EPA/600/R-95/162
November 1995
External Review Draft
egic Plan for the
Office of Research and
Development
Recycled/Recyclable
Punted on paper mat ontains at least
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Notice
THIS DOCUMENT IS AN EXTERNAL REVIEW DRAFT.
It has not been formally released by the U.S. Environmental Protection Agency and does not constitute Agency
policy. It is being circulated for comment on its scientific and policy implications.
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DRAFTDO NOT QUOTE OR CITE
ORD's Strategic Plan
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC 20460
November 1995
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Foreword
I am very pleased to present for external peer review this new Strategic Plan for environ-
mental 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 ;" Corporates and builds on these ideas to provide a blueprint
fc"- _iidrnng a co^^e 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 at ORD recently reorganized our nationwide
system of laboratories to conform to the fundamental components of the widely used risk assess-
ment and risk management processes. With this Strategic Plan, we are instituting a new system
for determining research priorities based on risk assessment and risk management principles. We
will use this -. stem to sharpen the focus of our research bv 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 pro-
motes greater partnership between ORD and its primary clientsEPA's program and regional
officesas 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.
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 look forward to receiving external peer review comments on our new plan. We will modify
the plan as appropriate based on these comments and publish a final plan in 1996. After that
time, we will periodically revisit and, as necessary, modify this Strategic Plan to ensure the contin-
ued 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 insti-
tuted at ORD (listed on the back inside cover), offer unparalleled opportunities for ORD to
improve the overall quality and relevancy of its research and development. I am confident that,
in the coming years, these changes will serve as essential catalysts for moving EPA into the high-
est echelon of leadership in environmental science.
Robert J. Huggett
Assistant Administrator
Office of Research and Development
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Contents
Introduction 1
ORD's Reinvention Around the Risk Paradigm 1
ORD's Strategic Plan 3
Part A: ORD's Research Strategy 7
ORD's Vision 7
ORD's Mission 7
ORD's Long-Term Goals and Objectives 8
ORD's Priority-Setting Process 8
Risk Criteria for Setting ORD Research Priorities 11
Translating ORD's Strategic Plan Into a Research Program . . . 11
Measuring Success 13
Infrastructure and Human Resources 14
Part B: ORD's Long-Term Goals and Objectives 17
Goall 17
Goal 2 19
Goal3 19
Goal 4 21
GoalS 22
Goal 6 22
Appendix A: ORD's Near-Term Research Priorities 25
Appendix B: The ORD Organization 45
Appendix C: Management Structure for Implementing
ORD's Strategic Plan 47
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Science is ant of the
the nation can make for the
science
environmental
better understanding of
to people and ec&$ystet%$f
target the hazards
, anticipate mm
fajote they reach & t%ie&H$@i
develop strategies
md the world's,
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 Academv of Sciences (NAS) and the Na-
j
tional Academy of Public Administration 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
Strategic Ptef' 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 substantial
changed our organization and operation so that u c
* Interim Report of the Committee on Research and Peer Rer.v . .
National Academy of Sciences Board on Environmental ~-r
and Toxicology. 1995. National Academy Press.
" Sitting Priorities, Getting Results. A New Direction for EPA
National Academy of Public Administration. 1995.
Washington, DC.
The \'eu< Generation of Environmental Protection. A Sum"'.:"'-
EP.'Vs Free-Year Strategic Plan. U.S. Environmental Ptvtr-.
Agencv (EPA). 1994. EPA200-2-94-001. Washington. D<
STRATEGIC PIAM FOR ORD
-------
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 I), which consolidated and gave
context to 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
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 upon 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
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 risn
Balance human health and ecological research.
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 and engineers 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.
4The NAS paradigm was developed specifically to define risk
assessment and risk management for human health. While ORD
recognizes there are distinctions for ecological risk assessment,
the general principles set forth in the MAS paradigm are still
useful as an organizing focus for ORD's strategic thinking.
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
from risk management activities. ORD is involved in
all 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 problem-.
The first major step in ORD's reinvention was to
reorganize ORD so that its new structure mirror-- the
risk paradigm shown in Figure 1. This new structure
is described in Appendix B. ORD's new Strategic
Plan is the second major step.
STRATEGIC PLAN FOR ORD
-------
Introduction
Figure 1.
The Risk Assessment/Risk Management Paradigm
Risk Assessment Risk Management
Statutory and Legal
Considerations
Hazard
Identification
Dose-Response
Assessment
KUDIIC Heaitn \ c
Considerations \ '-actors
Risk I V . ,
Characterization-*Rlsk Management
Decision
r
Risk
Exoosure \ / Management,
exposure \ t Opions
Assessment \ y
Political
Considerations
/
Public Health \ cSocial
s\ F
Economic t
Factors .
"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).
ORD's Strategic Plan
ORD's Strategic Plan, described in this document
and illustrated in Figure 3, is ORD's blueprint for
establishing a risk-based research program:
Part A of the plan defines new strategic direc-
tions (including ORD's vision, mission, and
goals) for ORD research, establishes a risk-based
process that we will use to determine our future
research priorities, describes how we translate
this Strategic Plan into a specific research pro-
gram (including research plans, operating plan-
and laboratory implementation plans), present-
approaches to measuring success, and descntv-
ORD's commitment to the infrastructure and
human resources essential to implementing th.
Strategic Plan.
Part B expands on ORD's goals and lists tho >;«
cific research objectives and activities ORD u <.'.'.
pursue to achieve its goals.
STRATEGIC PLAN FOR ORD
-------
Introduction
Figure 2.
The Scientific and Technical Contributions to Risk Management
Initiating Event or
Public Policy Mandate
Risk Management
. _ Dose-Response
Risk Assessment Assessment
Characterize 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
Public Health
Improvement
Monitor Environmental
and Public Health
Improvement
Public Health
Considerations
> Statutory and Legal
Considerations
1 Social Factors
1 Economic Factors
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 characterize the problem. This involves such activities as determining which stressor(s) (e.g., pol-
lutants, 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
characterized, 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.
STKATE6IC PlAN FOK OR0
-------
Introduction
ORD's Strategic Plan
Vision
Mission
1
Goals
Long-Term
Objectives
1
Activities To
Meet the
Objectives
Appendix A describes the near-term research
priorities that ORD has developed by applying the
priority-setting process set forth in Part A to ORD's
long-term objectives and activities.
Appendix C describes ORD's management struc-
ture for implementing the Strategic Plan.
Again, this Strategic Plan is designed to endure
while being dynamic. It includes sufficient flexibility
to constructively adapt the planning mechanisms to
changing EPA and national priorities over time. We
will periodically revisit and, as necessary, modify
the plan to ensure the continued productivity of
ORD's research and development efforts to meet
EPA and national environmental goals.
STRATEGIC PLAN FOB ORD
-------
THIS PAGE INTENTIONALLY
BLANK
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Part A
Research
X1""" . ' >.-. -. v*.fv. . '' ' i>. .
Strategy
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 pri-
mary 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 (Table 2), 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's vision is that:
ORD will provide the highest quality scientific
and engineering knowledge and tools to serve as
the basis for sound environmental decisions,
ORD's Mission
ORD's mission is to:
Perform research and development to identify,
understand, and solve current and future
environmental problems.
Interpret and integrate scientific information to
help organizations at all levels make better deci-
sions about improving the environment.
Provide national leadership in addressing emerg-
ing environmental issues and in advancing the
science and technology of risk assessment and
risk management.
STRATEGIC PIAN FOR OK0
-------
ORD's Research Strategy
Table 2.
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 three mission areas translate into six
long-term, overarching goals that we will strive to
meet in order to fulfill our mission (Table 3). 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.
ORD's Priority-Setting Process
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, however.
ORD, therefore, has developed a priority-setting
process that we will use to identify specific research
topics within the objective and activity areas that are
of primary importance to our vision, mission, and
goals. ORD's new priority-setting process, depicted
in Figure 4, involves the following steps:
First, we seek input from all parts of EPA.
Research Coordination Teams consisting of senior
representatives from ORD's new National Labora-
tories and Centers, the EPA program offices, the
Research Coordination Council (see Appendix C),
and EPA's ten regional offices identify the most
important and relevant areas for our research
efforts. (As more environmental protection is
moved to state and local governments, their
research needs will also be considered at this
stage.) We also work with EPA's Science Advisory
Board, the National Research 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. Finally, we consider the status and
results of our recent research activities. Based on
this information, ORD identifies potential
research topics.
Table 3.
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 int
comprehensive multimedia assessment methodology.
To provide common sense and cost-effective approaches for
preventing and managing risks.
Interpret and integrate scientific information to help
organizations at all levels make better decisions
about improving the environment.
To provide credible, state-of-the-art risk assessments, methods,
models, and guidance.
To provide reliable scientific, engineering, and risk assessment, n>k
management information to private and public stakeholders.
Provide national leadership in addressing emerging
environmental issues and in advancing the science
and technology of risk assessment and risk
management.
To provide national leadership and encourage others to participate
identifying emerging environmental issues, characterizing the r;-N-
associated with these issues, and developing ways of preventing r
reducing these risks.
STRATEGIC PLAN FOR O8D
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ORD's Research Strategy
Setting Research Priorities
External Scientific Community Input:
EPA Science Advisory Board
National Research Council
Private Sector
ORD National Laboratories and Centers
EPA Program Offices
Research Coordination Council
EPA Regional Offices
Identify Research Topics
Reject for No
ORD
Funding2
Apply Evaluation Criteria:
Human Health/Ecological Health
Risk Management
Methods/Models
I
Prioritized Research Topics
Reject for No
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.)
i
Research Products
1ln other words, ORD has no discretion to re|ect or delay this research.
2EPA program offices and regions may soil choose to fund, using ORD labs, grants, contracts, etc.. or a research source outside of ORD
STRATEGIC PLAN FOR ORJ>
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ORD's Research Strategy
We then separate the pool of potential topics into
two categories:
Those that are clearly mandated (i.e., ORD has
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, ecologi-
cal, and risk management criteria (Figure 5) to
compare the mission-related topics according to
their potential to support effective risk reduc-
tion. We also apply criteria (Figure 5) to consider
whether the research would develop broadly
applicable methods and models needed by EPA
programs. Through this screening process, we
set priorities 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.
For these remaining topics where ORD can make a
significant contribution, as well as all nondiscretion-
ary topics, we then define specific research and
development projects by considering 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), exposure assessment,
risk characterization, and risk management. At
this stage, we give priority to research that will
make the greatest contribution to reducing the un-
certainty associated with risk characterization.
We then develop research, operating, and labora-
tory implementation plans (see below) for each
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?
1 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?
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?
10
STRATE6IC PlAN FOR ORD
-------
ORD's Research Strategy
project and conduct the research via a variety of
mechanisms: in-house research, or external
research via grants, cooperative agreements, or
contracts. The research products and results
provide input into future planning efforts.
This approach to strategic planning clearly indicates
the following areas where ORD will not continue to
allocate resources:
Conduct of routine quality assurance programs in
the program offices and regions.
Support for routine environmental monitoring.
Exposure or effects research in areas of low risk.
Risk reduction research in areas of low risk.
Our new approach to strategic planning has many
strengths. It encompasses both scientific and
stakeholder priorities. It ensures that ORD will
continue to fully support EPA in fulfilling its
mandates. It focuses our resources where we can
make the most significant contributions. And, it
enables ORD to generate practical, credible
information and tools for risk-based
decision-making.
Risk 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
non-mandate-related 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. 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
Protection: the severity of response, the time scale,
permanence, and extent of the response, and the
level of organization. Table 4 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.
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. Each year, we will use this priority-setting
process and the criteria described above to identify
high-priority research topics that will help us
achieve ORD's goals and objectives. (Appendix A
lists ORD's current high-priority topics.) Many
topics will remain a high priority for several years.
Each year, 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.
Once we have identified our high-priority topics. v\ o
develop and implement a research program based
on these topics. This involves three steps:
STRATEGIC Ft AN FOR ORB
11
-------
ORD's Research Strategy
Table 4.
ORD's Human Health and Ecological Health Criteria
Ecological Health1
Human Health1
Severity of Response
Mortality
Morbidity
Premature mortality
Morbidity
Reproductive effects
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
1 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
1 Items are listed in descending order of priority.
An ecoregion is a geographic area that has similar topography, climate, and biota across the entire area.
Development of research plans. For each selected
research topic, Research Coordination Teams com-
posed of ORD scientists and representatives of
EPA's program offices and regions (see Appendix
C) develop research plans that:
Lay out the major research components and
directions 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.
These plans make clear to our clients both the
rationale for and the intended products of the
research and thus are important tools for measuring
accountability. They enable ORD to clearly track its
progress toward achieving its goals, as required by
the Government Performance and Results Act of
1993.
Development of operating plans. We then inte-
grate the 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.
Development of laboratory implementation
plans. Finally, based on the research plans and
budgetary decisions, ORD's laboratories and cen-
ters develop detailed plans for implementing
each area of research under their purview. These
laboratory implementation plans provide a blue-
print for laboratory and center work and form
the basis for managerial oversight and guidance
We involve ORD's main research clientsthe EPA
program and regional officesin all three step> to
ensure that final plans clearly include the reseat h
products that our clients need to fulfill their
responsibilities.
12
STRATESIC PLAN FOR ORD
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ORD's Research Strategy
Figure 6. Translating ORD's Strategic Plan Into a Research Program
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Plans
Measuring Success
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. For a mission-oriented
organization like ORD, other measures, such as the
extent that we help and support EPA in meeting its
goals, are equally important.
In measuring the success of this Strategic Plan, the
quality of the work that ORD is doing, and the
usefulness of the products that result from ORD
research, we use the following measures of success:
Significance: Is ORD working on the right issues?
This is a measure that the ORD program offices
and regions and the broad scientific community
can help us judge. For our research, developmL'nt
and support efforts to be useful, we must work
on the most important environmental issuer and
target areas for research that will significantly
improve risk assessment and/or risk management
in the Agency and elsewhere. Peer review tn
scientists in the external scientific commumt\
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 K -
judged by the degree to which ORD's contr : .
tions support Agency decisions.
STRATEGIC PLAN FOR ORD
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ORD's Research Strategy
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 consult-
ation and assessment needs in a timely manner,
providing research products according to sched-
ule, and responding to 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 deter-
mine whether ORD consultations and assessments
are being provided in time to be optimally useful
for Agency decisions. The middle part of this ques-
tion can be answered by 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 antici-
pating important environmental issues that are
just emerging and may not become critical prob-
lems 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
routinely gather the public's view on this issue.
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 will pre-
sent to EPA senior managers the entire EPA
research portfolio in a given area. These joint re-
views will focus primarily on the status and
accomplishments of the ORD research program
to ensure that ORD's research continues to meet
ORD and client objectives. They will also, how-
ever, 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 pro-
gress in completing planned research projects, to
track and evaluate research results, and to gener-
ally obtain feedback on ORD's work and any
adjustments that may be needed to help us better
meet our clients' needs. These reviews supple-
ment, rather than supplant, external peer reviews
(see below).
Annual ORD review of its research plans. ORD
examines its research plans annually and adjusts
them if warranted by our research results, by
changes in EPA or national priorities, or by emerg-
ing issues and concerns.
External peer reviews of ORD research plans and
products and overall progress in meeting our
goals and objectives. These reviews are con-
ducted at each step in our research planning and
implementation process.
Annual science workshops designed to make
the progress and results of all ORD research (in-
cluding 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.
Infrastructure and Human
Resources
The success of ORD's Strategic Plan depends on an
adequately funded and well-managed infrastructure.
To effectively implement our Strategic Plan, we must
provide our work force with:
Safe, environmentally sound, well-maintained,
state-of-the-art laboratories, equipment, and
supplies.
Environmental data management systems and ad-
vanced communications systems.
A host of other management, administrative, and
systems support.
ORD's strategic principles (Table 1) highlight the
critical role of infrastructure "to achieve and
maintain an outstanding research and development
program in environmental science."
ORD will work, within the limits of our available
resources, to maintain a sound, sufficient, and
productive infrastructure by:
Integrating planning for meeting infrastructun
requirements into the research planning pnv <--
Focusing resources on those infrastructure
ponents that are most important for achie\ ::.;
14
STRATEGIC PIAN FOR Q80
-------
ORD's Research Strategy
goals and objectives set forth in ORD's Strategic
Plan.
Managing all infrastructure components to obtain
maximum benefit and performance.
By far the most important component of ORD's
infrastructure is our work force of scientists,
engineers, managers, and support staff. ORD can
achieve its vision of providing the highest quality
scientific and engineering knowledge for
environmental decisions only if we can attract,
nurture, and support a world class work force.
ORD's strategic principles (Table 1) emphasize the
importance of nurturing and supporting "the
development of outstanding scientists and
engineers 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 B) and
staffing pattern into ORD. For example, our new
organization eliminates mid-level management
positions and broadens the control span of
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, world
class 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
personal growth.
Taking measures to maintain and enhance the
scientific competence and quality of ORD staff.
Building and maintaining solid linkages to the
external 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
scientific conferences).
As we implement our Strategic Plan, we will
monitor work force needs and provide other
programs, mechanisms, and support as necessarv
to cultivate a world class work force of scientists,
engineers, managers, and support staff and to
ensure that they have the tools and equipment they
will need to achieve ORD's vision and goals.
STRATEGIC PtAN FOR ORD
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BLANK
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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 3. Variations in the
specificity of the objectives listed below reflect differ-
ences 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 in-
ternal and external stakeholders to understand
specifically how ORD plans to accomplish its objec-
tives.
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's Research Coordination Teams (see Appendix
C) will apply ORD's priority-setting process
(described in Part A) to review and identify specific
research topics that best further these objectives. The
resulting set of research topics will constitute the basis
for ORD's research program. Appendix A describes
the first set of near-term priority research topics that
resulted from applying this process.
Goal 1: To Develop Scientifically
Sound Approaches to Assessing
and Characterizing Risk 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
develop risk management strategies and research
priorities.
Greater certainty in risk assessment would impnn
the efficiency and effectiveness of EPA's risk
management efforts and provide a better found.i:
STRATEGIC PLAN FOR ORD
1 7
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ORD's Long-Term Goals and Objectives
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 inadquate. 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 - u se
patterns and developing measures of land-
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 Highland-1
to evaluate alternative monitoring design-.
and to develop techniques to integrate data
across geographic scales.
18
STRATEGIC PJ.AN FOR ORD
-------
ORD's Long-Term Coals and Objectives
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 problemsall ^o
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 M-rk
to maximize the health and environmental benrriN
of risk management by focusing risk managerv.i :
STRATEGIC PtAisr FOR ORD
19
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ORD's Long-Term Goals and Objectives
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-makinga 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
byproducts 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 non-aqueous-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 problem^
(e.g., fine particulates, drinking water, wet
weather flow controls).
Develop and provide risk management alterna
rives to maintain and/or restore ecosystem^ Thi-
will include:
STRATIGIC PIAN FOR ORD
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ORD's Long-Term Goals and Objectives
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., dioxin, mercury).
Assessing the risks to ecosystems from non-
chemical stressors (e.g., habitat loss and
habitat fragmentation).
Conducting comparative risk assessment of
competing risks (e.g., those posed by micro-
organisms in drinking water versus those
posed by disinfection byproducts).
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, ha/.uJ
ous air pollutants, waste sites, and drinking
water.
STRATE6IC PLAN FOR ORD
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ORD's Long-Term Goals and Objectives
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.
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 Provide Reliable
Scientific, Engineering, and Risk
Assessment/Risk Management
Information to 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 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 provide 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 resource
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.
Goal 6: To Provide National
Leadership and Encourage Others
To Participate in Identifying
Emerging Environmental Issues,
Characterizing the Risks Associa-
ted 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
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 ot
emerging issues. Thus, we must develop and
disseminate data and methods to permit credible
decision-making in the face of very high uncertamt\
At ORD, we are committed to working with other
groups within EPA, the Agency's Science Advisor-.
Board (SAB), the National Academies of ScierKe u .:
STRATEGIC PIAN FOR ORE>
-------
Engineering (NAS and NAE), and others to develop
new ways of analyzing emerging issues.
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 are
in a position 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.
ORD's Long-Term Goals and Objectives
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 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, reaching consensus on crucial research
needs, and defining the role of ORD and others in
addressing those needs.
STRATEGIC PIAN pom ORD
IS
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Appendix A
ORD's Near-Term Research
Priorities
The goals and objectives listed in Part B
define an ambitious research program for
ORD. Within this program, however, the
extent of research that ORD can actually
perform will be limited by the available resources.
Therefore, ORD uses the priority-setting process
(described in Part A) to select from its overall pro-
gram those topics that are of highest priority for
research. Applying its priority-setting process for
the first time, ORD has established its research
priorities for the next few years. The six highest
priority topic areas are (in no particular order):
Drinking water disinfection.
Particulate matter.
Human health protection.
Ecosystem protection.
Endocrine disrupters.
Pollution prevention and new technologies.
Proposed research for these areas is summarized in
Table A-l. Tables A-2 through A-7 provide a detailed
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. ORD's research agenda also includes
additional topics necessary to help the Agency fulfill
its nondiscretionary mandates. ORD's entire
research program will be captured in the research
plans that will be developed by the Research
Coordination Teams (see Appendix C).
The following three examples illustrate how applica-
tion of the selection criteria described in Part A gave
rise to the high-priority research topics described in
this appendix.
Drinking Water Disinfection
Although disinfection of drinking water has been
one of the greatest public health success stories of
the twentieth century, some public health concerns
still remain. For example, hundreds of people have
died and many thousands of hundreds have become
ill during recent outbreaks of exposure to the bacte-
rium 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 re-
ceiving 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 de-
gree of uncertainty about whether disinfection
byproductsthe chemical byproducts 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 i>-
sue is of high priority to EPA's Office of Water and
to ORD's research agenda.
Particulate Matter
Recent publications in the scientific literature indi-
cate that exposure to particulate matter poses A ^!
potential human health risk. At the same time, rum
ever, there is a high degree of uncertainty about the
size and composition of the particles that mav h<
STRATEGIC PtAN FOR OR0
-------
Appendix A
responsible for these effects, the biological mecha-
nisms 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 EPA's Office of Air and
Radiation and of high priority for ORD's research
agenda.
Ecosystem Protection
Many ecological effects are potentially related to
pollution and other environmental factors. The
consensus among environmental scientists and
decision-makers is that methods are needed to
assess ecological risks. Such methods would serve
all EPA programs and are extremely important for
understanding risks at both the local and commu-
nity levels. Because of the broad applicability of these
methods and their significant potential for improving
ecological risk assessment and risk management, ORD
has selected ecosystem protection as a high-priority
topic for its research agenda.
$TRATE6IC PlAN FOR ORB
-------
Table A-1. Summary of EPA/ORD Research Program for Six High-Priority Research Topics
Research Topics Strategic Focus
Tasks
Products
Drinking Water
Disinfection
What is the comparative
risk between wnterborne
microbial disease and the
disinfection byproducts
(DBPs) 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 DBP risk
assessments, and evaluate alternative
treatment processes for DBP/microbial
control.
Data on effects, dose-response,
exposure, comparative risk, and
treatment for pathogens/DBPs.
Particulate What morbidity/mortality
Matter 's 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.
Uses
To support DBP/microbial risk
assessment/risk reduction
rulemakmg and compliance
monitoring.
To improve criteria documents and
risk assessments in support of I'M
National Ambient Air Quality
Standards review; to provide
information for evaluating
alternative PM control strategies.
Human Health
Protection
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 so jrce/pathway
contributions to total exp.-sure.
Improved exposure measurement
and assessment methods, models,
and data.
To support exposure assessment
during risk-based decision-making
(Continued)
9
9
It
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Table A-l. Summary of EPA/ORD Research Program for Six High-Priority Research Topics (Continued)
Research Topics Strategic Focus
Tasks
Products
Uses
Ecosystem
Protection
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 the debate on ecosystem
ecosystem effects/risks, national
land-cover map, baseline data for
documenting future changes,
ecosystem exposure profiles, and
information on risk reduction
approaches for ecosystems.
protection, ecosystem assessment,
environmental planning, and
ecosystem risk
reduction/restoration.
It
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3
Endocrine What is known about
Disruptors endocrine disruptor (EDC)
exposure, human/
eco-effects, and risk
assessment?
What research still needs to
be done?
Review existing literature on EDCs, conduct Reports on research needs,
To prioritize research needs, review
workshops on research needs, develop
QSAR/PBPK/BBDR3 methods/models,
conduct field measurements of EDCs, and
assess effects on highly exposed cohorts.
analytical methods, risk assessment test guidelines, and conduct
methods, data from field hazard/effect and preliminary
measurements, and cause-effect data, exposure/risk assessments.
Pollution
Prevention and
New Technology
How can pollution
prevention be integrated
into environmental
decision-making?
Study engineering/performance costs for
pollution prevention; develop technologies;
identify audiences needing technical
Pollution prevention cost accounting To evaluate and implement
protocols, cost data, technology pollution prevention approaches
transfer products, life-cycle analysis
assistance; develop life-cycle analysis/audit tools, audit procedures, pollution
tools; and assist in disseminating
technologies to the commercial sector.
prevention technologies, and
performance data.
aQSAR - quantitative structure-activity relationships.
PliPK = physiologically based pharmacokinetic.
DBDR = biologically based dose-response.
-------
Table A-2. Drinking Water Disinfection
Subtopic
Health
Effects
Exposure
3
PC
o
Strategic Focus
Tasks
Products
Initial Uses
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 tor
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 Qualitative/quantitative data on To assess the risks of different
reproductive/developmental effects cancer, reproductive effects, and disinfection processes, combining
and, if feasible, on cancer. other effects.
Conduct toxicity studies on
individual DBFs and mixtures if
feasible.
Risk assessments for individual
DBPs.
epidemiology, toxicity, and mixtures
information, to support DBP rules.
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.
As a survey tool for developing
occurrence data.
To support exposure assessments to
predict pathogen occurrence in
drinking water under different
treatment processes.
Future Uses
To provide
methods for
compliance
by water
utilities.
What levels of DBPs
are people exposed to?
Develop methods for measuring
occurrence of DBPs in drinking
water.
Improved practical field and
research methods for DBPs in
drinking water.
To support exposure assessments
for DBPs from different treatment
processes.
To provide
methods for
compliance
by water
utilities.
Study the level of DBPs in drinking
water supplies.
Identity of new DBPs under
different disinfection practices.
Data on DBP exposure from
drinking water.
(Continued)
o
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Table A-3. Particulate Matter (Continued)
Subtopic Strategic Focus
Tasks
Products
Initial Uses
Future Uses
Risk What options (e.g., process
Management changes, upgrades of existing
(Continued) 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.
T3
A
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o.
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Table A-3. Participate Matter
Subtopic Strategic Focus
Tasks
Products
Initial Uses
Future Uses
Health Effects What health effects are caused
by particulate matter (PM) and
its components?
i
I
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.
To provide health effects
data for further risk
assessment (updated
Criteria Documents) to
support PM NAAQS.
To provide health effects
data for further risk
assessment (updated
Criteria Documents) to
support PM NAAQS.
What is the relationship
between PM exposure and
dose?
What is the role of dose for
effects in sensitive
subpopulations?
Exposure What PM species and
concentration levels are present
in ambient air?
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.
To provide health effects
data for further risk
assessment (updated
Criteria Documents) to
support PM NAAQS.
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 To identify sources of
concentration levels for PM and address PM
regulatory development formation, transport,
and epidemiologic study and fate.
k To help develop control
strategies for
implementating PM
regulation(s).
(Continued)
"O
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Table A-3. Participate Matter
Subtopic Strategic Focus
Tasks
Products
Initial Uses
Future Uses
Health Effects What health effects are caused
by participate matter (I'M) and
its components?
3
§
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 I'M National
Ambient Air Quality
Standards (NAAQS).
To provide health effects
data for further risk
assessment (updated
Criteria Documents) to
support PM 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.
To provide health effects
data for further risk
assessment (updated
Criteria Documents) 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.
To provide health effects
data for further risk
assessment (updated
Criteria Documents) to
support PM NAAQS.
bxposure 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 To identify sources of
concentration levels for PM and address PM
regulatory development formation, transport,
and epidemiologic study and fate.
" ' To help develop control
strategies for
implementating PM
regulation(s).
(Conliniu'tl)
n
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Table A-3.
Subtopic
Participate Matter (Continued)
Strategic Focus
Tasks
Products
Initial Uses Future Uses
What options (e.g., process
Management changes, upgrades of existing
(Continued) 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.
8
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o
9
n
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§
Table A-4. Human Health Protection
Subtopic Strategic Focus
Exposure Wnat 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
pharmacokinetic 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 fordisadvantaged
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.
Initial 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 tor risk
assessment and to ensure
adequacy of rules/regulations.
To identify the pathways that
contribute most to risk and
hence require mitigation.
To improve the scientific basis
for cancer and noncancer risk
assessments.
Future Uses
Similar to initial use, but
expanded to be more
broadly applicable.
Similar to initial use, but
expanded to be more
broadly applicable.
Similar to initial use, but
expanded to be more
broadly applicable.
To improve risk
assessments and enhance
risk management
decisions.
To reduce uncertainty in
risk assessment and risk
management decisions.
n
3
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J*
(Continued)
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tl
e
Table A-4. Human Health Protection (Continued)
Subtopic
Hazard
Identification
and
Characterization
Dose-Response
Relationship
Special Problems
Strategic Focus
How can we
improve our ability
to detect hazards?
How can we better
interpret toxicity
data to predict and
define hazards?
How can we reduce
uncertainty in
extrapolations (e.g.,
from high doses in
animals to
environmental
exposures in
humans)?
What toxicities are
associated with
mixtures?
Tasks
Develop screening methods to set
testing priorities.
Develop cost-effective methods
for toxicity data collection.
Develop improved methods for
data interpretation. For example,
identify biomarkers of exposure
and effect and validate the use of
biomarkers in human populations.
Develop quantitative models for
predicting tissue and organism
response to target tissue dose (i.e.,
biologically based dose-response
models).
Develop improved empirical
dose-response models (e.g.,
benchmark dose models).
Develop methods to assess the
toxicity of chemical mixtures.
Products
Validated screening protocols
using, for example, in vivo, in
vitro, and structural activity
relationship (SAR) methods.
New and revised standard
toxicity testing protocols.
Guidance document on
interpretation of toxicity data.
Models for predicting toxicity
due to chemical exposures, winch
can be modified and applied in
chemical-specific risk
assessments.
Validated benchmark dose
models and guidelines for
applications.
Validated and standardized
testing protocols.
Initial Uses
To identify and rank existing
pesticides and industrial
chemicals in terms of
potential toxicity.
To develop Agency test
guidelines.
For incorporation into risk
assessment guidelines.
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 improve reference dose
concentration procedures.
To identify chemical mixtures
with potential toxicity that is
other than addictive.
Future Uses
To screen new chemicals
as they enter the
regulatory system; to
assess relative toxicity.
To support regulatory
activities (e.g., TSCA'1 test
rules and consent
agreements, FIFRA data
call-ins).
To improve health risk
assessments in support of
risk management
decisions.
To provide a
state-of-the-science basis
for replacing default,
primarily empirical risk
assessment approaches.
To improve the basis for
risk management
decisions.
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 To improve risk
likely to have synergistic or management decisions
supra-additive toxic effects. concerning risks posed by
mixtures.
n, i-s ( i.nirnl Ail
i h. i.li I illicit itlr. .uul KiHlt'Mlu klr Ail
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Q.
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Table A-5. Ecosystem Protection
Subtopic Strategic Focus
Tasks
Products
Initial Uses
Future Uses
o
it
3
a.
Effects
8-
s.
O
Exposure
What levels of
anthropogenic stress
(chemical and nonchemical)
can ecosystems tolerate and
still be sustained/
maintained?
Understand and develop
models to predict ecosystem
vulnerability to alternative
management practices and
changing stressors at multiple
scales.
Develop screening and testing
methods to assess viability
and sustainability at multiple
levels of biological
organization.
Quantitative models predicting To inform debate on societal
complex and cascading effects values with respect to ecosystem
of multiple stressors at multiple protection; to provide
geographic and temporal scales, information to support future
Criteria for maintaining
ecosystems.
community-based ecosystem
protection.
To provide
information to
evaluate comparative
risks and drive
strategic research
planning.
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.
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.
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.
(Continual)
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Table A-5. Ecosystem Protection (Continued)
Subtopic Strategic Focus
Tasks
Products
Initial Uses
Exposure What is the current Develop models to link Methods for assessing exposure. To .support relative risk
(Continued) distribution of exposure to transport, transformation, and assessments.
these stressors across fate of stressors to exposure to
vulnerable ecosystems? ecosystems at appropriate
time and space scales.
Support an interagency
exposure reference site
network.
Future Uses
To identify vulnerable
systems at watershed
regional and national
scales.
i
3
JB
3
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.
How will current patterns Conduct demographic and
of exposure change in 5, 10, economic studies to assist in
25, and 50 years? 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 identify sources for
risk reduction
technology
development
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)
"O
It
3
Q.
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Table A-5. Ecosystem Protection (Continued)
Subtopic Strategic Focus
Tasks
Products
Initial Uses
Future Uses
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.
Assess the risks and their
economic implications.
Quantitative/qualitative
regional, comparative risk
assessments
To support regional and local
community-based ecosystem
protection plans.
To conduct
comparative ecological
risk assessments.
To assist in prioritizing
research and ecological
protection efforts
Develop an expert system for Links between human health
assessing ecological benefits and ecological risks.
of alternative management
strategies at multiple scales.
Conduct comparative risk
assessments.
As a tool for environmental To assist in
management at watershed scales, environmental
management and
planning at multiple
scales.
i
?5
Risk
Management
What are the most
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 To avoid an ecological
approaches for reducing "train-wreck."
ecological risk.
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.
O
o
A
a
a.
X
J>
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Table A-6. Endocrine Disrupters
Subtopic Strategic Focus
Tasks
Products
Initial Uses
Future Use
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?
o
9)
O
Develop QSAR 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
modifying the testing guidelines improve data 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 PBPKcand 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
that can set the bounds on
effects in less highly exposed
populations.
To conduct preliminary risk
assessments.
To develop remedial actions where
adverse effects of EDCs in the
environment have been confirmed.
(Continued)
O
A
3
Q.
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Table A-6. Endocrine Disrupters (Continued)
Subtopic Strategic Focus
Tasks
Products
Initial Uses
Future Use
Effects
(Continued)
For wildlife species, what
procedures, are available for
extrapolating effects of the
individual to populations?
What are the status and trends
of sentinel and keystone species
in the various ecological areas?
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.
TO
o
n
a
a.
X
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 To improve effects assessment for
non-additivity among EDC environmentally important multiple
health endpoints. exposures to EDCs.
Exposure What are the pathways of
exposure of EDCs?
I
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 hybrk
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 lo
characterize EDCs in
multimedia, to assess transport, exposure
fate, and exposure, and to
provide input to source-receptor
models.
To improve source and receptor
models and assessments of EDC
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 A-6. Endocrine Disrupters (Continued)
Subtopic Strategic Focus
Tasks
Products
Initial Uses
Future Use
Exposure What exposures are experienced
(Continued) by populations affected by
EDCs?
Quantitate exposure in
populations showing effects of
EDCs, particularly those with
developmental exposures.
Delineation of causes and effects To conduct preliminary risk
which can set the bounds on assessments.
effects in less highly exposed T() deve|op remedia, actions where
P°Pulahons adverse effects of EDCs in the
environment have been confirmed.
Assessment What strengths and weaknesses
are present in assessment of
existing information on EDCs
and related topics?
Convene EPA working group to Report of literature review.
critically review existing
biological effects information.
To refine ORD's research strategy.
To develop regulatory policy on
EDCs.
'EDC - endocrine-disrupting chemical.
bQSAR - quantitative structure-activity relationship.
1PBI'K = physiologically based pharmacokmetic
1 HBDK =- biologically based dose-response.
A
a
a.
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Table A-7. Pollution Prevention and New Technology
Subtopic
Strategic Focus
Tasks
Products
Initial Uses
Future Uses
o
o
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.
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.
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.
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.
Lor 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.
7o provide technical
guidance for regulatory
programs and private
sector 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.
(Contimii'tl)
-------
Table A-7. Pollution Prevention and New Technology (Continued)
Subtopic
Strategic Focus
Tasks
Products
Initial Uses
Future Uses
Risk
Management
(Continued)
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.
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,
demons tra tions).
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.
o
n
3
a.
x
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Appendix B
The ORD Organization
ORD's new organization, depicted below, mirrors
the risk assessment/risk management
paradigm:
ORD's New Risk-Based Organization
The National Health and Environmental Effects
Research Laboratory investigates the potential ef-
fects of stressors on humans and ecosystems. This
Office of Resource
Assistant Administrator for Research and Development
Administration for Management Administrator for Science
National Health and
Environmental Effects
Research Laboratory
Management and
Coordination
Division (RTF, NC/
Washington. DC)
Research and
Administrative
Support Division
(RTF. NC)
Developmental
Toxicology Division
(RTP. NC)
Environmental
Toxicology Division
(RTP, NC)
Environmental
Carcinogenesis
Division (RTP. NC)
Neurotoxicology
- Division (RTP, NC)
Human Studies
- Division (RTP. NC)
Gulf Ecology Division
- (Gulf Breeze, FL)
Mid-Continent
Ecology Division
(Duluth. MN)
Western Ecology
Division
National - National Center
Exposure for Environmental
Research Assessment
Communications and Office
Liaison Staff _ NCEA Washington,
(Washington. DC) Dc office
- Program Operations l_ NCEA Cincinnati
Staff (RTP. NC) OHOffke
Atmospheric
Processes Research
Division (RTP. NC)
Air Measurements
Research Division
(RTP. NC)
Mode ing Division
(RTP. NC)
Air Exposure
Research Division
(RTP. NC)
Human Exposure
Research Division
(Cincinnati. OH)
Ecological Research
Division
Office of Science Policy i:
Office
of Research and
Science Integration
National Risk
Management
Research
Water Supply and
Water Resources
Division
(Cincinnati, OH)
Land Remediation
and Pollution
Control Division
(Cincinnati, OH)
Sustainable
Technology Division
(Cincinnati. OH)
Air Pollution
Prevention and
Control Division
(RTP, NC)
Subsurface
National Center
for Environmental
Research and
Environmental
Engineering
Research Division
(Washington, DC)
Environmental
Sciences Research
Division
(Washington. DC)
Quality Assurance
Division
(Washington, DC)
L- Peer Review Division
(Washington. DC)
Protection and
Remediation Division
(Ada. OK)
Technology Transfer
and Support Division
(Cincinnati. OH)
(Cincinnati. OH) - lecnnologv
Coordination Staff
Characterization (Washington. DC)
Research Division
(Las Vegas. NV)
I Ecosystems Research
(Corvallis, OR) Division
Atlantic Ecology (Athens. GA)
" Division
(Narragansett. Rl)
STRATEGIC Pi AN FOR OR0
4S
-------
Appendix B
work provides the scientific basis for hazard identi-
fication and dose-response assessment.
The National Exposure Research Laboratory
measures and predicts the extent to which hu-
mans and ecological resources are exposed to
pollutants and other stressors. This work pro-
vides the basis for exposure 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.
ORD's National Risk Management Research
Laboratory supports risk management by develop-
ing, evaluating, and disseminating effective tools
and approaches for preventing or reducing cur-
rent and anticipated risks to human health and
the environment.
ORD also has created a National Center for Envi-
ronmental Research and Quality Assurance
(NCERQA), which represents a major and
renewed commitment by ORD to help EPA
achieve the highest possible quality of science.
NCERQA's main purpose is to direct ORD's
newly expanded external grants and fellowship
programs, which are designed to involve the
nation's top scientists and engineers in research
issues of importance to the Agency. NCERQA
also provides managerial oversight of EPA
quality assurance programs.
40
STRAT86JC PlAN FOB ORD
-------
Appendix C
Management Structure for
Implementing ORD's
Strategic Plan
Successful implementation of ORD's Strategic
Plan requires coordinated input and involve-
ment 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 mecha-
nisms 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.
Executive Council
ORD's Executive Council is chaired by ORD's Assis-
tant Administrator and consists of ORD's Deputy
Assistant Administrators for Science and Manage-
ment 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 deci-
sions. 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 Resource Management and Administration
(who serves as the Vice Chair), and the Deputy Di-
rectors for Management of ORD's laboratories and
centers. ORD's Management Council provides sen-
ior management leadership for developing and
implementing effective management policies, proce-
dures, and systems. For example, the Management
Council is leading the development of ORD's Man-
agement Information System, a management system
to ensure that ORD's resources are efficiently admin-
istered. The Management Council also provides
input, feedback, and guidance on issues that signifi-
cantly 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 pro-
vide 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.
The Science Council serves as the principal forum
for identifying, discussing, and providing advice
and recommendations to ORD's Assistant Adminis-
trator on scientific and technical issues that
significantly affect ORD's overall scientific and tech-
nical operations. For example, the Science Council
had the lead role in developing ORD's Strategic
Plan and will review all research plans.
STRATEGIC FIAN FOR OR0
47
-------
QB ORD Management Structure
^
?
n
n
H
t
o
»
O
50
G>
Office of Resource
Management and
H
Assistant Administrator for Research and
Deputy Assistant Del
AU 1»lldUu" " Administrator for
Director Management
I 1
1 1
National Health and
Environmental Effects
Research Laboratory
Director
Deputy Director for
/Management
Associate Associate
Ofrecwrfor C8nec«w&f
Ecotogy Health
Assistonf laboratory
Directors for Air, Water,
Waste, Twdcahgy/
Pesticides, and Multimedia
National Exposure
Research Laboratory
Director
Deputy Director for
Management
Associate Associate
Director for Directorfor
Ecotegy HeaWi
Assistant laboratory
Waste, Toxicology/
Pestfeiaes,ondrVtuftimeuty Assistant
Administrator for
Office of Science Policy
Director
Office of Research and
Cf-irtnrn
JC'LrM-1- """" " Science Inlegialion
* Director
*
Research
Coordination
II Representatives from the
1 EPA program «nd regional
National Center for
Environmental Assessment
OJrector
Deputy Director for
Manai
Associate
Director fcr
£<«%
Cement
Associate
Direcwrfor
HeoWi
Assistant Cenf i Directors
/or Air, Water, Waste,
raxta*^/rV
>$ticWes,and
Multimedia
National Risk Management
Research Laboratory
Director
Deputy Director for
Management
Associate Associate
Directorfor Directorfor
MV IM»
Assistont Laboratory Direaors
for Air, Water, Waste,
Toxteofogy/ P«*c«
-------
Research Coordination Council
The Research Coordination Council is a group of
senior staff representing all EPA program and
regional offices and their respective Assistant
Administrators or Regional Administrators. 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 poten-
tial 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
Appendix C
multimedia), the teams assess ORD clients' needs,
recommend research priorities, monitor ORD pro-
gress 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
Resource 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 repre-
sentatives from EPA's program and regional offices.
The Research Coordination Teams take the lead in
developing ORD's research plans and in organizing
and conducting media-based program reviews of
ORD progress and outputs.
STRATEGIC Ft AN FOR ORJ>
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ORD Response to Blue-Ribbon Panel Recommendations
Recommended Action
ORD Response
EPA should take steps to improve science
quality and enhance peer review.^'
ORD needs a coherent research-planning
process, a robust mission statement, and a
vision statement.1"1
c.d.i.i
ORD should enhance environmental
education programs for training the next
generation of scientists
, a.d.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.11'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.glh
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.
ORD should balance short-term and
long-term research.11'6'8'1
ORD should balance health and ecological
research.ax
EPA should designate ORD's Assistant
Administrator (AA/ORD) as the Agency's
Chief Scientific Officer.1
In 1995, we created the Science To Achieve Results (STAK) 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.'
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.
'Future Risk: Research Strategies for the 1990s. U.S. EPA, Science Advisory Board. 1988.
b Reducing Risks: Setting Priorities and Strategies for Environmental Protection. U.S. EPA, Science Advisory Board. 1990.
''Safeguarding the Future: Credible Science, Credible Decisions. Report of the Expert Panel on the Role of Science at EPA. U.S. EPA. 1992.
Enrironmental Research and Dei'elopment: Strengthen the Federal Infrastructure. The Carnegie Commission. 1992.
"Research 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: Re-cieu* of the MITRE Corp. Draft Report on the EPA Laboratory Study. U.S. EPA, Science Advisory Board/Research Strateo
Advisory Council. May 1994.
hA Rerieu', Evaluation and Critique of a Study of EPA Laboratories by the MITRE Corporation and Additional Commentary on EPA Science and TV
Programs. National Academy of Public Administration. June 1994.
'Setting Priorities, Getting Results: A Netu 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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