[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

U.S. GOVERNMENT PRINTING OFFICE
71-346 WASHINGTON : 2011
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing Office,
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202�09512�091800, or 866�09512�091800 (toll-free). E-mail, gpo@custhelp.com.

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

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.

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.