<DOC>
[110th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:33802.wais]
THE ENVIRONMENTAL PROTECTION AGENCY
FISCAL YEAR 2008 RESEARCH
AND DEVELOPMENT BUDGET PROPOSAL
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON ENERGY AND
ENVIRONMENT
COMMITTEE ON SCIENCE AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
MARCH 14, 2007
__________
Serial No. 110-11
__________
Printed for the use of the Committee on Science and Technology
Available via the World Wide Web: http://www.science.house.gov
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______
COMMITTEE ON SCIENCE AND TECHNOLOGY
HON. BART GORDON, Tennessee, Chairman
JERRY F. COSTELLO, Illinois RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas F. JAMES SENSENBRENNER JR.,
LYNN C. WOOLSEY, California Wisconsin
MARK UDALL, Colorado LAMAR S. SMITH, Texas
DAVID WU, Oregon DANA ROHRABACHER, California
BRIAN BAIRD, Washington KEN CALVERT, California
BRAD MILLER, North Carolina ROSCOE G. BARTLETT, Maryland
DANIEL LIPINSKI, Illinois VERNON J. EHLERS, Michigan
NICK LAMPSON, Texas FRANK D. LUCAS, Oklahoma
GABRIELLE GIFFORDS, Arizona JUDY BIGGERT, Illinois
JERRY MCNERNEY, California W. TODD AKIN, Missouri
PAUL KANJORSKI, Pennsylvania JO BONNER, Alabama
DARLENE HOOLEY, Oregon TOM FEENEY, Florida
STEVEN R. ROTHMAN, New Jersey RANDY NEUGEBAUER, Texas
MICHAEL M. HONDA, California BOB INGLIS, South Carolina
JIM MATHESON, Utah DAVID G. REICHERT, Washington
MIKE ROSS, Arkansas MICHAEL T. MCCAUL, Texas
BEN CHANDLER, Kentucky MARIO DIAZ-BALART, Florida
RUSS CARNAHAN, Missouri PHIL GINGREY, Georgia
CHARLIE MELANCON, Louisiana BRIAN P. BILBRAY, California
BARON P. HILL, Indiana ADRIAN SMITH, Nebraska
HARRY E. MITCHELL, Arizona VACANCY
CHARLES A. WILSON, Ohio
------
Subcommittee on Energy and Environment
HON. NICK LAMPSON, Texas, Chairman
JERRY F. COSTELLO, Illinois BOB INGLIS, South Carolina
LYNN C. WOOLSEY, California ROSCOE G. BARTLETT, Maryland
DANIEL LIPINSKI, Illinois JUDY BIGGERT, Illinois
GABRIELLE GIFFORDS, Arizona W. TODD AKIN, Missouri
JERRY MCNERNEY, California RANDY NEUGEBAUER, Texas
MARK UDALL, Colorado MICHAEL T. MCCAUL, Texas
BRIAN BAIRD, Washington MARIO DIAZ-BALART, Florida
PAUL KANJORSKI, Pennsylvania
BART GORDON, Tennessee RALPH M. HALL, Texas
JEAN FRUCI Democratic Staff Director
CHRIS KING Democratic Professional Staff Member
SHIMERE WILLIAMS Democratic Professional Staff Member
ELAINE PAULIONIS Democratic Professional Staff Member
STACEY STEEP Research Assistant
C O N T E N T S
March 14, 2007
Page
Witness List..................................................... 2
Hearing Charter.................................................. 3
Opening Statements
Statement by Representative Nick Lampson, Chairman, Subcommittee
on Energy and Environment, Committee on Science and Technology,
U.S. House of Representatives.................................. 9
Written Statement............................................ 9
Statement by Representative Bob Inglis, Ranking Minority Member,
Subcommittee on Energy and Environment, Committee on Science
and Technology, U.S. House of Representatives.................. 10
Prepared Statement by Representative Jerry F. Costello, Member,
Subcommittee on Energy and Environment, Committee on Science
and Technology, U.S. House of Representatives.................. 10
Witnesses:
Dr. George M. Gray, Assistant Administrator for Research and
Development, Environmental Protection Agency
Oral Statement............................................... 11
Written Statement............................................ 13
Biography.................................................... 16
Dr. M. Granger Morgan, Chair, Environmental Protection Agency
Science Advisory Board
Oral Statement............................................... 16
Written Statement............................................ 18
Biography.................................................... 25
Dr. Jennifer Sass, Senior Scientist, Health and Environment
Program, Natural Resource Defense Council
Oral Statement............................................... 25
Written Statement............................................ 27
Biography.................................................... 36
Dr. Bruce C. Coull, Carolina Distinguished Professor Emericut and
Dean Emeritus, School of Environment, University of South
Carolina; President, U.S. Council of Environmental Deans and
Directors, National Council for Science and the Environment
Oral Statement............................................... 36
Written Statement............................................ 39
Biography.................................................... 51
Discussion
The Superfund Innovative Technology Evaluation (SITE) Program.. 51
Laboratory Infrastructure...................................... 52
Employee Morale................................................ 67
Endocrine Disrupter Research................................... 68
External and Internal Research................................. 69
Data Sources and Concerns...................................... 70
Program Assessments............................................ 70
Integrated Risk Information Systems (IRIS)..................... 73
Funding Reductions for Great Lakes Research.................... 74
Nanotechnology Research........................................ 75
Near Road Pollutants........................................... 78
EPA Budget Request............................................. 79
Appendix 1: Answers to Post-Hearing Questions
Dr. George M. Gray, Assistant Administrator for Research and
Development, Environmental Protection Agency................... 82
Dr. M. Granger Morgan, Chair, Environmental Protection Agency
Science Advisory Board......................................... 107
Dr. Jennifer Sass, Senior Scientist, Health and Environment
Program, Natural Resource Defense Council...................... 110
Appendix 2: Additional Material for the Record
Statement of the American Chemical Society....................... 116
THE ENVIRONMENTAL PROTECTION AGENCY FISCAL YEAR 2008 RESEARCH AND
DEVELOPMENT BUDGET PROPOSAL
----------
WEDNESDAY, MARCH 14, 2007
House of Representatives,
Subcommittee on Energy and Environment,
Committee on Science and Technology,
Washington, DC.
The Subcommittee met, pursuant to call, at 2:00 p.m., in
Room 2318 of the Rayburn House Office Building, Hon. Nick
Lampson [Chairman of the Subcommittee] presiding.
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HEARING CHARTER
SUBCOMMITTEE ON ENERGY AND ENVIRONMENT
COMMITTEE ON SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
The Environmental Protection Agency
Fiscal Year 2008 Research
and Development Budget Proposal
WEDNESDAY, MARCH 14, 2007
2:00 p.m.-4:00 p.m.
2318 rayburn house office building
Purpose
On Wednesday, March 14, 2006 at 2:00 p.m. the House Committee on
Science and Technology's Subcommittee on Energy and Environment will
hold a hearing to examine the Environmental Protection Agency's (EPA)
fiscal year 2008 (FY08) budget request for Science and Technology
(S&T).
Witnesses
Dr. George Gray, Assistant Administrator for the Office of Research and
Development and Science Advisor, U.S. Environmental Protection Agency.
Dr. M. Granger Morgan, Chair, EPA's Science Advisory Board (SAB); Lord
Chair Professor in Engineering and Professor and Department Head,
Department of Engineering and Public Policy, Carnegie Mellon
University.
Dr. Jennifer Sass, Senior Scientist, Health and Environment, Natural
Resources Defense Council.
Dr. Bruce Coull, Dean Emeritus, School of the Environment, University
of South Carolina and the National Council for Science and the
Environment.
Background
Overall FY 2008 for EPA
Environmental Protection Agency's (EPA) overall FY08 budget request
is $7.2 billion, a reduction of 5.5 percent compared to the FY06
enacted level of funding for the Agency. EPA is one of two agencies
that are cut in the President's FY08 request for federal spending.
The table below shows the eight primary accounts of the Agency's
budget. The Environmental Program and Management (EPM) account funds
the Agency's air, water, waste, toxics and pesticides programs. The
Superfund account supports clean up of hazardous waste sites. The
Superfund account also includes funds for Superfund enforcement,
Science and Technology (S&T) to develop and test new methods for clean
up and set clean-up standards, and funds for the Inspector General's
office to address Superfund issues. The State and Tribal Assistance
Grants (STAG) account provides grants to states and local communities
to support water and sewage treatment infrastructure construction and
improvements. The largest reduction is in the STAG account.
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FY 2008 Science & Technology Account
The presentation of the Administration's budget request in the
Agency's Congressional Justification for S&T is $781 million. This
includes the S&T account funding the Office of Research and Development
(ORD) and S&T activities conducted by the program offices (e.g., Office
of Air, Office of Water), $755 million, as well as funds requested for
S&T activities associated with the Superfund program, $26 million. In
the past, the Superfund S&T funds were drawn primarily from the
Superfund trust that was funded by the dedicated Superfund tax. Since
the expiration of the tax, this fund no longer exists and all funds
must be appropriated from the general treasury.
Nearly $540 million (69 percent) of S&T funding is for EPA's Office
of Research and Development (ORD), which is the primary research arm of
the Agency. Typically, most of the remaining S&T funds go to the Office
of Air and Radiation, and a smaller amount to the Office of Water and
to the other program offices.
However, the S&T number presented in the FY08 request is not
directly comparable to the FY06 enacted level of funding for S&T
because it includes an accounting change the Administration initiated
with the presentation of the FY07 budget request. The actual budget
request for S&T programs is $690 million, a reduction of 5.6 percent
below FY06 funding.
In the FY07 budget request, the Administration instituted an
accounting change that transferred the cost of operations and
maintenance of all S&T facilities from the Environmental Program and
Management account to the S&T account. Prior to FY07, the funding for
S&T facilities was included with all other facilities in the EPM
account. When this transfer is accounted for, the actual FY08 S&T
request is reduced by $65 million to $716 million, a $41 million
reduction below FY06 enacted funding levels.
Office of Research and Development
ORD conducts and sponsors both fundamental research in
environmental science and more targeted research that inform EPA's
regulatory programs. For example, ORD develops the scientific risk
information for the Agency's Integrated Risk Information System (IRIS),
a database about human health effects from chemicals in the
environment. This program is used by EPA, States, and other government
agencies to determine hazardous waste site clean up levels, drinking
water, and other health-based standards. In air quality, ORD develops
the scientific underpinning for EPA's air quality standards in areas
such as particulate matter and ozone. ORD also investigates emerging
environmental questions such as the environmental implications and
applications of nanotechnology.
To carry out these responsibilities, ORD conducts intramural
research at EPA's laboratories, awards contracts, and supports
fellowships and research at colleges and universities through the
Science to Achieve Results (STAR) grant program. The table below
provides the breakout of ORD funds among the various research programs
at ORD.
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Budget Highlights
<bullet> If enacted, the FY08 request ($539.8 M) for ORD would
be its lowest funding level since FY00 and $106.7 million less
than its peak funding level of $646.5 million in FY04.
<bullet> The FY08 S&T request includes $10.2 million for
research on the environmental implications of nanotechnology in
the Human Health & Ecosystems program, a 91 percent increase
over the FY06 enacted level.
<bullet> The FY07 S&T request includes $68.2 million for
Ecosystem Research, $6 million (or eight percent) below the
FY06 enacted level, and $28 million (26 percent) below the FY04
enacted level. Almost all of the FY07 reduction ($5 million)
would be taken from the Environmental Monitoring Assessment
Program, (EMAP), which supports states' measurements of water
quality conditions and ecosystem health.
<bullet> The FY08 budget proposes the elimination of the
Superfund Innovative Technology Evaluation (SITE) Program ($1.2
million) and the elimination of funding for the Environmental
Technology Verification (ETV) program ($3.0 million). Both
programs support the development and testing of innovative
environmental technologies for cleanup of hazardous substances.
The SITE program was created in the Superfund statute.
<bullet> The FY08 President's Budget merges the Air Toxics and
NAAQS programs into a Clean Air program which will focus on
multi-pollutant sources and effects rather than sources and
effects of individual pollutants.
<bullet> The FY08 budget reduces funding for the STAR grant
program by nearly $10 million as compared to FY06 enacted
funding to $61.9 million.
Key Issues
The overall spending by EPA's research programs has been declining
for several years. The Administration argues that the Agency's research
is adequately funded given overall constraints on the federal budget
and that EPA S&T funds have been focused on emerging priorities, while
programs that are not as pressing or effective have been scaled back.
Critics of the budget, including EPA's Science Advisory Board, have
argued that EPA's core research programs are being eroded in ways that
will limit understanding of the environment and hamper the Agency's
ability to formulate sound policies.
The information below describes programs that have received some of
the most significant cuts or increases.
Land
The land research program is tasked with the objective of reducing
potential risks to human health and the environment at contaminated
waste sites by providing the science to accelerate clean-up decisions.
Research activities focus on contaminated sediments, ground water
contamination, site characterization, analytical methods, and site-
specific technical support. The President's FY08 budget requests $32.4
million for the Office of Research and Development's land research
program, a $3.6 million dollar decrease from FY06 enacted funding. This
10 percent reduction in funding could undermine future U.S. remediation
efforts as the Agency will lack the necessary scientific research to
cost-effectively clean contaminated waste sites.
Human Health
The human health research program leads the Agency's research
efforts on cumulative risks to human beings. Research focuses on risk
intervention and prevention strategies that aim to reduce human risk
associated with exposures to single and multiple environmental
stressors.
In its budget analysis, EPA expresses the importance of funding
critical research to address the health risks of susceptible sub-
populations, including: children, adolescents, and the elderly.
However, the President's FY08 Budget request for $56.8 million reflects
a $4.7 million dollar decrease from the FY06 enacted funding. This
seven percent cut in funding from $61.5 million stands at odds with the
important mission of protecting human health, especially vulnerable
populations. Furthermore, the overall budget request of Human Health
and Ecosystem receives a $22.7 million decrease compared with FY06
enacted funding, a 14 percent cut.
Ecological Research
Within the Environmental Protection Agency, ecological research
aims to assess ecosystem conditions and trends, diagnose impairments,
forecast ecosystem vulnerability, and restore degraded ecosystems. The
proposed FY08 budget request of $68.2 million represents an $18.1
million (31 percent) decrease from the FY06 enacted level and a $40
million (37 percent) reduction since FY04. The FY08 cut would be taken
primarily in the Environmental Monitoring Assessment Program (EMAP),
which supports data collection in the lower Mississippi River and Gulf
of Mexico wetlands.
In the EPA budget analysis, the Agency describes the necessity of
providing critical research on the restoration of large flood plain
rivers and to improve scientific understanding of causal links between
stressors and changes in ecosystem processes. However, the repeated
cuts in funding for ecological research have drastically reduced the
Agency's ability to monitor or protect our nation's ecosystems.
Pesticides and Toxics
The pesticide and toxics research program examines risks resulting
from exposure to pesticides and toxic chemicals. This research supports
the Agency's efforts to reduce current and future risk to the
environment and humans by controlling the production and release of
potentially hazardous chemicals. The President's FY08 Budget requests
$24.8 million, which is a decrease of $5.6 million from the $30.4
million FY06 enacted funding level. This 18 percent reduction will
negatively impact important research used to develop a screening
process for potential neuro- and immuno-toxicity of chemicals.
Fellowships
The Environmental Protection Agency created the Science to Achieve
Results (STAR) grant program in 1995 and the program was funded at just
over $100 million per year between the late 1990s and 2002. The program
was recommended by an outside advisory panel convened in 1992 and
reaffirmed in National Academy of Sciences reports in 2000 and 2003.
These reports stated that EPA should increase its funding of students
and research in academia to draw on a wider range of research. The bulk
of STAR funds have been allocated to competitive research grants in
targeted mission-critical areas, with a smaller portion reserved for
graduate fellowships and for exploratory research on the next
generation of environmental challenges.
The STAR program provides both research grants and graduate student
fellowships. Since its peak funding level of just over $102 million in
FY02, the grants program has declined every year. The FY08 budget
proposes reducing the fellowships to a level of $8.4 million or $3.3
million (28 percent) below the FY06 enacted level of $11.7 million.
STAR grants would be reduced to $61.9 million.
Technology Programs
The Superfund Act (Section 311) established the SITE program and
directed EPA ``to carry out a program of research, evaluation, testing,
development and demonstration. . .of innovative treatment
technologies.'' (Sec 311 (b)(1) ). After significantly downsizing the
program in FY06, EPA proposes eliminating it in FY07 and has again
proposed its elimination in FY08. By all accounts, including EPA's own,
the SITE program has conducted high-quality field demonstrations of
remediation technologies, and there are many SITE evaluated
technologies now on the market that have saved money and led to more
effective remediation efforts.
The budget also proposes to eliminate the Environmental Technology
Verification program. ETV was created in the mid-1990s to help
technology developers verify the performance of their products in areas
other than remediation technologies. It was developed using SITE as a
model. The FY08 request would eliminate the remaining $3 million in
funding that the Agency has used to partner with technology vendors to
test the performance of their products.
Sustainability Research
EPA's Science and Technology for Sustainability program is designed
to advance sustainability goals, specifically in the areas of air,
ecosystems, energy, land, materials, and water. The Office of Research
and Development's Sustainability Research program (formerly called the
Pollution Prevention Research program) would receive a $3.6 million or
14 percent decrease in FY08 ($22.5 million) from the FY06 enacted level
of $26.1 million.
Chairman Lampson. I am now happy to call this meeting to
order. I wish everyone a good afternoon and welcome everyone
here to today's Subcommittee hearing on the Environmental
Protection Agency's fiscal year 2008 Science and Technology
budget request.
Environmental issues present increasing challenges for our
country. We all want a robust economy and access to products
and services that sustain and improve our quality of life. We
also want a clean, healthy environment. It is through our
investments in research and development that we have been able
to strike a balance between environmental protection and
economic growth.
A clean, healthy environment is not a luxury. It is a
necessity. For example, when water pollution problems result in
beach closures or closure of fisheries, water pollution becomes
a threat to public health and to the economic health of
communities dependent upon recreation and fisheries.
Unfortunately, the Administration has failed for the 4th
consecutive year to offer a budget that will enable us to
achieve further successes in environmental protection. Four
years ago the EPA's research budget sustained a five percent
cut. In fiscal year 2006, it was reduced again by two percent,
and this year's proposal further reduces that budget yet again.
Sustainability cannot be achieved by EPA in our society if
the Agency cannot find a way to sustain the programs that
support environmental protection in this country. EPA cannot
advance environmental research with a retreating budget.
Targets for cuts include programs studying children's health,
endocrine disrupters, toxic waste cleanup, pesticides,
ecosystem research, technology verification programs, and
global climate change. Cuts to the STAR Grant and Fellowship
Program not only reduces funding for research, it reduces
essential funds for training the environmental scientists of
the future.
The bottom line is this budget is inadequate to support the
kind of research and development enterprise we need to find
creative solutions to environmental problems.
I believe several of our witnesses today will be in
agreement with me. First, I want to welcome our entire
distinguished panel to this afternoon's hearing. I look forward
to your testimony and to your recommendations for improving
EPA's scientific enterprise.
And at this time I will recognize the distinguished Ranking
Member, Mr. Inglis of South Carolina, for his opening
statement.
[The prepared statement of Chairman Lampson follows:]
Prepared Statement of Chairman Nick Lampson
Good Afternoon. I want to welcome everyone here to today's
Subcommittee hearing on the Environmental Protection Agency's FY 2008
Science and Technology (S&T) budget request.
Environmental issues present increasing challenges for our country.
We all want a robust economy and access to products and services that
sustain and improve our quality of life. We also want a clean, healthy
environment. It is through our investments in research and development
that we have been able to strike a balance between environmental
protection and economic growth.
A clean, healthy environment is not a luxury. It is a necessity.
For example, when water pollution problems result in beach closures or
closure of fisheries, water pollution becomes a threat to public health
and to the economic health of communities dependent upon recreation and
fisheries. Unfortunately, the Administration has failed for the fourth
consecutive year to offer a budget that will enable us to achieve
further successes in environmental protection.
Four years ago, the EPA's research budget sustained a five percent
cut. In FY06, it was reduced again by two percent, and this year's
proposal further reduces the budget yet again.
Sustainability cannot be achieved by EPA in our society if the
Agency cannot find a way to sustain the programs that support
environmental protection in this country. EPA cannot advance
environmental research with a retreating budget. Targets for cuts
include programs studying our children's health, endocrine disruptors,
toxic waste cleanup, pesticides, ecosystem research, technology
verification programs, and global climate change. Cuts to the STAR
grant and fellowship program not only reduces funding for research, it
reduces essential funds for training the environmental scientists of
the future.
The bottom line is, this budget is inadequate to support the kind
of research and development enterprise we need to find creative
solutions to environmental problems. I believe several of our witnesses
today will be in agreement with me.
I want to welcome our entire distinguished panel to this morning's
hearing. I look forward to your testimony and to your recommendations
for improving EPA's scientific enterprise.
Mr. Inglis. Thank you, Mr. Chairman, and good afternoon.
Thank you for holding this hearing about the President's fiscal
year 2008 request for the Environmental Protection Agency's
Science and Technology Account. Most of the budget requests
before the Congress relate to the regulatory functions of the
EPA, and of course, that is to be expected. The EPA also has
within its request the Office of Science and Technology and the
Office of Research and Development. Research from those offices
is used to improve the regulatory framework of the EPA. I trust
that the objective of that research is to use science to
continually improve the regulatory framework.
As we discuss the proposed fiscal year budget request for
EPA Science and Technology funding, I hope that the panel will
help establish the priorities of the use of EPA's science
resources. By investing in EPA scientific research and
development today we can get better regulations for tomorrow.
I look forward to hearing from our witnesses today, and I
am especially pleased to welcome Dr. Bruce Coull of the
University of South Carolina here. So thank you, Mr. Chairman,
for the hearing.
Chairman Lampson. You are welcome. Thank you, Mr. Inglis.
And I ask unanimous consent that all additional opening
statements submitted by Subcommittee Members be included in the
record. Without objection, so ordered.
[The prepared statement of Mr. Costello follows:]
Prepared Statement of Representative Jerry F. Costello
Good afternoon. I want to thank the witnesses for appearing before
this subcommittee to examine the Environmental Protection Agency's
(EPA) fiscal year 2008 (FY08) budget request for Science and Technology
(S&T).
First, I am concerned about the Administration's FY08 budget
proposal cuts to EPA programs because it represents the lowest funding
request in this century. Consequently, this reduction will have a
devastating impact on partnerships with academia and State and local
governments to protect and safeguard human health and the environment,
as well as curtailing on-going efforts to advance research in human
health, ecosystems, the environment, and energy sustainability.
Further, I am concerned that the budget cuts to EPA's programs
collection and data assessment programs will leave the Federal
Government with inadequate information upon which to base policies and
regulations. In particular, there are gaps in policy-relevant research
needs that will not be filled by other agencies, industry, or academia.
I am hopeful our subcommittee can work in a bipartisan fashion to
ensure adequate funding is provided for the EPA to ensure its programs
are not eroded in ways that could limit our understanding of the
environment and hamper the Agency's ability to formulate sound
policies.
Finally, I am opposed to the continuing trend within EPA of not
providing full public access and proper oversight on the Agency's
regulatory decision-making process. I believe the Science and
Technology Committee must continue to monitor EPA's progress to ensure
our nation's highest environmental research priorities are not
undermined.
I welcome our panel of witnesses and look forward to their
testimony.
Chairman Lampson. And it is my pleasure to introduce the
excellent panel of witnesses that we have with us this
afternoon. Dr. George Gray is the Assistant Administrator for
the Office of Research and Development and Science Advisor with
the U.S. Environmental Protection Agency. Dr. M. Granger Morgan
is the Chair of EPA's Science Advisory Board. In addition, Dr.
Morgan is a Lord Chaired Professor in Engineering and
Department head with the Department of Engineering and Public
Policy at Carnegie Mellon University. Dr. Jennifer Sass is a
Senior Scientist with the Health and Environment Division of
the Natural Resources Defense Council in DC.
And at this time I will recognize Representative Inglis for
an introduction of Dr. Coull.
Mr. Inglis. And we are particularly pleased, I mention, to
welcome Dr. Bruce Coull, the Dean Emeritus of the University of
South Carolina School of the Environment and a member of the
National Council on Science and the Environment. We are
particularly pleased to have you here today, sir.
Chairman Lampson. Thank you, Mr. Inglis, and welcome to all
of you. You will each have five minutes for your spoken
testimony. Your written testimony will be included in the
record for the hearing. When all four of you have completed
your testimony, we will begin with questions, and each Member
will have five minutes to question the panel.
Dr. Gray, please begin.
STATEMENT OF DR. GEORGE M. GRAY, ASSISTANT ADMINISTRATOR FOR
RESEARCH AND DEVELOPMENT, ENVIRONMENTAL PROTECTION AGENCY
Dr. Gray. Thank you, Mr. Chairman, Members of the
Committee. I am pleased to be here today to discuss the fiscal
year 2008 budget request from the Environmental Protection
Agency.
In keeping with the President's charge to EPA to accelerate
the pace of environmental protection while maintaining our
nation's economic competitiveness, the 2008, budget request
includes $7.2 billion to support the work of EPA and our
partners.
Included in that request is $754.5 million for science and
technology. That request reflects the President's strong
commitment to ensure that environmental regulations to protect
human health and the environment are based on the best
available science.
The request demonstrates the President's continued
commitment to provide the resources needed to address our
nation's highest environmental research priorities, enabling us
to protect our environment while sustaining our environmental
growth.
The request includes $539.8 million for the Office of
Research and Development to continue the work of providing the
sound science that informs the Agency's decision. Ninety-five
percent of those resources are in the S&T budget.
We are always looking forward in ORD for ways to become
more efficient and effective at both producing and assessing
the best available scientific information to inform
environmental decision-making, and that is reflected in our
proposed budget. For example, in fiscal year 2008, at the
advice of the Science Advisory Board, our Board of Scientific
Counselors, the National Academy of Sciences and others, we are
combining our $12.3 million Air Toxics Program with our $66.5
million National Ambient Air Quality Standards Research Program
into an integrated Air Research Program. With increased
resources and that reflects a shift to a more holistic view,
more holistic approach of the science that poses, that
addresses the challenges of air pollution.
We are also requesting increased funding for high priority
work, including clean air, human health risk assessment, and
research to study the fate, transport, and other issues that
might be associated with nanomaterials.
Now, at EPA we are good stewards of our environment, but we
are also good stewards of our nation's tax dollars.
Importantly, this budget request will enable ORD to continue to
fund critical research on the restoration of large flood plain
rivers, develop decision support tools that enable managers to
balance ecosystem requirements with human needs, and emphasize
the development of methods to characterize the services that
are provided by ecosystems.
The point is that this budget will enable ORD to continue
to fund research and meet our critical performance commitments.
In addition to those areas of increased emphasis, I would
like to highlight some work that EPA and ORD have done over the
last year, contributions we have made and continue to make in
the number of other key areas, including clean air, risk
assessment, nanotechnology, homeland security, and global
change.
The President's fiscal year 2008 budget includes a major
commitment to strengthening the science that supports the
Agency's efforts to ensure clean air for all Americans. The
President is requesting $81.1 million for air quality research,
which is a $3.4 million increase over the fiscal year 2007,
request.
A major focus of this increase will be improving our
understanding of air pollution near roads. This is an area of
special concern for children especially because of the location
of many schools and playgrounds for example. Using both ORD's
in-house expertise and the unique capabilities of America's
universities and research institutions, we plan to improve
measurement and characterization of emissions near roads, study
the extent of human exposure and health effects from these
emissions, and examine the effectiveness of potential controls
such as barriers or changes in building or roadway design.
Our fiscal year 2008 request also includes $42.8 million
for human health risk assessment, an increase of $4.5 million
over the 2007 request. This increase will primarily support two
areas; an enhanced process for science reviews to support
National Ambient Air Quality Standards, and enhanced
characterization of risk in our IRIS system and other risk
assessments.
Nanotechnology is another important area. It has the
potential to improve the environment through direct
applications to detect and remove pollutants, to reduce
pollution from manufacturing processes and products, or to
serve as sensors of pollution in the land, air, or water.
However, some of the novel beneficial properties, such as
greater reactivity that make nanomaterials especially useful,
also raise questions about potential risks of nanomaterials for
both humans and the environment.
This year ORD began an in-house research program focusing
on the human health and environmental implications of
engineered nanomaterials to complement our existing Extramural
Grants Program. In fiscal year 2008, we plan a modest expansion
of our efforts by $1.6 million to study the fate and transport
of engineered nanomaterials in the environment.
The Office of Research and Development also has
responsibilities in the area of homeland security. Our Homeland
Security Research Program continues to develop, enhance, and
disseminate information on the decontamination of buildings,
the protection of water systems, and rapid risk assessment. For
example, this past year ORD revised its Standard Analytical
Methods Manual that helps ensure consistency in sample analysis
during emergencies.
Finally, with global change, I am sure many of you closely
watched the release from the Intergovernmental Panel on Climate
Change, their fourth assessment for policy-makers. Global
change is an issue that EPA is very active in, and the
President's fiscal year 2008 budget includes $16.9 million for
global change research in ORD. EPA is a member of the U.S.
Climate Change Science Program, and ORD's highest priorities
for fiscal year 2008, will be working with our partners to
support completion of the two CCSP assessments for which EPA is
responsible; a preliminary review of adaptation options for
climate-sensitive ecosystems and resources, and an analysis of
the effects of global change on human health, welfare, and
human systems.
So by uniquely combining human health and ecological
research in one federal agency, employing world-class
scientists, ORD continues to develop a better understanding of
environmental risks to both human health and ecosystems. The
results of this research consistently and effectively inform
EPA's environment decision-making, as well as that of others,
leading to environmental policies that are based on sound
science at the federal, State, tribal, and local levels.
Well, thanks for the opportunity to tell you about some of
the exciting work that we conduct in ORD, and I would be happy
to answer any questions that you have.
[The prepared statement of Dr. Gray follows:]
Prepared Statement of George M. Gray
Mr. Chairman and Members of the Committee, I am pleased to be here
today to discuss the Fiscal Year (FY) 2008 budget request for the
Environmental Protection Agency (EPA). In keeping with the President's
charge to EPA to accelerate the pace of environmental protection while
maintaining our nation's economic competitiveness, the 2008 budget
request includes $7.2 billion to support the work of EPA and our
partners.
Included in this request is $754.5 million for science and
technology (S&T), a significant increase over the 2007 Enacted. The
request reflects the President's strong commitment to ensure that
environmental regulations to protect human health and the natural
environment are based on the best science available. The request
demonstrates the President's continued commitment to provide the
resources needed to address our nation's highest environmental research
priorities, enabling us to protect our environment while sustaining our
economic growth.
This request includes $539.8 million for the Office of Research and
Development (ORD) to continue the work of providing the sound science
that informs the Agency's decisions. Ninety-five percent of these
resources are requested in the S&T account.
We are always looking for ways to become more efficient and
effective at both producing and assessing the best available science to
inform environmental decision-making and this is reflected in our
proposed budget. For example, in FY 2008 we are combining our $12.3
million Air Toxics and $65.5 million NAAQS research into an integrated
air research program, with increased resources, that reflects a shift
to a more holistic approach for addressing the science challenges air
pollution poses. We are requesting increased funding for high priority
work including clean air, human health risk assessment and research to
study fate, transport and other issues associated with nanomaterials.
At EPA, we are good stewards of our environment AND good stewards
of our nation's tax dollars. Importantly, the budget request will
enable ORD to continue to fund critical research on the restoration of
large flood plain rivers, develop decision-support tools that enable
managers to balance ecosystem requirements with human needs, and
emphasize the development of methods to optimize the services provided
by ecosystems. The budget will also enable ORD to continue to fund
research and meet our critical performance commitments. The human
health research funding will allow us to conduct research regarding the
health risks of susceptible populations. Additionally, the President's
budget request will provide funding for two additional Children's
Environmental Health Centers, increasing the number from seven to nine.
In addition to these areas of increased emphasis, I would now like
to highlight progress ORD has made, and continues to make, in a number
of other key areas, including homeland security, global change, and
computational toxicology.
FY 2008 President's Budget
Integrating and Enhancing Air Research
The President's FY 2008 budget includes a major commitment to
strengthening the science that supports the Agency's efforts to ensure
clean air for all Americans. The President is requesting $81.1 million
for air quality research, which is a $3.4 million increase over the FY
2007 request. A major focus of this increase will be improving our
understanding of air pollution near roads. This is an area of special
concern for children, due to the location of many schools and
playgrounds. Using both ORD's in-house expertise and the unique
capabilities of America's universities and research institutions, we
plan to improve measurement and characterization of emissions near
roads, study the extent of human exposure to and health effects from
these emissions, and examine the effectiveness of potential controls
such as barriers or changes in building and roadway design.
This ``source-to-health-outcome'' approach--from vehicle emissions
in the near-road micro-environment, to health effects, and ultimately
to control strategies--is emblematic of a larger shift in ORD's air
quality research. In FY 2008, in response to recommendations from
external scientific reviews, the President's request reflects an
integration of the National Ambient Air Quality Standards (NAAQS) and
air toxics research programs into a single ``one atmosphere'' research
program. This integration will facilitate a multi-pollutant approach
that better tracks emissions from sources to outcomes.
Enhancing Health Risk Assessments
Our FY 2008 request also includes $42.8 million for human health
risk assessment, an increase of $4.5 million over the FY 2007 request.
This increase will primarily support two areas: an enhanced process for
science reviews to support National Ambient Air Quality Standards, and
enhanced characterization of risk in our IRIS system and other risk
assessments.
As part of the new NAAQS process developed by the Agency, we are
committed to meeting the Clean Air Act mandate that EPA assess the
science of six ``criteria'' air pollutants every five years (we have
never met this goal) and this funding increase will help us develop the
Scientific Assessments (formerly known as Criteria Documents) to
support this process.
One of my goals is to both to enhance the transparency of EPA's
process for developing health values for the Integrated Risk
Information System (IRIS) chemical profiles and the scientific
characterization they contain. IRIS is a database containing
information on human health effects that may result from exposure to
various chemicals in the environment. It has grown into a premier
national and international source for chemical hazard and effects.
These increased resources will make IRIS stronger through an enhanced
development process and by supporting the development of quantitative
risk assessment methods to allow improved analysis and characterization
of uncertainty.
Expanding Nanotechnology Research
Nanotechnology has the potential to improve the environment through
direct applications to detect and remove pollutants, to reduce
pollution from manufacturing processes and products or to serve as
sensors of pollution in land, water or air. However, the novel
beneficial properties, such as greater reactivity, also raise questions
about the potential risks of nanomaterials for both humans and the
environment. EPA, under its various authorizing statutes, has a
responsibility to ensure that any potential environmental risks are
adequately understood and managed.
This year ORD began an in-house research program focusing on the
human health and environmental implications of engineered nanomaterials
to complement our existing extramural grants program. In FY 2008, we
plan a modest expansion of our effort by $1.6 million to study the fate
and transport of engineered nanomaterials in soils and aquatic
ecosystems.
Homeland Security
ORD's homeland security research program continues to develop,
enhance and disseminate information on the decontamination of
buildings, the protection of water systems, and rapid risk assessment.
For example, this past year ORD revised its Standard Analytical Methods
Manual (SAM) that helps ensure consistency in sample analysis during
emergencies. The SAM was used recently during a water security threat
in Blackstone, Massachusetts, and has since been incorporated into the
emergency response plans for each of the 10 EPA regions. We also
developed more than 80 oral and inhalation draft Provisionary Advisory
Levels for different levels of exposure to agents of potential homeland
security concern. To aid responders in detection and sampling, ORD, in
conjunction with the Department of Defense, built a prototype of a
portable, real-time anthrax and ricin detector, which is currently
undergoing testing and modification for ruggedness.
Global Change
I am sure many of you closely watched the release from the
Intergovernmental Panel on Climate Change's fourth assessment. Global
change is an issue that EPA is very active in, and the President's FY
2008 budget includes $16.9 million for global change research in ORD.
We are focusing our efforts on assessing how climate change will affect
air and water quality, human health, and the condition of ecosystems
and on providing natural resource managers with the information needed
to respond effectively to climate change. For example, climate change
and variability are expected to produce more frequent and more intense
rainstorms in certain areas, and the results of our research are
providing local officials with the information they need to make
informed decisions on water infrastructure investments.
EPA is a member of the U.S. Climate Change Science Program (CCSP),
and ORD's highest priority in FY 2008 will be working with our partners
to support completion of the two CCSP assessments for which EPA is
responsible--``Preliminary review of adaptation options for climate-
sensitive ecosystems and resources'' and ``Analyses of the effects of
global change on human health and welfare and human systems.'' \1\
---------------------------------------------------------------------------
\1\ OAR is leading the CCSP assessment titled ``Coastal elevation
and sensitivity to sea level rise.''
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Computational Toxicology
ORD will continue its important work in computational toxicology,
applying molecular biology, information management and mathematical and
computer models to assess the risks chemicals may pose to human health
and the environment. The resulting tools could build upon and replace
traditional ways to screen and test chemicals, increasing the
efficiency and effectiveness of risk assessment processes while
reducing the use of animals. In FY 2008, ORD's computational toxicology
research program will focus on information-mining technology, chemical
prioritization and categorization tools, systems biology models, and
cumulative risk assessment.
Water Infrastructure
Our nation's extensive water infrastructure has the capacity to
treat, store, and transport trillions of gallons of water and waste
water per day through millions of miles of pipelines. However, as our
infrastructure deteriorates, there are increasing concerns about the
ability of this infrastructure to keep up with our future needs.
As part of our effort to address these concerns, in FY 2007 ORD
initiated a new water infrastructure research program. This program
will generate the science and engineering needed to evaluate promising,
innovative technologies to repair existing and provide new water
infrastructure that improve effectiveness at reduced cost.
Conclusion
By uniquely combining human health and ecological research in one
federal agency employing world-class research scientists, ORD continues
to develop a better understanding of environmental risks to both human
health and ecosystems. The results of this research consistently and
effectively inform EPA's environmental decision-making, as well as that
of others, leading to environmental policies based on sound science at
the federal, State, tribal and local levels.
As our nation shifts to a green culture, Americans are realizing
that environmental responsibility is everyone's responsibility. Today,
EPA has 300 million citizen-partners. President Bush's budget request
will fund EPA's role as our country enters this next phase of
environmental progress.
Thank you for this opportunity to tell you about the exciting work
we conduct in ORD. I would be happy to answer any questions you have.
Biography for George M. Gray
On November 1, 2005, Dr. Gray was sworn in to serve as the
Assistant Administrator for the Office of Research and Development,
which is the 1,900-person, $600 million science and technology arm of
the Environmental Protection Agency. Dr. Gray was appointed to this
position by President George W. Bush and confirmed by unanimous consent
by the U.S. Senate.
Prior to joining EPA, George was Executive Director of the Harvard
Center for Risk Analysis and a Lecturer in Risk Analysis at the Harvard
School of Public Health. In 16 years at HSPH, his researched focused on
scientific bases of human health risk assessment and its application to
risk policy with a focus on risk/risk tradeoffs in risk management.
George taught toxicology and risk assessment to both graduate students
and participants in the School's Continuing Professional Education
program.
George holds a B.S. degree in biology from the University of
Michigan, and M.S. and Ph.D. degrees in toxicology from the University
of Rochester. He and his wife, Ann, and their two children make their
home in McLean, Virginia.
Chairman Lampson. Thank you, Dr. Gray, and Dr. Morgan,
please proceed.
STATEMENT OF DR. M. GRANGER MORGAN, CHAIR, ENVIRONMENTAL
PROTECTION AGENCY SCIENCE ADVISORY BOARD
Dr. Morgan. Thanks very much. I appreciate the opportunity
to appear here this afternoon.
The mission of EPA is to protect human health and the
environment. While the challenge and the complexity of
environmental problems continues to grow, between 2004 and the
proposed 2008 budget, support for R&D at EPA has declined by 25
percent in inflation-adjusted terms. This year the Science
Advisory Board adopted a strategic approach in its annual
budget review. They asked EPA to give us a cross-cutting look
at all the research they are doing to better address four big
environmental challenges: climate change; sensitive human and
ecological populations; environmental and ecological
consequences of urban sprawl, and natural and terrorist-caused
environmental disasters. Our written testimony details some of
the specifics of what we learned, from which we drew the
following, more general insights.
Because the EPA's research programs have long been
overstretched, the planning process in many programs has fallen
into a reactive mode, too often playing catch-up. Too many R&D
funding decisions are incremental rather than strategic.
On the positive side the introduction of a new system of
national program directors holds the promise to improve
strategic design and balance within existing program areas.
However, the Agency urgently needs to develop a higher-level
research planning effort that: considers and adjusts the
balance and focus among major program areas; breaking down the
stovepipes within which they operate; better coordinates with
the research programs of other federal agencies; benchmarks the
quality and content of programs; and restores our National
leadership in environmental science and engineering so as to
assure that our international competitiveness is sustained and
provide the knowledge and technology that Americans will need
for a clean and healthy environment in the 21st century.
I turn now to a few comments on the proposed 2008 budget.
The decline in funding for ecosystem research has continued,
down roughly 40 percent in inflation-adjusted terms between
2004, and the proposed 2008 budget. The agency is abandoning
past efforts to monitor key ecosystems. For example,
terminating a long-term program to track the impacts and
benefits of reduced acid rain.
The agency has expressed a commitment to estimate the
economic value of ecosystem services. However, the proposed
budget eliminates many of the financial and human resources
needed to do that. Economics and decision science resources at
the Agency have always been small. The proposed budget will
reduce them by more than half, and an associated reorganization
will essentially eliminate behavioral social science
disciplines that are key to effective risk management and risk
communication.
An equally-disturbing trend is the continuing decline in
support for extramural research through the STAR Program, down
32 percent in inflation-adjusted terms between 2004 and the
proposed 2008 budget.
There are a few bright spots. These include growth in
support for the program in nanotechnology and the small new
effort in sustainability research and the remarkable continued
effort by staff to make the best of an ever-worsening financial
environment. But that said, we are deeply concerned about staff
morale as budgets shrink. There is also a growing risk that as
ORD struggles to maintain staff size, an ever-higher proportion
of funds will have to go to salaries with less to cover all the
other costs of doing research.
As you on the House Committee on Science and Technology
confer with your colleagues on the Appropriations Committee, we
particularly urge four actions. One, reverse the downward trend
in support for ecosystem research so that that program can
continue its essential monitoring of the health of vital
ecosystems, develop and implement new measures of the value of
environmental services, and create the basic understanding that
will be needed to respond to the challenges of climate and new
technology, such as biomass fuel and nanotechnology.
Two, reverse the downward trend in support for the STAR
extramural and Fellowship Programs so that the Agency can
continue to benefit from fresh ideas from the outside and
continue a robust program of educating the next generation of
environmental scientists and engineers.
Three, reinstate the program in economics and decision
sciences within ORD and add support for sustainability increase
or for substantially increasing its capabilities in behavioral
social science. Even the best science and engineering is
useless if it is not combined with a sufficient understanding
of human risk perception and behavior.
And finally, four, provide a significant increase in
support for the programs in sustainability and global change,
because these topics are both inherently important, and they
provide effective vehicles for moving the Agency in the
direction of the innovative, cross-cutting research needed to
address the critical environmental problems of the 21st
century.
Thanks very much.
[The prepared statement of Dr. Morgan follows:]
Prepared Statement of M. Granger Morgan
Good morning, Mr. Chairman and Members of the Subcommittee on
Energy and Environment. My name is Granger Morgan. I chair EPA's
Science Advisory Board (SAB or Board). I am a faculty member at
Carnegie Mellon University where I am a University Professor, hold the
Lord Chaired Professorship in Engineering, and am Head of the
Department of Engineering and Public Policy, a department in the
Engineering College.
Thank you for this opportunity to present the SAB's views about the
Agency's 2008 Research and Development budget request.
The mission of the Environmental Protection Agency is to protect
human health and the environment. To do that in an effective and
efficient way requires a deep understanding of environmental science
and technology. However, between 2004 and the proposed 2008 budget, the
overall support for Research and Development at EPA has declined by 25
percent in inflation adjusted terms.\1\
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\1\ As reported by the AAAS R&D Budget and Policy Program at http:/
/www.aaas.org/spp/rd/cht9508b.pdf.
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For many years the EPA Science Advisory Board (SAB) has performed
detailed reviews of the Agency's Research and Development (R&D) budget.
However, we have seen little noticeable effect from our annual plea to
redress what we have seen as the continuing erosion of the ability to
grow the knowledge base at EPA. This year, therefore, the SAB decided
to take a different approach. I have submitted our final report from
this review to this subcommittee for today's hearing record.
While we again offer some commentary about some specifics of the
Agency's research budget, we have focused much of our attention on a
longer-term more strategic look, attempting to assess how well the
EPA's current research program is likely to prepare the Agency to
address four key environmental challenges over the coming decades.
While the Agency will face many challenges, the four we chose to
focus on, and asked EPA to address, are:
a) Climate change, including both impacts (for example on:
natural ecosystems; water, coastal regions through sea level
rise; air quality) as well as key issues such as terrestrial
and deep geological sequestration that may arise as a result of
future efforts in abatement.
b) Sensitive populations, both human and ecological.
c) Urban sprawl and the associated consequences for land use,
stresses on ecosystems, stresses on sensitive populations,
water contamination, air quality, loss of open space, and
related issues.
d) Environmental disasters, both those that may arise as a
result of natural causes (such as hurricanes, ice storms,
drought, earthquakes and volcanism) as well as terrorist
induced events.
The full text of our request to Dr. George Gray, Assistant
Administrator for Research and Development, is attached.
Agency staff made a serious attempt to respond to this request,
revealing a mixed picture. While the Agency can identify a variety of
lines of research relevant to each problem, it is very clear that there
has been far too little cross-EPA or interagency research planning on
these topics. Specifically:
a) Research related to climate change was identified to us as
the most coherently planned. While there is clear coherence
within the domains of climate change impacts on air and water,
there are large and important issues not being addressed. For
example, while the Department of Energy is performing research
on deep geological sequestration of CO<INF>2</INF>, the EPA is
not looking carefully at whether this research will provide the
necessary basis for future science-based regulation. Similarly,
land use, soil and water issues that may arise in connection
with biomass energy production are not being seriously studied,
nor, to our knowledge, are these and several similar issues
being addressed elsewhere across the federal system.
b) The Agency has ongoing, though shrinking, programs to study
certain human populations that are sensitive to some important
environmental stressors. However, studies of sensitive
ecosystems are very limited, as are studies of human
populations which are dependent upon those ecosystems.
c) While there is considerable research directed at cleaning
up legacy problems in land contamination (some of which remain
very important), there is not yet a coherent program to
systematically understand and redress the environmental
problems arising from such land-use issues as shifting
population distributions, urban sprawl, and development
pressures on already vulnerable low-lying coastal areas which
will become even more stressed in the future as a result of sea
level rise and other impacts of climate change.
d) While there is limited work drawing lessons from Hurricane
Katrina, we found no systematic research program to anticipate
and mitigate possible future environmental disasters. Indeed
the proposed budget would totally eliminate Central Basin
(Mississippi-Missouri River) monitoring, and cut EPA's already
under-funded wetlands program. While the EPA has only partial
regulatory and management responsibility for dealing with
natural or terrorist-induced environmental disasters, this is
no justification for devoting so little attention to this
critical topic.
From this look at a sample of four important environmental
problems, we draw the following general conclusions:
<bullet> The Agency's research programs have long faced
greater demands than they have had money, time, or attention to
address; the planning process has fallen into a reactive mode
that is too often playing catch up.
<bullet> With a few important exceptions, the Agency's funding
decisions in R&D appear to be incremental rather than
strategic, leaving allocations within and across major program
areas rather stable. In many cases there is an overemphasis on
yesterday's problems and insufficient attention to new and
emerging problems.
<bullet> On the positive side, the introduction of a new
system of National Program Directors, with wide-ranging
responsibility to set priorities within specific program areas
(such as air, water, or human health), and across Centers and
Laboratories, holds the promise of improved balance and a more
strategic design of research plans within existing program
areas.
<bullet> The Agency urgently needs to develop a higher level
research planning effort that can:
consider and adjust the balance and focus among
major program areas and increase coordination and
collaborations across program areas (i.e., begin to
break down the ``stovepipes'' within which many of
these program have been operating);
be better coordinated with, and build upon, the
research programs of other federal agencies;
benchmark EPA's research with other cutting edge
programs in environmental research around the world;
and
restore our national leadership in environmental
science and engineering so as to assure our
international competitiveness and provide the knowledge
and technology that Americans will needs in the 21st
Century.
However, effective high level research planning is unlikely to
occur in the face of a continually eroding research budget, when so
much attention must be directed at simply holding things together.
In addition to this general assessment, the SAB also reviewed the
Agency's existing program structure, in each case asking:
1. Is the balance within the program appropriate? Are the most
critical scientific questions receiving a high priority? Have
adequate financial resources been allocated to address them?
Are there important questions that have been left out?
2. Is the Agency, and particularly the Office of Research and
Development (ORD), being sufficiently proactive in designing
research programs that will adequately meet the Agency's likely
future needs?
The Agency scientific and technical staff and managers are doing a
remarkable job of sustaining high quality research in the face of a
continuing erosion of financial support. However, in our examination of
existing research program areas, we found three developments to be
especially troubling.
The decline in funding for ecosystem research has continued (see
Figure 1). One consequence of these cuts is that the Agency is largely
abandoning past efforts to monitor the status of key ecosystems (e.g.,
terminating a long-term program tracking the impacts and benefits of
reduced acid deposition on streams and lakes in the mid-Atlantic and
North East). The Agency has expressed a commitment to estimate the
economic value of ``ecosystem services.'' However, as explained below,
many of the financial and human resources needed to do this well, have
been eliminated.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
In order to assess ecosystem services it is essential to collect
the data needed to assess the health of ecosystems over time and to
develop a basic scientific understanding of the complex interactions
within ecosystems. For example, as climate changes, not all species
will be able to respond in the same way so entire coherent ecosystems
will not be able to gradually move north (or up mountains). Instead,
separate species will, or will not, be able to move, new pests will
emerge, etc. The current EPA ecosystem research program will not
provide the science needed to understand, predict, and plan for these
changes, their consequences or how they might be mitigated. As a
result, EPA will fail the country in this vital mission.
One argument that has been used to justify the ongoing cuts in
support for ecosystem research has been that this program has not been
able to quantify the benefits that it is producing. At the same time
there is a proposal to eliminate the ORD program in Economics and
Decision Sciences Research. It appears seriously misguided to raise the
bar for comprehensive cost-effective or benefit-cost justification for
environmental science research, while simultaneously shrinking the
resources devoted to the types of research needed to assess the net
social benefits of the outcomes of environmental science research.
Economics and Decision Science resources at the Agency were small
to start with (about $2.5 million). This budget has been reduced to
about $1 million as staff from the program in ORD are relocated to the
National Center for Environmental Economics (NCEE) within the Office of
Policy, Economics and Innovation (OPEI). In jeopardy are the already
very limited resources for extramural research. Also threatened will be
Agency's tradition of partnering with other institutions to co-sponsor
(at roughly $10-20,000 each) its series of recurring research workshops
and conferences. These events have long been a key forum in which to
identify and explore the frontiers of environmental economics research.
The transition to the NCEE also appears to almost completely eliminate
other social sciences disciplines, so that the representation of
essential human behavior disciplines (such as psychology, sociology,
and anthropology) is decreased to near zero.
An equally disturbing trend is the continuing decline in financial
support for extramural research through the STAR program. Figure 2
shows this trend. A number of EPA research programs that could greatly
benefit from contributions from extramural research conducted through
the STAR program, are not participating.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
An especially troubling part of this downward trend is the erosion
of the STAR Graduate Fellowship program, down from $9.7 million in FY
2003 to a proposed $5.9 million in 2008. This program has been
critically important in educating the next generation of environmental
scientists and engineers who will be needed by EPA, the States and the
private sector. It has played a vital role in supporting
interdisciplinary study of environmental problems. There are several
changes that we found to be very positive. The current focus and modest
growth in support for the program in nanotechnology are both good
developments, because understanding the fate and transport of
nanomaterials is likely to be increasingly important to the Agency in
the future. It is also time to begin a modest program of research to
identify possible strategies for regulation, because the classic
``toxicological testing'' approach is unlikely to be viable if it is
applied unchanged to nanotechnology evaluations.
Although very small, the new Sustainability Research Strategy and
associated Multi-year Plan could provide a valuable integrating
framework for EPA core and problem-driven research. These efforts
support the transition from the traditional single media approach of
environmental protection to a more systems-based and fully integrative
process based on life cycle principles. ORD's sustainability research
program should be developed in a way that enables the Agency to address
the most challenging and multi-faceted environmental issues, such as
urban sprawl, climate change, the environmental consequences of
biofuels production, and ecosystem degradation in interdisciplinary
ways that can provide cost-effective options for reducing a range of
environmental impacts. In addition to the modest progress in
nanotechnology and sustainability, there are other fine research
programs and activities within ORD.
The SAB is concerned that, as the overall level of financial
support for research in the Agency continues to decline, despite the
growing number of difficult and complex environmental challenges, two
dynamics will further erode the EPA's research capabilities:
<bullet> Staff morale will suffer, resulting in an accelerated
loss of outstanding people, and it will be increasingly
difficult to recruit new young scientists and engineers, who
will see options for more rewarding careers elsewhere.
<bullet> As budgets shrink, and the Agency struggles to keep
staffing size reasonably stable, a higher proportion of funds
will go to salaries, and less to the other costs of research
(laboratories, field studies, computers, research travel for
collaboration and discussion of findings at professional
conferences, etc.).
Agency staff are doing an outstanding job of nurturing and
sustaining a high quality program of research in the face of very
serious constraints. They must be provided far better budgetary support
if they are to lead and catalyze our efforts to develop the knowledge
and approaches necessary to protect the Nation's human health and the
environment in the face of hazards that increasingly exhibit integrated
characteristics resulting from man-made behavior and natural processes.
As the House Committee on Science and Technology confers on these
matters with its colleagues on the Appropriations Committee, we urge
particular attention to the following needs to:
<bullet> Reverse the downward trend in support for ecosystem
research so that this research program can continue its
essential monitoring of the health of vital ecosystems, develop
and implement new measures of the value of environmental
services, and create the basic understanding that will be
needed to respond to the challenges facing our ecosystems from
climate change and from the ``externalities'' of new
technologies such as biomass fuel and nanotechnology.
<bullet> Reverse the downward trend in support for the STAR
extramural and Fellowship programs so that the Agency can
continue to benefit from fresh ideas and flexibility provided
by institutions from outside EPA and continue a robust program
of educating the next generation of environmental scientists
and engineers.
<bullet> Reinstate the program in economics and decision
sciences within ORD and add support to substantially increase
its capabilities in behavioral social science. Even the best
science and engineering results are useless if they are not
combined with a sufficient understanding of human risk
perception and behavior.
<bullet> Provide a significant increase in support for the
programs in sustainability and global change, because these
topics are both inherently important and provide effective
vehicles for moving the Agency in the direction of the
innovative, cross-cutting research needed to address the
critical environmental problems of the 21st century.
Thank you again for the opportunity to testify about EPA's research
and development strategy and budget request for 2008. I would be
pleased to answer your questions.
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Biography for M. Granger Morgan
U.S. EPA Science Advisory Board
Dr. M. Granger Morgan is University Professor and Head of the
Department of Engineering and Public Policy at Carnegie Mellon
University where he is also Lord Chair Professor in Engineering, and is
a professor in the Department of Electrical and Computer Engineering
and in the H. John Heinz III School of Public Policy and Management. He
holds a B.A. from Harvard College (1963) where he concentrated in
physics, an M.S. in astronomy and space science from Cornell (1965),
and a Ph.D. from the department of applied physics and information
sciences at the University of California at San Diego (1969).
Dr. Morgan's research addresses problems in science, technology,
and public policy. Much of it has involved the development and
demonstration of methods to characterize and treat uncertainty in
quantitative policy analysis. He works on risk analysis, management and
communication; on problems in the integrated assessment of global
change; on energy systems, focused particularly on electric power; on
problems in technology and domestic security; on improving health,
safety, and environmental regulation; and on several other topics in
technology and public policy.
Chairman Lampson. Thank you very much. And now Dr. Sass.
STATEMENT OF DR. JENNIFER SASS, SENIOR SCIENTIST, HEALTH AND
ENVIRONMENT PROGRAM, NATURAL RESOURCE DEFENSE COUNCIL
Dr. Sass. Thank you. My name is Jennifer Sass. I am a
senior scientist with the Natural Resources Defense Council,
which is an environmental advocacy group, and I am based here
in DC. I am a toxicologist and developmental neurobiologist by
training, and I will be focusing primarily on health impacts of
this budget.
EPA is finding itself spiraling into an increasingly weaker
scientific state. It is faced with the impossible task of
balancing a decreasing budget with an increasing need for
robust data in order to design and inform human health and
environmental regulations that are protective. To deal with
this, the Agency often turns to the regulated industries or
paid contractors who often have clients or members from the
regulated industries to supply it with data, data that is often
suspect and selectively biased. The lack of resources in staff
within EPA leaves it unable to provide adequate oversight of
these data or the scientific products, which are often shielded
from public scrutiny by confidential business information
claims. The result is that EPA is increasingly under pressure
to make regulatory and policy decisions with inadequate data or
sometimes even no data at all.
We strongly recommend that EPA reverse its trend of
reducing its own in-house scientific and technical experts.
These civil servants represent the Nation's brain trust.
Lacking these experts, EPA decisions, relying on confidential
data, lack transparency, oversight, and clear lines of
accountability. For example, the Agency's relationship with the
International Life Sciences Institute, ILSI, demonstrates how
scientific quality may be compromised when transparency and
oversight are lacking. ILSI represents several hundred
corporations, including DuPont, and reportedly received at
least $2.1 million in EPA grants in 2005, the last date for
which I can get publicly-available information. In 2003, EPA
paid an ILSI subgroup to draft an EPA policy document assessing
a large class of toxic chemicals that included some of the
Teflon chemicals manufactured by DuPont, one of ISLI's members.
The ILSI draft was rejected by an expert review panel, but it
did recommend that those chemicals should be deemed safe. Two
years later, more recently, DuPont was fined by EPA, the
largest fine in EPA's history, for withholding data on the
hazards of these chemicals while releasing them as waste
products into the surrounding water. Just today a local
newspaper reported on a Government study that showed elevated
cancer rates in the people that live around the DuPont
Manufacturing Plant that makes these chemicals.
The fiscal year 2008 budget cuts funding to core priorities
such as susceptible populations, ecological research, and human
health diminish EPA's ability to make informed and effective
regulatory decisions and to allocate its resources wisely and
to evaluate the efficacy of its programs. These cuts impair the
ability of regional and state regulators to assess real world
problems as well. For example, the budget reduces funding for
the National Children's Study, a landmark study that would
enhance global understanding of childhood afflictions such as
obesity, autism, early onset diabetes, learning disorders, and
asthma and could potentially lead to healthcare savings of
between 3.3 and $5.5 billion annually.
These kinds of budget reductions or cuts to these programs
are also being seen in the area of publicly available
information, such as the Integrated Risk Information System,
the IRIS database, and also EPA libraries. The IRIS database
contains publicly-available EPA scientific consensus positions
on potential human health effects from environmental
contaminants. State and federal and even international
regulators routinely rely on this information to support an
array of critical environmental health measures such as setting
clean-up standards at waste sites. The IRIS database is likely
to slow its pace because the fiscal year 2008 budget diverts
resources to redundant layers of review by the Office of
Management and Budget and others that serve no purpose other
than to delay final action because of additional review time.
For decades EPA's network of scientific libraries has served as
a goldmine of resources for EPA and the public, but over the
past months EPA has closed five of these libraries and reduced
access to four others, despite EPA's own cost benefit analysis
showing that the libraries actually save approximately $7.5
million annually in staff time and cost only $2.5 million to
operate.
Finally, the fiscal year 2008 budget increases funding to
support research in new technology areas such as
nanotechnologies but fails to develop a clear research agenda
that is actually strategically designed to support policy and
regulatory needs. We know that EPA has already reviewed 15 of
these new nano-scale chemicals, but because of confidential
business information protection claims, we can't learn the
names of these chemicals, their uses, or even their
manufacturers. EPA is considering a voluntary pilot program now
where industry could submit data on nanomaterials to fill the
regulatory breach, but EPA still appears unwilling to commit to
comprehensive, enforceable regulations.
Congress should direct the Agency to allocate adequate
resources to examine toxicity and to develop a robust
regulatory framework to insure that nanomaterials in the
marketplace are safe and that unsafe materials are
appropriately managed from cradle to grave. We recommend that
Congress increase the research budget for EPA, specifically
favoring programs that provide publicly available, policy-
relevant data for priority issues such as children's health,
environmental justice, and susceptible populations. And
Congress should insure that EPA's funds are used in a manner
that preserves scientific integrity, insures adequate
transparency, and encourages public accountability. And most
importantly, EPA must expand and support its technical in-house
experts, its most valuable asset.
Thank you.
[The prepared statement of Dr. Sass follows:]
Prepared Statement of Jennifer Sass
SUMMARY
EPA is finding itself spiraling into an increasingly weaker
scientific state. It has been dealt a decreasing budget for providing
scientific infrastructure and resources, despite an increasing need for
robust data to support human health and environmental protective
policies and regulations. Unable to provide for all the data needs of
the Agency, it is increasingly reliant on data supplied by the very
industries that it regulates and by paid contractors who often have
clients or members from the regulated industries. In all cases, the
data are suspect, and in some cases, the data are selectively biased.
To make matters worse, EPA is increasingly unable to provide adequate
oversight of industry data submissions or contractor-generated
scientific products due to lack of staff and resources. Moreover,
industry data are often shielded from public scrutiny by claims of
confidential business protections on matters that would have to be more
transparent if the work was done by civil servants. The result is that
EPA is increasingly under pressure to make regulatory and policy
decisions with no data, inadequate data, or poor-quality data. These
increasing scientific uncertainties leave EPA programs vulnerable to a
poor grade by the Office of Management and Budget.
The Administration's fiscal year (FY) 2008 budget proposal cuts
programs in the Environmental Protection Agency by $400 million from
the Continuing Resolution for FY 2007 to $7.2 billion. This proposal
represents the lowest funding request in this century in real dollars,
FY 2004 being the high at $8.4 billion. In fact, this request cuts
almost $2.5 billion from the Agency high when accounting for inflation.
The FY08 EPA funding dedicated to Research and Development (R&D) would
be cut by 3.5 percent from the FY07 level, to $547 million.
Many of the cuts to EPA scientific research will not be compensated
by related research spending in other agencies. Although overall
federal investment in R&D would increase by 1.4 percent (to $143
billion) from FY07, an analysis by the American Association for the
Advancement of Science indicates that the increase is all in
development rather than research, and that generally, this budget, like
last year's, increases spending for weapons, defense, and homeland
security, while decreasing health, environment, and discretionary
spending across the federal agencies.\1\
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\1\ American Association for the Advancement of Science. AAAS
Analysts See Mixed Prospects for Federal R&D Investment in 2007 and
2008. Edward W. Lempinen. February 12, 2007. www.aaas.org/news/
releases/2007/0212budget.shtml
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The mission of EPA is to protect and safeguard human health and
environment; yet, this budget continues down the path of deep cuts and
out-sourcing in the face of overwhelming evidence of need.
We recommend that Congress increase the research budget for EPA
specifically favoring programs that provide publicly available policy-
relevant data for priority issues such as children's health,
environmental justice, and susceptible populations.
QUESTION ONE: Is the overall level of Science and Technology (S&T)
funding in the FY 2008 budget request for EPA appropriate and does the
budget request allocate funds in a way to best achieve the Agency's
mission?
EPA's Office of Research and Development has identified the
following high priority research goals in its FY08 multi-year plan,
with a total level of appropriations of $539.8M:
<bullet> Goal 1 ($81.1M): Clean Air (Toxics; Particulates)
<bullet> Goal 2 ($105M): Clean Water (Drinking Water; Water
Quality)
<bullet> Goal 3 ($32.4M): Land Preservation and Restoration
(Contaminated Sites; Hazardous Waste)
<bullet> Goal 4 ($298.9M): Healthy Communities and Ecosystems
(Ecological Research; Human Health; Human Health Risk
Assessment; Global Change; Mercury; Endocrine Disruptors; Safe
Pesticides/Safe Products)
<bullet> Goal 5 ($22.4M): Compliance and Environmental
Stewardship (Economics and Decision Science; Science and
Technology for Sustainability)
While these are laudable goals, sadly, the budget cuts to critical
data collection and data assessment programs that support these
priorities will leave the Federal Government with inadequate
information upon which to base policies and regulations. In particular,
there are gaps in policy-relevant research needs that will not be
filled by other agencies, industry, or academia. Bluntly put, no, this
budget allocation will not achieve the Agency's mission. Moreover,
decreasing data and the consequent increasing scientific uncertainties
leave EPA programs at a disadvantage during review by the Office of
Management and Budget (OMB) Program Assessment Rating Tool (PART),
which favors measurable program impacts and demonstrable efficiency and
efficacy.\2\
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\2\ http://www.whitehouse.gov/omb/part/
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My detailed response follows.
I. The FY08 budget cuts funding to programs that gather reliable real-
world data that would reduce scientific uncertainty, often leaving EPA
increasingly reliant on either no data or data provided by the
regulated industries.
EPA recognizes the need to reduce uncertainty in the science that
supports risk assessment, risk management, and regulatory decisions in
all of its programs. Sadly, budget cuts to key monitoring and data
collection programs will result in less data, and therefore greater
scientific uncertainty. In many cases, ``free'' or ``cheap'' data are
volunteered by the regulated industries. The increased reliance on data
from the regulated industries calls into question the quality and
credibility of the data. This problem is exacerbated by the decreasing
ability of EPA to provide adequate oversight due to budget cuts for
staffing, resulting in reduced technical expertise within EPA, and by
frequent Confidential Business Information (CBI) protections that
prevent public scrutiny to the data.
For example, the Clean Air Mercury Rule (CAMR, May, 2005) requires
EPA to reduce and permanently cap mercury emissions from coal-fired
power plants. Coal-fired power plants are the largest source of human-
derived mercury emissions in the U.S., with much of it ending up in
fish that people eat.\3\ Although implementing this rule requires data
to evaluate the effectiveness of reduction and control measures (S&T-
8), EPA abandoned its promise to fund a mercury hot-spot monitoring
study focused on mercury power plant emissions. The Scientific Advisory
Board (SAB) noted that ``the support for research on global sources,
transport, and fates'' of mercury is ``seriously deficient,'' and that
the 2007 budget levels ``cannot even begin to address the issue.'' \4\
The reality of these budget slashes has left EPA reliant on the
regulated industry to provide monitoring capacity (S&T-8), calling into
question the ability of EPA to deliver credible, reliable data to
inform and implement the CAMR adequately.
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\3\ Once in the human body, mercury acts as a neurotoxin,
interfering with the brain and nervous system. Exposure to mercury is
particularly hazardous for developing fetuses and small children. More
than 13 million lake-acres and 750 thousand river-miles in the United
States are subject to fish consumption advisories due to mercury
contamination. In addition to mercury, coal plants also emit soot and
soot-forming pollutants, which can cause attacks, heart disease and
other health problems, shortening the lives of nearly 24,000 Americans
each year. Children and the elderly are especially vulnerable.
\4\ Report of the U.S. EPA Scientific Advisory Board (SAB), 2007
Budget Review, March 2-3, 2006.
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The Air Toxics Program presents another example of the impact of
these budget cuts on acquiring reliable scientific data. The program
identified the need to, ``reduce uncertainty in both national- and
community-scale assessments as well as residual risk'' (S&T-65). It
also noted that OMB rated its program more favorably when improvements
were made to ``reducing uncertainty in the science that supports
standard-setting and air quality management decisions'' (S&T-68). The
budget report notes that the Air Toxics Program is reviewing other
federal research programs with the goal of measuring progress ``toward
reduction in scientific uncertainty'' (S&T-68). In fact, the FY08
budget provides additional funding to develop ``quantitative risk
assessment methods to allow improved analysis and characterization of
uncertainty in human health risk assessment.'' \5\ Despite the
expressed need to reduce scientific uncertainty, air monitoring
activities that would have provided EPA with real-world data to reduce
uncertainty are significantly reduced. Although the SAB praised the Air
Toxics Program for its efforts to evaluate the current air monitoring
systems, SAB was highly critical of EPA's failure to support air
monitoring resources overall, noting that this ``diminishes the ability
of EPA to make informed decisions on the effective and efficient
management of air quality.'' \6\ A robust, reliable empirical database
is essential for reliable human health risk assessment.
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\5\ Teichman, K. Acting Deputy Assistant Administrator for Science,
ORD. Power Point presentation to the EPA Science Advisory Board
Executive Committee, February 22, 2007.
\6\ Report of the U.S. EPA Scientific Advisory Board (SAB), 2007
Budget Review, March 2-3, 2006.
II. FY08 budget continues the trend of reducing funding for agency
growth of scientific expertise, despite spending significant funds to
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out-source these tasks.
One of the most significant changes at EPA in recent years has been
the degree to which the Agency has out-sourced responsibility for some
of its important functions in a manner that undermines scientific
credibility and public accountability.
EPA is accountable to the people of the United States, the
Congress, and the Executive Branch to fulfill its mission in a manner
that meets both the letter and intent of the law and that appropriately
identifies protecting human health and the environment as the primary
objective of the Agency's activities. Both public trust and EPA's
ability to meet its obligations to the public are seriously undermined
when the Agency farms out critical task without any transparency,
oversight or accountability, in many cases to the very industries that
it is charged with regulating.
In fact, EPA is spending millions of dollars to fund entities that
are specifically beholden to the industries that EPA regulates.
Moreover, in many cases, this funding is directed toward activities
that are central to the Agency's regulatory decision-making process.
EPA does this without ensuring transparency, without adequate
oversight, and without demanding public accountability. In particular,
these arrangements are not subject to important ``sunshine'' laws
intended to provide the public with access to the regulatory process
and to prevent undue industry influence over Agency decisions. These
laws, including the Federal Advisory Committee Act and the Freedom of
Information Act, play a critical role in ensuring government
accountability.
Originally the practice of encouraging these cooperative
partnerships was intended to bring all stakeholders together for
constructive dialogue regarding regulatory policy; however, in recent
years it has transformed into something quite different, and many
stakeholders (such as NRDC and other environmental and public health
groups) have been shut out of the process. In many cases these
partnerships have developed into little more than opportunities for the
regulated industry to take over direct responsibility for key
activities that provide the foundation for EPA's regulatory functions--
in particular scientific analysis and risk assessment. This trend has
had significant implications for the quality of the science upon which
EPA relies for its regulatory activities.\7\
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\7\ A very similar issue was recently raised with regard to the
National Institute of Health (NIH). In January of this year, Members of
Congress, 44 prominent physicians, and 16 health organizations agreed
that, in order to preserve scientific integrity, when appointing
committees for drafting guidelines the NIH ``must strive to ensure that
all members are free from conflicts of interest.'' This letter was
prompted in part by specific concerns regarding the fact that many
recent committees have been dominated by Members with conflicts of
interest. These same problems exist, perhaps to an even greater degree,
at EPA.
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One example of a relationship that has demonstrably compromised the
quality of EPA's scientific inquiry is the Agency's relationship with
the International Life Sciences Institute (ILSI). ILSI represents
several hundred corporations in the chemical, processed food, agro-
chemical and pharmaceutical industries and received at least $2.1
million in EPA grants in 2005.\8\ Members of ILSI include companies
such as DuPont, 3M, Syngenta, Eli Lilly, ExxonMobil Biomedical
Sciences, and Dow Chemical.\9\ ILSI routinely hosts workshops (often
co-funded by EPA) where industry specialists, academics and agency
officials come together to discuss science and policy. There often is
little or no effort made to inform the public or the public interest
community about these meetings, and as a result the public health and
environmental voice is frequently entirely absent, marginalized, or
ignored when final decisions are made. As a result, EPA policy
decisions that emerge from this kind of process are flawed, and those
decisions are being overturned.
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\8\ The ILSI IRS Form 990 for 2005 lists $2.5 million in government
contributions. The EPA Grants Awards Database reports over $2 million
in awards to the ILSI Risk Science Institute. In a January, 2007
response to a FOIA request from NRDC, the EPA provided a list of the
ILSI projects that EPA participates in. FOIA Request HQ-RIN-0029-07 to
Jennifer Sass, NRDC.
\9\ See the ILSI website for a full list of its membership: http://
www.ilsi.org/AboutILSI/.
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For example, in 2003, EPA issued a proposed a guidance (based on a
proposed policy that was drafted by a sub-group of ILSI) on how to
assess a class of chemicals that includes perfluorochemicals used by
DuPont to make Teflon. The ILSI-EPA proposed policy claimed that while
these chemicals caused cancer in laboratory animals, they were not
carcinogenic to humans. An independent scientific panel rejected the
ILSI-EPA draft policy because it was not supported by data.\10\ In
fact, laboratory studies reported that these chemicals are associated
with liver and testicular cancer, developmental impairment, and immune
system suppression. Later, in December of 2005, DuPont paid more than
$16 million to settle charges that it hid information for more than two
decades showing that its Teflon chemicals are a significant threat to
human health.\11\
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\10\ See EPA Advisors Split Over Use of Animal Studies In Human
Risk Reviews, Inside EPA (Dec. 10, 2003).
\11\ See DuPont fined more than $10M over Teflon, Randall Chase,
Associated Press (December 14th, 2005); Consent Agreement, December 14,
2005. (available at: www.epa.gov/compliance/resources/cases/civil/tsca/
eabmemodupontpfoasettlement121405.pdf).
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In response to a request under FOIA, we have received a list of
projects that EPA has undertaken with ILSI. Below we list selected
current and recent-past projects between EPA and ILSI:\12\
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\12\ Freedom of Information Request HQ-RIN-0606-07 to Jennifer
Sass, NRDC.
<bullet> The Office of Pesticides (OPP) reports that they have
numerous ILSI agreements that incurred the following costs:
$58,000 in FY06, $60,500 in FY05, $245,000 in FY04, $150,000 in
FY03, and $287,500 in FY02, for a cost to the program over five
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years of $801,000.
<bullet> Project title: cross-study analyses of children's
biomonitoring cohort studies. Description: ILSI Health and
Environmental Sciences Institute (ILSI-HESI) \13\ will identify
relevant cohorts and data sets, recruit participation from
researchers, work with researchers to develop a data analysis
and quality assurance plan, compile the data, coordinate the
cross-study analyses, and compile results for reporting to EPA.
Timeline: EPA received a proposal from ILSI-HESI in December,
2006. Funding: Anticipated level of funding is $100,000 from
EPA ORD under Goal 4 (Healthy Communities and Ecosystems).
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\13\ The ILSI Health and Environmental Sciences Institute (HESI)
reports to the ILSI Assembly of Members. Although HESI is structured
and claims to operate as a ``public, non-profit scientific foundation''
(www.hesiglobal.org/AboutUs/), they state in their recent job
advertisement for an Executive Director of ILSI-HESI that this person
should ``ensure that the scientific issues important to [ILSI] member
companies are raised and appropriately addressed by the organization.''
(E-mail to: hesi@hesiglobal.org. Subject: Executive Director of HESI
Job Description. Tuesday, 10 Oct. 2006).
<bullet> Project title: International biomonitoring workshop.
Description: EPA co-sponsored a workshop on September, 2004
with ILSI-HESI and the American Chemistry Council, a trade
organization for the chemical industry. Key questions relate to
the use of biomonitoring data for environmental public health
protection. Funding: $50,000 from EPA ORD under Goal 4 (Healthy
---------------------------------------------------------------------------
Communities and Ecosystems).
<bullet> Project title: Cooperative agreement for working
groups, workshops, and other events on topics in risk
assessment. Time: 1999-2002. Funding: $333,330 over several
years from ORD.
<bullet> Project title: Mode of action in assessing human
relevance of animal tumors. Description: A systematic
evaluation of comparability, or lack of comparability, between
the postulated animal mode of toxicity and related information
from human data sources. Time: 2000-2003. Funding: amount not
disclosed. Cooperative agreement with the EPA Office of
Pollution Prevention and Toxics (OPPTS) and Office of Pesticide
Programs (OPP). Additional support was provided by Health
Canada. http://rsi.ilsi.org/Projects/
Human<INF>-</INF>Relevance.htm
<bullet> Project title: Using mode of action (MOA) and life
stage information to evaluate the human relevance of animal
toxicity data. Description: The purpose of this project was to
draw on the ILSI-Risk Sciences Institute (ILSI-RSI) project for
MOA analysis of animal tumors and to expand this into a
harmonize framework for all endpoints including reproductive,
neurological and developmental effects. Time: 2004-2005.
Funding: amount not disclosed. ILSI-RSI project was funded by
EPA's Office of Pollution Prevention and Toxics (OPPT) via
their cooperative agreement and Health Canada. http://
rsi.ilsi.org/Projects/Human<INF>-</INF>Relevance.htm
<bullet> Project title: Training course on use of mode of
action in assessing human relevance. Description: The purpose
of this project is to train the scientific community on how to
conduct mode of action analyses for evaluating the human
relevance of animal responses. Participants consisted of
experts from various government agencies, including the EPA and
Health Canada. Time: 2006, ongoing. Funding: amount not
disclosed. http://rsi.ilsi.org/HumanRelevance.htm
<bullet> Project title: ILSI Risk Science Institute
Developmental Neurotoxicity (DNT) Project. Description: The
goal of this project was to assess the lessons learned from the
implementation of standardized tests for developmental
neurotoxicity in experimental animals, such as the U.S. EPA
OPPTS Health Effects Test Guideline 870.6300 (Developmental
Neurotoxicity Study) and similar protocols, and the subsequent
application of test results to human health risk assessment.
Time: 2004-2007. Funding: OPP funded this ILSI-RSI project via
a Cooperative Agreement.
EPA's continued use of agency funds to support closed-door,
industry-driven science that feeds directly or indirectly into the
regulatory process raises tremendous concerns from a public health and
sound science perspective.
III. FY08 budget is cutting funding to core priorities such as
susceptible populations, ecological research, and human health.
Research on human health and ecosystems has seen a steadily
declining budget over the last three years, from $242.9M (2006), to
$228.2M (2007), to $217.5M (2008) (S&T-3). However, from the FY08
budget it is impossible to identify exactly what programs will be
impacted, because the document fails to clearly link funding amounts
with projects, and fails to clearly identify projects that will be
reduced or eliminated. A short list of specific programs that are
slated to be reduced or eliminated was identified in a Power Point
presentation by ORD Acting Deputy Assistant Administrator for
Science.\14\ This list included:
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\14\ Teichman, K. Acting Deputy Assistant Administrator for
Science, ORD. Power Point presentation to the EPA Science Advisory
Board Executive Committee, February 22, 2007.
<bullet> The loss of data collection in the lower Mississippi
River and Gulf of Mexico wetlands, despite the increased
awareness that these precious areas are critical to mitigating
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severe flooding in the Katrina and Rita hurricane hit areas.
<bullet> The loss of funding for ECOTOX, a critical
searchable, publicly-available web-based database of ecological
effects of toxic chemicals.
<bullet> Reduce assistance to states for development of their
watershed management plans and establishment of Total Maximum
Daily Load values, which are the maximum allowable level of a
pollutant that a waterbody can receive without exceeding water
quality standards. These standards are set to protect the
drinking water supply, swimming areas, and aquatic life.
<bullet> Reduced efforts to collect data on the exposure and
effects of toxic chemicals in children, adolescents, older
adults, and other identifiable susceptible populations.
<bullet> Reduce support for the National Children's Study.
These cuts will eliminate significant research and public access to
important data. They will also diminish the ability of EPA to make
informed and effective regulatory decisions, to allocate its resources
wisely, and to evaluate the efficacy of its programs. In particular,
much of the results of the ecological research identified above is
particularly valuable to regional, state, and local communities and
regulators who are tasked with assessing real-world problems in
regional ecological systems such as watersheds. The SAB identified that
the need for these data are of great importance to EPA, and that the
data are not likely to be supplied by other sources such as industry
and academia.\15\
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\15\ Report of the U.S. EPA Scientific Advisory Board (SAB), 2007
Budget Review, March 2-3, 2006.
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The reduced support for the National Children's Study highlights
the extent to which vulnerable sub-populations will suffer under the
proposed budget. As noted in a 2006 letter from pediatricians, public
health specialists, and patient advocacy groups to the Senate Committee
on Appropriations, the National Children's Study would provide
substantial information for regulators to allocate resources directed
towards improvements in the health of children and adults.\16\ The
research results of this important study are estimated to provide
potential health care savings in the range of $3.3-$5.5 billion
annually based on an economic analysis by the National Institute of
Child Health and Human Development (NICHHD). Information from the
National Children's Study will enhance global understanding of
childhood afflictions such as obesity, autism, early-onset diabetes,
developmental delay, mental illness, learning disorders, lead
poisoning, asthma, auto-immune disease, and chemical intolerance/
sensitivity. The data from these and similar initiatives will be of
particular help to economically-disadvantaged communities whose members
often must play, work, and learn in polluted outdoor and indoor
environments. Compared with adults, prenatal and later periods of
development are uniquely vulnerable to many pollutants in both the
outdoor and indoor environments, due in part to rapid growth and
development, behaviors and activities, eating patterns, and physiology.
Understanding and reducing the severity and/or incidence of diseases
and disabilities will require sustained public investment in research
on childhood exposures to environmental toxicants.
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\16\ Letter to Honorable Thad Cochran, Chairman, and Honorable
Robert C. Byrd, Ranking Member. Senate Committee on Appropriations.
From E. Miller, R. Zdenek, D. Croser, J. Greenwood, C. Gavigan, F.
Perera, P. Shah, J. Balbus, P.J. Wood, N. Gendel, C. Barnett, D.
Wallinga, S. Gilbert, T. Hill, K. Lawson, J. Behm, H. Loukmas, L.
Redwood, T. Schettler, V. Garry. February 14, 2006.
IV. FY08 budget eliminates or diminishes support for publicly
available information on toxics: the IRIS chemical evaluation program,
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EPA libraries.
Inadequate resources and OMB interference have prevented EPA from
keeping the IRIS chemical database as up-to-date as would be
expected for a source of information so important to U.S.
policy decisions.
Many of the EPA assessments of regulated chemicals are publicly
available on its database, the Integrated Risk Information System
(IRIS), which contains EPA scientific consensus positions on potential
human health effects from environmental contaminants. While not a legal
regulatory standard per se, such information is used by regulators at
the State and federal level and by the international community in
combination with exposure data to set cleanup standards and various
exposure standards for air, water, soil, and food. The database
receives over a half-million visits monthly, from over fifty countries,
underscoring its widespread use. At this time, there are over 540
chemicals listed on IRIS. While a substantial number of these chemicals
are economically significant (i.e., they are produced or imported at a
rate greater than 10,000 pounds per site annually), these chemicals
make up a small percentage of the over 8,000 economically significant
chemicals found in the U.S. and 15,000 chemicals in commerce
altogether.\17\ Even when compared to a smaller subset of chemicals
that should have assessments available, IRIS is obviously insufficient.
For instance, the EPA is responsible for regulating the emissions of
188 hazardous air pollutants (HAPs) under the Clean Air Act. Of these
188 HAPs, only 129 do appear in the IRIS database--meaning that in
almost 20 years since IRIS, the EPA has been unable to complete
assessments of the toxicity and carcinogenicity of nearly one-third of
these dangerous pollutants. Even when important chemicals are on the
IRIS database, the risk assessments available for these chemicals are
often quite old. The average assessment on IRIS is over 13 years old.
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\17\ American Chemistry Council: Federal Regulations That Help
Ensure Chemical Safety, available at http://www.accnewsmedia.com/docs/
1200/1156.pdf (last updated April 1, 2003).
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According to its website on ``what's new'' (www.epa.gov/iris/
whatsnewarch.htm), in addition to performing a literature screen and
confirming about a dozen existing IRIS assessments annually, EPA
finalized the following number of new chemical assessments:
<bullet> In 2006, IRIS finalized two new assessments.
<bullet> In 2005, IRIS finalized five new assessments (n-
hexane, toluene, zinc and compounds, barium and compounds,
perchlorate and perchlorate salts).
<bullet> In 2004, IRIS finalized three new assessments (boron
and compounds, dibromomethane, lead and inorganic compounds).
With so few assessments finalized each year, it is evident that EPA
needs more resources, both money and personnel, to develop robust
timely IRIS assessments. The FY08 budget promises that IRIS will
complete 16 health hazard assessments of high priority chemicals and
post eight finalized assessments on the Internet (S&T-89). Its hard to
see how IRIS is going to finalize eight assessments, given its recent
trend of finalizing two to five each year. In fact, the IRIS program
should be finalizing as many as 16 assessments each year.
Unfortunately, the reality is that IRIS is likely to slow its pace
further because of FY08 initiatives to ``expand opportunities for
interagency review and public comment'' and expand ``consulting with
the National Academies of Sciences'' on risk assessment methods and
approaches (S&T-89), as required by the OMB PART review (S&T-90). These
costly and time-consuming delays will significantly slow an already
delayed process. Moreover, OMB interference has also weakened the
utility of IRIS assessments:
<bullet> OMB has blocked IRIS from posting acute (less than 24
hrs.) risk values.\18\ Acute risk values are relevant to
communities that are exposed by burst releases of toxics
(smokestacks, etc.) that may not exceed short-term (days-weeks)
or long-term (months-years) regulatory standards, but may still
pose a hazard to acutely exposed individuals.
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\18\ EPA Eyes Expanded Risk Database Used In Toxic Regulation,
Cleanups. The managers of an EPA chemical risk database are considering
adding short-term and acute exposure categories on several chemicals to
gauge the resources needed to add the broader risk data to the system.
January 27, 2003. Inside Washington Publishers.
<bullet> OMB is blocking IRIS from posting summaries of its
assessments, arguing that the summaries give a naive public and
regulators inaccurate impressions, contribute to
misunderstandings, and are misused. EP staff should be able to
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post summaries of IRIS data on chemicals to the public.
<bullet> OMB has blocked the implementation of the
supplemental cancer guidelines on children's exposure.\19\
Ethylene oxide is the first example where IRIS staff
recommended applying a 10-fold safety factor to site-specific
assessments where children may be exposed. OMB blocked this.
The next relevant chemical for this process will be acrylamide,
for which children's exposures are high.
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\19\ OMB Opposes First-Time Child Cancer Factor Use In EPA Risk
Assessment. The White House Office of Management & Budget (OMB) is
reportedly objecting to EPA's first-time use of a new children's cancer
guideline in a draft risk assessment for ethylene oxide (EO) that seeks
to significantly strengthen the safe exposure level, according to EPA
sources. . .. The draft risk assessment, released Sept. 22 of last year
by the Agency's National Center for Environmental Assessment, proposes
tightening the Agency's 1985 bench point of 3.6 parts per billion to
0.06 parts per trillion--a significant change that could have a host of
ramifications for industry. . .. Ethylene oxide is a common chemical
that is widely manufactured, and is used as a medical sterilant as well
as to make anti-freeze, detergents and polyester. January 26, 2007.
Inside Washington Publishers.
IRIS has come under intense scrutiny from OMB and the regulated
industries, and that the EPA goal of producing robust scientific
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assessments of toxic chemicals in a timely manner is not shared by OMB.
Closing EPA Libraries limits public access to information.
For decades, EPA's network of 26 scientific libraries has served as
a gold mine of resources for scientists, community members, and EPA's
own staff. Expert librarians made themselves available to locate
information, and the library collections themselves contained unique
materials, not available elsewhere. Over the past four months EPA has
closed five libraries and reduced access at four others, including my
local EPA library.\20\
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\20\ Congressional Research Service. Restructuring EPA's Libraries:
Background and Issues for Congress. RS22533. January 3, 2007.
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According to press reports, the EPA libraries fielded about 134,000
information requests in fiscal year 2005.\21\ Of these, the now-closed
EPA regional libraries in Chicago, Kansas City, and Dallas handled more
than 32,000 requests for information.\22\ Representatives of 10,000 EPA
scientists, engineers, environmental protection specialists and support
staff protested the closure of the technical libraries in a letter to
the Chair and Ranking Member of the Senate Appropriations Committee,
Interior and Related Agencies Subcommittee in June of 2006.\23\ This
letter noted that EPA's own cost-benefit analysis\24\ estimated that
the library networks saved Agency staff time, resulting in annual cost
savings of approximately $7.5 million, far more than the library budget
of $2.5 million. Thus, the Public Employees for Environmental
Responsibility suggest that, ``while cloaked as a budgetary measure,
the actual motives appear to be rooted more in controlling access by
both EPA staff and the public to information.'' \25\
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\21\ Joal A. Mintz and Rebecca Bratspies. Closing Agency Libraries
Deals Serious Blow. South Florida Sun-Sentinel. December 11, 2006.
\22\ Robert McClure. EPA gets an earful on library closures.
Seattle Post-Intelligencer. January 22, 2007.
\23\ Letter from Dwight A. Welch et al. Presidents of 16 Local
Unions to Conrad Burns and Byron Dorgan, United States Senate. June 29,
2006. www.peer.org/docs/epa/
06<INF>-</INF>29<INF>-</INF>6<INF>-</INF>union<INF>-</INF>library<INF>-</INF>
ltr.pdf
\24\ EPA Office of Environmental Information. Business Case for
Information Services: EPA's Regional Libraries and Centers. EPA 260-R-
04-001. January 2004.
\25\ http://www.peer.org/campaigns/publichealth/
epa<INF>-</INF>library/index.php
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Linda Travers, acting Assistant Administrator for the EPA Office of
Environmental Information said in December 2006 that ``all EPA-
generated documents from the closed libraries would be online by
January and the rest of the Agency's 51,000 reports would be digitized
within two years.'' \26\ Not surprisingly, this has not been done.
Digitizing between 50,000 and 80,000 reports is a monumental task and
there does not appear to be any budget for carrying this out. Rather
than saving the Agency money, these closures will cost the Agency in
staff productivity, and in money and time for digitization. The cost to
local communities is hard to calculate, since information--when you
really need it--is priceless.
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\26\ Tim Reiterman. Closure of six federal libraries angers
scientists: Cost-cutting moves at the EPA and elsewhere deny
researchers and the public access to vital data, critics say. Los
Angeles Times, December 8, 2006.
IV. The FY08 budget increased funding to support research on new
technology areas such as nanotechnologies, but has failed to develop a
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clear research agenda that would support policy and regulatory needs.
Nanotechnology (the convergence of biology, chemistry, and
engineering at the nanoscale) has emerged as one of the most rapidly
developing, dynamic, and exciting fields of scientific research and
commercial development. Nanoscale materials approximately 100
nanometers (nm) or less in any dimension offer potentially tremendous
advances in fields ranging from medical technologies to power
generation and storage to environmental remediation strategies.
However, the rapid emergence of new nanomaterials and their increasing
use in products and processes raises serious concerns regarding the
potential for adverse impacts on human health and the environment.
Already, EPA has reviewed 15 new chemical uses that were small enough
to be considered nanoscale; all are protected by Confidential Business
Information (CBI) provisions under the Toxic Substances Control Act;
the public is unable to learn the names of these chemicals, their uses,
or even their manufacturers.
Current EPA research activities include assessing potential
ecological and human health exposures and effects from nanomaterials
likely to be released into the environment (S&T-108, -109). However,
this research is poorly coordinated, inadequately funded, and poorly
tailored to EPA's authority to regulate nanomaterials.\27\ In fact, in
September, 2006, the House Science Committee Chairman Sherwood Boehlert
(R-NY), Ranking Minority Member Bart Gordon (D-TN) and non-government
witnesses identified the need for EPA to develop a better-funded
research strategy to address health and environmental risks, noting
that the current research agenda lacked coordination.\28\
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\27\ Summary Report of the Peer Review Workshop on the
Nanotechnology White Paper: External Review Draft. Washington, DC,
April 19-20, 2006. Prepared by the US EPA Office of the Science
Advisor, by Versar, Inc. www.epa.gov/OSA/pdfs/nanotech/nanotechnology-
peer-review-workshop-summary-report-final-070706.pdf
\28\ U.S. House of Representatives (www.house.gov/science) Science
Committee. Boehlert calls for better coordination and greater funding
to understand nanotechnology risks: Administration Releases Report on
``Research Needs.'' September 21, 2006.
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A voluntary pilot program now under consideration by the EPA will
request that industry participants submit data on material
characterization, toxicity, exposure potential, and risk management
practices. While this program may act as a stopgap to fill the
regulatory breech, it would only involve those companies that volunteer
to participate and would gather data regarding only those products that
participating companies choose to disclose. Companies with the riskiest
products, as well as those with poor business ethics--that is, those
most likely to need government oversight--are least likely to
participate. A coalition of more than 20 public interest groups
including NRDC, Friends of the Earth, Greenpeace, and Sierra Club
insist that a voluntary program without a mandatory regulatory
component will not be able to address potential risks. The reliance on
voluntary stewardship initiatives has left a regulatory void that could
harm both human health and the economic stability of the nanotechnology
industry. Nonetheless, the EPA appears unwilling to commit to
comprehensive, enforceable regulations.
Congress should specifically direct EPA to allocate adequate
resources not only to examine nanomaterial toxicity (an absolutely
essential first step), but also simultaneously and aggressively develop
a robust regulatory framework that will adequately ensure that
nanomaterials in the marketplace are safe, and that unsafe materials
are appropriately managed from cradle to grave. Any such framework
should be based on a precautionary approach to managing toxic chemicals
and should:
<bullet> Prohibit the untested or unsafe use of nanomaterials.
Because preliminary data demonstrates the potential for
toxicity, unsafe or untested nanomaterials should not be used
in a manner that may result in human exposures or environmental
releases over the life cycle of the material.
<bullet> Conduct full life cycle environment, health, and
safety impact assessments as a prerequisite to
commercialization. Robust testing is urgently needed to
identify potential risks early in development, across the life
cycle of the material. The results of testing should made
available to the public.
<bullet> Facilitate full and meaningful participation by the
public and workers in nanotechnologies development and control;
consider the social and ethical impacts of nanotechnologies.
The potential of nanotechnologies to transform the global
social, economic, and political landscape means we must move
the decision-making out of corporate boardrooms and into the
public realm.
<bullet> Implement precautionary regulatory requirements for
nanomaterials. We urgently need regulations to ensure that
risks are adequately addressed and that communities and workers
are protected.
Nanomaterials represent a large, but not a new, challenge for the
regulatory agencies. The need to regulate a commercial material about
which little is known of its safety is reminiscent of our introduction
of asbestos into global markets. By the 1930s, asbestos was being
linked to deaths; as of 2004, the cumulative financial liabilities from
the substance were projected at more than $200 billion. In the U.S., we
still have more than one death per hour--approximately 10,000 per
year--as a legacy from past and continuing exposure to asbestos; the
global death rate is estimated at 10 times higher. Insurer Lloyds of
London and Swiss Re have already noted that asbestos serves as a
warning to the nanotech industry. To use another analogy, with
nanotechnologies we are right now at the point of deciding whether to
put lead into gasoline.
QUESTION TWO: What roles should research partnerships, extramural
grants, contracts, and in-house research play in helping the Agency to
obtain the scientific information needed to serve their mission of
environmental and public health protection?
Congress adopted strong sunshine laws in part to prevent
clandestine manipulation of the regulatory process, and that objective
is in serious jeopardy if EPA is permitted to out-source critical
responsibilities. Congress should ensure that the money going to EPA is
used in a manner that preserves the scientific integrity of the
regulatory process and that any important science activities funded by
EPA are conducted with adequate transparency and direct lines of public
accountability. In particular, EPA should not be funding or relying on
regulated industries or their representatives to develop EPA guidance
or policy documents, or to develop scientific assessments of their own
chemicals for EPA. Rather, industry-funded or industry-supported
assessments and recommendations should be submitted to EPA as a public
comment, publicly available, and subjected to the same consideration
and review as all public comments.
EPA should support and expand its use of in-house scientific and
technical experts. These people represent the Nation's brain-trust, and
their work products should be publicly available. The Agency's own
technical experts have to be enabled to investigate and disclose what
dangers we truly face from environmental pollutants, despite myriad
influences of business interests. Grievous and irreversible damage is
being done to this Agency's capacity to protect human health and the
environment.
Biography for Jennifer Sass
Jennifer Sass is a Senior Scientist at the Natural Resources
Defense Council (NRDC) based in Washington, DC. She works in the Health
and Environment Program, which reviews the federal regulation of
industrial chemicals and pesticides. Over her five-plus years with
NRDC, Dr. Sass has published over two dozen articles in scientific
journals, provided written and oral testimony to the Environmental
Protection Agency and National Academies of Science, as well as served
on federal scientific and stakeholder committees. Dr. Sass completed
postdoctoral studies at the University of Maryland in toxicology,
doctoral studies at the University of Saskatchewan in developmental
biology, and a Master's thesis in neurobiology.
Jennifer also directs NRDC's work on nanotechnologies, and has
served on several U.S. federal scientific and stakeholder committees
related to nanotechnology, including the National Toxicology Program
Nanotechnology Working Group, NIEHS. Jennifer has published articles on
the risks of nanotechnologies, and need for regulations, including:
Nanotechnologies: The promise and the perils. Sustainable Development
Law & Policy journal (Spring, 2006).
Chairman Lampson. Thank you, Dr. Sass. Please now proceed,
Dr. Coull.
STATEMENT OF DR. BRUCE C. COULL, CAROLINA DISTINGUISHED
PROFESSOR EMERITUS AND DEAN EMERITUS, SCHOOL OF ENVIRONMENT,
UNIVERSITY OF SOUTH CAROLINA; PRESIDENT, U.S. COUNCIL OF
ENVIRONMENTAL DEANS AND DIRECTORS, NATIONAL COUNCIL FOR SCIENCE
AND THE ENVIRONMENT
Dr. Coull. I am here actually, well, I am from the
University of South Carolina. I am proud to be a South
Carolinian, Bob, okay. I am actually here representing the
National Council of Environmental Deans and Directors of the
United States, of which there are 134 colleges and universities
who are members of the Dean's Council.
The Dean's Council is part of that National Council for
Science and Environment, whose mantra is we need good science
to make informed decisions. And the tenet of our major
discussion today is that we don't think that EPA has had the
resources to generate the science that is needed for good
decisions across the board in various aspects of the
environment.
As you have heard from Dr. Sass and Dr. Morgan, the EPA
research budget has been declining over the last several years,
and my written testimony and their work lays out the details
for you. The EPA budget has essentially been flat for a quarter
of a century, which the environmental challenges have become
much more complex, and there are needs for new approaches. We
didn't know 25 years ago about endocrine disrupters. We didn't
know 25 years ago about nanoparticles. We didn't know about a
lot of things then. It is time to ratchet up the EPA research
budget for these new modern looks at the environment, and the
tables in the handout give you the details of the declines that
we have seen, and you have seen the data from the others.
It is almost across the board that we look at this. One of
the things that I think we need to consider is what don't we
know that we should have known, and I want to specifically give
you an example from South Carolina. I have colleagues at the
university, at Clemson University, and I do talk to people at
Clemson, and at the National Ocean Science Laboratory in
Charleston, who have been funded by EPA through the STAR
Program to look at endocrine disrupters in coastal ecosystems.
This is particularly relevant to your statement, Mr. Lampson,
about economic health of communities dependent upon
recreational and fisheries. This work was done primarily in the
Hilton Head region, very close to your birthplace, Congressman,
and the results are that crustaceans, which are an important
part of the industry in South Carolina, shrimp, particularly,
and crabs, are inhibited in their reproduction by several of
the endocrine disrupters sprayed on golf courses at Hilton
Head.
Two kinds. One, a particular pesticide called Fipronil,
which the EPA has indeed identified as a potential endocrine
disrupter, which is sprayed on golf courses so we can keep the
bugs down, and we don't have too many bugs on your green while
you are trying to punt, excuse me, trying to putt. All right.
And secondly, it may be trying to punt, and secondly, the town
of Hilton Head actually used sewage effluent from the city to
spray on the golf courses. This is all within regulation.
Bacteria are killed, the water is clean per se, but it hasn't
cleaned the water of those birth control products that are
still in the water, Viagra has been measured in the water. I
guess that is to keep the shrimp going. I don't know. And
various antibiotics in the particular system. My colleagues at
the three institutions had been funded significantly by the EPA
STAR Program. They are now receiving 25 percent of the funding.
They do not know, they cannot tell us now how this, these
endocrine disrupters are passed up food chains. Am I eating
endocrine messed up shrimp? That doesn't do anything to me. I
am well past the reproductive age. Okay. But it may for others
in the environment.
Secondly, we also have a problem with mercury, and that
budget has been zeroed out in the proposed budget. The
endocrine disrupter budget has been zeroed out in the proposed
budget. Mercury is a goal of EPA's from last year, and the goal
is to find out where it is and how it affects the population.
There is no way that the Agency, either through its labs or
through its extramural programs, can attempt to look at those
things. Promising approaches mentioned by Dr. Morgan in
sustainability, socio-economic aspects, and ecosystems are also
being greatly reduced across, and we can't go into the details
of all of those.
It is nice to see the influence and the money coming in to
the Nano Program. Nanoparticles are an important part of our
life. They are going to either be the PCBs of the next
generation, or they are going to be the world savers, or they
are going to be something in-between.
Our point is you cannot make science-based decisions
without the science. The role of extramural research, academic
research, which is, as a former administrator, and I must tell
you that one of the best names to have in a university setting
attached to your name is emeritus. That means you are retired,
and you don't have to deal with lots of other things. All
right. But our schools, our 134 said schools, all right, are
producing 40 to 50 percent of the students, the grants, and the
publications of all ORD research. So the said schools represent
a good portion of the extramural research going on in the
United States through the Office of Research and Development.
We bring the expertise of the entire scientific community to
bearing problems. We provide the training for the next
generation. We are the people who do that. Of the STAR Fellows
Program 88 of our 134 institutions have educations STAR
Fellows, that is the fellows that are declining so rapidly as
we saw in Dr. Morgan's presentation.
And the thing that is so interesting here is that
extramural research, both grants and fellowships, can be ramped
up very quickly with additional funding. We don't need new
infrastructure. We have it. We don't need new people to run
this personnel. This is out there, and there are very hungry,
bright, young faculty, not emeritus ones, but bright, young
ones out there who are very capable at all institutions ready
to do these kinds of things.
Just knowing that this is not within your purview, I also
want to reiterate the statement of Dr. Sass on environmental
libraries, and I also want to reiterate the statement we have
heard before related to environmental education. We in
universities, of course, are educators primarily, and the
Environmental Education Program and the Library Programs have
been significantly cut from the general EPA budget. And we
would hope that your Committee could work with the Education
Committee to try to make that something we need. Environmental
education now as our Earth becomes more and more under siege is
critical if we don't educate the public and our students how
they are doing.
It is time for the Science Committee to provide leadership,
send a strong message to the appropriators and other
authorizing committees, as well as the Agency itself. We need a
strong investment in environmental research, education, and
information. EPA needs to be the Agency that takes the lead in
this and needs to be consistent with the rederick about
science-based decision-making.
[The prepared statement of Dr. Coull follows:]
Prepared Statement of Bruce C. Coull
Summary
The U.S. Environmental Protection Agency research budget situation
is chronically bad and getting worse. In order to fulfill its mission,
EPA needs increased investments in both its intramural and extramural
science programs as well as associated services such as environmental
education and libraries. The proposed cuts in research areas are
devastating exactly the areas EPA ought to be investing in
socioeconomic, sustainability, ecological, and exploratory research as
well as partnerships with academia and State and local government.
These areas are essential to move environmental protection from a
command-and-control regulatory system to a more rational, compliance-
based approach.
The National Council for Science and the Environment (NCSE) urges
Congress to appropriate a minimum of $700 million for EPA's Office of
Research and Development (bringing it back to FY 2004 levels),
including at least $150 million for EPA's Science to Achieve Results
(STAR) research grants program and $20 million for EPA's STAR graduate
fellowship program. We recommend a total of $900 million for EPA's
Science and Technology account. NCSE also urges Congress to restore
full funding for the Office of Environmental Education at a level of at
least $10 million. Finally, we urge Congress to stop the ill-conceived
and poorly-executed closure of EPA's libraries.
The National Council for Science and the Environment is dedicated
to improving the scientific basis for environmental decision-making. We
are supported by over 500 organizations, including universities,
scientific societies, government associations, businesses and chambers
of commerce, and environmental and other civic organizations. NCSE
promotes science and its essential role in decision-making but does not
take positions on environmental issues themselves.
NCSE's Council of Environmental Deans and Directors (CEDD) includes
the leaders of environment programs at more than 130 colleges and
universities in the U.S. These institutions produce the bulk of the
Nation's environmental scientists and environmental professional
workforce. CEDD meets the critical national needs to ensure continued
excellence in academic environmental programs and to provide a high
quality environmental workforce and an informed public.
Introduction
Mr. Chairman, thank you for the opportunity to testify at this
important hearing on science and technology at the Environmental
Protection Agency (EPA). My name is Bruce Coull. I am testifying in my
capacity as 2006-2008 President of the U.S. Council of Environmental
Deans and Directors (CEDD) a program of the National Council for
Science and the Environment (NCSE). I am also Carolina Distinguished
Professor Emeritus and Dean Emeritus, School of the Environment,
University of South Carolina in Columbia, South Carolina.
Previously, as Dean of the School of the Environment, I led the
University of South Carolina (USC) to approach environmental issues
through multi-disciplinary research, education and community outreach.
I headed the South Carolina Sustainable Universities Initiative (http:/
/www.sc.edu/sustainableu), a multi-university project educating about
frugal use of Earth's resources and was the architect of the greening
of the University of South Carolina. I also led USC's environmental
efforts in the Ukraine related to the Chernobyl nuclear accident of
1986. Currently, I direct the South Carolina Lowcountry Initiative of
the Chicago and New York-based Center for Humans and Nature (http://
www.humansandnature.org). This initiative aims to assist local
decision-makers in making sensible use of resources in the South
Carolina coastal region.
I am a marine biologist by training. I am here today to discuss the
importance of greater investments in environmental research, education,
and information and the consequences of chronic under-investment on
environmental decision-making.
Environmental Science and Decision-making
The call for decisions, environmental and otherwise, to be made on
the basis of science is almost a mantra used across the political
spectrum. Yet, behind the rhetoric, a simple truth remains. Without
investment in science and in scientists, there can be no science-based
decision-making.
Despite this statement of the obvious, many federal departments and
agencies and those in Congress who fund them try to get environmental
decision-making on the cheap. This has been the case with the
Environmental Protection Agency for a very long time and the proposed
budget only worsens this sorry situation. The EPA R&D portfolio of $540
million in the FY 2008 budget request would be a 3.3 percent cut from
the likely 2007 funding level with increases for homeland security-
related research somewhat masking cuts to most research areas. This
would leave EPA's Office of Research and Development with its lowest
budget since 2000 in nominal dollars and its lowest budget in constant
dollars since at least 1990 (AAAS data).
In real dollar terms, EPA's funding of science is nearly unchanged
since at least 1990, and has been steadily declining since FY 2004
(Figure 1). In fact, the flat budget extends back at least as far back
as the early 1980s. During these decades, the magnitude and complexity
of our nation's environmental challenges has increased many-fold.
Science, including that conducted by EPA, has helped us to make great
advances with the local issues of point-source pollution. But the
problems faced by EPA, our nation and our planet today encompass local,
regional, national and even global scales. They will not be addressed
by science-funding as usual. As then-Chairman Representative Vernon
Ehlers said last year, ``just as we can't afford to spend too much, we
can't afford to spend too little.''
A research budget of less than $600 million for an agency dealing
with these challenges is simply unacceptable. In contrast, the National
Institutes of Health (NIH) has an R&D budget of over $28 billion (50
times more than EPA research). NASA's budget of $12 billion is almost
20 times larger than EPA's research budget.
In order to focus on the highest priority issues and provide
coordination for achieving its research goals, EPA's Office of Research
and Development has produced multi-year plans (http://www.epa.gov:80/
osp/myp.htm) for the following high priority research areas that are
linked to EPA's five major strategic goals:
Goal 1: Air
<bullet> Air Toxics
Particulate Matter
Goal 2: Water
<bullet> Drinking Water
Water Quality
Goal 3: Land
<bullet> Contaminated Sites
Hazardous Waste
Goal 4: Communities & Ecosystems
<bullet> Ecological Research
Human Health
Human Health Risk Assessment
Global Change
Mercury
Endocrine Disruptors
Safe Pesticides/Safe Products
Goal 5: Compliance and Environmental Stewardship
<bullet> Economics and Decision Science
Science and Technology for Sustainability
Nearly half of these issues were largely unknown 25 years ago, yet
the amount of available funding is actually less. In fact, even the
meager amount of money for most of these issues continues to decline.
We increasingly understand the connection between environmental
quality and human health. Last month, ``Integrating Environment and
Human Health'' was the theme of NCSE's 7th National Conference on
Science, Policy and the Environment, which involved more than 800
scientists and decision-makers. Numerous examples were presented to
demonstrate the dependence of human health on the quality of the
environment, including emerging diseases such as avian influenza,
episodic diseases such as cholera, toxicants such as arsenic and
mercury, and illnesses that result from our lifestyle such as the
relationship between suburban sprawl, urban blight, other aspects of
the built environment and a host of health problems including
cardiovascular diseases and obesity.
Additionally, climate change is already having impacts on health,
including more than 30,000 Europeans who died in the heat wave of the
summer of 2003, Arctic peoples who are unable to continue subsistence
hunting due to the rapidly melting polar ice caps, and the residents of
the Gulf Coast and Atlantic coast killed, sickened or made homeless by
intensified hurricanes such as Katrina. Scientists and professionals
are once again realizing that we can't have healthy people in unhealthy
environments. EPA, with its mission to protect human health and the
environment is the ideal place for integrated research to happen and be
funded, but funding levels are not sufficient to be effective. An
editorial from this week's issue of Science magazine, by Richard
Jackson, former Director of the CDC National Center for Environment and
Health, who was one of the speakers at our recent conference, that
shows the tight connection between environment and health is attached
to this testimony.
EPA's strategic plan calls for science-based decision-making, but
it's not possible to achieve this goal if the Agency's capacity to
conduct science is continually reduced. EPA's strategic plan for 2003-
2008 says, ``EPA has identified reliance on sound science and credible
data among the guiding principles we will follow to fulfill our mission
to protect human health and the environment.'' EPA needs to reverse the
decline in its capacity to conduct science in order to fulfill its
mission.
EPA's proposed science budget
Compared to FY 2006, EPA's overall budget would fall $400 million
or 5.5 percent to $7.2 billion under the President's FY 2008 budget,
after a similar cut in 2006. EPA's shrinking R&D portfolio would
decline to $540 million in FY 2008, after declining to $595 million in
FY 2006 from $621 million in FY 2005 and a high water mark of $647 in
FY 2004. Funding for most EPA research areas would decline. EPA's R&D
funding would fall to its lowest level in almost two decades in real
terms (Figure 1). If EPA's FY 2008 budget proposal is enacted, the
Agency's Science and Technology (S&T) funding would decline by $71
million or 12 percent since FY 2004 and the Office of Research and
Development budget would decline by $107 million or 16.5 percent during
the same period.
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A healthy research program depends on having sufficient resources
to:
a. keep up with and use the newest scientific methods,
b. provide the most up-to-date scientific information for the
Agency's regulatory decisions and core research programs, and
c. build and maintain strong ties with the external research
community and foster graduate student work in the environmental
sciences.
Unfortunately EPA's research program is in a chronically unhealthy
state. Despite major successful reforms (including a new extramural
research and fellowship program) in response to criticisms leveled in
the 1980s and early 1990s, EPA's ability to garner the best science for
its decision-making has been constrained severely by a lack of
resources. This is particularly vexing given the desire of many policy-
makers to move away from a ``command and control model'' to a more
rational market-based approach to environmental performance. A market-
based approach will succeed only if all participants have access to
high quality science-based information on which to make their
decisions. Additional science is needed to develop metrics of success
and to monitor progress toward desired outcomes.
According to the President's budget demand, funding for EPA's S&T
account is projected to fall in 2008, 2009, and 2010 before rebounding
slightly in 2011. After adjusting for inflation, EPA R&D could fall a
further 16 percent over the next five years. Even if Congress adds to
the administration's request during the appropriations process,
congressional add-ons may end up going to earmarked projects rather
than to boost core EPA research programs, leaving most EPA research on
a downward path with further cuts to come. This situation is
unsustainable and should be unacceptable to this committee.
EPA's Extramural Science and Education Programs
EPA created the extramural Science to Achieve Results (STAR)
program as part of a set of reforms to EPA science proposed by the
National Academy of Sciences in the 1990s. STAR provides EPA an
opportunity to better take advantage of the intellectual and scientific
resources of the academic community and apply these resources to the
challenges faced by EPA. It is EPA's principal means of getting the
best environmental researchers in our colleges and universities to
direct their attention to the most critical environmental problems of
the Nation. STAR grants complement EPA's own scientific staff by
bringing an additional independent voice and excellence in additional
fields of science. STAR also provides funds for preparing the next
generation of environmental scientists and engineers, both through
graduate fellowships and as research assistants on grants to faculty
members. We note as of January 2006, Project Investigators (PIs) from
colleges and universities included in CEDD have published more than
3463 journal articles (representing 43 percent of all journal articles
published by NCER funded PI's). 36 Project Investigators have been
listed as highly cited (publications influential for other researchers)
authors. (CEDD accounts for 41 percent of all NCER funded PI's listed
as highly cited.)
As we will show, this area has born the brunt of the recent cuts in
EPA's research leading to critical problems not being understood and
new environmentally beneficial technologies not being produced.
The STAR program has been widely praised. The National Academies
issued a laudatory report, The Measure of STAR, which concluded that
the program supports excellent science that is directly relevant to the
Agency's mission. According to the report, the STAR program has
``yielded significant new findings and knowledge critical for
regulatory decision-making.'' The report says, ``The program has
established and maintains a high degree of scientific excellence.'' It
also concludes, ``The STAR program funds important research that is not
conducted or funded by other agencies. The STAR program has also made
commendable efforts to leverage funds through establishment of research
partnerships with other agencies and organizations.''
The EPA STAR research program compares favorably with programs at
other science agencies. According to the National Academies report,
``The STAR program has developed a grant-award process that compares
favorably with and in some ways exceeds that in place at other agencies
that have extramural research programs, such as the National Science
Foundation and the National Institute of Environmental Health
Sciences.''
The STAR research grants program expands the scientific expertise
available to EPA by awarding competitive grants to universities and
independent institutions, to investigate scientific questions of
particular relevance to the Agency's mission. The National Academies
report says, ``The STAR program should continue to be an important part
of EPA's research program.''
From the standpoint of a university administrator, our ability to
set priorities is greatly influenced by patterns of federal funding.
Where resources are made available, academic research will flourish and
new discoveries will be made. This is happening in the biomedical
sciences and society is reaping the benefits of increased funding for
biomedical research. In areas such as environmental science, even
though there is great interest among student and faculty, it is hard
for us to establish new programs and hire new faculty and take on
additional students if we know that funding is not likely to be
available. STAR grants that support research centers and individual
scientists allow universities to make their own investments with some
assurance of concurrent federal support.
Research centers funded by the STAR program at universities
affiliated with NCSE are making scientific breakthroughs on topics
including:
<bullet> remediation of mine waste sites
<bullet> microbial risk assessment
<bullet> remediation of volatile organic compounds in
groundwater and soil
<bullet> air quality--reducing the health effects of
particulate matter and aerosols
<bullet> assessment of aquatic resources
<bullet> children's environmental health and disease
prevention (several centers).
Funding for the STAR program has been cut repeatedly over the past
several years. The FY 2008 request for the STAR programs (including
fellowships) is $61.9 million, which is approximately 45 percent below
the FY 2002 level of $110 million. If the proposal is enacted, STAR
will have been cut by more than $21 million or 25 percent since FY
2004. NCSE proposes that the STAR research budget be increased to $150
million, which would allow expansion of areas and scientists supported
and would send a signal that Congress is serious about merit-based
science for environmental decision-making.
We do commend EPA for boosting grants to $5 million for exploratory
research on the environmental effects of nanotechnology, an emerging
issue which was the subject of Science Committee hearings last year.
However, even in this case, the research is trying to catch up to a
genie that is already out of the bottle. NCSE co-sponsored a conference
with EPA's Office of Research and Development in fall 2005 on the
possible benefits of nanotechnology for cleanup of hazardous wastes,
such as contaminated ground water. Although, small scale field trials
show considerable promise, the risks, large or small, are largely
unknown. We also note with disappointment that absolutely no money is
budgeted for exploratory research grants on any other subject. The
nanotechnology research, as well as endocrine disruption research,
originally came from the exploratory research area. The current budget
leaves no money to study any new issues that emerge during the upcoming
year or that have been identified but not studied.
Table 1 shows a breakdown of EPA extramural research by program
area and fellowships over the past five years. It also shows a breaking
down of the extramural program itself. Prior to the period shown on
Table 1, the STAR program provided approximately $100 million annually
in research grants from FY 2000 to 2002. The proposed budget for FY
2008 would reduce that total to $56 million--a stunning cut of 44
percent during the current Administration.
This table shows continued attrition and termination of research
programs. Research grant areas terminated since 2004 include:
<bullet> Water quality
<bullet> Land protection and restoration
<bullet> Endocrine disruptors
<bullet> Ecosystems (formerly more than an $18 million annual
investment)
<bullet> Mercury
<bullet> Pollution Prevention
<bullet> Sustainability
<bullet> Economics and Decision-making
<bullet> General exploratory research
Each of these shutdowns has real world negative consequences. I
provide a few examples, but there are many more. In addition, most of
the research areas presently still addressed by EPA are done so in a
paltry fashion with the expenditures for research very small relative
to the scale of the problem.
Consequences: Research Funding Cuts Lead to Health and Environmental
Problems
Endocrine Disruption. EPA's grants for research on endocrine
disruption (ED), which totaled $4.6 million in FY 2003, were terminated
in the FY 2007 budget request. EPA's $10 million request in this field
is down nearly 20 percent since FY 2003.
Examination of the phenomenon of endocrine disruptors (chemicals
that mimic naturally occurring hormones, many of which are passed from
the mother to the developing fetus and affect sexual and other types of
development) provides examples of the consequences of these
terminations. Headlines are raising questions about bisexual fish in
rivers across the U.S. and are reporting the loss of more and more
natural commercial fisheries around the world. International biomedical
experts are agreeing that the growing incidence of human male
reproductive organ disorders including testicular cancer, are the
result of prenatal exposure to environmental chemicals. In the U.S.,
there has been an age-independent decline in testosterone levels in men
over the past twenty years. Epidemiologists have linked unusual
external genitalia development in newborn boys with plastic components
in their mothers' urine during pregnancy. The Centers for Disease
Control and Prevention report that one in 150 children born today has
an autism spectrum disorder. The latest evidence concerning the role of
environmental contaminants and reproductive health from the gene and
early stages of development to the gray-haired population is extremely
worrisome. Yet, despite the all evidence of growing numbers of trans-
generational disorders that were rare only two generations ago, ED
research at in the Office of Research and Development is declining.
In South Carolina, endocrine disruptive chemicals are used on golf
courses at several locales, including Hilton Head Island, both as
pesticides (e.g., Fipronil), and via treated sewage effluent that is
used for irrigation (such effluent contains estradiols, birth control
remnants, antibiotics, etc.), which run-off into the very productive
estuarine salt marsh systems. Colleagues at the University of South
Carolina and the NOAA National Ocean Science Laboratory in Charleston
were funded by EPA via the endocrine disruption program to determine
the effects on commercially important estuarine species. They have
discovered that crustaceans (shrimp, crabs, copepods) have their
reproduction shut down when exposed to these chemicals and that some
fish are unable to reproduce and have both male and female
characteristics when exposed. The question now is how are these
chemicals passed up food chains, what is the impact on coastal
fisheries yields, can humans bioaccumulate these endocrine mimics, and
what are the effects? Despite these findings, present funding is now 25
percent of what was originally funded by EPA. Clearly, eliminating the
endocrine disruption research grants program will not provide the data
for informed decision-making related to environmental and human health.
Mercury. EPA research on mercury has been reduced to $4.3 million
in FY 2008 (slightly up from 2006) from $7 million in FY 2004. Grants
for mercury research were terminated in FY 2005. According to ORD's
Multi-year plan (MYP): ``A 1997 EPA Mercury Study Report to Congress
discussed the magnitude of mercury emissions in the United States, and
concluded that a plausible link exists between human activities that
release mercury from industrial and combustion sources in the United
States and methyl mercury concentrations in humans and wildlife.
Regulatory mandates require EPA to address these risks. The Agency is
developing risk management research for managing emissions from coal-
fired utilities (critical information for rule-making) and non-
combustion sources of mercury; risk management research for fate and
transport of mercury to fish; regionally-based ecological assessments
of the effects of methyl mercury on birds; assessment of methyl mercury
in human populations; and risk communication methods and tools. EPA has
established two long-term goals for mercury research. The long-term
goals established in this MYP are:
1. To reduce and prevent release of mercury into the
environment.
2. To understand the transport and fate of mercury from
release to the receptor and its effects on the receptor.
However, as a result of the cuts to the already small budget, EPA
is not presently studying the cycling of mercury in the environment.
Thus it is hard to imagine how EPA will accomplish these goals.
Ecosystems. As recently as FY 2004, EPA was spending $108 million
on ecosystem research. In FY 2005, what had been an $18 million program
of grants for ecosystem research was completely eliminated from STAR.
The FY 2008 budget request would further reduce funding for ecosystem
research to $68 million. At this level, essentially all external
participation--grants, cooperative agreements and contracts--would be
eliminated. The remaining EPA researchers who were able to produce a
major product every year or two would only be able to produce a major
product every four to six years. Additionally, the most recent cuts
will limit the participation of State and local government in the
Environmental Monitoring and Assessment Program (EMAP).
The ecosystem research program is combined with human health in ORD
Goal 4, so it is sometimes difficult to determine what constitutes
ecosystem research. Additionally, there is some confusion about the
relationship between the water quality research program and ecosystem
research, although there is actually little overlap. We hope that with
a new emphasis on valuation and ecosystem services, this research
program will grow again.
Sustainability, pollution prevention, economics and decision-
making. The suite of research efforts in pollution prevention,
sustainability, and economics and decision-making are EPA's pro-active
agenda to get ahead of environmental problems through prevention,
development of new technology, and partnerships with State and local
government and other stakeholders. The Office of Research and
Development should be commended for developing a sustainability
strategy that was recently approved by EPA's Science Advisory Board.
As documented at our recent national conference, the field of
``green chemistry''--using products designed from nature without
harmful side effects--offers great promise to reduce the need for
regulation and contamination. Everything from natural, short-lived
biodegradable pesticides to new energy sources can be made safer and
will provide great economic opportunities as well as environmental and
health benefits. Sustainability provides new partnerships as well as
new technologies. Communities and other stakeholders are brought into
the research program from the beginning.
Unfortunately, ORD's efforts to be pro-active and implement a new
sustainability approach, as is being done in the business community is
being undermined by debilitating cuts to a budget that is too small
already. The very small but effective grants program in Cooperative
Science and Technology is to be terminated in the FY 2008 budget. This
program provided grants to states, counties and others from New York
City to Puerto Rico that need science to help resolve or prevent
problems.
The remaining sustainability research is largely what had been
called pollution prevention. This intramural program includes key tools
to support decision-making such as life cycle analysis, metrics of
sustainability and flows of materials, technological assistance,
including using SBIR incentive funding to develop and commercialize
innovative environmental technologies needed by EPA regions and states
and agency regulatory and compliance programs to protect human health
and the environment. Sustainability research is planned to be cut to $
22.5 million, a little more than half of the $42 million provided as
recently as FY 2004.
Initiated in 1994 and modified in 1999, the STAR grant Economics
and Decision Sciences (EDS) program supports innovative economics and
decision science research. It is the only significant research effort
at the EPA that addresses behavioral science research issues. EDS
results have led to decreased pollution control costs, and improvements
the efficiency and effectiveness of environmental policies. These
practical and usable results improve understanding of polluter
motivations as well as the incentive structures of policies and how
people value human and ecosystem health.
According to a 2005 presentation by Kohler and Clark for the
Association of Public Policy Analysis and Management, the EDS program
``has established an incredible track record that has generated
practical results now being used by environmental policy-makers
throughout Federal, State, local and international governments.'' STAR
EDS research is influencing the design of international and federal
multi-pollutant legislative initiatives. EDS research on cost-benefit
analysis ``contributed to the Office of Management and Budget's
recommendation that EPA not use an age-adjustment factor in its cost-
benefit analyses of air quality regulations.'' Another important
beneficial outcome of EDS research has been information that enables
states to efficiently prioritize habitat protection programs. EDS
research is providing local governments tools to preserve their most
important local lakes, streams, and wetland. They also provide numerous
examples of how this research has been used by various EPA offices and
the private sector as well.
Kohler and Clark conclude, ``Since its inception, funding for EDS
research has amounted to $20 million over approximately 10 years,
averaging two million per year. Potential savings from widespread
application of economic incentives to solving environmental problems
could reach $45 billion annually (Anderson and Lohof 2001). On a
practical level, acid rain trading savings are at least $700 million
annually. Research on the private benefits of R&D shows that the market
value of private spending on R&D is capitalized at a rate of 2.5 to
eight (with most estimates centered at five and six) (Hall 2000). By
comparison the social benefit of EDS R&D can range up to 22,500 times
the investment of public money in research, assuming that all average
annual funding for EDS research to date can account for these potential
$45 billion annual savings. However, this back-of-the-envelope
calculation does not include the investment in time of policy-makers
and legislators necessary for new legislative initiatives. Assuming
that only one percent of the potential savings accrued to the U.S.
society are associated with EDS research would yield an annual benefits
rate of 225. More specifically, funding for the Burtraw study amounted
to $251,000 over two years, and can be associated with up to $700
million savings per year from trading programs--a rate of 56 times
(assuming a one percent association between EDS research and public
benefits), which is well above the market value of private sector
R&D.''
Despite these successes, this high impact, low cost $2 million
grant program is scheduled for elimination in FY 2008.
Without these innovative approaches that underlie a preventative,
flexible and market-based approach, environmental protection will be
left with the same old command and control system to ineffectively
minimize the number of poisons that industrialized society feeds
ourselves, our children, and our fellow living beings.
Graduate Fellowship Programs
To ensure a strong supply of future environmental scientists and
engineers, EPA created the STAR Fellowship program. There is
considerable concern about the retirements of the baby boom generation
and the need to replace the scientific and technical skills of the
federal, state and private workforce. The STAR fellowship program is
the only federal program aimed specifically at students pursuing
advanced degrees in environmental sciences. According to the National
Academies report, ``The STAR fellowship program is a valuable mechanism
for enabling a continuing supply of graduate students in environmental
sciences and engineering to help build a stronger scientific foundation
for the Nation's environmental research and management efforts.'' A
majority of the STAR Fellows conduct ecological research, where the
funding sources are very scarce compared with environmental health. We
note that a large percentage of the STAR fellowships have been awarded
to graduate students in CEDD member universities and colleges. As of
January 2006, 88 of 134 CEDD institutions have been awarded NCER grants
or fellowships. A total of 581 grants (including 26 centers), and 595
fellowships have been awarded to CEDD institutions for a total more
than $389 million dollars.
As academic administrators of most of the Nation's environmental
programs, the CEDD membership recognizes increasing student interest to
``do something for (or about) the environment.'' There are many, many
bright deserving students who want to work to make the Earth a better
and safer place to live. There is also a cadre of young faculty truly
dedicated to working across disciplines to affect good decision-making
based on science. Increases in the STAR program are important to
produce the scientists and engineers needed for the future.
The STAR Fellowship program has also been repeatedly proposed for
budget cuts by this Administration, only to be restored each year by
Congress. Ironically, because Congress has restored funds after this
program was zeroed out by the Administration in the FY 2003 request,
the EPA regards the STAR fellowship to be ``an earmark.'' The budget
for the fellowship program has been slightly under $10 million for most
of its 10 year history. However, because of the unusual appropriations
process for FY 2006, EPA is only adding $1.8 million to the FY 2006
request of $5.9 million for a total of $7.7 million in the soon-to-be-
released EPA operating plan. Thus the program and the number of
graduate students it can support is being reduced by some 20 percent
this year.
The President's budget request has again has proposed cuts in the
STAR graduate fellowship program to $5.9 million (an additional cut of
some 20 percent). As noted in the Science Committee's Views and
Estimates on the FY 2007 budget, this is ``one of the most troubling
decreases.'' The Committee stated that ``the fellowship program should
be funded at $10 million, the level restored by Congress in each year
beginning with FY03.'' We thank this subcommittee under former Chairman
Ehlers for its leadership and strong support to keep the STAR
fellowship program alive although it is now wounded. We hope that under
the leadership of Chairman Lampson and Ranking Member Inglis, you can
help this program and the number of environmental scientists and
professionals it produces to grow.
The STAR fellowship program is highly competitive, with only seven
percent of applicants being awarded fellowships. The current level of
funding is insufficient to allow all students whose applications are
rated as excellent to receive fellowships and it is insufficient to
meet national needs for a scientifically trained workforce. Based on
the experience of NCSE staff as reviewers of the STAR fellowship
applications and CEDD members as advisors for students who have applied
for and have not received fellowships, we recommend doubling the
funding for STAR fellowships to $20 million, which can be accomplished
without any decrease in the quality of the awardees.
The lack of diversity in the environmental field, which is one of
the least diverse fields of science, is also a key issue, as the
demographics of America are rapidly changing. EPA has begun to address
this challenge by creating the Graduate Research Opportunities (GRO)
Fellowship. This program was intended to be specifically for students
from ethnic minorities, but it now needs authorization to allow a focus
on diversity as well as dedicated and sufficient funding. We recommend
that the Science Committee authorization of EPA research in FY 2008
include specific language restoring the purpose of the GRO Fellowship
to bring more minorities into the environmental field.
Office of Environmental Education
The FY 2008 budget request once again proposes no funding for the
EPA Office of Environmental Education. Since 2003, the Administration
has tried to zero out this office, which support the programs mandated
by the National Environmental Education and Training Act, programs
administered by this office. The Congress has seen fit to appropriate
about $7-$9 million each year over the past decade. However, as with
the STAR fellowship program, EPA regards it as an earmark, so its
future is uncertain. NCSE strongly encourages Congress to restore
funding of at least $10 million. The programs of the Office of
Environmental Education provide national leadership for environmental
education at the local, State, national and international levels,
encourage careers related to the environment, and leverage non-federal
investment in environmental education and training programs. We also
request that the Science Committee encourage the Education Committee to
re-authorize and strengthen the National Environmental Education Act of
1990 (P.L. 101-619), as the funding authorization under this law
expired in 1996.
EPA Libraries
Every scientist needs access to a library in order to keep current
on developments in the field and to support their professional
activities. EPA had an exemplary library system, where as a network,
every library at EPA helped their colleagues every day in many ways to
keep EPA's information services viable. The EPA Headquarters libraries
and the 27 regional and laboratory libraries, staffed with experienced,
professional librarians who facilitate access to information, fielded
134,000 research requests from EPA scientists and enforcement staff and
others in the last year. The EPA Libraries house and catalog unique
collections, including approximately 50,000 primary source documents
not available elsewhere in any format, on vital environmental issues.
They also serve as institutional repositories for internal
documentation as well as commercially published literature about the
topics agencies regulate, investigate, and research; operate public
reading rooms, providing access to collections that are specifically
tailored to meet the needs of constituents in their geographic region,
at times specifically offering that access to comply with federal law.
Despite this, EPA is in the process of dismantling this network,
with no coordination budget and at least seven locations closed,
ostensibly to move to online information systems. The proposed FY 2007
budget for EPA Libraries contained a $2.5 million cut, which, according
to the American Library Association has already resulted in the closure
and imminent closure of some headquarters, regional and laboratory
libraries and the reduction of staff at other EPA Libraries; will put
the collections and services of the EPA Libraries at risk, causing
essential information about the environment to be lost; would
compromise the public's health and safety by making it difficult, even
impossible, for the EPA staff and scientists, other scientists and
researchers, the public, contractors and regulated industries, and
federal, State, and local policy-makers to find accurate and high-
quality information upon which to base decisions about health and
safety concerns. Foremost among the critics of the EPA plans to close
or reduce services and access to collections and otherwise remove
information resources critical to the EPA's mission, are the EPA
employees. Within weeks of implementing plans to close regional
libraries and libraries and special library collections in the EPA Head
Quarters in Washington, DC, the presidents of 17 union locals
representing more than 10,000 EPA researchers, scientists, and support
personnel, lodged formal protests against these EPA actions. (http://
www.peer.org/docs/epa/
06<INF>-</INF>29<INF>-</INF>6<INF>-</INF>union<INF>-</INF>library<INF>-</INF>
ltr.pdf)
The EPA could have made a very cogent statement about their need to
reconfigure the entire EPA Library Network. They could have easily
justified closing some of the individual libraries. However, the
complete lack of a management plan and an 80 percent cut in the budget
to see such a transition through to completion leads us to question
both the intent and effectiveness of the closures. With a $2.5 million
increase in its budget to see that such a reconfiguration was done
properly with great care given to seeing that the transition was done
effectively, efficiently, and with equity, the EPA Library Network and
its managers could have designed one of the largest scientific
libraries (or information centers) of the 21st century. We recommend
that Congress direct EPA to cease the closures and prepare a management
plan and a budget of sufficient magnitude to allow transition to a
state-of-the-art environmental information system.
Conclusion
In order to fulfill its mission, EPA needs increased investments in
both its intramural and extramural science programs, as well as such
associated services as environmental education and information. The
National Council for Science and the Environment and our Council of
Environmental Deans and Directors urges Congress to appropriate a
minimum of $700 million for EPA's Office of Research and Development
(bringing it back to FY 2004 levels), including at least $150 million
for EPA's Science to Achieve Results (STAR) research grants program and
$20 million for EPA's STAR graduate fellowship program. We recommend a
total of $900 million for EPA's Science and Technology account. NCSE
also urges Congress to restore full funding for the Office of
Environmental Education at a level of at least $10 million and to
terminate the effort to eliminate EPA libraries absent a sufficiently
funded modernization and management plan. Even these levels of funding
would, for the most part, bring EPA science back to its level in FY
2004. We hope that in future years, EPA's science budget will grow to
better match the Nation's needs.
In the case of EPA, there is a strong relationship between input to
environmental research and education and output in terms of
environmental protection. If the Nation wants more effective and
efficient environmental protection, we need to make the upfront
investment in science. It really is the ounce of prevention that is
worth many pounds of the cure.
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Biography for Bruce C. Coull
Dr. Bruce Coull is the 2006-2008 President of the U.S. Council of
Environmental Deans and Directors (CEDD) a program of the National
Council for Science and the Environment (http://www.ncseonline.org/
CEDD). He leads this professional organization of deans, institute
directors and environmental program administrators at more than 130
colleges and universities across the U.S. CEDD is carrying out projects
to improve environmental curriculum, better prepare alumni for
environmental careers, increase diversity in the field and to advance
interdisciplinary education. CEDD works with partner organizations in
Canada and the UK.
Dr. Coull recently became emeritus at the University of South
Carolina, where as a Carolina Distinguished Professor and Dean of USC's
School of the Environment, Coull led USC to approach environmental
issues through multi-disciplinary research, education and community
outreach. He headed the South Carolina Sustainable Universities
Initiative (http://www.sc.edu/sustainableu), a multi-university project
educating about frugal use of Earth's resources and was the architect
of the greening of the University of South Carolina. He also led USC's
environmental efforts in the Ukraine related to the Chernobyl nuclear
accident of 1986. In his emeritus status he directs the South Carolina
Lowcountry Initiative of the Chicago and New York based Center for
Humans and Nature (http://www.humansandnature.org). This initiative
aims to effect sensible use of resources in the South Carolina coastal
region. Local decisions-makers are the target of this project.
Coull was educated at Moravian College and Lehigh University--both
of which are located in Bethlehem, Pennsylvania. He was a postdoctoral
fellow at the Duke University Marine Laboratory in North Carolina and
an Assistant Professor at Clark University, Massachusetts before
joining the University of South Carolina (USC) faculty in 1973. While
at USC he taught over 10,000 students in Marine and Environmental
Sciences and held research grants from the Environmental Protection
Agency (EPA), the National Science Foundation (NSF), the National
Oceanic and Atmospheric Association (NOAA) and multiple private
foundations. He has directed over 60 theses and Ph.D. dissertations at
USC.
He was a senior Fulbright Research Fellow at Victoria University of
Wellington, New Zealand in 1981 and a Visiting Professor in Marine
Sciences at the University of Queensland, Brisbane, Australia in 1994.
He was President of the American Society of Zoologists, the American
Microscopical Society, and the International Association of
Meiobenthologists as well as advisor to the European Community on
Marine Pollution. He is the author of 130 scientific papers in Ecology,
Ecotoxicology and Sustainability in Higher Education and the editor of
four Marine Ecology books.
He is married to Judith, a graduate of Wheaton College,
Massachusetts. They have two children, Brent (Associate Professor of
Biostatistics, Harvard University) and Robin (Social Worker, Brooklyn,
NY) and one grandchild. Hobbies include fishing, walking, canoeing, and
nature-based tourism.
Discussion
The Superfund Innovative Technology Evaluation (SITE) Program
Chairman Lampson. Thank you very much. So let us begin our
questions. Dr. Gray, in EPA's fiscal year budget, the Agency
indicated that it would clean up 40 Superfund sites. In the
Energy and Commerce Committee hearing last week Administrator
Johnson indicated that the Agency would not be able to clean up
40 sites this year and that the new estimate to clean up would
be 24 sites. Is that correct?
Dr. Gray. That Superfund is handled within a different
office, but it is my understanding, I was at that hearing, and
that is what the Administrator said.
Chairman Lampson. Okay. The Administrator indicated to the
Energy and Commerce Committee that the reduction in the
projected number of site cleanups this year is due to the fact
that the sites remaining to be cleaned up present greater
challenges, have more complex problems, and take more time and
effort to clean up. Is that your understanding?
Dr. Gray. Yes, it is.
Chairman Lampson. And can you explain to the Subcommittee
why if we still have complex cleanups that require more time
and money to complete than the average site, the administration
has chosen to eliminate funding for the Technology Development
and Verification Program Congress mandated in the Superfund
Law. The Superfund Innovative Technology Evaluation or SITE
Program?
Dr. Gray. Certainly. The SITE Program is a mature program
that has been around for very many years. It has demonstrated a
wide range of technologies and approached that have the
opportunity to improve the efficiency of cleanups at Superfund
sites. However, at this point this is something that is more
appropriately handled in the private sector, and the SITE
Program now is being closed down, and the private sector is
picking up many of those technologies that were identified and
verified through the SITE Program and making them available.
It is important to recognize that the Office of Research
and Development continues to support the Superfund Program. We
have seven technical support centers across the country in
which we provide direct, both scientific and engineering
support, to the program managers out there in the field, on the
ground, at Superfund sites, making sure that they have access
to that science and to that engineering information.
Chairman Lampson. Dr. Gray, is this an example of the
President, again, choosing not to follow the law passed by this
Congress and signed by him?
Dr. Gray. This is a situation in which we have to make as
an agency and as an office decisions about scientific
priorities while making sure that we are meeting our
environmental commitments. In this case we are--our commitment
to help the Superfund Program through our technical support
centers is something that we will continue.
Laboratory Infrastructure
Chairman Lampson. Are there plans to reduce staffing or
space of EPA's laboratories?
Dr. Gray. No, there isn't. Actually, I am glad you asked me
that question, because there is some sort of--there is rumors
and misinformation running around out there. What has happened
is we have been asked, and ORD has been asked to take the lead
on a study of the laboratory infrastructure of the EPA. We have
been asked to look at the efficiency and the effectiveness of
our 27, I believe, I am not sure about the number, of all our
laboratory assets that are spread across this country.
The last time we did this was back in 1993, and we thought
it was time to do something like this again. What we are doing
is a short-term effort and a long-term effort. The short-term
effort is looking for place-specific efficiencies, best
practices that are happening in one laboratory that we can
transfer to another. The longer-term will bring in an outside
group to help us look at our laboratory infrastructure to
understand that work that is being done there and understand
options we have for making it efficient and effective.
A very important thing to recognize, and this is something
that the Administrator said at our House Appropriations
Committee hearing is that he is not intending to shut down any
laboratories, no laboratories will be shut down, and no
scientists will be let go.
Chairman Lampson. Let me continue. I have two copies or I
have copies of two memos here; one dated June 8, 2006, authored
by Lyons Gray, Chief Financial Officer, and the other dated
October 26, 2006, by Lek Kedeli, Deputy Assistant Administrator
for ORD. They both relate to the preparation of the fiscal year
2008 budget and to some future budgets, and both discuss the
development of plans to reduce costs associated with EPA's
laboratories. I ask first unanimous consent that they be placed
in the record for this hearing. Without objection, so ordered.
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Chairman Lampson. The June 8 memo instructs ORD to put
together a work group to develop a laboratory consolidation
plan. The October 26 memo appears to be a response to this
direction and invites input from deputy assistant
administrators and deputy regional administrators to comment on
the draft charter for the plan and asks for their responses to
a series of questions. And I have some questions about those
memos and this plan.
Does the Agency, agency's inclusion of stakeholders in this
process include a role for Congress?
Dr. Gray. We would certainly work with all of our
stakeholders, not only our scientists but outside groups that
are interested, including our union partners, and we would be
happy to keep Congress apprised as we make progress here.
Chairman Lampson. These labs are located in Members'
districts across the country. Has the Agency contacted any of
these Members and informed them of laboratory review?
Dr. Gray. This is a process that is just getting underway,
and it, at this point we believe that we have to formulate our
plans and understand how we are going to approach this. This is
coming into view, as I said, with the short-term and long-term
approach, and for that reason we have not widely contacted.
Chairman Lampson. Have not contacted members. Which EPA
stakeholders are involved in the preparation and review of this
plan?
Dr. Gray. This plan is being reviewed and addressed. At
this point there is not a plan. You have to recognize we do not
have a plan. We are putting together an approach to look at our
laboratory infrastructure. In the short-term we will be looking
for opportunities like has been demonstrated in Region 1 where
they have a certified green building, and they found ways to
reduce their energy use 19 percent. We want to find out how
they did that and share it. In the long-term we will have an
open process that will include many of our, all of these
stakeholders that will help to bring together the data, do the
analysis for a longer-term look. That, again, is something that
we envision being a year or two or three down the road.
Chairman Lampson. Does the Agency intend to or has the
Agency asked for input from the EPA Science Advisory Board on
the laboratory consolidation plan?
Dr. Gray. Again, we don't have a consolidation plan. We
are--have a plan to look at our laboratory infrastructure, and
at this point, as I said, there is not a plan that we can yet,
that we are yet ready to share.
Chairman Lampson. I had the staff look through the
Congressional justification for some discussion of the Agency's
intention to review the laboratory infrastructure and
development of some kind of a consolidation plan, whether we
call it a plan or not. They didn't locate any such discussion.
Did we miss it, and where in the Congressional justification is
this discussed?
Dr. Gray. I am afraid I am not as familiar with the, or I
am not familiar with the Congressional justification at that
level, but I would be happy to get something back to you for
the record.
Chairman Lampson. Okay. If you would, I would appreciate
that. The memo refers to a target savings of 10 percent in
2009, and another 10 percent in 2010. Do you have any idea how
those targets might have been set? And what is the
justification for those mandated cuts?
Dr. Gray. I do not know how those targets were set, and the
idea of our short-term effort is to look for efficiencies that
might help us find ways to save some, save resources in our
laboratories.
Chairman Lampson. Frankly, Dr. Gray, it sounds like a lot
of this process used to consolidate and streamline EPA's
libraries, that process was dreadful, and we are still trying
to sort that out. I sincerely hope that the Agency is not going
to repeat the, that process with EPA's laboratories. I will be
following up with a request for more information about this
plan and the process to develop it. I expect the Committee to
be provided this information in a timely fashion and well prior
to the plan being finalized in May as Mr. Kedeli's memo
suggests.
And I ask indulgence of the Committee for my having gone
over, and I recognize the Ranking Member at this time.
Employee Morale
Mr. Inglis. Thank you, Mr. Chairman. Dr. Gray, Dr. Coull
testified in his written testimony that EPA's ability to garner
the best science for its decision-making has been hamstrung by
a severe lack of resources, and I think Dr. Morgan testified
about the morale. What is your response to that? Is it, do you
have some rejoinder to that?
Dr. Gray. Well, I think I have one rejoinder. This is
simply anecdotal in direct response to the morale issue. The
Scientist Magazine is something widely read as you might guess
by scientists. Every year they do a survey of post-doctoral
researchers across the country, and what is the best place to
be a post doc? EPA, ORD has made, well, we are in basketball
season. We made the final four for the last three years. We
were number one three years ago. We have been three and three.
That tells me that the morale among our scientists, the folks,
even the young ones that we are bringing in, the new ideas, the
new techniques, the new talent that we are bringing into our
laboratories like working for ORD. I think that we don't have
at this point any kind of a morale problem. We have got a lot
of very dedicated people; scientists, engineers, and the
support staff to help us do what we do, that are very happy
working in the Office of Research and Development.
Endocrine Disrupter Research
Mr. Inglis. Let me take up a case study Dr. Coull
mentioned. You got my attention with this endocrine inhibiter
research and maybe first before I come back to Dr. Gray to ask
about that, explain, give me some background on what, how that
works, particularly, you understand my great concern is
Bluffton oysters and shrimp, because my brother is a hobby
shrimperman, shrimper. So help me out with that.
Dr. Coull. I over-spoke on one issue and want to correct
it. I did not mean to indicate that EPA had eliminated all
endocrine disrupter and mercury research, only the external
grants in those particular cases. So there still is that kind
of research going on internally, but let me explain. Hormones
that we need to live and do well are also important to other
creatures in the environment. Hormones are necessary for
reproduction. Hormones are necessary for nervous function, and
these chemicals, various chemicals interfere. They are called,
endocrines are one kind, interfere with these endocrines. And,
therefore, in studies done on shrimp, crab, and copepods, which
are another small kind of crustacean, very tiny but very basic
to the food chain, and essentially the basis of a good part of
the food chain and all those salt marshes we have in South
Carolina and in throughout the Gulf Coast, the reproduction is
shut down when these animals are exposed to these particular
chemicals.
Now, this particular research is relevant because it
relates to ecosystems, which is, how does an ecosystem work?
That salt marsh ecosystem outside of Bluffton is one of the
most productive natural ecosystems on earth next to coral reef
before they all started getting bleached by warming climate.
That is an aside. And tropical rain forests. So these are
important aspects of the ecosystems. Those systems are the
nursery grounds for all of those shrimp that are either being
caught on the South Carolina coast or the Texas coast or the
Louisiana coast, all right, up to about Cape Haderous, North
Carolina, all right, and all the way around to Corpus Christi.
Those systems are where it happens. Those are the nursery
grounds. And if we continue to pour nasty chemicals to
interfere with the reproductive rate and the behavior of those
particular organisms, we have a problem.
The Extramural Program in the fiscal year 2008 budget for
endocrine disrupter research in the data that we have does not
exist.
Mr. Inglis. And so, Dr. Gray, what is your response to
that, the cutoff of external funding?
Dr. Gray. Well, first, I want you to recognize that
endocrine disrupting compounds is an important part of the ORD
research portfolio, and I am glad that Dr. Coull was able to
let you know that, in fact, it is one, well, he didn't let you
know, it is one of areas of this budget where we actually ask
for an increase from the fiscal year 2007 budget. It is an area
that we take very seriously where we are doing work not only to
help the program offices to better identify and, to identify
and prioritize these compounds, including pesticides and other
compounds, but we are also doing work that is directly relevant
here. A situation in which we are working on the recent
discovery of inter-sex fish in the Potomac River. You remember
seeing questions about fish that appeared to have endocrine
alterations or some sort of alterations of their secondary
sexual characteristics, and we are working with our state
partners, our regions to help work on that particular issue.
Mr. Inglis. Now, what is, the Chairman is showing me some
numbers here. He is showing a four percent reduction in
endocrine inhibiter research.
Dr. Gray. In the fiscal year 2007 President's budget we
asked for $9.1 million. In the fiscal year 2008 President's
budget we are asking for $10.1 million, a $1 million increase
in EDCs.
Chairman Lampson. This is the last, or it is a four percent
decrease from the last enacted budget. According to our numbers
here, this chart that I have indicates a four percent----
Dr. Gray. We work from President's budget to President's
budget, and in that case we actually are asking for $1 million
more this year than we did last year.
External and Internal Research
Mr. Inglis. Oh, I see. Okay. So that is based on the
request, the President's request. I got you. Okay. So talk to
me a little bit about the--I know I am over time but the
difference between internal and external. Dr. Coull is a
proponent of external research, and you are apparently
preferring internal here in this case.
Dr. Gray. Oh, no. First of all, I will tell you the
research that we do, ORD is made up of about 1,900 people. At
least 1,000 of them are scientists and engineers who are doing
acts of science every day. And they are talented people. They
are smart people.
Dr. Coull. And they are very good, many of them, they are
wonderful people. They do very good work.
Dr. Gray. And they have a lot to do, and we do a lot of our
science inside. We also do work with our partners in
universities, our STAR Program that has been mentioned several
times, Science to Achieve Results Program, is a very important
way in which we take advantage of some of the best brains in
the country to work on science that helps advance EPA's
mission.
Even in these fiscally-challenging times, we work hard, for
example, to leverage that work. We are doing research in
nanotechnology through our STAR Program, and we have actually,
in that case we have partnered with other federal agencies,
with the National Science Foundation, the National Institute of
Occupational Safety and Health to increase the size of the pot
that we can have for our STAR Programs. So it is a situation in
which we have a very rigorous, very competitive system that
brings in some of the best ideas from the universities around
the country, and whenever we can, we look to leverage those
funds to make sure that we have the greatest opportunity we can
to draw on the kinds of smarts that Dr. Coull and his friends
and colleagues and students can bring to us.
Mr. Inglis. Thank you. Thank you, Mr. Chairman.
Chairman Lampson. The numbers that I was sharing was from
the document, this document that you all handed us, and in '06,
the budget for--that was enacted by Congress was 10 million,
$10.5 million, and the request is $10.1 million. So you, what
you are basing yours on is what the President requested in '06,
I guess, but what was actually enacted by Congress indicates
that those numbers are different. So just for clarification.
Data Sources and Concerns
If you will bear with me just one minute, let me get a
couple questions in, and then we will go to you. Dr. Sass, in
your testimony you refer to free or cheap data provided by
regulated industries, several laws, Pesticide Law, Toxic
Substances Control Act, are set up to mandate the provision of
data by a regulated industry. EPA has the authority to require
the production of data under those statutes. Should these
systems be changed, or is this a problem of inadequate EPA
staffing to review the quality of these data and sufficient
peer review of the data provided?
Dr. Sass. I mean, that is a good point. What you are saying
is there are programs, particularly in the pesticide office,
actually, where the regulated industry is obligated to supply
data on the toxicity of its products and also under TOSCA the
industry is obligated to provide any information it has, be it
its own or not its own.
No, I mean, I think that is great. I think the regulated
industry should be contributing both its funds and its
technical power to develop that kind of data and submit to the
agencies. Our concerns are what you suggest, which is, A, when
the Agency can't provide appropriate oversight, either because
it doesn't have the internal resources, staff or time, or when
it doesn't have the ability to actually get to the underlying
data and really do a data quality check on that submitted data.
Our other concern is that EPA in many cases, and the pesticide
office is an example of this, relies wholly or predominantly on
that submitted data, sometimes without really scrutinizing and
incorporating more publicly-available data often from the peer-
reviewed literature and sometimes from its own sister agencies.
So, for example, with atrazine, the pesticide office right
now is relying on data that it has requested and been waiting
for from the manufacturer, Cingenta, on water monitoring, but
it isn't incorporating data from USGS on water monitoring of
pesticides.
Chairman Lampson. Thank you very much. Mr. Diaz-Balart, you
are recognized.
Program Assessments
Mr. Diaz-Balart. Thank you, Mr. Chairman. Thank you for
this very important hearing. Dr. Gray, one of the issues that I
constantly run into is, you know, government has a tendency to
judge results by how much money we spent, not on actual
results. One of the things that always comes to mind in a
number of hearings that we have had in this Subcommittee and
elsewhere is, for example, some of the Inspector General
reports where they will come back, and they will tell us about
EPA, particularly in some of the outside grants in a bunch of
different areas where they really frankly don't have, EPA
doesn't have a good handle as to if we are getting any results
at all. We are spending the money for good-sounding things, but
frankly, there is no way of telling, I am sure there are ways
of telling, but we don't have any good data that tells us that
we are actually paying for this, the actual studies as opposed
to just good-sounding studies, and we are not getting the
results.
A couple of questions based on that. Is there a way for the
EPA to get other players, your other partners and do you get
other partners coming back to you with recommendations of where
EPA can save money and can be more efficient? Is there a way to
do that? Do you have a way that you can get that source? Does
the, I don't know, the Science Advisory Board, come to you and
tell you, hey, look, these are, there are some areas here that
we think we can find some efficiencies, or is that something
that is not accepted by the EPA? It is not solicited, or it is
just not, you just don't get a lot of that, and that would be
my first question.
Dr. Gray. Well, within the Agency we are always looking to
make sure that we are getting results for the resources that we
are putting out, and I think that it is a place, especially if
you look at the Office of Research and Development, one where
we are pretty confident that the way in which we run our Grant
Program, the way in which we integrate it into our intramural
research program so that there is alignment between the work
that we are doing and the work that we are asking folks in the
university community to do, actually does come together and
help us make a difference in the science that is used by the
Agency.
A great example of this is looking at National Ambient Air
Quality Standards. We write what is called a, used to be called
a criteria document. We now call it a science assessment for
ambient air quality standards. The last one that was done for
particulate matter, over 40 percent of the citations, the
science that was used to support the ultimate decision that was
made, came from work that was done by us or supported by us. So
I am quite confident that, in fact, we do a good job.
On these areas of efficiencies I will tell you that I don't
know the exact name. The agency, in addition to its Science
Advisory Board, does have a Financial Advisory Board, and these
are folks from outside of the Agency who are there to help us
think about the way in which we run the business of EPA, how
can we do things well, how can we be more efficient. I could
get you more information about that if you would like for the
record.
Mr. Diaz-Balart. Actually, I would, and if you have, if
there is something that you have that kind of shows, you know,
some results in different areas, I would like to have it. If it
is something that even members of Congress can understand, it
would be obviously helpful.
Dr. Sass, you mentioned, for example, the clean air and
mercury rule in your testimony and your concern over the
Agency's ability to implement the CAMR adequately to lack of,
and I don't know if I am misquoting you, you know, credible or
reliable data. Should we wait to implement that or not because
we don't have the reliable science or the reliable data? And
should we work, should we not, should we wait, should we not
wait?
Dr. Sass. Well, I mean, my hope is that EPA is going to go
ahead on the best data that it has. The complication of that is
that the EPA plan is sort of a Cap and Trade Plan, and Cap and
Trade makes the assumption that the pollutions are shared or
distributed evenly. So if you remove it over here, you are
really helping, you are reducing the whole pot of pollution let
us say. Without being able to do sampling to look at whether
there is mercury hotspots, particular areas that are
particularly vulnerable because they have high exposures, for
instance, around cold-fired power plants that release mercury,
EPA is not going to know whether its Cap and Trade Program is
actually effective. If you are reducing it in one area but on
population is taking all the risks, then your National risk may
go down, but your environmental justice issues, your
populations at higher risk, remain at higher risk.
So EPA should move ahead with the data it has, but it needs
to do that hotspot monitoring so that it can measure the
efficacy of its programs.
Dr. Morgan. Do you mind if I--the other issue is that
mercury, I mean, what was just said is absolutely correct.
There are hotspots. But mercury is also a global pollutant, and
a significant amount of the mercury that we see in this country
comes from natural sources around the world and from power
plants in China and similar sorts of things. And unfortunately,
while the Agency does have a program to look at local and
regional mercury issues, it doesn't have resources to try to
understand the global mass balance of mercury, that is where it
comes from, how it moves through the environment, where it ends
up. And without that sort of fundamental scientific
understanding, there is limits to just how far you can go and
even to knowing whether the enormous amounts of money that
power plants are going to be called upon and are being called
upon to spend will always necessarily get the improvements we
want. None of this is to say we shouldn't take action. It is to
say, however, that there are important fundamental science
issues that one really needs to underpin the development of
regulation. Because absent that you could do things that were
inefficient or counterproductive.
Mr. Diaz-Balart. Mr. Chairman, if I may, thank you, sir.
Thank you for your indulgence. I am not quite sure, but, I
mean, am I hearing that we should or should not wait to
implement? I am not quite sure if with that answer you are
saying that we should wait to implement or we should not wait
to implement. I am not quite sure.
Dr. Sass. We should move forward with the data we have and
then continue to collect the data we need.
Mr. Diaz-Balart. And Mr. Morgan, let me just ask you this,
because you pointed something about other countries. Is the
United States the first country to require reduction of mercury
emissions?
Dr. Morgan. Well, mercury issues are serious all around the
world, and I can't tell you in detail what the regulatory
environment across the EU is, but I know there are similar
concerns. But the other point is that one needs to
differentiate between a scientific standard, I mean, in science
you don't publish until you have, I mean, you try to avoid
false positives, that is to suggest things that aren't there.
But regulation is essentially a public health issue, and there
you need to move when there is strong suggestive evidence, even
if it isn't definitive because the point there is to be
protective of human health. And so there is a clear difference
between, you know, whether I should say something definitively
scientifically, that is whether I can get it published in a
journal, and whether the Agency should move on something when
the evidence is sufficient to suggest there is a problem. Then
it behooves the Agency to be protective.
Mr. Diaz-Balart. I understand that, Mr. Morgan, but
obviously, you know, that can sometimes be very, very, very
controversial because there is always a cost associated with
that but I understand where you are coming from.
When I was listening to the Chairman, and I tend to agree
with him about making sure that, Mr. Chairman, I am not
paraphrasing what you said, about making sure that, you know,
that there is input as much as possible, and again, I am not
going to put words in your mouth, but I tend to agree with
that, tends to be where you come from in a lot of cases.
Integrated Risk Information Systems (IRIS)
Let me ask you in regard to the IRIS process, Dr. Sass, and
again, I don't want to put your words in your mouth either, but
you seemed to be, I guess, a little bit frustrated for the lack
of finalized assessments in the recent past and point to more
opportunities for public comments as kind of like, I guess, you
know, further slowing the pace. Could you explain if you are
not in favor of more opportunity for public comment in that
context, because I kind of, again, you know, with an open
caveat there, tend to be a little bit apprehensive about not
having as much open comment and, again, on a separate issue
that I think the Chairman mentioned which is totally unrelated,
but I just want to know what your comments are on that. Did I
read that right? Did I understand that correctly?
Dr. Sass. Especially, you might be confused because I am
the one that is always commenting, too, so why wouldn't I want
opportunities to comment. The IRIS Program, which is very
important, I mean, it gets hits every month, it gets thousands
of hits every month. I think 50,000 hits a month the last time
I looked from almost 100 counties in the world every month,
down actually in July and August, I have noticed. So it is
incredibly important that, and the IRIS database is, does
provide quantitative estimates of toxicity or hazard, and then
you use that site specific in places to estimate exposure. And
then when you know the toxicity and you know the exposure, you
can do a risk assessment. So it is incredibly valuable all
around the world. They are considered one of the gold standards
of the world to be used. In the last few years they have only
done somewhere between two and five finalized assessments every
year. They have ongoing reviews and assessments, but they
finalize only two to five. In the budget they actually promise
finalizing eight a year. I don't know how they are going to do
that, but I have talked to EPA staff who tell me they should be
finalizing about 16 a year. What is the difference between 16
and two to five? The difference is the delays that happen
because of interference. I don't think it is oversight. I think
it is interference. The reason why is there are built-in
opportunities for public comment and for oversight, and there
is built-in opportunities for OMB review, early and late, and
there is built-in opportunities for interagency review already.
In addition to those, they would now have, I think it is
about three more rounds of this, and each one of those will add
on about six months to a year or extend the process by six
months to a year.
Mr. Diaz-Balart. Mr. Chairman, will you indulge me in one
last one? I thank you. You have been very generous.
Chairman Lampson. Help yourself.
Mr. Diaz-Balart. Thank you. When you mention, now, again,
there is obviously a difference between input and interference.
I understand that, and you are saying now three more
opportunities or layers of interference, not of input, not of
comment?
Dr. Sass. At this point since everybody has had an
opportunity to comment early, including OMB and the agencies
and they get an opportunity later, then I would say the
intervening several opportunities just become delay.
Mr. Diaz-Balart. I think I would like to get an idea of
what those are. If I, I don't know if Dr. Gray, if you can kind
of get back with me or whenever, I mean, whoever can do that,
it would be nice.
Dr. Gray. Yeah. We are very proud of the process we use to
develop our IRIS assessments. It is one of the reasons as Dr.
Sass said, they are gold standard around the world, and we can
get something to you.
Mr. Diaz-Balart. Great. Thank you. And, again, thank you,
Mr. Chairman, for----
Chairman Lampson. You are very welcome.
Mr. Diaz-Balart.--allowing me to go way over. Thank you,
sir.
Chairman Lampson. That is okay. Thank you. I did myself
awhile ago, so I am glad I could pay you back. Mr. Lipinski,
you are recognized.
Funding Reductions for Great Lakes Research
Mr. Lipinski. Thank you, Mr. Chairman. I am very glad that
you all went over so much so I could get here in time to ask
these questions.
I want to start by talking about the Great Lakes and
certainly the, over the last 20 years the discharge of toxic
substances in the Great Lakes has been reduced, but we still
have those high concentrations of contaminants in the bottom of
the lakes and, you know, surrounding areas. And, of course,
there are great concerns about this. As you know, there is
advisories against fish consumption in most locations
throughout the Great Lakes. Now, in order to address this
problem, in 2002, Congress passed and the President signed into
law the Great Lakes Legacy Act. My concern in this budget is
that the budget request represents a reduction of $14 million
from last year, from $49.6 million to $35 million for this, and
I am concerned that the program is going to be significantly
impacted by this decrease. So what is the reason for this
significant cut?
Dr. Gray. I assume that is a question for me.
Mr. Lipinski. Yes.
Dr. Gray. What I--and this question that you raise, for
example, cleaning up sediments, is actually one of the priority
areas for our, what we call our land research area. It is one
of those things that were recognize is an ongoing question. It
is not just in the Great Lakes. It is in a variety of parts of
the country, both in fresh waters and marine waters. So this is
something that we take very, very seriously, and we want to be
part of the solution. The Office of Research and Development is
about being part of the solution. We not only do the science to
help identify potential problems as we have heard. We also do
the science to find the solutions. We have a great group of
engineers that helps us to get to the place where we can help
clean up these situations.
In the case of our budget, we are in a situation in which
we have to set priorities, and we have before us a budget that
helps us, that funds the high priority science that the Agency
needs.
Mr. Lipinski. So this is not a high priority then?
Dr. Gray. No. We are funding it. I said this is one, this
is something that we consider a high priority.
Mr. Lipinski. You do consider it, and then, but a $14
million cut is a significant amount from $49.6 million to $35
million. Is this correct?
Dr. Gray. I am honestly not sure what numbers you are
talking about. Not knowing the budget I don't want to get
numbers wrong, so I would be happy to get back to you.
Mr. Lipinski. Okay. All right.
Dr. Gray. For the record.
Nanotechnology Research
Mr. Lipinski. Very good. Well, one thing that I am pleased
to see is the ninety-one percent increase in the research on
environmental implications of nanotech. I certainly have seen a
lot and talked to a number of researchers. I believe that
nanotech, it could possibly really be the next industrial
revolution as it is, as the proponents say that it is. And so I
am happy to see that we are putting more funding into
researching the environmental implications of nanotech. I, you
know, I don't know if there is any really negative
environmental impact here, but it is something that I think we
need to do more research on to know for sure and also so that
the public, the public has some concerns over nanotech, and I
think that also needs to be put to rest, if indeed it should be
put to rest.
Now, Dr. Gray or anyone else who wants to elaborate on
this, talk about the current research agenda that the EPA has
regarding nanotech.
Dr. Gray. Well, I would certainly be happy to start there.
I think this is a situation that is a great example of the way
in which the Agency identified something kind of out on
horizon, used our STAR Grant Program to begin research back in
2001. We were funding research on nanotechnology back in 2001.
As it has become more clear that this is an issue that we have
to look at both from an application side, how can we use
nanotechnology to clean up the environment, to make processes
cleaner, to reduce waste, but also the implications. That is,
are there potential health affects. We have increased our
efforts here, and in fact, the funding that we asked for in
this present budget is to bring some research in-house, to use
our in-house scientists to help to address some key issues. And
here what we have done, the National Nanotech Initiative across
the Government is spending lots of money on nanotechnology. We
have worked very hard to identify where it is that there is a
nitch for EPA where our knowledge and our expertise can make a
difference and where people aren't doing this research. And
what you will see here is that our focus is on, for this, for
the 2008 budget, on the fate and transport of nanomaterials in
the environment. That is, what happens to them when they get
out? We know that in some cases in some kinds of media, in
water, they can glom up and become no longer nanomaterials. And
then there are different kinds of risks. In other cases they
may say dispersed, they may be able to travel long distances,
and we are trying to understand that.
In our STAR Program we continue to fund work in
universities around the country looking at potential health
implications of nanotechnology so that we can understand
whether there are risks of this technology that we need to
manage to get some of those benefits that you described.
Mr. Lipinski. Thank you. Anyone else have any comments on
that?
Dr. Morgan. Yes. The SAB, the Science Advisory Board looked
at this new program and is quite positive about it. It has made
significant progress since we looked at it last year, and I
would agree that understanding fate and transport is really
quite important. At the same time we also expressed a concern,
which is that if one approached the regulation of nanomaterials
in the same way that we have approached say the regulation of
chemicals, that is with extensive toxicological tests for each
new particle type, we are going to get swamped. I mean, we have
already been swamped with chemicals, because you can make new
chemicals faster than you can run the toxicological studies,
and if you think that is bad, material scientists can make new
nanoparticles even more rapidly, and you know, if the molecule
sticks out there or sticks out here, it can have very different
toxicological properties.
So the one thing we would hope the Agency starts doing as
well is trying to figure out some new ways to frame and think
about the regulatory problem, because the simple notion that
every time I come forward with a new particle I am going to
have to run the full set of animal toxicity tests and so on, I
mean, that isn't going to work. And so while we are very
positive about the fate and transport issue, it is a critical
first step. There is an important second step that we have
urged the Agency to take, and I think they have heard us but so
far, you know, it is still a nascent program.
Dr. Coull. The first research as I remember in nanotech in
the EPA and nano environment came out of a program called
Exploratory Research. This was an external extramural-funded
program out to universities and colleges around the country.
And it was from there as I remember that we saw the first
implications and studies in this. The entire program in
Exploratory Research, that is what kind of ideas are out there
in this academic, intellectual, and or consulting world that
are looking ahead in the future and seeing issues that are
going to occur. I think the first, I am trying to remember the
dates, and I don't have them exactly in my head, but it was in
the late '90s where we saw nano-research, and then we now have
an initiative on that, and that is great, and I am really
supportive of that, and I think that is really important for us
to do.
But the whole concept of Exploratory Research, what is the
problems? What are the problems in 2015, that we are going to
be looking at, would be a really nice thing to see to let the
intellectual, bright, young minds of the future have an input
into these kinds of things. And we don't have that anymore at
the ORD at EPA per se. It is all sort of prescribed and defined
within certain categories; endocrine disrupters, nano, et
cetera, et cetera.
Mr. Lipinski. Thank you.
Chairman Lampson. Mr. Inglis.
Mr. Inglis. I want to follow up on Mr. Lipinski's line of
questioning there about nanotechnology. In particular, Dr
Coull, you mentioned earlier it is either the, you said the PCB
of the future or the world saver. So back up and tell me a
little bit about that so that I can understand how it could be
the PCB.
Dr. Coull. I think others have spoken to that issue. It is
at what are the environmental consequences of this.
Mr. Inglis. Right.
Dr. Coull. And we don't know. Right? But are we going to
make major breakthroughs and have stints that we can put, made
out of nanoparticles that are going to save our lives from
having heart attacks and things? We are starting to know about
those things, but we don't know a lot about them either. And
that is why I made that comment, is that those who are
interested in nanotechnology to make new products to sell on
the market are telling us that this is the best thing since,
you know, traditionally sliced bread. But, you know, those of
us who are concerned with the environment, where are those? You
know, are they going to wind up in the sediments of the Great
Lakes like the PCBs have done or in Charleston Harbor of the
future, and I don't know the answer to that. And that is why I
think we need research to look at what is the effect of these.
There are colleagues, again, at USC and at the National
Fisheries Lab looking at the effects of nano-tubuals on
attracting contaminants and sediments. That is all I can tell
you, and I don't know the results of their research, and that
is funded by the STAR Program also.
Mr. Inglis. Dr. Morgan, you had----
Dr. Morgan. Yes. If I could just add something. I mean, we
all talk about nanomaterials as though they are some uniform
set of things. In fact, of course, it is an enormous
heterogeneous bunch of stuff, and if I have put nanoparticles
in paint on a new car to make it shiny, it is probably not
going to pose any significant health risk because it is all
bound up in a paint matrix. On the other hand, if I am
producing mono-disperse sub-micron material that can penetrate
the blood brain barrier to take a medication to the brain, then
I have to worry a bit about whether it might do other things as
well. And so it is a very complex domain, and you know, we need
to be careful not to think about all of these topics as though
they are exactly the same. I mean, I don't worry too much if it
is embedded in the matrix of a paint, and I worry quite a bit
if it is mono-dispersed, but as Dr. Gray said, one of the
things you have to quickly understand is how these things
behave in the environment. I mean, very fine particles in the
atmosphere, this room is full of them, quickly adhere to larger
ones, and so, you know, does the particle then retain its same
properties when I inhale it? We don't know the answer in many
cases, and that is why some basic research is important in this
field as well as some applied research to support regulation.
Mr. Inglis. Yeah, and Dr. Gray, you mentioned in your
testimony, I believe, that you are comfortable with the
research budget for the, I guess precisely what Dr. Morgan was
just mentioning.
Dr. Gray. Yeah. This budget gives us the resources we need
in this case to look at nanotechnology and really to do it in a
multi-pronged approach. We are still, much of your early
research focused as several people have mentioned, on some of
the potential environmental applications of nanotechnology, and
there are some great examples. There are things being
demonstrated using, in fact, at Carnegie Mellon, using zero
valiant nanoparticles of iron to clean up chlorinated solvents
that are contained in ground water. A great use of it. What we
have done more and more is to focus on implications. That is,
how do we understand what might be happening, what might be
some adverse affects. We have had STAR Grant studies looking at
the absorption through skin of these nanoparticles to help
address some of these questions that Dr. Morgan raised, and
then what we are doing now is bring some of this research in-
house to use our smarts. We have got great engineers who are
very excited about this area, to understand what it means when
these materials get out into the environment, how people might
be exposed.
So this budget gives us the resources we need to really get
a great start on that.
Near Road Pollutants
Mr. Inglis. Yeah. One other question, Dr. Gray. You
mentioned the Air Pollution Near Roads Initiative. Tell me a
little bit more about that. That is particular significant for
those of us who have a non-attainment issue.
Dr. Gray. This is something that, again, came out of some
of the research that we have supported, primarily in the area
of particulate air pollution. One of the big areas of focus in
our clean air effort, one of the big parts of our STAR Program
are particulate air pollution centers that we fund at
universities across the country. And one of the things that has
come out of some of the epidemiology there are hints that there
may be differential risks around roadways, and so what we are
doing is making sure that we start focusing our research, both
the folks that we have got in ORD and the research that we are
doing in our particle centers, to think about this near roadway
exposure.
And also then to think not only about how it happens but
what the health affects might be and back to one of the things
I think is important to remember that ORD does, what are some
solutions that we might have.
Mr. Inglis. Thanks, Mr. Chairman.
EPA Budget Request
Chairman Lampson. Dr. Morgan, does the SAB find the EPA's
annual budget presentation to Congress to be straightforward?
Does the presentation provide a clear picture of what funds the
Agency is requesting and the programs that are receiving
increases and decreases?
Dr. Morgan. We have trouble unscrambling the numbers from
time to time as I suspect you may also. We got probably one of
the better briefings this year from the Agency that we have had
in quite awhile. We asked them to show us, and I think you held
up the presentation that we got, where the budget had undergone
significant decreases and increases. But, you know, there are,
particularly this year with operating under a continuing
resolution and the fact that it is really hard to know how in
the current fiscal year the money is going to get allocated
within or across programs, it has been a bit of a struggle.
Chairman Lampson. Anyone else want to make a comment? I got
a couple more questions but----
Dr. Sass. I actually did my best analysis of the budget by
looking at the presentation of ORD to the Scientific Advisory
Board because there is no numbers associated with the different
programs.
Chairman Lampson. Dr. Coull.
Dr. Coull. We had trouble understanding the budget.
Chairman Lampson. Okay. A number of years, 10 years ago as
a matter of fact I created the Congressional Caucus on Missing
and Exploited Children. I have a lot of interest in children
and child safety and issues, and while this doesn't have to do
with a child abduction issue, it does have something to do with
children's health and safety. Protecting the health of our
children is important. It is an important part of EPA's
mission.
In your testimony, Dr. Gray, you state that EPA's ``Human
health research funding will allow us to conduct research
regarding the health risks of susceptible populations.'' But,
in fact, the President is proposing to cut the funding to help
protect children and the elderly by seven percent. Is that
correct?
Dr. Gray. Again, sir, I don't know exactly which line you
are speaking to, so I don't know. If you have a more precise
question, I would be happy to get back to you with budget and
with the exact numbers.
Chairman Lampson. It appears to me that it goes from $61.5
million to $56.8 million, which is a decrease of $4.7 million.
Let me ask Dr. Coull. In Dr. Gray's testimony he argues
that, ``At EPA we are good stewards of our environment and good
stewards of our nation's tax dollars.'' However, in your
testimony you discussed many emerging new environmental threats
including avian influenza, episodic diseases such as cholera,
toxicants such as arsenic and mercury. Without additional
research, could these emerging threats be expensive for the
U.S. Government to address or contain? If we under invest in
environmental research, are we being good stewards of our
taxpayers' dollars, because will it not cost of through the
nose in the future?
Dr. Coull. Absolutely. Money spent upfront to know things
is better than having to spend it after the gates. I mean,
that, in the environmental world we call this the precautionary
principle. We would like to have precaution on certain things
that may be brought about by environmental change. Are we going
to have palm trees in Maine? You know, that is not the same
level of issues that you are talking about, but are we going to
have malaria in Florida? And these are environmental issues
related to global climate change.
So certainly EPA cannot afford to do them now under the
budget that I have seen for the last several years and the
present budget. So that is, it will cost us more later than now
to do this.
Chairman Lampson. That is a huge concern. It should be a
huge concern to all of us, and I hope it is to you as well, Dr.
Gray, and I made my comments strongly earlier, and I feel very
strongly about them. This is an agency that the people of the
United States of America rely on, and we need to see that same
kind of care and concern and particularly when our Congress,
and these budgets have been pushed forth by a Republican
Congress prior and signed by our Republican President. It is
not about partisanship. I don't know whether my kids are going
to grow up to be Democrats or Republicans, but I know that I
want them to grow up to be healthy. And we do have that
obligation. We are the stewards of their future. I don't feel
like we are honoring that. So I would beg you to please go look
again and do what Congress asks. That is why we have a
procedure. And then if you don't agree with it, then come back
and bring realistic information to us. I think it is a
catastrophe for us to see the kinds of things that are
happening right now and putting us in huge jeopardy for our
future.
And with that I will turn to the Ranking Member again.
Mr. Inglis. I have no further questions, Mr. Chairman, and
I thank the witnesses, though, for appearing.
Chairman Lampson. Likewise. I thank you for your tolerance
this afternoon, all of you for taking the time and for bringing
your information up here. Your testimony indeed is helpful, and
if there is no objection, the record will remain open for
additional statements from Members and for answers to any
follow-up questions that the Committee may ask of the witness.
Without objection, it is so ordered, and we are now adjourned.
Thank you all very much.
[Whereupon, at 3:50 p.m., the Subcommittee was adjourned.]
Appendix 1:
----------
Answers to Post-Hearing Questions
Responses by George M. Gray, Assistant Administrator for Research and
Development, Environmental Protection Agency
Questions submitted by Chairman Nick Lampson
EPA LABORATORY STUDY
Q1. With respect to EPA's study of the laboratories infrastructure,
you indicated in your response that ``. . .no laboratories will be shut
down, and no scientists will be let go.'' The Congressional
justification indicates the Administration is proposing to cut Total
Work-years for Science and Technology from 2,433 in FY 2006 to 2,406 in
FY 2008. Where are the cuts to the Science and Technology workforce
coming from? Are there plans to reduce the administrative support staff
of the laboratories? Is the Administration making plans to offer
buyouts to any of the senior management, support, or scientific staff
of the laboratories over the next two years? Please provide the
section/s and page number/s in the Congressional Justification and/or
the Strategic Plan that describes and discusses the Agency- wide study
of EPA's laboratory infrastructure.
A1. The 27 work-year decline between FY 2006 and FY 2008 represents a
one percent decline in workforce levels overall to the S&T account. A
portion of the decline has occurred in each of the Agency's five
strategic goals and in both the programmatic and administrative areas.
The plan is to achieve all reductions through attrition, and a portion
of the reductions in the administrative area reflects expected
efficiency improvements. The study is briefly discussed in the
Justification on page 82 of the Appendix.
Q2. You mentioned the Agency is looking for opportunities to increase
efficiency at the laboratories and used the Region One laboratory as an
example. You indicated that the Region One laboratory found ways to
reduce their energy use by 19 percent. Over what time period did the
Region One laboratory achieve this reduction in energy use? What
changes did they make to achieve these savings?
A2. The reduction in energy use of 19 percent cited in my testimony
before the Committee reflected reductions achieved by the EPA Region
One laboratory between fiscal years 2005 and 2006. If one looks at the
reductions in energy use over a two year period, from fiscal years 2004
to 2006, the reduction is an even more impressive 28 percent.
When opened in 2001, EPA New England's laboratory received a LEED
Gold Rating for its green design, in recognition of its energy
efficient design, its active and passive solar power, its use of
recycled materials in construction, and its environmentally-friendly
landscaping. However, the laboratory has worked to do even better.
Over the last two years, the EPA Region One laboratory in
Chelmsford, Massachusetts reduced its energy consumption from 25,154
million British thermal units (mmBtu) in fiscal year 2004 to 18,107
mmBtu in fiscal year 2006, for a total reduction of 28 percent. The
laboratory reduced its energy consumption by 11.2 percent in fiscal
year 2005 (compared to 2004 levels) and an additional 18.9 percent in
fiscal year 2006 (compared to 2005 levels). Using an average mmBtu cost
of $26.60, the cost savings from these reductions were $187,451 in
fiscal year 2006 alone.
The Region One laboratory implemented a variety of building
modifications and operational changes to achieve these reductions in
energy use. The largest physical modification to the building was
installation of 23 fan powered units, which were necessary to correct
temperature imbalances in the building. This modification was funded
entirely by the building owner, after pressure from EPA. This
modification had no direct cost to EPA. The fans enhanced heat
distribution in the perimeter offices, improving both temperature and
energy efficiency.
EPA did pay $41,372 for other modifications to the HVAC system. EPA
had two goals in modifying the laboratory's HVAC system. The first
priority was to assure availability of HVAC redundancy for the computer
room, telephone switch room, and the UPS room. The second priority was
to increase building efficiency. This was accomplished by connecting
the primary facilities HVAC system to the previously mentioned rooms
and using the original less efficient units for redundancy, in an
emergency, should the house system fail.
The Region 1 laboratory instituted several other changes in
operation which did not have significant cost. During a routine
operations maintenance audit in 2005, the laboratory discovered that
its gas boilers were wasting energy by operating more pumps and motors
than required to meet the building heating demands. The lab found that
defective sensors were the problem and replaced them to increase system
efficiency. In June 2005 the facilities staff began working with new
on-site management to monitor HVAC performance on a daily basis and
make adjustments to system set points according to outdoor air
temperatures, actions which continue to improve efficiency and save
energy.
The facility manager worked closely with the property manager to
modify the operation of the building in other energy-saving ways,
including:
<bullet> Expanding night/weekend hours when lab and office
temperatures and air volumes are moderated in order to save
heating and cooling;
<bullet> Identifying analytical equipment and processes which
can be shut down when not in use and/or batch processed when
constant operation is not necessary;
<bullet> Manually adjusting chiller/heat supply temperature
and humidity controls relative to the demand due to seasonal
ambient temperature and humidity loads;
<bullet> Reducing illumination levels in common areas by
utilizing emergency and natural lighting only in building
hallways; and
<bullet> Conducting daily ``end of day'' laboratory and office
walk-throughs manually closing fume hoods and shutting lights.
EPA hopes to achieve further energy savings at the Region One
laboratory. In March 2007, EPA embarked upon a feasibility study to
site a wind, solar or geothermal generation project at the laboratory.
Q3. Has the Agency funded any workshops or meetings to solicit input
to EPA's work in developing guidance or test protocols with the
academic, public health, or public interest community similar to the
International Life Sciences Institute sessions described by Dr. Sass in
her testimony? If so, please provide a list of these meetings funded
over the past five years and the amounts of funding provided for each
meeting.
A3. EPA's professional staff takes full responsibility for drafting
scientific guidelines, risk assessments, and similar documents. They
draw on their professional training, the experience gained at EPA,
advice from other professional colleagues, and publicly available
scientific literature. EPA does not customarily organize meetings with
external groups to solicit input on the development of its scientific
guidance documents outside of the accepted Federal Advisory Committee
Act (FACA) process. However, EPA has occasionally funded outside
organizations to hold meetings on scientific topics that are related to
the development of guidelines and risk assessment methodologies used in
its programs. For example, EPA has supported:
Drinking Water Scientist-to-Scientist Meeting
EPA invited representatives from other federal agencies, academia,
industry/trade organizations, and environmental advocacy organizations
to attend a meeting concerning the effects of drinking water treatment
on organic pollutants. The meeting afforded participants the
opportunity to describe current and planned research and models. The
participants also discussed the direction of future drinking water
treatment research, as well as how to use study results in the
pesticide program's drinking water exposure assessments.
AOAC International
AOAC International is a widely recognized, nonprofit standard
setting organization. Among other efforts AOAC publishes methods
related to testing the efficacy of antimicrobial pesticides; EPA
requires studies using these methods to support applications for
registration of antimicrobial pesticides with public health uses. The
pesticides program has provided funding to AOAC to coordinate
workshops, symposia, and roundtable discussions with interested
stakeholders on modifications of existing methods and the development
of new methods. In addition, AOAC has coordinated the recent, ten
laboratory Three Step Method (TSM) validation to evaluate a new
quantitative method for determining the efficacy of sporicides (for
Homeland Security purposes).
International Life Sciences Institute (ILSI)
ILSI is a nonprofit worldwide foundation whose mission is to
improve public health through scientific advances. EPA has funded work
through ILSI to develop science papers on issues related to human
health. ILSI used the funds to support expert workshops that included
scientists from federal agencies, international organizations, drug and
chemical companies, academia, and nongovernmental organizations to
review public literature and other available information on selected
scientific topics. ILSI has focused on particular issues related to
toxicology testing, exposure assessment, and identifying mechanisms of
action, and on developing new tools and methods for risk assessment.
The results of these efforts are a series of publications that appear
in the peer reviewed literature. These projects are not done
specifically for the benefit of EPA but are done to benefit the area of
health broadly and are widely used nationally and internationally. ILSI
does not work on specific chemical risk assessments or on regulatory
policy papers for OPPTS.
Anthrax Interagency Expert Panel
The panel comprises technical experts from numerous government
agencies (DOD, FDA, EPA, etc.) who provide technical insight and advice
on research goals related to test method development for select
biological agents (anthrax and others). EPA provided funding to
Tetratec for logistical meeting support (not technical support),
including the compilation of meeting minutes, maintaining a webpage,
etc.
World Health Organization (WHO) Workshop on Setting Acute Reference
Doses
Along with other donors, EPA provided funding to the WHO to support
the development of guidance concerning the derivation of benchmarks
reflecting safe acute (one day or shorter) exposure levels for
pesticides. The WHO formed a Working Group of senior scientists from
various national pesticide regulatory organizations who met repeatedly
to develop detailed guidance on the performance of acute risk
assessments. The Working Group's efforts resulted in a lengthy document
that eventually appeared as a publication in peer review literature.
Joint Meeting on Pesticide Residues (JMPR) Annual Meeting
Along with other donors, EPA funds the World Health Organization
portion of the annual meeting of the JMPR. The JMPR is an international
expert scientific group jointly administered by the UN Food &
Agriculture Organization and the World Health Organization. The annual
JMPR meetings recommend Maximum Residue Levels (MRLs), i.e., the amount
of a pesticide residue in food to which people may safely be exposed.
Published information can be accessed through: http://www.who.int/ipcs/
food/jmpr/ Although EPA independently determines safe levels of
pesticide residues in food and sets tolerances that apply to food and
feed products in the United States, EPA considers relevant MRLs
recommended by JMPR in its tolerance-setting process.
The EPA High Production Volume (HPV) Challenge Program Conference
EPA funded a cooperative agreement with the Northeast Waste
Management Officials' Association (NEWMOA) to conduct a National
Conference on Characterizing Chemicals in Commerce: Using Data on High
Production Volume Chemicals. The purpose of the conference, which took
place December 12-14, 2006, was to educate a wide variety of
stakeholders including federal/State agencies, international
organizations, NGOs, academia, and industry about the EPA High
Production Volume (HPV) Challenge Program, as well as other sources of
chemical toxicity and environmental information; to share experiences
of key stakeholders about the use of data made available by the EPA HPV
Challenge Program, and to develop ideas on how to make sources of HPV
chemicals information and other data user friendly, accessible, and
relevant to a diverse audience. As a result EPA has received many
comments and suggestions about EPA review of data quality and setting
priorities for further work, and about making the HPV Information
System easier to use.
The Perfluorooctanoic Acid (PFOA) Meetings
In 2003, EPA initiated an enforceable consent agreement (ECA)
process under section 4 of the Toxic Substances Control Act (TSCA) to
generate information on the sources of perfluorooctanoic acid (PFOA) in
the environment and the pathways leading to human and environmental
exposures (68 FR 18626; April 16, 2003). Fifty-one organizations and/or
individuals registered as Interested Parties to participate in the
public negotiation process leading to the development of testing under
ECAs that EPA signed with individual companies. A series of 16 public
meetings ranging from one to three days in length were held at EPA
Headquarters from June 2003 through June 2006 to provide a forum in
which all the Interested Parties, including industry, environmental
groups, government agencies, public utilities, public health groups,
and others could participate in the drafting of two ECAs for
incineration testing on fluorotelomers (70 FR 39624; July 8, 2005:
available online in docket number EPA-HQ-OPPT-2001-0001 via ``Advanced
Search'' on http://www.regulations.gov) and fluoropolymers (70 FR
39630; July 8, 2005; docket number EPA-HQ-OPPT-2003-0071); provide
input on the creation of two voluntary Memoranda of Understanding
(MOUs) between EPA and industry for environmental sampling and
monitoring at two fluoropolymer manufacturing facilities (EPA-HQ-OPPT-
2004-0112 and EPA-HQ-OPPT-2004-0113); and participate in discussions on
method development and study design for telomer biodegradation and
telomer and fluoropolymer aged article testing. The meetings were held
in EPA Headquarters meeting space. The only cost concerned meeting
support in the form of an EPA contractor recording the meetings for the
purpose of preparing meeting summaries, which were entered into the
PFOA ECA docket, EPA-HQ-OPPT-2003-0012, and distributed via e-mail to
all meeting attendees, Interested Parties, and others expressing
interest in following the topic. The initial meeting included the
preparation of a full meeting transcript. Information on the meetings
is available on the EPA's PFOA website at http://www.epa.gov/opptintr/
pfoa/meetings/meetings.htm and http://www.epa.gov/opptintr/pfoa/
meetings/pfoarchive.htm, and in the online PFOA ECA docket, EPA-HQ-
OPPT-2003-0012. The information obtained through the PFOA ECA process
and through voluntary activities initiated as a result of this process
will contribute to the EPA's ongoing risk assessment work on PFOA. EPA
will seek SAB review on any final PFOA risk assessment document.
NPPTAC Nanoscale Public Meetings
On June 23, 2005, EPA held a public meeting to solicit input on the
potential development of a stewardship program to address various
issues related to nanoscale materials under TSCA. This meeting was
funded by the Office of Pollution Prevention and Toxics (OPPT), and
included an electronic docket for submission of comments.
As a result of the public meeting, the National Pollution
Prevention and Toxics Advisory Committee (NPPTAC) was asked to develop
possible courses of action for OPPT to address the potential issues
related to nanoscale materials under TSCA. At their June 30, 2005
meeting, NPPTAC established an Ad Hoc Work Group to take up the
request. The Work Group held a public meeting September 29, 2005 to
solicit comments on a potential voluntary program. In addition, the
full NPPTAC held a public meeting October 13-14, 2005 as well as a
public teleconference November 17, 2005 to finalize a document
outlining elements of a voluntary program. This document was officially
forwarded to EPA on November 22, 2005.
On October 19-20, 2006, OPPT held a public scientific peer-
consultation to receive input on the risk management practices elements
of the stewardship program being developed in response to public and
NPPTAC input. Two more meetings--a public scientific peer-consultation
on materials characterization and a public meeting on the stewardship
program as a whole--are being planned for summer, 2007. EPA typically
seeks public input from all interested stakeholders including FACAs.
Toxicology Excellence for Risk Assessment (TERA)
This project, under a cooperative agreement with TERA, is the
backbone of the Voluntary Children's Chemicals Evaluation Program
(VCCEP): it provides a mechanism for peer consultation on VCCEP
chemicals in which technical experts representing all stakeholders in
VCCEP have an opportunity to discuss and comment on proposed risk
assessments for chemicals of concern to children.
Q4. Were any of the products of these meetings--guidelines or
recommended research protocols--subject to review by the Science
Advisory Board? What is the review process for the materials that
emerge from these meetings?
A4. EPA works carefully to ensure that our documents and regulations
are supported by strong, peer reviewed science, and we typically
solicit input from our stakeholders, the public, and other federal
agencies as we develop our materials. EPA has institutionalized formal
mechanisms for reviewing its scientific work and evaluating it against
the highest professional scientific standards and integrity. For
example, the most influential scientific products are subject to
independent, external peer review. These external peer reviews by
experts like the Science Advisory Board in the various subject areas
help ensure that EPA's science and research achieve defensible
scientific results and quality.
In addition, EPA welcomes any comments that are intended to
strengthen the scientific underpinnings of the documents we
disseminate. While EPA often solicits external expert advice on
scientific issues and draft work products, EPA retains the
responsibility for final determinations on risk analyses and other
scientific findings, and their use in Agency decisions.
Q5. GAO released a report in February 2005 in response to a request by
Rep. Udall and Rep. Johnson of this committee. The report recommended
that EPA ``develop formal policies for evaluating and managing
potential conflicts of interest when entering into research
arrangements with non-governmental organizations, particularly those
that represent regulated industry.'' Please provide EPA's formal
policies for evaluating and managing potential conflicts of interest
produced in response to the recommendations by GAO in this report.
A5. EPA's formal policies for evaluating and managing potential
conflicts of interest produced in response to recommendations made by
GAO in their February 2005 Report are included as Attachment A.
Q6. In your testimony, you indicated that the President's FY 2008
request of $754.5 million for science and technology (S&T) is a
significant increase over the 2007 enacted funding for science and
technology programs. Does the $754.5 million figure include funding to
support operations and maintenance for S&T facilities? If so, what is
the amount of funding from the $754.5 million total that is allocated
to this category of spending? Does the FY 2006 enacted total for S&T of
$731 also include the funding to support operation and maintenance for
S&T facilities? If so, what is the amount of funding from the $731
million that was allocated to this spending category in FY 2006?
A6. Yes, the $754.5 million FY 2008 President's Budget Science &
Technology (S&T) request includes $65.1 million for rent, security and
utilities. Prior to FY 2007 direct laboratory rent, security and
utilities for S&T-funded personnel were paid for through the
Environmental Programs and Management (EPM) appropriation. Starting in
the FY 2007 budget, EPA proposed shifting these resources from EPM to
S&T to more accurately account for the overall costs for S&T personnel.
EPA's overall funding is not changed, nor are any S&T programs reduced
by this change. The restructuring is being phased in the FY 2007
Enacted budget ($23.6 million) and would be fully implemented in the FY
2008.
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Q7. The National Academy of Sciences' report, Assessing the Human
Health Risks of Trichlorethylene: Key Scientific Issues, was released
in July 2006. The Committee found: ``. . .Thus the committee recommends
that federal agencies finalize their risk assessment with currently
available data so that risk management decisions can be made
expeditiously.'' [emphasis added]
It has been nearly one year since the NAS issued this report.
When is EPA going to issue new health-protective standards for
trichloroethylene under the Safe Drinking Water Act and other
appropriate statutes that mandate containment and clean up of toxic
substances?
A7. Pursuant to requirements in the Safe Drinking Water Act, EPA is
currently reviewing existing national primary drinking water
regulations for TCE and 72 other regulated contaminants. As part of
this review, EPA analyzes new scientific and technological data and
information on health effects associated with each regulated
contaminant. If the Agency identifies a potential health or
technological basis for a revision to the drinking water regulation,
this would necessitate a series of follow-up analyses for potential
regulatory revision. For example, EPA would need to conduct occurrence
and exposure analysis, and evaluate available economic information to
determine if changes to the standard are needed. EPA currently
anticipates completing this review after the final revised risk
assessment for TCE is complete.
The final revised risk assessment for TCE represents a key piece of
information that is needed for the Agency to complete its review of the
drinking water regulation. EPA is considering the NAS report, along
with previously submitted Science Advisory Board (SAB) and public
comments and newly published research, to prepare a new draft TCE
assessment. This draft assessment will be released for peer review as
well as additional public review and comment and then finalized.
INTEGRATED RISK INFORMATION SYSTEM REVIEW PROCESS
Q8. During the hearing Dr. Sass indicated that finalizing chemical
assessments for inclusion in the Integrated Risk Information System
(IRIS) data base was very slow and that it has become slower due to
additional review procedures.
Q8a. Please provide the current procedure for informal and formal
reviews of a chemical assessment from the point where the initial DRAFT
assessment is produced until the assessment is finalized. Include all
opportunities for internal, external (e.g., formal peer review and
public comment), and interagency reviews that are now part of this
process.
A8a. EPA's current process for developing chemical health assessments
that ultimately are posted to EPA's IRIS database consists of: (1) an
annual Federal Register announcement of EPA's IRIS agenda and call for
scientific information from the public on selected chemical substances;
(2) a comprehensive search of the current scientific literature; (3)
development of draft IRIS health assessments utilizing EPA's risk
assessment guidelines and state-of-the-art scientific methods; (4)
review within EPA; (5) interagency review; (6) independent external
peer review and public review and comment; (7) public external peer
review meeting; (8) preparation of final IRIS documents based on
independent expert review and public comment; (9) interagency review;
(10) final EPA review and clearance; and (11) posting of completed IRIS
assessments on to the database.
EPA is continuing to build and update the IRIS database by
addressing the foremost user needs, as expressed within EPA, by other
federal agencies, and by the public. EPA will also work toward updating
the assessments in the IRIS database where new scientific information
is sufficient.
Q8b. Indicate which of the steps is constrained to a specific time
period (e.g., public comments for 60 days).
A8b. At this time, the only step in the health assessment development
process that is constrained to a specific time period is public review
and comment. EPA's current process calls for at least one opportunity
for public review and comment on each draft health assessment. This
comment period, which is announced to the public via a Federal Register
notice, ranges from 30 days to 60 days depending on the complexity of
the assessment and the level of stakeholder interest in what is
recognized as a high profile assessment. Generally, EPA times the end
of the public comment period so that it ends one to two weeks prior to
the peer review meeting. Then, prior to the peer review meeting, all
comments submitted to the Agency by the close of the public comment
period are provided to the members of the peer review panel for their
pre-meeting review.
Q8c. Indicate the agencies that are involved in any interagency review
process and the nature of their role in the process.
A8c. The agencies involved in any interagency review process for any
particular chemical depends on the chemical itself and an individual
agency's interest in that chemical. The Office of Management and Budget
(OMB) coordinates and participates in the interagency review process.
The interagency group may consist of representatives from the: Office
of Science and Technology Policy (OSTP), Council on Environmental
Quality, Department of Health and Human Services (HHS) [including
representation from the Agency for Toxic Substances and Disease
Registry (ATSDR), Centers for Disease Control and Prevention (CDC),
National Institutes of Health (NIH), National Institute for
Environmental Health Sciences (NIEHS), National Institute for
Occupational Safety and Health (NIOSH) and Food and Drug Administration
(FDA)], Department of Defense (DOD), Department of the Interior (DOI),
Department of Labor (DOL), National Air and Space Administration
(NASA), Department of Energy (DOE), Department of Transportation (DOT)
[including representation from the Federal Aviation Administration
(FAA)], Department of Agriculture (USDA), and the Consumer Product
Safety Commission (CPSC).
Q8d. Indicate the points in this process that the Office of Management
and Budget, the Office of Science and Technology Policy, and any other
White House office or committee are involved in the formal or informal
review of the assessment and the nature of their role in the process.
A8d. OMB is involved in steps 5 and 9 of the review process described
in the response to question (a) above. In step 5, EPA provides to OMB
the draft health assessment and the draft charge to the external peer
reviewers. OMB distributes these draft documents to the others in the
interagency group for review and comment. EPA then revises the draft
health assessment and charge, as appropriate, to respond to the
comments. After interagency review is completed, the draft assessment
is released for public comment and begins independent peer review. In
step 9, after peer review is complete and EPA has addressed comments
from the independent peer reviewers and the public, OMB and the other
federal agencies are again provided the draft assessment for review.
This provides an opportunity for OMB and the other federal agencies to
review any changes by EPA arising from external peer review comments.
After step 9 is completed, the final assessment is publicly released by
inclusion on IRIS.
Q8e. What is the maximum, minimum, and average time required to
complete this review process for a chemical assessment?
A8e. EPA, in cooperation with an interagency group, is reviewing the
Agency's development process for health assessments that will be posted
on IRIS. Thus, the review process is evolving. The current process,
however, as described above, in which EPA sends draft health
assessments for interagency review at two points in the process [prior
to external peer review (Step 5) and before posting on IRIS (Step 9)]
has been followed for over a year. As this review process has
developed, several assessments (e.g., toluene, n-hexane, and phosgene)
were completed and posted on IRIS. EPA will be happy to provide updated
information as more assessments are finalized. In addition, the Agency
has developed annual goals of completing 16 health hazard assessments
of high priority chemicals for interagency review or external peer
review and posting eight finalized assessments on the Internet.
HUMAN HEALTH
Q9. The Agency's proposed budget in FY 2008 for human health risks of
susceptible populations is reduced by $4.7 million as compared to the
FY06 enacted funding. What specific research projects or activities
will be eliminated to accommodate the proposed reduction in funding for
research in this area?
A9. The reduction includes a redirection of some resources to support
higher priority research in several areas, such as Clean Air, Human
Health Risk Assessment (HHRA), and Sustainability. While no major
programs will be eliminated by the reduction, some lower priority
research will be impacted. EPA will continue to fund critical core
research to address health risks of susceptible sub-populations, (such
as mechanistic work, aggregate and cumulative risk assessments, and the
Children's Environmental Health Centers) and will meet critical
performance commitments.
INTEGRATED RISK INFORMATION SYSTEM
Q10. In her testimony, Dr. Sass listed several types of information
that are not being included in the current postings of chemical
assessments on the IRIS data base listed within the past year or two:
acute risk values and summaries of the assessments. Dr. Sass also
indicated that EPA's supplemental cancer guidelines providing for
consideration of children's exposure has not been applied to the posted
assessment on ethylene oxide. Dr. Sass attributes these features of
recently posted chemical assessments on the IRIS data base to decisions
of the Office of Management and Budget.
Q10a. Why have acute risk values been excluded from the recent IRIS
assessments?
A10a. Acute risk values have not been part of traditional IRIS
assessments. The IRIS database is focused on health effects from
longer-term exposures. Other federal agencies, such as the Agency for
Toxic Substances and Disease Registry (ATSDR), develop values for less-
than-lifetime exposures. EPA also supports the development of Acute
Exposure Guidance Levels or AEGLs (http://www.epa.gov/opptintr/aegl/
pubs/process.htm) and Provisional Assessment Levels or PALs (http://
www.epa.gov/NHSRC/news/news062906.html) for short-term exposures.
Additionally, EPA began a pilot effort in 2003 to evaluate the
application of methods, procedures, and resource needs for deriving
less-than-lifetime exposure duration values. This effort focused on
some ``pilot'' chemical as part of this methods development effort.
Q10b. Why don't the recently posted chemical assessments on the IRIS
data base contain summaries?
A10b. When an IRIS assessment is completed, EPA's practice is to post
the final toxicological review document and IRIS summary after external
peer review is completed.
In addition, EPA is in the process of enhancing the IRIS system by
employing new electronic technologies, making the system more useful to
users. The current format for IRIS is dated and relies heavily on text
instead of an integrated and interactive approach to displaying the
risk information in IRIS. The direction we're heading is to move the
IRIS database into the 21st century by revising the format of the
summaries to utilize hot links to the appropriate discussions in the
toxicological review documents. This will enhance the information
transfer to users and eliminate redundancy in the current system.
Q10c. Have the supplemental cancer guidelines providing for
consideration of children's exposure been followed in the preparation
of the IRIS listing for ethylene oxide in the toxicological review and
in the summary assessment? If not, why not?
A10c. The external review draft of the Evaluation of the
Carcinogenicity of Ethylene Oxide (EPA, August 2006) follows the
Agency's 2005 Supplemental Guidance for Assessing Susceptibility from
Early-Life Exposure to Carcinogens. The assessment draft concludes that
``Because the weight of the evidence supports a mutagenic mode of
action for EtO carcinogenicity, and in the absence of chemical-specific
data on early-life susceptibility, increased early-life susceptibility
should be assumed and, if there is early-life exposure, the age-
dependent adjustment factors (ADAFs) should be applied, as appropriate,
in accordance with EPA's Supplemental Guidance for Assessing
Susceptibility from Early-Life Exposure to Carcinogens. . .'' (p. 2,
line 18-23).
Q10d. What information does the Agency use to decide when and how the
supplemental cancer guidelines providing for consideration of
children's exposure will be applied in the development of chemical
assessments posted on the IRIS data base?
A10d. The Agency considers chemical-specific data (from humans or
animals) demonstrating increased early-life susceptibility to cancer.
If no such data are available but the chemical has been determined to
be carcinogenic by a mutagenic mode of action, then the default factors
supplied in the Supplemental Guidance are used to estimate risk
corresponding to children's exposure.
Q10e. What role has OMB played in determining the type and scope of
information to be included in chemical assessments included in the IRIS
data base?
A10e. EPA is the author of chemical assessments included in the IRIS
data base and EPA determines the type and scope of information that
will be included in the assessments. However, EPA does make revisions
to draft documents based on public comments, peer review comments, and
comments from interagency review, including comments from OMB.
Questions submitted by Representative Ralph M. Hall
BOARD OF SCIENTIFIC COUNSELORS
Q1. I understand that in addition to working with the Science Advisory
Board (SAB) you also work closely with the Board of Scientific
Counselors (BOSC). Please describe the BOSC and how it assists with
improving the efficiency of your efforts.
A1. The BOSC was established by the U.S. Environmental Protection
Agency (EPA) in 1996 to provide advice and recommendations about the
Office of Research and Development (ORD) research program. It is one of
approximately 25 Federal Advisory Committees at EPA. Since the BOSC is
a Federal Advisory Committee, it must comply with the Federal Advisory
Committee Act (FACA) (5 U.S.C. App. C) and related regulations.
Consequently, the BOSC has an approved charter, which must be renewed
biennially, announces its meetings in the Federal Register, opens its
meetings to the public, and provides opportunities for public comment
on issues before the Board.
The BOSC members constitute a distinguished body of scientists and
engineers who are recognized experts in their respective fields. The
BOSC currently has 14 members, and they meet three to five times each
year. BOSC members are Special Government Employees (SGEs), and are
required to complete ethics training and an extensive confidential
disclosure form (3110-48) that is reviewed for potential conflicts of
interest, and approved by the Designated Federal Officer (DFO) and
Designated Agency Ethics Official prior to commencing any work for the
BOSC. The BOSC provides advice and recommendations to ORD on:
<bullet> science and engineering research, programs and plans,
laboratories, and research-management practices of ORD
<bullet> ORD's program development and progress, ORD's
research planning process, and research program balance
<bullet> peer review, including evaluation of ORD's peer
review policies, and review of ORD Offices, National
Laboratories and Centers, and research plans and products
<bullet> human resources planning, such as scientist career
development and rotational assignment programs, and the
appropriate scope and design of training programs for
environmental research professionals.
With the approval of EPA, the BOSC Executive Committee establishes
subcommittees for any purpose consistent with the BOSC's charter.
Subcommittees have no authority to make decisions on behalf of the
BOSC, nor can they report directly to EPA. Subcommittees may not work
independently of the chartered Executive Committee, and must report
their recommendations and advice to the BOSC Executive Committee for
full deliberation and discussion. ORD has been implementing periodic
independent expert retrospective/prospective reviews of the relevance,
structure, performance, quality, scientific leadership, coordination
and communication, and outcomes of each of its research programs since
2004, and is using BOSC subcommittees as the independent expert review
mechanism for these reviews.
An ORD representative serves as the DFO for the BOSC Executive
Committee and each Subcommittee, coordinating all of their activities
and related administrative activities. Current BOSC members,
activities, and copies of BOSC meeting minutes and reports are
available at www.epa.gov/osp/bosc.
Although the ``efficiency'' of ORD research is not explicitly
addressed by the BOSC reviews of ORD programs, it is implicitly
addressed by asking the BOSC to comment on whether ORD is doing the
right science, doing the science right, satisfying client/stakeholder
needs, and achieving needed outcomes in its reviews. The BOSC
recommendations help ORD to: plan, implement, and strengthen its
programs; compare the program under review with programs designed to
achieve similar outcomes in other parts of EPA and in other federal
agencies; make research investment decisions over the next five years;
prepare EPA's performance and accountability reports to Congress under
the Government Performance and Results Act; and respond to evaluations
of federal research, such as the Performance Assessment Rating Tool.
Between 2004 and 2006 the BOSC conducted program reviews and issued
reports for the following ORD research programs: drinking water,
particulate matter and ozone, ecology, human health, endocrine
disrupting chemicals, water quality, land, and global change. Each of
these reviews has provided valuable advice for improving ORD research.
ORD plans to continue periodic retrospective/prospective analysis of
its research programs at intervals of four to five years, and sees the
BOSC reviews as an important feedback mechanism for how well ORD is
conducting its research, responding to client needs, and achieving
outcomes.
NEAR ROAD ENVIRONMENT RESEARCH
Q2. You mentioned in your testimony vehicle emissions in the near road
environment. What are your plans with near road environment research
and how do you plan on reducing public exposure to air pollution?
A2. A growing number of health studies have identified an increase in
the occurrence of adverse health effects, including respiratory
disease, cancer, and even mortality, for populations living near major
roads.\1\ These initial reports have raised concerns about the siting
of schools near roadways, the quality of indoor air in existing schools
near roadways, and the general health impacts on people living near
roads. Additionally, recent studies assessing the health impacts of
airborne particulate matter have shown a source signal (e.g., copper,
nitrogen oxides, or engine or brake metals) associated with roadway
traffic.
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\1\ For more details, see:
Peters A, von Klot S, Heier M, Trentinaglia I, Hormann A, Wichmann
HE, Lowel H. (2004). Exposure to traffic and the onset of myocardial
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infarction. N Engl J Med. 351(17):1721-30.
Kim JJ, Smorodinsky S, Lipsett M, Singer BC, Hogdson AT, Ostro B.
(2004) Traffic-related air pollution near busy roads: the East Bay
Children's Respiratory Health Study. American Journal of Respiratory
Critical Care Medicine 170:520-526.
Gauderman WJ, Avol E, Lurmann F, Kuenzli N, Gilliland F, Peters J,
McConnell R. (2005) Childhood asthma and exposure to traffic and
nitrogen dioxide. Epidemiology 16(6):737-743.
EPA plans to evaluate the impact of roadways on health risk by
conducting research following the paradigm of ``source to ambient air
to exposure to health outcome'' in an attempt to rank this medium in
the hierarchy of emission sources associated with air pollution.
Comprehensive studies are planned in collaboration with the Federal
Highway Administration over the next four years in Las Vegas, Detroit
and Raleigh--each representing distinct, representative meteorological
and topographical environments and traffic situations. Initial studies
will include: near-road emissions (diesel and gasoline), distance from
road measurements, development of local-environment dispersion models,
and assessment of low-cost mitigation strategies in indoor school
environments. This effort will expand beginning in Detroit to include
the broader significance of near-road emissions in the context of
multiple other sources and more specific personal exposure assessments
on people and potential health impacts. In addition to assessment of
roadway exposures as a health risk, specific information as to
potential measures for mitigation of exposures (through the use of
barriers and horticulture, changes in building ventilation, etc.) and
tools for addressing the problem (through models that suggest altered
traffic flow or road and urban design) will be developed.
EPA Libraries
Q3. In her testimony, Dr. Sass, from the Natural Resources Defense
Council, mentioned that EPA had not finalized digitizing documents
housed in EPA libraries on schedule. Please clarify the current
situation in regard to the libraries and digitizing of documents. Also,
please describe any plans (including timelines) EPA has for closing its
libraries.
A3. The Agency has met its commitment to digitize all unique EPA
documents held by the Regions 5, 6, and 7 libraries and the OEI-run
Headquarters Library by January 31, 2007.
EPA plans to complete digitization of unique EPA documents in other
libraries by the end of fiscal year 2008.
EPA has no plans to close other libraries.
Questions submitted by Representative Daniel Lipinski
Q1. The Administration's FY 2008 budget request for the Great Lakes
Legacy program represents a reduction of $14 million from FY 2006
enacted funding (from $49.6 million to $35 million). I believe this
cutback will hamper efforts to address persistent high concentrations
of contaminants in the bottom sediments of rivers and harbors that
represent a risk to aquatic organisms, wildlife, and humans. Two of
these ``areas of concern'' (AOCs) are located near the Chicagoland area
and my district. What degree of contaminated sediment remediation has
been accomplished by this program since it became law five years ago?
What is the anticipated date that remediation of these areas will be
completed? How will the program be impacted by this proposed budget
cut? What activities will be discontinued to achieve the $14 million
reduction in funding for this program?
Q1a. What degree of contaminated sediment remediation has been
accomplished by this program since it became a law five years ago?
A1a. The program first received funding in FY 2004. Since then, the
program has remediated 250,000 cubic yards of contaminated sediments at
three completed sites in three Areas of Concern. Project Agreements
have been signed for two additional sediment remediation projects which
are expected to remediate an additional 640,000 cubic yards of
contaminated sediments (Ashtabula River, Ohio, and Tannery Bay, Sault
Ste. Marie, Michigan). These two projects are underway and are
scheduled to be completed by the end of 2007.
Q1b. What is the anticipated date that remediation of these areas will
be completed?
A1b. U.S.EPA has received proposals for Legacy Act funding for
remediation of sites within Waukegan Harbor and Grand Calumet River
Areas of Concern. We will be able to estimate a remediation date for
projects in these Areas of Concern if the projects score favorably and
are selected for funding, in accordance with the Great Lakes Legacy Act
implementation rule. The Great Lakes Program works with the full gamut
of enforcement and regulatory programs in the 30 remaining Areas of
Concern (including the Waukegan and Grand Calumet AOCs), along with the
Great Lakes Legacy Act to find solutions to addressing the remaining
problems in the AOCs. Specifically, we are working closely with the
Illinois EPA, the Illinois DNR, the Indiana Department of Environmental
Management, and the Indiana DNR to find solutions to the remaining
problems at Waukegan and the Grand Calumet River.
Q1c. How will the program be impacted by this proposed budget cut?
A1c. If the President's budget is enacted, the Legacy Act program will
actually receive an increase of about $5 million over the FY06 enacted
level, for a total of $35 million.
Q1d. What activities will be discontinued to achieve the $14 million
reduction in funding for this program?
A1d. See #1c. If the President's budget in enacted, no activities will
be discontinued.
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Answers to Post-Hearing Questions
Responses by M. Granger Morgan, Chair, Environmental Protection Agency
Science Advisory Board
Questions submitted by Chairman Nick Lampson
Q1. You indicated in your testimony and in response to subsequent
questions that EPA's proposal for increased research on nanomaterials
was improved and that a focus on fate and transport research is
important. Last year the Wilson Center released a report indicating
that there are already a number of products on the market that contain
nanomaterials, and EPA has made some determinations under the Toxic
Substances Control Act (TSCA) that several nanomaterials are
substantially similar to existing chemicals and therefore has not
required testing of these substances. Did the SAB evaluate the
nanomaterials research program in relation to its ability to deliver
information to support decisions that EPA is now making under TSCA and
future decisions the Agency may be required to make under other
environmental statutes? Is the proposed level of funding and the scope
of the program sufficient to support both EPA's regulatory mission and
an exploration of future questions that may arise related to
nanomaterials?
A1. As indicated in my testimony, and our written report on this issue,
this year, the SAB focused on a strategic review of ORD's research
program. Thus, we did not look at the details of each ORD research
program, for example, the nanotechnology research program in relation
to TSCA. Thus, our responses reflect what I believe to be strategic
advice to EPA on its research programs, especially as its program
components relate to each other and become parts of an integrated
overall research program. My response to this question, and the other
questions below, should be considered in recognition of this larger
view.
It is tempting to think of nanomaterials as just another form of
chemical substance that needs to be evaluated with classic
toxicological testing before it is used in settings that might involve
exposure to people or the environment. However, for several reasons it
is not appropriate to think about most nanomaterials in this way.
Nanoparticles may undergo substantial transformations once they
have been introduced into the environment. For example very small (sub-
micron) particles rather quickly stick to larger particles. In addition
one must ask:
-- What sorts of chemical and physical transformations might
the material undergo?
-- What will happen to any ``external coatings'' that may be
applied?
-- What will be the degradation processes and what sorts of
other materials will result from those processes?
-- How will the electrical properties of some particles impact
living cells?
When we said we were pleased to see EPA/ORD undertaking research on
fate as well as physical and chemical transformation in the environment
(and presumably in the future in living organisms), it was because
without an adequate understanding of the answers to such questions, it
will be difficult for EPA to develop an appropriate science-based
approach to the regulation of these materials.
However, if the agency were to apply classical toxicological
testing to evaluate nanomaterials it seems likely that those classic
toxicological testing procedures would rapidly become overwhelmed.
Existing laboratory capacity is already over-taxed by such testing for
chemicals and the situation for nanomaterials could be far worse. For
example, it is entirely possible that without changing the chemical
properties of a particle, minor topological changes (for example,
whether a specific string of molecules protrudes on the left or right
side) could have profound toxicological or other effects.
I believe that in addition to its work on fate and transport, we
face an urgent need to develop new thinking about how to approach the
task of regulating such materials. To date, there has been little
progress made by EPA, or anyone else, on this issue. The problem is
probably best addressed by broadly engaging the thinking of many smart
people both inside, and especially outside, the Agency.
You specifically asked:
-- Did the SAB evaluate the nanomaterials research program in
relation to its ability to deliver information to support
decisions that EPA is now making under TSCA and future
decisions the Agency may be required to make under other
environmental statutes?
-- Is the proposed level of funding and the scope of the
program sufficient to support both EPA's regulatory mission and
an exploration of future questions that may arise related to
nanomaterials?
The answer to the first part of your question is that with the
program's very limited scope and funds, even if it were to focus
entirely on assessing the toxicity of specific new products or
materials now under regulatory review, as is the common practice under
TSCA, it would never be able to develop the more fundamental insights
and understanding needed to support development of efficient science-
based regulation in the longer-term. If one wants the program in ORD to
do both, then a substantially expanded level of support will be needed.
The answer to the second part of this question is ``no.'' While the
current funding supports a modest program of research to improve our
understanding of the fate, as well as the physical and chemical
transformation of these materials in the environment, it is far too
small to address all the important issues, and it does not currently
support the broader extramural effort I suggest above that is needed to
develop new and efficient ways to address the regulatory challenges
these materials pose.
Q2. Dr. Morgan, was the SAB briefed by the Agency on any plans to
study, reduce funding for, or consolidate EPA's laboratory personnel,
operations or infrastructure? Was the SAB ever asked by EPA to consider
or evaluate their plan to consolidate EPA's libraries and restructure
their service delivery to Agency employees and the public?
A2. The SAB was not briefed on any plans to consolidate EPA's
laboratory infrastructure. However, it has been clear for over 20 years
that EPA's research funding was at best flat and as I stated in my
testimony this year and last, the EPA research budget is now being
significantly decreased. The Agency has been open about these cuts but
has maintained, as it must in budgeting, that it can still do important
research. Our current and past comments recognize that continuing cuts
to research resources, coupled with a desire to maintain an intramural
staff of EPA experts, will diminish the resources associated with those
things actually needed to conduct research (i.e., equipment, supplies,
and appropriate laboratory facilities).
The SAB was not briefed on EPA's library plans, though the issue
was raised by SAB members during the FY 2007 research budget review
meeting. ORD representatives noted at that time that libraries were
managed outside their office and thus were not in their control.
Q3. In your testimony you state that it is important to consider land
use, soil and water issues related to development of biomass as an
energy source. Is EPA factoring these considerations into their
research on biomass energy?
A3. The materials provided to the SAB to support its review of EPA's
strategic research directions and the EPA FY 2008 research budget
suggest that biomass energy is just beginning to make its way onto the
research agenda. The SAB stated on page 8 of its report of March 13,
2007:
``Many of the responses to global change may also have impacts
that should be studied so that they can be understood and plans
can be made to manage them appropriately before they arise. For
example, while biomass fuel holds the potential to drastically
limit future net CO<INF>2</INF> emissions to the atmosphere, it
will require vast amounts of land and may have important
impacts on ecosystems, on soil degradation, and on water
quality and water demand. These fuels can also yield different
combustion products that will present changing concerns for air
quality. While some of these issues now appear to be on the
agenda of the new sustainability initiative, they have yet to
be addressed in a serious way, or integrated with the global
change research program.''
Q4. The FY 2008 Budget again proposes to eliminate funding for its
technology verification programs, the Superfund Innovative Technology
Evaluation (SITE) program and the Environmental Technology Verification
(ETV) program at EPA. Should EPA continue to have these programs or is
this something the private sector can do on its own as Dr. Gray
suggested in his testimony?
A4. Dr. Gray's assessment of the need for future federal support of
these programs seems to reflect the difficult choices that ORD must
make in allocating scarce and declining resources to develop the
scientific knowledge to support EPA's mission. I have consulted on this
issue with Dr. Michael McFarland, Chair of the SAB's Environmental
Engineering Committee, and we offer the following personal opinion
based on what we know of SITE and ETV.
The Agency plays a critical role as an honest broker in both the
SITE and ETV programs. Environmental technology evaluation and
verification can, in principle, be conducted within the private sector.
However, results from these activities are often fraught with consumer
concerns including the possibility of technical inaccuracies,
unbalanced testing methods, inadvertent or deliberate bias and possibly
even outright fraud.
The overt presence of the Agency within the technology evaluation/
verification process lends an important degree of credibility to the
marketplace. In other words, we believe that consumer confidence is
much higher when the Agency is known to be involved with the
development, implementation and assessment of environmental technology
evaluation processes. It is important to recognize that the Agency does
not choose technology winners or losers in either the SITE or the ETV
programs. The Agency merely provides the marketplace with the assurance
that the technology evaluation process was conducted as advertised.
The appropriate level of Agency involvement with the development,
implementation and assessment of technology evaluation processes (and
methods) is arguably the most relevant question and, of course, how
those activities should be financially supported. From our evaluation
of the SITE and ETV programs, we would strongly argue that the Agency
needs to maintain an explicit (and transparent) role in SITE and ETV to
ensure that the processes (and methods) used to evaluate environmental
technologies are scientifically sound and applied in a balanced way.
Although the private sector has a clear interest in financially
supporting environmental technology evaluation and verification
processes, it is not entirely obvious how competing demands on private
sector resources will influence the development, implementation and/or
assessment of technology testing procedures. Explicit Agency
involvement provides a means of ensuring vital standardization in
technology testing.
Of course, with declining federal budgets, it is clear that
increasing financial support for the SITE and ETV programs will be
difficult to achieve. However, consideration should be given to
maintaining these programs at a level sufficient for them to engage in
meaningful discussions with private trade groups and testing
organizations (e.g., American Society of Testing Materials--ASTM) to
assure the marketplace and the general public that environmental
technology claims are supported by scientifically sound and fully
documented procedures.
Answers to Post-Hearing Questions
Responses by Jennifer Sass, Senior Scientist, Health and Environment
Program, Natural Resource Defense Council
Questions submitted by Chairman Nick Lampson
International Life Sciences Institute (ILSI) contracts and projects
with EPA
Q1. Was NRDC or any other public interest group invited to participate
or observe any of the workshops or meetings funded under these
contracts?
A1. No. However, if NRDC or any other public interest group had been
invited to participate, this would have still left the public interest
overwhelmingly under-represented in a highly technical debate. The
public relies on its publicly-supported federal agencies to represent
the public interests, and expects its products to be available for
public scrutiny by all interested parties. It would be unreasonable to
expect the public and public interest groups to provide adequate
technical representation during a long, drawn-out process of workshop
proceedings. Rather, we expect the final products of such events to be
disclosed as corporate/industry work products, submitted to federal
agencies during appropriate stages in the regulatory process, available
for public scrutiny, and treated with the same consideration, and no
more, as all public submissions.
Q2. What is the nature of NRDC's concern about these workshops and
meetings?
A2. The ILSI, like any trade group or industry, has the right, and is
even encouraged to conduct scientific inquiries (research or analysis)
regarding the risks associated with its member's products. Such
inquiries should be welcomed as submissions to the regulatory agencies
for their review and consideration. When conducted through the proper
channels, such submissions are available for public scrutiny, and are
submitted to the agencies during appropriate times in the regulatory
process. For example, pesticide registrants are required to submit
safety data on their products as a prerequisite for registration\1\,
and are required to submit adverse effects information as it becomes
evident during the products commercial use.\2\ While the registration
of new chemicals does not require safety data, all chemical
manufacturers, importers, processors and distributors are required to
submit all available information on the risks of their products.\3\ The
difference between these industry-submissions and the ILSI-EPA
activities is that the latter are conducted in a manner that parallels,
manipulates, and even co-opts the Agency's activities, so that a final
work product represents the corporate response to regulatory needs, but
without the disclosure that it is a corporate work product, without the
limitations placed on a public submission, and without the
participation of public advocacy groups. ILSI describes itself as,
``bringing together scientists from academia, government, and
industry.'' \4\ While it is expected that ILSI will sponsor research,
conferences, workshops, and publications to increase awareness of its
scientific research and viewpoints, it is of great concern that
government officials from regulatory agencies participate in and even
sponsor many of these efforts, influencing government policy positions
while by-passing federal requirements for balance of perspectives and
transparency such as those embodied in the Federal Advisory Committee
Act (FACA).\5\
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\1\ The data requirements for registration of pesticides are
intended to generate data and information necessary to for EPA to
assess the identity, composition, potential adverse effects and
environmental fate of each pesticide. EPA's requirements for data are
listed in the Code of Federal Regulations, Chapter 40, Part 158. http:/
/www.epa.gov/pesticides/regulating/data.htm
\2\ Section 6(a)(2) of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) requires pesticide product registrants to
submit adverse effects information about their products to the EPA.
http://www.epa.gov/pesticides/fifra6a2/
\3\ Section 8(e) of the Toxic Substances Control Act (TSCA)
requires U.S. chemical manufacturers, importers, processors and
distributors to notify EPA within 30 calendar days of new, unpublished
information on their chemicals that may lead to a conclusion of
substantial risk to human health or to the environment. http://
www.epa.gov/opptintr/tsca8e/
\4\ http://www.ilsi.org/AboutILSI/
\5\ 5 U.S.C. Appendix 2.
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For the reasons above, at a meeting in January, 2006, the World
Health Organization (WHO) took action to limit the participation of
ILSI in its activities, specifically preventing ILSI from participating
in ``normative activities,'' defined as setting chemical or contaminant
levels for food and water. This decision followed a public letter from
NRDC, Environmental Working Group, United Steelworkers of America and
15 other health, environmental and union groups calling on the WHO to
sever all official ties with ILSI. In response to the WHO decision, an
e-mail from Craig Barrow of Dow Chemical to ILSI leadership pledges the
support of Dow to, ``work with ILSI to develop and implement a
proactive strategy'' to prevent ``further discredit to industry and
ILSI in the U.S.'' \6\ As the Dow e-mail demonstrates, the interests of
ILSI are the interests of its corporate members.
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\6\ E-mail from Barrow, Craig (CS). Sent: Monday, January 30, 2006
8:32 AM. To: Holsapple Mike (Holsapple, Mike); Gibson Jim (work),
(Gibson, Jim (work)); Goodman Jay (Goodman, Jay). Cc: Bus, Jim (JS).
Subject: WHO Bans ILSI Participation
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Many ILSI workshops result in recommendations for more scientific
study by raising uncertainty and doubt regarding existing science. This
technique often serves to stave off liability and health-protective
regulations, as described in the now-famous 1969 tobacco memo as
follows: ``Doubt is our product since it is the best means of competing
with the `body of fact' that exists in the mind of the general
public.'' \7\ Similar misinformation campaigns have been used by ILSI
members representing asbestos, beryllium, lead, mercury, vinyl
chloride, chromium, benzene, and other toxic chemical and
pharmaceutical agents.\8\<SUP>,</SUP>\9\ This strategy (calling for
more research while avoiding meaningful action) also has been the
hallmark of global warming opponents, who have misrepresented the
scientific consensus, resulting in a decades-long delay in U.S. efforts
to curb global warming emissions; a delay that may prove costly indeed
for the American people.\10\
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\7\ Burgard, JW. Executive at Brown and Williams. August, 1969.
Available at the Legacy Tobacco Documents Library, University of
California, San Francisco. Bates number 680559702. Available at http://
legacy.library.ucsf.edu/tid/wjh13f00
\8\ Michaels, David. Doubt is their product. Scientific American
June, 2005. pp. 96-101
\9\ Special Issue. The Corporate Corruption of Science. Eds. D
Egilman, S Rankin-Bohme. Int J Occup Env Health, Vol II, No 4. October-
December, 2005. http://www.ijoeh.com/
\10\ White house white-washes global warming data. June 8, 2005. A
top White House environmental official--and former oil industry
lobbyist--repeatedly manipulated government reports to downplay the
threat of global warming. Available at NRDC Bush Record: http://
www.nrdc.org/bushrecord/2005<INF>-</INF>06.asp
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EPA is finding itself spiraling into an increasingly weaker
scientific state. It has been dealt a decreasing budget for providing
scientific infrastructure and resources, despite an increasing need for
robust data to support human health and environmental protective
policies and regulations. The result is that EPA is increasingly under
pressure to make regulatory and policy decisions with no data,
inadequate data, or poor-quality data. NRDC recommends that EPA support
and expand its use of in-house scientific and technical experts. These
people represent the Nation's brain-trust, and their work products
should be publicly available. The Agency's own technical experts have
to be enabled to investigate and disclose what dangers we truly face
from environmental pollutants, despite myriad influences of business
interests. With the current cuts to the EPA budget, and under current
EPA leadership, grievous and irreversible damage is being done to this
Agency's capacity to protect human health and the environment.
Questions submitted by Representative Daniel Lipinski
Nanotechnology
Q1. What is your opinion of the EPA's current research agenda
regarding nanotech?
A1. While it focuses on collecting much needed information about
nanomaterial toxicity, it fails to either take advantage of existing
authority to require the generation and submission of certain
information or to explain how this information will inform or support
regulatory action, and the nature of regulatory action that EPA plans
to take. Thus, EPA's current agenda is missing a vitally important
element: a commitment to ``develop and enforce regulations that
implement environmental laws enacted by Congress'' \11\ to protect
human health and the environment. EPA should use existing authorities
to require safety testing of nanomaterials and to prevent exposure to
or release of untested or unsafe nanomaterials. In short, EPA is
failing to develop new regulations, or amend existing regulations, to
adequately address the dangers that potentially toxic nanomaterials may
pose to human and the environmental.
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\11\ http://www.epa.gov/epahome/aboutepa.htm (statement and
explanation of EPA's mission).
Q2. What is your opinion of the efficacy of the EPA voluntary pilot
---------------------------------------------------------------------------
program on nanotech?
A2. A voluntary pilot program now under consideration by the EPA will
request that industry participants submit data on material
characterization, toxicity, exposure potential, and risk management
practices.\12\ While this program may help to fill the regulatory
breech, it will only involve those companies that volunteer to
participate, and will gather data regarding only those products that
participating companies choose to disclose. Companies with the riskiest
products, as well as those with poor business ethics--that is, those
most likely to need government oversight--are least likely to
participate. A coalition of more than 20 public interest groups
including NRDC, Friends of the Earth, Greenpeace, Sierra Club, and ETC
Group insist that a voluntary program without a mandatory regulatory
component will not be able to address potential risks.\13\
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\12\ National Pollution Prevention and Toxics Advisory Committee
(NPPTAC). Interim Ad Hoc Work Group on Nanoscale Materials, Overview of
Issues for public discussion and consideration by NPPTAC. U.S.
Environmental Protection Agency, September 21, 2005.
\13\ J. Sass, NRDC comments on EPA proposed voluntary pilot program
for nanomaterials, July 20, 2005, Docket: EPA-OPPT-2004-0122-0013.
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As a result, the pilot program may generate some useful data, but
it falls well short of what is need to ensure that we can identify and
address significant potential health threats before they cause
widespread damage.
Despite its shortcomings, the Toxic Substances Control Act (TSCA),
enacted by Congress in 1976 to gather information about chemical
substances and control those deemed dangerous to the public or the
environment, is the most obvious candidate for regulating
nanomaterials. NRDC and other public interest groups urged the EPA to
identify all engineered nanomaterials as ``new chemical substances''
under TSCA because they meet the standard of ``organic or inorganic
substance[s] of a particular molecular identity.'' \14\ This would
trigger TSCA section 5 pre-manufacture notice (``PMN'') reporting
requirements prior to the commercial manufacture or import of
nanomaterials.\15\ The U.S. Patent and Trademark Office issued more
than 8,600 nanotechnology-related patents in 2003, suggesting that at
least one arm of the government already considers these materials to be
new.
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\14\ Toxic Substances Control Act (``TSCA'') 3(2)(A); 42 U.S.C.
2602(2)(A).
\15\ TSCA 5 authorizes the EPA to review activities associated
with the manufacture, processing, use, distribution in commerce, and
disposal of any new chemical substance before it enters commerce, and
requiring pre-manufacture notice (``PMN'') reporting prior to
commercial manufacture or import under 5 and 42 U.S.C. 2604.
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In addition to pre-manufacture (PMN) reporting, the EPA has
authority to issue test rules under TSCA section 4, and may waive the
regulatory production volume thresholds that otherwise would not be
triggered by the miniscule product volume of most nanomaterials.\16\
EPA also has authority under TSCA section 6 to prohibit or limit anyone
manufacturing, importing, processing, distributing in commerce, using,
or disposing of a chemical if there is a reasonable basis to conclude
the chemical presents, or will present, an ``unreasonable risk of
injury to health or the environment.'' EPA has not taken advantage of
these authorities to address the risks that nanomaterials pose. Indeed,
the EPA has failed to regulate any new chemical using the TSCA's
section 6 authority since that provision was gutted by the U.S. Court
of Appeals for the Fifth Circuit in the 1991 case Corrosion Proof
Fittings v. EPA, rejecting the EPA's application of the TSCA's section
6 to asbestos).\17\ The court's decision and subsequent problematic EPA
interpretations of that decision make it extraordinarily difficult for
the agency to adopt regulations under TSCA's section 6.
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\16\ TSCA 4(a) states that where there are insufficient data to
assess the effects of the manufacture, distribution, processing, use or
disposal of a chemical substance, and testing is necessary to develop
such data, the TSCA provides that the EPA shall promulgate regulations
requiring manufacturers and/or processors of such substances to develop
new data that are needed to assess potential risks to human health and
the environmental if the administrator finds: (1) that manufacture,
distribution, use, and disposal practices may present an unreasonable
risk of injury ( 4(a)(1)(A)(i)); or (2) that the chemical will be
produced in substantial quantities and that it enters or may be
reasonably anticipated to enter the environment in substantial
quantities or that there is or may be significant or substantial human
exposure to the substance, 4(a)(1)(B)(i)).
\17\ Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir.
1991).
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In the end, EPA's current agenda leaves the American public
virtually unprotected, the de facto guinea pigs of the nanotechnology
industry. While NRDC believes that requiring pre-manufacture notice,
issuing test rules, and promulgating regulations under TSCA may
ultimately be insufficient to protect public health and the
environment, EPA's current agenda fails even to identify how it will
use these authorities reduce the risk associated with nanomaterials. As
a result, legislative action by Congress, the states, and potentially
the courts will be necessary to ensure that concerns regarding
nanomaterials are adequately addressed.
Q3. Is the EPA research plan designed to support Agency decisions and
key questions about potential risks?
A3. This is an important question, and one that is difficult to answer,
since the EPA research strategy is not clearly coordinated with
identified regulatory needs. In other words, the research does not
identify what question it is designed to answer, and what regulatory
action may be associated with that answer. For example, Section 3.3.5
of the White Paper (Feb 2007; EPA 100/B-07/001) provides some general
discussion of the important issue of ``bioavailability and
bioaccumulation of nanomaterials,'' and then later in Section 5.1.3,
identifies the need for research on the extent that nanomaterials used
in environmental remediation may themselves be persistent,
bioaccumulative, and/or toxic. This extremely limited view fails to
identify the critical need for this research on all nanomaterials,
whether in remediation applications, commercial products, or industrial
processes. Moreover, the White Paper fails to make recommendations
about regulatory actions based on this information. If a nanomaterial
is shown to be persistent, bioaccumulative, and toxic, what is EPA to
do? The failure of our regulatory agencies to identify and regulate
persistent bioaccumulative toxics represents a failure of public health
prevention, and an abdication of responsibility from our publicly-
entrusted federal agencies to the private realm via voluntary
agreements.
An array of good stewardship approaches to nanotechnology
development would increase public confidence and market stability. In
public comments on the EPA external review draft nanotechnology white
paper, NRDC and other public interest groups and public health experts
requested that EPA do the following:\18\
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\18\ NRDC comments on the US EPA external review draft
nanotechnology white paper. January, 2006. Docket ID: EPA-HQ-ORD-2005-
0504
<bullet> take immediate action to prevent uses of
nanomaterials that may result in human exposures or
environmental releases, unless reasonable assurances of safety
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are demonstrated beforehand;
<bullet> label products that contain nanomaterials, or are
made with processes that use nanomaterial;
<bullet> publicly disclose information on potential risks;
<bullet> include toxicity information on nanomaterials for
worker protection on material safety data sheets;
<bullet> increase safety testing conducted by independent or
government laboratories subject to ``sunshine laws'' that allow
public access;
<bullet> conduct comprehensive assessment of the environmental
and human health concerns that may arise across the life-
cycle--including production, use, and disposal--of nanotech
products.
The potential of nanotechnologies to transform the global social,
economic, and political landscape makes it essential that the public
participate in the decision-making regarding the introduction and
management of these new technologies to ensure that public values and
preferences inform the development of this transformative new
technology. It is essential that such public participation directly
inform public policy development and nanotechnology decision-making,
rather than limiting public `engagement' to a one way process in which
government and the scientific community `educate' the public. Public
preferences should also inform the allocation of public funding for
nanotechnologies' research and development; commercially-oriented
research should not be at the expense of public interest research.
Consideration of nanotechnology's broader social implications and
ethical issues should occur at each stage of the development process.
Social impact and ethical assessment, alongside the expression of
community preference, should guide the allocation of public funding for
research; new nano-products should be subject to a social impact and
ethical assessment process as part of the regulatory approval process
prior to their commercialization; and social science analysis of
nanotechnology's implications should take place in real time alongside
that of the toxicological sciences. Meaningful public participation
will require transparency of both scientific and social issues, and
will require rapid public access to credible information.
Appendix 2:
----------
Additional Material for the Record
Statement of the American Chemical Society
The American Chemical Society (ACS) would like to thank Chairman
Bart Gordon and Ranking Member Ralph Hall for the opportunity to submit
testimony for the record on the Environmental Protection Agency (EPA)
science and technology programs for fiscal year 2008.
ACS is a non-profit scientific and educational organization,
chartered by Congress, representing more than 160,000 individual
chemical scientists and engineers. The world's largest scientific
society, ACS advances the chemical enterprise, increases public
understanding of chemistry, and brings its expertise to bear on State,
national, and international matters.
As Congress and the Administration consider funding priorities for
FY 2008 in a tight budgetary environment, ACS urges policy-makers to
support the important work carried out by the Environmental Protection
Agency's Science and Technology Program. In reviewing the President's
budget request, ACS has identified four areas of focus for EPA:
1. Growing the EPA Science & Technology account and increasing
support for scientific research supported by the Agency,
particularly through the Office of Research and Development
(ORD).
2. Restoring important programs that build the talent pipeline
for the environmental sciences, such as the Science To Achieve
Results (STAR) fellowships.
3. Increasing support for green chemistry and engineering
programs and reversing the short-sighted decision to eliminate
the Technology for Sustainable Environment research program.
4. Reforming the management structure for science at EPA.
We look to science to understand environmental challenges and to
develop more intelligent, less burdensome solutions. Over the past two
decades, demand for more scientific evidence--whether it's to set or
improve regulations--has grown substantially. The amount of research
envisioned in EPA-related authorizations also has increased.
Nevertheless, appropriations for EPA science programs have not kept
pace with the need for more and better science.
Over the last 20 years, the EPA S&T account, which includes the ORD
and research programs in other EPA Offices, has fluctuated between
seven and ten percent of the Agency's total budget. In order for EPA
set science-based national environmental standards, conduct research
and environmental monitoring, and provide technical assistance to
states, local governments, and businesses, the S&T account needs to
increase as a percentage of the Agency's total budget, ultimately to a
stable ten percent level. The President's budget request is $755
million, a roughly 3.3 percent increase over FY 2006 (final FY 2007
spending levels from H.J. Res. 20 are not available); however, with the
expiration of the Superfund tax, previously funded Superfund support
activities now come out of the S&T account and cancel out any nominal
increase in account funding. ACS recognizes the tight fiscal situation
the country faces, but strongly believes that substantial constant-
dollar decreases in funding for the S&T account will only hinder the
ability of EPA to achieve its mission.
For FY 2008, ACS recommends the ORD account should receive $646
million, consistent with its 2004 funding high point. This represents
an increase of 8.6 percent relative to FY 2006 funding levels. ACS
recommends that the additional funds be applied to the following
priority areas:
<bullet> Provide $10 million for the STAR fellowships.
<bullet> Increase overall STAR programmatic funding to $110
million.
<bullet> Increase funding of green chemistry and engineering
to advance the development and use of innovative,
environmentally benign products and processes.
<bullet> Invest in EPA's ability to recruit, develop, and
retain an effective scientific workforce.
<bullet> Continue investing in federal research and technology
development to reduce or avoid greenhouse gas emissions and
address the potential impacts of global climate change.
<bullet> Support innovative and high-risk research that may
help identify and explore future environmental problems and
develop new sets of technologies to solve existing problems.
The FY 2008 budget request continues a pattern of declining support
for science at EPA for the Office of Research & Development, which is
the largest part of the S&T account. The Administration requested $540
million for ORD for FY 2008. This represents a minus nine percent cut
in ORD resources over FY 2006. The $55 million decrease in ORD accounts
from FY 2006 threatens ORD's mission to carry out world class
environmental research, further damaging the government's ability to
provide top notch research on behalf of the American taxpayer and
ensure America's policy-makers use sound scientific advice in decision-
making.
The Administration's proposal to continue the dramatic reductions
in the STAR fellowship program is a good case in point. This program is
the only federal program dedicated to graduate study in environmental
sciences at colleges and universities across the country. The STAR
fellowships are part of a cohesive effort to characterize critical or
emerging environmental problems and create solutions to address them.
EPA designed this extramural research grant program to work in
cooperation with a fellowship program. Together, they provide ideas,
information, new discoveries, and new researchers. Today's STAR fellows
will become tomorrow's environmental experts working for industry,
government agencies like EPA, and academic institutions. The loss of
this program's resources will further erode the Agency's capability to
attract an excellent workforce and will reduce the amount of scientific
information available to inform agency decisions.
ACS supports increased funding for green chemistry and engineering
programs to advance the development and use of innovative products and
process, reducing or eliminating the use of hazardous substances.
Because chemistry and chemical products fuel the economy of every
industrialized nation, the tools and strategies chemists and chemical
engineers develop will be instrumental in meeting the dual challenges
of protecting the environment and strengthening the economy. The
elimination of the Technology for Sustainable Environment research
program under STAR was an unfortunate decision that hobbles the
Agency's ability to work creatively with industry and others to carry
out the mission through cost-effective technology substitution as
opposed regulatory burdens.
Finally, ACS remains concerned about broader management issues
raised by the long-term decline in support for EPA science and
technology programs. ACS understands the often confrontational nature
of the regulatory process; however, EPA's organizational structure
reinforces this tension by housing the Agency's main scientific
functions in an office that is:
<bullet> Inadequately funded;
<bullet> Not budgeted independently or separately by-lined in
the annual appropriations process;
<bullet> Not often given specific authorizing legislation;
<bullet> Forced to compete with its own internal offices--its
principal customers--for attention and resources; and
<bullet> Often criticized for the quality of its science and
its inability to apply this science to environmental decisions.
In previous Congresses, the Science Committee passed legislation
addressing many of these issues; unfortunately the situation today is
even more important and urgent. The ability of the government to
marshal scientific expertise and resources in the wake of the terrorist
attacks has been tested severely. New issues also have arisen, such as
the need to assure that access to government information does not
provide tools to terrorists and the need for stronger data quality
standards within government agencies. ACS endorses the creation of a
Deputy Administrator for Science and Technology, as suggested by the
National Research Council's report in 2000, Strengthening Science at
the U.S. Environmental Protection Agency. A Deputy Administrator for
Science and Technology would add considerably to an effective and
efficient EPA response to these challenges.
ACS is a long-term advocate for increased attention to research
programs at EPA, both in budgetary and in management terms, and our
enthusiasm for these programs remain strong. We also appreciate the
Science Committee's support for EPA Science and Technology programs and
look forward to working with the Committee, Congress, and the
Administration to ensure their future vitality. ACS thanks the
Committee for this opportunity to submit testimony and would be happy
to answer any questions.