[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]



 
                   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



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              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

                    HON. RALPH M. HALL, Texas, Chair
F. JAMES SENSENBRENNER, JR.,         EDDIE BERNICE JOHNSON, Texas
    Wisconsin                        JERRY F. COSTELLO, Illinois
LAMAR S. SMITH, Texas                LYNN C. WOOLSEY, California
DANA ROHRABACHER, California         ZOE LOFGREN, California
ROSCOE G. BARTLETT, Maryland         BRAD MILLER, North Carolina
FRANK D. LUCAS, Oklahoma             DANIEL LIPINSKI, Illinois
JUDY BIGGERT, Illinois               GABRIELLE GIFFORDS, Arizona 
W. TODD AKIN, Missouri                   (Resigned from Congress on 
RANDY NEUGEBAUER, Texas                  January 25, 2012)
MICHAEL T. McCAUL, Texas             DONNA F. EDWARDS, Maryland
PAUL C. BROUN, Georgia               MARCIA L. FUDGE, Ohio
SANDY ADAMS, Florida                 BEN R. LUJAN, New Mexico
BENJAMIN QUAYLE, Arizona             PAUL D. TONKO, New York
CHARLES J. ``CHUCK'' FLEISCHMANN,    JERRY McNERNEY, California
    Tennessee                        JOHN P. SARBANES, Maryland
E. SCOTT RIGELL, Virginia            TERRI A. SEWELL, Alabama
STEVEN M. PALAZZO, Mississippi       FREDERICA S. WILSON, Florida
MO BROOKS, Alabama                   HANSEN CLARKE, Michigan
ANDY HARRIS, Maryland                VACANCY
RANDY HULTGREN, Illinois
CHIP CRAVAACK, Minnesota
LARRY BUCSHON, Indiana
DAN BENISHEK, Michigan
VACANCY
                                 ------                                

                 Subcommittee on Energy and Environment

                   HON. ANDY HARRIS, Maryland, Chair
DANA ROHRABACHER, California         BRAD MILLER, North Carolina
ROSCOE G. BARTLETT, Maryland         LYNN C. WOOLSEY, California
FRANK D. LUCAS, Oklahoma             BEN R. LUJAN, New Mexico
JUDY BIGGERT, Illinois               PAUL D. TONKO, New York
W. TODD AKIN, Missouri               ZOE LOFGREN, California
RANDY NEUGEBAUER, Texas              JERRY McNERNEY, California
PAUL C. BROUN, Georgia                   
CHARLES J. ``CHUCK'' FLEISCHMANN,        
    Tennessee                            
RALPH M. HALL, Texas                 EDDIE BERNICE JOHNSON, Texas


                            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

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

                   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.















    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?
    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--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 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).
    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, anti-
science 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.
    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, reinforcing 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 University Regulatory Studies Center 
and Research Professor in the Trachtenberg School of Public Policy and 
Public Administration. \1\
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    \1\ The 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.
---------------------------------------------------------------------------
    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 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.
---------------------------------------------------------------------------
    \2\ Institutions and Incentives in Regulatory Science, Lexington 
Books, Jason Johnston ed., forthcoming spring 2012.

  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 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.
                                  ***

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-final-report

      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 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.

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.

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.

  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 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.

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 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 submitted, 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, 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 non-profit, non-partisan public policy research 
institutions across North America. I began career studying air quality 
regulations in California, and later expanded that 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 risk-assessment 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.

    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\
---------------------------------------------------------------------------
    \1\ Garrett A. Vaughn (2006). ``Regulatory Sleight of Hand: How the 
EPA's Benefit-Cost Analyses Promote More Regulation and Burden 
Manufacturers. (VA: Manufacturers Alliance)
---------------------------------------------------------------------------
As economist Anne E. Smith recently testified to this Subcommittee \2\:
---------------------------------------------------------------------------
    \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

      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 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 science-policy 
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 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.
    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.
---------------------------------------------------------------------------
    \1\ Cary Coglianese and Gary E. Marchant, Shifting Sands: The 
Limits of Science in Setting Risk Standards, 152 PENN. L. REV. 1255-
1360 (2004).
    \2\ Wendy E. Wagner, The Science Charade in Toxic Risk Regulation, 
95 COLUMBIA LAW REVIEW 1613-1723 (1995).

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 quality, and the agency's policies and regulations 
are frequently perceived as lacking a sound scientific foundation.'' 
\4\
---------------------------------------------------------------------------
    \3\ Robert M. Sussman, Science and EPA Decision-making, 12 JOURNAL 
OF LAW AND POLICY 573-587 (2004).
    \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).
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \5\ See, e.g., ROBERT K. MERTON, THE SOCIOLOGY OF SCIENCE: 
THEORETICAL AND EMPIRICAL INVESTIGATIONS. Chicago: Chicago University 
Press (1973).
---------------------------------------------------------------------------
    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).
---------------------------------------------------------------------------
    \6\ NATIONAL RESEARCH COUNCIL, RISK ASSESSMENT AND RISK MANAGEMENT 
IN THE FEDERAL GOVERNMENT. Washington, D.C.: National Academy Press 
(1983).
---------------------------------------------------------------------------
    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 
institutionally 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 policy-making. 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\
---------------------------------------------------------------------------
    \7\ HEALTH EFFECTS INSTITUTE, ABOUT HEI, http://
www.healtheffects.org/about.htm (last visited Aug. 22, 2008).
    \8\ Terry 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/
efsa_locale-1178620753812_AboutEfsa.htm .
---------------------------------------------------------------------------
    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:
---------------------------------------------------------------------------
    \9\ 

  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\
---------------------------------------------------------------------------
    \10\ Id.

    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\
---------------------------------------------------------------------------
    \11\ See, 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/mb_managementplan2008-
adopted,3.pdf?ssbinary=true.

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.''
---------------------------------------------------------------------------
    \13\ Angus Macbeth and Gary Marchant. Improving the Government's 
Environmental Science. 17 N.Y.U. ENVTL L.J. 134-169 (2008). 
---------------------------------------------------------------------------
    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 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 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 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 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.
    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 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 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.
    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 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 temperature 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 Administrator 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.
    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.
    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.
    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?
    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.
    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 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.]


                               Appendix I

                              ----------                              

                   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 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 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.''
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 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.

  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 
(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.
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 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):

    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.

    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 risk-assessment 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 concentrated 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 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 decision-making 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.
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 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.


                   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.


                            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).
---------------------------------------------------------------------------
    \1\ See Appendix 1 for EPA organizational structure.

    
    

    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \4\ 42 U.S.C. Sec. 7408(a)(2) (2000).
    \5\ 42 U.S.C. Sec. 300g-1(b)(3)(A)(i).
    \6\ 33 U.S.C. Sec. 1314(a)(1).
---------------------------------------------------------------------------
    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 Committee-passed appropriations level is $777.6 million, and the 
FY 2012 Senate Committee draft appropriations level is $809 million.
---------------------------------------------------------------------------
    \7\ See Appendix 2.
    \8\ See Appendix 3.
---------------------------------------------------------------------------
    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.







    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 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.

    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 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, 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-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 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, measurement 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 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 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;

      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.
---------------------------------------------------------------------------
    \1\ Bipartisan Policy Center. 2009. Improving the Use of Science in 
Regulatory Policy. Washington, DC: Bipartisan Policy Center.

---------------------------------------------------------------------------
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.

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 well-qualified 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 highest-quality 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 recent 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\
---------------------------------------------------------------------------
    \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.

        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.
---------------------------------------------------------------------------
    \3\ Krewski 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.

      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.
---------------------------------------------------------------------------
    \5\ www.ihapss.jhsph.edu.

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 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 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.

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\
---------------------------------------------------------------------------
    \1\ Science Integration for Decision Making at the U.S. 
Environmental Protection Agency (EPA) (draft January 5, 2012).
---------------------------------------------------------------------------
    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.1A\3\
---------------------------------------------------------------------------
    \2\ EPA's Strategic Research Directions 2008: An Advisory by the 
EPA Science Advisory Board. EPA-SAB-09-006.
    \3\ Office of Research and Development Strategic Research 
Directions and Integrated Transdisciplinary Research. EPA-SAB-10-010.
---------------------------------------------------------------------------
    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 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.
---------------------------------------------------------------------------
    \4\ Guidelines for Ensuring and Maximizing the Quality, 
Objectivity, Utility, and Integrity of Information Disseminated by the 
Environmental Protection Agency. EPA/260R-02-008.
---------------------------------------------------------------------------
    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 
Cooperation 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.
---------------------------------------------------------------------------
    \1\ The 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 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.
---------------------------------------------------------------------------
    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 well-known 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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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 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\
---------------------------------------------------------------------------
    \3\ Government 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.
---------------------------------------------------------------------------
    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 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.
---------------------------------------------------------------------------
    \4\ OMB ``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).
---------------------------------------------------------------------------
    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 Act (ERDDA) is 
reauthorized, Congress can direct EPA to develop and implement these 
standards.
---------------------------------------------------------------------------
    \5\ These 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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \6\ See 71 Fed. Reg. 2600 (Jan. 17, 2006).

---------------------------------------------------------------------------
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:
---------------------------------------------------------------------------
    \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.

      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 questions that involve scientific 
judgments and questions that involve judgments about economics, ethics 
and other matters of policy.'' \8\
---------------------------------------------------------------------------
    \8\ The Center's report is available at http://
www.bipartisanpolicy.org/sites/default/files/
BPC%20Science%20Report%20fnl.pdf.

      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\
---------------------------------------------------------------------------
    \9\ See 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.

    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 assessments 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 Long-range 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:
---------------------------------------------------------------------------
    \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.

      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.

      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.
---------------------------------------------------------------------------
    \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).

      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.
    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 Academy 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\
---------------------------------------------------------------------------
    \1\ The views expressed here are my own and do not necessarily 
represent those of Regulatory Checkbook.
---------------------------------------------------------------------------
    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 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\
---------------------------------------------------------------------------
    \2\ Barack Obama. ``Scientific Integrity.'' Federal Register, 2009, 
74(46), 10671-10672.
    \3\ John P. Holdren. ``Memorandum for the Heads of Executive 
Departments and Agencies: Scientific Integrity,'' Office of Science and 
Technoloy Policy, 2010.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \4\ OSTP'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.''
    \5\ President 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.''
    \6\ The 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.''
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.''
    \9\ Susan 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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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 of the Government's 
        regulatory priorities. In some cases, the distortion of 
        priorities may actually increase health and safety risks. \12\
---------------------------------------------------------------------------
    \12\ 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. 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.

    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\
---------------------------------------------------------------------------
    \13\ National Research Council. Risk Assessment in the Federal 
Government: Managing the Process. Washington, D.C.: National Academies 
Press, 1983, p. 151.

    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\
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.

    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 of Agency 
policy officials is constrained or misdirected by their practice of 
purposefully overestimating risk. \16\
---------------------------------------------------------------------------
    \16\ U.S. Environmental Protection Agency Office of the Science 
Advisor (2004, pp. 14-16).

---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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 real-world 
regulatory agency. \18\ &&
---------------------------------------------------------------------------
    \18\ The 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/Mis-Read 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 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.

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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\
---------------------------------------------------------------------------
    \19\ Office 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).
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \23\ U.S. Environmental Protection Agency (2002, p. 10).
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \24\ Paul 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).
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \25\ U.S. Environmental Protection Agency (2002, pp. 16-17).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \26\ Some 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.
---------------------------------------------------------------------------
    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 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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.''
---------------------------------------------------------------------------
    \30\ Office of Management and Budget. ``Final Information Quality 
Bulletin for Peer Review.'' Federal Register, 2005, 70(10), 2664-2667.
---------------------------------------------------------------------------
    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 house. There is no 
obligation for peer reviewers to do anything with this information.
---------------------------------------------------------------------------
    \31\ Office of Management and Budget (2005, p. 2675). Emphasis 
added.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \32\ Office 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.

---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \34\ U.S. Environmental Protection Agency (2006, p. 17).

    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\
---------------------------------------------------------------------------
    \35\ National Research Council. Review of the Environmental 
Protection Agency's Draft IRIS Assessment of Formaldehyde. Washington, 
D.C.: National Academies Press, 2011.
    \36\ This 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.
---------------------------------------------------------------------------
    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 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\
---------------------------------------------------------------------------
    \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.

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\
---------------------------------------------------------------------------
    \38\ U.S. Environmental Protection Agency (2006, p. 59).
    \39\ U.S. Environmental Protection Agency (2006, p. 61).

---------------------------------------------------------------------------
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.
    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\
---------------------------------------------------------------------------
    \40\ M.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.
    \41\ George 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.''

---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \43\ The National Academies. ``Policy on Committee Composition and 
Balance and Conflict of Interest,'' The National Academies, 2003.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.

---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 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\
---------------------------------------------------------------------------
    \49\ See, 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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.

---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.

    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?
---------------------------------------------------------------------------
    \52\ See, e.g., ``Clean Air Act.'' 44 U.S.C. 7401 et seq. 1970. See 
Sec.  7409(d)(2)(B), referring back to Sec. 108(a)(2).

---------------------------------------------------------------------------
Some 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\
---------------------------------------------------------------------------
    \53\ This 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.''
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \54\ The 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.
---------------------------------------------------------------------------
    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 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.
---------------------------------------------------------------------------
    \55\ Pub. 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 controversial among recipients of federal research 
funds who considered the data they collected to be their private 
intellectual property.
---------------------------------------------------------------------------
    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, 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\
---------------------------------------------------------------------------
    \56\ The 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.

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 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.
---------------------------------------------------------------------------
    \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.
    \58\ See 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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \60\ Office of Management and Budget. ``Proposed Bulletin on Peer 
Review and Information Quality.'' Federal Register, 2003, 68, 54023-
54029.
    \61\ We 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.

---------------------------------------------------------------------------
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 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\
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.''
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.''
---------------------------------------------------------------------------
    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.

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.

    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.

    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 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.
    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 one-quarter 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.




    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.




    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.''

    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.




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);

      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 one-pollutant-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, Office 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.
    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.
    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.
    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.
    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.
    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. 
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 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 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 before 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 academic 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 
too-small 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 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 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 therefore 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.
    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-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.]
                               Appendix I

                              ----------                              


                   Answers to Post-Hearing Questions




                   Answers to Post-Hearing Questions
Responses by Mr. Daniel Greenbaum,
President and Chief Executive Officer,
Health Effects Institute









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







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

















Responses by Dr. Richard Belzer,
President, Regulatory Checkbook

















































Responses by Dr. Jerald Schnoor,
Allen S. Henry Chair in Engineering,
Department of Civil and Environmental Engineering,
University of Iowa



















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










                              Appendix II

                              ----------                              


                   Additional Material for the Record




              Reprint from American Journal of Entomology:
                ``Reproducible Epidemiologic Research''















              ``Deming, Data and Observational Studies,'':
               Article by S. Stanley Young and Alan Karr












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