v-xEPA
United States
Environmental Protection
Agency
Research and
Development
(8101)
EPA/600/R-97/015
April1997
1997 Update to
ORD's Strategic Plan
Printed on paper that contains at least 20% postconsumer fiber.
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EPA/600/R-97/015
April 1997
1997 Update to
ORD's Strategic Plan
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC 20460
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Foreword
I am pleased to present the 1997 Update to the Strategic Plan for the U.S. Environmental Protection
Agency's (EPA's) Office of Research and Development (ORD). This plan summarizes the basis for
the actions we have taken to respond to recommendations of numerous expert advisory groups
committed to improving science at EPA. The plan serves as a framework for ORD to provide the
highest possible quality environmental science to meet today's needs and lead us into the next century.
Central to our strategy is a system for determining research priorities based on risk assessment and risk
management principles. We use this system to direct our resources to the nation's most important
environmental issuesthose areas with the greatest risk to people or the environment, those areas of
greatest uncertainty in characterizing risk, and those areas with the greatest need to improve the efficacy
of, or reduce the cost of, risk management.
We continue to enhance the quality of ORD's science products through independent peer review, of all
major aspects of the program, including research plans and proposals, science products, and even our
own organization. We augment the efforts of our in-house cadre of experts through our expanding
Science to Achieve Results program, which engages the best environmental scientists and technologists
from United States universities and laboratories outside EPA. The plan also promotes greater partner-
ship between ORD and our primary clients, EPA's Program and Regional Offices, as well as the external
scientific community.
This plan is the foundation for ORD's future. We have designed our strategy to endure and yet be
dynamic in the face of advancing scientific knowledge and understanding. While the plan details our
current research planning process, long-term research goals and objectives, and near-term priority
research topics, these components continue to evolve. Thus, this 1997 Update presents a snapshot of
ORD's scientific and management evolution at this point in time. We are continuing to hone our
strategic goals and objectives to better focus our work and align ORD's mission and activities with
Agency priorities under EPA's new strategic planning process. Also, we have already begun to consider
how advances in the state of environmental science and new human health and ecological issues on the
horizon provide important perspectives for our 1998 planning efforts.
I take tremendous pride in being part of the team that is keeping ORD a strong and cogent scientific
organization. I look forward to achieving ORD's vision for providing the scientific foundation to
support EPA's mission guided by the continuing evolution of our Strategic Plan.
Robert J.Huggett
Assistant Administrator, Office of Research and Development
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Contents
List of Acronyms v
Executive Summary vii
Strategic Principles vii
ORD's Vision, Mission, and Long-Term Goals viii
Setting ORD Research Priorities '. .. .viii
High-Priority Research ...-.' ix
Planning for the Future ix
Chapter 1: Introduction ., 1
ORD and the Risk Assessment/Risk Management Paradigm 1
Audiences for This Document ....:.... 5
Critical Players and Linkages for Implementing ORD's Strategic Plan 5
Looking Ahead 6
Evolution of the Strategic Plan Over Time 6
A Roadmap for This Document 7
Chapter 2: ORD's Strategy for Planning Research 9
ORD's Vision . . 9
ORD's Mission 9
ORD's Long-Term Goals and Objectives 10
Identifying Specific Research Topics 10
Identifying Emerging Issues, Anticipatory Research, and Exploratory Research 11
ORD's Priority-Setting Process 11
Criteria for Setting ORD Research Priorities 14
Strengths of ORD's Research Planning Process 15
Chapter 3: Translating ORD's Strategy Into a Research Program ... 17
Developing Science Research Strategies and Plans .. . 17
Deciding Who Will Do the Work 19
Internal Research 19
Extramural Research 19
Integrating Information Management Planning Into the Process 19
Measures of Success .20
Mechanisms for Evaluation and Accountability 21
Closing Out Completed Work 21
Technical Support 21
ORD Customer Focus 22
Human Resources and Infrastructure .' 22
Challenges for the Future 24
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Chapter 4: ORD's High-Priority Research 25
Evolution of ORD Priority Areas Over Time 26
Selection of the Six High-Priority Research Topics 26
Appendix A: ORD's Long-Term Goals and Objectives 55
Appendix B: The ORD Organization 63
Appendix C: Management Structure for Implementing
ORD's Strategic Plan 67
Appendix D: Relationship of Fiscal Year 1997 STAR Focused
Requests for Applications to ORD's High-Priority Research .
.71
Appendix E: Relationship of Fiscal Year 1997 and 1998
Program Enhancements to ORD's High-Priority Research
.73
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List of Acronyms
AMI Advanced Measurement Initiative
CRADA Cooperative Research and Development Agreement
DBF disinfection by-product
DOE U.S. Department of Energy
EDC endocrine-disrupting chemical
EPA U.S. Environmental Protection Agency
GPRA Government Performance and Results Act
IRIS Integrated Risk Information System
LCA life-cycle assessment
NAE National Academy of Engineering
NAS National Academy of Sciences
NASA National Aeronautics and Space Administration
NCEA National Center for Environmental Assessment
NCERQA National Center for Environmental Research and Quality Assurance
NERL National Exposure Research Laboratory
NHEERL National Health and Environmental Effects Research Laboratory
NOAA National Oceanic and Atmospheric Administration
NRC National Research Council
NRMRL National Risk Management Research Laboratory
ORD Office of Research and Development
ORMA Office of Resources Management and Administration
OSP Office of Science Policy
PM particulate matter
R&D Research and Development
RFA Request for Applications
SAB Science Advisory Board
STAR Science to Achieve Results
USGS U.S. Geological Survey
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Executive Summary
The U.S. Environmental Protection Agency's
Office of Research and Development (ORD)
has instituted significant changes in its organi-
zation and management procedures to provide
the vision and direction for the scientific foundation of
EPA's mission.
First, ORD has aligned its organizational structure to
comport with risk assessment and risk management
principles and has made these principles central to
our strategy for determining risk-based research
priorities. In this way ORD can assure that science
resources are directed to the most pressing
environmental problems nationwidepollution
posing the greatest risks to people or the
environment; environmental risks most difficult to
understand and describe; and areas where we most
need to improve the effectiveness and efficiency of
managing environmental risk.
Further, ORD has strengthened interactions with the
larger scientific community in two ways:
By expanding our competitive extramural grants
and graduate fellowship programs, we are work-
ing to stimulate research in areas vital to EPA by
more broadly involving universities and other
not-for-profit institutions.
By intensifying our peer review process, we
ensure that all major facets of our science program
are independently reviewed by experts external to
our organization.
Both of these activities leverage and potentiate our
scientific expertise and capabilities.
Most importantly, ORD's strategic planning and
management process for selecting research priorities,
instituted in 1995, has set us firmly on course to meet
the science needs of today while positioning
ourselves to identify and aid in resolving the
environmental problems of tomorrow.
EPA's Mission
The mission of the United States Environmental
Protection Agency is to protect public health and to
safeguard and improve the natural environment-air,
water, and landupon which life depends. EPA's
purpose is to ensure that:
Federal environmental laws are implemented and
enforced fairly and effectively.
Environmental protection is an integral
consideration in U.S. policies concerning economic
growth, energy, transportation, agriculture, industry,
international trade, and natural resources.
National efforts to reduce environmental risk are
based on the best available scientific information.
All parts of society-business, state, and local
government, communities, and citizenshave full
access to information so that they can become full
participants in preventing pollution and protecting
human health and the environment.
May 6, 1996
This 1997 Update to the ORD Strategic Plan describes
our revised strategy for research planning, the process
for deploying our research plan, and our current
research priorities.
&
Strategic Principles
The ORD Strategic Plan is based on nine strategic oper-
ating principles, summarized below, which draw on the
many recommendations ORD has received from outside
groups in recent years:
Focus research and development on the greatest
risks to people and the environment.
Focus research on reducing uncertainty in risk
assessment and improving cost-effectiveness in risk
prevention and management.
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Executive Summary
Balance human health and ecological research.
Infuse ORD's work with a customer/client ethic.
Give priority to maintaining strong and viable core
capabilities.
Nurture and support the development of outstanding
scientists, engineers, and other environmental
professionals.
Recruit and engage the best scientists front outside
EPA through competitively awarded grants and
fellowships.
Require the highest level of independent peer review
and quality assurance.
Provide the infrastructure to achieve and maintain an
outstanding R&D program.
Most important of these principles is the explicit use of
the risk paradigm to shape and focus our organizational
structure and research agenda.
ORD's Vision, Mission, and
Long-Term Goals
ORD's commitment to develop a risk-based research
agenda requires us to examine our vision, mission, and
goals and to develop a risk-based process for selecting
and ranking those research areas of primary importance
to EPA. ORD's vision and mission for the future arise
from a consideration of the key role that ORD science
plays within EPA and in the broader context of our
nation's environmental research agenda. Our vision is
that ORD will provide the scientific foundation to sup-
port EPA's mission. Our mission statement is divided
into four main components: research and development,
technical support, integration of scientific information,
and anticipatory research. This translates into six long-
term, overarching goalsbroad areas of research and
development where we believe ORD can and must
make important contributions to EPA's mission and
mandates and to our nation's overall environmental
research agenda.
Setting ORD Research Priorities
Essential to meeting our long-term goals is a process
we use to set priorities within the universe of possible
research and to focus our efforts on those areas of pri-
mary importance to EPA's mission. Our priority-setting
process involves the following steps:
First, we involve all parts of EPA, including ORD's
own researchers and staff, in helping us set research..
priorities. The Research Coordination Council, the
Science Council, and Research Coordination Teams
consisting of senior representatives from ORD's
National Laboratories and Centers and EPA's
Program and Regional Offices each identify
important and relevant areas for our research efforts.
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. Based on this
input, we identify potential research topics.
We then narrow the pool of potential topics by
selecting areas that clearly will contribute to
fulfilling Agency mandates.
To these remaining areas falling within ORD's
mission and goals, we apply a series of human
health, ecological health, and risk management
criteria to set priorities according to their potential
to support effective risk assessment and enhance risk
reductionfor example, by reducing the
uncertainties in risk assessment. We use comparative
risk analyses, as needed, to ascertain the most
pressing problems. We also consider whether the
research would develop broadly applicable methods
and models needed by EPA programs. We then
ascertain whether ORD can make a significant
contribution. Through this screening process, we set
priorities among the research topics.
We then define our specific R&D projects by
considering each topic area in totality. For each topic
area, we systematically examine the research needs
within each component of the risk paradigm: effects,
exposure, assessment, and risk management. Based
on this analysis, we define a series of high-priority
research activities across the risk paradigm that will
produce a comprehensive set of useful risk-based
results.
Once we have identified our high-priority topics, we
develop and implement a research program with
specified roles for intramural and extramural
participants, identifiable products, and provisions for
accountability and visibility regarding progress on
our commitments.
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High-Priority Research
ORD has used the process described above to establish
our research priorities for the next few years. Using our
risk-based planning process and criteria, ORD has iden-
tified six high priorities that will receive special,
expanded attention within the broader ORD program.
These high priorities include three areas of research on
environmental problems and three broad-based areas of
research on methods and approaches that will impact
many additional topics:
Environmental Problem Areas
Safe drinking water (with a near-term focus on
microbial pathogens, disinfection by-products, and
arsenic)
High-priority air pollutants (with a near-term, focus
on particulate matter)
Emerging environmental issues (with a near-term
focus on endocrine disrupters)
Broad-Based Methods and
Approaches Areas
Research to improve ecosystem risk assessment
Research to improve health risk assessment
Pollution prevention and new technologies for
environmental protection
Planning for the Future
The Strategic Plan provides a blueprint for designing
and implementing a research program to produce the
sound science needed to support EPA's mission. In the
years to come, ORD will place a continuing priority on
providing the communication, infrastructure, and sup-
port necessary for successful implementation of the plan.
For ORD's stakeholders, including the EPA Program
and Regional Offices, academia, the private sector, and
other government agencies, the plan serves as a
roadmap that explains ORD's research planning and
implementation process, defines how our stakeholders
contribute to this process, and specifies the goals, objec-
tives, and products they can use to hold us accountable
for our progress in environmental research. This plan is
intended to serve as a practical tool for ensuring the
constructive involvement of our stakeholders in estab-
lishing and executing ORD's research agenda during
the coming years.
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Science provides the foundation for credible envi-
ronmental decision-making. It is vital to achiev-
ing a healthy population, thriving environment,
and robust economy. Only through adequate
knowledge about the risks to human health and ecosys-
tems, and innovative solutions to prevent pollution and
reduce risk, can we continue to enjoy a high quality of
life. EPA has identified strong science and credible data
as one of the guiding principles to fulfill the Agency's
mission to protect human health and environmental
quality. While all of EPA uses science for policy and reg-
ulatory decision-making, and various EPA offices con-
tribute to the scientific underpinnings of the Agency's
decisions, the responsibility for leadership in science at
EPA and for the bulk of EPA's research and develop-
ment work resides in EPA's Office of Research and
Development (ORD).
ORD and the Risk Assessment/Risk
Management Paradigm
We at ORD have shaped our organization and research
agenda to 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 efforts are based on a set of strategic prin-
ciples we have developed (Table 1) that draw on the
many recommendations we have received from outside
groups and our own staff in recent years. The most
important of these principles is the explicit use of the
risk paradigm.
Risk assessment 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 under-
stand and evaluate the magnitude and probability of
risk posed to human health and ecosystems by environ-
mental stressors, such as pollution or habitat loss or
change. The resulting risk characterization, together
with other public health, statutory, legal, social, eco-
nomic, political, and technical factors, provides the criti-
cal input for deciding whether and how to manage the
risk associated with a particular stressor. Risk manage-
ment options may include both regulatory programs
and voluntary activities (e.g., recycling) to reduce or
eliminate the stressor or the consequences of subse-
quent risks.
T
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Introduction
The risk assessment process is one component of the
overall process of risk management. The risk manage-
ment process involves the recognition of a potential
new risk and a decision by authorities to respond to
concern about the risk. It includes risk assessment as
well as a series of other scientific and technical activi-
ties, illustrated in Figure 2, that provide the scientific
and technical data for making and implementing a risk
management decision. The risk management process
concludes with the selected risk management option(s)
being implemented and the resulting environmental
and/or public health improvements being monitored.
Figure 2 expands on the Risk Management Options por-
tion of the original NAS paradigm to show the many
scientific and technical activities, in addition to risk
assessment, that are part of risk management. These
Table!. ORD's Strategic Principles
Focus research and development on the greatest
risks to people and the environment, taking
into account their potential severity, magnitude,
variability, and uncertainty.
Focus research on reducing uncertainty in risk
assessment and on cost-effective approaches for
preventing and managing risks.
Balance human health and ecological research.
Infuse ORD's work with a customer/client ethic
that breaks down organizational barriers and
ensures responsiveness to ORD's internal and
external customers.
Give priority to maintaining the strong and viable
scientific and engineering core capabilities that
allow us to conduct an intramural research and
technical support program in areas of highest risk
and greatest importance to the Agency.
Through an innovative and effective human
resources development program, nurture and sup-
port the development of outstanding scientists,
engineers, and other environmental professionals
at EPA.
Take advantage of the creativity of the nation's best
research institutions by supporting competitively
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 requir-
ing 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.
History of This Document
Work on this Strategic Plan began in 1995 by a task
force comprised of staff from ORD's National
Laboratories and Centers, as well as our Headquarters
Offices/As we developed the plan, we consulted with
our clients in EPA's Program and Regional Offices, and
external stakeholders, to ensure that the plan would
enable ORD to effectively meet their needs and main-
tain good customer relations. We also relied heavily
on the advice of the National Research Council and
EPA's Science Advisory Board.
In May 1996, we finalized our Strategic Plan and it has
guided our program for a year. The plan has been fully
peer-reviewed and reflects ORD's maturing process for
evaluating and setting research priorities. The basic
principles and priorities outlined in the 1996 plan
remain unchanged, and substantial portions of the
original text are intact. We are continually improving
this process, based on our interactions with outside
stakeholders and our own internal deliberations. For
example, ORD staff identified several organizational
improvements at our First Annual Workshop on
Managing Change. This revision to our Strategic Plan
reflects ORD's continuing evolution, as we address
these recommendations. Major changes appearing in
the 1997 plan include:
Elaboration on the evaluation criteria for determin-
ing research priorities.
Clarification of high-priority research topics/areas.
Inclusion of information on and commitments from
ORD's First Annual Workshop on Managing
Change in WNIiamsburg, Virginia, December 1996.
Expansion of the plan's discussion of technical sup-
port to EPA Program arid Regional Offices.
Information on ORD's new Information
Management Plan.
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Figure 1. The Risk Assessment/Risk Management Paradigm
Risk Assessment Risk Management
Statutory and Legal
Considerations
Dose-Response
Assessment
Public Health \ s°cial
\
Considerations Factors
Hazard
Identification
Characterization->Risk 0$**
Risk , _ .
Management / Economic
Options / Factors
Exposure
Assessment
Political
Considerations
*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 kinds of analyses:
Hazard identification involves the description by scientists of the adverse effects (e.g., short-term illness, cancer,
reproductive 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
exposure, and epidemiologic research.
As part of the dose-response assessment scientists determine the toxicity or potency of a stressor. The dose-
response assessment describes the quantitative relationship between the exposure to a stressor and the extent
of injury or disease.
Exposure assessment involves scientists describing the nature and size of the population(s) or ecosystem(s)
exposed to a stressor and the magnitude, duration, and spatial extent of exposure. It 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 sensi-
tive subgroups, such as pregnant women and children.
In risk characterization, assessors use the data collected in the three previous analyses 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 expo-
sure. This estimate can be qualitative (e.g., high or low probability) or quantitative (e.g., one in a million proba-
bility of occurrence).
The NAS paradigm was developed mainly in terms of principles relating to risk assessment and risk management
for human health. While ORD recognizes that there are distinctions for ecological risk assessment and that scientific
approaches to risk assessment have evolved and expanded since development of the NAS paradigm, the general
principles set forth in the NAS paradigm are useful as an organizing focus for ORD's strategic thinking, and they
have been supplemented by new guidelines relating to ecological risk assessment.
i^w-
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Introduction
Figure 2. The Scientific and Technical Contributions to Risk Management
Identification of Future Problem,
Initiating Event or Public Policy Mandate
Risk Assessment
Risk Management
forrnatata trie Problem
* "\
Define RISK Management
Qbfectiv.es , <
Risk
Characterization
Identity anil Evaluate
Risk Management Options
"
Risfc Management Oecisfon
Devetop Compliance
Assurance Models and Methods
Impternent Opttonfe)
Develop Measures o
Sm!!?taiA
Pubhc Healtb
Improvement
"* Monitor Srotannwrtal
, mAfaV(v:
improvement
Public.Health
Considerations
Statutory and Legal
Considerations
Social Factors
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.
First, the problem must be formulated. This involves such activities as determining which stressor(s) (e.g., pollutants, habitat
loss) is causing the problem, characterizing the sources of the stressor(s), how these stressor(s) reach target populations,
and which human or ecological populations are affected. Once the problem has been sufficiently formulated, the risk
assessment process can begin.
If sufficient information is available at this point, scientists and engineers can also begin to define risk management objec-
tives (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 activities 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 identified, scientists and
engineers evaluate the options to determine their performance and cost. Risk management options may include, for exam-
ple, pollution control technologies, banning or controlling the use of certain chemicals, cleaning up or preventing access to
con-taminated areas, implementing educational programs to encourage voluntary behavior changes on the part of the pub-
lic 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 characterization
(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).
Upon selecting a risk management strategy, scientists and engineers then develop compliance assurance models and meth-
ods (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 implemented, scientists and engi-
neers monitor the environmental and public health improvement Monitoring data provide feedback to the risk manage-
ment decision-makers about whether the risk management strategy is achieving 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.
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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 contributes to many of the areas depict-
ed in Figure 2. In this way, ORD not only identifies and
characterizes environmental problems but also helps to
find and implement efficient, cost-effective solutions
to these problems.
Audiences for This Document
This Strategic Plan is an important document for many
different groups:
Within ORD, the plan provides OJRD stej^with a
blueprint for designing and implementing ORD's
research program in the years to come. Also, it
enables ORD staff to relate the individual research
projects for which they are responsible to ORD's
strategic goals and objectives, as well as to the
Agency's environmental goal of "ensuring that the
nation's environmental policies are based on the best
science and information available."
For our many stakeholders, including EPA's Program
and Regional Offices, academia, the private sector,
and other government agencies, the plan serves as a
roadmap that:
Explains how we plan research and translate our
plans into a research program.
Defines an explicit role for stakeholders in crafting
and reviewing ORD's research agenda.
Specifies goals, objectives, and products that can
be used to measure and hold us accountable for
our progress in environmental research.
Critical Players and Linkages for
Implementing ORD's Strategic Plan
The success of ORD's Strategic Plan relies on the contri-
butions of many individuals, institutions, and sectors,
as described below.
ORD Staff
First and foremost, ORD staff are crucial to the plan's
success. ORD's scientists and engineers, in particular,
are the repository of the core scientific and engineering
capability in the Agency, as well as a vital conduit for
the needs and potential contributions of ORD's research
clients and partners.
Successful implementation of the Strategic Plan will
depend on the success of ORD managers in communi-
cating the plan to all our staff and in earning a sense of
ownership of the plan and a shared vision of the work
to be accomplished. While leadership for communicat-
ing this plan must cascade through ORD's management
to our scientific, engineering, managerial, administra-
tive, and clerical staff, ownership and implementation
of the plan will depend on the expertise and dedication
of our work force. ORD will place a continuing priority
on "360-degree" communication and support to enable
and inspire effective implementation of this plan.
At its First Annual Workshop on Managing Change in
December 1996, ORD identified five cross-organiza-
tional improvement opportunities to improve our
products, processes, and work environment. These five
improvement opportunities (described in more detail
on page 23 of this document) are: reducing red tape,
improving communications, enhancing career develop-
ment, providing adequate infrastructure to support
ORD science, and integrating science with EPA's mis-
sion. In summarizing the next steps for implementing
these organizational improvement measures, ORD staff
Figure 3.
ORD's Strategic Plan
tt)K&is&&»jiiiii!iiSMfSf ji
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Introduction
noted that each measure has both a "head" and "heart"
component. Each measure simultaneously provides for
meeting organizational (head) needs for time, informa-
tion, expertise, tools, and strategic direction, as well as
personal (heart) needs for empowerment, access,
respect, opportunity, and alignment of each individ-
ual's work with Agency and ORD goals.
EPA Program and Regional Offices
Linkages between ORD and its primary clients (EPA's
Program and Regional Offices) are essential to success-
ful implementation of this plan. One important linkage
is the day-to-day contact that ORD scientists and engi-
neers have with EPA's Program and Regional Offices.
This ongoing informal contact helps ensure that the
ORD scientists and engineers involved in our planning
process understand our client's needs.
In addition, this Strategic Plan establishes formal areas
of linkage to ensure client input as we plan our
research. We directly solicit input on priority needs and
products from the Program and Regional Offices during
the planning process.
ORD's Research Planning Advisors
Our planning process also relies on the contributions
of many other groups who provide crucial input for
formulating and executing our research program and
priorities. These include other federal agencies (both
directly and through the National Science and Tech-
nology Council and its Committee on Environment and
Natural Resources), as well as the National Research
Council, EPA's Science Advisory Board, and ORD's
Board of Scientific Counselors.
ORD's Research Partners
Successful plan implementation also relies on ongoing
partnerships between ORD and other research organiza-
tions in academia, the private sector, and other govern-
ment agencies. These partnerships benefit all parties.
They provide a common-sense and cost-effective way for
ORD to utilize the special expertise residing outside our
organization, while also reducing overlapping and
duplicative work. Our partners enrich our research plan-
ning process and help ensure that our research products
are appropriately targeted to stakeholder needs. ORD
accesses and involves partner organizations in imple-
menting our research program through a variety of
cooperative arrangements and funding mechanisms.
Shared Leadership
In the context of environmental science, ORD serves
both as a team leader for research planning within EPA
and as a national leader within the larger scientific
community for conducting the nation's environmental
science. ORD implicitly shares responsibility for this
leadership through our peer review protocols, which
ensure both internal and external vetting of each critical
step in our research processfrom identifying research
priorities to evaluating our eventual success.
Looking Ahead
As ORD implements its Strategic Plan in the years to
come, we will strengthen our links with our clients and
partners. We will work to expand our partnerships with
other agencies, universities, and the private sector and
to integrate our planning efforts with EPA's overall
planning based on the Agency's Strategic Plan. Also, we
will strive to forge links with, the planning efforts of
other federal agencies and other nations as appropriate.
Evolution of the Strategic Plan
Over Time
ORD's Strategic Plan is designed to be a robust "living"
document. The plan provides a solid underpinning for
ORD research that will allow us to maintain continuity
and momentum in our work in the coming years, while
also constructively adapting to changing EPA and
national priorities over time. EPA is currently develop-
ing a new Agency strategic plan. ORD will work with
other Agency offices to ensure that science is a strong
element of that plan and supports Agency decision-
making. We will adapt the ORD Strategic Plan as appro-
priate to ensure that it supports the Agency's strategy.
Additionally, we will periodically revisit and, as neces-
sary, modify our Strategic Plan to ensure the continued
productivity of ORD's research and development efforts
to meet EPA, national, and international environmental
goals. At the same time, we will work to ensure that, as
the plan evolves, it continues to reflect goals and objec-
tives that are shared throughout ORD.
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A Roadmap for This Document
Chapter 2 of this plan defines strategic directions
(including OKD's vision, mission, and long-term
goals) for ORD research; describes how we identify
specific research topics; lays out an approach to
identifying emerging issues; establishes a risk-based
process for determining our research priorities; and
discusses the criteria used in priority setting.
B Chapter 3 discusses ORD's new plan for information
management; describes how we translate our
Strategic Plan into a specific research program
(including research plans, operating plans, laboratory
implementation plans, and Requests for
Applications); relates how we determine who does
the work and when to close it out; describes how we
will determine priorities for technical support;
presents approaches to measuring success, as well as
rnechanisms for evaluation and accountability; and
describes ORD's commitment to our human
resources and infrastructure, including commitments
to organizational improvement made at our First
Annual Workshop on Managing Change in ORD.
Finally, it identifies challenges for future
consideration by ORD.
Chapter 4 describes the six high-priority research
topics and areas selected when we applied our
priority-setting process to the array of science needs
identified by the Agency, and in the context of our
long-term goals and objectives.
Appendix A expands on ORD's long-term goals and
lists the specific research objectives and activities
ORD will pursue to achieve its goals.
Appendix B describes ORD's organization built
around the risk assessment/risk management
paradigm.
Appendix C describes ORD's management structure
for implementing the Strategic Plan.
Appendix D shows how ORD's extramural
investments (in the form of Requests for Applications
for research grants) relate to the high-priority
research described in Chapter 4.
Appendix E shows how ORD's fiscal year 1997 and
1998 program enhancements correlate to our high-
priority research.
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ORD's commitment to develop a risk-based
research agenda undergirds our vision, mis-
sion, and long-term goals. This commitment
also is embodied in our 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 environmen-
tal science. Our vision, described below, represents the
overall level of achievement that we will strive for in all
our research and development work. Our mission state-
ment, also described below, defines the broad areas of
research and development where we believe ORD can
and must make important contributions to EPA's mis-
sion and mandates and to our nation's overall environ-
mental research agenda.
ORD's Vision
ORD will provide the scientific foundation to support
EPA's mission.
ORD's Mission
ORD's mission is to:
Perform research and development to identify,
understand, and solve current and future
environmental problems.
Provide responsive technical support to EPA's
.mission.
Integrate the work of ORD's scientific partners
(other agencies, nations, private sector organizations,
and academia).
Provide leadership in addressing emerging
environmental issues and in advancing the science
and technology of risk assessment and risk
management.
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ORD's Strategy for Planning Research
ORD's Key Role
Public and private sector institutions have long been
significant contributors to our nation's environmental
and human health research agenda. EPA's Office .of
Research and Development, however, is unique
among scientific institutions in this country in combin-
ing 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 environ-
mental issues. As part of a regulatory Agency that
establishes national priorities and sets national stan-
dards, 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 environmental decisions and standards.
ORD's Long-term Goals and
Objectives
ORD's four mission areas translate into six long-term,
overarching goals (Table 2) that we will strive to meet in
order to fulfill our mission. ORD's long-term goals and
objectives are detailed in Appendix A. The objectives
add another level of detail to our goals that will aid us
in organizing and setting more detailed priorities in our
annual research planning efforts. Some of the objectives
also include a set of specific activities that we will
undertake to achieve those objectives. These activities
allow both internal and external stakeholders to see
how we will conduct our work. Activities are listed
under each objective.
We are working on refining our research goals and
objectives to make them more specific and to enable us
to clarify intended outcomes of ORD's science agenda.
This refinement will not only better align our program
with Agency-wide strategic planning, but will also
allow us to track our progress toward achieving our
program goals, as required by the Government
Performance and Results Act of 1993 (GPRA).
Identifying Specific Research Topics
The objectives and activities listed in Appendix A of this
plan provide detail about how ORD will go about meet-
ing its long-term goals. Each objective and activity still
represents a relatively broad research area. ORD, there-
fore, has developed a priority-setting process and crite-
ria, illustrated in Figures 4 and 5 and described below,
for identifying specific research topics that are of prima-
ry importance to our vision, mission, and goals. We will
use this priority-setting process and criteria periodically
Table 2.
Mission Area
ORD's Long-Term Goals
Goals
Perform research and development to identify,
understand, and solve current and future
environmental problems.
To develop scientifically sound approaches to assign and
characterize risks to human health and the environment.
To integrate human health and ecological assessment methods into a
comprehensive multimedia assessment methodology.
To provide common-sense and cost-effective approaches for
preventing and managing risks.
Provide responsive technical support of EPA's
mission.
To provide credible, state-of-the-art risk assessments, methods,
models, and guidance.
Integrate the work of ORD's scientific partners.
To exchange reliable scientific, engineering, and risk assessment/risk
management information among private and public stakeholders.
Provide leadership in addressing emerging
environmental issues and in advancing the science
and technology of risk assessment and risk
management.
To provide leadership and encourage others to participate in
identifying emerging environmental issues, characterizing the risks
associated with these issues, and developing ways of preventing or
reducing these risks.
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to identify high-priority research topics that will help us
achieve ORD's goals and objectives.
Each year since 1995 we have applied our priority-
setting process and criteria to examine our ongoing
research and identify important new initiatives. This
year we have retained and refined our six priority
research topics from 1996. As before/some of our priori-
ties are specific to a particular environmental problem
and others are broad-based, since they contribute basic
science improvements in both risk assessment and risk
management. These six research topics are described in
Chapter 4 of this document.
Many topics will remain a high priority for several
years. Each year, working with our program partners
and external advisory bodies, we will examine the pre-
vious year's topics to add new topics as appropriate
and remove previous topics for which sufficient
research has been conducted.
Identifying Emerging Issues,
Anticipatory Research, and
Exploratory Research
In recent years, EPA has begun moving beyond environ-
mental regulation to environmental protection in its
broadest sense, including anticipating and preventing
problems before they mushroom into major concerns.
To support EPA in this endeavor, ORD is evaluating the
best means to anticipate tomorrow's environmental
problems and provide EPA with the necessary informa-
tion to evaluate findings, interact with other agencies
and organizations, and possibly act on early warnings
of emerging environmental issues.
The EPA Science Advisory Board's January 1995 report
Beyond the Horizon: Using Foresight to Protect the
Environmental Future suggests many useful measures
we will evaluate for possible implementation. One
measure we are currently considering is the creation of
"lookout panels" comprised of individuals from inside
and outside the federal government to identify, screen,
evaluate, and prioritize emerging issues. As a first step
in this direction, the National Research Council estab-
lished, at ORD's request, a Committee on Research
Opportunities and Priorities for EPA. This committee
was tasked with thinking creatively about ORD's
research areas and identifying high-priority research
topics key to solving some of our nation's most press-
ing current and future environmental problems. Such
research could spark entirely new approaches to envi-
ronmental management in the future. Each year, we
will consider high-priority topics related to anticipatory
research as we review and revise our research agenda.
ORD's Priority-Setting Process
ORD's priority-setting process, depicted in Figure 4,
involves the following steps:
First, we seek input from all parts of EPA, including
ORD's own researchers and staff. The Research
Coordination Council, the Science Council, and
Research Coordination Teams (see Appendix C)
consisting of senior representatives from ORD's
National Laboratories and Centers, the EPA Program
Offices, and EPA's Regional Offices identify the most
important and relevant areas for our research efforts.
(As state and local governments play a larger role in
environmental protection, their research needs must
also be 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, for both
intramural and extramural investments.
We then separate the pool of potential topics into two
categories:
Those that are clearly mandated because of statu-
tory requirements or court orders (i.e., EPA may
have no discretion to reject or delay the research).
All other topics.
For all other topics, we narrow the pool by retaining
only those that are within ORD's mission and goals.
We then apply a series of human health, ecological
health, and risk management criteria (Figure 5) to
compare the mission-related topics according to
their potential to support effective risk reduction.
We use comparative risk analyses to help ascertain
the most pressing environmental problems. We
also apply criteria to consider whether the
research would develop broadly applicable meth-
ods and models needed by EPA programs.
Through this screening process, we set priorities
among the research topics.
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ORD's Strategy for Planning Research
Figure 4. 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
Topic Clearly
Mandated'1
Reject for No /the Topic
ORD -^rt( Within ORD's
Funding2 > Mission and
Apply Evaluation Criteria:
Human Health/Ecological Health
Risk Management
Methods/Models
Prioritized Research Topics
Determine Research Needs:
Effects
Exposure
Risk Characterization
Risk Management
Conduct Research
(In-house, Grant, Coop, Contract, etc.)
Research Products
Reject for No x/ORD Make \ Yes
ORD ^ Q a Significant
Funding2 ^^Contribution?
11n other words, ORD has no discretion to reject or delay this research.
ZEPA Program Offices and Regions may still choose to fund, using ORD labs, grants, contracts, etc., or a research source outside of ORD.
-------
We then further narrow this pool of topics by
retaining only those areas where ORD can make a
significant contribution to environmental science.
Factors we consider at this stage include: Is the
work feasible from a scientific and resource per-
spective? Does ORD have access to the appropri-
ate expertise? What contributions are other
research organizations making to this area of
research?
For these remaining topics where ORD can make
a significant contribution, as well as all
nondiscretiqnary 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 uncertainty
associated with risk characterization, or will improve
the efficacy of or reduce the cost of risk management.
This approach to strategic planning clearly indicates the
following areas where ORD will reduce or eliminate
resources:
Exposure or effects research in areas of low risk or
where the risk is well characterized.
Risk reduction research in areas of low risk or where
cost-effective risk reduction approaches already exist.
Routine measurements and monitoring where
R&D has been completed or that does not support
R&D efforts.
Figure 5. ORD Criteria for Evaluating and Ranking Potential Research Topics
What type of effect would the research
investigate/mitigate and how severely
might this effect impact humans or
ecosystems?
Over what time scale might this effect
occur?
How easily can the effect be reversed,
and will it be passed on to future
generations?
What level of human or ecological
organization would be impacted by the
effect?
On what geographic scale might this
effect impact humans or ecosystems?
How broadly applicable is the proposed
method or model expected to be?
To what extent will the proposed method or
model facilitate or improve risk assessment
or risk management?
How large is the anticipated user community
for the proposed method or model?
Risk Management Cri
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?
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ORD's Strategy for Planning Eesearcfi
Criteria for Setting ORD
Research Priorities
A key component of ORD's planning process is the
criteria we use to set priorities among research topics.
We currently employ three sets of criteria: human and
ecological health research criteria, risk management
research criteria, and methods/models development cri-
teria (Figure 5). These criteria, described below, are not
set in concrete, nor are they universally applicable to all
research areas. Additional or alternative criteria may be
used in some cases as appropriate.
We are continuing to refine these criteria. In particular,
the criteria have been undergoing extensive discussion
and review during fiscal year 1997 with the twin goals
of creating a system that will more directly link ORD's
work to the important issues facing the Agency and that
will more closely integrate human health and ecological
research. We anticipate future modifications to these
criteria that will both improve our ability to evaluate the
effectiveness of ORD research and help our scientists
understand how their research will be used to answer
the Agency's most important risk-based questions.
Human and Ecological Health
Research Criteria
ORD's human and ecological health criteria are based
on five broad categories: the severity, time scale, and
permanence of the response; the level or organization
where the response is expected to occur; and the geo-
graphic extent of the response. Table 3 lists criteria ORD
has developed in each, of these five categories. These
factors help us determine the importance of a human or
ecological health problem in terms of its magnitude of
risk and extent of scientific uncertainty, and thus point
to the areas most needing research (Figure 6a).
(Conversely, areas of low risk or well-understood risk
typically need the least new research.)
Table 3. ORD's Human and Ecological Health Research Criteria
Ecological Health
Human Health
Severity of Response/
Function of Stressor
Mortality
Morbidity
1 Degree of physical disruption
Mortality
1 Morbidity
Time Scale of Response
Immediate effects
Effects that will occur in the future
Acute effects
Subchronic effects
Chronic effects or effects with a
long latency period
Permanence of Response
Irreversible effects
Effects that can be reversed only by
human intervention
Temporary effects that reverse
naturally over a long time
Temporary effects that reverse
naturally over a short time
Transgenerational effects
Nontransgenerational effects
Level of Organization
Effects on an entire ecosystem/community
Effects on a single species
1 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 effects1
Effects on several localities
Localized effects
Global effects
International effects
National effects
Effects on several localities
Localized effects
1 An ecoregion is a geographic area that has similar topography, climate, and biota across the entire area.
14
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Stratsgf for Planning Research
Risk Management Research 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
riskmanagement 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. Applying these
factors directs us toward research investments in areas
where risk problems are adequately characterized and
where risk management options do not exist, are poorly
characterized, are out-dated or inefficient, are too costly,
or might be significantly improved (Figure 6b). (Con-
versely, areas where risk problems are as yet poorly
characterized or where management options are already
optimized typically need the least new research.)
Methods/Models Development Criteria
The methods/models development criteria are applied
to research concerning the development or application
of methods or models for gathering, analyzing, or
applying 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 commu-
nity, and the degree to which the method or model
would improve risk assessment or risk management.
As a result, ORD can then direct research attention to
those areas where tools would be most broadly appli-
cable and where uncertainty in risk assessment or risk
management would-be most reduced (Figure 6c).
(Conversely, tools with narrow applicability or low
potential for reducing uncertainty reduced will typically
receive the least support.)
Strengths of ORD's Research
Planning Process
Our planning approach 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 our most
significant contributions.
It reinforces our sense of direction and
accomplishment as we see our objectives met
and goals realized.
It establishes a structure linking us to Agency-wide
strategic planning and the GPRA.
It enables us to generate practical, credible
information and tools for risk-based decision-
making.
Figure 6.
Setting Research Priorities
a. Human and Ecological Health Effects,
Exposure, and Assessment Research
Greatest
Need for
Research
-" >*»
Well
Least
Need for
Research
Adapted from Paul Slovic, Risk Perception
b. Risk Management (RM) Research
Greatest
Need for RM
too Costly, Research
Least
Need for
RM Research
c Methods and Models Research
Greatest
Mure Need for Tool
Ite^faTB^ Development
Reduction
Least Reducttort
Need for Tool ' C£^ ,<; - -
Development '**&$'
-------
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The steps involved in translating ORD's
Strategic Plan into a research program are illus-
trated in Figure 7. Once we have identified our
high-priority research topics, we develop and
implement a research program based on these topics.
This involves:
Developing science research strategies and plans.
Deciding whether the work will be conducted in-
house or extramurally. (ORD's research program is
comprised of intramural and extramural research.)
For intramural research, developing budget operat-
ing plans and laboratory implementation plans.
For extramural research, selecting and implement-
ing the appropriate mechanisms to access the
external scientific community.
Integrating information management into research
planning.
Developing Science Research
Strategies and Plans
Once ORD has identified its high-priority research top-
ics using the process described in pages 11 to 13, teams
composed of ORD scientists and engineers as well as
representatives of EPA's Program and Regional Offices
develop science research strategies and plans for each
topic. These plans:
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.
Describe how the data and information to be
generated by the research will be used and managed.
Delineate the major outputs to be produced over the
next several years.
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Translating ORD's Strategy Into a Hesearcti
Figure 7. Translating ORD's Strategic Plan Into a Research Program
ORD'S STRATEGIC PLAN
: EPA Program and Regional Office Involvement
' External Scientific Community Involvement
Laboratory
Implementation
Plans
Program
Review and
Evaluation
Research plans are important tools for measuring
accountability because they make clear to our clients
and stakeholders the rationale for and intended prod-
ucts of our research. And, by explicitly specifying
up-front how we will manage our scientific data and
information products, we ensure that the results of ORD
research will be effectively communicated to our clients
and stakeholders. Research plans also enable ORD to
clearly track its progress toward achieving its goals, as
required by the 1993 Government Performance and
Results Act.
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We consult ORD's main research clientsthe EPA
Program and Regional Officesto ensure that the final
research plans clearly include the research products
they will need to fulfill their responsibilities. In addi-
tion, all our research plans are subjected to rigorous
external peer review.
Deciding Who Will Do the Work
This is the point of ORD's planning process where we
decide whether the work would best be accomplished
internally at ORD or externally through one of several
mechanisms: grants to universities or nonprofit centers;
cooperative agreements with another government
agency or with universities; or by contract. Many factors
influence this decision, including:
Which organization has the most appropriate
expertise.
What type of work is called for (risk assessment and
regulatory support work are generally retained in-
house, whereas research, including assessment
methods research work, may be done externally).
How urgently the research products are needed
(since some mechanisms are faster than others).
If there would be value in involving multiple
institutions.
The extent to which we can specify what is needed
(contracts). The extent to which we must rely on the
creativity and insight of the researcher (grants).
What is our available in-house capacity.
What are the opportunities for leverage.
Internal Research
Development of Budget
Operating Plans
For internal research, ORD integrates the science
research plans with budgetary decisions in order to allo-
cate resources to the selected research topics by labora-
tory program and research component. This helps
ensure that our priority-setting decisions (guided by
science) also reflect budgetary realities.
Development of Laboratory
Implementation Plans
Based on the science research plans and budgetary deci-
sions, ORD's Laboratories and Centers develop detailed
plans for implementing each area of research to be under-
taken internally. These laboratory implementation plans
provide a blueprint for Laboratory and Center work and
form the basis for managerial oversight and guidance.
Extramural Research
Extramural research is conducted via grants, coopera-
tive agreements, or contracts. Rigorous external peer
review is a key mechanism we use to evaluate both the
proposals for and results of external research.
One of ORD's primary mechanisms for involving exter-
nal scientists is the Science to Achieve Results (STAR)
program. STAR targets the best scientists from universi-
ties and nonprofit centers because they are an integral,
and important part of the environmental research
community. STAR consists of focused Requests for
Applications (RFAs), investigator-initiated exploratory
research grants, graduate fellowships, and several
"critical mass" environmental research centers.
The bulk of the STAR program supports RFAs that focus
on specific research needs to support the mission of the
Agency. Working with EPA's Program and Regional
Offices, we write these RFAs to be consistent with ORD's
Strategic Plan and science research plans, and comple-
mentary to ORD's in-house work. The RFAs are
announced annually to scientists at U.S. academic and
nonprofit institutions. Proposals from the external scien-
tific community are peer-reviewed and projects are then
selected for funding, in consultation with EPA's Program
Offices and Regions, through grants or cooperative
agreements. ORD leverages the STAR program resources
by jointly funding research with other federal agencies.
Appendix D shows how the fiscal year 1997 RFA topic
areas relate to ORD's high-priority research topics.
Integrating Information Management
Planning Into the Process
To further enhance the quality and value of our work,
we have been developing a plan for managing data and
information in ORD. The plan is based on coordinating
and enhancing existing ORD and EPA systems and
resources. It is built on four fundamental tenets of suc-
cessful information management:
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Translating ORD's Strategy Itits? a Sesearch Pregrastss
Planning and incorporating policies for information
management.
Making potential users aware that information exists.
Making the information accessible to users.
Making the information usable.
The plan sets forth an approach to managing all levels
and types of ORD informationfrom the scientific data
and information that result from ORD's in-house or
extramural research (e.g., raw data collected at field
sites, health or ecological risk assessments, aggregated
data sets) to the administrative information needed to
manage ORD research (e.g., resource data, grant award
information, and laboratory implementation plans).
ORD's information management plan will provide a
consistent, ORD-wide approach to efficiently planning
for, collecting, documenting, manipulating, exchanging,
archiving, and distributing science data and informa-
tion. It will address the full spectrum of ORD's informa-
tion management needs, including data management;
policies and standards; management, staffing, and bud-
get issues; and electronic information technologies.
Information management planning for specific research
projects will commence as soon as ORD has identified
its specific project needs. For each research project, ORD
management and budget decisions will be made consid-
ering the entire project, from data collection through
long-term archiving of data sets. Information manage-
ment planning will, to differing degrees, encompass all
ORD research projectsincluding in-house research as
well as the extramural research that ORD funds with
contracts, cooperative agreements, and grants.
Measures of Success
In general, the success of a research organization can be
measured in several ways: by the number of articles
published in prestigious scientific journals, by the num-
ber of times that articles written by the organization's
scientists are cited in other journal articles, and so on.
However, for a mission-oriented organization like ORD,
measures of the extent that we help and support EPA in
meeting its goals are equally crucial. In measuring the
success of this Strategic Plan, the quality of ORD's
work, and the usefulness of our research products, we
will use the following measures of success.
Significance: Is ORD Working on the
Right Issues?
This is a measure that the EPA Program Offices and
Regions and the broad scientific community can help us
judge. For our research, development, and support
efforts to be useful, we must work on the most impor-
tant environmental issues and target areas for research
that will significantly improve risk assessment and/or
risk management in the Agency and elsewhere. Peer
review by scientists in the external scientific community
will assist us in judging significance.
Relevance: Is ORD Providing Data That
the Agency Can Use?
This question can best be answered by the rest of the
Agency and is best judged by the degree to which
ORD's contributions support EPA decisions. ORD will
strive to ensure that its work is useful to the Agency and
has a positive impact on advancing EPA's mission.
ORD's new information management plan seeks to
ensure that we make our stakeholders aware of and able
to access ORD's science data and information products.
Credibility: Is ORD Doing Research of
the Highest Quality?
'ORD's credibility can best be judged by the external sci-
entific community through such mechanisms as peer
review of ORD products, reviews of programs: at the
ORD Laboratories, peer-reviewed journal articles, scien-
tific citations, and external recognition of both ORD and
its people. Further, we will be judged by the external
scientific community on the extent to which we advance
the state of environmental science. ,
Timeliness: Is ORD Meeting EPA's
Expert Consultation and Assessment
Needs in a Timely Manner, Providing
Research Products According to
Schedule, and Addressing Long-Term
Issues With Adequate Forethought and
Preparation?
The first part of this question can best be answered by
EPA's Program Offices and Regions as they determine
whether ORD consultations and assessments are being
provided in time to be optimally useful for Agency
decisions. The middle part of this question can be
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answered by ORD managers and EPA's Program Offices
and Regions through annual program reviews and
other activities. The final aspect of timeliness is more
subjective and therefore more difficult to assess. ORD
has accepted the challenge of anticipating important
environmental issues that are just emerging and may
not become critical problems until well into the next
century. The U.S. public is the ultimate judge of how
successful ORD has been in this effort. ORD will strive
to regularly gather the public's view on this issue.
Mechanisms for Evaluation
and Accountability
ORD has several mechanisms for evaluating its perfor-
mance, communicating progress and results, and mea-
suring success. These include:
Annual research program reviews, jointly organized
by ORD's Research Coordination Teams and EPA's
Program and Regional Offices, that present to EPA
senior managers the entire EPA research portfolio in
a given area. These joint reviews focus on the status
and accomplishments of the ORD research program
to ensure that ORD's research continues to meet ORD
and client objectives. They also present the ongoing
research being conducted by the Program Offices and
Regions so that the total research agenda can be
viewed. The objectives of these reviews are to
evaluate progress in completing planned research
projects, to track and evaluate research results, and to
generally obtain feedback on ORD's work and any
adjustments that may be needed to help us better
meet our clients' needs. These reviews complement,
rather than supplant, external peer reviews.
ORD review of its science research plans. ORD
examines its research plans periodically and adjusts
them if warranted by our research results, by changes
in EPA or national priorities, or by emerging issues
and concerns.
External peer reviews of ORD science research plans
and products and overall progress in meeting our
goals and objectives. These reviews are conducted at
key intervals in our research planning and
implementation process.
External peer reviews of research proposals received
from extramural research scientists in response to the
Requests for Applications.
External peer reviews of ORD Laboratories and of
ORD's use of peer review through our Board of
Scientific Councilors under the Federal Advisory
Committee Act.
Annual science workshops designed to make the
progress and results of all ORD research (including
the external grants program) accessible to EPA's
Program Offices and Regions.
A data tracking system, part of ORD's Management
Information System, which tracks resources and
progress.
"Yearly evaluations under the Government
Performance and Results Act.
Through these mechanisms, ORD will strive to develop
and conduct the most responsive, scientifically justifi-
able research program possible within the constraints of
our available resources.
Closing Out Completed Work
Through the continuing involvement of the Research
Coordination Teams and the annual program reviews
mentioned above, ORD will assess ongoing research to
evaluate:
Whether the research is on track for meeting its goals
and schedule.
When the research should be concluded.
Prudent management of evolving priorities and declin-
ing resources requires that we clearly define our research
and conclude it within an appropriate time frame, so we
can begin work on new priorities without delay.
Technical Support
One of ORD's most important functions is to provide
technical support to EPA Program Offices and Regions
and states. ORD is committed to a strong and sustained
technical support program.
In 1996, the EPA Program Offices, ORD, and the EPA
Regions initiated the first comprehensive assessment of
all technical support activities within EPA, with particu-
lar emphasis on ORD's roles and responsibilities for
technical support. The purpose of this evaluation was to
ensure that ORD:
Provides the types and quantities of technical
support most needed by the Program and Regional
Offices, states, and others.
-------
Translating ORD's Strategy firsts a Research Program
Focuses its technical support efforts in areas where
ORD has unique capability or where the support is
not readily available outside EPA.
Fosters greater involvement of the EPA Program
Offices and Regions in guiding ORD's technical
support activities.
Promptly develops exit or entrance strategies for
activities that are being phased out or newly
introduced.
As an outgrowth of this initial effort, ORD comprehen-
sively assessed its technical support function. We
defined the term technical support, developed criteria for
setting support priorities, inventoried the current distri-
bution of our technical support resources, and devel-
oped a process for making technical support decisions.
As defined by our assessment, ORD technical support
comprises activities ORD conducts in response to spe-
cific requests by the Program Offices, Regions, or states
to address well-defined needs that are not covered by
ORD's research program. For example, ORD's current
technical support activities include maintaining the
Integrated Risk Information System for the Agency and
consulting with the Office of Water on sediment quality
criteria guidelines.
The criteria ORD will now use to set its technical sup-
port priorities are the extent to which:
The proposed technical support will provide
fundamental support for regulatory programs.
ORD has unique scientific and or technical
capabilities to address the problem.
Environmental quality and human health will
directly benefit from the activity, relative to the
resource requirements of the technical support.
ORD can help solve the problem.
ORD technical support decisions for fiscal year 1998
were made during fiscal years 1996 and 1997 using a
process that involved the Research Coordination Teams,
the Research Coordination Council, the Environmental
Monitoring Management Council, and others. This
allowed participants to resolve long-standing issues and
develop a common reference point for making future
decisions. In the future, decisions about the type and
quantity of ORD technical support will be made as part
of ORD's overall research planning process.
ORD Customer Focus
ORD is committed to providing excellent service to
all external and internal customers. To this end, we
will support our employees in applying the Agency's
customer service standards, and our senior executives
will provide leadership in advocating high quality
customer service.
Human Resources and Infrastructure
The success of ORD's Strategic Plan depends on an
adequately funded and well-managed infrastructure,
including ORD's work force, systems, and equipment.
ORD's recognition of the importance of our infrastruc-
ture is reflected in our strategic principles (Table 1),
which highlight the critical role of infrastructure in
achieving and maintaining an outstanding research and
development program in environmental science.
Because we recognize that scientific excellence must
be built on a strong foundation, we are committed
to constant improvement of our organization and
infrastructure. As we implement this Strategic Plan, we
will continue to devote leadership and resources to
developing and fostering our work force, modeling
effective management, and creating a supportive work
environment.
ORD's Work Force
By far the most important component of ORD's infra-
structure is our work force of scientists, engineers, man-
agers, other environmental professionals, and support
staff. ORD can achieve its vision of providing the scien-
tific foundation to support EPA's mission only if we can
attract, nurture, and support a productive work force.
ORD's strategic principles (Table 1) emphasize the
importance of nurturing and supporting the develop-
ment of outstanding scientists, engineers, and other
environmental professionals at EPA.
The cutting-edge nature of research and development at
ORD places great demands on our scientists and engi-
neers to continually upgrade their skills and knowledge
in response to and anticipation of new scientific develop-
ments. ORD maintains its commitment to 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). In addition, we will provide opportunities
for ORD scientists and engineers to increase their contri-
bution, as respected members of the scientific community
-------
and leaders in the environmental sciences, to the general
scientific literature and community (e.g., through publi-
cation of scientific articles in peer-reviewed journals
and participation in national and international scientific
conferences).
Further, our work force support must include an effec-
tive 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 organizational structure (see Appendix B) relies
on a relatively small headquarters staff and places pro-
gram management responsibilities in the hands of
ORD's field Laboratories and Centers. This flattened
organizational structure requires a team-based, matrix-
management approach in place of the traditional, more
hierarchical approach to management.
ORD's Organizational
Improvement Activities
ORD held its First Annual Workshop on Managing Change
in Williamsburg, Virginia, on December 2-5,1996. This
meeting marked the beginning a long-term process for
managing change within ORD. The overarching pur-
pose of the workshop was to improve the delivery of
high-quality science in EPA by:
Understanding the new directions in ORD.
Building the ORD team and improving
communications.
Sharing ideas and listening to all participants' views.
Developing action plans and identifying change agents
to achieve specific organizational improvements.
Strengthening strategic management of ORD's
research program.
The workshop was the first of its kind for ORD in terms
of its scope, design, and breadth of participation.
Participants included a cross-section of staff from ORD
Laboratories, Centers, and Offices. ORD's Strategic Plan
provided the overall framework for the deliberations.
Participants identified 564 issues and then consolidated
and prioritized them to specify five focal areas for
improvement: '
Reduce red tapeEmpower staff by reducing
unnecessary paperwork.
CommunicationsDevelop and implement a
comprehensive communications plan to improve
two-way communication and make electronic
communications more effective within ORD.
Career advancement and developmentProvide
career enhancement opportunities for all employees.
Resources and infrastructureDefine "infrastructure"
and provide adequate resources to support science.
Integrate science with EPA's missionTake action to
put science first at EPA and to better integrate science
with EPA's mission.
Follow-on activities to address these five improvement
opportunities include: "local" initiatives to keep com-
mitments made at the workshop; Laboratory/Center/
Office groups to identify additional specific actions; the
development and administration of the second ORD
Organizational Climate Survey to assess progress in
implementing improvement in the five areas of concen-
tration; and establishing an ORD-wide Improvement
Network that enhances the communications among
and between the various ORD Laboratories, Centers,
and Offices.
Common problems identified through the Network will
be addressed utilizing the Executive, Management,
Science, and Human Resource Councils. The Network
will also assist in the annual organizational survey and
the next annual workshop.
In addition to supporting the innovative actions taken
within each ORD Laboratory, Center, and Office, the
Network showcases new ideas as models for replication,
thereby keeping alive, the "spirit" of Williamsburg. Key
to this "spirit" is the participation of all levels of employ-
ees, an ORD atmosphere of openness, and a commitment
to action by a management team that listens.
Systems and Equipment
To promote successful implementation of this Strategic
Plan by our work force, ORD is committed to providing
safe, environmentally sound, well-maintained, state-of-
the art laboratories, equipment, and supplies. Further,
by implementing our information management plan
described on pages 19 and 20, we will provide ORD
staff with data management, technical, and fiscal infor-
mation systems to support the conduct of research, as
well as the management, planning, budgeting, and
- <»-«
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-------
Translating ORD's Strategy info a lesearcli Program
accountability functions.
As we implement our Strategic Plan, we will monitor
work force needs and strive to provide other programs,
mechanisms, and support as necessary to ensure that
our work force has the tools, work environment, and
equipment it needs to achieve ORD's vision and goals.
Challenges for the Future
ORD is continuing to study peer reviewer and internal
staff recommendations for use in future updates of our
Strategic Plan. Comments we are considering include
the following:
Reviewers recommended that ORD periodically
reexamine the basis for its Strategic Plan to
accommodate ongoing changes in risk assessment
concepts generally, and in the risk assessment/risk
management framework in particular. Such
reexamination is a central feature of the process
envisioned by this plan, and ORD is committed to
the concept that its risk-based priority-setting system
will evolve with evolving risk assessment and risk
management concepts.
Reviewers also commented that the risk assessment
paradigm has limited applicability for some EPA
programs, thus limiting the utility of a plan based on
the paradigm. ORD recognizes the validity of this
comment in particular cases. As we implement this
Strategic Plan, we will be working in close
collaboration with EPA's Program and Regional
Offices to ensure that our research agenda is tailored
to their particular programs and priorities. Based on
this experience, we will consider modifications to
the plan over time to accommodate these special
circumstances, as necessary.
In addition, ORD is currently involved in several activi-
ties that will impact future updates of this plan:
We will continue our work to refine the evaluation
criteria for determining research priorities.
In cooperation with the EPA Program Offices, we will
continue to merge ORD's goals and objectives into
EPA's strategic planning process and GPRA activities.
Finally, and most importantly, we will examine
emerging environmental issues and new scientific
information to determine whether we need to adjust
our major scientific directions, goals, or objectives in
light of new knowledge and developments.
-------
The goals and objectives listed in Appendix A of
this plan define an ambitious research program
for ORD. Within this program, however, the
extent of research we can actually perform will
be limited by the available resources. Therefore, in con-
sultation with EPA's Program Offices, ORD uses the pri-
ority-setting process to select from its overall program
those topics that are of highest priority for research.
Priorities to be emphasized for the next few years are
(in no particular order):
Safe drinking water (with a near-term focus on
microbial pathogens, disinfection by-products, and
arsenic)
High-priority air pollutants (with a near-term focus
on particulate matter)
Emerging environmental issues (with a near-term
focus on endocrine disrupters)
Research to improve ecosystem risk assessment
Research to improve health risk assessment
Pollution prevention and new technologies for
environmental protection
These areas will receive more intense research attention
(and resources). Intramural efforts will be supplement-
ed with the talents of extramural scientists through
external grants, cooperative agreements, interagency
agreements, and contracts.
Proposed research for the six high-priority areas is sum-
marized in Table 4. Tables 5 through 10 provide a break-
out, by risk assessment/risk management area, of the
strategic issues and proposed research tasks, products,
and applications in each of the six topic areas. Tables 4
through 10 can be found at the end of this chapter on
pages 31 through 54.
Other areas of high importance that will continue to be
a major part of ORD's research program include:
Tropospheric ozone
Global change
Environmental monitoring
Contaminated sitesground water, soils, and
sediments
Exposures to pesticides and toxic substances
-------
ORD's High-Priority Research
Ecosystem water quality
Air toxics
ORD's research agenda also includes additional topics
necessary to help the Agency fulfill its nondiscretionary
mandates.
Other topics were considered during the planning
process, but they did not meet the criteria to be includ-
ed in ORD's research program. In general, these include
exposure or effects research in areas of low risk, risk
reduction research in areas of low risk, and routine
measurements and monitoring where R&D has been
completed. In general, ORD will not pursue major
research programs in areas where other research organi-
zations are capable of making a more significant impact.
ORD's entire research program will be captured in more
detail in the science research plans being developed by
the Research Coordination Teams. These research plans
will be finalized after a rigorous peer review. Interested
readers should consult these documents.
ORD also uses the principles and priorities of this
Strategic Plan as a basis for developing its annual bud-
get requests to fund our research agenda. Our fiscal
year 1997 and 1998 requests were based on this plan, as
will be our fiscal year 1999 budget proposals.
Evolution of ORD Priority
Areas Over Time
The six high-priority areas intentionally are a mixture
of:
Research targeted at specific pollution problems (i.e.,
safe drinking water, high-priority air pollutants, and
emerging issues).
Broad-based research in methods and approaches to
advance the fields of risk assessment and risk
management (i.e., research to improve ecosystem and
health risk assessment, and pollution prevention and
new technologies for environmental protection).
We will evaluate progress on all research targeted at
specific pollution problems periodically to ensure that
our research program continues to focus on the most
significant problems. As work on problem-specific
topics progresses and moves toward closure, we will
redirect our research and resources to emerging high-
priority areas. For example, as we successfully com-
pleted work in one of our former priority areas (the
health risks of ozone), we shifted resources to particu-
late matter, one of our current high-priority topics. In
the future, the particulate matter research likely will
give way to other topics of emerging priority.
We will also evaluate progress on our broad-based
methods, measurement, and models development
research annually. These cross-media areas, which
reflect ORD's fundamental risk assessment and risk
management research programs, will remain high-
priority topics. However, the individual projects within
these areas will change to reflect research progress and
emerging concerns. As the individual projects change,
we will revisit and revise research plans for these areas.
Selection of the Six High-Priority
Research Topics
The following summaries illustrate how application of
the selection criteria described in Chapter 2 gave rise to
the six high-priority research topics.
Safe Drinking Water (Microbial
Pathogens, Disinfection By-Products,
and Arsenic)
The 1996 Safe Drinking Water Act Amendments reem-
phasized the importance of EPA research on disinfec-
tants, disinfection by-products, and pathogens in
drinking water. The Amendments also stressed the need
for research on arsenic, sulfates, and radon; risk assess-
ment in sensitive subpopulations (e.g., children); mix-
tures; and estimating the risk-reduction benefits of
drinking water regulations. ORD's near-term focus in
this research will be to address uncertainties in drinking
water disinfection and arsenic.
Disinfection of drinking water has been one of the
greatest public health success stories of the twentieth
century. Nevertheless, some public health concerns still
remain. For example, many hundreds of thousands of
people have become ill and some have died during
recent outbreaks of exposure to the protozoan
Cryptosporidium in drinking water. Recent studies
demonstrate that there is a low threshold of infectivity
for Cryptosporidium and that people with compromised
immune systemssuch as the elderly, HIV-positive
individuals, and persons receiving chemotherapymay
be at greater risk. In addition, other microorganisms
exist in drinking water that may also pose serious risks
of infection.
We still lack methods to measure many known path-
ogens in water and are uncertain about their infectivity
§26
-------
rs High-priority teseareti
doses and risks. There is also a high degree of uncer-
tainty about whether disinfection by-productsthe
chemical by-products that result when disinfectants
react with organic matter in drinking waterpose a sig-
nificant human health threat. Because of the high uncer-
tainty, the widespread human exposure to drinking
water/the severity of the known effects from certain
microbes, and the potentially high costs of further regu-
lation of drinking water, this issue is the highest priori-
ty to EPA's Office of Water and ORD's water research
agenda.
The current U.S. standard for arsenic in drinking water
is based on policy recommendations developed in 1942
that predate modern cancer and other health-related
data. Even today, regulation of arsenic in drinking
water is controversial because of the health risk uncer-
tainties and the costs of removing arsenic from drinking
water. However, legislation now requires EPA to issue a
revised standard for arsenic by 2001. Reports of hun-
dreds of thousands of people being poisoned by arsenic -
in their drinking water in other countries (Taiwan, , _
China, India, Bangladesh, and Chile)as well as the
fact that people in the U.S. on public and private water
supplies are exposed to arsenic, particularly in the '
Southwesthave also heightened the need to address ..
these health uncertainties. Accordingly, this issue is also-
of high priority to EPA's Office of Water and ORD's
water research agenda.
High-Priority Air Pollutants
(Particulate Matter)
Recent publications in the scientific literature indicate
that exposure to particulate matter (PM) poses a high
potential human health risk. These studies suggest
exposures to PM alone, and in combination with other
priority pollutants such as ozone, may shorten the
human life span of susceptible subpopulations (e.g., the
elderly) and cause illness in these and other susceptible
groups such as children. There is, however, a high
degree of uncertainty about the size and composition of
the particles that may be responsible for these' effects,
the biological mechanisms of action, and the nature of
the concentration-response relationship across a wide
range of concentrations and conditions. In addition,
control costs are potentially very high. For all these rea-
sons, this area is of very high priority to EPA's Office of
Air and Radiation and of high priority to ORD's
research agenda.
Emerging Environmental Issues
(Endocrine Disrupters)
Through the 1990s, concern has grown that humans and
wildlife have suffered adverse health effects .from expo-,
sure to environmental chemicals that interact with the
endocrine system. Collectively these substances are
known as endocrine-disrupting chemicals (EDCs). The
endocrine system as the central mediator of toxicity
may explain effects ranging from increased incidence of
some birth defects in humans and wildlife, to dimin-
ished semen quality in adult males, to increases in cer-
tain cancers (breast, prostate, testes). For example, we
have clear evidence of a cause-and-effect relationship in
the nearly complete mortality of Lake Ontario lake
trout in the sac-fry stage, presumably from exposure to
dioxin-like EDCs.
Despite these reports, we still know relatively little
about the causes of many of the adverse health out-
comes in humans of endocrine disruption. However, we
do know that endocrine factors regulate the normal
functions of all organ systems. Even small disturbances
in endocrine function, especially during certain stages
of the life cycle, can lead to profound and lasting effects.
Developing offspring are likely to be the most sensitive
to EDC exposure.
ORD is already committed to explicitly considering
health risks to children when assessing environmental
risks. EDC issues only heighten our concern that this
special population be provided adequate levels of pro-
tection from environmental exposures.
Based on the potential scope of the EDC problem, the
possibility of serious effects on the health of popula-
tions, and the persistence of some endocrine-disrupting
chemicals in the environment, this area has been desig-
nated as a high priority for ORD research. Consistent
with ORD's long-term goals and objectives, particularly
pollution prevention, ORD leads international efforts to
define the scope of the EDC problem, identify the areas
of scientific uncertainty, and develop recommendations
for research. Working via an Endocrine Disrupter
Work Group under the Committee on the Environment
and Natural Resources of the National Science and
Technology Council, we have helped develop a
-------
ORD's High-Priority Research
Atmospheric Administration) are working cooperatively
to identify, evaluate, and develop new advanced tech-
nology solutions.
Specifically, ORD has initiated a programthe
Advanced Measurement Initiative (AMI)to guide the
identification, research, and application of advanced
monitoring tools and enabling technologies in support
of EPA's mission. Examples of the kinds of technologies
to be evaluated include:
Thermal infrared sensing of water and watersheds
Light Detection and Ranging (LIDAR) measurements
of air pollutants
Very high-resolution, visible and infrared wavelength
imaging of polluted land areas
AMI'S initial emphasis has been applications for remote-
ly sensed information, with NASA and DOE as primary
partners. We will progress to investigating other (e.g., in
situ) monitoring approaches and will expand to include
other agencies and nonfederal developers.
In addition to AMI, the application of high-performance
computing to environmental science can improve our
ability to access and use data, environmental models,
and graphical/analytical tools for informed, risk-based
decision-making. Further, the demonstration of new tech-
nologies through activities such as the Environmental
Technology Verification Progiiram will accelerate develop-
ment by independently and objectively verifying and
reporting technology performance under real-world
conditions.
Because of the broad applicability of these new or
improved technical solutions to environmental prob-
lems, their significant potential for enhancing risk
assessment and risk management, the potentially large
economic and environmental benefits of these approach-
es, and the opportunities to leverage EPA's resources,
pollution prevention and new technologies are of high
priority for ORD's research agenda.
-
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-------
Appendix A
ORD's Long-Term Goals
and Objectives
To help focus selection of research priorities, ORD has
defined a set of long-term, research objectives within
each of the six long-term goal areas listed in Table 2.
Variations in the specificity of the objectives listed
below reflect differences in the maturity and complexity
of the science underlying each objective. Many of the
objectives include a set of activities (listed under the
objective) that support the objective.
The goals and research objectives described here will
assist decisions about research directions for years to
come. Each year ORD senior management, working
with the Research Coordination Teams, will apply
ORD's priority-setting process to review current topics
and identify specific new research topics that best fur-
ther program goals and objectives. We would not expect
to make major changes in priorities every year, but we
will evaluate the continuing timeliness and importance
of our research topics on an annual basis. The resulting
set of research topics will constitute the basis for ORD's
research program. ORD is currently refining its strategic
goals and objectives to better align with Agency strate-
gic planning and priorities.
The research objectives state, in a more specific and con-
crete manner than do the goals, what ORD will work
to achieve in each of its focal research areas. We intend,
after further refinement, to use the objectives and cor-
responding activities to introduce another level of
accountability for results into the ORD planning process,
as required by the Government Performance and Results
Act (GPRA). Senior management will review the
research objectives periodically to ensure that appropri-
ate progress is being made toward their achievement,
per GPRA. As necessary, adjustments in focus or
approachrwill be made early on to avoid wasting time
or resources. Once ORD has achieved its research objec-
tives, we will devote resources to other high-priority
areas. When new high-priority research areas are devel-
oped, we will craft new objectives as appropriate.
Goal 1: To Develop Scientifically
Sound Approaches to Assessing and
Characterizing Risks to Human Health
and the Environment
Risk assessments and the associated risk management
decisions are often based on limited data obtained in
species or under exposure conditions that differ from
real-world circumstances. Inevitably, scientists must
extrapolate from these data sets to the human or environ-
mental 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 improve the
efficiency and effectiveness of EPA's risk management
efforts and provide a better foundation for establishing
the Agency's research priorities. ORD, therefore, will
work to improve existing risk assessment data,
methods, and models and to develop new methods for
high-risk areas where data currently are inadequate.
Akeady, for example, the science has advanced suffi-
ciently 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 inter-
dependence 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,
-------
Appendix A
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 noncancer
health risks with more scientifically grounded,
biologically plausible approaches and models. This
will include:
Studying the heightened sensitivity/susceptibility
of certain subpopulations (e.g., children).
Studying the predictive relationship between toxi-
cologic endpoints and human disease (e.g., to
facilitate animal-to-human extrapolation).
Developing integrated mechanistic information to
support biologically credible health assessments.
Develop methods and models founded on
measurement 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 exposure
sources and multiple exposure pathways, includ-
ing characterizing the sources and determining 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 pollu-
tant fate and transport process descriptions for use
in risk assessment.
Developing and applying exposure measurement
methods to reduce the uncertainty in exposure-
dose relationships, especially analytical 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 pre-
dict exposure levels, frequencies, and distributions
in populations.
Delineating and quantifjring the role of exposure
in the development of effects in individuals and
populations, including susceptible populations.
Establish approaches to characterizing and
understanding risks to ecosystems and, in
cooperation with other agencies, develop a national,
multiscale, integrated environmental status and
trends program. This will include:
Developing indicators of the condition of repre-
sentative ecosystems.
Supporting hypothesis-driven, long-term moni-
toring of important exposure and effects indicators
at national reference sites.
Characterizing national land-cover/land-use pat-
terns and developing measures of landscape
condition at multiple scales for specific sites, water-
sheds, landscapes, and ecoregions.
Conducting pilot studies in ecologically important
regions (e.g., the mid-Atlantic Highlands) to evalu-
ate alternative monitoring designs and to develop
techniques to integrate data across geographic
scales.
Understand and predict ecosystem exposures,
responses, and vulnerabilities to high-risk chemical
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 assess-
ment and risk reduction efforts, and (2) to measure
progress toward meeting environmental goals.
Developing diagnostic tools at all levels of biologi-
cal organization for retrospective assessments and
for characterizing the key sources and stressors in
multistressed ecosystems.
Developing tools for predicting the vulnerability
of ecosystems at multiple geographic and tempo-
ral 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 dis-
ciplines. As a result, EPA has developed and used sepa-
rate 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 assess-
ments 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 interactions on disease
vectors such as mosquitoes, ticks, and rodents).-
Develop tools and techniques to facilitate the
assessment of relative risks to human health and the
environment.
Harmonize extrapolation methodologies for relating
data on toxicity mechanisms for endocrine
disrupters, immunotoxins, developmental hazards,
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 pre-
vention, 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 so that we can better help regions, com-
munities, and the private sector analyze pollution
problems and achieve risk reductions efficiently and
cost-effectively. This common-sense approach will seek
to maximize the health and environmental benefits of
risk management by focusing risk management research
on those aspects of a process or situation that cause the
greatest risks.
To that end, our pollution prevention and control
research will now focus on multimedia life-cycle analy-
ses, green technologies, and pollution prevention meth-
ods that small- and medium-sized companies can use to
achieve significant reductions in risk across media. Our
maturing site and spill remediation program will con-
centrate on developing cleanup options for complex risk
situations and faster, lower-cost natural recovery sys-
tems. 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 identify-
ing and reporting the benefits and costs of risk manage-
ment 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.
-------
Appendix A
Objectives
Within this goal area, ORD will work to:
Provide cost-effective risk management technologies
and approaches for high-risk threats to human health
and the environment. This will include:
Characterizing sources of fine-particulate emis-
sions, air toxics, and ozone precursors, and identi-
fying, adapting, and developing risk management
approaches that control emissions to acceptable
levels.
Providing cost-effective, reliable technologies and
management approaches that reduce drinking
water exposures to disinfectant by-products while
protecting water supplies from microbial contami-
nation.
Providing communities with proven technologies
for wet weather flow watershed management,
wellhead protection, and restoration of contami-
nated 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-performance
computing systems to predict the fate of pollu-
tants through the multimedia pathways leading
to human and ecosystem exposure to these
pollutants.
Catalyze the development and use of cost-effective
risk management approaches for the most difficult
and costly environmental management problems.
This wUl include:
Developing cost-effective techniques for character-
izing and remediating soils and ground water
contaminated with nonaqueous-phase liquids,
chlorinated and other hazardous organics, and
toxic metals.
EL~TI
Developing cost-effective techniques for character-
izing and remediating contaminated sediments.
Verifying the performance of innovative risk
reduction and measurement/monitoring technolo-
gies and accelerating their commercial use.
Provide cost-estimating/engineering assessment
tools and methods for more accurate and meaningful
cost-benefit analyses. This will include:
Developing data standards and cost reporting
protocols.
Developing methods and cost analyses for emerg-
ing, high-risk environmental problems (e.g., fine
particulates, drinking water, wet weather flow
controls).
Develop and provide risk management alternatives
to maintain and/or restore ecosystems. This will
include:
Developing diagnostic aind 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 manage-
ment approaches and technical guidance for
restoring riparian zones, remediating contaminated
soils and sediments, and applying best manage-
ment practices to restore or maintain 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 scien-
tists as well as scientists in the environmental, industri-
al, 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 assessments.
These assessments either will serve as prototypes
-------
demonstrating new approaches to risk assessment
or will respond to Agency needs by assessing multi-
media, multiprogram, of contentious 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 integrat-
ing data and models developed by ORD and the gen-
eral scientific community into risk assessment efforts.
ORD will integrate human health and ecological con-
cerns into all these activities.
Objectives
Within this goal area, ORD will work to:
Prepare risk assessments for those stressors currently
considered of high risk to humans and the environ-
ment. 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 contaminants (e.g.,
chlorinated dioxins, mercury).
Assessing the risks to ecosystems from nonchemi-
cal stressors (e.g., habitat loss and UvB due to
stratospheric ozone depletion).
Conducting comparative risk assessment of com-
peting risks (e.g., those posed by microorganisms
in drinking water versus those posed by disinfec-
tion by-products).
Complete development of new cancer risk guidelines
and other guidelines and provide support to the
Program Offices and Regions to facilitate their
implementation. This will include:
Developing and supporting the implementation of
guidelines for assessing the ecological impacts of
environmental stressors.
Supporting the implementation of new guidelines
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 information
from ORD Laboratories and other sources to pro-
vide a sound scientific base and technical support
for Agency decisions and policy.
Developing and supporting the implementation 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 assess-
ments for criteria air pollutants, hazardous air
pollutants, waste sites, and drinking water.
Providing training in risk assessment to state and
local stakeholders.
Continuing to support and improve the Integrated
Risk Information System (IRIS) and expert systems
such as Risk Assistant.
Assuring adequate quality assurance for all
research, testing, and applications.
Develop methods and assess methods developed
by others for providing quality-assured data for
environmental assessment. This will include:
Supporting the development of models that can be
readily used by Regions and states.
Goal 5: To Exchange Reliable Scientific,
Engineering, and Risk Assessment/Risk
Management Information Among Private
and Public Stakeholders
Effective risk assessments and risk management deci-
sions 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 infor-
mation, we are committed to providing, coordinating,
and exchanging expertise and information to decision-
makers inside and outside EPA. We will work to identi-
fy and fulfill user needs by providing appropriate tools
and information through interconnected communica-
tion and technical support networks.
-------
Appendix A
Our goal is to facilitate information that is impartial,
up-to-date, and relevant to user needs. To that end,
we must improve and update existing information
systems and develop new systems and information
transfer solutions to meet future needs. Working with
other EPA offices, we will help to develop an opera-
tional 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 information to
a broad user community. This will include:
Developing plain-language guidance and training
that adequately and clearly communicate the
appropriate use of technical information and that
describe limitations and inappropriate applica-
tions.
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 implementation.
Maintain and increase support for existing scientific,
engineering, and risk information systems. This will
include:
Ensuring that current information resources are
accurate, relevant, and up-to-date.
Developing electronic and other methods of bring-
ing databases (e.g., IRIS, ECOTOX) to state and
local governments and other stakeholders.
Developing data management systems that make
data readily available to all ORD Laboratories and
Centers, EPA Program Offices and Regions, and
states.
Goal 6: To Provide Leadership and
Encourage Others To Participate in
Identifying Emerging Environmental
Issues, Characterizing the Risks Associated
With These Issues, and Developing Ways
of Preventing or Reducing These Risks
With our very broad missions, we in ORD and the
Agency as a whole must have some means of evaluat-
ing, 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 of
emerging issues. Thus, we must develop and dissemi-
nate data and methods to permit credible decision-
making in the face of very high uncertainty. At ORD,
we are committed to working with other groups within
EPA, the Agency's Science Advisory Board (SAB), the
National Academies of Science and Engineering (NAS
and NAE), and others to develop new ways of analyz-
ing emerging issues. We recognize that ORD cannot and
should not assume leadership in every area of environ-
mental science. Our challenge is to be cognizant of
where others are already leading and where ORD
should undertake that role.
EPA's general approach to environmental manage-
mentassessing risks, evaluating the potential benefits
of risk reduction, and devising risk management and
risk reduction strategies accordinglyis increasingly
being adopted by others in this country and abroad.
More than any other organization, ORD has been in the
forefront of developing the risk assessment and risk
management methods that undergird this risk-based
approach to environmental management.
More than any other organization, therefore, we should
be expected to provide leadership in the development
of new, more credible ways of comparing and ranking
risks. In providing this leadership, we renew our commit-
ment to encouraging and enabling others in the public
and private sectors to participate in identifying, character-
izing, and resolving emerging environmental issues.
-------
Objectives
Within this goal area, ORD will work to:
Collaborate with other parts of the Agency, the
SAB, the NAS, and others to develop methods of
identifying emerging issues and assessing their
potential risks.
Develop partnerships (via research grants,
cooperative agreements, CRADAs, and other
mechanisms) with other federal agencies, the White
House Committee on Environment and Natural
Resources, industry, and academia.
Provide national and international leadership in risk
assessment and its application for risk reduction and
risk management.
Conduct/sponsor workshops and symposia that will
provide forums for stimulating interest and
discussion on current or emerging environmental
issues (e.g., endocrine disrupters), reaching
consensus on crucial research needs, and defining the
role of ORD and others in addressing those needs.
-------
-------
Appendix B
The ORD Organization
ORD's organization, depicted below, mirrors the risk
assessment/risk management paradigm. The functions
of ORD's National Laboratories, Centers, and Offices
are described on the following pages.
ORD's Risk-Based Organization
Management and
National Health and
Environmental Effects
Research
w
%f,;...-.immm^
.aboratory
"O**** -*''"- -
A
1
Assistant Administrator for Research and Development
~ Deputy Assistant Administrator
for Management
I
yt
i
j
Reproductive
Toxicology Division
(RTF, NC)
Experimental
Toxicology Division
(RTF, NC)
Carcinogenesis
Division (RTF, NC)
Neurotoxicology
Division (RTF, NC)
Division (RTF, NC)
Gulf Ecology Division
(Gulf Breeze, FL)
Mid-Continent
Ecology Division
(Duluth, MN)
Western Ecology
Division
(Corvallis. OR)
Atlantic Ecology
Division
(Narragansett, Rl)
National
Exposure
Research <
Laboratory ?
, <
Atmospheric
- Processes Research
Division (RTF, NQ
Air Measurements
_ Research Division
(RTF,
NC)
Deputy Assistant
Administrator for Science
I
1
i
Office of Science Policy
National Center I National Risk
for Environmental 1 Management
1
4
H
Assessment ? Research jj
" "ii-iHal
1
Siij«s4?Trvii-', ^
NCEA Kir, INI, (
Office
- NCEA Washington,
DC Office
NCEA Cincinnati,
OH Off'i-f
Atmospheric
- Modeling Division
(RTF, NC)
Air Exposure
_ Research Division
(RTF, NC)
Human .Exposure
Research Division
(Cincinnati, OH) .
Ecological Exposure
- Research Division
(Cincinnati, OH) ,
Characterization
Research Division
(Las Vegas, NV)
Ecosystems Research
Division
(Athens, GA)
Laboratory |
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
(RTF, NC)
National
1'
1
Center
for Environmental
Research and
Quality Assurance
1
1
Environmental
Engineering
Research Division
(Wash ngton, DC)
Environmental
Sciences Research
Division
(Washington, DC)
Quality Assurance
Division
(Washington, DC)
Peer Review Division
(Washington, DC)
Subsurface '
Protection and
Remediation Division
(Ada. OK)
Technology Transfer
and Support Division
(Cincinnati, OH)
- Technology
Coordination Staff
(Washington, DC)
-------
Appendix B
National Health and Environmental
Effects Research Laboratory
ORD's National Health and Environmental Effects
Research Laboratory (NHEERL) performs laboratory
and field research to help EPA answer two fundamental
questions:
What are the health and/or ecological effects of
exposures to man-made stressors?
What is the likelihood that these effects will occur
under conditions of environmental exposure?
NHEERL's research contributes to improving three
steps in the risk assessment process:
In the hazard identification area, NHEERL works to
improve both assessment test methods and the
interpretation of data developed by these methods
(i.e., the relationship of effects measures to
health/ecological outcome).
In the dose-response assessment area, NHEERL
performs mechanistic research to address major
uncertainties, as well as research to develop and
improve extrapolation and multi-tier models.
In the risk characterization area, NHEERL provides
data on carefully selected priority problems.
National Exposure Research
Laboratory
The work of ORD's National Exposure Research
Laboratory (NERL) improves the scientific bases for
human and ecosystem exposure assessments that are
part of the risk assessment, risk management, and com-
pliance processes. Researchers from NERL conduct
methods, measurement, and modeling research to eval-
uate multimedia and multipathway exposures to a wide
variety of physical, chemical, and biological stressors.
They also apply their expertise to special problems, as
in providing technical consultation to the Program
Offices and Regions. The main components of NERL's
program are:
Source/Exposure Research focuses on investigating the
emissions of chemicals from sources. Although most of
ORD's research is in this category, NERL has unique
expertise and interests here for sources that are part of
the pathway of subsequent NERL exposure studies.
Chemical, Physical, and Biological Process Modeling
Research seeks to understand and predict chemical
Location of ORD's National Laboratories and Centers
Duluth, MN
Grosse lie, Ml
Cincinnati,
Narragansett, Rl
dison, NJ
Washington, DC
Las Vegas,
NV
Reseaixh Triangle
Park, NC
Ada, OK
is*1^,, -';,":"", ' ;;""'!
164
-------
and nonchemical stressor distributions. Major
programs include fate, transport, and transformation
research and advanced multimedia modeling.
Environmental Characterization Research focuses on
increasing understanding of stressors, receptors, and
the related portions of the environment (e.g., ambient
air, water, soil, biological quality, and a wide variety
of microenvironments). Major program activities
include landscape characterization, multimedia-
multipathway human exposure measurement, and
microbial identification and 'occurrence.
Exposure Assessment and Analysis Research is
conducted to estimate current and future exposures
to humans and ecosystems. Major programs focus on
developing total human exposure models and
landscape assessment models.
Exposure/Dose Research modeling provides the
bridge between the exposures that occur and the
dose to the target which ultimately can lead to
effects. To improve the bridging and obtain data
for the modeling, research collaborations with
NHEERL exist.
National Center for Environmental
Assessment
ORD's National Center for Environmental Assessment
(NCEA) serves as the national resource center for the
overall process of human health and ecological risk
assessments and the integration of hazard, dose-
response, and exposure data and models to produce risk
characterizations. Also, NCEA occupies a critical posi-
tion in ORD between (1) the researchers in other ORD
components who are generating new findings and data,
and (2) the regulators in the EPA Program Offices and
Regions who must make regulatory, enforcement, and
remedial action decisions. Thus, NCEA is uniquely posi-
tioned to influence ORD's future research agenda to
ensure that it addresses research needs identified by risk
assessments and to serve as consultants to the Programs
and Regions on the use of science in environmental
decision-making. In support of these functions, NCEA
focuses its work in three major areas:
Development of methodologies that reduce
uncertainties in current approaches:
Dose-response models and factors
Exposure models and factors
Probabilistic models
Community-based risk assessment
Assessments of contaminants and sites of national
significance
Guidance and support to risk assessors:
Databases
Risk assessment guidelines
Expert tools
Expert consultation and program support
Risk assessment training
Also, through the Risk Assessment Forum staff, NCEA is
responsible for coordinating and implementing the
health and ecological assessment activities of the Forum.
These activities include scientific and science policy
analysis of selected precedent-setting or controversial
risk assessment issues of Agency-wide interest, such as
risk assessment guidelines and development of cross-
Agency positions on important risk assessment issues.
National Risk Management
Research Laboratory
Research by ORD's National Risk Management Research
Laboratory (NRMRL) provides the scientific basis for
environmental risk management. Specifically, NRMRL
conducts research to reduce the uncertainty associated
with making and implementing risk management deci-
sions. This research focuses on two important areas:
Characterizing pollutant sources that require
management.
Identifying, developing, and evaluating tools and
technologies for prevention, control, restoration, and
remediation of environmental problems that are high
risk, high cost, or that lack effective management
alternatives.
NRMRL catalyzes the development and commercial
application of some of the more cost-effective risk
management alternatives through joint efforts with
public and private sector partners, and through pro-
grams, to verify the performance and cost of innovative
technologies.
NRMRL also provides technology transfer and technical
support to risk management stakeholders to encourage
improved risk management decision-making.
-------
Appendix B
National Center for Environmental
Research and Quality Assurance
ORD's National Center for Environmental Research
and Quality Assurance (NCERQA) represents a major
and renewed commitment by ORD to help EPA achieve
the highest possible quality of science. In particular,
NCERQA has made a major commitment to ensure the
high quality of ORD's extramural research by establish-
ing the Science to Achieve Results (STAR) program.
The primary purpose of the STAR program is to
include the foremost research scientists from universi-
ties and nonprofit centers around the country in the
ORD research program to meet the specific science
needs of the Agency. STAR consists of four compo-
nentsfocused Requests for Applications, an
Exploratory Research Grants Program, a Graduate
Fellowships Program, and targeted Environmental
Research Centersall of which address issues of
importance to EPA. All applications to the STAR pro-
gram must pass rigorous external peer review by
national experts before being considered for funding. A
portion of the STAR program is conducted jointly with
other federal agencies.
In addition to the STAR program, NCERQA manages
the Environmental Research Centers Program and the
Hazardous Substance Research Centers and provides
managerial oversight of EPA's quality assurance pro-
grams. Finally, NCERQA has a major Agency-wide
leadership and oversight role in peer review and quality
assurance activities.
Office of Resources Management
and Administration
The Office of Resources Management and Administration
(ORMA) ensures that ORD's management operations
promote sound science and efficient operations.
Geographically dispersed and encompassing a wide
array of scientific and engineering disciplines, ORD
poses significant management challenges. ORMA, in
partnership with ORD's Management Council, provides
the administrative and operational framework integrat-
ing ORD's Laboratory and Center activities into a cohe-
sive unit. Serving as the principal staff office to ORD's
Senior Resource Official, ORMA provides leadership in
budgeting, financial management, procurement, informa-
tion systems, organizational development, facility opera-
tions, and infrastructure. In this capacity, ORMA
independently evaluates ORD Laboratory and Center
management, bench-marking success against the contri-
bution of administrative processes toward the attainment
of ORD's strategic goals.
Office of Science Policy
ORD's Office of Science Policy (OSP) is a bridge
between ORD and its many constituents and is a key
link between ORD science and EPA policies and regula-
tion. OSP supports current Agency science needs by
participating in ongoing regulatory and science policy
activities of EPA's Laboratories, Program and Regional
Offices, and the Agency-wide EPA Science Policy
Council. OSP provides for future Agency science needs
by leading ORD and Agency research planning activi-
ties. Working closely with ORD's National Laboratories
and Centers and EPA's Program and Regional Offices,
OSP coordinates their input into ORD's research
agenda. Further, OSP provides scientific information,
counsel, and assistance in policy formulation and other
regulatory development activities. These functions all
support strategic planning of ORD's research program.
In addition, OSP administers the Science Policy Council,
a standing interoffice committee comprising senior EPA
science managers and chaired by EPA's Deputy
Administrator. Focusing on selected environmental
issues that go beyond program and regional bound-
aries, the Council develops information and policies to
guide EPA decision-makers in their use of scientific and
technical information.
1997 UPDATE TO-OHB's
-------
Appendix C
Management Structure
for Implementing
ORD's Strategic Plan
Successful implementation of ORD's Strategic Plan
requires coordinated input and involvement by all ORD
Laboratories, Centers, and Offices as well as EPA's
Program and Regional Offices. Several councils and
teams, illustrated and described below, provide mecha-
nisms for this participation. Collectively, these groups
involve all levels of ORD senior management from
ORD's Assistant Administrator through to ORD's
Assistant Laboratory Directors (see figure). The Research
Coordination Council and ORD's Research Coordination
Teams, described below, provide mechanisms for
Program and Regional Office involvement. One of the
important roles of the councils and teams is to assure
upward communication from the experts in ORD's
Laboratories and Centers.
Executive Council
ORD's Executive Council is chaired by ORD's Assistant
Administrator and consists of ORD's Deputy Assistant
Administrators for Science and Management and the
Directors of ORD's National Laboratories, Centers, and
Offices. The Executive Council serves as the primary
decision-making body for major planning and manage-
ment decisions. Based on input from the Management
and Science Councils, Research Coordination Council,
and Research Coordination Teams, the Executive
Council coordinates major policy and budget issues
across ORD, including consensus recommendations to
ORD's Assistant Administrator.
Management Council
ORD's Management Council is chaired by ORD's
Deputy Assistant Administrator for Management and
includes the Deputy Assistant Administrator for Science
as an ex officio member, the Director of ORD's Office of
Resources Management and Administration (who
serves as the Vice Chair), and the Deputy Directors for
Management of ORD's Laboratories and Centers.
ORD's Management Council provides senior manage-
ment leadership for developing and implementing
effective management policies, procedures, and sys-
tems. For example, the Management Council is leading
the development of ORD's Management Information
System, a management system to ensure that ORD's
resources are efficiently administered. The Management
Council also provides input, feedback, and guidance on
issues that significantly affect ORD's overall manage-
ment operations.
Science Council
ORD's Science Council is chaired by ORD's Deputy
Assistant Administrator for Science and includes the
Deputy Assistant Administrator for Management as an
ex officio member. Science Council members provide a
balance between health and ecological research. They
include the Associate Directors for Health and Ecology
of ORD's National Laboratories and Centers, the
Associate Director for Science of ORD's National Center
for Environmental Research and Quality Assurance, the
Associate Director for Science of ORD's Office of
Science Policy (OSP), and the Director of OSP.
The Science Council serves as the principal forum for
identifying, discussing, and providing advice and
recommendations to ORD's Assistant Administrator on
scientific and technical issues that significantly affect
ORD's overall scientific and technical operations. For
example, the Science Council had the lead role in
developing ORD's first Strategic Plan and will review all
research plans.
-------
Appendix C
:68
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Human Resources Council
In fiscal year 1996, ORD established a Human Resources
Council to provide guidance and direction to ORD man-
agement in implementing ORD's Human Resources
Program. Chaired by an ORD Laboratory Director as the
executive lead, the Council has 25 appointed employees
who represent each ORD Office, Laboratory, and Center,
with at least one representative from each geographical
unit. The representatives reflect ORD's diversity in terms
of job types, gender, ethnicity, and grade. In addition,
the Council includes representatives from EPA's Human
Resources Office; the labor unions who serve ORD
Offices, Laboratories, and Centers; and EPA's Office of
Civil Rights. ORD's Office of Resources Management
and Administration provides staff support and serves as
the executive secretary to the Council.
Research Coordination Council
The Research Coordination Council comprises the
Assistant Administrators from key Program Offices and
the EPA Regional Administrators, supported on a day-
to-day basis by their senior staff. The Research
Coordination Council serves as a focal point for integra-
tion between ORD and EPA's Program and Regional
Offices. The Council provides ORD with a cross-agency
perspective, participates in ORD's planning process,
and recommends potential topics for ORD's research
agenda and extramural grants program. The Council is
supported by a steering committee made up of senior
scientists from their respective EPA offices
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 multime-
dia), the teams assess ORD clients' needs, recommend
research priorities, monitor ORD progress toward meet-
ing these priorities, facilitate integration of intramural
and extramural research activities, and ensure communi-
cation of results to ORD clients. Each Research
Coordination Team includes a Team Leader from ORD's
Office of Science Policy, the Assistant Laboratory
Directors from ORD's Laboratories and Centers, a
program analyst from ORD's Office of Resources
Management and Administration, a representative from
ORD's National Center for Environmental Research and
Quality Assurance to provide input on ORD's grants
program, and representatives from EPA's Program and
Regional Offices. The Research Coordination Teams take
the lead in developing ORD's science research plans and
in organizing and conducting media-based program
reviews of ORD progress and outputs.
-------
-------
Appendix D
Relationship of Fiscal Year
1997 STAR Focused
Requests for Applications
(RFAs) to ORD's High-
Priority Research
-------
Appendix D
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-------
Appendix E
Relationship of Fiscal Year
1997 and 1998 Program
Enhancements to ORD's
High-Priority Research
-------
Appendix E
Fiscal Year 1997
Drinking Water Disinfection
and By-Products
Particulate Matter
Endocrine Disrupters
Community-Based
Environmental Protection
and Ecosystems Research
Benefit/Cost Research
Fiscal Year 1998
Particulate Matter and
Urban Toxics
Endocrine Disruptors
Global Change
Contaminated Sediments
Children's Health and Food
Quality Protection Act
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Advanced Measurement
Initiative
Environmental Information
for Communities
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