimed its regulations cost, the implication was 

that ‘‘EPA’s rate of return on capital exceeded 500%, compared to the private sector’s 7 percent.’’ That is an absurd thought which should have triggered an agency 

‘‘reality check,’’ but clearly did not. 1

As economist Anne E. Smith recently testified to this Subcommittee 2: 

• EPA is relying to an extreme degree on coincidental ‘‘co-benefits’’ from PM2.5 

reductions to create the impression of benefit-cost justification for many air regulations that are not intended to address PM2.5. 

• In 2009, EPA vastly increased the levels of mortality risks that it attributes to 

PM2.5 simply by starting to assign risks to levels of PM2.5 down to zero exposure, thus ‘‘creating’’ risks from ambient exposures that are well within the safe 

range established by the PM2.5 NAAQS. 

• This single change nearly quadrupled the pool of purported US deaths due to 

PM2.5 that RIAs can now count as ‘‘saved’’ by minor incremental reductions in 

already-low ambient PM2.5 levels projected under new rules. 

• This additional pool of PM2.5-related mortality consists of the most noncredible 

sort of risk estimate, as it is derived from an assumption that a unit of exposure 

at PM2.5 levels well below any observed in the epidemiological studies poses 

just as much risk as a unit of exposure at the higher PM2.5 levels where associations have been detected. 

• With this change, EPA is now assuming that 13% to 22% of all deaths in the 

Eastern U.S. were due to PM2.5 in 2005, and that 25% of all deaths nationwide 

were due to PM2.5 as recently as 1980. 

• The decision to inflate the PM2.5 risk estimates by presuming risks continue 

down to zero has its greatest impact on co-benefits estimates because—for rules 

that do not address PM2.5 directly—a much greater share of their incremental 

reduction of PM2.5 will occur in areas that are already in attainment with the 

PM2.5 NAAQS (and thus that have PM2.5 levels that EPA has deemed safe). 

Yet, EPA now attributes about 200,000 more PM2.5-related deaths per year to 

exposures in those areas. 

• If it were viewed as credible that such large effects exist below the level of the 

PM2.5 NAAQS, the appropriate policy remedy would be to tighten the PM2.5 

standard, and not to regulate something else altogether in order to obtain those 

benefits through ‘‘coincidence.’’ 

Smith further observed that: 

• ‘‘One associated and interesting effect of this benefits inflation, however, is the degree to which it makes the total number of deaths attributed to PM2.5 implausible. EPA’s presumption that fully 320,000 deaths in the U.S. were ‘‘due to 

PM2.5’’ in 2005 represents over 13% of all deaths in the U.S. on average. And 

behind that average is the presumption that in large expanses of the Eastern US, 

between 16% and 22% of all deaths in 2005 were ‘‘due to PM2.5’’. By extension 

(although EPA has not reported this calculation), EPA’s estimates imply that 

about 25% of all deaths nationwide were due to PM2.5 as recently as 1980.’’ 

I am sure that we all agree that protecting the environment and the health of 

all Americans is an important pursuit. Having grown up with asthma myself, I’m 

keenly aware of the role that poor air quality can play in determining one’s quality 

of life. 

But I hope we also agree that there is no benefit in over-protection, especially 

when such over-protection costs society a great deal of money that could be put to 

better uses elsewhere, such as, in the general economy where it might create jobs, 

which are also important determinants in people’s quality of life. 

EPA’s use of science tends to systematically over-estimate the risks humans face 

from environmental exposures to pollutants such as particulate matter. Combined 
31 

this with under-estimated compliance and regulatory costs, EPA’s use of science 

leads to inefficient use of scarce public resources, and imposes regulatory burdens 

that may well do more harm than good. To me, this is the core of EPA’s sciencepolicy problem, and is probably where any reform efforts should begin. 

I thank you again for this opportunity to testify, and look forward to your questions. 

Chairman HARRIS. Thank you. 

I now recognize our fourth and final witness, Dr. Gary Marchant, 

Professor of Law and Executive Director of the Center for Law, 

Science, and Innovation at Arizona State University. 

STATEMENT OF DR. GARY MARCHANT, 

PROFESSOR OF LAW AND EXECUTIVE DIRECTOR, 

CENTER FOR LAW, SCIENCE AND INNOVATION, 

ARIZONA STATE UNIVERSITY 

Dr. MARCHANT. Thank you, Mr. Chairman Harris and Ranking 

Member Miller and Members of the Committee. I am delighted to 

be here. My name is Gary Marchant. As was said I am a law professor at ASU, and I direct our Center for Law, Science, and Innovation, which we bill ourselves as the oldest and largest academic 

center in the country looking at the intersection of law with science 

and technology. And one of the major issues we focus on is to try 

and improve the use of science in various types of legal institutions 

and decision making, including regulatory agencies. I am delighted 

to be here. 

I really want to make two points today. The first one is the importance of science in our environmental regulatory decision making has never been higher both from the demand and supply side. 

From the demand side that the easy problems in environmental 

policy have been addressed, the things we can smell and see with 

our own eyes and ears and nose. We pretty much have dealt with 

the problems. 

The problems we have left are much more subtle, much more 

long term, and they really require science to tell us the answers. 

We are not going to detect it with our own senses. We can’t tell 

as individuals what is a problem of what we are exposed to. We 

really need science to tell us that. 

So science from a demand side has never been in greater need, 

and then from the supply side we have a lot of new science methods coming forward today of toxicogenomics and biomarkers and 

model ecosystem effects and so on. 

So we are getting a lot of new scientific methods coming into our 

environmental policy world as well, and the combination of those 

two I think have made science really critical more than ever before 

in how we deal with environmental policymaking. 

Now, two caveats about that, one, as Ms. Dudley has mentioned, 

science can’t answer the questions. Science is an extremely important input in our environmental decision making, but the decisions 

that EPA has to make are at the end normative. They incorporate 

science but a lot of other factors as well. 

And the second point is that science is always going to have uncertainty. You know, there is always going to be things we don’t 

know in science that is inherent to science. And so it is almost as 

important for scientists and science to tell us what we don’t know 

as much as we do know so that the decision makers at EPA and 
32 

elsewhere can make informed decisions based on that uncertainty. 

That is inherent to their decision making. 

So my second point is that the context and the institutional environment in which science is dealt with really matters. Science has 

these norms of how it works in and of itself, of objectivity, of neutrality, of looking at the data and making our decisions based on 

the data, not on personal values and interests and so on. 

And because scientists are humans we never get that perfectly 

right, but there are different ways in which science is done and different institutional contexts that make a big difference. If you don’t 

believe me, you know, just go into a courtroom these days and 

watch how science is delivered there. It is completely adversarial, 

and you are not getting the way science is supposed to be done. 

They are getting two hired guns on opposite extremes. 

What you need is a type of process that encourages sort of the 

consensual way that science works best, and when it is done in an 

adversarial or politicized environment, it doesn’t work as good as 

it should. 

And so you get two kinds of problems. You get a blending of 

science and policy, the two overlap, and it is hard to draw the line, 

what Wendy Wagner has called the Science Charade, often where 

agencies will explain a decision as a scientific decision that involves 

a lot of science but also involves some normative decisions that 

should also be expressly recognized. 

And the second one is you get both conscious but even more importantly subconscious change in your view on the science based on 

the policy preferences of the organization you are in. 

So I think both of those are problems that EPA faces because 

EPA is at root a very political and policy organization. I don’t mean 

that in a derogatory—they have to be that way. They are making 

these complex decisions that involve science but also politics and 

policy and values and all kinds of different factors, and they have 

to work in that sort of messy world. That is not a good world for 

science, and so the idea I would like you to consider is the idea of 

creating some kind of separate institution to deal with the science. 

This was brought up way back in the ’80s, in the so-called Red 

Book, the National Academy of Science considered that, that it is 

important to separate the science and the policy but didn’t agree 

we should put them in separate institutions. 

But what I would like to suggest is that it might be time to reexamine that, to put the science in a separate organization. I have 

written a couple of articles I suggest something called an Institute 

for Scientific Assessments, that would basically do these type of assessments in a neutral organization that runs on a scientific model 

rather than a more policy-type model. And from the bottom to the 

top, from the DNA of that organization, it works on the scientific 

model. 

And I think there is a couple of really good examples of that we 

can look at. The Health Effects Institute here in the United States, 

Europe created something called the European Food Safety Authority that works that same way, and both of those organizations inculcate sort of scientific values top to bottom, and the result is a 

product coming out of them that is respected across the board. 
33 

1 Cary Coglianese and Gary E. Marchant, Shifting Sands: The Limits of Science in Setting 

Risk Standards, 152 PENN. L. REV. 1255–1360 (2004). 2Wendy E. Wagner, The Science Charade in Toxic Risk Regulation, 95 COLUMBIA LAW REVIEW 1613–1723 (1995). 3 Robert M. Sussman, Science and EPA Decision-making, 12 JOURNAL OF LAW AND POLICY 573–587 (2004). 

And so if we can do that, we can start with this baseline of what 

science can tell us and what it can’t, and then we can go from there 

and make our political and policy decisions, and if we can do that, 

I think we will end up with both good science and good regulation. 

Thank you. 

[The prepared statement of Dr. Marchant follows:] 

PREPARED STATEMENT OF DR. GARY MARCHANT, PROFESSOR OF LAW AND EXECUTIVE

DIRECTOR, CENTER FOR LAW, SCIENCE & INNOVATION, ARIZONA STATE UNIVERSITY

Good afternoon Mr. Chairman and Members of the Committee. I am Gary 

Marchant, a tenured Professor of Law at the Sandra Day O’Connor College of Law 

at Arizona State University. Among other responsibilities, I am the Faculty Director 

of the Center for Law, Science & Innovation at ASU, the nation’s oldest and largest 

academic center studying the intersection of law with science and technology. One 

of the central missions of my Center is to promote better use of scientific evidence 

in legal institutions, including legislatures, regulatory agencies and courts. My testimony today is therefore closely aligned with that mission, although the views expressed here represent my own personal perspective on the question of improving 

science at EPA. 

The Critical Role of Science at EPA 

Science plays a critical role in EPA’s mission to protect human health and the environment. Over the past couple decades, the agency’s focus has shifted from the 

‘‘low hanging fruit’’ of obvious pollution problems that we can all see billowing out 

of pipes and smokestacks to more subtle and uncertain environmental problems that 

we cannot detect with our own senses. Increasingly we have to rely on science to 

inform us about the risks (or lack thereof) from chronic exposure to individual (or 

combinations of) chemicals, low-level exposures to ionizing or electromagnetic radiation, new materials such as nanotechnology, ecological disruptions, and climate 

change, to name but a handful of the almost unlimited inventory of possible environmental risks. As the demand for scientific inputs into environmental regulatory 

decision-making has grown, so too has the supply of new scientific models, techniques and methods that could be used in environmental decisions. This trend of 

an increasing demand for, and the supply of, scientific inputs into environmental 

regulatory decision-making will surely continue and even accelerate for the foreseeable future. 

While science is critical to EPA’s decision-making, there are two important caveats about the role of science. First, science alone can rarely if ever decide an environmental issue on its own. While sound science can and should inform the regulatory decision, the ultimate decision on whether, how, and to what level to regulate 

an environmental problem is an inherently normative decision that goes beyond 

science. 1 Thus, agency attempts to justify or defend regulatory decisions as being 

dictated by science is a fallacy that Wendy Wagner and others have described as 

the ‘‘science charade.’’ 2 The second caveat is that, without diminishing the role of 

science, the practical reality is that science is always full of uncertainties and gaps. 

Thus, it is almost as important to know what science can’t tell us as it is to know 

what science can tell us. 

The Institutional Context of Science 

While science is critical to EPA’s activities, many have been critical of EPA’s 

treatment of science. Former Deputy Administrator of EPA Robert Sussman wrote: 

‘‘The bottom line is that nobody likes EPA science. Congress does not like it, the 

scientific community does not like it, the environmental groups do not like it, and 

industry certainly does not like it.’’ 3 Even the EPA, in a 1992 assessment of the 

role of science in its own decision-making, concluded that ‘‘EPA science is of uneven 
34 

4 Environmental Protection Agency, Safeguarding the Future: Credible Science, Credible Decisions, Report of the Expert Panel on the Role of Science at EPA. Washington, D.C.: Government 

Printing Office (1992). 5See, e.g., ROBERT K. MERTON, THE SOCIOLOGY OF SCIENCE: THEORETICAL AND 

EMPIRICAL INVESTIGATIONS. Chicago: Chicago University Press (1973). 6 NATIONAL RESEARCH COUNCIL, RISK ASSESSMENT AND RISK MANAGEMENT IN 

THE FEDERAL GOVERNMENT. Washington, D.C.: National Academy Press (1983). 

quality, and the agency’s policies and regulations are frequently perceived as lacking 

a sound scientific foundation.’’ 4

The central focus of my testimony is that the institutional context in which EPA 

considers and incorporates science into its regulatory decision-making inevitably 

tilts, and/or is perceived as tilting, its scientific findings in the direction of the agency’s political and policy preferences. Science is not supposed to be influenced by such 

policy preferences—that is a recipe for the actual and perceived bias and distortion 

of science. At its ideal, science strives to be as neutral and objective as possible, 

driven by the data itself rather than extrinsic considerations such as politics, policy 

preferences, personal values, and bias. 5 The closer science approaches that ideal, 

the more useful it is, because it is then informing the decision-maker what we know 

and what we don’t know. Of course, since science is a human undertaking, it never 

achieves its absolute ideal, but my primary comment is that the institutional context in which science is presented and considered is a key factor for how closely 

science approaches its objective ideal. 

When science is addressed in an advocacy or partisan institutional context, it 

tends to be distorted to fit preferred outcomes, with selective reliance on the data, 

one-sided inferences and assumptions, and uncertainties dismissed or downplayed. 

Science much more closely approaches its objective ideal when it is addressed in an 

institutional context that emphasizes the norms of the scientific community - with 

a preference for consensus-based decisions, an emphasis on the actual data (especially if it has been peer reviewed and published in good scientific journals), express 

recognition of the inappropriateness of relying on personal or institutional preferences or interests, and openly acknowledging uncertainties and limitations of the 

data and resulting findings. 

EPA is an inherently partisan and political organization. This statement is not 

intended to be derogatory or critical. Rather, EPA necessarily and appropriately 

makes decisions that are based on a messy mix of politics, policy, economics, law, 

interests, and values, with a clear and important institutional mission to protect the 

environment and human health. This mixing bowl of facts/policy/values is necessary 

for making ultimate environmental regulatory decisions, but is not a good environment in which to develop and evaluate science. Of course, EPA should and does also 

bring science into its decision-making mix, but it would be better if the scientific 

input injected into that decision-making process was developed in a more objective, 

reliable, and credible forum than within the political cauldron itself. In other words, 

it would be best if the science was developed and evaluated separately, and in particular in a separate institutional context, from the more political decision-making 

process. 

This issue of whether and how science should be separated from policy and everything else was addressed in an influential 1983 report by the National Research 

Council (NRC), which is often referred to as the ‘‘Red Book.’’ 6 That report set forth 

a framework for regulatory risk analysis that has generally been followed ever since 

by U.S. and many foreign regulatory agencies. A central issue in the report was that 

of separating risk assessment, a primarily scientific undertaking, from risk management, a more policy-related undertaking. The Red Book found that ‘‘[a]t least some 

of the controversy surrounding regulatory actions has resulted from a blurring of 

the distinctions between risk assessment policy and risk management policy,’’ and 

accordingly recommended that ‘‘regulatory agencies take steps to establish and 

maintain a clear conceptual distinction between assessment of risks and consideration of risk management alternatives’’ (p.3). 

While recommending the separation of risk assessment from risk management 

within a regulatory agency, the NRC report recommended against dividing risk assessment and risk management into separate institutions because of the need for 

risk assessors and risk managers to communicate with each other. While there are 

some benefits to integrating science with policy within an institution, there are also 

clear disadvantages with regard to the objectivity and credibility of science produced 

from such a hybrid organization. As the role of science becomes ever more important 

to EPA’s mission, and as the perception of EPA’s science continues to be skeptical 

across the political spectrum, it may be time to consider a different model that insti-
35 

7 HEALTH EFFECTS INSTITUTE, ABOUT HEI, http://www.healtheffects.org/about.htm (last 

visited Aug. 22, 2008). 8Terry J. Keating, Lessons from the Recent History of the Health Effects Institute, 26 SCI 

TECH. HUM. VALUES 409–430 (2001).9 EUROPEAN FOOD SAFETY AUTHORITY, ABOUT 

EFSA, http://www.efsa.europa.eu/EFSA/efsallocale-1178620753812lAboutEfsa.htm . 9

10 Id. 11See, e.g., Ragnar E. Lofstedt, A European Perspective on the NRC ‘‘Red Book,’’ Risk Assessment in the Federal Government: Managing the Process, 9 HUM. & ECOLOGICAL RISK ASSESSMENT 1327, 1332 (2003). 12 Europeon Food Safety Administration, Management Plan of the European Food Safety Authority for 2008 7 (2007), available at http://www.efsa.europa.eu/cs/BlobServer/DocumentSet/ 

mblmanagementplan2008-adopted,3.pdf?ssbinary=true. 13 Angus Macbeth and Gary Marchant. Improving the Government’s Environmental Science. 17 

N.Y.U. ENVTL L.J. 134–169 (2008). 

tutionally separates the generation and assessment of science from the application 

of that science in regulatory decision-making. 

Successful Examples of Separating Science from Policy 

There are some useful precedents of institutionally separating science from policymaking. Two entities that have been successful in this regard are the Health Effects 

Institute and the European Food Safety Authority. 

The Health Effects Institute (HEI) is a nonprofit corporation created in 1980 to 

provide independent research on air pollution issues that is co-funded by EPA and 

the automobile industry. The objective of the HEI was to provide ‘‘high-quality, impartial, and relevant science on the health effects of air pollution.’’ 7 Although HEI 

was initially a purely research organization, it subsequently assumed a secondary 

function of providing neutral scientific assessments of controversial issues. The 

HEI’s commitment to providing a neutral, objective scientific assessment of controversial air pollution issues, implemented through both its organizational structure and procedures, has made it a highly-regarded and credible ‘‘honest broker’’ on 

air pollution science. 8

The European Food Safety Authority (EFSA) was created by the European Union 

in 2002 to serve as ‘‘an independent source of scientific advice and communication 

on risks associated with the food chain.’’ 9 The structure of EFSA is explicitly based 

on separating science-based risk assessment and policy-based risk management into 

separate institutions: 

In the European food safety system, risk assessment is done independently from 

risk management. As the risk assessor, EFSA produces scientific opinions and advice to provide a sound foundation for European policies and legislation and to support the European Commission, European Parliament and EU Member States in 

taking effective and timely risk management decisions . . . EFSA’s most critical 

commitment is to provide objective and independent science-based advice and clear 

communication grounded in the most up-to-date scientific information and knowledge. 10

EFSA therefore provides scientific and risk assessments relating to food safety to 

the regulatory bodies of the European Union (i.e., the EU Commission and the EU 

Council of Ministers) as well as individual member nations, and issues such assessments in response to specific requests or ‘‘questions’’ from its ‘‘clients.’’ While the 

EFSA has not been without some controversy, it has generally been perceived as 

responsible for restoring credibility and public trust to the European regulation of 

food safety after a series of European food controversies. 11 Again, the primary reason for EFSA’s success is an institutional commitment to scientific objectivity, as 

seen by the commitment in its Mission Statement ‘‘to the core standards of scientific 

excellence, openness, transparency, independence and responsiveness.’’ 12

A Proposed Institute for Scientific Assessments 

To separate institutionally science from policy in environmental regulation decision-making, my colleague Angus Macbeth and I proposed in 2008, as part of the 

‘‘Breaking the Logjam’’ project, the creation of an Institute for Scientific Assessments (ISA). 13 I have since elaborated on this proposal in an upcoming chapter 

written for a new book to be published in 2012 edited by Professor Jason Johnston 

at the University of Virginia School of Law on the broader topic of improving regulatory science tentatively titled ‘‘Institutions and Incentives in Regulatory Science.’’ 

The ISA would be an independent, stand-alone scientific assessment body that can 

provide highly valuable and credible scientific input into the regulatory process. It 

would be structurally and procedurally designed to limit its activities to scientific 
36 

matters and to resist any temptation to stray into policy advocacy. The ISA would 

be staffed and managed by full-time federal employee scientists hired using an independent process based on scientific merit, and overseen by an external advisory 

board that would include prominent national scientific experts, such as the leaders 

of the National Academy of Sciences (NAS) and the American Association for the 

Advancement of Science (AAAS). 

As Angus Macbeth and I initially described the operation and function of the proposed ISA: 

This new scientific assessment agency would not conduct its own research, but 

rather would gather, evaluate and assess the existing data in a manner that could 

be used by a regulatory agency in making decisions. The regulatory agencies could 

identify questions on which they needed scientific assessments through an annual 

regulatory agenda, supplemented with ad hoc requests as they arise throughout 

the year (similar to the EU Commission’s requests to EFSA or EPA’s occasional 

requests for scientific reviews by the National Research Council or its own Science 

Advisory Board). In addition to requesting risk assessments for specific 

rulemakings, an agency may also request a scientific analysis from the ISA on a 

more general or cross-cutting issue. Congress could also request a scientific opinion 

from the ISA, helping to fill the gap in Congressional science advice since the demise of the Office of Technology Assessment in 1995 (pp. 162–163). 

In conducting its assessment, the ISA would be committed to following the norms 

of scientific inquiry as closely as possible, including objectivity, disclosure of uncertainties and competing hypotheses, and consensus-seeking. 

As has been the experience with both EFSA and HEI, instilling a culture of scientific objectivity from top to bottom of the organization will be critical to the ISA’s 

success. In my new chapter about the ISA, I describe the potential benefits of the 

ISA: ‘‘First, the ISA structure, limiting consideration to scientific data and issue 

only, would squeeze out much of the perceived or actual political and policy influence currently afflicting regulatory agency science . . . Second, the ISA approach 

could reduce the ‘‘science charade’’ . . . Because the ISA would provide a credible 

independent assessment about what the science does and cannot tell us, it will be 

much harder for regulatory agencies to camouflage their policy preferences as 

science. Thus, regulatory decision-making will be more transparent. A third potential benefit of the ISA would be to harmonize scientific assessments of the same 

issue between different federal agencies . . . ’’ 

I also acknowledge in my new chapter that the ‘‘creation of an ISA would no doubt 

raise a number of administrative and procedural issues. For example, what if a regulatory agency wanted to depart from the scientific findings of the ISA? What opportunity would there be for public comment and perhaps even judicial review of ISA 

assessments? Could a party challenging in court an agency regulation that relied 

on an ISA assessment raise claims against the ISA assessment on the merits? These 

and other issues would require careful consideration.’’ However, there are models 

and approaches to address these implementation issues, and the potential benefits 

for improving the credibility of EPA’s science may justify this type of institutional 

change. 

In summary, a proposed Institute for Scientific Assessments, staffed and designed 

to follow the scientific model of objectivity, could enhance the utility and credibility 

of the scientific inputs into EPA’s regulatory decisions. Thank you for considering 

my suggestion, and I will be happy to address any questions you may have. 

Chairman HARRIS. Thank you very much for your testimony, and 

we will start the round of questions—reminding Members Committee rules limit questioning to five minutes. 

The chair will at this point will open the round of questions, and 

I recognize myself for five minutes. 

Dr. Marchant, by the way, it is an excellent point, you know. In 

medicine we have the NIH to do the research. Totally separate, 

about as not politicized as you get, and then, of course, the information is public and can be interpreted whatever way it needs to 

be interpreted. 

Ms. Dudley, you know, one thing that has kind of bothered me 

about some of the science that is presented, because we have had 

science used as justification for policy decisions, and you know, 

phrases such as, well, you would save up to, you know, 300,000 
37 

cases of asthma a year if only you lowered this particulate matter 

standard or mercury standard or some co-benefit or whatever. 

And as scientist, I mean, if I ever made a presentation at a scientific meeting and in my results section I said up to something, 

I would be laughed off the stage. You know, they want the mean, 

they want the standard error, the standard error of the mean, 

standard deviation, whatever. 

But you know, with something like that I wasn’t—I have only 

been here a year. I wasn’t here at the last round of reductions in 

pollution, but I will bet you the claim was made that if only we reduced that pollution, asthma will go down by hundreds of thousands of cases a year, and of course, we all know asthma hasn’t 

gone done. It has gone up. 

So do you think that more of the agency’s science funds should 

go actually toward retrospective research to figure out whether 

EPA regulations in the past, what the exact impact has been and 

whether they have accomplished their environmental and health 

goals? Because I bet you we go look at some claims made ten years 

ago about the incidence of asthma if only we could reduce pollution, 

and we would be very surprised by the lack of result. 

Ms. DUDLEY. I think that is a very interesting proposal. I think 

one thing that is lacking is the feedback mechanism. I think one 

of the reasons it may be hard to do is that even though there are 

large benefits, and we would all recognize there are large benefits, 

they still may not be observable in the number of asthma cases. 

For example, we have observed tremendous reductions in lead. 

We have reduced lead in the atmosphere, we have reduced it in 

children’s blood, and the reason that we do all that is because there 

is a real link between child blood levels and IQ, and yet even 

though we have done tremendous things, we can’t measure that 

change in IQ even with huge changes in lead levels. 

So it is hard, but I think it is certainly worth doing. I think it 

is a very intriguing idea. 

Chairman HARRIS. Okay. Dr. Marchant, you had said that, you 

know, that one of the problems is that you would change, you 

might change the view. Say if you blend two things, you change the 

view of science based on policy preference, and I got to tell you we 

have had testimony from the head of research at EPA about, you 

know, outlining, for instance, the need for hydrofracturing research 

to figure out if it is safe. 

Dr. MARCHANT. Uh-huh. 

Chairman HARRIS. And I asked them at the last panel, I said, 

look. There have been 1.2 million applications of hydrofracturing. 

Zero incidences of documented drinking water contamination. Now, 

a scientist would say in my—wearing my hat as my old profession 

as a physician, we applied the therapy 1.2 million times, and it was 

good, and it didn’t have an adverse consequence, we would call it 

a miracle drug, and we would sell it everywhere around the world. 

Here the EPA scientist says, no. We have to study the safety of 

it. Is that one incidence where perhaps if you had separated the 

science from the policy preference we might have a cleaner scientific method or a justification for scientific projects? 

Dr. MARCHANT. Possibly. I am not an expert on that particular 

issue, but I think there is, just as it is human nature that when 
38 

you are working for an organization that has a policy mission, 

which EPA does, that your view of the world is affected by that. 

Just like when I was a practicing lawyer, it is affected by what client I worked for. My view of the issue is changed when I start 

working for a client. 

There is just a fundamental matter of human nature, and so I 

might deliberately skew my views to favor my institution, my employer, but even more subtle, which I think a lot of good scientists 

will have happen to them, even though they try not to have their 

view intentionally skewed, would be this implicit, this subconscious 

way of how you look at the world affected by your organization you 

are in. 

And so if your organization is one that says, all we want to know 

is what the science tells us, don’t—we don’t care about the policy, 

you might get a different answer than one that very much has an 

important policy. 

Chairman HARRIS. Yes. Thank you. Dr. Moghissi, you think the 

EPA’s federal, the Scientific Federal Advisory Committee, standing 

committees, ad hoc panels should be recommending policy decisions 

in addition to advising of scientific or technical issues, or should 

there be a firewall between that? 

Dr. MOGHISSI. I believe it should be a firewall. As you can see 

from my accent I wasn’t born in Alexandria, Virginia, and believe 

me I have—where I come from I recall—I was too young during the 

second World War, but there was a number of exceptionally competent scientists who where when it came to policy issues or came 

to the societal issues, were frankly stupid. Johannes Stark was an 

Nobel-prize winning, the Stark Effect in physics, one of the most 

important ones, and he was a Nazi. How do you explain that? 

I believe there is a place for science, and there is a place for policymakers, and I believe it would be bad idea to mix them. 

Chairman HARRIS. Okay. Thank you. Let me just ask one last 

quick question. Dr. Green, you know, testimony—I recall testimony 

I think it was one panel or two ago that every dollar spent on regulation we have $40 in benefit, economic benefit. I just suggested, 

well, it is simple. Let us just go and spend a trillion dollars and 

pay off our debt and then gain some to that. 

Do you think part of the problem is that, again, because the testimony in front of the Committee in the past has been, well, you 

know, you are going to save up to 300,000 of this or up to 10,000 

of this, and I don’t know what the range is. Maybe the range of 

the real science was you actually might lose lives, you know, to 

save lives. I don’t know. 

Where are they getting these estimates of 30, $40? I mean, how 

do they come up with something—because when I talk to business 

people, they know the real cost of regulation, and they say, no. 

There is a real cost to these regulations. This disparity between 

what the two opposing philosophies believe, that regulation costs a 

lot or regulation saves us a lot. 

Dr. GREEN. Well, I think you ask an important question, and you 

raise—use an important word, which is estimates. These are estimates of lives saved, estimates of illness averted, and increasingly 

as others have pointed out, including Anne Smith, who has testified for your Subcommittee in the past, EPA bases these estimates 
39 

on what are called willingness to pay surveys in which they ask 

people, what would you pay to avoid losing a day at work because 

your lungs are too tight? What would you pay to not have a case 

of bronchitis or to not have a case of lung cancer? 

And the problem is this willingness to pay surveys, not only do 

they not make sense when they compare to each other, the evaluations you get from them are often nonsensical, the literature on 

willingness to pay surveys specifically says that they really are not 

indicators of what people would actually pay in the real world. 

And so you are using a methodology that you are not—you know 

is not going to get you what you want but representing it as if 

somebody has actually been challenged to pay. What would you 

pay, and would you pay more to avoid cancer than you would bronchitis? Well, logically you would say yes, but some of these willingness to pay surveys don’t necessarily bear that out. 

Chairman HARRIS. Good. Thank you very much. 

And I now recognize Mr. Miller and give you a couple extra minutes here. 

Mr. MILLER. Don’t worry about it overly much, Mr. Chairman. 

I am puzzled by the testimony. I think I agree with the fundamental idea that science should not be the only criteria. It should 

inform decisions that policymakers will apply, the information that 

comes from science, the ways in which science informs policy, but 

then there are other criteria, other considerations that come into 

affect. 

But what I did not really get from your testimony is how does 

that then happen? Ms. Dudley said that she didn’t think that the 

agency should make the decision. The EPA has criteria set by Congress, passed by statute. We are policymakers. Our names actually 

appear on ballets. It is right in the Constitution, Article 1, and it 

sets out how to decide what the criteria are and then apply those— 

apply science to those statutory criteria and reach a result. 

If not the agency, who? And on what basis? Ms. Dudley? 

Ms. DUDLEY. I didn’t mean to say that agencies shouldn’t make 

a decision. I am not sure what I said that led you to suggest that. 

I certainly think that agencies should make a decision as delegated 

under the constraints delegated from Congress. 

My recommendation was that when Congress delegate authority 

to agencies, don’t do so under the pretense a decision can be made 

solely based on science. Allow the agency to consider, to be able to 

separate the science from a policy decision and base the policy on 

the range of factors that are relevant for making policy. 

Mr. MILLER. But those factors should be set out in statute, right, 

and they should be decided by Congress and then applied by the 

agency. Isn’t that the way you think it should proceed? 

Ms. DUDLEY. By Congress and applied by the Executive Branch. 

Certainly. 

Mr. MILLER. Okay. 

Ms. DUDLEY. And so my recommendation to you was when delegating to agencies, recognize that there are there are three things 

to think of. One is the pure science. Then there is the risk assessment that brings together those different assumptions and judgments, make that transparent and separate that from the policy 

decision. 
40 

Mr. MILLER. Okay. I really did not hear from anyone’s testimony 

how to coordinate science and research at the EPA so that it neither creates a bias against regulation or for regulation. How do we 

make sure that it provides useful, detached information that policymakers who wish to apply all the proper criteria can rely upon? 

And I did not really hear that. 

I know that you have an hour-long presentation, Doctor. 

Dr. MOGHISSI. No, no. My apologies if I wasn’t clear. 

Mr. MILLER. Okay. 

Dr. MOGHISSI. It is the responsibility of the scientists to say that 

is what the science says and the chairman brought it up, he said 

up to so much blah, blah, blah. What do you mean up to so much? 

What is the scientists—we have a statistical process. There is a 

middle point, there is an upper 95 percentile, there is a lower five 

percentiles. The task of the scientist said this is the science. The 

administrator in Ruckelshaus is good at it. You go to the public 

and say me, the administrator, based on the authority provided to 

me by Congress, I am taking this number, and that is my decision. 

The hearing process as you will know is a little more complicated 

than I make it be. In fact, it is, you know, you have to have—announce it on 30 days and so on and so forth. 

But he went and said—there was famous hearings in someplace 

in I think in Seattle or in Tacoma, in which he exactly did that. 

This is the science. My conclusion from the science is—that is the 

decision. Like it or not that is my decision. 

Mr. MILLER. Any of you really want to address how, in statute, 

we can revise the ERDDAA statute to make sure that we get the 

science that does not have a bias one way or the other? 

Dr. Green, and the bias should also not be anti-regulatory. 

Dr. GREEN. Well, I agree, and far be it from me to tell you how 

to do you job. I am not a legislator, I never have been. 

Mr. MILLER. That is actually what the people at that table do all 

the time. That is your job. 

Dr. GREEN. I will eschew the activity myself. What I would say 

is there are some problems with transparency that have been mentioned before and transparency and timeliness. One issue I could 

suggest, for example, when EPA does regulatory impact analyses, 

I remember in the 1997, revisions to the National Ambient Air 

Quality Standards, the regulatory impact analysis was not final 

until after the rules were passed and written. 

Therefore, there really was no opportunity for an outside analysis of whether or not you would be getting the right return on investment. That should not be allowed. I don’t see where you can 

allow a draft regulatory impact assessment to be the only assessment available before passing something of such far-reaching consequences. 

So, a suggestion of greater transparency and slowing things 

down. I mean, if you look at the length of the regulations we are 

getting, the complexity levels, as we say, as was mentioned earlier, 

the really easy stuff, getting the photochemical smog out of the air, 

the things you can see. That is done. The things we are working 

on now are much more complicated and yet the regulatory process 

has gotten compressed by timelines that are very tight and make 

it very hard to review and also there are burdens, more obstacles 
41 

being placed in people who do the reviews. It is not a career-building activity for you to participate in reviews for the agency, especially when you have to drop everything to scramble to evaluate a 

rule that is put out the evening before Thanksgiving weekend, 

which is all too frequently the case as well. 

Mr. MILLER. Okay. Using my last minute of my extended time, 

we will have additional hearings on this subject. We have—the majority and minority have been in conversation, have been in discussions about how to have a balanced panel that will present views 

on how to amend the statute, how to revise the statute that has 

been on the books for 30 years now. 

And who should be at that table to present the proper range of 

use? I mean, now, obviously, for various reasons this panel is of one 

mind, but there are certainly other points of views, and who should 

be at that table to present the proper range of views for future 

hearings? 

Dr. MARCHANT. I don’t think we are of one mind, but I think that 

it is important to separate out two different issues here, so I am 

not really talking about the research that EPA does. I am talking 

about the science that includes some of their own research but a 

lot of other research and making a regulatory decision. 

And those are sort of two different issues. How they do their research, what type of research EPA should do itself intramurally is 

one set of issues, which I think is what this statute addresses. The 

issue I address and some of my colleagues here is more how does 

EPA incorporate science from its own laboratories but also outside 

those laboratories in making a regulatory decision? 

Those are two separate issues. You might want to separate them. 

Chairman HARRIS. Thank you very much. 

The gentleman from California, Mr. Rohrabacher, is recognized. 

You want Mr. Hall? It is your turn but—okay. Mr. Rohrabacher. 

Mr. ROHRABACHER. All right. Thank you very much. 

You know, I would just like to start out by reading a quote from 

President Eisenhower in his farewell address, and people always 

look at that address, and I had it—I Googled it up the other night. 

It is 15 minutes long. I just would recommend taking a look at the 

insights of this man who helped defeat the Nazis and saved the 

world from that terrible threat and then came on as leader of our 

country and did in retrospect a pretty good job as President of the 

United States. But he had an incredible vision of things that were 

happening, both before he became President and when he was 

younger and what it might look like in the future. And he warned 

us, yes, against the military industrial complex. Everybody knows 

that. That is a famous part of his speech, but he also spent just 

as much time warning us about the corruption of science. 

And let me read a part of that. ‘‘The prospect of domination of 

the Nation’s scholars by federal employment, project allocations, 

and the power of money is ever present and is gravely to be regarded. Yet in holding scientific research and discovery in respect, 

as we should, we should also be alert to the equal and opposite 

danger that public policy could itself become captive of a scientific 

technological elite.’’ 

And we have lots of evidence of that since Eisenhower left, and 

I just know that we—just in my lifetime I have seen—I remember 
42 

when we didn’t eat cranberries for Thanksgiving and Christmas because some scientist came up with the idea that it was going to 

cause cancer. Of course, it didn’t cause cancer. 

We also, we know that—and these aren’t things that are necessarily being done intentionally. Maybe this scientist at that moment thinks it is really important. We have outlawed DDT, and the 

scientific, all sorts of scientific evidence, and I bet the scientific 

league got behind this because it became very trendy because bird 

shells do, indeed, become less able to protect the developing bird 

with—if DDT is in the environment. But we also know now that 

DDT kills mosquitoes, yeah, and mosquitoes cause malaria, and by 

making sure we protected birds, a number of hundreds of thousands of birds, we have condemned millions of children in Africa 

to a horrible death of malaria. 

Just examples like this where, you know, you have got scientists 

being used basically to determine policy, and a lot of times their 

policy is wrong. Maybe the science might even be right, but the policy is wrong. 

And so I am very sympathetic with Ms. Dudley’s suggestion 

there. I take it from what you are trying to do is trying to separate 

policy decisions from scientific research so the scientists should just 

be answering to the policymakers as to what the exact science is. 

Is that what we are saying here today? 

Ms. DUDLEY. I think that is part of it, and that has been accepted since I think it was 1983, when the National Academies of 

Sciences issued a report that said let us separate the risk assessment from the risk management. So that is part of it, and I think 

some of our statutes don’t allow us to do that. 

But I think then the second part is even in a risk assessment— 

Professor Marchant was talking about this—even in a risk assessment you have pure science but then you also have some of these 

judgments. And that—you can’t totally separate that, but we 

should at least make transparent where the science ends. 

Mr. ROHRABACHER. Well, Malthus was supposedly a scientist. I 

mean, he was the mathematician of his day, and he gave us a chart 

that said that the entire world would starve to death 50 years ago 

if Malthus was correct, and I remember the cyclamates. Remember 

cyclamates? The industry put hundreds of millions of dollars into 

developing a synthetic type of sweetener and somebody said, well, 

it might cause cancer. Then scientists became a trendy thing. They 

outlawed it, by the way, they never outlawed it in Canada. Ten 

years after research they found out it wasn’t cancer causing and 

what ended up, what was the problem then? Well, the fact is high 

fructose corn syrup was developed in-between and put into place, 

and if you want to add—and most of us know, I hope this isn’t 

trendy science as well, but high fructose corn syrup isn’t really 

good for people. My wife has outlawed it in our household anyway. 

So with that said, Mr. Chairman, I want to thank you for making 

sure you had a secondary follow up because it is the EPA decision 

making on science that really can affect so many people’s lives in 

a positive way but also in a negative way. 

Thank you very much. 

Chairman HARRIS. I thank you. 

I recognize the gentleman from New York, Mr. Tonko. 
43 

Mr. TONKO. Thank you, Mr. Chair. I thank the panelists for appearing before the Committee, and you have all stated your support for environmental protection, but you have also offered harsh 

criticism for EPA’s science and EPA’s regulations. 

Could you offer specific illustration of one specific example of 

good regulation and one specific example of bad regulation? 

Ms. DUDLEY. Do you want me to start? I will start. 

At EPA I would say an example of good regulations was the removal of lead from gasoline. That was one that was really based 

on clear science and then a clear risk management analysis as 

well. So the science informed the risk assessment, which informed 

the risk management regulatory decision, and I think that has 

brought about dramatic improvements. It is probably the biggest 

success story at EPA. 

I think the Ambient Air Quality Standards are an example of decisions where we do blur the lines between the science and the policy, and that frankly is because the statute says EPA must make 

its decision based on public health and public health alone, and yet 

in the analysis there is no way to draw that line. If you have a linear dose response curve that goes to zero, how do you set a standard that is requisite to protect public health and choose anything 

other than zero? 

And so that forces, EPA to kind of wave their hands and make 

up all kinds of reasons why they are setting a non-zero standard. 

And so the real reasons for making that decision is obscured. 

Mr. TONKO. Dr. Moghissi. 

Dr. MOGHISSI. I am glad you asked. The date is 1970-something 

when the Toxic Substance Control Act was passed, and up to that 

time there were no regulations relative to manufacturing of chemicals, and for all practical purposes the industry could just release 

chemicals as they saw fit. 

The regulations were excellent. They came at the right time and 

resulted in limitations of what the chemical industry could do. And 

they proved to be cost effective, and they were useful. 

Let me give you a bad one. The date is about 1990-something. 

There is a place called Waste Isolation Pilot Plan in New Mexico 

and in which radioactive waste from reprocessing of weapons transuranic waste is disposed. Now, the way it is set up, transuranic 

waste and chemical waste, hazardous waste were combined. That 

is just the way it worked. And the poor guys had to go and open 

up this highly-radioactive 55—the container and analyze for chemicals, the chemicals disposal facility is intended to, I don’t know, 

maybe a couple of hundred years, Waste Isolation Pilot Plan is intended to—for thousand years. And, yes, they had to do it. And finally my organization based on the request of someone who, some 

government agency, we developed way back, we developed a panel, 

which included the guy who wrote hazardous waste regulations, 

and they said, don’t do it. But the EPA had problems and finally 

the only way it happened was the Congress, through appropriations, said you can’t do it. 

So that was the end of it, and it saved a lot of human life, a lot 

of enormous costs. Can you imagine the requests—requirements for 

opening up the damn, excuse my French, the 55-gallon container 
44 

and radioactive waste to analyze for a little Benzene or something 

like that? 

Good two examples. 

Mr. TONKO. Dr. Green. 

Dr. GREEN. Thank you. I think there are two points. I agree with 

Susan, first of all, Professor Dudley, that the handling of lead is 

an example of good regulation. We had an event not that long ago 

in which that was discussed at some length, and I would say there 

is also a distinction that needs to be made between early rounds 

of the National Ambient Air Quality Standards and later rounds, 

in that you are going to have a greater return on your investment 

when you are casing high levels of pollutants, and you have higher 

level effects. 

The wisdom of a regulation can go from being good to being bad 

based on the rounds and evolution of the problem, and a lot of 

times the regulations are not written with end feedback evolutionary mechanisms in mind to prevent that from happening. 

And so I think it is important these things be made. As for 

things that go wrong, it is not just EPA, but you have things where 

it is asbestos regulations which required greater exposures that 

walls had to be torn open that otherwise humans wouldn’t be exposed to that created risks for the clean-up workers for example. 

That would have to be offset against the risks that people might 

face in exposure to it. 

And finally, approach matters, which is I might agree with you 

that—we might agree on there is a problem. We might even agree 

that there is a regulatory or a need for the government to intervene 

to address that problem, but there is choice options. I can go with 

an eco tax, I could go with a direct emission fee, or I can go with 

a regulation or a technology standard or picking and choosing an 

approach or technology approach. 

And those are going to have different costs and benefit return on 

investment profiles as well as influencing people’s lives and individual liberty and commercial liberty and so forth. 

Dr. MARCHANT. I think most environmental regulations have 

done more good than harm. My main concern is how they are explained to the public and really at the margins, but I think if you 

are looking at beneficial ones, you would have to start with the 

Ambient Air Quality Standards. They have by far the biggest bang 

that we have spent on them, and particularly I think there is some 

issues with the ozone one at the margin, but particulate matter 

and lead and carbon monoxide have all been tremendously beneficial. The Sewage Treatment Program has been tremendously beneficial. So there is a lot of examples of good ones. 

There are ones that are bad, and I think it is interesting looking 

at the bad ones to see where it went wrong, but I mean, my favorite is one, the DC. Circuit struck down a chemical manufacturing 

versus EPA case a few—about a decade ago where EPA modeled 

these high-risk chemicals under the Hazardous Air Program and 

one particular chemical, basically a solid at the modeling characteristics that EPA used, and the company, you know, gave them clear 

data that that was a fact, that there would be no exposure, and 

EPA simply ignored it and says, you have got to be regulated like 

this because we are going to assume that at this level, this tem-
45 

perature you are not a solid, and they was just clearly scientifically 

wrong, and yet they just went ahead with the regulation anyhow. 

And fortunately, the DC. Circuit struck it down as lacking any 

plausibility in science whatsoever. 

Chairman HARRIS. Thank you very much. 

The Chairman, Mr. Hall, is recognized. 

Chairman HALL. Thank you very much. 

Ms. Dudley, you are exactly right when you delegated authority 

solely on science. I am sure—I think, I don’t think that anybody 

in here disagrees with that, but I know you didn’t intend to say 

that you ignore good and reliable science, and I respect every one 

of you that are here. You are Professor of Public Policy, Regulatory 

Science, Enterprise, Center for Law, Science, and Innovation. You 

are not with the Administration, and I think Dr. Green did his best 

to compliment the Environmental Protection Agency. I didn’t read 

enough of it. I quit reading it when I gathered that. 

Talk just a minute about the EPA. Maybe—I don’t know how 

long ago, but I was here when we passed the Clean Air Act and 

the Clean Water Act, and we gave the EPA a place in the sun in 

that legislation and had expectations that they would use science 

and use other knowledge that was available to them. And it is my 

opinion that they have deviated from that, and they have deviated 

it to the extent that it is very damaging to institutions in my district and all across this country. 

Dr. Moghissi, in September I sent EPA a letter requesting information on their Integrated Planning Model. You all call it the IPM. 

This is the model that the agency used to analyze the Cross-State 

Air Pollution Rule. You are familiar with that, aren’t you? 

And the assumptions driving this model have never been made 

public, and their knowledge of the model itself has never been peer 

reviewed. 

Now, how would the IPM model fare if evaluated by the ethics 

principle of regulatory science that you described in your testimony? 

Dr. MOGHISSI. What they would have to do, they would announce 

the assumptions, every piece of an assumption, and I am familiar 

with half of them but not all of them, many of those assumptions 

on the extreme side of the scientific business, they would have to 

say what would happen if I make a different assumption on the 

other side of it and but how would the conclusion be different. 

That would be subject to independent peer review and if I might 

add, the peer review says you have to be qualified if you are a peer 

reviewer. You do not—may have conflict of interest but those who 

have a stake in the outcome of the peer review may not be peer 

reviewers nor may participate in the selection of the reviewers. 

And in my opinion that is very often violated. Therefore, it is imperative that this Sunshine Act that I am suggesting open up to 

the public. Let them—if the people know what they are doing as 

you are suggesting, if the model, the assumptions in the model are 

described, if the judgments are described, if the—if alternative assumptions on judgments are described, and the conclusions that 

are from it described, then the role of the science is done. The next 

step is the Administrator has to go and say, I pick up this because 

in my opinion this is the right choice. This is my opinion as an Ad-
46 

ministrator of the EPA. That is what I would like to do. It is not 

poor regulation. It is not anti-regulation. It is just the truth in regulation. 

Chairman HALL. How would the IPM model fare if evaluated by 

the ethics principle or regulatory science that you described in your 

testimony? How would that be? 

Dr. MOGHISSI. Thank you, sir. 

Chairman HALL. If you can’t knock that one out of the park, I 

will give you another one in a minute. 

Dr. MOGHISSI. In other words, the peer review must say, include 

in the peer review not I picked up this assumption, I picked up this 

alternatives, these are why I did it. I did not—if I include societal 

objective in it, that is why I did it. Could I have done without it? 

The openness, the transparency is the key issue. Again, it does not 

change anything in terms of pro regulations or anti regulations. 

What it says is you should tell the public. You gentlemen over 

there are a hell of a lot more qualified on policy than I am, and 

I am a scientist, and I am not necessarily all that modest, but I 

am not qualified. You are qualified. 

So, therefore, in my opinion these ethical requirements and it 

took several years to develop them, are very important to comply 

with. 

Chairman HALL. IPM is the model that the agency used to analyze the Cross-State Air Pollution Rule, as you know, and it affected adversely all over this country but it particularly affected an 

entity in my District at Mount Pleasant, Texas, Luminant case. I 

think you may be familiar with that, but it cost them 500 jobs almost immediately, and it is my opinion and my opinion alone that 

there was such an outcry from that and how it affected a lot of 

other states, not just Luminant, but they began to make some kind 

of a realization that they might have made a mistake in leaving, 

in bypassing or ignoring some science in arriving at their opinions. 

This—we had an EPA assistant administrator, Gina McCarthy, 

here before us, and when she was pressed for some reason, she did 

something there and gave some ruling without her applying the 

proper science to it, but she gave us the arrogant answer, we are 

not in the business of creating jobs, and I left her space to make 

an apology for that in the testimony, but it never came. 

And that is what we get from EPA today. Should EPA continue 

its path to implement the Cross-State Rule given that the IPM 

model is not peer reviewed and it is not transparent, or should 

EPA discontinue their current efforts until such a time that the 

IMP model is peer reviewed and transparent? Is that the way you 

think they ought to go? 

Dr. MOGHISSI. The way to remedy that, sir, to pass the Regulatory Science Sunshine Act to impose upon the EPA they have to 

be transparent, they have to pass the peer review consistent with 

the requirement of ethics of the regulatory science. 

People are not stupid. The people understand it. The arrogance 

of some of the science within or in policymaking I know better 

what is best for the country. No. The people of the United States 

know what is best for the country, and therefore, the Sunshine Act 

open up to the public, and again, this is not pro or against regulations. It just opens it up. 
47 

Chairman HARRIS. Thank you very much. 

Chairman HALL. My time is up. Thank you, Mr. Chairman. 

Chairman HARRIS. Thank you very much. 

I recognize the gentleman from California, Mr. McNerney. 

Mr. MCNERNEY. Thank you, Mr. Chairman. Mr. Chairman, I 

would like to address one of the issues you bring up often, hydraulic fracturing. The EPA was authorized by Congress in 2010 to 

open up a study in hydraulic fracturing and its potential impact on 

groundwater. 

Now, maybe you disagree with that decision, but we saw when 

we were discussing nuclear waste a few weeks before that if the 

public doesn’t buy into a procedure in their district, you are going 

to end up in courts, there is going to be fights, it is going to go nowhere. And so it was wise, I think, for Congress to authorize the 

EPA because there is a groundswell of public concern about potential pollution from hydraulic fracturing. 

So if we can prove that it is not a problem, that is good. If we 

can prove it is a problem, it needs to be done, and so I just wanted 

to address your continued concern about that. 

Now, about the issue that we are discussing today, I didn’t necessarily disagree with what was said by the panel. I think Ms. 

Dudley’s use of the word, charade, regarding a policy in science 

was needlessly inflammatory. But, one of the things that I kept 

hearing was that we need to have science separated from policy. An 

example we have of that in the 1990s, we have the Office of Technology Assessment did unbiased work, and the then Speaker of the 

House of Representative, Newt Gingrich, disbanded that organization because in my opinion he didn’t like what they were doing. 

So separating science and policy is not really possible in this sort 

of political environment. I don’t know exactly where to go from 

there, but the objective of this hearing to decide how we should empower or enable scientific research to inform regulatory decision 

making. 

Now, one of the things that Ms. Dudley says is—and all of you, 

I think, really is that science is not certain, and that is for sure. 

Science is never certain, but there are ways to include probability 

assessments in scientific judgments, and there are statistical tools 

that can be used in decision making with uncertainly. 

I have been—I am a mathematician, so I am aware of those 

tools. So what do you say, Ms. Dudley, in terms of using that approach because we can never have absolute certainty in science? 

Ms. DUDLEY. I think that is an excellent suggestion, and the National Academies have suggested that regularly to improve the 

quantitative uncertainty analysis for regulations that are likely to 

have the biggest impacts. And the reason that is so important is 

then you make more transparent what the assumptions that are 

going into that risk assessment are. 

So I think that is key. 

Mr. MCNERNEY. So we don’t have to have absolute certainty. We 

can’t have absolute certainty. 

Ms. DUDLEY. Oh, no, you can’t. 

Mr. MCNERNEY. But we can make decisions in the absence of absolute certainty. 
48 

Ms. DUDLEY. Absolutely. I don’t think anyone suggests that you 

have to wait for certainty. In fact, your point is related to the 

science charade, which I did not mean to be inflammatory. It is actually a phrase that Wendy Wagner coined a decade or so ago in 

an excellent article. I have been doing some research lately and 

find that all the incentives in the regulatory system are to perpetuate that charade, and the charade is that when we make the pretenses that something is based solely on science, we are hiding the 

real decisions. 

And what you are suggesting is a way to step back and make 

that clear: here are our assumptions, and here is the range of assumptions we could have used, and if we do this quantitative uncertainty analysis, that makes transparent for everyone. It is an 

excellent suggestion. 

Mr. MCNERNEY. Okay. Mr. Green. 

Dr. GREEN. I think your point is very well taken. It is also important for people to, I think, to understand. Science is provisional and 

that science has a culture which is rather different than the culture of policy, and that is science is provisional in that everyone 

understands that a paper that they put out one week can be overturned the next week. 

Mr. MCNERNEY. Uh-huh. 

Dr. GREEN. And the consequence is simply that somebody goes 

back to the lab. But once you start entraining the scientific findings into a regulatory process, it is often hard to reverse the train. 

And so as I was saying before, I think some feedback mechanisms 

and evolutionary mechanisms that allow for the provisionality of 

science to feed back and have faster impacts on slowing the train 

or changing the course of direction would be very important. 

One last comment is I think the transparency issue is very important. Proprietary models are a real problem when you have an 

agency that is running propriety health models or having proprietary data that can’t be analyzed by—from outside. It is very hard 

to assess whether or not the work itself really does reflect science 

or reflects simply assumptions that are put into models no one can 

see. 

Mr. MCNERNEY. Okay. Mr. Chairman, I yield back. 

Chairman HARRIS. Thank you very much. 

Yeah. We will have—we have a little more time left, so we are 

going to have a second round of questions, but it is limited to three 

minutes per Member, and I will have the first questions of the second round. 

Dr. Green, the Federal Advisory Committee Act, which governs 

EPA’s Science Advisory Board and CASAC, the Clean Air Scientific 

Advisory Committee, requires that advisory peer review panels be, 

‘‘fairly balanced in terms of the points of view be represented.’’ 

However, a recent hearing raised a number of issues related to 

these panels. For example, five of the seven standing members of 

CASAC have recently received EPA funds. They are actually direct 

recipients of funds, and the current CASAC Particulate Matter Review Panel includes nine scientists who had previously recommended lowering the annual standards. So, you know, maybe 

have a little bit of policy preference there. 
49 

Do you think the requirements for scientific, balanced scientific 

advice is met by these EPA committees at this point in time? 

Dr. GREEN. As I have seen them, I am not—I guess the answer 

I would say is probably not, but the question is how do you best 

represent balanced points of view, and I think a lot of the times 

the discussion comes down in the wrong framework. That is it is 

industry views versus agency views or university views versus private sector views, public sector versus private sector views. 

Without a recognition that there is expertise on both sides, the 

person doing applied chemistry at Kodak or at a chemical company 

has very detailed, specific information that could inform policy 

process. The question is do we capture those people who have direct field experience as much as we capture the expertise of people 

with university experience or agency experience or agency culture 

or leaning. 

From that I have seen of review panels I rarely have seen one 

as—you were mentioning the—the Ranking Member was mentioning the lack of balance on the panel here. Imbalanced panels 

seem to be the norm rather than balanced panels. 

Chairman HARRIS. Thank you very much. Professor Dudley, earlier this year the U.S. EPA’s long-awaited study of formaldehydes 

toxicity was panned by the National Academy of Sciences panel 

that sharply disagreed with the agency’s conclusions and declared 

the effort in need of, ‘‘substantial revision.’’ The panel stated, and 

I am quoting from their statement. ‘‘Overall the committee found 

that EPA’s draft assessment was not prepared in a logically-consistent fashion, lacks clear links to an underlying conceptual framework, and does not sufficiently document methods and criteria used 

to identify evidence for selecting and evaluating studies.’’ 

Now, NAS added that EPA’s chemical assessments have consistently displayed these problems in recent years. How should the 

EPA modify the Integrated Risk Information System in response to 

the criticisms that were raised by NAS? 

Ms. DUDLEY. I think the NAS report itself gave some very constructive suggestions, and it comes back to the transparency that 

we have all been talking about, both you and your panel today. 

More transparency so that we understand why decisions are 

made because risk assessments require a lot of those assumptions, 

including which studies do you choose, which models do you choose, 

what default assumptions do you use? If we can make that more 

transparent and perhaps follow Dr. Moghissi’s, those steps to make 

sure that we really do understand the range of assumptions, I 

think that would address the Academy’s concerns. 

Chairman HARRIS. Thank you very much. 

Mr. Miller. 

Mr. MILLER. Ms. Dudley, the IRIS procedures have changed at 

least three times in the last decade. There was sort of an early 

Bush Administration procedure, a late Bush Administration procedure that I think you were the principle author of, and then the 

Obama Administration has developed their own procedures. 

The criticisms of the formaldehyde decision or the formaldehyde 

decision that was criticized by GAO, under which set of procedures 

was that decision made? 
50 

Ms. DUDLEY. First let me say I was not the architect of the procedures. It was EPA who changed the IRIS procedures. And OIRA 

was not the architect of that. 

I am not sure. I am sure it was over time. I don’t know that the 

new procedures will change that because the procedures really 

were how you do the vetting, interagency and with the public, and 

that certainly helps. I think bringing, engaging a broader perspective will address some of the concerns, but I won’t use all your 

time. 

Mr. MILLER. Dr. Marchant, you discussed institutional biases at 

EPA and said that it had sorted science and policies and values 

into one big mess, but there are—there were panels, review panels 

that—advisory panels that had been established by statute, and I 

think maybe by EPA on their own, the scientific, to review scientific research activities. 

What role can those or do those advisory panels play, those 

boards play? Are they functioning, and how can they or do they 

separate science and policy decisions? 

Dr. MARCHANT. I think they do help. They are sort of an intermediate step to have sort of an independent scientific check on 

what the agency is doing to give them advice. I do think they are 

still somewhat beholden to the agency as opposed to a completely 

separate and independent institute that is basically made up of career scientists who work for that institute rather than being appointed by an agency. 

I also think that those committees should not be making recommendations on policy. I don’t think they should be telling the 

EPA what level to set the standard. They should be telling them 

what the science is and then it is the agency’s job to set the standard. The scientist shouldn’t be making those policy decisions. They 

aren’t policy experts. 

Mr. MILLER. Okay. Dr. Green, same question to you. 

Dr. GREEN. Well, I think Dr. Marchant’s point is exactly right, 

which is you do need review agencies. You need review panels, but 

it is difficult not to have them be captured or capture the agency 

that they are associated with if there is some sort of benefit, 

whether it is a prestige benefit or an influence benefit or a potential grant benefit or any kind of interaction. It is hard to separate 

those things out. 

It’s not that it can’t be done, but I think that the important thing 

is that they should simply draw the line in saying, here is what 

we read the science as. It is all published, it is all public. Here is 

how we interpret it. Here is what we think the science says is, and 

it is not our job to say what it should be or what should be done, 

and they should hand that—that should be clearly—a clearly political decision by the administrative side of the agencies. 

We did—but instead we have previous decisions that would defend it as being the decision is dictated or driven by the science. 

It is science based. It is science driven. The science says we must 

X, and science can never tell you what to do. It can only tell you 

what it is. 

And so I guess my, one of my—my only suggestion would be that 

we should ban the phrase, the science says we must, from statutory 

language entirely, and we might get improvement that way. 
51 

Chairman HARRIS. Thank you very much. 

The gentleman from California, Mr. Rohrabacher. 

Mr. ROHRABACHER. Thank you very much, Mr. Chairman, and let 

me just note, and again, this is a very—this is not a scientific analysis of what has been said, it might be impacted by my political 

opinions, but I would suggest that the Office of Technology Assessment was not eliminated by Newt because it was doing things that 

he didn’t like. No. I was here when that happened. We tried to balance the budget, and that was one of the years that we were able 

to balance the budget by eliminating what we thought were extraneous groups that were not doing—the job that they were doing 

was not worth the money that was being paid. 

In the case of the Office of Technology Assessment, they would 

often give us their assessment a year or two after we requested it, 

and it was no longer necessary to hear their opinion, but they 

weren’t doing a good job, and at least that is what those of us who 

voted to eliminate that part of our budget in order to have a balanced budget. 

I also don’t believe that there was ever a groundswell of public 

concern for fracking, that it might impact on the groundwater. 

There was a groundswell among liberal politicians who controlled 

the House at that time, again, another scientific expertise by politicians, who wanted to prove that—or who believe in like global 

warming is caused by CO2 and that they would do anything they 

could to prevent more availability of oil and gas because that would 

create CO2, which created global warming. Again, a political decision. 

Let me ask my one question, which is at a recent hearing I asked 

Dr. Paul Anastas, I guess you pronounce it. I am sorry if I have 

mispronounced it. The Assistant Administrator for EPA’s Office of 

Research and Development, and the EPA Science Advisor, I might 

add, about new regulations for perchlorate, and this was—basically 

I asked him in the face of decades of scientific work by—from the 

National Academies and other reputable scientific institutions, saying that no such regulation was needed, why were they moving forward, and his answer simply, well, it implied that a scientific basis 

was not required for EPA to create regulations. 

I would like to hear from the panel just whether or not—we don’t 

have much time, but a yes or no whether you think that—whether 

or not EPA should require a scientific basis to create a new regulation. 

Just a yes or no or whatever your quick thoughts are. 

Dr. MOGHISSI. If they want to develop a regulation, which is 

based on science, that would be absolutely necessary. How else do 

you do? The gentleman over there, he is a physician. How else do 

you go and treat someone with medicine if you don’t know what the 

medicine is? 

So, therefore, the disease and medicine are related to each other, 

and therefore, without having the scientific foundation, the regulation is arbitrary. 

Dr. GREEN. I would agree with that. I think you need to have a 

scientific foundation. 

That being said, I mean, there could—you could envision in some 

cases where the science is so clear that something is damaging that 
52 

setting the level could be based on other factors than that. You 

may not actually have to question the science, but I agree. The key 

thing is if you are going to regulate, you need a rationale for regulation. If it about environmental protection that suggests you have 

measured something that needs protecting, you determine what 

needs to be done in order to protect it. All of those are scientific 

activities, and without them it is hard to see how you have a rationale for your actions as opposed to simply acting randomly. Why 

couldn’t they then just pass any regulation they want to on any 

subject if there is no rationale and no linkage to their mission? 

Mr. ROHRABACHER. All right. 

Dr. MARCHANT. I think personally that is a terrible idea to base 

it not on science, but I am glad that they would explain it. More 

honestly, if there isn’t science to back it up, to be explicit about 

that rather than trying to say that there is science so now we can 

all evaluate it and make our own judgment whether that is a good 

regulation or not, and I would think it wouldn’t be if there is no 

science to back it up. 

Mr. ROHRABACHER. Thank you, Mr. Chairman. 

Chairman HARRIS. Thank you. 

The gentleman from New York, Mr. Tonko. 

Mr. TONKO. I am set. 

Chairman HARRIS. Thank you. Okay. I want to thank the witnesses for their valuable testimony and the Members for their 

questions. 

The Members of the Subcommittee may have additional questions for the witnesses, and we ask you to respond to those in writing as quickly as possible. 

The record will remain open for two weeks for additional comments from Members. The witnesses are excused. Without objection, the hearing is recessed subject to call of the chair to a date 

to be determined for a second day of testimony for this hearing. 

[Whereupon, at 3:40 p.m., the Subcommittee was adjourned.] 
(53) 

Appendix I 

ANSWERS TO POST-HEARING QUESTIONS
54 

ANSWERS TO POST-HEARING QUESTIONS

Responses by Ms. Susan Dudley, 

Director, Regulatory Studies Center, 

and Research Professor of Public Policy 

& Public Administration, 

The George Washington University 

Questions submitted by Subcommittee Chairman Andy Harris 

Q1. We briefly discussed the potential for retrospective ‘‘accountability research’’ to 

serve as a feedback mechanism about past regulations and their health and environmental outcomes. What steps could be taken to ensure that these targeted 

reviews fully and usefully evaluate past regulations to inform future decisions? 

A1. Agencies face little incentive to conduct retrospective evaluations of the accuracy of ex ante predictions of health or environmental effects resulting from regulatory action. Unlike federal programs that don’t get reauthorized if they don’t demonstrate success, regulations tend to stay in place absent some new action. Congress 

could provide incentives for agencies to examine ex post actuarial data of key outcomes (such as children’s IQ, mortality rates, etc.) through sunset provisions that 

linked continued authorization to a demonstration of a regulation’s effectiveness. 

Perhaps a pilot project, where Congress identified a particular regulation or target 

pollutant and health effect for review, would help EPA develop a methodology for 

conducting such reviews. 

Q2. The Bipartisan Policy Center’s 2009 report, ‘‘Improving the Use of Science in 

Regulatory Policy’’ was mentioned several times during the hearing. This report 

made several suggestions that may be useful in guiding this Subcommittee’s efforts to reform regulatory science, including: 

• ‘‘Studies used in the formulation of regulation should be subject to data access 

requirements equivalent to those under the Data Access Act.’’ 

• ‘‘The process of conducting literature reviews’’ and ‘‘the process of naming advisory committees’’ should be made more transparent. • ‘‘Agencies should avoid turning repeatedly to the same scientists for service on 

advisory committees.’’ 

• Executive branch agencies need to ‘‘help clarify for both officials and the general 

public which aspects of disputes are truly about scientific results and which concern policy.’’ 

• ‘‘Policy makers should be wary of conclusions of risk that are expressed as a single number.’’ 

• ‘‘Federal agencies need to experiment with ways to increase the number of scientists who participate in peer review.’’ 

• ‘‘In presenting the conclusions of literature reviews, agencies and their scientific 

advisory committees need to be as open and precise as possible in discussing levels of risk and uncertainty.’’ 

Do you agree with any or all of these recommendations? Do you have any additional 

comments or advice in pursuing these goals? 

A2. Yes, I agree with these BPC recommendations. Congress could support these 

(particularly 4th, 5th and 7th bullets) by explicitly recognizing in authorizing statutes that good policy decisions depend on a range of information, and avoid delegating decisions to agencies on the pretense that ‘‘science’’ alone can make the normative determination of what policy should be. To quote further from the BPC report: 

• ‘‘The first impulse of those concerned with regulatory policy should not be to claim 

‘the science made me do it’ or to dismiss or discount scientific results, but rather 

to publicly discuss the policies and values that legitimately affect how science gets 

applied in decision making.’’ (BPC 2009, 4) 

• ‘‘Distinguishing between science and policy is not always easy or straightforward, 

and scientists may make choices based on values in the course of their work. 

Nonetheless, policy debate would be clarified and enhanced if a systematic effort 

were made to distinguish between questions that can be resolved through scientific judgments and those that involve judgments about values and other matters of policy when regulatory issues comprise both. This transparency would both 
55 

help force values debates into the open and could limit spurious claims about, and 

attacks on science.’’ (BPC 2009, 15) 

Legislators should also take care to limit the role of scientific advisory panels to 

advising on science, and avoid embedding their policy views in their scientific recommendations. I would also highlight the following BPC recommendation: 

• ‘‘In general, scientific advisory panels should not be asked to recommend specific 

regulatory policies.’’ (BPC 2009, 5) 

Q3. A recent joint report from the EPA’s Science Advisory Board and Board of Scientific Councilors recommended that the Agency ‘‘include sustainability in its research vision’’ in order to allow ‘‘EPA to adopt sustainability as a core principle 

to inform decisions and actions.’’ Is this emphasis on sustainability appropriate 

for EPA’s research and science activities? 

A3. I am not familiar with this report or recommendation. 

Q4. Many of the regulatory activities that EPA is currently undertaking are based 

upon statutes and priorities from several decades ago. In your view, are we focusing our attention and scientific resources on the most pressing environmental 

issues? Are there ways that EPA could better prioritize? 

A4. A concerted effort to focus resources on the most pressing environmental issues 

would be a welcome change. In 1987, EPA ranked its regulated activities according 

to the risks they posed to human health and the environment. It found that the activities that commanded the largest share of federal resources and public dollars 

were not the ones that posed the greatest risk. However, the allocation of resources 

tracked public perception of risks very well. (U.S. Environmental Protection Agency. 

Unfinished Business: A Comparative Assessment of Environmental Problems. February 1987) To my knowledge, EPA has not repeated this exercise but it would likely be fruitful. 

Q5. Dr. Marchant recommended the Health Effects Institute or the European Food 

Safety Agency as potential models for conducting independent scientific assessments as an alternative to the current EPA practices. In your experience, are 

there other governmental or non-governmental organizations that demonstrate 

characteristics in scientific assessment or R&D that could serve as a useful 

model for science reform at EPA? 

A5. I do not believe that an independent group of risk assessors, insulated from 

challenge, would address the problems we see in risk assessment in the U.S. While 

isolating risk assessors might be an appropriate solution to a problem of ‘‘politicized 

science,’’ as the BPC report concluded, ‘‘some disputes over the ‘politicization’ of 

science actually arise over differences about policy choices that science can inform, 

but not determine.’’ EPA’s Office of Research and Development arguably fits the 

Marchant model, yet its IRIS process is widely recognized to be broken, with long 

delays and the perception that policy preferences are embedded in numbers that are 

presented as purely risk-based assessments. 

The peer-review process may offer a better model for reform, where challenge and 

debate are encouraged, leading to more robust hypothesis testing and more reliable 

theories. 

Q6. Many EPA science activities are housed within regulatory offices. For example, 

EPA’s Office of Air and Radiation (rather than the Office of Research and Development) manages the National Fuel and Vehicle Emissions Laboratory, as well 

as the National Air and Radiation Environmental Laboratory. In your view, 

should science activities be organizationally insulated from regulatory activities 

to ensure objectivity and balance? 

A6. The organizational location of the unit doing the analysis is less important than 

requirements for transparency so that all analyses can be examined from different 

perspectives and subjected to challenge. Rather than insulating different groups 

from challenge, analyses should be replicable, transparently distinguish scientific information from assumptions and policy judgments, and be able to withstand legitimate challenge. Further, the use to which the scientific assessments are put influences the quality of the assessment. Assessments that are factors in policy decisions 

that permit balancing of risks, costs, and benefits (such as conducted under TSCA 

or FIFRA) are more likely to be transparent and objective than those conducted for 

decisions for which they will be the deciding factor (such as NAAQS). 

Q7. Some scientific information that is disseminated by federal agencies is subject 

to specific data quality requirements. Are there additional steps that you think 
56 

could be taken to ensure that these peer review and data quality guidelines are 

followed or expanded for important scientific information at EPA? 

A7. More conscientious adherence to existing information quality and peer review 

requirements would improve both the information disseminated and the policy decisions on which that information is based. The most rigorous research I’ve seen on 

agency compliance with information quality guidelines is that of Dr. Richard Belzer 

(a former OIRA analyst). He has found that through FY2010 EPA’s average response times were 166 days for petitions and 316 days for appeals. This record is 

worse than the government as a whole, which has average response times of 148 

days and 186 days, respectively. In its information quality guidelines, EPA committed to respond to both petitions and appeals within 90 days. (See his presentations in November and December 2010 here http://www.rbbelzer.com/presentations.html) 

Checks and balances from other branches of government (legislative and judicial) 

could provide needed incentives to follow these guidelines. Agencies might be more 

responsive if responding were made a nondiscretionary duty, or if there were penalties that came into force automatically for failure to meet reasonable response 

deadlines. But it’s also possible that the quality of agency responses would decline 

if responding by the deadline were all that mattered to avoid the penalty. Thus, Dr. 

Belzer argues for incentives that encourage timeliness and quality in agency responses, not one at the expense of the other. He suggests compliance might improve 

if agencies could correct errors without having to admit that they were wrong. 

Q8. Nearly all of EPA’s recent Clean Air Act regulations have been justified on the 

basis of two studies that rely on entirely on data from the American Cancer Society and the so-called Harvard Six Cities Study. Despite the fact that these data 

sets were developed with government funds and provide the basic Agency justification for costly regulations, they are not publicly-available so they can be 

analyzed by other scientists. Do you support making this type of information 

transparent? In your view, would making these underlying data sets available 

to everyone improve the Agency’s regulatory decisions? 

A8. Yes, as the BPC report stated, ‘‘Studies used in the formulation of regulation 

should be subject to data access requirements equivalent to those under the Data 

Access Act.’’ Risk assessments depend on numerous assumptions and choices, so 

making underlying data available allows results to be replicated and tested under 

alternative assumptions. It helps decision makers understand the sensitivity of predictions to different assumptions, and improves the rigor of the analysis and the 

quality of the regulatory decision. 

Q9. As you know, the Office of Management and Budget (OMB) defines agency scientific assessments as ‘‘highly influential’’ if they ‘‘could have a clear and substantial impact on important public policies with a potential effect of more than 

$500 million in any one year.’’ Assessments that fall into this category are required to undergo rigorous and transparent peer-review. However, in many instances EPA has refused to designate even obvious assessments as highly influential—such as its greenhouse gas endangerment finding that is the basis for 

tens of billions in regulatory costs. 

Q9 a. In your experience as head of OIRA, how did you apply this test? Do you think 

the EPA Endangerment Finding constitutes a highly influential assessment, 

and if so how can Congress better ensure EPA follows standing OMB requirements? 

A9 a. The Information Quality Bulletin provides agencies some discretion in defining ‘‘highly influential,’’ however EPA’s IG recently opined that the endangerment 

finding should have been designated as such. 

Q9 b. At the Subcommittee’s November 17th hearing, EPA Assistant Administrator 

Paul Anastas said that the agency has not yet determined whether its study 

on hydraulic fracturing would be designated as highly influential. In your 

view is it advisable for EPA to determine whether a study will be ‘‘highly influential’’ and thus subject to greater peer review before it actually begins to 

collect and analyze data? 

A9 b. Yes. As, OMB’s Information Quality Bulletin for Peer Review states with regard to planning for upcoming disseminations: ‘‘The agency shall provide its prediction regarding whether the dissemination will be ‘‘influential scientific information’’ or a ‘‘highly influential scientific assessment,’’ as the designation can influence 

the type of peer review to be undertaken.’’ 
57 

Responses by Dr. Alan Moghissi, 

President, Institute for Regulatory Science 

Questions submitted by Subcommittee Chairman Andy Harris 

I am greatly honored to have been invited to testify before the Subcommittee on 

Energy and Environment of the House Committee on Science, Space, and Technology. Your questions and my response to them are as follows: 

Q1. The Bipartisan Policy Center’s 2009 report, ‘‘Improving the Use of Science in 

Regulatory Policy’’ was mentioned several times during the hearing. This report 

made several suggestions that may be useful in guiding this Subcommittee’s efforts to reform regulatory science, including: 

• ‘‘Studies used in the formulation of regulation should be subject to data access 

requirements equivalent to those under the Data Access Act.’’ 

• ‘‘The process of conducting literature reviews’’ and ‘‘the process of naming advisory committees’’ should be made more transparent. 

• ‘‘Agencies should avoid turning repeatedly to the same scientists for service on 

advisory committees.’’ 

• Executive branch agencies need to ‘‘help clarify for both officials and the general 

public which aspects of disputes are truly about scientific results and which concern policy.’’ 

• ‘‘Policy makers should be wary of conclusions of risk that are expressed as a single number.’’ 

• ‘‘Federal agencies need to experiment with ways to increase the number of scientists who participate in peer review.’’ 

• ‘‘In presenting the conclusions of literature reviews, agencies and their scientific 

advisory committees need to be as open and precise as possible in discussing levels of risk and uncertainty.’’ 

Do you agree with any or all of these recommendations? Do you have any additional 

comments or advice in pursuing these goals? 

A1. I am in fundamental agreement with the above items. Before I respond to the 

question permit me to briefly address certain issues that would simplify my response to this and other questions: 

1. It may be recalled that in my testimony on November 30, 2011, I provided a 

definition for regulatory science which is the generalized version of definition used 

by various organizations. I also provided five principles as the foundation of Metrics 

for Evaluation of Regulatory Science Information (MERSI) and three pillars for scientific information (SI) derived from the MERSI principles. Furthermore, my testimony emphasized the need to identify assumptions, judgments, application of default data, and other non-reproducible (NR) segments in SI. 

2. A large number of contested decisions of the EPA are traceable to its history 

and how the regulatory process at the EPA evolved. President Nixon established the 

EPA in December of 1970 by combining a number of organizations from various federal agencies. Upon its formation, the EPA faced a number of legally mandated 

deadlines and during the early history of the EPA many laws were enacted or reauthorized including Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA in 

1972), Safe Drinking Water act (SDWA in 1974), Toxic Substances Control Act 

(TSCA in 1976), Clean Water Act (CWA in 1977), and Clean Air Act (CAA in 1977). 

In the overwhelming majority of cases, the scientific information and supporting 

data were insufficient to promulgate regulations based on acceptable science. During 

the Initial Phase of the EPA’s history that lasted about one decade, the administrators had no other choice but to use what has become known as Best Available Technical Information (BATI). Although in a few cases, they were able to use Partially 

Reproducible SI, in the majority of cases they were forced to rely upon SI at lower 

level of scientific maturity notably judgment of the EPA staff and EPA consultants. 

In order to be protective of heath and environmental effects of pollutants they chose 

what they called the ‘‘conservative’’ approach and overestimated, and often significantly overestimated the human health end environmental effects of the pollutant. 

During this period, the independent peer review process was virtually unknown. 

3. The next decade of the EPA’s history could be appropriately called the Exploratory Phase. That phase started with the reappointment of William Ruckelshaus by 
58 

President Reagan and followed by his successor, Lee Thomas. These administrators 

attempted to move the scientific foundation of regulator decisions from the Initial 

Phase to a process that would be scientifically more acceptable. However, during 

this phase the process used during the Initial Phase continued and the BATI process remained the predominant process at the EPA. 

4. I and many other EPA employees had hoped that the Exploratory Phase would 

quickly come to an end and a final phase would use scientific methods and approaches commonly used in most scientific disciplines. Unfortunately, despite an 

enormous level of funding; objections by regulated communities; court cases; and reviews and comments by organizations such as National Academies, Bipartisan Policy Center, and Institute for Regulatory Science, EPA has yet to leave the Exploratory Phase and often relies upon BATI that was common during its Initial Phase. 

In the following I will try to respond to the items identified in the first question: 

Question: ‘‘Studies used in the formulation of regulation should be subject to data 

access requirements equivalent to those under the Data Access Act.’’ 

Response: The Data Access Act requires that agencies provide information to 

those who request it using the Freedom of Information Act (FOIA). Experience 

shows repeated abuse of FOIA and thus a more appropriate approach would be compliance with Transparency Principle of MERSI. Congress should mandate that all 

scientific data with the exception of those that would violate laws dealing privacy 

or national security, should be placed on the Internet so that the entire scientific 

community could have access to the information and use the data for scientific assessments. 

Question: ‘‘Agencies should avoid turning repeatedly to the same scientists for 

service on advisory committees.’’ 

Response: As will be described in the response to the question on peer review, it 

is imperative to ensure that information included in NR/SI is not based on the philosophical, ideological, or other views of an individual. Therefore, it is necessary to 

avoid seeking repeatedly the services of the same individuals as members of the advisory committees. 

Question: Executive branch agencies need to ‘‘help clarify for both officials and the 

general public which aspects of disputes are truly about scientific results and which 

concern policy.’’ 

Response: There is a similarity between the views expressed by the report of the 

Bipartisan Policy Center of 2009. It may be recalled that the third pillar of MERSI 

is ‘‘areas outside the purview of science.’’ Mixing science with policy and other nonscientific issues is not only undesirable but may have adverse consequences. As 

sated above, it is imperative to separate science from its policy implications. Whereas properly performed independent peer review can evaluate the validity of scientific 

claims, and the reasonableness of selection of NR/SI including potential alternatives, 

a scientific panel is not necessarily qualified to judge the acceptability of chosen 

policies or identify potential alternatives. 

Question: ‘‘Policy makers should be wary of conclusions of risk that are expressed 

as a single number.’’ 

Response: This question addresses one of the most important issues that led to 

my recommendation of passing the Regulatory Science Sunshine Act. During my 

tenure at the EPA I managed a risk research program which led to the development 

of the methodology of ecological risk assessment, a process currently used at the 

EPA but also globally accepted. Risk assessment for human health and ecology consists of several steps including: source assessment; transport and transformation of 

pollutant leading to exposure assessment; exposure-effect assessment also known as 

dose-response function; effect assessment; and finally risk characterization. In most 

cases, the EPA uses the steps following source assessment to regulate emission of 

pollutants. In every step there are assumption, judgments and numerous other 

areas that I called NR in the above description. In virtually every step statistical 

methods can be and often are used. Instead of statistically evaluating the combined 

uncertainties in various steps, EPA often uses the upper 95th percentile in each 

step and then combines the values and statistically evaluates the values. In the 

final step the upper 95th percentile is reported. EPA has all the right to use the 

upper 95th percentile provided the midpoint and lower 5th percentile are also provided. 
59 

Question: ‘‘Federal agencies need to experiment with ways to increase the number 

of scientists who participate in peer review.’’ 

Response: One of the fundamental principles governing peer review and scientific 

assessment is to avoid using an individual repeatedly in these activities. Increasingly, a rule of thumb has been established requiring that an individual who is 

qualified to be a ‘‘peer’’ may not be used more than three times .The consequence 

of violating this rule is more significant that it may appear. It may be recalled that 

scientific foundation of EPA’s actions is at best Partially Reproducible SI, and often 

lower level of scientific maturity going down to SI based on Judgment. In all of 

these SI classes, there are assumptions, judgments, application of default data and 

on occasion societal objectives, identified described above as NR/SI. The repeated 

use of an individual institutionalizes his/her selection of NR/SI and societal objectives. 

Question: ‘‘On presenting the conclusions of literature reviews, agencies and their 

scientific advisory committees need to be as open and precise as possible in discussing levels of risk and uncertainty.’’ 

Response: In the past and to some extent today, the EPA reviews the existing literature and chooses one or a select number of information as the foundation of the 

scientific decisions. It is necessary for the EPA to include all information, identify 

NR/SI and justify the choices. 

Q2. A recent joint report from the EPA’s Science Advisory Board and Board of Scientific Councilors recommended that the Agency ‘‘include sustainability in its research vision’’ in order to allow ‘‘EPA to adopt sustainability as a core principle 

to inform decisions and actions.’’ Is this emphasis on sustainability appropriate 

for EPA’s research and science activities? 

A2. I remember fondly the establishment of the Science Advisory Board. The task 

of the Board was to provide scientific advice to the EPA managers and review their 

scientific activities. Although I am unfamiliar with the Board of Scientific 

Councilors, I presume that their mission is to provide scientific advice. Sustainability is a societal goal much like many other societal goals such as energy independency or global food supply that include environmental considerations. The two 

scientific organizations would be well advised to consider the statement by William 

Ruckelshaus who stated ‘‘ . . . all scientists must make it clear when they are speaking as scientists—ex cathedra—and when they are recommending policy they believe should flow from scientific information.. What we need to hear more of from 

scientists is science.’’ Much like many other societal goals sustainability is a highly 

desirable but should be mandated by Congress and not by scientific groups. 

Q3. Many of the regulatory activities that EPA is currently undertaking are based 

upon statues and priorities from several decades ago. In your view, are we focusing our attention and scientific resources on the most pressing environmental 

issues? Are there ways that EPA could better prioritize? 

A3. I believe that currently, the EPA is focusing its efforts including significant resources to activities that have marginal human health and environmental benefits 

with high-levels of expenditure. By exaggerating the benefits and underestimating 

the costs EPA tries to justify its decisions. Traditionally, the EPA has attempted to 

address chemical and radiological agents and has left decisions on microbiological 

agents to other agencies. EPA would be well advised to address the exceedingly complex microbiological pollution. 

Q4. Dr. Marchant recommended the Health Effects Institute or the European Food 

Safety Agency as potential models for conducting independent scientific assessments as an alternative to the current EPA practices. In your experience, are 

there other governmental or non-governmental organizations that demonstrate 

characteristics in scientific assessment or R&D that could serve as a useful 

model for science reform at EPA? 

A4. There is a distinction to be made between performing scientific assessments 

and having the resulting activity independently peer reviewed. EPA and its contractors are capable of preparing scientific assessments. What is missing is a properly 

performed independent peer review of the so prepared scientific assessment. The Institute for Regulatory Science has performed over 300 peer reviews for government 

agencies at federal, state, and local levels and for Congress. In most cases, the oversight of these reviews was performed by a committee established by the American 

Society of Mechanical Engineers in cooperation with several other professions societies. The critical part of thee reviews was the proper formulation of review criteria 
60 

(questions provided to the reviewers).The subject is too complex to be addressed in 

this response and our upcoming text book on peer review (as references in my testimony) provides details of the peer review requirements. 

Q5. Many EPA science activities are housed within regulatory offices. For example, 

EPA’s Office of Air and Radiation (rather than the Office of Research and Development) manages the National Fuel and Vehicle Emissions Laboratory, as well 

as the National Air and Radiation Environmental Laboratory. In your view, 

should science activities be organizationally insulated from regulatory activities 

to ensure objectivity and balance? 

A5. As initially designed the sole objective of having scientists and engineers assigned to program offices was to ensure scientific competency within those offices 

so that scientific issues could be addressed within those offices in promulgation or 

enforcing regulations. In order for these Individuals to be informed on the technical 

development, they were permitted to participate in technical activities of their respective professions. If the above-mentioned laboratories or any other laboratory in 

the EPA is predominantly performing R&D, it should be assigned to the Office of 

Research and Development. 

Q6. Some scientific information that is disseminated by federal agencies is subject 

to specific data quality requirements. Are there additional steps that you think 

could be taken to ensure that these peer review and data quality guidelines are 

followed or expanded for important scientific information at EPA? 

A6. As stated several times both in my testimony and in response to question in 

this document, the scientific foundation of EPA’s decision often include assumption, 

judgments, default data and occasionally societal objectives. Consequently, the review criteria (questions provided to the reviewers) should include the following: 

• Are the assumptions (defined as information that cannot be reproduced by any 

individual with sufficient knowledge and equipment, if required) justified? 

• How would the conclusions be different if the assumptions chosen by the EPA 

would be replaced by other assumptions? 

• Are the judgments (as defined under assumptions) justified and would the conclusions be different if the judgment chosen by the EPA would be replaced by 

other? 

• Are the chosen defaults data justified and would the conclusions be different 

if the default data chosen by the EPA would be replaced by others? 

• Has the EPA provided justification for including non-scientific criteria (often 

justified for being protective) in the science instead of including it in the administrative and policy decisions? 

Q7. Nearly all of EPA’s recent Clean Air Act Regulations have been justified on the 

basis of two studies that rely on entirely on data from the American Cancer Society and the so-called Harvard Six Cities Study. Despite the fact that these data 

sets were developed with government funds and provide the basic Agency justification for costly regulations, they are not publicly-available so that they can 

be analyzed by other scientists. Do you support making this type of information 

transparent? In your view, would making these underlying data sets available 

to everyone improve the Agency’s regulatory decisions? 

A7. In the interest of transparency, let me start be declaring that the late Ben Ferris, one of the leaders of the Harvard Six City Study, was a friend and I was briefly 

the project officer for that study. Both studies can be classified as Correlation-Based 

SI and it is highly likely that other investigators using the same data would come 

to different conclusions than those reached by the respective authors. I strongly recommend that the raw data from both the Harvard and American Cancer Society 

studies be placed on the web. There is no justification for not making the raw data 

available to other scientists. 
61 

Responses by Dr. Kenneth P. Green 

Resident Scholar, 

American Enterprise Institute 

Questions submitted by Subcommittee Chairman Andy Harris 

The views expressed in this testimony are those of the author alone and do not necessarily represent those of the American Enterprise Institute. 

Q1. The Bipartisan Policy Center’s 2009 report, ‘‘Improving the Use of Science in 

Regulatory Policy’’ was mentioned several times during the hearing. This report 

made several suggestions that may be useful in guiding this Subcommittee’s efforts to reform regulatory science, including: 

• ‘‘Studies used in the formulation of regulation should be subject to data access 

requirements equivalent to those under the Data Access Act.’’ 

• ‘‘The process of conducting literature reviews’’ and ‘‘the process of naming advisory committees’’ should be made more transparent. 

• ‘‘Agencies should avoid turning repeatedly to the same scientists for service on 

advisory committees.’’ 

• Executive branch agencies need to ‘‘help clarify for both officials and the general 

public which aspects of disputes are truly about scientific results and which concern policy.’’ 

• ‘‘Policy makers should be wary of conclusions of risk that are expressed as a single number.’’ 

• ‘‘Federal agencies need to experiment with ways to increase the number of scientists who participate in peer review.’’ 

• ‘‘In presenting the conclusions of literature reviews, agencies and their scientific 

advisory committees need to be as open and precise as possible in discussing levels of risk and uncertainty.’’ 

Do you agree with any or all of these recommendations? Do you have any additional 

comments or advice in pursuing these goals? 

A1. The suggestions of the Bipartisan Policy Center (BPC) referenced in the Subcommittee’s follow-up questions have considerable merit. More transparency; more 

data-sharing; greater diversity of agency reviewers; greater distinctions between scientific findings and value-driven decisions; more accurate descriptions of proposed 

risks; and greater explanations of uncertainty levels could only lead to better public 

policy development. 

I am not convinced that the BPC’s recommendation to ‘‘avoid turning repeatedly to 

the same scientists for service on advisory committees’’ is either necessary, nor particularly feasible. There are, after all, a limited pool of scientists who will have particular expertise, time, willingness, and capability of giving quality service on a review committee. It seems reasonable that an agency might repeatedly turn to a particular reviewer who has shown a willingness and ability to participate in previous 

reviews. Should sufficient safeguards be in place to guarantee balanced points of 

view, avoid conflicts of interest, etc., agencies should, I think, have the discretion 

to use a person as a ‘‘regular’’ reviewer. 

Q2. A recent joint report from the EPA’s Science Advisory Board and Board of Scientific Councilors recommended that the Agency ‘‘include sustainability in its research vision’’ in order to allow ‘‘EPA to adopt sustainability as a core principle 

to inform decisions and actions.’’ Is this emphasis on sustainability appropriate 

for EPA’s research and scienceactivities? 

A2. EPA’s efforts to insert a ‘‘sustainability’’ agenda into their mission is, I believe, 

politically driven and unwise. I most certainly do not believe that the EPA should 

‘‘include sustainability in its research vision.’’ ‘‘Sustainability’’ is a highly subjective 

term in both spatial and temporal domains. One can define actions as sustainable 

in a region, or with regard to the entire planet. One can define actions as sustainable for a year, a decade, a century, or for eternity. Such a plastic term would grant 

EPA extremely wide latitude in its ability to regulate activities that are far outside 

what I feel is its only legitimate function, which is to protect human health and 

property from damage via environmental contamination. Additionally, arguments 

about ‘‘sustainability,’’ are often used to promote favored technologies at the expense 

of disfavored technologies, and plays into the hands of both rent-seekers and activist 

governments. Thus, by declaring fossil fuels ‘‘unsustainable,’’ and wind or solar 
62 

power ‘‘sustainable,’’ EPA could slant the playing field against fossil fuel development (as they already do, to the limits of their abilities). 

Q3. Last year you wrote about one specific example of EPA’s National Center for Environmental Research providing $1.4 million dollars to recruit people to ‘‘dredge 

through EPA’s databases in order to gin up new things for the agency to worry 

about and possibly regulate.’’ Can you discuss the role of these epidemiological 

associations in establishing major regulations, and whether EPA-funded research is being overly protective? 

A3. In any large set of data, one can search for, and usually find, any number of 

correlations. In fact, in very large sets of data, such correlations are virtually certain 

to exist. But correlations do not equal causality, and it’s highly likely that researchers dredging through very large data sets will find statistically significant correlations that are not causally related. As the saying goes, ice cream sales correlate with 

heat-stroke incidence, but that’s not because ice cream causes heat stroke, it’s because they both correlate with hot weather. 

As I wrote in the article you referenced, 

‘‘It is one thing for scientists to identify sick populations, and to investigate what 

it is that might be making them sick. It is another thing entirely to sift through 

large data bases in order to come up with correlations that may have no causal relationship. 

And, ever helpful, EPA gives some examples of what such data-dredging exercises 

might look like: 

For example, while air pollution associations with respiratory and cardiovascular 

disease have been studied most extensively, evidence is beginning to emerge of possible air pollution impacts on additional health conditions including diabetes, neurological disorders, and reproductive and developmental outcomes. Studies also might 

evaluate factors that confer increased sensitivity to air pollution effects such as compromised health status, genetic variants, social and neighborhood conditions, higher 

exposure and others. In addition, some research groups have developed innovative 

methods and models to characterize exposure that might be applied to health effects 

analyses in other cohorts to understand whether certain sources or atmospheric 

components contribute to observed geographic heterogeneity in health-exposure associations. 

Further, EPA has specific outcomes in mind. This is not random data dredging, 

which would be bad enough. This program seeks to fund directional data dredging 

that looks only for relationships suggesting that exposures to various air pollutants 

causes harm to human health. In EPA’s words: 

EPA is interested in research to explain heterogeneity in health responses to air 

pollutants. Heterogeneity might be explained by: 1) Individual characteristics and 

other environmental/social conditions that increase the likelihood of an adverse 

health outcome among a subset of the population. [emphasis mine] 

To pay for this innovative regulatory fishing expedition, EPA proposes to give 

away $1.4 million dollars in portions up to $300,000, for projects that could last up 

to three years. 

Now, there’s nothing wrong with trying to ensure that people’s health is protected 

from dangerous air pollutants (in fact, I’d argue that it’s a very legitimate function 

of government), but there is something wrong with organizing taxpayer funded fishing expeditions to probe for new regulatory potential by seeking out obscure relationships in large databases. And those problems are intrinsic to data dredging, an 

frequently abused form of data mining. 

Data dredging, according to Wikipedia, is ‘‘the inappropriate (sometimes deliberately so) use of data mining to uncover misleading relationships in data. These 

relationships may be valid within the test set but have no statistical significance 

in the wider population.’’ Wikipedia gives a particularly relevant example: ‘‘Suppose 

that observers note that a particular town appears to be a cancer cluster, but lack 

a firm hypothesis of why this is so. However, they have access to a large amount 

of demographic data about the town and surrounding area, containing measurements for the area of hundreds or thousands of different variables, mostly 

uncorrelated. Even if all these variables are independent of the cancer incidence 

rate, it is highly likely that at least one variable will be significantly correlated with 

the cancer rate across the area.’’ 

Or, as the Congressional Research Office explains (in the context of fishing for terrorists in air-travel databases): 
63 

Although data mining can help reveal patterns and relationships, it does not tell 

the user the value or significance of these patterns. These types of determinations 

must be made by the user. Similarly, the validity of the patterns discovered is dependent on how they compare to ‘‘real world’’ circumstances. For example, to assess 

the validity of a data mining application designed to identify potential terrorist suspects in a large pool of individuals, the user may test the model using data that 

includes information about known terrorists. However, while possibly re-affirming 

a particular profile, it does not necessarily mean that the application will identify 

a suspect whose behavior significantly deviates from the original model. 

Another limitation of data mining is that while it can identify connections between behaviors and/or variables, it does not necessarily identify a causal relationship. For example, an application may identify that a pattern of behavior, such as 

the propensity to purchase airline tickets just shortly before the flight is scheduled 

to depart, is related to characteristics such as income, level of education, and Internet use. However, that does not necessarily indicate that the ticket purchasing behavior is caused by one or more of these variables. In fact, the individual’s behavior 

could be affected by some additional variable(s) such as occupation (the need to 

make trips on short notice), family status (a sick relative needing care), or a hobby 

(taking advantage of last minute discounts to visit new destinations). 

In other words, with data dredging, it really is a situation of ‘‘Seek and ye shall 

find.’’ It is one thing for scientists to identify sick populations, and to investigate 

what it is that might be making them sick. It is another thing entirely to sift 

through large data bases in order to come up with correlations that may have no 

causal relationship, but that might, nonetheless, cause EPA to spend scarce taxpayer money researching the potential linkage, or worse, to endlessly dredge 

through databases in search of ever lower, ever more obscure health impacts to justify expanded regulation and EPA intrusion into the economy. 

Q4. Many of the regulatory activities that EPA is currently undertaking are based 

upon statutes and priorities from several decades ago. In your view, are we focusing our attention and scientific resources on the most pressing environmental 

issues? Are there ways that EPA could better prioritize? 

A4. Partly because of regulations, and partly because of the normal march of technology, which leads to greater efficiency and environmental cleanliness, most indicators of environmental quality have improved dramatically in the last 40 years. The 

lowest hanging fruit of environmental protection have been plucked, the largest 

risks and degradations mitigated. We now chase after ever smaller risk-reductions, 

and the EPA seems to think that no pollution of any kind is acceptable anywhere, 

for even transient moments where no persons are present. A zero-risk and zero-contamination mindset has us spending ever greater sums for ever smaller benefits. 

Contrary to EPA’s self-congratulatory analysis, economists widely recognize that 

regulation imposes a drag on economic growth. It is never a good idea to waste public funds, but it is unconscionable to do so under the kind of economic conditions 

we face today. Policy analysts point out that regulations also impose burdens on 

people and by restricting their liberty, can deprive them of opportunity. 

Thus, I think it is very important, as your question mentions, that EPA’s activities 

should focus on areas of greatest environmental risk—and even better, focus on approaches to reducing those highest-risks with as little economic destruction as possible. 

Unfortunately, as I mentioned in my testimony, EPA’s questionable use of science— 

particularly risk assessment as it relates to particulate matter and low-dose exposures to various airborne toxics—drives the agency’s prioritization and activities. 

To quote from my testimony: 

As is common in the Public Health community, EPA’s science-culture seems highly risk-averse, so much so that when confronted with a range of possible risks, they 

tend to accept assumptions and design analytical protocols and frameworks in ways 

that lead to ever-greater estimations of health risk from ever-lower levels of pollution exposure. This is sometimes referred to as being ‘‘conservative,’’ or ‘‘precautionary.’’ In a medical context, this can be beneficial, and indeed, nobody wants 

an agency to blithely dismiss proclaimed risks to the public health. 

However, when such artificially elevated risk estimates are translated into economic estimates of regulatory benefit and cost, the product is increasingly costly 

regulations that do increasingly little good, or worse, actually imposes costs greater 

than the benefits it produces. 
64 

This is where things diverge from harmless (if excessive) ‘‘risk-aversion’’ into poor 

public policy, and it is, I think, a serious problem: having a sound understanding 

of the proposed benefits and costs of regulation is a prerequisite for rational public 

policy development. 

Without rigorous benefit-cost estimates, it is impossible for an agency to determine regulatory priorities. Thus, even where an agency’s proposals might do more 

harm than good, they cannot optimally bring resources to bear to secure the biggest 

safety return-on-investment for regulatory investments potentially wasting scarce 

public tax resources. This applies between agencies as well. If agency A uses methodologies that inflate the risk posed by the things they regulate, they may well draw 

public resources away from agency B, which uses more scientifically accurate riskassessment methods. 

Q5. Dr. Marchant recommended the Health Effects Institute or the European Food 

Safety Agency as potential models for conducting independent scientific assessments as an alternative to the current EPA practices. In your experience, are 

there other governmental or nongovernmental organizations that demonstrate 

characteristics in scientific assessment or R&D that could serve as a useful 

model for science reform at EPA? 

A5. I have not made a formal study of how agencies other than EPA manage risk 

assessment, so I will yield to Dr. Marchant on this matter. I believe that other agencies, such as OSHA take a more pragmatic approach to risk assessment, but again, 

having not formally studied their methdologies, I can not say if they’d do better with 

environmental risk assessment than does the EPA. 

Q6. Many EPA science activities are housed within regulatory offices. For example, 

EPA’s Office of Air and Radiation (rather than the Office of Research and Development),manages the National Fuel and Vehicle Emissions Laboratory, as well 

as the National Air and Radiation Environmental Laboratory. In your view, 

should science activities be organizationally insulated from regulatory activities 

to ensure objectivity and balance? 

A6. As I believe I mentioned in my testimony, it seems obvious to me that having 

too many related functions within one agency is a problem at EPA. Separation of 

functions such as risk assessment; peer-review of risk assessments; crafting of risk 

management plans; sponsoring of scientific inquiry related to risks the agency itself 

has a motivation to regulate; and cost-benefit analysis could only improve the quality of our efforts to manage environmental risk. Just as we know that monopolies 

lead to reduced competitiveness and lower-quality products over time, the same is 

true for government agencies and entities. 

Q7. Some scientific information that is disseminated by federal agencies is subject 

to specific data quality requirements. Are there additional steps that you think 

could be taken to ensure that these peer review and data quality guidelines are 

followed or expanded for important scientific information at EPA? 

A7. In 2009, I testified before the Senate Environment and Public Works Committee on the question of scientific integrity and transparency. This is what I told 

the Committee: 

As more and more of our nation’s public policy decisions involve the use of complex scientific information, it becomes more and more important that our policymaking institutions make use of such information in a process that is free of bias, 

is open to outside review and analysis, allows for the airing of divergent opinion, 

and is deliberative enough to ensure that the decisions we make are the right ones. 

As recent experience has shown, this is not currently the case. Policies intended 

to mitigate climate change and conventional pollution with the use of corn-ethanol 

have backfired badly. Rather than reduce greenhouse gas emissions, poorly-thought 

out ethanol mandates have increased them. Rather than reduce conventional air 

pollution, corn-ethanol has increased them, along with polluting surface and ground 

water, contaminating fish stocks with pesticide and herbicide residues, and expanding oceanic dead-zones caused by algae which bloom as they are over-fed by fertilizer run-off from corn agriculture. Most of these problems were raised by non-governmental analysts before the ethanol mandates were passed, but the policymaking 

process proved opaque to such cautionary voices. 

Now, warnings are coming from non-governmental policy analysts and scientists 

that we may see equally perverse impacts from other forms of renewable energy 

that are being promoted at breakneck speed through the spending of stimulus 

money, and pending legislation involving energy and climate change. For example, 

new scientific reports are validating concerns expressed by energy analysts that con-
65 

centrated solar power systems may have unsustainable water demand and will imperil fragile desert ecosystems. 

Warnings that wind turbines are not environmentally benign are being validated 

as they are found to cause noise pollution, visual blight, bird and bat kills, and potentially harm livestock. One recent study has found that mass transit systems may 

well produce more pollution than the automobiles and air travel they seek to displace. Left and right, we are seeing failings of our government’s policymaking bodies 

to listen to cautionary voices in the development of public policy dependent on the 

sound use of scientific information. 

The President’s memoranda on Transparency and Open Government and on Scientific Integrity are a good start, but they can only be considered a start in the process to ensure that scientific information is used properly in the process of public policy formation. 

On the positive side of the ledger, the memoranda correctly identify certain important elements of a transparent process featuring scientific integrity. The President 

is exactly correct when he says that ‘‘political officials should not suppress or alter 

scientific or technological findings and conclusions.’’ 

It is also reassuring to see the President order that ‘‘To the extent permitted by 

law, there should be transparency in the preparation, identification, and use of scientific and technological information in policymaking.’’ 

Of particular importance, I think, is the President’s declaration that ‘‘Government 

should be participatory.’’ As the President observes, ‘‘Public engagement enhances 

the Government’s effectiveness and improves the quality of its decisions. Knowledge 

is widely disbursed in society, and public officials benefit from having access to that 

dispersed knowledge.’’ 

The President’s call for Executive departments and agencies to offer Americans 

greater opportunities to participate in policymaking processes and to infuse the decision-making process with their ‘‘collective expertise and information’’ is spot on. 

But all too often, I have seen an assumption that only scientists working within 

government, or dependent on governmental grants have worthwhile knowledge to 

inject into public policy decision-making. There is, I believe, an inherent bias 

against scientists in the private sector, even though those are often the people who, 

day by day, in their laboratories, are producing the prescription drugs that save millions, and who develop the technologies that empower billions. 

The same is true with regard to the President’s (and agency) emphasis on the 

peer-reviewed literature. As we have discovered through revelations about fraud in 

the scientific and medical literature, peer-review is no guarantee of accuracy. And 

often, the keys to publication are in the hands with those who have a vested interest 

in preserving the theory that gained them the prestige and standing to be considered as peer-reviewers. As a recent article, ironically published in the peer-reviewed 

journal PLOS Medicine demonstrated, ‘‘most claimed research findings are wrong.’’ 

The President, Congress, and regulatory agencies should explicitly recognize that 

there is a legitimate role for non-governmental, independent scientific participation 

in the public policy decision-making process in terms of both personnel, and the injection of scientific research conducted outside the peer-reviewed literature. 

Many times, over my career, I have seen a lack of real opportunity for consultation in the policymaking process. I have seen massive scientific reports issued by 

state and federal governmental agencies the day before Thanksgiving weekend, or 

just before the Christmas season, with minimal time allowed for the review of thousand-page scientific summary documents, and only trivial opportunities for meaningful consultation. We may see that again in coming months, where we’ve been 

promised the passage of landmark legislation on climate change, just in time for the 

Independence Day holiday, and many people’s summer vacation. 

Post-regulatory release of Regulatory Impact Assessments, as was the case with 

the 1997 revisions to the National Ambient Air Quality Standards, have sometimes 

made a mockery of the very idea of consultative decision making. 

Massive dockets in which thousands of review comments receive little more than 

blithe dismissals have been common features of governmental decision-making on 

important scientific issues I have sought to analyze over the last 18 years. 

Well-credentialed and experienced scientists have too often been frozen out of consultative processes because they are viewed as tainted by an industrial connection, 

or because they hold unorthodox views. 

In conclusion, the President’s memoranda on Transparency and Open Government, and Scientific Integrity are a good step, but only a single step in improving 
66 

the way that our government makes use of scientific information at all levels of the 

decision-making process. 

As more and more issues require the use of such information, more attention 

needs to be paid to reforming the processes by which scientific information is gathered, validated, balanced, summarized, and used to inform the decision-making 

process. 

Finally, it must always be remembered that science may be able to tell us ‘‘what 

is,’’ but it can never tell us ‘‘what to do.’’ Science informs—it does not compel. Public 

policy formation involves the balance of many factors, social, economic, ethics, equity, individual rights, personal responsibility, and more. 

Creating openness and transparency in the scientific elements of the decisionmaking process is important, but that same level of openness, transparency, and 

consultation should infuse every element of the public policy development process. 

Q8. Nearly all of EPA’s recent Clean Air Act regulations have been justified on the 

basis of two studies that rely on entirely on data from the American Cancer Society and the so-called Harvard Six Cities Study. Despite the fact that these data 

sets were developed with government funds and provide the basic Agency justification for costly regulations, they are not publicly-available so they can be 

analyzed by other scientists. Do you support making this type of information 

transparent? In your view, would making these underlying data sets available 

to everyone improve the Agency’s regulatory decisions? 

A8. While I understand the need to protect privileged information, and the confidentiality of the doctor-patient relationship, I believe that it is of utmost importance that the key data used to determine risk-assessments be available for independent review: not simply by an institution picked by EPA, or by any given agency, 

but by anyone who wants to examine the data. 

As we have seen with climate change data manipulation in the case of the infamous hockey stick graph, and the revelation of a cliquish mentality on the part of 

researchers that was clearly to the detriment of our understanding of climate 

science, outside review is absolutely vital if we are to have confidence in the quality 

of the data that is being used to formulate far-reaching public policy initiatives. 

There is no reason why suitably blinded data could not be made available to allow 

others to review the validity of the ACS and Harvard 6-Cities studies which, as you 

point out, are overwhelmingly important in how EPA develops air quality policy. 
67 

Responses by Dr. Gary Marchant, 

Professor of Law and Executive Director 

Center for Law, Science & Innovation, 

Arizona State University 

Questions submitted by Subcommittee Chairman Andy Harris 

Q1. The Bipartisan Policy Center’s 2009 report, ‘‘Improving the Use of Science in 

Regulatory Policy’’ was mentioned several times during the hearing. This report 

made several suggestions that may be useful in guiding this Subcommittee’s efforts to reform regulatory science, including: 

• ‘‘Studies used in the formulation of regulation should be subject to data access 

requirements equivalent to those under the Data Access Act.’’ 

• ‘‘The process of conducting literature reviews’’ and ‘‘the process of naming advisory committees’’ should be made more transparent. 

• ‘‘Agencies should avoid turning repeatedly to the same scientists for service on 

advisory committees.’’ 

• Executive branch agencies need to ‘‘help clarify for both officials and the general 

public which aspects of disputes are truly about scientific results and which concern policy.’’ 

• ‘‘Policy makers should be wary of conclusions of risk that are expressed as a single number.’’ 

• ‘‘Federal agencies need to experiment with ways to increase the number of scientists who participate in peer review.’’ 

• ‘‘In presenting the conclusions of literature reviews, agencies and their scientific 

advisory committees need to be as open and precise as possible in discussing levels of risk and uncertainty.’’ 

Do you agree with any or all of these recommendations? Do you have any additional 

comments or advice in pursuing these goals? 

A1. I agree with all these recommendations of the Bipartisan Policy Center’s report. 

I think the 4th recommendation listed on the importance of separating science from 

policy is critical. If the two are mixed together and confused, accountability and 

oversight, as well as public participation, are undermined. Putting scientific determinations in a separate institution from policy decisions, such as the Institute for 

Scientific Assessments I have proposed, would achieve this crucial separation. 

Q2. A recent joint report from the EPA’s Science Advisory Board and Board of Scientific Councilors recommended that the Agency ‘‘include sustainability in its research vision’’ in order to allow ‘‘EPA to adopt sustainability as a core principle 

to inform decisions and actions.’’ Is this emphasis on sustainability appropriate 

for EPA’s research and scienceactivities? 

A2. I have not read this report so cannot comment on it specifically. I do believe 

sustainability, if defined and applied broadly, can provide an appropriate framework 

for EPA’s research program. It would broaden EPA’s focus from solely environmental impacts to consider also broader economic and social values and impacts. It 

could help move EPA from the adversarial, command and control philosophy that 

was developed in the 1970s to a more collaborative, cooperative paradigm that is 

more appropriate to the more complex challenges facing us today. 

Q3. Many of the regulatory activities that EPA is currently undertaking are based 

upon statutes and priorities from several decades ago. In your view, are we focusing our attention and scientific resources on the most pressing environmental 

issues? Are there ways that EPA could better prioritize? 

A3. The 1970s-era environmental statutes and regulations are increasing obsolete, 

and tend to shackle EPA into rigid, media specific, end of pipe controls that no 

longer represent the current priorities facing the nation. EPA should have more 

flexibility to explore market, cooperative/partnership, and other innovative approaches to address remaining problems. For example, the EPA Project XL program 

was a win-win for the environment and companies subject to artificially rigid and 

narrow regulations. That program was terminated because it was not consistent 

with the outdated 1970s-era statutes EPA continues to regulate under. 

Q4. You proposed the establishment of an ‘‘Institute for Scientific Assessment’’ to conduct R&D that is currently housed within EPA. Please describe which particular 
68 

science and R&D activities this Institute could take over from the Agency. In 

particular, please assess the feasibility of this organization overseeing and conducting: Integrated Risk Information System assessments; integrated science assessments for National Ambient Air Quality Standards; and determinations 

about research priorities. 

A4. The Institute for Scientific Assessments (ISA) as I have proposed it would not 

oversee research programs, but would conduct scientific assessments. The ISA 

would conduct assessments such as IRIS evaluations and NAAQS integrated scientific assessments. The results of these assessments would then be forwarded to 

EPA for its regulatory decisions. As I have proposed it, the ISA would not provide 

recommendations on research priorities, but it is conceivable that the mission of the 

ISA could be expanded in that direction. 

Q5. Many EPA science activities are housed within regulatory offices. For example, 

EPA’s Office of Air and Radiation (rather than the Office of Research and Development),manages the National Fuel and Vehicle Emissions Laboratory, as well 

as the National Air and Radiation Environmental Laboratory. In your view, 

should science activities be organizationally insulated from regulatory activities 

to ensure objectivity and balance? 

A5. Yes, I believe scientific activities should be institutionally separated from regulatory activities. Placing scientific assessments within the institutional context of, 

and under the control of, regulatory officials has the potential to consciously or subconsciously influence and bias the nature and outcome of the scientific assessments. 

This is inconsistent with good scientific practice, which should be insulated from political, policy and personal influences as much as practically possible. 

Q6. Some scientific information that is disseminated by federal agencies is subject 

to specific data quality requirements. Are there additional steps that you think 

could be taken to ensure that these peer review and data quality guidelines are 

followed or expanded for important scientific information at EPA? 

A6. I have two suggestions. The first one would be to place the activities subject 

to the peer review and data quality guidelines within an institutional context that 

is familiar with and dedicated to the principles of good scientific practice that are 

behind the guidelines. I think an organization like the Institute of Scientific Assessments that I have proposed, that is operated and managed from top to bottom by 

scientists applying scientific methods and customs, would be more likely to take seriously and adhere to the peer review and data quality guidelines. My other suggestion is to make the guidelines enforceable through judicial review. Unless the guidelines have teeth, they are unlikely to be influential in an environment with so many 

other factors influencing decision-making. 

Q7. 1Nearly all of EPA’s recent Clean Air Act regulations have been justified on the 

basis of two studies that rely on entirely on data from the American Cancer Society and the so-called Harvard Six Cities Study. Despite the fact that these data 

sets were developed with government funds and provide the basic Agency justification for costly regulations; they are not publicly-available so they can be 

analyzed by other scientists. Do you support making this type of information 

transparent? In your view, would making these underlying data sets available 

to everyone improve the Agency’s regulatory decisions? 

A7. I definitely think the data should be transparent and publicly available. Transparency is a key requirement of science in order to allow scientific findings to be 

replicated. As one recent review of what makes good science stated: ‘‘The essence 

of good science is repeatability. Different scientists, in different places, at different 

times, can repeat good science if they follow the same methods and protocols.’’ Dr. 

Samuel McNaughten, What is Good Science?, Natural Resources & Envt. (ABA), 

Spring 1999, at 513. A recent special section in the journal Science on the importance of data replication and reproducibility states: ‘‘Replication—the confirmation 

of results and conclusions obtained independently in another—is considered the scientific gold standard . . . The importance of replication and reproducibility for scientists is unquestioned. Sometimes attempts to replicate reveal scientific uncertainties. This is one of the main ways that sciences progresses. Unfortunately, in rare 

instances (compared to the body of scientific work), it can also indicate fraud.’’ B.R. 

Jasney et al., Again, and Again, and Again . . . , Science 234:1225 (Dec. 2, 2011) (citations deleted). If the underlying data are not made available, they cannot be replicated, and thus the scientific validity of the original study cannot be verified. 
(69) 

FOSTERING QUALITY SCIENCE AT EPA: 

PERSPECTIVES ON COMMON SENSE 

REFORM—DAY II 

(PART II) 

FRIDAY, FEBRUARY 3, 2012 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON ENERGY AND ENVIRONMENT, 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY, 

Washington, DC. 

The Subcommittee met, pursuant to call, at 9:52 a.m., in Room 

2318 of the Rayburn House Office Building, Hon. Andy Harris 

[Chairman of the Subcommittee] presiding. 
70 

RALPH M. HALL, TEXAS EDDIE BERNICE JOHNSON, TEXAS 

U.S. HOUSE OF REPRESENTATIVES 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

2321 RAYBURN HOUSE OFFICE BUILDING 

WASHINGTON, DC 20515-6301 

(202) 225-6371 

www.science.house.gov 

Subcommittee on Energy & Environment 

Fostering Quality Science at EPA: Perspectives on Common Sense ReformDay!! 

Friday 3,2012 

10:00 a.m. to 12:00 p.m. 

2318 Rayburn. House Office Building 

Mr. Daniel Greenbaum, President and Chief Executive Officer, Health Effects Institute 

Dr. Deborah Swackhamer, Professor, Environmental Health Sciences, University of Minnesota, and 

Chairwoman, EPA Science Advisory Board 

Mr. Michael WaIls, Vice President, Regulatory and Technical Affairs, American Chemistry Council 

Dr. Richard Belzer, President, Regulatory Checkbook 

Dr. Jerald Schnoor, Allen S. Henry Chair in Engineering, Department of Civil and Environmental 

Engineering, University ofIowa 

Dr. S. Stanley Young, Assistant Director for Bioinformatics, National Institute of Statistical Sciences 
71 

1See Appendix 1 for EPA organizational structure. 

HEARING CHARTER

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

SUBCOMMITTEE ON ENERGY AND ENVIRONMENT 

U.S. HOUSE OF REPRESENTATIVES 

Fostering Quality Science at EPA: 

Perspectives on Common Sense Reform—Day II 

FRIDAY, FEBRUARY 3, 2012

10:00 A.M.—12:00 P.M. 

2318 RAYBURN HOUSE OFFICE BUILDING

Purpose 

On Friday, February 3, 2012, the Subcommittee on Energy and Environment of 

the Committee on Science, Space, and Technology will hold a second day of testimony to provide external perspectives on the need to reauthorize and reform 

science, research, and development activities at the Environmental Protection Agency (EPA); explore the intersection of Agency-supported science and its regulatory 

mission; and receive focused recommendations to raise the level, quality, usefulness, 

and objectivity of EPA science, including any necessary changes to the Environmental Research, Development and Demonstration Authorization Act. 

Witnesses 

• Mr. Daniel Greenbaum, President and Chief Executive Officer, Health Effects 

Institute 

• Dr. Deborah Swackhamer, Professor, Environmental Health Sciences, University of Minnesota, and Chairwoman, EPA Science Advisory Board 

• Mr. Michael Walls, Vice President, Regulatory and Technical Affairs, American Chemistry Council 

• Dr. Richard Belzer, President, Regulatory Checkbook 

• Dr. Jerald Schnoor, Allen S. Henry Chair in Engineering, Department of 

Civil and Environmental Engineering, University of Iowa 

• Dr. S. Stanley Young, Assistant Director for Bioinformatics, National Institute 

of Statistical Sciences 

Background 

The Environmental Research, Development, and Demonstration Authorization Act 

(ERDDA) authorizes research and scientific activities at the Environmental Protection Agency (EPA). Originally enacted in 1976, Congress subsequently passed annual authorizations through fiscal year 1981. In addition to establishing annual authorization levels, these statutes also directed EPA policy in a variety of 

areas,including establishing the Office of Research and Development (ORD), 1 requiring a five-year environmental R&D plan, and creating EPA’s Science Advisory 

Board (SAB). 
72 

2 HR 3115 (1982), HR 2804 (1982), S. 1205 (1982), S. 2577 (1983), HR 2899 (1984), S. 1292 

(1984), HR 2319 (1985), S. 2702 (1985), S. 1144 (1986), HR 2355 (1987), HR 1523 (1987), HR 

2153 (1989), HR 4873 (1990), HR 2404 (1991), S. 1655 (1991), HR 1994 (1993), S. 1545 (1993), 

HR 2405 (1995), HR 1814 (1995), HR 3322 (1996), HR 1276 (1997), HR 1742 (1999), HR 1743 

(1999). 3 Congressional Research Service, ‘‘Environmental Laws: Summaries of Major Statutes Administered by the Environmental Protection Agency,’’ RL30798, August 11, 2011. 4 42 U.S.C. §7408(a)(2) (2000). 

5 42 U.S.C. §300g–1(b)(3)(A)(i). 

6 33 U.S.C. §1314(a)(1). 

7See Appendix 2. 

8See Appendix 3. 

Since 1981, there have been a number of bills introduced to reauthorize ERDDA 

that were not ultimately enacted into law. 2 As a result, explicit authorization of 

EPA’s environmental R&D ended at the end of fiscal year 1981. This failure to comprehensively reauthorize EPA research, development, and demonstration programs 

and activities illustrates a broader trend among expired environmental statutes. 

The Congressional Research Service notes this trend, stating, ‘‘Although Congress 

somewhat recently has renewed the authorization of appropriations for certain EPA 

programs and activities through targeted amendments to various statutes, a more 

comprehensive reauthorization of many of the statutes that EPA administers has 

not been enacted for a number of years.’’ 3

In addition to ERDDA, EPA also derives authority for R&D activities through 

other major environmental statutes. For example, under the Clean Air Act, the EPA 

Administrator must issue criteria that ‘‘accurately reflect the latest scientific knowledge useful in indicating the kind of extent of all identifiable effects on public health 

or welfare which may be expected from the presence of such pollutant in the ambient air.’’ 4 Through the Safe Drinking Water Act (SDWA), EPA sets standards based 

on ‘‘the best available, peer-reviewed science and supporting studies conducted in 

accordance with sound and objective scientific practices.’’ 5 Similarly, the Clean 

Water Act (CWA) requires EPA to publish water quality information ‘‘accurately reflecting the latest scientific knowledge.’’ 6

In many cases, these major regulatory statutes also authorize specific R&D programs and activities. For example, the Clear Air Act established a national research 

and development program for the prevention and control of air pollution including 

establishing technical advisory committees and research on air pollutant monitoring. The SDWA authorized the Administrator of EPA to conduct research and 

studies relating to the causes, diagnosis, treatment, control, and prevention of physical or mental diseases resulting directly or indirectly from contaminants in the 

water including improved methods to identify and measure contaminants in drinking water and improved methods to identify and measure the health effects of contaminants in drinking water. The CWA directed the Administrator to establish national programs for the prevention, reduction, and elimination of pollution and as 

part of such programs to work in cooperation with other State and federal agencies 

to coordinate and accelerate research, investigation, experiments, demonstrations, 

and studies relating to the causes, effects, extent, prevention, reduction, and elimination of pollution in the navigable waters of the U.S. 

The science enterprise at EPA is spread across program offices and regions. ORD 

is organized into three national labs (comprised of 18 separate labs) and four national centers (which have 19 divisions). 7 In addition to 18 labs within ORD, there 

are nine labs split among several program offices and each of the 10 regions has 

its own lab. 8 In FY 2010, the appropriations level for EPA Science and Technology 

activities (S&T includes ORD and the other 19 labs) was $874.9 million. The appropriations level for FY 2011 was $840.3 million. The FY 2012 House Committeepassed appropriations level is $777.6 million, and the FY 2012 Senate Committee 

draft appropriations level is $809 million. 

The fragmented nature of EPA R&D presents a challenge to program management and coordination and has complicated efforts to evaluate the effectiveness of 

these activities. Numerous studies conducted by the EPA Office of Inspector General, the Government Accountability Office, and others have cited significant concerns with the science activities of the Agency and the difficulties in evaluating the 

usefulness of the science to program needs. These studies have offered recommendations on how to improve the science enterprise at EPA, but many of these recommendations have not been implemented. 
73 

Appendix 1 
74 

Appendix 2 

1 2 3 

The bottom of this chart shows three national labs and four national centers. The three national labs are broken down in 

I\ppendix 3. 
75 

Appendix3 

Column 1 shows 10 regional labs. Column labs. Column 3 shows 18 ORD labs. 
76 

Chairman HARRIS. The Subcommittee on Energy and Environment will come to order. 

Good morning. Welcome to day two of the hearing entitled ‘‘Fostering Quality Science at EPA: Perspectives on Common Sense Reform.’’ 

In front of you are packets containing the written testimony, biographies and Truth in Testimony disclosures for today’s witness 

panel. 

I want to welcome everyone, and we will have five minutes for 

opening statements by myself and the ranking member. I want to 

welcome everyone to the second day of our hearing on fostering 

quality science at EPA. As this is a continuation of the hearing 

held on November 30th of last year, I will be brief. 

Unfortunately, the Environmental Research, Development, and 

Demonstration Authorization Act, or ERDDAA, which is the statute authorizing R&D at EPA as well as the Science Advisory 

Board, was last reauthorized for fiscal year 1981. I think we can 

all agree that our fiscal, environmental, and economic priorities 

have changed dramatically over the past 30 years, and we should 

have statutes and a Congressional role in environmental policy 

that reflects those changes. As we have held nearly a dozen oversight hearings on specific EPA issues during this Congress, we 

have seen patterns of behavior that suggest the need for significant 

reforms. 

At day one of this hearing, we received testimony from several 

witnesses with decades of experience with the Agency: Susan Dudley of George Washington University, who formerly served as head 

of the White House Office of Information and Regulatory Affairs; 

Alan Moghissi of the Institute for Regulatory Science; Ken Green 

of the American Enterprise Institute; and Gary Marchant of Arizona State University. They provided specific recommendations on 

reforming scientific activities at EPA, including the need to separate science and policy; to quantify uncertainties; to ensure greater 

transparency in the data, models, and assumptions used in regulatory decisions; to prioritize environmental problems and solutions; and to stop overly alarmist approaches to benefit-cost analysis. 

I want to thank the witnesses for appearing before the Subcommittee, and I look forward to continuing this important conversation with this panel of experts. That concludes my opening 

statement. 

[The prepared statement of Mr. Harris follows:] 

PREPARED STATEMENT OF CHAIRMAN ANDY HARRIS

I want to welcome everyone to the second day of our hearing on ‘‘Fostering Quality Science at EPA: Perspectives on Common Sense Reform.’’ 

As this is a continuation of the hearing held on November 30th of last year, I will 

be brief. 

Unfortunately, the Environmental Research, Development, and Demonstration 

Authorization Act, or ERDDAA (ERDA), which is the statute authorizing R&D at 

EPA as well as the Science Advisory Board, was last reauthorized for fiscal year 

1981. I think we can all agree that our fiscal, environmental, and economic priorities have changed dramatically over the last 30 years, and we should have statutes 

and a Congressional role in environmental policy that reflects these changes. As we 

have held nearly a dozen oversight hearings on specific EPA issues during this Con-
77 

gress, we have seen patterns of behavior that suggest the need for significant reforms. 

At day one of this hearing, we received testimony from several witnesses with decades of experience with the Agency: Susan Dudley of George Washington University, 

who formerly served as head of the White House Office of Information and Regulatory Affairs; Alan Moghissi of the Institute for Regulatory Science; Ken Green of 

the American Enterprise Institute; and Gary Marchant of Arizona State University. 

They provided specific recommendations on reforming scientific activities at EPA, 

including the need to separate science and policy; to quantify uncertainties; to ensure greater transparency in the data, models, and assumptions used in regulatory 

decisions; to prioritize environmental problems and solutions; and to stop overly 

alarmist approaches to benefit-cost analysis. 

I want to thank the witnesses for appearing before the Subcommittee, and I look 

forward to continuing this important conversation with this panel of experts. 

Chairman HARRIS. Mr. Miller. 

Mr. MILLER. Thank you, Chairman Harris. 

Today the Subcommittee, as Chairman Harris said, meets again 

for part two of the hearing we held at the end of November on 

science at the EPA. The first two hearings in this series were a disappointment, and a missed opportunity to build a helpful record in 

preparation for the reauthorization of the Environmental Research, 

Development, and Demonstration Authorization Act. Mercifully, 

there is an acronym: ERDDAA. 

However, today, I am pleased to see that we have some panelists 

with the experience and knowledge required to address in detail 

critical improvements that can make EPA’s research enterprise 

more effective, efficient, and transparent. At the least, this is not 

just a panel of witnesses armed only with talking points and flailing criticism meant to undermine or dismantle the one agency 

charged with protecting our citizens and the environment from unlawful pollution. Let us use their time and ours wisely. 

As I have said before, I approach this task hoping to work with 

my Republican counterparts in pursuing reforms that will lead to 

better research practices that help EPA accomplish its mission. 

While we will not always agree on the best way to do that, I am 

not interested in restructuring EPA to take the only environmental 

cop off the beat. There are legitimate concerns related to EPA’s research infrastructure and processes, but they are complex, and we 

have to approach the process in a well-thought out and planned 

manner. 

I have authored and co-authored many bills in my time here. I 

understand the amount of research, stakeholder conversations, and 

thought that must take place to write legislation as important and 

ambitious as the reauthorization of ERDDAA. 

EPA’s scientific research is increasingly important as we seek to 

understand and address more complex environmental issues that 

continue to emerge and evolve. That was demonstrated just 48 

hours ago when this Subcommittee met to consider EPA’s role in 

examining groundwater research and the start of the Pavillion 

Study process. 

Scientific research knowledge and technical information are fundamental to EPA’s mission, and to inform its standard-setting, regulatory, compliance, and enforcement functions. That is why Congress created advisory bodies such as the Clean Air Scientific Advisory Committee and the Science Advisory Board that were created 

to provide independent advice on the science that allows the Ad-
78 

ministrator to make regulatory decisions. In addition to advice 

from an array of experts from many fields, the scientific process 

also involves the use of epidemiology and modeling to aid in hazard 

identification, which is only the first stage of quantitative risk assessment. 

But in the scientific process, epidemiology and modeling investigations are not the only approach to research studies. It is a multidisciplinary approach that includes real-time monitoring, clinical 

and laboratory studies, model development, measurement and exposure methods, characterization of sources, and control technologies. Just like the process we need in reauthorizing ERDDAA, 

the responsibility of the scientific process and regulatory decision 

making takes a host of perspectives, methods, and techniques. 

In short, science should inform and support the decisions we 

make, that Congress makes and the EPA makes, and most important, we all have an ultimate responsibility to do everything we can 

to make sure that everyone enjoys a decent quality of life. 

And Chairman Harris, I yield back. 

[The prepared statement of Mr. Miller follows:] 

PREPARED STATEMENT OF RANKING MEMBER BRAD MILLER

Thank you, Chairman Harris. Today the Subcommittee meets again for part two 

of the hearing we held at the end of November on science at the EPA. The first two 

hearings in this series were a disappointment and a missed opportunity to build a 

helpful record in preparation for the reauthorization of the Environmental Research, 

Development, and Demonstration Authorization Act, or ERDDA. 

However, today I am pleased to see that we have some panelists with the experience and knowledge required to address in detail critical improvements that can 

make EPA’s research enterprise more effective, efficient, and transparent. At the 

least, this is not just a panel of witnesses armed only with talking points and flailing criticism meant to undermine or dismantle the one agency charged with protecting our citizens and the environment from unlawful pollution. Let’s use their 

time and ours wisely. 

As I have stated before, I approach this task hoping to work with my Republican 

counterparts in pursuing reforms that will lead to better research practices that 

help EPA accomplish its mission. While we will not always agree on the best way 

to do that, I am not interested in restructuring EPA to take the only environmental 

cop off the beat. 

There are legitimate concerns related to EPA’s research infrastructure and processes, but they are complex, and we have to approach this process in a well-thoughtout and planned manner. I have authored and co-authored many bills in my time 

here. I understand the amount of research, stakeholder conversations, and thought 

that must take place to write legislation as important and ambitious as the reauthorization of ERDDA. 

EPA’s scientific research is increasingly important as we seek to understand and 

address more complex environmental issues that continue to emerge and evolve. 

This was demonstrated just 48 hours ago when this Subcommittee met to consider 

EPA’s role in examining ground-water research and the start of the Pavilion Study 

process. 

Scientific research, knowledge, and technical information are fundamental to 

EPA’s mission, and inform its standard-setting, regulatory, compliance, and enforcement functions. That is why Congress created advisory bodies such as the Clean Air 

Scientific Advisory Committee (CASAC) and the Science Advisory Board (SAB) that 

were created to provide independent advice on the science which allows the Administrator to make regulatory decisions. In addition to advice from an array of experts 

from many fields, the scientific process also involves the use of epidemiology and 

modeling to aid in hazard identification, which is only the first stage of quantitative 

risk assessment. 

But in the scientific process that epidemiology and modeling investigations are 

not the only approach to research studies. It is a multidisciplinary approach including real-time monitoring, clinical and laboratory studies, model development, meas-
79 

urement and exposure methods, characterization of sources, and control technologies. Just like the process we need in reauthorizing ERDDA, the responsibility 

of the scientific process and regulatory decision making takes a host of perspectives, 

methods, and techniques. 

In short, science should inform and support the decisions we make. And most important, we all have an ultimate responsibility to do everything we can to ensure 

that EVERYONE continues to enjoy a decent quality of life. 

With that, Chairman Harris, I yield back. 

Chairman HARRIS. Thank you very much. 

At this time I would like to introduce our witness panel and 

thank each of them for appearing before us today. 

Our first witness is Mr. Daniel Greenbaum, President and CEO 

of the Health Effects Institute. He has been a member of the U.S. 

National Research Council, Board of Environmental Studies and 

Toxicology, and Vice Chair of its Committee for Air Quality Management. Mr. Greenbaum has over three decades of governmental 

and non-governmental experience in environmental health. 

Our next witness is Dr. Deborah Swackhamer, a Professor of Environmental Health Sciences at the University of Minnesota and 

the Chairwoman of the EPA Science Advisory Board. She is also 

a Governor appointee on the Minnesota Clean Water Council and 

recently completed a one-year term as President of the National Institute of Water Resources. She is also a member of the Editorial 

Advisory Board for the Journal Environmental Science and Technology and is Chair of the Editorial Advisory Board of the Journal 

of Environmental Monitoring through the end of last year. 

Our third witness is Mr. Michael Walls, Vice President of Regulatory and Technical Affairs for the American Chemistry Council. 

He has experience in a wide range of domestic chemical regulatory 

issues including the Toxic Substance Control Act, Emergency Planning and Community Right to Know Act, and the Resource Conservation and Recovery Act. His experience also includes work on 

international chemical regulatory issues, including the Europe 

Commission’s Registration, Evaluation and Authorization of 

Chemicals. 

Our fourth witness is Dr. Richard Belzer, President of Regulatory 

Checkbook. From 1988 to 1998, Dr. Belzer served as Staff Economist in OMB’s Office of Information and Regulatory Affairs, where 

he reviewed major federal regulations and the supporting analyses. 

He focused primarily on the assessment of benefits and opportunity 

costs, both of which involve crucial links to human health risk assessments. 

Our fifth witness is Dr. Jerald Schnoor, Allen S. Henry Chair in 

Engineering in the Department of Civil and Environmental Engineering at the University of Iowa. Dr. Schnoor chaired the Board 

of Scientific Counselors for the Environmental Protection Agency, 

Office of Research and Development, from 2000 to 2004. While 

serving as Editor in Chief of Environmental Science and Technology, he guided the leading journal in the world in both environmental engineering and environmental science. 

Our sixth and final witness is Dr. S. Stanley Young, the Assistant Director for Bioinformatics at the National Institute of Statistical Sciences. He is a fellow of the American Statistical Association 

and the American Association for the Advancement of Science. He 

has authored or co-authored over 50 papers including six Best 
80 

Paper Awards and a highly cited book, Resampling Based Multiple 

Testing. Thank you all for appearing before the Subcommittee today. As 

our witnesses should know, spoken testimony is limited to five minutes each, after which the Members of the Committee will have five 

minutes each to ask questions. 

I now recognize our first witness, Mr. Daniel Greenbaum of the 

Health Effects Institute. 

STATEMENT OF MR. DANIEL GREENBAUM, 

PRESIDENT AND CHIEF EXECUTIVE OFFICER, 

HEALTH EFFECTS INSTITUTE 

Mr. GREENBAUM. Mr. Chairman and Members of the Committee, 

I am pleased to appear before you today. I am Dan Greenbaum, as 

you said, from the Health Effects Institute. We are a nonprofit research institute with joint and balanced funding from U.S. EPA 

and industry that for over 30 years has produced trusted science 

to inform air quality decisions. I draw on HEI’s and other experiences to highlight five important principles for producing credible 

science. 

HEI was born out of controversy between EPA and industry over 

whose science could be believed. We were established as an independent, nonpartisan entity to produce health science that could be 

agreed to by all parties, and we are designed with several key elements to ensure impartiality: an independent, high-level board of 

directors of distinguished science and policy leaders who are not 

from sponsors; standing committees of independent, respected experts; a research committee to oversee all research; and a separate 

review committee to conduct intensive peer review of all research 

and prepare a commentary on the findings. The board also appoints special expert committees to conduct targeted re-analyses of 

key studies and systematic reviews of the literature. 

All results from HEI are published and available for free, and we 

work to actively provide access to all underlying data. And importantly, HEI produces policy-relevant science, but we do not take 

policy positions. 

Now, HEI was not established to replace all science produced for 

air quality and other environmental decisions but HEI’s design was 

designed to produce science of the highest quality and credibility 

in often controversial circumstances. Five key principles guide this 

work. 

First, we engage scientists who are independent and objective, 

scientists from a wide variety of arenas, not just environment and 

health. It is essential that public and private science organizations 

actively reach out to the widest possible range of scientists with diverse perspectives and skills. Now, scientist recruitment must also 

avoid real or readily perceived conflicts of interest, and HEI, the 

National Academies, EPA and others have procedures in place to 

identify these, but these reviews of conflicts should not become a 

straitjacket that, for example, disqualifies well-qualified scientists 

just because they have been funded at times by industry or EPA 
81 

or an environmental organization. We need the best science, as 

long as it is objective, from wherever it can come. 

Second, science should be funded through vigorous, open competition. HEI and a number of others including U.S. EPA’s Star Grant 

program, which has received exemplary reviews from the National 

Research Council, use well-established techniques for soliciting, reviewing, scoring and selecting projects. Again, the broad-based recruitment of scientists to compete and participate in these processes is essential to ensuring a level playing field for the widest 

possible sets of institutes and science perspectives. 

Third, we need to apply the full range of multidisciplinary skills, 

drawing on experts in emissions, exposure, toxicology and epidemiology, but perhaps most important, we at HEI have placed the field 

of statistics at the center of our work, insisting on predesigned statistical analysis plans and subjecting each study’s results to detailed statistical review to make sure that the best techniques were 

applied. 

Fourth, all results must be subjected to intense peer review and 

re-analysis if needed. Now, peer review has been a cornerstone of 

science for many years, but with the profusion of scientific journals 

in recent years, the quality of peer review can vary substantially. 

This is further complicated by the tendency of some journals to be 

more interested in publishing studies that have found a positive effect, or so-called publication bias. HEI’s peer review process requires a comprehensive report of all findings, not only positive results, a broad-based standing expert peer review panel which has 

had nothing to do with the study, the active engagement of at least 

two statisticians in each review, and the ability to request and gain 

access to all underlying data as part of that review. 

And finally, science should be conducted and reported with full 

transparency. HEI seeks to produce its work with the widest degree of disclosure of results and underlying data. This is critical to 

ensuring that all positive and negative results are reported and 

that the broader science community can access and further analyze 

the results and data. We have even placed entire databases for our 

studies on the Web for anybody to go to at any time when that was 

possible. 

Thank you for this opportunity to testify. I would be pleased to 

answer any questions. 

[The prepared statement of Mr. Greenbaum follows:] 

PREPARED STATEMENT OF MR. DANIEL GREENBAUM, 

PRESIDENT AND CHIEF EXECUTIVE OFFICER, 

HEALTH EFFECTS INSTITUTE

Summary 

The production of high-quality, credible science is of critical importance to informing often-controversial policy decisions on environment and health. For over 30 

years, the Health Effects Institute, an independent, not-for-profit research institute 

with joint and balanced funding from U.S. EPA and industry, has produced trusted 

science in a variety of forms to inform air quality decisions. This testimony draws 

from that experience—and from the results of the recent report of the Bipartisan 

Policy Center (Improving the Use of Science in Regulatory Policy)—to highlight key 

principles of producing credible science, including: 

• Engaging scientists who are independent and objective; 
82 

1 Bipartisan Policy Center. 2009. Improving the Use of Science in Regulatory Policy. Washington, DC: Bipartisan Policy Center. 

• Funding science through vigorous open competition; 

• Applying the full range of multi-disciplinary skills; 

• Subjecting all results to intense peer review, and re-analysis if needed; and 

• Conducting and reporting science with full transparency. 

This testimony describes how each of these key principles contributes to producing 

credible science; the critical elements necessary for applying them successfully, and 

the degree to which practice at US EPA and elsewhere in government includes these 

approaches currently and/or could be enhanced. 

Testimony 

Mr. Chairman, and Members of the Committee, it is my pleasure to appear before 

you at this important hearing, ‘‘Fostering Quality Science at EPA: Perspectives on 

Common Sense Reform—Day II.’’ I am Daniel S. Greenbaum, President of the 

Health Effects Institute (HEI), an independent, not-for-profit research institute with 

joint and balanced funding from U.S. EPA and industry that, for over 30 years, has 

produced trusted science in a variety of forms to inform air quality decisions. I also 

was pleased to serve recently on the Committee of the Bipartisan Policy Center on 

Science and Policy, a multi-party expert panel that made recommendations 1 on improving the development and use of science in policy. I draw on the rich experience 

of HEI, and the recommendations of the Science and Policy Committee to highlight 

several important principles for producing credible science to inform environment 

and health decisions. 

The Health Effects Institute 

HEI was born out of controversy. During implementation of the Clean Air Act 

rules for air quality and vehicle emissions in the 1970s, there was substantial disagreement between manufacturers and the U.S. EPA about the underlying health 

science driving decisions. HEI was established with the support of U.S. EPA and 

industry as an independent, non-partisan entity to produce health science that could 

be agreed to by all parties—and could serve as the basis for better decisions. HEI 

is designed with several key elements to ensure its impartiality: 

• Joint and balanced core funding from US EPA and industry; 

• An independent, high-level Board of Directors of distinguished science and policy 

leaders to guarantee the integrity of the science, with members agreed to by the 

EPA Administrator and industry but not containing any current sponsor employees; 

• Standing Committees of subject matter experts in exposure, toxicology, epidemiology, statistics and other disciplines who are not employees of sponsors and 

who may not have demonstrated ‘‘a lack of objectivity’’ in their field: 

• Research Committee to design, conduct competitions for, and oversee all research; 

• Review Committee to conduct intensive peer review of all HEI-funded research, and prepare a Commentary on the scientific findings and their implications for decisions. 

• Special Expert Committees appointed according to the same principles to conduct targeted reanalyses of key studies and systematic reviews of the literature 

in important areas. 

• Full transparency, with all results published and available for free electronically, and active provision of access to underlying data; 

• Importantly, HEI produces policy-relevant science, but does not take policy positions. 

With these elements in place, HEI has funded over 250 studies of a wide range 

of air pollutants; reanalyses of a number of epidemiologic studies central to decisions; and special reviews of the literature on diesel exhaust, air toxics, traffic effects, and more. HEI’s work has been widely accepted as credible and comprehensive 

and is regularly cited in decision making in the U.S. and worldwide. 
83 

Principles of Credible Science 

HEI was not established to replace all science produced for air quality policy decisions. Much science was then, and is today, produced directly with funding from 

U.S. EPA, the National Institutes of Health, and others. But HEI’s design was developed to produce science of the highest quality and credibility at the most critical 

and often controversial junctures of science and decisions, and the key principles 

that HEI has applied can inform the enhancing of credibility of all science produced 

for informing decisions. These key principles are: 

• Engaging scientists who are independent and objective: Quality science for decisions requires the active involvement of a wide range of talented individuals 

from diverse perspectives. Many scientists are fully engaged in their research 

and teaching and hesitant to become overly involved in often-controversial 

science/policy settings. One result of this is that at times one can find a range 

of scientists actively engaged in the work of organizations like the National 

Academy of Sciences, but despite the best recruitment efforts of entities such 

as the Science Advisory Board, unwilling to engage in the scientific work of 

agencies like EPA. To further enhance skills, HEI has sought to engage scientists from a wide variety of arenas, not just environment and health; it is essential that public and private science organizations actively reach out to the 

widest possible range of scientists, seeking consciously to engage scientists with 

diverse perspectives and skills. 

For maximum credibility, scientist recruitment must also ensure that scientists 

do not carry with them real or readily perceived conflicts of interest, e.g., a direct financial interest in the outcome of the scientific deliberation. The BPC 

Science and Policy Report systematically reviews the many detailed approaches 

that have been adopted by U.S. EPA, other federal agencies, the NAS, and others for identifying both biases and conflicts of interest, and recommends enhanced approaches to this important task. 

It is important, however, that such reviews of bias and conflicts not act to unnecessarily place scientist selection in a ‘‘strait jacket’’ that, for example, disqualifies wellqualified scientists simply because they have been funded by industry or U.S. EPA, 

or have done work or work currently for industry or an environmental organization. 

Some of the best experts have received funds from a range of sponsors, are capable 

of providing a balanced perspective on the science, and should be included unless 

there is a real and current conflict of interest. 

• Funding science through vigorous open competition: A hallmark of the highestquality science is to ensure that it is selected and funded through the highest 

levels of peer-reviewed competition. HEI and a number of other research programs, including U.S. EPA’s STAR grants program (which has received exemplary reviews from the National Research Council) have used well-established 

techniques for soliciting, reviewing, scoring, and selecting such projects. At the 

same time, this is an area where the broad-based recruitment of scientists to 

participate in these selection processes, and the recusal of scientists from reviewing applications from their own institutions, is essential to ensuring a 

‘‘level playing field’’ for competitors from the widest possible set of institutions 

and scientific perspectives. 

• Applying the full range of multi-disciplinary skills: Since its inception, HEI has 

seen fully multi-disciplinary science as the only way to answer complex questions facing decision makers in environmental health. Thus, for example, a 

team studying the health effects of certain emissions, or peer reviewing the results of such a study, must include engineering and exposure measurement expertise. And the best health studies will draw on a combination of toxicological 

and epidemiological techniques to determine whether a certain exposure is having an effect. Perhaps most important, HEI has placed the field of biostatistics 

at the center of its work, insisting on pre-designed statistical analysis plans for 

each major project, and subjecting each study’s results to intense statistical review to ensure that (a) the best and most appropriate statistical techniques 

were applied and (b) any positive results (i.e., those showing an ‘‘effect’’) are 

placed in the context of the full range on positive and negative results before 

interpreting the study’s conclusions. 

• Subjecting all results to intense peer review, and re-analysis if needed: Peer review has been a cornerstone of science for generations and has served well, in 

general, to identify the strongest contributions to the scientific literature on a 

wide variety of topics. However, with the profusion of scientific journals in re-
84 

2 Cf. Samet J.M., Zeger S.L., Dominici F., Curriero F., Coursac I., Dockery D.W., Schwartz J., 

Zanobetti A. 2000. The National Morbidity, Mortality, and Air Pollution Study, Part II: Morbidity and Mortality from Air Pollution in the United States. Research Report 94. Health Effects 

Institute, Cambridge, MA. 3Krewski D., Burnett R.T., Goldberg M.S., Hoover K., Siemiatycki J., Jerrett M., 

Abrahamowicz M., White W.H. 2000. Reanalysis of the Harvard Six Cities Study and the American Cancer Society Study of Particulate Air Pollution and Mortality. A Special Report of the 

Institute’s Particle Epidemiology Reanalysis Project. Health Effects Institute, Cambridge, MA. 4 Cf. HEI Panel on the Health Effects of Traffic-Related Air Pollution. 2010. Traffic-Related 

Air Pollution: A Critical Review of the Literature on Emissions, Exposure, and Health Effects. 

HEI Special Report 17. Health Effects Institute, Boston, MA. 5www.ihapss.jhsph.edu. 

cent years, and the diversification of peer review processes, the degree to which 

any particular journal article is subjected to the highest level of peer review can 

vary substantially. This is further complicated by the tendency of journals to 

be more interested in publishing studies that have found a positive ‘‘effect,’’ a 

‘‘publication bias’’ which has now been documented in a number of settings. 2

The HEI peer review process was designed to address these shortcomings, especially for science at critical intersections between science and decisions. That 

process includes several key elements: (a) a comprehensive report of all findings, not necessarily only the ‘‘positive’’ results; (b) a broad-based standing 

panel of experts (the HEI Review Committee) which has had nothing to do with 

the study and meets in person to review each report and to prepare a detailed 

Commentary on the study findings and their implications; (c) the active engagement of at least two biostatisticians in each review; and (d) the contractual ability to request and gain access to all underlying data generated in the study and 

used in the analysis. These and other steps result in a level of peer review that 

is widely regarded as being as intense as, and in some cases more intense than, 

the peer review at the best scientific journals. 

HEI has, at times, also been asked by Congress, U.S. EPA, industry, and others 

to go beyond its intensive peer review of its own studies to play two other intense review roles: the reanalysis of key studies that are particularly central to 

decisions (e.g., the HEI reanalysis of the Harvard Six Cities and American Cancer Society studies), 3 and the systematic review of the complete scientific literature on emissions, exposure, and health (e.g., recent reviews of the science 

on the potential effects of exposure to air toxics and to traffic-generated air pollution). 4 In each of these cases HEI’s Board of Directors appoints multi-disciplinary expert panels according to the same principles of independence to oversee 

reanalysis and systematic literature reviews. And those efforts are then in turn 

subjected to high levels of peer review by experts who have not previously been 

involved. 

• Conducting and reporting science with full transparency: From its inception, 

HEI has sought to produce its work with the widest degree of disclosure of results and underlying data. This is critical to ensuring that all results—both 

positive and negative—are reported, and that the broader science community 

can fully access, and further analyze, the results and data. HEI’s comprehensive 

reports present, for free Web distribution, all methods and results, along with 

the Commentary of the HEI Review Committee. And since the mid-1990s, HEI’s 

Board of Directors has had in place a Data Access Policy that has both encouraged HEI investigators to make their data and analysis freely available on the 

Web (for example, the data underlying HEI’s National Morbidity, Mortality and 

Air Pollution Study (NMMAPS)), 5 and to facilitate—wherever HEI investigators 

have full ownership of underlying data—access for other investigators to the 

data. 

Conclusions—Toward Credible Science for Environment and Health Decisions 

In conclusion, it is clear that science can and should play an important role in 

providing the foundation for decisions on environment and health, and that to do 

so, the science needs to be of the highest quality and credibility. U.S. EPA and other 

agencies have established procedures to produce and review science for decisions, 

and in many cases those procedures work to enhance the quality and credibility of 

the science. The HEI experience, founded out of a desire by both industry and U.S. 

EPA for more readily trusted science, has illustrated a number of key principles 

that can lead to even better science for decisions in the years to come. Thank you 
85 

for this opportunity to testify. I would be pleased to answer any questions the Committee may have. 

Chairman HARRIS. Thank you very much. 

I now recognize our second witness, Dr. Deborah Swackhamer of 

the University of Minnesota and Chairwoman of the EPA Science 

Advisory Board. 

STATEMENT OF DR. DEBORAH SWACKHAMER, PROFESSOR, 

ENVIRONMENTAL HEALTH SCIENCES, 

UNIVERSITY OF MINNESOTA, 

AND CHAIRWOMAN, EPA SCIENCE ADVISORY BOARD 

Dr. SWACKHAMMER. Good morning, Chairman Harris, Ranking 

Member Miller and distinguished Committee Members. My name 

is Deborah Swackhamer, and I hold the Denny Chair in Science 

Technology and Public Policy at the Humphrey School of Public Affairs at the University of Minnesota. I am trained as an environmental chemist, and I am Professor of Environmental Health 

Sciences in the School of Public Health and co-direct the University’s Water Resources Center. 

I was appointed Chair of the SAB in 2008 by EPA Administrator 

Stephen Johnson and reappointed for a second term in 2010 by Administrator Lisa Jackson. While my perspectives and opinions are 

my own, I am testifying today on behalf of the SAB. 

The SAB provides science advice to the EPA Administrator on a 

wide range of scientific and technical issues. These issues are complex, and they require a diversity of experience to address. The 

SAB membership brings expert knowledge from the natural and 

physical sciences, engineering, health sciences, and social sciences 

including economics. Based on my years of service on the board, I 

believe that the agency has a robust process for identifying members with outstanding scientific credentials who are committed to 

helping improve the quality of agency science. The SAB and its 

committees and panels review agency work products, undertake 

special studies when requested, and perform self-initiated studies 

on topics that the Board considers to be of critical importance. 

Recent SAB advice that is directly relevant to this hearing includes two reports we produced in 2009 and 2010 on strategic directions for EPA research prepared for ORD to encourage approaches and strategies needed to do their science most effectively. 

These two reports have been instrumental in moving ORD’s research enterprise towards a more interdisciplinary approach and 

one that can respond more nimbly and effectively to the needs of 

the program offices and the regional offices. The Administrator’s 

One EPA and ORD Assistant Administrator Anastas’s ‘‘The Path 

Forward’’ strategies are consistent with our previous advice. The 

board is in the process of finalizing a report on how the agency can 

do a better job of integrating science and problem formulation in 

its decision making. 

The SAB is supportive of many changes that have taken place 

in ORD in recent years. More could be done, more is being done, 

but I believe and our reports have indicated that ORD is moving 

in the right direction. We have advised strongly for an integrated 

approach to EPA’s scientific research, and the agency has responded, as indicated by the realignment of research programs 
86 

from 13 independent programs to six integrated programs. We have 

advised to include a greater degree of social and decision science 

research, and the agency is moving to fill this need. We have advised to develop the capacity to respond to emerging issues and the 

new program structure should move them in the right direction. 

We have advised the agency to partner more nationally and internationally and develop truly collaborative research efforts in these 

times of limited and shrinking resources, and they have been creative in doing so. Finally, we urged ORD to support and creative 

incentives for their scientists to be more innovative, and they have 

responded. 

The SAB and presumably this Subcommittee share the goal and 

commitment to assist EPA in producing and using high-quality 

science to protect human health and the environment. The best 

available science is essential to sound decision making but is not 

the only aspect of sound policy decisions. What is best available 

science? While hard to provide a simple one-size-fits-all definition, 

generally, it is scientific results, conclusions, and technical information that has been produced using proven methods that has been 

peer reviewed where hypotheses are tested with objective and unbiased approaches and that has the support for its conclusions from 

other independent studies. The role of the SAB is to examine the 

scientific and technical knowledge that was synthesized within the 

agency on a given issue and provide advice as to whether this 

science was appropriate and adequate for its intended use. 

Finally, the letter from Chairman Harris requested that I comment on the capability of EPA to conduct and use the best available science to fulfill its mission. The agency certainly has the capability, given its excellent scientific enterprise. It is sorely short 

of resources to provide the capacity needed for all the science questions at the agency, and yet, there is no other agency where such 

environmentally focused and directed science is being done to fill 

the unique mission of protecting the public’s health and the environment on which they depend. 

Investing in EPA science is a wise investment. That said, this capability would be improved by continuing to address scientific questions from an interdisciplinary approach, by partnering more creatively with others, by involving stakeholders in problem formulation, and integrating science across the agency for the most effective decision making. 

Thank you for the opportunity to speak with you today. 

[The prepared statement of Dr. Swackhamer follows:] 

PREPARED STATEMENT OF DR. DEBORAH SWACKHAMER, PROFESSOR, 

ENVIRONMENTAL HEALTH SCIENCES, UNIVERSITY OF MINNESOTA, 

AND CHAIRWOMAN, EPA SCIENCE ADVISORY BOARD

My name is Deborah Swackhamer, and I hold the Charles M. Denny, Jr., Chair 

in Science, Technology, and Public Policy in the Hubert H. Humphrey School of Public Affairs at the University of Minnesota, and co-direct the University’s Water Resources Center. I am trained as an environmental chemist and am also professor 

of Environmental Health Sciences in the School of Public Health. 

I was appointed chair of the SAB in 2008 by EPA Administrator Stephen Johnson 

and reappointed for a second term in 2010 by EPA Administrator Lisa Jackson. 

From 2006–2008, I served on the Board of Scientific Counselors (BOSC) for EPA’s 

Office of Research and Development (ORD). While my views, perspectives, and opinions are my own, I am testifying at this hearing on behalf of the SAB. 
87 

1Science Integration for Decision Making at the U.S. Environmental Protection Agency (EPA) 

(draft January 5, 2012). 2 EPA’s Strategic Research Directions 2008: An Advisory by the EPA Science Advisory Board. EPA-SAB-09-006. 3Office of Research and Development Strategic Research Directions and Integrated 

Transdisciplinary Research. EPA-SAB-10-010. 

The Role of the SAB 

The SAB provides science advice to the EPA Administrator on a wide range of 

scientific and technical issues. These issues are complex and require a diversity of 

expertise to address. The SAB membership brings expert knowledge from the natural and physical sciences, engineering, health sciences, and social sciences including economics. Based on my years of service on the Board, I believe that the Agency 

has a robust process for identifying members with outstanding scientific credentials 

who are committed to helping improve the quality of Agency science. The SAB and 

its committees and panels review Agency work products, undertake special studies 

when requested, and perform self-initiated studies on topics that the Board considers to be of critical importance. The Board is in the process of finalizing a report 

on how the Agency can do a better job of integrating science and problem formulation in its decision making. 1

Recent SAB advice that is directly relevant to this hearing includes the two reports we produced (2009, 2010) 2 on Strategic Directions for EPA Research, prepared 

for ORD to encourage approaches and strategies needed to do their science most effectively. These two reports have been instrumental in moving ORD’s research enterprise towards a more interdisciplinary approach, and one that can respond more 

nimbly and effectively to the needs of the Program Offices and Regional Offices. The 

Administrator’s ‘‘One EPA’’ and ORD Assistant Administrator Anastas’ ‘‘The Path 

Forward’’ strategies are consistent with our previous advice.1A3

The SAB is supportive of many changes that have taken place in ORD in recent 

years. We have advised strongly for an integrated approach to EPA’s scientific research, and the Agency has responded, as indicated by its realignment of research 

programs from 13 individual programs to six integrated programs. We have advised 

to include a greater degree of social and decision science research, and the Agency 

is moving to fill this need. The social sciences are a needed component to adequately 

address issues such as sustainability, homeland security, risk communication, valuation, and environmental stewardship and human behavior. The Agency needs to 

develop a strategy for developing this capability. We have advised to develop capacity to respond to emerging issues, and the new program structure should move them 

in that direction. We have advised the Agency to partner more nationally and internationally and develop truly collaborative research efforts in these times of limited 

and shrinking resources, and they have been creative in doing so. Finally, we urged 

ORD to support and create incentives for their scientists to be more innovative, and 

they have created a highly successful internal program for Innovation Grants and 

have modified their internal rewards system to encourage the best scientific publications. 

To summarize, we are supportive of these changes at ORD. More could be done, 

more is being done, but I believe, and our reports have indicated, that ORD is moving in the right direction. 

Quality, Usefulness and Objectivity of EPA Science—the Role of SAB 

The SAB, and presumably this Subcommittee, share the goal and commitment to 

assist EPA in producing and using high-quality science to protect human health and 

the environment. The best available science is essential to sound decision making 

but is not the only aspect to sound policy decisions. What is ‘‘best available science’’? 

While hard to provide a simple one-size-fits-all definition, generally it is scientific 

results, conclusions, and technical information that has been produced using proven 

methods, that has been peer reviewed, where hypotheses are tested with objective 

and unbiased approaches, and that has support for its conclusions from other independent studies. EPA cannot possibly do all of the science needed by the Program 

Offices and Regional Offices. Some of this needed science is conducted within EPA, 

and some science is used from outside research to verify, supplement, and in general 

add to the collective body of knowledge used to inform a given decision. 

The role of the SAB is to examine the scientific and technical knowledge that was 

synthesized within the Agency for a given issue, and provide advice as to whether 

this science was appropriate and adequate for its intended use. In SAB reviews of 

EPA science assessments, we consider whether the data, reports, and other resources used were peer reviewed and compared and contrasted appropriately. It is 
88 

4Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency. EPA/260R-02-008. 

my understanding that EPA has clear guidance regarding peer review of its own scientific work, and for data quality and transparency. 4 For purposes of maximum 

transparency and quality assurance, we usually advise the Agency not to include 

reports that have not been peer reviewed, or journal manuscripts in preparation or 

draft form but not yet published. 

As a researcher who has received funding from EPA and many other agencies, 

I have found that EPA has very high standards for data quality and assurance. 

Enhancing EPA Science 

Finally, the letter from Chairman Harris requested that I comment on the capability of EPA to conduct and use the best available science to fulfill its mission. The 

Agency certainly has the capability given its excellent scientific enterprise. It is 

sorely short of resources to provide the capacity needed for all the science questions 

at the Agency, and yet there is no other agency where such environmentally focused 

and directed science is being done to fill the unique mission of protecting the 

public’s health and the environment on which they depend. Investing in EPA 

science is a wise investment. That said, this capability would be improved by continuing to address scientific questions from an interdisciplinary approach, by 

partnering more creatively with others, by involving stakeholders in problem formulation, and integrating science across the Agency for the most effective decision 

making. 

Thank you for the opportunity to speak to you today. 

Chairman HARRIS. Thank you very much. 

I now recognize our third witness, Mr. Michael Walls of the 

American Chemistry Council. 

STATEMENT OF MR. MICHAEL WALLS, 

VICE PRESIDENT, REGULATORY AND TECHNICAL AFFAIRS, 

AMERICAN CHEMISTRY COUNCIL 

Mr. WALLS. Good morning, and thank you very much for the opportunity to provide this testimony on behalf of the American 

Chemistry Council. 

Now, the business of chemistry is fundamentally the business of 

science. The chemical industry practices high-quality science to foster the discovery of new chemistries and the development of new 

tools by which we can assess the hazards, uses, and exposures of 

chemicals. We similarly expect high-quality science and reliable assessment procedures to underpin effective and efficient regulatory 

decisions by the government. 

Now, my testimony today boils down to a very simple message: 

the process for bringing science to bear in regulatory and policy decision making at EPA and at other federal agencies is broken. The 

quality of the science has suffered as a result, and the credibility 

and reliability of the decisions made on the basis of that science is 

at stake. Now, Congress, the agencies, the industry and the American public have a significant interest in using the best science to 

ground those decisions. The fact is that science and the government 

are reasonably likely to lead the regulatory decisions, and those decisions have practical implications for businesses, State, and local 

governments and individuals. 

I would just like to focus on several examples drawn from EPA’s 

IRIS program as well as some other government programs. The 

IRIS draft assessment on n-Butanol relies on two studies determined to be unreliable by the Organization for Economic Coopera-
89 

1The American Chemistry Council (ACC) represents the leading companies engaged in the 

business of chemistry. ACC members apply the science of chemistry to make innovative products 

and services that make people’s lives better, healthier, and safer. ACC is committed to improved 

Continued 

tion and Development in a review that was sponsored by yet another office within EPA. There is no indication that that conflict is 

going to be resolved. The National Academy of Sciences directed 

EPA to do nonlinear modeling in support of its IRIS assessment of 

dioxin. Five years later, EPA published yet another draft of the assessment that similarly failed to do the nonlinear modeling that 

was requested. EPA Science Advisory Board justly criticized the 

draft for that failure. The National Toxicology Program, part of the 

Department of Health and Human Services, issued its 12th report 

on carcinogens in July 2011. The report makes many of the same 

errors in its assessment of formaldehyde that the National Academy criticized EPA for in its own review of formaldehyde. That 

12th report also viewed styrene and came to a sharply different 

conclusion than a 2010 evaluation by another division within HHS. 

Why do we need to get this right? Well, in the IRIS case, it is 

particularly important because 80 percent of IRIS assessments 

haven’t been updated in more than 15 years. Ninety percent are at 

least ten years old. Meanwhile, the science that informs our understanding of chemicals and of exposures has continued to advance 

by leaps and bounds. That new science should surely inform our 

regulatory and policy decisions. 

The Federal Government’s processes for assessing risk lack a 

consistent, coherent framework. That framework should bind the 

agencies to an appropriate and transparent approach to weigh the 

evidence, consider uncertainty, and keep up with advances in the 

field. Peer review is a critical step to ensure a high level of quality 

and reliability. Despite recommendations from the NAS and from 

the SAB, little has been done to ensure that peer review is consistent within and among the federal agencies. In short, we need 

to modernize and streamline these processes to meet both today’s 

needs and our future challenges. 

My written testimony outlines some recommendations for improving the quality and process of science in three areas. Number 

one, establishing sound risk assessment procedures, standards and 

criteria; two, enhancing peer review; and three, leveraging the 

emerging science and technology to reach better decisions. 

The chemical industry looks forward to working with this Subcommittee in its continuing effort to improve science and risk assessment in the government. I very much appreciate the invitation 

to join the discussion today and look forward to your questions. 

[The prepared statement of Mr. Walls follows:] 

PREPARED STATEMENT OF MR. MICHAEL WALLS, 

VICE PRESIDENT, REGULATORY AND TECHNICAL AFFAIRS, 

AMERICAN CHEMISTRY COUNCIL

Summary 

The American Chemistry Council (ACC) 1 very much appreciates this opportunity 

to provide testimony on common-sense measures to foster quality science at the Environmental Protection Agency (EPA) and throughout the Federal Government. 
90 

environmental, health, and safety performance through Responsible Carer, common-sense advocacy designed to address major public policy issues, and health and environmental research and 

product testing. The business of chemistry is a $674 billion enterprise and a key element of the 

Nation’s economy. It is one of the Nation’s largest exporters, accounting for 10 cents out of every 

dollar in U.S. exports. Chemistry companies are among the largest investors in research and 

development. It is also one of the Nation’s most heavily regulated industries. 2 EPA’s Integrated Risk Information System (IRIS) has been the focus of much critical attention recently. As the Subcommittee is well aware, the National Academy of Sciences (NAS) has 

expressed concern over ‘‘[t]he persistence of limitations of the IRIS assessment methods and reports, particularly in light of the continued evolution of risk-assessment methods and the growing societal and legislative pressure to evaluate many more chemicals in an expedient manner.’’ 

The NAS report further cites a lack of clarity and transparency as a ‘‘repeating theme’’ over 

the last decade, insufficient documentation on methods and criteria for identifying evidence from 

relevant studies, and a lack of information useful in assessing the weight of the evidence, among 

other problems. These concerns are not limited to IRIS, or even EPA. For example, the Report 

on Carcinogens (RoC) issued by National Toxicology Program (NTP), housed in the Department 

of Health and Human Services (HHS). The 12th RoC, released in July 2011, makes many of 

the same methodological errors in its evaluation of formaldehyde as IRIS did in its review, and 

the 12th RoC’s review of styrene conflicts with a 2010 evaluation by another HHS entity. Similar concerns exist with EPA’s Clean Air Scientific Advisory Committee. 

The business of chemistry is fundamentally the business of science. This business 

of science is a critical component for manufacturing safe products required to house, 

feed, and protect people in the United States as well as provide for the tremendous 

quality of life experienced by American citizens who enjoy many high-quality and 

safe consumer goods that were unavailable just a few decades earlier. ACC member 

companies rely on science to conduct the research necessary to discover new chemistries and identify new applications of existing chemistries. They also rely on 

science to develop new tools for assessing the potential hazards, exposures, and 

risks of chemical substances. As one of the Nation’s most regulated industries, ACC 

member companies similarly expect high-quality science—and reliable assessment 

processes—to underpin effective and efficient regulatory decisions by the Federal 

Government. 

Unfortunately, processes for conducting and reviewing chemical assessments at 

EPA and other government agencies are not always based on the consistent use of 

the best available science. The lack of scientific quality and reliability directly compromises societal access to cost-effective and safe products that house, feed, and protect us while making life more enjoyable at the same time. While there has been 

much recent focus on EPA’s Integrated Risk Information System (IRIS), the problems identified by the National Academy of Sciences (NAS) in the IRIS program are 

also evident in other government chemical assessment programs. 

EPA has acknowledged many of the deficiencies in the IRIS program and is taking some welcome steps to address the concerns identified by the NAS. EPA is also 

making an important effort to develop and evaluate emerging technologies to improve chemical assessments, and ACC has been pleased to support these efforts. 

ACC’s testimony today outlines a number of recommendations to improve the 

quality and process of science at EPA and more broadly through the Federal Government. The following areas should receive particular attention: 

• Improving the quality of science through sound risk assessment processes, 

standards and criteria. 

• Improving the quality of science through enhanced peer review. 

• Enhancing the quality of science by leveraging emerging science and technology. 

I. Improving the Quality of Science Through Sound 

Risk Assessment Processes, Standards, and Criteria 

The Subcommittee’s inquiry into the level, quality, usefulness, and objectivity of 

science at the Environmental Protection Agency (EPA) is timely. There are wellknown deficiencies in EPA’s Integrated Risk Information System (IRIS)—deficiencies that Congress has directed the National Academy of Sciences to review. But 

the problems that affect the Agency’s ability to assure that the science generated, 

reviewed, and used is of the highest quality are not unique to EPA. 2 ACC’s testimony today outlines a number of recommendations to improve the quality and process of science at EPA and more broadly through the Federal Government. 

At the heart of the problem in the Federal Government’s processes for assessing 

risks to environment and human health is the lack of a consistent, coherent, 

science-based framework that binds the agencies to an appropriate and transparent 

approach for weighing evidence, considering uncertainty, and keeping up with advances in the field. The processes for considering scientific information and data and 
91 

3Government Accountability Office, ‘‘Chemical Assessments: Challenges Remain With EPA’s 

Integrated Risk Information System Program,’’ GAO-12-42, Dec 9, 2011. Available at http:// 

www.gao.gov/assets/590/586620.pdf. 

the standards and criteria used in risk assessment need to be modernized and 

streamlined to meet both today’s needs and greater challenges of the future. 

A. Integrated Risk Information System (IRIS) 

Despite continued evolution of the EPA IRIS process, specific fundamental improvements to the program are necessary to ensure that IRIS assessments developed by EPA are firmly based on up-to-date scientific knowledge, meet the highest 

standards of scientific inquiry and integrity, and are evaluated in accordance with 

acceptable scientific approaches. 

IRIS is used by EPA as the primary source of information regarding the potential 

adverse human health effects of chemicals. IRIS is also a leading source of health 

risk information for other federal, State, and international regulatory bodies. Given 

the importance that IRIS evaluations have for EPA program offices, other federal 

agencies, and State governments, as well as their impacts on the private and public 

sectors, it is clear that significant improvements are warranted and long overdue. 

Many of these necessary improvements were outlined in Chapter 7 of the April 

2011 NAS scientific peer review report on formaldehyde and underscored during two 

recent Congressional oversight hearings on IRIS. Despite general agreement with 

the need to make the changes recommended by the NAS, EPA has yet to provide 

further details on how it will implement the NAS IRIS improvements. The U.S. 

Government Accountability Office (GAO) has called on EPA to develop a clear plan 

for fixing IRIS. 3

In an effort to move EPA in this direction, Congress recently passed bipartisan 

legislation which directs EPA in FY 2012 to: 

• Incorporate, as appropriate, the recommendations of Chapter 7 of the National 

Research Council’s Review of the Environmental Protection Agency’s Draft IRIS 

Assessment of Formaldehyde into the IRIS Process; and 

• Issue a progress report to House and Senate Committees on Appropriations and 

relevant Congressional authorizing committees no later than March 1, 2012, describing its implementation of the National Research Council’s Chapter 7 recommendations for ongoing and new assessments. 

This action by Congress rightfully underscores the widespread agreement that 

more work is needed to improve IRIS so the program delivers scientifically defensible assessments. 

EPA does not need to go back to square one to improve IRIS and the assessments 

already underway. But more than a cursory review and more than simple improvements are needed. In particular, EPA should determine whether all ongoing assessments—including those that the Agency is revising to take into account peer review 

and public comments—meet the NAS standards for reviewing studies, evaluating 

weight of evidence, determining mode of action, establishing cause and effect, and 

for selecting the dose-response method for quantifying potential health risks. If an 

IRIS assessment falls short, it must be upgraded. 

ACC firmly believes that this process can be accomplished without undue delay 

in making IRIS assessments final. All stakeholders have an interest in IRIS assessments that rely on the best available scientific information regarding hazard and 

exposure; employ consistent, objective methods and models; utilize transparent evaluation procedures for data quality, cause and effect; and that weigh the full body 

of scientific evidence. If an ongoing IRIS assessment does not meet these criteria 

(for example, if a draft IRIS assessment does not employ a robust weight-of-the-evidence approach), the program must accept that more time will be needed to get the 

assessment right. The credibility of the IRIS program is not enhanced by assessments that fail to address the basic criteria for quality and reliability. 

Importantly, there is nothing in the current IRIS program that provides an incentive for companies to develop new data and information and to use new toxicological 

methods and tools to generate and gather that data. Indeed, the industry has little 

confidence that new informationand data can overcome the conservative default assumptions employed in the program or the persistent problems identified in peer review. 

In ACC’s view, two principal solutions can help meet the Federal Government’s 

need to enhance chemical risk assessment, and to restore credibility in the results. 

First, federal agency standards for risk assessment need to be updated. Ideally, the 

same set of updated standards would apply across the Federal Government. There 
92 

4OMB ‘‘Final Information Quality Bulletin for Peer Review’’ and OMB’s ‘‘Updated Principles 

for Risk Analysis’’ (http://www.whitehouse.gov/sites/default/files/omb/memoranda/fy2005/ 

m05-03.pdf; http://www.whitehouse.gov/sites/default/files/omb/assets/regulatory¥matters¥pdf/m07-24.pdf). 5These proposals do not address who is responsible for generating the data that is used in 

these assessments. ACC assumes that companies will typically have that responsibility. 

are a variety of ways this might be accomplished. Second, the laws and rules governing scientific peer reviews should be updated to make that vital process more effective and transparent. 

B. Improved Standards for Risk Assessment 

Under existing authority, there is a clear role for the Office of Management and 

Budget (OMB) in reviewing agency assessments and coordinating a robust interagency review to promote uniformity in process and results. It is clear that federal 

risk assessment activities are not being coordinated, despite direction and guidance 

provided by OMB bulletins and memoranda. 4 Moreover, there is no current governmentwide oversight to ensure coordination. As a consequence, the lack of a coordinated approach to these various assessment programs creates the potential for duplication and inconsistent findings. Most troubling, each federal agency conducting 

such assessments does so in a different way, using different processes and standards. 

To address this lack of coordination and consistency, federal agencies need to 

adopt updated state-of-the-art standards for human health and environmental risk 

assessments. Ideally, agencies would all follow a consistent set of standards. Agencies should be required to explain how they followed these standards, including providing a clear articulation of reasons for choices they made in the process. Agency 

compliance with those requirements would be enhanced if it were subject to regular 

oversight, including judicial review. 

Federal standards for risk assessment should: 

• Include criteria for evaluating the validity of test methods and the reliability 

and credibility of data. 

• Require an assessment of the weight of evidence regarding hazard and exposure, based on criteria that should include elements such as a systematic review 

of all relevant and reliable toxicological, epidemiological, and mechanistic data, 

including negative results; a preference for human data, where it is relevant 

and adequate; and consideration of biologically plausible modes of action most 

relevant to humans. 

• Require agencies to present the distribution of estimated hazards or risks, including central tendency values. 

• Require agencies to characterize uncertainty and variability quantitatively, 

where feasible, and to explain these and other limitations of the analysis with 

sufficient clarity to be understood by non-scientists. 

• Require full disclosure of: 

• Data, methods and models sufficient to allow independent reanalysis by 

qualified experts; 

• Rationales for choosing key studies, methods and models; 

• Assumptions, extrapolations and policy judgments; 

• Plausible alternatives and related impacts; and 

• Major risk conclusions and degree of confidence based on uncertainties. 

• Outline a process of stakeholder engagement, including: 

• An interactive ‘‘problem formulation’’ at the outset of each assessment to 

identify key issues and data needs; 

• Timing assessments to make maximum use of relevant external research; and 

• Outreach regarding proposed charge questions for peer review of the assessment. 

• Consider how the concept of proportionality can be addressed in risk assessment standards, so that risk assessments are more closely linked to the decision 

they are used to justify. 

There are a number of options by which these standards can be developed and 

appropriate oversight of Agency adherence to the standards established. 5 For example, if the Environmental Research, Development, and Demonstration Authorization 
93 

6See 71 Fed. Reg. 2600 (Jan. 17, 2006). 

7 U.S. Environmental Protection Agency, Peer Review Handbook 3rd Edition, EPA/100/B-06/ 

002, at 12. Available at http://www.epa.gov/peerreview/pdfs/peer¥review¥handbook¥2006.pdf. 

Act (ERDDA) is reauthorized, Congress can direct EPA to develop and implement 

these standards. 

Congress could also consider a mandate that federal agencies collaborate in an 

interagency committee that would be tasked with developing risk assessment standards that all agencies would have to follow. This might include standards outlining 

the basic assumptions underlying risk assessment methodologies (such as concepts 

of threshold versus linear modeling), the use of animal data, and weight of the evidence approaches. The logic behind this approach is that it could bring together the 

agencies charged with balancing competing risks and benefits from protective interventions (e.g., the Food and Drug Administration, the Centers for Disease Control) 

with those agencies whose mandates are to reduce risks (e.g., EPA and the National 

Toxicology Program). The critical point, of course, is to avoid the development of 

lowest common denominator standards that simply preserve the status quo. 

Congress could also direct the practice of federal agency risk assessment across 

the Federal Government by requiring the Office of Management and Budget (OMB) 

and the Office of Science and Technology Policy (OSTP) to develop standards broadly applicable across the government. Both OMB and OSTP have career staff knowledgeable about risk assessment and are interested in improving agency estimates 

of risks. In 2006, OMB and OSTP issued a proposed bulletin providing guidance to 

federal agencies regarding their conduct of health, safety, and environmental assessments. 6 Ultimately, OMB reinforced existing guidance, and noted an expectation 

that agencies would follow the principles. Unfortunately, agencies appear to routinely ignore these principles. Upper- and lower-bound estimates are not provided, 

negative studies are not discussed, and the uncertainties and limitations of the assessment are not articulated. Congress should ensure that agencies follow these 

basic principles. 

II. Improving the Quality of Science Through Enhanced Peer Review 

Integrating scientific methods across EPA and the federal agencies also requires 

enhancing the manner in which the broader scientific community is engaged in the 

assessment process. In ACC’s view, the standards governing scientific peer reviews 

should be updated to make this vital process more effective. Peer engagement and 

review are two critical factors in the effort to ensure high-quality, reliable science 

supports decision making. Although ACC focuses on EPA in this section, the recommendations we provide should inform enhanced peer review across the government. 

Independent peer review is a critical element of EPA’s scientific policies and practices, and to date has received less attention than other elements of IRIS. Peer review is defined by EPA as ‘‘an in-depth assessment of the assumptions, calculations, 

extrapolations, alternate interpretations, methodology, acceptance criteria, and conclusions pertaining to the specific major scientific and/or technical work product and 

of the documentation that supports them.’’ 7 Peer review plays a crucial role in development of the best scientific evaluation and is integral to identifying information 

that would reduce uncertainty in significant areas of the assessment. The process 

of peer review should be structured to accomplish these objectives. There are several 

areas to consider for enhancing EPA’s peer review process: 

• Peer review panels need to have sufficient time and resources to fulfill their responsibilities. 

• Rather than base peer review charge questions solely on the input provided by 

the lead agency office, the preparation of these charge questions should reflect 

stakeholder input and be developed using an iterative process. Development of 

the charge questions should be initiated at the problem formulation step, and 

then issued as a refined draft coinciding with the release of the draft IRIS assessment. Public comments on the draft charge questions should be solicited. 

• Peer review charge questions should be written in order to facilitate objective 

consideration of alternative plausible scientific views rather than from the vantage point of giving deference to the interpretation presented in the Agency assessment. This provides peer reviewers greater opportunity to consider alternative scientific views such as those offered by stakeholders. 

• As recommended in the Bipartisan Policy Center’s report ‘‘Improving the Use 

of Science in Regulatory Policy,’’ EPA should ‘‘explicitly differentiate between 
94 

8The Center’s report is available at http://www.bipartisanpolicy.org/sites/default/files/ 

BPC%20Science%20Report%20fnl.pdf. 9See Society of Toxicology, Appointment and Participation of Scientists on Peer Review Panels 

and Scientific Advisory Boards, available at http://www.toxicology.org/pm/AdvisoryBoard.asp. 

questions that involve scientific judgments and questions that involve judgments about economics, ethics and other matters of policy.’’ 8

• Peer review meetings should be structured to encourage open scientific dialogue 

and thoughtful scientific deliberation. Stakeholder input should not be limited 

to a few minutes at the beginning of a meeting; greater effort should be made 

to structure the meetings so that stakeholder input is provided and deliberated 

at strategic times throughout the meeting. Moreover, peer reviewers should not 

be dissuaded from embarking on open technical discussion/ scientific exchange 

with stakeholders. 

• In selecting peer review panel members, the foremost consideration should be 

given to expertise. Qualified scientists from industry should be given equal consideration for appointment based on the subject matter, and in accordance with 

applicable conflict-of-interest provisions. There is unanimity among the most 

authoritative sources on this point, including the National Academies of Science 

and the Society of Toxicology: 

Appointments to scientific advisory bodies should be based principally on the 

scientific credentials, demonstrated accomplishments, and professional credibility of the nominee. His/her source of employment and funding (past or 

present), religious beliefs, political persuasion, sexual orientation, gender, or 

race/ethnicity should not be used as (a) determinant(s) of exclusion to such a 

scientific advisory body. 9

The Office of Government Ethics (OGE) has issued detailed rules under the Ethics 

in Government Act (EGA) and the federal criminal code addressing conflict of interest, and impartiality, on the part of government employees, including ‘‘Special Government Employees’’ serving part-time on peer review committees. Fairly interpreted, the EGA and those rules strike a fair balance and allow persons employed 

by industry or non-governmental organizations to serve as reviewers in many cases. 

However, agencies have tended to interpret these rules in ways that (i) restrict the 

participation of industry personnel and (ii) are too accepting of persons who are not 

really independent of the agency or the work being reviewed. Congress may wish 

to revisit the EGA and the rules, and their role in promoting high-quality, reliable 

science. 

In ACC’s view, EPA’s Science Advisory Board (SAB) has adopted generally sound 

processes and criteria for peer review of Agency action. There is room for improvement, however. For example, the SAB should ensure that the SAB peer reviewers 

fully understand their independent roles as peer reviewers. At times, however, it appears that peer reviewers are overly deferential to EPA, reluctant to be seen as 

criticizing EPA staff. It also appears that EPA staff have an unfettered ability to 

comment throughout the peer review meetings, and their constant presence may 

have a chilling effect on frank and open discussion among the peer reviewers. This 

practice contrasts sharply with NAS peer reviews. 

ACC is generally encouraged by EPA’s recent announcement that it will establish 

a standing SAB panel for IRIS assessments. Assuming that that standing panel is 

truly independent, and the panel process addresses the concerns such as the role 

of EPA staff and how review comments are incorporated into completed IRIS assessments, this approach could help promote a more reliable and consistent IRIS process. 

Responding to peer review and public comments is another area where the Agency 

needs to make improvements in its practices. It is imperative that the Agency provide a robust response in writing to comments as part of the assessment revision 

process that follows the publiccomment and peer review phases. Where the Agency 

elects not to address a peer review finding or recommendation, or a significant public comment, EPA should provide a written justification. This practice should be 

made routine for all federal agencies. 

The current practice of having the same office that develops the assessment draft 

the charge questions, review public and peer review comments, decide which recommendations and findings to act on and which to ignore, and develop the final assessment is clearly not a best practice. The inherent value of peer review—indeed 

the inherent value of EPA’s SAB—is to provide an objective, robust scientific review 

of the agency’s scientific work product. ACC believes there is value in having an 

‘‘honest broker’’ to oversee and ensure that the Agency adequately revises assess-
95 

10 ACC estimates that as a whole, the business of chemistry spent some $55 billion on research and development in 2010, the last year for which complete data are available. Slightly 

over 40% of that amount was spent on basic and applied research. 

ments in a manner that addresses both public comments and the findings and recommendations of independent scientific peer review. At this time, upon receiving a 

SAB or NAS panel report, EPA unilaterally decides what elements to accept or reject—a practice that clearly has not worked, particularly given the NAS report on 

formaldehyde. Reviewing bodies should have an opportunity to address how the 

Agency intends to implement the recommendations. 

III. Improving the Quality of Science by Leveraging Emerging Science and 

Technology 

One of ACC’s key objectives is to ensure that federal risk assessment policies and 

practices rely on 21st century knowledge of toxicology, biological modes of action, 

and advanced mechanistic technologies. There are dramatic changes underway in 

the science and technology of assessing chemical risks. These changes promise a 

revolution in the speed and accuracy with which chemical hazards, exposures, and 

risks are evaluated and managed. 

While EPA has made important investments in developing new, highly reliable 

technologies that can speed chemical assessments, not all offices within EPA appear 

disposed to adopt these technologies when appropriate. Successful integration of 

emerging science and technology into risk assessment will require a concerted and 

methodic approach to evaluate the science and build consensus around their readiness. 

The field of toxicology has grown more sophisticated as we have learned more 

about the biochemical mechanisms of toxicity and the differences between humans 

and test animals. New and exciting technologies for evaluating chemicals are emerging. In some cases, however, agencies are not well prepared to implement these new 

tools. Many federal agencies still cling to a set of conservative default assumptions 

little changed from the 1960s and ’70s, and appear to be reluctant to adopt new 

technologies. 

In ACC’s view, it is critical that the Federal Government and the chemical industry be actively engaged in the transformation of chemical safety sciences. ACC member companies have made a significant, continuing investment in the ACC Longrange Research Initiative (LRI) to inform and advance this objective. ACC currently 

commits some $5 million annually 10 to the program, which is designed to help: 

• Drive development of innovative approaches to assess and interpret health risks 

from low-dose exposures to chemicals and exposures to mixtures. 

• Develop and apply new tools to interpret the explosion of biomonitoring and 

high-throughput testing data regarding human health risks. 

• Accelerate the shift away from traditional high-dose animal toxicological testing 

by developing, validating, and promoting broad acceptance of approaches with 

greater relevance for humans. 

• Translate emerging research outcomes for decisions about the safety of our 

chemicals by partnering with thought leaders from industry, government, academia, and public interest groups. 

The LRI program’s hallmark is the collaborative work to catalyze technological innovations in chemical safety sciences with the Federal Government, principally EPA 

and the National Institutes of Health. Examples of current collaborations between 

industry and governmental agencies include several ongoing projects between the 

Hamner Institute for Health Sciences and the EPA’s National Center for Computational Toxicology (NCCT) and its National Center for Environmental Assessment 

(NCEA). 

Other collaborative projects funded by the LRI extend ongoing work at the National Institute of Environmental Health Sciences (NIEHS). The unprecedented collaborations that the LRI has fostered among industry, governmental and regulatory 

agencies, and academia and demonstrates how an industry-sponsored initiative can 

effectively partner with other stakeholders to provide knowledge for science-informed decisions. 

Among the collaborative research supported by the LRI program: 

• Efforts to deliver state-of-the-art exposure science to advance the 

ExpoCast©component of EPA’s ToxCast©program. 

• Advance the interpretation of high-throughput data. 
96 

11 Judson, R., et al., In Vitro Screening of Environmental Chemicals for Targeted Testing 

Prioritization: The ToxCast Project, Environmental Health Perspectives 118:485–492 (2010). 

• Accelerate the paradigm shift in chemical risk assessment by incorporating 

ToxCast©data and toxicogenomics information into EPA’s NexGen Risk Assessment program. 

• Support validation of innovative biomarkers of cumulative exposures. 

• Promote development of alternatives to animal testing. 

The LRI program adheres to a stringent set of principles designed to ensure that 

the collaborative research we fund meets the highest standards for scientific excellence, transparency, and fairness. 

The LRI program is focused not only on the new technologies for toxicological testing that are revolutionizing risk-based decision making, but is also helping to develop innovative biologically relevant approaches to understanding exposure. These 

technologies present an opportunity to develop a new paradigm for toxicity testing 

of chemicals, facilitate understanding of chemical hazards, and improve chemical 

safety evaluations. The current problem that they present is the growing gap between the advancements in these new technologies and the science to interpret and 

understand the emerging data. 

In addition to providing state-of-the-art science and technology for chemical safety 

and risk assessments, LRI promotes development of tools that can be used by chemical companies for product innovation. For example, the LRI currently manages one 

of the most comprehensive portfolios of exposure projects that relates directly into 

efforts to (a) predictively develop exposure information, and (b) make existing exposure data widely available. Without these tools and data, there would be an increased likelihood that the next generation of risk assessments would be based entirely on hazard information or on overly conservative exposure assumptions. 

ACC has suggested to EPA that the transition to new integrative and predictive 

molecular and computational techniques can be enhanced by focusing on critical 

issues such as: 

• The need for an improved understanding of what short-timescale in vitro assays 

can foretell about the likelihood of long-timescale processes that lead to in vivo 

toxicity endpoints. 11 For example, specific response profiles in certain in vitro 

assays or combinations of assays could provide insights into potential toxicity 

endpoints, such as cancer, and may be useful in such decisions as prioritizing 

chemicals for additional testing. Considerable work is underway to enhance confidence in the use of these approaches and better interpret the results. 

• The value of increased collaboration and engagement across the scientific community to interpret ToxCast©data for chemical prioritization. Increased transparency of relevant data and algorithms will allow EPA to leverage its intellectual resources and garner stronger understanding of and support for its approaches. EPA’s NexGen Risk Assessment process already provides a similar 

mechanism to engage experts and stakeholders in the emerging science. 

Conclusion 

Ensuring that EPA decision making is firmly based on the use of high-quality 

science is critical to helping the Agency meet its obligation to protect human health 

and the environment. This can be achieved by common-sense reforms that will lead 

to more efficient and effective regulatory decisions. ACC looks forward to working 

with members of the Subcommittee to ensure that the science and processes that 

support the important regulatory work of the Federal Government meet the highest 

standards for quality and reliability. 

Chairman HARRIS. Thank you very much. 

I now recognize our fourth witness, Dr. Richard Belzer of Regulatory Checkbook. 

STATEMENT OF DR. RICHARD BELZER, 

PRESIDENT, REGULATORY CHECKBOOK 

Dr. BELZER. Chairman Harris, Ranking Member Miller, thank 

you for the invitation to testify. My views are my own and based 

on over 25 years of experience in this field. 
97 

Previous witnesses last November have testified that EPA’s 

science is not well. The symptoms include the politicization of 

science, which occurs if agency policy officials change scientific information to benefit their preferred policy decisions; the 

scientization of policy, which occurs when agency risk assessors 

make policy decisions behind a veil of science; insufficient transparency reproducibility in agency risk assessments, perhaps best 

exemplified by the National Academy’s recent report on formaldehyde; and dissatisfaction with EPA peer review, perhaps best revealed when Congress seeks peer review by the academy instead. 

My analysis leads to a four-part diagnosis. First, the 

politicization of science is not something only EPA policy officials 

might do. EPA staff also politicize science, such as when they 

choose a desired result and seek only the science that supports it. 

Second, the scientization of policy is not something only EPA risk 

assessors might do. EPA officials scientize policy, such as when 

they say their policy decisions merely follow the recommendations 

of the scientists. Third, EPA risk assessments are not objective. 

This is not my opinion. An agency staff report says ‘‘EPA’s policy 

is that risk assessment should not knowingly underestimate or 

grossly overestimate risks.’’ Fourth, EPA peer review often does not 

serve the purposes for which it presumably was intended. EPA 

guidelines to the contrary, information quality is irrelevant to 

agency peer review. EPA always controls the charge and often the 

experts, who are often required to interpret science through EPA’s 

policy lenses. Amazingly, peer reviewers often are charged with indirectly reviewing their own work. Fifth, EPA advisory committees 

are especially susceptible to politicizing science and scientizing policy. In April 2008, CASAC protested then-Administrator Johnson’s 

decision to set the primary National Ambient Air Quality Standard 

for Ozone at .075 parts per million. CASAC members had every 

right to disagree with that decision on policy grounds, but they 

went off the rails, saying that it was their ‘‘consensus scientific 

opinion that his decision violated the Clean Air Act.’’ Science cannot determine what is ‘‘requisite’’ to protect public health or what 

constitutes an ‘‘ample’’ margin of safety. Those lie beyond science. 

I recommend several possible remedies for your consideration. 

First, Congress could require the EPA risk assessments, principal 

components, and key studies adhere to information quality principles and standards. Risk assessment should not be based on undisclosed data or models unless perhaps national security is at 

stake. It also should be objective. Deciding how much precaution 

should be accounted for in regulatory decisions is not part of an analyst’s job. It belongs to the relevant agency official. 

Second, Congress could revamp the EPA’s peer review practices 

to explicitly require them to invest in information quality, to strictly limit peer reviews to science, and to remove the agency’s ability 

to substantially control outcomes through procedural means. 

Third, Congress could require advisory committees to ‘‘establish 

and maintain a clear conceptual distinction between assessment of 

risk and consideration of risk management alternatives’’ and ensure that their reports ‘‘clearly distinguish between the scientific 

basis and the policy basis for the conclusions and recommendations.’’ That advice isn’t mine. It was made by the National Acad-
98 

1The views expressed here are my own and do not necessarily represent those of Regulatory 

Checkbook. 2 Barack Obama. ‘‘Scientific Integrity.’’ Federal Register, 2009, 74(46), 10671–10672. 

emy committee that wrote the 1983 Red Book. It makes perfect 

sense for advisory committees. EPA officials making decisions 

should not have to struggle to discern where an advisory committee’s scientific review ends and its policy advice begins. 

These reforms would go a long way toward improving the quality 

of the EPA science. None of them would politicize science or 

scientize policy. Indeed, they would help prevent both by making 

them stick out like sore thumbs. 

Thank you again for the opportunity to testify. I am happy to answer any questions when the time permits. 

[The prepared statement of Mr. Belzer follows:] 

PREPARED STATEMENT OF DR. RICHARD BELZER, 

PRESIDENT, REGULATORY CHECKBOOK

Introduction 

Chairman Harris, Ranking Member Miller, and Members of the Subcommittee, 

thank you for inviting me to testify on ‘‘Fostering Quality Science at EPA: Perspectives on Common-Sense Reforms.’’ I am Dr. Richard B. Belzer, president of Regulatory Checkbook, a nonpartisan, nonprofit organization whose mission includes the 

promotion of quality improvements in science, economics, and information quality. 1

I was elected Treasurer of the Society for Risk Analysis in 1998 and 2000, and 

earned its Outstanding Service Award in 2003. Previously I was named a Fellow 

of the Cecil and Ida Green Center for the Study of Science and Society. In 2009 and 

2011, I was elected Secretary/Treasurer of a new professional organization, the Society for Benefit-Cost Analysis. 

From 1988 through 1998, I was a career economist in OMB’s Office of Information 

and Regulatory Affairs, where I reviewed many risk assessments that were integral 

parts of agencies’ Regulatory Impact Analyses, for it is impossible to estimate costs 

and benefits without first estimating risks. My job was to examine agency analyses 

of the risks, costs, and benefits of draft regulations, and present to OMB officials 

and other Executive Office staff the most objective portrayal possible. Typically, this 

could not be done based on the risk assessments performed by the agencies. Agency 

risk assessments were purposefully biased to make risk appear greater than it was 

and the benefits of regulation appear greater than they were. 

I have been president of Regulatory Checkbook since its founding in 2001. Regulatory Checkbook does not lobby or take public positions on substantive legislation 

or rule making; there is no shortage of organizations committed to doing that. Our 

sparsely populated niche is to seek improvements in the quality of risk assessment 

and economic analysis regardless of whether it tends to support or oppose specific 

regulatory actions. For that reason, we are interested in how quality is affected by 

various procedures, such as public comment, peer review, information quality principles and standards, and Executive oversight. No one has compensated Regulatory 

Checkbook or me for my testimony. 

I am familiar with testimony previously provided to the Subcommittee. I will try 

to build on that and not be redundant. 

Symptoms of the Quality Deficit 

The purpose of these hearings has been to identify ways to improve the quality 

of science used by EPA in regulatory decision making. This, of course, implies that 

the state of the science for science at the Agency is not well. Numerous symptoms 

have been identified. 

Politicization of Science or Scientization of Policy? 

In March 2009, President Obama issued a Memorandum on Scientific Integrity 

stating, among other things, ‘‘Political officials should not suppress or alter scientific 

or technological findings and conclusions.’’ 2 The President also made a commitment 

to transparency, saying, ‘‘If scientific and technological information is developed and 
99 

3 John P. Holdren. ‘‘Memorandum for the Heads of Executive Departments and Agencies: Scientific Integrity,’’ Office of Science and Technoloy Policy, 2010. 4OSTP’s guidance is mostly hortatory, saying agencies ‘‘should’’ do various things 19 times 

but never saying ‘‘shall’’ or ‘‘must.’’ Eight times, these suggestions apply only if the agency 

judges them to be ‘‘appropriate.’’ Four times, they apply only if ‘‘practicable.’’ 5President Obama’s memorandum did not include this qualification, stating: ‘‘The selection of 

scientists and technology professionals for positions in the executive branch should be based on 

their scientific and technological knowledge, credentials, experience, and integrity.’’ 6The President’s memorandum went further, saying ‘‘Political officials should not suppress or 

alter scientific or technological findings and conclusions’’ (emphasis added). The difference is 

surely not accidental, but its significance is not transparent. Possibly it shows that the White 

House has learned about the scientization of policy. 7 Holdren (2010, p. 2). ‘‘In no circumstance may public affairs officers ask or direct Federal 

scientists to alter scientific findings.’’ 8 Bipartisan Policy Center. ‘‘Improving the Use of Science in Regulatory Policy,’’ Washington, 

D.C.: Bipartisan Policy Center, 2009, p. 15. ‘‘[S]ome disputes over the ‘politicization’ of science 

actually arise over differences about policy choices that science can inform, but not determine.’’ 9Susan E. Dudley. ‘‘Written Testimony Before the U.S. House of Representatives Committee 

on Science, Space, and Technology, Subcommittee on Energy and the Environment, Hearing on 

‘Fostering Quality Science at EPA: Perspectives on Common Sense Reforms,’ ’’ 2011. 10 Albert L. Nichols and Richard J. Zeckhauser. ‘‘The Dangers of Caution: Conservatism in Assessment and the Mismanagement of Risk,’’ Smith, Advances in Applied Micro-Economics: Risk, 

Uncertainty, and the Valuation of Benefits and Costs. Greenwich, Conn.: JAI Press, 1986a, 55– 

82. For a less technical version of this paper, see —————. ‘‘The Perils of Prudence: How Conservative Risk Assessments Distort Regulation.’’ Regulation, 1986b, 10(6), 13–24. 11 It is not clear, however, if this practice illustrates the scientization of policy, or the 

politicization of science by Agency staff rather than by Agency policy officials. It may have elements of both. 

used by the Federal Government, it should ordinarily be made available to the public.’’ It is my observation, based on over 20 years in risk assessment, that these principles are are universally agreed to—in principle. Putting them into policy turns out 

to be more difficult. It took 22 months for the White House Office of Science and 

Technology Policy—an office whose director the President directly supervises—to 

issue guidance implementing his memorandum. 3

Moreover, OSTP’s guidance is crafted with considerable structural and procedural 

ambiguity. 4 It calls for ‘‘policymakers [to] involve science and technology experts 

where appropriate,’’ without clearly stating the circumstances where it wouldn’t be. 

It directs agencies to select candidates for scientific positions ‘‘based primarily on 

their scientific and technological knowledge, credentials, experience, and integrity,’’ 

thereby leaving wide open the option of giving substantial weight to their political 

affiliation or policy views. 5 It calls for ‘‘independent peer review by qualified experts,’’ but only ‘‘where feasible and appropriate.’’ The guidance says ‘‘political officials should not suppress or alter scientific or technological findings,’’ but it does not 

actually generally prohibit this practice. 6 Only agency public affairs officers are expressly forbidden from doing this. 7

The lesson from this is that it is much easier to announce a policy that seems 

straightforward than to implement it. It turns out that the intersection of policy and 

science is a lot more complicated than newspaper reporters, activists, and even candidates for president might think. 

As the Subcommittee has heard, the 2009 report of the Bipartisan Policy Center’s 

Science Policy Project discreetly pointed in a different direction—what is increasingly being called ‘‘the scientization of policy.’’ 8 The BPC’s Science Policy Project included former policy officials who, unsurprisingly, had a different perspective on the 

policy/science divide. Former OIRA Administrator Susan Dudley’s testimony to the 

Subcommittee appears to be indicative of this, presumably reflecting her own experience. 9

It turns out that this is an old issue. In 1986, Harvard Kennedy School professors 

Albert Nichols and Richard Zeckhauser published papers claiming that cancer risk 

was systematically overstated at EPA. 10 They wrote that this was done by Agency 

risk assessors for the purpose of influencing risk management decisions. 11

In 1990, the Office of Management and Budget elaborated upon this problem in 

its Regulatory Program of the United States Government: 

Unfortunately, risk-assessment practices continue to rely on conservative models and assumptions that effectively intermingle important policy judgments 

within the scientific assessment of risk. Policymakers must make decisions 

based on risk assessments in which scientific findings cannot be readily differentiated from embedded policy judgments. This policy environment makes it 

difficult to discern serious hazards from trivial ones, and distorts the ordering 
100 

12Office of Management and Budget. ‘‘Current Regulatory Issues in Risk Assessment and Risk 

Management,’’ Regulatory Program of the United States, April 1, 1990–March 31, 1991. Washington, DC: Office of Management and Budget, 1990, 13–26. Full disclosure: I was the author 

of OMB’s white paper. It is out of print but available on my Web site athttp:// 

www.rbbelzer.com/uploads/7/1/7/4/7174353/omb¥1990¥risk¥assessment.pdf. 13 National Research Council. Risk Assessment in the Federal Government: Managing the 

Process. Washington, D.C.: National Academies Press, 1983, p. 151. 14 Bipartisan Policy Center (2009, p. 13). ‘‘Political decision makers should never dictate what 

scientific studies should conclude, and they should base policy on a thorough review of all relevant research and the provisions of the relevant statutes. But some disputes over the 

‘politicization’ of science actually arise over differences about policy choices that science can inform, but not determine’’ (p. 13). 15 U.S. Environmental Protection Agency Office of the Science Advisor. ‘‘An Examination of 

EPA Risk Assessment Principles and Practices; Staff Paper, EPA/100/B-04/001,’’ 2004, p. 13. 

This does not necessarily mean that EPA always succeeds in overstating risk, or that there are 

not circumstances in which EPA does not understate risks, whether by accident or intent. 

of the Government’s regulatory priorities. In some cases, the distortion of priorities may actually increase health and safety risks. 12

OMB noted with approval the recommendation made by the committee that wrote 

the National Research Council’s 1983 Red Book: 

Regulatory agencies should take steps to establish and maintain a clear conceptual distinction between assessment of risks and the consideration of risk management alternatives; that is, the scientific findings and policy judgments embodied in risk assessments should be explicitly distinguished from the political, 

economic, and technical considerations that influence the design and choice of 

regulatory strategies. 13

Like the authors of the Red Book, OMB thought that fidelity to the Red Book recommendations was at least part of the solution. Though it was published more than 

20 years ago, the problem OMB highlighted is the same thing that the BPC identified. 14

While this is an old story, that does not mean it is outdated. In 2004, EPA published a staff report that explains its risk assessment policies and practices with signal clarity. This report acknowledges that EPA risk assessments are intentionally 

biased to overstate risk, and that this is done for the purpose of scientizing policy: 

[S]ince EPA is a health and environmental protective agency, EPA’s policy is 

that risk assessments should not knowingly underestimate or grossly overestimate risks. 15

All risk assessments err because they are estimates. What the EPA staff said is 

that they have a strong preference for erring on the side of overestimating risk, just 

not ‘‘grossly’’ overestimating it. They justify this preference based on the ‘‘health and 

environmental mission’’ of the Agency. This preference for overestimating the magnitude of risk is in addition to a preference for erring on the side of promulgating 

regulations that err on the side of overprotection. 

It is worth reflecting on what this would mean if other federal agencies did the 

same thing: 

• Would it be reasonable for engineers at the Federal Aviation Administration to 

intentionally overestimate the risk of air travel, perhaps by assuming all aircraft were as risky as the riskiest of them, and use those overestimates to motivate the FAA Administrator to promulgate more stringent safety regulations for 

all aircraft? 

• Would it be reasonable for examiners in the Department of the Treasury to 

knowingly overstate the risk that a major bank might fail, in order to persuade 

the Secretary to take over that bank? 

• Would it be reasonable for analysts at the Central Intelligence Agency to purposefully overstate the likelihood that the Islamic Republic of Iran will succeed 

in developing an fielding a nuclear weapon, thereby encouraging the President 

to launch a preemptive military attack? 

To ask these questions is to answer them. It is the obligation of federal risk assessors, no matter where they work, to estimate risk as objectively as possible. They 

should never misuse the tools of risk assessment to manipulate decision makers into 

taking specific actions. Remarkably, the EPA staff report denies that the discretion 
101 

16 U.S. Environmental Protection Agency Office of the Science Advisor (2004, pp. 14–16). 17 In previous testimony to this Subcommittee, EPA Administrator Jackson’s decision to revise 

the 2008 National Ambient Air Quality Standard for ozone following the recommendations of 

the Clean Air Scientific Advisory Committee was described by a former CASAC chairman in 

similar but more strident terms. See Roger O. McClellan. ‘‘Written Testimony Before the U.S. 

House of Representatives, Committee on Science, Space, and Technology, Subcommittee on Energy and the Environment, Hearing on ‘Quality Science for Quality Air,’ ’’ 2011. 18The author of this recommendation on behalf of the Red Book committee believes that EPA 

officials misinterpreted and misapplied it. See D. Warner North. ‘‘Reflections on the Red/MisRead Book, 20 Years After.’’ Journal of Human and Ecological Risk Assessment , 2003, 9(5), 

1145–1154. A somewhat different interpretation is that implementation as envisioned by the 

Committee was not administratively or politically feasible, an interpretation Professor Marchant 

appears to favor. See Gary E. Marchant. ‘‘Written Testimony Before the U.S. House of Representatives Committee on Science, Space, and Technology, Subcommittee on Energy and the 

Environment, Hearing on ‘Fostering Quality Science at EPA: Perspectives on Common Sense Reform,’ ’’ 2011, p. 5. ‘‘As the role of science becomes ever more important to EPA’s mission, and 

as the perception of EPA’s science continues to be skeptical across the political spectrum, it may 

be time to consider a different model that institutionally separates the generation and assessment of science from the application of that science in regulatory decision making.’’ Marchant 

Continued 

of Agency policy officials is constrained or misdirected by their practice of purposefully overestimating risk. 16

Diagnosis 

Whether science has been politicized or policy has been scientized is a useful distinction, but it is not complete. For example, it is assumed that science is politicized 

when policy officials invade the space of the scientists; and conversely, policy is 

scientized when agency scientists attempt to make policy decisions that Congress 

has delegated to agency heads. 

This model is incomplete because Agency policy officials and risk assessors appear 

equally prone to do both. Sometimes, it is agency policy officials who scientize policy, 

such as when they try to attribute their policy choices to science. A policy official 

can avoid a lot of controversy if he is perceived as ‘‘merely following the science.’’ 17

Agency risk assessors may be willing or even pleased to go along, for it increases 

their power and authority inside the agency, in its battles with OMB, and for deflecting Congressional criticism. Thus, Agency risk assessors may have no more interest than Agency policy officials in revealing the extent to which officials have attributed policy decisions to science. Similarly, Agency officials and risk assessors 

alike may prefer not to make transparent the extent to which risk assessors actually 

make policy decisions under the cover of science. 

Conflict arises, however, when Agency officials and risk assessors do not agree on 

policy. In these situations, Agency policy officials must first reclaim from Agency 

risk assessors the authority delegated to them by Congress to make policy decisions. 

It is easy for risk assessors to accuse their political bosses of politicizing science and 

nearly impossible for policy officials to defend themselves when the charge is false. 

On the other hand, sometimes it is Agency risk assessors who politicize science. 

This happens when risk assessors choose the best available science that supports 

their preferred policy decision. Few policy officials would ever be the wiser, because 

it requires from them independent scientific expertise, substantial issue-specific 

knowledge, and more time than they have available. 

The desired principles can be clearly expressed, if not easily implemented: 

• Agency policy officials should be limited to making policy. 

• Agency risk assessors should be limited to assessing risk. 

• Risk assessment should be performed as objectively as possible and not be misused as a tool for achieving policy objectives through the back door. 

Policy officials should stay out of science. They should allow science to inform 

their decisions but never allow it to control them, never hide behind it, and never 

tell scientists what conclusions to reach. They also should be persistent about asking risk assessors the right questions and getting second opinions from external authorities. 

This goal begins with the Red Book recommendation and goes much further. 

Whereas the Red Book authors envisioned a smoothly interactive and iterative relationship between risk assessors and risk managers, with a ‘‘clear conceptual distinction’’ between science and policy ‘‘established and maintained,’’ 30 years of history 

has shown that this model has either failed or cannot be implemented in a realworld regulatory agency. 18
102 

does not credibly explain how an external science production entity, such as his proposed Institute for Scientific Assessments, staffed and managed by full-time federal employees, would not 

succumb to the twin temptations of politicization and scientization. 19Office of Management and Budget. ‘‘Guidelines for Ensuring and Maximizing the Quality, 

Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies; Notice; Republication.’’ Federal Register, 2002, 67(36), 8452–8460. 20 ‘‘Information Quality Act.’’ 44 U.S.C. 3516 note. 2000. 21 U.S. Environmental Protection Agency. ‘‘Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency (EPA/260R-02-008),’’ 2002. 22 U.S. Environmental Protection Agency (2002, pp. 10–14). 23 U.S. Environmental Protection Agency (2002, p. 10). 24Paul Anastas. ‘‘Written Testimony Before the U.S. House of Representatives Committee on 

Science Space and Technology, Subcommittee on Oversight, Hearing on ‘EPA’s Integrated Risk 

Information System,’ ’’ 2011, p. 1. ‘‘IRIS assessments provide a scientific foundation for EPA decisions to protect public health across EPA’s programs and regions under an array of environmental laws’’ (emphasis added). 25 U.S. Environmental Protection Agency (2002, pp. 16–17). 26Some requests for correction are misguided attempts to change regulatory decisions. However, these requests are easy for EPA to dismiss on the ground that they concern matters that 

are exempt from the information quality paradigm. 

Information Quality Principles and Standards 

In the following sections I focus on three areas in which EPA science has specific, 

notable deficiencies. These are information quality, peer review, and the confused 

role of federally chartered advisory groups. 

In 2002, OMB issued governmentwide guidelines 19 to implement a statutory directive to improve information quality. 20 Like almost every other covered agency, 

EPA issued its own agency-specific guidelines before the October 1, 2002, deadline. 21 These guidelines commit EPA to adhere to certain standards of transparency, reproducibility, integrity, objectivity, and utility, and to establish administrative mechanisms whereby any person may seek and obtain the correction of noncompliant information. Indeed, EPA expressed the view that adhering to OMB’s 

guidelines would not pose any challenge because its existing policies and procedures 

already ensured and maximized information quality. 22

EPA’s information quality guidelines say the Agency ‘‘is dedicated to the collection, generation, and dissemination of high quality information’’ and ‘‘seeks to foster 

the continuous improvement of existing information quality activities and programs.’’ ‘‘In implementing these guidelines,’’ EPA said ‘‘ensuring the quality of information is a key objective alongside other EPA objectives, such as ensuring the success of Agency missions, observing budget and resource priorities and restraints, 

and providing useful information to the public.’’ 23 EPA also established well-defined 

administrative procedures for managing requests for correction and administrative 

appeals. 

To be clear, information quality standards are expansive. They apply to ‘‘any communication or representation of knowledge such as facts or data, in any medium or 

form’’—but not to policy decisions. Thus, they apply to risk assessment documents 

to the extent that they contain ‘‘representation[s] of knowledge such as facts or 

data.’’ Because EPA officials claim that Agency risk assessment products are scientific, 24 there is no doubt that they are fully covered by applicable information 

quality guidelines. 

The Subcommittee should be aware that EPA has exempted press releases and 

fact sheets from its information quality guidelines, which it describes as 

‘‘[i]nformation of an ephemeral nature.’’ Given that press releases and fact sheets 

are often the only information Congress and the press know about a complex risk 

issue, this exemption is obviously problematic. Further, the Subcommittee should be 

aware that EPA also exempts ‘‘[i]nformation presented to Congress as part of the 

legislative or oversight processes.’’ 25 EPA testimony may have many desirable attributes, but adherence to information quality principles and standards is not one 

of them. 

Many error correction requests submitted to EPA concern Agency risk assessments or components thereof, which the petitioner claims contain factual errors. 

Some requests are intended to seek full disclosure of data and methods to enable 

third parties to test for error, which both OMB’s and EPA’s information quality 

guidelines require. 26

EPA committed to respond to requests for correction and appeals within 90 days. 

EPA’s actual performance, however, has not lived up to these commitments. As of 

September 30, 2010, EPA’s average response time for a request for correction was 

no less than 166 days. EPA’s average response time for an appeal was no less than 
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27 Richard B. Belzer. ‘‘Risk Assessment and Information Quality: An Empirical Study of Federal Agency Performance, 2010 Update,’’ Society for Risk Analysis 2010 Annual Meeting, Salt 

Lake City, Ut., 2010. Since this paper was presented, EPA has received four new requests for 

correction. 28 Eleven of 44 requests for correction and one of 16 appeals remained open at the end of FY 

2010. The average response time, once these open actions were resolved, could only be greater. 29 U.S. Environmental Protection Agency. ‘‘Peer Review Handbook (1st Ed.),’’ Washington, 

D.C.: U.S. Environmental Protection Agency Science Policy Council, 1988, —————. ‘‘Peer Review Handbook (2d Ed.),’’ Washington, D.C.: U.S. Environmental Protection Agency Science Policy Council, 2000, —————. ‘‘Peer Review Handbook (3rd Ed.),’’ Washington, D.C.: U.S. Environmental Protection Agency Science Policy Council, 2006. 30Office of Management and Budget. ‘‘Final Information Quality Bulletin for Peer Review.’’ 

Federal Register, 2005, 70(10), 2664–2667. 31Office of Management and Budget (2005, p. 2675). Emphasis added. 

316 days. 27 These figures are biased downward, and thus understate EPA’s dilatory 

behavior, because they include requests and appeals that were still open at the end 

of FY 2010. 28

In short, EPA’s well-written administrative procedures have in practice failed to 

enable affected persons to ‘‘seek and obtain’’ the correction of information that does 

not comply with applicable information quality principles. Assuming it takes only 

45 days to review EPA’s response to a request for correction and file an appeal, it 

has taken on average more than 527 days for EPA’s internal administrative process 

to run its course. 

The substantive merits of these requests for correction vary, but it cannot be denied that many are highly meritorious. This can be seen by reviewing specific requests or logically inferred by the length of time EPA takes to respond. It should 

be easy for the Agency to quickly refute requests for correction that lack any merit, 

especially those which impermissibly seek to challenge Agency policy decisions. Conversely, requests for correction that are highly meritorious could be very hard to refute. If acknowledging error would undermine the legal standing or political legitimacy of a major regulation or an important EPA policy, no one should be surprised 

that the Agency takes a long time to decide how to respond, or that its responses 

are ambiguous, technically weak, misleading, or flatly wrong. 

If an agency’s response to a request for correction is incomplete, misguided, or 

lacks merit, the only recourse is an appeal within the agency. One cannot appeal 

to another Executive branch agency or seek review by a federal court. For that reason, public enthusiasm is limited even for submitting the most meritorious of error 

correction requests. Governmentwide, the number of requests for correction filed annually has declined by more than 75% since FY 2003. This is not because federal 

agencies have suddenly stopped disseminating erroneous information. It is because 

the agencies have responded to the Information Quality Act as if it were a potentially lethal virus and developed effective antibodies to prevent reinfection. 

Peer Review 

EPA is perhaps the federal agency that has committed the most to peer review. 

It conducts numerous peer reviews every year and has published a series of handbooks that guide Agency staff through the process. 29 Nevertheless, there appears 

to be widespread dissatisfaction with the actual performance of EPA peer review. 

This is self-evident given Congress’ repeated decisions to supplement or even bypass 

EPA peer review in favor of the National Academy of Sciences. 

Several problems afflicting EPA’s peer review program are discussed below. 

OMB’s Bulletin on Peer Review Contains Obvious Errors 

OMB issued governmentwide guidance on peer review in 2005. 30 This guidance 

is generally very useful and helpful. For example, it clearly states, ‘‘Peer reviewers 

shall be charged with reviewing scientific and technical matters, leaving policy determinations for the agency.’’ 

But OMB’s guidance is especially weak exactly where it should have been strongest. Even though enhancing information quality was its raison d’etre, the guidance 

includes no requirement that agencies actually make information quality principles 

and standards an integral part of scientific peer review. OMB waffles, saying 

‘‘[r]eviewers shall be informed of applicable access, objectivity, reproducibility and 

other quality standards under the Federal laws governing information access and 

quality.’’ 31 In short, an EPA peer review complies with OMB’s guidance as long as 

peer reviewers are informed about information quality, perhaps similar to one of the 

dozens of disclosure forms that must be provided at settlement when purchasing a 
104 

32Office of Management and Budget (2005, p. 2675). ‘‘Principal findings, conclusions and recommendations in official reports of the National Academy of Sciences are generally presumed 

to have been adequately peer reviewed.’’ OMB may have tried to hedge this blanket endorsement by limiting it to ‘‘principal findings,’’ but the effectiveness of this hedge seems likely to 

be ephemeral. 33 An incontrovertible violation would occur in any instance where the Academy gives policy 

advice. See the discussion surrounding footnote 30. 34 U.S. Environmental Protection Agency (2006, p. 17). 35 National Research Council. Review of the Environmental Protection Agency’s Draft IRIS Assessment of Formaldehyde. Washington, D.C.: National Academies Press, 2011. 36This does not mean the formaldehyde committee ignored information quality in its review. 

Several places in the report one can find discussions that indicate the committee wrestled with 

quality issues. Similarly, the ‘‘road map’’ has numerous references to ‘‘quality’’ because it wanted 

EPA to focus on ‘‘high-quality’’ studies. But the committee was bereft of a framework for defining quality because it apparently knew nothing about EPA’s Information Quality Guidelines. 

house. There is no obligation for peer reviewers to do anything with this information. 

OMB’s guidance also includes a pair of extraordinarily large loopholes. First, 

OMB allows agencies to infer that studies published in peer-reviewed literature adhere to information quality principles and standards, including the crucial standards of presentational and substantive objectivity. This is bizarre. Adherence to 

these principles plays no role in journal review. If they knew about them, some editors of scholarly journals probably would consider information quality principles and 

standards wholly irrelevant or contradictory to the journal’s mission. No matter; to 

OMB, peer review by a scholarly journal means the information contained in it is 

presentationally and substantively objective. 

Second, OMB exempts reports of the National Academy of Sciences from any scrutiny whatsoever. 32 This is true even if there is no evidence that the review took account of applicable information quality principles and standards or there is incontrovertible evidence that the review violated these principles and standards. 33

Information Quality Is AWOL from EPA Peer Review 

EPA’s latest Peer Review Handbook mentions information quality several places, 

but each reference is little more than boilerplate. Here is the most substantive reference I can find: 

The Agency recognizes peer review as a component of pre-dissemination review 

that complements and enhances the ‘‘objectivity’’ and ‘‘utility’’ of EPA’s information products. The Agency recommends that offices conduct pre-dissemination 

reviews of information to ensure that the information is of appropriate quality 

before it is disseminated to the public. Pre-dissemination review is especially 

important for influential scientific information and highly influential scientific 

assessments. 34

Notice that pre-dissemination review, which applicable information quality guidelines require agencies to perform, is reduced to a mere recommendation. The Handbook does not even include OMB’s requirement that peer reviewers be ‘‘informed’’ 

about information quality principles and practices, so it should surprise no one 

when they aren’t. 

A reasonable inference is that EPA’s Science Policy Council, the author of the 

Peer Review Handbook, does not want information quality to play a meaningful role 

in Agency peer review. Rather, the SPC hopes that by conducting peer review EPA 

will be treated as if it had complied with information quality principles and standards. This is wholly unjustified. Peer reviews conducted fully in compliance with the 

letter of the Handbook do not and cannot adhere to information quality principles 

and standards because those principles and standards are AWOL. 

EPA’s Science Advisory Board and the National Academy of Sciences are not solutions to this problem, for their reviews are no more likely to take information quality seriously. To take one obvious example, many observers have strongly endorsed 

Chapter 7 of the Academy’s review of EPA’s draft assessment of formaldehyde as 

a highly desirable step forward for improving the quality of IRIS assessments. 35

Perhaps it is, but the Academy’s formaldehyde report does not include adherence 

to information quality principles and standards anywhere in its ‘‘road map.’’ Indeed, 

the report never even mentions information quality, which suggests that the formaldehyde committee was utterly unaware of EPA’s information quality guidelines. 36

For this reason, the Chapter 7 ‘‘road map’’ might not be as helpful as its advocates 

hope. Most disturbingly, any Congressional directive to EPA insisting that it adhere 
105 

37 It is an open question whether this question is researchable. ‘‘Compliance’’ with a complex 

guidance document is not a binary state. The research task would involve a painstaking review 

of a representative sample of peer reviews. The sample would have to be large enough to have 

the statistical power to reject the null hypothesis. 38 U.S. Environmental Protection Agency (2006, p. 59). 39 U.S. Environmental Protection Agency (2006, p. 61). 

to the ‘‘road map’’ is an implicit invitation for the Agency to ignore information quality. Surely Congress did not intend this to happen. 

Noncompliance with the Peer Review Handbook 

There are numerous anecdotes suggesting that EPA peer reviews do not actually 

comply with the Peer Review Handbook. I am unaware of any systematic research 

on this question that would permit a more comprehensive inference. Clearly, such 

research could be valuable if it were conducted rigorously and independently of 

EPA. 

Obviously, if research showed that EPA’s adherence the Peer Review Handbook 

was as spotty as is the Agency’s adherence to its information quality guidelines, this 

might go a long way toward explaining why there appears to be such widespread 

dissatisfaction with EPA peer review. Research also could discover if noncompliance 

with the handbook was random or causally associated with specific issues or regulatory programs. 37

Excessive Agency Control 

EPA’s Peer Review Handbook makes clear that the Agency retains full control 

over the peer review charge and de facto control over the selection of peer reviewers. 

This is obviously true when a peer review is conducted by a panel established by 

EPA under the Federal Advisory Committee Act (FACA). But it is also true when 

the EPA conducts a workshop or contracts with a private company to conduct peer 

review. In these circumstances, EPA still controls the charge 38 and has the authority to veto the contractor’s selection of peer reviewers. 39

Nonscientific Content in EPA’s Charge to Scientific Peer Reviewers 

EPA peer review panels often are given a charge that includes crucial nonscientific content for which scientists have no special skills or insights. This occurs, 

for example, when a peer review panel is constrained to look at scientific information through the Agency’s policy lenses. Common examples include the derivation 

of unit risk factors for carcinogens and Reference Doses for noncarcinogens, both of 

which have scientific content but are controlled by policy choices. When a scientific 

peer review panel is asked to review a proposed unit risk factor or Reference Dose, 

it is being asked to ratify the Agency’s policy choices. 

Insufficient Expertise 

By virtue of their size, peer review panels may appear to be capable of reviewing 

all the relevant scientific questions posed by a draft risk assessment. This may not 

be true, however, if the issues presented are very broad and cross multiple disciplines. On a panel containing the 15 best external scientists, there may be just 

a couple who have crucial expertise related to a specific issue. If the number of scientific issues is large, reviewers will be assigned to those issues on which then have 

the most expertise. When it comes time to put the review together, panel members 

will be inclined to jealously guard the portion of the review they performed but defer 

completely to other members with respect to the rest. Instead of a single peer review 

performed by a panel of 15, the final report may be a half-dozen or more separate 

reviews, each performed by a small number of scientists, then repackaged as is it 

were a single document. 

Excessive Expertise, of a Certain Form 

It is becoming increasingly common to observe a peer review panel consisting of 

experts who are the authors of the research on which EPA has based its risk assessment. These experts are valuable and important, for they alone can ensure that the 

Agency has interpreted their work correctly. But they have no business serving on 

a peer review panel whose job will be to review whether these studies were performed correctly, whether they are the best available, whether they are objective, 

etc. 
106 

40M.L. Bell, F. Dominici and J.M. Samet. ‘‘A meta-analysis of time-series studies of ozone and 

mortality with comparison to the national morbidity, mortality, and air pollution study.’’ Epidemiology, 2005, 16(4), Michelle L. Bell, Aidan McDermott, Scott L. Zeger, Jonathan M. Samet 

and Francesca Dominici. ‘‘Ozone and Short-term Mortality in 95 US Urban Communities, 1987– 

2000.’’ JAMA, 2004, 292(19), 2372–2378. 41George D. Thurston. ‘‘Written Testimony Before the U.S. House of Representatives, Committee on Science, Space, and Technology, Subcommittee on Energy and the Environment, Hearing on ‘Quality Science for Quality Air’: RE: The Science of Air Pollution Health Effects and 

The Role of CASAC in EPA Standard Setting,’’ 2011, p. 2. 42 U.S. Environmental Protection Agency (2006, p. 37). ‘‘Since it would probably result in a 

perceived, if not real, conflict of interest, the group that is generating the work product usually 

cannot conduct or perform the peer review of its own work product.’’ 43The National Academies. ‘‘Policy on Committee Composition and Balance and Conflict of Interest,’’ The National Academies, 2003. 44 A more extensive discussion of the contrasts between scholarly and governmental peer review can be found in a paper I wrote for a 2002 conference sponsored by the Society for Risk 

Analysis. See Richard B. Belzer. ‘‘Interests and Incentives in Government Peer Review,’’ Conflict, Consensus, and Credibility: A Forum on Regulatory Peer Review, Alexandria, VA, 2002. 

Available at http://www.rbbelzer.com/presentations.html#2002. 45 Andrew Stark. Conflict of Interest in American Life. Cambridge, Mass.: Harvard University 

Press, 2000. 46 U.S. Environmental Protection Agency (2006, p. 49). ‘‘To ensure that public participation 

does not unduly delay activities, Offices should specify time limits for public participation 

throughout the peer review process.’’ 47 U.S. Environmental Protection Agency (2006, p. 74 [distribution to peer reviewers is required for ‘‘influential scientific assessments’’]). See also p. 49: ‘‘When employing a public comment process as part of the peer review, Offices should, whenever practical, provide peer reviewers with access to public comments that address significant scientific or technical issues.’’ 48 Robert F. Phalen. ‘‘Written Testimony Before the U.S. House of Representatives, Committee 

on Science, Space, and Technology, Subcommittee on Energy and the Environment, Hearing on 

‘Quality Science for Quality Air’: The CASAC–PM Committee—Setting Air Quality Standards,’’ 

2011. ‘‘The public comments were not weighed and discussed by CASAC–PM in spite of the fact 

that most were well-reasoned and relevant. If the agenda included time for discussion of public 

comments and formal acceptance or rejection of their recommendations, the process might be 

improved.’’ 

This practice is disturbingly commonplace. The Clean Air Scientific Advisory 

Committee (CASAC), which performs a peer review function under Section 109(d)(2) 

of the Clean Air Act, is chaired by an author of studies on which EPA bases risk 

assessments for mortality caused by ambient air pollutants. 40 Four of the seven current members of CASAC have published research referenced in EPA’s latest Integrated Science Assessment for ozone, which CASAC is responsible for reviewing. A 

scientist who formerly served on CASAC has testified before this Subcommittee that 

he was also a contributing author of multiple ISAs. 41 It is simply impossible for 

CASAC to independently peer review EPA risk assessment documents that rely on 

its members’ own research. In fact, it violates EPA’s Peer Review Handbook, for it 

represents the ultimate conflict of interest. 42

Conflicts of Interest 

Most observers seem to agree that conflicts of interest ought to be avoided if at 

all possible, and that peer review panels should manage bias by ensuring that a 

‘‘balance of biases’’ is obtained. This principle is key to the National Academy’s 

model, for example. 43

I unapologetically take a different view. 44 We are saddled with conflict-of-interest 

policies that were written by lawyers in a way that makes them easy for lawyers 

to implement. 45 They treat appearances the same as facts, and minor financial interests related to for-profit employment more gravely than huge financial interests 

related to dependence on government research grants. Conflict-of-interest policies 

include measures to balance bias because scientific peer review panels routinely do 

more than review science—they opine on policy. 

Public Participation Is Limited and Public Comments Are Ignored 

EPA’s Peer Review Handbook purports to welcome public participation in peer review, but it treats the public as a burden to be endured rather than a source of insight. 46 Similarly, the Handbook endorses the practice of making public comments 

available to peer reviewers, 47 but it does nothing to encourage, never mind require, 

that peer reviewers consider even the most significant scientific content of public 

comments. Unsurprisingly, public comments are routinely ignored in practice, and 

public participation is typically constrained to presentations lasting a few minutes. 48
107 

49See, e.g., William C. Adams. ‘‘Public Comment to CASAC Ozone Review Panel Teleconference.’’ Available at http://www.epa.gov/sab/pdf/pub¥comments¥03-05- 

07¥dr¥wm¥adams¥uc-davis.pdf; accessed January 29, 2012. 50 I use the term zoological to describe EPA peer reviews to reflect the fact that the public’s 

role is strictly observational. Even tapping on the glass is prohibited. 51 Rogene Henderson. ‘‘April 7, 2008, Letter to Stephen L. Johnson from CASAC on ‘Clean Air 

Scientific Advisory Committee Recommendations Concerning the Final Rule for the National 

Ambient Air Quality Standards for Ozone,’ ’’ CASAC April 7, 2008, Letter on O2 NAAQS. Washington, D.C.: U.S. Environmental Protection Agency Office of the Science Advisory Board, 2008, 

p. 2. Emphasis added. 52See, e.g., ‘‘Clean Air Act.’’ 44 U.S.C. 7401 et seq. 1970. See § 7409(d)(2)(B), referring back 

to §108(a)(2). 

This means peer reviews of draft EPA risk assessments tend to be dialogues between the peer review panel and Agency staff, who might (or might not) have written (part of) the document. Unless they happen to be members of the peer review 

panel, primary researchers are rarely present and would in any case be relegated 

to cameo presentations during the limited time permitted for public comment. 49

In the section below on remedies, I describe an alternative to this zoological style 

peer review in which public participation is taken seriously, and primary researchers have the lead in presenting scientific information but do not play a role in evaluating it. 50

Federally Chartered Advisory Committees 

Even more than peer review panels, advisory committees are susceptible to politicizing science and scientizing policy. To the extent that they can locate a scientific 

rationale for the advice they want to provide, it can only make their recommendations more persuasive. Like Congress, the public often fondly hopes for scientific answers to difficult policy questions. If a policy choice can be made to appear scientific, 

it may have a much easier time gaining public acceptance. 

One of the most striking examples of scientization occurred in 2008, after EPA 

finalized its revision to the ozone National Ambient Air Quality Standard. CASAC 

sent Administrator Stephen Johnson an unsolicited letter strenuously disagreeing 

with his decision. By itself, this might have been noteworthy but it should not have 

been overly controversial. After all, advisory committees that are independent of an 

agency’s control must be free to offer whatever policy advice they see fit, and Agency 

officials are never obligated to accept policy recommendations from advisory committees. 

But CASAC went much, much further. CASAC misrepresented its policy advice 

as science: 

It is the Committee’s consensus scientific opinion that your decision to set the 

primary ozone standard above this range [0.060 to 0.070 ppm] fails to satisfy 

the explicit stipulations of the Clean Air Act that you ensure an adequate margin ofsafety for all individuals, including sensitive populations. 51

This is wrong in multiple ways, and it should have drawn widespread opprobrium 

instead of acclaim. Science might be able to determine what human health effects 

occur at defined ozone concentrations, though even this ability becomes suspect as 

concentrations approach background. But it is impossible for science to determine 

what concentration is ‘‘requisite to protect the public health’’ or determine what constitutes ‘‘an adequate margin of safety.’’ ‘‘Requisite’’ and ‘‘adequate’’ are squishy policy terms; they cannot be defined scientifically. But CASAC attempted to scientize 

air pollution policy—to make it appear as if science is the rightful venue for determining the meaning of ‘‘requisite’’ and ‘‘adequate.’’ Equally disturbing, CASAC attempted to arrogate the authority to make these policy decisions despite knowing 

full well that Congress delegated them to the Administrator. 

This incident exposed a serious defect in the Clean Air Act’s procedures, one that 

has lessons for advisory committees generally. By asking CASAC to review the scientific record to ensure that it ‘‘accurately reflects the latest scientific knowledge,’’ 

52 but simultaneously ask CASAC to give policy advice to the Administrator concerning what the standard ought to be, Congress practically invited CASAC to 

scientize policy. For CASAC members, it was their scientific credentials and expertise that gave them power, which they willfully abused. And because they did so, 

it is entirely reasonable to be skeptical about the quality of CASAC’s scientific review. Did CASAC also politicize the science to make it support members’ personal 

opinions about air pollution policy? Has anyone conducted a rigorous review to find 

out? 
108 

53This principle is highlighted in previous testimony to the Subcommittee without reference 

to applicable information quality guidelines. See Anastas (2011, p. 1). ‘‘IRIS assessments provide 

a scientific foundation for EPA decisions to protect public health across EPA’s programs and regions under an array of environmental laws. While not regulations, IRIS assessments are critical to many Agency decisions. After becoming Administrator in early 2009, Administrator Jackson reviewed the IRIS program and asked the Office of Research and Development (ORD) in 

May 2009 to implement a new IRIS process that would revitalize the program and make it more 

responsive to the needs of the Agency. The aim of the new process was to ensure the highest 

level of scientific quality, integrity, transparency, and timeliness.’’ 54The scientific information classification scheme recommended to the Subcommittee by Dr. 

Moghissi also has significant merit as a way to identify where scientific knowledge is weakest 

so that investments in research could be targeted to have the greatest value. See A. Alan 

Moghissi. ‘‘Written Testimony Before the U.S. House of Representatives, Committee on Science, 

Space, and Technology, Subcommittee on Energy and Environment, Hearing on ‘Fostering Quality Science at EPA: Perspectives on Common-Sense Reform:’ The Need for Regulatory Science 

Transparency at the EPA,’’ 2011. 55Pub. L. 105–277, 112 Stat. 2681–495: ‘‘That the Director of OMB amends Section ——.36 

of OMB Circular A-110 to require Federal awarding agencies to ensure that all data produced 

under an award will be made available to the public through the procedures established under 

the Freedom of Information Act.’’ OMB’s implementation of this provision was highly controverSome Possible Remedies 

Several remedies can be envisioned that follow from my diagnosis. 

Information Quality 

The key problem noted above is that EPA does not adhere to its information quality guidelines. It largely ignores its procedural and substantive commitments. It 

does not respond in a timely manner to requests for correction and appeals. When 

it does respond, it tends to obfuscate. When it acknowledges errors, it does not correct them. 

These deficiencies are no doubt caught up in program offices’ desire to defend 

their past or pending regulatory decisions. But that cannot explain the Agency’s unwillingness to adhere to information quality principles and standards in its science 

program, which EPA leadership claims is not regulatory. 53

A reasonable inference is that EPA’s research programs may be infected by both 

scientization (the desire to make policy decisions through science) and politicization 

(the abuse of science for policy purposes). Requiring EPA research programs to fully 

adhere to information quality principles and standards would go a long way toward 

overcoming these problems if they exist. If they do not exist, then full adherence 

to information quality principles and standards would earn EPA the credibility it 

believes it is deserved, and once and for all refute its many critics. 

There are simple reforms that Congress could make that would breathe life into 

the information quality paradigm, thereby achieving a dramatic improvement in the 

quality of EPA science. In particular, Congress could require one or more of the following: 

Require Full Disclosure of All Data, Models and Methods for Any Study Used as the 

Basis for a Risk Assessment or Component Thereof 

There appears to be a broad consensus in favor of transparency and reproducibility, the two procedural information quality standards. Under applicable information quality guidelines, data, models, and methods must be fully disclosed such that 

qualified third parties can reproduce the agency’s results and obtain essentially the 

same result. If third parties are unable to even make such an attempt, then the 

agency work product is per se insufficiently transparent and violates applicable 

standards. If third parties can make the attempt but cannot reproduce EPA’s results, then the information should be presumed to fail the objectivity test. In either 

case, the information involved should not be disseminated, much less used for risk 

assessment. 54

Agencies avoid the full force of this transparency standard by claiming, correctly, 

that published articles in scholarly journals do not disclose enough information to 

meet the transparency and reproducibility standards. Congress can best solve this 

problem by altering incentives. 

Contracting regulations already permit federal agencies to demand that recipients 

of federal research funds submit their data upon request. Unfortunately, agencies 

still have the discretion not to ask, and they often do so precisely to avoid having 

to disclose the information to the public as the Shelby Amendment otherwise requires. 55 Congress could relieve federal agencies of this conundrum by requiring 
109 

sial among recipients of federal research funds who considered the data they collected to be their 

private intellectual property. 

them to obtain research data if they want to use a federally funded study as the 

basis for risk assessment. Requiring disclosure imposes only trivial costs on the 

agencies and does not violate the contractual terms of any federally funded researcher. No burden would be imposed on anyone if the agency did not want to use 

a federallyfunded study as the basis for risk assessment, and no researcher would 

be compelled to accept federal research funds to conduct a study likely to be useful 

in risk assessment. 

If an agency wants to rely on a study that was funded by another party, whether 

that be a State, business, trade association, or nongovernmental organization, nothing currently prevents the agency from asking that this information be supplied, nor 

is there any general legal barrier to the other party providing it. States, businesses, 

trade associations, and nongovernmental organizations that want their research to 

be used for public policy should happily volunteer to provide it. Some do. 

Moreover, an ever-increasing number of scholarly journals now require disclosure 

as a condition for publication. Congress can expedite this trend by prohibiting federal agencies from basing risk assessments on studies published by journals that do 

not practice full disclosure. Researchers who want their work to influence policy will 

seek publication in journals that require disclosure. 

Require That Any Study Used as the Basis for a Risk Assessment or Component 

Thereof Adhere to Substantive Information Quality Standards 

Information quality standards, particularly the standards of presentational and 

substantive objectivity, should not apply to all scientific research. Exploratory, hypothesis-generating research often has merit, but by its nature it often cannot comply. However, hypothesis-testing research should always comply, particularly if it is 

going to be used for risk assessment. By requiring crucial studies to adhere to substantive information quality standards, much of the controversy over study selection 

could be eliminated. 

Notice that I would not require prior publication in a peer-reviewed journal or 

give special weight to such studies. Journals publish studies for many reasons, some 

of which are incompatible with their use in risk assessment. Full disclosure is a 

much better threshold requirement. Deference should be given to studies that, after 

full disclosure, have been reproduced and not refuted. 

Require That Agency Risk Assessments or Components Thereof Adhere to Substantive 

Information Quality Standards 

While it is crucial that key studies adhere to information quality standards, it is 

not sufficient. Considerable analysis is performed subsequent to the selection of key 

studies, so it is essential that information quality standards also apply to risk assessments and other derivative work products. 

In practice, this would mean that cancer risk assessments (including those containing unit risk values) and noncancer risk assessments (including those containing 

Reference Doses or Reference Concentrations) would have to adhere to the information quality paradigm. 

In the short run, this would be very difficult for EPA because, as I noted above, 

it is the published policy and practice of the Agency not to produce objective risk 

assessments. In the long run, however, this requirement would unleash a torrent 

of new research into more objective risk assessment methods. Currently, there is 

very little ‘‘market demand’’ for objective methods because EPA is essentially a 

monopsonist in this ‘‘market.’ That is, EPA is the only buyer; as long as EPA does 

not want objective risk assessment methods, the market will not supply any. 

Enforcement 

If Congress were to require EPA research programs to adhere to information quality principles and standards, it would have to devise a way to enforce this requirement. We know that hortatory appeals and executive certifications do not work. We 

also know that inviting judges to ‘‘do science’’ cannot be much of an improvement, 

for they are just as susceptible to the temptation to politicize science. Even if judicial review never erred, it also would be an expensive remedy that only a few could 

utilize. 

One way to reduce the cost of judicial review is to narrowly tailor it to take advantage of the courts’ comparative advantage in administrative procedure. Thus, 
110 

56The echo is deafeningly loud when peer reviewers also share the same policy or ‘‘science 

policy’’ views as Agency staff—yet another good reason for strictly limiting scientific peer review 

to science. 57 It should be expected that contractors who want to maintain their business relationships 

with EPA are cognizant of EPA’s desires with respect to panel selection. 

courts might be authorized to render opinions on agency adherence to published information quality principles and practices, but they must be kept away from substantive scientific disputes. 

Peer Review 

Several specific reforms of EPA peer review could be considered. 

Explicitly Require Peer Reviews to Address Information Quality 

The reforms recommended above in the section on information quality would go 

a long way to solving this problem. They would make clear that adherence to information quality principles and standards is not optional for studies on which EPA 

intended to base a risk assessment, or for risk assessments themselves. 

As I noted above, EPA’s Peer Review Handbook gives short shrift to information 

quality. Congress could remedy this by explicitly requiring peer reviews to include 

rigorous information quality review. This should be done early in the process so that 

EPA does not commit itself to basing risk assessments on noncompliant studies. 

EPA could be sure early on that the studies on which it intends to rely are fully 

compliant and will not be the subject of a spurious later controversy. Information 

quality review also should be done later to ensure that subsequent analyses performed by the Agency also comply. Waiting until EPA has already published a draft 

risk assessment may be too late, for by that time Agency risk assessors often have 

dug in their heels. 

Considerable effort would be needed to train scientist-peer reviewers in information quality principles and standards, or alternatively, establish information quality 

as a distinct discipline that must be represented on every peer review panel. I prefer 

training scientist-peer reviewers so that they become better equipped to detect information quality errors as a regular part of their own professional discipline. This has 

external benefits insofar as it would introduce concern for information quality into 

journal peer review, and thus into scholarly research destined for journal publication. 

Strictly Limit Scientific Peer Reviews to Science 

It might seem superfluous to make such a requirement explicit, but the record 

shows that it is needed. Peer reviewers have incentives to scientize policy, and EPA 

staff have incentives to ask peer reviewers to conduct their reviews in ways that 

at least implicitly ratify embedded policy decisions. By strictly limiting scientific 

peer reviews to science, it would be much easier to discern when any actor in the 

peer-review process—EPA staff, peer reviewers, and public commenters alike—has 

exceeded the charge. 

At a practical level, this would mean removing so-called ‘‘science policy’’ issues 

from peer review. This is highly desirable, for it is within the domain of ‘‘science 

policy’’ that politicization and scientization are most likely to occur. Also, removing 

‘‘science policy’’ would make peer review a much easier task for scientists to perform. It would improve the scientific quality of the peer review charge, for controversies over embedded policy choices within the charge would go away. 

If policy issues were removed from the scope of scientific peer review, the importance of balancing bias among members of a peer review panel would appreciably 

diminish. Instead of worrying about balancing different policy views, greater attention could be devoted to ensuring that peer review panels have diverse intellectual 

perspectives. When there is a coincidence of intellectual interests among peer reviewers or between the panel and the Agency, as the current regime encourages, 

the result can be an echo chamber. 56

Make the Selection of Reviewers and the Charge Independent of the Agency 

It’s a well-known secret that the ability to select peer reviewers and write the 

charge creates the opportunity to control the outcome. For this reason, EPA should 

not control the charge and peer reviewers should not be selected by EPA or its contractors. 57 In its Peer Review Handbook, EPA displays a high degree of skepticism 
111 

58See U.S. Environmental Protection Agency (2006, p. 72). 59 EPA appears to object even to peer reviews paid for by third parties where there is ample 

evidence of independence or no evidence of third-party control. 60Office of Management and Budget. ‘‘Proposed Bulletin on Peer Review and Information 

Quality.’’ Federal Register, 2003, 68, 54023–54029. 61We did not follow EPA’s practice of limiting the participation of independent experts to 

staged five-minute didactic presentations. 62 Richard B. Belzer, James S. Bus, Ercole L. Cavalier, Steven C. Lewis, D. Warner North and 

Richard C. Pleus. ‘‘The naphthalene state of the science symposium: Objectives, organization, 

structure, and charge.’’ Regulatory Toxicology and Pharmacology, 2008, 51(2(1)), 1–5; Kenneth 

T. Bogen, Janet M. Benson, Garold S. Yost, John B. Morris, Alan R. Dahl, Harvey J. Clewell 

III, Kannan Krishnan and Curtis J. Omiecinski. ‘‘Naphthalene metabolism in relation to target 

tissue anatomy, physiology, cytotoxicity and tumorigenic mechanism of action.’’ Regulatory Toxicology and Pharmacology, 2008, 51(2(1)), 27–36; David Brusick. ‘‘Critical assessment of the genetic toxicity of naphthalene.’’ Regulatory Toxicology and Pharmacology, 2008, 51(2(1)), 37–42; 

David Brusick, Mitchell S. Small, Ercole L. Cavalieri, Dhrubajyoti Chakravarti, Xinxin Ding, 

David G. Longfellow, Jun Nakamura, Eleanor C. Rogan and James A. Swenberg. ‘‘Possible 

genotoxic modes of action for naphthalene.’’ Regulatory Toxicology and Pharmacology, 2008, 

51(2(1)), 43–50; Fumie Y. Griego, Kenneth T. Bogen, Paul S. Price and Douglas L. Weed. ‘‘Exposure, epidemiology and human cancer incidence of naphthalene.’’ Regulatory Toxicology and 

Pharmacology, 2008, 51(2(1)), 22–26; D. Warner North, Kamal M. Abdo, Janet M. Benson, Alan 

R. Dahl, John B. Morris, Roger Renni and Hanspeter Witschi. ‘‘A review of whole animal bioassays of the carcinogenic potential of naphthalene.’’ Regulatory Toxicology and Pharmacology, 

2008, 51(2(1)), 6–14; Paul S. Price and Michael A. Jayjock. ‘‘Available data on naphthalene exposures: Strengths and limitations.’’ Regulatory Toxicology and Pharmacology, 2008, 51(2(1)), 15– 

21. 

about external parties conducting peer reviews of their own work products. 58 It is 

therefore hardly unreasonable for others to be similarly skeptical of peer reviews of 

EPA work products conducted by EPA. 59 A simple expedient might be to establish 

and maintain lists of qualified, independent panel members for each discipline and 

select the requisite number of members from each list by lottery. 

In 2006, Regulatory Checkbook organized and conducted a scientific review that 

I believe follows another superior model that EPA could adopt. We followed OMB’s 

draft peer review guidelines, 60 which were much stronger than the final version. We 

strictly limited the review to science—where possible, only primary scientific research was considered—and excluded all manner of policy considerations, such as 

the derivation of a unit risk factor. We focused on just four major scientific questions, thus conserving resources to address only the most important issues, with a 

separate peer review panel for each. Rather than control information exchange, we 

delegated that responsibility to universally respected, bona fide subject matter experts. So long as it did not stray into policy, we encouraged open discussion among 

all participants, including members of the public. 61 Finally, to avoid any interference by the sponsors, we established a Planning Committee whose role was to 

select the issues to be examined, select the subject matter experts and peer review 

panelists, write the charge, and coordinate the submission of the final reports for 

consideration by a scholarly journal subject to another round of peer review. 62

Federally Chartered Advisory Committees 

A key lesson for Congress from the CASAC experience is to refrain from asking 

advisory committees to perform tasks that are inherently in conflict, such as conducting scientific review and giving policy advice. 

Where this cannot be avoided, such as existing committees whose charters it is 

impracticable to change, advisory committees should be required to abide by relevant Red Book recommendations. They should ‘‘establish and maintain a clear conceptual distinction between assessment of risks and consideration of risk management alternatives,’’ and ensure that their reports ‘‘clearly distinguish between the 

scientific basis and the policy basis’’ for their conclusions and recommendations. 

This can be easily enforced, such as by authorizing the EPA Administrator to ignore 

reports from advisory committees that demonstrably do not comply. The threat of 

being ignored is a powerful incentive. 

What Agency Officials Can Do Without Congressional Action 

I do not want to convey the impression that nothing can be done unless Congress 

acts. This is clearly not true. Obviously, EPA officials could, if they wanted to, insist 

that staff adhere to applicable information quality principles and standards. EPA 

officials could, if they wanted to, direct the Science Policy Council to amend the Peer 

Review Handbook to explicitly include information quality review. They could, if 
112 

63 In its 2004 report explaining and defending its risk assessment policies and practices, EPA 

staff say that Congress has, in fact, directed EPA to use risk assessment methods that are ‘‘protective’’ (i.e., tend to overstate risk). See National Research Council (1983, pp. 151, 153). However, the report does not provide a single example of a statutory provision requiring EPA to estimate risk in a biased manner. Every example given is either irrelevant to the question or it 

conflates risk assessment with risk management. See ibid., pp. 14–16. 64 U.S. Environmental Protection Agency Office of the Science Advisor (2004,p. 14). ‘‘Congress 

establishes legal requirements that generally describe the level of protectiveness that EPA regulations must achieve and, infrequently, Congress imposes specific risk assessment requirements.’’ ‘‘EPA seeks to adequately protect public and environmental health by ensuring that risk 

is not likely to be underestimated’’ (emphasis in original). 65 EPA staff deny this, but unconvincingly. ‘‘[A]ny science policy position or choice used in the 

risk assessment process does not direct the risk assessment itself toward a specific risk management decision, e.g., the use of a specific risk estimate,’’ they write. ‘‘Rather, the risk assessment 

informs the decision maker about the potential risks and uncertainties around the risk estimate(s). These characterized risks are then considered in light of the other factors before a decision is made.’’ (ibid., p. 13). Except that it misinforms decision makers, making it harder for 

them to take account of ‘‘other factors.’’ 66 U.S. Environmental Protection Agency Office of the Science Advisor (2004,p. 11). Professor 

Marchant advocates removing the production and review of science from EPA’s jurisdiction: ‘‘it 

would be best if the science was developed and evaluated separately, and in particular in a separate institutional context, from the more political decision-making process.’’ 

they wanted to, insist that Agency peer reviews comply with the Peer Review Handbook. 

EPA officials also could, if they wanted to, require Agency peer reviews to be 

strictly limited to science. It would take hardly any effort at all for EPA officials 

to modify the charters of Agency advisory committees and specifically include within 

each a requirement to abide by the Red Book. 

In short, most of the reforms I have proposed actually require Congress to do anything. The reason why the Subcommittee is conducting oversight and considering 

legislation, however, is that EPA officials—officials appointed by Democratic and 

Republican presidents alike—have not made any of these reforms. 

Final Remarks 

My diagnosis of the problems afflicting EPA science is not novel; indeed, I have 

specifically cited papers published in 1986 that make many of the same points. 

To the best of my knowledge, Congress has never politicized EPA science by, for 

example, requiring it to estimate risk inaccurately or in a misleading way. 63 These 

are things EPA has done on its own, often by misusing the tools of risk assessment 

(the estimation of what risk is) to justify particular risk management decisions (the 

policy determination of what risk ought to be). 64

In this way, EPA risk assessors and other staff have scientized policy and politicized science. They have scientized policy by claiming that science can answer questions that science can inform but not decide. They have politicized science by choosing not to estimate risk accurately. By scientizing policy, Agency risk assessors and 

other staff have taken away from Agency officials the authority and responsibility, 

delegated by Congress, to make policy decisions. They take away from policy officials alternatives that are well within the range of plausible interpretations of their 

statutory directives. 65

The remedies I have proposed should not be controversial if the goal is to improve 

scientific quality while preserving the Agency’s legitimate discretion under the various laws Congress has directed it to implement. They are grounded in the ideals 

of the National Academy’s 1983 Red Book, yet recognize that the Red Book model 

has either failed or cannot be implemented. Instead of ‘‘establishing and maintaining a clear conceptual distinction between assessment of risks and the consideration 

of risk management alternatives,’’ I believe it is time to effect a full and complete 

separation. I believe this is essential to restore science to its rightful place, freeing 

it from politicization, while at the same time aggressively policing the boundary between science and policy to ensure that policy making also is free from scientization. 

Some recommend removing risk assessment from EPA, believing that it is simply 

not possible for science to be performed within ‘‘the political cauldron’’ of EPA because its ‘‘messy mix of politics, policy, economics, law, interests, and values’’ make 

it ‘‘not a good environment in which to develop and evaluate science.’’ 66 I understand the sentiment but I am not ready to give up, nor is it clear to me that giving 

up is a realistic option. 

Thank you again for the opportunity to testify today on this important subject. 

I would be pleased to answer any question that members of the Subcommittee 

might have. 
113 

References 

1. ‘‘Clean Air Act.’’ 44 U.S.C. 7401 et seq. 1970. 

2. ‘‘Information Quality Act.’’ 44 U.S.C. 3516 note. 2000. 

3. Adams, William C. ‘‘Public Comment to CASAC Ozone Review 

PanelTeleconference.’’ Available athttp://www.epa.gov/sab/pdf/ 

pub¥comments¥03-05-07¥dr¥wm¥adams¥uc-davis.pdf; accessed January 29, 

2012. 

4. American Association for the Advancement of Science. ‘‘AAAS Policy Brief: Access to Data.’’ Available athttp://www.aaas.org/spp/cstc/briefs/accesstodata/ 

index.shtml;accessed January 27, 2012. 

5. Anastas, Paul. ‘‘Written Testimony Before the U.S. House of Representatives 

Committee on Science Space and Technology, Subcommittee on Oversight, Hearing 

on ‘EPA’s Integrated Risk Information System,’ ’’ 2011. 

6. Bell, M.L.; F. Dominici and J.M. Samet. ‘‘A meta-analysis of time-series studies 

of ozone and mortality with comparison to the national morbidity, mortality, and air 

pollution study.’’ Epidemiology, 2005, 16(4). 

7. Bell, Michelle L.; Aidan McDermott; Scott L. Zeger; Jonathan M. Samet and 

Francesca Dominici. ‘‘Ozone and Short-term Mortality in 95 US Urban Communities, 1987–2000.’’ JAMA, 2004, 292(19), 2372–2378. 

8. Belzer, Richard B. ‘‘Interests and Incentives in Government Peer Review.’’ Conflict, Consensus, and Credibility: A Forum on Regulatory Peer Review, Alexandria, 

Va., 2002. 

9. ————. ‘‘Risk Assessment and Information Quality: An Empirical Study of 

Federal Agency Performance, 2010 Update.’’ Society for Risk Analysis 2010 Annual 

Meeting, Salt Lake City, Ut., 2010. 

10. Belzer, Richard B.; James S. Bus; Ercole L. Cavalier; Steven C. Lewis; D. 

Warner North and Richard C. Pleus. ‘‘The naphthalene state of the science symposium: Objectives, organization, structure, and charge.’’ Regulatory Toxicology and 

Pharmacology, 2008, 51(2(1)), 1–5. 

11. Bipartisan Policy Center. ‘‘Improving the Use of Science in Regulatory Policy,’’ 

Washington, D.C.: Bipartisan Policy Center, 2009. 

12. Bogen, Kenneth T.; Janet M. Benson; Garold S. Yost; John B. Morris; Alan 

R. Dahl; Harvey J. Clewell III; Kannan Krishnan and Curtis J. Omiecinski. ‘‘Naphthalene metabolism in relation to target tissue anatomy, physiology, cytotoxicity and 

tumorigenic mechanism of action.’’ Regulatory Toxicology and Pharmacology, 2008, 

51(2(1)), 27–36. 

13. Brusick, David. ‘‘Critical assessment of the genetic toxicity of naphthalene.’’ 

Regulatory Toxicology and Pharmacology, 2008, 51(2(1)), 37–42. 

14. Brusick, David; Mitchell S. Small; Ercole L. Cavalieri; Dhrubajyoti 

Chakravarti; Xinxin Ding; David G. Longfellow; Jun Nakamura; Eleanor C. Rogan 

and James A. Swenberg. ‘‘Possible genotoxic modes of action for naphthalene.’’ Regulatory Toxicology and Pharmacology, 2008, 51(2(1)), 43–50. 

15. Dudley, Susan E. ‘‘Written Testimony Before the U.S. House of Representatives Committee on Science, Space, and Technology, Subcommittee on Energy and 

the Environment, Hearing on ‘Fostering Quality Science at EPA: Perspectives on 

Common Sense Reforms,’ ’’ 2011. 

16. Griego, Fumie Y.; Kenneth T. Bogen; Paul S. Price and DouglasL. Weed. ‘‘Exposure, epidemiology and human cancer incidence of naphthalene.’’ Regulatory Toxicology and Pharmacology, 2008, 51(2(1)), 22–26. 

17. Henderson, Rogene. ‘‘April 7, 2008, Letter to Stephen L. Johnson from CASAC 

on ‘Clean Air Scientific Advisory Committee Recommendations Concerning the Final 

Rule for the National Ambient Air Quality Standards for Ozone,’ ’’ CASAC, April 

7, 2008, Letter on O2 NAAQS. Washington, D.C.: U.S. Environmental Protection 

Agency Office of the Science Advisory Board, 2008. 

18. Holdren, John P. ‘‘Memorandum for the Heads of Executive Departments and 

Agencies: Scientific Integrity,’’ Office of Science and Technoloy Policy, 2010. 

19. Marchant, Gary E. ‘‘Written Testimony Before the U.S. House of Representatives Committee on Science, Space, and Technology, Subcommittee on Energy and 

the Environment, Hearing on ‘Fostering Quality Science at EPA: Perspectives on 

Common Sense Reform,’ ’’ 2011. 
114 

20. McClellan, Roger O. ‘‘Written Testimony Before the U.S. House of Representatives, Committee on Science, Space, and Technology, Subcommittee on Energy and 

the Environment, Hearing on ‘Quality Science for Quality Air,’ ’’ 2011. 

21. Moghissi, A. Alan. ‘‘Written Testimony Before the U.S. House of Representatives, Committee on Science, Space, and Technology, Subcommittee on Energy and 

Environment, Hearing on ‘Fostering Quality Science at EPA: Perspectives on Common Sense Reform:’ The Need for Regulatory Science Transparency at the EPA,’’ 

2011. 

22. National Research Council. Review of the Environmental Protection Agency’s 

Draft IRIS Assessment of Formaldehyde. Washington, D.C.: National Academies 

Press, 2011. 

23. ————. Risk Assessment in the Federal Government: Managing the Process. 

Washington, D.C.: National Academies Press, 1983. 

24. Nichols, Albert L. and Richard J. Zeckhauser. ‘‘The Dangers of Caution: Conservatism in Assessment and the Mismanagement of Risk,’’ V. Kerry Smith, Advances in Applied Micro-Economics: Risk, Uncertainty, and the Valuation of Benefits 

and Costs. Greenwich, Conn.: JAI Press, 1986a, 55–82. 

25. ————. ‘‘The Perils of Prudence: How Conservative Risk Assessments Distort Regulation.’’ Regulation, 1986b, 10(6), 13–24. 

26. North, D. Warner. ‘‘Reflections on the Red/Mis-Read Book, 20 Years After.’’ 

Journal of Human and Ecological Risk Assessment, 2003, 9(5), 1145–1154. 

27. North, D. Warner; Kamal M. Abdo; Janet M. Benson; Alan R. Dahl; John B. 

Morris; Roger Renni and Hanspeter Witschi. ‘‘A review of whole animal bioassays 

of the carcinogenic potential of naphthalene.’’ Regulatory Toxicology and Pharmacology, 2008, 51(2(1)), 6–14. 

28. Obama, Barack. ‘‘Scientific Integrity.’’ Federal Register, 2009, 74(46), 10671– 

10672. 

29. Office of Management and Budget. ‘‘Current Regulatory Issues in Risk Assessment and Risk Management,’’ Regulatory Program of the United States, April 1, 

1990—March 31, 1991. Washington, DC: Office of Management and Budget, 1990, 

13–26. 

30. ————. ‘‘Final Information Quality Bulletin for Peer Review.’’ Federal Register, 2005, 70(10), 2664–2667. 

31. ————. ‘‘Guidelines for Ensuring and Maximizing the Quality, Objectivity, 

Utility, and Integrity of Information Disseminated by Federal Agencies; Notice; Republication.’’ Federal Register, 2002, 67(36), 8452–8460. 

32. ————. ‘‘Proposed Bulletin on Peer Review and Information Quality.’’ Federal Register, 2003, 68, 54023–54029. 

33. Phalen, Robert F. ‘‘Written Testimony Before the U.S. House of Representatives, Committee on Science, Space, and Technology, Subcommittee on Energy and 

the Environment, Hearing on ‘Quality Science for Quality Air’: The CASAC–PM 

Committee—Setting Air Quality Standards,’’ 2011. 

34. Price, Paul S. and Michael A. Jayjock. ‘‘Available data on naphthalene exposures: Strengths and limitations.’’ Regulatory Toxicology and Pharmacology, 2008, 

51(2(1)), 15–21. 

35. Stark, Andrew. Conflict of Interest in American Life. Cambridge, Mass.: Harvard Universitry Press, 2000. 

36. The National Academies. ‘‘Policy on Committee Composition and Balance and 

Conflict of Interest,’’ The National Academies, 2003. 

37. Thurston, George D. ‘‘Written Testimony Before the U.S. House of Representatives, Committee on Science, Space, and Technology, Subcommittee on Energy and 

the Environment, Hearing on ‘Quality Science for Quality Air’: RE: The Science of 

Air Pollution Health Effects and The Role of CASAC in EPA Standard Setting,’’ 

2011. 

38. U.S. Environmental Protection Agency. ‘‘Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated 

by the Environmental Protection Agency (EPA/260R-02-008),’’ 2002. 

39. ————. ‘‘Peer Review Handbook (1st Ed.),’’ Washington, D.C.: U.S. Environmental Protection Agency Science Policy Council, 1988. 

40. ————. ‘‘Peer Review Handbook (2d Ed.),’’ Washington, D.C.: U.S. Environmental Protection Agency Science Policy Council, 2000. 
115 

41. ————. ‘‘Peer Review Handbook (3rd Ed.),’’ Washington, D.C.: U.S. Environmental Protection Agency Science Policy Council, 2006. 

42. U.S. Environmental Protection Agency Office of the Science Advisor. ‘‘An Examination of EPA Risk Assessment Principles and Practices; Staff Paper, EPA/100/ 

B–04/001,’’ 2004. 

Chairman HARRIS. Thank you very much. 

I now recognize our fifth witness, Dr. Jerald Schnoor of the University of Iowa, Department of Civil and Environmental Engineering. 

STATEMENT OF DR. JERALD SCHNOOR, 

ALLEN S. HENRY CHAIR IN ENGINEERING, 

DEPARTMENT OF CIVIL AND ENVIRONMENTAL ENGINEERING, 

UNIVERSITY OF IOWA 

Dr. SCHNOOR. Good morning, Chairman Harris, Ranking Member 

Miller, distinguished Committee Members. Thank you for the 

chance to testify before the Subcommittee. I am Jerry Schnoor, Professor of Civil and Environmental Engineering at the University of 

Iowa. My views are my own today, and I have had the pleasure of 

serving on a number of committees concerning science at EPA, and 

I come to you with the shared interest in fostering quality science. 

But what constitutes quality science? EPA’s mission is to protect 

human health and the environment from detrimental effects of pollution and other hazards. Their science should be relative to the 

mission. It should be of high quality and high priority, and it 

should be reviewed by qualified scientists and engineers constantly. 

Such high-quality science enables excellent policy decisions to be 

made by decision makers including Congress, yourselves. In addition, EPA science should help in identifying future and emerging 

environmental issues. I can testify that the EPA and ORD offer 

world-class science in a number of areas, including especially air 

quality modeling, monitoring, and development of emission databases. 

Improvements in air quality over the past 40 years are remarkable and a testament to the good science at EPA. Please see figure 

1. In the top panel here, increasing population and consumption as 

measured by gross domestic product, the vehicle miles traveled in 

America, and energy consumption are drivers. They serve to elevate the emissions in the United States. If one wants to keep up 

with the ever-increasing pollution from these drivers, it requires increasingly stringent regulations just to maintain the status quo. 

For the most part, U.S. greenhouse gas emissions—that is CO2

emissions on the slide—have mirrored the increasing U.S. population, which continues to grow at about one percent per year in 

figure 1. Notice all three lines in the middle are in lockstep. 

But the surprising news from figure 1 is that in the bottom 

panel, six aggregate air pollutants have been reduced by 41 percent 

over the past 18-year period. This illustrates a tremendous success 

story, which constitutes lives saved, better respiratory health for 

Americans, and billions of dollars in medical costs avoided, not to 

mention clearer, purer air. 

The United States achieved these results by virtue of steadfast 

EPA adopting new rules and enforcing the Clean Air Act and its 

amendments. The Clean Air Act is the most expensive legislation 
116 

to enforce in the entire U.S. Code, but it has a 30:1 benefit-to-cost 

ratio still. It has saved thousands of lives and will result in the creation of 1.5 million new jobs over the next five years for the ambient air quality standards alone. 

The Office of Research and Development provides a significant 

portion of scientific research at EPA. In 2011, ORD, as we have 

heard, realigned their programs from 13 to six, shown on this slide. 

The realignment was in concert with peer review provided over the 

past years by both the Science Advisory Board and the Board of 

Scientific Counselors. Motivation for this consolidation and realignment of programs reflects an emphasis on integrated 

transdisciplinary research, multipollutant exposures, and sustainability. These are not new programs but rather they represent a 

new way of thinking within ORD, and I believe considerable 

synergies may be realized in combining research into the four programmatic areas shown on the right-hand side of the slide and the 

two smaller programs in Homeland Security and human health 

risk assessment, also on the right. 

As a member of EPA Science Advisory Board and several NRC 

committees concerned with EPA research, I can assure you that 

EPA is transparent and heavily peer reviewed already. The entire 

scientific process from major reports to published research journal 

articles, from their labs, centers, and divisions to the proposed regulations, all are reviewed by SAB, BOSC, CASAC and other entities. If anything, I would say the scrutiny and accountability of 

EPA has increased in recent years, based on my own experience 

serving on those committees. 

Thank you very much for the chance to testify. 

[The prepared statement of Dr. Schnoor follows:] 

PREPARED STATEMENT OF DR. JERALD SCHNOOR, 

ALLEN S. HENRY CHAIR IN ENGINEERING, 

DEPARTMENT OF CIVIL AND ENVIRONMENTAL ENGINEERING, 

UNIVERSITY OF IOWA

Good morning, Chairman Harris, Ranking Member Miller, Distinguished Committee Members, ladies and gentleman. Thank you for the chance to testify before 

the Subcommittee. I am Jerald Schnoor, Professor of Civil and Environmental Engineering at the University of Iowa and Co-Director of the Center for Global and Regional Environmental Research. I am also Editor-in-Chief of the American Chemical 

Society journal, Environmental Science and Technology, a leading journal in environmental science and engineering. I have had the good fortune to teach and perform research in the environmental area for over 35 years. During that time, I 

served as the Chair of the Board of Scientific Counselors for EPA Office of Research 

and Development (ORD) from 2000–2004, and more recently as a member of the 

Science Advisory Board (SAB) to EPA. I also am a member of the National Academy 

of Engineering and, as such, have served on a number of National Research Council 

committees of the National Academies, including one which I am chairing now on 

science for EPA’s future. So I come to you with shared interest in fostering quality 

science at EPA, and I have organized my testimony in response to the questions 

posed to me in the invitation letter from Chairman Harris dated January 25, 2012. 

What constitutes quality science to support EPA’s mission? EPA’s mission 

is to protect human health and the environment from detrimental effects of pollution and other hazards. Thus, EPA’s science should be relevant to its mission; it 

should be of high quality and high priority; and it should be reviewed by qualified 

scientists and engineers. Such high-quality science enables excellent policy judgments to be made by decision makers. In addition, EPA science should help to identify future and emerging environmental issues. 
117 

One recent example which illustrates how quality science can help to inform policy even in a time of crisis involved the Macondo oil spill on April 20, 2010, and 

the subsequent release of almost 200 million gallons of oil and addition of two million gallons of dispersant to the Gulf of Mexico. Shortly after the accident occurred, 

EPA was asked about the toxicity of the dispersant that was chosen to break up 

the oil plume. The toxicological data on dispersants at the time were sparse, but 

EPA-ORD rapidly engaged in high-throughput testing on eight commercial 

dispersants at the National Center for Computational Toxicology in the EPA Lab 

at Research Triangle Park, North Carolina. EPA scientists learned quickly that 

Corexit 9500, the dispersant used, was comparable or relatively less toxic than other 

alternative products. In fact, EPA scientists performed the research, wrote and submitted a scientific journal article, and subsequently published the peer-reviewed results on June 30, 2010, only 10 weeks after the original explosion and release of 

oil (Judson et al., 2010)—a remarkable accomplishment. Those events point to another characteristic of quality science—it should be timely. 

EPA should provide high-quality science to inform regulatory decisions. As a research engineer and editor, I can testify that the Office of Research and Development offers world-class science in a number of areas including air quality monitoring, modeling, and development of emissions databases. Improvements in air 

quality that the U.S. has achieved over the past 40 years are a testament to the 

good science at EPA. Let’s consider air quality in recent decades in the U.S. as a 

case study for sound science to improve human health and the environment. 

Increasing population and consumption are ‘‘drivers’’ serving to elevate emissions 

both in the U.S. and globally. If one wants to ‘‘keep up’’ with ever-increasing pollution from these drivers, it requires increasingly stringent regulations just to maintain the status quo. For the most part, U.S. greenhouse gas emissions (CO2-equivalents) have mirrored the increasing population which continues to grow at about one 

percent per year. Figure 1 shows the lock-step of increasing CO2 emissions, population, and energy consumption in the U.S. since 1990. They track each other closely, and increasing population and energy consumption result in greater CO2 emissions. Note that CO2 emissions have not increased nearly as rapidly as the Gross 

Domestic Product (GDP), which indicates improved efficiency in a changing economy. Also, the trend in the transportation sector, responsible for approximately onequarter of all greenhouse gases (GHGs), shows that Americans drove many more 

miles during this period. Vehicle miles traveled increased 36% from 1990–2008, but 

the rate of release of greenhouse gas emissions due to transportation has been much 

less, especially in recent years. 

The surprising news from Figure 1 is that six aggregate air pollutants have been 

reduced by 41% over the 18-year period. This illustrates a tremendous success story 

which constitutes lives saved, better respiratory health for millions, and billions of 

dollars in medical costs avoided, not to mention cleaner/purer air. The U.S. achieved 

these results by virtue of a steadfast EPA adopting new rules and enforcing the 

Clean Air Act and its amendments. The Clean Air Act is the most expensive legislation to enforce in the entire U.S. code, but it has a highly positive benefit-to-cost 

ratio and has resulted in lower morbidity and mortality due to lung and cardiovascular disease, and the creation of many jobs by achieving and abiding by the new 

standards (CERES, 2010). CERES, an organization that articulates the views of 

major American corporations on their social responsibilities, recently estimated that 

enforcement of the National Ambient Air Quality Standards alone will result in the 

creation of 1.5 million jobs over the next five years. The country needs clean energy 

and clean air as well as high-paying jobs, and the former can augment the latter. 

In March 2011, EPA issued The Benefits and Costs of the Clean Air Act from 1990– 

2020. According to this study, the direct benefits from the 1990 Clean Air Act 

Amendments are estimated to be almost $2 trillion for the year 2020, exceeding 

costs by a factor of more than 30:1. 
118 

From Figure 2, one can see the large decline in specific emissions of NO2 (30 %), 

Volatile Organic Chemicals (VOC, 53%), carbon monoxide (CO, 54%), sulfur dioxide 

(SO2, 55%), and particulate matter less than 10 microns (PM2, 65%) since the inception of EPA in 1970, and the implementation and enforcement of the Clean Air Act 

and its Amendments (1967, 1976, 1990). Despite a doubling of the U.S. GDP during 

this period (and large increases in vehicle miles traveled, population, energy consumption, and CO2 emissions), regulation of the transportation and industrial sectors has allowed a decline in emissions of air pollutants. Note, however, that the 

majority of emission reductions from 1970–2005 in Figure 2 occurred prior to 1995 

(with the exception of NO2), illustrating that the rate of improvements have slowed. 
119 

Sometimes, there is no single entity or agency that is sufficiently interested, capable, or funded to perform research necessary to protect human health and the environment from pollution. Many times, it is advantageous to form partnerships to 

combine expertise and resources. A case in point is science to understand the emissions, fate, and effects of fine particulate matter (PM2) in the 1990s. EPA partnered 

with the National Institute of Environmental Health Sciences (NIEHS) and the 

Electric Power Research Institute (EPRI) to fund this seminal research. The famous 

Harvard Six Cities Study (Dockery et al., 1993) found evidence that not only lung 

cancer mortality was elevated when fine particles were prevalent in the air of U.S. 

cities, but cardiopulmonary disease also increased. However, the etiology of the disease, the cause of cardiopulmonary mortality, was unknown. How could fine particles cause disease, let alone death by heart attack or stroke? So it must have been 

with some trepidation that EPA began to develop regulations in 1996 to regulate 

fine particulate matter less than 2.5 microns in diameter (PM2) in order to protect 

the public health. 

Today scientists have a much better idea of how fine particles can kill. In 2000, 

a reanalysis of the Harvard Six Cities Study was reported by the Health Effects Institute (HEI) and, in 2004, research was completed that validated the initial morbidity results (Krewski et al., 2004). An extended follow-up study by Francine Laden 

and colleagues was published in 2006 (Laden et al., 2006) and a summary of the 

beneficial effects on life expectancy by Pope et al. (2009). Laden was quoted in a 

Harvard School of Public Health Press Release at the time: 

‘‘The follow-up study found that an average of three percent fewer people died 

for every reduction of one microgram per cubic meter in the average levels of 

PM2 fine particulate matter, defined as having a diameter of 2.5 microns or 

less—narrower than the width of a human hair. This decreased death rate is 

approximate to saving 75,000 people per year in the U.S.’’ 
120 

That’s an example of quality science performing well—hypotheses are followed by 

hypothesis testing. Continual challenges in the peer-reviewed literature are followed 

by subsequent publication and peer review and iterated for further scrutiny of the 

results until the conclusion emerges and new questions arise. Today EPA funds research at the Rochester PM research Center and the Southern California Particle 

Center on the health effects of even finer particles, ultrafine particulate matter 

(UFP). EPA’s (2011) Progress Report states, ‘‘Ultrafine particulate matter (UFP) is 

easily transported throughout the body even beyond the cardiopulmonary system. 

Tissue and cell analysis shows evidence for the translocation of UFP to the liver, 

kidneys and central nervous system. Surprisingly, there is potential for UFP to 

cross into the circulatory and lymphoid systems, which could allow the particles to 

reach sensitive sites, such as the heart, spleen and bone marrow.’’ 

How does EPA currently produce quality science? Science is performed by 

the Office of Research and Development (ORD), by EPA Agency Offices (e.g., Office 

of Water), through extramural grants and contracts, and through small funding to 

the EPA Regional Offices and states (NRC, 2000). Science to inform EPA regulations is developed throughout the Agency, conveyed to the Administrator’s Office, 

and utilized accordingly. Of course, funding is provided through the budgetary process and Congress, and oversight is performed by GAO, OMB, and others. EPA employs a strategic planning process to utilize science effectively. ORD seeks to maintain a balance between ‘‘problem-driven’’ research to address immediate policy and 

regulatory needs and ‘‘core’’ research in the basic environmental sciences, including 

research to understand future and emerging issues. ORD recently implemented a 

strategy to support innovation at the bench in ORD laboratories, demonstrate the 

power of trans-disciplinary research, broaden their network of problem solvers 

(crowd sourcing), and to showcase the products of such research. 

Partnerships are formed within EPA offices and across outside agencies and institutions to perform both intramural and extramural research. Peer review of major 

products and publications is the system by which objective evaluation and criticism 

of the science occurs. Increasingly, the National Research Council of the National 

Academies has played an important role in peer review and advice to the Agency. 

Considering the importance of air quality for the Agency and the Nation, EPA contracted with NRC to produce a series of reports advising the Agency on airborne 

particulate matter in the late 1990s and early 2000s. These were viewed as quite 

helpful at a critical juncture in scientific research to inform rulemaking and policy 

(NRC, 1998; NRC, 1999). In addition, three FACA committees provide a wide range 

of important scientific peer review and advice: the Science Advisory Board (SAB), 

the Board of Scientific Counselors (BOSC), and the Clean Air Scientific Advisory 

Committee (CASAC). The SAB reviews the President’s budget request and provides 

reviews on various reports which the Agency produces. BOSC provides advice on 

management of ORD, its multi-year program plans, and reviews of its various centers, laboratories and divisions. Of course, CASAC reviews air pollution reports, 

rules, and regulations. 

The Office of Research and Development (ORD) provides a significant portion of 

scientific research for the Agency. In 2011, EPA ORD realigned their programs from 

13 to six (Figure 3). The realignment was in concert with advice provided in recent 

years by both the Science Advisory Board (SAB) and the Board of Scientific Counselors (BOSC). Thirteen major programs proved somewhat unwieldy, and the realignment has received positive review from the SAB (SAB, 2011). Motivation for 

this consolidation and realignment of programs reflects an emphasis on integrated 

trans-disciplinary research, multi-pollutant exposures, and sustainability. These are 

not new programs but represent a new way of thinking within ORD. Considerable 

synergies may be realized in combining research into the four programmatic areas: 

Air, Climate and Energy; Safe and Sustainable Water Resources (water quality plus 

drinking water); Sustainable and Healthy Communities; and Chemical Safety for 

Sustainability; plus two smaller programs in Homeland Security Research and 

Human Health Risk Assessment (Figure 3). 

I believe ORD’s realignment is wise, moving EPA research in a new and effective 

direction. ORD is moving from a risk management paradigm, which has guided and 

influenced research over the past two decades, towards a sustainability paradigm. 

That effort will pay dividends. It is consistent with a public health approach of ‘‘preventing disease’’ rather than a medical approach to ‘‘treating disease’’ after it occurs, 

and it recognizes that environment and health are an interconnected system. And 

it follows on early pioneering research which EPA did on Pollution Prevention in 

the 1990s. Restructuring EPA’s research programs, however, is a significant challenge to an established Agency, and ORD must effectively translate research results 

from these new amalgamated programs into scientifically informed environmental 

policy. 
121 

What Improvements Are Needed for Future Science at EPA? 

With a 41-year history, EPA finds itself in the second decade of the new Millennia 

with different challenges and variable public support for its mission to protect 

human health and the environment. EPA has successfully controlled pollution and 

improved public health and welfare since it was formed in 1970. Success has 

stemmed largely from establishment and enforcement of its regulatory programs 

under the Safe Drinking Water Act, the Clean Air Act, FIFRA, Superfund, TSCA, 

and others. Those successes have been informed by good research, both intramurally 

and extramurally, within the Agency and outside the Agency by universities, colleges, and partnering agencies/institutions. 

But EPA has been successful in reducing pollution mainly at the local scale for 

single conventional pollutants where the legislative mandate was strong. Now, our 

environmental problems are at larger scale (regional to global) and involve aspects 

without solid legislative authority (e.g., agricultural runoff, land use and climate 

change, and choice of energy systems). Some factors driving these new challenges 

to human health and the environment in the U.S. include the following: 

• Population growth and geographic shifts towards the South, West, and the 

coasts; 

• Land use change (urban sprawl, coastal development, agricultural practices); 
122 

• Energy choices (biofuels, shale gas by hydraulic fracturing, deep offshore oil, oil 

sands, coal bed methane, concentrated solar power, wind energy); 

• Increased consumption and technological changes (globalization of trade and 

invasive species, e-waste and complexity of new electronic devices from 11 to 

60 elements of the periodic table, new plastics and flame retardants, endocrine 

disrupting chemicals); 

• Climate change (increased precipitation intensity, changing precipitation patterns, increasing floods, droughts, forest fires, tornadoes, hurricanes). 

These factors have resulted in a new suite of emerging environmental challenges 

for EPA: 

• Air quality deterioration due to warmer, moister climate; 

• Agricultural runoff and nutrient quality criteria from climate change and land 

use choices; 

• Urban stormwater and by-pass exacerbated by sprawl and storm severity; 

• Terrestrial ecosystem degradation (loss of species such as birds, bees, butterflies, bats); 

• Coastal waters ecosystems degradation (harmful algal blooms, red tides, and 

hypoxia). 

EPA’s science in the future will require a new and innovative approach to investigating problems of broader scope where legislative mandates are not strong. Land 

use change, energy choices, coastal development, and climate change represent 

‘‘wicked’’ problems of the future for which quality science is needed to chart the path 

forward. 

EPA must employ the most modern emerging technologies and tools to address 

these problems. A nimbleness and adaptability will be required to identify new environmental threats. Partnering and networking with other agencies, other countries, 

and U.S. citizenry to fashion creative innovative solutions to thorny problems must 

become the norm. Every form of efficiency and innovation will be necessary. Certainly, a science budget commensurate to these pressing problems and sufficient to 

support policy decisions and regulatory actions will be needed to protect human 

health and the environment in the future. This includes better use of social, behavioral, and decision scientists who understand how to develop alternative approaches 

for desired environmental behaviors, rather than end-of-pipe command-and-control 

regulations. Sometimes there is no alternative to direct control and regulation, but 

EPA must think more creatively and seek market and behavioral solutions when 

they present themselves. 

Given the planned shift toward multi-pollutant cumulative risk assessment and 

the backlog of ten thousand chemicals that need to be assessed, there is a need to 

invest in modernizing the human risk assessment approach to move beyond the onepollutant-at-a-time framework. ORD should develop a clear plan for how the outputs 

of the Chemical Safety for Sustainability (CSS) program (e.g., Tox 21, NexGen) will 

be used by the Human Health Risk Assessment program.The Safe and Sustainable 

Water Resources SSWR program will need to increase their focus on viewing water 

and wastewater holistically as an integral part of the overall water cycle. Wastewater is not a ‘‘waste,’’ but rather a resource from which we will recover water, nutrients, and energy for reuse, and it will be used to make communities more socially, 

economically, and environmentally sustainable. This is in concert with EPA’s changing role from not only a regulatory agency, but to one that promotes sustainable and 

healthy communities.Lastly, EPA should assume leadership in the social, behavioral, and decision sciences more broadly as an explicit research enterprise and 

cross-cutting strategy. Scientific research in these areas is inexpensive relative to 

the costs involved in much of the physical and biological sciences. Relatively modest 

investments in this cross-cutting domain could have large future benefits to protect 

human health and the environment (SAB, 2011). 

References 

1. CERES (2011). New Jobs Cleaner Air: Employment Effects under Planned 

Changes to the EPA’s Air Pollution Rules, University of Massachusetts, Political 

Economy Research Institute 9 James Heintz, Heidi Garrett-Peltier, Ben Zippere), 

www.ceres.org/epajobsreport. 

2. Dockery, D.W. et al. (1993). An association between air pollution and mortality 

in six U.S. cities, The New England Journal of Medicine 329 (24), 1753–1759. 

Environmental Protection Agency (2011). Science and Research at the U.S. Environmental Protection Agency—EPA Progress Report 2010, EPA/600/R–011/067, Of-
123 

fice of Research and Development, U.S. Environmental Protection Agency, Washington, D.C., 79 pp. 

Judson, RS, et al. (2010). Analysis of eight oil spill dispersants using rapid, in 

vitro tests for endocrine and other biological activity, Environ. Sci. Technol. 44, 

5979–5985. 

Krewski, D. et al. (2004). Validation of the Harvard Six Cities Study of particulate 

air pollution and mortality, New England Journal of Medicine 350 (2), 198–199. 

Laden, F., Schwartz, J., Speizer, F.E., Dockery, D.W. (2006). Reduction in fine 

particulate air pollution and mortality, Am J Respir Crit Care Med 173, 667–672. 

National Research Council (1998). Research Priorities for Airborne Particulate 

Matter I. Immediate Priorities and a Long-Range Research Portfolio, National Academy Press, National Academy of Sciences, 195 pp. 

National Research Council (1999). Research Priorities for Airborne Particulate 

Matter II. Evaluating Research Progress and Updating the Portfolio, National Academy Press, National Academy of Sciences, 111 pp. 

National Research Council (2000). Strengthening Science at the U.S. Environmental Protection Agency—Research Management and Peer-Review Practices, National Academy Press, National Academy of Sciences, 159 pp. 

Pope, A., Ezzati, M., Dockery, D.W. (2009). Fine-particulate air pollution and life 

expectancy in the United States, New England Journal of Medicine 360, 376. 

SAB Science Advisory Board (2011). Science Advisory Board Comments on the 

President’s Requested FY 2012 Research Budget, EPA-SAB-11-007, U.S. Environmental Protection Agency, Washington, D.C., 30 pp. 

Chairman HARRIS. Thank you very much. 

And now our final witness, Dr. S. Stanley Young, the Assistant 

Director for Bioinformatics at the National Institute of Statistical 

Sciences. 

STATEMENT OF DR. S. STANLEY YOUNG, 

ASSISTANT DIRECTOR FOR BIOINFORMATICS, 

NATIONAL INSTITUTE OF STATISTICAL SCIENCES 

Dr. YOUNG. Mr. Chairman, Mr. Harris and others, today I am 

here to speak to making data sets used in papers supporting regulation by the APA publicly available. 

It is just good science to have data used in papers public. A claim 

can be made. Is it plausible? If the data is not available, then the 

claim is effectively ‘‘trust me’’ science. You might think a claim is 

made in a peer reviewed journal. Surely that makes it right. Peer 

review only says that the work meets the standards of the discipline, and on the face of it, the claims are plausible. Scientists 

doing peer review essentially never ask for the data set. They look 

for obvious things to correct, agree or not with the claims, agree 

or not that the claims make some sense. 

How often do claims prove false or dramatically less pronounced 

in the original paper? Ioannidis in 2005 showed that for medical 

observational studies, claims fail about 80 percent of the time. I 

have kept an informal count of claims coming from medical observational studies and then tested in randomized clinical trials. Over 

90 percent of the claims have failed to replicate. Yes, 90 percent 

failure rate. I refer you to a recent paper that covers these findings, 

Karr and Young, 2011. 

There are a number of technical systems and reasons for the 

high failure rate, which I will not deal with here. I will say that 

the work of Congress and the work of regulatory agencies often depend on valid science. With the best of intentions and incorrect scientific claims, you can make spectacularly bad decisions. 
124 

To give a historical medical example, two very large observational studies made the claim that vitamin E will protect against 

heart attacks. Several large, randomized clinical trials did not support those claims. Hundreds of millions of dollars were spent on the 

randomized clinical trials. 

My goal here is to suggest several things that can be done to improve the situation. Any regulation that depends on epidemiology 

studies, for example, formaldehyde, should make data sets public. 

The ACS CPC II data set that is being relied on for air pollution 

regulations should be public. 

It makes sense to fund the data generation and the data analysis 

separately. One group collects and stages the data and posts it. 

Separate groups of scientists can be funded to analyze the data. 

Other interested scientists can analyze the data. Scientists can become vested in the claims they derive from a data set. One group 

of scientists should not own a data set. 

Making efficient running of science is a good way forward. 

Science is much more efficient if the scientists have access to the 

data used to make claims. One scientist can make a claim and another can say let’s examine the data and see if the claim is supported. Maybe there is a problem. For example, a Duke University 

study that led to clinical trials was discovered to have data-staging 

errors, just the handling of the data. 

Perhaps the scientific analysis strategy is flawed. I examined a 

data set where a claim was made that eating breakfast cereal 

would make boy babies more likely. Examination of the data set 

showed the claim was a result of a flawed statistical analysis strategy. Evidence from medical observational studies indicates that 

claims most often fail to replicate. Environmental epidemiology 

studies are just as subject to error. 

On publication of a paper where research is used to—is funded 

by the EPA, the data should be made public. When the EPA proposes a regulation based on science, it should name the papers it 

is depending on and should make the data sets used in those papers publicly available. The agency should want to move forward 

based on good science. Congress should want the EPA regulations 

based on good science. The EPA would be more efficient if the entire scientific process is utilized. Congress would then depend not 

only on the EPA but on the normal operating of science. Claims are 

more likely to be valid and resulting policy sensible. Let normal 

science help in the vetting process. Make the data sets available. 

[The prepared statement of Dr. Young follows:] 

PREPARED STATEMENT OF DR. S. STANLEY YOUNG, 

ASSISTANT DIRECTOR FOR BIOINFORMATICS, 

NATIONAL INSTITUTE OF STATISTICAL SCIENCES

I am Dr. S. Stanley Young. 

I am the Assistant Director for Bioinformatics at the National Institute of Statistical Sciences, NISS. NISS is a not-for-profit, non-governmental statistics organization. NISS’ mission is to identify, catalyze, and foster high-impact, cross-disciplinary 

research involving the statistical sciences. I am also the CEO of Omicsoft Corporation, a company that designs software. 

I graduated from North Carolina State University, BS, MES and a Ph.D. in statistics and genetics. 
125 

I’ve worked in the pharmaceutical industry on all phases of pre-clinical research, 

first at Eli Lilly and then at GlaxoSmithKline. I’ve authored or co-authored over 60 

papers and book chapters, including six ‘‘best paper’’ awards. I co-authored a highly 

cited book, Resampling-Based Multiple Testing, which deals with false positives, 

among other things. I have three issued patents. I conduct research in the area of 

data mining. 

I am a Fellow of the American Statistical Association and the American Association for the Advancement of Science. I am an adjunct professor of statistics at North 

Carolina State University, the University of Waterloo, and the University of British 

Columbia. 

Today I am here to speak to making data sets used in papers supporting regulation by the EPA publicly available. It is just good science to have data used in papers public. A claim may be made. Is it plausible? If the data is not available, then 

the claim is effectively ‘‘trust me’’ science. 

You might think the claim is made in a peer reviewed journal; surely that makes 

it right. Peer review only says that the work meets the standards of the discipline 

and that on the face of it, the claims are plausible. Scientists doing peer review essentially never ask for the data set; they look for obvious things to correct and agree 

or not that the claims make some sense. 

How often do claims prove false or dramatically less pronounced than in the original paper? Ioannidis, 2005, showed that for medical observational studies, claims 

fail about 80 percent of the time. I have kept informal count of claims coming from 

medical observational studies and then tested in randomized clinical trials. Over 

90% of the claims have failed to replicate. Yes, 90% failure rate. I refer you to a 

recent paper covering these findings, Young and Karr (2011). 

There are a number of technical and systems reasons for the high failure rate, 

which I will not deal with here. I will say that the work of Congress and the work 

of regulatory agencies often depends on valid science. With the best of intentions 

and incorrect scientific claims, you can make spectacularly bad decisions. To give 

a historical medical example, two very large observational studies made the claim 

that Vitamin E will protect against heart attacks. 

Several very large randomized clinical trials did not support those claims. Hundreds of millions of dollars were spent on the RCTs. 

My goal here is to suggest several things that can be done to improve the situation. Any regulation that depends on epidemiology studies, e.g., formaldehyde, 

should make data public. The ACS CPS II database that is being relied upon for 

air pollution regulations should be public. 

It makes sense to separately fund data generation and data analysis separately. 

One group collects and stages the data and posts it. Separate groups of scientists 

can be funded to analyze the data. Interested scientists can analyze the data. Scientists can become vested in the claims they derive from a data set. One group of 

scientists should not ‘‘own’’ a data set. 

Making efficient the running of science is a good way forward. Science is much 

more efficient if scientists have access to the data used to make claims. One scientist can make a claim and another can say, let’s examine the data and see if the 

claim is supported. Maybe there is a problem. For example, a Duke University study 

that lead to clinical trials was discovered to have data staging errors. Perhaps, the 

statistical analysis strategy is flawed. I examined a data set where a claim was 

made that eating breakfast cereal would make a boy baby more likely. Examination 

of the data showed the claim was the result of a flawed statistical analysis strategy. 

Evidence from medical observational studies indicates that claims most often fail to 

replicate. Environmental epidemiology studies are just as subject to error. 

On publication of a paper where research is funded by the EPA, the data should 

be made public. When the EPA proposes a regulation based on science, it should 

name the papers it is depending on, and it should make data sets used in those papers publicly available. The agency should want to move forward based on good 

science. Congress should want the EPA regulations based on good science. The EPA 

would be more efficient if the entire scientific process is utilized. Congress would 

then depend not only on the EPA but the normal operating of science. Claims are 

more likely to be valid and the resulting policy sensible. Let normal science help 

in the vetting process. Make the data available. 

Chairman HARRIS. Thank you very much for your testimony, and 

now we will begin the round of questions. I will recognize myself 

for the first five minutes. And again, I want to thank you all for 

taking the time to come here and advise the Committee on such 

an important topic. 
126 

It is kind of interesting that sandwiched between the first hearing and this hearing, we had the hearing Wednesday about the 

Pavillion, Wyoming, study, which of course the ORD participated 

in, and one of the things that we discovered at the hearing was 

that in fact data was withheld until the night before the hearing, 

certainly not an example of the transparency I think some of you 

have called for. 

Let me just ask, Dr. Swackhamer, the Health Effects Institute 

has recently conducted retrospective accountability research in specific instances to see if regulatory decisions actually produce predicted health outcomes, and Doctor, you understand that we get 

testimony such as, you know, gee, if we just passed this rule or regulation, you will have 200,000 less asthma cases and, you know, 

600 million less cardiac deaths and all the rest. My understanding 

is that EPA devotes a very small portion of their R&D budget toward this kind of research, and my interest is piqued because every 

single time we have had an air pollution hearing, we have been 

promised that asthma incidence would go down, and I am a physician. You know what happened to asthma incidence in the last 30 

years, that same graph that shows that wonderful decline in air 

pollution over the last 30 years? I suggest, Dr. Schnoor, that perhaps you should graph the incidence of asthma. It has gone up over 

30 years. What is the EPA doing in their R&D budget to look at 

whether or not these health benefits that are claimed actually come 

to pass in the magnitude that they are claimed? Because, again, we 

have testimony that you have a 30:1 benefit ratio of doing these. 

Well, my suggestion is, great, let us spend half a billion dollars and 

we can solve our federal debt if it is a 30:1 ratio. That would be 

quite simple. As a scientist, I have to believe that is an oversimplification and, I suspect, an exaggeration. If we just look at 

asthma as an index case, could you tell me whether that kind of 

backward-looking evaluation would improve agency decision making? 

Dr. SWACKHAMER. What I can tell you, Mr. Chairman, is that I 

am not in charge of EPA’s budget so I don’t really know how they 

are spending their budget in terms of these kinds of studies. 

Chairman HARRIS. Would you recommend the Science Advisory 

Board, since the Science Advisory Board should recommend how 

science is used and they use science—see, that is the thing, and 

this is the crux of the matter. The policymakers, as has been pointed out by the panel, point to science as a justification and claimed 

scientific studies that claim hundreds of thousands of less asthma 

cases, which appear not to have occurred. 

Dr. SWACKHAMER. Mr. Chairman, one of the things that we are 

recommending is integrating science into decision making, and 

what that means—that is kind of a fancy phrase, but what it 

means is that there is a process that both the National Academy 

has recommended, and now the Science Advisory Board in a draft 

report is recommending, and part of that process—you know, you 

look at a diagram—is to first formulate the problem, then do the 

science necessary to address the problem, and then complete the 

loop that you are talking about and looking at assessing whether 

the fix was appropriate and making adjustments as you go. 

Chairman HARRIS. Well, thank you. 
127 

Dr. SWACKHAMER. So we are recommending to do exactly what 

you are asking. 

Chairman HARRIS. Dr. Belzer, you have criticized the EPA’s retrospective look at the overall cost of the Clean Air Act, again, you 

know, this 30:1 benefit ratio. Is there a better way to assess regulatory outcomes to maximize what are finite EPA resources? 

Dr. BELZER. Well, certainly, these estimates are done ex ante. 

The estimates are done before the jury comes in. It certainly would 

helpful to have retrospective analysis. I think that is a very useful 

thing. I think as a general rule, agencies don’t like to do it broadly. 

I think the NHTSA may be a good exception to that. They are a 

bunch of engineers. They really like doing that sort of thing. 

The larger problem with this set of rules is that it is EPA that 

is charged by Congress with doing the retrospective review of its 

own work and so I think—— 

Chairman HARRIS. I understand the implicit conflict of interest 

when you are charging with looking back at whether or not you 

have been effective. 

Dr. BELZER. I certainly have always been effective. 

Chairman HARRIS. I understand that. 

Mr. Walls, last year the EPA announced numerous changes to 

their IRIS process to respond to criticism from NAS and GAO including the creation of a standing IRIS advisory panel. Is the problem fixed? 

Mr. WALLS. Mr. Chairman, we think that the announcements 

from EPA are a very good step in the right direction, but I think 

we are in a situation where we really have to trust but verify. We 

have to ascertain that these changes are in fact addressing the 

problems that have been identified. I think there are still some concerns, for example, of how this new SAB committee that IRIS has 

established is going to work. I have every confidence that Dr. 

Swackhamer and her colleagues are committed to doing a great review of those assessments but I question whether or not the process is really independent. I think we have heard that EPA staff has 

kind of unfettered access to the reviewers. You know, that contrasts sharply with peer review done by the National Academy. So 

we are encouraged. We will wait to see more. 

Chairman HARRIS. Thank you very much. 

I recognize the Ranking Member. 

Mr. MILLER. Thank you, Mr. Chairman. 

Since there have been more than 30 years since ERDDAA was 

reauthorized, or authorized, the scientific community has had some 

time to think about it, and in preparing for reauthorizing 

ERDDAA, there have been several suggestions that would improve 

or suggestions for how to improve EPA research, to make it more 

efficient, transparent, and even more credible. One that we have 

heard repeatedly is there could be more integrated science within 

the EPA, and the National Academy of Sciences has called for a top 

science official. They say the lack of a top science official is a formula for weak scientific performance in the agency, and they suggest that Congress create a new position of Deputy Administrator 

for Science and Technology with responsibility for coordinating and 

overseeing agencywide scientific policy, peer review quality assurance. 
128 

Dr. Swackhamer and everyone, what is your opinion, what is 

SAB’s opinion on the advantages or disadvantages of creating a position like that? Would that make the head of ORD—creating a 

deputy-level position make the head of ORD an obsolete position? 

Or is it realistic to think that one person, one position, would be 

able to handle the responsibility for the large test of overseeing all 

of EPA’s research so that we would need both a deputy and the 

head of ORD? 

Dr. SWACKHAMER. Mr. Chairman, Mr. Miller, the Science Advisory Board has a panel right now that is drafting a report on 

science integration at the agency, and one of the things they have 

discussed is the need for scientific leadership across the agency, not 

just ORD, which obviously has a science leader, but to improve the 

leadership across the entire agency linking the science enterprise 

both at the program offices and the regional offices with the entire 

agency to integrate across the whole agency. So we recognize the 

need for improved integrated leadership and coordination across 

the agency. We have not made a stand or made a statement or 

come to a conclusion about how to implement that in terms of 

whether it is a deputy or not. 

Mr. GREENBAUM. Just to reiterate the importance of this, understanding that more than two-thirds of all scientists at EPA do not 

work at ORD. They work in other parts of the program, and one 

of the big challenges is that they are all working at that place 

where they are both creating some science but they are then involved in the interpretation of that science. So making sure 

through some enhanced science leadership, there is currently a 

chief science advisor, whether that is the right mechanism or some 

other one, that there are consistent procedures for transparency, 

for peer review and various other things across the agency is an 

important factor. Whether or not the full deputy is the right approach, as you know, there are plusses and minuses to creating a 

new senior position of that type. 

Mr. MILLER. There may be more opinion than there is time, so 

could you state an opinion succinctly, Dr. Belzer? 

Dr. BELZER. I just want to comment that this idea has come up 

many times in the past. One of the things to keep in mind is that 

for a Deputy Administrator for Science to be effective, the deputy 

would have to have a very large staff and that staff would have to 

be independent of all the program offices and independent of ORD. 

So when you think about this as an idea, think about what it takes 

to fully flesh it out so that it actually has the capacity to be effective in an agency with, what, 14,000 employees or something like 

that. 

Mr. MILLER. Dr. Schnoor, did you have an opinion? 

Dr. SCHNOOR. Very quickly. I would agree with much of what has 

been said. I am not positive that it has got to be a deputy administrator level, but the need for coordination of science throughout 

EPA, even down at the regional, I agree with wholeheartedly, and 

that needs to be better coordinated. 

Mr. MILLER. Dr. Young? 

Dr. YOUNG. Just a quick comment. We can talk about top down 

or we can talk about bottom up. Top down, you have a director. 
129 

Bottom up, if you make all the data sets available, good decisions 

will start at the bottom and the top will take care of itself. 

Mr. MILLER. Anyone else? Okay. I will yield back 25 seconds. 

Chairman HARRIS. Thank you very much, and the gentleman 

from California to my left is going to defer to the gentleman from 

California on my right while he prepares his questions. Anyway, I 

recognize Mr. McNerney from California for five minutes. 

Mr. MCNERNEY. Thank you, Mr. Chairman. I thank my friend 

from California for letting me go first. 

I also want to thank the Chairman and the Majority Staff for 

making what appears to be a good effort at sort of a balanced approach to this. It is a complicated subject. The EPA is a big organization, a lot of science going on, a lot of money being spent, and 

we all want to make sure that it is done right, that the money is 

effective, we don’t make regulations that cause more problems than 

they solve, and so I really welcome the witnesses and the hearing. 

My first question goes to Dr. Belzer. In your testimony, you stated and made a point that the EPA should be free from 

politicization. I think everybody would agree with that. There 

should be some policing of the agency to make sure there is a good 

boundary between science and policy. My question to you is, what 

about industry? Should industry have the same standards that 

draws a boundary between science and policy, or should industry 

be able to just run roughshod over policy and any decisions that 

are being made here in Washington? 

Dr. BELZER. I don’t see any reason why there would be any difference with respect to science. The issue—I don’t think industry 

makes regulatory decisions. It is a little bit different for government. It has certain responsibilities that exceed those of all the interest groups that feed into it. Transparency in science and effective peer review are probably the very best tools available for dealing with problems like scientization or politicization. I think that 

that is the best that we can do and it should be applied to everyone. I like the idea of having more and more competition, more and 

more people playing in this and participating and doing research, 

and let the best research win. 

Mr. MCNERNEY. Well, I think you said the right word, the transparency. If we could make sure that industry is transparent in 

their impact on policy, then I think we would be a lot better off. 

Mr. Greenbaum, thank you for your input this morning. In your 

testimony, one of the things that was disturbing is that you mentioned scientists are hesitant about getting involved in the controversial policies with the EPA or involving EPA reviewing. Could 

you give us some clue as to how we could better that situation? 

Mr. GREENBAUM. Yeah, and I tried to make it very clear. I know 

that the Science Advisory Board goes out of its way to try and recruit a wide range of scientists, but if you do look at the rosters 

of people who are willing, for example, to join panels at the National Research Council and the group that is at EPA, is not a complete overlap. There are people who are hesitant to become involved because of the public scrutiny that comes in, the criticism, 

sometimes unfair, that comes in, and the time involved, and I think 

you need to reach out. It is particularly important to reach out beyond the immediate people, for example, who are only doing work 
130 

in environment and health. An example of that is statisticians. 

There are a number of very good statisticians who have worked in 

the medical arena. We recruit some of those. We are able to do 

that, and sometimes because of who we are, we are able to get 

those people into the academies, and I think the more you can do 

that, the better off you will be because you get fresh perspectives 

and new ideas. It is not a criticism. I do think that the Science Advisory Board has tried to reach out, but there are scientists who 

will hesitate to sort of put themselves out of the frying pan and 

into the fire by going right to work for—— 

Mr. MCNERNEY. Do you think the peer review process is working 

in terms of helping the EPA come to decisions? 

Mr. GREENBAUM. That is a broad statement, because peer review 

applies to a lot of what the agency does, and I think it varies across 

all of the various programs and others. I think there are many 

cases certainly in the process by which the science is peer reviewed, for example, in the clean air decisions. I think that the 

science part of that goes extremely well and is done as a model 

compared to, for example, the way Europe sets similar standards 

or others. But in other areas, I think there are more questions 

about exactly how that peer review operates. 

Mr. MCNERNEY. Thank you. 

Dr. Young, you made some pretty sweeping claims about the peer 

review process. I have been involved in it, and you say that most 

peer reviewers don’t even ask for data. That is pretty—that is a 

pretty blanket statement, and I again come to the conclusion from 

your testimony that you don’t think peer review is sufficient. If 

that is the case, what do you think would be sufficient? And do you 

follow those practices in your own case? Do you follow what you 

think would be sufficient? 

Dr. YOUNG. I always make my data sets available unless they 

are controlled by somebody else. I have made lots of data sets 

available. I am very experienced with the peer review process. I 

peer review for 10 or 15 different journals and I talk to a wide 

range of scientists that are peer reviewers. I think my statement 

is pretty accurate. The peer review of a journal article, if a scientist 

is very conscientious, he may take a day to look at a paper, he may 

take only a few hours. There is no way that that person can look 

at the data. He is trusting that the scientists on the other side did 

the work in a very legitimate way. 

Now, the other thing to say is, the 90 percent of the papers that 

I have looked at where the things did not hold up, those all came 

from peer reviewed journals. They came from JAMA. They came 

from the New England Journal of Medicine. They came from the 

best journals on the planet. Peer review does just what I said. It 

is a quick look at the data. Obvious things are fixed but the data 

is not looked at, and the evidence is, it doesn’t hold up, particularly 

in the case of observational studies, particularly in the case of epidemiology studies. Ninety percent of the time, the claims do not 

hold up, and it is not just me. You guys are trusting that those 

claims are good, and I am saying with a lot of—— 

Mr. MCNERNEY. So what should be done to replace peer reviews? 

Dr. YOUNG. Peer review replacements, I am going in incremental 

steps. Make the data available. The scientific process is that then 
131 

other scientists can look at the data and see if they reach the same 

conclusions. Don’t rely on the peer review system, don’t rely on a 

few experts; rely on the entire scientific process. And if you make 

the data set available, that will come into play and eventually 

truth will come out. 

Mr. MCNERNEY. May I ask another question, Mr. Chairman? 

Chairman HARRIS. We would like to get at least everybody in before we break for votes and then decide. Do you have one quick 

question? 

Mr. MCNERNEY. Well, Dr. Schnoor would like to—— 

Dr. SCHNOOR. May I just add something to what Dr. Young said? 

Chairman HARRIS. Sure, really quickly. 

Dr. SCHNOOR. As a journal editor, our policy is, and most journals, that if the data is asked for, we do give it, but I agree with 

Dr. Young that often it is not asked for, for the reasons that he has 

expressed. 

But I would add one thing that I think is important to the story, 

and that is that usually an important paper will get eventually reproduced. Somebody will try to do that again, and if it fails, then 

the literature will change. I tried to represent that in my written 

testimony. 

Chairman HARRIS. Thank you very much. I hope they allow them 

to come in and try to verify the Pavillion findings. 

I now recognize the gentleman from California, Mr. Rohrabacher. 

Mr. ROHRABACHER. Thank you very much, Mr. Chairman, and let 

me just note about the point that was just made, that I think that 

we should take that very seriously, that all data should be made 

available, not just conclusions that the people in charge of a project 

have made about the data. When we see what happened in the 

Climategate scandal, well, half of it is where we have these scientists talking to each other about how they are going to limit how 

much other people know about the data they have collected. That 

is what got everybody angry, and I know there is a group of people 

in the scientific community that want to just ignore that atrocity, 

but it is an atrocity when you hear a scientist talking about limiting knowledge, limiting the availability of knowledge to other people. So now on with my questions. 

I am concerned about conflict of interest in the scientific community, and especially in terms of the SAB and what we need here, 

let me just ask, you can have a bias towards certain businesses but 

you can have also biases towards certain positions. In the academic 

community, we find these incredible conflicts where some people 

won’t even let someone be hired by their department at a university if they disagree with them, and so we have to consider that 

if someone is getting, for example, EPA grants in order to prove 

something, that would suggest that they have perhaps a bias. Let 

me ask Dr. Swackhamer here on this, does SAB policy make a distinction between the conflict of interest related to receiving federal 

grants from the EPA, for example, for research and conflicts with 

private industry? Shouldn’t both of them be considered prejudicial, 

let us say? 

Dr. SWACKHAMER. Mr. Chairman, Mr. Rohrabacher, yes, the SAB 

has a very rigorous process of looking at conflict of interest prior 

to every activity, so it is not just an annual kind of event. It is be-
132 

fore every single activity we take on. Every member who participates fills in a conflict of interest form and must answer questions, 

not just related to financial conflict of interest but in terms of impartiality, whether they have made public statements on the topic, 

whether they have grants related to that topic. So we actually look 

at the issues, the very issues you have raised. We are actually very 

sensitive to those issues. 

Mr. ROHRABACHER. So someone can receive EPA grants but—in 

other areas but they cannot serve and exercise authority in areas 

they have already received EPA grants? 

Dr. SWACKHAMER. Well, as an example, what we do is, the SAB 

does not look at individual EPA projects or individual grants. We 

look at overall programming. So if an investigator gets an EPA 

grant and also sits on the Science Advisory Board, if the grant is 

unrelated to—that specific grant is unrelated to the overall activity 

that we are reviewing, then that is not considered a conflict. But 

as an example, I have a long history of EPA funding, and we just 

recently reviewed the Great Lakes Restoration Initiative study 

plan, and I recused myself on that particular issue because the 

GLRI is such a broad program, I felt that I did have a conflict. 

Mr. ROHRABACHER. Well, Mr. Walls described in his testimony 

that sometimes peer reviewers are often overly deferential to the 

EPA and the EPA staff. After all, especially if they are—if the EPA 

is giving them a grant for something, but do you think that insisting that EPA staff be present at such meetings has a chilling effect? I will ask that to Mr. Walls. 

Mr. WALLS. Yes, Mr. Rohrabacher. We do believe that there 

needs to be a higher degree of independence for the SAB in conducting these peer reviews. I think there are some practices within 

peer review in the agency and indeed across the government that 

suggest some greater links between those who are actually conducting these assessments and the peer reviewers, so we need to 

have a greater degree of independence. 

Mr. ROHRABACHER. And Dr. Schnoor, is that the—okay. Good. 

You served on the SAB Board of Science Counselors, but around 

the same time you were very active in various issues. For example, 

you wrote an article about hydraulic fracturing entitled ‘‘Regulate 

Baby, Regulate,’’ and you also filmed a YouTube video in which you 

said that all coal-powered electric generation should be shut down. 

Do you think that someone who is such an advocate as this, doesn’t 

that represent a conflict of interest with making—giving people advice, providing scientific advice for the EPA? 

Dr. SCHNOOR. Just one small correction. The issue on coal was 

no new coal-fired power plants, not to shut down—— 

Mr. ROHRABACHER. All right. Well, that is still quite an—— 

Dr. SCHNOOR. It is a strong statement. 

Mr. ROHRABACHER. It is still advocating—— 

Dr. SCHNOOR. It is a strong statement, and those are opinion 

pieces, and they are labeled as opinion pieces as such, and I do declare them in my activities on the SAB board. I do declare them 

and sometimes recuse myself from an issue directly involved—— 

Mr. ROHRABACHER. Well, let us just note that when someone 

works for an industry, yeah, we have to understand they have a 

conflict of interest there, but if people, and especially in the aca-
133 

demic world, have made a specific advocacy, that becomes part of 

their self-interest as well. 

Dr. SCHNOOR. It is, and of course, it is out there for everyone to 

see because it is freely available and published and it is disclosed 

whenever those—— 

Mr. ROHRABACHER. As long as the same standard is for industry, 

that is fine. 

Chairman HARRIS. Thank you very much. 

The gentleman from New York, Mr. Tonko, is recognized for five 

minutes. 

Mr. TONKO. Thank you, Mr. Chair. 

The Subcommittee attempts to explore the areas of transparency, 

and in keeping in that vein, Dr. Belzer, your CV indicates that you 

are an independent consultant. Can you indicate for whom you consult? 

Dr. BELZER. I am not prepared to reveal the identifies of existing 

or past clients because they are covered by confidentiality agreements that I am obligated to honor. I am sorry. That is far as I 

could do on that. 

Mr. TONKO. The agreements are confidential or your relationship 

to them is confidential? 

Dr. BELZER. I am not entirely sure—— 

Mr. TONKO. Well, confidential materials with which you are consulting, to which you are consulting, or the groups themselves, the 

clients themselves? 

Dr. BELZER. I really don’t know. I am not sure that I am understanding it clearly enough, because it seems like a fine distinction 

that is important to you but I don’t quite follow it. When I do 

things that are public or when I put my name on something, a 

piece of work that I produced, then I disclose who I did it for. 

Mr. TONKO. And the Regulatory Checkbook of which you serve as 

president is described as a nonprofit organization? 

Dr. BELZER. It sure is. 

Mr. TONKO. Who funds the Regulatory Checkbook? 

Dr. BELZER. It is funded by a small number of unfortunately toosmall donations. We have done projects in the past and we were 

able to engineer a large project. I bring an example along. I have 

done a few things like that. But a large project will take a lot of 

donors, and those are disclosed. I brought one along. I would be 

happy to leave it for you. But the work of the project is published 

in a scholarly journal, and it has got, you know, complete disclosure of every organization that funded the work. So I have done 

other work here. I have got another thing recently published on the 

National Toxicology Program, and that is identified who funded it. 

I have done work for the government of Canada, and that is here 

as well and, you know, you are welcome to have a copy of that, too. 

Mr. TONKO. Dr. Swackhamer and Dr. Schnoor and Mr. Greenbaum, you as a threesome seem to have the most experience on 

this panel reviewing EPA’s science, and each of you has provided 

helpful suggestions to maintain or improve science at EPA. At the 

same time, we do hear a lot of criticism of the agency’s science routinely. And I would like to present to you—share with you a question and ask for a simple yes or no answer. You can elaborate after 

your yes or no. With the understanding that individual efforts may 
134 

fall short of quality goals and that things can always be improved 

upon, is the science conducted, in your opinion, by the EPA generally of poor quality? 

Dr. SCHNOOR. I would say no, it is of good quality, but it does 

vary from topic to topic, and that means that there is always room 

for improvement. 

Dr. SWACKHAMER. I believe that the answer to that is no, it is 

not of poor quality. It is of good quality. At times it is very high 

quality. 

Mr. TONKO. Thank you. 

Mr. Greenbaum? 

Mr. GREENBAUM. I would agree that the answer is no. I do think 

that there are cases where it is of—it might almost become poor 

quality, but I think also the agency has shown its ability to learn 

from mistakes, for example, in the air quality area it created an 

entire new database of the latest science on air quality and health 

which it is using and which is available to everybody who wants 

to use it to find the latest studies. That is a place where it had 

been criticized in the past and it is now doing it very well. In fact, 

it is a leader in the world in that. 

Mr. TONKO. Thank you, Mr. Chair. I will yield back. 

Chairman HARRIS. We are not going to have to go to vote for 

about 10 more minutes so we are going to take another five minutes. We have agreed to divide five minutes per side. So let me— 

I will start and then I will turn it over to Mr. Miller. 

Dr. Schnoor, I am going to follow up a little bit about what the 

Congressman from California here on my left asked about, and 

that is the—when a scientist veers into personal advocacy, writes 

an opinion piece called, you know, ‘‘Regulate Baby, Regulate,’’ you 

have to look at—although it is an opinion piece, I mean, I read 

through it. I thought it was pretty interesting. Well, I thought it 

was interesting because first of all, I think you were the editor of 

the journal when you wrote the opinion piece, so that is not just 

kind of a Tom, Dick and Harry writing an opinion piece, that is the 

editor of the journal. 

Now, I am going to use a phrase, because as a scientist, you have 

to appreciate, and we brought this out at the hearing two days ago, 

that a scientist uses words very specifically. Like for instance, if 

you say ‘‘likely’’ that means then it probably has, you know, more 

likely than not it occurred. If you say it is the ‘‘best supporting evidence,’’ that means it is probably not likely but it is probably the 

best among a wide variety of alternatives. And by the way, these 

are terms that were used in the Pavillion report. You say in your 

opinion piece that for hydro fracturing causing—in addition to 

causing tap water to burn, you used the word ‘‘cause,’’ a very specific scientific word that means there is a cause and effect. You 

cause it to burn. I looked through the entire literature yesterday 

and I couldn’t find scientific evidence that hydro fracturing caused 

anybody’s tap water to burn. I went back and looked at that case 

in Colorado, and I am sure you reviewed that before you wrote the 

word ‘‘cause’’ where in Colorado they tested that water and found 

that that water that you mentioned that comes in that Gasland 

film was in fact biogenic, not thermogenic, that in fact there is 

overwhelming evidence that it was not a result of gas coming from 
135 

deeper sources but it was a relative—you understand the science 

behind it. There is large series—and yet you choose to use the word 

‘‘cause’’ as a scientist. Does that mean when you write an opinion 

piece, you use different words than when you write a science piece? 

Fill me in on this, because this blurring is a bone of contention on 

our oversight at the EPA. When a scientist takes work and uses 

words and then the press office uses slightly different words and 

then they kind of blend these two and then you dig a little bit, and 

oh, by the way, we don’t want to share the data until the night before the hearing so none of our experts have a chance to look at 

it before they have a hearing. Call me skeptical. Could you address 

your use of the word ‘‘cause’’ in that article? 

Dr. SCHNOOR. Thank you, Chairman Harris. Yes, I can. First of 

all, the use of the word was in the context of the Gasland film as 

having caused the—— 

Chairman HARRIS. Well, if you pardon me a second, I am looking 

at the paragraph, and you said—and it is a different paragraph. It 

says—it implies that hydro fracturing caused tap water—and a 

home has exploded. Now, I won’t even get to the home exploding 

because I didn’t even know about that. 

Dr. SCHNOOR. It was in the context of referring to the Gasland 

film, and also I would like to clarify that, you know, in my job as— 

I did write that as Editor in Chief of Environmental Science and 

Technology, one of the leading journals in the world in environmental science and engineering, and I wrote it—that is a part of 

my job actually. 

Chairman HARRIS. Sure, and—— 

Dr. SCHNOOR. So in the—— 

Chairman HARRIS. I only have 1–1/2 minutes. Do you feel that 

there is scientific evidence that would permit you to use the word 

‘‘cause’’? 

Dr. SCHNOOR. To cause—— 

Chairman HARRIS. Yeah, that hydraulic fracturing—— 

Dr. SCHNOOR. In the context of the film—— 

Mr. HARRIS [continuing]. Caused—— 

Dr. SCHNOOR [continuing]. That is what I was talking about. 

Chairman HARRIS. So you feel that at the time you wrote in 2010 

that evidence indicated—— 

Dr. SCHNOOR. And regulate refers—— 

Mr. HARRIS [continuing]. Knowing—— 

Dr. SCHNOOR. If I could just finish answering the question, ‘‘Regulate Baby, Regulate’’ refers to a lack of regulation that is laid out 

in the editorial on the oil and gas industry, which caused the 

Macondo oil well spill, 200 million gallons to the Gulf of Mexico, 

and has caused problems with pits, ponds and lagoons left over 

from natural gas—— 

Chairman HARRIS. Sure. Well, as part of our written questions, 

I am going to ask you to submit the proof of the use of the word 

‘‘cause’’ because I looked over the science. I am convinced that the 

overwhelming evidence is that it didn’t cause it. 

Does anyone on the panel disagree with Dr. Young’s recommendation that data used to justify regulations should be made 

publicly available without any—I mean, that should be taken for 

granted. Controversial data, make it publicly available, and there-
136 

fore do you think the EPA should have taken well over two months 

or just about two months to release the data associated with a 

highly controversial study that was a draft report where it is the 

most important place to release preliminary data, that you are asking people to suggest peer reviewers. Does anybody disagree that 

they should be total data transparency on an issue that important? 

Does that hand mean you disagree? 

Dr. SWACKHAMER. No, it doesn’t, Mr. Chairman. I just wanted to 

add to that. 

Chairman HARRIS. Sure. 

Dr. SWACKHAMER. I certainly believe that data should be made 

available for peer review and that all data that goes into making 

conclusions in a scientific study should be made available, but it is 

important that the data be through a quality review and that the 

data has been qualified assured before it is released. 

Chairman HARRIS. But it should have done that before you wrote 

the initial draft report, right? 

Dr. SWACKHAMER. Absolutely. 

Chairman HARRIS. Thank you. Okay. I am talking about the 

draft report. Thank you very much. 

Mr. Miller, we have—they just called votes but we have plenty 

of time for the five minutes or so. 

Mr. MILLER. Drs. Schnoor, Swackhamer and Mr. Greenbaum, Dr. 

Young proposed funding data generation and data analysis separately so one group would collect and stage the data and post it 

and then a separate group of scientists with separate funding 

would analyze the data. Do you agree with that proposal? 

Mr. GREENBAUM. Actually, I would not agree with that, partly 

because the design, the building of the database is a fundamental 

scientific enterprise. It is not some rote process by which somebody 

just goes out and collects data and then makes it available so that 

I do think that—and we have a data access policy, a very open data 

access policy since long before the Shelby amendment. We have always assumed that the first data collection is being done. We are 

funding it. People are designing a study and then collecting the 

data to do it. Now, having said that, once they have had the chance 

to go through their data, make their data—analyze it, we have had 

a chance to peer review that, we very strongly believe they should 

be able to make that data publicly available and anybody should 

be able to come in and get it, and that is what I referred to in my 

testimony. We have actually put data from our studies up on the 

Web. So I don’t think it should be totally separate but I do think 

there should be access to the underlying data afterwards. 

Mr. MILLER. Okay. Succinctly, Dr. Swackhamer. 

Dr. SWACKHAMER. I would agree very much with what you just 

heard. Thank you. 

Mr. MILLER. Okay. Dr. Schnoor. 

Dr. SCHNOOR. Again, the policy is that if you ask for the data, 

you will get it from the journals such as ours, but I would say that 

the general impression is that the person who generated the data 

should be able to publish and work on it first, so that it is a bit 

different than what Dr. Young is proposing. 

Mr. MILLER. Dr. Young, I would be delighted to, but we just don’t 

have time. 
137 

I now yield the balance of my time to Mr. McNerney, my time 

to Mr. McNerney. 

Mr. MCNERNEY. Well, thank you. 

I think the peer process is kind of what we are talking about 

here then. Apparently, from what we are hearing from the panel 

this morning, most submitters do supply data with papers. Is that 

your impression? I see some shaking yes and some shaking no. 

Dr. SCHNOOR. Actually in our journal, they do, and I think Dr. 

Young agrees with that, but not every journal maybe has the same 

policy. 

Mr. MCNERNEY. But what is coming out of this is that most reviewers don’t ask for the data. So, I mean, are we in a position 

where we have to say if you want to review this, you are going to 

have to look at the data? And I don’t think that is a viable option 

because aren’t going to want to review papers if you do that. 

The other thing that kind of came out earlier was that important 

papers are reproduced, which is actually a much bigger step than 

just a peer review. If you can reproduce a paper, you have done a 

lot more than just reviewing. So requiring important papers to be 

reproduced, now, that is another level of expense and delay and so 

on. Where can we go that we don’t have to take those kind of 

steps? Yes, Dr. Young. 

Dr. YOUNG. I refer you to a study that was done in the 1950s, 

type A personality and heart attacks. We all know it is true, don’t 

we? That study was replicated twice and both times it failed. After 

the first replication, a learned group of scientists got together and 

said the second study was wrong. Well, when it was tried to be replicated a third time and it was—it didn’t replicate, it meant the 

first study itself was wrong. So a false positive occurred in the first 

step, two more steps, and it has taken 20 years and that is a legend in our time right now. I will tell you, Congressman, you don’t 

have to lay back, you don’t have to be cool. You can be a type A 

personality and you are not going to get a heart attack. 

Mr. MCNERNEY. There aren’t any type A personalities in here. 

Don’t worry about it. 

Dr. YOUNG. What I am saying is that if you release the data as 

soon as possible, the scientific process can take over, and we are 

talking about not just a correct answer but how fast you get it. 

Type A personality took 20 years to overturn, and it is still a legend, so we want it to be fast and we want—— 

Mr. MCNERNEY. Let Mr. Greenbaum answer. 

Mr. GREENBAUM. Science is a messy business. There are thousands and thousands of papers published every year, and they can 

have a wide variety of results. They get peer reviewed. I did note 

that the quality of peer review can vary according to journals. 

There is a hierarchy, though, and as papers become—first of all, as 

they get replicated, and I even know of cases where EPA has funded explicit attempts, independent attempts to replicate important 

results, they and Congress and industry came to us to re-analyze 

some key studies. As you get closer to key studies that are going 

to be making a difference in a risk assessment or in a decision on 

an ambient air quality standard, then you do need to get to the 

next level of understanding what the underlying data is, what the 

peer review is. I would agree with you, we cannot have detailed re- 
138 

analysis of every single paper out there or we would have paralysis. On the other hand, when we get to the really key studies, I 

think there is a higher standard, and that is part of why HEI was 

set up, but we are not the only ones. There are mechanisms for 

doing that. 

Chairman HARRIS. Thank you very much. I thank the witnesses 

for their valuable testimony and the Members for their questions. 

The Members of the Subcommittee may have additional questions for the witnesses, and we will ask you to respond to those in 

writing. The record will remain open for two weeks for additional 

comments from Members. 

The witnesses are excused with my thanks, and the hearing is 

adjourned. 

[Whereupon, at 11:12 a.m., the Subcommittee was adjourned.] 
(139) 

Appendix I 

ANSWERS TO POST-HEARING QUESTIONS
140 

ANSWERS TO POST-HEARING QUESTIONS

Responses by Mr. Daniel Greenbaum, 

President and Chief Executive Officer, 

Health Effects Institute 
141 

The principle need,jor establishing such a model are commitments ~y both the regulatory agency 

(EPA) and industry to: 

support the establishment of a tntlv independent Board of Directors and Scientific 

Committees that can implement the scientific activities without undue involvement of the 

sponsors; 

providefimdingfor the effort over a multi-year period and in a balancedform, so as to 

take the issue affunding and credibility "afj'the tahle;" and 

regular~v contrihute usefUl information on the most pressing scientific issues and 

questions that need to be addressed. 

Iflhese conditions can be met, the !IEI model could be applied 10 a wide range of health and 

other environmental science issues. Having said that, the HE! model may not be necessaryfor 

every aspecl of the science under~ving regulatory decisions (which needs to be continually 

improved within EPA), but may hest be applied to the most controversial areas of scientific 

debate, where the impacts of potential decisions can be greatest (e.g. air poilution. groundwater 

contamination from energy activities, certain chemical risk assessments). 

2 
142 

U.S. HOUSE OF REPRESENTATIVES 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

Subcommittee on Energy & Environment 

Hearing Questions for the Record 

The Honorable Randy Neugebauer 

Fostering Quality Science at EPA: The Needfor Common Sense Re(orm Day lJ 

February 3. 2012 

Mr. Daniel Greenbaum 

1. What type ofresearch does the EPA currently conduct to confirm predicted health outcomes 

of previously promulgated rules? In what ways can we improve existing efforts to examine 

the real effects of EPA rules, and what else can the Agcncy be doing to incrcasc 

accountability for health and environmental predictions? 

EPA has engaged in some significant efforts to re-visit whether actions they have taken have 

had the health benefits that they predicted they would have, most notably the mandated 

"Section 812" analyses in the Clean Air Actthat require them to look back atthe costs and 

benefits of the Act. However, this effort, and most others, have not been based primarilv on 

actual measurement of changes that have occurred, but on modeled estimates of the changes 

that are like~v to have occurred which, although done wilh signi{tcant peer revielv, cannot 

actually measure what has happened. 

EPA has, along with HEr's industry sponsors, strongly supported HE! 's efforts to conduct 

"health outcomes ., or "accountability" research which attempts to actually measure whether 

there have been improvements in air qualitv and health in response to EPA rules and other 

actions. Tofilrther enhance this e[(ort, EPA could (a) build into every major new rule a 

"health outcomes research plan" which would plan out the co/lection o( air qualitv and 

health data from hefbre the rule is implemented to an appropriate period of time 'ifter 

implemenration and (b) engage HE! and other organizations in producing this research in an 

independentfashion so as to ensure it is a fCdr and open evaluation 0/ the rule's 

'{fJixtiveness. 

2. Are there any legitimate concerns about making public the data sets that attempt to justify 

EPA rcgulations? Arc there real concerns about confidentiality, and if so, do they outwcigh 

thc nccessity of accountability, transparency, and opcn and sound scicntific cxamination'! 

There are legitimate concerns about ensuring that the personal medical and other data 

rontained il1 the record, ofsuhjects involved il1 research (e.g. memhers ofa population of 

people being studied in an epidemiologic study) are never divulged and linked to that 

individual. However, there are readily available mechanisms/or masking all personal detail 

so that this hreach o/privacv would never OCCllr, and this should allow academic 

investigators, government agencies, and private companies to make the data underlying their 

studies available. (,'Vote that these procedures may result in slightly smaller data sets, as the 

masking 0/ individual identity is harder i/the people come/rom small communities (e.g. 

where there may only he one death each day and it would be possible to link that death to a 

particular individual). Bur that should not undermine the value a/the broader data set.) 
143 

U.S. HOUSE OF REPRESENTATIVES 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

Subcommittee on Energy & Environment 

Hearing Questions for the Record 

The Honorable Brad Miller 

Fostering Quolity Science at EPA: The Need/or Common Sense Re/orm Day rr 

February 3, 2012 

Mr. Daniel Greenbaum 

EPA ORO Realignment 

I. In the realignment of the Ot1icc of Research and Development programs, has the reduction 

and integration ofthe number of programs down from 13 to 6, proven to be a more efficient 

and effective strategy for EPA-ORD research activities~ Ilow has this alignment improved 

ORD's coordination with the program and regional omces~ v,'hat more can and needs to be 

done to strengthen the EPA overall research enterprise? 

It is still early in the implementation olthis new realignment, but it appears to be a much 

hetter and integrated way to plan out, on a multi-year basis. research strategies/or a series 

0/ highly interrelated topics (e.g. Air Quality. Climate. and Energ;y alf in one plan). It is not 

yet clear how this will change andlor improve the coordination with the program and 

regional offices, and bath the EPA Science Advisory Board and a separate National 

Research Council committee on Science/or EPA's Future are examining how this can be 

better integrated agency-wide. 

This issue - 0/ better integrating the ORD science and scientific activities across the agency 

and the assurance (lithe same level olscientific transparency and quality in all places - is the 

single largest challenge and opportunity/or ensuring that EPA science is enhanced across 

the board. 
144 

Responses by Dr. Deborah L. Swackhamer, 

Professor, Environmental Health Sciences, 

University of Minnesota 

and Chairwoman, EPA Science Advisory Board 
145 

2. In discussing problems with the EPA Science Advisory Board process, Mr. Walls noted that 

"qualified scientists from industry should be given equal consideration" to serve au advisory 

panels. Do you support that recommendation? 

In my years on the SAIl and as Chair. our Iloard and Panels have had balance. including 

membership from qualified scientists from industry. In my experience, their contributions have 

becn immcnsely valuable. 

3. Many EPA science activities are housed within regulatory offices. For example, nearly half 

of EPA's laboratories do not reside 1n the Office of Research and Development. In your 

view, should scientific activities be organizationally insulated from regulatory activities to 

ensure objectivity and balance? 

The organizational structure of EPA is the responsibility of the EPA and the SAIl has never been 

asked to advise on the overall organizational structure of the Agency. Good scicnce and relevant 

outcomes can be found in ORO as well as in the Program and Regional offices. 

Hearing Questions from the Honorable Randy Neugebauer: 

1. What type of research does the EPA currently conduct to confirm predicted health 

outcomes of previously promulgated rules? In what ways can we improve existing 

effOlts to examine the real effects of EPA rules, and what else can the Agency be doing to 

increase accountability for health and environmental predictions? 

The SAB is sllpportive of evaluating health ou(eomes as a result of EPA actions. The SAB 

recommends the need to do such evaluations to "close the loop" and then make appropriate 

adjustments as needed in its recent draft report on the integration of science and decision-making 

at EPA1

• However, the SAB recognizes that conducting such evaluative studies can be very 

expensive and difficult to conduct. 

2, Are there any legitiinate concerns about making public the data sets that attempt to justifY 

EPA regulations? Are there real concerns about confidentiality, and if so; do they 

outweigh the necessity of accountability, transparency, and open and sound scientific 

examination? 

The SAIl recommends that literature and data used by EPA be peer-reviewed and made available 

to the public. When the SAB conducts peer reviews and evaluations, it prefers to review all data 

associated with the document in question. It is my experience that EPA makes its best effort to 

provide all data to (he SAB, subject (0 ethical and legal restrictions. 

11 Science Integration for Decision 1\:1aking at the U.s. Environmental Protection Agency (EPA} (draft January 5 

mn 
146 

Questions from the Honorable Brad Miller: 

EPA-SAB 

1. Testimony atthe hearing alluded to conc<,ms thattbe SAB and EPA staff is "cozy" in 

their peer review of EPA activities. To ensure that this is not the case, what processes are 

in place to prevent conflict of interest Of undue influence? 

As a FACA committee, the SAB has strict processes that must be followed in its deliberations. 

All SAB meetings (including phone calls) are announced in the Federal Register and all 

discussion, presentations, deliberations are completely open to the public (i.e. very transparent). 

All SAD members are required to submit a conflict of interest form for EPA evaluation for each 

new advisory activity. Weare explicitly instructed not to discuss SAB activities outside of this 

public venue (i.e. no private deliberations) and we are explicitly instructed not to interact with 

EPA staff on the activity at hand. All questions for EPA staff outside of the official meeting must 

go through the Designated Federal Oftieer (DFO) who has responsibility for the SAB committee 

or panel. The SAB takes FACA, transparency, and conflict of interest very seriously. 

EPA ORD Realignment . 

2. In the realignment of the Office of Research and Development programs you both 

described in your testimony, has the reduction and integration of the number of programs. 

down from 13 to 6, proven to be a more efficient and effective strategy for EPA·ORO 

research activities? How has this alignment improved ORD's coordination with the 

program and regional offices? What more can and needs to be done to strengthen the 

EPA overall research enterprise? 

The SAB is supportive of the realignment of EPA ORO programs. To date, it appears that the 

realignment has led to greater interdisciplinary interactions and greater communication. It is too 

early to tell if it has been proven an effective strategy for research outcomes. This realignment 

should result in improved coordination with the Program and Regional offices by its very design. 
147 

Responses by Mr. Michael Walls, 

Vice President, Regulatory and Technical Affairs, 

American Chemistry Council 
148 

assumptions, calculations, extrapolations, alternate interpretations, methodology, criteria, and 

conclusions, Given the pivotal role that peer review plays in agency scientific determinations, 

there is a need for to agencies to evaluate their scientific peer review programs and adopt 

improvements. Such improvements should include: 

Providing opponunity for more meaningful public comment on dratt assessments to 

include a facilitated public dialogue session with stakeholders on the key issues and also 

on the draft peer review charge questions. 

Ensuring peer review panels are composed of experts across the necessary disciplines, 

with selection based principally on scientific expertise. Affiliation and employment, and 

funding (either past or present) that are not direct conflicts of interest should not be used 

to exclude individuals. The procedures to appoint peer reviewers should assure both 

objectivity and lack of sih'11ificant bias of the individual reviewers, and a balance of 

scientific perspectives across the peer review panel. Policies and procedures for full 

disclosurc of conflict of intercst and bias, as dcscribed in the NAS Conflict of Interest 

Policy, should be clearly defined and implemented. 

Structuring the peer review process to provide sunicient opportunity for robust 

discussion and consideration of public comments by the independent scientilic peer 

reviewers. Peer reviewers also must be afforded ample time to devote to peer reviews. 

Responding in writing to comments as pan of the assessment revision process that 

follows the public commcnt and peer revicw phases. Whcrc the Agency elcets not to 

address a peer review linding or recommendation, or a signi Ii cant public comment, EPA 

shall issue a written justification lor such action. 

Conducting a separate and independent review ofthe assessment atter public comment 

and peer review comments are incorporated, consistent with NAS practices for scientific 

report review ofNAS reports, to ensure that the agency assessment addresses comments 

received, is supported by the totality ofthe scientific evidence, and is consistent with 

cstablishcd report review criteria. 

Ce!tifying that an agency assessment reflects best available science, that public 

comments and the findings and recommendations of independent peer review have been 

addressed, and that the report is impartial and objective. 

2. Last year, EPA's Science Advisory Board accepted comments from stakeholders on 

ways to improve public participation in the Board's meetings and !'eviews, and 

made some changes to their process. Did these changes address all ofthe Council's 

concerns? 

In June 2011, thc EPA Science Advisory Board (SAB) Staff Office solicited public comment on 

ways to enhance public involvement in SAB activitics. The American Chemistry Council, 

among other interested stakeholders, provided written and oral suggestions to SAB. We were 

pleased to see that the Starf Office has developed additional practices to enhance public 

involvement (see 

hlln://yosemil~llJLQv/sab/sabproducl.llsl!WebSARSOir_ubliclnYolvement00penDocument 

ACC, however, continues to have concerns with the SAB process. 

2 
149 

The SAB Staff Office must ensure that the SAB peer reviewers fully understand their 

independent roles as peer reviewcrs. In general, ACC believes that mcmbers of EPA's SAB 

office (ineluding the Designated Federal Oftieials) perfoml their review function diligently and 

appropriately. At times, however, it appears that peer reviewers are overly del"erentialto EPA 

programs, and are reluctant to be seen as criticizing EPA program staff. Also, EPA program 

staff are often given unfettered ability to COlmnent throughout the peer review meetings and their 

constant presence may have a chilling effect on frank and open discussion among the peer 

reviewers. In addition, in selecting peer review panel members, the foremost consideration 

should be given to expertise. Qualified scientists from industry should be given equal 

consideration for appointment based on the subject matter, and in accordance with applicable 

contlict of interest provisions. Authoritative bodies agree, including the National Research 

Council ol"the National Academies and the Society ol"Toxieology. 

ACC's concems are particularly applicable to EPA's recent announcement that it has established 

a dedicated SAB peer review panel for assessments in the Integrated Risk and Information 

System (IRIS). The National Academy of Sciences (NAS) noted in its recent review of the IRIS 

lonnaldehyde assessment several persistent problems with peer review 01" drall assessments. It is 

vital that the dedicated panel operate more independently Irom EPA, and create processes that 

enhance public and stakeholder confidence in SAB reviews ofIRIS assessments. 

ACC is coneemed that a standing panel, which uses the same reviewers tor multiple assessments, 

may not be sufficiently independent fiom the Agency. The OMB Infonnation Quality Bulletin 

for Peer Review (see 

Agencies shall avoid repeated use ofthe same reviewer on multiple assessments unless 

his or her participation is essential and cannot be obtained elsewhere." For influential 

scientific assessments, "Agencies arc encouraged to rotatc membcrship on standing 

panels across the pool of qualitied reviewers. 

Similarly, the EPA Peer Review Handbook (see: 

bltp:!/ww'YJ;~pa.gov/peerrevievv/p@;'QeerJ~Lew hanQ!1ooL~Q06.illLl), states that 

There is no prohibition on using the same peer reviewer more than once on the same product 

or for multiple products of the same office. However, it is preferable to use difterent people 

each time to provide a broader perspective. When using a contractor to provide peer review 

services, you should recognize that contractors may have a "pool" of reviewers that they use 

regularly. lfthe samc peer reviewers are used repeatedly, they may lose their independence 

(or the appearance of independence) Ii-om the work product(s). Ifa peer reviewer is asked to 

participate in multiple reviews ofthe same product it should be noted in the peer review 

record. 

Later in the EPA handbook, the Agency states: 

Although persons who are familiar with and have a substantial reputation in the field are 

ollen called upon repeatedly to be reviewers, it is important to keep a balance with new 

3 
150 

people who bring fresh perspectives to the review of a work product. The idea here is to 

avoid the repeated use of the same reviewer on multiple assessments unless his/her 

participation is essential and cannot be obtained elsewhere. 

We recommend that EPA follow the OMll suggestion that "the agency rotate membership 

among qualified scientists in order to obtain fresh perspectives and reinforce the reality and 

perception of independence from the agency." 

3. Generally speaking, do you think your members would be comfortable with an EPA 

policy to make the underlying data and models used in regulatory decisions publicly 

available? 

In gcneral, ACC and its mcmbcrs would support an EPA policy to make the underlying data and 

models used in regulatory decision making publicly available. Clearly, objective evaluation of 

data is a foundation of science-based regulatory decision-making. The public release of data, 

methods, and models used in a scientific analysis in a f01111 that allows independent peer 

reviewers, and stakeholders, to independently verify the Agency's calculations (and conclusions) 

and to reanalyze the data using other statistical methods and alternative models will improve 

transparency and increase public and stakeholder confidence in the decisions being supported by 

the agency's scientific analyses. 

In many instances it is important to evaluate plausible alternative modes of action, models and 

assumptions, the choices made among those alternatives, and impacts of one choice vs. another 

on the assessment. Without the data, the impact of key assumptions and extrapolations used by 

the Agency in the analysis cannot be readily discerned. 

In ACC's view, it is also important to distinguish between "complete data sets" and "sufficient 

data sets." For example, one legitimate concern with making "aU" health and safety data 

"public" is data compensation. Companies develop health and safety data of this nature at 

considerable expense. If complete data sets were always made public, the "public" at large and 

competitors could make use of it in regulatory programs -- both inside and outside of the U.S. It 

is important that those who developed the data should be compensated for the time and expense 

of developing the data. 

Data compensation is a well-recognized issue and has been addressed through some EPA 

regulations (e.g. under the Federal Fungicide, Insecticide and Rodenticide Act (FIFRA) dealing 

with pesticides) and general industry practices for sharing and being compensated for data. 

A second potential practical conce111 of making data sets publicly availahle is the potential /()r a 

burdensome "data dump" on the Agency. A solution to this prohlem was developed by EPA in 

consultation with industry for the U.S. High Production Volume (IfPV) Chemical Challenge 

Program, which began in 1998. In the HPV Program hazard data and other relevant scientific 

information for U.S. HPY chemicals (either existing or newly acquired information) were 

submitted to EPA. 

4 
151 

From a practical standpoint, EPA determined that it was not reasonable to attempt to create an 

electronic version of full study reports (especially old reports from the 1960s or earlier) for the 

HPV Challenge program. Sec: lh':!Q;L/vv,y,y,,£Du.gOvlj1pv/pubs/gcncri!llIpbsumgd.htm. Instead, 

detailed electronic summaries of full study reports were prepared that contained the appropriate 

technical in IiJrmation for that particular endpoint. The term "robust summary" was used to 

descrihe this technical content. 

Robust study summaries are intended to provide sufficient data/information to allow a 

technically qualified person to make an independent assessment of a given study report without 

having to go back to the full study report. They were also intended to allow EPA to reach 

decisions whether the existing data, together with other relevant information, were sufficient or 

whether additional testing would he needed. The details of these rohust summaries -- "sufficient 

data sets" -- also enahled the puhlic, including environmental NGOs and animal wei fare 

stakeholders, to evaluate proposed test plans in the HPV Challenge program. 

A rohust study summary therefore might be a path forward to ensure "sufficient data sets" are 

made public, since a robust summary reflects the objectives, methods, results, and conclusions of 

the full study report. So, while there may be practical concerns about overly burdening the 

Agency with a "data dump" of "complete" data sets, (which the Agency doesn't always need to 

make its decisions), the rohust study summary approach is a viahlc solution to this potential 

concern. 

A third potential concern relates to requirements to submit data and information before scientists 

have had a chance to analyze it and publish the data themselves. One of the witnesses at the reb. 

3 hearing called for the scientists who developed data for the government to turn the data sets 

over immediately to other scientists who would analyze the data. This proposal was 

recommended as a means of avoiding problems of bias, inadequate data analysis and similar 

concerns hy the scientists who collected the data. 

A requirement to submit all data immediately would remove an important incentive for scientists 

to conduct research and collect data. The scientific community relies on scientists to develop 

new hypotheses, design new methods and innovative approaches to study these hypotheses, and 

to collect, analyze and publish their research results in the scientific literature. These rescarehers 

should be afforded the opportunity to analyze and puhlish the results oftheir research efforts 

before others are given the opportunity to analyze the data In sum, timing of the release of 

scientific data is certainly one concern with making "all" data sets which EPA might rely upon, 

puhlielyavailahle. 

The Bipartisan Policy Center report mentioned in your first question ("Improving the Use of 

Science in Policy," available at 

recommends the formulation ofregulation should he to data access 

requirements equivalent to those under the Data Access Act (Shelhy Amendment) and its 

implementing Circular regardless of who conducted or sponsored the study. In addition, the Data 

Quality Act and Agency implementing guidelines provide henchmarks and critelia that are to he 

followed hy agencies in disseminating data and other relevant infonnation that support 

regulatory evaluations. 
152 

4. A recent joint report from the EPA's Science Advisory Board and Board of 

Scientific Counselors recommended that the Agency "include sustain ability in its 

research vision" in order to allow "EPA to adopt sustain ability as a core principle to 

inform decisions and actions." Is this empbasis on sustainability appropriate for 

EPA's l'esearch and science activities? Do you have any concerns about this new 

mission'! 

Sustainability is primarily conccrned with maximizing bencfit, while addressing risks of concern, 

rathcr than being an exercise focused mainly on achieving risk based standards. ACC believes 

that adopting sustainability as a core prineiplc to inform decisions and actions will in fact enable 

EPA to lonnally incorporate consideration ofbenelits in the their risk-bene lit evaluations - but 

only iCit is implemented appropriately. A sustainability framework will encourage EPA to take 

on a more integrated and systems-based approach to environmental management that can be 

superior to the current patchwork approach. A recent report by the National Academy of 

Sciences ("Sustainability and the U.S. EPA," (2011)) outlined one possible approach to 

implementing sustainability in EPA activities. 

The ACC believes that the private sector, and our industry, in particular, has a ricb experience in 

incorporating sustainability into our business processes. We believe tlle Agency would benefit 

significantly from engaging stakeholders in developing a strategy to operationalize sustainability 

in its vision. 

5. Many EPA science activities aI"e boused witbin regulatory offices. For example, 

uearly half of EPA's laboratories do not reside iu tbe Office of Research and 

Development. In your view, sbould scientific activities be organizationally insulated 

from regulatory activities to ensure objectivity and balauce? 

As one of the Nation's most regulated industries, ACe member companies expect high quality 

science - and reliable assessment processes to underpin elTeetive and eflicient regulatory 

decisions by the Federal government. It is critically important that EPA laboratories conduct 

research that is mission-critical and can be held to the highest standards of excellence. 

Part of ensuring this quality requires that EPA make certain that research is conducted in an 

objective manner that is not intluenced by a desire lor a predetermined outcome. [fwe look at 

the IRIS program, there is a lack 01' a consistent, coherent, science-based framework that binds 

the agency to an appropriate and transparent approach for weighing evidence, considering 

uncertainty, and keeping up with advances in the field. These deficits greatly impact stakeholder 

confidence in IRIS database. 

Objectivity and high quality are not necessarily a function of where an assessment program is 

located or organizcd. The IRIS program is housed in an Officc of Research and Developmcnt 

Laboratory (the National Center tor Environmental Assessment) and yet we see that the 

independence from regulatory activities has not necessarily guaranteed the objectivity and high 

quality science that all stakeholders would like to see. 

6 
153 

A draft repOIt released by the EPA Science Advisory Board (SABl in January 2012, noted that 

scicntific intcgration could bc strengthened and that the agcney's focus on program and 

disciplinary "silos" remains a significant barrier to science integration. ACC supports measures 

to improve scienti fic inlegralion thal result in furlher enhancements in science based regulalory 

decisions. 

7 
154 

The Honorable Randy Neugebauer 

1. What type of research does the EPA currcntly conduct to confirm prcdictcd hcalth 

outcomes to previously promulgated rules? In what ways can we improve existing 

efforts to examine the real effects of EPA rules, and what else can the Agency be 

doing to increase accountability for health and envkonmental predictions? 

ACC is not aware of any standardized approaches or practices used by EPA to confirm predicted 

hcalth outcomes to previously promulgated rules. While EPA docs have access to anecdotal 

infonnation (for example, we know that blood lead levels in Americans decreased substantially 

afler lead was removed from most gasoline), a more systematic approach to collecting and 

evaluating this infonnation would be welcomed. 

2. Are there any legitimate concerns about making public the data sets that attempt to 

justify EPA regnlations? Are there real concerns about confidentiality, and if so, do 

they outweigh the necessity of accountability, transparency, and open and sound 

scientific examination? 

ACC's response to Dr. Harris' third question outlines a number of general concerns that may 

arise from requirements to make public data sets that justify EPA regulation. 

One potential disconnect in considering the release of data sets that justify federal regulation is 

that many fcderally supported researchers may havc no idea that thc work thcy arc doing may 

somcday be thc basis, or part ofthc basis, of a rcgulatory action by some agency bcfore which 

they have never appeared and about which they know lillIe. It would be natural to assume that 

there would be some resistance in the research community at a broad requirement for disclosure 

of data sets generated by researchers without prior knowledge of the possible use as a basis for 

regulation, and without an opportunity to full leverage the scientific and research potential ofthat 

data. 

In ACC's view, it may be ditTicult to implement a blanket requirement to disclose the data sets 

underlying regulatory programs. One approach would be to providc inecntives for cnhaneed data 

sharing. That might include resources for investigators to clean up data sets, meel data quality 

criteria, and submit them to a managed database. 

Finally, there are indeed important and legitimate concerns regarding the protection of 

confidcntiality with respect to some data sets generated by private research. For example, much 

ofthc innovation in chemistry depends on confidential chemical identities, which often cannot bc 

patented. ACC strongly supports transparency and the public availability orhealth and safety 

inforn1ation about potential effects of chemicals, while still protecting competitive business 

interests. We believe these often competing interests can be reconciled by distinguishing 

between the full disclosure ofheallh and safety effects infonnation and the nondisclosure of 

legitimate confidential business infonnation a11d confidential chemical identities. 
155 

Responses by Dr. Richard Belzer, 

President, Regulatory Checkbook 
156 

Committee on Science, Space, and Technology 

"Quality Science at EPA: Perspectives on Common Sense Reform- Day II" 

Responses to Questions for the Record 

Page 2 

Some of the committee's recommendations are basically fond wishes for 

someone-anyone-to implement by magic wand. Other recommendations 

appear to be plausible ideas that unfortunately are grounded on dubious 

premises. 

The BPC committee's recommendations should be subjected to a 

sequential three-part analysis: 

1. If the recommendation could be implemented immediately at no 

cost, would it solve the identified problem? If it wouldn't, then it is 

unclear why Congress should devote much time to it. 

2. If the recommendation could solve the identified problem, is there 

a practical strategy proposed by which to implement it? If the 

recommendation cannot be implemented, then its interest will be 

limited to academics and theoreticians. 

3. If there is a practical strategy by which the recommendation could 

be implemented, what unintended consequences could occur; 

which of them are likely; and how could they be prevented? 

With that preface, my responses to each of the bulleted inquires 

follows below. 

"Studies used in the formulation of regulation should be 

subject to data access requirements equivalent to those 

under the Data Access Act. " 

I am generally in agreement with the objective of the BPC committee 

recommendation, but it appears to be too timid. Data access rules 

"equivalent to those" under the Data Access Act cannot solve the problem 

the SPC committee identified. Agencies can and do behave strategically to 

evade the Shelby Amendment. They often rely substantially on the work of 

federally-funded researchers but intentionally do not obtain their data. 

Meanwhile, OMS Circular A-130 is burdensome and ineffective. In short, this 

recommendation fails the first element of my three-part test. 

A SUPERIOR ALTERNATIVE 

In my testimony before the Committee, I said the full disclosure of 

data, models, and assumptions should be required for scientific information 

that EPA (or any other agency) either disseminates in a manner connoting 

agreement or which it relies on, in whole or in part, for regulatory decision 

making. As I testified: 

Congress could relieve Federal agencies of this conundrum by 

requiring them to obtain research data if they want to use a Federally 

funded study as the basis for risk assessment. Requiring disclosure 
157 

Committee on Science, Space, and Technology 

"Quality Science at EPA: Perspectives on Common Sense Reform- Day II" 

Responses to Questions for the Record 

Page 3 

imposes only trivial costs on the agencies and does not violate the 

contractual terms of any Federally-funded researcher. No burden 

would be imposed on anyone if the agency did not want to use a 

Federally-funded study as the basis for risk assessment, and no 

researcher would be compelled to accept Federal research funds to 

conduct a study likely to be useful in risk assessment. 2 

In my testimony I also agreed with the BPC committee that no 

distinction should be made based on the source of research funding: 

If an agency wants to rely on a study that was funded by another 

party, whether that be a state, business, trade association, or 

nongovernmental organization, nothing currently prevents the agency 

from asking that this information be supplied, nor is there any general 

legal barrier to the other party providing it. States, businesses, trade 

associations, and nongovernmental organizations that want their 

research to be used for public policy should happily volunteer to 

provide it. 3 

Even if it were true that industry-funded studies always pointed to 

lower risk and government/nonprofit studies always pOinted to higher risk, 

that would not justify applying different disclosure standards. Rather, it 

reinforces the need for the same standards to apply to all scientific 

information, regardless of the source of funding or the direction in which the 

research might alter risk assessment. 

"The process of conducting literature reviews" and "the 

process of naming advisory committees" should be made 

more transparent. 

These excerpts comes from different recommendations addressing 

different issues, though with an overlapping remedy.4 

LITERATURE REVIEW 

The BPC committee correctly recognized that if the scientific record is 

not assembled well at the outset, the rest of the process will go badly, and 

transparency has been lacking with regard to this process. Further, the 

committee also noted that EPA's criteria for evaluating the literature lacked 

consistent principles, which is a discreet way of saying that Agency 

procedures are ad hoc, and in many cases post hoc. 

2 Belzer (2012), p. 23. 

3 Ibid. 

4 Bipartisan Policy Center (2009), p. 41 [Recommendation Three] and p. 18 

[Recommendation Two]. 

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What the committee did not say, but almost surely knew, is that EPA's 

opacity with respect to conducting literature reviews is intentional. Opacity 

maximizes the Agency's policy discretion to interpret scientific information as 

it sees fit. Thus, the committee's recommendation is very nearly a request 

that EPA bind itself to interpret and use science in predictable ways. Unless it 

is required by law, this is something neither EPA nor its advisory committees 

are likely to do. Thus, it fails the second element of my three-part test. 

SELECTION OF MEMBERS OF ADVISORY COMMITTEES 

The BPC committee's recommendation for transparency in the 

selection of scientific advisors is similarly at odds with the incentives of EPA 

officials, staff, and its scientific advisors. Each has incentives that are 

incompatible with each other, and with good government. Officials and staff 

alike tend to prefer scientific advisors who agree with them and be loyal 

defenders of their parochial interests. Officials and staff sometimes agree 

with each other, but sometimes do not. Thus, conflict is built into the process 

when an agency allows third parties inside. 

It is useful to remember that advisory committees were the last 

generation's good-government solution to the problem of agencies failing to 

rely on the best available science. The BPC committee's conclusion that the 

advisory committee process needed reform indicates that this reform has not 

been successful and it has had significant unintended consequences. Among 

those unintended consequences is a new source of pressure to scientize 

policy. 

Being a scientific advisor to EPA confers prestige and power, and for 

academics it also provides a potential trail to money in the form of research 

grants. Prestige is obvious; power arises because of the ability to influence 

policy; and research grants are the mother's milk of academia. It would be 

na"lve to think that scientific advisors are motivated solely by altruism. 

The BPC committee called for the process of naming advisory 

committee members being made more transparent, but it is not clear which 

problem the committee was trying to solve. The committee said there was a 

"proper" way advisory committees should be used; implied that agencies' 

actual use of them was not "proper"; and concluded that transparency in the 

selection of members would restore "propriety .,,5 The committee did not 

explain how this would happen. 

5 Ibid. p. 68. 
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Transparency is certainly a good thing, but it isn't likely to be a 

solution to the underlying problem (i.e., failure to use the best available 

science) or advisory committees' unintended consequences (e.g., 

scientization). These unintended consequences can be reduced, but not 

eliminated, by strictly limiting the role of scientific advisory committee to 

science. For both scientific and policy advisory committees, there would be 

additional benefit in making committee selections randomly from lists of 

qualified individuals, thus reducing the potential for lobbying, logrolling, or 

various forms of corruption. Ironically, this would make the selection process 

less transparent, not more so. 

RELATED ISSUES 

I wish to comment upon one of the committee's recommendations in 

this area that I find troubling: 

In general, papers in high impact, peer reviewed journals 

should be given great weight, and papers that have not been 

peer reviewed should be treated with skepticism. However, the 

quality of peer review varies widely, and journal rankings and impact 

factors do not guarantee that peer review of a specific paper was 

performed adequately. Agencies and scientific advisory 

committees need to extend their inquiry beyond simply 

ascertaining whether a paper was peer reviewed; peer review 

is a necessary but not sufficient determinant of quality. That 

further inquiry might explore how the peer review was conducted, how 

the paper fits into the larger body of literature under review, and 

perhaps most important, the methodology behind the conclusions 

described in the paper (for example, how a cohort to study was chosen 

in an epidemiological study).6 

This advice is internally inconsistent. The committee says that studies 

published in "high impact, peer reviewed journals" deserve "great weight/" 

but then cautions that the "quality of peer review varies widely/" which of 

course also is true for "high impact, peer reviewed journals." If that is so, 

then what could possibly be the justification for giving deference to these 

studies? It is a short step from giving deference to studies published in 

prestigious journals to giving deference to studies authored by prestigious 

researchers. Prestige is not a predictor of accuracy / and what we ought to be 

seeking to encourage is a scientific culture in which accuracy is what leads to 

prestige. 

6 Ibid. pp. 41-42; bold in original. 

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The additional criteria suggested by the committee are early steps of 

the pre-dissemination review required by OMB (and EPA) information quality 

guidelines. However, the BPC committee curiously excluded federal 

information quality standards from the scope of its work-an obvious lost 

opportunity.7 

In my testimony, I recommended that Congress require that EPA risk 

assessments, components, and studies used as the basis for a risk 

assessment or component, adhere to information quality standards. 8 This is 

a much better path forward. It would establish a well-defined and consistent 

performance standard for all scientific information used in support of 

regulation. It focuses on the objectivity of scientific research and its utility for 

decision making, not weak, poorly correlated proxies such as the perceived 

prestige of the journal (or the researcher). 

For this reason it is curious that OMB's peer review guidelines do not 

require adherence to federal information quality standards, even though 

information quality was advertised as their raison d'etre. Information quality 

review also is missing from EPA's Peer Review Handbook.9 Apparently EPA 

does not want its scientific peer reviews to get distracted by the burden of 

ensuring that information quality principles, including objectivity, are met. 

"Agencies should avoid turning repeatedly to the same 

scientists for service on advisory committees. " 

This advice from the BPC committee is part of a series of elements in 

its second recommendation, the purpose of which is as unclear as the theme 

linking the elements is elusive. '° Though the committee apparently found it 

easy to recommend against going to the same well too often, it did not make 

clear what might be wrong with its water. 

7 Ibid. p. 43; footnote 6. This is peculiar. No less than nine references in the 

Report's bibliography concern federal information quality standards. Even more 

curiously, this footnote does not appear to be relevant to the text to which it is 

assigned. 

B Belzer (2012), pp. 24-25. 

9 U.S. Environmental Protection Agency (2006), p. 17. Nothing in the Peer 

Review Handbook explains how to actually perform an information quality review. 

10 Bipartisan Policy Center (2009). The BPC committee's second 

recommendation is that the Administration promulgate guidelines implementing the 

committee's list of recommendations about when to consult advisory committees, 

how to appoint them, and how they should operate. 
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There are several problems that can arise if EPA relies repeatedly on 

the same scientists for advice. The agency may prefer to retain sCientists 

who share the same perspective on the agency's mission and policy direction, 

or who are more easily managed by the career staff. These scientists would 

reflect too narrow a perspective, and easily could become so powerful that 

they are (or perceive themselves to be) de facto regulatory decision makers. 

As I noted in my testimony, in 2008 the Clean Air Scientific Advisory 

Committee (CASAC) seems to have succumbed to this misunderstanding of 

its role with respect to its review of the ozone NAAQS." More recently, in its 

now-abandoned proposal to "reconsider" the 2008 ozone NAAQS, EPA 

Administrator Jackson appears to have welcomed the opportunity to implicitly 

delegate to CASAC the authority to set the standard .'2 The scientization of 

policy is inappropriate whether it is committed by scientists on an advisory 

committee or the Administrator herself. 

At the same time, there may be good reasons for asking the same 

scientists to serve over an extended period. For example, a regulatory 

development process (e.g., the NAAQS) that takes five years may need 

multiple reviews. If the reviewers change midstream, there is a significant 

chance that the second group of reviewers will give advice that is contrary to 

that of the first. While the first group's advice might have been wrong, it's 

just as plausible that it was right and it is the second group's advice that 

isn't. The quality of EPA's science is not necessarily enhanced when it 

receives conflicting advice from multiple committees. 

In my view, when EPA gets conflicting advice, it is likely that the 

reason is not because of the length of service of certain peer reviewers and 

advisory committee members. Rather, conflicting advice arises because the 

nature of their role is conflicted. This happens when scientist/reviewers are 

asked to conduct both a scientific review (which should be neutral and 

objective) and opine on policy (which cannot be). Whether there is churn 

among per reviewers and advisory group members may not matter a great 

deal if they limit their work to science. But it could matter a lot if they are 

providing policy advice, something the BPC committee explicitly advised 

against. Thus, the more important first step is to strictly limit scientific 

reviews to science and get advisory committees out of the business of doing 

both scientific review and giving policy advice. 

11 Belzer (2012), pp. 19-20. 

12 U.S. Environmental Protection Agency (2009), U.S. Environmental 

Protection Agency (2010a), p. 2943. 
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Executive branch agencies need to "help clarify for both 

officials and the general public which aspects of disputes are 

truly about scientific results and which concern policy." 

The BPC committee's suggestions in this section of their Report are all 

interesting and potentially very useful, but they beg the question: why 

haven't any of them already been implemented? After all, like other 

regulatory agencies EPA has been subject to centralized review by OMB's 

Office of Information and Regulatory Affairs for consistency with various 

regulatory principles for over 30 years. 

One answer is that abstract presidential directives and guidelines are 

not always consistent with the president's agenda or enjoy bipartisan 

congressional support. Even when these barriers do not exist, they are far 

from self-implementing. The OIRA professional staff is too small and its 

authority too limited to be as effective as its advocates hope and its 

d etra cto rs fea r. 

Even when the stars are properly aligned, OIRA's review process is not 

structured in a manner that enhances effectiveness. One obvious example: 

OIRA review occurs too late in the process to ensure that presidential 

guidelines have been met. Thus, even if guidelines that the BPC committee 

considered ideal could be drafted, neither OIRA nor anyone else could 

enforce them. What the BPC committee did not say, but which has to be 

true, is that the reforms it wants the President to implement are contrary to 

the bureaucratic interests of the agencies he superintends. Note also that the 

BPC committee did not propose that OIRA's authorities be expanded enough 

to enforce them, or that a new organization be established and given this 

authority. 

There are many strategies that might be considered for ensuring that 

EPA (and other agencies) "clarify for both officials and the general public 

which aspects of disputes are truly about scientific results and which concern 

policy." In my testimony, I recommended that Congress require agencies to 

comply with Federal information quality guidelines and explicitly give the 

courts the limited authority to adjudicate adherence to these procedures and 

standards. 13 This recommendation is much more practical and easier to 

implement than yet another unenforceable presidential guidance document. 

13 Belzer (2012), pp. 21-25. 

cH 
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It satisfies at least the first two elements of the three-part test I presented at 

the outset.!4 

"Policy makers should be wary of conclusions of risk that 

are expressed as a single number. " 

The BPC committee's advice here is welcome but, if anything, seriously 

understated and na"lve. The notion that risk can be reduced to a single 

number is a longstanding and durable myth, but unfortunately it is one that 

Congress encourages.!S Risk assessment is scientifically uncertain and risk is 

inherently variable across any population, but policy makers across both the 

Executive and Legislative branches persist in seeking single number (and 

single word) characterizations of risk. The use of single numbers (and single 

words) to represent or describe risk is a common way that policy issues are 

scientized-i.e., where science is used to make it appear as if no genuine 

policy issue exists. 

The proper way to report risk estimates is by first objectively 

characterizing the entire distribution, to the extent that is feasible, and then 

by conducting a rigorous analysis of the most important scientific 

uncertainties. Not only is distributional variability rarely reported and 

uncertainty analysis rarely performed, human health risk is not estimated 

objectively. If adherence to Federal information quality guidelines and 

standards were statutorily required in an enforceable manner, these 

longstanding problems would have a short shelf life. 

"Federal agencies need to experiment with ways to increase 

the number of scientists who participate in peer review." 

The BPC committee's concerns about the effectiveness of 

governmental peer review are certainly well-founded, but I am not 

persuaded by the committee's diagnosis, which depends on several dubious 

premises and factual claims that are not well supported by empirical 

14 The most likely unintended consequence would be judicial interference with 

science. My recommendation does not include giving the courts the authority to 

review and substantively opine on science, but the courts might not heed such a 

restriction. 

15 A non-EPA example of some interest: Congress directed the Department of 

Health and Human Services (through the National Toxicology Program) to determine 

whether substances are "known" or "reasonably anticipated to be" human 

carcinogens-special forms of the "single number" problem. However, neither of 

these conditions is discernable SCientifically, and as a result the NTP's biennial Report 

on CarCinogens has little scientific merit.~eE'! Belzer (2012), pp. 19-20. 

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evidence. For example, it is not clear that peer review has ever been, as the 

BPC committee claims, "the primary guarantor of integrity in the scientific 

system.,,'6 

Scientific integrity has never been guaranteed by anything, and peer 

review would be a poor insurance policy. This is not because "[s]cientists 

may feel too burdened to review their colleagues' papers or may do so with 

insufficient care," or because "[p]eer review is no longer assumed to be a 

professional obligation," though both concerns may be valid. The reason is 

more mundane: the historic purpose of peer review has been to allocate 

limited research funds across competing proposals and to decide which 

manuscripts among competing submissions deserve to be published in 

scholarly journals whose pages are limited. Scholarly integrity is a product of 

training reinforced by character; it is not part of peer review. A more 

plausible reason for the decline in the quality of peer review, if indeed that 

has happened, is that academic institutions no longer spend as much time 

inculcating integrity among junior scholars and valuing character. 

There is an increasing tendency for academic scholarship to be infused 

with policy advocacy. Whereas a generation ago, men and women chose 

scholarly pursuits to advance knowledge, it seems that an increasing 

proportion of them do so nowadays to advance hobby horse public policy 

objectives. This is a trend that so many academic institutions and 

professional societies foster that it is getting harder every day to find 

scientists to conduct peer review who are as interested in the science as they 

are in whether the science advances the achievement of their public policy 

preferences. For this reason alone, the BPC committee's suggestion that 

universities and professional societies do a better job fostering peer review 

seems unlikely to be effective. It fails at least the second element of my 

three-part test. 

A larger problem is that governmental peer review is structured very 

differently from scholarly peer review and has a completely different 

objective. Whereas scholarly peer reviewers are never selected by the 

authors of the manuscripts they review, governmental peer reviewers often 

are. Whereas scholarly peer reviewers have substantial influence over 

whether manuscripts are published, governmental peer reviewers never do. 

Whereas scholarly peer reviewers are supposed to determine whether a 

16 Bipartisan Policy Center (2009), p. 45 (and pullout text on p. 46). 

k 
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manuscript deserves to be published, governmental peer reviewers are asked 

to determine whether a risk assessment is correct.17 

As a result of testimony given by several of the witnesses at the 

February 3 hearing, the Committee is now aware, perhaps for the first time, 

that peer reviewers in both scholarly and governmental settings virtually 

never review a study's underlying data. The Committee also appears to have 

become aware for the first time that peer review is a poor tool for 

ascertaining whether the conclusions of research are scientifically correct. 

This misunderstanding preceded, but seems to have been exacerbated 

by, OMB's government-Wide peer review guidelines. 's The stated purpose of 

these guidelines was to provide a mechanism for pre-dissemination 

information quality review. Inexplicably, however, OMB's guidelines 

contained no requirement that peer review actually include pre-dissemination 

information quality review. Instead of providing a tool for preventing the 

dissemination of error, the guidelines made it possible for Federal agencies to 

use peer review to shield themselves from charges that information they 

disseminated is false. 

For these reasons, and others, I am skeptical of the BPC committee's 

recommendations for improving peer review. Some of them are unlikely to 

help, even if they could be implemented at no cost, because they are too 

ambiguous (e.g., "strengthen peer review," "experiment with different ways 

of conducting peer reviews") or contrary to self-interest (e.g., "[u]niversities 

should do more to make service as a peer reviewer an expected and 

appreciated aspect of a scientist's career"). For other recommendations (e.g., 

"[s]cientific journals should improve the quality control of peer review," or 

have "clear, publicly accessible conflict-of-interest policies"), the BPC 

committee neglected to offer strategies for actually implementing them. 

In my written testimony, I noted that much of the problem with 

governmental peer review is that the task relies on scientists but often 

involves substantial policy content. This policy content could be explicit (e.g., 

an agency seeks policy advice) or implicit (e.g., an agency seeks ratification 

of a risk assessment in which the agency's preferred policy is embedded in 

the methodology). I recommended that scientific peer reviews be strictly 

limited to science, noting several desirable attributes that would result. '9 In 

my experience organizing strictly scientific peer review, it has been a 

17 Belzer (2002). 

18 Office of Management and Budget (2005). 

19 Belzer (2012), pp. 21-25. 
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challenge to persuade scientists that policy matters are truly beyond the 

scope of the charge, but once they are convinced of this they find the peer 

review task much more interesting and intellectually stimulating. 

One of the challenges of implementing strictly scientific peer review is 

it requires a fundamental cultural change. This is generally not in the 

interests of Federal agencies that sponsor a peer review program they 

consider effective, so it will not occur systematically without congressional 

action. 

"In presenting the conclusions of literature reviews, 

agencies and their scientific advisory committees need to be 

as open and precise as possible in discussing levels of risk 

and uncertainty. " 

This is part and parcel of the tyranny of single number risk 

characterizations, discussed above. What the BPC committee did not 

acknowledge, but what everyone knows, is that it often is contrary to an 

agency's actual or perceived interest to acknowledge uncertainty, much less 

give full attention to it. Agency risk assessors may do the right thing and try 

to provide full disclosure and analysis of uncertainty, but agency officials 

often do not want this information. They may find the information too 

complex or just psychologically unsettling. Further, agency attorneys tend to 

dislike disclosure of uncertainty because they fear that doing so compromises 

the defense of promulgated regulations. Courts are obliged by Chevron v. 

NRDC (467 U.S. 837, 1984) to give substantial deference to agency 

expertise, and deference is easier to give if the agency's experts say they are 

sure about something even when they have hardly any idea at all. 

Like a few other BPC committee recommendations, this one is mostly 

wishful thinking. Yes, it would be much better if agencies and their scientific 

advisory committees properly characterized variability and uncertainty when 

discussing risk. No, this is not going to happen unless and until Congress 

acts---to remove the ambiguity that creates agency discretion, to replace the 

Supreme Court's Chevron jurisprudence with something else, or to make the 

full disclosure or variability and uncertainty a nondiscretionary agency duty. 

To the extent that full disclosure is at least implicitly required by the Federal 

information quality standard of presentational objectivity, a simple remedy 

Congress can implement is to mandate that agencies adhere to this standard 

and make agency compliance judicially reviewable. 
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2. This Subcommittee's oversight has highlighted a pattern in EPA 

science: the Agency has protocols or guidelines to encourage 

transparency, objectivity, or information quality, but these 

standards are often ignored. What steps could be taken by 

Congress to ensure these standards are followed? 

There are two general problems with the way agencies use guidance. 

First, they often publish it with the intent of achieving regulatory outcomes 

without bearing the burden of adhering to the rulemaking requirements of 

the Administrative Procedure Act. This practice is contrary to law but 

nonetheless widespread because of the savings to the agency if successful 

and the expense required to mount a legal challenge.20 Second, when 

agencies use guidance properly, such as to limit their own exercise of 

discretion in order to reduce uncertainty, they often refuse to honor these 

commitments. 

EPA's information quality guidelines provide an excellent example of 

the latter phenomenon. 21 These guidelines are generally well thought out, 

but EPA has not been forthright in honoring the commitments they contain. 

Similarly, EPA's Peer Review Handbook mentions information quality but 

includes no provisions for actually integrating it into the peer review 

processY 

Several years ago, OMB issued government-wide guidance on the use 

of guidance. 23 In addition to a number of housekeeping provisions, OMB 

established a pair of very simple and straightforward substantive principles: 

Guidance must "[n]ot include mandatory language such as 'shall,' 

'must,"required' or 'requirement,' unless the agency is using these 

words to describe a statutory or regulatory requirement, or the 

language is addressed to agency staff and will not foreclose agency 

consideration of positions advanced by affected private parties" 

(§ II(2)(h)); and 

"Agency employees should not depart from significant guidance 

documents without appropriate justification and supervisory 

concurrence" (§ II(l)(b)). 

20 Congress could ameliorate this discrepancy by allowing plaintiffs who 

successfully challenge illegal guidance to recover their costs, perhaps including a 

penalty, from the agency's budget rather than the judgment fund. 

21 U.S. Environmental Protection Agency (2002). 

22 U.S. Environmental Protection Agency (2006). 

23 Office of Management and Budget (2007). 
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The first principle deals with the problem of using guidance illicitly for 

regulatory purposes. The second would require senior officials to explicitly 

waive limits on agency discretion contained in guidance and provide a 

justification for such waivers. In combination, these two principles reject the 

misuse of guidance for regulatory purposes and the failure to honor agency 

commitments. 

To make sure that EPA (or any other agency) complies with these 

principles, Congress would have to codify them in statute. 24 

3. EPA's recently-released final Scientific Integrity Policy 

"[e]stablishes the expectation that when communicating scientific 

findings, Agency employees include a clear explication of 

underlying assumptions, accurate contextualization of 

uncertainties, and a description of the probabilities associated 

with both optimistic and pessimistic projections, if applicable. " In 

your view, has the Agency adequately followed this policy in the 

past? 

It is too soon for anyone to give an informed opinion concerning the 

extent to which EPA has followed this new policy, which has its genesis in a 

March 2009 Executive Order.2s My concern with the policy is I have mixed 

feelings about whether adherence to it is always beneficial. I have no qualms 

with the excerpt cited above, or with numerous other excerpts and 

provisions, especially those which promote greater transparency and 

objectivity. However, these excerpts are accompanied by other text that is 

problematic at best. 

A comprehensive scientific integrity policy must include provisions 

addressing both the politicization of science and the scientization of policy. 

After an extended delay, the Office of Science and Technology (OSTP) finally 

issued government-Wide guidance in December 2010. 26 As my written 

testimony explained, this guidance handles the politicization of science 

ambiguously and the scientization of policy not at al1. 27 

24 Agencies try to comply with this second principle without ever tying their 

hands by including a standard disclaimer, such as the one included in EPA's 2010 

Scientific Integrity Policy. see U.S. Environmental Protection Agency (2010b). 

25 Obama (2009b). 

26 Holdren (2010). 

27 Belzer (2012), pp. 2-3. 
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In some respects, EPA's scientific integrity policy is somewhat better 

than the OSTP guidance. For example, whereas OSTP prohibits only public 

affairs staff from altering scientific information, EPA's policy "[pJrohibits £I! 

EPA employees, including SCientists, managers, and other Agency leadership, 

from suppressing, altering, or otherwise impeding the timely release of 

scientific findings or conclusions. ,,28 

While EPA says its policy "builds upon existing Agency and 

government-wide policies and guidance documents,,,29 its record of 

compliance with these other policies and guidance documents does not set 

an encouraging example. This concern is intensified by the disconnect 

between EPA's establishment of a cadre of "Scientific Integrity Officials" with 

responsibility to "champion" scientific integrity, "provide oversight for the 

implementation" of the policy, and "act as liaisons for their respective 

Programs and Regions," but no apparent authority for them to actually do 

anything. Months of work on the guidance did not enable EPA to eliminate 

useless, circular language. 3D EPA says the policy repeats guidance issued by 

the Agency in 1999,31 so it's not clear whether it contains anything new. In 

any case, EPA states that the policy is unenforceable by any entity other than 

EPA itself,32 so this may not be a distinction with any difference. 

In other respects, however, EPA's policy is much worse than the OSTP 

guidance. Like OSTP, EPA does not acknowledge the scientization of policy as 

a deficit in scientific integrity. Unlike OSTP, however, EPA's policy statement 

is not benign: it requires adherence to certain previously issued Agency 

guidelines whose very purpose is to scientize policy.33 Why include this 

particular reference in scientific integrity guidelines? It ensures that the 

scientization of policy is exempt, while simultaneously making it appear that 

Agency officials "politicize science" if they ever try to reclaim the authority 

28 U.s. Environmental Protection Agency (2010b), p. 4. 

29 Ibid. p. 1. 

3D See, e.g. Ibid. p. 3 ("To support a culture of scientific integrity within the 

Agency, this policy ... [pjromotes a culture of scientific integrity"). 

31 Ibid. 

32 Ibid. p. 2: The Scientific Integrity Policy "does not create any obligation, 

right or benefit for any member of the public, substantive or procedural, enforceable 

by law or in equity by any party against the United States, its departments, 

agencies, or entities, its officers, employees or agents, or any other person." 

33 Ibid. p. 4 (requiring adherence to EPA's GUidance for Risk 

Characterization) . 
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delegated by Congress to make policy decisions that are now made 

"scientifically" by career staff. 

Finally, EPA's scientific integrity policy includes an extensive section 

"[t]o assure the protection of Agency scientists," presumably from 

interference by Agency officials. 34 Notice that there is no parallel section 

protecting Agency officials from interference by Agency scientists in the 

exercise of their statutory authorities. 

4. A recent joint report from the EPA's Science Advisory Board and 

Board of Scientific Counselors recommended that the Agency 

"include sustainability in its research vision" in order to allow 

"EPA to adopt sustainability as a core principle to inform decisions 

and actions. " Is this emphasis on sustainability appropriate for 

EPA's research and science activities? Do you have any concerns 

about this new mission? 

A comprehensive review of the SAB and BOSC foray into 

"sustainability" must await a clear definition of the term. EPA's existing 

definition is highly subjective and too ambiguous to be measured. 35 When a 

goal is subjectively defined or cant be measured, it can never be shown that 

it hasn't been achieved and it's anybody's guess whether achieving it is even 

a good thing. 

The joint SAB/BOSC letter has similar difficulties. It recommends that 

EPA's Office of Research and Development 

include sustainability explicitly in its research vision, invoke a definition 

of sustainability shared across ORD, and demonstrate clearly how 

planned research relates to the key components of sustainability (the 

environment, the economy, and society).36 

In lieu of a coherent definition, SAB/BOSC point to a recent National 

Research Council report, which also lacks a clear definition.37 The NRC 

committee's review, which EPA sponsored, begins with numerous additional 

caveats. For example, the committee did not examine whether 

34 Ibid. p. 5; Sec. IV(A)(3). 

35 U.S. Environmental Protection Agency (n.d.). 

36 U.S. EPA Science Advisory Board (2011), p. 6. 

37 National Research Council (2011), p. 3. '''Sustainability' and 'sustainable' 

mean to create and maintain conditions, under which humans and nature can exist in 

productive harmony, that permit fulfilling the social, economic, and other 

requirements of present and future generations." 

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"sustainability," so defined, is consistent with the statutes that govern EPA's 

authorized activities. 3s 

It is always a concern when a Federal agency embarks on a new 

mission that is not explicitly authorized by law, and even more so when 

cheered on by scientists whose advice is sought primarily because they 

happen to embrace that mission. Public choice theory predicts that agencies 

will do this to expand their authority, power, staff, and resources. This is 

particularly characteristic of agencies such as EPA that have largely achieved 

the statutory objectives Congress originally assigned to it. Like private firms, 

agencies strive to reinvent themselves, including the creation of new 

missions, when it becomes clear that the need for their goods or services has 

dwindled, or they have become irrelevant or overcome by technological 

change. Federal agencies differ, however, insofar as they have no 

constitutional role to engage in activities that Congress has not authorized. 

This suggests an inherent weakness in both the SABjBOSC and NRC 

reports, and of course EPA's approach as well. Both reports could have, but 

did not, examine the extent to which the complicated and sometimes 

inconsistent patchwork of statutes that EPA implements has the perverse 

effect of making it harder for "humans and nature [to] exist in productive 

harmony." An obvious example might be the regulation of criteria air 

pollutants; the Clean Air Act can be interpreted to require the PM,.5 and 

ozone NAAQS to be set at zero, in which case the statute is a suicide 

compact for humans and nature alike. 

5. There was some discussion about the importance of objectivity 

and the role of peer review in EPA risk assessments. 

a. Please describe how greater objectivity in assessments can 

be achieved, and what the practical effects of these 

improvements would be. 

Among the witnesses testifying before the Committee on February 3, 

there appeared to be universal agreement that objectivity is not optional in 

science. Objectivity is an essential attribute of the scientific method, one that 

38 Ibid. pp. 17-18. The NRC committee attempts to show that Congress 

authorized EPA to implement sustainability via the National Environmental Policy Act 

of 1969. This logic is circular. NEPA did not establish "sustainability" as a governing 

principle; rather, President Obama borrowed hortatory language from NEPA to define 

"sustainability," whose definition the NRC committee then used. See Obama (2009a), 

p. 52126. Sec. 19(1). 
172 

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"Quality Science at EPA: Perspectives on Common Sense Reform- Day II" 

Responses to Questions for the Record 

Page 18 

is required via government-wide and EPA information quality guidelines. 39 

Sometimes, objectivity (or one of its synonyms, "accuracy") is explicitly 

required by law. 40 

The hearing did not effectively distinguish between "science" and "risk 

assessment," however. EPA risk assessments are routinely described as 

scientific, even by Agency officials. 41 This is not correct. EPA risk 

assessments are notoriously lacking in objectivity, and as I testified before 

the Committee, this is a matter of design, not accident.42 

Objectivity in risk assessment would serve three crucial purpOses that 

current practices do not. First, it would ensure that EPA officials, Congress, 

and the public had unbiased information about the risks within EPA's 

jurisdiction. Second, it would enable these risks to be ranked so that 

resources devoted to risk reduction could be rationally allocated. Third, the 

authority to make risk management decisions that Congress has delegated to 

Agency officials would finally be made by those Agency officials, not by 

Agency scientists and career program managers with strong policy views. 

b. Please describe the different types of peer reviews that 

science funded by or used by EPA may be subjected to, 

including which areas raise the most concerns. 

As I have noted elsewhere in these replies and in my written 

testimony, peer review takes several different forms. Moreover, the purpose 

of scholarly peer review (to ration scarce journal pages) is fundamentally 

different than the purpose of governmental peer review (to ascertain what is 

correct). The procedures used for the former are ill-suited for the latter. For 

this reason, too much emphasis has been placed on scholarly peer review. 

EPA peer review is governed by OMS gUidelines and EPA's Peer Review 

Handbook, which have useful features but serious limitations and defects, as 

I have already discussed. To recap, these include too much Agency influence 

39 Office of Management and Budget (2002), U.S. Environmental Protection 

Agency (2002). 

40 s~~, e.g., Clean Air Act, Sec. 108(a)(2): "Air quality criteria for an air 

pollutant ~tl<!IL<!ITlJr_~~llL@n~c:! the latest scientific knowledge useful in indicating 

the kind and extent of all identifiable effects on public health or welfare which may 

be expected from the presence of such pollutant in the ambient air, in varying 

quantities" (emphasis added). 

41 See, e.g., Anastas (2011), oral testimony. 

42 Belzer (2012), p. 5. 
173 

Committee on Science, Space, and Technology 

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Responses to Questions for the Record 

Page 19 

over the selection of reviewers and absolute control over their charge. EPA's 

peer review process is designed to maximize concordance with EPA's policy 

objectives. Finally, peer reviews of EPA risk assessments are suffused with 

risk management policy judgments. 

In my testimony, I recommended that EPA peer reviews be strictly 

limited to science. I also suggested other reforms to the process, such as 

giving the most knowledgeable researchers on a scientific issue the 

responsibility of educating peer reviewers and coordinating open debate in 

which the public could actively participate. Unlike EPA practice, peer 

reviewers would never be drawn from the ranks of researchers who have 

published research or taken positions on the specific issue. 

OUESTIONS FROM REP. RANDY NEUGEBAUER 

1. What type of research does the EPA currently conduct to confirm 

predicted health outcomes of previously promulgated rules? In 

what ways can we improve existing efforts to examine the real 

effects of EPA rules, and what else can the Agency be doing to 

increase accountability for health and environmental predictions? 

I am not aware of any significant EPA effort to confirm predicted 

health outcomes for previously promulgated rules. The closest thing I can 

think of is EPA's reconstructions of the benefits and costs of the Clean Air 

Act, as it was required to do under Section 812.43 These reports do not 

confirm anything, except perhaps the foolishness of asking an agency to 

conduct its own performance evaluation. 44 

If Congress is serious about estimating how actual health outcomes 

compare with predictions, it must ensure that the review is conducted 

rigorously, independently, and transparently. Not only does this exclude EPA 

from performing the review, it also excludes the National Academy of 

43S_e~ most recently, U.S. Environmental Protection Agency (2011). 

44 For a review of EPA's first foray into self-examination in this area, ~s~~ 

Lutter and Belzer (2000). 
174 

Committee on Science, Space, and Technology 

"Quality Science at EPA: Perspectives on Common Sense Reform- Day II" 

Responses to Questions for the Record 

Page 20 

Sciences, which does not practice transparency in the selection of experts:5 

committee deliberation:6 or internal peer review.47 

2. Are there any legitimate concerns about making public the data 

sets that attempt to justify EPA regulations? Are there real 

concerns about confidentiality, and if so, do they outweigh the 

necessity of accountability, transparency, and open and sound 

scientific examination? 

There are only two areas in which confidentiality is a legitimate 

concern in human health risk assessment. The first involves confidential 

business information, such as perhaps studies performed on proprietary 

mixtures. I am unaware of any serious controversies in this area, but they 

may exist. 

The second involves personally identifiable information, which 

epidemiologists long ago learned how to anonymize. It is an exceedingly rare 

study in which the identity of subjects must be known by the researchers and 

statisticians analyzing the data. Usually, knowledge of subjects' identities, 

whether they belong to a case or control group, and similar matters are 

purposely hidden from researchers themselves to ensure objectivity. 

Researchers often desire not to disclose their data because they 

consider it their own intellectual property. The case for this is very weak 

when the data collection was publicly funded, but strong otherwise. In my 

testimony, I offered a straightforward solution: EPA should be required to 

fully disclose any data it intends to rely upon for risk assessment or any 

component thereof. Disclosure of federally-funded research, to which the 

government already has a right, would be mandatory if the study met this 

condition. Similarly, any third party that wants EPA to rely upon its data 

would have to meet the same disclosure standard. 

My approach would impose no involuntary burden on researchers, 

federal or otherwise. Researchers could decide whether to restrict access to 

their data or influence public policy, but they no longer would be allowed to 

45 The National Academies (2003), The National Academies (2005), p. 6. 

46 The National Academies (2005), p. 10. "Committee meetings, particularly 

as the committee gathers information, are usually open to interested individuals and 

the news media. However, meetings are closed when the committee is deliberating 

to develop its findings and during discussion of financial and personnel matters. 

Closed meetings are not open to the public or to any person who is not a 

committee member or an official, agent, or employee of the Academies." 

47 The National Academies (2008). 

k 
175 

Committee on Science, Space, and Technology 

"Quality Science at EPA: Perspectives on Common Sense Reform- Day II" 

Responses to Questions for the Record 

Page 21 

do both. Full disclosure must be the price for seeking to influence public 

policy, regardless of the source of funding. 

OUESTIONS FROM REP. PAUL TONKO 

1. Private Consulting. 

Prior to the February 3rd EPA E&E Subcommittee hearing, 

Ranking Member Mr. Miller asked you to provide a list of the clients 

for whom you conduct private consulting work that may have an 

interest in the subject matter of that hearing. You declined to 

identify any of your past or present clients because you claimed a 

"confidentiality agreement" exists between you and your clients and 

that providing this basic information would violate that agreement. It 

is my understanding that the majority of "confidentiality 

agreements" revolve around the specific issues that a 'client' hires a 

'contractor' to perform, particularly the results of that work. It is less 

common that a "confidentiality agreement" would bar from public 

disclosure the mere fact that a business relationship exists between 

a client and a contractor. 

Please list all clients you have signed a confidentiality 

agreement with broadly related to the subject of environmental 

science and/or regulatory issues over the past five years. 

The public disclosure of the existence of a confidential relationship 

would be tantamount to breaching its contents. As I said in my reply to 

Ranking Member Miller, I intend to honor these agreements and thus 

respectfully decline to identify past and present clients. 

It is clear from information already in the public domain that 

you worked for the U.S. Department of Defense, through a consulting 

agreement with Booz Allen Hamilton; advising DOD on issues 

revolving around the chemical Perchlorate in 2003 and 2004. 

Please indicate if you still have a business relationship with Booz Allen 

Hamilton and/or DOD? If not, please indicate when that relationship 

ended? 

I do not have a current business relationship with Booz Allen Hamilton 

and/or DoD. I believe that my previous relationship ended in April 2005. 

ci-f€cKsaok 
176 

Committee on Science, Space, and Technology 

"Quality Science at EPA: Perspectives on Common Sense Reform- Day II" 

Responses to Questions for the Record 

Page 22 

2. Public Disclosure. 

At the Feb. 3rd hearing you said: "When I do things that are 

public, when I put my name on something, a piece of work that I've 

produced then I disclose who I did it for. " It was unclear from your 

response, however, what work products you consider to be "public". 

Please provide a list of work products you have produced over 

the past five years where you publicly disclosed who you did 

this work for, as you indicated you had done in your 

congressional testimony. Please include the title or name of the 

work product, the client's name you performed the work for, 

and where and when this work was presented or appeared. 

I have uploaded to my personal website at YL\AI'II'.r:t>l:J_eJ2:~.j:QIrr every 

publication, presentation, public comment, or similar work product that I 

have been able to locate-peer-reviewed or otherwise. For work products 

that are covered by a copyright owned by someone else, I provide links to 

web sites where copies can be purchased. I also have disclosed documents I 

authored on behalf of the Federal government. 

Some of this work pre-dates the Internet era, however, so my website 

is regrettably incomplete. 

REFERENCES 

Allison G. 1971. Essence of Decision: Little Brown. 

Anastas P. 2011. Written Testimony Before the U.S. House of 

Representatives Committee on Science Space and Technology, 

Subcommittee on Oversight, Hearing on 'EPA's Integrated Risk 

Information System'. [July 14]; 

http://science.housf3.govjsites/republicans.science.house.govjfiles[doc 

umentsjI1earingsj071411_Anastas. pdf. 

Belzer RB. 2002. Interests and Incentives in Government Peer Review. 

"Conflict, Consensus, and Credibility: A Forum on Regulatory Peer 

Review". Alexandria, Va.: Society for Risk Analysis [May 29,2002]; 

httP:!L\AI\AI"',Cl:JI:J~J2:~L'I::QmjpI",sf3ntaJ:iQns,htmJ _2QQ~. 

Belzer RB. 2012. Testimony Before the Subcommittee on Energy and the 

Environment, Committee on Science, Space, and Technology, U.S. 

House of Representatives, Hearing on "Fostering Quality Science at 

EPA: Perspectives on Common Sense Reforms--Day II". [February 

3]. 
177 

Committee on Science, Space, and Technology 

"Quality Science at EPA: Perspectives on Common Sense Reform- Day II" 

Responses to Questions for the Record 

Page 23 

Bipartisan Policy Center. 2009. Improving the Use of Science in Regulatory 

Policy. Washington, D.C.: Bipartisan Policy Center [August 5]; 

httjl:jj~ww . billa rt;igllJJ2Qli~Y~I"9L@s:~l~t<1a u It/fi le!';LEl£<;_~l~nce_~~QQrt: 

fIlLjJJ11'. 

Holdren JP. 2010. Memorandum for the Heads of Executive Departments and 

Agencies: Scientific Integrity. Office of Science and Technoloy Policy; 

http://www . white house .gov /sites/ defa u It/files/m icrosites/ostp!scientifi 

Q:int~gri1'L::m~rng=1:2JZ:2Q1Q.QdJ. 

Lutter R, Belzer RB. 2000. EPA Pats Itself on the Back. Regulation 23(3): 23-

28. 

National Research Council. 2011. Sustainability and the U.S. EPA. 

Washington, D.c.: National Academies Press. 

Obama B. 2009a. Executive Order 13514: Federal Leadership in 

Environmental, Energy, and Economic Performanc. Federal Register 

74 ( 194): 5211 7 - 5 212 7 (hj:tll:1L~d ockej:,i'lC:C:EO.5ii~9I)Q.gQylIQQ21j:lClfl E:~: 

24518.pdf). 

Obama B. 2009b. Scientific Integrity. Federal Register 74(46): 10671-10672. 

Office of Management and Budget. 2002. Guidelines for Ensuring and 

Maximizing the Quality, Objectivity, Utility, and Integrity of 

Information Disseminated by Federal Agencies; Notice; Republication. 

Federal Register 67(36): 8452-8460 

(htt:J2:1!www.whitehouse,govl omb/fed reg/reproducible2~1. 

Office of Management and Budget. 2005. Final Information Quality Bulletin 

for Peer Review. Federal Register 70(10): 2664-2667 

(b.~VlI/V.whitehojJse.gov/ombjfedreg/2005/0114~.~L.I!9fl. 

Office of Management and Budget. 2007. Final Bulletin for Good Guidance 

Practices. Federal Register 72(16): 3432-3440 

(bJl[l;ilwww.VI.hitehguse ... qov!orIl.blasse.ts!requlatQIY..JIlatters,J2QJLm07 

~13.pdf). 

The National Academies. 2003. Policy on Committee Composition and 

Balance and Conflict of Interest. The National Academies [May 12]. 

The National Academies. 2005. Getting to Know the Committee Process. 

Washington, D.c.: The National Academies; 

http://www . nationalacademies. orq/n re/Com mitteeProcess. pdf. 

The National Academies. 2008. Guidelines for the Review of National 

Academies Reports. Washington, DC: National Research Council, 

Report Review Committee. 

c k 
178 

Committee on Science, Space, and Technology 

"Quality Science at EPA: Perspectives on Common Sense Reform- Day II" 

Responses to Questions for the Record 

Page 24 

U.S. Environmental Protection Agency. 2002. Guidelines for Ensuring and 

Maximizing the Quality, Objectivity, Utility, and Integrity of 

Information Disseminated by the Environmental Protection Agency 

(EPA/260R-02-008). 

hll:j:l~iLv\lww . ~QCl.gQYLg I,LCllitl'1LQfllJ:Dli'lJ;iQlNlJ1Q~1i nesld_QQ,JlILefl~ A ll}f 

oQual ityGuidelines. pdf. 

U.S. Environmental Protection Agency. 2006. Peer Review Handbook (3rd 

Ed.). Washington, D.C.: U.s. Environmental Protection Agency Science 

Policy Council; http://www.epa.gov/peerreview/pdfs/Peer Review 

Ha~cll::Jookf'151yQ~. 

U.S. Environmental Protection Agency. 2009. Regulatory Agenda #142. 

Reconsideration of the 2008 Ozone National Ambient Air Quality 

Standards. Federal Register 74(233): 64327 

(httl:J~LlI'\Il'{\\[.gQ9---9Q,",!f<:LsY?LpJ(gLER- 2 Q03=12~QliQQf.LX09=L8_12QLQdll· 

U.S. Environmental Protection Agency. 2010a. National Ambient Air Quality 

Standards for Ozone; Proposed Rule. Federal Register 75(11): 2938-

3052. 

U.S. Environmental Protection Agency. 2010b. Scientific Integrity Policy' . '. 

Available: 

http://www .epa .gov /osa/ pdfs/ epa_scientific_integrity _policy_20 120 11 

~.pdf [accessed March 3, 2012]. 

U.S. Environmental Protection Agency. 2011. The Benefits and Costs of the 

Clean Air Act from 1990 to 2020; Final Report - Rev. A. Washington, 

D.C.: U.S. Environmental Protection Agency. 

U.s, Environmental Protection Agency. n.d, Sustainability; Basic Information; 

What is is Sustainability? Available: 

U.S. EPA Science Advisory Board. 2011. Office of Research and Development 

(ORO) New Strategic Research Directions: A Joint Report of the 

Science Advisory Board (SAB) and ORO Board of Scientific Councilors 

(BOSC). Available: 

http://yosem ite. epa .gov /sab/sabproduct. nsf/804D 1A3A4A393C028525 

793000732744/$File/EPA-SAB-12-00 1-unsigned. pdf [accessed March 

3, 2012]. 

ci-itcksock 
179 

Responses by Dr. Jerald Schnoor, 

Allen S. Henry Chair in Engineering, 

Department of Civil and Environmental Engineering, 

University of Iowa 
180 

2. In discussing problems with the EPA Science Advisory Board process, Mr. Walls noted 

that "qualified scientists from industry should be given equal consideration" to serve on 

advisory panels. Do you support that recommendation? 

3. Many EPA science activities are housed within regulatory offices. For example, nearly 

half of EPA's laboratories do not reside in the Office of Research and Development. In 

your view, should scientific activities be organizationally insulated trom regulatory 

activities to ensure objectivity and balance? 

4. In an August 2010 editorial in the joul11al Environmental Science and Tcehnology titled 

"Regulate, Baby, Regulate", you asserted that hydraulic fracturing associated with shale 

gas development was "causing tap water to bum." Please provide evidence to support this 

assertion and describe how they relate to the standards employed by the publication in 

ensuring accuracy and appropriate communication of scienti lic uncertainties in joul11al 

editorials. 
181 
182 

U.S. HOUSE OF REPRESENTATIVES 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

Subcommittee on Energy & Environment 

Hearing Questions for the Record 

The Honorable Randy Neugebauer 

Fostering Q1Iaiity Science at EPA: The Needfi!r Common Sense Refi!rm D,(v II 

February 3, 2012 

Dr. Jerald Schnoor 

1. What type of research does the EPA currently conduct to confirm predicted health 

outcomes of previously promulgated rules? In what ways can we improve existing efforts 

to examine the rcal effects of EPA rules, and what else can the Agency be doing to increase 

accountability for health and environmental predictions? 
183 

2. Are there any legitimate concerns about making public the data sets that attempt to justify 

EPA regulations? Are there real concerns about confidentiality, and if so, do they 

outweigh the necessity of accountability, transparency, and open and sound scientific 

examination? 
184 

U.S. HOUSE OF REPRESENTATIVES 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

Subcommittee on Energy & Environment 

Hearing Questions for the Record 

The Honorable Brad Miller 

Fostering Quali(v Science at EPA: The Needfor Common Sense Reform Day II 

February 3, 2012 

Dr. Jerald Schnoor 

EPA ORD Realignment 

I. In the realignment of the Office of Research and Development programs you both 

described in your testimony, has the reduction and integration of the number of programs 

dOWll from 13 to 6, proven to be a more etlicient and etTeetive strategy for EPA-ORO 

research activities? How has this alignment improved ORO's coordination with the 

program and regional otlices? What more can and needs to be done to strengthen the EPA 

overall research enterprise? 
185 

US. HOUSE OFREPRESE~"TATIVES 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

Subcommittee on Energy & Environment 

Hearing Questions for the Record 

The Honorable Andy Harris 

Fostering Quality Science atEPA: The Needfor Cornman Sense Reform Day n 

February 3, 2012 

Dr. S. Stanley Young 

1. The Bipartisan Policy Center's 2009 report, "Improving the Use of Science in Regulatory 

Policy" was mentioned during the hearing. This report made several suggestions that may be 

useful in guiding this Subcommittee's efforts to reform regulatory science,. including: 

• "Studies used in the fomiulation of regulation shoUld be subject to data access 

requirements equivalent to those under the Data Access Act. " 

.• "The process of conducting literature reviews" and ''the process of naming advisory 

committees" should be made more transparent. 

• "Agencies should avoid turning repeatedly to the same scientists for service on advisory 

committees." 

• Executive branch agencies need to "help clarify for both officials and the general public 

which aspects of disputes are truly about scientific results and which concern policy." 

• "Policy makers should be w:ary of conclusions of risk thatare expressed as a single 

number." ' 

~ "Federal agencies need to experiment with ways to increase the number of scientists 

. who participate in peer review." 

• "In presenting the conclusions of Iitera:tuIe reviews, agencies and their scientific 

advisory committees need to be as open and precise as possible in discussing levels of 

risk and uncertainty." 

Do you agree with any or ail of these recommendations? Do you have any additional 

comments or advice in pmsuing these goals? . 

2. In discussmg problems with the EPA Science Advisory Board process, l'VIr. Wails noted that 

"qualified scientists from industry should be given equal consideration" to serve on advisory 

. panels. Do you support that recommendation? 

3. Dr. Schnoor's testimony cites work done on the link between fine particulate matter (PM) 

and premature mortality by Dr. Francine Laden, including the claim that PM-related 

regulations had saved more than 75,000 lives, as "an example of quality science performing 

welL". Have you examined this literature based on epidemiological studies, and, liso, do you 

find it rigorous enough to justify major, costly EPA regulations? . 
186 

4. SumepeopIe-have 'expressed concerns about the practical effects of making'underlying data· .. ~ 

sets publically available, citing significant costs and concerns about contidcntiality. Are these 

concerns valid? Why or why not? To the extcnt you believe such concerns are valid, how 

might they be addressed to minimize potential negative impacts of making data publicly 

available? 
187 

u.s. HOUSE OF REPRESENTATIVES 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

Subcommittee on Energy & Enviroument 

Hearing Questions for the Record 

The Honorable Randy N eilgebauer 

Fostering Quality Science at EPA: The Need for Common Sense Reform Day II 

February 3, 2012 

Dr. S, Stanley Young 

1. What type of research does the EPA currently conduct to confirm predicted health . 

outcomes of previously promulgated rules? In what ways can we improve existing 

efforts to examine the real effects of EPA rules, and what else can the Agency be doing to 

increase accountability for health and environmental predictions? 

2. Are there any legitimate concerns about making public the data sets that attempt to justify 

EPA regulations? Are there real concerns about confidentiality, and if so, do they 

outweigh the necessity of accountability, transparency; and open and sound.scientific 

examination? 
188 

Responses by Dr. S. Stanley Young, 

Assistant Director for Bioinformatics, 

National Institute of Statistical Sciences 
189 

being used to help justifY policy decisions, data used in these papers should be secured, 

electronic (easily readable and ready for analysis) copies of this data should be posted on 

the agcncy web sitc. 

Tfthe agency is funding work, then it should seriously consider funding data collection, 

staging and posting separately from data analysis. The group collecting the data should in 

no sense "own" the data. The data should be a public good. 

Tfthe data is public, then the whole scientific process can be used for peer review. 

Qucstion 2. " ... qualificd scicntists from industry ... " 

Scientists do not live in a tinancial vacuum. University scientists compete for grants and 

industrial scientists work to advance their company. Hopefully data and methods will 

lead both to sound conclusions. Tf government funded scientists are allowed to 

participate, so should industrial scientists. 

Questions 3. " ... link between ... PM and premature mortality ... " 

I have examined this literature to some degree. For acute deaths, if a person is going to 

die within two weeks and they die sooner by a few days rather than later in a few weeks 

has a life been saved? Most of the literature I have read is not capable of addressing this 

issue. For long-term deaths, environmental epidemiology is not capable of reliably 

detecting effects as small as those observed. The risk ratios at issue, less than 1.5 and 

often as small as 1.05, could easily be the result of some bias in the data. 

Two recent papers, Laden et a1. (2007) and Birdsey et a1. (2011), of diesel give 

conflicting claims. Neither paper observes an increase in all-cause mortality due to diesel 

exposure; both appeal to the "healthy worker effect". Laden et al. (2007) claim an 

incrcase in lung cancer, but thc confidence limits overlap 1.00 so most would not 

consider their evidence compelling. There is also a claim an increased heart disease with 

a RR of 1.41. Birdscy et al. (2011) find ncithcr an incrcasc in lung cancer nor any cffcct 

on heart disease. 

Birdsey et al. comment: "Previous research suggests that truck drivers are at increased 

risk for lung cancer ... , prostate cancer ... heart disease, hypcrtcnsion ... ,stomach ulccrs 

... , bladder cancer, and stomach cancer." 

but find with their data set that 

"Mortality was not increased for any of the health conditions previously shown to be 

elevated among truck drivers ... , although the lack of statistically significant estimates 

for cancers of the stomach, bladder, and prostate indicates that excess mortality from 

these causes cannot be totally eliminated (Table 3)." Note that Laden et a1. do not 

confirm previous claims. Bias, multiple testing and multiple modeling are likely all at 

play, and as Koop et ai, cited later, indicate, findings from observational environmental 

studies can be unreliable. 
190 

Some, e.g. Laden, make a claim for a very small effect and then multiply their small risk 

times the US population to make a elaim for a large number of statistical deaths. Claims 

coming from epidemiology studies arc notoriously unreliable, Young and Karr (200 I). In 

the case of the Laden claims against diesel are not supported by Birdsay. Neither Laden 

nor Birdsay lind any elTecl 011 mortality for truck drivers. 

A recent paper where Laden is a co-authors states, "Conclusions: Among this cohort of 

men with high socioeconomic status living in the midwestern and northeastern United 

States, the results did not support an association of chronic PM exposures with all-cause 

mortality and cardiovascular outcomes in models with time-varying covariates." So 

Laden appears to be on both sides orthe air pollution and mortality question. 

A recent press release from the EPA made a claim of 160,000 lives saved in 2010. Again, 

very small and quite variable risk estimates arc mUltiplied by the size of the US 

population. The risk estimates are all well within the range of study bias. The press 

release also makes a claim for preventing more than 170,000 asthma attacks. The Koop ct 

a1.(20 1 0) and theretore calls those claims into question as they saw no increase in 

hospital admissions lix asthma related to air pollution. 

Birdsey J, Alterman T, Li J, Petersen MR, Sestito J. Mortality among members of a truck 

driver trade association. AAOHN Journal 20 1 O. 58, 473-480. 

EPA Press Release 

http://yosem ite.epa.gov/opaiadmpress.nsfn ebdf4dOb217978b8525 73 5 9004044 3a/fSad34 

85 e788be5a8525784600540649! OpenDocument 

Koop G, Ross McKitrick R, Tolc L. Air pollution, economic activity and respiratory 

illness: Evidence from Canadian cities, 1974-1994. Environmental Modelling & 

Sojiware 2010 25, 873·885. 

Laden F, Hart IE, Smith TJ, Davis ME, Garshick E. (2007). Cause-specific mortality in 

the unionized US trucking industry. Environmental Health Perspectives. 2007. 115, 

1192-1196. 

Puett RC, Hart IE, Suh H, Mittleman M, Laden F. (20 II) Particulate matter exposures, 

mortality, and cardiovascular disease in the Health Professionals Follow-up Study. 

Environ Health Perspect 119: 1130-1135. 

Young SS, Karr A. Deming, data and observational studies, a process out of control and 

needing fixing. Significance. September2011, 116-120. 

Question 4. Cost of making data available 

Data is collected, then staged into an "analytical data set" suitable for statistical analysis. 

The collection and staging of data is expensive, but it has to be done for any published 

paper. The cost of making this analytical data set electronically available is typically 
191 

quite low. With planning, meta data describing the analytical data set is also inexpensive 

to produce. One to a few sentences can be given to instruct another analyst what the 

variablcs mean. There is a NSF fimded data repository, sec datadryad.org, where the 

analytical tile and the meta data can be deposited, which removes the burden or 

responding to individual data requests. Tn short, once data is staged to be used in a 

publication, the incremental cost of making data available is low. 

General Comments: 

Question from Chairman Harris, "What is the EPA doing in their R&D budget to look at 

whether or not these health benefits that arc claimed actually come to pass in the 

magnitude that they are claimed?" 

Answer: One of the supposed strengths of science is that over time replication of results 

gives results credence. There is a premium in science tor being tirst with a claim and also 

journals favor new results, not replication of results. The agency could and should fund 

studies attempting to replicate important claims. In the area of medical observational 

studies, claims most often fail to rcplieate. See Young and Karr (20 II). loannidis, JAMA, 

(2005) notes that 5/6 claims coming from medical observational studies failed to replicate 

or the claimed size of the eflect was greatly reduced. The agency should identify 

important claims and fund independent studies to determine if the claims replicate. For 

example, do claimed mortality affects ofPM2.5 in the East replicate in the West? Do 

claimed effects during the time 1990-1999 replicate during the time 2000-2009? Note 

that making data available at the time of publication of a paper would greatly speed up 

the scientific evaluation of the claims made in the paper. 

Mr. Greenbaum notes that scientists within the agency are both "creating some science 

but they are then involved in the interpretation of that science." A clear separation of data 

collection and staging from data analysis and interpretation would help the scientific 

process. For example in a FDA supervised clinical trial, the statistical analysis is prespccified. Data is collected and staged. Finally the eleancd data is givcn to statisticians 

for analysis. The data is also givcn to the FDA. No one group is responsible for all steps 

in the process. joannidis, JAMA, 2005, notes that claims coming from randomized 

clinical trials replicate over 80% of the time. Administrative procedures can be put in 

place to support normal science. Make data sets publicly available on the publication of a 

paper. To verifY important claims, independent studies should be funded. Separate data 

collection and staging from analysis and interpretation. Etc. 

Correction: Line 1012. Change "data." to "paper." 

Line 1037 and again Line 1373. Mr. Schnoor makes the statement, "As a journal editor, 

our policy is, and most journals, that irthe data is asked lor, we do give it." It is a fact 

that most journals do not require that authors make their data available as a condition of 

publication. Science, Nature, PNAS are exceptions. Even when authors sign agreements 

to make data available, most often they do not. About 2/3s ofthe time, data asked for is 

not provided. Onc solution would be to rcquire the data files used in analysis be deposited 

with the joumal or a data repository, datadryad.org. 
192 

Line 1204ff. "Is the science conducted, in your opinion, by the EPA generally of poor 

quality'?" 

Answer: We really do not know the quality of their work for several reasons: 

I. Striclly intemal work is not subject to independent peer review. 

2. Papers they publish are subjected to peer review, but peer review most typically 

does not examine the data set and reanalyze it. Peer review only says that paper 

meets the general standards of the area. Note well: for observational studies 

claims most often do not replicate, Young and Karr, 20 II. 

3. Much ofthc critical work of the EPA is via contract. EPA scientists do not 

necessarily get the data sets (as the FDA would) and they do not do an 

independent re-analysis of the data. 

We are largely observing "trust me" science. At best we have no idea of the quality of 

their work. At worst, claims coming from environmental epidemiology studies are no 

better than claims coming from medical observational studies. With medical 

observational studies claims fail to replicate 80 to 90% of the time, Ioannidis, lAMA, 

2005 and Young and KalT (20 II). 

Line 1442 Mr. Greenbaum, " ... we cannot have detailed re-analysis of every single 

paper. .. " 

Answer: If the data is publicly available, then anyone with an interest can have a reanalysis computed. Support the normal working of science by making data public. For 

key claims, the agcney should fund an independent re-analysis or indeed a new study. 

Remember, we are not working in an area where claims are generally reliable. 
(193) 

Appendix II 

ADDITIONAL MATERIAL FOR THE RECORD
194 

REPRINT FROM American Journal of Entomology: 

‘‘REPRODUCIBLE EPIDEMIOLOGIC RESEARCH’’ 
195 

784 Peng et al. 

The signal-to-noise ratio in today's epidemiologic studies 

tends to be smaller than it was in decades past simply 

because much of the "low-hanging fruit" has been picked. 

Paclors with large rc:lativc risks. such as ~moking, ~ocioeconomlc statu.;;, family history, and obesity. are well 

established for major diseases. The targets of current investigations tend to have smaller relative lisks that are more 

easily confounded. For example, in air pollution epidemiology, the national relative risk of increased mortality is estimated to he 1.005 per 10 parts per billion of 24-hour ol.onc. 

Remarkahly, an integrated analysis of 1ll0lial1ty in 95 metropolitan areas can detect this signal, which translates into 

thousands of excess deaths per year given the universality 

of ozone exposure (3). Nevertheless. the potential for unexplained confounding cannot be denied for slleh a small 

relative risk (4, 5), 

The explosion of new biologic measurements presents exciting opportunities for epidemiologic studies. We can now 

quantify DNA sequences, single nucleolide polymorphi:-.ms, 

and gene and protein expression. \Ve can image the structure 

and function of the brain and other organs. We can quantify 

diet with lengthy dietary-recall questiounaires and can quantify disease symptoms and health conditions with multiitem 

instruments. However. because the data are inherently complex and high dimensional, there is an increased potential for 

identifying spurious associations hetwccn their components 

and risk factors or health outcomes (6). 

The widespread availability of statistical and computing 

technology is yet another factor contributing to the potential 

for false positive epidemiologic iiudings. It is now easy for 

a researcher to routinely engage in sophisticated optimizations across a large number of models and/or variables to 

identify associations that are of potential scientific interest. 

Even with a single risk factor and a single response. it is 

standard practice to consider a potentially large numher of 

models in an effort to adjust for differences among the exposed and the unexposed. As the numher of covariables 

measured increases, so do the degrees of freedom for infiu-

~ncing the association bet \~'Gcn the risk factor and outcome 

and for identifying subgroups in \vhich the association is 

particularly strong. 

The development.., identified above also have the potentia1 

to increase fhe power and precision of epidemiologic research by enhancing our understanding of disease mechani:-.ms and leading to studies with more targeted hypotheses. 

Modern computing makes possible the organization and 

analysis of large databases. so that we can look farther 

and wider for systematic patterns indicating the health effects of various risk factors. The reproducibility of epidemiologic f1ndiugs from currcut and fulure studies wi]] be 

crucial to providing the substance for informed debate regarding policies affecting the public's health. 

DEFINING REPRODUCIBLE RESEARCH 

Reproducihility is a minimum step that can he taken in 

any study. Tn the context of epidemiology. a study is reproducihle when it satisfies the criteria in table 1, adapted from 

the paper by Schwab et aL (7) and others, We illustrate 

reproducibility requirements separately for each of the folTABLE 1. Criteria for reproducible epidemiologic research 

Research 

component 

Data 

Methods 

Documentation 

Distribution 

Requirement 

Analytical data set is available 

Computer cod~ underlying figures, tables., 

and other pnncipal results IS made available 

in a human-readable form. In addition. the 

software environment necessary to execute 

that code is available 

Adequate documentation of the computer 

code, software environment, and analytical 

data set is available to enable others to 

repeat the analyses and to conduct other 

similar ones. 

Standard methods of distribution are used for 

others to access the software. data, and 

documentation. 

lowing research components: data. methods. documentation. and distribution. 

Epidemiologic data ""ets can he difficult to define because 

of the complexity of the data collection and the preprocess~ 

ing. Tn addition, a puhlished finding may usc only a subset 

of the data collected for a particular study, the other parts being irrelevant to the reproducibility of the finding, We therefore separate the data into "analytical" data, \vhich serve as 

the input to a statistical analysl!-. program to produce the 

re<.;ults found in the table/figure supporting the paper'<.; conclusions, and "measured" data, which consist of all data and 

functions thereof that are used to create the analytical data, 

whether or not they arc part or thc analytical data. This 

classification is crude and far from ideal, but it strikes a compromise hetween those data that are neces..,ary for reproduction and those that may be of secondary interest. \Ve propose 

as a first requirement that the analytical data set be made 

availahle to others for reproducing results. 

\Vith the increased usc of advanced statistical methodology and larger data sets, analyses today are almost ahvays 

implemented on a computer. Given that. the simplest way to 

reproduce the statistical methods is to examine the computer 

code or instructions for the analysis. \VhiJe some analyses 

may be comidered too rudimeutary to \varrant puhlishing 

computer code, most statistical software routines, for example, contain m,my options th<lt need to be set hy the user. 

Since it is not ahvays clear from the outset which options 

can have an impact on the numerical results. this information can he critical for reproducing ~eicntitic !indings, particularly when investigating small relative lisks (8, 9). 

REPRODUCIBtLiTY OF CURRENT EPtDEMIOLOGIC 

RESEARCH 

To measure the reproducibility of reccnt epidemiologic 

re~carch, we reviewed 90 epidemiology m1icles from the 

American Journal of Epidemiolog:-' aud the JournaL of 

the American Afedical Associ{lf;on. \Ve selected every aJti~ 

c1e published in 2005 in the time period between January 

and the time at which we conducted the reviev.' Cr...1ay). We 

developed a questionnaire to collect informatiou relevaut to 

Am J Epidemiol 2006;163;783-789 
196 

TABLE 2. Results from examining the epidemiologic 

Uterature: articles from the American Journal of Epidemiology 

and the Journal of the American Medical Association published 

between January 2005 and May 2005 

Observational studies 

Cross-sectional 

Case-control 

Cohort 

Source of outcome data 

Original study 

Ongoing study 

Government 

Other 

Statistical analysis implementation 

Not reported 

By hand 

Use of software package 

Method of processing measured data 

Not reported 

By hand 

Use of software package 

Outcome data reported to be available 

Exposure data reported to be available 

Code for statistical analysis available 

Code for processing measured data available 

69 

20 

20 

29 

31 

29 

21 

48 

43 

13 

reproducibility lhat is availahle at http://www.biostaLjhsph. 

eduJ-rpeng/reproducible/survey/. Some of the articles se~ 

leeted during this time period were excluded on the basis 

of the criteria developed in the questionnaire. 

We focnscd our tCViC\\i of an article on the abstract's 

concluding statement summarizing the main scientific finding..;" Each statement contained information about an outcome and an exposure variahle or lisk factor, as \-vel] as 

potential confounders and/or effect modifiers. For a given 

article, we first determined the type of study: randomized 

tria1. methodology, literature review or meta-analysis, or 

Oliginal ohservational study. The survey addressed only 

the last category. a"i it forms the hulk of epidemiologic research. Articles describing other types of studies were excluded. Given an observational s,tudy. we determined the 

study design, the primary outcome and exposure variables, 

and the tables or figures providing the evidence supporting 

the concluding statement. Vle also recorded details of how 

the statistical analysis was implemented and \vhether or not 

data were reported to be available. The data availability was 

dctcnnincd ~eparatcly for the primary {)utt;ome. the exposure, any potential confounders, and any cifect modifiers, 

since it is commonly the case that the diflerent variahles 

have different sources. 

The results of our sun'ey are summarized in table 2. In 

total, we examined 90 arti~les, 69 of which were observaAm J Epidemiof 2006;163:783-789 

Reproducible Epidemiologic Research 785 

tional studies and had either a cross-sectional. case-control, 

or cohort design: We focus only on these 69 articles. For 84 

percent of the articles. the data for the outcome and exposure came from O1iginal studies or from large ongoing studies. ~one of the articles reported that the outcome data were 

available to others, either from the authors or from a third 

party. In only one study \,-"'ere the exposure data available. 

Hmvever. in this study, "time"' was the relevant exposure 

variable. with the study examining trends in cardiovascular 

risk ractors through a series or ~urveys. It should be noted 

that we did not attempt to eontact the authors and to request 

the analytical data and computer code used for their published analyses. Had the authors been contacted, it is not 

known how many would have been willing or able to pro~ 

vide the data and code. 

Thirty percent of the artic1eo;; did not report how the statistical analyses were implemented, while the remaining 70 

percent reported using a specific software package. Neither 

the software for the statistical analvsis nor the software for 

processing the mea,'mred data intoV 

analytical data \vas reported to he availahle. Of the articles where measured data 

required processing, 93 percent did not report how this processing was implemented. 

METHODS FOR REPRODUCIBLE RESEARCH 

Articlcs printed in journals m"c still the primary means by 

wtrictJ scienti fie n:sulls are preM.:llleu. However, n:prouucible research as defined in the previous section requires that 

arrangements be made for the distribution of analytical data 

and methods. While journals typically govern the distribution of the scientific findings, the task of distributing data 

and methods is reJeg<:lted to the authors. 

Today, the World Wide \Veb is the most convenient medium for distributing information to other researchers and is 

already playing a central role in the implementation of rcproducihle rescarch. Many journals now have wehsites that 

can host supplemenL1ry materials for published articles, 

"!ueh as data that can be downloaded along with computer 

code for reproducing specific analyses. In addition, more 

detailed explanations of methods and complementary figure~ can be provided to the reader v/ho intends to reproduce 

the published findiugs and to conduct competing analyses of 

the same data set. 

LITERATE PROGRAMMING 

The practice of pos,ting data and code on either personal 

or journal \vcbsitcs is a significant first step. While making 

data and code availahle is certainly necessary, it is typically 

insufficient for others to reproduce results. An author must 

additionally provide details about hO\v the code is linked to 

the data and which code sections arc applied to which data. 

A compendium is an artide linked together with the data 

and code necessary for producing all of the rc~ults in the 

article (10, I I). The tools for constructing a compendium are 

modeled on the idea of literate progmnuning, a phrase coined 

by Donald Knuth (12) and a concept extended by many 

others (13). A literate prognun combines a documentation 
197 

786 Peng et al. 

language with a programming language to produce an overall program that is self-documenting and more "literate," 

Knuth's original \VEll system for writing literate programs 

combined the T EX documentation langLlagc with the Pascal 

programming language. In a literate program, one \-,:eaves 

the text and code to produce a human-readable document 

and t(1n~les the code to produce a machine-executable file. 

The advantage of the literate programming approach is that 

the code and text can provide a running commentary on each 

other. 

The specific details of how a compendium is created 

depend on the computing environment and programming 

languages used by the author. Gentleman and Temple Lang 

(10) propose using the R software environment (15) coupled 

with the LATEX document-formatting language. The general idea of a compendium is not tied to any one ~oftware 

package but, rather, the ideas of literate programming are 

easily applied to the documentation and programming language with which the researcher is familiar. 

OPEN RESEARCH DATA LICENSES 

It is understandable that authors do not make their research data available. if only because once data are released, 

there is little control over ho\v the data will be u~ed (16). 

A regime whereby partial rlght~ to research data coulll he 

granted would allow some flexibility for anthon.; to make 

data available \\'ithout giving up complete controL For reproducible research to become the standard in epidemiology, limited access to data is a necessity. 

We propose dilTerent classes of data licenses that provide partial rights to research data under prespecified 

conditions. In developing these classes, we bOlTo,",,' from 

standards created by the Creative Commons project (http:// 

crcativecommons.org), an organization devoted to creating 

licenses that proviue p31iial lights to literary works. These 

ideas have also been discus.;;ed in the soft\vare conuTIunity, 

where "open source" licenses are commonly used to provide 

partial rights to software products (e.g .. the Open Source 

Initiative at http://opensource.org/). 

The following list deHnes four possible classes of data 

licenses 111 order of increasing restrictivenes". We choose 

not to use precise legal definition.;; but rather outline the 

basic ideas. 

I. Full arcess. The data can he used for any purpose. 

2. A.ttribuaon. The data can be ur.:,ed for any pUfJXIse so 

long as the authors are cited (a specific citation should 

be provided). 

3. Share alike. The data can be lIsed to producc new finu~ 

ings or results.. Any modification'S to the data. includ~ 

ing transformations, additions. or linkages to other data, 

which are used to produce the new findings. must be 

made available under the same terms. 

4. Reproduction. Thc data can be u,eJ fur the purpose of 

reproducing the re .... ulls in the associated published 

articlc or for commenting on those results via a lettcr 

to the editor. No original findings based on the data may 

be published without explicit permission from the original investigators in a separate agreement. 

Licenses providing partial rights to data can benefit both 

the donor and the recipient. The recipient obtains access to 

the data and an explicit understanding of the rights granted 

to him or her. The donor meets data disclosure ohligations 

(from either granting agencies or journals) and j" provided 

~ome measure of control over others' use of the data in au 

undesirable manner. In addition, the donor is relieved of 

having to negotiate potentially numerous requests for the 

data set. \\lith the benefits also come the costs of such a li~ 

eensing regime. The recipiem mlLst accept limitations to the 

data set by the donor, while tbe donor must initially invest 

time to alTange for data sharing and risks agreement violations by those using the data. 

REPRODUCIBLE RESEARCH IN AIR POLLUTION AND 

HEALTH: A CASE STUDY 

We demonstrate one implcmentation of reprouucible re~ 

search with a large observational study of the health effects 

of air pollution. the National Morbidity. Mortality, and Air 

Pollution Study (NMMAPS). NMMAPS is a national timeseries study on the shon-term health effects of air pollution, 

the goals of which are to 1) integrate mUltiple government 

database~ that contain information on population health, 

ambient air pollution levels, weather variables, anu socioeconomic variables for air pollution epidemiology; 2) deve10p 

statistical methods and computational tools for analyzing and interpreting the resulting database: and 3) estimate 

the short-term effects of air pollution on mortality and its 

uncertainty for the large<.;t es metropolitan areas anu for 

several geographic regions (17. 18). 

Because of the regulatory context, quantification of air 

pollution risks is. controversial. The aSSeS\111ents of risks 

arc pali of a high 11' charged policy debate and. consequently, 

statistical methods and data sources are snbject to intense 

scrutiuy by other scientists aud interested pmties. A receut 

review of the epidemiologic evidence on the health effects 

of line particles lberibcJ this debate (19), which willlikdy 

be rcvisited nm\' that the Environmental Protcction Agcncy 

(20) has promulgated its latest daily and annual standards 

for particulate matter. In the la~t few year').. NfvfrvtAPS and 

several other large epidemiologic studies (21-23) have been 

a part of this policy debate (5). 

A ..... a fLr~t stcp lowaru devcloping higher standarus of 

reprodueihility, we created the Inte1l1ct Health and Air Pollution Surveillance System for disseminating the entire 

NMMAPS database and the sofnvare for implementing all 

of our statistical analyses (http://www.ihapss.jh!-!.ph.eduf). 

Other scientists call fully reprouuce om results, apply our 

metbodology to their own data, or apply their methodology 

to the NI\1MAPS database. One of the goals of our approach 

is to raise the level of scientific debate by making all of our 

methods publicly available and to create new tools and 

~tandards that encourage others to do the ~amc. 

In addition to thc Internet Health and Air Pollution Surveillance Sys.tem website. \ve have createu a compendium 

for arecent publication, "Seasonal Analyses of Air Pollution 

and Mortality in 100 US Cities" (24), which contains an 

analysis of the seasonal anu regional variability o[the hcalth 

Am J Epidemiol 2006:163:783-789 
198 

TABLE 3. Making results from the National Morbidity, 

Mortality, and Air Pollution Study reproducible'" 

Research 

component 

Data 

Methods 

Documentation 

Distribution 

What we have done 

The entire NMMAPSt database is available to 

the public via the iHAPSSt website and the 

NMMAPS data package for R; the data are 

available under a "fuJI access" class of 

license 

A full compendium written in LATEX and R is 

available for download. 

We have outlined our data-processing pipeline 

on the iHAPSS website, and papersl 

technical reports are available for download. 

We use the World Wide Web to disseminate 

our data and software 

~: Details at http://www.biostat.jhsph.edu/~·rpeng/reproducible/. 

t NMMAPS, National Morbidity, Mortality, and Air Pollution Study; 

iHAPSS, Internet Health and Air Pollution Surveillance System. 

effects of patiiculate matter. To allow others to reproduce 

our findings, we have developed a simple wehpage that 

contains links to all of the data and computer code fOT 

generating the figures and tables in the article. The compen~ 

dium is written with the literate programming techniques 

described in the previous section, an excerpt of which is 

shown in the Appendix. Readers can inspect the code for 

producing the results and for creating the tables/figures, as 

well as downloJd the code and data to their o\vn computers 

to nln other analyses or produce different figures, A summary of our effort~ can be found in table 3. and we have 

posted complete infonnation about the data and mcthods 

used in this paper at http:/h.v\vw.hiostat.jhsph.edn/~rrellg/ 

reproducible/. In a recent study of fine pmiiculate matter 

and hospitalizations among the elderly (25). we have applied the ~ame principles of reproducibility and have posted 

infonnation at http://www.hiostat.jhsph.edufMCAPSI. 

DISCUSSION 

Tn this article, we have prnp0'ied that reproducihle research be the minimum standard in disseminating epidemiologic findings and have demonstrated the possibilities with 

a large ongoing study of air pollution and health. The policy 

implications of epidemiologic studic\ coupled \vith thc investigation of smaller targets, the increasing use of complex 

databases, and the application of sophisticated statistical 

modeling can lead to research that is subject to intense 

scrutiny. The reproducibility of principal Ilndings can fo~ter 

rational discussion,,> regarding the evidence in the data and 

serve as a bulwark against uninformed critici lim. 

The standard of reproducibility addresses some critical 

scientific issue~, but its reach is still limited. In order to 

identify the issues that reproducibility can address, \Ve must 

first agree on a model of the r~scareh process itself. One can 

think of an epidcmiologic .... tudy as a sequence of stages, 

starting from the generation of the data by natural or other 

processes, to the collection of these data. to data processing and analysis. and then to the reporting of results. Prior to 

AmJ Epidemiol 2006;163:783-789 

Reproducible Epidemiologic Research 787 

the generation of the data. one might also include the formulation of the hypotheses and the design of the study. 

Reproducibility becomes meaningful in the stages of 

a SlLldy following the data collection. The processing of 

the data, a"> well as the analysis and subsequeut presentation. 

can all be inspected if the research is reproducible. Beyond 

checking for statistical and programming errors. one can 

evaluate the sensitivity of the findings to certain modeling 

choices. By having the computer code used to process and 

analyze the data, other~ can ohtain u~eful infomIation reganhng the many important choices made as part of the 

study. 

Among the issues that cannot be addressed by reproducible rc~eareh are those arising from stages of the research 

proccss prior to the data collection stage. Questions ahout 

the study design. the selection of <.;ubjects, the handling of 

nonrespondems. and many other facets of a study cannot he 

re~olved with the analytical data alone. Similarly. it may not 

be possihle to examine all relevant modeling choices, par~ 

ticularly thosc involving vatiablcs for v.'hich no data wcre 

originally collected. However. when we discuss these types 

of issues, we are moving closer to calling for full replication. 

If a particular study is fully replicable. then all aspects of the 

original study can be adjusted or modified. Clearly, full 

replication remains the ultimate standard hy \vhich \vc evaluate scientific evidence. 

Data availability is the tirst and foremost challenge to 

reproducible epidemiologic research. Although this problem 

is not unique to epidemiology (26), being observationaL 

evidence from epidemiologic stuuics is more often open to 

ditfeling interpretations. It is exactly in such a circum..,tance 

that work needs to be open and reproducible. We have proposed a framework of "partial rights" to research data that 

would modulate the all-or-nothing scenario that eXlsts today. 

One impediment to making data available l~ preserving 

confidentiality. Health data are often obtained by making 

promises to individuals (either directly or through an intermedial)') that confidential information about those individuals will not bc released to the puhlic. Lndcr our delinition, 

it would seem impossible to simultaueously honor those 

promises and make onc'~ research reproducihle. However, 

while the measured data often mu~t be kept confidenti<.il. it 

may still be possible to provide summary statistics of the 

data upon which the analysis is based. For example. with 

time-series studies of air pol1ution and mortality, the individual mortality data arc confidential, but the time series of 

aggregate counts for each county can be made <lvailahle for 

large enough counties. Since the analysis is based entirely 

on those aggregate values, there is no need to release the 

individual-level datil. This is a limited example, and although there is active discu">sion in tbe literature ahout dio,;-

closure limitation methods (27), the issue of releasing data 

for the purposes of reproducing scientific findings is in need 

of ~erious uiscussion. 

Thc literature rcyiew served both to assess the state of 

reproducihility in the epidemiologic literalllrc and to provide 

a "checklist"' for producing a reproducible study. In addition 

to data availability, we identified a number of additional 

problems preventing epidemiologic findings from being 

reproduced. The sparse reporting of analytical methods 

o 

~ 

I 

a 

3 
199 

788 Peng et al. 

and the lack of computer code describing those methods are 

of concern. \Ve have demonstrated hmv to use literate programming techniques to produce a reproducible document 

and the \Vcb for distributing data and solhvarc. The reproducibility oUhe document is en-;.ured by the use of tools that 

allow text and code to be intermingled to form a common 

source for the finished paper. Tn general, programming 

languages and statistical packages tend to change, and \ve 

do not presume that there is a single "best"' environment. 

Rather, we describe the general concept of literate programming and highlight some specific tools that are available for 

encouraging such practice. 

The call for reproducible research has already been echoed in other fields where computation and complex statistical methodology arc critical for ohtainlllg substantive results 

(7, to, 11,28-31). Biologists have made enonnous progress 

to\l,:ard integrating databases, sharing software, and making 

their analyses reproducible. Journals such as Science and 

Nature require deposiliou of hiologic data into public repositories at the time of publication, and organiJ'ations such 

as the Microarray Gene Expression Data Society have developed rigorous standards for the reporting of micl'Oarray 

data (32). The Inter-University Consortium for Political and 

Social Research is a vast repository for social science data, 

providing archiving resources as well as standardiLation of 

data sets for a numher of software environments. Social 

science investigators intent on making their research reproducible have a clear resource for sharing their data. 

In addition to various field-specific efforts. the US Nationalln .... tilutcs or Health now requires many of its grantees 

to implement a data-sharing policy for any research sponsored by the Institutes. Even more broadly, the federal 

government, via the Shelby Amendment of 1999 and the 

subsequent revision to the Office of !vlanagement and Budget Circular A 11 0, requires data from any federally sponsored research to be made <1vailable upon request if the data 

were used in "developing an agency action that has the 

force and effect of law" (33. p. 220). It is not yet known 

what the full impact of either of these policies will be un the 

reproducibility of all biomedical research. 

In the ab~cncc of full rcpllcalion, rcproducihility ...,hould 

become the minimum standard for epidemiologic re"earch. 

In particular, studies with potential policy impact should be 

made reproducible to aUmv others to verify published findings amI to conduct alternative analy!o.cs of the data. ,"'e have 

demonstrated through our ca"ie study that the standard of 

reproducihility can he achieved and have proposed a framework in which the results can be disseminated. The apparent 

unreliability of epidemiologic investigations predicted 10 

years ago can be thwarted today by adopting new standards 

and embracing a more open research environment. 

ACKNOWLEDGMENTS 

Funding \vas provided by the Natioual Institute of 

Environmental Health Sciences (grants ROIESOl2054 and 

ROIES012054-03SI). the National Institute of Environmental Health Sciences Center in Urban Environmental 

Health (grant PES003819). and the Health Effects Institute 

(grant HEI 025). 

The author..., thank Dr. Ronald S. BrookmeyeT ror his 

comments and sugge"ition"i and the faculty and students of 

the departments of Biostatistics and Epidemiology who 

helped with the survey. 

Conflict of interest: none declared. 

REFERENCES 

1. Samet 11\1. Epidemiology and policy: Lhe pump handle meets 

lhe new rnilleniurn. Epidemiol Rev 2000;22: 145-54. 

2. Tauhes G. Rpidemiology face<; its limits. Science 1 !,)95;2ft9: 

164-9. 

3. BeIl1·fL, McDermott A. Zeger SL, et al. Ozone and short-term 

mortality in 95 US urban communi[ics, 1987- 2000. lAMA 

2004;292:2372-8. 

4. Kaiser 1. Researchers and lawmaker" cl8'ih over aL:ces:>.to data. 

Science 1997;277:467. (00(: IO.1126/<;cience.277.5325A67). 

5 Kaiser J. Evidence mounts that tiny palticles can kill. Science 

2000;289;22·). (DOl: 10.1 126/science.289.5476.22). 

6. The PLoS Mcdicinc Editors. Why bigger is not yet bcttcr: the 

prohlems with huge dataset~. PLoS Med 2.005;2:e55. (DOl: 

10.137I1journal.pmed.(020055). 

7. Schwab M, Karrenbach N, Claerbout 1. Making scientific 

computations reproducible. Com put Sci Eng 2000;2:61-7. 

(http://'c.epwww.stanford.cdu/rcsearch/rcdoc/). 

8. Kai<;er 1. Software glitch threw off morlali!y estimates. Science 

2002;296: 1945-7. (DOl: 1 O.112ft!science.296.5575.1945). 

9. Colburn KA, Johnson PRS. Air pollution concerns not 

changed by S·PLUS ftaw. Science 2003;299;665 ·6. (DOl; 

10. 1126/scicncc. 1082105). 

10. Gt~ntlcman R, Temple Lang D. Statistical analyses and reproducible re ... e8rd. Berkeley, CA: Berkeley Electronic Pre"", 

2()04. (http://www.hepress.com/hioconductor/paper2). 

11. Rusehhaupt M, Huher W, Poustka A. et al. A compendium 

to ensure computational reproducibility in high-dimensional 

classification tasks. Stat Appl Gcnet Mol BioI 2004:3:m1iclc 

37. (hUp:llwww.bepre .. s.com/sagmb/vo13/iss1/arI37). 

12. Knulh DE. Literate programming. Stanford, CA: Center for 

the Study of Language and Information. 1992. 

13. Rossini A. Litcrate statistical practicc. In: Hornik K. Lcisch F, 

eds. Presented al Lhe 2nd Inlernalional \Vorkshop on DisLribuled Stali.,tical Computing, Vienr18. Auslria. March 15-17. 

2(lO 1. (http://www.ci.tmvien.ac.atfConferenceslDSC-2()01/ 

Proceedings/Rossini.pdf). 

14. Ihaka R, Gentleman R. R: a language for data analysis and 

graphics. 1 Cumput Graph Stat 1996;5:299-·3 [4. 

15. R Development Cure Team. R: a language :md envIronment 

for <;tati'i[ical compuLing. Vienna. Austria: R roundation for 

Statif>tical Computing, 2005. (http://\.vww.Rprojecf.org). 

16. Rmven L, Wong GKS, Lane RP, et al. Intellectual property. 

Publication rights in the era of open data release policies. 

Science 2000;289:1881. (DOl: IO.J I 26/scicncc.289.5486. 

1881). 

17. Samet 1M, Zeger SL. Dominici r, et a1. The National Morhidity, Mortality, and Air Pollution StUdy. part 1: methods and 

methodological issues. Cambridge, MA: Health Effects Institute, 2000. 

18. Samet 1M, Zeger SL. Dominici r, et a1. The Natjonal Morhidity, Mortality, and Air Pollution Study. part 11: morhidity 

and mortality from air pollution in the United States. Cambridge, MA: Health Effects Institute, 2000. 

Am J Epidemiol 2006;163:783-789 
200 

19. Kaiser 1. Mounting evidence indicts fine-particle pollution. 

S<.:icncc 2005;307: 1858-61. 

20. National ambient air quality ~tandanb for particulate maUer. 

Research Triangle Park. NC: US Environmental Protection 

Agency Office of Air Quality Planning and Standards, 2005 

21. Dockery D, Pope CA. Xu X. et al. An association between 

air pollution and m0l1ality in six U.S. cities. I\ Engl J Mcd 

1993;329: 1753-9. 

T1 Pope CA. Thull M, I\:amboodiri M, et aJ. Particulate air pollution as a predictor of mortality in a prospective study afU.S. 

adults. Am J Rcspir Crit Care ~ed 1995:151 :669" 74. 

23. Pope CA, Burnett RT. Thun MJ, ct a1, Lung cancer, cardiopulmonary mortality. and long-term expo~ure to flne particulate air pollution. JAMA 2002:2X7: 1132-41. 

24. Peng RD. Dominici f-<~ Pastor-Rarrimo R, et a1. Sea<:;onal 

analyses of alr pollution and mOltality in 100 LS cities. Am J 

Epidcmio1 2005: 161 :585-94. 

25. Dominici F, Pcng RD, Bdl ML, ct a1. Fine particulate air 

pollution and ho'>pitlll admi'ision for cardiovascular and 

respiratory diseases . .lAMA 2006;295: 1127-35. 

26. Campbell EG. Clarridge BR, Gokhale M. et a1. Data withholding in academic genetics: evidence from a national survey. 

JAMA 2002:287:473 80. 

Reproducible Epidemiologic Research 789 

27. Fienbcrg SE. Conflicts between the needs for access to statistical information and dcmamb for confidentiality. 1 Off Stat 

1994: 10: 115-32. 

2X. Gentleman R. Reproducihle research: a hioinfonnlltics case 

"!tudy. Stat Appl <1enet Mol Bioi 2005:4:article 2. (http:// 

www.bepress.eom!sagmb!vo14/issl/art2). 

29. 10hnson DH. Three objections to da[abases ans\vcrcd. In: APS 

ohserver. Vol 14. Washington, DC: Association flJ1' Psychological Science, 20()1. (http://vv·\J,'w.psychologicalscience.org! 

observerlllOlldatabase.htmll. 

30. Buckhcit 1, Donoho DL. Wavelab and reproducible rcseareh. 

In: Antoniadi~ A, cd. Wavelets and statistics, New York, NY: 

SpringerVerlag, 1995. 

J I. Gentleman RC, Carey V.I, Bates D\1, et a1. Riocondnctor: 

open software devel~pment for computational hiology and 

bioinformatics, Genome Bio12004:5:R80. (DOl: 10.ll86/ 

gb-2004-5-10-r80). 

32. Ball CA, Sherlock G, Parkinson H, et ai. Standard~ for uucroaITay data. (Letter). Science 2002:298:539. (DOl: 10.1126/ 

science.29X.55'--n.5J9b). 

33. 45CrR74.36. Washington. DC: US Government Printing 

Office, 2003:220···1. (http://www.peo7.com/CFRFiles/ 

PEOusCFR ... 45PUBLICWELFARE . 119259.htm). 

APPENDIX 

Sweave Example 

The foUmving is taken from a vignette for reproducing the results reported in the paper by Peng et ill. (24). The document 

lS written in the Li\T EX document-formatting language, and the portions he tween the < <> >.....,. and @ symbols arc written in 

the R language. 

The national average estimates of the overall and seasonal short-term effects of \PMTen\ 

on mortality for lags 0, and 2 are summarized in Table 2. These estimates were obtained by 

pool'lng the ci ty-specific maximum likelihood estimates from the main effect and poLlutantseason interaction models according to the hierarchical normal model. 

«nationaIAverageEstimates, results=tex, echo=false»= 

Seasons <- c("~\Jinter", "Spring", "Summer", "Fall" f "All Seasons") 

Lags <-pas'Ce(\\Lag" , 0:2); exclude <-c{"hono", "anch") 

## Load non-seasonal estimates 

load(file.path( "results", "city-specific-est.prn10.rda")) 

results <- lapply(results, function(x) x[setdiff (names (x) I exclude)]) 

## Pool estimates 

betacovTotal <- lapply (resul ts, extractBetaCov I pollutant...:... poll) 

pooledTotal <- lapply(betacovTotal, poolCoef} 

## Load seasonal estimates 

load (file. path ( "results", "seasonal. factor2 . lag. 012 . pm10. rda" ) ) 

results <- lapply (resul ts f ::unction (x) x [setdiff (names (x), exclude)]) 

## Pool estimates by season 

pooledSeas <- lapply (resul ts, coefSeasonal, pollutant=poll, 

rnethod~rnethod) 

pooled < - lapply (seq (along ~ poolcdScas), function (i) { 

rn <- rbind(pooledSeas [[ill, pooledTotal [[ill) 

rO\f,ffiames (m) <- Seasons 

}) 

@ 

AmJ Epidemiol 2006;163:783-789 
201 

‘‘DEMING, DATA AND OBSERVATIONAL STUDIES,’’: 

ARTICLE BY S. STANLEY YOUNG AND ALAN KARR
202 

observational claims. They all confirmed no 

117 
203 

is not made. 

The "observational industry" must 

build a good product;journai editors cannot 

inspect bad product out at the 

stage, let alone the 

with observational studies: Multiple testing, 

bias, and multiple modelling. 

Multiple testing 

False positives do occur, even in an ideal world. 

When many questions are asked of the same data, 

118 

Risk 

zidovudine 19.0 

stavudine 18.8 

3.43 

3.72 

3 lamivudine 18.6 3.68 

4 didanosine 22.1 

5 abacavir 27.5 

4.47 

6.13 
204 

How can it be fixed? A new, combined 

strategy 

It should be clear by now that more than smallscale remedies are needed. The entire 

of observational studies and the claims 

are made from them is no longer functional, 

nor is it fit for What can be done to 

fix this broken There are no principled 

Data cleaning and analysis separate 

Analysis of A only data set 

Journal accepts paper based on A only 

Analysis of B data set gives Addendum 

119 
205 

Æ 

120