UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C. 20460
OFFICE OF THE ADMINISTRATOR
SCIENCE ADVISORY BOARD
November 26, 2008
EPA-SAB-09-006
The Honorable Stephen L. Johnson
Administrator
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, D.C. 20460
Subject: EPA's Strategic Research Directions 2008: An Advisory by the
EPA Science Advisory Board
Dear Administrator Johnson:
In October 2007, the chartered EPA Science Advisory Board (SAB) initiated a
series of interactions with EPA's Office of Research and Development (ORD) senior
management and National Program Directors (NPD) to develop a better understanding of,
and offer advice on, the strategic directions for EPA's research programs. This set of
activities was motivated by a desire to move beyond the SAB's annual review of a single
year's research program budget and to think more strategically about the Agency's overall
research program in relation both to EPA's stated needs and the SAB's perspectives on
the environmental challenges the Agency is likely to face in coming years.
The Agency asked the SAB to consider where EPA research should be as it plans
its research for the next five years and beyond. To assist the SAB in its review, ORD
prepared an overview of ORD's strategic research directions for each of its research areas
and provided brief documents that summarized the strategic directions and current focus
for each specific area. Additionally, EPA staff and Board members discussed these
strategic research descriptions in break-out sessions during the October 2007 SAB
meeting. The SAB continued its discussions of EPA's research vision in several
meetings. Though quite valuable, these sessions did not provide sufficient depth of
information to allow the SAB to develop a detailed understanding of each research area
or provide a full assessment of those programs.
However, the briefings and other interactions have provided the SAB with
sufficient insight about current Agency plans to begin to develop broad strategic advice.
The SAB plans to continue to conduct follow-up discussions with ORD, and possibly
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other EPA scientists, on EPA's strategic research program directions and from time to
time offer additional, more complete and detailed, advice.
The Agency's research and development program provides the scientific
foundation and support for EPA's actions to carry out its mission to protect human health
and the environment. Included in these activities are: i) conducting research and
development to identify, understand, and solve current and future environmental
problems; ii) providing technical support to EPA's Programs and Regions; iii)
collaborating with EPA's scientific partners in academia, other agencies, state and tribal
governments, private sector organizations, and nations; and iv) exercising leadership in
considering and preparing to deal with emerging environmental issues and advancing the
science and technology of risk assessment and risk management.
ORD's research program structure contains sixteen (16) specific research areas.
These program areas address EPA's science and technology needs in topics such as:
human health; air and global change; economics and sustainability; environmental
technology; ecosystems; water; and homeland security. In this Advisory, the SAB
discusses and comments on the fundamental and overarching issues associated with these
programs. More detailed comments are provided in the Appendix of this report.
The SAB believes that EPA has made progress in identifying the strategic needs
within its 16 focused research areas. Similarly the National Academy of Sciences has
remarked on the importance to research efficiency of good planning and implementation,
and concluded that".. .EPA and its ORD have a sound strategic planning architecture that
provides a multi-year basis for the annual assessment of progress and milestones for
evaluating research programs, including their efficiency" (NAS, 2008). The SAB is
pleased by the EPA's efforts to engage in a dialogue on strategic research planning. This
willingness to engage the Board and others openly about research directions and
strategies is laudable as EPA comes to grips with the need for major new science
understandings to meet current environmental protection issues, as well as the emerging
issues that will be a part of its mission in the future.
The Agency's current 16 focal areas are important. However, if it is to be prepared
to address future needs, EPA's research program will have to adopt a more integrated
view, one that reflects the inherent complexities and interconnections among human and
ecological systems, gives greater consideration to feedbacks, and focuses on the relevant
scales of each issue. In this context, it is clear that if the Agency is to truly protect the
environment, it must undertake a larger program of research that goes beyond its
immediate regulatory needs and address the broad array of environmental problems
facing the nation.
Of course, focused research in support of current regulatory programs is needed.
However, it appears to the SAB that a balanced program that has been recommended by
the SAB and the National Academy of Sciences in a number of past reports (NAS, 2000;
SAB, 2006; SAB 2007) is being lost as a result of constant pressures to address the near-
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term data needs of the Agency's operating programs in the face of ever more serious
resource constraints.
Several changes are needed to address pressing environmental problems that do not
fall neatly within existing regulatory mandates. Today these needs are only addressed
within the Agency's research plans in fragmentary ways, even though they are often
interrelated. In its research programs, the SAB believes that EPA should:
1) Broaden the interpretation of "landpreservation" to take a greater leadership
role in future land-use decision making and in managing the consequences of bio-
fuels, sprawl, green-field development, and the pressures of unconstrained coastal
development. This program has historically focused on cleanup activities
associated with contaminated sites and releases. In addition, issues associated
with the Resource Conservation Challenge have been a part of the program.
Though latitude for change in this program may be limited by funding
restrictions, EPA should consider broadening the program to enable it to focus on
issues that are key to the success of EPA's new Sustainability programs, including
research to understand the environmental and ecosystem consequences of
incentive structures associated with land use decisions.
2) Expand the focus on the environmental consequences of new technologies to
include a broader consideration of the life-cycle of new products and their
globalization. Understanding changes in where and how products are
manufactured and in the types of products manufactured are important to
understanding risks. Shifting locations of production within and outside the U.S.
can present unique risks to the U.S. population (e.g., changed water and energy
usage and availability, contaminated products, long-range transport of pollutants,
and movement of living organisms to new locations of the world, to name a few).
EPA must conduct research to better understand these issues and how they
influence human health and the environment, as well as conduct research on the
efficacy of alternative regulatory mechanisms for protecting human health and the
environment in the face of these changes.
3) Expand the analysis of water infrastructures, supply, demand and quality in light
of changing socio-economic pressures and climate. Increased water demand from
expanding populations in water-short or drought-stricken areas is leading
governments and agencies to consider agreements for large-scale transfers of
water from one watershed or region to another. EPA needs to conduct research
that will improve our understanding of ecosystem and service impacts associated
with such transfers to be prepared to make informed decisions on water
management issues in the future.
4) Reinvigorate and modernize research on sensitive human and ecological
populations including research involving chemical mixtures. EPA should
continue to give primary emphasis to sensitive populations - this information
will also provide critical data to protect the general population. In this sense,
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sensitive populations refer to humans as well as to plant and animal populations,
where the latter may be part of an interdependent ecological web. These studies
will also help identify effective interventions when needed. Studies should also
address the critical need for information on chemical mixtures that are reflective
of actual situations in the world.
5) Improve the science foundation needed to respond to unexpected and emerging
problems and environmental disasters. The science and technologies impinging
on human health and environmental evaluations are exponentially expanding in
terms of complexity and pace of development. Examples include the likely
emergence of transforming sciences such as toxicogenomics and
nanotechnology. Resource-limited organizations such as EPA will be
increasingly challenged to develop creative mechanisms to provide the Agency
access to this science within the realistic constraints of EPA human and budget
resources. On the topic of environmental disasters, the SAB has recently sent you
a separate self initiated report, which includes a number of research
recommendations (SAB, 2008).
6) Expand policy-relevant research on developing, testing and evaluating new and
innovative alternatives to conventional command and control regulation. There
is a modest research literature on the relative advantages and disadvantages of
different approaches in different contexts and on the development of new
approaches. However, that literature is too small and insufficiently
comprehensive given the importance of the issues that are at stake. Since existing
programs are subject to review from time to time, and new issues such as the need
to control of the emissions of greenhouse gases will likely arise in the future, the
Agency would be well advised to build a vigorous research program that is
focused on developing, testing and evaluating alternative strategies that might be
able to more effectively and efficiently achieve future environmental goals.
7) Improve dramatically the integration of economics and the decision and
behavioral social sciences into research and policy development across the
Agency. The new research focus on ecosystem services is designed to provide
inputs in a form that can be used in economic analysis and assessment of Agency
programs. However, to be successful, evaluations of ecosystem services must
build on an underpinning of solid ecological science, an area in which EPA has
recently been dramatically reducing its research investments. The Agency will
need to reverse this trend if the effort in ecosystem services is to meet its full
potential. While the agency has reasonable staff resources in economics, and
maintains some research on issues in environmental economics, its capability in
the behavioral social sciences, and decision sciences, is so limited that it typically
is not even in a position to ask the right questions. Given that risk perceptions
and the behavioral response of members of the public are central to the design of
many of the Agency's most important programs, the lack of staff resources and
the absence of a coherent behavioral and sciences research program is a
deficiency in urgent need of attention.
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8) Continue to work on improving the effective communication of research results to
potential users both inside and outside the Agency. The Agency has a variety of
formal and informal strategies to move the results of its research into the hands of
government and private decision makers, research groups in universities and the
private sector, and the general public. Clearly if the results of EPA research are to
have maximum value in promoting good environmental understanding, and
informed decision making, these activities will require continued attention.
The SAB appreciates the very considerable assistance that it has received from
Senior Staff in ORD, and the ongoing opportunity to work with the Agency in
understanding and contributing to the improvement of its research vision. With a
renewed commitment to reversing the recent trend of shrinking ORD research budgets,
the SAB believes that EPA research will be able to address, well, the Agency's future
needs for knowledge of human health, ecosystems, human behavior and the environment.
In doing this, it should strive to build a broader and more forward-looking research
program, and continue its efforts to break down barriers and promote greater strategic
integration across its research programs. The SAB also believes that in this way, EPA
research can set a high standard internationally for creative, forward looking, mission-
motivated environmental research.
The SAB looks forward to your comments on its reflections on the EPA strategic
research vision, and to its continued interactions with EPA on these critically important
issues.
Sincerely,
/Signed/ /Signed/
Dr. Deborah L. Swackhamer, Chair Dr. M. Granger Morgan
Science Advisory Board Immediate Past Chair
Science Advisory Board
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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.
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U.S. Environmental Protection Agency
Science Advisory Board 2008*
CHAIR
Dr. M. Granger Morgan, Lord Chair Professor in Engineering; Professor and Department Head,
Department of Engineering and Public Policy, Carnegie Mellon University, Pittsburgh, PA
SAB MEMBERS
Dr. Thomas Burke, Professor and Co-Director Risk Sciences and Public Policy Institute, Bloomberg
School of Public Health The Johns Hopkins University, Baltimore, MD
Dr. James Bus, Director of External Technology, Toxicology and Environmental Research and
Consulting, The Dow Chemical Company, Midland, MI
Dr. Deborah Cory-Slechta, J. Lowell Orbison Distinguished Alumni Professor of Environmental
Medicine, Department of Environmental Medicine, School of Medicine and Dentistry, University of
Rochester, Rochester, NY
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. David Dzombak, Professor, Department of Civil and Environmental Engineering, Carnegie Mellon
University, Pittsburgh, PA
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. James K. Hammitt, Professor of Economics and Decision Sciences, Harvard Center for Risk
Analysis, Harvard University, Boston, MA
Dr. Rogene Henderson, Scientist Emeritus, Lovelace Respiratory Research Institute, Albuquerque, NM
Dr. James H. Johnson, Professor and Dean, College of Engineering, Architecture & Computer Sciences,
Howard University, Washington, DC
Dr. Bernd Kahn, Professor Emeritus and Director, Environmental Resources Center, School of Nuclear
Engineering and Health Physics, Georgia Institute of Technology, Atlanta, GA
*The SAB roster reflects the membership during Fiscal Year 2008.
11
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Dr. Agnes Kane, Professor and Chair, Department of Pathology and Laboratory Medicine, Brown
University, Providence, RI
Dr. Meryl Karol, Professor Emerita, 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, 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 Emeritus, Institute of Ecology, University of
Georgia, Lopez Island, WA
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 Medical Center, Washington, DC
Mr. David Rejeski, Director, Foresight and Governance Project, Woodrow Wilson International Center
for Scholars, Washington, DC
Dr. Stephen M. Roberts, Professor, Department of Physiological Sciences, Director, 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
Dr. James Sanders, Director, Skidaway Institute of Oceanography, Savannah, GA
Dr. Jerald Schnoor, Allen S. Henry Chair Professor, Department of Civil and Environmental
Engineering, Co-Director, Center for Global and Regional Environmental Research, University of Iowa,
Iowa City, IA
Dr. Kathleen Segerson, Professor, Department of Economics, University of Connecticut, Storrs, CT
Dr. Kristin Shrader-Frechette, O'Neil Professor of Philosophy, Department of Biological Sciences and
Philosophy Department, University of Notre Dame, Notre Dame, IN
Dr. Kerry Smith, W.P. Carey Professor of Economics, Dept. of Economics, Carey Scl of Business,
Arizona State University, Tempe, AZ
Dr. Deborah Swackhamer, Professor, School of Public Health and Co-Director, Water Resources
in
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Center, University of Minnesota, Minneapolis and St. Paul, MN
Dr. Thomas L. Theis, 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 at the
Stanford Law School and Director, Woods Institute for the Environment Director, Stanford University,
Stanford, CA
Dr. Robert Twiss, Professor Emeritus, University of California-Berkeley, Ross, CA
Dr. Lauren Zeise, Chief, Reproductive and Cancer Hazard Assessment Branch, Office of Environmental
Health Hazard Assessment, California Environmental Protection Agency, Oakland, CA
LIAISONS
Dr. Steven Heeringa, (FIFRA SAP), Research Scientist and Director, Statistical Design Group,
Institute for Social Research (ISR), University of Michigan, Ann Arbor, MI
Dr. Melanie Marty, (CHPAC Chair), Chief, Air Toxicology and Epidemiology Branch, Office
of Environmental Health Hazard Assessment, California EPA, Oakland, CA
Dr. Henry Anderson, (CHPAC 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, 20460
IV
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Table of Contents
1. Introduction 1
2. US EPA Research Program Structure 2
3. Response to the Charge 4
3.1 General Comments 4
3.2 Human Resources for the Conduct of Science at EPA 10
3.3 Comments on Research Effectiveness and Efficiency 12
3.4 Moving Forward with the SAB - EPA Strategic Research Discussions 16
Appendix A SAB Comments on Specific Research Areas A-l
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EPA's Strategic Research Directions 2008: An SAB Advisory
1. Introduction
The EPA Science Advisory Board (SAB), senior managers of the EPA Office of
Research and Development (ORD), and the ORD National Program Directors (NPD),
began an evaluation and dialog on the strategic directions for EPA's research program in
October, 2007. This dialog has continued over several meetings since that time, and the
parties intend that these discussions continue for at least the next several years. This
interaction between the SAB and EPA is motivated by a desire to begin to think about
EPA's strategic vision for research in a way that is broader than the view that can be
obtained through the lens of each year's annual review of the EPA research program
budget. Both the SAB and EPA want to engage and to think more strategically about the
Agency's overall research program in relation both to EPA's stated needs and the SAB's
perspectives on the environmental challenges the Agency is likely to face in coming
years.
In initiating this interaction, the EPA Assistant Administrator for Research and
Development asked the SAB to consider the strategic directions for EPA's 16 specific
research areas and to provide its perspectives on:
a) Where EPA research should be in the next five years, i.e., 2012 and beyond in
terms of:
i. Research areas that will need continued emphasis;
ii. Research areas that might need increased emphasis; and
iii. Research areas that might be given decreased emphasis over the next several
years.
b) What scientific factors EPA should consider to get to this point?
i. Changes in "environmental science" itself;
ii. Ways in which the workforce, and the skills available through the workforce,
might be adjusted to further evolve and improve the research program (i.e.,
strategic workforce planning); and
iii. Opportunities for efficiency
Are there areas with opportunities for greater coordination and synergy
within ORD, across EPA, and across other organizations both inside and
outside of government;
Are there other research "themes" that could strengthen EPA's research
strategy (e.g., cross-cutting advice on sprawl, disasters, climate change);
and
How might the SAB - EPA dialogue on strategic science planning for
research be improved in the future?
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Section 1 of this "enclosure to the letter to the Administrator" is this Introduction.
Section 2 identifies EPA's 16 research areas as they were presented to the SAB during
October 2007 and groups them according to how they were considered by the SAB at that
meeting and since. In Section 3 the SAB offers its initial response to the Agency's
charge to the SAB for these interactions. Specifically, Section 3.1 offers general SAB
comments on a number of overarching issues that emerged during its October 2007
discussions with EPA on its strategic research directions. In Section 3.2 the SAB
comments on the human scientific resource needs of EPA, focusing on the problems of
sustaining and renewing EPA's excellent and highly motivated scientific research staff.
In Section 3.3 the SAB comments on strategies that ORD might consider in enhancing its
research effectiveness and efficiency. In Section 3.4 the SAB offers some suggestions
for additional dialogue between the SAB and EPA on its strategic research vision.
Finally, in the Enclosure, the SAB offers more specific comments on the current research
program directions described in EPA's 16 strategic research area descriptions (SAB,
2007a). However, as noted above, these are preliminary comments because the depth
with which the SAB was able to learn about each strategic research area was at best
modest during these initial interactions with ORD.
2. EPA Research Program Structure
The EPA Office of Research and Development (ORD) began a new strategic
planning effort during 2006 that involved ORD's National Program Directors (NPD), the
ORD Executive Council (OEC) and the ORD Science Council (SC). ORD also involved
EPA's program and regional offices in this effort.
ORD research is intended to provide the scientific foundation to support EPA's
mission by:
a) conducting research and development to identify, understand, and solve
current and future environmental problems;
b) providing responsive technical support to EPA's Programs and Regions;
c) collaborating with EPA's scientific partners in academia, other agencies, state
and tribal governments, private sector organizations, and nations; and
d) exercising leadership in addressing emerging environmental issues and
advancing the science and technology of risk assessment and risk management.
For its interactions with the SAB, ORD structured its research program
descriptions around sixteen specific research areas. These program areas are summarized
in a set of strategic documents that formed the information base for the SAB - EPA
discussions during its October 2007 meeting. The sixteen specific research programs are
listed in Table 1.
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Because of an SAB request during the SAB-EPA interaction on the FY 2008 and
2009 research budgets, ORD moved toward discussing examples of cross-cutting
research (e.g., in cross cutting areas such as sprawl, climate change, sensitive
populations, etc.). Though a cross-cutting view of these themes is not directly addressed
in the descriptions listed in Table 1, ORD can identify and describe a number of linkages
across research areas and they jointly plan some parts of this research across a variety of
specific areas. In addition, EPA views the individual programs as being either Program-
Targeted Research (e.g., Clean Air, Drinking Water, Water Quality, Land Preservation,
Safe Pesticides and Products, Homeland Security, Global Change, and GEOSS/AMI) or
Cross-Program Research (e.g., Human Health, Computational Toxicology, Human
Health Risk Assessment, Endocrine Disrupting Chemicals, Ecosystems, Economics and
Decision Sciences, Science and Technology for Sustainability, and Nanotechnology).
Table 1. EPA Research Areas
SAB Grouping
ORD Research Areas
Technology
i) Land Preservation and Restoration
ii) Nanotechnology
iii) GEOSS / Advanced Monitoring Initiative
Economics and Sustainability
i) Economics and Decision Sciences
ii) Technology for Sustainability
Ecosystems, Water and
Security
i) Ecosystems Protection
ii) Water Quality
iii) Drinking Water
iv) Homeland Security
Air and Global Change
i) Clean Air
ii) Global Change
Human Health
i) Human Health
ii) Computational Toxicology
iii) Endocrine Disrupters
iv) Human Health Risk Assessment
v) Safe Pesticides and Products
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3. Response to the Charge
3.1 General Comments
The SAB believes that EPA has made progress in identifying the strategic needs
within its sixteen focused research areas. Similarly the National Academy of Sciences
Committee on Evaluating the Efficiency of Research and Development at the U.S.
Environmental Protection Agency1 has noted, "The key to research efficiency is good
planning and implementation. EPA and its ORD have a sound strategic planning
architecture that provides a multi-year basis for the annual assessment of progress and
milestones for evaluating research programs, including their efficiency" (NRC, 2008)2.
The SAB is pleased by the EPA's efforts to engage in a dialogue on strategic
research planning. This willingness to engage the Board and others openly about
research directions and strategies is laudable as EPA comes to grips with the need for
major new science understandings to meet current environmental protection issues, as
well as the emerging issues that will be a part of its mission in the future.
All of the Agency's current focal areas are individually important. However, if it is
to be prepared to address future needs, EPA's research program should adopt a more
integrated view, one that recognizes the inherent complexities and interconnections
among human and ecological systems, gives greater consideration to feedbacks, and
focuses on the relevant scales of each issue. In this context, it is clear that if the Agency
is to truly protect the environment, it must undertake a larger program of research that
goes beyond its immediate regulatory needs and addresses the broad array of
environmental problems facing the nation.
Of course, focused research in support of current regulatory programs is needed.
However, it appears to the SAB that a balanced program that has been recommended by
the SAB and the National Academy of Sciences in a number of past reports (NRC, 2000;
SAB, 2006; SAB 2007) is being lost as a result of constant pressures to address the near-
term data needs of the Agency's operating programs in the face of ever more serious
resource constraints.
National Research Council, Evaluating Research Efficiency in the U.S. Environmental Protection Agency,
Report of the Committee On Evaluating The Efficiency Of Research And Development Programs At The
U.S. Environmental Protection Agency, 132pp, 2008.
2.
The NRC Committee also provided a framework for evaluating the efficiency of EPA research. The
Committee identified two types of research efficiency. Investment Efficiency addresses three questions:
are the right investments being made, is the research being performed at a high level of quality, and are
timely and effective adjustments being made in the multi-year course of the work to reflect new scientific
information. NAS states that these questions are best evaluated by use of expert judgment not quantitative
measures. Process Efficiency involves quantitative measures of inputs and outputs (e.g., publication rates,
time required to conduct research, and percent of grants that are peer-reviewed) and these can be measured
in units such as dollars, hours and numbers. PART emphasizes Process Efficiency. Investment Efficiency
is best judged by expert advice.
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Several changes are needed to address pressing environmental problems that do not
fall neatly within existing regulatory mandates. Today these needs are only addressed
within the Agency's research plans in fragmentary ways. In its research programs, the
SAB believes that EPA should:
1) Broaden the interpretation of "land preservation" to take a greater
leadership role in future land-use decision making and in managing the
consequences of bio-fuels, sprawl, green-field development, and the pressures
of unconstrained coastal development.
The Agency's Land Preservation area has historically focused on cleanup
activities associated with contaminated sites, uncontrolled releases, spills, and
leaking underground tanks. There are genuine, and considerable, needs
associated with containing and removing contamination in the land environment,
but while the Agency continues to address these issues, the Board believes that its
focus should be broadened. For example, there is little research on land use topics
such as measuring the benefits of Brownfields clean up and revitalization, urban
sprawl and the built environment, and the multiple land sustainability issues that
surround agriculture and biofuels.
There have been recent efforts to include waste minimization activities, mostly
through the Resource Conservation Challenge (RCC), a voluntary partnering
program aimed at helping companies and institutions overcome barriers to
implementing waste minimization programs. This is a potentially valuable
program, but it has not been systematically evaluated to assess its efficacy or to
develop plans for improvement. This should be done.
Private actions associated with land use decisions, local and regional land use
policies motivated by short-term commercial concerns (especially in coastal
regions), water needs for residential and agriculture uses, bio-fuels as responses to
shortfalls in conventional energy resources, globalization of the supply chain for
increasing numbers of commodities and numerous other examples, illustrate
choices made in response to the incentives provided by private markets and
current regulations. Too often we learn the environmental consequences of these
incentive structures only after problems have emerged. EPA's research in all
media needs to better anticipate environmental and ecosystem costs and benefits
of the incentives faced by independent individuals and organizations as they make
decisions and drive developmental choices.
2) Expand the focus on the environmental consequences of new technologies to
include a broader consideration of the life-cycle of new products and their
globalization.
A number of factors associated with product life cycles influence the types of
risks that are emerging in the U.S. and worldwide, as well as how and why those
risks emerge. It matters where products are manufactured and how they are
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manufactured. In addition, new technologies are emerging that will have to be
considered in view of their own life cycles.
EPA needs to understand where things will be manufactured in the future. Thirty
years ago, 80 percent of automobile-related manufacturing took place in less than
20 counties in the U.S. Today that number is less than 50 percent. Auto
manufacturing left the Rustbelt and moved into the American southeast (a shift
from Brownfields to Greenfields). Just-in-time inventory processes have
dramatically increased the transportation-related impacts for the production life
cycle, especially for high-weight, low value inputs. Thus, the location of
production and any attendant risks has changed within the U.S. The increase of
international trade has made it more important to think about how human health
and the environment in the U.S. might be influenced by manufacturing outside
our boarders.
Examples of US human health and environmental problems that can result, at
least partially from pollution released in other countries, include not only global
effects such as climate change and stratospheric ozone depletion, but also
environmental transport of pollutants such as particulate matter and mercury.
Additionally, transport of contaminants through products (e.g., lead in children's
toys; pesticides in food products), and accidental or incidental transport of living
organisms associated with increased global transportation (e.g., invasive species
such as zebra mussels, disease vectors) can cause adverse effects to human health
and the environment in the U.S.
ORD should develop mechanisms, and next generation of environmental impact
assessment tools, to anticipate significant changes in the methods and locations of
industrial production that could have impacts on EPA's mission and programs.
Shifts in hydrocarbon synthesis (biofuels) are already on the radar screen but
other changes loom large. Research is needed to better understand the effects of
globalization on risks to human health and the environment in the US and
elsewhere.
Production locations and methods are not only changing for existing products, but
new technologies are giving rise to new types of products that must be evaluated.
For example, to continue to reduce the cost and size of computer chips, the
semiconductor industry is exploring alternative production methods ranging from
water-based lithography to the use of DNA and nano-scale quantum techniques to
produce logic. Similar transitions are underway in the production of batteries as
companies explore alternatives to lithium ion such as nano-phosphate. These
shifts in industrial production methods could result in dramatic changes in
material inputs, water and energy requirements, emissions, and end-of-life issues.
When they happen, where, and how all need to be better understood by EPA.
The growing globalization of the world's economy also presents challenges.
When supply chains stretch to other parts of the world, especially into developing
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countries, it becomes difficult to assure that environmental impacts are being
adequately addressed. This can be further complicated by World Trade
Organization (WTO) free-trade rules. There is a need for work on alternative
approaches such as programs to assist non-US producers in developing or
adopting more environmentally or health-friendly products and processes (e.g.,
ongoing US-China efforts, development of energy-star, and other product
standards).
3) Expand the analysis of water infrastructures, supply, demand and quality in
light of changing socio-economic pressures and climate.
Expanding populations, depleted reserves of fossil ground water, and the growing
impacts of climate change are making water supply an ever more pressing issue in
a number of water-short or drought-stricken areas of the U.S. such as, Atlanta,
Las Vegas, and Phoenix. This, in turn, is leading local government water
management agencies to negotiate agreements for large-scale transfers of water
from distant regions. The long-term ecosystem and ecosystem service impacts,
and water quality impacts, of such transfers have received little study. Because
interest in inter-basin transfers of water is likely to grow in the future, an
improved understanding of the ecosystem impacts associated with such transfers
will be necessary to make informed decisions on regional and interstate water
management/reuse as well as land uses which contribute to increased water
demand. In addition, these impacts must also be understood in the context of
climate change.
These first three items reflect problems that arise when many independent decisions
are made by individuals and organizations that do not face prices, other incentives, or
regulations that capture the externalities, full life cycle and longer term consequences of
these decisions. Rather than dealing with the consequences piecemeal and after the fact,
it would be wise for the Agency to begin to more systematically think about how it might
become more anticipatory in addressing such issues.
4) Reinvigorate and modernize research on sensitive human and ecological
populations including research on chemical mixtures.
The study and protection of sensitive populations (including plants, animal, and
human) should continue to be a prime emphasis for the EPA. If the Agency
protects those populations that may be the most susceptible to toxins and other
stressors it will likely fulfill its primary mission of protecting the general
population. While this has always been a key part of EPT's mission, new
advanced experimental methods hold the potential to dramatically strengthen and
support this effort.
Sensitive human groups include populations at various stages of life (fetus,
pregnant females, children, elderly, etc) and populations of individuals with
specific diseases (such as asthma), specific genotypes, or specific exposures.
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Studies of these sensitive populations, not only provide critical data to protect the
general population, but also provide insight into what chemicals are toxic, their
mechanism of action or pathways of toxicity, and potentially help to identify
opportunities to protect these populations and the general population as a whole.
Studies of effects on sensitive plant and animal populations, where these may be
part of an interdependent ecological web, are also important. Such studies will
also provide insight to mechanisms of action of environmental chemicals and
possibly avenues of intervention (including nutrapharmaceuticals, nutrition, etc)
when various species or ecosystems are at risk. The study of these sensitive plant
and animal populations is also important in helping to understand the effects of
population losses on the entire ecosystems. The study of sensitive populations
must also consider how changes to sensitive ecosystems can affect the entire
system.
Often, environmental research and environmental protection actions focus on
single pollutants, species, or stressors. While valuable, such work often fails to
reflect the mixture of exposures that arise in the field.
Mixtures pose an enormous research challenge. Developing general ways to
determine what combinations and in what concentrations are of greatest concerns
is still largely unresolved problems. While the Agency has made some progress
on mixtures of agents whose health or other effects are produced by common
mechanisms (organophosphate pesticides, dioxin), these represent only part of the
problem. Many mixtures to which people and ecosystems are exposed do not
have common causal mechanisms; also exposures typically occur within the
context of other xenobiotic and endogenous chemical stressors as well as non-
chemical risk modifiers that can also change the effects resulting from such
environmental mixture exposures. While some brute force testing of specific
mixtures is probably necessary, an expanded focus on developing more
fundamental and generalizable strategies for addressing mixtures is clearly
warranted.
5) Improve the science foundation needed to respond to unexpected and
emerging problems and environmental disasters.
The science and technologies impinging on human health and environmental
evaluations are exponentially expanding in terms of complexity and pace of
development. Examples include the likely emergence of transforming sciences
such as toxicogenomics and nanotechnology. EPA will be increasingly
challenged to develop creative mechanisms to provide the Agency access to this
science within the realistic constraints of EPA human and budget resources.
The SAB has recently sent the Administrator a separate self initiated report,
which includes a number of research recommendations that should allow the
Agency to become better able to anticipate and respond to environmental
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disasters. Rather than repeat those recommendations here readers are referred to
the SAB report An SAB Advisory: Preparing for Environmental Disasters (EPA
SAB, 2008).
6) Expand policy relevant research on developing, testing and evaluating new
and innovative alternatives to conventional command and control regulation.
Most of EPA's programs in environmental regulation and control operate under
legislative mandates that stipulate specific strategies (use best available control
technology; control to a specific emissions level per unit of activity; adopt a cap
and trade regime; report all emissions to TRI; etc.). There is a modest research
literature on the relative advantages and disadvantages of such different
approaches in different contexts and on the development of new approaches.
However, that literature is too small and insufficiently comprehensive given the
importance of the issues that are at stake. Since existing programs are subject to
review from time to time, and new problems such as control of the emissions of
greenhouse gases will likely arise in the future, the Agency would be well advised
to build a large and more vigorous research program that is focused on
developing, testing and evaluating new alternative strategies that might be able to
more effectively and efficiently achieve future environmental goals.
7) Improve dramatically the integration of economics and the decision and
behavioral social sciences into research and policy development across the
Agency.
The new research focus on ecosystem services is designed to provide inputs in a
form that can be used in economic analysis and assessment of Agency programs.
However, to be successful, evaluations of ecosystem services must build on an
underpinning of solid ecological science, an area in which EPA has recently been
dramatically reducing its research investments. The Agency will need to reverse
this trend if the effort in ecosystem services is to meet its full potential. While the
agency has reasonable staff resources in economics, and maintains some research
on issues in environmental economics, its capability in the behavioral and
decision sciences is so limited that it typically is not even in a position to ask the
right questions. These are interdisciplinary fields of empirically based social
science that have seen rapid development over the past few decades. They
provide both valuable insight into how people think about issues of risk and how
they frame and make decisions in the face of uncertainty. At least as important,
they offer guidance on how best to design programs and messages to aid citizens
and others in decision making. At its core, EPA makes decisions to protect
human health and the environment based on knowledge in several technical areas
relevant to risk assessment and risk reduction. To be effective, these decisions
need to be informed by science that studies various environmental issues (domain
knowledge), decision sciences that identify factual information from these
domains that are critical to considering what actions should be taken, and
knowledge from the behavioral social sciences that helps EPA to understand what
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people perceive about this factual basis and how that relates to their goals
regarding the problem or issue being addressed by the EPA.
Given that risk perceptions and the behavioral response of members of the public
are central to the design of many of the Agency's most important programs, the
lack of staff resources and the absence of a coherent research program is a
deficiency in urgent need of attention. In the past, ORD teamed with the Decision
and Management Science program at the National Science Foundation (NSF) to
support some work in this area. In addition to hiring staff with expertise in this
area, reestablishing that collaboration might be one strategy by which the Agency
could move forward.
8) Continue to work on improving the effective communication of research
results to potential users both inside and outside the Agency.
The Agency has a variety of formal and informal strategies to move the results of
its research into the hands of government and private decision makers, research
groups in universities, the private sector, and the general public. Clearly if the
results of EPA research are to have maximum value in promoting good
environmental understanding and informed decision making, these activities will
require continued attention.
Communicating research results to the public, links closely to the issues discussed
under 7 above, since the effectiveness of such communication can be considerably
enhanced through the application of good modern empirical methods in
communication design and evaluation.
With a few exceptions, such as the new initiative in sustainability, most of EPA's
current research programs are tied to specific media and their focus is driven by current
regulatory strategies, statutory mandates and needs. The SAB understands the forces and
budgetary limitations that have created this situation. However, in thinking about 2012
and beyond the SAB believes that a broader and more systems-oriented approach to
research will be needed. Many of the elements of such a program already exist, but in the
words of Administrator Johnson, currently the work is much too "stove-piped."
3.2 Human Resources for the Conduct of Science at EPA
In addition to asking the SAB for its views on research needs, EPA expressed an
interest in the implications of workforce changes on the quality and responsiveness of the
Agency's research programs. The question was primarily focused on strategic workforce
planning, that is, how the skills available through the workforce might be adjusted to
further evolve and improve the research program.
While expanding expertise into new areas is important, it is also important to ensure
that many areas of existing expertise do not undergo erosion as staff turnover occurs from
retirement and limited EPA investments in science staff, laboratory equipment, supplies,
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travel and other things needed for researchers to be able to design and to carry out top
flight research.
The SAB has discussed new areas of expertise that will be needed in several of its
recent reviews of EPA research budgets. Areas of need range from emerging fields such
as nanotechnology to existing fields in which the agency has insufficient expertise such
as behavioral and decision sciences. Solving our environmental problems will require
resources. However with many senior people in the existing workforce moving into
retirement, there may also be opportunities to update the skill base with little increase in
cost.
The EPA has long enjoyed a remarkably dedicated and highly qualified scientific
research staff. However, in our discussions with bench-level scientists during our
October, 2007 visit to RTF, and in the individual interactions that members of the SAB
have had in recent years with both junior and senior agency researchers, several issues
have emerged that deserve ongoing and expanded attention from EPA's senior managers.
These include:
a) The erosion and/or disillusionment of senior staff. Continually shrinking research
budgets have resulted in growing numbers of senior staff who are becoming
disillusioned, and this risks loss of the high level of dedication that brought them
to the agency in the first place.
b) Recruiting and retaining young talent. The agency has developed an outstanding
program to attract postdoctoral scientists to the ORD labs, and an active program
to recruit new young scientific staff. However, the SAB is concerned that too
many of the scientists who are participating in these programs are losing interest
when real opportunities and permanent, challenging jobs at the Agency do not
become available or other more promising opportunities beckon from outside the
Agency.
c) Continuing Education and Training. The agency has long had formal and
informal programs to support continued education, up to and including
opportunities for MS-level scientists and engineers to pursue PhD studies.
However, it is time to review and revitalize these activities.
When the SAB has raised such concerns in the past we have been told that all is well,
and been given survey results to support this assertion. It is not our place to engage in an
extended debate with Agency personnel on this matter. The SAB once again reports the
impressions it has developed from its formal and informal interactions with staff at all
levels across the EPA and with knowledgeable observers on the outside. With the
exception of our recurrent recommendations to reverse the continued erosion of research
budgets, the SAB is not close enough to the details of ORD operations to suggest specific
strategies to address these issues. However we know enough about recent staffing trends
to recommend that the issues of sustaining and strengthening ORD and the Agency's
scientific human resources deserves continued and expanded attention.
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3.3 Comments on Research Effectiveness and Efficiency
EPA asked the SAB for advice on whether it sees opportunities for improving the
research program's efficiency. Specifically, they asked the SAB to consider there are
opportunities for greater coordination and synergy within ORD, across EPA, and across
other organizations both inside and outside of government, and whether the SAB sees
"themes" that could strengthen EPA's research strategy. The SAB has discussed a
number of such themes in the paragraphs above.
The recent National Academy of Sciences' report, Evaluating Research Efficiency
in the US Environmental Protection Agency (NAS, 2008) offers valuable suggestions on
evaluating both investment efficiency and process efficiency for US EPA research
programs. The SAB supports the findings of the NRC report and notes that the role of
expert review by SAB is most helpful in evaluating investment efficiency in research. In
this regard, the SAB offers the following thoughts for consideration.
a) Strategies by which the EPA might make greater use of results from its own
research program (we offer examples in sustainability and in nanotechnology) and
relevant research from other organizations.
EPA should be the leader in using its own research results. The following are
examples of current opportunities:
i. The recent Agency and government-wide initiative on
nanotechnology has provided significant research results
demonstrating the properties of nanomaterials. Incorporation of
these results in technology development activities into the water and
air monitoring and treatment holds potential to yield significantly
improved process performance.
ii. The Technology for Sustainability Research Program has identified
three interrelated ideas drawn from economics, social, and
environmental realms. These have been translated into six program
themes. Integration of the ideas and themes into other research
programs will yield program results that reflect EPA's view of "...
meeting basic environmental, economic, and social needs now and
in the future without undermining the natural systems upon which
life depends."
iii. The Ecosystem Research Program's new direction on assessing
ecosystem services needs to be integrated into Agency Program
offices and should help in prioritizing and evaluating the
effectiveness of their activities.
iv. ORD has passed the tools developed in EMAP to the Program and
Regional offices, however, there is still an on-going need for the
development of new monitoring strategies and tools. This parallels
the opportunities in nanotechnology presented above.
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The SAB has noted on many occasions that other governmental and non-
governmental organizations either fund or conduct research that can be useful in
supporting EPA's mission achievement. To its credit, EPA has a long history of
using such results to the extent that they are relevant to EPA's conduct of its own
research and in considering the need for action on various environmental issues.
EPA ORD should continue to actively look for and use the relevant research
results from other governmental and nongovernmental organizations in ways
similar to that noted above for its own research results. EPA should enhance and
improve this effort by instituting a systematic process that ensures that such
research results are captured by EPA and used to support the Agency mission
when it is appropriate for such uses. This systematic mining of others' research
results can also identify opportunities for EPA collaboration and partnerships to
leverage the use of EPA's own resources.
Of course, as the SAB has remarked before, much of the research conducted by
these outside organizations, though generally categorized as "environmental
research" is not of the type that directly answers important questions that are
relevant to EPA's specific mission.
b) Strategies to engage citizens for data collection, and for computational
resources for advanced modeling and analysis.
Communications is shifting from a one-to-many paradigm (i.e., the approach that
dominated radio and television for decades) to a many-to-many, net-centric
paradigm. Nicholas Negroponte, the Director of MIT's Media Lab, called this the
move from "passive old media" to "interactive new media." Interconnected
people now have the technological tools that allow users to generate and distribute
their own content everything from computer code (Linux) to course curriculum
(iTunes University). People can collaborate to make their content better (peer-to-
peer design and development) and they can apply their collective wisdom to
solving important scientific challenges.
To take advantage of these changes, ORD should explore the possibility of
developing a strategy to engage a new generation of "citizen scientists" to help
the agency collect, analyze, and apply the results of these activities to
environmental issues. In this, EPA could consider the integration of citizens and
outside organizations into their "macroscope", possibly as a Citizen's
Environmental Science Corps. In this manner, EPA could create opportunities for
citizens to work as observers and participants in a variety of efforts that would be
useful to EPA's achievement of its mission. Citizens could perform
measurements, analyze data, and support efforts to attain environmental
improvements. In addition to making direct observations; such a "Science
Environmental Corps" might participate in EPA websites to give their advice on
what EPA should be doing on various issues following a collaborative model of
the sort illustrated by Wikipedia; and they might analyze EPA's data bases
through competitions that reward the best ideas for new environmental science,
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solutions, and technologies3. The Agency might, with some imaginative effort,
determine how it could turn a few million GPS-enabled cell phones with cameras
into a participatory sensing system. EPA might consider using a virtual world
like Second Life to test reactions to product labeling schemes or work on
collaborative strategies to manage ecosystems.
An example of a successful venture in this area is the effort to link together
America's 70 million bird watchers. Web-based systems like Bird Source and
Journey North have allowed birders to share sitings and see new spatial patterns
of migration never before possible. John Fitzpatrick, director of the Laboratory
for Ornithology at Cornell, commented that, "We'll be able to count them,
monitor them, and observe their population crashes, on a continental scale."
In addition, a few years ago, NASA found that people with a bit of training could
identify craters on the surface of Mars and classify them by age (humans can still
beat computers on many pattern recognition tasks). Instead of just borrowing
computer power (SETI project), NASA borrowed the brains of thousands of
people in what was called the Clickworker's Project. People did this for the
challenge and learning experience, not for money.
More recently, thousands of people poured over satellite images trying to find the
downed plane of pilot Steve Fossett (Help find Steve Fossett with Google Earth).
A similar technique was used to search for Jim Gray, a Microsoft scientist who
went missing on his sailboat off the coast of California.
c) Expansion and greater integration of behavioral and decision science into many
ORD research programs
The SAB pointed out in point 7 of this advisory (see pages 9-10) that without a
scientific understanding of human behavior and decision processes, the EPA
cannot fulfill its responsibility to the American people.
An element of human judgment is part of every analysis that the Agency
conducts. It is present in the definition of fundamental terms, such as risk,
benefit, exposure, discount rate, and equity. It is present in the selection and
weighting of data. It is present in the selection of values for sensitivity analyses
and the assessment of scientific uncertainties. The roles of judgment and their
limits have been studied extensively for some forty years. If that science is not
reflected in EPA's analytical processes, then the results of those analyses are less
than they should be and they are conveyed with greater confidence than is
warranted. These are the issues that, in part, motivated OMB's Risk Assessment
Bulletin. Although that effort was faulted as fundamentally flawed by the
See for example Don Tapscott and Anthony D. Williams, Wikinomics : how mass collaboration changes
everything, Portfolio, New York, 351pp, 2008.
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National Academy of Sciences and subsequently abandoned by OMB, the need
for systematic treatment of scientific judgment remains.
Many EPA analyses attempt to assess processes that depend on human behavior.
For example, the risks from toxic chemicals depend on exposure processes shaped
by human behavior (what people eat, whether they can use protective clothing,
etc.). They may also depend on the behavior of people who must maintain
equipment, interpret malfunctions, issue warnings, and respond to cautions or
evacuation orders. In the publicly available reports from two consultations, the
SAB's Homeland Security Advisory Committee raised serious questions about the
behavioral realism of important programs that were sound in other ways. Unless
EPA bases its analysis on social and behavioral science, its assumptions will be
little more than guesswork.
The value of much of EPA's work depends on its ability to convey research and
analytical results to people who must make decisions informed by them. It is well
established in the scientific literature that many technical issues are understood in
different ways by expert and lay audiences. With scientifically sound
communications, however, it is possible to make research results clear to those
willing to attend to them. At one time, the Agency was a leader in scientifically
sound communication. Today, however, EPA's communications are almost all
improvised, without any rigorous analytical identification of its audiences'
information needs or empirical evaluation of its effects. As a result, the Agency
may not only fail to extract the full value of its research, but inadvertently
misinform its audiences.
The Agency is in urgent need of an ambitious program of scientific research in the
behavioral and decision sciences. At the moment, its ranks are so depleted that it
has difficulty commissioning sound work from the outside, lacking staff with the
expertise needed to evaluate proposals and products. There is no substitute for
aggressive hiring, investment in dedicated STAR graduate fellowships, and
extramural research to fulfill the most pressing gaps until EPA has created
adequate intramural research programs. As noted above, it may be wise for EPA
to partner with an agency such as NSF that has social science expertise in order to
build this program.
d) An alternative organizational structure for EPA Research
The Agency may wish to consider alternative models for the management of the
activities pursued within its laboratory system. Historically EPA research has
been organized according to media-specific, pollutant-specific, and problem-
specific areas as well as the risk management paradigm (air, radiation,
assessment, effects, toxicology, exposure, risk management, homeland security,
etc.). Such a model has served the regulatory side of the Agency well, but makes
it difficult to respond to modern environmental problems which are increasingly
cross-media, systemic, and complex. A focus that is finely tuned to the
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regulatory side of the Agency also is vulnerable to changes in regulatory
priorities. Over the years the SAB has observed a tendency for calls at EPA to
shift away from existing research - research that may have taken several years to
incorporate within plans and budgets - into new areas. This undermines the
normal pursuit of research which almost always requires consistent attention over
some protracted timeframe to reach successful conclusion. Alternative models
that are more adaptive, multidisciplinary, and systems-oriented would allow the
Agency to better anticipate new environmental challenges, and be less reactive.
These would very likely permit cost and functional efficiencies to be gained, as
well as create a more stable research environment within the research
organization. The Board recognizes that a transition to an alternative model for
management is a painstaking endeavor accompanied by a culture change and
resistance by some. The long term rewards, however, might be best for the
protection of human health and the environment.
3.4 Moving Forward with the SAB - EPA Strategic Research Discussions
EPA asked how future SAB-to-EPA interactions on strategic science planning
might be improved. Since 2005, the annual review of the EPA research budget has been
the responsibility of the Chartered Science Advisory Board. The SAB made the decision
to move the review from an SAB subcommittee to the chartered Board because of its
desire to reflect the importance of the review and because it allowed the Board to add to
the number of individuals on the team that actually reviewed the report. It also arranged
for the span of expertise used in the review to be increased. The SAB believes that
retaining this activity as a Chartered SAB responsibility will allow the improvements
already gained from this change to be preserved and it will also allow the benefits to be
increased in the future.
In its consideration of EPA's overall research picture, largely through the window
of a budget review, the SAB has explored a variety of approaches to conduct the actual
review and considered a variety of types of information that would help it in the conduct
of these reviews. EPA and the SAB continue to work to identify an optimal set of
background documents to be given to the SAB so that it can carry out a meaningful
review of EPA's research budget. Over time the amount of documentation has
decreased. The SAB believes that it should continue to work with EPA to refine the set
of background documents necessary to allow a high quality review of EPA's research
program portfolio.
In addition, the SAB and EPA have varied the specific organizations involved in
the review from having the SAB interact with just ORD to having all the client offices
participate in the discussions of research needs. This is because the span of activities
conducted under the ORD research and development program overlaps with similar
activities that are pursued by various program and regional offices. Thus, it has been the
goal of the SAB and ORD to have regional and program offices all involved in the
discussions so that the full science program would be a part of the discussions, not just
that part carried out by ORD. At this point, the Program and Regional Offices are not
participating in the interaction as fully as the SAB and ORD would like. The SAB
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believes that EPA's program and regional offices should be more involved in these
discussions in the future. This is both so that the SAB can learn from programs and
regions of how well their needs are being met by ORD and also because program and
regional offices also conduct science activities that are of a similar nature to those
conducted by ORD. To best provide advice to ORD on how its research efforts should
evolve, it will be important to understand the full EPA science program and those
components that are not under the direction of ORD.
The SAB has long thought that engaging in discussions of the overall research
program over the long term was not as successful when done in association with
discussions on EPA's research budget. Generally, open discussion is restricted when it
occurs as a part of the budget process because of rules that constrain the Agency's ability
to thoroughly discuss how well a given budget meets the needs for conducting research
that is identified in its long-term strategic planning. Thus, the SAB and ORD agreed to
separate the two activities into a two-phased process in which the SAB and EPA are
engaging in a continuing series of discussions of the strategic directions for EPA research
so that the Board can better understand the overall directions of Agency research and how
that might change. In addition, the SAB each February evaluates and advises the
Administrator on the coming year's research budget in terms of how that budget will
contribute to the Agency's accomplishment of the goals and objectives that are embodied
in the longer term strategic directions for each research program. The SAB believes that
continuing this separation, and pursuing discussions with EPA over time will contribute
to better communications between the SAB and ORD on the overall research program.
This will, in turn, provide a contextual basis for the SAB's use in advising EPA, and the
U.S. Congress, on each year's budget.
The topics which come to the SAB for consideration and advice differ from those
sent to the ORD Board of Scientific Counselors (BOSC) and other advisory bodies. For
example, SAB review topics tend more toward being peer reviews of scientific
assessments or assessment methods than the actual conduct and progress on specific
research programs - the latter usually being done by the BOSC. The SAB believes that
deliberations on the adequacy and completeness of EPA research program strategies and
budgets could be enhanced if it incorporates additional representation from other
advisory bodies into its own reviews. The SAB will pursue this for future activities in
these two areas.
One of the difficulties in evaluating research budgets and strategies from year to
year comes from changes that EPA makes to the structure, nomenclature, and
organization of its research programs. Thus, from one year to the next, the location of
specific research topics might fall within different categories. Further, when considering
resource levels allocated to specific programs, and to the component activities within
given programs, it is important to have information on what resource levels are actually
associated with each component and program from year to year. Without this, it is quite
difficult to know how a program is progressing over time. In addition, resource
allocations rarely are given, when they are given, on a consistent basis over a series of
years (e.g., some years show budget levels while some show appropriated levels) and
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thus it is difficult to see resource trends over time. The SAB believes that its discussions
on EPA research could be improved if it could be provided with a consistent set of
resource numbers over a period of at least 5 years for specific programs and program
components. Further, if requirements change in a way that causes programs, and their
components, to be renamed from one year to the next, information should be provided
that makes those changes clear.
Specific research programs carried out by or for EPA, typically, do have an actual
beginning and end. Often the end of an activity within an ORD research program signals
the need for a follow-on action by a Program or Regional Office. The SAB believes that
improved consideration of EPA's research programs conducted by ORD could be gained
from participation of Regional and Program Office personnel who could indicate how
specific completed research activities are to be implemented in their own offices (e.g., the
continuation of the EMAP is such an issue since it is being indicated by ORD now as an
area where research has completed the development of a method/approach and that the
benefits gained from information coming from implementation of those methods will
now be the responsibility of other EPA offices. Knowing that such things will happen is
important to the SAB as it develops its advice on ORD's research programs and budgets).
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APPENDIX A
SAB Comments on EPA's Specific Research Areas
Contents
Introduction A-2
2. Comments on Specific EPA Research Programs A-2
2.1 Technology Research Areas A-2
2.1.1 Land Preservation & Restoration A-2
2.1.2 Nanotechnology Research A-3
2.1.3 Global Earth Observation System of Systems (GEOSS)/Advanced
Monitoring Initiative A-4
2.2 Economics and Sustainability Research Areas A-6
2.2.1 Economics and Decision Sciences A-6
2.2.2 Technology for Sustainability A-8
2.3 Ecosystems, Water and Security Research Areas A-10
2.3.1 Ecosystem Protection A-10
2.3.2 Water Quality A-12
2.3.3 Drinking Water A-13
2.3.4 Homeland Security A-14
2.4 Air and Global Change Research Area A-15
2.4.1 Clean Air Research A-15
2.4.2Global Change Research A-16
2.5 Human Health Research Area A-17
2.5.1 Human Health A-18
2.5.2 Computational Toxicology A-20
2.5.3 Endocrine Disrupters A-20
2.5.4 Human Health Risk Assessment A-21
2.5.5 Safe Pesticides and Products A-22
ATTACHMENT 1: ADDITIONAL DISCUSSION A-24
1. Detailed Recommendations Technology for Sustainability Research
Program A-24
2. Additional Research Topics For the Human Health Area A-26
A-l
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1. Introduction
This Appendix contains specific comments of members of the EPA Science
Advisory Board (SAB) Subgroups that were established by the SAB to evaluate and
comment on each of the Office of Research and Development's (ORD) research program
areas. General comments are contained in the SAB Advisory to which this Appendix is
attached. The comments in this Appendix are the interim responses of the review Teams
that evaluated the EPA strategic directions research materials during the meetings from
October 2007 through July 2008. Sections 2.1 through 2.5 of this Appendix discuss the
research areas within each team's primary purview, the key directions for the research in
each of the specific research areas, and provide the SAB's initial comments on each of
the specific research areas.
2. Comments on Specific EPA Research Programs
2.1 Technology Research Areas
For the purposes of these discussions between the SAB and ORD, the
Technology Research Area includes: i) Land Preservation and Restoration, ii)
Nanotechnology, and the iii) Global Earth Observation System of
Systems/Advanced Monitoring Initiative (GEOSS/AMI). Each of these programs
has attributes the SAB believes represent the evolution and revolution of changes
in the environmental arena. Research activities in the Land Preservation and
Restoration Program have evolved from the traditional studies on hazardous waste
treatment and management to Brownfields cleanup and revitalization. The
Nanotechnology Research and GEOSS/AMI represent strategic research
initiatives on the implications of modern technology and on innovative uses of
data to support EPA's mission.
2.1.1 Land Preservation & Restoration research supports the needs of the
Office of Solid Waste and Emergency Response (OSWER) as it
implements provisions of the Resource Conservation and Recovery Act
(RCRA), the Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA), and the Superfund Amendments and
Reauthorization Act (SARA) in the detection, assessment, and evaluation of
the effects on and risks to human health of hazardous substances in the
environment. The purpose of the research program is to provide more cost-
effective tools, models, and methods to support decisions on land
restoration, materials management, and reuse/land revitalization (SAB,
2007a).
The key directions of ORD's current research program in this area include
(Teichman, 2007a):
Development of sustainable planning criteria for land use plans, e.g.,
Brownfields.
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Evaluation of alternative remediation technologies for contaminated
sediments.
In situ treatments and permeable reactive barriers for ground water
protection, study of the operation of landfills as bioreactors, and
assessment of asbestos risks.
SAB Comments: The Agency's Land Preservation area has historically
focused on cleanup activities associated with contaminated sites,
uncontrolled releases, spills, and leaking underground tanks. More
recently efforts have been made to include waste minimization activities,
mostly through the Resource Conservation Challenge (RCC), a voluntary
partnering program aimed at helping companies and institutions overcome
barriers to implementing waste minimization programs. This is a
potentially valuable program, but it needs to be systematically evaluated to
assess its efficacy or to develop plans for improvement.
The Board recognizes that there are emerging environmental research
needs that fall within the purview of this technology area that should be
explored. Generally, these research needs fall within the well-recognized
field of Land Use and include, but are not limited to, measuring the
environmental and economic benefits of Brownfields cleanup and
revitalization, documenting the multiple environmental challenges
associated with urban sprawl and the built environment, clarifying the
complex relationship between agriculture, biofuels, and environmental
protection, and improvements in the rigor of Life Cycle Analysis (LCA)
for use in land use remediation and protection. The Board urges the EPA
to examine more closely the complimentary nature of an expanded Land
Use program and its nascent, but important, research program in
Sustainability with a view toward recognizing opportunities for cross-
disciplinary collaboration.
The EPA Environmental Technology Validation (ETV) and Superfund
Innovative Technology Evaluation (SITE) programs are essential to
moving technology to commercialization and have involved substantial
leveraging of limited EPA funds. The National Advisory Council on
Environmental Policy and Technology (NACEPT) and other studies view
these evaluation activities as having high value to private environmental
technology organizations, and to the accomplishment of EPA's mission.
2.1.2 Nanotechnology Research addresses the environmental protection
challenge of ensuring ".. .that, as nanotechnology develops and engineered
nanomaterials are manufactured and used, unintended consequences of
exposures to humans and ecosystems are prevented or minimized. In
addition, knowledge concerning how best to apply products of this
emerging technology to detect, monitor, prevent, control, and clean up
pollution is also needed." In this regard, EPA has developed a research
portfolio by working with others including federal agencies, industry,
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academia, and non-governmental organizations to ensure research gaps are
covered, critical issues are addressed, and information is communicated to
all interested parties." (SAB, 2007a).
The key directions of ORD's current research program in this area include
(Teichman, 2007a):
Understanding sources, fate, transport, and exposure throughout the
life-cycle of nanomaterials.
Developing risk assessment and test methods.
SAB Comments: The Agency's Nanotechnology research program
appears to be well integrated into the broader National Nanotechnology
Initiative, a positive development, and has shown that it can reach out to
the broader international community as well as the manufacturing
companies themselves. The ORD program on nanomaterials has been
formulated strategically, considering EPA needs and with an eye towards
leveraging and potential future regulatory decisions. There is involvement
with many external groups. EPA has given careful attention to building on
areas of internal expertise such as fate and transport, ecological assessment,
and small particle inhalation. The program integrates activities at the
international, national, and cross-agency levels. An important,
unaddressed challenge is the implication of mixtures and environmental
transformations of nanomaterials and other contaminants.
2.1.3 Global Earth Observation System of Systems (GEOSSVAdvanced
Monitoring Initiative (AMI) EPA's GEOSS/AMI program grew from
recognition that the goals of the US EPA's 2006-2011 strategic plan (US
EPA, 2006a) and those of the GEOSS were mutually reinforcing. GEOSS
envisions a future in which ".. .decisions and actions are informed by
information." GEOSS intends to integrate ".. .multiple Earth observation
systems (networks, databases) and using computer modeling and decision
support tools to help revolutionize our understanding of Earth's complex
processes." EPA activity in this multi-agency program began with its
participation in groups leading the effort to plan and support GEOSS and
with its own Advanced Monitoring Initiative that is aimed at showing some
major tangible results by September 2008. EPA's efforts involve 34
projects in four areas (Air Quality Forecasting/Assessment and Decision-
making for Human Health; Coastal/Source Water Quality and Decision-
making for Human Health; Integrated Air-Water-Land-Biota Decision-
making for Healthy Communities and Ecosystems; and Information
Technology/Information Management (SAB, 2007a).
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The key directions of ORD's current research program in this area include
(Teichman, 2007a):
Transition from pilot projects to focusing on user needs, capacity
building, and communities of practice.
Develop best practices guide to forecast air quality and inform decision
making.
SAB Comment: The GEOSS/AMI initiative is well-conceived and
planned. It has a strong cross-media focus, especially for air and water,
supports the goals of multiple Multi-Year Plans (MYPs), and has good
cross-agency (e.g. National Science Foundation) connections. Some of the
benefits of GEOSS are that it develops a technologically collaborative
culture, creates an understanding of the need to plan for such collaboration,
and, done right, it will work itself out of business. To accelerate and further
the development of this technologically collaborative culture, the Agency
should select a few high impact projects, such as the Chesapeake Bay and
Mississippi River, for demonstration during the next phase of this program.
At this early stage the Board supports GEOSS/AMI, but with two caveats:
There is a need to guard against moving toward a "data-
rich/information poor" state, and
Parallel concerns about the need for evaluating data quality and
uncertainty exist.
One potential application of GEOSS/AMI in relation to Homeland Security
would be to organize the data from multiple labs from multiple samples
from multiple field teams of the air, water, and land. However, without
additional integration with economics and decision sciences, it would
become just another store house of data, without much assessment. By
adding the components of cost benefit analyses, compliance, and
participation behavior, it would be possible to determine if allowing the
public back into an contaminated area, but restricting their exposure
through protective actions such as interdiction of crops would be
adequately protective of public health and would be publicly acceptable.
As a specific example, there are a number of protective actions which have
been discussed involving milk which had been contaminated with a short
lived radionuclide. Would it be acceptable to use the milk to make cheese
since the aging process would allow radioactive decay to take place?
Could it be turned into powdered milk for consumption after 10 half-lives?
What would the public's reaction to this milk be? By integrating
economics and decision sciences with geo-mapped land use areas, it would
be possible to make some better assumptions about public acceptance.
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Another specific example would be to allow people to return to their homes
following an incident involving deposition of a hazardous substance in
their neighborhood, but not allow them to consume vegetables from their
backyard garden, and require them to wipe their pet's feet every time the
pet enters the house after running around on the lawn. Would people
comply with this directive?
2.2 Economics and Sustainability Research Areas
For the purposes of these discussions between the SAB and ORD, the
Economics and Sustainability Research Area includes: i) Economics and Decision
Sciences, and ii) Technology for Sustainability.
Fundamentally, EPA makes decisions that are intended to protect human
health and the environment from a suite of pollutants and behaviors that are
addressed by nearly a dozen environmental laws. EPA makes choices about how
to address a wide variety of environmentally linked risks based on knowledge and
procedures in several areas. Choices inevitably call upon individuals to modify
their behavior in regard to the issue. Informing EPA's decision-making requires
several types of knowledge, i.e., factual scientific and technical knowledge
about the risk issue and possible management approaches; decision sciences
knowledge that identifies the scientific and technical information that is critical in
evaluating possible actions to take to address the issue, and social sciences
knowledge to determine people's perspectives in relation to how they see the key
science as well as their desired outcomes associated with actions that might be
taken to respond to the issue. Further, it is important that this aspect be started in
the beginning of EPA evaluation efforts in support of decision-making and that
the capability to do this be available to and used by all EPA Program Offices.
2.2.1 Economics and Decision Sciences. This research program area is
managed by the EPA National Center for Environmental Economics
(NCEE) which plans the research component of its program in cooperation
with the Office of Research and Development. This "...research is designed
to improve our understanding of human and organizational environmental
behavior and preferences, which is critical for improving EPA's decision-
making, cost-benefit analyses, and implementation strategies."...This
research program ".. .focuses on how people value their health and the
environment; corporate and consumer environmental behavior; and market
mechanisms and incentives (SAB, 2007a).
The key directions of NCEE's current research program in this area include
(Teichman, 2007a):
Developing risk assessment metrics that can be used for valuation
purposes;
Finding ways to transfer air market mechanisms to other environmental
issues; and
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Developing advanced computational tools needed to support analytic
models capable of evaluating policies on both micro- and macro-
economic scales.
SAB Comments: The research plan for Economics and Decision Sciences
follows closely the Environmental Economics Research Strategy. It
identifies three major research areas (pp. 56-57):
health benefits valuation (both mortality and morbidity),
ecological benefits valuation, and
treatment of uncertainty.
It also proposes research in three additional areas: environmental justice,
costs and benefits of climate change, and compliance/participation
behavior.
The health valuation research is designed to improve the estimation of
costs and benefits of EPA actions, primarily for use in Regulatory Impact
Analyses (RIAs) and related assessments. An extensive literature exists on
the valuation of mortality risks (i.e., estimating the value of a statistical life
(VSL)), and the proposed research appears to be aimed at refining those
estimates to provide estimates that vary with factors such as income, age,
and health status. While more information on this topic would clearly be
valuable, before investing significant additional resources in VSL
estimation by sub-group, the SAB urges the Agency to consider how the
new information will be used in benefits assessment to ensure that the
research results are policy-relevant.
The SAB applauds the research direction related to ecological benefits
valuation. Since this work requires extensive integration of ecological and
economic analysis, the SAB urges the Agency to extend this research area
to include participation from other program areas. Note that meaningful
ecological benefits valuation requires more than applying an average value
estimate (e.g., the "value of a hectare of wetlands") to an estimate of
environmental effect (e.g., hectares of wetlands preserved). Rather, it
requires a meaningful assessment of the value of a policy-driven change in
ecosystem services that reflects important bio-physical and socio-economic
characteristics of the impacted ecosystem and population. Research in this
area should build on results of the recent SAB project from its Committee
on Valuing the Protection of Ecological Systems and Services (CVPESS).
The EDS strategy focuses almost exclusively on economics, particularly
measuring costs and benefits, with little attention to other behavioral and
decision science issues (other than the proposed work on
compliance/participation in voluntary programs). Yet, behavior of firms
and individuals drives environmental performance. This behavior is in
response to policy-induced incentives, as well as cognitive and decision-
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making processes employed by individuals. The SAB urges EPA to expand
the EDS research strategy to include research focused on these issues. This
could include work on the incentives and likely effectiveness of alternative
policy approaches (evaluated relative to specific policy contexts), business
management decisions, information processing, technology/product
adoption (including consumer behavior), and risk and other communication
strategies.
As a practical example, with the growing emphasis on energy conservation,
a market for compact fluorescent lamps (CFLs) has been stimulated. It is
common to see CFLs in mass distribution markets, such as most major
department stores. However, CFLs contain mercury which is released if the
bulb is accidentally broken. It may be necessary to consider whether
regulation is needed to require locations that sell CFLs to institute "take-
back" programs. What incentives will inspire the public to return the bulbs
rather than put them into the normal household waste stream?
More generally, the EDS research strategy should be broadened to identify
and include links with other program areas. The current strategy is defined
more from a disciplinary than a problem-oriented perspective. For nearly
all of the EDS research areas, closer interaction with other program areas
would be fruitful. Specific examples include revitalization of contaminated
lands (with land preservation), effectiveness of TMDLs (with water), and
managing water quantity (with water and global change).
Finally, the EDS research strategy seems to be driven to a large extent by
short-term national assessment needs, most notably for RIAs. This is likely
to become even more pronounced now that EDS has moved from ORD to
the EPA National Center for Environmental Economics and its budget has
been sharply reduced. The SAB urges the Agency to broaden its research
agenda to contribute to improvements in other decision contexts (e.g.,
regional planning applications and site-specific decisions) and to look
beyond the short-term in identifying research priorities.
2.2.2 Technology for Sustainability research has emerged as the new emphasis
for programs that originated at EPA under the concepts of pollution
prevention in the early 1990's. According to EPA, in this context,
"sustainability" refers to ".. .meeting the needs of the present without
compromising the ability of future generations to meet their own needs.
From a public policy perspective, sustainability means meeting basic
environmental, economic, and social needs now, and in the future, without
undermining the natural systems upon which life depends." Sustainability
goes "...beyond traditional end-of-pipe control strategies and embraces
system-based, long-term solutions." Early efforts under Pollution
Prevention and New Technologies aimed to provide ".. .tools and
technologies that advanced the idea of environmental systems management
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while preventing and controlling pollution and reducing risks to human
health and ecosystems originating from multiple economic sectors.
Strategic directions for this research program begin with the notion that
sustainability ".. .must combine interrelated ideas drawn from economic,
social and environmental realms" - often thought of as the "Three Pillars of
Sustainability." Given EPA's narrowly focused mission, the EPA
sustainability research program is focused on environmental dimensions of
sustainability while recognizing that sustainable environmental outcomes
are best achieved in a systems-based context." The resulting EPA research
program is broader than the usual stove-piped media-focused program and
it adopts a focus that is multimedia and systems wide. EPA's sustainability
research program has six themes: 1) Natural Resource Protection, 2) Non-
renewable Resource Conservation; 3) Long-term Chemical and Biological
Impacts; 4) Human-built Systems and Land Use; 5) Economics and Human
Behavior; and 6) Information and Decision-making (SAB, 2007a).
The key directions of ORD's current sustainability research program
include (Teichman, 2007a):
Development of sustainability metrics for use in EPA's Report on the
Environment, informing design and production, and evaluating
innovative technologies.
Provide decision support tools to address energy and environmental
impacts, e.g., water and land use.
Promote collaborative partnerships.
SAB Comments: The ORD's research initiative in the area of
sustainability is an important and timely step forward. The SAB supports
ORD's research efforts to develop metrics and tools to advance the
Agency's ability to achieve protection of human health and the environment
through sustainable practices. The SAB believes the "6 Themes of
Environmental Sustainability" identified as the framework for this research
are appropriate and important areas upon which to focus. Additionally,
EPA's intent to work on sustainability metrics, decision support tools and
innovative technologies expressed in the long-term goals statements seems
to capture the broad categories of tools and techniques in which the agency
should be working. That said the review team felt that the written
description provided to the SAB on the intended research actions under the
long-term goals did not clearly link to the 6 themes for sustainability. The
agency representatives did note that their forthcoming research strategy
document will show this linkage. A post meeting, inspection of the June
13, 2007 draft of the strategic research strategy draft contains a table (5.1)
on page 43 which gives some indication of linkages between the 6 themes
and the 3 long-term goals. A table such as this with some more details on
research projects would have helped to clarify these linkages in the
information provided for this current discussion. The SAB looks forward to
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seeing those linkages further developed in the final Sustainability Research
Strategy.
In conclusion, the SAB suggests that the agency allow itself wide latitude in
the way it approaches sustainability research since this new systems-based
approach to environmental protection will require a fundamental departure
from the current stove-pipe single-media based regulatory framework. The
SAB recommends the following (expanded details for each of these
recommendations are included in Attachment 1 to this Appendix).
Recommendations
Clearly define the intended audience(s)
Behavior and decision science research is needed
Establish (or clearly define) linkage to other Research areas and
programs
Go beyond Technology - green chemistry and pollution prevention
LCA tools don't incorporate directly what matters to people so they
can't incorporate value or benefits
Need for a clear definition of the sustainable condition or future state
the agency desires to maintain or achieve.
Explore developing a bridge between risk and performance to achieve
sustainability.
2.3 Ecosystems, Water and Security Research Areas
For the purposes of these discussions between the SAB and ORD, the
Ecosystems, Water and Security Research Area includes: a) Ecosystem
Protection, b) Water Quality, c) Drinking Water, and d) Homeland Security.
2.3.1 Ecosystem Protection. The Ecological Research Program (ERP) is taking
a new strategic direction that is intended to fill the need "... for better
understanding the implications of human impacts on ecosystems and the
resources they provide." This new program direction recognizes that, even
though "The nation's health, security, economic potential, and much of its
culture are directly and intimately tied to ecosystem characteristics and
quality", environmental policy ".. .decisions have failed to take these
relationships into account." The redirected ERP intends to build on past
research efforts in ecosystem monitoring, restoration, and functions, to
develop operational methods to incorporate quantitative information on
ecosystems services into decision making routines. Using internal
resources, and a suite of unique partnerships with outside organizations
(academia, NGOs, other governmental agencies, etc.), the ERP will conduct
research designed to ".. .answer multiple questions about ecosystem
services. ... and develop multiple measures of services, including
biophysical and monetary measures, to estimate incremental changes to
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ecosystem services, as well as suites of 'bundled' services associated with
land, air, and water systems over explicitly defined spatial and temporal
scales." The "... goal is to inform a wide range of issues related to
questions of social choice, with a special focus on informing trade-offs
among ecosystem services provided under alternative management and
policy decisions." ERP, through its own work and that of its partners, will
create products in four categories: 1) measurements and dynamic maps of
ecosystem services; 2) predictive models relating to the response of
stressors; 3) tools for analysis of management options; and 4) decision
support tools (SAB, 2007a). Approaches developed by ORD to monitor
ecosystem conditions (e.g., Environmental Monitoring and Assessment
Program-EMAP) will now be passed to the Program and Regional Offices
to implement.
The key directions of ORD's current ecosystems research program include
(Teichman, 2007a):
Assessing the benefits of ecosystem services to human well-being, and
Understanding how policy and management choices affect the type,
quality, and magnitude of services we receive from ecosystems.
SAB Comments: The SAB noted the changes from the historically,
diverse research program in this area to one that is refocused on ecosystem
services. The SAB believes that ORD has a strong vision of where it is
going in this area; however, that vision is not yet integrated across EPA
Research and EPA Program Offices. Additionally, even though ORD has
passed the tools developed in EMAP to the Program and Regional Offices
for implementation, the SAB believes that there continues to be a need to
link ecological conditions to goals and that there is a need for additional
development of monitoring systems, especially for some of the
contemplated trading systems that involve ecosystem services. Success in
this research area will depend greatly on adding expertise in economics to
the program. Decision support tools are also critical to the aspirations of
this program; however, current activity in this area does not seem
sufficient. ORD should invest in system support science more heavily in
the future, given that it will benefit Ecosystems Research as well as several
other programs. ORD has a history of taking the outcomes from their
research and helping to infuse those results into EPA practice. This will be
very important for research on ecosystem services. An ecosystem services
perspective will require staff with a holistic perspective and this
perspective must be communicated to user communities. The opportunity
to think at the strategic level instead of just focusing on the "issue of the
week" is important to getting these new programs on a strong footing.
Integrating across diverse scales is important.
This new focus will also require support of the STAR grants program to be
successful. ORD recognizes the importance of establishing research
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partners in the broader research community to accomplish its challenging
goals. The SAB believes that the elimination of the ERP-STAR program
due to budget cuts is a strategic error.
The ERP description reports that the EMAP program (a status and trend
program) has been transferred to the Water Quality Program for technical
support and to the Program Offices for survey monitoring and assessment.
In light of the SAB's criticism of the Report on the Environment 2007 for
not including long-term trend information and little trend analysis for
indicators questions arises in my mind 1) does the Water Quality Program
have the capability to provide technical assistance needed, 2) and do the
Program Offices have the capability to implement the survey monitoring
and assessment need to generate indicator trend data and analysis for future
Reports on the Environment.
2.3.2 Water Quality research supports EPA's Office of Water and Regional
Offices in implementation of the Clean Water Act (CWA). The
restructured water quality research program (WQRP) consolidates past
work done under a separate goal into three remaining goals that focus on: 1)
Water Quality Integrity Research - research in support of aquatic life
guideline revisions, recreational water criteria, emerging contaminants,
nutrients, biocriteria, stream biota, and biological condition gradients for
Tiered Aquatic Life Uses; 2) Watershed Management Research - research
in support of Total Maximum Daily Load allocation processes; and 3)
Infrastructure Research - research on innovative solutions to manage the
nation's aging water and wastewater infrastructure (SAB, 2007a).
The key directions of ORD's current research program in this area include
(Teichman, 2007a):
Supporting development of aquatic life guidelines and recreational
water criteria, by studying the impact of stressors, including habitat
alteration, nutrients, pathogens, and emerging contaminants.
Improving watershed management by applying diagnostic tools to
assess impairment and guide mitigation efforts to manage both point
and non-point sources.
SAB Comments: Several National Program areas have responsibilities for
water-related research areas, including Water Quality, Drinking Water,
Ecosystems, Global Change, and Sustainability. While there are structures
in place to encourage and facilitate interactions among the research
programs and the program offices, these arrangements are not always
effective in communicating when ORD's effort is to end and OW's effort
is to begin.
The SAB believes that EPA must begin to actively integrate its research
and programs for water quality and drinking water. A holistic "Clean
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Water" program should be pursued analogous to the way in which research
is now pursued as a "one atmosphere" concept in the air medium. More
work is needed in watershed management, infrastructure, and integrated
criteria development (across biological, chemical and physical criteria).
Research is also needed on modeling, monitoring, and measurement to
support water quality decision making. Climate change, and the
relationship of water quality to land use practices, must be incorporated
throughout this research area.
2.3.3 Drinking Water research is ".. .an applied research program designed to
develop new scientific data, models, innovative methods, and cost-effective
technologies for characterizing and managing the quality and sustainability
of drinking water resources in support of EPA's goal of 'Clean and Safe
Water.'" "The Drinking Water Research Program (DWRP) is moving
towards an integrated framework for addressing drinking water issues in the
context of the water cycle." Major themes in the DWRP are in the areas of
1) Assessment Tools; 2) Source Water/Water Resources; 3) Treatment/
Residuals; 4) Distribution/Storage/Infrastructure; and 5) Water Use/Health
Outcomes. Increased emphasis is being placed on source water protection
and sustainability; water distribution/storage systems/infra-structure;
microbial risk associated with pathogen exposure; and health outcomes
(SAB, 2007a).
The key directions of ORD's current research program in this area include
(ORD, 2007a):
Develop sustainable source water protection approaches.
Assess exposure to contaminants from water storage and distribution
systems.
Improve tools for characterizing and monitoring pathogens and
biofilms, and develop methodologies for microbial risk assessment.
Develop methodologies to quantify the impacts of SDWA rule
implementation on public health outcomes.
SAB Comments: Members noted that for Drinking Water Research most
attention is on total coliform and CCL research with groundwater source
protection getting some attention. It is understood that these priorities are
driven by the regulatory drivers of the Total Coliform Rule, the Candidate
Contaminant List (CCL), and Underground Injection Control (UIC,
geologic carbon sequestration). While the regulatory drivers are important,
the future strategic direction should focus on the most important risks
which could be non-regulatory. A watershed focus may provide the
greatest opportunity for public health protection via prevention. More
attention is needed for surface source water protection and distribution
systems. Research on the protection of surface water sources of drinking
water is at the intersection of the SDWA and CWA. Again, the "One
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Hydrosphere" approach is suggested for EPA use in integrating its research
on a variety of water issues.
2.3.4 Homeland Security responsibilities of EPA include: 1) the protection of
water systems in general and for detecting and recovering from terrorist
attacks affecting water systems; 2) decontaminating buildings and outdoor
areas impacted by a terrorist attack; and 3) developing a nationwide
laboratory network to support routine monitoring and response
requirements. The EPA Homeland Security Research Program "... is
currently conducting a year-long exercise to align the program more closely
with these responsibilities. The original Homeland Security Research
Program covered broad emergency response issues; however, the realigned
research program will focus primarily on terrorist attacks. Even so, ".. .the
program will continue to nurture research collaborations with the broader
scientific community, seeking supplemental expertise, fostering valuable
collaborations and leveraging of additional resources. In addition, although
research products will be planned to meet the needs of Agency customers,
ORD will conduct research that benefits multiple EPA programs and other
Federal agencies as much as possible." Goals focus on developing 1)
".. .products and expertise to improve protection from and the capability to
respond to terrorist attacks on the nation's water and wastewater
infrastructure" and 2) ".. .products and expertise to improve the capability
to respond to terrorist attacks affecting buildings and the outdoor
environment." Behavioral research program requirements are still being
explored in a white paper being developed by EPA on homeland security-
related research needs in the behavioral sciences (e.g., risk communication
and perception during crises) (SAB, 2007a).
The key directions of ORD's current homeland security research include
(Teichman, 2007a):
Identifying and validating methods to detect and quantify biological
agents.
Developing a methodology to assess microbial risks and risk-based
advisory levels.
Developing decontamination and disposal approaches for chemical,
biological, and radiation (CBR) agents in both large outdoor areas and
in water infrastructure.
Improving the communication of risk and risk management options
during a crisis.
SAB Comments: The SAB recognizes that the Homeland Security
Research program began in a crisis mode and focused on getting as much
done as quickly as possible. The need now is to become more strategic and
to define program boundaries so that this strategic focus has a goal. Even
though the strategic directions state the intent to focus only on terrorism,
EPA must think beyond terrorism and conduct research to enhance
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responses to natural disasters as well. EPA also needs to think about how
to increase collaborative research with other agencies and other
stakeholders as well as to obtain more collaboration within EPA. A cross-
cutting issue is the need to coordinate with others to better define EPA's
niche in the response area and how that influences research needs.
Important research areas identified include: risk communications; detection
methods for contamination, decontamination, disposal and outdoor
exposure. Issues such as determining "how much clean up is necessary"
have social research needs beyond communications.
EPA should ensure that it integrates the work and lessons learned from
others, including:
Other countries (UK, Canada, Australia)
Other federal agencies (DOD, USD A, CDC, DHS, DOE),
Multiple EPA offices (ORD, OW; other multi-year plans),
The States, and
that it involves new areas/opportunities with new resources.
2.4 Air and Global Change Research Areas
For the purposes of these discussions between the SAB and ORD, the Air
and Global Change Research Area includes: a) Clean Air, and b) Global Change.
2.4.1 Clean Air Research provides research results needed to develop and
implement the National Ambient Air Quality Standards (NAAQS) -
primarily particulate matter (PM) and ozone as high risk pollutants.
Secondarily it also provides research for Hazardous Air Pollutant (HAP)
management. Clean Air Research (CAR) has been restructured over the last
several years into an integrated program in contrast to the previous research
program that focused on individual pollutants. Ultimately the research
program will provide information that allows EPA to adopt a multi-
pollutant program that will lead to targeted control of emissions products
that most affect human health. Long-term goals for the CAR fall into five
thematic areas.
Theme 1 supports the development of NAAQS and other air quality
regulations;
Theme 2 supports implementation of air pollution regulations;
Theme 3 develops a multi-pollutant approach to research;
Theme 4 identifies specific source-to-health linkages using 'near
roadway' as the prototype; and
Theme 5 assesses health and environmental improvements due to past
regulatory actions (SAB, 2007a).
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The key directions of ORD's current research program in this area include
(Teichman, 2007a):
Support the development and implementation of the NAAQS and other air
quality regulations.
Develop a multi-pollutant "one atmosphere" approach, focusing on
identifying specific source-to-health-outcome linkages, e.g., near
roadway exposures.
Assess health and environmental improvements from past actions
SAB Comments: As noted above, the Clean Air Research Program
identified three key directions for their research agenda. The SAB agrees
that all of these meet the criteria of being high priority research areas and
are particularly supportive of the more holistic systems approach that the
"one atmosphere" concept encompasses. In addition, we believe it is also
important for ORD to maintain a robust research program on air toxics, and
on air quality in indoor environments, which are critical for human
exposure. In addition to these current focus areas, the SAB agrees that
research on interactions of global change and air quality is an important
new priority for both the Clean Air and Global Change programs. Further,
the SAB believes significant societal benefits would result from increased
research on the global mass balance of mercury and its fate and transport.
Policy relevant research to support developing, testing and evaluating new
and innovative alternative policy approaches (e.g., marketable permit
systems for multimedia pollutants, effectiveness of various types of
voluntary instruments, etc.) would also yield high social returns.
2.4.2Global Change Research is a part of the interagency U.S. Climate Change
Science Program (CCSP) mandated by the Global Change Research Act of
1990. "The primary focus of ORD's Global Program is on the assessment
of the potential consequences of global change (particularly climate
variability and change) on air quality, water quality/aquatic ecosystems, and
human health. Results of the program's assessments are used to investigate
adaptation options that improve society's ability to effectively respond to
the risks and opportunities presented by global change. The program
emphasis is shifting toward developing decision support tools to help
managers consider global change during the decision making process (SAB,
2007a).
The key directions of ORD's current research program in this area include
(Teichman, 2007a):
Continue to prepare the Synthesis and Assessment Products mandated
by the Global Change Research Act.
Refine the assessment of climate change on air quality in the U.S.
Characterize the potential impacts of global change on water quality
and aquatic ecosystems.
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SAB Comments: The first key direction is largely driven by regulatory
requirements whereas the second two areas are more anticipatory in
nature. There seems to be very strong collaboration between the global
change program and other research areas such as the water quality
research, ecosystems protection, and clean air. There also appears to be a
very healthy view concerning coordination of research efforts with other
agencies. One area that could yield high returns from a focused research
program is the development of guidance concerning mitigation and
adaptation strategies, particularly with respect to the additional
environmental benefits (or costs) these strategies might have (e.g., a
practice that sequesters carbon in agricultural soils might also generate
increased nutrient runoff). A second key direction of high importance is
research on the design and development of policy instruments to
implement greenhouse gas reductions cost-effectively. Greenhouse gases
will inevitably become regulated. EPA should have a research portfolio
now which assesses various policy actions and their cost-effectiveness for
reducing greenhouse gas emissions (cap-and-trade, carbon tax, command-
and-control, etc.). Various technologies could also be assessed for their
cost-effectiveness.
Relative to reducing the nation's greenhouse gas emissions, Carbon
Capture and Sequestration (CCS) is thought to be mandatory for the use of
coal in the future. CCS is a major research area in which EPA will likely
be involved in regulating and permitting carbon dioxide geological
sequestration, but also in encouraging and leading research and
demonstration efforts (especially in view of the recent cancellation of the
Future-Gen project, the only major CCS demonstration project in the
country to date). At the present time, EPA has taken a rather narrow view
of its charge in this area to be limited to protection of groundwater quality
under the Clean Water Act. SAB recommends that ORD begin partnering
with DOE to provide risk assessments, encourage demonstration projects,
and estimate leakages to the atmosphere. This should be a high national
priority and EPA should play a prominent role.
2.5 Human Health Research Area
For the purposes of these discussions between the SAB and ORD, the
Human Health Research Area includes: a) Human Health, b) Computational
Toxicology, c) Endocrine Disrupters, d) Human Health Risk Assessment, and the
e) Safe Pesticides and Safe Products.
SAB General Comments for this Research Area. Research directed at human
health impacts should encompass a broad perspective to include public health
approaches, exposure assessment, and epidemiology. Potential gene-environment
interactions, including lifestyle, the built environment, diet, drug, and other
xenobiotic exposures, and epigenetics should be included in assessment of human
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health endpoints. This will require adequate numbers of individuals trained in
epidemiology and public health.
The Agency has put forward an impressive array of research objectives to support
long term needs in human health assessment, including an increased emphasis on
research to support the new toxicity testing paradigm. The SAB notes that there
are some important areas of research that were not included in the materials
received by the Board for its October 2007 meeting. Still, the research portfolio
presented had few items where efforts may be decreased, and these were already
noted by the Agency. Therefore the additional research areas identified below and
discussed in Appendix A would ideally be accomplished with the infusion of
funding. Only one long term goal was identified as an objective that could be de-
emphasized. The Board did not have enough time to make any firm
recommendations on prioritizing this research.
A critical evaluation of how new toxicological testing paradigm, including the in
vitro and in vivo approaches, can support risk assessment and ultimately risk based
decision-making should be conducted within the next five years. This dialogue
should include industry, NGOs, the public, and international groups in making this
evaluation.
There are several research areas that the Board believed were in need of greater
emphasis. Briefly, they include:
Long-term research to support the shift toward the new toxicity testing
paradigm, such as the development of in silico methods to predict
metabolism, addressing the issue of exposure duration in designing the
high throughput tests, test strategies to ensure that novel agents from
poorly studies chemical classes are adequately characterized, and
epidemiological surveillance to support data interpretation;
Research on methodologies for developing IRIS guidance levels (from
non-apical endpoints) for chemicals that have sparse data sets.
Work to evolve the Agency's hazard identification and dose response
practices and Guidance guidelines to keep pace with the emergence of
data from new types of toxicity tests.
Epidemiological surveillance, particularly emphasizing the interactions
of genes, lifestyle and environmental chemicals to gain a better
understanding of "background additivity" and how to interpret results
of the emerging high throughput tests.
These are further described in Attachment 1 to this Appendix.
2.5.1 Human Health research provides fundamental information to improve our
understanding of and to predict levels of human health effects associated
with environmental agents that are managed through a variety of statutory
mandates. Research themes in this program focus on: 1) developing data,
methods and models for risk assessment; 2) research to characterize
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aggregate and cumulative risk; 3) research on susceptible subpopulations;
and 4) research to evaluate the public health impact of environmental
decisions. Historically, Human health research focused on biological
mechanism of toxicity, cumulative effects associated with exposures,
understanding susceptible subpopulations, the internal factors associated
with vulnerability, life stages in relation to vulnerability, and the evaluation
of public health outcomes. A recent NAS report (NAS, 2007) has made it
clear that additional emphasis is needed on the development of new ways to
characterize and predict toxicity. In addition, EPA's desire to continue to
improve its "Report on the Environment" requires research for evaluating
the effectiveness of decisions targeting public health (SAB, 2007a).
The key directions of ORD's current research program in this area include
(Teichman, 2007a):
Establish relationships between environmental decisions and changes in
health indicators.
Focus on characterizing toxicity pathways for dose-response and
extrapolation models for risk assessment.
SAB Comments: Long term research focused on both of the key research
directions is needed but should not sacrifice critical research efforts
addressing sensitive populations and understanding their vulnerability. The
main goals for the new initiative in toxicity testing approach are expected
to achieve results in the 10 to 20 year time frame. Nearer term, research
outputs are needed to support program office needs in cumulative and
aggregate risk assessment, and to support characterizations of human
susceptibility and variability to develop more scientific approaches for
modeling dose response relationships. Also, methods are needed to take
existing test data to the next step to enable better predictions especially for
chemicals with non-apical endpoint data or limited data sets, as discussed
in Attachment 1 to this Appendix. Community level risk assessment can
better direct regulatory focus and depending on the nature of the
assessment tool provide a conduit for stakeholder involvement in decision-
making. There is an increasing need for tools that can be used by
communities. On the ground for particular problems, collaborations
between an EPA Region and local authorities in both risk assessment and
risk management aspects can be important, but on a research level tools
developed by agency would help facilitate efforts in the field.
To the extent that the program is continuing to support methods to
characterize variability, susceptibility and cumulative risk, this should be
stated explicitly for the sake of transparency and clarity. This should be
done both internally for organizing EPA efforts and during external
evaluations. It is not clear whether the repackaging of the research
portfolio presented by the Agency represents a shift in program focus away
from some of the critical nearer term objectives.
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2.5.2 Computational Toxicology research develops enhanced tools for
prioritization of hazards, and improved methods for quantitative risk
assessment. Traditional methods can not keep pace with the current
demands for hazard and risk evaluations, thus methods employing modern
tools of molecular biology, information management, and computational
models are being developed to identify, characterize hazard and risk
quicker, cheaper and in a more scientifically robust way. Objectives of the
program are to improve our understanding of the link between chemical
sources and adverse health outcomes; to provide predictive models for
screening and testing; and to improve quantitative risk assessment by
providing a better understanding of basic mechanisms and their underlying
biology (SAB, 2007a).
The key directions of ORD's current research program in this area include
(Teichman, 2007a):
Provide predictive models for screening and testing of chemicals to
improve source-to-outcome linkages.
Develop new approaches and technologies to better predict a
chemical's hazard, and identify toxicity testing priorities.
Develop new systems biology models, such as the virtual liver.
SAB Comments: The SAB believes that this program continues to be
headed in the right direction. The objectives of providing predictive
models for screening and testing chemicals, developing new approaches
and technologies for predicting chemical hazard and testing priorities and
developing new systems biology models such as the virtual liver are
reasonable objectives to advance toxicity testing and predictive biology
within the agency. Ultimately, a large research effort will be needed to
fully realize the NAS toxicity testing vision so that the testing strategy can
serve as the basis for most agency assessments. This can not be
accomplished by elements reflected in the current research strategy. The
Computational Toxicology Research Program is taking the first steps to
build capacity and collaborations and to lay down initial work for proof of
concept. The Board heard about the Agency's efforts to ensure that data
supporting the work of the Program was publicly available on-line and the
SAB compliments the Program for overcoming the obstacles to make this
happen.
2.5.3 Endocrine Disrupters research improves our understanding of chemicals
that interact with the endocrine system. Research has been conducted to: 1)
develop methods, models and measures for understanding and managing
risks from endocrine disrupting chemicals (EDCs); 2) apply these methods
to determine the extent of endocrine disrupter impacts to humans and
wildlife; and 3) support the EPA screening and testing program on EDCs
mandated by the Food Quality Protection Act and the Safe Drinking Water
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Act Amendments. Over the last five years, the program has increased its
emphasis on research to characterize sources and occurrences of EDCs
(SAB, 2007a).
The key directions of ORD's current research program in this area include
(Teichman, 2007a):
Complete development of protocols for EDC screening and testing
assays.
Improve understanding of EDCs' mechanisms of action, dose response,
and cumulative risk issues.
Develop exposure assessment and risk management tools to
characterize and reduce exposure to EDCs.
SAB Comments: This program has been focused on completing the
screening and testing assays, and is well along in this effort. The SAB
agrees with the phase down for Tier I test development and suggests a
greater attention to support hazard identification and explore how dose
response can be characterized based on less than ideal data sets. The SAB
also suggests exploring methods for estrogen and androgen compounds
considering "background" exposures and exploring cumulative risk
assessment approaches given background levels. The Agency might
explore developing TEF approaches for several classes of compounds.
2.5.4 Human Health Risk Assessment. This research program is at the
forefront of applying quantitative methods advances to risk assessments
(e.g., use of physiological based pharmacokinetic (PBPK) models to reduce
uncertainty in risk extrapolations or to replace default uncertainty factors).
The program maintains its leadership role in incorporating mode of action
evaluations to support decision-making. Products of the program include
IRIS assessments, Integrated Science Assessments (ISAs), and other
assessments that respond directly to Program Office needs and are primary
considerations in Agency actions to protect human health and the
environment. Human Health Risk Assessment (HHRA) also incorporates
contemporary science advances into agency practice to improve risk
assessment methods, models, and guidance for other EPA offices (SAB,
2007a).
The key directions of ORD's current research program in this area include
(Teichman, 2007a):
Continue to support IRIS profiles, PPRTVs, and other priority
assessments.
Develop methods, models, and guidance for improved health risk
assessments.
Conduct integrated science assessments for ambient air pollutants.
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SAB Comments: The SAB recognizes that this as one of EPA's "bread
and butter" research programs. The SAB supports the three objectives in
this research area and notes that there is an opportunity for developing and
incorporating new approaches for sparse data sets to expand the capacity to
develop guidance values. Staff in this research program should therefore
collaborate closely with those in the Human Health Research program in
these efforts. In addition, to have better assurance that sensitive populations
are adequately addressed, collaboration between these programs is also
needed to develop a better understanding of how to approach the use of
variability assumptions in risk assessment. EPA should also consider
better integration of HHRA with its Endocrine Disrupter Program to
develop Reference Doses (RfDs) for chemicals with less than optimal data
sets.
The SAB notes its concern with delays and challenges posed by OMB
reviews. The SAB encourages the EPA to make use of suggestions
provided in the recent NAS document (NAS 2008) on reviewing research
efficiencies to improve their ability to work with OMB in a more efficient
manner. The SAB sense is that OMB has a very limited scientific review
capacity and EPA needs to find improved ways of addressing these delays.
One way is to work with OMB to develop a sufficient level of comfort so
that OMB will increasingly rely on EPA's own document review
processes.
2.5.5 Safe Pesticides and Products research supports the problem-driven
science needs of EPA's Pesticides and Toxic Substances programs. Safe
Pesticides and Safe Products research tends to focus on high priority
science needs that are not addressed by other research programs and work
on both human health issues and ecological issues. The program's long-
term goals focus on: 1) developing methods, models and data as the
scientific foundation for prioritizing test requirements, enhancing data
interpretation, and improving decision-making; 2) developing probabilistic
risk assessments focused on natural populations of birds, fish, other
wildlife, and plants; and 3) conducting research to provide the scientific
foundations for decision-making on biotechnology products (SAB, 2007a).
The key directions of ORD's current research program in this area include
(Teichman, 2007a):
Develop predictive tools for chemical prioritization and testing
requirements, and enhanced interpretation of exposure and toxicity
studies.
Develop mathematical models for integrating dose-response and habitat
relationships for wildlife population and plant communities.
Develop approaches to assess allergenicity potential from GM crops
and to assess the risks of gene flow from GM crops.
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SAB Comment: The SAB believes that this research area has reasonable
objectives. However, there is a need for greater emphasis on toxicity tools
to enable migration to safer products based on human, as well as ecological
systems, health protection.
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ATTACHMENT 1: ADDITIONAL DISCUSSION
1. Detailed Recommendations Technology for Sustainability Research Program
(See Appendix A, Subsection 2.2.2, Page A-8)
a) Clearly define the intended audience(s): It appeared to the review team that
the ultimate objective of this research is to develop improved information, tools
and approaches that will lead to changes in behavior. The intended audience or
audiences (e.g., Agency, firms, and individuals) from which such behavior change
is expected is not clear and needs to be more explicit. For example, who are
EPA's "clients" as mentioned in paragraph 5 under section "Making a
Difference"?
b) Behavior and decision science research is needed: The concept of
sustainable development has an implicit element of people or organizations
making decisions that lead to behaving in a manor such that their actions do not
diminish environmental conditions resulting in either current impacts to human
health or the environment nor reduce opportunities for use of that environment by
future generations. Therefore, the area of behavioral and decision sciences should
play an important role in helping EPA develop tools and information to aid such
sustainable practice by individuals and organizations. The current research
strategy does not reflect a focus on behavioral or decision science and the
designers should revisit this area for research opportunities. Although the agency
is planning to work on decision support tools such as life-cycle assessment (LCA)
this is not the same as research on how and why people or organizations make
decisions with regard to Sustainability. Such behavioral research should not only
address whether behavior is elicited but also if once elicited it is leads to positive
improvements.
c) Establish (or clearly define) linkage to other Research areas and
programs: Sustainability as a research area is truly cross-cutting at it core.
Although the research strategy overview provided to the SAB indicates a degree
of cross linkage in planning with other ORD areas, the SAB recommends a
systematic and thorough planning effort that cross-links Sustainability research
with other programs. Examples of opportunities for such cross planning include:
Revitalization of contaminated lands (economics and Land restoration)
Effectiveness of TMDLs (economics and water)
Managing water quantity (water-Global change- Sustainability)
In addition, the agency should be taking a fresh page on this research. Don't just
repackage former areas such as "land preservation" go beyond land contamination
to management to avoid reduction in ecological services and or other human
health services.
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d) Go beyond Technology - green chemistry and pollution prevention: Eg
Research on Smart growth; sustainable cities.
e) LCA tools don't incorporate directly what matters to people so they can't
incorporate value or benefits. The review team also supports EPA's move
towards taking a "systems" approach to environmental management. To this we
note ORD's interest in focusing on tools based on LCA techniques. The review
group cautions that the typical system boundaries and the inputs and out-puts of
such analysis do not include any consideration of the benefits or the costs
associated with the process or system under review. LCA as currently practiced is
an excellent planning and design aid to manage raw material consumption,
energy, hazard and waste production but it should not be relied on for integrated
management decisions or balancing trade-offs among benefits without further
development. It would be exciting and important if the agency can identify
opportunities to integrate or couple LCA, and similar tools, with economic or
valuation techniques.
f) Need for a clear definition of the sustainable condition or future state the
agency desires to maintain or achieve. Sustainability, or its stated operational
objective, sustainable development, has a variety of meanings depending on the
audience that considers the term. Therefore, it seems essential that the agency
start its Sustainability effort by defining in specific systems terms the operating
condition it plans to protect or restore. For example, water quality is generally
defined in terms of expected or designated uses such as fishable, swimable or
drinkable. If such conditions were attained, would EPA deem these systems to be
sustainable? If so, what metric would the agency use to track Sustainability? To
the degree that the agency can specifically define the acceptable operating
conditions for any specific environmental regime, it will assist itself in identifying
sustainable metrics and designing Sustainability tools to support sustainable
practice for that regime. The definition of an environmental regime is itself in
question. Historically one might that appropriate regimes are air, water and land,
but if one attempts to manage a river or a lake, sustainable outcomes will not be
achieved if the interfaces of land and air with that water body are not part of the
management strategy and design of sustainable practices. The SAB does not
suggest that this will be easy, or even how this might be done, but EPA should
work diligently to do a conceptual mapping or otherwise the breakthrough
expected from the Sustainability research will not yield the needed behavioral
changes that achieve sustainable conditions.
There may be value for EPA if it were to develop a vision of sustainable
conditions in collaboration with other agencies that have complimentary
responsibilities for land (e.g. USDA/NRCS), and water (e.g. USGS and ACOE).
g) Explore developing a bridge between risk and performance to achieve
Sustainability: The risk assessment paradigm is a core management
conceptualization for EPA, and for that matter most of the entities it regulates. If
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the Agency plans to lead the nation to a higher state of environmental
management performance, then it must build a bridge of understanding between
the risks associated with the stressors it manages and how they link to functional
process and the benefits associated with those processes. So in ecological terms
this would mean linking chemical, physical or biological stressor loads to
predicted adverse ecological responses in functional ecological processes which
are ultimately linked to the ecological services humans enjoy from a landscape. If
the agency succeeds in establishing this analytical chain then it can test and
understand the implications of risk management to ecological performance
sustainability. This would suggest the agency should be trying to move beyond
the management of individual agents to the management of environmental
regimes or landscapes (e.g. lakes, rivers, forests, cities etc.) based on their actual
condition or performance.
The Agency should test the assumption that following a risk assessment/risk
reduction strategy can lead to defining sustainability tools and achieve sustainable
practices. The SAB believes that sustainability is tied to an expected set of
performance criteria and the absence of unacceptable risk or risk reduction to
acceptable levels is no guarantee of a sustainable outcome. The extreme but very
real example of controlling ecological risks by removing the forest to get to the
underlying contaminated soil highlights a use of risk assessment that is not framed
in a sustainability context. If the Agency wants to achieve sustainable
management of contaminated sites it will need to put risk projections into the
context of actual ecological conditions which should be held up against a
definition or set of design criteria of sustainable condition for the ecological
habitat in question. Clearly, this means that data collected on sites must include
data on ecological conditions and not just levels of contamination. This example
is intended to illustrate the need to understand how the risk paradigm aligns with
the type of decisions to be made, and that the current practice used to conduct
regulatory reviews and reach decisions (e.g. data we collect) may need to evolve
within the policy context of sustainability rather than risk control.
2. Additional Research Topics For the Human Health Area
(See Appendix A, Subsection 2.5, Page A-17 forward)
What follows outlines important areas of research that could be given increased emphasis
in the general research area of human health, and then briefly comments on research by
individual groups or laboratories as described in the October 2 Compilation and captured
in bullets in Deputy Assistant Administrator Teichman's presentation.
a) Long-Term Research to Support Toxicity Testing Paradigm Shift. In
support of the new toxicity testing initiative, various areas for increased
emphasis were noted. These include:
Predicting metabolism: Development of strategies to support identification
and characterization of possible active metabolites in humans and breakdown
products. This is a critical area for research because failure to miss important
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metabolites can lead to missing toxic activities and under-predicting human
risk.
Addressing exposure duration: Rapid high throughput tests of exposed cells
and cell components will eventually be used to shed light on the consequence
of complex, long term human exposures - by their nature reflecting real life
exposure of cells at various ages to a wide spectrum of various endogenous
and exogenous chemicals.
Addressing novel agents: An understanding of the extent that the tests capture
the behavior of agents that fall outside the chemical sets used to develop the
assays, and approaches to address novel agents will be needed.
Epidemiologic surveillance: A critical piece for predicting human toxicity
from high throughput test results for a chemical exposure will be an
understanding of other exogeneous and endogenous exposures that perturb the
same toxicological process, the degree of human exposures to them, and the
variable human responses to such exposures. Research is needed to support
the development of human surveillance strategies to provide the needed
human data to interpret high throughput findings.
The NAS (2007) Toxicity Testing report notes these and a variety of other
research areas that require attention in order to support the development of
toxicity test batteries for wide use - to address the large number of environmental
chemicals that are not now tested for lack of resources and rapid methods. The
NAS envisioned a large scale research venture over many years to bring the
testing vision to fruition, involving an NTP-like effort in terms of scale. The
Agency's impressive but necessarily modest effort to move forward and gain
experience and capacity in the area is noted. As the Agency by itself and in
collaboration with other Federal agencies and institutions makes progress in its
research, it is encouraged to turn frequently to the scientific community through
the SAB and other scientific expert groups to optimize its research effort in this
area.
b) Research to Develop Numerical (IRIS) Guidance Levels for Chemicals
with Limited Apical Endpoint Test Data. Chemicals go uncharacterized
because data from classical toxicity test results (e.g., long term bioassays) are not
available. In some cases, in vitro and metabolic studies and other data would
enable the prediction of toxicity endpoints and levels. One example where the
Agency does make quantitative activity estimates and estimates risk in the
absence of full bioassay data is dioxin-like compounds based on toxic
equivalency factors. Research is needed to support the application of this
approach to other chemical classes. In the long term approaches will be needed to
develop guidance levels based on data emerging from the toxicity testing vision
discussed above. Nearer term research can enable the Agency to move forward
on chemicals using short term in vivo and in vitro data and structure activity
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relationships. This kind of information can be quite valuable in supporting green
chemistry and other initiatives aimed at moving toward using less toxic materials.
c) Evolving Agency Hazard Identification and Dose Response Practice and
Guidance as New Test Data Emerge. Clearly there is a need to evolve risk
assessment techniques and practice as the practice of toxicity testing changes.
With the exception of pesticides, there are significantly fewer chronic studies
being performed today than twenty years ago. REACH promises to produce large
volumes of toxicity data, but many chemicals are likely to have non-classical
toxicity tests, particularly given the REACH guidance to where possible minimize
the use of animals. Agency guidance and practice needs to evolve to take
advantage of the available toxicity data, particular in cases where chemicals go
uncharacterized. While the Carcinogen Guidelines and Supplemental Guidance
did advance over previous versions, they were long in coming, and the
International Agency for Research in Cancer has now developed guidance that is
considered by some to be more up to date. There is a research component to
develop new practice - new methods need to be developed to capitalize on
findings, and sensitivity and specificity of the new approaches need to be
understood in a general sense. It is recognized that development and incorporation
of new approaches to chemical hazard and dose response prediction are
challenges for a variety of practical reasons. Predictability of agency response to
particular types of test data, consistency across chemicals in methods of analysis,
and the need for researchers to have the skill set and understanding to replicate
analyses all come into play in maintaining the status quo. On the other hand when
there are exposures to apparently toxic agents that go uncharacterized and are not
included in risk assessments, or better replacement chemicals are harder to
identify, or agency assessments appear out of step with the science, opportunities
for better decision-making are lost and agency credibility suffers.
d) Epidemiological Research: Surveillance, Understanding Gene-Lifestyle-
Environment Interactions. The SAB saw in-house capacity in the area of
epidemiologic research limited to a few specialized areas. Most of the long term
research is "bottom up" in nature, with the long term goal of inferring risks and
effects in individuals from mechanistic understanding and data. "Top down" look
at exposures and disease can be used to quantitatively generate as well as check
hypotheses. It can also help to develop more scientifically rigorous basis for
individual variability assumptions used in dose response analyses. Also,
epidemiologic understanding of endogenous and exogenous exposures and health
status should prove critical in applying the results of high throughput screening to
individuals and populations. Molecular epidemiology is key to identifying
relationships between specific diseases and genes. Disease pathways can be
discovered through associations between genes in susceptible individuals and
diseases. An understanding of background processes and exposures is also
critical to understanding the potential for linear dose response relationships due to
"background" additivity. The Board supports the partnerships EPA has
developed with agencies such as CDC in health tracking and biomonitoring, as
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well as the extramural research conducted to support the assessment of the criteria
air pollutants and cumulative risk assessment. Still, greater in-house capacity
including at a senior level could provide a public health and epidemiologic
perspective to the research program and potentially synergize activities in the
toxicity testing initiative.
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REFERENCES
Fischhoff, Baruch (2005). "Cognitive Processes in Stated Preference Methods." Chapter
18. Handbook of Environmental Economics. Volume 2. Ed. K.G. Maler and J.R.
Vincent. ElsevierB.V.
Fischhoff, Baruch (2007). "Nonpersuasive Communication about Matters of Greatest
Urgency: Climate Change." Environmental Science and Technology. Volume 41.
pp.7204-7208.
NAS (2000). Strengthening Science at the U.S. Environmental Protection Agency.
Research-Management and Peer-Review Practices. National Academy of
Sciences, National Research Council. National Academy Press, 155 pp.
NAS (2007). Toxicity Testing in the Twenty-first Century: A Vision and a Strategy.,
National Academy of Sciences, National Research Council, Committee on
Toxicity testing and Assessment of Environmental Agents. Board on
Environmental Studies and Toxicology.
NAS (2008). Evaluating Research Efficiency in the U.S. Environmental Protection
Agency. National Academy of Sciences, National Research Council, Committee
on Evaluating the Efficiency in the U.S. Environmental Protection Agency. Board
on Environmental Studies and Toxicology.
SAB (2006). "Science and Research Budgets for the U.S. Environmental Protection
Agency for Fiscal Year 2007; An Advisory Report of the Science Advisory
Board." March 30, 2006. EPA-SAB-ADV-06-003.
SAB (2007). "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." March 13, 2007. EPA-SAB-07-004.
SAB (2007a). "Compilation of EPA ORD Research Program Descriptions," Compiled
by US EPA Science Advisory Board Staff Office, October 2, 2007 from
individual descriptions provided by National Program Directors from EPA's
Office of Research and Development in support of the October 3-5, 2007 Science
Advisory Board meeting. 92 pp.
SAB (2008). SAB Advisory Report "Preparing for Environmental Disasters." October
24, 2008, EPA-SAB-09-002.
Tapscott, D. and A. D. Williams, "Wikinomics : how mass collaboration changes
everything," Portfolio, New York, 351pp, 2008
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Teichman, K. (2007a). "Strategic Research Directions. Presentation to the EPA Science
Advisory Board. October 4, 2007 PowerPoint presentation of Dr. Kevin
Teichman to the US EPA SAB. 16 pp.
US EPA (2006a). 2006-2011 EPA Strategic Plan: Charting Our Course. US
Environmental Protection Agency, September 30, 2006. Washington, DC. 180 pp.
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