United States
Environmental Protection
Agency
Research and
Development
(8101)
EPA/600/R-96/059
May 1996
&EPA Strategic Plan for the
Office of Research and
Development
> Printed on paper that contains at least 20% postconsumer fiber.
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ORD's Strategic Plan
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC 20460
May 1996
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Foreword
I am very pleased to present this new Strategic Plan for environmental research at the U.S.
Environmental Protection Agency's (EPA's) Office of Research and Development (ORD). In
recent years, many important groupsincluding EPA's Science Advisory Board and blue
ribbon panels convened by the National Academy of Public Administration and the
National Research Councilhave made many excellent suggestions for improving science at
EPA. This plan incorporates and builds on these ideas to provide a blueprint for charting a course
of strong, credible science at EPA into the next century.
This plan is the culmination of a number of strategic changes to institute a more effective,
risk-based research program at ORD. For example, we reorganized our nationwide system of
laboratories to conform to the fundamental components of the widely used risk assessment and
risk management processes. With this Strategic Plan, we have instituted a new system for
determining research priorities based on risk assessment and risk management principles. We
will use this system to sharpen the focus of our research by directing our resources where we can
contribute most effectively to understanding and solving environmental problems, while also
fully supporting EPA in fulfilling its mandates.
By providing clear mechanisms and opportunities for stakeholder involvement, this plan promotes
greater partnership between ORD and its primary clientsEPA's Program and Regional Offices
as well as the external scientific community. And, by clearly delineating ORD's research planning
process, goals, and objectives, this plan is a tool our stakeholders can use to measure our success in
providing practical, credible, and timely information and tools for risk-based decision-making. To
ensure the utmost transparency, this plan also includes a detailed description of how ORD translates
its research priorities into a research program, as well as a discussion of our commitment to providing
the infrastructure needed to conduct high quality research.
This plan is a foundation for the future. We have designed this Strategic Plan to endure and yet
be dynamic in the face of continually advancing scientific knowledge and understanding. That is
why we have selected time-tested risk-based organizing and decision-making principles that
transcend economic and political changes. At the same time, we have designed the plan to be
flexible, providing capacity for our planning mechanisms to constructively adapt to changing
EPA and national priorities over time.
We invited other EPA offices and Regions as well as numerous external organizations to peer
review a draft of this plan. This final version of the plan now incorporates many of their useful
suggestions. We will periodically revisit and, as necessary, modify this Strategic Plan to ensure
the continued productivity of ORD's research and development efforts to meet EPA and national
environmental goals.
I firmly believe that this Strategic Plan, coupled with the other strategic changes we have
instituted at ORD (listed on the back inside cover), offer unparalleled opportunities for ORD to
improve the overall quality and relevancy of EPA research and development. I am confident that,
in the coming years, these changes will serve as essential catalysts for moving EPA into the
highest echelon of leadership in environmental science.
Robert J. Huggett
Assistant Administrator, Office of Research and Development
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Contents
List of Acronyms v
Executive Summary vii
Strategic Principles vii
ORD's Vision, Mission, and Long-Term Goals vii
Setting ORD Research Priorities viii
High-Priority Research viii
Looking Ahead viii
Introduction 1
ORD's Reinvention Around the Risk Paradigm 1
Audiences for This Document 5
Critical Players and Linkages for Implementing ORD's Strategic Plan 5
Evolution of the Strategic Plan Over Time 6
A Roadmap for This Document 6
Part A: ORD's Research Strategy 9
ORD's Vision 9
ORD's Mission 9
ORD's Long-Term Goals and Objectives 10
Identifying Specific Research Topics 10
Identifying Emerging Issues, Anticipatory Research, and Exploratory Research 12
ORD's Priority-Setting Process 13
Criteria for Setting ORD Research Priorities 13
Strengths of ORD's Priority-Setting Process and Criteria 15
Translating ORD's Strategic Plan Into a Research Program 15
Measures of Success 17
Mechanisms for Evaluation and Accountability 18
Closing Out Completed Work 18
Technical Support 18
Human Resources and Infrastructure 18
Challenges for the Future 20
STRATEGIC PLAN FOR ORD III
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Part B: ORD's Long-Term Goals and Objectives 21
Goal 1 21
Goal 2 23
GoalS 23
Goal 4 25
GoalS 26
Goal 6 26
Appendix I: ORD's High-Priority Research 29
Appendix II: The ORD Organization 51
Appendix III: Management Structure for
Implementing ORD's Strategic Plan 55
Appendix IV: Relationship of Fiscal Year 1996 Requests
for Applications to ORD High-Priority Research Topics 59
IV STRATEGIC PLAN FOR ORD
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List of Acronyms
CRADA
Cooperative Research and Development Agreement
EPA
U.S. Environmental Protection Agency
IRIS
Integrated Risk Information System
NAE National Academy of Engineering
NAPA National Academy of Public Administration
NAS National Academy of Sciences
NCEA National Center for Environmental Assessment
NCERQA National Center for Environmental Research and Quality Assurance
NERL National Exposure Research Laboratory
NHEERL National Health and Environmental Effects Research Laboratory
NRC National Research Council
NRMRL National Risk Management Research Laboratory
ORD Office of Research and Development
ORMA Office of Resources Management and Administration
ORSI Office of Research and Science Integration
OSP Office of Science Policy
RCC
RCT
R&D
RFA
ROPE
Research Coordination Council
Research Coordination Team
research and development
Request for Application
Research Opportunities and Priorities for EPA
SAB
STAR
Science Advisory Board
Science to Achieve Results
STRATEGIC PLAN FOR ORD
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Executive Summary
The U.S. Environmental Protection Agency's
Office of Research and Development
(ORD) has undertaken some of the most
dramatic changes in its organizational
history, setting the vision and direction for the
research that will provide the scientific foundation
to support EPA's mission:
ORD realigned its organizational structure to use
risk assessment and risk management as organiz-
ing principles for its nationwide laboratory
system.
ORD strengthened its interaction with the larger
scientific community by expanding its competi-
tive extramural grants and graduate fellowship
programs. These programs stimulate research in
areas vital to EPA by involving universities and
other not-for-profit institutions.
ORD intensified its peer review process to ensure
that all science meets our standards for excel-
lence.
And, most importantly, ORD instituted a new
strategic planning and management process by
which we identify and select our research priori-
ties. This new process sets us on a course that will
allow us to more clearly define the next genera-
tion of environmental needs and identify the
research to address those needs.
Describing this strategic planning and management
process, and providing the framework for research
priorities, is the ORD Strategic Plan.
Strategic Principles
The ORD Strategic Plan is based on nine strategic
operating principles, summarized below, which
draw on the many recommendations ORD has
received from outside groups in recent years:
Focus research and development on the greatest
risks to people and the environment.
Focus research on reducing uncertainty in risk
assessment.
Balance human health and ecological research.
Infuse ORD's work with a customer/client ethic.
Give priority to maintaining strong and viable
core capabilities.
Nurture and support the development of out-
standing scientists, engineers, and other
environmental professionals.
Increase competitively awarded research grants.
Require the highest level of independent peer
review and quality assurance.
Provide the infrastructure to achieve and main-
tain an outstanding R&D program.
Most important of these principles is the explicit use
of the risk paradigm to shape and focus our
organizational structure and research agenda.
ORD's Vision, Mission, and
Long-Term Goals
ORD's commitment to develop a risk-based research
agenda has required us to rethink our vision, mission,
and goals and to develop a risk-based process for
selecting and ranking those research areas of primary
importance to EPA. ORD's vision and mission for the
future arise from a consideration of the key role that
ORD science plays within EPA and in the broader
context of our nation's environmental research
agenda. Our vision is that ORD will provide the
scientific foundation to support EPA's mission. Our
new mission statement is divided into four main
components: research and development, technical
support, integration of scientific information, and
anticipatory research. This translates into six
long-term, overarching goalsbroad areas of
research and development where we believe ORD
can and must make important contributions to
STRATEGIC PLAN FOR ORD
VII
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Executive Summary
EPA's mission and mandates and to our nation's
overall environmental research agenda.
Setting ORD Research Priorities
Essential to meeting our long-term goals is a process
we will use to set priorities within the universe of
possible research, and to focus our efforts on those
areas of primary importance to EPA's mission. Our
new priority-setting process involves the following
steps:
First, we involve all parts of EPA, including
ORD's own researchers and staff, in helping us
set research priorities. The Research Coordina
tion Council, the Science Council, Research
Coordination Teams consisting of senior repre-
sentatives from ORD's new National Laboratories
and Centers and EPA's Program and Regional Of-
fices identify the most important and relevant
areas for our research efforts. We also work with
EPA's Science Advisory Board, the National Re-
search Council, and the private sector early in the
planning process to obtain recommendations
from the external scientific community regarding
the major scientific directions and priorities for
our research program. Based on this input, we
identify potential research topics.
We then narrow the pool of potential topics by
selecting areas that clearly will contribute to
fulfilling Agency mandates.
To these remaining areas falling within ORD's
mission and goals, we apply a series of human
health, ecological health, and risk management
criteria to set priorities according to their poten-
tial to support effective risk assessment and
enhance risk reductionfor example by reducing
the uncertainties in risk assessment. We use com-
parative risk analyses, as needed, to ascertain the
most pressing problems. We also consider
whether the research would develop broadly ap-
plicable methods and models needed by EPA
programs. We then ascertain whether ORD can
make a significant contribution. Through this
screening process, we set priorities among the
research topics.
We then define our specific R&D projects by con-
sidering each topic area in totality. For each topic
area, we systematically examine the research
needs within each component of the risk para-
digm: effects, exposure, assessment, and risk
management. Based on this analysis, we define a
series of high-priority research activities across
the risk paradigm that will produce a comprehen-
sive set of useful risk-based results.
Once we have identified our high-priority topics,
we develop and implement a research program
with specified roles for intramural and extramu-
ral participants, identifiable products, and
provisions for accountability and visibility regard-
ing progress on our commitments.
High-Priority Research
ORD has used the process described above to establish
our research priorities for the next few years. Using
our new risk-based planning process and criteria,
ORD has identified six high priorities that will receive
special, expanded attention within the broader ORD
program. These high priorities include three discrete
research topics and three broad-based areas that can
incorporate many additional specific topics:
Drinking water disinfection
Particulate matter
Endocrine disrupters
Research to improve ecosystem risk assessment
Research to improve health risk assessment
Pollution prevention and new technologies
Looking Ahead
The Strategic Plan provides a blueprint for
designing and implementing a research program to
produce the sound science needed to support EPA's
mission. In the years to come, ORD will place a
continuing priority on providing the
communication, infrastructure, and support
necessary for successful implementation of the plan.
For ORD's stakeholders, including the EPA Program
and Regional Offices, academia, the private sector,
and other government agencies, the plan serves as a
roadmap that explains ORD's research planning and
implementation process, defines how our stakeholders
contribute to this process, and specifies the goals,
objectives, and products they can use to hold us
accountable for our progress in environmental
research. This plan is intended to serve as a practical
tool for ensuring the constructive involvement of
our stakeholders in establishing and executing
ORD's research agenda during the coming years.
viii
STRATEGIC PLAN FOR ORD
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Introduction
Science is one of the soundest investments
the nation can make for the future. Strong
science provides the foundation for credible
environmental decision-making. With a
better understanding of environmental
risks to people and ecosystems, EPA can
target the hazards that pose the greatest
risks, anticipate environmental problems
before they reach a critical level, and
develop strategies that use the nation's,
and the world's, environmental protection
dollars wisely.
Expert Panel on the Role of Science at
EPA
Safeguarding the Future: Credible
Science, Credible Decisions
In recent years, a convergence of thinking has
occurred about science at the U.S. Environ-
mental Protection Agency (EPA). The Agency's
own Science Advisory Board (an independent
group of engineering and science advisors to EPA)
and expert blue-ribbon panels convened by the
National Academy of Sciences (NAS) and the
National Academy of Public Administration
r\
(NAPA) all have emphasized the importance of
science at EPA and made many recommendations
concerning its role and direction.
As these groups affirmed, science provides the
foundation for credible environmental
decision-making. It is vital to achieving a healthy
population, thriving environment, and robust
economy. Only through adequate knowledge about
the risks to human health and ecosystems, and
innovative solutions to prevent pollution and
reduce risk, can we continue to enjoy a high quality
of life. In July 1994, EPA published a five-Year
o
Strategic Plan that adopts strong science and
credible data as one of seven guiding principles to
fulfill the Agency's mission to protect human health
and environmental quality. While all of EPA uses
science for policy and regulatory decision-making,
and various EPA offices perform research, the
responsibility for leadership in science at EPA and
for the bulk of EPA's research and development
work resides in EPA's Office of Research and
Development (ORD).
ORD's Reinvention Around the
Risk Paradigm
In the past two years, we at ORD have substantially
changed our organization and operation so that we
Interim Report of the Committee on Research and Peer Review at EPA
National Academy of Sciences Board on Environmental Studies
and Toxicology. 1995. National Academy Press.
2 Setting Priorities, Getting Results. A New Direction for EPA. Na-
tional Academy of Public Administration. 1995. Washington, DC.
3 The New Generation of Environmental Protection. A Summary of
EPA's Five-Year Strategic Plan. U.S. Environmental Protection
Agency. 1994. EPA200-2-94-001. Washington, DC.
STRATEGIC PLAN FOR ORD
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Introduction
can strengthen EPA's science base and improve the
Agency's and our nation's ability to effectively
respond to the complex environmental challenges of
the future. These changes represent a significant
departure from the past. They are based on a set of
strategic principles we have developed (Table 1) that
draw upon the many recommendations we have
received from outside groups in recent years. The
most important of these principles is the explicit use of
the risk paradigm to shape and focus our
organizational structure and research agenda.
The risk assessment paradigm has been defined many
times over the years, most notably in 1983 by the NAS
(Figure 1), which consolidated and gave context to
Table 1.
ORD's Strategic Principles
Focus research and development on the greatest
risks to people and the environment, taking into
account their potential severity, magnitude, and
uncertainty.
Focus research on reducing uncertainty in risk
assessment and on cost-effective approaches for
preventing and managing risks.
Balance human health and ecological research.
Infuse ORD's work with a customer/client ethic
that breaks down organizational barriers and
ensures responsiveness to ORD's internal and
external customers.
Give priority to maintaining the strong and viable
scientific and engineering core capabilities that
allow us to conduct an intramural research and
technical support program in areas of highest
risk and greatest importance to the Agency.
Through an innovative and effective human
resources development program, nurture and
support the development of outstanding scien-
tists, engineers, and other environmental
professionals at EPA.
Take advantage of the creativity of the nation's
best research institutions by increasing competi-
tively awarded research grants to further EPA's
critical environmental research mission.
Ensure the quality of the science that underlies
our risk assessment and risk reduction efforts by
requiring the very highest level of independent
peer review and quality assurance for all our
science products and programs.
Provide the infrastructure required for ORD to
achieve and maintain an outstanding research
and development program in environmental
science.
terms that had been defined in different ways up to
that point. Risk assessment is the process that
scientists use to understand and evaluate the
magnitude and probability of risk posed to human
health and ecosystems by environmental stressors,
such as pollution or habitat loss or change. The
resulting risk characterization, together with other
public health, statutory, legal, social, economic,
political, and technical factors, provides the critical
input for deciding whether and how to manage the
risk associated with a particular stressor. Risk
management options may include both regulatory
programs and voluntary activities (e.g., recycling) to
reduce or eliminate production of the stressor.
The risk assessment process is one component of the
overall process of risk management. The risk
management process begins when a potential new
History of This Document
Work on this Strategic Plan began in 1995 by a task
force comprised of staff from ORD's National Labo-
ratories and Centers, as well as our headquarters
Offices. As we developed the plan, we consulted
with our clients in EPA's Program and Regional Of-
fices to ensure that the plan would enable ORD to
effectively meet their needs and maintain good cus-
tomer relations. We also relied heavily on the
advice of the National Research Council and EPA's
Science Advisory Board. In late 1995, we distributed
a review draft of the plan to solicit comments from
our external partners and stakeholders. Based on
peer reviewer comments, we refined and expanded
our plan to produce this final version. Major
changes reflected in the final plan include:
Clarification of our vision, mission, and research
goals.
Better linkage between our research plan-
ning process and our criteria for setting
research priorities.
A better balance of health and ecological con-
cerns.
Clarification of our approach to anticipatory
research and emerging environmental problems.
Discussion of ORD's role in providing enhanced
technical support to EPA's Program Offices.
A more complete discussion of our grants
process.
A brief discussion of "Challenges for the Future"
that peer reviewers brought to our attention and
to which we plan to devote further study.
STRATEGIC PLAN FOR ORD
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Introduction
Figure 1.
The Risk Assessment/Risk Management Paradigm
Risk Assessment Risk Management
Statutory and Legal
Considerations
Dose-Response
Assessment
'Adapted from:
Risk Assessment in the
Federal Government:
Managing the Process.
National Academy of
Sciences. 1983.
Science and Judgement
in Risk Assessment.
National Research
Council. 1994.
The risk assessment process consists of four steps:
During hazard identification, scientists describe the adverse effects (e.g., short-term illness, cancer, reproduc-
tive effects) that might occur due to exposure to the environmental stressor of concern. To identify potential
hazards, scientists use the results of experimental studies on test organisms, reports about accidental expo-
sure, and epidemiologic research.
During dose-response assessment, scientists determine the toxicity or potency of a stressor. The dose-
response assessment describes the quantitative relationship between the amount of exposure to a stressor
and the extent of injury or disease.
During exposure assessment, scientists describe the nature and size of the population(s) or ecosystem(s)
exposed to a stressor and the magnitude and duration of exposure. Exposure assessment includes a
description of the pathways (e.g., air, food, water) by which the stressor travels through the environment;
the changes that a stressor undergoes en route; the environmental concentrations of the stressor relative to
time, distance, and direction from its source; potential routes of exposure (oral, dermal, or inhalation); and
the distribution of sensitive subgroups, such as pregnant women and children.
During risk characterization, scientists use the data collected in the three previous steps to predict the
effects of human or ecological exposure to the stressor of concern. They estimate the likelihood that a
population will experience any of the adverse effects associated with the stressor, under known or expected
conditions of exposure. This estimate can be qualitative (e.g., high or low probability) or quantitative (e.g.,
one in a million probability of occurrence).
The NAS paradigm was developed specifically to define risk assessment and risk management for human
health. While ORD recognizes that there are distinctions for ecological risk assessment and that scientific ap-
proaches to risk assessment have evolved and expanded since development of the NAS paradigm, the general
principles set forth in the NAS paradigm are still useful as an organizing focus for ORD's strategic thinking.
risk comes to light and authorities decide or are
mandated to respond to concern about the risk. It
involves risk assessment as well as a series of other
scientific and technical activities, illustrated in
Figure 2, to provide the scientific and technical data
for making and implementing a risk management
decision. The risk management process ends when
the selected risk management option (s) is
implemented and the resulting environmental
and/or public health improvements are monitored.
Figure 2 expands on the "Risk Management
Options" portion of the original NAS paradigm
to show the many scientific and technical
activities, in addition to risk assessment, that are
essential to risk management. These include
characterizing the sources of environmental
problems; identifying risk management options
and evaluating their performance, cost, and
effectiveness; and monitoring improvements in
environmental quality and public health that result
PLAN
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Introduction
Figure 2.
The Scientific and Technical Contributions to Risk Management
Identification of Future Problem,
Initiating Event, or Public Policy Mandate
Risk Management
, , Dose-Response
Risk Assessment Assessment
Define the Problem
Define Risk Management
Objectives
\
Hazard Risk
Identification Characterization
Identify and Evaluate
Risk Management Options
Exposure
Assessment
Risk Management Decision
Develop Compliance
Assurance Models and Methods
Implement Option(s)
Develop Measures of
Environmental and ^MonjtOr Environmental
Public Health and pubNc Hea,tn
Public Health
Considerations
1 Statutory and Legal
Considerations
1 Social Factors
1 Economic Factors
1 Political Considerations
Reduced Environmental
and/or
Public Health Risk
Scientific and technical activities contribute to every stage of the risk management process. Environmental risk
management is initiated when a potential new environmental risk comes to light (such as an unusually high disease
rate in a particular population) and authorities decide or are mandated to investigate it.
The first step is to define the problem. This involves such activities as determining which stressor(s) (e.g., pollutants,
habitat loss) is causing the problem, characterizing the sources of the stressor(s), how these stressors reach target
populations, and which human or ecological populations are affected. Once the problem has been sufficiently char-
acterized, the risk assessment process can begin.
If sufficient information is available at this stage, scientists and engineers can also begin to define risk management
objectives (i.e., the degree to which the risk should be managed or reduced) and identify risk management options
that can meet the objectives. Frequently, however, these steps must await further information, provided by the risk
assessment, on which populations are at risk and how great that risk is. Once potential options have been identi-
fied, scientists and engineers evaluate the options to determine their performance and cost. Risk management
options may include, for example, pollution control technologies, banning or controlling the use of certain chemi-
cals, cleaning up or preventing access to contaminated areas, implementing educational programs to encourage
voluntary behavior changes on the part of the public or industry, and redesigning industrial processes to reduce or
eliminate toxic waste production.
The resulting information on the feasibility of potential risk management options, together with the risk charac-
terization (and public health, statutory, legal, social, economic, and political factors), is used to make a risk
management decision. Typically, this will involve selecting one or more of the potential risk management options
and designing a regulatory and/or nonregulatory strategy for implementing the chosen option(s).
Once a risk management strategy has been selected, scientists and engineers then develop compliance assurance
models and methods (if the strategy is regulatory) and measures of environmental and public health improvement
to monitor the success of the strategy in reducing risk to humans or ecosystems. Once the selected option(s) is im-
plemented, scientists and engineers monitor the environmental and public health improvement. Monitoring data
provide feedback to the risk management decision-makers about whether the risk management strategy is achiev-
ing the desired goals. Decision-makers may then amend the strategy, as necessary, based on these results. The final
outcome of a successful risk management process is reduced environmental and/or public health risk.
PLAN
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Introduction
Figure 3.
ORD's Strategic Plan
from risk management activities. ORD contributes
to many of the areas depicted in Figure 2. In this
way, ORD not only identifies and characterizes
environmental problems but also helps to find and
implement efficient, cost-effective solutions to these
problems.
The first major step in ORD's reinvention was to
reorganize ORD so that its new structure mirrors the
risk paradigm shown in Figure 1. This new structure
is described in Appendix II. ORD's new Strategic
Plandescribed in this document and illustrated in
Figure 3is the second major step. This Strategic
Plan is the blueprint for ORD's risk-based research
program.
Audiences for This Document
This Strategic Plan is an important document for
many different groups:
Internally at ORD, the plan provides ORD staff
with a blueprint for designing and implementing
ORD's research program in the years to come.
Also, it enables ORD staff to relate the individual
research projects for which they are responsible
to ORD's strategic goals and objectives, as well as
to the Agency's environmental goal of "ensuring
that the nation's environmental policies are based
on the best science and information available."
For our many stakeholders, including EPA's Pro-
gram and Regional Offices, academia, the private
sector, and other government agencies, the plan
serves as a roadmap that:
Explains how we plan research and translate
our plans into a research program.
Defines an explicit role for stakeholders in
crafting and reviewing ORD's research agenda.
Specifies goals, objectives, and products that can
be used to measure and hold us accountable for
our progress in environmental research.
Critical Players and Linkages for
Implementing ORD's Strategic Plan
The success of ORD's Strategic Plan relies on the
contributions of many individuals, institutions, and
sectors, as described below.
ORD Staff
First and foremost, ORD staff are crucial to the plan's
success. ORD's scientists and engineers, in particular,
are the repository of the core scientific and engineering
capability in the Agency, as well as a vital conduit for
the needs and potential contributions of ORD's
research clients and partners.
Successful implementation of the Strategic Plan
will depend on the success of ORD managers in
communicating the plan to all our staff and in
evoking a sense of ownership of the plan and a
shared vision of the work to be accomplished. While
leadership for communicating this plan must
cascade through ORD's management to our
scientific, engineering, professional, and support
staff, ownership and implementation of the plan
will depend on the strength of our work force. ORD
will place a continuing priority on internal
communication and support to enable and inspire
effective implementation of this plan.
EPA Program and Regional Offices
Linkages between ORD and its primary clients
EPA's Program and Regional Officesare essential
to successful implementation of this plan. One
important linkage is the day-to-day contact that
ORD scientists and engineers have with EPA's
Program and Regional Offices. This ongoing
informal contact helps ensure that the ORD
STRATEGIC PLAN FOR ORD
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Introduction
scientists and engineers involved in our planning
process understand our client's needs.
In addition, this Strategic Plan establishes formal
areas of linkage to ensure client input during
research planning. As Part A of this plan describes,
we directly solicit input on priority needs and
products from the Program and Regional Offices
during the planning process.
ORD's Research Planning Advisors
As described in Part A of this document, our planning
process also relies on the contributions of many other
groups who provide crucial input for formulating and
executing our research program and priorities. These
include other federal agencies (both directly and
through the National Science and Technology Council
and its Committee on Environment and Natural
Resources), as well as the National Research Council
and EPA's Science Advisory Board.
ORD's Research Partners
Successful plan implementation also relies on ongoing
partnerships between ORD and other research
organizations in academia, the private sector, and
other government agencies. These partnerships benefit
all parties. They provide a common sense and
cost-effective way for ORD to utilize the special
expertise residing outside our organization, while also
reducing overlapping and duplicative work. Our
partners enrich our research planning process and
help ensure that our research products are
appropriately targeted to stakeholder needs. ORD
accesses and involves partner organizations in
implementing our research program through a variety
of competitive, grant, and contractual mechanisms.
Shared Leadership
In the context of environmental science, ORD serves
both as a team leader for research planning within
EPA and as a national leader within the larger
scientific community for conducting our nation's
environmental science. ORD implicitly shares
responsibility for this leadership through our peer
review protocols, which ensure both internal and
external vetting of each critical step in our research
process, from identifying research priorities to
evaluating our eventual success.
Looking Ahead
As ORD implements its Strategic Plan in the years to
come, we will strengthen our links with our clients
and partners. We will work to expand our
partnerships with other agencies, universities, and
the private sector and to integrate our planning
efforts with EPA's overall planning based on the
Agency's Strategic Plan. Also, we will strive to forge
links with the planning efforts of other federal
agencies and other nations as appropriate.
Evolution of the Strategic Plan
Over Time
ORD's Strategic Plan is designed to be a robust
"living" document. The plan provides a solid
underpinning for ORD research that will allow us to
maintain continuity and momentum in our work in
the coming years, while also constructively adapting
to changing EPA and national priorities over time.
We will periodically revisit and, as necessary,
modify our Strategic Plan to ensure the continued
productivity of ORD's research and development
efforts to meet EPA, national, and international
environmental goals. At the same time, we will
work to ensure that, as the plan evolves, it continues
to reflect goals and objectives that are communally
derived and universally shared throughout ORD.
A Roadmap for This Document
Part Aof the plan defines strategic directions
(including ORD's vision, mission, and goals) for
ORD research; lays out an approach to identify-
ing emerging issues; establishes a risk-based
process for determining our research priorities;
describes how we translate this Strategic Plan
into a specific research program (including re-
search plans, operating plans, laboratory
implementation plans, and Requests for Applica-
tions); describes how we determine who does the
work and when to close it out; describes how we
will determine priorities for technical support;
presents approaches to measuring success; and
describes ORD's commitment to our human re-
sources and infrastructure that are essential to
implementing the Strategic Plan. Finally, Part A
identifies challenges for future consideration by
ORD.
STRATEGIC PLAN FOR ORD
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Introduction
Part B expands on ORD's goals and lists the
specific research objectives and activities ORD
will pursue to achieve its goals.
Appendix I describes the six high-priority
research topics and areas selected when we ap-
plied our new priority-setting process (described
in Part A) to our long-term objectives and activi-
ties (described in Part B).
Appendix II describes ORD's new organization
around the risk assessment/risk management
paradigm.
Appendix III describes ORD's management struc-
ture for implementing the Strategic Plan.
Appendix IVshows how ORD's extramural invest-
ments (in the form of Requests for Applications
for research grants) relate to the high-priority
research described in Appendix I.
STRATEGIC PLAN FOR ORD
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-------
Part A
4
ORD's
Researc
Strategy
^^ R
[A] strategic plan should consist at a
minimum of a vision statement, a
mission statement, and a plan for
achieving them. [It] should be robust and
specific enough to enable [evaluation of]
the intended role of ORD and its
organizational components in providing
scientific and technical knowledge to
support national environmental
programs, policies, and decisions, as well
as to identify unnecessary geographical
and functional duplication and
significant gaps in ORD activities.
National Research Council
Interim Report of the Committee on
Research and Peer Review in EPA
(March 1995)
ORD's commitment to develop a
risk-based research agenda has required
us to rethink our vision, mission, and
goals and to develop a risk-based
process for selecting and ranking those research
topics of primary importance to ORD and EPA.
ORD's vision and mission for the future arise from a
consideration of the importance of science at EPA
and in the broader context of our nation's
environmental research agenda, and of ORD's key
role in environmental science. Our vision, described
below, represents the overall level of achievement
that we will strive for in all our research and
development work. Our mission statement,
described below, defines the broad areas of research
and development where we believe ORD can and
must make important contributions to EPA's
mission and mandates and to our nation's overall
environmental research agenda.
ORD's Vision
ORD will provide the scientific foundation to
support EPA's mission.
ORD's Mission
ORD's mission is to:
Perform research and development to identify,
understand, and solve current and future
environmental problems.
Provide responsive technical support to EPA's
mission.
Integrate the work of ORD's scientific partners
(other agencies, nations, private sector organiza-
tions, and academia).
Provide leadership in addressing emerging envi-
ronmental issues and in advancing the science
and technology of risk assessment and risk man-
agement.
STRATEGIC PLAN FOR ORD
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ORD's Research Strategy
ORD's Key Role
Public and private sector institutions have long
been significant contributors to our nation's environ-
mental and human health research agenda. EPA's
Office of Research and Development, however, is
unique among scientific institutions in this country
in combining research, analysis, and the integration
of scientific information across the full spectrum of
health and ecological issues and across both risk
assessment and risk management. This broad
scope has resulted in scientific and engineering
expertise, physical facilities, and equipment that
permit and encourage integrated multimedia and
multidisciplinary research on environmental issues.
As part of a regulatory Agency that establishes national
priorities and sets national standards, ORD research
is conducted to protect human and ecosystem
health in a cost-effective manner and to provide a
firm scientific and technical foundation for environ-
mental decisions and standards.
ORD's Long-Term Goals and
Objectives
ORD's four mission areas translate into six
long-term, overarching goals that we will strive to
meet in order to fulfill our mission (Table 2). Part B
of this plan describes these goals in detail and
breaks each goal down into a series of specific
research objectives and activities that ORD will
pursue to achieve its goals.
Identifying Specific Research
Topics
The objectives and activities listed in Part B of this
plan provide detail about how ORD will go about
meeting its goals. Each objective and activity still
represents a relatively broad research area. ORD,
therefore, has developed a priority-setting process
and criteria, illustrated in Figures 4 and 5 and
described below, for identifying specific research
topics within the objective and activity areas that are
of primary importance to our vision, mission, and
goals. Each year, we will use this priority-setting
process and criteria to identify high-priority
research topics that will help us achieve ORD's
goals and objectives.
We applied our new priority-setting process and
criteria for the first time in 1995, when we used
them to reexamine our ongoing research and
identify important new initiatives. Based on this
first application, we identified six high-priority
research topicssome specific and others broad-
basedfor the next few years. These six topics are
described in Appendix I.
Many topics will remain a high priority for several
years. Each year, working with our program
partners and external advisory bodies, we will
examine the previous year's topics to add new
topics as appropriate and remove previous topics
for which sufficient research has been conducted.
Table 2.
Mission Area
ORD's Long-Term Goals
Goals
Perform research and development to identify,
understand, and solve current and future
environmental problems.
To develop scientifically sound approaches to assessing and
characterizing risks to human health and the environment.
To integrate human health and ecological assessment methods into a
comprehensive multimedia assessment methodology.
To provide common sense and cost-effective approaches for
preventing and managing risks.
Provide responsive technical support of EPA's
mission.
To provide credible, state-of-the-art risk assessments, methods,
models, and guidance.
Integrate the work of ORD's scientific partners.
To exchange reliable scientific, engineering, and risk assessment/risk
management information among private and public stakeholders.
Provide leadership in addressing emerging
environmental issues and in advancing the science
and technology of risk assessment and risk
management.
To provide leadership and encourage others to participate in
identifying emerging environmental issues, characterizing the risks
associated with these issues, and developing ways of preventing or
reducing these risks.
10
STRATEGIC PLAN FOR ORD
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ORD's Research Strategy
Figure 4.
Setting Research Priorities
External Scientific Community Input:
EPA Science Advisory Board
National Research Council
Other Government Agencies
Private Sector
ORD National Laboratories and Centers
EPA Program Offices
EPA Regional Offices
Research Coordination Council
Identify Research Topics and
Evaluate Research Products
Is
the Topic
Within ORD's
Mission and
Goals?
Reject for
ORD
Funding2
Apply Evaluation Criteria:
Human Health/Ecological Health
(Use Comparative Risk Analyses
as Appropriate)
Risk Management
Methods/Models
Prioritized Research Topics
Reject for
ORD
Funding2
Can
ORD Make
a Significant
Contribution?
Determine Research Needs:
Effects
Exposure
Risk Characterization
Risk Management
Conduct Research
(In-house, Grant, Coop, Contract, etc.)
Conduct External
Peer Review of
Extramural
Research Proposals
Research Products
1lf so, EPA may have no discretion to reject or delay this research.
2EPA program offices and regions may still choose to fund, using ORD labs, grants, contracts, etc., or a research source outside of ORD.
STRATEGIC PLAN FOR ORD
1 1
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ORD's Research Strategy
Identifying Emerging Issues,
Anticipatory Research, and
Exploratory Research
In recent years, EPA has begun moving beyond
environmental regulation to environmental
protection in its broadest sense, including
anticipating and preventing problems before they
mushroom into major concerns. To support EPA in
this endeavor, ORD is evaluating the best means to
anticipate tomorrow's environmental problems and
provide EPA with the necessary information to
evaluate findings, interact with other agencies and
organizations, and possibly act on early warnings of
emerging environmental issues.
The EPA Science Advisory Board's January 1995
report Beyond the Horizon: Using Foresight to Protect
the Environmental Future suggests many useful
measures we will evaluate for possible imple-
mentation. One measure we are currently
considering is the creation of "lookout panels"
comprised of individuals from inside and outside
the federal government to identify, screen, evaluate,
and prioritize emerging issues. As a first step in this
direction, the National Research Council has
established, at ORD's request, a Committee on
Research Opportunities and Priorities for EPA
(ROPE). This committee is tasked with thinking
creatively about ORD's research areas and
identifying high-priority research topics key to
solving some of our nation's most pressing current
and future environmental problems. Such research
could spark entirely new approaches to environ-
mental management in the future. Each year, we
will consider any high-priority topics related to
anticipatory research as we review and revise our
research agenda.
Figure 5.
ORD Criteria for Evaluating and Ranking Potential Research Topics
Human Health and
Ecological Health Criteria
What type of effect would the research
investigate/mitigate and how severely
might this effect impact humans or
ecosystems?
Over what time scale might this effect
occur?
How easily can the effect be reversed,
and will it be passed on to future
generations?
What level of human or ecological
organization would be impacted by the
effect?
On what geographic scale might this
effect impact humans or ecosystems?
Methods/Models Criteria
How broadly applicable is the proposed
method or model expected to be?
To what extent will the proposed method or
model facilitate or improve risk assessment
or risk management?
How large is the anticipated user community
for the proposed method or model?
Risk Management Criteria
Have the problem's source(s) and risk been
characterized sufficiently to develop risk
management options?
Do risk management options (political, legal,
socioeconomic, or technical) currently
exist? If so, are they acceptable to
stakeholders, implementable, reliable, and
cost-effective?
Could new or improved technical solutions
prevent or mitigate the risk efficiently, cost-
effectively, and in a manner acceptable to
stakeholders?
Are other research organizations (e.g.,
agencies, industry) currently investigating/
developing these solutions or interested in
working in partnership with ORD on these
solutions?
12
STRATEGIC PLAN FOR ORD
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ORD's Research Strategy
ORD's Priority-Setting Process
ORD's new priority-setting process, depicted in
Figure 4, involves the following steps:
First, we seek input from all parts of EPA, includ-
ing ORD's own researchers and staff. The
Research Coordination Council, the Science
Council, and Research Coordination Teams (see
Appendix III) consisting of senior representatives
from ORD's National Laboratories and Centers,
the EPA Program Offices, and EPA's Regional Of-
fices identify the most important and relevant
areas for our research efforts. (As state and local
governments play a larger role in environmental
protection, their research needs must also be con-
sidered at this stage.) We also work with EPA's
Science Advisory Board, the National Research
Council, and the private sector early in the plan-
ning process to obtain recommendations from the
external scientific community regarding the
major scientific directions and priorities for our
research program. Finally, we consider the status
and results of our recent research activities. Based
on this information, ORD identifies potential re-
search topics, for both intramural and extramural
investments.
We then separate the pool of potential topics into
two categories:
Those that are clearly mandated because of
statutory requirements or court orders (i.e.,
EPA may have no discretion to reject or delay
the research).
All other topics.
For all other topics, we narrow the pool by retain-
ing only those that are within ORD's mission and
goals.
We then apply a series of human health, eco-
logical health, and risk management criteria
(Figure 5) to compare the mission-related
topics according to their potential to support
effective risk reduction. We use comparative
risk analyses to help ascertain the most press-
ing environmental problems. We also apply
criteria to consider whether the research
would develop broadly applicable methods
and models needed by EPA programs.
Through this screening process, we set priori-
ties among the research topics.
We then further narrow this pool of topics by
retaining only those areas where ORD can
make a significant contribution to environ-
mental science. Factors we consider at this
stage include: Is the work feasible from a scien-
tific and resource perspective? Does ORD
have access to the appropriate expertise?
What contributions are other research organi-
zations making to this area of research?
For these remaining topics where ORD can
make a significant contribution, as well as all
nondiscretionary topics, we then define specific
research and development projects by consider-
ing each topic in totality. For each topic, we
determine what the research needs are within
each component of the risk paradigm: effects (hazard
identification and dose-response assessment), expo-
sure assessment, risk characterization, and risk
management. At this stage, we give priority to
research that will make the greatest contribution
to reducing the uncertainty associated with risk
characterization, or will improve the effectiveness
of risk management.
This approach to strategic planning clearly indicates
the following areas where ORD will reduce or
eliminate resources:
Exposure or effects research in areas of low risk.
Risk reduction research in areas of low risk.
Routine measurements and monitoring where
R&D has been completed or that does not sup-
port R&D efforts.
Criteria for Setting ORD Research
Priorities
A key component of ORD's new planning process is
the criteria we will use to set priorities among
research topics. Three sets of criteria are used:
human and ecological health criteria, risk
management criteria, and methods/models criteria
(Figure 5). These criteria, described below, are not
set in concrete, nor are they universally applicable to
all research areas. We will periodically revisit the
criteria, and they likely will evolve with use and
experience. Additional or alternative criteria may be
used in some cases as appropriate.
Human and Ecological Health Criteria
ORD's human and ecological health criteria are
based on five broad categories outlined in the EPA
Science Advisory Board's 1990 report, Reducing Risk:
Setting Priorities and Strategies for Environmental
STRATEGIC PLAN FOR ORD
13
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ORD's Research Strategy
Table 3.
ORD's Human Health and Ecological Health Criteria
Ecological Health
Human Health
Severity of Response/
Function of Stressor
Mortality
Morbidity
Degree of physical disruption
Mortality
Morbidity
Time Scale of Response
Immediate effects
Effects that will occur in the future
Acute effects
Subchronic effects
Chronic effects or effects with a long
latency period
Permanence of Response
Irreversible effects
Effects that can be reversed only by human
intervention
Temporary effects that reverse naturally over
a long time
Temporary effects that reverse naturally over
a short time
Transgenerational effects
Nontransgenerational effects
Level of Organization
Effects on an entire ecosystem/community
Effects on a single species
Effects on a population within a single species
Effects on individual animals or organisms
Effects on the general population
Effects on a subpopulation
Effects on individuals
Extent of Response
Global effects
Ecoregional effects
Effects on several localities
Localized effects
Global effects
International effects
National effects
Effects on several localities
Localized effects
An ecoregion is a geographic area that has similar topography, climate, and biota across the entire area.
Protection: the severity, time scale, and permanence
of the response; the level or organization where the
response is expected to occur; and the geographic
extent of the response. Table 3 lists the criteria that
ORD has developed for each of these five categories.
Risk Management Criteria
Risk management criteria are applied to those
research topics that concern risk management.
These criteria, listed in Figure 5, are designed to give
priority to research that will produce the most
effective and useful risk management options. The
criteria consider whether sufficient risk
characterization information is available to set
meaningful objectives for the risk management
research; the availability, acceptability to
stakeholders, reliability, and cost-effectiveness of
existing options; the potential benefits of the
proposed research; and whether other research
organizations are already conducting or interested
in this type of research.
Methods/Models Criteria
The methods/models criteria are applied to
research concerning the development or application
of methods or models for gathering or analyzing
risk-related data. These criteria give priority to
research that will likely produce the most useful
results. The criteria consider how broadly the
method or model would be used, the size of the
anticipated user community, and the degree to
which the method or model would improve risk
assessment or risk management.
14
STRATEGIC PLAN FOR ORD
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ORD's Research Strategy
Strengths of ORD's
Priority-Setting Process and
Criteria
Our new process and criteria for setting research
priorities have many strengths. They encompass
both scientific and stakeholder priorities. They
ensure that ORD will continue to fully support EPA
in fulfilling its mandates. They focus our resources
where we can make the most significant
contributions. And, they enable ORD to generate
practical, credible information and tools for
risk-based decision-making.
Translating ORD's Strategic Plan
Into a Research Program
The steps involved in translating ORD's Strategic
Plan into a research program are illustrated in
Figure 6. Once we have identified our high-priority
research topics, we develop and implement a
research program based on these topics. This
involves:
Developing science research plans.
Deciding whether the work will be conducted in-
house or extramurally (ORD's research program
is comprised of intramural and extramural re-
search; however, resources for these two areas are
kept separate.)
For intramural research, developing budget oper-
ating plans and laboratory implementation plans.
For extramural research, selecting and implement-
ing the appropriate mechanisms to access the
external scientific community.
Developing Science Research Plans
For each selected research topic, Research
Coordination Teams composed of ORD scientists
and engineers as well as representatives of EPA's
Program and Regional Offices develop science
research plans that:
Lay out the major research components and direc-
tions we will pursue over the next few years.
Describe how these components fit into the risk
assessment/risk management paradigm.
Delineate the major outputs to be produced over
the next three years.
Research plans are important tools for measuring
accountability because they make clear to our clients
and stakeholders the rationale for and intended
products of our research. They also enable ORD to
clearly track its progress toward achieving its goals,
as required by the Government Performance and
Results Act of 1993.
We consult ORD's main research clientsthe EPA
Program and Regional Officesto ensure that the
final research plans clearly include the research
products they will need to fulfill their responsibilities.
In addition, all our research plans are subjected to
rigorous external peer review.
Deciding Who Will Do the Work
After modifying the science research plans in
response to peer reviewer comments, ORD then
decides whether the work would best be
accomplished internally at ORD or externally
through one of several mechanisms: grants to
universities or nonprofit centers; Cooperative
Research and Development Agreements (CRADAs)
with the private sector; cooperative agreements with
another government agency or universities; or by
contract. Many factors influence this decision,
including:
Which organization has the most appropriate ex-
pertise?
What type of work is called for (risk assessment
and regulatory support work are generally re-
tained in-house, whereas research work may be
done externally)?
How urgently are the research products needed
(since some mechanisms are faster than others)?
Would there be value in involving multiple insti-
tutions?
To what extent can we specify what is needed
(contracts)? To what extent must we rely on the
creativity and insight of the researcher (grants)?
What is our available in-house capacity?
What are the opportunities for leverage?
Internal Research
Development of budget operating plans. For internal
research, ORD integrates the science research plans
with budgetary decisions in order to allocate
resources to the selected research topics by
laboratory program and research component. This
helps ensure that our priority-setting decisions
(guided by science) also reflect budgetary realities.
STRATEGIC PLAN FOR ORD
15
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ORD's Research Strategy
Figure 6.
Translating ORD's Strategic Plan Into a Research Program
ORD'S STRATEGIC PLAN
T
Higli-
Pnority
Research
Projects
A
Science
Research
Plans
1
EPA Program and Regional Office Involvement
External Scientific Community Involvement
.
Development of laboratory implementation plans.
Based on the science research plans and budgetary
decisions, ORD's Laboratories and Centers develop
detailed plans for implementing each area of
research to be undertaken internally. These
laboratory implementation plans provide a
blueprint for Laboratory and Center work and form
the basis for managerial oversight and guidance.
Extramural Research
Extramural research is conducted via grants,
cooperative agreements, CRADAs, or contracts.
Rigorous external peer review is a key mechanism
we use to evaluate both the proposals for and
results of external research.
One of ORD's primary mechanisms for involving
external scientists is the Science to Achieve Results
16
STRATEGIC PLAN FOR ORD
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ORD's Research Strategy
(STAR) program. STAR targets the best scientists
from universities and nonprofit centers because
they are an integral and important part of the
environmental research community. STAR consists
of focused Requests for Applications (RFAs),
investigator-initiated exploratory research grants,
graduate fellowships, and several "critical mass"
environmental research centers.
The bulk of the STAR program derives from RFAs
that focus on specific research needs to support
the Agency. Working with EPA's Program and
Regional Offices, Research Coordination Teams
write these RFAs to be consistent with ORD's
Strategic Plan and science research plans, and
complementary to ORD's in-house work. The
RFAs are announced annually to scientists at U.S.
academic and nonprofit institutions. Proposals
from the external scientific community are
peer-reviewed and projects are then selected for
funding through grants or cooperative
agreements. ORD leverages the STAR program
resources by jointly funding research with other
federal agencies. Appendix IV shows how the
fiscal year 1996 RFA topic areas relate to ORD's
high-priority research topics.
Measures of Success
In general, the success of a research organization
can be measured in several ways: by the number
of articles published in prestigious scientific
journals, by the number of times that articles
written by the organization's scientists are cited in
other journal articles, and so on. However, for a
mission-oriented organization like ORD, measures
of the extent that we help and support EPA in
meeting its goals are equally crucial. In measuring
the success of this Strategic Plan, the quality of
ORD's work, and the usefulness of our research
products, we will use the following measures of
success.
Significance: Is ORD Working on
the Right Issues?
This is a measure that the EPA Program Offices
and Regions and the broad scientific community
can help us judge. For our research, development,
and support efforts to be useful, we must work on
the most important environmental issues and
target areas for research that will significantly
improve risk assessment and/or risk management
in the Agency and elsewhere. Peer review by
scientists in the external scientific community will
assist us in judging significance.
Relevance: Is ORD Providing Data
That the Agency Can Use?
This question can best be answered by the rest of
the Agency and is best judged by the degree to
which ORD's contributions support EPA
decisions. ORD will strive to ensure that its work
is useful to the Agency and has a positive impact
on advancing EPA's mission.
Credibility: Is ORD Doing Research
of the Highest Quality?
ORD's credibility can best be judged by the external
scientific community through such mechanisms as
peer review of ORD products, reviews of programs
at the ORD Laboratories, peer-reviewed journal
articles, scientific citations, and external recognition
of both ORD and its people.
Timeliness: Is ORD Meeting EPA's
Expert Consultation and Assessment
Needs in a Timely Manner, Providing
Research Products According to
Schedule, and Addressing Long-Term
Issues With Adequate Forethought
and Preparation?
The first part of this question can best be answered
by EPA's Program Offices and Regions as they
determine whether ORD consultations and
assessments are being provided in time to be
optimally useful for Agency decisions. The middle
part of this question can be answered by ORD
managers and EPA's Program Offices and Regions
through annual program reviews and other
activities. The final aspect of timeliness is more
subjective and therefore more difficult to assess.
ORD has accepted the challenge of anticipating
important environmental issues that are just
emerging and may not become critical problems
until well into the next century. The U.S. public is
the ultimate judge of how successful ORD has been
in this effort. ORD will strive to regularly gather the
public's view on this issue.
STRATEGIC PLAN FOR ORD
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ORD's Research Strategy
Mechanisms for Evaluation and
Accountability
ORD has implemented, or plans to implement,
several mechanisms for evaluating its performance,
communicating progress and results, and measuring
success. These include:
Annual research program reviews, jointly organ
ized by ORD's Research Coordination Teams and
EPA's Program and Regional Offices, that present
to EPA senior managers the entire EPA research
portfolio in a given area. These joint reviews
focus on the status and accomplishments of the
ORD research program to ensure that ORD's
research continues to meet ORD and client objec-
tives. They also present the ongoing research
being conducted by the Program Offices and
Regions so that the total research agenda can be
viewed. The objectives of these reviews are to
evaluate progress in completing planned research
projects, to track and evaluate research results,
and to generally obtain feedback on ORD's work
and any adjustments that may be needed to help
us better meet our clients' needs. These reviews
complement, rather than supplant, external peer
reviews (see below).
Annual ORD review of its science research plans.
ORD examines its research plans annually and ad-
justs them if warranted by our research results,
by changes in EPA or national priorities, or by
emerging issues and concerns.
External peer reviews of ORD science research
plans and products and overall progress in meet-
ing our goals and objectives. These reviews are
conducted at key steps in our research planning
and implementation process.
External peer reviews of research proposals re-
ceived from extramural research scientists in
response to the Requests for Applications.
External peer reviews of ORD Laboratories and
of ORD's use of peer review through our Board of
Scientific Councilors under the Federal Advisory
Committee Act.
Annual science workshops designed to make the
progress and results of all ORD research (includ-
ing the external grants program) accessible to
EPA's Program Offices and Regions.
A data tracking system, part of ORD's Manage-
ment Information System, which tracks resources
and progress.
Through these mechanisms, ORD will strive to
develop and conduct the most responsive,
scientifically justifiable research program possible
within the constraints of our available resources.
Closing Out Completed Work
Through the continuing involvement of the
Research Coordination Teams and the annual
program reviews mentioned above, ORD will assess
ongoing research to evaluate:
Whether the research is on track for meeting its
goals and schedule.
When the research should be concluded.
Prudent management of evolving priorities and
declining resources requires that we clearly define
our research and conclude it within an appropriate
timeframe, so we can begin work on new priorities
without delay.
Technical Support
ORD is refining its process for providing technical
support to EPA's Program Offices. Using an
Interoffice Management Work Group and the
Environmental Monitoring Management Council,
we are working to:
Define technical support/assistance.
Create a plan for new and existing technical assis-
tance.
Create transition and exit strategies for some tech-
nical assistance areas where appropriate.
Areas where technical support will continue include
development of new methods, models, and
measures or approaches; litigation; regulatory
support; and scientific advice. ORD will not
continue to conduct routine monitoring and quality
assurance/quality control for studies other than its
own, but will design transition and exit strategies so
that the Program Offices and Regions are prepared
to assume these responsibilities.
Human Resources and
Infrastructure
The success of ORD's Strategic Plan depends on an
adequately funded and well-managed
infrastructure, including ORD's work force, systems,
and equipment. ORD's recognition of the
importance of our infrastructure is reflected in our
strategic principles (Table 1), which highlight the
18
STRATEGIC PLAN FOR ORD
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ORD's Research Strategy
critical role of infrastructure "to achieve and
maintain an outstanding research and development
program in environmental science."
Because we recognize that scientific excellence must
be built on a strong foundation, we are committed
to constant improvement of our organization and
infrastructure. As we implement this Strategic Plan,
we will continue to devote leadership and resources
to developing and fostering our work force,
modelling effective management, and creating a
supportive work environment.
ORD's Work Force
By far the most important component of ORD's
infrastructure is our work force of scientists,
engineers, managers, other environmental
professionals, and support staff. ORD can achieve
its vision of providing the scientific foundation to
support EPA's mission only if we can attract,
nurture, and support a productive work force.
ORD's strategic principles (Table 1) emphasize the
importance of nurturing and supporting "the
development of outstanding scientists, engineers,
and other environmental professionals at EPA."
The cutting edge nature of research and
development at ORD places great demands on our
scientists and engineers to continually upgrade their
skills and knowledge in response to and
anticipation of new scientific developments.
Therefore, our work force support must include an
effective human resources program that encourages
an increasingly diverse cadre of employees to
continuously learn new skills and a career
development program that promotes career
development in directions congruent with ORD's
mission. In addition, we must anticipate work force
needs and recruit new, culturally diverse employees
with the appropriate skills and experience to
support ORD's mission.
ORD's recent reorganization has introduced a new
organizational structure (see Appendix II) and
staffing pattern into ORD. For example, our new
organization eliminates certain mid-level
management positions and broadens the control
span of many supervisors. This flattened
organizational structure will require a team-based,
matrix-management approach to replace our former,
more hierarchical approach to management.
ORD is addressing these needs and challenges by
taking several steps to ensure a productive, effective
work force. These include:
Developing and implementing innovative, effec-
tive management approaches to accomplishing
ORD's mission, such as matrix management and
team-based operation.
Supporting senior managers, via training and
other mechanisms, in implementing these new
management approaches.
Developing tools to accurately assess current job
effectiveness and determine development needs.
Providing training and development programs to
advance the knowledge and skills of ORD's staff.
Providing effective career management support
with an emphasis on self-directed career plan-
ning (e.g., through mentoring, in-placement and
out-placement services, and career counseling
and development services).
Creating opportunities for professional and per-
sonal growth.
Taking measures to maintain and enhance the sci-
entific and technical competence and quality of
ORD staff.
Building and maintaining solid linkages to the ex-
ternal scientific community, with an emphasis on
scientist-to-scientist interactions (e.g., through
ORD-sponsored scientific workshops).
Providing opportunities for ORD scientists and
engineers to contribute, as respected members of
the scientific community and leaders in the envi-
ronmental sciences, to the general scientific
literature and community (e.g., through publica-
tion of scientific articles in peer-reviewed journals
and participation in national and international sci-
entific conferences).
Systems and Equipment
For our work force to successfully implement the
Strategic Plan, we must provide them with:
Safe, environmentally sound, well-maintained,
state-of-the-art laboratories, equipment, and
supplies.
Environmental data management systems and
advanced communications systems.
Upgraded technical and fiscal information sys-
tems to support the conduct of research,
STRATEGIC PLAN FOR ORD
19
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ORD's Research Strategy
management, planning, budgeting, and account-
ability functions.
A host of other management, administrative, and
systems support.
As we implement our Strategic Plan, we will
monitor work force needs and strive to provide
other programs, mechanisms, and support as
necessary to ensure that our work force has the tools
and equipment it needs to achieve ORD's vision and
goals.
Challenges for the Future
The 1995 peer review of the Strategic Plan
produced many useful recommendations that
ORD incorporated in this final version of the plan
(see History of This Document on page 2). ORD is
continuing to study other peer reviewer
recommendations for possible use in future
updates of our Strategic Plan. Recommendations
we are considering include:
Periodic reexamination of the plan in light of
changes in the risk assessment/risk management
framework. Reviewers recommended that ORD
periodically re-examine the basis for the Strategic
Plan to accommodate ongoing changes in risk as-
sessment concepts generally, and in the risk
assessment/risk management framework in par-
ticular. Such reexamination is a central feature of
the process envisioned by this plan, and ORD is
committed to the concept that its risk-based prior-
ity-setting system will evolve with evolving risk
assessment and risk management concepts.
Reviewers also commented that the risk
assessment paradigm has limited applicability for
some EPA programs, thus limiting the utility of a
plan based on the paradigm. ORD recognizes the
validity of this comment in particular cases. As we
implement this Strategic Plan, we will be working
in close collaboration with EPA's Program and
Regional Offices to ensure that our research agenda
is tailored to the particular programs and priorities
of each EPA office. Based on this experience, we will
consider modifications to the plan over time to
accommodate these special circumstances, as
necessary.
Attention to cost-benefit considerations. Review
ers recommended that ORD give more attention
to using information on economics and potential
costs and benefits in its research prioritization
process.
Value of information analysis. Reviewers recom
mended that EPA undertake a "value of
information" analysis and conduct a pilot project
on a selected research topic to determine where
to make our best time and resource investments,
and to identify potential customers.
Expansion of strategic goals. Reviewers recom
mended that ORD expand its strategic goals to
give additional attention to economics, cost-
benefit analyses (including incentives),
community-based environmental protection,
cumulative risk, environmental justice, and
multi-pathway analyses.
Capacity and incentives for long- term research.
Reviewers recommended that ORD give more at-
tention to building capacity and incentives for
long-term environmental research.
Each of these areas warrants special attention and
study.
20
STRATEGIC PLAN FOR ORD
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The Agency must improve the
scientific data and analytical
methodologies needed to make
sound decisions; to set risk-based
priorities for protecting health and
the environment; to support a new
emphasis on protecting the health
of the nation's ecosystems (such as
forests, lakes, and wetlands); and to
contribute to international
environmental efforts.
The Expert Panel on the Role of
Science at EPA
Safeguarding the Future: Credible
Science, Credible Decisions
To help focus selection of research priorities,
ORD has defined a set of long-term
research objectives within each of the six
broad ORD goal areas listed in Table 2.
Variations in the specificity of the objectives listed
below reflect differences in the maturity and
complexity of the science underlying each objective.
Many of the objectives include a set of activities
(listed under the objective) that ORD intends to
undertake to achieve the objective given sufficient
resources. This detail allows ORD's internal and
external stakeholders to understand specifically
how ORD plans to accomplish its objectives.
Designed to be robust and stable, the goals and
research objectives described here will guide
decisions about research directions for years to
come. Each year ORD senior management, working
with the Research Coordination Teams, will apply
ORD's priority-setting process (described in Part A)
to review current topics and identify specific new
research topics that best further these objectives. We
would not expect to make major changes in
priorities every year, but we will evaluate the
continuing timeliness and importance of our
research topics on an annual basis. The resulting set
of research topics will constitute the basis for ORD's
research program. Appendix I describes the first set
of high-priority research topics that resulted from
applying this process.
Goal 1: To Develop Scientifically
Sound Approaches to Assessing and
Characterizing Risks to Human Health
and the Environment
Risk assessments and the associated risk
management decisions are often based on limited
data obtained in species or under exposure
conditions that differ from real-world
circumstances. Inevitably, scientists must extrapolate
from these data sets to the human or environmental
setting of concern to characterize human health or
ecological risks. Extrapolation injects uncertainty
into risk characterizations, which EPA relies on to
STRATEGIC PLAN FOR ORD
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ORD's Long-Term Goals and Objectives
develop risk management strategies and research
priorities.
Greater certainty in risk assessment would improve
the efficiency and effectiveness of EPA's risk
management efforts and provide a better foundation
for establishing the Agency's research priorities.
ORD, therefore, will work to improve existing risk
assessment data, methods, and models and to
develop new methods for high-risk areas where
data currently are inadequate. Already, for example,
the science has advanced sufficiently to warrant
more refined approaches to risk assessment in
several areas, including ecological impacts, effects
on vulnerable subpopulations of people or
environmental species, and noncancer effects in
humans. As ORD develops improved methods, we
will work with other parts of the Agency to ensure
that these methods are credible and used in ways
that are scientifically sound.
In recent years, we have begun to recognize the
interdependence of ecosystems and to understand
that we must consider the landscape as a whole to
maintain the integrity of vital ecosystems into the
next century. While continuing to develop and
refine scientifically sound approaches to assessing
risks to human health, we intend to expand our
ecological research. For example, we intend to study
concurrent impacts of multiple anthropogenic and
natural stressors and to develop techniques to
examine nonchemical stressors. The results of this
researchincluding enhanced data on and
understanding of ecosystems at multiple levels of
organization and geographic and temporal
scaleswill provide a scientific foundation for
developing risk assessment/risk management
strategies and techniques for restoring vital
ecosystems (see Goal 3).
Objectives
Within this goal area, ORD will work to:
Replace the current approach to assessing non-
cancer health risks with more scientifically
grounded, biologically plausible approaches and
models. This will include:
Studying the heightened sensitivity/suscepti-
bility of certain subpopulations (e.g., children).
Studying the predictive relationship between
toxicologic endpoints and human disease (e.g.,
to facilitate animal-to-human extrapolation).
Developing integrated mechanistic informa-
tion to support biologically credible health
assessments.
Develop methods and models founded on meas-
urement data and sound theoretical concepts that
can be used to better characterize, diagnose, and
predict total human exposures to chemical and
microbial hazards, to improve and validate
exposure models, and to reduce uncertainties in
exposure assessments, risk assessments, and risk
management decisions. This will include:
Determining the relationship between expo-
sure sources and multiple exposure pathways,
including characterizing the sources and deter-
mining the influence of transport,
transformation, and fate on exposure.
Developing and evaluating an integrated
mass-balance/multimedia/multipathway
exposure model that incorporates state-of-the-
science pollutant fate and transport process
descriptions for use in risk assessment.
Developing and applying exposure measure-
ment methods to reduce the uncertainty in
exposure-dose relationships, especially analyti-
cal methods for identifying and enumerating
microbial pathogens and biomarker and
chemical marker methods for estimating site-
specific exposures.
Continuing activity pattern research to reduce
uncertainty in models and assessments that
predict exposure levels, frequencies, and distri-
butions in populations.
Delineating and quantifying the role of
exposure in the development of effects in
individuals and populations, including
susceptible populations.
Establish approaches to characterizing and under-
standing risks to ecosystems and, in cooperation
with other agencies, develop a national, multi-
scale, integrated environmental status and trends
program. This will include:
Developing indicators of the condition of rep-
resentative ecosystems.
Supporting hypothesis-driven, long-term
monitoring of important exposure and effects
indicators at national reference sites.
Characterizing national land-cover/land-use
patterns and developing measures of land-
22
STRATEGIC PLAN FOR ORD
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ORD's Long-Term Goals and Objectives
scape condition at multiple scales for specific
sites, watersheds, landscapes, and ecoregions.
Conducting pilot studies in ecologically impor-
tant regions (e.g., the mid-Atlantic Highlands)
to evaluate alternative monitoring designs
and to develop techniques to integrate data
across geographic scales.
Understand and predict ecosystem exposures,
responses, and vulnerabilities to high-risk chemi-
cal and nonchemical stressors at multiple levels
of biological organization and geographic scales.
This will require:
Developing ecological criteria for water (both
freshwater and marine), air, soil, and sediment
quality (1) as needed for the Agency's risk
assessment and risk reduction efforts, and (2)
to measure progress toward meeting environ-
mental goals.
Developing diagnostic tools at all levels of
biological organization for retrospective
assessments and for characterizing the key
sources and stressors in multistressed ecosys-
tems.
Developing tools for predicting the vulnerabil-
ity of ecosystems at multiple geographic and
temporal scales to ecosystem stressors (e.g.,
climate change, altered land use, changes in
air, soil, or water quality).
Goal 2: To Integrate Human Health
and Ecological Assessment Methods
Into a Comprehensive Multimedia
Assessment Methodology
Human health risk assessments and ecological risk
assessments have different histories at EPA and have
traditionally been thought of as involving different
disciplines. As a result, EPA has developed and used
separate methodologies for those assessments. As
we have begun to take a more integrated view of
risk, however, we have noted that human health
and ecological risk assessments actually make use of
similar types of data and science. We have realized
that we must use a more integrated, multimedia
approach to risk assessment if we are to understand
and reduce many current and future risks. We will
therefore conduct research to develop an accessible,
seamless, common methodology for combined
human health and ecological risk assessments so
that we can provide decision-makers at all levels
with the integrated view of risk that they need to
make sound decisions.
Objectives
Within this goal area, ORD will work to:
Integrate fate and transport modeling techniques
with biologically based models needed in human
health and ecological risk assessment.
Integrate human health and ecological exposure
and trends monitoring research.
Better understand the relationship between
human health and the condition of ecosystems
(e.g., to assess the impact of human consumption
of contaminated fish or wildlife or the influence
of landscape characteristics and climate interac-
tions on disease vectors such as mosquitos, ticks,
and rodents).
Develop tools and techniques to facilitate the
assessment of relative risks to human health and
the environment.
Harmonize extrapolation methodologies for relat-
ing data on toxicity mechanisms for endocrine
disrupters, immunotoxins, developmental haz-
ards, and other chemicals with effects in sensitive
human subpopulations, wildlife, and aquatic
organisms.
Improve extrapolation models by integrating
toxicologic and mechanistic data obtained in
laboratory and field investigations (epidemiology
and ecology).
Identify and validate wildlife species as sentinels
for human health risks.
Goal 3: To Provide Common Sense,
Cost-Effective Approaches for
Preventing and Managing Risks
To enhance the practicality and cost-effectiveness of
the products of ORD's risk management research,
we are changing the way we study pollution control
and prevention, contaminated site and spill
remediation, and technology development. To the
extent possible, we are integrating our air, water,
and waste-related research, and we are increasingly
focusing on emerging, high-risk problems all so
that we can better help regions, communities, and
the private sector analyze pollution problems and
achieve risk reductions efficiently and cost-
effectively This common sense approach will seek
STRATEGIC PLAN FOR ORD
23
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ORD's Long-Term Goals and Objectives
to maximize the health and environmental benefits
of risk management by focusing risk management
research on those aspects of a process or situation
that cause the greatest risks.
To that end, our pollution prevention and control
research will now focus on multimedia life-cycle
analyses, "green" technologies, and pollution
prevention methods that small- and medium-sized
companies can use to achieve significant reductions
in risk across media. Our maturing site and spill
remediation program will concentrate on
developing cleanup options for complex risk
situations and faster, lower cost natural recovery
systems. In addition, we will continue forging
partnerships with the private sector to analyze
high-risk needs and to develop, evaluate, and verify
new pollution prevention and risk reduction
technologies.
We have also begun efforts in ecosystem restoration
and cost-benefit assessment. Our ecosystem
restoration research (connected to that described
under Goal 1 above) will focus on developing and
demonstrating principles, technologies, and
guidance materials that regions and communities
can use to help restore local ecosystems. Our
cost-benefit assessment research will focus on
developing a systematic approach to identifying and
reporting the benefits and costs of risk management
technologies and alternatives. Such an approach is
needed to satisfy the rapidly growing demand for
cost-benefit analyses to support environmental
decision-making a demand engendered by the
rising cost of environmental protection in an era of
limited resources.
Objectives
Within this goal area, ORD will work to:
Provide cost-effective risk management technolo-
gies and approaches for high-risk threats to
human health and the environment. This will
include:
Characterizing sources of fine-particulate
emissions, air toxics, and ozone precursors,
and identifying, adapting, and developing risk
management approaches that control emis-
sions to acceptable levels.
Providing cost-effective, reliable technologies
and management approaches that reduce
drinking water exposures to disinfectant
by-products while protecting water supplies
from microbial contamination.
Providing communities with proven technolo-
gies for wet weather flow watershed
management, wellhead protection, and resto-
ration of contaminated areas.
Provide pollution prevention approaches and
analytical tools to the private sector. This will
include:
Providing risk-based systems and tools to
analyze options for multimedia pollution
prevention for major industrial sectors.
Identifying and evaluating the performance
and costs for pollution prevention options for
small- and medium-sized businesses.
Develop advanced air quality simulation models
that relate sources, emissions, and receptors. This
will include:
Developing models based on high-perform-
ance computing systems to predict the fate of
pollutants through the multimedia pathways
leading to human and ecosystem exposure to
these pollutants.
Catalyze the development and use of cost-effec-
tive risk management approaches for the most
difficult and costly environmental management
problems. This will include:
Developing cost-effective techniques for reme-
diating soils and ground water contaminated
with nonaqueous-phase liquids, chlorinated
and other hazardous organics, and toxic
metals.
Developing cost-effective techniques for reme-
diating contaminated sediments.
Verifying the performance of innovative risk
reduction technologies and accelerating their
commercial use.
Provide cost-estimating/engineering assessment
tools and methods for more accurate and mean-
ingful cost-benefit analyses. This will include:
Developing data standards and cost reporting
protocols.
Developing methods and cost analyses for
emerging, high-risk environmental problems
(e.g., fine particulates, drinking water, wet
weather flow controls).
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ORD's Long-Term Goals and Objectives
Develop and provide risk management alterna-
tives to maintain and/or restore ecosystems. This
will include:
Developing diagnostic and characterization
methods and protocols for use in determining
appropriate ecosystem restoration goals and
requirements for specific sites, watersheds,
landscapes, and ecoregions.
Identifying, testing, and providing risk man-
agement approaches and technical guidance
for restoring riparian zones, remediating con-
taminated soils and sediments, and applying
best management practices to restore or main-
tain ecosystems in urban, suburban, and
urbanizing areas.
Developing methods to restore and maintain
soil ecosystems.
Goal 4: To Provide Credible,
State-of-the-Science Risk Assessments,
Methods, Models, and Guidance
ORD continues to be a national leader in the field of
risk analysis of human health and ecological effects
and will continue to serve as a catalyst for advances
in the science of risk assessment. ORD will achieve
this goal by working to facilitate cooperation and
the exchange of ideas between and among federal,
state, and local scientists as well as scientists in the
environmental, industrial, and academic
communities. In addition, ORD will focus on three
primary activities:
Using an open and participatory process, ORD
will conduct timely, state-of-the-art risk assess-
ments. These assessments either will serve as
prototypes demonstrating new approaches to risk
assessment or will respond to Agency needs by
assessing multimedia, multiprogram, or conten-
tious or sensitive issues.
ORD will support other risk assessment efforts by
providing guidance, consultation, training, and
information products to assist colleagues, both
inside and outside EPA, in conducting their own
risk assessments. These efforts will respond
directly to the needs of the risk assessment
community and will target areas of uncertainty in
the science and conduct of risk assessment.
ORD will improve the state-of-the-science of risk
assessment by developing scientifically sound
and defensible approaches for incorporating and
integrating data and models developed by ORD
and the general scientific community into risk
assessment efforts.
ORD will integrate human health and ecological
concerns into all these activities.
Objectives
Within this goal area, ORD will work to:
Prepare risk assessments for those stressors cur-
rently considered of high risk to humans and the
environment. This will include:
Assessing ubiquitous pollutants in the air that
affect human health (e.g., fine particles, ozone).
Assessing the risks associated with highly
toxic and persistent environmental contami-
nants (e.g., chlorinated dioxins, mercury).
Assessing the risks to ecosystems from non-
chemical stressors (e.g., habitat loss and UvB
due to stratospheric ozone depletion).
Conducting comparative risk assessment of
competing risks (e.g., those posed by microor-
ganisms in drinking water versus those posed
by disinfection by-products).
Complete development of new cancer risk guide-
lines and other guidelines and provide support to
the Program Offices and Regions to facilitate their
implementation. This will include:
Developing and supporting the implementa-
tion of guidelines for assessing the ecological
impacts of environmental stressors.
Supporting the implementation of new guide-
lines for cancer, neurotoxicity, and
reproductive risks.
Provide expert advice and technical support to
EPA staff, other agencies, and EPA stakeholders.
This effort will include:
Integrating scientific and technical informa-
tion from ORD Laboratories and other sources
to provide a sound scientific base and techni-
cal support for Agency decisions and policy.
Developing and supporting the implementa-
tion of guidelines for assessing the ecological
impacts of environmental stressors.
Supporting the implementation of new
guidelines for cancer, neurotoxicity, and
reproductive risks.
Supporting chemical- and site-specific risk
assessments for criteria air pollutants,
STRATEGIC PLAN FOR ORD
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ORD's Long-Term Goals and Objectives
hazardous air pollutants, waste sites, and
drinking water.
Providing training in risk assessment to state
and local stakeholders.
Continuing to support and improve the Inte-
grated Risk Information System (IRIS) and
expert systems such as Risk Assistant.
Assuring adequate quality assurance for all
research, testing, and applications.
Develop methods and assess methods developed
by others for providing quality-assured data for
environmental assessment. This will include:
Supporting the development of models that
can be readily used by Regions and states.
Goal 5: To Exchange Reliable
Scientific, Engineering, and Risk
Assessment/Risk Management
Information Among Private and Public
Stakeholders
Effective risk assessments and risk management
decisions depend on the availability of accurate
sources of scientific and engineering data and
information, risk assessments, analytical methods,
and guidance. As a leader in the development of
such methods and information, we are committed to
providing, coordinating, and exchanging expertise
and information to decision-makers inside and
outside EPA. We will work to identify and fulfill
user needs by providing appropriate tools and
information through interconnected communication
and technical support networks.
Our goal is to facilitate information that is impartial,
up-to-date, and relevant to user needs. To that end,
we must improve and update existing information
systems and develop new systems and information
transfer solutions to meet future needs. Working
with other EPA offices, we will help to develop an
operational communication and information
transfer system for on-line scientific, engineering,
and risk information that can be accessed by
professionals or by members of the public who are
involved in community-level analysis and
decision-making.
Objectives
Within this goal area, ORD will work to:
Provide current and relevant technical informa-
tion to a broad user community. This will include:
Developing plain-language guidance and
training that adequately and clearly communi-
cate the appropriate use of technical
information and that describe limitations and
inappropriate applications.
Developing electronic communication and
other information dissemination systems that
can be accessed and understood by broad and
diverse user communities.
Complete the development of the new cancer risk
guidelines and provide support to the program
offices and regions to facilitate their implementa-
tion.
Maintain and increase support for existing scien-
tific, engineering, and risk information systems.
This will include:
Ensuring that current information resources
are accurate, relevant, and up-to-date.
Developing electronic and other methods of
bringing databases (e.g., IRIS, ECOTOX) to
state and local governments and other stake-
holders.
Developing data management systems that
make data readily available to all ORD Labs
and Centers, EPA Program Offices and
Regions, and states.
Goal 6: To Provide Leadership and
Encourage Others To Participate in
Identifying Emerging Environmental
Issues, Characterizing the Risks
Associated With These Issues, and
Developing Ways of Preventing or
Reducing These Risks
With our very broad missions, we in ORD and the
Agency as a whole must have some means of
evaluating, comparing, and setting priorities for
competing needs. We use risk as the common
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ORD's Long-Term Goals and Objectives
denominator for comparing divergent issues and
making decisions. Our focus on relative risks and
risk-based decision-making demands that we look
beyond the obvious problems of yesterday and
today to identify and assess issues just over the
horizon; we must determine the potential risks that
these issues pose and work to solve them. Often,
however, few data exist to support assessments of
emerging issues. Thus, we must develop and
disseminate data and methods to permit credible
decision-making in the face of very high uncertainty.
At ORD, we are committed to working with other
groups within EPA, the Agency's Science Advisory
Board (SAB), the National Academies of Science and
Engineering (NAS and NAE), and others to develop
new ways of analyzing emerging issues. We
recognize that ORD cannot and should not assume
leadership in every area of environmental science.
Our challenge is to be cognizant of where others are
already leading and where ORD should undertake
that role.
EPA's general approach to environmental
managementassessing risks, evaluating the
potential benefits of risk reduction, and devising
risk management and risk reduction strategies
accordinglyis increasingly being adopted by
others in this country and abroad. More than any
other organization, ORD has been in the forefront of
developing the risk assessment and risk
management methods that undergird this
risk-based approach to environmental management.
More than any other organization, therefore, we
should be expected to provide leadership in the
development of new, more credible ways of
comparing and ranking risks. In providing this
leadership, we renew our commitment to
encouraging and enabling others in the public and
private sectors to participate in identifying,
characterizing, and resolving emerging
environmental issues.
Objectives
Within this goal area, ORD will work to:
Collaborate with other parts of the Agency, the
SAB, the NAS, and others to develop methods of
identifying emerging issues and assessing their
potential risks.
Develop partnerships (via research grants,
cooperative agreements, CRADAs, and other
mechanisms) with other federal agencies, the
White House Committee on Environment and
Natural Resources, industry, and academia.
Provide national and international leadership in
risk assessment and its application for risk reduc-
tion and risk management.
Conduct/sponsor workshops and symposia that
will provide forums for stimulating interest and
discussion on current or emerging environmental
issues (e.g., endocrine disrupters), reaching con-
sensus on crucial research needs, and defining
the role of ORD and others in addressing those
needs.
STRATEGIC PLAN FOR ORD
27
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Appendix I
ORD's High-Priority
Research
The goals and objectives listed in Part B of this plan
define an ambitious research program for ORD.
Within this program, however, the extent of research
we can actually perform will be limited by the
available resources. Therefore, in consultation with
EPA's Program Offices, ORD uses the priority-
setting process (described in Part A) to select from
its overall program those topics that are of highest
priority for research. Priorities to be emphasized for
the next few years are (in no particular order):
Drinking water disinfection
Particulate matter
Endocrine disrupters
Research to improve ecosystem risk assessment
Research to improve health risk assessment
Pollution prevention and new technologies
These areas will receive more intense research
attention (and resources). Intramural efforts will be
supplemented with the talents of extramural
scientists through external grants, cooperative
agreements, interagency agreements, and contracts.
Proposed research for the six high-priority areas is
summarized in Table 1-1. Tables 1-2 through 1-7
provide a breakout, by risk assessment/risk
management area, of the strategic issues and
proposed research tasks, products, and applications
in each of the six topic areas.
Other areas of high importance that will continue to
be a major part of ORD's research program include:
Air pollutants
Indoor air
Global change
Drinking water (in addition to disinfection issues)
Waste site risk characterization
Waste management and site remediation
ORD's research agenda also includes additional
topics necessary to help the Agency fulfill its
nondiscretionary mandates.
Other topics were considered during the planning
process but they did not meet the criteria to be
included in ORD's research program. In general,
these include exposure or effects research in areas of
low risk, risk reduction research in areas of low risk,
and routine measurements and monitoring where
R&D has been completed. In addition, ORD will not
pursue research in areas where other research
organizations are capable of making a more
significant impact.
ORD's entire research program will be captured in
more detail in the science research plans being
developed by the Research Coordination Teams.
These research plans will be finalized after a
rigorous peer review. Interested readers should
consult these documents.
ORD also uses the principles and priorities of this
Strategic Plan as a basis for developing its annual
budget requests to fund our research agenda. Our
fiscal year 1997 budget request was based on this
plan, as will be our fiscal year 1998 budget
proposals.
Evolution of ORD Priority Areas
Over Time
The six high-priority areas intentionally are a
mixture of:
Research targeted at specific pollution problems
(i.e., drinking water disinfection, particulate
matter, and endocrine disrupters).
STRATEGIC PLAN FOR ORD
29
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Appendix I
Broad-based fundamental research in risk assess
ment and risk management (i.e., research to
improve ecosystem and health risk assessment,
and pollution prevention and new technologies).
The tables in this appendix reflect the differences in
these two areas of research. Tables 1-2 through 1-4,
which describe the more specific research areas, tend
to have more details than Tables 1-5 through 1-7, which
describe the broad-based, fundamental areas.
We will evaluate progress on all research targeted at
specific pollution problems annually to ensure that
our research program continues to focus on the
most significant problems. As work on problem-
specific topics progresses and moves toward
closure, we will redirect our research focus and
resources to emerging high-priority areas. For
example, as we successfully completed work in one
of our former priority areas (the health risks of
ozone), we shifted resources to particulate matter,
one of our current high-priority topics. In the future,
the particulate matter research likely will give way
to other topics of emerging priority.
We will also evaluate progress on our broad-based
fundamental research annually. These broad-
based areas, which reflect ORD's fundamental
risk assessment and risk management research
programs, will remain high-priority topics.
However, the individual projects within these
areas will change to reflect research progress and
emerging concerns. As the individual projects
change, we will revisit and revise research plans
for these areas.
Selection of the Six High-Priority
Topics
The following summaries illustrate how application
of the selection criteria described in Part A gave rise
to the six high-priority research topics.
Drinking Water Disinfection
Disinfection of drinking water has been one of the
greatest public health success stories of the
twentieth century. Nevertheless, some public health
concerns still remain. For example, hundreds of
people have died and many hundreds of thousands
have become ill during recent outbreaks of exposure
to the protozoan Cryptosporidium in drinking water.
Recent studies demonstrate that there is a low
threshold of infectivity for Cryptosporidium and that
people with compromised immune systemssuch
as the elderly, HIV-positive individuals, and persons
receiving chemotherapymay be at greater risk. In
addition, other microorganisms exist in drinking
water that may also have serious adverse effects.
There still is a high degree of uncertainty about how
to measure microorganisms in water and what their
infectivity level is. Additionally, there is a high
degree of uncertainty about whether disinfection
by-productsthe chemical by-products that result
when disinfectants react with organic matter in
drinking waterpose a significant human health
threat. Because of the high uncertainty, the
widespread human exposure to drinking water, the
severity of the known effects from certain microbes,
and the potentially high costs of further regulation
of drinking water, this issue is of high priority to
EPAs Office of Water and to ORD's research agenda.
Particulate Matter
Recent publications in the scientific literature
indicate that exposure to particulate matter poses a
high potential human health risk. At the same time,
however, there is a high degree of uncertainty about
the size and composition of the particles that may be
responsible for these effects, the biological
mechanisms of action, and the dose-response
relationships at low levels of exposure. In addition,
control costs are potentially very high. For all these
reasons, this area is of high priority to EPAs Office
of Air and Radiation and of high priority for ORD's
research agenda.
Endocrine Disrupters
Evidence has been accumulating that humans and
wildlife have suffered adverse health consequences
resulting from exposure to environmental chemicals
that interact with the endocrine system. Several
reports of declines in the quality and quantity of
sperm production in humans over the last four
decades, and reported increases in the incidence of
certain cancers that may have an endocrine-related
basis, have led to speculation about environmental
causes.
There is considerable scientific uncertainty
regarding the causes of these reported effects.
However, we do know that endocrine factors
regulate the normal functions of all organ systems
and that small disturbances in endocrine function
especially during certain stages of the life cycle such
as development, pregnancy, and lactationcan lead
to profound and lasting effects. The critical issue is
30
STRATEGIC PLAN FOR ORD
-------
Appendix I
whether there are sufficiently high levels of
endocrine-disrupting chemicals in the ambient
environment to exert effects in the general
population.
Given the potential scope of the problem, the
possibility of serious effects on the health of
populations, and the broad occurrence and
persistence of some endocrine-disrupting agents in
the environment, this area is of high priority for
ORD's research agenda. Research will focus on the
most critical gaps in our knowledge base to promote
more informed decisions on public health,
ecosystem effects, and related management options.
Research To Improve Ecosystem Risk
Assessment
We have made considerable progress in reducing
the most egregious harm to our environment from
air and water pollution and from areas of
devastation around industrial plants. Much remains
to be done, however, if we are to avoid potential
disasters on a tragic scalesuch as forest decline,
widespread epidemics of toxic microorganisms in
estuaries, reproductive failure of wildlife because of
global pollutant transport or destruction of critical
habitat, the reappearance of vector-borne epidemic
diseases, and global climate change.
Ecological research has the potential to significantly
reduce many of the uncertainties associated with
our understanding of ecosystems. In particular, it is
critical that EPA develop:
Techniques for quantitative risk assessments so
that decisions about where to focus ecological
research and what solutions are most appropriate
can be based on sound science.
Risk management strategies that take maximum
advantage of pollution prevention and the self-
purifying potential of natural systems.
To accomplish these goals, research in ecosystem
monitoring, processes, modelling, risk assessment,
risk management, and restoration is needed for
chemical and nonchemical stressors, multiple scales
of effects and exposures, and multiple levels of
biological organization. Because of the broad
applicability of these methods and their significant
potential for enhancing ecological risk assessment
and risk management, ORD has selected research to
improve ecosystem risk assessment as a high
priority for its research agenda.
Research To Improve Health Risk
Assessment
Health risk assessment is the process EPA uses to
identify and characterize environmental health
problems. The results of health risk assessment
are crucial to decisions on health protection
measures. ORD's research to improve health risk
assessment addresses major deficiencies and
uncertainties in health risk assessment (including
both problem- or agent-specific risk assessment, as
well as cross-cutting or generic risk assessment). For
example, ORD's research to improve health risk
assessment includes:
Developing state-of-the-art testing approaches for
noncancer and cancer endpoints.
Conducting mechanistic and toxicokinetic
research to improve the exposure and dose-
response steps in the risk assessment process.
Identifying biomarkers that can be used to meas-
ure genetic and other biological events.
Determining how individuals vary in their re-
sponse to toxic insults, so that EPA can better
identify sensitive groups.
Research to improve health risk assessment
provides the essential foundation for reliable and
scientifically strong risk assessments based on new
science and state-of-the-art methods. In addition,
this research area supports the development of:
Computer-based tools to assist risk assessors at
the federal, state, and local levels.
Information management databases that EPA
uses to effectively communicate risk information
to stakeholders.
Ultimately, the results of this research will enhance
risk assessments to support national environmental
goals, such as safe drinking water, safe indoor
environments, clean air, and safe food. Because of
the broad applicability of improved methods for
health risk assessment to many user communities,
research to improve health risk assessment is a high
priority for ORD's research agenda.
STRATEGIC PLAN FOR ORD
31
-------
Appendix I
Pollution Prevention and New
Technologies
Pollution prevention, or anticipating and stopping
problems before they occur, is a valuable risk
management tool because it is far more
cost-effective and protective of the environment
than solving environmental problems after they
have been created. Pollution prevention, supported
by objective scientific and technical data, can
actually reduce or eliminate the need for legal
actions and regulatory standards, which can be
costly and difficult to implement.
Pollution prevention will be the first strategy
considered for all EPA programs and EPA will lead
the nation in efforts to reduce and eliminate
pollution at the source. Because of the broad
applicability of pollution prevention strategies and
the potentially large economic and environmental
benefits of this approach to risk management,
pollution prevention and new technologies are of
high priority for ORD's research agenda. This
research builds on ORD's commitment to support
and respond to EPAs Program Offices' and Regions'
needs for prevention options and information on
how to best implement them.
32
STRATEGIC PLAN FOR ORD
-------
Table 1-1. Summary of EPA/ORD Research Program for Six High-Priority Research Topics
Research Topics Strategic Focus
Tasks
Products
Uses
Drinking Water
Disinfection
What is the comparative
risk between waterborne
microbial disease and the
disinfection byproducts
(DBFs) formed during
drinking water disinfection?
How can both be
simultaneously controlled?
Develop methods for measuring
pathogen/DBP exposure from drinking
water, determine effects and dose-response
for them, develop/apply a microbial risk
assessment framework, improve DBF risk
assessments, and evaluate alternative
treatment processes for DBP/microbial
control.
Data on effects, dose-response,
exposure, comparative risk, and
treatment for pathogens/DBPs.
To support DBP/microbial risk
assessment/risk reduction
rulemaking and compliance
monitoring.
H
to
O
O
O
to
O
&
O
Participate What morbidity/mortality
Matter is associated with low
ambient levels of particulate
matter (PM), and what cost-
effective methods are
available to reduce PM
emissions to an acceptable
level?
Conduct clinical/epidemiology studies of
PM effects; reanalyze past epidemiology
studies; conduct pharmacokinetic and
biological studies; characterize the
size/species of PM; conduct a human
exposure study; and evaluate, develop, and
demonstrate technologies to reduce PM
emissions.
Morbidity/mortality, dose-response,
and mechanistic data; dosimetric
model; methods for measuring PM
mass/species; improved human
exposure estimates; data on
emissions composition; improved
risk estimates; and data on
cost-effectiveness of PM control
strategies.
To improve criteria documents and
risk assessments in support of PM
National Ambient Air Quality
Standards review; to provide
information for evaluating
alternative PM control strategies.
Endocrine What is known about
Disrupters endocrine disrupter (EDC)
exposure, human/
eco-effects, and risk
assessment?
What research still needs to
be done?
Review existing literature on EDCs, conduct
workshops on research needs, develop
QSAR/PBPK/BBDR3 methods/models,
conduct field measurements of EDCs, and
assess effects on highly exposed cohorts.
Reports on research needs,
analytical methods, risk assessment
methods, data from field
measurements, and cause-effect
data.
To prioritize research needs, review
test guidelines, and conduct
hazard/effect and preliminary
exposure/risk assessments.
Research To
Improve
Ecosystem Risk
Assessment
How can we determine
ecosystem risk and capacity
to tolerate stress?
What are the chemical and
nonchemical exposures to
the most sensitive systems?
Which ecosystems are
vulnerable? Where?
How can we reduce risk in
a cost-effective manner?
Study ecosystem vulnerability and
stressor-response relationships; identify
eco-effect measures; characterize habitat
distribution and chemical exposures;
develop/apply eco-risk assessment
methods; and study eco-risk reduction.
Ecosystem criteria, models to predict To inform stakeholders about
ecosystem effects/risks, national
land-cover map, baseline data for
documenting future changes,
ecosystem exposure profiles, and
information on risk reduction
approaches for ecosystems.
ecosystem protection, ecosystem
assessment, environmental
planning, and ecosystem risk
reduction/restoration.
W
w
(Continued)
-------
Table 1-1. Summary of EPA/ORD Research Program for Six High-Priority Research Topics (Continued)
Research Topics Strategic Focus
Tasks
Products
Uses
(D
(/i
H
to
O
O
Research To
Improve Health
Risk Assessment
How can we better
define/predict hazards,
improve dose extrapolation,
and better understand
mixture toxicity?
Develop or improve methods for screening
hazard data, collecting toxicity data, and
interpreting hazard data; develop models to
estimate target tissue dose and responses to
those doses; and develop methods/models
for assessing mixtures toxicity.
Hazard screening/testing protocols,
models for predicting chemical
disposition in the body, and test
protocols/models for mixtures
toxicity.
To rank/screen chemicals, develop
test guidelines, provide guidance for
risk assessment, and identify
mixtures toxicity.
What is the population
distribution of total
exposure?
What are the
source-exposure-dose
relationships?
Determine how exposure is influenced by
age, lifestyle, behavior, and socioeconomic
factors. Develop total human exposure
models, which include source/pathway
contributions to total exposure.
Improved exposure measurement
and assessment methods, models,
and data.
To support exposure assessment
during risk-based decision-making
Pollution
Prevention and
New
Technologies
How can pollution
prevention be integrated
into environmental
decision-making?
Study engineering/performance costs for
pollution prevention; develop technologies;
identify audiences needing technical
assistance; develop life-cycle analysis/audit
tools; and assist in disseminating
technologies to the commercial sector.
Pollution prevention cost accounting To evaluate and implement
protocols, cost data, technology pollution prevention approaches.
transfer products, life-cycle analysis
tools, audit procedures, pollution
prevention technologies, and
performance data.
O
to
aQSAR = quantitative structure-activity relationships.
PBPK = physiologically based pharmacokinetic.
BBDR = biologically based dose-response.
-------
Table 1-2.
Drinking Water Disinfection
Subtopic Strategic Focus
Tasks
Products
Uses
Health
Effects
H
to
O
O
O
to
O
f«
O
What dose levels of
pathogens cause
illness in exposed
populations?
Conduct dose-response studies on
waterborne pathogens.
Data for risk assessment models
to predict disease incidence.
To provide health effects data for risk assessment to
support upcoming surface water and ground-water
treatment rules.
What are endemic and
epidemic illness rates
for waterborne
microbial disease?
Conduct epidemiology studies for
pathogen-caused disease.
Indication of magnitude of risks
and verification of risk models.
To provide health effects data for risk assessment to
support upcoming surface water and ground-water
treatment rules.
What are the relative
risks of disinfection
byproducts (DBFs)
from different
disinfection processes?
Conduct epidemiology studies on
reproductive/developmental effects
and, if feasible, on cancer.
Qualitative/quantitative data on To assess the risks of different disinfection processes,
cancer, reproductive effects, and
other effects.
combining epidemiology, toxicity and mixtures
information, to support DBF rules.
Conduct toxicity studies on
individual DBFs and mixtures if
feasible.
Risk assessments for individual
DBFs.
Exposure
What levels of
pathogens are people
exposed to?
Develop analytical methods that
detect viable/infective organisms.
Practical analytical methods for
pathogens.
Identify sources of pathogens and
factors affecting occurrence levels in
surface and ground waters.
Analyses of pathogen occurrence
in source waters.
Information on pathogen
exposures in drinking water.
Survey tool for developing occurrence data; basis for
compliance methods for water utilities.
To support exposure assessments to predict
pathogen occurrence in drinking water under
different treatment processes.
What levels of DBFs
are people exposed to?
Develop methods for measuring
occurrence of DBFs in drinking
water.
Improved practical field and
research methods for DBFs in
drinking water.
To support exposure assessments for DBFs from
different treatment processes; provide basis for
compliance methods for water utilities.
Study the level of DBFs in drinking
water supplies.
Identity of new DBFs under
different disinfection practices.
Data on DBF exposure from
drinking water.
Risk What are the
Assessment comparative risks
from DBFs and
microbes?
w
ui
Develop appropriate risk assessment
paradigm for microbes, including
dose-response models.
Improved risk assessment
procedures and risk estimates
for microbes.
Apply advances in cancer and
noncancer risk assessment to
individual DBFs and mixtures of DBFs.
Improved risk assessment
procedures and risk estimates
for DBFs.
To provide a comparative risk framework for risk
assessments for surface water treatment rules and
DBF rules.
(Continued)
-------
Table 1-2. Drinking Water Disinfection (Continued)
Subtopic
Strategic Focus
Tasks
Products
Uses
(D
Risk
Management
H
to
Which technologies
can simultaneously
control pathogens and
DBFs?
Evaluate treatment processes for
pathogen control, including
identification of surrogate measures
of treatment effectiveness,
technologies for small systems, and
control of bacterial growth in
distribution systems.
Simultaneously evaluate processes
for controlling DBFs (including
chlorine vs. alternative disinfectants)
and practices for removing DBF
precursors (granular activated
carbon, membrane filtration).
Data on the effectiveness of
different processes.
To evaluate different treatment options and
regulatory strategies for reducing DBF and microbial
risks.
To provide guidance for operation of treatment
plants and distribution systems.
O
O
O
to
O
&
O
-------
Table 1-3. Particulate Matter
Subtopic Strategic Focus
Tasks
Products
Uses
Health Effects What health effects are caused
by particulate matter (PM) and
its components?
H
to
O
O
O
to
O
f«
O
Conduct epidemiologic studies of
mortality and morbidity coupled with
improved exposure characterization.
Conduct clinical studies of respiratory
effects in controlled human studies.
Qualitative and
quantitative data on
mortality and/or
respiratory diseases.
To provide health effects data for risk assessment
(Criteria Document) to support PM National
Ambient Air Quality Standards (NAAQS).
What are the causal
mechanisms/particles that
explain/support epidemiologic
observations?
Conduct animal and clinical studies of
biochemical and physiologic events
initiated by PM and its components.
Dose-response data
describing biochemical
and physiologic events
induced by PM and their
relationship to disease.
To provide health effects data for risk assessment
(Criteria Document) to support PM NAAQS.
What is the relationship
between PM exposure and
dose?
What is the role of dose for
effects in sensitive
subpopulations?
Develop dosimetric model of particle
deposition in the lungs under various
exposure and population conditions.
Dosimetric model
linking animals to
humans and normal
humans to sensitive
subpopulations (e.g.,
children, individuals
with preexisting disease).
To provide health effects data for risk assessment
(Criteria Document) to support PM NAAQS.
Exposure What PM species and
concentration levels are present
in ambient air?
Develop ambient PM measurement
methodology capable of discriminating
particles by size and species.
Methods for measuring
fine-particle mass and
characterizing species
(e.g., acid aerosols,
inorganic and organic
species).
To serve as a Federal Reference Method for new
fine-particle NAAQS.
To provide PM methodology for atmospheric
chemistry research and total exposure research.
Conduct PM size and species
characterization studies.
PM characterization
data.
To assess PM size and concentration levels for
regulatory development and epidemiologic study
design.
To identify sources of PM and address PM
formation, transport, and fate.
To help develop control strategies for
implementing PM regulation(s).
(Continued)
-------
w
00
Table 1-3. Particulate Matter (Continued)
Subtopic Strategic Focus
Tasks
Products
Uses
(D
Exposure What PM species and
(Continued) concentration levels are people
exposed to?
Conduct prospective epidemiologic and
human exposure studies.
Verification of current
epidemiologic
observations.
Improved estimates of
human exposure to PM.
Reduced uncertainty
regarding the size and
physical properties of
PM that may cause
health effects.
To determine the effects of ambient fine and coarse
PM on adults' lung function and daily mortality.
To evaluate and extend findings on size-specific
PM exposure and daily mortality.
H
to
O
O
O
to
O
&
O
Risk How can we reduce
Assessment uncertainties associated with
estimates of the PM
mortality/morbidity risks at
low ambient levels?
Conduct statistical reanalyses of existing
epidemiologic databases to further
characterize:
-The shape of exposure-response
relationships (possible 'thresholds').
-The influence of synoptic weather
patterns.
-The size/chemical composition of key
PM components.
Quantitative data
analyses providing
reduced uncertainties in
PM risk estimates.
To provide health effects data for risk assessment
(Criteria Document) to support PM NAAQS.
Risk What are the emission rates and
Management physical and chemical
characteristics of fine particles
from sources that pose the
greatest risk to public health?
Characterize fine-particle emissions from Technical reports and
sources of concern (e.g., heavy duty
diesel trucks, fugitive sources,
combustion systems, other stationary
sources).
data on the size
distribution, chemical
composition, and
quantity of fine-particle
emissions from key
mobile and stationary
sources.
To provide emissions data to focus regulatory
strategies on the most critical sources.
To provide methods and models for states to
develop fine-particle emissions inventories.
(Continued)
-------
Table 1-3. Particulate Matter (Continued)
Subtopic Strategic Focus
Tasks
Products
Uses
Management
(Continued)
H
to
O
O
What options (e.g., process
changes, upgrades of existing
controls, application of new
technologies) are available that
both reduce fine-particle
emissions to acceptable levels
and are cost-effective?
Investigate options for reducing
fine-particle emissions:
-Demonstrate the extent to which
improved operation and maintenance
of existing control equipment for
combustion systems can further reduce
emissions.
-Develop advanced, more cost-effective
technologies (e.g., improved
electrostatic precipitators and fabric
filters) to control fine particles from
stationary sources.
-Determine the effectiveness of indoor
air cleaners for reducing personal
exposure to fine particles.
Compare the costs of these and other
approaches.
Technical reports and
data on the performance
and cost-effectiveness of
competing risk
management approaches.
User-friendly computer
models and other
technical assistance tools
that transfer risk
management
information to key users.
To support evaluations of competing regulatory
strategies, cost/benefit analyses, and development
of guidance documents.
To provide guidance to states and the regulated
community on the performance and cost of
competing fine-particle risk management
approaches.
O
to
O
f«
O
W
(O
-------
o
Table 1-4. Endocrine Disrupters
Subtopic Strategic Focus
Tasks
Products
Uses
(D
Identify
Research
Needs
What do we know about the
sources, chemical and physical
properties, transport pathways,
ecological and human effects of
EDCs,a and where are the major
gaps in our knowledge base?
Conduct workshops involving
principal stakeholders in
developing consensus on the
research needs for exposure,
and health and environmental
effects.
Reports on the research needs
for (1) reproductive, neurologic,
immunologic, and carcinogenic
effects of EDCs, (2) ecological
risk, and (3) exposure
assessment.
To develop prioritized research needs.
Effects What are the important
chemical classes for interaction
with the endocrine system, and
what is their range of potency?
H
to
o
o
O
to
O
&
O
Develop QSARD models for
hormone receptor-ligand
binding and transcriptional
activation.
QSAR models to identify and
prioritize in vivo research to
define dose-response effects.
As first-tier computer models to predict hazard.
Do our current testing and
monitoring approaches
adequately evaluate and assess
effects on the endocrine system?
Develop in vivo and in vitro
test procedures and biomarkers
to detect the action of EDCs and
to identify critical life stages at
multiple phylogenetic levels.
Recommendations for To revise testing guidelines and improve data
modifying the testing guidelines interpretation.
for potential adverse ecological
and human health effects.
Field and laboratory tools to
better quantitate effects of
putative EDCs.
What are the shapes of the
dose-response curves for EDCs
at relevant exposures, and what
tissue levels are responsible for
inducing adverse effects?
Develop PBPKC and BBDRd
models that include relevant
species-specific parameters.
Define potency of EDCs in
target species.
Increased understanding of the
comparative exposure levels
associated with risks.
Reduced uncertainty in
extrapolating effects.
To reduce uncertainty in chemical-specific risk
assessments and relative potency comparisons.
What is the normal endocrine
profile in target wildlife species
on a seasonal and regional basis?
Study populations and
determine normal profiles for
endocrine function during
various life stages, seasons, and
regions.
Database on endocrine function
in wildlife exposed to potential
EDCs.
To improve interpretation of endocrine data from
field studies and to improve understanding of the
magnitude of the EDC problem in wildlife
populations.
What are health outcomes
experienced by populations
receiving high-level exposure to
EDCs?
Assess spectrum of effects in
highly exposed cohorts,
particularly those with
developmental exposures.
Delineation of causes and effects To conduct preliminary risk assessments.
that can set the bounds on T , , ,. , . , , ,
lo develop remedial actions where adverse effects
effects in less highly exposed of EDC§ ^ the envlronment have been conflrmed.
populations.
(Continued)
-------
Table 1-4. Endocrine Disrupters (Continued)
Subtopic Strategic Focus
Tasks
Products
Uses
Effects
(Continued)
H
to
O
O
O
to
O
f«
O
For wildlife species, what
procedures are available for
extrapolating effects of the
individual to populations?
Develop models for
extrapolating effects measured
in individuals to reproductive
capacity in wildlife populations.
Models for predicting
population-level effects from
study at lower levels of
biological organization.
To facilitate ecological risk assessment based on
effects observed in individuals.
What are the status and trends
of sentinel and keystone species
in the various ecological areas?
Identify and periodically
conduct censusing of sentinel
and keystone species.
Early warning indicators of
environmental quality,
especially in terms of
contamination by EDCs.
For environmental monitoring.
What are the effects of exposure
to multiple EDCs?
Determine potential for
synergism or potentiation
within and among various
modes of action.
Assessment of the potential for
non-additivity among EDC
health endpoints.
To improve effects assessment for environmentally
important multiple exposures to EDCs.
Exposure What are the pathways of
exposure of EDCs?
Develop source-receptor
models to assess exposure from
specific sources via multimedia
pathways.
Validated models to assess
exposure to EDCs.
To improve source-receptor relationships
determined via hybrid models.
Do we adequately understand
multimedia transport (including
phase equilibrium and
deposition mechanisms),
persistence, bioaccumulation,
and biomagnification of EDCs?
Develop methods to monitor
exposure to EDCs and methods
to characterize exposure
half-life, speciation, uptake, and
phase equilibrium.
Analytical methods adequate to
characterize EDCs in
multimedia, to assess transport,
fate, and exposure, and to
provide input to source-receptor
models.
To improve source and receptor models and
assessments of EDC exposure.
Do we have adequate (sensitive,
reliable, and inexpensive) tools
to monitor populations for
exposures to EDCs?
Develop biomarkers for
exposure of EDCs applicable to
the phylogenetic levels
considered to be at greatest risk
to EDCs.
Field and laboratory tools to
better quantitate the exposures
and effects of putative EDCs.
Improved algorithms to
calculate EDC exposure.
To improve data interpretation.
What are the environmental
concentrations of EDCs in all
principal media?
Conduct field studies to
measure high-priority EDCs.
Database on EDC levels in the
human environment and
various ecosystems to assist in
designing future exposure
strategies.
Preliminary environmental exposure assessments.
(Continued)
-------
Table 1-4. Endocrine Disrupters (Continued)
o
to
O
&
O
Subtopic Strategic Focus
Tasks
Products
Uses
(D
Exposure What exposures are experienced Quantitate exposure in
(Continued) by populations affected by populations showing effects of
EDCs? EDCs, particularly those with
developmental exposures.
Delineation of causes and effects To conduct preliminary risk assessments.
which can set the bounds on
effects in less highly exposed
populations.
To develop remedial actions where adverse effects
of EDCs in the environment have been confirmed.
Assessment What strengths and weaknesses Convene EPA working group to Report of literature review.
are present in assessment of critically review existing
existing information on EDCs biological effects information.
and related topics?
To refine ORD's research strategy.
To develop regulatory policy on EDCs.
o
o
aEDC = endocrine-disrupting chemical.
QSAR = quantitative structure-activity relationship.
°PBPK = physiologically based pharmacokinetic.
dBBDR = biologically based dose-response.
-------
Table 1-5. Research to Improve Ecosystem Risk Assessment
Subtopic Strategic Focus
Tasks
Products
Uses
Effects
H
to
O
O
O
to
What levels of
anthropogenic stress
Understand and develop
models to predict ecosystem
(chemical and nonchemical) vulnerability to alternative
can ecosystems tolerate and management practices and
still be sustained/
maintained?
changing stressors at multiple
scales.
Quantitative models predicting
complex and cascading effects
of multiple stressors at multiple
geographic and temporal scales.
Criteria for maintaining
ecosystems.
To inform debate on societal values with respect to
ecosystem protection; to provide information to support
future community-based ecosystem protection.
To provide information to evaluate comparative risks and
drive strategic research planning.
Develop screening and testing
methods to assess viability
and sustainability at multiple
levels of biological
organization.
How do ecosystem
components respond to
changing exposures to
stressors?
Conduct research to
quantitatively understand
stressor-response
relationships.
Quantitative models relating
levels of exposure to effects for
single stressors.
To support ecological effects
assessment.
What are the best measures Identify indicators (measures) Evaluation of indicators of
of ecosystem effects? of effect that correspond as effect.
closely as possible to
assessment endpoints.
To provide indicators that can serve as state variables in
risk assessment models and as measures of condition for
status and trends monitoring.
To support objective evaluation of success in risk
management decision-making.
Exposure
What are the most
significant sources of
stressors in various
ecoregions of the United
States?
Develop methods for
characterizing sources of
relevant stressors.
Methods for characterizing
sources of exposures.
As tools for exposure assessments.
As components of expert systems to predict exposure.
What is the extent and
distribution of highly
vulnerable systems based
on predicted changes in
stressors at multiple scales?
Develop methods to
efficiently characterize
regional landscapes and
habitat distribution.
Baseline data for regional
assessments.
Assessments of highly
vulnerable ecosystems, within
and among ecoregions.
A national land-cover map of
the United States.
To support relative risk assessments.
To identify vulnerable systems at watershed and regional
scales.
(Continued)
-------
Table 1-5. Research to Improve Ecosystem Risk Assessment (Continued)
Subtopic Strategic Focus
Tasks
Products
Uses
(D
Exposure
(Continued)
What is the current
distribution of exposure to
these stressors across
vulnerable ecosystems?
Develop models to link Methods for assessing exposure. To support relative risk assessments.
transport, transformation, and
fate of stressors to exposure to To identify vulnerable systems at watershed regional and
ecosystems at appropriate national scales.
time and space scales.
Support an interagency
exposure reference site
network.
H
to
O
O
O
to
O
&
O
Conduct exposure
vulnerability assessments at
multiple geographic and
temporal scales.
What sources are now Develop diagnostic tools for
causing the most significant retrospective assessments.
exposures?
Indicators of source/exposure
relationships.
To apportion source strengths.
To identify sources for risk reduction technology
development.
How will current patterns
of exposure change in 5, 10,
25, and 50 years?
Conduct demographic and
economic studies to assist in
predicting future sources of
stressors.
Link landscape and pollutant
models to predict future
environments.
Documentation of highest
priority stressors.
Data for predictive models.
Predictive models for use by
community-based ecosystem
protection planners.
Predictions of future pollutant
and stressor distributions
To support environmental planning at multiple scales.
To assist in avoiding the unintended consequences of our
current management decisions.
Assessment What are the assessment
endpoints of primary
concern to local, watershed,
and regional communities?
Develop an ORD-wide
ecological data management
system.
Data systems to support risk
management.
To support ecological risk assessment.
To conduct comparative ecological risk assessments to
prioritize research and ecological protection efforts.
(Continued)
-------
Table 1-5. Research to Improve Ecosystem Risk Assessment (Continued)
Subtopic Strategic Focus
Tasks
Products
Uses
H
to
H
M
O
O
O
to
Assessment
(Continued)
What are the comparative
risks to populations,
communities, and
ecosystems from multiple
stressors?
Develop risk assessment and Improved risk assessment
characterization methods for methods.
single/multiple resources and
stressors.
As tools for ecological risk assessment.
To conduct comparative ecological risk assessments.
Assess the risks and their
economic implications.
Quantitative/qualitative
regional, comparative risk
assessments.
To support regional and local community-based ecosystem
protection plans.
To assist in prioritizing research and ecological protection
efforts.
Develop an expert system for
assessing ecological benefits
of alternative management
strategies at multiple scales.
Conduct comparative risk
assessments.
Links between human health
and ecological risks.
As a tool for environmental management at watershed
scales.
To assist in environmental management and planning at
multiple scales.
What are the most
Management cost-effective and efficient
ways to reduce risk to
ecosystems?
Identify and evaluate
promising options for risk
reduction.
Risk management technologies
for contaminants, sediments,
hazardous wastes, and other
stressors.
Data on technology
effectiveness.
Recommendations on optimal
ecosystem management
approaches.
As tools to select and implement approaches for reducing
ecological risk.
To avoid an ecological "train-wreck."
How are degraded
ecosystems best restored?
Conduct field restoration
projects.
Restoration techniques.
To improve restoration techniques.
To restore ecosystems.
To provide manuals and guidance on management
practices.
Ul
-------
H
to
O
O
O
to
O
&
o
Table 1-6. Research to Improve Health Risk Assessment
Subtopic Strategic Focus
Exposure what is the
source-exposure
relationship?
What is the
population
distribution of
exposures from all
media?
What are the
determinants of
exposure?
Dose What is the
Estimation exposure-dose
relationship for
pollutants from
each pathway?
How can we
improve dose
estimations across
species and
exposure scenarios?
Tasks
Develop verified models that trace
the prospective and retrospective
relationship between sources and
total exposure.
Develop quantitative total human
exposure models based on sound
theoretical and experimental
information.
Determine which behavioral,
socioeconomic, or lifestyle factors
increase exposure to pollutants;
determine the relationship of age
(young and old) and preexisting
disease to exposure.
For pollutants having multiple
pathways, determine the
quantitative contribution of each
pathway to total exposure and
target-site dose.
Develop methods and models for
estimating dose to target tissues
(i.e., physiologically based
pharmaco kinetic models).
Products
Verified source-exposure models
that incorporate fate and
transport processes.
Improved methods for exposure
measurements:
- Activity pattern database.
- Microenvironmental exposure
measurements.
- Field studies of populations
with a variety of exposure risk
factors.
- Computer-based exposure
model platform.
Multimedia/pathway exposure
data for disadvantaged
populations, children, the elderly,
and persons living near selected
sources (e.g., pesticide use).
Exposure models for highly
exposed subpopulations.
Models of relative intakes of
persistent chemicals from
inhalation, oral, and dermal
routes based on measurement
data.
Models for predicting disposition
of chemicals in the body from all
routes.
Uses
To identify the most effective risk management targets.
To support health risk assessments; to measure
effectiveness of risk management decisions.
To identify at-risk subpopulations for risk assessment and
to ensure adequacy of rules/regulations.
To identify the pathways that contribute most to risk
hence require mitigation.
and
To improve the scientific basis for cancer and noncancer
risk assessments.
To reduce uncertainty in risk assessment and risk
management decisions.
(D
(Continued)
-------
Table 1-6. Research to Improve Health Risk Assessment (Continued)
Subtopic
Strategic Focus Tasks
Products
Uses
(/i
H
to
O
O
O
to
O
fS
a
Hazard
Identification
and
Characterization
How can we
improve our ability
to detect hazards?
Develop screening methods to set
testing priorities.
Validated screening protocols
using, for example, in vivo, in
vitro, and structural activity
relationship (SAR) methods.
To identify and rank existing pesticides and industrial
chemicals in terms of potential toxicity.
To screen new chemicals as they enter the regulatory
system; to assess relative toxicity.
Develop cost-effective methods
for toxicity data collection.
New and revised standard
toxicity testing protocols.
To develop Agency test guidelines.
To support regulatory activities (e.g., TSCAa test rules
and consent agreements, FIFRA data call-ins).
How can we better
interpret toxicity
data to predict and
define hazards?
Develop improved methods for
data interpretation. For example,
identify biomarkers of exposure
and effect and validate the use of
biomarkers in human populations.
Guidance document on
interpretation of toxicity data.
For incorporation into risk assessment guidelines.
Dose-Response
Relationship
How can we reduce
uncertainty in
extrapolations (e.g.,
from high doses in
animals to
environmental
exposures in
humans)?
Develop quantitative models for
predicting tissue and organism
response to target tissue dose (i.e.,
biologically based dose-response
models).
Models for predicting toxicity
due to chemical exposures, which
can be modified and applied in
chemical-specific risk
assessments.
To provide critical examples of development and use of
mechanistic models; to evaluate the potential of these
models for replacing default approaches for cancer and
noncancer risk assessment.
To provide a state-of-the-science basis for replacing
default, primarily empirical risk assessment approaches.
Develop improved empirical
dose-response models (e.g.,
benchmark dose models).
Validated benchmark dose
models and guidelines for
applications.
To improve reference dose concentration procedures and
thereby improve the basis for risk management decisions.
Special Problems Wnat toxicities are
associated with
mixtures?
Develop methods to assess the
toxicity of chemical mixtures.
Validated and standardized
testing protocols.
To identify chemical mixtures with potential toxicity that
is other than addictive.
To assess site-specific relative risk; to support pollution
prevention and risk management decisions.
Develop models to predict the
toxicity of chemical mixtures.
Validated and standardized
predictive models.
To identify chemical mixtures likely to have synergistic or
supra-additive toxic effects.
To improve risk management decisions concerning risks
posed by mixtures.
aTSCA = Toxic Substances Control Act.
FIFRA = Federal Insecticide, Fungicide, and Rodenticide Act.
-------
Table 1-7. Pollution Prevention and New Technologies
Subtopic
Strategic Focus
Tasks
Products
Uses
(D
Risk
Management
How can pollution
prevention strategies be
integrated into federal,
state, and private sector
decision-making?
Develop life-cycle
assessment (LCA) tools and
models.
LCA tools that include health
and ecological impacts.
To demonstrate how LCA can evaluate options for
multimedia pollution prevention and risk management that
are keyed to the greatest risks.
As objective, scientifically credible LCA procedures for
regulatory and private sector use.
Develop pollution
prevention modules for
industrial plant, product,
and process design
procedures.
H
to
O
O
O
to
O
f«
O
Generic and specific LCA case
studies with private and
public sector partners.
Mathematical models and
computer-based simulators
for process design.
To establish partnerships to demonstrate risk-based pollution
prevention design and process simulation opportunities.
For commercial plant and process design methods, models,
and procedures.
To provide technology transfer to the private sectors through
Cooperative Research and Development Agreements and
licensing agreements.
Develop pollution
prevention measurement
and audit tools for small
businesses.
Pollution prevention
accounting methods and
models.
Audit procedures for
pollution prevention.
As tools for measuring and estimating "pollution prevented"
in small businesses.
To provide technical guidance for regulatory programs and
private sector needs.
How can pollution be
prevented?
Develop precompetitive
and enabling pollution
prevention and innovative
technologies for major
industrial sectors.
Pollution prevention and
innovative technologies for
Common Sense
Initiative-related industrial
sectors and high-risk problems,
including information on
technology costs.
To improve technical and cost data and designs for pollution
prevention and innovative technologies keyed on CSI
industries and other high-risk needs.
To provide a basis for commercially available pollution
prevention and innovative technologies for a wide array of
U.S. industrial sectors and high-risk problem areas.
Evaluate and verify these
technologies for technical
performance and
cost-effectiveness.
Technology verification
protocols, third-party
verification organizations, and
outreach to technology
enablers and users.
Performance and cost data for
pollution prevention and
innovative technologies.
Enhanced and more credible information to inform
decision-makers about pollution prevention and innovative
technology options emphasizing both performance and cost.
As a basis for developing scientifically credible and
commercially available pollution prevention and innovative
technologies for both U.S. and foreign markets.
(Continued)
-------
Table 1-7. Pollution Prevention and New Technologies (Continued)
Subtopic
Strategic Focus
Tasks
Products
Uses
Risk
Management
(Continued)
(/i
H
to
O
O
O
to
O
&
a
How can reliable and
appropriate cost data be
generated for pollution
prevention and
innovative technologies?
Develop process cost
models for pollution
prevention and innovative
technologies.
Develop cost data reporting
standards and protocols for
improved cost
comparability.
Cost estimating and reporting
protocols and standards.
To improve cost estimating tools for use in cost-effectiveness
and cost-benefit methods development.
To provide reliable, scientifically credible cost-estimation
packages for environmentally preferable approaches and
technologies.
Develop engineering and
performance costs for
pollution prevention and
innovative technologies.
Cost data for pollution
prevention and innovative
technologies.
For cost-benefit assessments by EPA and other regulatory and
nonregulatory decision-makers.
How can pollution
prevention and
innovative technologies
be disseminated to effect
a reduction in
environmental risk
worldwide?
Identify specific industry
and government audiences
worldwide, their needs for
information, and
appropriate products to
meet those needs (e.g.,
seminars, bulletins,
demonstrations).
A variety of technology
transfer products
disseminated via the Internet,
teleconferencing, electronic
bulletin board, and other more
conventional means (e.g.,
reports, workshops).
To increase the awareness and knowledge of environmental
professionals and others about the validity and benefits of
pollution prevention and innovative technologies, thereby
leading to their increased application and broader use.
To improve decision-making among innovative technology
users and permitting officials.
To support widespread use of applicable pollution prevention
and innovative technologies that maximize risk reduction.
Industry-targeted information
dissemination products that
will include technical and cost
data and performance
analyses.
To improve environmental compliance and reduce
compliance costs.
To encourage the private sector to value and routinely use
pollution prevention and innovative technologies as the first
or only preference for environmental protection and
compliance.
-------
-------
Appendix II
The ORD Organization
ORD's new organization, depicted below, mirrors
the risk assessment/risk management paradigm.
The functions of ORD's National Laboratories,
Centers, and Offices are described on the following
pages.
ORD's New Risk-Based Organization
Office of Resources
Management and
Administration
National Health and
Environmental Effects
Research Laboratory
Reproductive
Assistant Adminis
trator for Research and Developn
lent Office
of Science Policy
^ A
for Management Administrator for Science Office of Research and
Toxicology Division
(RTP, NC)
Experimental
Toxicology Division
(RTP, NC)
Environmental
Carcinogenesis
Division (RTP, NC)
Neuro toxicology
Division (RTP, NC)
Division (RTP, NC)
Gulf Ecology Division
(Gulf Breeze, FL)
Mid-Continent
Ecology Division
(Duluth, MN)
Western Ecology
Division
(Corvallis, OR)
Atlantic Ecology
Division
(Narragansett, Rl)
National
Exposure
Research
Atmospheric
Processes Research
Division (RTP, NC)
Air Measurements
_ Research Division
(RTP,
NC)
Science Integration
National Center National Risk
for Environmental Management
Assessment Research
NCEA RTP, NC
Office
NCEA Washington,
DC Office
OH Office
Atmospheric
Modeling Division
(RTP, NC)
Air Exposure
Research Division
(RTP, NC)
Human Exposure
Research Division
(Cincinnati, OH)
Ecological Exposure
Research Division
(Cincinnati, OH)
Characterization
Research Division
(Las Vegas, NV)
Ecosystems Research
* Division
(Athens, GA)
~ Water Supply and
Water Resources
Division
(Cincinnati, OH)
Land Remediaton
and Pollution
Contro Division
(Cincinnati, OH)
Sustainable
Technoogy Division
(Cincinnati, OH)
Air Pollution
Prevention and
Contro Division
(RTP, NC)
Subsurface
Protect on and
Remediation Division
(Ada, OK)
Technology Transfer
and Support Division
(Cincinnati, OH)
- Technology
Coord nation Staff
(Washington, DC)
National Center
for Environmental
Research and
Environmental
Engineering
Research Division
(Washington, DC)
Environmental
Sciences Research
Division
(Washington, DC)
Quality Assurance
Division
(Washington, DC)
1 Peer Review Division
(Washington, DC)
STRATEGIC PLAN FOR ORD
51
-------
Appendix 11
National Health and
Environmental Effects Research
Laboratory
ORD's National Health and Environmental Effects
Research Laboratory (NHEERL) performs
laboratory and field research to help EPA answer
two fundamental questions:
What are the health and/or ecological effects of
exposures to man-made stressors?
What is the likelihood that these effects will occur
under conditions of environmental exposure?
NHEERL's research contributes to improving three
steps in the risk assessment process:
In the hazard identification area, NHEERL works
to improve both assessment test methods and the
interpretation of data developed by these
methods (i.e., the relationship of effects measures
to health/ecological outcome).
In the dose-response assessment area, NHEERL
performs mechanistic research to address major
uncertainties, as well as research to develop and
improve extrapolation and multi-tier models.
In the risk characterization area, NHEERL
provides data on carefully selected priority
problems.
National Exposure Research
Laboratory
The work of ORD's National Exposure Research
Laboratory (NERL) forms the basis for the human
and ecosystem exposure assessments that are part of
the risk assessment process. NERL researchers
measure, predict, and apply multimedia data to
assess with known certainty the multiple routes by
which humans and ecosystems are exposed to
environmental stressors. This work includes:
Characterizing the physical and chemical
properties that govern exposure in atmospheric,
terrestrial, aquatic, benthic, and aquifer
environments in order to identify and quantify
phenomena that result in exposure.
Developing, testing, and demonstrating
mathematical and computerized models to:
Predict multimedia exposure routes.
Describe the status of ecological systems.
Evaluate stressor fate and transport
mechanisms that affect mitigation, restoration,
prevention, and risk management options to
minimize exposure.
Location of ORD's National Laboratories and Centers
Newport, OR
Corvallis, OR
Las Vegas,
NV
Ada, OK
Duluth, MN
Grosse Me, Ml
Cincinnati, OH
Narragansett, Rl
Edison, NJ
Washington, DC
Research Triangle
Park, NC
STRATEGIC PLAN FOR ORD
-------
Appendix 11
National Center for
Environmental Assessment
ORD's National Center for Environmental
Assessment serves as a national resource center for
the overall process of risk assessment: integrating
hazard, dose-response, and exposure data and
models to produce risk characterizations.
National Risk Management
Research Laboratory
Research by ORD's National Risk Management
Research Laboratory (NRMRL) provides the
scientific basis for environmental risk management.
Specifically, NRMRL conducts research to reduce
the uncertainty associated with making and
implementing risk management decisions. This
research focusses on two important areas:
Characterizing pollutant sources that require
management.
Identifying, developing, and evaluating tools and
technologies for prevention, control, restoration,
and remediation of environmental problems that
are high risk, high cost, or that lack effective
management alternatives.
NRMRL catalyzes the development and commercial
application of some of the more cost-effective risk
management alternatives through joint efforts with
public and private sector partners, and through
programs to verify the performance and cost of
innovative technologies. NRMRL also provides
technology transfer and technical support to risk
management stakeholders to encourage improved
risk management decision-making.
National Center for
Environmental Research and
Quality Assurance
ORD's National Center for Environmental Research
and Quality Assurance (NCERQA) represents a
major and renewed commitment by ORD to help
EPA achieve the highest possible quality of science.
In particular, NCERQA has made a major
commitment to ensure the high quality of ORD's
extramural research by establishing the Science to
Achieve Results (STAR) program. The primary
purpose of the STAR program is to access the
foremost research scientists from universities and
nonprofit centers around the country to meet the
specific science needs of the Agency. STAR consists
of three componentsa focused Requests for
Applications, an Exploratory Research Grants
Program, and a Graduate Fellowships Program
all of which are targeted to issues of importance to
EPA. All applications to the STAR program must
pass rigorous external peer review by national
experts before being considered for funding. A
portion of the STAR program is conducted jointly
with other federal agencies.
In addition to the STAR program, NCERQA
manages the Environmental Research Centers
Program and the Hazardous Substance Research
Centers and provides managerial oversight of EPA's
quality assurance programs.
Office of Resources Management
and Administration
The Office of Resources Management and
Administration (ORMA) provides support services
and leadership to ORD's Laboratories and Centers
in many areas: budgeting, finance, human resources,
training, information systems and technology,
administrative procedures, health and safety, facility
operations, and ORD's equipment and laboratory
infrastructure. ORMA also serves as the principal
staff office to ORD's Senior Resource Official. In this
capacity, ORMA oversees all of ORD's contracting
and assistance activities and conducts independent
reviews of ORD Laboratory and Center
management to ensure efficient operations in
support of sound science.
Office of Research and Science
Integration
ORD's Office of Research and Science Integration
(ORSI) is the bridge between ORD and its many
constituents:
ORSI is the key link between ORD science and
EPA policies and regulation. ORSI coordinates
ORD input into the policy and regulatory
development process, as well as ORD feedback
on proposed policies and regulations. ORSI also
STRATEGIC PLAN FOR ORD
53
-------
Appendix 11
coordinates ORD's support to EPA's Program and
Regional Offices.
ORSI coordinates EPA's research planning
process, working closely with ORD's National
Laboratories and Centers and EPA's Program and
Regional Offices to constructively coordinate
their input into ORD's research agenda.
Office of Science Policy
ORD's Office of Science Policy administers the
programs of two standing interoffice committees:
the Science Policy Council and the Risk Assessment
Forum.
The Science Policy Council is an EPA
organization comprising senior EPA science
managers and chaired by EPA's Deputy
Administrator. Focusing on selected
environmental issues that go beyond program
and regional boundaries, the Council develops
information and policies to guide EPA
decision-makers in their use of scientific and
technical information.
The Risk Assessment Forum is comprised of
senior agency scientists who study and develop
guidance on generic risk assessment issues. The
Risk Assessment Forum program includes
technical analysis and consensus-building on a
small set of selected risk science issues, usually
controversial or precedent-setting, that relate to
evaluating health and ecological risks.
In addition, the Office of Science Policy is
responsible for supporting ORD's Assistant
Administrator in selected projects.
54
STRATEGIC PLAN FOR ORD
-------
Appendix III
Management Structure for
Implementing ORD's
Strategic Plan
Successful implementation of ORD's Strategic
Plan requires coordinated input and
involvement by all ORD Laboratories,
Centers, and Offices as well as EPA's
Program and Regional Offices. Several councils and
teams, illustrated and described below, provide
mechanisms for this participation. Collectively, these
groups involve all levels of ORD senior manage-
ment from ORD's Assistant Administrator through
to ORD's Assistant Laboratory Directors (see figure).
The Research Coordination Council and ORD's
Research Coordination Teams, described below,
provide mechanisms for Program and Regional
Office involvement. One of the important roles of
the councils and teams is to assure "upward"
communication from the experts in ORD's
Laboratories and Centers.
Executive Council
ORD's Executive Council is chaired by ORD's
Assistant Administrator and consists of ORD's
Deputy Assistant Administrators for Science and
Management and the Directors of ORD's National
Laboratories, Centers, and Offices. The Executive
Council serves as the primary decision-making
body for major planning and management
decisions. Based on input from the Management
and Science Councils, Research Coordination
Council, and Research Coordination Teams, the
Executive Council coordinates major policy and
budget issues across ORD, including consensus
recommendations to ORD's Assistant Administrator.
Management Council
ORD's Management Council is chaired by ORD's
Deputy Assistant Administrator for Management
and includes the Deputy Assistant Administrator for
Science as an ex officio member, the Director of
ORD's Office of Resources Management and
Administration (who serves as the Vice Chair), and
the Deputy Directors for Management of ORD's
Laboratories and Centers. ORD's Management
Council provides senior management leadership for
developing and implementing effective manage-
ment policies, procedures, and systems. For
example, the Management Council is leading the
development of ORD's Management Information
System, a management system to ensure that ORD's
resources are efficiently administered. The
Management Council also provides input, feedback,
and guidance on issues that significantly affect
ORD's overall management operations.
Science Council
ORD's Science Council is chaired by ORD's Deputy
Assistant Administrator for Science and includes the
Deputy Assistant Administrator for Management as
an ex officio member. Science Council members
provide a balance between health and ecological
research. They include the Associate Directors for
Health and Ecology of ORD's National Laboratories
and Centers, the Associate Director for Science of
ORD's National Center for Environmental Research
and Quality Assurance, and the Director of ORD's
Office of Research and Science Integration.
STRATEGIC PLAN FOR ORD
55
-------
Appendix 111
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PLAN
-------
Appendix 111
The Science Council serves as the principal forum
for identifying, discussing, and providing advice
and recommendations to ORD's Assistant
Administrator on scientific and technical issues that
significantly affect ORD's overall scientific and
technical operations. For example, the Science
Council had the lead role in developing ORD's
Strategic Plan and will review all research plans.
Research Coordination Council
The Research Coordination Council comprises the
Assistant Administrators from key Program Offices
and the EPA Regional Administrators, supported on
a day-to-day basis by their senior staff. The Research
Coordination Council serves as a focal point for
integration between ORD and EPA's Program and
Regional offices. The Council provides ORD with a
cross-agency perspective, participates in ORD's
planning process, and recommends potential topics
for ORD's research agenda and extramural grants
program.
Research Coordination Teams
The Research Coordination Teams coordinate
ORD's research program with ORD's clients and
across ORD Laboratories and Centers. Organized
by environmental media (air, water, waste,
toxics/pesticides, and multimedia), the teams
assess ORD clients' needs, recommend research
priorities, monitor ORD progress toward meeting
these priorities, facilitate integration of intramural
and extramural research activities, and ensure
communication of results to ORD clients. Each
Research Coordination Team includes a Team
Leader from ORD's Office of Research and Science
Integration, the Assistant Laboratory Directors from
ORD's Laboratories and Centers, a program analyst
from ORD's Office of Resources Management and
Administration, a representative from ORD's
National Center for Environmental Research and
Quality Assurance to provide input on ORD's
grants program, and representatives from EPA's
Program and Regional Offices. The Research
Coordination Teams take the lead in developing
ORD's science research plans and in organizing and
conducting media-based program reviews of ORD
progress and outputs.
STRATEGIC PLAN FOR ORD
57
-------
-------
Appendix IV
Relationship of Fiscal Year
1996 Requests for
Applications (RFA's) to ORD
High-Priority Research Topics
Drinking Particulate
water matter in
disinfection the air
Research to
improve
ecosystem
Endocrine risk
disruptors assessment
Research to
improve
health risk
assessment
Pollution
prevention
and new
technologies
Ecological Assessment,
including regional
ecosystem protection and
restoration and global
climate change
Exposure of Children to
Pesticides
Air Quality, including
tropospheric ozone, air
toxics, and indoor air
Analytical and Monitoring
Methods, including field
analytical methods,
continuous measurement
methods, and leachability
prediction
Drinking Water, including
microbial pathogens and
disinfection by-products
STRATEGIC PLAN FOR ORD
59
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Appendix IV
Research to
improve Research to Pollution
Drinking Particulate ecosystem improve prevention
water matter in Endocrine risk health risk and new
disinfection the air disrupters assessment assessment technologies
Environmental Fate and J J J
Treatment of Toxics and
Hazardous Wastes,
including fate and mobility
of contaminants in salts and
ground water and the
assessment of risks of
contaminated soils and
treatment residuals
Environmental Statistics J J J
High Performance J J J
Computing
Risk-based Decisions for J J J
Contaminated Sediments
Endocrine Disrupters J J J
Role of Interindividual J
Variability in Human
Susceptibility to Cancer
Water and Watersheds J J
Technology for a J J J
Sustainable Environment,
including green chemistry
Decision-making and J
Valuation for
Environmental Policy
Bioremediation
60 STRATEGIC PLAN FOR ORD
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RD Response to Blue-Ribbon Panel Recommendations
Recommended Action
ORD Response
EPA should take steps to improve science
quality and enhance peer review.0'1
ORD needs a coherent research-planning
process, a robust mission statement, and a
0' ''J
vision statement.
ORD should enhance environmental
education programs for training the next
generation of scientists.3' >e
We instituted standard operating procedures for peer review in 1994.
To engage the nation's best research institutions, we expanded our program for
extramural research grants selected from competitive, peer-reviewed proposals.
We created a Peer Review Division in our National Center for Environmental Research
and Quality Assurance.
We developed the ORD Strategic Plan (this document) and distributed it for comment
in November 1995.
We implemented a risk-based research planning process.
We realigned ORD's organizational structure to use risk assessment and risk
management as principal priority-setting criteria.
We initiated an expanded graduate fellowship program initiated, with 100 awards in
1995.
ORD should streamline its existing
laboratory organization by collapsing the
twelve laboratories into four national
laboratories.
d,f,h
We consolidated ORD laboratories into three national laboratories and two centers in
1995 to align laboratories according to risk assessment and risk management
components.
ORD should improve its management
systems to track planning resources and
accomplishments.8'
ORD should balance short-term and
long-term research.3'e'gj
ORD should balance health and ecological
research.3'0
EPA should designate ORD's Assistant
Administrator (AA/ORD) as the Agency's
Chief Scientific Officer.J
We are developing the ORD Management Information System to track resources and
projects on an ORD-wide basis.
We established a Management Council, a Science Council, and (together with the
program offices and regions) a Research Coordination Council (see Appendix C of this
Strategic Plan).
We will conduct annual research program reviews to evaluate the status and
accomplishments of our research.
We are developing research plans to inform internal and external audiences about the
policy relevance, specific objectives, technical approaches, and expected products of our
research.
In 1995, we created the Science To Achieve Results (STAR) Program of peer-reviewed
investigator-initiated grants relevant to ORD's mission.
As described in this Strategic Plan, we give equal consideration to short- and long-term
research needs in our priority-setting process.
We have adopted a balance between ecological risks and human health risks as a major
strategic principle (see Table 1 of this Strategic Plan).
We appointed Laboratory Associate Directors for Health and Ecology for each national
laboratory.
The EPA Deputy Administrator appointed the AA/ORD as EPA's Scientific and
Technical Activities Planner in March 1995.
EPA must improve its capability to
anticipate environmental problems.3"0
EPA signed an agreement in 1995 with the National Research Council to establish a
group to review environmental issues for the next decade and recommend necessary
research.
aFutureRisk: Research Strategies for the 1990s. U.S. EPA, Science Advisory Board. 1988.
^Reducing Risks: Setting Priorities and Strategies for Environmental Protection U.S. EPA, Science Advisory Board. 1990.
cSafeguarding the Future: Credible Science, Credible Decisions. Report of the Expert Panel on the Role of Science at EPA. U.S. EPA. 1992.
dEnvironmental Research and Development: Strengthen the Federal Infrastructure. The Carnegie Commission. 1992.
eResearch to Protect, Restore, and Manage the Environment National Research Council. 1993.
Assessment of the Scientific and Technical Laboratories and Facilities of the U.S. EPA MITRE Corporation. May 1994.
sAn SAB Report: Review of the MITRE Corp. Draft Report on the EPA Laboratory Study. U.S. EPA, Science Advisory Board/Research Strategy
Advisory Council. May 1994.
A Review, Evaluation and Critique of a Study of EPA Laboratories by the MITRE Corporation and Additional Commentary on EPA Science and Technology
Programs. National Academy of Public Administration. June 1994.
letting Priorities, Getting Results: A New Direction for EPA National Academy of Public Administration. April 1995.
Interim Report of the Committee on Research and Peer Review in EPA National Research Council. March 1995.
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