UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C. 20460
OFFICE OF THE ADMINISTRATOR
SCIENCE ADVISORY BOARD
September 28, 2012
EPA-SAB-12-012
The Honorable Lisa P. Jackson
Administrator
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, N.W.
Washington, D.C. 20460
Subject: Implementation of ORD Strategic Research Plans: A Joint Report of the Science
Advisory Board and ORD Board of Scientific Counselors
Dear Administrator Jackson:
The Science Advisory Board (SAB) and the Executive Committee of Office of Research and
Development (ORD's) Board of Scientific Counselors (BOSC) have strongly supported the
consolidation of EPA's research programs as part of an integrated transdisciplinary approach to research
that aligns with your priorities and takes a systems approach to sustainability. Over the past year, the
ORD has realigned its research into six new program areas: Air, Climate and Energy; Safe and
Sustainable Water Resources; Sustainable and Healthy Communities; Chemical Safety for
Sustainability; Human Health Risk Assessment; and Homeland Security Research. ORD requested that
the SAB and the BOSC provide advice on implementation of these new program areas. The SAB and
the BOSC agree that ORD has made remarkable progress towards integrated transdisciplinary research,
systems approaches and sustainability despite changes in leadership over the past year. The Strategic
Research Action Plans developed by ORD for its six research programs are important achievements.
These plans crystallize and communicate ORD's new approach to its mission.
There was general consensus that ORD has been highly responsive to previous advice from the SAB and
the BOSC, including advice on program restructuring provided by the SAB and the BOSC in 2011. The
Air, Climate and Energy; Safe and Sustainable Water Resources; and Chemical Safety for Sustainability
programs are making good progress on identifying and implementing a new vision for ORD research
that emphasizes sustainability, integration across programs and alignment with the EPA's goals. The
Human Health Risk Assessment, Homeland Security, and Sustainable and Healthy Communities
programs have also made progress but could benefit from further refinement of their vision and
implementation strategy.
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The SAB and the BOSC recommend that the EPA develop an implementation plan for each research
program that includes specific tasks and milestones. In some cases the EPA has listed all deliverables for
completion of a task as due in 2017. This makes it difficult to assess the interim progress that the EPA is
making towards completion of the task. While the SAB and the BOSC understand that implementation
plans are in development, the EPA should consider including a more detailed timeline with deliverables
for planned activities with specific milestones and/or intermediate deliverables. This would assist
reviewers in better understanding the anticipated rate of the EPA's progress towards achieving its
longer-term goals and plans.
ORD has wisely adopted a common definition of sustainability for all ORD programs. In addition,
however, research plans should identify more clearly how each ORD research program links to the
concept of sustainability and describe how the plans incorporate ecological health and human health into
the definition of sustainability.
We have identified several other major recommendations to strengthen ORD research across all six
programs. Sustainability research integrates social, economic, and environmental components, requiring
a greater commitment on the part of EPA to augment research in the natural sciences with social,
behavioral, and decision science research. The SAB and the BOSC provided advice in 2011 to help
ORD strengthen capabilities in this area, and we provide additional advice in this report. We recommend
that ORD coordinate research planning with EPA's National Center for Environmental Economics and
develop strategies to address the social, behavioral and decision science research needed to accomplish
the goals of ORD's major programs.
We recommend that ORD develop "roadmaps" depicting key linkages across ORD programs, linkages
to other EPA research programs, linkages to the research of partners outside EPA, and linkages to the
decisions EPA must make to address environmental problems. ORD has made a good start on such a
roadmap for its nitrogen work, which is built on a robust conceptual model.
ORD should build on its initial effort to develop strategic research action plans to link research activities
more clearly to the goals of research programs and their major themes. Consistent with this
recommendation, ORD should focus the next efforts of its innovation program on the major goals and
themes identified for its six research programs and use the innovation program to address some of their
most challenging research questions. There is a need for ORD to communicate more effectively the
findings and knowledge gained from ORD research and the value of that knowledge for the EPA and
other stakeholders. Understanding the relationships between the many benefits of ORD research and
environmental decisions can help focus research priorities.
The report attached provides recommendations to strengthen each research program. Some highlights
are listed below:
The Air, Climate and Energy program should include a plan for energy research and indicate
how this research will integrate with the plans for climate and air quality research.
The Chemical Safety for Sustainability program should demonstrate how its research products
impact upon end users (e.g., risk managers, policy makers) and how it brings value for informing
decisions.
The Safe and Sustainable Waters program should identify and seek opportunities for leveraging
research of other federal agencies and engage with communities in setting the program's
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research priorities and research development. Program linkages with sustainability, nutrient
management and green infrastructure are critical to the success of this program.
ORD should develop and implement a strategic vision for the Human Health Risk Assessment
program to enhance linkages among the program's four thematic areas and other research
programs, particularly the Chemical Safety for Sustainability program.
The Homeland Security Research Program, a valuable national resource, should evaluate its
potential contributions to sustainability and consider adopting a broader mission that considers
the multiple benefits of its products and application of its research to help respond to a wide
variety of environmental disasters.
The Sustainable and Health Communities program should focus its science questions and
research more clearly; articulate how it will interact with local communities, state environmental
agencies and regional offices; and clearly distinguish research from implementation of
environmental programs.
Finally, the EPA will be best equipped to address emerging environmental issues if the EPA's scientists
are at the frontier of environmental science. The best way to ensure that the agency is aware of the latest
trends and problems is to ensure that its scientists serve as leaders in research areas critical to informing
environmental decisions. ORD should strive wherever possible to craft its research so that it fulfills the
dual goals of meeting specific programmatic goals while also maintaining and expanding the Agency's
core capabilities in critical research areas.
The SAB and the BOSC congratulate ORD leadership at all levels for its continued commitment to
integrated transdisciplinary research, systems approaches and sustainability. We encourage the agency
to continue these efforts to promote research and science integration to inform decision making. We
look forward to any comments you have on these reflections regarding implementation of ORD's new
research directions.
Sincerely,
/Signed/ /Signed/
Dr. Deborah L. Swackhamer Dr. Katherine von Stackelberg
Chair Chair
Science Advisory Board ORD Board of Scientific Counselors
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NOTICE
This report has been written as part of the activities of the EPA Science Advisory Board (SAB) and the
Office of Research and Development (ORD) Board of Scientific Counselors (BOSC). The SAB is 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. The BOSC is also a
balanced, expert public advisory group. It provides extramural scientific information and advice to the
ORD Assistant Administrator. 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 or other agencies in the Executive Branch of the Federal government. Mention of
trade names of commercial products does not constitute a recommendation for use. Reports of the SAB
are posted on the EPA website at http://www.epa.gov/sab, and reports of the BOSC are posted on the
EPA website at http://www.epa.gov/osp/bosc.
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U.S. Environmental Protection Agency
Science Advisory Board
CHAIR
Dr. Deborah L. Swackhamer, Professor, Hubert H. Humphrey School of Public Affairs and Co-
Director of the Water Resources Center, University of Minnesota, St. Paul, MN
SAB MEMBERS
Dr. George Alexeeff, Acting Director, Office of Environmental Health Hazard Assessment, California
Environmental Protection Agency, Oakland, CA
Dr. David T. Allen, Professor, Department of Chemical Engineering, University of Texas, Austin, TX
Dr. Pedro Alvarez, Department Chair and George R. Brown Professor of Engineering, Department of
Civil & Environmental Engineering, Rice University, Houston, TX
Dr. Joseph Arvai, Svare Chair in Applied Decision Research, Institute for Sustainable Energy,
Environment, & Economy, Haskayne School of Business, University of Calgary, Calgary, Alberta,
Canada
Dr. Claudia Benitez-Nelson, Full Professor and Director of the Marine Science Program, Department
of Earth and Ocean Sciences, University of South Carolina, Columbia, SC
Dr. Patricia Buffler, Professor of Epidemiology and Dean Emerita, Department of Epidemiology,
School of Public Health, University of California, Berkeley, CA
Dr. Ingrid Burke, Director, Haub School and Ruckelshaus Institute of Environment and Natural
Resources, University of Wyoming, Laramie, WY
Dr. Thomas Burke, Professor and Jacob I and Irene B. Fabrikant Chair in Health, Risk and Society
Associate Dean for Public Health Practice, Johns Hopkins Bloomberg School of Public Health, Johns
Hopkins University, Baltimore, MD
Dr. Terry Daniel, Professor of Psychology and Natural Resources, Department of Psychology, School
of Natural Resources, University of Arizona, Tucson, AZ
Dr. George Daston, Victor Mills Society Research Fellow, Product Safety and Regulatory Affairs,
Procter & Gamble, Cincinnati, OH
Dr. Costel Denson, Managing Member, Costech Technologies, LLC, Newark, DE
Dr. Otto C. Doering III, Professor, Department of Agricultural Economics, Purdue University, W.
Lafayette, IN
Dr. Michael Dourson, President, Toxicology Excellence for Risk Assessment, Cincinnati, OH
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Dr. David A. Dzombak, Walter J. Blenko, Sr. Professor of Environmental Engineering , Department of
Civil and Environmental Engineering, College of Engineering, Carnegie Mellon University, Pittsburgh,
PA
Dr. T. Taylor Eighmy, Senior Vice President for Research, Office of the Vice President for Research,
Texas Tech University, Lubbock, TX
Dr. Elaine Faustman, Professor and Director, Institute for Risk Analysis and Risk Communication,
School of Public Health, University of Washington, Seattle, WA
Dr. John P. Giesy, Professor and Canada Research Chair, Veterinary Biomedical Sciences and
Toxicology Centre, University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Dr. Jeffrey K. Griffiths, Professor, Department of Public Health and Community Medicine, School of
Medicine, Tufts University, Boston, MA
Dr. James K. Hammitt, Professor, Center for Risk Analysis, Harvard University, Boston, MA
Dr. Barbara L. Harper, Risk Assessor and Environmental-Public Health Toxicologist, and Division
Leader, Hanford Projects, and Program Manager, Environmental Health, Department of Science and
Engineering, Confederated Tribes of the Umatilla Indian Reservation (CTUIR), West Richland, WA
Dr. Kimberly L. Jones, Professor and Chair, Department of Civil Engineering, Howard University,
Washington, DC
Dr. Bernd Kahn, Professor Emeritus and Associate Director, Environmental Radiation Center, Georgia
Institute of Technology, Atlanta, GA
Dr. Agnes Kane, Professor and Chair, Department of Pathology and Laboratory Medicine, Brown
University, Providence, RI
Dr. Madhu Khanna, Professor, Department of Agricultural and Consumer Economics, University of
Illinois at Urbana-Champaign, Urbana, IL
Dr. Nancy K. Kim, Senior Executive, Health Research, Inc. Troy, NY
Dr. Cecil Lue-Hing, President, Cecil Lue-Hing & Assoc. Inc. Burr Ridge, IL
Dr. Judith L. Meyer, Professor Emeritus, Odum School of Ecology, University of Georgia, Lopez
Island, WA
Dr. James R. Mihelcic, Professor, Civil and Environmental Engineering, University of South Florida,
Tampa, FL
Dr. Christine Moe, Eugene J. Gangarosa Professor, Hubert Department of Global Health, Rollins
School of Public Health, Emory University, Atlanta, GA
in
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Dr. Horace Moo-Young, Dean and Professor, College of Engineering, Computer Science, and
Technology, California State University, Los Angeles, CA
Dr. Eileen Murphy, Director of Research and Grants , Ernest Mario School of Pharmacy, Rutgers
University, Piscataway, NJ
Dr. James Opaluch, Professor and Chair, Department of Environmental and Natural Resource
Economics, College of the Environment and Life Sciences, University of Rhode Island, Kingston, RI
Dr. Duncan Patten, Research Professor, Hydroecology Research Program , Department of Land
Resources and Environmental Sciences, Montana State University, Bozeman, MT
Dr. Stephen Polasky, Fesler-Lampert Professor of Ecological/Environmental Economics, Department
of Applied Economics, University of Minnesota, St. Paul, MN
Dr. C. Arden Pope, III, Professor, Department of Economics, Brigham Young University, Provo, UT
Dr. Stephen M. Roberts, Professor, Department of Physiological Sciences, Director, Center for
Environmental and Human Toxicology, University of Florida, Gainesville, FL
Dr. Amanda Rodewald, Professor of Wildlife Ecology, School of Environment and Natural Resources,
The Ohio State University, Columbus, OH
Dr. Jonathan M. Samet, Professor and Flora L. Thornton Chair, Department of Preventive Medicine,
Keck School of Medicine, University of Southern California, Los Angeles, CA
Dr. James Sanders, Director and Professor, 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. Gina Solomon, Deputy Secretary for Science and Health, Office of the Secretary, California
Environmental Protection Agency, Sacramento, CA
Dr. Daniel O. Stram, Professor, Department of Preventive Medicine, Division of Biostatistics,
University of Southern California, Los Angeles, CA
Dr. Peter Thorne, Professor and Head, Occupational and Environmental Health, College of Public
Health, University of Iowa, Iowa City, IA
Dr. Paige Tolbert, Professor and Chair, Department of Environmental Health, Rollins School of Public
Health, Emory University, Atlanta, GA
Dr. John Vena, Professor and Department Head, Department of Epidemiology and Biostatistics,
College of Public Health, University of Georgia, Athens, GA
Dr. Robert Watts, Professor of Mechanical Engineering Emeritus, Tulane University, Annapolis, MD
iv
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Dr. R. Thomas Zoeller, Professor, Department of Biology, University of Massachusetts, Amherst, MA
LIAISON MEMBERS
Board of Scientific Counselors
Dr. Katherine von Stackelberg, Research Manager, Harvard Center for Risk Analysis, Harvard
School of Public Health and Principal, E Risk Sciences, LLP, Boston MA
Children's Health Protection Advisory Committee
Dr. Pamela Shubat, Supervisor, Health Risk Assessment, Minnesota Department of Health, St.
Paul, MN
FIFRA Scientific Advisory Panel
Dr. Daniel Schlenk, Professor, Department of Environmental Sciences, University of California,
Riverside, CA,
SCIENCE ADVISORY BOARD STAFF
Dr. Angela Nugent, Designated Federal Officer, U.S. Environmental Protection Agency, Science
Advisory Board
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U.S. Environmental Protection Agency
Office of Research and Development (ORD)
Board of Scientific Counselors (BOSC) Executive Committee
CHAIR
Dr. Katherine von Stackelberg, Research Manager, Harvard Center for Risk Analysis, Harvard School
of Public Health and Principal, E Risk Sciences, LLP, Boston MA
BOSC MEMBERS
Dr. Edward W. Carney, Associate Director, Predictive Toxicology, The Dow Chemical Company,
Ann Arbor, MI
Dr. Susan E. Cozzens, Professor and Associate Dean for Research, Ivan Allen College, School of
Public Policy, Georgia Institute of Technology, Atlanta, GA
Dr. Lisa Dilling, Assistant Professor, Environmental Studies, Center for Science and Technology
Policy, Cooperative Institute for Research in Environmental Science, University of Colorado, Boulder,
Colorado
Dr. Henry Falk, Consultant, U.S. Dept. Health and Human Services, Centers for Disease Control and
Prevention, Atlanta, GA
Dr. Charles N. Haas, L.D. Betz Professor of Environmental Engineering, Department of Civil,
Architectural, and Environmental Engineering, Drexel University, Philadelphia, PA
Dr. Earthea A. Nance, Assistant Professor, Department of Planning and Urban Studies, University of
New Orleans, New Orleans, LA
Dr. Diane E. Pataki, Associate Professor of Ecology and Biology, Urban Ecology Research
Laboratory, Department of Biology, University of Utah, Salt Lake City, UT
Dr. Dennis J. Paustenbach, President, ChemRisk, Inc. San Francisco, CA
Dr. Rosemarie Szostak, Technology Analyst, Nerac, Inc. Tolland, CT
Dr. John P. Tharakan, Professor and Director, Biochemical and Bioenvironmental Research
Laboratory, Department of Chemical Engineering, Howard University, Washington, DC
Dr. Russell S. Thomas, Director, Center for Genomic Biology & Bioinformatics, The Hamner Institutes
for Health Sciences, Research Triangle Park, NC
Ms. Marie E. Zhuikov, Science Communicator, University of Wisconsin Sea Grant Institute, Superior,
WI
VI
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BOARD OF SCIENTIFIC COUNCELORS STAFF
Mr. Greg Susanke, Designated Federal Officer, Office of Research and Development
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TABLE OF CONTENTS
Acronyms and Abbreviations ix
1. BACKGROUND AND CHARGE 1
2. GENERAL FINDINGS AND OVERARCHING RECOMMENDATIONS 2
2.1. INTRODUCTION 2
2.2. FIRST YEAR PROGRESS 2
2.3. SUSTAINABILITY 3
2.4. BALANCING IMMEDIATE PROGRAM NEEDS AND EMERGING ISSUES 4
2.5. INTEGRATION 5
2.6. INNOVATION 7
3. RECOMMENDATIONS FOR SPECIFIC RESEARCH PROGRAMS 10
3.1. AIR, CLIMATE AND ENERGY 10
3.2. CHEMICAL SAFETY FOR SUSTAINABILITY 13
3.3. HUMAN HEALTH RISK ASSESSMENT 17
3.4. SAFE AND SUSTAINABLE WATER RESOURCES 26
3.5. HOMELAND SECURITY 29
3.6. SUSTAINABLE AND HEALTHY COMMUNITIES 32
REFERENCES R-l
APPENDIX A: CHARGE TO THE SAB AND THE BOSC A-l
APPENDIX B: REFERENCES ON INNOVATION IN RESEARCH B-l
Vlll
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ACE
ATSDR
BOSC
CRTS
CSS
EDSP
FTTA
HHRA
HSRP
IRIS
ISA
ORD
QSAR
SAB
SHC
SSWR
Acronyms and Abbreviations
Air, Climate and Energy
Agency for Toxic Substances and Disease Registry
Board of Scientific Counselors
Community Risk and Technical Support
Chemical Safety for Sustainability
Endocrine Disrupters Screening Program
Federal Technology Transfer Act
Human Health Risk Assessment
Homeland Security Research Program
Integrated Risk Information System
Integrated Science Assessment
Office of Research and Development
Quantitative structure-activity relationship models
Science Advisory Board
Sustainable and Healthy Communities
Safe and Sustainable Water Resources
IX
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1. BACKGROUND AND CHARGE
In 2012, the EPA Office of Research and Development (ORD) developed strategic research action plans
for its six research areas and an overview plan after receiving advice from the Science Advisory Board
(SAB) and Board of Scientific Counselors (BOSC) (U.S. EPA SAB 201 la) on the research framework
documents. The restructured research programs comprise six program areas: Air, Climate, and Energy;
Safe and Sustainable Water Resources; Sustainable and Healthy Communities; Chemical Safety for
Sustainability; Human Health Risk Assessment; and Homeland Security. ORD requested additional
advice in 2012 on ORD's research implementation plans (strategic research action plans), efforts to
strengthen program integration, and efforts to strengthen and measure innovation.
The SAB and the BOSC held a public meeting on July 10-11, 2012, to discuss the strategic research
action plans, information about five integration topics presented by ORD (nitrogen; global climate
change; children's health/environmental justice; applying new chemical assessment approaches in
human health risk assessment; and endocrine-mediated dose-response) and ORD efforts to encourage
research innovation. The SAB and the BOSC also held a public teleconference on September 19, 2012
to discuss a draft of this report.
ORD requested the SAB and the BOSC to address a series of charge questions provided in Appendix A.
The charge included questions related to first year progress, sustainability and balancing immediate
needs and emerging issues for each of the major research areas; specific questions for each program
area; and questions pertaining to integration and innovation in ORD programs.
Section 2 provides an overview of general findings and recommendations, applicable to all the research
programs, related to the charge questions below. Section 3 provides program-specific findings and
recommendations and responses to the program specific charge questions. ORD research programs
appear in section 3 in the order they were discussed during the face-to-face meeting on July 10-11, 2012.
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2. GENERAL FINDINGS AND OVERARCHING RECOMMENDATIONS
2.1. Introduction
The SAB and the BOSC have strongly supported the consolidation of research programs to align with
the EPA Administrator's priorities and to reflect an integrated, transdisciplinary approach to research
that takes a systems approach to sustainability (U.S. EPA SAB 201 la and 201 Ib). Because this
approach is new and will require significant changes in ORD's approach to research, the SAB and the
BOSC welcomed the opportunity to review ORD's plans to implement its new programs.
2.2. First year progress
How are the ORD research programs progressing in the first year of implementation? Are the
research activities planned for FY13 and future years appropriate for answering the science
questions in the Strategic Research Action Plan?
2.2.1. Response
ORD developed Strategic Research Action Plans for each of the six major research programs (US EPA
2012a, 2012b, 2012c, 2012d, 2012e, 2012f). Creation of these well-structured plans marks major
progress for the first year of implementation of ORD's new research program. The plans communicate a
central problem statement for each research program and (except for the Homeland Security Program,
which has a unique mission and mandate) the program vision. Each plan also briefly describes how the
ORD research supports the EPA's priorities and mandates. Each plan describes the program's efforts to
integrate across ORD research programs and collaborate with research partners within the EPA and with
external organizations. The plans identify research themes and priority science questions. They provide
a summary table of major research outputs and expected outcomes by theme.
The Strategic Research Action Plans vary in detail and effectiveness in how they communicate the
overall vision of particular programs and how that vision would be achieved. The differences across the
plans make it difficult to answer the question about first year progress collectively. The plans are most
useful when they clearly identify deliverables and outputs with specific milestones for achieving desired
outcomes. Section 3 of this report provides more detail on each research program. The Air, Climate and
Energy; Safe and Sustainable Water Resources; and Chemical Safety for Sustainability programs are
making good to very good progress on identifying and implementing a new vision for ORD research that
emphasizes sustainability, integration across programs and alignment with the EPA's goals. The Human
Health Risk Assessment, Homeland Security, and Sustainable and Healthy Communities programs have
also made good progress but could benefit from further refinement of their vision and implementation
strategy. ORD has wisely adopted a common definition of sustainability across all ORD programs.
Research plans, however, should identify more clearly how each ORD research program links to the
concept of sustainability and describe how the plans incorporate ecological health and human health into
the definition of sustainability.
The SAB and the BOSC recommend that the EPA develop an implementation plan for each research
program that includes specific tasks and milestones. In some cases the EPA has all deliverables for the
completion of a task scheduled for as late as 2017. This makes it difficult to assess the interim progress
that the EPA is making towards completion of the task. While the SAB and the BOSC understand that
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implementation plans are in development, the EPA should consider including a more detailed timeline
with deliverables for planned activities with specific milestones and/or intermediate deliverables. This
would assist reviewers in better understanding the anticipated rate of the EPA's progress towards
achieving its longer-term goals and plans.
2.2.2. Recommendations
ORD should consider including a more detailed timeline with deliverables for planned activities
for each research program with specific milestones and/or intermediate deliverables.
In future action plans, ORD should provide a comprehensive mapping of projects to goals, and
not just provide examples.
2.3. Sustainability
How are ORD programs contributing to sustainability through their research plans and activities?
What advice do the SAB and the BOSC have for each research program about advancing
sustainability in future research?
2.3.1. Response
All of the programs would benefit from defining sustainability more clearly and specifically for their
programs. Although the definition of sustainability from the National Environmental Policy Act
provides a common definition across programs, the SAB and the BOSC advise that ORD explain more
specifically what sustainability means to each research program and how those research goals will be
achieved.
The SAB and the BOSC suggest that strategic research action plans explicitly incorporate ecological
health as well as human health into the definition of sustainability.
Incorporating sustainability into research plans and activities will also require greater integration of
social, behavioral and decision science research in addition to the natural sciences. Investment in social
and behavioral sciences is needed to complement ORD's investments in ecological and human health
research. The SAB has repeatedly made the recommendation for increased inclusion of social and
behavioral sciences into ORD activities (U.S. EPA SAB 201 la and 201 Ib), and ORD has made some
progress, but the new focus on sustainability calls for an even greater level of effort. More projects are
needed, including some flagship projects that deliberately study the economic, social, and environmental
dimensions of sustainability. This will require more staff, including both junior (post-doc) and senior
researchers. In addition, more focus on systems science is needed. Finally, ORD should lead federal
agencies in studying and implementing the effectiveness of sustainable business practices at the scale of
a large distributed federal agency.
The SAB and the BOSC recommend that ORD should collaborate with other partners in the EPA,
including the National Center for Environmental Economics, to develop a social science research plan to
support sustainability research. A useful first step would be for ORD to plan a workshop on this topic
and seek SAB and BOSC advice in workshop planning. This workshop should address the integration of
the social and natural sciences necessary to achieve the goals of ORD's strategic research action plans
and build on past SAB and BOSC advice (U.S. EPA BOSC 2009; U.S. EPA SAB 201 la). Focusing on
ORD's five integration topics would also provide an opportunity to identify specific applications for
social, behavioral and decision sciences.
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If social scientists cannot be brought into ORD's research programs easily, ORD should take advantage
of avenues such as EPA's Science to Achieve Results fellowship program, the American Academy of
Arts and Sciences program, or EPA's Title 42 Authority to develop and acquire social science expertise.
2.3.2. Recommendations
Each ORD program should define more specifically what sustainability means within the
program context, and identify how each plan incorporates ecological and human health into the
definition of sustainability.
ORD should collaborate with other partners in the EPA, including the National Center for
Environmental Economics, to develop a plan to develop the social, behavioral and decision
science needed to support sustainability research and other goals identified in ORD's six major
research programs. A useful first step would be for ORD to plan a workshop on this topic and
seek SAB and BOSC advice in workshop planning.
2.4. Balancing immediate program needs and emerging issues
As we consider science for the future, while budgets continue to shrink, how should ORD balance its
commitments in the Strategic Research Action Plan with the need to advance science on emerging
issues?
2.4.1. Response
Although it will sometimes be difficult to separate basic, immediate research needs from emerging
research needs, ORD must identify and address significant emerging research needs. ORD has
demonstrated the flexibility and capability to make necessary changes in research plans from year to
year. The SAB and the BOSC encourage ORD to develop a structured approach (e.g., through a risk
portfolio analysis) to assess the relative priorities of emerging issues vis a vis existing and legacy
research activities.
A risk portfolio analysis approach to research and development management would involve the
evaluation of a portfolio of current and potential ORD projects to determine ORD's competitive
advantage, namely, areas where ORD is uniquely able to make progress on scientific issues important to
the EPA's mission. The BOSC has advised ORD to use decision science tools in a structured way to
plan its portfolio of research activities (U.S. EPA BOSC 2009). A specialized literature exists to
describe the institutional changes that would be necessary to make such an approach successful (NRC
1999; Youngblood et al. 2003; Serewitz and Thernstrom 2012). In addition to portfolio analysis, the
SAB and the BOSC recommend that ORD plan explicitly for the resources needed to advance
sustainability research, evaluating its current framework of client interactions to develop a roadmap for
future research.
Anticipatory research requires a strategy to identify and evaluate emerging issues. Equally important is
for ORD to assess what has contributed to slow responses in the past to identifying and conducting
research related to emerging / important issues. What permits the early detection of a signal before an
environmental problem reaches a critical state? What cultural, institutional, technical barriers to
detecting such signals have existed? ORD should undertake evaluative case studies to identify past
barriers to identifying and conducting research related to important emerging issues.
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Emerging issues will be better identified and anticipated if the EPA's scientists are at the frontier of the
science. The best way to ensure that the agency is aware of the latest trends and problems is to have
scientists who are leaders in research areas critical to informing environmental decisions. ORD should
strive wherever possible to craft its research such that it fulfills the dual goals of meeting specific
programmatic goals while also maintaining and expanding the Agency's core capabilities in critical
research areas.
The SAB and the BOSC realize that the EPA's mandates have become so broad, and science changes so
rapidly, that it is not possible for its staff to be the scientific leaders in every endeavor relevant to the
mission. Accordingly, it is also imperative that the agency continue to utilize the external scientific
community through a variety of avenues, from collaborative or sponsored research in specific areas to
the regular solicitation of input from its advisory groups on emerging issues.
ORD's transition toward greater integration across disciplines requires a considerable increase in staff
re-training and an enhanced culture of continual learning, which is expected to result in a more
diversified suite of skill sets across ORD. Integration creates more efficient networks of expertise that
can be more rapidly and effectively tapped when new issues arise. Integration also promotes cross-
fertilization of ideas and skill sets. Webinars, seminars, and short-courses can help keep staff abreast of
emerging issues. ORD should make training and development of its scientists a priority and seek new
ways to interact with colleagues outside the EPA through partnerships with other agencies and academic
institutions. These steps will enhance ORD's capacity to adapt to critical emerging issues even in a
fiscally lean environment.
2.4.2. Recommendations
ORD should develop a structured approach (e.g., through a risk portfolio or decision science-
based analysis) to assess the relative priorities of emerging issues vis a vis existing and legacy
research activities.
ORD should make training and development for ORD staff a priority and seek new ways to
interact with scientists outside the EPA through partnerships with other agencies and academic
institutions to keep staff on the frontier of science and alert to emerging issues.
ORD should strive wherever possible to craft its research such that it fulfills the dual goals of
meeting specific programmatic goals while also maintaining and expanding the agency's core
capabilities in critical research areas.
2.5. Integration
Based on the presentation of five integrated topics, what advice can the SAB and the BOSC provide
to help ORD succeed in integrating research across the ORD programs? How can different
approaches to integration help us achieve our research goals?
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2.5.1. Response
The SAB and the BOSC commend ORD for significantly improving how it integrates research across its
programs. ORD's consolidation of research into six major programs is a significant achievement and has
stimulated rapid progress. The five specific integration topics presented by ORD at the July 2012 SAB-
BOSC meeting (climate change; nitrogen; children's health and environmental justice; applying new
chemical assessment approaches in human health risk assessment; and nonmonotonic dose response
curve analysis) provide insightful examples of different ways to stimulate and encourage integration.
The nitrogen and climate change integration topics are excellent examples of the potential for integration
across program areas. ORD should define how other topics for integration will be identified, how
roadmaps are created, and how senior leadership teams with responsibilities for integration can be
assembled.
ORD could facilitate progress in the integrated research topics if it developed individual "roadmaps"
with goals and an outline of paths to those goals for each of the integrated research topics, similar to the
roadmap being developed for the nitrogen integration topic. In addition, the SAB and the BOSC
recommend that ORD develop a graphical framework for each integrated research topic that identifies
the various participating EPA programs and external agencies and groups, the distribution of
responsibilities, and how the various participants are linked to each other and to the research effort. This
framework should clearly identify the EPA program that would take the lead in the integrated research
effort.
The SAB and the BOSC offer the following additional suggestions to strengthen ORD's work on the
five integration topics:
Whenever possible, try to directly link ORD science to end users, such as regulators at the
regional, or program office level.
Highlight examples of successful integration. For example, in the children's
health/environmental justice integration topic, the integration of both chemical and non-chemical
stressors was emphasized.
The nitrogen topic could be further integrated by incorporating consideration of community-
based ground water exposure data.
Some areas of research integration have an obvious rationale, such as integration of chemical safety with
air and water research, but the need for integration across other areas requires careful consideration. The
five discrete integration topics selected by the EPA are good ones. Integration of research should be
initiated when there is a compelling topic and it makes sense to do so, recognizing that not all topics will
require assistance from all program areas.
2.5.2. Recommendations
ORD should develop individual "roadmaps" with goals and an outline of paths to those goals for
each of the integrated research topics, similar to the roadmap being developed for ORD's
nitrogen topic.
ORD should develop a graphical framework for each integrated research topic that identifies and
discusses the responsibilities and relationships of the various participating EPA programs and
external agencies and groups.
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ORD should enhance its internal and external communication between research programs and
provide more opportunities for formal exchange of research information.
2.6. Innovation
How can ORD's initial innovation activities be improved to ensure continued and long term benefits
for EPA? Are there useful experiences and lessons from other research organizations about
managing innovation? What guidance can the SAB and the BO SC provide for ORD in developing
metrics that would be most effective in assessing the success of our innovation efforts?
2.6.1. Response
Improving ORD's initial innovation activities
ORD should be commended on its efforts to foster innovation. The innovation program has four major
components: (1) Pathfinder Innovation Projects (an internal competition for Agency scientists that
provides one-year seed funding and time for projects deemed to be innovative, high-risk, and high-
reward); (2) Open Innovation (processes for "challenges" and prizes to fill priority gaps in
environmental protection programs; (3) Apps and Sensors for Air Pollution (development of real-time,
low-cost environmental sensors and apps that hold promise for regulators, researchers and
communities); and (4) Culture and Collaboration (programs and activities to move EPA and ORD
toward a culture of innovation, where interdisciplinary collaboration and risk-taking are supported and
rewarded). The success of ORD's innovation efforts is strongly dependent on ORD leadership and the
continued fostering of innovation within ORD. The program also appears to yield the additional benefit
of enhancing integration, as many of the innovation projects are characterized by cross-fertilization
across disciplines.
The initiation of the Pathfinder Innovation Projects, along with the many responses to the call for
proposals and some preliminary results, indicates a very good start. However, it is important that the
EPA ensure that all proposed innovation activities are tied to the agency mission. Innovative activities
and support of those activities should be prioritized to reflect the EPA's most pressing needs. ORD
should provide more information on the guiding principles that govern how questions for challenges are
chosen and how Pathfinder Innovation Projects grants are awarded. What are those Grand Challenges
that, if addressed in an innovative way, will lead to a major transformation in the way the EPA performs
its duties? For example, imagine the value of having output of Integrated Risk Information System
(IRIS) toxicological profiles increase by an order of magnitude.
The SAB and the BOSC note that much of the innovation program is currently focused on technological
innovations ("widgets"). Often the most inventive solutions to environmental problems involve new
ways of doing things, through new organizational forms or ways of working together, rather than new
technologies (National Academy of Engineering 1999). In addition, existing technologies can become
part of "socio-technical systems" that involve changing the way people use technologies (Trist and
Bamford 1951; Cherns 1975; Fox 1995; Trist 1981; Waden 2011). ORD should provide as much
encouragement for social and socio-technical innovations as for purely technological ones. As ORD's
innovation program matures, it may be beneficial to shift the focus from innovation in devices to
identifying systemic ways to incorporate innovative thinking into the agency's culture and policies.
Specifically, innovation in environmental modeling and in policy strategies (e.g., market-based systems)
could be targeted. The EPA can use its leverage in regulation and in public information to catalyze
additional innovation outside of the agency. Efforts could be broadened to identify ways to promote
environmental innovation by businesses, households and consumers in their use of environmental
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resources. Research in the social, behavioral and decision sciences could play a critical role in this
process.
The SAB and the BOSC support ORD's efforts to develop innovative ideas from across ORD but also
recognize that some individuals are innately more innovative than others (i.e., there are repeat Pathfinder
Innovation Projects award winners). ORD should undertake additional efforts to identify and leverage
the top innovators via mentoring of others and/or assembling the top innovators in small teams to
promote further breakthroughs.
Approaches to innovation beyond the Pathfinder Innovation Projects program could include:
Public competitions to provide incentives for competition for environmental innovation modeled
after the efforts of the X Prize Foundation to provide incentives for technological development;l
Open innovation/crowd sourcing, utilizing communities and students;
Looking to young investigators for fresh ideas;
Skunkworks approach (taking a small number of innovative thinkers and encouraging wild ideas
and experimentation while accepting that there will be failures as well as successes. These
investigators would be allowed to operate with minimal reporting requirements and enhanced
programmatic flexibility. Innovative thinkers from very different fields would work together to
increase the potential for innovation as each brings a completely different set of ideas to the
table); and.
Using competitions or targeted outreach efforts to identify examples of successful innovation
projects implemented in communities and utilities across the country. Other countries [e.g.,
India and Brazil (Lobler 2012)] have found success in identifying solutions to their
environmental problems by soliciting innovative approaches directly from community groups
experiencing the negative impacts for which innovative solutions are sought.
Experiences and lessons on innovation from other research organizations
Appendix B provides a list of references on innovation from other research organizations that may be
useful to ORD. References include lessons-learned reports, publications on innovation related to
research and innovation metrics.
Metrics for assessing the success of ORD innovation efforts
The development of metrics presents an enormous challenge. Other than development of an award
system that encourage innovative research and further development of a culture of innovation within
ORD, the SAB and the BOSC at this time have not reached substantive agreement on a single approach
to metrics for assessing the success of ORD innovation. Members generally agree that ORD should
consider multiple benefits when assessing innovation, but some members suggest that metrics are not as
important as initiating and conducting innovative research. Some members suggest that metrics that are
common for academic decisions on innovation (number of publications, citations, patents etc.) would be
acceptable. Other members suggest that business innovation metrics should be avoided and, instead, that
ORD identify and focus its metrics on the goals of EPA's organizations and their specific projects when
assessing potential innovation projects and the impacts of innovation projects. Some members note that
1 See http://www.xprize.org/ (accessed 09/05/12).
2 Gupta, Anil. 2010. India's hidden hotbeds of invention. TED; Ideas Worth Spreading.
http://www.ted.com/speakers/anil_gupta.html (accessed 09/04/12).; Villgro incubates, funds and supports early-stage,
innovative social-enterprises that impact the lives of India's rural poor, http://www.villgro.org/ (accessed 09/04/12); Society
for Research Initiatives for Sustainable Technologies and Institutions, http://www.sristi.org/cms/en (accessed 09/04/12); next
billion; development through enterprise http://www.nextbillion.net/ (09/04/12).
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learning from failed projects can represent success. Telling success stories, encouraging proposals for
innovation, and soliciting innovation challenges could be effective measurement strategies. Tracking the
application of innovations and consequent time and cost savings could provide other metrics.
There may be different metrics for different aspects of a proposed innovative project, as indicated by the
questions below:
Does the proposal fit a mission area?
Is the proposal innovative or just evolutionary?
Are there different phases in the proposal (e.g., idea development, proof of concept, or
innovation development)? If so there may be metrics needed for each phase in order to justify
funding from one phase to the next.
What is the transition plan (what happens after the project is successful)? Who is the customer?
The EPA? If there is no buyer for the technology, does it have value to the agency and still worth
pursuing?
Given the importance and complexity of this question, the SAB and the BOSC recommend that ORD
sponsor a focused workshop on metric development for innovation that would result in a set of metrics
that represents a reasonable fit with the ORD mission and desire for innovation.
2.6.2. Recommendations
When assessing potential innovation projects and impacts of innovation projects, ORD should
consider multiple benefits of such projects, and identify and focus its metrics on the goals of the
EPA's organizations and their specific need rather than on conventional business performance
metrics.
Innovative activities and support of those activities should be prioritized to reflect the EPA's
most pressing needs.
ORD should provide more information on the guiding principles that govern how Pathfinder
Innovation Projects grants are awarded and how questions for challenges are chosen.
ORD should undertake additional efforts to identify and leverage the top innovators via
mentoring of others and/or assembling the top innovators in small teams to promote further
breakthroughs.
ORD should provide as much encouragement for social and sociotechnical innovations as for
purely technological ones.
ORD should use solicit and support innovation research projects in communities and utilities
across the country.
ORD should develop an award system that would align with the desired behavioral changes in
moving the ORD culture to one of innovation.
ORD should sponsor a focused workshop on metric development for innovation that would
result in a set of metrics that represents a reasonable fit with the ORD mission and desire for
innovation.
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3. RECOMMENDATIONS FOR SPECIFIC RESEARCH PROGRAMS
3.1. Air, Climate and Energy
The Air, Climate and Energy (ACE) program is intended to provide cutting-edge scientific information
and tools to support the EPA's strategic goals of protecting and improving air quality and taking action
on climate change in a sustainable manner. The SAB and the BOSC strongly support the efforts of the
ACE program, which aligns with the sustainability paradigm. The responses below suggest ways to
strengthen the program through further enhancements to the ACE Strategic Research Action Plan, more
investments in systems approaches and analyses, more investments in social, behavioral and decision
science research and increased focus and resources for the energy component of the program.
3.1.1. First year progress
How are the ORD research programs progressing in the first year of implementation? Are the
research activities planned for FY13 and future years appropriate for answering the science
questions in the Strategic Research Action Plan?
The development of the Strategic Research Action Plan for the ACE program is clearly a major
accomplishment, providing a well-articulated plan for the newly created program. An area of potential
improvement for the plan would be a more explicit mapping of the long list of individual projects and
project outputs to strategic research themes and the overarching vision. While the high-level goals for
this program area are exciting, it was not always evident from the examples presented how the ACE
goals translate into specific research activities. A compelling, well described example of how projects fit
together to address strategic research goals was provided by the nitrogen integration topic.
Additional areas of potential improvement of the plan include: (1) development of an explicit energy
research plan and more explicit integration of energy research with the plans for climate and air quality
research; (2) a description of how ORD's ACE activities are positioned within the portfolio of other
research activities at the EPA and the research of other federal agencies; (3) broadening the portfolio of
projects that address the interaction of air quality, energy and climate; and (4) the inclusion of more
social science and behavioral research. More social and behavioral science research could be integrated
in the ACE plan by examining, for example, the impact of air pollution and monitoring activities on
different socio-demographic groups, by analyzing different types of innovative policy incentives that
would encourage pollution prevention and energy conservation, and by examining the effects of
providing information about air quality on decision making and human health.
Plans for activities in FY 13 and beyond appear appropriate and well-positioned to advance the agenda
described in the ACE Strategic Research Action Plan. Each of the three primary ACE research themes -
assessing impacts of air pollution and climate change, preventing and reducing emissions, and
responding to changes in climate and air quality - is supported by activities that will provide information
critical to these themes. Since the Summary Tables of Outputs and Outcomes only provides the year the
specified output is expected, and since so few (30 out of 145) project deliverables are targeted for
completion in FY12, it is difficult to have a sense of the overall timeline of and investment in each of the
activities; for instance, some may entail major, multi-year efforts and others may be minimal. More
discussion of the rationale for selecting and prioritizing the specific research activities planned for 2013
would be informative in assessing their appropriateness.
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3.1.2. Sustainability
How are ORD programs contributing to sustainability through their research plans and activities?
What advice do the SAB and the BOSC have for each research program about advancing
sustainability in future research?
The sustainability paradigm provides a framework for integrated research on air, climate and energy. By
considering these three areas jointly, it is possible to create a more holistic view of how these inter-
related areas impact one another and to consider co-benefits and unintended consequences of actions in
one area on another. The Strategic Research Action Plan for the ACE program describes these
interactions and the EPA's interest in studying co-benefits and unintended consequences, but more
development is needed for creating the systems approaches needed. To accelerate the development of
systems approaches, it may be helpful to bring systems expertise into the program, and to encourage
extramural research in this area.
Incorporating sustainability into research plans and activities within the ACE program will require more
effort in social, behavioral and decision science research as well as a greater focus on systems science.
ORD should lead federal agencies in studying and implementing the effectiveness of sustainable
business practices at the scale of a large distributed federal agency. This would include evaluating
energy and material use and the economic consequences of implementing sustainable practices.
3.1.3. Balancing immediate program needs and emerging issues.
As we consider science for the future, while budgets continue to shrink, how should ORD balance its
commitments in the Strategic Research Action Plan with the need to advance science on emerging
issues?
The ACE program is charting an effective balance between short and long term projects and ending
projects that have reached their objectives. As budget challenges grow, ORD will need to increasingly
rely on partners for achieving its objectives. A balance between in-house projects and importing
externally developed tools will be needed.
To achieve greater efficiency in the use of ORD resources, ORD should conduct a careful assessment of
the balance between intramural and extramural research and the positioning of ORD research relative to
research in other institutions. ORD should focus its efforts on identifying gaps critical to EPA's mission
and finding ways to apply and adapt research from other organizations.
3.1.4. Integrating ACE research elements as a coherent whole
How do we bring together research on biofuels, oil and gas measurement methods, combustion
related pollutant effects and modeling/decision support tools into a coherent whole to address
the environmental effects of energy production and use?
Effectively incorporating more energy projects into the ACE research portfolio will be a key challenge
for the ACE group. The scope of potential research at the intersection of energy and the environment is
enormous and ORD resources are limited. A mapping of energy research needs for ORD would be a
useful first step.
In addition, developing a comprehensive and integrated energy program is a prime example of a
research area in which systems approaches will be key (see response to Charge Question regarding ACE
first-year progress in section 3.1.1). For example, encouraging human behavior that promotes safer,
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sustainable use of chemicals throughout the energy life cycle may offer an effective lever for solving
many energy-based environmental problems. Developing a full understanding of the entire spectrum of
human health and ecosystem impacts of energy options (using life-cycle analysis and incorporating
externalities) will be critical to providing effective decision support tools and providing the scientific
foundation for policy decisions regarding sustainably meeting energy needs on multiple scales
(community, regional, national, global). Most current ORD work focuses on facets of the impacts of
energy on air quality and climate, with minimal effort devoted to making the connections between these
facets and understanding energy systems behavior. This additional systems-level focus on energy will
require senior leadership to provide necessary systems science expertise and ensure that the connections
between energy research projects are drawn and made explicit. In addition, a workgroup of staff from
across ORD and the agency who are working on energy-related science issues could convene
periodically to review work and identify connections and possibilities for integration and collaboration.
Several synthesis reports on fuels are planned for the 2013-2016 period, and the development of these
reports offer opportunities to develop integrated, systems approaches. These syntheses should integrate
sustainability issues related to biomass production, land use change, soil carbon and food and fuel
markets. An integrated framework should be developed that allows evaluation of the competitiveness of
alternative energy sources, their intended and unintended effects and implications for policy.
Finally, legislative activity and funding has driven a focus on biofuels and hydraulic fracturing that is
likely to become a research center-piece of focused research in the coming year. While these responses
to emerging issues are important, ORD should still seek to develop, in partnership with other groups, a
broad set of energy capabilities. Life cycle approaches and frameworks will help ORD address issues
such as the impacts of land use changes and the ecological impacts and responses to catastrophic events
such as heat waves and droughts. Demographic, regional migration patterns and other social changes
(including responses to threats and to protection/management programs and outcomes) may also be very
important components of the energy/climate/environment dynamic. Again, partnership with other
organizations will be critical.
3.1.5. Recommendations for the ACE program
ORD should more explicitly map the long list of individual projects and project outputs in the
Strategic Research Action Plans to strategic research themes and the overarching vision.
The Strategic Research Action Plan should include a plan for energy research and indicate how
this research will integrate with the plans for climate and air quality research.
To support this additional systems-level focus on energy, ORD should identify senior leadership
to provide necessary systems science expertise and ensure that the connections between energy
research projects are drawn and made explicit.
The Strategic Research Action plan should include a description of how ORD's ACE activities
are positioned within the portfolio of other research activities at the EPA and the research of
other federal agencies.
The Strategic Research Action Plan needs more comprehensive and greater depth in planned
social science and behavioral research.
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3.2. Chemical Safety for Sustainability
The Chemical Safety for Sustainability (CSS) program is intended to provide critical research
supporting the scientific foundations of agency programs to ensure safety in the design, manufacture and
use of existing and future chemicals. This program is appropriately ambitious and bold, consistent with
the radical transformation across the entire field of chemical safety assessment required to meet the
changing needs of today's world. The CSS program must be prepared to address questions such as: how
to design and produce safer chemicals; how chemicals and their byproducts interact in the environment;
what are the sources of chemical exposure; how might chemicals and other exposures alter cellular and
molecular control pathways leading to adverse outcomes; how to promote safer, sustainable use of
chemicals throughout their lifecycle; and what contribution does chemical exposure make to the overall
disease burden in humans (including susceptible subpopulations) and the environment.
Clearly, transforming safety assessment to meet these challenges is a major undertaking that will take
many years to fully accomplish. However, the journey is now underway and it is imperative that it
succeed. At stake are not only major opportunities to improve public and environmental health, but to do
so in ways that are swift, cost effective and supportive of development of new, more sustainable
products. Overall, the SAB and the BOSC voice strong support and endorsement of the Strategic
Research Action Plan for the CSS program. This report also offers a number of specific suggestions for
improving upon this already strong plan.
3.2.1. First year progress
How are the ORD research programs progressing in the first year of implementation? Are the
research activities planned for FY13 and future years appropriate for answering the science
questions in the Strategic Research Action Plan?
The SAB and the BOSC are impressed with the progress made in the first year of the CSS program's
implementation and note that it "exceeded expectations" in some instances. This progress was primarily
related to creating a new, highly integrated management infrastructure that is radically different from the
previous structure. This was no small task to create, and will also take much work to maintain, but it is
fundamental and necessary to achieving the desired level integration along multiple axes and to
accomplish the ambitious goals articulated in the Strategic Research Action Plan. The scope of the plan
goes beyond the traditional confines of risk assessment. Examples include the application of high
throughput predictive toxicology data and computational approaches to inform "Green Chemical"
design, as well as the consideration of product life cycle in the development of new approaches to safety
assessment. While not a research product in and of itself, the Strategic Plan should be considered a
major accomplishment in its own right.
Given that this is just the first year of a multi-year research program, it is too early to judge success in
terms of specific research deliverables, but certainly early progress is very encouraging. Approximately
75 percent of the CSS research program portfolio deals with the development of new tools for safety
assessment. Assuming that these new tools are found useful by users and their outputs accepted by
stakeholders (more on this later), the impact from the CSS is expected to be quite high and readily
quantifiable.
In regard to the appropriateness of the research activities planned for FY 13 and future years for
answering the science questions in the Strategic Research Action Plan, the SAB and the BOSC consider
the CSS research plan to be comprehensive. It contains all of the key elements needed to answer the
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science questions in the Strategic Research Action Plan. This report highlights three areas of special
interest: exposure, cumulative risk, and ecosystems.
The SAB and the BOSC are pleased that exposure research has a greater presence in the plan than in any
previous plan. While it was agreed that exposure is embedded throughout most, if not all, aspects of the
plan, additional focus needs to be placed on the refinement and validation of proximal and consumer
(also referred to by some as "near field") exposure models. Some members of the SAB and the BOSC
suggest that exposure be specifically highlighted as a theme of its own. If this were the case, exposure
might get even more attention and resources, which is strongly encouraged. It should be noted that
"exposure" as referred to here includes both external exposure and internal exposure (i.e.,
toxicokinetics), and applies to humans, wildlife and ecosystems. The SAB and the BOSC encourage the
EPA to obtain information on ranges of human health exposure levels to ensure that highly exposed
populations are not ignored and that the levels of toxicological assessment from in vitro high-throughput
assays can be applied in a risk assessment context.
Regarding cumulative risk, one example of the benefits of integration relates to the potential value of
systems models and toxicity pathways data for informing chemical grouping schemes based on common
modes of action. The SAB and the BOSC also support the inclusion of both chemical and non-chemical
stressors (e.g., socioeconomic factors). It is recommended that the CSS Research Action Plan more
clearly state and describe how the research relates to chemical impacts on ecosystems and ecological
endpoints (e.g., high-throughput for ecological endpoints).
3.2.2. Sustainability
How are ORD programs contributing to sustainability through their research plans and activities?
What advice do the SAB and the BOSC have for each research program about advancing
sustainability in future research?
The CSS Strategic Research Action Plan identifies many contributions to sustainability research. These
contributions include, but are not limited to, the following:
The use of high throughput, predictive toxicology approaches to inform Green Chemical Design,
thus supporting the production of newer chemicals with more sustainable characteristics (e.g.,
reduced intrinsic hazards, less energy-consumptive, more biodegradable);
New assessment approaches that consider product life cycles (cradle to grave) to enable
protection against not only the chemical itself, but its environmental degradation products and
unique types of exposures that might occur during different phases of the product's life cycle;
Research to understand life- stage variability to help enhance protection of sensitive age-specific
subpopulations;
Development of more holistic ecosystems-based approaches to ensure more integrated, "one
environment" safety assessments;
The use of systems approaches to transform chemical safety assessment from a series of isolated
tests to a much more integrated and quite likely, more efficient and cost-effective enterprise; and
"Extrapolation" approaches to link different levels of biological organization.
As previously emphasized by the SAB and the BOSC (U.S. EPA SAB 201 la), it is highly recommended
that specific metrics be created to measure the contributions to sustainability derived from the CSS
program. The SAB and the BOSC also recommend that ORD take care, when describing CSS research
and its deliverables, to demonstrate how the research impacts end users (e.g., risk managers, policy
makers) and how the research helps inform decisions.
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3.2.3. Integration
Based on the presentation of five integrated topics, what advice can the SAB and the BOSC provide
to help ORD succeed in integrating research across the ORD programs? How can different
approaches to integration help us achieve our research goals?
Within the CSS program, the SAB and the BOSC recommend that ORD increasingly utilize the Adverse
Outcome Pathway concept, defined as "a conceptual construct that portrays existing knowledge
concerning the linkage between a direct molecular initiating event and an adverse outcome at a
biological level of organization relevant to risk assessment" (Ankley et al. 2009). Such an approach is an
inherently integrative process in itself. One example is the project on vitellogenin from ORD's
laboratory in Duluth, Michigan, which linked the pathway from disruption of key cellular events to
population level changes (Miller et al. 2006).
3.2.4. Endocrine disrupting chemicals, nanotechnology, and computational toxicology
Is the CSS program well positioned to support EPA needs in the three key areas of endocrine
disrupting chemicals, nanotechnology, and computational toxicology research?
ORD is not only well positioned, but often uniquely positioned to support needs in all three areas. In
particular, the key partnerships and linkages being established will be extremely helpful. That said, a
number of specific suggestions for each of the three key areas are noted below.
Endocrine disrupting chemicals
The SAB and the BOSC strongly encourage the CSS program's transitional Endocrine Disrupters
Screening Program (EDSP), which is extremely cost-, time- and animal-intensive, to an "EDSP21" that
relies more heavily on higher throughput methods. There are many challenges associated with a shift
from animal-based to high throughput endocrine screening methods, but it is important that ORD
address these issues in a direct, objective manner. In the context of the larger movement toward toxicity
pathways-based testing, the current suite of pathways falling under the umbrella of the current EDSP
program is actually fairly limited (i.e., estrogen, androgen and thyroid). There are numerous other
toxicity pathways constituting the complete suite of pathways that warrant evaluation in a
comprehensive, high throughput screening program. Therefore, the knowledge gained toward
transit!oning endocrine screening from its current form to an EDSP21 version will undoubtedly inform
similar efforts with other toxicity pathways and thus support future efforts to create an entirely new
paradigm of safety assessment.
Nanotechnology
Related to the theme of inherency, which involves research to understand the relationship between
inherent physicochemical properties (e.g., mass, conductivity, reactivity, heat of combustion) of a
chemical; fate and effects; and human and wildlife health outcomes after chemical exposure, the SAB
and the BOSC suggest that the CSS Strategic Research Action Plan clarify whether nanomaterials will
be compared to the bulk form of the chemical, as well as to environmental transformation products.
Clarification as to whether the CSS program will have the appropriate models (e.g., in vivo models, fate
and transport models) should be included.
Because nanotechnology is such a large field, ORD's unique roles and anticipated contributions should
be clearly articulated to demonstrate differences from those of other research organizations. In other
words, CSS should specify the program's niche in the larger world of nanotechnology research and
leverage the many ongoing efforts in this area.
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Computational toxicology
Many new tools are already being generated by the CSS program. However, the plan says little about
how these new assays and tools will be "qualified" or verified (validate is a term used in other circles,
but was thought to be less appropriate in this case) for their intended purposes. This verification process
needs to be done in a transparent and robust manner in order to gain the confidence across diverse
stakeholders within and outside the agency, many of whom are not at comfortable or familiar with these
methods. Therefore, the SAB and the BOSC recommend that the plan describe its proposed approach for
transparency and qualification of new tools and that this proposed approach be presented for review by
the BOSC. The SAB and the BOSC also note that the SAB is developing a report aimed at providing
further advice to assist the EPA in advancing the application of ORD's computational toxicology
research for hazard screening and risk assessment.
The CSS program is leading a transition from a dependence on in vivo testing for safety assessment to a
new strategy using a large battery of high throughput in vitro assays predictive of toxicity. This strategy
will require an understanding of adverse outcome pathways and how these will be revealed in the large
amount of data being generated from high-throughput assays. Many pathways can produce different
phenotypic outcomes depending on the context in which the pathways are activated, and both adaptive
and adverse outcomes are possible. There is a need to define the typical range of intra- and inter-
individual variation in pathway activation. At the beginning, the new computational toxicology tools
being developed by the CSS program will most likely be inserted as components of larger, tiered testing
frameworks with high throughput methods comprising initial tiers, followed by more targeted testing,
typically in animal models. The SAB and the BOSC recommend that the Strategic Research Action Plan
address how the computational toxicology program will dovetail with higher tier-targeted testing,
describing how targeted testing in animals can fill critical gaps and current limitations of computational
methods (e.g., complex cell and organ level interactions, toxicokinetics and determination of dose to the
target site). ORD is uniquely positioned to accomplish this integration of computational methods with
targeted testing because two of its laboratories are located in close proximity to one another (i.e., the
National Center for Computational Toxicology and the National Heath and Environmental Effects
Research Laboratory are both located on the Research Triangle Park campus). The SAB and the BOSC
suggest that the CSS program also work with the National Toxicology Program (also on the same
campus) to suggest types of data that could be generated by National Toxicology Program in order to
strengthen bridges between animal-based and computational safety assessment methods.
The SAB and the BOSC strongly encourage the computational toxicology program to place greater
emphasis on toxicokinetics (absorption, distribution, metabolism and elimination) and physiologically-
based pharmacokinetic models as these factors are major determinants of toxicity. Some effort has been
made in the CSS program towards developing and applying higher-throughput methods for measuring
parent chemical metabolic clearance and plasma protein binding, but additional efforts (both
experimental and computational) need to be made towards estimating volume of distribution/partition
coefficients, renal excretion, bioavailability, the metabolites generated, and the potential toxicity of
metabolites. Incorporation of these determinants is central to the determination of risk. In the absence of
toxicokinetic understanding, risks will be both over- and underestimated for large numbers of chemicals.
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3.2.5. Exposure research
How well has the exposure component of the CSS research program progressed since its
inception?
Response to this charge question was addressed earlier under the question related to "research activities
planned for FY 13 in section 3.2.1.
3.2.6. Recommendations for the CSS program
General
Clearly demonstrate how CSS research impacts upon end users (e.g., risk managers,
policy makers) and how it brings value for informing decisions.
Increase focus on the refinement and verification of proximal and consumer exposure
models, including both external and internal dosimetry.
Endocrine Disrupting Chemicals
In the effort to transition toward EDSP21, place greater attention on the challenges
involved in using reductionist approaches (e.g., ToxCast) in evaluating highly integrated
physiological networks, such as the endocrine system.
Frame the research on EDSP21 as a precedent for addressing analogous challenges for
evaluating other complex integrated biological systems (e.g., nervous system).
Nanomaterials
Define ORD' s unique niche within the broader landscape of nanotechnology research.
Computational Toxicology
Clearly and transparently describe the proposed approach for verification of new
computational toxicology tools for their intended purpose and with respect to risk
assessment, and present to BOSC for review.
Define the typical range of intra- and inter-individual variation in biological control pathways
in order to distinguish between adaptive vs. adverse changes. Address how the program will
dovetail with higher tier targeted testing.
Place greater emphasis on integration of toxicokinetics (ADME) and physiologically-
based pharmacokinetic models.
3.3. Human Health Risk Assessment
The Strategic Research Action Plan for the Human Health Risk Assessment (HHRA) program
articulates the following vision for the program: "The Agency will generate timely, credible human
health risk assessments to support all priority Agency risk management decisions, thereby enabling the
Agency to better predict and prevent risk." Given this vision, ORD should consider the critical place of
risk assessment in the overall activities of the EPA and how to best integrate HHRA's thematic tasks to
maximize application, problem scoping and management to support all of the research programs in
ORD. Risk assessment represents a methodological foundation for activities of multiple research
programs. Linkages to all relevant ORD research programs should be emphasized in the HHRA plan to
reflect the importance and broad translational role of risk assessment within the EPA. Reports from the
NRC (NRC 2009, 2011) and other bodies (e.g., U.S. Government Accountability Office 2008, 2011),
have recommended improvements to approaches to risk assessment. ORD has already made significant
steps towards implementing some of those recommended improvements, but a more cohesive approach
to risk assessment could be taken across the six research areas.
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The present plan provides a straightforward description of activities within its four themes [Integrated
Risk Information System (IRIS) health hazard and dose-response assessments (Theme 1); Integrated
Science Assessments (ISAs) of criteria air pollutants (Theme 2); Community Risk and Technical
Support for exposure and health assessments (Theme 3); and Modernizing Risk Assessment Methods
(Theme 4)]. However, it neither provides a strong overall vision nor identifies synergies across the four
components or across related programs such as CSS. At this point, the four themes have certain
commonalities and their merger into a single program reflects these cross-cutting elements, particularly
the reliance on the quantitative methods of risk assessment. These limitations of the current plan are well
recognized by the ORD leadership, ORD scientists and other EPA scientists and there is intent to
address them.
The EPA and ORD staffs have substantial expertise in the methods of risk assessment and their
application. With an extensive portfolio of risk assessment activities, the HHRA program provides a
platform for carrying out applied research to develop risk assessment methods. The SAB and the BOSC
recommend that the leadership of the HHRA pro-actively utilize this opportunity to advance the risk
sciences. An agenda of research should be maintained that builds strategically on this opportunity and
attention given to assuring that such methodological research is not set aside.
The EPA should carefully examine the placement and support for the risk sciences within the agency to
assure that there is sufficient integration and intellectual exchange among risk scientists. The EPA's
Risk Assessment Forum provides a platform, but perhaps a venue is needed for discussion, exchange
and collaboration among risk scientists more broadly.
3.3.1. First year progress
How are the ORD research programs progressing in the first year of implementation? Are the
research activities planned for FY13 and future years appropriate for answering the science
questions in the Strategic Research Action Plan?
As for most ORD programs, it is early to evaluate the trajectory of progress within the HHRA program,
and much remains to be done in the coming years. There is an inherent tension and competition within
the program between the need to produce various assessments in a timely fashion (HHRA Themes 1-3)
and the need to incorporate strategies based on "new and emerging" science into its activities (HHRA
Theme 4). ORD should explicitly acknowledge this inherent tension and consider it in setting
benchmarks for the program.
The Strategic Research Action Plan provides a straightforward description of activities within its four
themes. The research activities planned for FY 13 seem appropriate for answering the science questions
in the plan but they are only generally specified for later years covered by the plan. There are potential
challenges that may interfere with the planned agenda over the longer-term. One is the trade-off between
the demands of producing timely assessment while assuring that methodological research continues. In
addition, ORD resource limitations may constrain efforts to carry out this ambitious set of research
activities. Decisions about what to prioritize and what to omit will be challenging and should be made
only after the overall vision has been further developed.
Considering the linkage between the HHRA program and decision making, it is important to remember
the importance of the exposure sciences, which are not sufficiently reflected in the Strategic Research
Action Plan. Exposure assessment cuts across the four themes but the underlying exposure sciences do
not receive sufficient emphasis. The National Research Council report on the exposure sciences (NRC
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2012) is likely to increase attention to this area and provide prioritized research needs that should be
considered in the planning for the HHRA program. The discussion of exposure sciences should be
expanded beyond the brief discussion in Theme 3 (Community Risk and Technical Support) in the plan.
The use of HHRA assessments will benefit substantially from state-of-the-art exposure data and
methods. The HHRA program will also benefit from enhanced ties to the ecological risk assessment
community to better integrate human and ecological health considerations.
3.3.2. Sustainability
How are ORD programs contributing to sustainability through their research plans and activities?
What advice do the SAB and the BOSC have for each research program about advancing
sustainability in future research?
The HHRA plan did not specifically mention sustainability, yet the program mission by definition
contributes to sustainable decision-making. The HHRA program generates data and tools that help
decision makers achieve goals designed to be sustainable. The HHRA program advances the science
underlying National Ambient Air Quality Standards that have driven major air quality improvements
nationwide that further sustainability goals that pertain to human health and ecological health. Similarly,
the HHRA program produces risk assessments for high priority chemicals (in the IRIS program) and
rapid risk assessments (i.e., Provisional Peer Reviewed Toxicity Values). These assessments contribute
to the goal of identifying and controlling health risks from toxic chemicals and, through HHRA's Theme
4 (Modernizing Risk Assessment Methods), contribute to developing new tools to predict chemical risk
using less in vivo data. The HHRA efforts in Theme 4 to develop and improve the ability to identify and
measure cumulative risks can help advance environmental justice and identify opportunities for
communities to reduce exposures. Finally, the HHRA program's efforts to train risk assessors in state-of-
the-art methods and approaches through the Risk Assessment Training and Experience program, which
provides comprehensive risk assessment guidance and training, will ensure future contributions to
sustainability. The SAB and the BOSC recommend that the HHRA program more clearly and explicitly
communicate its significant contributions to sustainability science.
3.3.3. Balancing immediate program needs and emerging issues.
As we consider science for the future, while budgets continue to shrink, how should ORD balance its
commitments in the Strategic Research Action Plan with the need to advance science on emerging
issues?
ORD will need to think and act creatively to work with the likelihood of reduced budgets, while at the
same time addressing requests for assistance from various programs and from an increasingly informed
public. In addition, three recent NRC reports (NRC 2007; NRC 2008a; NRC 2009) provide an agenda
and a strong impetus for the EPA to transform its overall approach to risk assessment. This
transformation needs to occur in parallel with the ongoing production of individual risk assessments,
since there is a continuing need to provide the most credible possible risk numbers for decision makers.
ORD needs to build capacity to incorporate new toxicology data from the CSS program and other
sources into a new risk assessment approach.
In addition to more careful coordination and priority setting with the CSS program, ORD has several
other options for leveraging available resources. For example, ORD might consider the development of
cooperative agreements with outside parties via the Federal Technology Transfer Act (FTTA). This act
specifically allows for external funding to be put into the agency in the pursuit of technology developed
by the EPA, such as technology developed on emerging issues and/or issues related to sustainability.
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ORD might also link more directly with other federal agencies, such as the Agency for Toxic Substances
and Disease Registry (ATSDR), which has a similar mission for hazard identification and dose-response
assessment. For example, ORD might consider jointly developing Provisional Peer Reviewed Toxicity
Values and Minimal Risk Levels with ATSDR. Moreover, if ORD has found its current collaboration
around toxicity assessment with California to be helpful, ORD could partner with other outside parties,
such as the State of Minnesota, National Science Foundation International, or even other governments
that also conduct similar hazard identification and dose-response assessment work. Of course, ORD
would be well served to work even more closely with existing groups within the agency, such as the
EPA's Office of Water or its Office of Pesticides Program for developing dose-response assessment
values. As examples, adding recent Office of Pesticides Program toxicity values or updating older
pesticide values would be a valuable addition/update to IRIS.
ORD could also respond to this likelihood of reduced budgets by addressing emerging problems through
the use of newer sources of data, such as high throughput assays, that have the promise of abundant data
at reasonable cost. These approaches should be assessed and pursued for use by HHRA in order to
improve, streamline and make the present assessment programs more cost effective. Demonstration of
these emerging tools and early feedback on them would serve to improve their utility, efficacy, and
acceptance. Another advantage in the use of these emerging tools is that they have the potential to
expedite assessments overall.
In addition, ORD might consider active partnerships with other entities in order to build opportunities to
use high throughput testing and to develop complementary opportunities based on new epidemiology
studies or on established cohorts to apply such methodologies. There are several advantages of these
approaches including the reduced use of experimental animals, the direct use of toxicity data based on
human cell cultures and the ready application of high throughput testing.
The EPA's effort to develop the concept of Conditional Toxicity Values (CTV) (Guyton 2012) is
particularly noteworthy because it incorporates consideration of new toxicity testing methods, and offers
the potential to create screening or interim risk values for large numbers of chemicals of concern. The
CTV and other similar approaches3 are designed to produce health-protective risk values that can help to
guide risk management until additional chemical-specific data become available. If the HHRA
specifically or ORD generally decides to take this approach, then linkages with other agencies or
organizations with interest in these and related methods will be important.
ORD should consider incorporating shorter-term testing to improve the basis of its risk assessments, as
long as timelines for the risk assessment are not unduly lengthy. Such shorter-term testing should not be
considered when a delay would be associated with remediable, ongoing human exposures and
potentially significant human health or ecological risk. ORD should also consider how to prioritize
within Theme 3 (Community Risk and Technical Support for exposure and health assessments) and
Theme 4 (Modernizing Risk Assessment Methods) of its research plan, given the possibility of limited
resources.
3.3.4. Integration
Based on the presentation of five integrated topics, what advice can the SAB and the BOSC provide
to help ORD succeed in integrating research across the ORD programs? How can different
approaches to integration help us achieve our research goals?
3 See ISLI. n.d. Threshold of lexicological Concern Task Force,
http://www.ilsi.org/Europe/Pages/TF ThresholdToxicological.aspx (accessed 09/21/2012)
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Much of the work of HHRA focuses upon mandated activity and is highly task-oriented. Because of the
large amount of mandated work and because HHRA outputs (e.g., IRIS) provide the basis for hazard
identification and dose-response assessments, in part, for the regulatory and advisory work of the EPA,
integration efforts should be prioritized carefully so as not to impose unnecessary burdens (i.e., undue
time and effort) that could detract from core activities.
Nevertheless there were a number of research topics identified for which there is high need or potential
for integration/collaboration between HHRA and other ORD programs. The SAB and the BOSC
recommend that cross-program collaboration between CSS and HHRA be emphasized more strongly in
the Strategic Research Action Plans for the two programs. While cross- program integration is
mentioned, the relevant agendas within these two programs are largely separated and the basis for
selecting outputs and priority setting is not clear. For example, transparent evidence synthesis is integral
to both the IRIS Program and the development of the IS As, but the methodologies used by the groups
are distinct. The SAB and the BOSC encourage heightened interactions between the groups working in
Themes 1 and 2 that could lead to synergy in development of methods. Additionally, the SAB and the
BOSC recommend that ORD revise the CSS and HHRA documents so that they more clearly
communicate the inter-related science and research priorities for these two programs.
The areas of children's health and of the health and exposures of other sensitive and vulnerable
subgroups require a high level of integration across all ORD research programs. The HHRA Strategic
Research Action Plan should identify key gaps between research outputs and assessment needs so that
EPA can focus research to address the needed integrative models in the areas of exposure assessment,
computational toxicity, developmental toxicity, in vivo effects, animal data, mechanistic models and
pathway analysis. With children's health and environmental justice as an integrating focus, the HHRA
program should plan to provide multiple reference doses, including short-term duration doses,
specifically suitable for evaluating windows of vulnerability to high exposure. HHRA assessments
should also identify populations that may face greater risks due to genetic or other factors and should
quantify these risks, using the new possibilities afforded by advances in genetics and exposure
assessment. There is need for integration of HHRA activities and approaches into various rapid risk
assessment processes (e.g., in conjunction with Homeland Security research program), when there are
needs for assessment of chemo-toxicity of short-term exposures and for the development of Provisional
Advisory Levels.
ORD should monitor for topics that are candidates for integrated efforts and ORD should have
approaches in place for initiating integrative activities and giving them appropriate priority. Very
importantly, when new issues requiring integration arise within HHRA all ORD programs should be
notified, since there may be interests in the same topics from researchers in other ORD research
programs. Additionally, HHRA, as with other programs, would benefit from the integration of social,
behavioral and decision scientists into the activities related to risk assessment methodology to support
environmental decision-making. The SAB and the BOSC recommendation in 2011 (U.S. EPA 201 la)
regarding the importance of integrating social, behavioral, and decision science remains relevant. That
report stated that ORD should conduct or support social, behavioral and decision science research and
analyses to understand the public's perception of uncertainty and risk assessment. Shedding light on
public attitudes and knowledge will enable the agency to communicate HHRA findings more
effectively.
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3.3.5. Innovation
How can ORD's initial innovation activities be improved to ensure continued and long term benefits
for EPA? Are there useful experiences and lessons from other research organizations about
managing innovation? What guidance can the SAB and the BO SC provide for ORD in developing
metrics that would be most effective in assessing the success of our innovation efforts?
Beyond the findings and recommendations provided in section 2.5, there are opportunities for
innovation to help "reinvent" the IRIS program by: (1) substantially shortening and streamlining the
documents to make them easier to use and to review; (2) incorporating Tox21 data, initially in
qualitative discussions, then in parallel with traditional toxicology data, and ultimately, as appropriate,
as part of critical pathway-based extrapolations; and (3) incorporating the key recent NRC
recommendations (NRC 2009) with a particular focus on cumulative risk, making implicit default
assumptions more explicit, improving characterization of uncertainty, and not assuming that the dose-
response for all non-carcinogens includes a threshold. These points are all reflected in the HHRA
Strategic Research Action Plan but are not described as clearly as they could be.
3.3.6. Modernizing methods
What aspects of the hazard and dose-response assessments produced by the HHRA research
program are most likely to benefit from the application of state-of-the-art data streams and
methods (e.g., in vitro toxicity testing results, gene expression profiling data, bioinformatics and
QSAR modeling)? Additionally, what approaches can be envisioned to enhance risk managers'
understanding, use and acceptance of these new methods?
The SAB and the BOSC recommend that ORD begin, as soon as possible, to implement and integrate
new types of data and methods into risk assessments. New methods may be used in qualitative if not
quantitative ways in such ORD products as Provisional Peer Reviewed Toxicity Values derived for the
EPA's Superfund programs and IRIS reviews. The HHRA program has begun to consider "omics" data
(e.g., genomics, proteomics, and metabolomics) and NRC-recommended innovations (NRC 2009) in
IRIS and other risk assessments. ORD should continue to integrate this information as quickly and
effectively as possible as one way to ensure that risk assessors and risk managers become familiar with
new types of data and methods and recognize the utility of the new information. Each upcoming IRIS
assessment for which the chemical has undergone testing under the Tox21 regime should at least present
the data and incorporate it into a qualitative discussion.
In regard to the variability and uncertainty that may be associated with these new methods, the SAB and
the BOSC recommend that HHRA incorporate new data and new approaches as they become available
and characterize the uncertainty and variability associated with each research result in a transparent
manner. As more data become available and methods are tested further, a component of this work
should include comparing traditional and non- traditional approaches to evaluate concordance of
outcomes.
New methods or approaches are considered widely acceptable when well respected and influential risk
assessment programs, including those outside of ORD and those in other agencies, incorporate new
approaches in a consistent manner. New approaches and new data will gain greater acceptance by risk
assessors and managers if ORD works with multiple EPA programs and other agencies to gain
consensus on the use of data and methods. Consensus on each risk assessment is not needed (e.g., the
Minimum Risk Levels produced by ATSDR need not match the IRIS reference doses produced by the
EPA), but consensus should be achieved on recommended methods, approaches and to the extent
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possible, application [e.g., Benchmark Dose (Lower Confidence Limit) methodology is now widely
accepted, although different groups may calculate different values]. Agreement within the risk
assessment community on the utility of the new approaches will enhance their credibility with risk
managers.
ORD should provide training and education tailored to the information needs and backgrounds of the
agency risk managers as well as those outside the agency (risk assessors, risk managers, academia, and
science advisors to the communities affected by risk management decisions). The HHRA program has
already given this problem careful consideration by meeting with agency risk managers in a focus group
venue to learn how risk managers receive and understand information about risk assessments. ORD has
also described the Risk Assessment Training and Experience program and an outcome for training
(FY15). ORD staff already influence peer scientists through offering, planning, and participating in
symposia, workshops, and continuing education offerings at professional meetings. ORD is also hosting
webinars and other remote learning opportunities. Many of these current activities are aimed not only at
ORD scientists, but also at peer scientists within and outside of the agency.
While these ORD efforts are laudable, education efforts targeted to risk assessors and managers should
be offered frequently and should focus on the new tools and methods in order to ensure that the
understanding and acceptance by potential users evolves along with the work that is produced. An added
advantage is that early training will provide ORD with timely feedback from stakeholders who may be
struggling to implement new approaches. Suggestions for strengthening training activities include:
Sustaining the development of risk assessment methods and their implementation into practice;
Targeting innovators and influencers in various sectors (e.g., regional offices, state risk
assessment programs, academia, science advisors from the non-profit sector, community leaders)
for specific training;
Optimizing training to match the background, experiences, and needs of change leaders;
Developing coursework and ensuring it is taught in influential toxicology and exposure science
academic training programs;
Developing public health policy training through public health institutes;
In-laboratory rotations targeting toxicologists and risk assessors unfamiliar with new
technologies; and,
Sharing information about the Risk Assessment Training and Experience program (course
content and focus, audience, and delivery) and implementing it as early as possible.
Education and training are resource-intensive activities that require dedicated staffing and the support of
management, and HHRA should be adding annual output goals in this area.
In regard to the second part of this charge question, which pertains to risk managers' understanding,
acceptance and use of these new methods, the SAB and the BOSC recommend that the HHRA program
systematically study, perhaps through the use of decision science, the utility of the new data sources for
decision making, and determine how evidence from new areas of investigation should be combined or
presented along with more traditional risk assessment approaches. The SAB and the BOSC recommend
four key steps to enhance risk manager's understanding, use, and acceptance of the new data and
methods that are being developed for implementation by HHRA (data such as high-throughput studies
and methods such as recommendations by NRC 2009). The key steps include: (1) consistent adoption of
new approaches across programs; (2) training and education; (3) immediate implementation of new
methods, and (4) evaluating the incorporation of new methods into decision-making. It is clear that risk
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managers need to have information presented in ways that demarcate what is known from what is not
known. Risk managers need information that characterizes uncertainty in a useful way. ORD should
conduct research on how to combine results from the new lines of investigation with health risk data
from "traditional" toxicity testing and epidemiology. The research should demonstrate the utility of
these new data sources for decision-making, not only what risk managers understand about these
approaches and how they may use them. ORD should consider involving decision-scientists to study the
perceived utility and acceptance of findings by risk managers.
3.3.7. Peer review
How can the HHRA research program efficiently obtain robust peer reviews that contribute to
the scientific integrity of assessments without impacting the timely provision of documents with
public health value? Additionally, can the SAB/BOSCprovide advice on the appropriate overall
balance of peer review of individual products versus other recommended scientific capacity-
building activities?
The SAB and the BOSC reflected on the difficult balance between the essential role of peer review and
the need for timeliness in producing risk assessments of public health importance. In some cases,
repeated rounds of demand for peer review may be driven more by external factors rather than by actual
limitations of the documents. In other cases, cumbersome, lengthy, and poorly written EPA assessments
have complicated the peer review process resulting in negative feedback to the agency. The SAB and the
BOSC applaud the commitments in the HHRA action plan to produce more readable, shorter and well-
organized IRIS assessments, and this shift should make the peer review process somewhat easier and
more efficient in the future. Overall, the SAB and the BOSC strongly support HHRA's commitment to
the scientific integrity and quality of its HHRA risk assessments and acknowledge that the EPA has
improved its responsiveness to peer review comments.
EPA often faces difficult decisions regarding as to implement conflicting or cumbersome
recommendations by peer reviewers. This issue extends beyond HHRA and is inherent in the peer
review process itself. Given the workload of HHRA and the demand of addressing peer review
comments, the SAB and the BOSC suggest that strategies be developed to more efficiently address peer
review comments while preserving the integrity and benefits of the peer review process. There are
approaches used by other entities that may offer strategies. For example, the National Academy of
Sciences typically solicits multiple peer reviews for their reports, generally 10 to 15 depending on the
report. An independent review monitor evaluates the substance of the comments and provides guidance
to the committee on the most critical issues to be addressed in the revised report. An editor plays a
similar role in the peer review process for manuscripts submitted to journals; the editor informs the
authors as to which peer review comments require changes to a manuscript. In cases where a consensus
body, such as the SAB or the National Academy of Sciences peer reviews an agency document, it would
be most helpful for the EPA to request that the group clearly distinguish priority recommendations from
other suggested advice in the peer review.
The level of peer review should be generally commensurate with the complexity and importance of the
document, and with the time-urgency of the assessment, which is the current practice of the HHRA. For
example, Provisional Peer Reviewed Toxicity Values-type assessments appropriately undergo a lesser
level of peer review than IRIS assessments, and the degree of review accorded an IRIS assessment
varies according to its importance. However, in a few cases, the mandated requirement for outside
review of documents by the National Research Council has created a strain on the budget and led to
delays. Recent mandates may impair the ability of the HHRA program to achieve its goals and
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objectives in the coming fiscal year. Budget cuts should not impair efforts to incorporate the new
scientific data and methods, as these new methods have the potential to ultimately help improve
efficiency and better protect public health by allowing screening-level assessments for many more
chemicals than can be addressed today.
The agency should have the overall goal of providing its assessments in a timely fashion. This goal has
not always been met, particularly for the IRIS assessments and past National Ambient Air Quality
Criteria Documents. More recently, the agency has completed the peer review of the IS As in a timely
fashion, in part because of court-ordered deadlines. Additionally, the switch from the Criteria Document
to the ISA format has led to more integrated and transparent documents that can be more readily
reviewed.
Toxicology values (including reference doses, reference concentrations and cancer slope factors) are
extremely important to programs across the EPA and in risk assessments conducted on behalf of state
and other federal agencies. It is possible that the reforms already being implemented in the IRIS
program that lead to greater transparency and stakeholder involvement early in the review process will
result in less onerous peer reviews. Stakeholders and peer reviewers may be able to target their
comments more effectively and to allow the EPA to address potential concerns.
3.3.8. Recommendations for the HHRA program
The EPA should broadly examine the diverse venues where risk assessment activities reside
within the agency and seek to establish connections and integration that will foster ongoing
enhancement of methodologies that are common to risk practitioners throughout the Agency.
ORD leadership should elaborate a strategic vision that enhances linkages among the thematic
areas of the HHRA and with the other research programs, particularly the CSS program, and that
emphasizes the way that the HHRA program contributes to sustainability research. This vision
will be needed for revising the HHRA strategic plan.
A wide- reaching plan is needed for incorporating data from emerging technologies, e.g.,
"omics" and high throughput testing, into EPA risk assessment approaches and for evaluating the
utility of these data for decision-making. This activity needs emphasis in Theme 4.
While progress by HHRA has been on pace during its first year, the agenda needs to be set for
the longer-term with priorities given to the most critical topics for decision-making, particularly
as resources may decline.
Exposure sciences need greater emphasis within the activities of the HHRA and further expertise
is needed in this cross-cutting area.
The addition of further social, behavioral, and decision scientists to HHRA would benefit many
of its activities and enhance integration with other programs. This recommendation echoes prior
reports and speaks to the broad, multidisciplinary nature of decision-making and communication
with regard to risk in the face of uncertainty. Long-standing gaps in expertise within the Agency
should be addressed.
Concerted and sustained efforts are needed to assure that scientists with HHRA and elsewhere in
EPA and decision-makers are fully versed in the latest risk assessment approaches and the
interpretation and application of their findings.
EPA risk managers should also be educated about new data and approaches to risk assessment,
leading to greater confidence in decisions based on these approaches. They need to be kept aware
of advances made under Theme 4.
Peer reviews of HHRA documents and assessments could be made more efficient. The plans for
changes in the IRIS assessments should benefit the peer review process. Additionally, the
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intensity of peer review should reflect the complexity and importance of the product. For
extensive peer reviews, it is important to evaluate and improve the process to triage comments so
that effort is directed at the points of criticism that are most important and that have significant
implications for overall risk estimates and decision-making. This may be facilitated by an
independent "monitor" or "editor."
3.4. Safe and Sustainable Water Resources
The Safe and Sustainable Water Resources (SSWR) Strategic Research Action Plan identifies the
following vision for the program: to use an integrated, systems approach to research for the
identification and development of the scientific, technological and behavioral innovations needed to
ensure clean, adequate, and equitable supplies of water that support human well-being and resilient
aquatic ecosystems.
3.4.1. First year progress
How are the ORD research programs progressing in the first year of implementation? Are the
research activities planned for FY13 and future years appropriate for answering the science
questions in the Strategic Research Action Plan?
The SAB and the BOSC find that research activities planned for FY 13 and future years are appropriate
for answering the science questions in the SSWR Strategic Research Action Plan and that ORD's
planned research activities for FY13 align appropriately with the overall research goals of the program.
ORD's progress in implementing the SSWR research program is commendable and the priorities in
identifying planned activities within the plan are well balanced.
The SSWR implementation plan includes specific tasks and milestones. In some cases ORD has all
deliverables scheduled in 2017 for the completion of a task. This makes it difficult to assess the rate of
progress that ORD is making towards completion of the task. While the SAB and the BOSC understand
that the implementation plan is in development, ORD should consider including a more detailed timeline
with deliverables for planned activities with specific milestones and/or intermediate deliverables. This
would assist reviewers in better understanding the anticipated rate of ORD's progress towards achieving
its longer-term goals and plans.
3.4.2. Sustainability
How are ORD programs contributing to sustainability through their research plans and activities?
What advice do the SAB and the BOSC have for each research program about advancing
sustainability in future research?
The SSWR Strategic Research Action Plan appropriately incorporates sustainability and greatly
improved how ORD integrates sustainability into its long-term research planning. Sustainability,
however, is a far-reaching goal, and much of the progress towards achieving the sustainable use and
management of water lies outside EPA's purview. The SAB and the BOSC recommend that ORD
further clarify the agency's focus vs. the focus of other agencies regarding SSWR sustainability-related
research. Such clarification will facilitate partnering and leveraging efforts and the activities of others, a
critically important activity.
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3.4.3. Balancing immediate program needs and emerging issues.
As we consider science for the future, while budgets continue to shrink, how should ORD balance its
commitments in the Strategic Research Action Plan with the need to advance science on emerging
issues?
There are a number of immediate, basic SSWR research needs, such as in the areas of storm water
management, microbial contamination of coastal waters and aging water and wastewater infrastructure.
As research budgets are reduced, research toward these immediate research needs will necessarily take a
larger portion of the SSWR research budget. Many states have a tight budget for protection of water
quality. They rely on ORD for research outputs on SSWR high-priority topics. Shrinking budgets will
make it more difficult to prioritize research on emerging water quality issues. Prioritization of emerging
issues will be needed.
The SAB and the BOSC note that some stakeholder communities and groups will favor prioritization of
SSWR research that differs from EPA priorities. Where research on emerging issues could benefit
certain communities, and those communities' priorities initially differ from EPA's priorities, ORD
should consider the magnitude and distribution of risks associated with the alternative research options.
The SAB and the BOSC recommend that EPA transparently communicate its efforts to prioritize
research and engage with communities when developing SSWR research priorities. Partnering with
other federal agencies would help leverage shrinking research dollars.
3.4.4. Integration
Based on the presentation of five integrated topics, what advice can the SAB and the BOSC provide
to help ORD succeed in integrating research across the ORD programs? How can different
approaches to integration help us achieve our research goals?
ORD should enhance its internal and external communication efforts relating to SSWR and provide
more opportunities for formal exchange of research information. ORD currently provides opportunities
for communication among research programs through its monthly SWAQ (Subcommittee on Water
Availability and Quality) teleconference calls that discuss current agency research and its periodic half-
day meetings of ORD National Program Directors to discuss research and budget priorities. The SAB
and the BOSC recommend that ORD identify and assess the adequacy of existing formal mechanisms
for sharing research information internally and among other agencies (e.g., Department of Energy,
National Oceanic and Atmospheric Administration, U.S. Geological Survey, U.S. Department of
Agriculture and others), identify barriers associated with such mechanisms (e.g., culture differences
between agencies, lack of an inventory of federal environmental research), and take leadership in
improving and developing new mechanisms where appropriate.
3.4.5. Nitrogen research gaps
ORD has integrated programmatic research, with EPA Program Office input, to begin
developing a strategic nutrient management plan for the nation with the intent of accomplishing
the SAB's recommended goal to reduce reactive nitrogen by 25 percent. Are there research gaps
that would impede accomplishing this goal? (For example, should we be looking at green
infrastructure for removing nutrients as well as for controlling storm water?)
In the SSWR Strategic Research Action Plan, there are several gaps in the description of EPA's strategic
nutrient management plan. The EPA should invest more in assessing use of market mechanisms for
nutrient control, i.e., "nutrient trading," including evaluation of programs that have been initiated in the
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United States and elsewhere. The EPA should also identify metrics for nutrient management (e.g.,
metrics that consider financial impacts vs. amount of nitrogen released) to help direct actions by the
EPA and other federal agencies, state agencies, companies, nongovernmental organizations, and
individuals. The EPA should be engaged with and knowledgeable about research on mechanisms and
forms of nutrient delivery in agriculture. Application of fertilizers consisting of highly soluble nitrogen-
bearing salts is at the core of much of the nitrogen management problem. The EPA should not
necessarily be conducting much research itself in nutrient delivery, but should be engaged with those
doing such research and motivating advances in this research.
The SAB and the BOSC also conclude that ORD should identify and seek opportunities for leveraging
limited research dollars and manpower with other federal agencies, and utilize ORD's strengths in areas
such as monitoring, data analysis and modeling within such leveraged efforts. A few potentially
significant leveraging opportunities include: the U.S. Department of Agriculture's Natural Resource
Conservation Service Mississippi River Basin Initiative; the Chesapeake Bay Program's modeling,
monitoring, and trading activities; the National Science Foundation's multi-nation request for proposals
due on February 1, 2013 entitled "Nitrogen: Improving on Nature4" and with private industry. In
addition, there are several opportunities for innovation, including mechanisms and forms of nutrient
delivery and improvements in nitrogen monitoring instrumentation. Innovative improvements in
monitoring toward more robust, less expensive, and portable instruments would be of great value to the
EPA Office of Water, U.S. Geological Survey, state agencies, and others, and could be achieved in
partnership with the private sector and universities, e.g., through open innovation competitions and the
Small Business Innovation Research program. To encourage innovation, the SAB and the BOSC
recommend that EPA leverage efforts of others, conduct outreach to engage the public and other federal
agencies, and conduct competitions that solicit innovative approaches in target areas.
3.4.6. Natural Infrastructure
To better accomplish our goal of using a variety of approaches to address stormwater issues,
should EPA also consider incorporating natural infrastructure into research on constructed
green and gray infrastructure?
ORD should incorporate natural infrastructure into its infrastructure research, and take a leadership role
in conducting green infrastructure research, which overlaps and integrates with ecosystem services. The
SAB and the BOSC recommends that ORD inventory best practices and innovation activities across the
United States to identify the current leaders in green infrastructure and their activities. ORD engagement
with and support of the storm water research initiatives of the Water Environment Research Foundation
is appropriate and commendable, but ORD should do more to be recognized as a leader in storm water
research. Additional partners may include the U.S. Department of Agriculture; the Environmental and
Water Resources Institute of American Society of Civil Engineers; architectural, engineering, and
landscape architectural companies and associations; universities; and organizers of the North American
Storm Water Conference and Exposition5. Innovative solutions in storm water management are being
/- "78
developed in cities such as Chicago , Philadelphia , and Atlanta ; their experience can supplement and
stimulate EPA's efforts.
4 See http://www.nsf.gov/funding/pgm_summ.jsp?pims_id=504773 (accessed 08/16/12)
5 See http://www. stormcon.com/ (accessed 08/16/12)
6 See http://www.cmap.illinois.gov/strategv-papers/stormwater-best-management-practices/stormwater-management: see also
http://www.epa.gOv/owow/NPS/natlstormwater03/2 lMalec.pdf (accessed 08/29/12)
7 See http://www.phillywatersheds.org/watershed_issues/stormwater_management (accessed 08/29/12)
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Much can be learned from these activities. The SAB and the BOSC encourage ORD to develop tools to
encourage and improve how states help communities address Combined Sewer Overflow consent order
requirements in innovative ways. ORD should also examine the NRC's recommendations (NRC 2008c)
for regulation and research needs on storm water monitoring and modeling. ORD should also support
competitions that solicit innovation in these areas.
3.4.7. Recommendations for the SSWR program
ORD should include specific tasks and milestones in the SSWR Strategic Research Action Plan.
The SSWR program should further clarify what is the agency's focus vs. the focus of other
agencies regarding SSWR sustainability-related research.
The SSWR program should develop a structured way to assess emerging issues in establishing
priorities.
The SSWR program should consider the magnitude and distribution of risks associated with not
pursuing emerging SSWR research issues that could benefit certain communities such as
environmental justice communities.
ORD should transparently communicate its efforts to prioritize research and conduct outreach
and actively engage with communities when developing SSWR research priorities.
EPA should invest more in assessing use of market mechanisms for nutrient control, and identify
metrics for nutrient management.
The SSWR program should be engaged with and knowledgeable about research on mechanisms
and forms of nutrient delivery in agriculture.
ORD should identify and seek opportunities for leveraging research related to nutrients with
other federal agencies and utilize ORD's strengths in areas such as monitoring, data analysis, and
modeling within such leveraged efforts.
ORD should assess and encourage opportunities for innovation in nutrient research.
The SSWR program should take a leadership role in conducting green infrastructure research and
incorporate natural infrastructure into its research.
The SSWR program should inventory best practices and innovation activities, and seek
partnership opportunities to assess lessons learned related to green infrastructure.
The SSWR program should develop tools to encourage/improve how states help communities
address Combined Sewer Overflow consent order requirements.
ORD should support competitions that solicit innovation in storm water monitoring and
modeling.
3.5. Homeland Security
The Strategic Research Action Plan for ORD's Homeland Security Research Program (HSRP) states
that the program was established "to conduct applied research and provide technical support that
increases the capability of EPA to achieve its homeland security responsibilities. The HSRP helps build
systems-based solutions by working with agency partners to plan, implement and deliver useful science
and technology products." Its role is to help address key science gaps that relate to EPA's homeland
security role, which has three parts: helping to protect water systems from attack, assisting water utilities
to build contamination warning and mitigation systems, and leading remediation of contaminated indoor
and outdoor settings and water infrastructure.
8 See http://www.atlantawatershed.org/bureaus/storm/WP-Stormwater-Mitigation-mainpage-a2.htm: see also
http://www.cleanwateratlanta.org/stormwater/default.htm (accessed 08/29/12)
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3.5.1. First year progress
How are the ORD research programs progressing in the first year of implementation? Are the
research activities planned for FY13 and future years appropriate for answering the science
questions in the Strategic Research Action Plan?
HSRP has engaged in transdisciplinary research with an extensive portfolio of external partners since
2002. Indeed, ORD's current emphasis on transdisciplinary, problem-solving research reflects much of
what HSRP has been doing for a decade. The immediate opportunities are for HSRP and ORD to better
integrate internally, for HSRP to communicate more clearly how its activities relate to sustainability, and
to explore extension of some of its research into an all-hazards approach (see section 3.5.4).
HSRP is highly accountable and has provided a large number of successfully delivered products for its
clients each year (80 in FY 2012). A sophisticated system exists for partner agreements, timeline
adherence, delivering useful products, and client follow-up - a cradle-to-grave approach to project
management. Partner needs assessment is a key initial step and continues through to product delivery.
The SAB and the BOSC find little reason for concern regarding progress to date, based upon the
information available. However, the ORD restructuring process is relatively new and a better template is
needed for measuring progress. For future reviews, ORD should consider developing metrics for
measuring progress and success at project conception. The HRSP should develop a set of metrics to
evaluate progress to be reviewed by the SAB and the BOSC.
Over the past decade, the HSRP has developed a substantial pipeline of research activities and products.
The pipelines of products are developed in partnership with their customers. As a result, HSRP has an
excellent focus on specific client needs. It may be helpful for HSRP to capture their client's assessment
of their work quality through a customer satisfaction survey.
Atri-agency agreement among the EPA, Department of Defense and the Department of Homeland
Security is in place, HSRP has high-quality collaborations with the Centers for Disease Control and
other agencies. The planned activities are appropriate for answering the science questions in the Science
Research Action Plan.
Although it is encouraging to see long-range planning in the Strategic Research Action Plan, the SAB
and the BOSC are concerned about the HSRP's maintaining its product stream with diminishing
resources. One of the major questions is how resources will be allocated in the future to assure that the
major outcomes will be achieved in the desired timeframe. A major opportunity exists for better
communication about the broad applicability of HSRP products and expertise and marketing HSRP
expertise to additional partners to increase resource leveraging.
3.5.2. Sustainability
How are ORD programs contributing to sustainability through their research plans and activities?
What advice do the SAB and the BOSC have for each research program about advancing
sustainability in future research?
HSRP has advanced sustainability. HSRP is at the core of community sustainability, as defined by the
concepts of resilient societies, economies and the environment. Prevention, mitigation, recovery and
emergency responses are core thrusts for HSRP. Its research products and capabilities are highly
relevant to sustainability. HSRP products will improve the capacity of communities to recover from not
only acts of terrorism, but also the consequences of natural disasters (see response section 3.5.2).
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The HSRP portfolio includes projects such as self-cleaning water treatment facilities and the safe
building program, which focus on improving sustainability. Other notable approaches include green
chemistry (e.g., remediation with fewer adverse effects - Enzymatic Decontamination of Chemical
Warfare Agents). A major opportunity exists for HSRP to expand its impact by identifying multiple
benefits for its products.
The HSRP could enhance its efforts by investing in the development of future human resources through
increasing HSRP's participation in fellowship opportunities such as the American Academy of Arts and
Sciences and Science to Achieve Results fellowship programs. As senior ORD scientists retire over the
next five years, it would be advantageous for HSRP to increase the number of fellows who can assist in
developing the new research programs that advance sustainability in HSRP.
3.5.3. Balancing immediate program needs and emerging issues.
As we consider science for the future, while budgets continue to shrink, how should ORD balance its
commitments in the Strategic Research Action Plan with the need to advance science on emerging
issues?
The HSRP process of client needs assessment provides an excellent mechanism for delivering
responsive products. The HRSP provides an example of an applied research culture with an established
network of relationships helps achieve balance between commitments to clients and advancement of
science on emerging issues. HRSP should seek out projects with one-to-three-year windows. In addition,
HRSP is acclimating well to the culture of innovation. Numerous HSRP projects were included in the
Pathfinder Innovation Program.
3.5.4. Program -specific questions
The HSRP has conducted research primary to support EPA homeland security mission, i.e.,
response to acts of terrorism. In 2011, the SAB and the BOSC stated that "the program should
consider expanding research and capabilities in relation to natural disasters... " What advice (e.g.,
strategic, tactical, structural) can the SAB give to guide the program toward this broader role?
The HSRP is a valuable national resource. An all-hazards approach, as recommended by the SAB and
the BOSC (U.S. EPA SAB 2011 a), will further enhance HSRP's value. Current products should be
assessed and mapped to the needs of potential new partners. HSRP is strongly encouraged to conduct
research portfolio analysis and develop road maps to illustrate the linkages across current and future
research.
Engagement with new partners could allow the partners to benefit from HSRP research capabilities;
provide HSRP with ideas for novel research; and stimulate HRSP thinking in new directions. The phrase
"natural disasters," as previously used, is not the full universe of events where HSRP expertise is
essential. HSRP is already envisioning an all-hazards approach. The national Wide Area Recovery and
Resiliency Program, in which HSRP is a partner, is an example of an all-hazards approach. The cause of
a hazard is often not the critical determinant for the ensuing response. While the required technological
response measures may be similar, the social responses often necessarily differ. Thus, the absence of
social scientists at HSRP is a challenge, given the requirement to engage with diverse audiences, and
ORD integration needs.
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The SAB and the BOSC advised in 2011 that the HSRP should proceed with caution into delving into an
all-hazards approach due to their resource constraints. As stated earlier, analysis should be conducted to
determine what products currently existing in HSRP could be applicable to other hazards, and these
products should be prioritized. Based on the prioritization and existing relationships with other agencies,
HRSP should strive to enhance relationships with other federal agencies where there is synergy. The
SAB and the BOSC consider that the HSRP is in the best position to determine where this synergy exists
and should be encouraged to pursue pilot projects.
3.5.5. Recommendations for the HSRP program
ORD should develop metrics for measuring progress and success at project conception.
The HSRP should document its impact by identifying the multiple benefits of its products. It
should concurrently expand its communication about the broad applicability and many benefits
of HSRP products and expertise; outline the value proposition to stake-holders; and market
HSRP expertise to additional partners to increase resource leveraging.
The HSRP, as a valuable national resource, should adopt an "all-hazards" approach to enhance its
value. Current products should be assessed and mapped to the needs of potential new partners.
HSRP is strongly encouraged to conduct research portfolio analysis and road mapping to
elucidate their current and future research needs.
HRSP should continue to enhance its relationships with other federal agencies where there is
synergy.
3.6. Sustainable and Healthy Communities
The Strategic Research Action Plan for the Sustainable and Healthy Communities (SHC) program
identifies the following vision: The Sustainable and Healthy Communities Research Program will
inform and empower decision-makers in communities, as well as in federal, state and tribal community-
driven programs, to effectively and equitably weigh and integrate human health, socio-economic,
environmental, and ecological factors into their decisions in a way that fosters community sustainability.
The program has four major themes: (1) data and tools to support community decisions; (2) forecasting
and assessing ecological and community health; (3) implementing near-term approaches to sustainable
solutions; and, (4) integrated solutions for sustainable outcomes.
3.6.1. First year progress
How are the ORD research programs progressing in the first year of implementation? Are the
research activities planned for FY13 and future years appropriate for answering the science
questions in the Strategic Research Action Plan?
The SAB and the BOSC recognize that developing and implementing the Strategic Research Action
Plan for such a visionary program is not an easy task and requires major shifts in research direction and
culture. The SAB and the BOSC applaud what the SHC program has accomplished so far. Overall, the
first three themes have made the most progress. The fourth theme will require more time, effort, and
importantlyfocus to fully develop. Overall, the SAB and the BOSC conclude that the SHC program is
on the right track. The SAB and the BOSC provide suggestions for strengthening the planned research
activities in several important areas: integrating ecological and human health; inclusion of social,
behavioral and decision sciences; distinguishing research from implementation; focusing the science
questions and research; engaging communities and building partnerships; and building a typology of
communities. The SAB and the BOSC also identify in this section a list of other issues that require ORD
attention to further strengthen the program.
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Integrating ecological and human health
In particular, the SAB and the BOSC commend the program for using ecosystem services as the vehicle
for integrating human and ecological health and for recognizing this integration as a priority. Although
this integration requires considerable effort, its importance makes it worthy of investment (Di Giulio and
Benson 2002). Moreover, EPA is the one agency that is positioned to do this. Although the
communication flow among the different experts (e.g., ecosystem scientists and human health scientists)
does not always occur at the level needed, ORD is attempting to make these interactions happen.
Sustained efforts to promote interaction and integration are needed. ORD should outline the barriers to
this integration and think creatively about strategies that might help to overcome them.
Challenges to integrating ecological & human health include:
Measuring human health at the community scale (privacy laws make it difficult to obtain fine-
scale human health/safety data, which is often needed to link to ecosystem services. ORD is
currently conducting meta-analyses in an effort to derive fine-scale information);
Funding, resources and time limitations;
A lack of expertise and critical mass for addressing these challenges (though webinars and
meetings are helping the agency to build capacity); and,
Entrenched disciplinary mindsets that will take time and effort to overcome.
Inclusion of social, behavioral and decision sciences
Social, behavioral and decision sciences represent an essential component of the SHC program. Social,
behavioral and decision sciences contribute to understanding human actions that drive environmental,
social and economic change, the value of ecosystem services, development of decision-support tools, the
design of policies, and the behavioral responses to policy changes. SHC has taken a step in the right
direction but much work remains to be done. The SAB and the BOSC were pleased with the recognition
of the importance of integration and efforts to engage social, behavioral and decision scientists, but
would like to see future efforts expanded.
Distinguishing research from implementation
Throughout the action plan, it was difficult to separate: (1) research from implementation, and (2) client
from partner from community. These lines were gray. The SAB and the BOSC expressed concerns that
the SHC Strategic Research Action Plan seems to indicate a move from research into program
implementation. SHC is not in a position to implement environmental protection programs, both because
of limited resources and because the fundamental mission of ORD is research. Implementation should
be done by others, including regional offices, state environmental agencies or partner communities.
Although implementation is of fundamental importance, the question is who should be doing it. The
SAB and the BOSC suggest that SHC articulate a plan for interacting with local communities, state
environmental agencies, and regional offices to better distinguish research from implementation in the
text of the Strategic Research Action Plan. For example, the research and tool development conducted
by ORD does support local communities, but that support is implemented through the regional offices.
This might have been the intention of SHC program, but it was not clear in the wording of the Strategic
Research Action Plan.
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Focusing the science questions and research
The Strategic Research Action Plan has too many science questions, most of which are broadly defined.
The plan needs to better explain how the questions will be answered. Moreover, the plan would benefit
from a sharper focus in terms of the stated research objectives, especially in light of resource constraints.
The SAB and the BOSC recognize the tension inherent in writing a plan for the resources one has or
writing a plan towards the desired resources. At the very least, the program should prioritize the science
questions. The SAB and the BOSC recommend that initially SHC emphasize focused questions and
small victories, rather than the most ambitious projects at the beginning. In other words, SHC should
emphasize those projects that are tractable and can be understood well.
Engaging communities and building partnerships
The SAB and the BOSC commend SHC for engaging stakeholders in community listening sessions.
However, more structured and guided methods will allow for a better understanding of community
values, needs/wants and constraints. There also remains some confusion about what the SHC program
means by community engagement. The SAB and the BOSC suggest that SHC clarify its view of what
community engagement, participatory research and community self-assessment mean for the program.
SHC can draw upon the previous work that has been done in this area (Israel et al 2005; NRC 2005;
NRC 2008b; Pasick et al. 2010; U.S. EPA SAB 2001).
Developing a typology of communities
The SAB and the BOSC are concerned about the time investment required to support the SHC plan to
develop a typology of communities and the classification schemes being used to identify and classify
communities. There are several different concerns. SHC's efforts to include both social and ecological
data in their typology can improve its usefulness to the EPA and distinguish the effort from traditional
approaches to typology, but the SAB and the BOSC recommend that the SHC program identify and
build upon typologies of communities already developed, for example, work done in urban planning and
demography (Frey 2007; Frey 2012). Furthermore, studying the typology of communities may not
provide the information needed by the SHC program. The program's focus on decision support makes it
clear that ongoing efforts to develop a typology of decisions related to the environment will likely offer
the most useful investment. Having a typology of community decisions and the kind of information
needed to inform choices, across different environmental decision making contexts or categories would
be valuable (Gregory et al. 2012). Ideally this typology would be widely accessible to those outside the
agency as well.
Other issues needing attention
Clearly identifying the responsible party for various activities and outputs (Sometimes it wasn't
clear if it was SHC or a partner that would be doing the work);
Clarifying how SHC would link with program offices and the agency's regulatory decisions;
Providing information about how many communities can/will be studied and how they are being
selected (How are they prioritized? The current case study community, Durham, NC, while
convenient, is not necessarily representative of many other communities);
Clarifying what is (and is not) meant by decision-support "tool;"
Improving alignment of science questions, activities, and outputs;
Explicitly identifying the clients and the decisions that the clients need to make;
Aiming for middle-ground models that have the right level of simplicity and synthesis;
Given that ORD wants to have communities at the table and engaged, communicating the
message of the Strategic Research Action Plan in ways accessible to communities;
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Refining the definition of sustainability that applies to communities and offers greater
functionality relative to the goals of the program than the overall EPA definition;; in addition,
determining where the "future generations" piece fits in the definition;
Developing a better interface with decision-makers and explaining how models like TRIO
support or aid decision-makers (e.g., What are the specific decisions that they need to make?
What is the level of detail of the data that they need? Which model will best provide this?); and,
Providing additional details about the models is needed (e.g., what is TRIO?). There is
considerable confusion about the application of specific models and their level of complexity.
3.6.2. Sustainability
How are ORD programs contributing to sustainability through their research plans and activities?
What advice do the SAB and the BOSC have for each research program about advancing
sustainability in future research?
The SHC program has integrated sustainability into its plans exceptionally well. The original foundation
and rationale for the existence of EPA, to promote human health and the environment, provides a strong
basis to pursue the SHC program. The SHC program brings that statement to life.
However, the emphasis on lack of integration as the chief barrier to sustainability does not sufficiently
recognize that communities themselves are better able to identify a wide range of specific problems
other than lack of integration that present barriers. Examples of barriers within the agency include
disparate goals among staff, and media-specific regulations that do not recognize the interconnectedness
of the environment. Barriers within the community may include lack of technical expertise, lack of data,
and lack of professional staff. Integration is one problem, but not the only problem.
3.6.3. Balancing immediate program needs and emerging issues
As we consider science for the future, while budgets continue to shrink, how should ORD balance its
commitments in the Strategic Research Action Plan with the need to advance science on emerging
issues?
Because SHC has a strong focus on both: (1) developing useful tools and platforms, and (2) identifying
the best processes for developing those tools, knowledge generated in this program will be applicable
across a wide range of issues. This approach is well designed to build capacity within the program to
meet unanticipated and emerging issues.
3.6.4. Providing tools to effectively support communities
The Sustainable and Healthy Communities Research Program incorporated a number of diverse
research elements (e.g., ecosystem goods and services, human health outcomes, waste and
contaminant remediation, environmental indicators) in building a research program focused on
supporting community decision-making. The SHC Strategic Research Action Plan aims to
provide science-based research and tools to assist communities in evaluating their decisions
from a sustainability perspective. What advice can the SAB/BOSC provide to help ensure this
research and these tools will most effectively support communities in doing so?
There is a need to build effective partnerships with communities so that both communities and the
agency have input and contribute to the process. This process should not be driven solely by the
community or by the agency but rather be a partnership of the two that builds capacity in both. The EPA
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should recognize that communities may not always know what they need, but that they also often have
important knowledge that is difficult for those outside the community to know. To facilitate these
interactions, SHC can collaboratively develop best practices and model structures by which
communities can engage.
The goal of tool development is not to have SHC "fix" communities but to develop processes that allow
communities to make better decisions. The tools that offer the greatest value will be applicable for a
wide range of communities with different social and ecological attributes and resources. The SAB and
the BOSC recommend that social, behavioral and decision scientists be a part of this dialogue and play
an important role in tool development so that tools, once developed, fit communities' needs and budgets.
SHC should acknowledge that information alone will not ensure that communities will make more
sustainable decisions. Information can sometimes help, but often other social, behavioral, political or
economic obstacles impede progress. It would be beneficial for SHC to direct more attention to research
that identifies how to select and use specific kinds of data to inform decisions and evaluate outcomes.
It is not always obvious to communities or decision makers how to use tools and information. SHC
needs to develop a plan to provide training and documentation to support use of the tools and
information that will be developed by the program. Even the best tools and information will not be used
without such support. Support tools can also provide information on the process for making good
choices. If the decision support tools allow stakeholders to see not only the outcome, but how good
decisions are made, then communities will learn about the process of decision making and the lessons
will be transferable across a variety of scales and communities.
Providing uniform, national-level data, as with the National Atlas, can be a valuable resource. Having
such a resource is likely to spur new applications that may not be known at the outset. The library of
ecosystem services is also an important value-added activity of the SHC program. There is opportunity
to collaborate with other programs. For example, outputs under "Enhancing Community Public Health"
can be pursued collaboratively with HHRA.
3.6.5. SHC Theme 4: Integrated Solutions for Sustainable Outcomes
The SHC's fourth theme investigates sustainability practices within four high priority decision
sectors identified during SHC community listening sessions. These sectors are: transportation,
land use, buildings and infrastructure, and waste and materials management. There are three
primary goals: to assess opportunities for communities to achieve greater synergies from
practices within a given sector and across multiple sectors; to provide methods to more
comprehensively account for these practices in terms of their social, economic, and
environmental outcomes; and to collaboratively apply and refine these findings in partnership
with specific communities (e.g., Durham, NC). Does the Committee agree that this fourth theme
provides a useful way to integrate research within SHC? If so, what are the most important
implementation questions that ORD must address?
The SAB and the BOSC applaud the integration that is evident in Theme 4. It is vital that tools and
analysis be truly integrative across social, economic and environmental realms. This theme is critical to
bringing the SHC program together and, in many ways, represents the fruition of the first three themes.
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While the set of four decision sectors chosen as a result of feedback from communities are important,
they are not all inclusive. It was not clear in the plan that all media (i.e., air, water, and land) will be
analyzed for each of the decision sectors.
The Strategic Research Action Plan does not clearly communicate how the extrapolation from one
place-based analysis to others occurs. Extrapolation could occur at the level of the decision support
processes and tools that are developed. The SHC program needs to explain this more clearly in the
Strategic Research Action Plan. There was also some concern expressed that focusing on a single site is
not sufficient. There is value in choosing multiple sites with different environmental, social and
economic contexts to provide comparisons. The question of how to scale up and provide nationally
relevant information from particular place-based research also deserves further thought. The point of
case studies is to learn about process, and the lessons about process can be extrapolated and applied to
other places.
There was concern about the ability of place-based research to identify outsourcing of negative impacts.
For example, a community that exports wastes may shift problems to other communities. Decision-
making tools should integrate across space just as systems approaches integrate across sectors.
The SHC program should review previous efforts to develop decision-making tools to ensure the utility
of the current effort. What contributed to the success or failure of other tool development efforts?
Learning from past failures is as important as learning from past successes.
While it is vitally important to take an integrative systems approach, there is a real danger that such
approaches can become so complex and unwieldy that they do not deliver useful results in a reasonable
time frame. The more processes and feedback loops that are integrated, the less tractable the approach
becomes. Great care needs to be taken to focus on the crucial aspects of the analysis for integration and
resist the impulse to overcomplicate the approach.
The SHC program should be cautious not to create sector-based silos (e.g., waste, infrastructure) as it
removes disciplinary silos. There is an opportunity to integrate across decision sectors, recognizing the
important interactions among them.
3.6.6. Proper balance between breadth and depth
Does the Committee feel that SHC has the appropriate balance of breadth and depth in its
design? If out year budgets continue to shrink, what areas should SHC maintain as the primary
areas of focus? Can the committee recommend areas that SHC should invest in if budgets
increase?
As a whole, there is good balance with the right balance between breadth and depth. However, the plan
could better highlight to understand system dynamics, including important interrelationships and the
possibility of thresholds. Currently, much of the emphasis is on collecting data and developing metrics
and less progress has been made on understanding system dynamics.
Data collection should be more tightly linked to the decision-support process. The SAB and the BOSC
recommend that SHC explicitly identify the likely suite of community objectives and desired outcomes,
determine the metrics needed to measure performance or progress towards the objectives, and direct data
collection efforts for those metrics.
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All of the themes were seen as important, with Theme 2 (forecasting and assessing ecological and
community health) perhaps being the most foundational to the other themes and science questions. Were
budgets to be cut, the recommendation would be to prioritize the science questions and address the most
important of these rather than eliminate any theme. In this regard, it was noted that it is important to
consider the architecture of the program and to be attentive to linkages among the themes. For example,
work is being undertaken in other themes to support efforts focused on Theme 2.
There is much valuable research that could be accomplished if budgets were to grow. As it stands, the
SHC program has set out a very ambitious plan without sufficient resources in the current budget to
accomplish all of it. Expanding the budget would allow the SHC program to accomplish more of its
research plan in greater depth, offering commensurate added value.
There is a strong need for more investment in social, behavioral and decision sciences. Decision-
scientists, economists, and sociologists should be integrated in ways appropriate to the specific question.
Individuals who study unintended consequences, which often arise as a result of behavioral responses,
would be very useful. Ultimately, investing in these skill sets will increase the efficiency/effectiveness
of SHC efforts. It also sends a strong signal to the academic community regarding the value of
transdisciplinary integration.
3.6.7. Recommendations for the SHC program
Integrating ecological and human health. The SAB and the BOSC commend EPA for
recognizing the importance of bringing together human health and ecosystem services.
Although this integration requires considerable effort, it is an important area that is
worthy of investment. Moreover, EPA is the one agency that is positioned to do this.
Although the communication flow among the different experts (e.g., ecosystem scientists
and, human health scientists) does not always occur at the level needed, ORD is
attempting to foster these interactions. Sustained efforts to promote interaction and
integration are needed. ORD should outline the barriers to this integration and think
creatively about strategies to help overcome them.
Inclusion of social, behavioral and decision sciences. Social, behavioral and decision
sciences are an essential component of the SHC program because they contribute to
understanding human actions driving environmental, social and economic change, the
value of ecosystem services, development of decision-support tools, the design of
policies, and behavioral responses to policy changes. SHC has taken a step in the right
direction but much work remains to be done. The SAB and the BOSC would like to see
future efforts expanded.
Distinguishing research from implementation. Throughout the action plan, it was difficult
to separate (a) research from implementation, and (b) client from partner from
community. The SAB and the BOSC suggests that SHC articulate more clearly its plan
for research and how this plan fits in terms of interacting with local communities, state
environmental agencies, and regional offices, and distinguish research from
implementation in the text.
Focusing the science questions and research. There was some concern that there were too
many science questions, with most too broad in scope. The SAB and the BOSC
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recommend that the Strategic Research Action be edited to explain how each of these
science questions will be answered given the research that will be undertaken. This task
would help SHC bring its stated research objectives into sharper focus, especially in light
of resource constraints. The SAB and the BOSC also recommend that, at the very least,
the program should prioritize the science questions.
Engaging communities and building partnerships. The SAB and the BOSC commend the
SHC program for engaging stakeholders in community listening sessions. However, more
structured and guided methods will allow for a better understanding of community
values, needs/wants, and constraints. There also remained some confusion about what
SHC means by community engagement. The SHC program should clarify its view of
what community engagement, participatory research, and community self-assessment
mean for the program. The SHC program should draw upon the previous work in this
area.
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REFERENCES
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Cherns, A. 1976. The Principleof SociotechnicalDesign. Human Relations Vol. 29 No. 8. pp 783-792.
Di Giulio, R.T. and W.H. Benson (eds.). 2002. Interconnections Between Human Health and Ecological
Integrity. SETAC Press, Pensacola, FL.
Fox, William A. Sociotechnical System Principles and Guideline: Past and Present. Journal of Applied
Behavioral Science, March 1995.
Frey, William H. 2007. America's New Demographics: Regions, Metros, Cities, Suburbs andExurbs.
http://www.brookings.edu/research/speeches/2007/02/12demographics-frey.
Frey, William H. 2012. Diversity Explosion : How New Racial Demographics are Remaking America.
Brookings Institution Press.
Gregory, R., L. Failing, M. Harstone, G. Long, T. McDaniels, andD. Ohlson. 2012. Structured Decision
Making: A Practical Guide to Environmental Management Choices. Wiley-Blackwell,
Chichester, UK.
Guyton, Kate Z. 2012. Applying New Chemical Assessment Approaches in Human Health Risk
Assessment, Slide Presentation July 10-11, 2012.
http://vosemite.epa.gov/sab/sabproduct.nsf/F5A3080F12C356CD85257A3300588CA3/$File/HH
RA CSS +Integration Guvton SAB 071012fmal.pdf (accessed 09/04/12).
Israel B.A., E.A. Parker, Z. Rowe, A. Salvatore, M. Minkler, et al. 2005. Community-Based
Participatory Research: Lessons Learned from the Centers for Children's Environmental Health
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http://ehp03.niehs.nih.gOv/article/fetchArticle.action7articleURMnfo:doi/10.1289/ehp.7675
(accessed 08/17/12).
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National Academy of Engineering. 1999. Industrial Environmental Performance Metrics: Challenges
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National Research Council. 2005. Decision Making for the Environment: Social and Behavioral Science
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Action Plan 2012-2016, EPA 601/R-12/007.
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Research Action Plan 2012-2016, EPA 601/R-12/004.
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APPENDIX A: CHARGE TO THE SAB AND THE BOSC
I. DRAFT SAB/BOSC CHARGE QUESTIONS FOR EACH BREAKOUT GROUP
1. FIRST YEAR PROGRESS
The Strategic Research Action Plans were developed during 2011, with the benefit of SAB and BOSC
advice [Office of Research and Development (ORD) New Strategic Research Directions: A Joint Report
of the Science Advisory Board (SAB) and ORD Board of Scientific Councilors (BOSC). ( EPA-SAB-12-
001)].
Charge Question: How are the ORD research programs progressing in the first year of
implementation? Are the research activities planned for FY 13 and future years appropriate for
answering the science questions in the Strategic Research Action Plan?
2. SUSTAINABILITY
The SAB and BOSC concluded in the October 21, 2011 report that".. .ORD's research frameworks can
advance EPA's adoption of sustainability as a core principle by more consistently and clearly describing
where and how ORD research relates to sustainability."
Charge Question: How are ORD programs contributing to sustainability through their research
plans and activities? What advice does the SAB and BOSC have for each research program about
advancing sustainability in future research?
3. BALANCING IMMEDIATE PROGRAM NEEDS AND EMERGING ISSUES
Meeting program and regional needs is a primary objective of ORD research. The highest priority needs
of the programs tend to be those that are most immediate. Another important role for ORD is to
anticipate the future scientific needs of the programs and regions, areas of research that tend to get less
support from the EPA partners. Anticipating emerging issues and investing in innovative approaches
that could lead to more sustainable, less expensive or timely solutions often requires longer term and
potentially higher risk research. The Strategic Research Action Plans strike a balance in addressing
current priorities and future science needs; however, new emerging issues will likely arise that are not
currently anticipated.
Charge Question: As we consider science for the future, while budgets continue to shrink, how
should ORD balance its commitments in the Strategic Research Action Plan with the need to
advance science on emerging issues?
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PROGRAM SPECIFIC QUESTIONS
Air, Climate and Energy Charge Question:
To create an integrated program, research in ACE is organized in three Themes: 1) Assess Impacts, 2)
Prevent and Reduce Emissions, and 3) Respond to Changes in Climate and Air Quality. Research related
to energy and environment is not a specific focus, but is most prevalent in Theme 2. Relevant topics
include research on near-road air pollution, multi-pollutant research, and greenhouse gas impacts.
How do we bring together research on biofuels, oil and gas measurement methods, combustion
related pollutant effects and modeling/decision support tools into a coherent whole to address the
environmental effects of energy production and use?
Safe and Sustainabile Water Resources Charge Questions:
ORD has integrated programmatic research, with EPA Program Office input, to begin
developing a strategic nutrient management plan for the nation with the intent of accomplishing
the SAB's recommended goal to reduce reactive nitrogen by 25 percent. Are there research gaps
that would impede accomplishing this goal? (for example, should we be looking at green
infrastructure for removing nutrients as well as for controlling storm water?)
To better accomplish our goal of using a variety of approaches to address stormwater issues,
should EPA also consider incorporating natural infrastructure into research on constructed green
and gray infrastructure?
Sustainable and Healthy Communities Charge Questions:
The Sustainable and Healthy Communities Research Program incorporated a number of diverse
research elements (e.g., ecosystem goods and services, human health outcomes, waste and
contaminant remediation, environmental indicators) in building a research program focused on
supporting community decision-making. The SHC Strategic Research Action Plan aims to
provide science-based research and tools to assist communities in evaluating their decisions from
a sustainability perspective. What advice can the SAB/BOSC provide to help ensure this research
and these tools will most effectively support communities in doing so?
The SHC's fourth theme investigates sustainability practices within four high-priority decision
sectors identified during SHC community listening sessions. These sectors are: transportation,
land use, buildings and infrastructure, and waste and materials management. There are three
primary goals: to assess opportunities for communities to achieve greater synergies from
practices within a given sector and across multiple sectors; to provide methods to more
comprehensively account for these practices in terms of their social, economic, and
environmental outcomes; and to collaboratively apply and refine these findings in partnership
with specific communities (e.g., Durham, NC). Does the Committee agree that this fourth theme
provides a useful way to integrate research within SHC? If so, what are the most important
implementation questions that ORD must address?
Does the Committee feel that SHC has the appropriate balance of breadth and depth in its
design? If out year budgets continue to shrink, what areas should SHC maintain as the primary
areas of focus? Can the committee recommend areas that SHC should invest in if budgets
increase?
Chemical Safety for Sustainability Charge Questions:
Is the CSS program well positioned to support EPA needs in the three key areas of endocrine
disrupting chemicals, nanotechnology, and computational toxicology research?
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How well has the exposure component of the CSS research program progressed since its
inception?
Human Health Risk Assessment Charge Questions:
The HHRA research program is committed to modernizing methods to evaluate the health effects
of pollutants, consistent with advice of the SAB/BOSC and National Academy of Sciences.
What aspects of the hazard and dose-response assessments produced by the HHRA research
program are most likely to benefit from the application of state-of-the-art data streams and
methods (e.g., in vitro toxicity testing results, gene expression profiling data, bioinformatics and
QSAR modeling)? Additionally, what approaches can be envisioned to enhance risk managers'
understanding, use and acceptance of these new methods?
In the 2010 mid-cycle progress review of the HHRA program the Board of Scientific Counselors
noted that "IRIS assessments and IS As are among the most heavily peer reviewed documents
provided by scientists anywhere." How can the HHRA research program efficiently obtain robust
peer reviews that contribute to the scientific integrity of assessments without impacting the
timely provision of documents with public health value? Additionally, can the SAB/BOSC
provide advice on the appropriate overall balance of peer review of individual products versus
other recommended scientific capacity-building activities?
Homeland Security Charge Question:
The HSRP has conducted research primary to support EPA's homeland security mission, i.e.,
response to acts of terrorism. In 2011, the SAB and BOSC stated that "the program should
consider expanding research and capabilities in relation to natural disasters..." What advice (e.g.,
strategic, tactical, structural) can the SAB give to guide the program toward this broader role?
II. DRAFT CHARGE QUESTIONS FOR GENERAL ORD/PLENARY SESSION
1. INTEGRATION ACROSS PROGRAMS
By their very nature, environmental issues are cross-disciplinary. Pollutants move and change across air,
land, water and species. Energy, health, environmental justice and ecology are cross cutting topics. To
organize research that is so intertwined requires a structure. By realigning its program from 16 distinct
research topics to six related programs, ORD has made it a priority to eliminate stove-piped research and
foster integrated, transdisciplinary research.
In the first year of implementation, the National Program Directors are in the early stages of managing
each research program, while also taking steps to integrate across the six programs. This requires a
balance of formally organizing and integrating research that relates to multiple programs, without
creating additional, separate research programs.
While there are numerous topics that involve integration, ORD has selected five examples to present as
case studies for the SAB and BOSC to consider. These five integrated topics reflect a range of
dimensions including:
topics that ORD has just begun to integrate and others that are further developed
topics germane to every research program and others more narrowly focused among two or three
topics that are more immediately client-driven and others that are longer-term
Integrated Topics:
Nitrogen
Global Climate Change
Children's Health/Environmental Justice
Applying new chemical assessment approaches in human health risk assessment
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Endocrine-mediated Dose-Response
Charge Question: Based on the presentation of five integrated topics, what advice can the SAB
and BOSC provide to help ORD succeed in integrating research across the ORD programs? How
can different approaches to integration help us achieve our research goals?
2. INNOVATION
The Path Forward principles that guide ORD's realigned research program emphasize pursuing
innovative, ground-breaking research. To address increasingly complex and expensive environmental
problems, innovative solutions are needed.
Charge Question: How can ORD's initial innovation activities be improved to ensure continued
and long term benefits for EPA? Are there useful experiences and lessons from other research
organizations about managing innovation? What guidance can the SAB and BOSC provide for
ORD in developing metrics that would be most effective in assessing the success of our innovation
efforts?
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APPENDIX B: REFERENCES ON INNOVATION IN RESEARCH
Lessons Learned Reports and Publications Related to Innovation and Research
Fagerberg, J., Mowery, D.C., & Nelson, R.R.(Eds.). 2006. The Oxford Handbook of Innovation, New
York: Oxford University Press.
Gupta, Anil. 2010. India's hidden hotbeds of invention. TED; Ideas Worth Spreading.
http://www.ted.com/speakers/anil_gupta.html (accessed 09/04/12).
Mumford MD. 2000. Managing creative people: strategies and tactics for innovation. Human Resource
Management Review 10(3):313-351
National Academies of Science. 2012. Fostering Partnerships and Linkages in Sustainability Science
and Innovation -A Symposium.
http://sites.nationalacademies.org/PGA/sustainability/SustainabilitySymposium/ (accessed
09/05/12)
National Institutes of Health. Review of Research for Innovation.
n.d.http://grants.nih.gov/grants/writing_application.htm (Writing your application -grants
process overview) and http://grants.nih.gov/grants/peer review_process.htm (Peer review
process) respectively (accessed 09/28/12).
Ness, R.B., 2012. Innovation generation: how to produce creative and useful scientific ideas. New York,
NY: Oxford University Press.
Samet, J.M., R. B. Ness. 2012. Epidemiology, austerity, and innovation. American Journal of
Epidemiology 175:975-978.
Slappendel C. 1996. Perspectives on innovation in organizations. Organization Studies 17(1): 107-129
Innovation and Metrics
Boly, V., L. Morel, M. Camargo, M. 2012. Improving performance evaluation metrics to manage
innovative projects. International Journal of Technology Intelligence and Planning, 8 (3), pp.
215-232.
Bonvillian, W.B., R van Atta, 2011. Applying the DARPA model to energy innovation. Journal of
Technology Transfer, 36 (5), pp. 469-513.
Benoit Godin, 2004 Measurement and Statistics on Science and Technology: 1920 to the Present.
London: Routledge.
Hamel, G. 2006. The why, what, and how of management innovation. Harvard Business Review, 84 (2),
pp. 72-84.
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McKinsey Quaraterly. 2008. McKinsey Global Survey Results.
http://www.mckinseyquarterly.com/McKinsey_Global_Survey_Results_Assessing_innovation_
metrics_2243 (accessed 09/05/12).
Muller, Amy, Liisa Valikangas, and Paul Merlyn. No date. Metrics for innovation: guidelines for
developing a customized suite of innovation metrics.
http://www.strategos.com/articles/InnovationMetrics/InnovationMetrics.pdf (accessed 09/05/12)
Rampersad, G., P. Quester, P., L. Troshani, 2009. Developing and evaluating scales to assess innovation
networks. International Journal of Technology Intelligence and Planning, 5 (4), pp. 402-420.
Scott D. Anthony, Mark W. Johnson, Joseph V. Sinfield, Elizabeth J. Altman. 2008. The Innovator's
Guide to Growth: Putting Disruptive Innovation to Work; Chapter 10: Innovation Metrics.
Harvard Business Press Books. Boston MA. 321 pages.
National Academies of Sciences. STAR Metrics Working Group.
http://sites.nationalacademies.org/PGA/fdp/PGA_057189 (accessed 09/19/2012)
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