UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C. 20460
OFFICE OF THE ADMINISTRATOR
SCIENCE ADVISORY BOARD
March 13, 2007
EPA-SAB-07-004
The Honorable Stephen L. Johnson
Administrator
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, D.C. 20460
Subject: Comments on EPA's Strategic Research Directions and Research
Budget for FY 2008, An Advisory Report of the U.S. Environmental
Protection Agency Science Advisory Board
Dear Administrator Johnson:
For many years the EPA Science Advisory Board (SAB) has performed detailed annual
reviews of the Agency's Research and Development (R&D) budget request. This year, ORD
requested that the Board provide advice on the strategic directions (over the next five years) of
its major research programs. For its part, the Board asked ORD to address its current and planned
research program in four key cross-program environmental challenge areas. These included: (1)
the impacts of climate change; (2) sensitive populations (both human and ecological); (3) the
environmental consequences of urban sprawl; and (4) large-scale natural and man-made
environmental disasters.
The SAB findings and recommendations are detailed in this report. Overall, the SAB
believes that EPA scientists are doing an outstanding job of sustaining a high quality program of
research in the face of severe budget constraints that appear to have caused EPA's research
planning to become more reactive and less strategic. With few important exceptions (e.g.
nanotechnology, sustainability research), the resulting research funding decisions appear to be
incremental rather than strategic, causing research programs to focus more on yesterday's issues
and less on new and emerging environmental problems.
Further, while the Agency was able to identify its longer term strategic directions for
many specific program areas, and also identified a variety of lines of research relevant to the four
cross-program issues identified by the Board, cross-program strategic planning is still very
limited. EPA 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
collaboration across program areas.
-------
With respect to the FY 2008 President's budget, the SAB has grave concerns about the
decreased trend in the funding of ecosystems research, decreased funding of STAR extramural
and fellowship programs, and the elimination of the economics and decision sciences research
program within ORD. The SAB is concerned that continuing intentions to decrease EPA's
support of research will erode staff morale and ultimately, if it has not already done so, harm
EPA's ability to maintain national leadership in environmental science and engineering.
The SAB looks forward to receiving your response concerning this year's advisory on
FY 2008 research budget request and to its continuing interactions with ORD on EPA's future
research needs and priorities.
Sincerely,
/Signed/
Dr. M. Granger Morgan
Chair
Science Advisory Board
-------
NOTICE
This report has been written as part of the activities of the EPA Science Advisory Board (SAB),
a public advisory group providing extramural scientific information and advice to the
Administrator and other officials of the Environmental Protection Agency. The SAB is
structured to provide balanced, expert assessment of scientific matters related to problems facing
the Agency. This report has not been reviewed for approval by the Agency and, hence, the
contents of this report do not necessarily represent the views and policies of the Environmental
Protection Agency, nor of other agencies in the Executive Branch of the Federal government, nor
does mention of trade names of commercial products constitute a recommendation for use.
Reports of the SAB are posted on the EPA website at http://www.epa.gov/sab.
-------
U.S. Environmental Protection Agency
Science Advisory Board*
CHAIR
*Dr. M. Granger Morgan, Professor and Head, Department of Engineering and Public Policy,
Carnegie Mellon University, Pittsburgh, PA
SAB MEMBERS
Dr. Gregory Biddinger, Environmental Programs Coordinator, ExxonMobil Biomedical
Sciences, Inc, Houston, TX
Dr. James Bus, Director of External Technology, Toxicology and Environmental Research and
Consulting, The Dow Chemical Company, Midland, MI
*Dr. Trudy Ann Cameron, Raymond F. Mikesell Professor of Environmental and Resource
Economics, Department of Economics, University of Oregon, Eugene, OR
Also Member: COUNCIL
Dr. Deborah Cory-Slechta, Director, Environmental and Occupational Health Sciences
Institute, Robert Wood Johnson Medical School, University of Medicine and Dentistry of New
Jersey and Rutgers University, Piscataway, NJ
Dr. Maureen L. Cropper, Professor, Department of Economics, University of Maryland,
College Park, MD
Dr. Virginia Dale, Corporate Fellow, Environmental Sciences Division, Oak Ridge National
Laboratory, Oak Ridge, TN
*Dr. Kenneth Dickson, Professor, Institute of Applied Sciences, University of North Texas,
Denton, TX
*Dr. Baruch Fischhoff, Howard Heinz University Professor, Department of Social and Decision
Sciences, Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh,
PA
Dr. James Galloway, Professor, Department of Environmental Sciences, University of Virginia,
Charlottesville, VA
Dr. Lawrence Goulder, Shuzo Nishihara Professor of Environmental and Resource Economics,
Department of Economics, Stanford University, Stanford, CA
*Dr. James K. Hammitt, Professor of Economics and Decision Sciences, Harvard Center for
Risk Analysis, Harvard University, Boston, MA
11
-------
*Dr. Rogene Henderson, Scientist Emeritus, Lovelace Respiratory Research Institute,
Albuquerque, NM
*Dr. James H. Johnson, Dean, College of Engineering, Architecture & Computer Sciences,
Howard University, Washington, DC
*Dr. Agnes Kane, Professor and Chair, Department of Pathology and Laboratory Medicine,
Brown University, Providence, RI
Dr. Meryl Karol, Associate Dean for Academic Affairs, Graduate School of Public Health,
University of Pittsburgh, Pittsburgh, PA
*Dr. Catherine Kling, Professor, Department of Economics, Iowa State University, Ames, IA
*Dr. George Lambert, Associate Professor of Pediatrics, Department Director Center for
Childhood Neurotoxicology, Robert Wood Johnson Medical School- UMDNJ, Belle Mead, NJ
*Dr. Jill Lipoti, Director, Division of Environmental Safety and Health, New Jersey Department
of Environmental Protection, Trenton, NJ
*Dr. Michael J. McFarland, Associate Professor, Department of Civil and Environmental
Engineering, Utah State University, Logan, UT
Dr. Judith L. Meyer, Distinguished Research Professor, Institute of Ecology, University of
Georgia, Athens, GA
*Dr. Jana Milford, Associate Professor, Department of Mechanical Engineering, University of
Colorado, Boulder, CO
*Dr. Rebecca Parkin, Professor and Associate Dean, Environmental and Occupational Health,
School of Public Health and Health Services, The George Washington University, Washington,
DC
Mr. David Rejeski, Foresight and Governance Project Director, Woodrow Wilson International
Center for Scholars, Washington, DC
Dr. Stephen M. Roberts, Professor and Director, Department of Physiological Sciences, Center
for Environmental and Human Toxicology, University of Florida, Gainesville, FL
Dr. Joan B. Rose, Professor and Homer Nowlin Chair for Water Research, Department of
Fisheries and Wildlife, Michigan State University, East Lansing, MI
*Dr. Jerald Schnoor, Professor, Department of Civil and Environmental Engineering,
University of Iowa, Iowa City, IA
in
-------
Dr. Kathleen Segerson, Professor, Department of Economics, University of Connecticut, Storrs,
CT
*Dr. Kristin Shrader-Frechette, O'Neil Professor of Philosophy- Concurrent Professor of
Biological Sciences-and Director of the Center for Environmental Justice and Children's Health,
Department of Biological Sciences and Philosophy Department, University of Notre Dame,
Notre Dame, IN
*Dr. Philip Singer, Professor, Department of Environmental Sciences and Engineering, School
of Public Health, University of North Carolina, Chapel Hill, NC
Dr. Robert Stavins, Albert Pratt Professor of Business and Government, Environment and
Natural Resources Program, John F. Kennedy School of Government, Harvard University,
Cambridge, MA
Dr. Deborah Swackhamer, Professor, Division of Environmental Health Sciences, School of
Public Health, University of Minnesota, Minneapolis, MN
*Dr. Thomas L. Theis, Professor and Director, Institute for Environmental Science and Policy,
University of Illinois at Chicago, Chicago, IL
*Dr. Valerie Thomas, Anderson Interface Associate Professor, School of Industrial and
Systems Engineering, Georgia Institute of Technology, Atlanta, GA
Dr. Barton H. (Buzz) Thompson, Jr., Robert E. Paradise Professor of Natural Resources Law,
Stanford Law School, and Director, Woods Institute for the Environment, Stanford University,
Stanford, CA
*Dr. Robert Twiss, Professor, University of California-Berkeley, Ross, CA
*Dr. Terry F. Young, Consultant, Environmental Defense, Oakland, CA
*Dr. Lauren Zeise, Chief, Reproductive & Cancer Hazard Assessment Branch, Office of
Environmental Health Hazard Assessment, California Environmental Protection Agency,
Oakland, CA
LIAISONS
*Dr. Steven Heeringa, (FIFRA Scientific Advisory Panel), Research Scientist and Director,
Statistical Design Group, Institute for Social Research (ISR), University of Michigan, Ann
Arbor, MI
Dr. Melanie Marty, (Children's Health Protection Advisory Committee Chair), Chief, Air
Toxicology and Epidemiology Branch, Office of Environmental Health Hazard Assessment,
California EPA, Oakland, CA
IV
-------
*Dr. Henry Anderson, (Children's Health Protection Advisory Committee Alternate), Chief
Medical Officer, Division of Public Health, Wisconsin Division of Public Health, Madison, WI
SCIENCE ADVISORY BOARD STAFF
*Mr. Thomas Miller, Designated Federal Officer, 1200 Pennsylvania Avenue, NW
1400F, Washington, DC, Phone: 202-343-9982, Fax: 202-233-0643, (miller.tom@epa.gov)
*Members attending the February 22-23, 2007 meeting during which the EPA strategic research directions and FY
2008 research budget were discussed.
-------
Table of Contents
1. GENERAL COMMENTS 1
2. AIR, GLOBAL CHANGE AND MERCURY RESEARCH 7
2.1 Clean Air Research 7
2.2 Global Change Research 8
2.3_Mercury Research 9
3. HOMELAND SECURITY 10
4. ECOLOGICAL PROTECTION, WATER QUALITY AND DRINKING WATER
RESEARCH 12
4.1 Ecological Protection Research 12
4.2 Water Quality 12
4.3 Drinking Water Research 13
5. HUMAN HEALTH AND HUMAN HEALTH RISK ASSESSMENT RESEARCH 15
5.1 Human Health Risk Assessment 15
5.2 Human Health Research 16
6. CONTAMINATED SITES/RESOURCE CONSERVATION AND
NANOTECHNOLOGY 18
6.1 Contaminated Sites/Resource Conservation (Land Preservation and Restoration)... 18
6.2 Nanotechnology 19
7. PESTICIDES AND TOXICS SUBSTANCES RESEARCH 20
7.1 Safe Pesticides/Safe Products Research 20
7.2 Endocrine Disrupters 20
7.3 Computational Toxicology 21
8. SCIENCE AND TECHNOLOGY FOR SUSTAIN ABILITY RESEARCH 23
9. ECONOMICS AND DECISION SCIENCES RESEARCH 25
REFERENCES R-l
APPENDIX A Al
VI
-------
1. GENERAL COMMENTS
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% in inflation
adjusted terms.1
For many years the EPA Science Advisory Board (SAB) has performed detailed reviews
of the Agency's Research and Development (R&D) budget. However, the SAb has seen little
noticeable effect from its annual plea to redress what it sees 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.
The SAB again offers commentary about some specifics of the Agency's research budget,
however, the SAB has focused much of its 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 chosen by the SAB for its focus, and which the SAB 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 in Appendix A to this advisory report.
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
As reported by the AAAS R&D Budget and Policy Program at http://www.aaas.org/spp/rd/cht9508b.pdf.
-------
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 CC>2,
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 bio-mass 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 that 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:
a) 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.
b) 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.
-------
c) 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.
d) The agency urgently needs to develop a higher level research planning effort that can:
i) 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);
ii) be better coordinated with, and build upon, the research programs of other
Federal agencies;
iii) benchmark EPA's research with other cutting edge programs in environmental
research around the world; and
iv) 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.
e) 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?
110
100
UJ
.5 90
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
80
1 70
Q
60
50
0
Ecoystem
research
constant
2004 $s
• Enacted
o President's budget
I
I
I
I
I
'04
'08
'05 '06 '07
Fiscal Year
Figure 1: Recent history of EPA
ecosystem research funding. Adjustment
to constant dollars done with the NASA
Gross Domestic Product Deflator
/Inflation Calculator available at
http://cost.jsc.nasa.gov/inflateGDP.html
-------
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.
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.
m
c.
o
jd
o
-o
O
STAR
extrmural funding
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.
90
80
70
60
constant
2004 $s
• Enacted
o President's budget
T
i
I
I
I
I
I
'03 '04 '05 '06 '07 '08
Fiscal year
Figure 2: Recent funding history of the
EPA STAR extramural program.
Adjustment to constant dollars done with
the NASA Gross Domestic Product
Deflator /Inflation Calculator available at
http://cost.jsc.nasa.gov/inflateGDP.html
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.
-------
An especially troubling part of this downward trend is the erosion of the STAR
Graduate Fellowship program, down from $9.7-milion 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 nano-technology are both good developments, because
understanding the fate and transport of nano-materials 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 "lexicological testing" approach is unlikely
to be viable if it is applied unchanged to nano-technology 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 multifaceted 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 nano-
technology 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:
a) 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.
b) 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 scientists 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:
a) 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.
b) 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.
c) 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.
d) 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.
-------
2. AIR, GLOBAL CHANGE AND MERCURY RESEARCH
2.1 Clean Air Research
EPA's 2008 Research Budget requests $81 million for clean air research, reflecting a
$3.3 million increase. The $81 million budget also reflects the consolidation of previously
separate research programs on air toxics and criteria pollutants. The increase in funding for
clean air research is important to assist the agency in meeting statutory requirements to review
the National Ambient Air Quality Standard (NAAQS) for each of the criteria pollutants every
five years. Additional support is also well justified to improve emissions inventories as needed
to implement the NAAQS, and to initiate a new effort focused on near-highway exposures to air
pollution. Consolidation of the research efforts on toxics and criteria pollutants is also consistent
with recommendations from numerous parties (including prior SAB budget reviews) calling on
EPA to follow an integrated, one-atmosphere approach. While consolidation of air toxics and
criteria pollutant research should create new opportunities to pursue projects with multiple
benefits and better exploit synergies in research efforts, the Agency needs to ensure that air
toxics research efforts are not further reduced as a result. The air toxics research effort has lost
significant funding since 2006 (a reduction from $18.5 million to $12 million) at a time when
critical research needs remain.
In a summary of its five-year strategic vision for Clean Air Research, EPA identified a
critical and appropriate strategic focus on improved mechanistic understandings of the health
effects of particulate matter. The Agency is addressing the relationship between particle
composition and toxicity as recommended by the National Research Council. The Agency
appears to be pursuing a sound strategy by considering this extremely complex issue by
examining the effects of compositional mixtures characterized by geographic location and
source. The SAB believes that EPA is appropriately pursuing the development of improved
processing tools to understand how future changes in climate will alter air quality. With
additional resources, it would be highly desirable to extend these efforts to further develop
coupled land-surface, meteorological and chemistry and transport models that would allow
comprehensive assessment of the consequences of the effect of land-use and atmospheric
composition changes on air quality.
Research on the effects of air pollution on ecosystems is a critical and growing gap in the
Agency's research portfolio. This research is needed to support EPA's obligation under the
Clean Air Act to set secondary air quality standards to protect the public welfare, and also to
improve the Agency's ability to demonstrate results for existing air quality management
programs. The National Research Council Committee on Air Quality Management in the United
States (2004) highlighted the need for the agency to better address ecosystem protection as part
of its air quality management programs. Recent Clean Air Scienctific Advisory Committee
(CASAC) reviews and recommendations on the PM and ozone standards affirmed this need.
This concern is even more important because of the dramatic drop in EPA's overall budget for
ecosystem research, its decision to terminate Environmental Monitoring and Assessment
Program (EMAP) efforts to track ecosystem condition at the regional scale, and its decision to
significantly reduce funding for deposition monitoring through the CASTNET program. As part
-------
of its EMAP budget reductions, EPA is proposing to terminate the TIME/LTM surface water
monitoring network in the Northeast, which has provided valuable data to both researchers and
public agencies for use in assessing the effect of the acid rain program. EPA should reconsider
its decision to reduce funding for these critical monitoring programs when their mission is far
from complete.
2.2 Global Change Research
Several Federal programs address specific parts of the global change issue. The EPA
research program in climate change is doing a good job of addressing a small part of this very
large problem. The EPA program is exploring the questions of how global change is likely to
impact air quality and water resources. These are obviously important questions both for the
nation and for the design and evolution of EPA's future regulatory efforts for clean air and clean
water. However they represent only a small part of the research needs raised by climate and
other issues of global change.
On the impacts side, climate change will profoundly affect natural ecosysystems. The
U.S. is a large developed country that already operates its society and economy across a wide
range of climates. Unlike many less-developed countries, the U.S. also enjoys high adaptive
capacity. A New England without birch, maple and white pine; Florida with much of the
Everglades lost to rising sea levels; or the loss of polar bears in Alaska may turn out to be of
greater concern to Americans than many of the more direct human impacts. However, because
of very limited resources, the EPA's global change research program is currently unable to
address any of the questions associated with these issues.
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 CC>2
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 combustions 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.
The U.S. has vast reserves of coal. Modern methods of carbon capture and deep
geological sequestration (CCS) hold the potential to allow the country to continue to make use of
those reserves without unacceptable emissions of CC>2. While the Department of Energy (DOE)
has the lead for developing these technologies, sooner or later the EPA will likely be responsible
for regulating some of the activities associated with their use. It is not too soon for the Agency
to begin to ask some important questions. For example, will the knowledge that is being
developed by the DOE (and other public and private sector research programs around the world)
be adequate to support science-based regulation of CCS when EPA is called upon to do so?
Current EPA managers in the global change program are technically knowledgeable and
proactive. With a substantial increase in research support, the program could be making much
larger and more important contributions.
-------
2.3 Mercury Research
Like the global change research program, the mercury program is of high quality, is
addressing a number of important questions, but is not able to address other key questions
because of severe budget constraints. While the U.S. spends growing amounts of money to
reduce emissions from industrial sources such as coal-fired power plants, we still do not fully
understand where all the mercury in the environment comes from, where it goes, and how
different chemical forms interact with the ecosystem and humans. The EPA program is
addressing some of these questions within a national context, but mercury is a global problem.
While the EPA program has begun to document important issues such as mercury that is carried
across the Pacific from Asia, both scientific understanding and the process of developing efficent
regulatory approaches would be considerably aided if there was a better understanding of the
global mass balance of mercury (i.e., where does it come from on a global basis, how much
comes from natural and from human sources, where is it transported, how is it converted
chemically, and where does it end up?) Whether EPA should undertake such a global program
on its own or in conjunction with another Federal agency (such as NOAA) is a legitimate policy
question, but either way, the need for a better understanding is urgent.
Clearly the EPA's focus on the United States, particularly on local "hot spots," is very
important. However, without a more basic understanding of global issues, serious limitations
may arise in our ability to limit human exposure to this neurotoxin.
-------
3. HOMELAND SECURITY
The Environmental Protection Agency bears responsibility for important elements of the
nation's homeland security, notably in areas of water protection, decontamination, and rapid risk
assessment. EPA's tasks require cutting-edge research in the natural and social sciences. On the
one hand, it needs technology capable of rapidly characterizing a wide variety of potential
contaminants, with sufficient precision to guide individuals with diverse needs (e.g., consumers,
healthcare professionals, water system operators, first responders). On the other hand, it needs to
ensure that these technologies are maintained despite long periods of inactivity and are integrated
with routine and emergency communications systems. The Agency must also establish and
maintain widespread public trust as an authoritative, useful information source in potentially
stressful and chaotic situations, and among multiple competitors.
The Agency's budget provides for some natural science and engineering research in the
Homeland Security program (as well as many other programs) However, it does not provide for
any significant social science research beyond basic cost-effectiveness assessment. Even when
the importance of social variables is recognized (e,g., risk communication and perception,
emergency response), the topics are treated in an unsophisticated, ad hoc way. Without sound
behavioral social science, it is impossible to take full advantage of the conscientious work done
by the Agency's natural scientists and engineers.
The SAB believes that the absence of social science expertise, other than the limited
amount of economics required for cost-effectiveness analysis, imperils the effectiveness of
programs throughout the Agency, wherever they influence processes that affect people or depend
on their behavior. The Agency must provide the science needed for specific projects, but it must
also develop a future workforce with these competencies. Although the Agency has made
workforce issues a priority, its proposed budget not only ignores social science, but eliminates
one of its few research programs (Economics and Decision Science) that made any significant
contributions to such development. Without a suitable workforce, the Agency has little to draw
upon when new challenges emerge, like homeland security, nanotechnology, or sustainability.
The SAB is also troubled by the lack of a compelling rationale for the Agency's overall
portfolio of homeland security research. All of the programs might be worth doing if executed
well (assuming they also included attention to their human behavior elements). However, it was
not clear that they are conceptualized in ways that would create results with the greatest
usefulness for the universe of homeland security threats - especially given the all-hazards
perspective that Hurricane Katrina brought into focus (e.g., it is easier to imagine the general
value of a technique to optimize sensor placement rather than that of a sensor for a specific
contaminant.)
A very significant omission from the Homeland Security research program is the lack of
activities that respond to the challenge of identifying the social values that should guide
decontamination standards (once the science has been summarized by technical specialists). As
mentioned earlier, EPA has also reduced work on developing restoration techniques for clean-up
10
-------
after a dirty bomb in an urban setting. EPA has experience with clean-up of radioactively
contaminated sites. However, EPA requires research support as it moves from technical
decommissioning projects to the integration of social values into decommissioning decisions
particularly with respect to those affecting urban areas.
A third omission, which also demonstrates the need to integrate natural and social
sciences, is the critical need for a plan for the disposal of infected animal carcasses, for which
EPA has leadership responsibility among federal agencies. The need for such disposal could
arise from avian flu, hoof-and-mouth disease, or a terrorist attack. Appropriate strategies must
consider where farms are sited, how to minimize carcass transport, the possibilities for mobile
incineration, the groundwater quality effects of burying carcasses or ashes, the acceptability of
disposal on public and private sites, and public understanding of residual risks (if any) to the
food supply. EPA has thus far failed to provide scientifically sound guidance, so states have
begun to perform their own rudimentary evaluations. Inevitably these state-level standards will
vary and this will send confusing signals to the public, which will see different practices in
different states.
A positive feature of the budget is that it proposes to reduce expenditures on the Water
Security Initiative, given completion of demonstration projects. That means both that the
program has achieved Agency milestones and that the science budget will not be burdened with a
long-term operational responsibility in this area.
11
-------
4. ECOLOGICAL PROTECTION, WATER QUALITY AND DRINKING WATER
RESEARCH
4.1 Ecological Protection Research
EPA's Ecological Research Program (ERP) in ORD has experienced a crippling decrease
in funding from $108 million in FY 2003 to $68 million in the FY2008 budget. The program
was in the process of developing the science for assessing the status, and trends in the health, of
several key components of our natural resource capital (streams, rivers, forests, and wetlands).
In this effort, the ERP has provided valuable methods and data. Now, the ecological research
program is in the planning stages of a program reorientation that would focus on defining and
evaluating ecological services, and changes in their levels. The SAB understands the need for a
clearer definition of ecological services and their values and therefore endorses this effort as an
added effort in ecosystem research. It is the SAB's belief that a clearer understanding and
illumination of these services may well lead to greater appreciation of their value to our society.
The SAB believes that this program has a fundamental need for the inclusion of economics and
behavioral science expertise.
High Quality research on ecological services must be built on a conceptual foundation
that rests on an understanding of ecosystem conditions and functions, and how ecosystems
respond to stresses. It will not be possible to implement the new focus on ecological services
without continuing EPA's core research on ecosystem function. Similarly, the focus on
ecological services is explicitly impacted by the phase-out of ecosystem condition assessments.
Such ecosystem assessments produce the inputs - in terms of both data and understanding -
needed to assess ecological services and their value to society. The termination of many of the
current programs will cause data gaps that preclude determination of long-term trends. The SAB
is concerned about the concurrent reduction in work and contributions to our understanding of
the status of our nation's ecosystems and the more basic science necessary to protect and restore
the same services in question. Given the continuing budget cuts to core programs for ecosystem
function and condition research, it is not clear how a shift in attention to ecological services can
be accomplished.
4.2 Water Quality
The Water Quality Research Program's strategic directions for 2008-2012 focus on water
integrity, watersheds and urban issues. High-priority research areas include: research in support
of developing nutrient criteria, research that supports improved TMDL decision-making
processes in watersheds, and research concerning strategic for dealing with the country's aging
wastewater infrastructure.
The three long-term goals appear to be an extension of the program's research goals as
stated over the last five years. However there is a shift in the priority attached to each of the
goals to address changing research needs of users. The SAB supports the long-term goals of the
water quality research program. The goals address important and critical research needs to
protect, restore and sustain the integrity of the nation's waters. However, the technical skills,
12
-------
time, and money available to develop and implement TMDLs appear to be a small fraction of
what is required to achieve the goals of the program, and progress has seemed glacially slow to
date. We encourage ORD to continue to refine its strategic directions for this research effort to
ensure that the research results can most effectively help speed the process of TMDL
development, especially in making TMDL development more operable and consistent at the
local and regional level.
4.3 Drinking Water Research
The strategic focus of the Drinking Water Research program is on pathogens, unregulated
contaminants, distribution systems, and source water protection. These topics respond to, and
anticipate, the needs of the program's major client, the Office of Water, and its rule-making,
enforcement, and guidance activities. Program plans intend to increase the emphasis of research
on epidemiological studies of gastrointestinal illness, development of methods for assessment of
viability, infectivity and virulence of water-borne pathogens, appropriate technology for small
systems, minimization of water quality changes in distribution systems, management of the aging
infrastructure of distribution systems, impact of water reuse on the safety of tap water,
development of well-head protection tools, impact of subsurface carbon dioxide storage on
source water quality, and development of best management practices for point and non-point
sources of contaminants. Decreasing emphasis is planned for research involving arsenic and
disinfection by-products as these contaminants have already been regulated by the Office of
Water. Emerging unregulated contaminants (both chemical and biological) will receive
continuing emphasis in response to Office of Water needs to address agents on the contaminant
candidate list.
The SAB believes that the Drinking Water Research program is being proactive and is
addressing the appropriate research needs related to drinking water. There appears to be a good
blend of long- and short-term research. The plan to address chemical mixtures rather than
individual contaminants is a good one, although regulation will still need to be done on a
contaminant-by-contaminant basis. In view of recent questions involving potential adverse
reproductive and developmental health effects of drinking water contaminants, the plan to
address non-cancer end-points is also a good one. While arsenic and regulated disinfection by-
products will receive decreased attention, it is good to see that there will still be a core
component addressing these regulated contaminants to support the required periodic reevaluation
of the public health benefits of the standards developed in previous rule-making activities.
The SAB notes that a number of Drinking Water Research Program activities intersect
with and complement the Water Quality Research Program (e.g. watershed protection) and the
Human Health Research Program (health effects of single contaminants versus mixtures;
viability, infectivity and virulence of pathogens). The SAB notes the importance of managing
the interface of these programs in order to maximize the value of the limited resources of the
Agency and to avoid duplication of effort. The SAB also notes that the Drinking Water Research
program is addressing a large number of very important questions. However, the rationale for the
current allocation of resources (dollars and manpower) to each of the research areas is not clear.
Without seeing such a breakdown, it is difficult to assess whether or not resources are adequate
for the issues being addressed. There appears to be a natural synergy between some Drinking
13
-------
Water research and some of the Homeland Security research activities, especially in the
development of better, rapid biologic contaminant detectors that might replace existing public
water supply monitoring methods for regulated contaminants.
14
-------
5. HUMAN HEALTH AND HUMAN HEALTH RISK ASSESSMENT RESEARCH
5.1 Human Health Risk Assessment
The Human Health Risk Assessment Program (HHRAP) is housed in the National Center
for Environmental Assessment, and is the principal EPA program for developing hazard and
dose response methodologies and some specific analyses to support program office and region
activities [most Program Offices also conduct assessments to support decision-making and, in so
doing, often collaborate with NCEA in the conduct of such assessments, (e.g., Office of
Prevention, Pesticides and toxic Substantces, Office of Water)]. Over the next five years, the
program plans to complete a large number of IRIS assessments (128), release many additional
provisional peer-reviewed toxicity values (400), institute its Integrated Science Assessment
program for the criteria air pollutants, and improve risk assessment methodologies. Uncertainty
analyses, variability analysis, increasing use of mode-of-action information, physiologically
based pharmacokinetic modeling, categorical regression, meta-analysis, approaches for assessing
risk of environmental exposures to age-susceptible populations, and less-than-lifetime
assessments were named as areas for improved assessment methodology development.
The $42.8 million budget for this program reflects a $4.5 million increase, which will
accommodate increased staff salary and benefits, the start up of the NAAQS Integrated Science
Assessments process, increased consultation with the National Academies on risk assessment
issues, and improved methodology for uncertainty analysis. In this regard, the SAB notes the
following:
a) The development of integrated science assessments (IS As) for criteria air pollutants
appears to be a major step forward in improving the efficiency of the review of the
NAAQS. The ISAs should be written in concert with a risk assessment document done
by the Office of Air and Radiation that describes the scientific basis for evaluating the
risks associated with various regulatory options.
b) The SAB recognizes and strongly supports the Agency's commitment to develop a large
number of IRIS and provisional peer-reviewed toxicity values.
c) In the development of approaches for uncertainty and variability analysis, the program
appears to have coordinated with other EPA programs - with the HHRAP developing the
methodology, the Human Health Research Program providing some data, and the
Computational Toxicology Research Program developing tools that would, in the long
term, provide a basis for susceptibility assessment. The SAB has in past reviews of EPA
assessments and methodologies, encouraged the Agency to develop and utilize
probabilistic approaches to better characterize health effects. The SAB notes that
research to develop or mine data and construct distributions to support the incorporation
of variability into assessments was not apparent. The degree to which probabilistic
approaches are being developed for non-cancer endpoints is also unclear. In this regard,
the EPA needs methodologies and research to better understand human-to-human
variability due to the cumulative impact of endogenous biological processes and
environmental exposure processes, as well as predisposing health conditions.
15
-------
5.2 Human Health Research
The Human Health Research Program within ORD provides mechanistic data and
exposure factors to support risk assessment activities by the HHRA program and several
program offices. It also provides tools to aid in assessing the effectiveness of regulatory
controls. The budget of $56.8 million reflects a cut of $4.0 million. Reductions were taken in
the EPA's contribution to support the National Children's Study; exposure and effects
assessment efforts for children, adolescents and older adults; cumulative risk and research on
exposure models. Over the next five years, research in this program is expected to produce:
"biologically interpretable indicators for health effects and chemical classes," a biomonitoring
information tracking system developed in collaboration with federal partners, tools and
approaches for assessing community risk, and tools to assess risk management decisions.
The baseline program budget for human health research has been essentially flat from
FY05. The $4.0 million drop in the FY08 budget request raises serious concerns about the
Agency's commitment to meeting public expectations for health protection. This is particularly
true for research concerning susceptible subpopulations, which will experience the deepest cut in
this budget area. Without continued, substantive engagement in research on subpopulations, the
Agency will not have the scientific bases it needs to support health-related decision making. The
Board is very concerned about this major decrease and strongly encourages the Agency to
identify ways to restore and further increase its FY08 support for subpopulation research.
The Risk Assessment Forum serves a crucial, integrative role for advancing risk
assessment strategies and methods. The Forum provides an important mechanism for risk
assessors to share knowledge and approaches, build skills across organizational units, and
advance the Agency's risk assessment capacity, even as personnel and programs change. The
SAB recognizes the synergistic value of the Forum and supports its activities. In addition, The
Agency has done a good job coordinating its research efforts with other Federal partners such as
the National Institute of Environmental health Sciences (NIEHS) and choosing areas of research
not being addressed already.
Adequate EPA funding for the National Children's Study is needed to ensure that the
effects of environmental chemicals are studied using state-of-the-art methods that address
appropriate hypotheses. The $0.5 million cut in support for this effort and the additional $2.5
million reduction of funding of research on exposure and effects in children, adolescents and
older children raises serious concerns. Given the still limited understanding of the quantitative
impact of environmental pollutants at early developmental stages, and in aging populations,
reductions in this area seem misguided. The SAB expresses its support for providing additional
resources to EPA to enable the Agency to support the National Children's Study.
Although aggregate and cumulative risk research is noted in documents provided to the
SAB by the EPA, there is no explicit mention of research focused on the impacts of chemical
mixtures. This is an important omission because mixtures make up the exposures actually
experienced by human populations. It is not clear whether this is addressed by the multiple
environmental stressors effort noted in the materials received by the SAB. Without research on
this topic, risk assessment will continue to be limited to the single chemical approach. To meet
16
-------
increasing public concerns about mixtures, the Board urges the Agency to find support for
research on mixtures if it is not contained in the budget already.
The objective of the program to assess the impact of multiple environmental stressors on
individual communities is timely and important. It is not clear what research efforts are being
considered in this area (e.g., spatial mapping of potential environmental hazards using GIS
technology in combination with human disease surveillance data).
While the SAB did not review the indicator research program in any detail, it notes the
very brief program description received by the SAB was vague and planned activities were
unclear (e.g., there is little information on what types of exposures and endpoints are being
considered).
The extent to which the research program overall will produce data that will assist in
human health risk assessment efforts was unclear. However, the extent of the effort appeared to
be limited given the deliverables expected for the 2008-2015 timeframe. The research appears to
focus on modeling and assessment tools for possible regulatory impact, as opposed to data
generation for direct use in risk assessment. There does not appear to be research utilizing state-
of-the-art approaches to elucidate gene-environment interactions. Research to support variability
assessments for probabilistic assessment appears limited as well. Decreased support of mode-of-
action research is also an area of concern to the SAB.
Improved linkages and collaboration with programs within and outside the Agency are
needed to develop methods and assessment approaches using structure activity relationships or
other predictive approaches to address existing chemicals for which toxicity test data do not
exist. This is clearly an area of large uncertainty which goes uncharacterized. To support
environmental decision-making, a research strategy needs to be articulated which will begin to
address this deficiency for existing chemicals.
The SAB understands that it is important to assess the effectiveness of regulatory and
research programs in general and the human health research program discussed above.
However, in this case as in the earlier discussion of shifting the ecosystems program focus to
services without conducting the needed underlying ecosystem function and condition research,
the SAB is concerned that the research to develop necessary underlying information that will
directly impact risk assessment has not been given a high enough priority in this proposal. Of
particular concern is the reduction of effort to support assessment of impacts upon susceptible
populations and a lack of emphasis on human variability research in general.
17
-------
6. CONTAMINATED SITES/RESOURCE CONSERVATION AND
NANOTECHNOLOGY
6.1 Contaminated Sites/Resource Conservation (Land Preservation and Restoration)
EPA's approach to Land Use and Preservation research remains strongly oriented toward
"legacy" issues, with a much greater level of resources focused on restoration rather than
prevention or preservation. Of the $32.4 million total FY2008 request, $20 million is provided
by the Superfund Trust Funds, $901,000 is dedicated to oil spill response, and $660,000 to the
LUST program. This leaves $10.7 million for discretionary S&T research. The major shift in
S&T for FY08 is $685,500 for research on nanotechnology fate and transport.
While this shift is applauded by the SAB, it is still small relative to the size of the S&T
budget in this area (approximately 7%). Research needs are significant in the area of land use,
preservation, and prevention of contamination. In the future, the SAB recommends that the
research emphasis shift to address the problems of the present and preventing those of the future,
and not just cleaning up problems which are legacies from the past. The Agency would be well-
advised to re-consider its strategy for such a shift, including the kinds of metrics that are
appropriate. The use of Superfund resources for research is interpreted too narrowly; the Agency
needs to think more carefully about the best use of these funds to protect the environment and
human health in the future. Such a need for preservation-based-thinking is immediate. As
examples, the Board raises the following concerns:
a) Urban sprawl and associated problems (sustainable transportation, stormwater,
infrastructure renewal, the built environment, etc.)
b) Intensive agriculture (nutrient flows, marginal lands brought under cultivation,
exacerbated by the policy of increased production of biofuels),
c) Population increases in coastal areas, with associated land-use implications,
d) Development of new regulatory approaces that are tailored to the specific properties of
challenges posed by a range of different types of nano-material.
The Resource Conservation Challenge (RCC) focus on increasing the supply of
recyclable materials, and to a lesser extent encouraging novel re-uses is apparent. The common
feature for both programs is on influencing human behavior. It is unclear why research on these,
and related, decision dynamics is not supported.
The RCC focus on relatively high volume, low toxicity materials (e.g. fly ash, consumer
packaging) is certainly important. However, it is not obvious given the strong emphasis on
hazardous waste remediation activities, why the RCC has declined to tackle more toxicity-related
problems, i.e. to prevent land disposal of toxic substances, not just relatively benign materials.
The RCC has not addressed, in any substantive way, the control of nano-based materials.
It could endeavor to influence the design of nano-products which would reduce the use of toxic
18
-------
materials. It could also seek to improve the probability that materials can be recoverd from
nano-products.
There should be more research related to recycling, waste minimization, and energy
recovery. These areas are poorly supported.
6.2 Nanotechnology
This is a new research area for EPA that is based on its traditional risk model (fate and
transport, exposure, toxicity, and risk management). The Agency has considerable experience
and expertise that is relevant to nanoparticles because of its earlier and ongoing paniculate
matter research programs. However, it is not evident whether these two research groups interact
and share their expertise.
EPA has described a clear strategic vision and timeline with appropriate short-term and
long-term goals. Following an initial focus on using nanotechnology for environmental
remediation, the STAR grant program has now identified several high priority areas:
environmental fate and transport, transformation and exposure, and monitoring and detection
methods. These priorities have been developed following collaboration and interaction with
other federal agencies in the context of the National Nanotoxicology Initiative.
EPA's immediate budget priorities are to continue the STAR grant program and to
develop an intramural research program. It is not certain whether the Agency has devoted
sufficient funds and infrastructure support to meet the following needs:
a) Assessment of novel structures and new materials used for nano-products
b) Environmental and human health impacts of manufacturing methods that
incorporate nanotechnology principles: advantages, disadvantages, or no impact?
c) Consideration of recovery/recycling/reuse of nanomaterials and nano-structures
The nanotechnology industry is expanding rapidly and the Agency needs to reach out to
small companies, particularly in the early stages of their development, to ensure that research is
conducted on environmental and human health impacts that might be associated with potential
nano-products. If firms address safety, health and environmental issues early in their prodluct
development cycle, they should increase the likelihood that health and safety issues will not later
become impediments to the realization of the economic benefits from investments in
nanotechnology. The Agency should support research to better understand what information is
needed to regulate nanomaterials, and also to identify an appropriate regulatory framework.
Nanotechnology is an international industry and the United States must act quickly to be
competitive. The Agency should engage international organizations in deliberating the proper
management of nanomaterials and should devote sufficient funds and effort to developing health
and safety guidelines for manufacture, use, and disposal of products based on nanomaterials.
19
-------
7. PESTICIDES AND TOXICS SUBSTANCES RESEARCH
7.1 Safe Pesticides/Safe Products Research
The ORD Safe Pesticides/Safe Products Research Program provides critical technical and
scientific support to the Office of Prevention, Pesticides and Toxic Substances (OPPTS) in
support of that office's risk assessments and pesticide review and registration processes. In
addition, the Program is conducting research in a number of scientific and bio-mathematical
areas that are important to future challenges and opportunities that will certainly arise in OPPTS
risk assessments. These include methods for monitoring gene flow from genetically engineered
crops and applications of advances in genomics and protein sciences to better understand modes
of action and quantify risks for existing and new pesticides and chemicals. The Safe
Pesticides/Safe Products Program is commendable for continuing to focus a share of its program
resources on the effects of pesticide and biotechnology products on non-target species (i.e. native
plants, wildlife, aquatic species, and birds).
The Program will undergo both a PART and BOSC review in 2007. The strategic plan
for 2008-2012 retains the balance in current program activities with emphasis in three major
areas: 1) continued research to improve methods, models and available data in support of OPPTS
testing requirements and risk assessments for new and existing pesticides and chemicals; 2)
continued development of tools for measuring impacts of pesticide and herbicide use on non-
target species; and 3) investment in biotechnology research that will enable OPPTS and other
EPA offices to better interpret data and the risk assessment/registration process for the increasing
number of products of biotechnology. Given current funding constraints this is a well-balanced
set of research activities and reflects the areas (if not the scale) of investment needed to upgrade
the scientific data and tools that OPPTS and other offices require in conducting risk assessments
and guaranteeing the safety of marketed pesticides and chemical products.
The SAB encourages the Program to keep a share of its focus on the development of data
and models for the assessment of effects of pesticides and related chemicals on non-target
species. The current plan anticipates continued work in this area, tapering off over the next eight
years. The plan to move resources out of the non-target species assessments and into research on
risk quantification tools, "omics," and biotechnology impacts should only proceed once EPA's
Long Term Goal 2 for this area has clearly been met.
7.2 Endocrine Disruptors
The President's budget for endocrine disrupter research for FY08 includes 54.4 FTE and
a budget of $10.1M dollars. This is about $1M more than the FY07 budget, but is about $1M
less than the FY06 budget. The SAB recommends that the EPA continue to support the
Endocrine Disrupter research program incorporating "omics" technologies as recommended by
the Board of Scientific Counselors (BOSC), and that additional funding be given to this program
to support STAR grants in this area.
EPA has recognized that exposure to endocrine-disrupting or hormonally active
chemicals may cause adverse health effects in wildlife and may affect human health as well. The
20
-------
EPA is to be commended for developing research strategies in partnership with several program
offices, including the Office of Water; Office of Prevention, Pesticides and Toxic Substances;
Office of Air and Radiation; Regional Offices; and ORD's laboratories. An example of
providing research support for a cross-cutting issue of great interest to several Regions is the
analysis of impacts downstream from Concentrated Animal Feeding Operations (CAFOs). As
described to the SAB, this work supports two of the program's long-term goals, including
reduction in uncertainty regarding the effects, exposure, assessment and management of
endocrine disrupters, and determination of the extent of the impact of endocrine disrupters on
humans, wildlife, and the environment. Endpoints include both androgenicity and estrogenicity,
and sources include swine and cattle CAFOs. Engagement in this research is regarded by the
SAB as a best practice because: 1) it was conceived with participation from several program
offices across the Agency, 2) it has immediate and direct relevance to some of the Regions who
have brought their concerns to the SAB's attention, 3) multiple sources and endpoints were
studied, 4) the studies were performed under extramural research grants, 5) the knowledge base
will be extended through training of Regions, States and Tribes, and 6) the research is important in
that it may set the stage for significantly improving the quality of ecological systems and threir ability to
support the animals and people who live there. However, the $1.6M funding for this CAFO research
(through the STAR program) was pieced together in the FY06 budget, and no further funding has
been provided for FY07 or FY08 budgets. This type of research could be better informed by
incorporating computational toxicological methods into the program.
The SAB commends the Agency for its work in developing a comprehensive battery of
screening assays for endocrine disruption. The SAB notes, however, that the overall endocrine
disruption identification program is structured to require whole-animal apical toxicological
testing to confirm activity and to develop data for use in risk assessment. EPA is encouraged to
develop a strategy which will allow the Agency to move away from apical multigenerational
testing to newer, and more-rapid approaches to developing toxicology information about
endocrine disruption without the need for confirmation in whole animal tests. Such efforts are
clearly needed because of the large backlog of chemicals to be evaluated, the limited budgets for
testing, the time involved from study initiation to results reporting, and emerging science
developments. The SAB encourages the Agency to consider adding this topic as a long-term
goal for strategic research and encourages continued collaboration with the Computational
Toxicology Program, European institutions, and other federal agencies such as NIEHS to
develop such a strategy.
Another concern is (what appears to be) limited research to support cumulative and
aggregate risk assessment for endocrine discuptors, and consideration of how background
endogenous processes and exposures may increase susceptibility.
7.3 Computational Toxicology
The SAB supports the current plans for the nascent Computational Toxicology Research
Program. Computational toxicology uses computing and information technology and biological
data to understand and model the advserse effects of chemicals at various levels of biological
organization. EPA's program is developing computational toxicology tools that may increase
the number of chemicals addressed in agency assessments as well as improve the scientific
foundation for Agency risk assessments.
21
-------
The personnel resources and level of funding ($15 million) appears reasonable for an
Agency start-up effort of this type and importance. As experience and anticipated successes
accrue, additional funding should be considered. The SAB heard about the Program's three
initial research projects: 1) the ToxCast project to begin evaluation of high-throughput screening
assays for initial screening and prioritization of chemicals for further testing; 2) the attempt to
develop a biological model for arsenic carcinogenicity; and 3) the development of a "virtual
liver" based on a systems biology approach for describing the impact of exogenous chemicals
and stressors on complex disease processes. There is the long-term promise that high-throughput
efforts will provide considerably greater coverage for the testing of potentially toxic chemicals,
and the nearer term benefit that these efforts may provide a basis for tiered testing by suggesting
potential types of toxicity for those chemicals screened. The ToxCast effort is a good initial
project for the EPA in this area. The Agency appears to be collaborating with NIEHS and its
approach appears realistic. One concern is the initial focus on pesticides, given the potential to
bias the evaluation of the high throughput screen due to the limited types of biological activities
of pesticides. The EPA is aware of this limitation and indicated plans to expand the project to a
chemical data set with more varied structures in a later phase.
Regarding the arsenic work, attempts to develop biological models of carcinogenesis
have had limited success over the past 25 years, and even the most recent of efforts have resulted
in multiple orders-of-magnitude differences in predictions in the hands of different but very good
and experienced model developers, supported by scientific experimentation. While Long Term
Goal 3 is laudable - i.e., use of new models based on the latest science to reduce uncertainties in
dose response assessment, cross-species extrapolation, and quantitative risk modeling - cancer
may not be the best endpoint to consider at this stage. The results may be controversial and may
not provide sufficient proof of concept. In this regard the second bulleted promise under this
Long Term Goal (LTG 3) seems especially problematic - "EPA will be less reliant on default
assumptions for risk assessment and better able to accurately characterize the uncertainty
associated with risk predictions for various chemical classes (e.g., EDCs) under conditions more
relevant to actual exposures and lifestyles." The SAB is aware of the need for more certainty in
regulatory decision-making on arsenic, especially as regards drinking water, and is also aware of
the need for responsiveness of the Computational Toxicology Program to this problem. While
the SAB does not object to the effort, it suggests that the Computational Toxicology Program
should proceed cautiously in undertaking this difficult scientific work and should not be overly
optimistic about the potential results from in this relatively high-risk venture. With regard to the
third project, beginning the systems biology work on the liver also appears a reasonable early
project given the prior efforts and successes of the pharmaceutical industry and the potential to
build on these findings in studying environmental chemicals.
Overall, the Computational Toxicology Research Program is headed in the right
direction, and in the long term, if the research effort pans out, will provide new scientific
approaches for the assessment of environmental chemicals and decision-making with respect to
their use. The systems biology work may eventually yield significant insights for understanding
the range of susceptibility to different compounds and this work may support alternative testing
approaches. The ToxCast effort may eventually provide for new and efficient approaches for
developing toxicity information concerning other chemicals that cannot be intensively studied.
22
-------
8. SCIENCE AND TECHNOLOGY FOR SUSTAINABILITY RESEARCH
Science and Technology for Sustainability (STS) is a new research program, scheduled to
begin on October 1, 2007. As appropriate for an environmental agency, EPA's focus is on
environmental Sustainability, which is narrower than, but consistent with the definition of
Sustainability recently issued in Executive Order 13423:
Sustainable means to create and maintain conditions, under which humans and nature can
exist in productive harmony, that permit fulfilling the social, economic, and other
requirements of present and future generations of Americans (White House 2007).
Specifically, the initial research tracks of the Science and Technology for Sustainability
Research Program will (1) develop and test metrics of environmental Sustainability, (2) develop
decision support tools to promote environmental stewardship and sustainable management
practices, and (3) support and develop technologies that can create sustainable outcomes.
The SAB has recently reviewed the Sustainability Research Strategy and the associated
multi-year plan; the SAB draft report is available and the final version will be issued in spring
2007 (SAB 2007). In its review, the SAB strongly endorses the establishment of a Sustainability
research program. Historically, environmental protection at the Agency has been carried out in
single-media regulatory programs. The SAB applauds the Agency's movement toward a
systems approach that reflects the complexity of the world in which we live and effectively
balances environmental protection, economic viability, and societal interests.
The Sustainability Research Strategy (SRS) and Multi-year Plan (Plan) has the potential
to provide an integrating framework for EPA core and problem-driven research in ORD and
across the Agency. The SRS and Plan supports the transition from the traditional single-media
stove-pipe approach of environmental protection to a more systems-based and fully integrative
process based on life-cycle principles. ORD's Sustainability research program would enable the
Agency to address some of the most challenging and multifaceted environmental issues. The
Sustainability plan provides an opportunity to address problems such as urban sprawl and the
environmental impacts of the built environment, climate change, the environmental
consequences of biofuels production, and ecosystem degradation. Taking an integrated, life-
cycle approach to environmental protection can provide cost-effective options for reducing a
range of environmental impacts, developing and deploying new technologies, and supporting
quality of life, economic development, and environmental quality.
The SAB recommends that the Agency clarify the definition and scope of its
environmental Sustainability ptorams. Early progress on the development of Sustainability
metrics could provide a firm foundation for defining the Agency's Sustainability efforts, and
could distinguish environmental Sustainability from the broad definition of "sustainable"
contained in E.G. 13423.
The Science and Technology for Sustainability Research Program is the first coordinated
effort within the Agency to address the research questions raised in the Sustainability Research
23
-------
Strategy. The Sustainability Research Strategy lays out a strategy in which sustainability will
not remain confined within an isolated research program, but will be incorporated throughout
ORD research programs. Success of this strategy will require development of a workforce with
training and skills related to sustainability. In addition, in order for sustainability research
questions to be addressed throughout ORD research programs, and will require ORD
management support.
The modest funding of the Science and Technology for Sustainability program limits
what it can achieve. A substantially higher commitment is needed to make the program visible,
to carry out research that will have a serious impact, and to provide a basis for the program to
succeed and grow.
24
-------
9. ECONOMICS AND DECISION SCIENCES RESEARCH
Economics and Decision Sciences (EDS) research is critically important to EPA's
operating programs. Some statutes permit explicit consideration of both benefits and costs in the
setting of environmental standards. Others specify a safety standard, regardless of cost, but
permit benefits and costs to be used in comparing alternative strategies for meeting that standard.
Even in those cases where a safety standard must be met, the Regulatory Flexibility Act/Small
Business Regulatory Enforcement Fairness Act (RFA/SBREFA) already provides the
opportunity for some small businesses to be given more latitude with respect to certain rules if
the cost of compliance is so high that their viability is jeopardized. As scientific understanding
points to evidence of measureable human health and ecological effects occurring at lower levels
of pollution, the need for research in Economics and Decision Sciences to help us maximize the
net benefits (benefits minus costs) of regulatory efforts will only increase. EPA cannot afford to
allow its resources for research in Econimics and Decision Sciences to continue to deteriorate
along its current trajectory.
Economics research can be credited with significant success in improving the efficiency
of environmental regulation. The development of economic-incentive-based regulatory
mechanisms as an alternative to command-and-control regulation has led to drastically reduced
costs of environmental protection. Traditional command-and-control rules require all firms to
adopt the same pollution-control equipment or meet the same emissions standards. In contrast,
economic-incentive mechanisms, such as tradable emissions permits, pollution taxes, and
deposit-refund systems, allocate emission reductions across firms and facilities in a more cost-
effective manner, substantially reducing the costs of compliance.
There are many good examples of the efficiency gains from economic incentive
approaches to regulation. Tradable permits have been used to reduce the cost of controlling a
number of environmental pollutants, including sulfur dioxide from power plants, lead in
gasoline, and CFCs that deplete stratospheric ozone. For example, the sulfur dioxide trading
program is estimated to have saved $700-$800 million per year compared with a uniform
emission-rate standard and twice as much as compared with requiring all plants to install
scrubbers (Carlson et al., 2000). Using tradable permits in the program to remove lead from
gasoline is estimated to have saved $250 million per year over the five year phaseout period
(Jaffe et al., 2003). A comprehensive evaluation of before and after estimates of the cost and
efficacy of environmental regulation, found that the cost per unit of emission reduction was
smaller than anticipated beforehand for seven of eight economic-inicentive-based regulations but
larger than expected for five of sixteen command-and-control regulations. Moreover, because
economic-incentive mechanisms provide an incentive for firms to exceed required environmental
standards, the same study found that emission reductions were greater than anticipated
beforehand for four of eight regulations that used economic-incentive mechanism, but fell short
of the anticipated level for eight of fourteen regulations that used command-and-control
mechanisms (Harrington, Morgenstern and Nelson, 2001).
25
-------
Economics and Decision Sciences research at the Agency is in large part a public good
shared by many different parts of the organization and by the broader community. As an
analogy, consider the fact that although each of us has a need for fire protection, we do not all
serve as our own fire department. Since there are economies of scale in provision, it makes
sense to centralize this service so that we can obtain sophisticated and effective fire protection
when we need it. Likewise, EPA some time ago decided to bring much of its core economics
expertise together under one roof. This has left EPA with a core complement of economists in
the National Center for Environmental Economics (NCEE), several additional research-focused
economists in ORD to manage an Economics and Decision Sciences grant program, and a
number of applied economists in Program Offices to conduct and manage extramural
performance of specific economic analyses there. EPA's Environmental Economics Research
Strategy, for example, was prepared jointly by all these groups with ORD taking the lead writing
role.
Even though this restructuring and consolidation of much of economics at EPA has
produced some of the benefits associated with economies of scale, funding of economics and
decision sciences research remains at a low level. This might be expected, since consolidation,
has converted EPA's intramural economics resources into somewhat of a public good.
Unfortunately, public goods are plagued, in most cases, by a free-rider problem that leads them
to be under-provided. Since more than one part of the Agency can simultaneously benefit from
the same economics/decision-science research (for example, risk communication and risk
perception), this research is a "non-rival" good. Likewise, if this research is provided for one
part of EPA, it is simultaneously provided for all. Access to the results of such research is not
denied to any group within the EPA.
To exploit scale economies, therefore, it is a good thing that research in Economics and
Decision Sciences is proposed for consolidation under one roof within the Agency. However,
the SAB is concerned that consolidation might actually decrease the amount of economics
research at EPA and also impede the development of a high quality research portfolio in
behavioral social and decision sciences. Evidence of this possibility is shown in the decreased
resources proposed for the program for 2008 (from about $2.4 million in 2007 to just over $1.0
million for 2008). Shifting Agency personnel responsible for research in economics and decision
sciences to NCEE also creates a significant risk that ORD would no longer encompass
Economics and Decision Sciences as part of its portfolio of research interests. Just as the SAB
has noted that ecosystems protection research is underprovided because of a failure to recognize
the essential services that ecosystems provide, Economics and Decision Science research will be
underprovided if the Agency does not fully realize the essential services these other disciplines
provide for eventual policy-making.
Therefore, the SAB feels that moving Environmental and Decision Sciences from ORD
to OPEI/NCEE is a risky strategy. OPEI already faces daunting responsibilities in terms of day-
to-day applied economics and benefit-cost analysis required for individual regulations. The
research mission of EDS could easily be diluted if it is moved to NCEE. The transition also
jeopardizes the role of other social sciences, since the NCEE has an almost exclusively
economics focus. Despite the expected scale economies from moving EDS to NCEE, the SAB
believes that the economic and other social science research needs of the Agency will be best
protected and enhanced if the research resources are housed within ORD.
26
-------
REFERENCES
Carlson, C., Burtraw, D., Cropper, M., and Palmer, K. (2000) Sulfur Dioxide Control by
Utilities: What are the Gains from Trade? J. of Political Economy, 108:1292-1326.
Harrington, W., Morgenstern, R., and Nelson, P. (2000) On the Accuacy of Regulaory Cost
Estimates../, of Policy Analysis and Management, 19:297-322.
Jaffe, A., Newell, R., and Stavins, R. (2003) Technological Change and the Environment.
Handbook of Environmental Economics. Vol. I, eds, Karl-Goran Maler and Jeffrey Vincent,
Chaper 11, pp. 461-516, Amsterdam: Elsevier Science.
SAB (2007). Draft Report on the Office of Research and Development's (ORD) Sustainability
Research Strategy and the Science and Technology for Sustainability Multi-year Plan. January
18, 2007. www.epa.gov/sab/pdf/sustainability_for_chartered_boardjan_l8_07.pdf
White House (2007). Executive Order 13423: Strengthening Federal Environmental, Energy,
and Transportation Management, www.whitehouse.gov/news/releases/2007/01/20070124-
2.html
R-l
-------
APPENDIX A
January 22, 2007
MEMORANDUM
FROM: Dr. M. Granger Morgan /S/
Chair
US EPA Science Advisory Board
TO: Dr. George M. Gray
Assistant Administrator for
Research and Development
US Environmental Protection Agency
As we have in past years, the meeting of the EPA Science Advisory Board on
February 22-23, 2007 will be devoted to a review of the Agency's research budget - not
just the budget of ORD but of all research across the Agency. However, in contrast to
years past, this year we do not want to do a detailed program-by-program review. Rather
we want to try to take a somewhat longer term strategic perspective. In that regard we
ask that you and your colleagues do two things that are more focused on the long term:
1. Briefly identify 3-5 issues which the agency believes will represent key
environmental challenges over the coming decade or longer and explain how,
whether, and to what extent, the R&D budget is designed to place the agency
in a position to meet these challenges.
2. The SAB would especially like to learn about how the Agency's research
plans will allow EPA to address four key problems that we believe will be of
continued and growing importance over the coming decades. These 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.
While we realize that the agency has a modest research program that
is labeled as climate change, we would actually like to hear a more
cross-cutting view. That is, how have concerns about the potential
impacts of climate change, and possible abatement activities,
influenced a range of research plans both within ORD and elsewhere
across the agency?
b) Sensitive populations, both human and ecological. We realize that
ORD has specific research programs targeted at specific human
populations such as children. While we'd like to hear briefly about
APP A-l
-------
those we'd also like a cross cutting view of how research plans will
address other issues such as the immune suppressed, those with
asthma, as well as a variety of other conditions. We are equally
interested in learning how research across the Agency is being shaped
to identify and address specific ecosystems that are at high risk and
certain populations that are particularly sensitive and vulnerable to
current or likely environmental stress and change.
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. In the case of the
latter we would be particularly interested in learning how research
across the Agency is helping to prepare EPA for the possible need to
clean up after widespread contamination resulting from chemical,
biological or radiological attack, contamination that may result from
attacks on facilities such as chemical plants and transportation
systems, and contamination that may result from the interruption of
key infrastructure services such as electric power (e.g. many sewer
systems can not operate without electric pumps).
If some of the topics addressed in 1 above are the same as those we have
identified in item 2 that would be fine with us.
3. In addition, we have two shorter term requests for information.
a. Please identify any research program for which the proposed FY 2008
budget level will substantially differ from the budget that was
proposed for FY 2007 (for example, 20% or more would be a
substantial increase or decrease). We understand that in fact the
Agency is running under a continuing resolution and so will use the
proposed FY 2007 budget only as a benchmark. Please provide us
with a brief explanation of the proposed decrease or increase.
b. As always, the SAB must be prepared to comment to the U.S.
Congress on the actual budget submission for FY 2008. Thus, we also
need information on the full research program at the level of Program
Projects that are a part of the EPA research effort. We received an
informative set of background descriptions last year for the FY 2007
budget review and an update of this set would be helpful as the SAB
considers commenting on the 2008 research budget. However, an
alternative would be to provide information on Program Projects as
envisioned in the ORD December 14, 2006 discussion with the SAB
APP A-2
-------
on this topic. In this discussion, ORD representatives noted that it
could provide background information based on NPD Key
Recommendations from the ORD December and January strategic
discussions on program change 2008-2012.
If in the course of addressing any of the topics listed above, you and/or your
colleagues can point to any examples of ways in which the past R&D budget reviews by
the SAB have influenced or shaped subsequent Agency budgetary plans, either in the
short or long run, we would be most grateful if you would list them for us. To be frank,
a number of members of the SAB are beginning to think that the annual budget review
has little or no effect on Agency plans and they question why members should spend so
much time on an annual review if in fact that impression is correct. Anything that you or
your colleagues can present that would enlighten members on this point would be much
appreciated.
Thanks very much to you and your staff for your assistance in these matters. We
look forward to meeting with you and other agency staff on February 22-23.
APP A-3
------- |