EPA/600/R-95/162
                         November 1995
                         External Review Draft
      egic Plan for the
Office of Research and
Development
                    Recycled/Recyclable
                    Punted on paper mat ontains at least 
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Notice
THIS DOCUMENT IS AN EXTERNAL REVIEW DRAFT.
It has not been formally released by the U.S. Environmental Protection Agency and does not constitute Agency
policy. It is being circulated for comment on its scientific and policy implications.

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       DRAFT—DO NOT QUOTE OR CITE
ORD's Strategic Plan
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC 20460
November 1995

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Foreword
I     am very pleased to present for external peer review this new Strategic Plan for environ-
    mental research at the U.S. Environmental Protection Agency's (EPA's) Office of Research
    and Development (ORD). In recent years, many important groups—including EPA's Science
    Advisory Board and blue ribbon panels convened by the National Academy of Public
Administration and the National Research Council—have made many excellent suggestions for
improving science at EPA. This plan ;" Corporates and builds on these ideas to provide a blueprint
fc"- _iidrnng a co^^e of strong, credible science at EPA into the next century.

This plan is the culmination of a number of strategic changes to institute a more effective, risk-
based research program at ORD. For example, we at ORD recently reorganized our nationwide
system of laboratories to conform to the fundamental  components of the widely used risk assess-
ment and risk management processes. With this Strategic Plan, we are instituting a new system
for determining research priorities based on risk assessment and risk management principles. We
will use this -. stem to sharpen the focus of our research bv directing our resources where we can
contribute most effectively to understanding and solving environmental problems, while also
fully supporting EPA in fulfilling its mandates.

By providing clear mechanisms and opportunities for stakeholder involvement, this plan pro-
motes greater partnership between ORD and its primary clients—EPA's program and regional
offices—as well as the external scientific community. And, by clearly delineating ORD's research
planning process, goals, and objectives, this plan is a tool our stakeholders can use to measure
our success in providing practical, credible, and timely information and tools for risk-based
decision-making.

We have designed this Strategic Plan to endure and yet be dynamic in the face of continually
advancing scientific knowledge and understanding. That is why we have selected time-tested
risk-based organizing and decision-making principles that transcend economic and political
changes. At the same time, we have designed the plan to be flexible, providing capacity for our
planning mechanisms to constructively adapt to changing EPA and national priorities over time.

We look forward to receiving external peer review comments on our new plan. We will modify
the plan as appropriate based on these comments and publish a final plan in 1996. After that
time, we will periodically revisit and, as necessary, modify this Strategic Plan to ensure the contin-
ued productivity of ORD's research and development efforts to meet EPA and national
environmental goals.

I firmly believe that this Strategic Plan, coupled with the other  strategic changes we have insti-
tuted at ORD (listed on the back inside cover), offer unparalleled opportunities for ORD to
improve the overall quality and relevancy of its research and development. I am confident that,
in the coming years, these changes will serve as essential catalysts for moving EPA into the high-
est echelon of leadership in environmental science.
Robert J. Huggett

Assistant Administrator
Office of Research and Development

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Contents
Introduction	1
ORD's Reinvention Around the Risk Paradigm	 1
ORD's Strategic Plan	 3

Part A: ORD's Research Strategy	7
ORD's Vision	 7
ORD's Mission	 7
ORD's Long-Term Goals and Objectives 	 8
ORD's Priority-Setting Process	 8
Risk Criteria for Setting ORD Research Priorities	11
Translating ORD's Strategic Plan Into a Research Program . . .	11
Measuring Success	13
Infrastructure and Human Resources	14

Part B: ORD's Long-Term Goals and Objectives	17
Goall 	17
Goal 2 	19
Goal3 	19
Goal 4 	21
GoalS 	22
Goal 6 	22

Appendix A: ORD's Near-Term Research Priorities	25

Appendix B: The ORD Organization	45

Appendix C: Management Structure for Implementing
ORD's  Strategic Plan	47

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                                                           Science is ant of the
                                                           the nation can make for the
                                                           science
                                                           environmental
                                                           better understanding of
                                                                to people and ec&$ystet%$f
                                                           target the hazards
                                                               , anticipate mm
                                                           fajote they reach & €t%ie&H$@i
                                                           develop strategies
                                                           md the world's,
     In recent years, a convergence of thinking has
     occurred about science at the U.S. Environ-
     mental Protection Agency (EPA). The Agency's
     own Science Advisory Board (an independent
group of engineering and science advisors to EPA)
and expert blue-ribbon panels convened by the
National Academv of Sciences (NAS)  and the Na-
                                       •j
tional Academy of Public Administration  all have
emphasized the importance of science at EPA and
made many recommendations concerning its role
and direction.
As these groups affirmed, science provides the
foundation for credible environmental
decision-making. It is vital to achieving a healthy
population,  thriving environment, and robust
economy. Only  through adequate knowledge about
the risks to human health and ecosystems, and
innovative solutions to prevent pollution and
reduce risk,  can we continue to enjoy a high quality
of life. In July 1994, EPA published a Five-Year
Strategic Ptef' that adopts strong science and
credible data as one of seven guiding principles to
fulfill the Agency's mission to protect human health
and environmental quality. While all of EPA uses
science for policy and regulatory decision-making,
and various EPA offices perform research, the
responsibility for leadership in science at EPA and
for the bulk of EPA's research and development
work resides in EPA's Office of Research and
Development (ORD).

ORD's  Reinvention Around the
Risk Paradigm
In the past two years, we at ORD have substantial
changed our organization and operation so that u c
* Interim Report of the Committee on Research and Peer Rer.v . .
 National Academy of Sciences Board on Environmental ~-r
 and Toxicology. 1995. National Academy Press.
" Sitting Priorities, Getting Results. A New Direction for EPA
 National Academy of Public Administration. 1995.
 Washington, DC.
 The \'eu< Generation of Environmental Protection. A Sum"'.:"'-
 EP.'Vs Free-Year Strategic Plan. U.S. Environmental Ptvtr-. •
 Agencv (EPA). 1994. EPA200-2-94-001. Washington. D<
                                      STRATEGIC  PIAM FOR ORD

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Introduction
can strengthen EPA's science base and improve the
Agency's and our nation's ability to effectively
respond to the complex environmental challenges of
the future. These changes represent a significant
departure from the past. They are based on a set of
strategic principles we have developed (Table 1) that
draw upon the many recommendations we have
received from outside groups in recent years. The
most important of these principles is the explicit use
of the risk paradigm to shape and focus our
organizational structure and research agenda.
The risk assessment paradigm has been defined
many times over the years, most notably in 1983 by
the NAS (Figure I), which consolidated and gave
context to terms that had been defined in different
ways up to that point.  Risk assessment is the process
that scientists use to understand and evaluate the
magnitude and probability of risk posed to human
health and ecosystems by environmental stressors,
such as pollution or habitat loss or change. The
resulting risk characterization, together with other
public health, statutory, legal, social, economic,
political, and technical factors, provides the critical
input for deciding whether and how to manage the
risk associated with a particular stressor. Risk
management options may include both regulatory
programs and voluntary activities (e.g., recycling) to
reduce or eliminate production of the stressor.
The risk assessment process is one component of the
overall process of risk management. The risk
management process begins when a potential new
risk comes to light and authorities decide or are
mandated to respond to concern about the risk. It
involves risk assessment as well as a series of other
scientific and technical activities, illustrated in
Figure 2, to provide the scientific and technical data
for making and implementing a risk management
decision. The risk management process ends when
the selected risk management option(s) is
implemented and  the resulting environmental
and/or public health improvements are monitored.
Figure 2 expands upon the "Risk Management
Options" portion of the original NAS paradigm to
show the many scientific and technical activities, in
addition to risk assessment, that are essential to risk
 Table 1.
ORD's Strategic Principles
     Focus research and development on the greatest
     risks to people and the environment, taking into
     account their potential severity, magnitude, and
     uncertainty.
     Focus research on reducing uncertainty in risk
     assessment and on cost-effective approaches for
     preventing and managing risn
     Balance human health and ecological research.
     Give priority to maintaining the strong and viable
     scientific and engineering core capabilities that
     allow us to conduct an intramural research and
     technical support program in areas of highest
     risk and greatest importance to the Agency.
     Through an innovative and effective human
     resources development program, nurture and
     support the development of outstanding scien-
     tists and engineers at EPA.
     Take advantage of the creativity of the nation's
     best research institutions by increasing competi-
     tively awarded  research grants to further EPA's
     critical environmental research mission.
     Ensure the quality of the science that underlies
     our risk assessment and risk reduction efforts by
     requiring the very highest level of independent
     peer review and quality assurance for all our
     science  products and programs.
     Provide the infrastructure required for ORD to
     achieve and maintain an outstanding research
     and development program in environmental
     science.
4The NAS paradigm was developed specifically to define risk
assessment and risk management for human health. While ORD
recognizes there are distinctions for ecological risk assessment,
the general principles set forth in the MAS paradigm are still
useful as an organizing focus for ORD's strategic thinking.
management. These include characterizing the
sources of environmental problems; identifying risk
management options and evaluating their performance,
cost, and effectiveness; and monitoring improvements
in environmental quality and public health that result
from risk management activities. ORD is involved in
all the areas depicted in Figure 2. In this way, ORD not
only identifies and characterizes environmental
problems but also helps to find and implement
efficient, cost-effective solutions to these problem-.
The first major step in ORD's reinvention was to
reorganize ORD so that its new structure mirror-- the
risk paradigm shown in Figure 1. This new structure
is described in Appendix B. ORD's new Strategic
Plan is the second major step.
                                       STRATEGIC  PLAN FOR  ORD

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                                                                                               Introduction
 Figure 1.
The Risk Assessment/Risk Management Paradigm
                             Risk Assessment    Risk Management
                                                    Statutory and Legal
                                                      Considerations
        Hazard
      Identification
Dose-Response
  Assessment
                    •  KUDIIC Heaitn \  c
                      Considerations \  '-actors

                Risk   I      V .           ,
           Characterization-*Rlsk Management
                                Decision
                             r
                          Risk
   Exoosure  \     / Management,
   exposure   \     t    Opions
  Assessment   \ y
                           Political
                        Considerations
                     /
                                                     Public Health \ cSocial
                                                               s\ F
                                                Economic t
                                                 Factors .
                                                                              "Adapted from:
                                                                              Risk Assessment in the
                                                                              Federal Government:
                                                                              Managing the Process.
                                                                              National Academy of
                                                                              Sciences. 1983.
                                                                              Science and Judgement
                                                                              in Risk Assessment
                                                                              National Research
                                                                              Council. 1994.
       The risk assessment process consists of four steps:
       •  During hazard identification, scientists describe the adverse effects (e.g., short-term illness, cancer, reproduc-
          tive effects) that might occur due to exposure to the environmental stressor of concern. To identify potential
          hazards, scientists use the results of experimental studies on test organisms, reports about accidental expo-
          sure, and epidemiologic research.
       •  During dose-response assessment, scientists determine the toxicity or potency of a stressor. The dose-
          response assessment describes the quantitative relationship between the amount of exposure to a stressor
          and the extent of injury or disease.
       •  During exposure assessment, scientists describe the nature and size of the population(s) or ecosystem(s)
          exposed to a stressor and the magnitude and duration of exposure. Exposure  assessment includes a
          description of the pathways (e.g., air, food, water) by which the stressor travels through the environment;
          the changes that  a stressor undergoes en route; the environmental concentrations of the  stressor relative to
          time, distance, and direction from its source; potential routes of exposure (oral, dermal, or inhalation); and
          the distribution of sensitive subgroups, such as pregnant women and children.
       •  During risk characterization, scientists use the data collected in the three previous steps to predict the
          effects of human or ecological exposure to the stressor of concern. They estimate the likelihood that a
          population will experience any of the adverse effects associated with the stressor, under known  or expected
          conditions of exposure. This estimate can be qualitative (e.g., high or low probability) or quantitative (e.g.,
          one in a million probability of occurrence).
ORD's Strategic  Plan

ORD's Strategic Plan, described in this document
and illustrated in Figure 3, is ORD's blueprint for
establishing a risk-based research program:
•  Part A of the plan defines new strategic direc-
   tions (including ORD's vision, mission, and
   goals) for ORD research, establishes a risk-based
   process that we will use to determine our future
   research priorities, describes how we translate
                                              this Strategic Plan into a specific research pro-
                                              gram (including research plans, operating plan-
                                              and laboratory implementation plans), present-
                                              approaches to measuring success, and descntv-
                                              ORD's commitment to the infrastructure and
                                              human resources essential to implementing  th. •
                                              Strategic Plan.
                                              Part B expands on ORD's goals and lists tho >;•«
                                              cific research objectives and activities ORD u <.'.'.
                                              pursue to achieve its goals.
                                         STRATEGIC PLAN  FOR  ORD

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Introduction
 Figure 2.
The Scientific and Technical Contributions to Risk Management
                                          Initiating Event or
                                          Public Policy Mandate
                         Risk Management
                            . _    Dose-Response
                   Risk Assessment    Assessment
                                               Characterize the Problem
                                                         Define Risk Management
                                                         Objectives
                               Hazard          Risk
                             Identification    Characterization
                                                           Identify and Evaluate
                                                           Risk Management Options
                                      Exposure
                                     Assessment
                                                          Risk Management Decision
                                    Develop Compliance
                               Assurance Models and Methods
                                          Implement Option(s)
                                    Develop Measures of
                                     Environmental and
                                       Public Health
                                       Improvement
                                      Monitor Environmental
                                      and Public Health
                                      Improvement
 Public Health
 Considerations
> Statutory and Legal
 Considerations
1 Social Factors
1 Economic Factors
• Political Considerations
                                                                             Reduced Environmental
                                                                                    and/or
                                                                                Public Health Risk
    Scientific and technical activities contribute to every stage of the risk management process. Environmental risk
    management is initiated when a potential new environmental risk comes to light (such as an unusually high disease
    rate in a particular population) and authorities decide or are mandated to investigate it
    The first step is to characterize the problem. This involves such activities as determining which stressor(s) (e.g., pol-
    lutants, habitat loss) is causing the problem, characterizing the sources of the stressor(s), how these stressors reach
    target populations, and which human or ecological populations are affected. Once the problem has been sufficiently
    characterized, the risk assessment process can begin.
    If sufficient information is available at this stage, scientists and engineers can also begin to define risk management
    objectives (i.e., the degree to which the risk should be managed or reduced) and identify risk management options
    that can meet the objectives. Frequently, however, these steps must await further information, provided by the risk
    assessment, on which populations are at risk and how great that risk is. Once potential options have  been  identi-
    fied, scientists and engineers evaluate the options to determine their performance and cost. Risk management
    options may include, for example, pollution control technologies, banning or controlling the  use of certain chemi-
    cals, cleaning up or preventing access to contaminated areas, implementing educational programs to encourage
    voluntary behavior changes on the part of the public or industry, and redesigning industrial processes to reduce or
    eliminate toxic waste production.
    The resulting information on the feasibility of potential risk management options, together with the risk charac-
    terization (and public health, statutory, legal, social, economic, and political factors), is used to make a risk
    management decision. Typically, this will involve selecting one or more of the potential risk management options
    and designing a regulatory and/or nonregulatory strategy for implementing the chosen option(s).
    Once a risk management strategy has been selected, scientists and engineers then develop compliance assurance
    models and methods (if the strategy is regulatory) and measures of environmental and public health improvement
    to monitor the success of the strategy in reducing risk to humans or ecosystems. Once the selected option(s) is im-
    plemented,  scientists and engineers monitor the environmental and public health improvement. Monitoring data
    provide feedback to the risk management decision-makers about whether the risk management strategy is achiev-
    ing the desired goals. Decision-makers may then amend the strategy, as necessary, based  on these results. The final
    outcome of a successful risk management process is reduced environmental and/or public health risk.
                                          STKATE6IC PlAN  FOK OR0

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                                                                                     Introduction
             ORD's Strategic Plan
                          Vision
                          Mission
                           1
                          Goals
                        Long-Term
                        Objectives
                           1
                        Activities To
                         Meet the
                        Objectives
Appendix A describes the near-term research
priorities that ORD has developed by applying the
priority-setting process set forth in Part A to ORD's
long-term objectives and activities.
Appendix C describes ORD's management struc-
ture for implementing the Strategic Plan.
Again, this Strategic Plan is designed to endure
while being dynamic. It includes sufficient flexibility
to constructively adapt the planning mechanisms to
changing EPA and national priorities over time. We
will periodically revisit and, as necessary, modify
the plan to ensure the continued productivity of
ORD's research and development efforts to meet
EPA and national environmental goals.
                                   STRATEGIC PLAN FOB ORD

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        BLANK

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   Part A
   Research
  X1"""    . ' •>.-.• •   -.• v*.fv. . ''    ••'••    i>. .
   Strategy
         ORD's commitment to develop a risk-
         based research agenda has required us
         to rethink our vision, mission, and goals
         and to develop a risk-based process for
selecting and ranking those research topics of pri-
mary importance to ORD and EPA.
ORD's vision and mission for the future arise from a
consideration of the importance of science at EPA
and in the broader context of our nation's
environmental research agenda, and of ORD's key
role in environmental science (Table 2), Our vision,
described below, represents the overall level of
achievement that we will strive for in all our
research and development work. Our mission
statement, described below, defines the broad areas
of research and development where we believe
ORD can and must make important contributions to
EPA's mission and mandates and to our nation's
overall environmental research agenda.
ORD's Vision
ORD's vision is that:
ORD will provide the highest quality scientific
and engineering knowledge and tools to serve as
the basis for sound environmental decisions,

ORD's Mission
ORD's mission is to:
• Perform research and development to identify,
  understand, and solve current and future
  environmental problems.
• Interpret and integrate scientific information to
  help organizations at all levels make better deci-
  sions about improving the environment.
• Provide national leadership in addressing emerg-
  ing environmental issues and in advancing the
  science and technology of risk assessment and
  risk management.
                                STRATEGIC PIAN FOR OK0

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ORD's Research  Strategy
 Table 2.
ORD's Key Role
   Public and private sector institutions have long
   been significant contributors to our nation's environ-
   mental and human health research agenda. EPA's
   Office of Research and Development, however, is
   unique among scientific institutions in this country
   in combining research, analysis, and the integration
   of scientific information across the full spectrum of
   health and ecological issues and across both risk
   assessment and risk management. This broad
   scope has resulted in scientific and engineering
   expertise, physical facilities, and equipment that
   permit and encourage integrated multimedia and
   multidisciplinary research on environmental issues.
   As part of a regulatory Agency that establishes national
   priorities and sets national standards, ORD research
   is conducted to protect human  and ecosystem
   health in a cost-effective manner and to provide a
   firm scientific and technical foundation for environ-
   mental decisions and standards.
ORD's  Long-Term Goals and
Objectives
ORD's three mission areas translate into six
long-term, overarching goals that we will strive to
meet in order to fulfill our mission (Table 3). Part B
of this plan describes  these goals in detail and
breaks each goal down into a series of specific
research objectives and activities that ORD will
pursue to achieve its goals.
ORD's Priority-Setting Process
The objectives and activities listed in Part B of this
plan provide detail about how ORD will go about
meeting its goals. Each objective and activity still
represents a relatively broad research area, however.
ORD, therefore, has developed a priority-setting
process that we will use to identify specific research
topics within the objective and  activity areas  that are
of primary importance to our vision, mission, and
goals. ORD's new priority-setting process, depicted
in Figure 4, involves the following steps:
• First, we seek input from all  parts of EPA.
  Research Coordination Teams consisting of senior
  representatives from ORD's new National Labora-
  tories and Centers, the EPA program offices, the
  Research Coordination Council (see Appendix C),
  and EPA's ten regional offices identify the  most
  important and relevant areas for our research
  efforts. (As more environmental protection is
  moved to state and local governments, their
  research needs will also be considered at this
  stage.) We also work with EPA's Science Advisory
  Board, the National Research Council, and the
  private sector early in the planning process to
  obtain recommendations from the external
  scientific community regarding the major
  scientific directions and priorities for our research
  program. Finally, we consider the status and
  results of our recent research activities. Based on
  this information, ORD identifies potential
  research topics.
 Table 3.
 Mission Area
ORD's Long-Term Goals
                               Goals
 Perform research and development to identify,
 understand, and solve current and future
 environmental problems.
                               To develop scientifically sound approaches to assessing and
                               characterizing risks to human health and the environment.

                               To integrate human health and ecological assessment methods int
                               comprehensive multimedia assessment methodology.
                               To provide common sense and cost-effective approaches for
                               preventing and managing risks.
 Interpret and integrate scientific information to help
 organizations at all levels make better decisions
 about improving the environment.
                               To provide credible, state-of-the-art risk assessments, methods,
                               models, and guidance.

                               To provide reliable scientific, engineering, and risk assessment, n>k
                               management information to private and public stakeholders.
 Provide national leadership in addressing emerging
 environmental issues and in advancing the science
 and technology of risk assessment and risk
 management.
                               To provide national leadership and encourage others to participate
                               identifying emerging environmental issues, characterizing the r;-N-
                               associated with these issues, and developing ways of preventing  r
                               reducing these risks.
                                       STRATEGIC PLAN  FOR O8D

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                                                                           ORD's  Research  Strategy
         Setting Research Priorities
External Scientific Community Input:
    • EPA Science Advisory Board
     • National Research Council
          • Private Sector
                       ORD National Laboratories and Centers
                             • EPA Program Offices
                         • Research Coordination Council
                              • EPA Regional Offices
                            Identify Research Topics
    Reject for    No
      ORD
     Funding2
                  Apply Evaluation Criteria:
               Human Health/Ecological Health
                    • Risk Management
                    •  Methods/Models
                           I
                 Prioritized Research Topics
  Reject for     No
    ORD
   Funding2
    Can
 ORD Make
 a Significant
Contribution?
Determine Research Needs:
         •  Effects
        • Exposure
  • Risk Characterization
    •  Risk Management
                                                     Conduct Research
                                            (In-house, Grant, Coop, Contract, etc.)
                                                           i
                                                     Research Products
 1ln other words, ORD has no discretion to re|ect or delay this research.
 2EPA program offices and regions may soil choose to fund, using ORD labs, grants, contracts, etc.. or a research source outside of ORD
                                   STRATEGIC  PLAN  FOR  ORJ>

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ORD's Research Strategy
   We then separate the pool of potential topics into
   two categories:
   •  Those that are clearly mandated (i.e., ORD has
      no discretion to reject or delay the research).
   •  All other topics.
   For all other topics, we narrow the pool by retain-
   ing only those that are within ORD's mission and
   goals.
   •  We then apply a series of human health, ecologi-
      cal, and risk management criteria (Figure 5) to
      compare the mission-related topics according to
      their potential to support effective risk reduc-
      tion. We also apply criteria (Figure 5) to consider
      whether the research would develop broadly
      applicable methods and models needed by EPA
      programs. Through this screening process, we
      set priorities among the research topics.
                                              •  We then further narrow this pool of topics by
                                                 retaining only those areas where ORD can
                                                 make a significant contribution to environ-
                                                 mental science.
                                             For these remaining topics where ORD can make a
                                             significant contribution, as well as all nondiscretion-
                                             ary topics, we then define specific research and
                                             development projects by considering each topic
                                             in totality.  For each topic, we determine what the
                                             research needs are within each component of the
                                             risk paradigm: effects (hazard identification and
                                             dose-response assessment), exposure assessment,
                                             risk characterization, and risk management. At
                                             this stage, we give priority to research that will
                                             make the greatest contribution to reducing the un-
                                             certainty associated with risk characterization.
                                             We then develop research, operating, and labora-
                                             tory implementation plans (see below) for each
 Figure 5.
ORD Criteria for Evaluating and Ranking Potential Research Topics
    Human Health and
    Ecological Health Criteria
       What type of effect would the research
       investigate/mitigate and how severely
       might this effect impact humans or
       ecosystems?
       Over what time scale might this effect
       occur?
       How easily can the effect be reversed,
       and will it be passed on to future
       generations?
       What level of human or ecological
       organization  would be impacted by the
       effect?
     1  On what geographic scale might this
       effect impact humans or ecosystems?
                                                 Methods/Models Criteria
                                                  •  How broadly applicable is the proposed
                                                    method or model expected to be?
                                                  •  To what extent will the proposed method or
                                                    model facilitate or improve risk assessment or
                                                    risk management?
                                                    How large is the anticipated user community
                                                    for the proposed method or model?
                                                      Management Criteria
                                                    Have the problem's source(s) and risk been
                                                    characterized sufficiently to develop risk
                                                    management options?
                                                    Do risk management options (political, legal,
                                                    socioeconomic, or technical) currently
                                                    exist?  If so, are they acceptable to
                                                    stakeholders, implementable, reliable, and cost-
                                                    effective?
                                                    Could new or improved technical solutions
                                                    prevent or mitigate the risk efficiently, cost-
                                                    effectively, and in a manner acceptable to
                                                    stakeholders?
                                                    Are other research organizations (e.g.,
                                                    agencies, industry) currently investigating/
                                                    developing these solutions or interested in
                                                    working in partnership with  ORD on these
                                                    solutions?
  10
                       STRATE6IC  PlAN FOR ORD

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                                                                     ORD's  Research Strategy
  project and conduct the research via a variety of
  mechanisms: in-house research, or external
  research via grants, cooperative agreements, or
  contracts. The research products and results
  provide input into future planning efforts.
This approach to strategic planning clearly indicates
the  following areas where ORD will not continue to
allocate resources:
• Conduct of routine quality assurance programs in
  the program offices and regions.
• Support for routine environmental monitoring.
• Exposure or effects research in areas of low risk.
• Risk reduction research in areas of low risk.
Our new approach to strategic planning has many
strengths. It encompasses both scientific and
stakeholder priorities. It ensures that ORD will
continue to fully support EPA in fulfilling its
mandates. It focuses our resources where we can
make the most significant contributions. And, it
enables ORD to generate practical, credible
information and tools for risk-based
decision-making.

Risk Criteria for  Setting ORD
Research Priorities

A key component of ORD's new planning process is
the  criteria we will use to set priorities  among
non-mandate-related research topics. Three sets of
criteria are used: human and ecological health
criteria, risk management criteria, and methods/
models criteria (Figure 5). These criteria, described
below, are not set in concrete, nor are they
universally applicable to all research areas. They
likely will evolve with use and experience.
Additional or alternative criteria may be used in
some cases as appropriate.

Human and  Ecological Health Criteria

ORD's human and ecological health criteria are
based on five broad categories outlined in the EPA
Science Advisory Board's 1990 report, Reducing Risk:
Setting Priorities and Strategies for Environmental
Protection:  the severity of response, the time scale,
permanence, and extent of the response, and the
level of organization. Table 4 lists the criteria that
ORD has developed for each of these five categories.
Risk Management Criteria

Risk management criteria are applied to those
research topics that concern risk management.
These criteria, Listed in Figure 5, are designed to give
priority to research that will produce the most
effective and useful risk management options.
The criteria consider whether sufficient risk
characterization information is available to set
meaningful objectives for the risk management
research; the availability, acceptability to
stakeholders, reliability, and cost-effectiveness of
existing options; the potential benefits of the
proposed research; and whether other research
organizations are already conducting or interested
in this type of research.

Methods/Models Criteria

The methods/models criteria are applied to
research concerning the development or application
of methods or models for gathering or analyzing
risk-related data. These criteria give priority to
research that will likely produce the most useful
results. The criteria consider  how broadly the
method or model would be used, the size of the
anticipated user community, and the degree  to
which the method or model would improve  risk
assessment or risk management.

translating ORD's Strategic  Plan
Into a Research  Program

The steps involved in translating ORD's Strategic
Plan into a research program are illustrated in
Figure 6. Each year, we will use this priority-setting
process and the criteria described above to identify
high-priority research topics that will help us
achieve ORD's goals and objectives. (Appendix A
lists ORD's current high-priority topics.) Many
topics will remain a high priority for several years.
Each year, we will examine the previous year's
topics to add new topics as appropriate and remove
previous topics for which sufficient research has
been conducted.
Once  we have identified our high-priority topics. v\ o
develop and implement a research program based
on these topics. This involves three steps:
                                     STRATEGIC Ft AN FOR ORB
                                           11

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ORD's Research  Strategy
 Table 4.
ORD's Human Health and Ecological Health Criteria
                                    Ecological Health1
                                                               Human Health1
Severity of Response
• Mortality
• Morbidity
• Premature mortality
• Morbidity
• Reproductive effects
Time Scale of Response
                    • Immediate effects
             • Effects that will occur in the future
             • Acute effects
           • Subchronic effects
• Chronic effects or effects with a long latency
                 period
Permanence of Response
                    • Irreversible effects
          • Effects that can be reversed only by human
                       intervention
          1 Temporary effects that reverse naturally over
                        a long time
          Temporary effects that reverse naturally over
                       a short time
        • Transgenerational effects
        Nontransgenerational effects
Level of Organization
          • Effects on an entire ecosystem/community
                 • Effects on a single species
         • Effects on a population within a single species
          • Effects on individual animals or organisms
     • Effects on the general population
       • Effects on a subpopulation
         • Effects on individuals
Extent of Response
                      • Global effects
                   • Ecoregional effects
                  Effects on several localities
                     • Localized effects
             • Global effects
          • International effects
            • National effects
       • Effects on several localities
            • Localized effects
1 Items are listed in descending order of priority.
 An ecoregion is a geographic area that has similar topography, climate, and biota across the entire area.
•  Development of research plans. For each selected
   research topic, Research Coordination Teams com-
   posed of ORD scientists and representatives of
   EPA's program offices and regions (see Appendix
   C) develop research plans that:
   • Lay out the major research components and
     directions we will pursue over the next few
     years.
   • Describe how these components fit into the
     risk assessment/risk management paradigm.
   • Delineate the major outputs to be produced
     over the next three years.
These plans make clear to our clients both the
rationale for and the intended products of the
research and thus are important tools for measuring
accountability. They enable ORD to clearly track its
progress toward achieving its goals, as required by
the Government Performance and Results Act of
1993.
                                         • Development of operating plans. We then inte-
                                            grate the research plans with budgetary decisions
                                            in order to allocate resources to the selected
                                            research topics by laboratory program and
                                            research component. This helps ensure that our
                                            priority-setting decisions (guided by science) also
                                            reflect budgetary realities.
                                         • Development of laboratory implementation
                                            plans. Finally, based on the research plans and
                                            budgetary decisions, ORD's laboratories and cen-
                                            ters develop detailed plans for implementing
                                            each area of research under their purview. These
                                            laboratory implementation plans provide a blue-
                                            print for laboratory and center work and form
                                            the basis for managerial oversight and guidance
                                         We involve ORD's main research clients—the EPA
                                         program and regional offices—in all three step> to
                                         ensure  that final plans clearly include the reseat h
                                         products that our clients need to fulfill their
                                         responsibilities.
  12
                       STRATESIC  PLAN FOR  ORD

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                                                                      ORD's  Research  Strategy
 Figure 6.        Translating ORD's Strategic Plan Into a Research Program

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Priority-
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^ Near-Term
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*•*
                          EPA Program Office Involvement
                          EPA Regional Office Involvement
                          External Scientific Community Involvement
                                                                          Plans
Measuring Success
The success of a research organization can be
measured in several ways: by the number of articles
published in prestigious scientific journals, by the
number of times that articles written by the
organization's scientists are cited in other journal
articles, and so on. For a mission-oriented
organization like ORD, other measures, such as the
extent that we help and support EPA in meeting its
goals, are equally important.
In measuring the success of this Strategic Plan, the
quality of the work that ORD is doing, and the
usefulness of the products that result from ORD
research, we use the following measures of success:
Significance: Is ORD working on the right issues?
This is a measure that the ORD program offices
and regions and the broad scientific community
can help us judge. For our research, developmL'nt
and support efforts to be useful, we must work
on the most important environmental issuer and
target areas for research that will significantly
improve risk assessment and/or risk management
in the Agency and elsewhere. Peer review tn
scientists in the external scientific commumt\
will assist us in judging significance.
Relevance: Is  ORD providing data that the
Agency can use? This question can best be
answered by the rest of the Agency and is K -•
judged by the degree to which ORD's contr :  .
tions support Agency decisions.
                                     STRATEGIC PLAN FOR  ORD

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ORD's  Research Strategy
•  Credibility: Is ORD doing research of the highest
   quality? ORD's credibility can best be judged by
   the external scientific community through such
   mechanisms as peer review of ORD products,
   reviews of programs at the ORD laboratories,
   peer-reviewed journal articles, scientific citations,
   and external recognition of both ORD and its
   people.
•  Timeliness: Is ORD meeting EPA's expert consult-
   ation and assessment needs in a timely manner,
   providing research products according to sched-
   ule, and responding to long-term issues with
   adequate forethought and preparation? The first
   part of this question can best be answered by
   EPA's program offices and regions as they deter-
   mine whether ORD consultations and assessments
   are being provided in time to be optimally useful
   for Agency decisions. The  middle part of this ques-
   tion can be answered by EPA's program offices
   and regions through annual program reviews
   and other activities. The final aspect of timeliness
   is more subjective and therefore more difficult to
   assess. ORD has accepted the challenge of antici-
   pating important environmental issues that are
   just emerging and may not become critical prob-
   lems until well into the next century. The U.S.
   public is the ultimate judge of how successful
   ORD has been in this effort. ORD will strive to
   routinely gather the public's view on this issue.
ORD has implemented or plans to implement
several mechanisms for evaluating its performance,
communicating progress and results, and measuring
success. These include:
•  Annual research program reviews, jointly organ-
   ized by ORD's Research Coordination Teams and
   EPA's program and regional offices, that will pre-
   sent to EPA senior managers the entire EPA
   research portfolio in a given area. These joint re-
   views will focus primarily on the status and
   accomplishments of the ORD research program
   to ensure that ORD's research continues to meet
   ORD and client objectives. They will also, how-
   ever, present the ongoing research being
   conducted by the program offices and regions so
   that the total research agenda can be viewed. The
   objectives of these reviews are to evaluate pro-
   gress in completing planned research projects, to
   track and evaluate research results, and to gener-
   ally obtain feedback on ORD's work and any
   adjustments that may be  needed to help us  better
   meet our clients' needs. These reviews supple-
                    ment, rather than supplant, external peer reviews
                    (see below).
                  • Annual ORD review of its research plans. ORD
                    examines its research plans annually and adjusts
                    them if warranted by our research results, by
                    changes in EPA or national priorities, or by emerg-
                    ing issues and concerns.
                  • External peer reviews of ORD research plans and
                    products and overall progress in meeting our
                    goals and objectives. These reviews are con-
                    ducted at each  step in our research planning and
                    implementation process.
                  • Annual science workshops designed to  make
                    the progress and results of all ORD research (in-
                    cluding the external grants program) accessible to
                    EPA's program offices and regions.
                  • A data tracking system, part of ORD's Manage-
                    ment Information System, which tracks resources
                    and progress.
                  Through these mechanisms, ORD will strive to
                  develop  and conduct the most responsive,
                  scientifically justifiable research program possible
                  within the constraints of our available resources.

                  Infrastructure and Human
                  Resources

                  The success of ORD's Strategic Plan depends on an
                  adequately funded and well-managed infrastructure.
                  To effectively implement our Strategic Plan, we must
                  provide our work  force with:
                  • Safe, environmentally sound, well-maintained,
                    state-of-the-art laboratories, equipment, and
                    supplies.
                  • Environmental data management systems and ad-
                    vanced communications systems.
                  • A host of other management, administrative, and
                    systems support.
                  ORD's strategic principles (Table 1) highlight the
                  critical role of infrastructure "to achieve and
                  maintain an outstanding research and development
                  program in environmental science."
                  ORD will work, within the limits of our available
                  resources, to maintain a sound, sufficient, and
                  productive infrastructure by:
                  • Integrating planning for meeting infrastructun
                    requirements into the research planning pnv <•--
                  • Focusing resources on those infrastructure
                    ponents that are most important for achie\ ::.;•••
  14
STRATEGIC PIAN FOR  Q80

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                                                                      ORD's  Research Strategy
   goals and objectives set forth in ORD's Strategic
   Plan.
•  Managing all infrastructure components to obtain
   maximum benefit and performance.
By far the most important component of ORD's
infrastructure is our work force of scientists,
engineers, managers, and support staff. ORD can
achieve its vision of providing the highest quality
scientific and engineering knowledge for
environmental decisions only if we can attract,
nurture, and support a world class work force.
ORD's strategic principles (Table 1) emphasize the
importance of nurturing and supporting "the
development of outstanding scientists and
engineers at EPA."
The cutting edge nature of research and
development at ORD places great demands on our
scientists and engineers to continually upgrade
their skills and knowledge in response to and
anticipation of new scientific  developments.
Therefore, our work force support must include an
effective human resources program that encourages
an increasingly diverse cadre of employees to
continuously learn new skills and a career
development program that promotes career
development in directions congruent with ORD's
mission. In addition, we must anticipate work force
needs and recruit new culturally diverse employees
with the appropriate skills and experience to
support ORD's mission.
ORD's recent reorganization has introduced a new
organizational structure (see Appendix B) and
staffing pattern into ORD. For  example, our new
organization eliminates mid-level management
positions and broadens the control span of
supervisors. This flattened organizational structure
will require a team-based matrix management
approach to replace our former, more hierarchical
approach to management.
ORD is addressing these needs and challenges by
taking several steps to ensure a productive, world
class work force. These include:
•  Developing and implementing innovative, effec-
   tive management approaches to accomplishing
   ORD's mission, such as matrix management and
   team-based operation.
•  Supporting senior managers, via training and
   other mechanisms, in implementing these new
   management approaches.
•  Developing tools  to accurately assess current job
   effectiveness and  determine development needs.
•  Providing training and development programs to
   advance the knowledge and skills of ORD's staff.
•  Providing effective career management support
   with an emphasis on self-directed career plan-
   ning (e.g., through mentoring, in-placement and
   out-placement services, and career counseling
   and development services).
•  Creating opportunities for professional and
   personal growth.
•  Taking measures to maintain and enhance the
   scientific competence and quality of ORD staff.
•  Building and maintaining solid linkages to the
   external scientific community, with an emphasis
   on scientist-to-scientist interactions (e.g., through
   ORD-sponsored scientific workshops).
•  Providing opportunities for ORD scientists and
   engineers to contribute, as respected members of
   the scientific community and leaders in the envi-
   ronmental sciences, to the general scientific
   literature and community (e.g., through publica-
   tion of scientific articles in peer-reviewed journals
   and participation  in national and international
   scientific conferences).
As we implement our Strategic Plan, we will
monitor work force needs and provide other
programs, mechanisms, and support as necessarv
to cultivate a world class work force of scientists,
engineers, managers, and support staff and to
ensure that they have the tools and equipment they
will need to achieve  ORD's vision and goals.
                                     STRATEGIC PtAN  FOR ORD

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        To help focus selection of research priorities,
        ORD has defined a set of long-term research
        objectives within each of the six broad ORD
        goal areas listed in Table 3. Variations in the
specificity of the objectives listed below reflect differ-
ences in the maturity and complexity of the science
underlying each objective. Many of the objectives
include a set of activities (listed under the objective)
that ORD intends to undertake to achieve the objective
given sufficient resources. This detail allows ORD's in-
ternal and external stakeholders to understand
specifically how ORD plans to accomplish its objec-
tives.
Designed to be robust and stable, the goals and
research objectives described here will guide decisions
about research directions for years to come. Each year,
ORD's Research Coordination Teams (see Appendix
C) will apply ORD's priority-setting process
(described  in Part A) to review and identify specific
research topics that best further these objectives. The
resulting set of research topics will constitute the basis
for ORD's research program. Appendix A describes
the first set of near-term priority research topics that
resulted from applying this process.

Goal 1: To Develop Scientifically
Sound Approaches to Assessing
and Characterizing Risk to Human
Health and the Environment
Risk assessments and the associated risk
management decisions are often based on limited
data obtained in species or under exposure
conditions that differ from real-world
circumstances. Inevitably, scientists must extrapolate
from these data sets to the human or environmental
setting of concern to characterize human health or
ecological risks. Extrapolation injects uncertainty
into risk characterizations, which EPA relies on to
develop risk management strategies and research
priorities.
Greater certainty in risk assessment would impnn • •
the efficiency and effectiveness of EPA's risk
management efforts and provide a better found.i:  •
                                    STRATEGIC PLAN  FOR ORD
                                          1 7

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ORD's  Long-Term Goals  and Objectives
for establishing the Agency's research priorities.
ORD, therefore, will work to improve existing risk
assessment data, methods, and models and to
develop new methods for high-risk areas where
data currently are inadquate. Already, for example,
the science has advanced sufficiently to warrant
more refined approaches to  risk assessment in
several areas, including ecological impacts, effects
on vulnerable subpopulations of people or
environmental species, and  noncancer effects in
humans. As ORD develops improved methods, we
will work with other parts of the Agency to ensure
that these methods are credible and used in ways
that are scientifically sound.
In recent years, we have begun to recognize the
interdependence of ecosystems and to understand
that we must consider the landscape  as a whole to
maintain the integrity of vital ecosystems into the
next century. While continuing to develop and
refine scientifically sound approaches to assessing
risks to human health, we intend to expand our
ecological research. For example, we  intend to study
concurrent impacts of multiple anthropogenic and
natural stressors and to develop  techniques to
examine nonchemical stressors. The results of this
research—including enhanced data on and
understanding of ecosystems at multiple levels of
organization and geographic and temporal
scales—will provide a scientific foundation for
developing risk assessment/risk management
strategies and techniques for restoring vital
ecosystems (see Goal 3).

Objectives

Within this goal area, ORD will work to:
•  Replace the current approach  to assessing non-
   cancer health risks with more scientifically
   grounded, biologically plausible approaches and
   models. This will include:
   •  Studying the heightened sensitivity/suscepti-
     bility of certain subpopulations (e.g., children).
   •  Studying the predictive relationship between
      toxicologic endpoints  and human disease (e.g.,
      to facilitate animal-to-human extrapolation).
   •  Developing integrated mechanistic informa-
      tion to support biologically credible health
      assessments.
•  Develop methods and models founded on meas-
   urement data and sound  theoretical concepts that
   can be used to better characterize, diagnose, and
                    predict total human exposures to chemical and
                    microbial hazards, to improve and validate
                    exposure models, and to reduce uncertainties in
                    exposure assessments, risk assessments, and risk
                    management decisions. This will include:
                     •  Determining the relationship between expo-
                       sure sources and multiple exposure pathways,
                       including characterizing the sources and deter-
                       mining the influence of transport,
                       transformation, and fate on exposure.
                     •  Developing and evaluating an integrated
                       mass-balance / multimedia/ multipathway
                       exposure model that incorporates state-of-the-
                       science pollutant fate and transport process
                       descriptions for use in risk assessment.
                     •  Developing and applying exposure measure-
                       ment  methods to reduce the uncertainty in
                       exposure-dose relationships, especially analyti-
                       cal methods for identifying and enumerating
                       microbial pathogens and biomarker and
                       chemical marker methods for estimating site-
                       specific exposures.
                     •  Continuing activity pattern research to reduce
                       uncertainty in models and assessments that
                       predict exposure levels, frequencies, and distri-
                       butions in populations.
                     •  Delineating and quantifying the role of
                       exposure in the development of effects in
                       individuals and populations, including
                       susceptible populations.
                    Establish approaches to characterizing and under-
                    standing risks to ecosystems and, in cooperation
                    with other agencies, develop a national, multi-
                    scale, integrated environmental status and trends
                    program. This will include:
                     •  Developing indicators of the condition of rep-
                       resentative ecosystems.
                     •  Supporting hypothesis-driven, long-term
                       monitoring of important exposure and effects
                       indicators at national reference sites.
                     •  Characterizing national land-cover / land - u se
                       patterns and developing measures of land-
                       scape condition at multiple scales for specific
                       sites,  watersheds, landscapes, and ecoregions
                     •  Conducting pilot studies in ecologically impor-
                       tant regions (e.g., the mid-Atlantic Highland-1
                       to evaluate alternative monitoring design-.
                       and to develop techniques to integrate data
                       across geographic scales.
  18
STRATEGIC PJ.AN FOR ORD

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                                                  ORD's  Long-Term  Coals and Objectives
• Understand and predict ecosystem exposures,
  responses, and vulnerabilities to high-risk chemi-
  cal and nonchemical stressors at multiple levels
  of biological organization and geographic scales.
  This will require:
   • Developing ecological criteria for water (both
     freshwater and marine), air, soil, and sediment
     quality (1) as needed for the Agency's risk
     assessment and risk reduction efforts, and (2)
     to measure progress toward meeting environ-
     mental goals.
   • Developing diagnostic tools at all levels of
     biological organization for retrospective
     assessments and for characterizing the key
     sources and stressors in multistressed ecosys-
     tems.
   • Developing tools for predicting the vulnerabil-
     ity of ecosystems at multiple geographic and
     temporal scales to ecosystem stressors (e.g.,
     climate change, altered land use, changes in
     air, soil, or water quality).

Goal 2: To Integrate Human
Health and  Ecological Assessment
Methods Into a Comprehensive
Multimedia Assessment
Methodology

Human health risk assessments and ecological risk
assessments have different histories at EPA and have
traditionally been thought of as involving different
disciplines. As a result, EPA has developed  and used
separate methodologies for those assessments. As
we have begun to take a more integrated view of
risk, however, we have noted that human health
and ecological risk assessments actually make use of
similar types of data and science. We have realized
that we must use a more integrated, multimedia
approach to risk assessment if we are to understand
and reduce many current and future risks. We will
therefore conduct research to develop an accessible,
seamless, common methodology for combined
human health and ecological risk assessments so
that we can provide decision-makers at all levels
with the integrated view of risk that they need to
make sound decisions.
Objectives

Within this goal area, ORD will work to:
•  Integrate fate and transport modeling techniques
   with biologically based models needed in human
   health and ecological risk assessment.
•  Integrate human health and ecological exposure
   and trends monitoring research.
•  Better understand the relationship between
   human health and the condition of ecosystems
   (e.g., to assess the impact of human consumption
   of contaminated fish or wildlife or the influence
   of landscape characteristics and climate interac-
   tions on disease vectors such as mosquitos, ticks,
   and rodents).
•  Develop tools and techniques to facilitate the
   assessment of relative risks to human health and
   the environment.
•  Harmonize extrapolation methodologies for relat-
   ing data on toxicity mechanisms for endocrine
   disrupters, immunotoxins, developmental haz-
   ards, and other chemicals with effects in sensitive
   human subpopulations, wildlife, and aquatic
   organisms.
•  Improve extrapolation models by integrating
   toxicologic and mechanistic data obtained in
   laboratory and field investigations (epidemiology
   and ecology).
•  Identify and validate wildlife species as sentinels
   for human health risks.

Goal 3: To Provide Common Sense,
Cost-Effective Approaches for
Preventing and Managing Risks

To enhance the practicality and cost-effectiveness of
the products of ORD's risk management research,
we are changing the way we study pollution control
and prevention, contaminated site and spill
remediation, and technology development. To the
extent possible, we are integrating our air, water,
and waste-related research, and we are increasingly
focusing on emerging, high-risk problems—all  ^o
that we can better help regions, communities, and
the private sector analyze pollution problems and
achieve risk reductions efficiently and cost-
effectively. This common sense approach will M-rk
to maximize the health and environmental benrriN
of risk management by focusing risk managerv.i :••
                                   STRATEGIC PtAisr  FOR ORD
                                          19

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ORD's  Long-Term Goals and Objectives
research on those aspects of a process or situation
that cause the greatest risks.
To that end, our pollution prevention and control
research will now focus on multimedia life-cycle
analyses, "green" technologies, and pollution
prevention methods that small- and medium-sized
companies can use to achieve significant reductions
in risk across media. Our maturing site and spill
remediation program will concentrate on
developing cleanup options for complex risk
situations and faster, lower cost natural recovery
systems. In addition, we will continue forging
partnerships with the private sector to analyze
high-risk needs and to develop, evaluate,  and  verify
new pollution prevention and risk reduction
technologies.
We have also begun efforts in ecosystem restoration
and cost-benefit assessment. Our ecosystem
restoration research (connected to that described
under Goal 1 above) will focus on developing  and
demonstrating principles, technologies, and
guidance materials that regions and communities
can use to help restore local ecosystems. Our
cost-benefit assessment research will focus on
developing a systematic approach to identifying and
reporting the benefits and costs of risk management
technologies and alternatives. Such an approach is
needed to satisfy the rapidly growing demand for
cost-benefit analyses to  support environmental
decision-making—a demand engendered by the
rising cost of environmental protection in an era of
limited resources.

Objectives

Within this goal area, ORD will work to:
•  Provide cost-effective risk management technolo-
   gies and approaches  for high-risk threats to
   human health and the environment. This will
   include:
   •  Characterizing sources of fine-particulate
      emissions, air toxics, and ozone precursors,
      and identifying, adapting, and developing risk
      management approaches that control emis-
      sions to acceptable levels.
   •  Providing cost-effective, reliable technologies
      and management approaches that reduce
      drinking water exposures to disinfectant
      byproducts while protecting water supplies
      from microbial contamination.
 •  Providing communities with proven technolo-
   gies for wet weather flow watershed
   management, wellhead protection, and resto-
   ration of contaminated areas.
Provide pollution prevention approaches and
analytical tools to the private sector. This will
include:
 •  Providing risk-based systems and tools to
   analyze options for multimedia pollution
   prevention for major industrial sectors.
 •  Identifying and evaluating the performance
   and costs for pollution prevention options for
   small- and medium-sized businesses.
Develop advanced air quality simulation models
that relate sources, emissions, and receptors. This
will include:
 •  Developing models based on high-perform-
   ance computing systems to predict the fate of
   pollutants through the multimedia pathways
   leading to human and ecosystem exposure to
   these pollutants.
Catalyze the development and use of cost-effec-
tive risk management approaches for the most
difficult and costly environmental management
problems. This will include:
 •  Developing cost-effective techniques for reme-
   diating soils and ground water contaminated
   with non-aqueous-phase Liquids, chlorinated
   and other hazardous organics, and toxic
   metals.
 •  Developing cost-effective techniques for reme-
   diating contaminated sediments.
 •  Verifying the performance of innovative risk
   reduction technologies and accelerating their
   commercial use.
Provide cost-estimating/engineering assessment
tools and methods for more accurate and mean-
ingful cost-benefit analyses. This will include:
 •  Developing data  standards and cost reporting
   protocols.
 •  Developing methods and cost analyses for
   emerging, high-risk environmental problem^
   (e.g., fine particulates, drinking water, wet
   weather flow controls).
Develop and provide risk management alterna
rives to maintain and/or restore ecosystem^ Thi-
will include:
                                     STRATIGIC  PIAN FOR ORD

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                                                   ORD's Long-Term Goals and Objectives
   • Developing diagnostic and characterization
     methods and protocols for use in determining
     appropriate ecosystem restoration goals and
     requirements for specific sites, watersheds,
     landscapes, and ecoregions.
   • Identifying, testing, and providing risk man-
     agement approaches and technical guidance
     for restoring riparian zones, remediating con-
     taminated soils and sediments, and applying
     best management practices to restore or main-
     tain ecosystems in urban, suburban, and
     urbanizing areas.
   • Developing methods to restore and maintain
     soil ecosystems.

Goal 4: To Provide Credible,
State-of-the- Science Risk
Assessments, Methods, Models,
and Guidance

ORD continues to be a national leader in the field of
risk analysis of human health and ecological effects
and will continue to serve as a catalyst for advances
in the science of. risk assessment. ORD will achieve
this goal by working to facilitate cooperation and
the exchange of ideas between and among federal,
state, and local scientists as well as scientists in the
environmental, industrial, and academic communities.
In addition, ORD will focus on three primary activities:
•  Using an open and participatory process, ORD
   will conduct timely, state-of-the-art risk assess-
   ments. These assessments either will serve as
   prototypes demonstrating new approaches to risk
   assessment or will respond to Agency needs by
   assessing multimedia, multiprogram, or conten-
   tious or sensitive issues.
•  ORD will support other risk assessment efforts by
   providing guidance, consultation, training, and
   information products to assist colleagues, both
   inside and outside EPA, in conducting their own
   risk assessments. These efforts will respond
   directly to the needs of the risk assessment
   community  and will target areas of uncertainty in
   the science and conduct of risk  assessment.
•  ORD will improve the state-of-the-science of risk
   assessment by developing scientifically sound
   and defensible approaches for incorporating and
   integrating data and models developed by ORD
   and the general scientific community into risk
   assessment efforts.
ORD will integrate human health and ecological
concerns into all these activities.

Objectives

Within this goal area, ORD will work to:
•  Prepare risk assessments for those stressors cur-
   rently considered of high risk to humans and the
   environment. This will include:
   • Assessing ubiquitous pollutants in the air that
     affect human health (e.g., fine particles, ozone).
   • Assessing the risks associated with highly
     toxic and persistent environmental contami-
     nants (e.g., dioxin, mercury).
   • Assessing the risks to ecosystems from non-
     chemical stressors (e.g., habitat loss and
     habitat fragmentation).
   • Conducting comparative risk assessment of
     competing risks (e.g., those posed by micro-
     organisms in drinking water versus those
     posed by disinfection byproducts).
•  Complete development of new cancer risk guide-
   lines and other guidelines and provide support to
   the program offices and regions to facilitate their
   implementation. This will include:
   • Developing and supporting the implementa-
     tion of guidelines for assessing the ecological
     impacts of environmental stressors.
   • Supporting the implementation of new guide-
     lines for cancer, neurotoxicity, and
     reproductive risks.
•  Provide expert advice and technical support to
   EPA staff, other agencies, and EPA stakeholders.
   This effort will include:
   • Integrating scientific and technical informa-
     tion from ORD laboratories and other sources
     to provide a sound scientific base and techni-
     cal support for Agency decisions and policy.
   • Developing and supporting the implementa-
     tion of guidelines for assessing the ecological
     impacts of environmental stressors.
   • Supporting the implementation of new
     guidelines for cancer, neurotoxicity, and
     reproductive risks.
   • Supporting chemical- and site-specific risk
     assessments for criteria  air pollutants, ha/.uJ
     ous air pollutants, waste sites, and drinking
     water.
                                     STRATE6IC PLAN FOR ORD

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ORD's Long-Term Goals and Objectives
   •  Providing training in risk assessment to state
     and local stakeholders.
   •  Continuing to support and improve the Inte-
     grated Risk Information System (IRIS) and
     expert systems such as Risk Assistant.
•  Develop methods and assess methods developed
   by others for providing quality-assured data for
   environmental assessment. This will include:
   •  Supporting the development of models that
     can be readily used by regions and states.

Goal 5: To Provide Reliable
Scientific, Engineering, and Risk
Assessment/Risk Management
Information to Private and Public
Stakeholders

Effective risk assessments and risk management
decisions depend on the availability of accurate
sources of scientific and engineering data and
information, risk assessments, analytical methods,
and guidance. As a leader in the development of
such methods and information, we are committed to
providing expertise and information to decision-
makers inside and outside EPA. We will work to
identify and fulfill user needs by providing
appropriate tools and information through
interconnected communication and technical
support networks.
Our goal is to provide information that is impartial,
up-to-date, and relevant to user needs. To that end,
we must improve and update existing information
systems and develop new systems and information
transfer solutions to meet future needs. Working
with other EPA offices, we will help to develop an
operational communication and information
transfer system for on-line scientific, engineering,
and risk information that can be accessed by
professionals or by members of the public who are
involved in community-level analysis and
decision-making.

Objectives

Within this goal area, ORD will work to:
•  Provide current and relevant technical informa-
   tion to a broad user community. This will include:
   •  Developing plain-language guidance and
     training that adequately and clearly communi-
     cate the appropriate use of technical
     information and that describe limitations and
     inappropriate applications.
   •  Developing electronic communication and
     other information dissemination systems that
     can be accessed and understood by broad and
     diverse user communities.
• Complete the development of the new cancer risk
  guidelines and provide support to the program
  offices and regions to facilitate their implementa-
  tion.
• Maintain and increase support for existing scien-
  tific, engineering, and risk information resource
  systems. This will include:
   •  Ensuring that current information resources
     are accurate, relevant, and up-to-date.
   •  Developing electronic and other methods of
     bringing databases (e.g., IRIS, ECOTOX) to
     state and local governments and other stake-
     holders.

Goal 6: To Provide National
Leadership and Encourage Others
To Participate in Identifying
Emerging Environmental Issues,
Characterizing the Risks Associa-
ted With These Issues, and
Developing Ways of Preventing or
Reducing These  Risks
With our very broad missions, we in ORD and the
Agency as a whole must have some means of
evaluating, comparing, and setting priorities for
competing needs. We use risk as the common
denominator for comparing divergent issues and
making decisions. Our focus on relative risks and
risk-based decision-making demands that we look
beyond the obvious problems of yesterday and
today to identify and assess issues just over the
horizon; we must determine the potential risks that
these issues pose and work to solve them. Often,
however, few data exist to support assessments ot
emerging issues. Thus, we must develop and
disseminate data and methods to permit credible
decision-making in the face of very high uncertamt\
At ORD, we are committed to working with other
groups within EPA, the Agency's Science Advisor-.
Board (SAB), the National Academies of ScierKe u .:
                                  STRATEGIC  PIAN  FOR ORE>

-------
Engineering (NAS and NAE), and others to develop
new ways of analyzing emerging issues.
EPA's general approach to environmental
management—assessing risks, evaluating the
potential benefits of risk reduction, and devising
risk management and risk reduction strategies
accordingly—is increasingly being adopted by
others in this country and abroad. More than any
other organization, ORD has been in the forefront of
developing the risk assessment and risk
management methods that undergird this risk-
based approach to environmental management.
More than any other organization, therefore, we are
in a position to provide leadership in the
development of new, more credible ways of
comparing and ranking risks. In providing this
leadership, we renew our commitment to
encouraging and enabling others in the public and
private sectors to participate in identifying,
characterizing, and resolving emerging
environmental issues.
ORD's Long-Term  Goals  and Objectives

   Objectives

   Within this goal area, ORD will work to:
   •  Collaborate with other parts of the Agency, the
      SAB, the NAS, and others to develop methods of
      identifying emerging issues and assessing their
      potential risks.
   •  Develop partnerships (via research grants and
      other mechanisms) with other federal agencies,
      the White House Committee on Environment and
      Natural Resources, industry, and academia.
   •  Provide national and international leadership in
      risk assessment and its application for risk reduc-
      tion and risk management.
   •  Conduct/sponsor workshops and symposia that
      will provide forums for stimulating interest and
      discussion on current or emerging environmental
      issues, reaching consensus on crucial research
      needs, and defining the role of ORD and others  in
      addressing those needs.
                                    STRATEGIC PIAN pom  ORD
                                              IS

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        BLANK

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Appendix  A
ORD's  Near-Term   Research
Priorities
       The goals and objectives listed in Part B
       define an ambitious research program for
       ORD. Within this program, however, the
       extent of research that ORD can actually
perform will be limited by the available resources.
Therefore, ORD uses the priority-setting process
(described in Part A) to select from its overall pro-
gram those topics that are of highest priority for
research. Applying its priority-setting process for
the first time, ORD has established its research
priorities for the next few years. The six highest
priority topic areas are (in no particular order):
• Drinking water disinfection.
• Particulate matter.
• Human health protection.
• Ecosystem protection.
• Endocrine disrupters.
• Pollution prevention and new technologies.

Proposed research for these areas is summarized in
Table A-l. Tables A-2 through A-7 provide a detailed
breakout, by risk assessment/risk management
area, of the strategic issues and proposed research
tasks, products, and applications in each of the six
topic areas. ORD's research agenda also includes
additional topics necessary to help the Agency fulfill
its nondiscretionary mandates. ORD's entire
research program will be captured in the research
plans that will be developed by the Research
Coordination Teams (see Appendix C).
The following three examples illustrate how applica-
tion of the selection criteria described in Part A gave
rise to the high-priority research topics described in
this appendix.
Drinking Water Disinfection

Although disinfection of drinking water has been
one of the greatest public health success stories of
the twentieth century, some public health concerns
still remain. For example, hundreds of people have
died and many thousands of hundreds have become
ill during recent outbreaks of exposure to the bacte-
rium Cryptosporidium in drinking water.  Recent
studies demonstrate that there is a low threshold of
infectivity for Cryptosporidium and that people
with compromised immune systems—such as the
elderly, HIV-positive individuals, and persons re-
ceiving chemotherapy—may be at greater risk. In
addition, other microorganisms exist in drinking
water that may also have serious adverse effects.
There still is a high degree of uncertainty about how
to measure microorganisms in water and what their
infectivity level is. Additionally, there is a high de-
gree of uncertainty about whether disinfection
byproducts—the chemical byproducts that result
when disinfectants react with organic matter in
drinking water—pose a significant human health
threat. Because of the high uncertainty, the widespread
human exposure to drinking water, the severity of the
known effects from certain microbes, and the potentially
high costs of further regulation of drinking water, this i>-
sue is of high priority to EPA's Office of Water and
to ORD's research agenda.

Particulate Matter

Recent publications in the scientific literature indi-
cate that exposure to particulate matter poses A • •^•!
potential human health risk. At the same time, rum
ever, there is a high degree of uncertainty about the
size and composition of the particles that mav h<
                                 STRATEGIC PtAN FOR OR0

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Appendix A

responsible for these effects, the biological mecha-
nisms of action, and the dose-response relationships
at low levels of exposure. In addition, control costs
are potentially very high. For all these reasons, this
area is of high priority to EPA's Office of Air and
Radiation and of high priority for ORD's research
agenda.

Ecosystem  Protection
Many ecological effects are potentially related to
pollution and other environmental factors. The
consensus among environmental scientists and
decision-makers is that methods are needed to
assess ecological risks. Such methods would serve
all EPA programs and are extremely important for
understanding risks at both the local and commu-
nity levels. Because of the broad applicability of these
methods and their significant potential for improving
ecological risk assessment and risk management, ORD
has selected ecosystem protection as a high-priority
topic for its research agenda.
                                      $TRATE6IC PlAN  FOR  ORB

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 Table A-1.  Summary of EPA/ORD Research Program for Six High-Priority Research Topics
Research Topics  Strategic Focus
                           Tasks
                                         Products
Drinking Water
Disinfection
What is the comparative
risk between wnterborne
microbial disease and the
disinfection byproducts
(DBPs) formed during
drinking water disinfection?
How can both be
simultaneously controlled?
Develop methods for measuring
pathogen/DBP exposure from drinking
water, determine effects and dose-response
for them, develop/apply a microbial risk
assessment framework, improve DBP risk
assessments, and evaluate alternative
treatment processes for DBP/microbial
control.
Data on effects, dose-response,
exposure, comparative risk, and
treatment for pathogens/DBPs.
Particulate        What morbidity/mortality
Matter            's associated with low
                  ambient levels of particulate
                  matter (PM), and what cost-
                  effective methods are
                  available to reduce PM
                  emissions to an acceptable
                  level?
                           Conduct clinical/epidemiology studies of
                           PM effects; reanalyze past epidemiology
                           studies; conduct pharmacokinetic and
                           biological studies; characterize the
                           size/species of PM; conduct a human
                           exposure study; and evaluate, develop, and
                           demonstrate technologies to reduce PM
                                             emissions.
                                         Morbidity/mortality, dose-response,
                                         and mechanistic data; dosimetric
                                         model; methods for measuring PM
                                         mass/species; improved human
                                         exposure estimates; data on
                                         emissions composition; improved
                                         risk estimates; and data on
                                         cost-effectiveness of PM control
                                         strategies.
                                   Uses
To support DBP/microbial risk
assessment/risk reduction
rulemakmg and compliance
monitoring.
                                   To improve criteria documents and
                                   risk assessments in support of I'M
                                   National Ambient Air Quality
                                   Standards review; to provide
                                   information for evaluating
                                   alternative PM control strategies.
Human Health
Protection
How can we better
define/predict hazards,
improve dose extrapolation,
and better understand
mixture toxicity?
Develop or improve methods for screening
hazard data, collecting toxicity data, and
interpreting hazard data; develop models to
estimate target tissue dose and responses to
those doses; and develop methods/models
for assessing mixtures toxicity.
Hazard screening/testing protocols,
models for predicting chemical
disposition in the body, and test
protocols/models for mixtures
toxicity.
To rank/screen chemicals, develop
test guidelines, provide guidance for
risk assessment, and identify
mixtures toxicity.
                  What is the population
                  distribution of total
                  exposure?
                  What are the
                  source-exposure-dose
                  relationships?
                           Determine how exposure is influenced by
                           age, lifestyle, behavior, and socioeconomic
                           factors. Develop total human exposure
                           models, which include so jrce/pathway
                           contributions to total exp.-sure.
                                         Improved exposure measurement
                                         and assessment methods, models,
                                         and data.
                                   To support exposure assessment
                                   during risk-based decision-making
                                                                                                                                                 (Continued)
                                                                                                                                                               •9
                                                                                                                                                               •9
                                                                                                                                                               It

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      Table A-l.  Summary of EPA/ORD Research Program for Six High-Priority Research Topics (Continued)
     Research Topics   Strategic Focus
                                             Tasks
                                                                     Products
                                                                            Uses
     Ecosystem
     Protection
                  How can we determine
                  ecosystem risk and capacity
                  to tolerate stress?
                  What are the chemical and
                  nonchemical exposures to
                  the most sensitive systems?
                  Which ecosystems are
                  vulnerable? Where?
                  How can we reduce risk in
                  a cost-effective manner?
                           Study ecosystem vulnerability and
                           stressor-response relationships; identify
                           eco-effect measures; characterize habitat
                           distribution and chemical exposures;
                           develop/apply eco-risk assessment
                           methods; and study eco-risk reduction.
                                          Ecosystem criteria, models to predict  To inform the debate on ecosystem
                                         ecosystem effects/risks, national
                                         land-cover map, baseline data for
                                         documenting future changes,
                                         ecosystem exposure profiles, and
                                         information on risk reduction
                                         approaches for ecosystems.
                                   protection, ecosystem assessment,
                                   environmental planning, and
                                   ecosystem risk
                                   reduction/restoration.
It
a
o.
X
>
I
3
JO
3
Endocrine         What is known about
Disruptors        endocrine disruptor (EDC)
                  exposure, human/
                  eco-effects, and risk
                  assessment?
                  What research still needs to
                  be done?
                                                  Review existing literature on EDCs, conduct  Reports on research needs,
                                                                                                       To prioritize research needs, review
                                                  workshops on research needs, develop
                                                  QSAR/PBPK/BBDR3 methods/models,
                                                  conduct field measurements of EDCs, and
                                                  assess effects on highly exposed cohorts.
                                                                     analytical methods, risk assessment   test guidelines, and conduct
                                                                     methods, data from field            hazard/effect and preliminary
                                                                     measurements, and cause-effect data, exposure/risk assessments.
Pollution
Prevention and
New Technology
How can pollution
prevention be integrated
into environmental
decision-making?
Study engineering/performance costs for
pollution prevention; develop technologies;
identify audiences needing technical
Pollution prevention cost accounting  To evaluate and implement
protocols, cost data, technology       pollution prevention approaches
transfer products, life-cycle analysis
                                                  assistance; develop life-cycle analysis/audit   tools, audit procedures, pollution
                                                  tools; and assist in disseminating
                                                  technologies to the commercial sector.
                                                                                      prevention technologies, and
                                                                                      performance data.
    aQSAR - quantitative structure-activity relationships.
     PliPK = physiologically based pharmacokinetic.
     DBDR = biologically based dose-response.

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      Table A-2. Drinking Water Disinfection
     Subtopic
     Health
     Effects
     Exposure
3
PC
o
Strategic Focus
Tasks
Products
Initial Uses
What dose levels of
pathogens cause
illness in exposed
populations?
Conduct dose-response studies on
waterborne pathogens.
Data for risk assessment models
to predict disease incidence.
To provide health effects data for
risk assessment to support
upcoming surface water and
ground-water treatment rules.
                    What are endemic and
                    epidemic illness rates
                    for waterborne
                    microbial disease?
                       Conduct epidemiology studies for
                       pathogen-caused disease.
                                    Indication of magnitude of risks
                                    and verification of risk models.
                                 To provide health effects data tor
                                 risk assessment to support
                                 upcoming surface water and
                                 ground-water treatment rules.
                    What are the relative
                    risks of disinfection
                    byproducts (DBFs)
                    from different
                    disinfection processes?
                       Conduct epidemiology studies on     Qualitative/quantitative data on    To assess the risks of different
                       reproductive/developmental effects   cancer, reproductive effects, and    disinfection processes, combining
                       and, if feasible, on cancer.             other effects.
                       Conduct toxicity studies on
                       individual DBFs and mixtures if
                       feasible.
                                    Risk assessments for individual
                                    DBPs.
                                                                    epidemiology, toxicity, and mixtures
                                                                    information, to support  DBP rules.
What levels of
pathogens are people
exposed to?
Develop analytical methods that
detect viable/infective organisms.
Practical analytical methods for
pathogens.
                       Identify sources of pathogens and
                       factors affecting occurrence levels in
                       surface and ground waters.
                                    Analyses of pathogen occurrence
                                    in source waters.

                                    Information on pathogen
                                    exposures in drinking water.
As a survey tool for developing
occurrence data.
To support exposure assessments to
predict pathogen occurrence in
drinking water under different
treatment processes.
Future Uses
To provide
methods for
compliance
by water
utilities.
                    What levels of DBPs
                    are people exposed to?
                       Develop methods for measuring
                       occurrence of DBPs in drinking
                       water.
                                    Improved practical field and
                                    research methods for DBPs in
                                    drinking water.
                                 To support exposure assessments
                                 for DBPs from different treatment
                                 processes.
                                    To provide
                                    methods for
                                    compliance
                                    by water
                                    utilities.
                                            Study the level of DBPs in drinking
                                            water supplies.
                                                           Identity of new DBPs under
                                                           different disinfection practices.

                                                           Data on DBP exposure from
                                                           drinking water.
                                                                                                                                                       (Continued)
                                                                                                                                                                     •o
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 Table A-3. Particulate Matter (Continued)
Subtopic     Strategic Focus
Tasks
Products
Initial Uses
                                                Future Uses
Risk          What options (e.g., process
Management  changes, upgrades of existing
(Continued)   controls, application of new
              technologies) are available that
              both reduce fine-particle
              emissions to acceptable levels
              and are cost-effective?
Investigate options for reducing
fine-particle emissions:
-Demonstrate the extent to which
 improved operation and maintenance
 of existing control equipment for
 combustion systems can further reduce
 emissions.
-Develop advanced, more cost-effective
 technologies (e.g., improved
 electrostatic precipitators and fabric
 filters) to control fine particles from
 stationary sources.
-Determine the effectiveness of indoor
 air cleaners for reducing personal
 exposure to fine particles.

Compare the costs of these and other
approaches.
Technical reports and
data on the performance
and cost-effectiveness of
competing risk
management approaches.
User-friendly computer
models and other
technical assistance tools
that transfer risk
management
information to key users.
To support evaluations
of competing regulatory
strategies, cost/benefit
analyses, and
development of
guidance documents.
To provide guidance to
states and the regulated
community on the
performance and cost of
competing fine-particle
risk management
approaches.
                                                                                                                                                               T3
                                                                                                                                                                A
                                                                                                                                                                a
                                                                                                                                                                o.

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      Table A-3. Participate Matter
     Subtopic      Strategic Focus
                                             Tasks
                                       Products
                        Initial Uses
                        Future Uses
     Health Effects  What health effects are caused
                    by particulate matter (PM) and
                    its components?
i
I
o
                                             Conduct epidemiologic studies of
                                             mortality and morbidity coupled with
                                             improved exposure characterization.
                                             Conduct clinical studies of respiratory
                                             effects in controlled human studies.
                                       Qualitative and
                                       quantitative data on
                                       mortality and/or
                                       respiratory diseases.
                        To provide health effects
                        data for risk assessment
                        (Criteria Document) to
                        support PM National
                        Ambient Air Quality
                        Standards (NAAQS).
                    What are the causal
                    mechanisms/particles that
                    explain/support epidemiologic
                    observations?
                                             Conduct animal and clinical studies of
                                             biochemical and physiologic events
                                             initiated by PM and its components.
                                       Dose-response data
                                       describing biochemical
                                       and physiologic events
                                       induced by PM and their
                                       relationship to disease.
                        To provide health effects
                        data for risk assessment
                        (Criteria Document) to
                        support PM NAAQS.
                        To provide health effects
                        data for further risk
                        assessment (updated
                        Criteria Documents) to
                        support PM NAAQS.


                        To provide health effects
                        data for further risk
                        assessment (updated
                        Criteria Documents) to
                        support PM NAAQS.
                    What is the relationship
                    between PM exposure and
                    dose?
                    What is the role of dose for
                    effects in sensitive
                    subpopulations?
Exposure      What PM species and
              concentration levels are present
              in ambient air?
                                             Develop dosimetric model of particle
                                             deposition in the lungs under various
                                             exposure and population conditions.
                                       Dosimetric model
                                       linking animals to
                                       humans and normal
                                       humans to sensitive
                                       subpopulations (e.g.,
                                       children, individuals
                                       with preexisting disease).
                        To provide health effects
                        data for risk assessment
                        (Criteria Document) to
                        support PM NAAQS.
                        To provide health effects
                        data for further risk
                        assessment (updated
                        Criteria Documents) to
                        support PM NAAQS.
Develop ambient PM measurement
methodology capable of discriminating
particles by size and species.
Methods for measuring
fine-particle mass and
characterizing species
(e.g., acid aerosols,
inorganic and organic
species).
To serve as a Federal
Reference Method for
new fine-particle
NAAQS.
To provide PM
methodology for
atmospheric chemistry
research and total
exposure research.
                                                  Conduct PM size and species
                                                  characterization studies.
                                                                                    PM characterization
                                                                                    data.
                                                               To assess PM size and     To identify sources of
                                                               concentration levels for   PM and address PM
                                                               regulatory development  formation, transport,
                                                               and epidemiologic study  and fate.
                                                                   k                    To help develop control
                                                                                       strategies for
                                                                                       implementating PM
                                                                                       regulation(s).
                                                                                                                                                       (Continued)
                                                                                                                                                                     "O
                                                                                                                                                                      n
                                                                                                                                                                      a
                                                                                                                                                                      o.
                                                                                                                                                                      x
                                                                                                                                                                      J»

-------
      Table A-3.  Participate Matter
     Subtopic      Strategic Focus
Tasks
                                                                                    Products
                        Initial Uses
                        Future Uses
     Health Effects What health effects are caused
                   by participate matter (I'M) and
                   its components?
3
§
Conduct epidemiologic studies of
mortality and morbidity coupled with
improved exposure characterization.
Conduct clinical studies of respiratory
effects in controlled human studies.
                                                                                    Qualitative and
                                                                                    quantitative data on
                                                                                    mortality and/or
                                                                                    respiratory diseases.
                        To provide health effects
                        data for risk assessment
                        (Criteria Document) to
                        support I'M National
                        Ambient Air Quality
                        Standards (NAAQS).
                        To provide health effects
                        data for further risk
                        assessment (updated
                        Criteria Documents) to
                        support PM NAAQS.
                   What are the causal
                   mechanisms/particles that
                   explain/support epidemiologic
                   observations?
Conduct animal and clinical studies of
biochemical and physiologic events
initiated by PM and its components.
                                                                                    Dose-response data
                                                                                    describing biochemical
                                                                                    and physiologic events
                                                                                    induced by PM and their
                                                                                    relationship to disease.
                        To provide health effects
                        data for risk assessment
                        (Criteria Document) to
                        support PM  NAAQS.
                        To provide health effects
                        data for further risk
                        assessment (updated
                        Criteria Documents) to
                        support PM NAAQS.
                   What is the relationship
                   between PM exposure and
                   dose?
                   What is the role of dose for
                   effects in sensitive
                   subpopulations?
Develop dosimetric model of particle
deposition in the lungs under various
exposure and population conditions.
                                                                                    Dosimetric model
                                                                                    linking animals to
                                                                                    humans and normal
                                                                                    humans to sensitive
                                                                                    subpopulations (e.g.,
                                                                                    children, individuals
                                                                                    with preexisting disease).
                        To provide health effects
                        data for risk assessment
                        (Criteria Document) to
                        support PM NAAQS.
                        To provide health effects
                        data for further risk
                        assessment (updated
                        Criteria Documents) to
                        support PM NAAQS.
bxposure      What PM species and
              concentration levels are present
              in ambient air?
Develop ambient PM measurement
methodology capable of discriminating
particles by size and species.
Methods for measuring
fine-particle mass and
characterizing species
(e.g., acid aerosols,
inorganic and organic
species).
To serve as a Federal
Reference Method for
new fine-particle
NAAQS.
To provide PM
methodology for
atmospheric chemistry
research and total
exposure research.
                                                  Conduct PM size and species
                                                  characterization studies.
                                       PM characterization
                                       data.
                                                                                                            To assess PM size and     To identify sources of
                                                                                                            concentration levels for   PM and address PM
                                                                                                            regulatory development   formation, transport,
                                                                                                            and epidemiologic study  and fate.
                                                                                                               "  '                  To help develop control
                                                                                                                                    strategies for
                                                                                                                                    implementating PM
                                                                                                                                    regulation(s).
                                                                                                                                                       (Conliniu'tl)
                                                                                                                                                                     n
                                                                                                                                                                     3
                                                                                                                                                                     a.

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Table A-3.
Subtopic
Participate Matter (Continued)
Strategic Focus
Tasks
Products
Initial Uses Future Uses
                   What options (e.g., process
     Management  changes, upgrades of existing
     (Continued)   controls, application of new
                   technologies) are available that
                   both reduce fine-particle
                   emissions to acceptable levels
                   and are cost-effective?
Investigate options for reducing
fine-particle emissions:
-Demonstrate the extent to which
 improved operation and maintenance
 of existing control equipment for
 combustion systems can further reduce
 emissions.
-Develop advanced, more cost-effective
 technologies (e.g., improved
 electrostatic precipitators and fabric
 filters) to control fine particles from
 stationary sources.
-Determine the effectiveness of indoor
 air cleaners for reducing personal
 exposure to fine particles.

Compare the costs of these and other
approaches.
Technical reports and
data on the performance
and cost-effectiveness of
competing risk
management approaches.
User-friendly computer
models and other
technical assistance tools
that transfer risk
management
information to key users.
To support evaluations
of competing regulatory
strategies, cost/benefit
analyses, and
development of
guidance documents
To provide guidance to
states and the regulated
community on the
performance and cost of
competing fine-particle
risk management
approaches.
8
o
                                                                                                                                                                     •o
                                                                                                                                                                     •9
                                                                                                                                                                      n
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§
Table A-4. Human Health Protection
Subtopic Strategic Focus
Exposure Wnat is the
source-exposure
relationship?
What is the
population
distribution of
exposures from all
media?
What are the
determinants of
exposure?
Dose What is the
Estimation exposure-dose
relationship for
pollutants from
each pathway?
How can we
improve dose
estimations across
species and
exposure scenarios?
Tasks
Develop verified models that trace
the prospective and retrospective
relationship between sources and
total exposure.
Develop quantitative total human
exposure models based on sound
theoretical and experimental
information.
Determine which behavioral,
socioeconomic, or lifestyle factors
increase exposure to pollutants;
determine the relationship of age
(young and old) and preexisting
disease to exposure.
For pollutants having multiple
pathways, determine the
quantitative contribution of each
pathway to total exposure and
target-site dose.
Develop methods and models for
estimating dose to target tissues
(i.e., physiologically based
pharmacokinetic models).
Products
Verified source-exposure models
that incorporate fate and
transport processes.
Improved methods for exposure
measurements:
- Activity pattern database.
- Microenvironmental exposure
measurements.
- Field studies of populations
with a variety of exposure risk
factors.
- Computer-based exposure
model platform.
Multimedia/pathway exposure
data fordisadvantaged
populations, children, the elderly,
and persons living near selected
sources (e.g., pesticide use).
Exposure models for highly
exposed subpopulations.
Models of relative intakes of
persistent chemicals from
inhalation, oral, and dermal
routes based on measurement
data.
Models for predicting disposition
of chemicals in the body from all
routes.
Initial Uses
To identify the most effective
risk management targets.
To support health risk
assessments; to measure
effectiveness of risk
management decisions.
To identify at-risk
subpopulations tor risk
assessment and to ensure
adequacy of rules/regulations.
To identify the pathways that
contribute most to risk and
hence require mitigation.
To improve the scientific basis
for cancer and noncancer risk
assessments.
Future Uses
Similar to initial use, but
expanded to be more
broadly applicable.
Similar to initial use, but
expanded to be more
broadly applicable.
Similar to initial use, but
expanded to be more
broadly applicable.
To improve risk
assessments and enhance
risk management
decisions.
To reduce uncertainty in
risk assessment and risk
management decisions.
                                                                                                                                                                                  n
                                                                                                                                                                                  3
                                                                                                                                                                                  0.

                                                                                                                                                                                  X

                                                                                                                                                                                  J*
                                                                                                                                                                  (Continued)

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•tl
e
Table A-4. Human Health Protection (Continued)
Subtopic
Hazard
Identification
and
Characterization
Dose-Response
Relationship
Special Problems
Strategic Focus
How can we
improve our ability
to detect hazards?
How can we better
interpret toxicity
data to predict and
define hazards?
How can we reduce
uncertainty in
extrapolations (e.g.,
from high doses in
animals to
environmental
exposures in
humans)?
What toxicities are
associated with
mixtures?
Tasks
Develop screening methods to set
testing priorities.
Develop cost-effective methods
for toxicity data collection.
Develop improved methods for
data interpretation. For example,
identify biomarkers of exposure
and effect and validate the use of
biomarkers in human populations.
Develop quantitative models for
predicting tissue and organism
response to target tissue dose (i.e.,
biologically based dose-response
models).
Develop improved empirical
dose-response models (e.g.,
benchmark dose models).
Develop methods to assess the
toxicity of chemical mixtures.
Products
Validated screening protocols
using, for example, in vivo, in
vitro, and structural activity
relationship (SAR) methods.
New and revised standard
toxicity testing protocols.
Guidance document on
interpretation of toxicity data.
Models for predicting toxicity
due to chemical exposures, winch
can be modified and applied in
chemical-specific risk
assessments.
Validated benchmark dose
models and guidelines for
applications.
Validated and standardized
testing protocols.
Initial Uses
To identify and rank existing
pesticides and industrial
chemicals in terms of
potential toxicity.
To develop Agency test
guidelines.
For incorporation into risk
assessment guidelines.
To provide critical examples
of development and use of
mechanistic models; to
evaluate the potential of these
models for replacing default
approaches for cancer and
noncancer risk assessment.
To improve reference dose
concentration procedures.
To identify chemical mixtures
with potential toxicity that is
other than addictive.
Future Uses
To screen new chemicals
as they enter the
regulatory system; to
assess relative toxicity.
To support regulatory
activities (e.g., TSCA'1 test
rules and consent
agreements, FIFRA data
call-ins).
To improve health risk
assessments in support of
risk management
decisions.
To provide a
state-of-the-science basis
for replacing default,
primarily empirical risk
assessment approaches.
To improve the basis for
risk management
decisions.
To assess site-specific
relative risk, to support
pollution prevention and
                                                                                                                                               risk management
                                                                                                                                               decisions.
                                             Develop models to predict the
                                             toxicity of chemical mixtures.
Validated and standardized
predictive models.
To identify chemical mixtures   To improve risk
likely to have synergistic or     management decisions
supra-additive toxic effects.     concerning risks posed by
                               mixtures.
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      Table A-5. Ecosystem Protection
     Subtopic      Strategic Focus
                            Tasks
                             Products
                               Initial Uses
                                 Future Uses
                           •o
                           it
                           3
                           a.
     Effects
8-
s.
O
     Exposure
What levels of
anthropogenic stress
(chemical and nonchemical)
can ecosystems tolerate and
still be sustained/
maintained?
Understand and develop
models to predict ecosystem
vulnerability to alternative
management practices and
changing stressors at multiple
scales.

Develop screening and testing
methods to assess viability
and sustainability at multiple
levels of biological
organization.
Quantitative models predicting  To inform debate on societal
complex and cascading effects    values with respect to ecosystem
of multiple stressors at multiple  protection; to provide
geographic and temporal scales,  information to support future
                                                                             Criteria for maintaining
                                                                             ecosystems.
                               community-based ecosystem
                               protection.
                                 To provide
                                 information to
                                 evaluate comparative
                                 risks and drive
                                 strategic research
                                 planning.
How do ecosystem
components respond to
changing exposures to
stressors?
Conduct research to
quantitatively understand
stressor-response
relationships.
                                                                             Quantitative models relating
                                                                             levels of exposure to effects for
                                                                             single stressors.
                               To support ecological effects
                               assessment.
                                 To support ecological
                                 effects assessment.
                    What are the best measures   Identify indicators (measures)   Evaluation of indicators of
                    of ecosystem effects?         of effect that correspond as     effect.
                                                closely as possible to
                                                assessment endpoints.
                                                                                        To provide indicators that can
                                                                                        serve as state variables in risk
                                                                                        assessment models and as
                                                                                        measures of condition for status
                                                                                        and trends monitoring.
                                                                                             To support objective
                                                                                             evaluation of success
                                                                                             in risk management
                                                                                             decision-making.
What are the most
significant sources of
stressors in various
ecoregions of the United
States?
Develop methods for
characterizing sources of
relevant stressors.
Methods for characterizing
sources of exposures.
As tools for exposure
assessments.
As components of
expert systems to
predict exposure.
                    What is the extent and
                    distribution of highly
                    vulnerable systems based
                    on predicted changes in
                    stressors at multiple scales?
                            Develop methods to
                            efficiently characterize
                            regional landscapes and
                            habitat distribution.
                             Baseline data for regional
                             assessments.
                             Assessments of highly
                             vulnerable ecosystems, within
                             and among ecoregions.
                             A national land-cover map of
                             the United States.
                               To support relative risk
                               assessments.
                                 To identify vulnerable
                                 systems at watershed
                                 and regional scales.
                                                                                                                                                         (Continual)

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      Table A-5.  Ecosystem Protection (Continued)
     Subtopic      Strategic Focus
                           Tasks
Products
Initial Uses
     Exposure       What is the current          Develop models to link        Methods for assessing exposure.  To .support relative risk
     (Continued)    distribution of exposure to   transport, transformation, and                                 assessments.
                    these stressors across        fate of stressors to exposure to
                    vulnerable ecosystems?      ecosystems at appropriate
                                               time and space scales.

                                               Support an interagency
                                               exposure reference site
                                               network.
Future Uses
                                                                                                                       To identify vulnerable
                                                                                                                       systems at watershed
                                                                                                                       regional and national
                                                                                                                       scales.
i
3
JB
3
o
                                              Conduct exposure
                                              vulnerability assessments at
                                              multiple geographic and
                                              temporal scales.
What sources are now       Develop diagnostic tools for
causing the most significant  retrospective assessments.
exposures?
Indicators of source/exposure
relationships.
                                                                                                          To apportion source strengths.
How will current patterns   Conduct demographic and
of exposure change in 5, 10,  economic studies to assist in
25, and 50 years?           predicting future sources of
                           stressors.

                           Link landscape and pollutant
                           models to predict future
                           environments.
Documentation of highest
priority stressors.

Data for predictive models.

Predictive models for use by
community-based ecosystem
protection planners.

Predictions of future pollutant
and stressor distributions
To support environmental
planning at multiple scales.
                                 To identify sources for
                                 risk reduction
                                 technology
                                 development
To assist in avoiding
the unintended
consequences of our
current  management
decisions.
     Assessment    What are the assessment
                    endpoints of primary
                    concern to local, watershed,
                    and regional communities?
                           Develop an ORD-wide
                           ecological data management
                           system.
Data systems to support risk
management.
To support ecological risk
assessment.
To conduct
comparative ecological
risk assessments to
prioritize research and
ecological protection
efforts.
                                                                                                                                                       (Continued)
                                                                                                                                                 "O
                                                                                                                                                 It
                                                                                                                                                 3
                                                                                                                                                 Q.

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     Table A-5.  Ecosystem Protection (Continued)
     Subtopic      Strategic Focus
                                          Tasks
                                                        Products
                                                            Initial Uses
                                                                Future Uses
     Assessment
     (Continued)
              What are the comparative
              risks to populations,
              communities, and
              ecosystems from multiple
              stressors?
                           Develop risk assessment and   Improved risk assessment
                           characterization methods for   methods.
                           single/multiple resources and
                           stressors.
                                                            As tools for ecological risk
                                                            assessment.
                                              Assess the risks and their
                                              economic implications.
                                                                       Quantitative/qualitative
                                                                       regional, comparative risk
                                                                       assessments
                                                                                       To support regional and local
                                                                                       community-based ecosystem
                                                                                       protection plans.
                                                                To conduct
                                                                comparative ecological
                                                                risk assessments.

                                                                To assist in prioritizing
                                                                research and ecological
                                                                protection efforts
                                               Develop an expert system for  Links between human health
                                               assessing ecological benefits    and ecological risks.
                                               of alternative management
                                               strategies at multiple scales.

                                               Conduct comparative risk
                                               assessments.
                                                                                                     As a tool for environmental        To assist in
                                                                                                     management at watershed scales,  environmental
                                                                                                                                      management and
                                                                                                                                      planning at multiple
                                                                                                                                      scales.
i
?5
Risk
Management
What are the most
cost-effective and efficient
ways to reduce risk to
ecosystems?
Identify and evaluate
promising options for risk
reduction.
Risk management technologies
for contaminants, sediments,
hazardous wastes, and other
stressors.
Data on technology
effectiveness.
Recommendations on optimal
ecosystem management
approaches.
As tools to select and implement    To avoid an ecological
approaches for reducing           "train-wreck."
ecological risk.
                   How are degraded
                   ecosystems best restored?
                                          Conduct field restoration
                                          projects.
                                                        Restoration techniques.
                                                           To improve restoration
                                                           techniques.
                                                               To restore ecosystems;
                                                               to provide manuals
                                                               and guidance on
                                                               management practices.
                                                           •O
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                                                            J>

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      Table A-6.  Endocrine Disrupters
     Subtopic     Strategic Focus
                               Tasks
                              Products
                               Initial Uses
                                   Future Use
     Identify
     Research
     Needs
What do we know about the
sources, chemical and physical
properties, transport pathways,
ecological and human effects of
EDCs,a and where are the major
gaps in our knowledge base?
Conduct workshops involving
principal stakeholders in
developing consensus on the
research needs for exposure,
and health and environmental
effects.
Reports on the research needs
for (1) reproductive, neurologic,
immunologic, and carcinogenic
effects of EDCs, (2) ecological
risk, and (3) exposure
assessment.
To develop prioritized research
needs.
     Effects        What are the important
                   chemical classes for interaction
                   with the endocrine system, and
                   what is their range of potency?
o
9)
O
                               Develop QSAR models for
                               hormone receptor-ligand
                               binding and transcriptional
                               activation.
                              QSAR models to identify and
                              prioritize in vivo research to
                              define dose-response effects.
                               As first-tier computer models to
                               predict hazard.
                   Do our current testing and
                   monitoring approaches
                   adequately evaluate and assess
                   effects on the endocrine system?
                               Develop in vivo and in vitro
                               test procedures and biomarkers
                               to detect the action of EDCs and
                               to identify critical life stages at
                               multiple phylogenetic levels.
                               Recommendations for           To revise testing guidelines and
                               modifying the testing guidelines improve data interpretation.
                               for potential adverse ecological
                               and human health effects.
                               Field and laboratory tools to
                               better quantitate effects of
                               putative EDCs.
What are the shapes of the
dose-response curves for EDCs
at relevant exposures, and what
tissue levels are responsible for
inducing adverse effects?
Develop PBPKcand BBDRd
models that include relevant
species-specific parameters.
Define potency of EDCs in
target species.
Increased understanding of the
comparative exposure levels
associated with risks.
Reduced uncertainty in
extrapolating effects.
                                                                                                               To reduce uncertainty in
                                                                                                               chemical-specific risk assessments
                                                                                                               and relative potency comparisons.
                   What is the normal endocrine
                   profile in target wildlife species
                   on a seasonal and regional basis?
                               Study populations and
                               determine normal profiles for
                               endocrine function during
                               various life stages, seasons, and
                               regions.
                               Database on endocrine function
                               in wildlife exposed to potential
                               EDCs.
                               To improve interpretation of
                               endocrine data from field studies
                               and to improve understanding of
                               the magnitude of the EDC problem
                               in wildlife populations
                   What are health outcomes
                   experienced by populations
                   receiving high-level exposure to
                   EDCs?
                               Assess spectrum of effects in
                               highly exposed cohorts,
                               particularly those with
                               developmental exposures.
                               Delineation of causes and effects
                               that can set the bounds on
                               effects in less highly exposed
                               populations.
                               To conduct preliminary risk
                               assessments.
                               To develop remedial actions where
                               adverse effects of EDCs in the
                               environment have been confirmed.
                                                                                                                                                       (Continued)
                                                                                                                                                  •O
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                                                                                                                                                   3
                                                                                                                                                   Q.

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      Table A-6.  Endocrine Disrupters (Continued)
     Subtopic     Strategic Focus
                               Tasks
                              Products
                               Initial Uses
                                   Future Use
     Effects
     (Continued)
For wildlife species, what
procedures, are available for
extrapolating effects of the
individual to populations?
What are the status and trends
of sentinel and keystone species
in the various ecological areas?
Develop models for
extrapolating effects measured
in individuals to reproductive
capacity in wildlife populations.
Models for predicting
population-level effects from
study at lower levels of
biological organization.
To facilitate ecological risk
assessment based on effects
observed in individuals.
TO
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 a
 a.
 X
                                                  Identify and periodically
                                                  conduct censusing of sentinel
                                                  and keystone species.
                              Early warning indicators of
                              environmental quality,
                              especially in terms of
                              contamination by EDCs.
                               For environmental monitoring.
                   What are the effects of exposure
                   to multiple EDCs?
                               Determine potential for
                               synergism or potentiation
                               within and among various
                               modes of action.
                              Assessment of the potential for   To improve effects assessment for
                              non-additivity among EDC      environmentally important multiple
                              health endpoints.               exposures to EDCs.
     Exposure      What are the pathways of
                   exposure of EDCs?
I
                               Develop source-receptor
                               models to assess exposure from
                               specific sources via multimedia
                               pathways.
                              Validated models to assess
                              exposure to EDCs.
                               To improve source-receptor
                               relationships determined via hybrk
                               models.
Do we adequately understand
multimedia transport (including
phase equilibrium and
deposition mechanisms),
persistence, bioaccumulation,
and biomagnification of EDCs?
Develop methods to monitor
exposure to EDCs and methods
to characterize exposure
half-life, speciation, uptake, and
phase equilibrium.
Analytical methods adequate lo
characterize EDCs in
multimedia, to assess transport,  exposure
fate, and exposure, and to
provide input to source-receptor
models.
                                                                                                               To improve source and receptor
                                                                                                               models and assessments of EDC
                   Do we have adequate (sensitive,
                   reliable, and inexpensive) tools
                   to monitor populations for
                   exposures to EDCs?
                               Develop biomarkers for
                               exposure of EDCs applicable to
                               the phylogenetic levels
                               considered to be at greatest risk
                               to EDCs.
                              Field and laboratory tools to
                              better quantitate the exposures
                              and effects of putative EDCs.
                              Improved algorithms to
                              calculate EDC exposure.
                               To improve data interpretation.
                   What are the environmental
                   concentrations of EDCs in all
                   principal media?
                               Conduct field studies to
                               measure high-priority EDCs.
                              Database on EDC levels in the
                              human environment and
                              various ecosystems to assist in
                              designing future exposure
                              strategies.
                               Preliminary environmental
                               exposure assessments.
                                                                                                                                                      (Continued)

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 Table A-6.  Endocrine Disrupters (Continued)
Subtopic      Strategic Focus
Tasks
Products
Initial Uses
Future Use
 Exposure      What exposures are experienced
 (Continued)   by populations affected by
               EDCs?
Quantitate exposure in
populations showing effects of
EDCs, particularly those with
developmental exposures.
Delineation of causes and effects  To conduct preliminary risk
which can set the bounds on     assessments.
effects in less highly exposed     T() deve|op remedia, actions where
P°Pulahons                    adverse effects of EDCs in the
                               environment have been confirmed.
Assessment    What strengths and weaknesses
               are present in assessment of
               existing information on EDCs
               and related topics?
Convene EPA working group to  Report of literature review.
critically review existing
biological effects information.
                               To refine ORD's research strategy.
                               To develop regulatory policy on
                               EDCs.
'EDC - endocrine-disrupting chemical.
bQSAR - quantitative structure-activity relationship.
1PBI'K = physiologically based pharmacokmetic
1 HBDK =- biologically based dose-response.
                                                                                                                                                                 A
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 Table A-7.  Pollution Prevention and New Technology
Subtopic
Strategic Focus
Tasks
Products
Initial Uses
Future Uses
                                                                                                                                               •o
                                                                                                                                               •o
Risk
Management
How can pollution
prevention strategies be
integrated into federal,
state, and private sector
decision-making?
Develop life-cycle
assessment (LCA) tools and
models.
LCA tools that include health
and ecological impacts.
To demonstrate how LCA can
evaluate options for multimedia
pollution prevention and risk
management that are keyed to
the greatest risks.
As objective, scientifically
credible LCA procedures
for regulatory and private-
sector use.
                                           Develop pollution
                                           prevention modules for
                                           industrial plant, product,
                                           and process design
                                           procedures.
                                                    Generic and specific LCA case
                                                    studies with private and
                                                    public sector partners.
                                                    Mathematical models and
                                                    computer-based simulators
                                                    for process design.
                                                        To establish partnerships to
                                                        demonstrate risk-based
                                                        pollution prevention design and
                                                        process simulation
                                                        opportunities.
                                           Develop pollution
                                           prevention measurement
                                           and audit tools for small
                                           businesses.
                                                    Pollution prevention
                                                    accounting methods and
                                                    models.
                                                    Audit procedures for
                                                    pollution prevention.
                                                        As tools for measuring and
                                                        estimating "pollution
                                                        prevented" in small businesses.
                  How can pollution be
                  prevented?
                         Develop precompetitive
                         and enabling pollution
                         prevention and innovative
                         technologies for major
                         industrial sectors.
                           Pollution prevention and
                           innovative technologies for
                           Common Sense
                           Initiative-related industrial
                           sectors and high-risk problems,
                           including information on
                           technology costs.
                             To improve technical and cost
                             data and designs for pollution
                             prevention and innovative
                             technologies keyed on CSI
                             industries and other high-risk
                             needs.
                                                            Lor commercial plant and
                                                            process design methods,
                                                            models, and procedures.
                                                            To provide technology
                                                            transfer to the private
                                                            sectors through
                                                            Cooperative Research and
                                                            Development Agreements
                                                            and licensing agreements.
                                                            7o provide technical
                                                            guidance for regulatory
                                                            programs and private
                                                            sector needs
                               To provide a basis for
                               commercially available
                               pollution prevention and
                               innovative technologies for
                               a wide array of U.S.
                               industrial sectors and
                               high-risk problem areas
                                           Evaluate and verify these
                                           technologies for technical
                                           performance and
                                           cost-effectiveness.
                                                    Technology verification
                                                    protocols, third-party
                                                    verification organizations, and
                                                    outreach to technology
                                                    enablers and users.
                                                    Performance and cost data for
                                                    pollution prevention and
                                                    innovative technologies.
                                                        Enhanced and more credible
                                                        information to inform
                                                        decision-makers about
                                                        pollution prevention and
                                                        innovative technology options
                                                        emphasizing both performance
                                                        and cost.
                                                            As a basis for developing
                                                            scientifically credible and
                                                            commercially available
                                                            pollution prevention and
                                                            innovative technologies for
                                                            both U.S. and foreign
                                                            markets.
                                                                                                                                                  (Contimii'tl)

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 Table A-7.  Pollution Prevention and New Technology (Continued)
Subtopic
Strategic Focus
Tasks
Products
Initial Uses
Future Uses
Risk
Management
(Continued)
How can reliable and
appropriate cost data be
generated for pollution
prevention and
innovative technologies?
Develop process cost
models for pollution
prevention and innovative
technologies.
Develop cost data reporting
standards and protocols for
improved cost
comparability.
Cost estimating and reporting
protocols and standards.
To improve cost estimating
tools for use in
cost-effectiveness and
cost-benefit methods
development.
To provide reliable,
scientifically credible
cost-estimation packages
for environmentally
preferable approaches and
technologies.
                                          Develop engineering and
                                          performance costs for
                                          pollution prevention and
                                          innovative technologies.
                                                   Cost data for pollution
                                                   prevention and innovative
                                                   technologies.
                                                        For cost-benefit assessments by
                                                        EPA and other regulatory and
                                                        nonregulatory decision-makers.
                                                           For cost-benefit
                                                           assessments by EPA and
                                                           other regulatory and
                                                           nonregulatory
                                                           decision-makers.
                 How can pollution
                 prevention and
                 innovative technologies
                 be disseminated to effect
                 a reduction in
                 environmental risk
                 worldwide?
                        Identify specific industry
                        and government audiences
                        worldwide, their needs for
                        information, and
                        appropriate products to
                        meet those needs (e.g.,
                        seminars, bulletins,
                        demons tra tions).
                           A variety of technology
                           transfer products
                           disseminated via the Internet,
                           teleconferencing, electronic
                           bulletin board, and other more
                           conventional means (e.g.,
                           reports, workshops).
                             To increase the awareness and
                             knowledge of environmental
                             professionals and others about
                             the validity and benefits of
                             pollution prevention and
                             innovative technologies,
                             thereby leading to their
                             increased application and
                             broader use.
                             To improve decision-making
                             among innovative technology
                             users and permitting officials.
                              To support widespread use
                              of applicable pollution
                              prevention and innovative
                              technologies that maximize
                              risk reduction.
                                                                    Industry-targeted information
                                                                    dissemination products that
                                                                    will include technical and cost
                                                                    data and performance
                                                                    analyses.
                                                                                To improve environmental
                                                                                compliance and reduce
                                                                                compliance costs.
                                                                                      To encourage the private
                                                                                      sector to value and
                                                                                      routinely use pollution
                                                                                      prevention and innovative
                                                                                      technologies as the first or
                                                                                      only preference for
                                                                                      environmental protection
                                                                                      and compliance.
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Appendix B
The ORD Organization
ORD's new organization, depicted below, mirrors
the risk assessment/risk management
paradigm:
ORD's New Risk-Based Organization
The National Health and Environmental Effects
Research Laboratory investigates the potential ef-
fects of stressors on humans and ecosystems. This

Office of Resource

Assistant Administrator for Research and Development

Administration for Management Administrator for Science




National Health and
Environmental Effects
Research Laboratory





















— Management and
Coordination
Division (RTF, NC/
Washington. DC)
Research and
— Administrative
Support Division
(RTF. NC)
Developmental
— Toxicology Division
(RTP. NC)
Environmental
— Toxicology Division
(RTP, NC)
Environmental
— Carcinogenesis
Division (RTP. NC)
Neurotoxicology
- Division (RTP, NC)
Human Studies
- Division (RTP. NC)
Gulf Ecology Division
- (Gulf Breeze, FL)
Mid-Continent
— Ecology Division
(Duluth. MN)
Western Ecology
— Division
National - National Center
Exposure for Environmental
Research Assessment


— Communications and Office
Liaison Staff _ NCEA Washington,
(Washington. DC) Dc office
- Program Operations l_ NCEA Cincinnati
Staff (RTP. NC) OHOffke
— Atmospheric
Processes Research
Division (RTP. NC)
— Air Measurements
Research Division
(RTP. NC)

Mode ing Division
(RTP. NC)
— Air Exposure
Research Division
(RTP. NC)
— Human Exposure
Research Division
(Cincinnati. OH)
— Ecological Research
Division







Office of Science Policy i:

Office
of Research and
Science Integration




National Risk
Management
Research




— Water Supply and
Water Resources
Division
(Cincinnati, OH)
— Land Remediation
and Pollution
Control Division
(Cincinnati, OH)
— Sustainable
Technology Division
(Cincinnati. OH)
— Air Pollution
Prevention and
Control Division
(RTP, NC)
— Subsurface


National Center
for Environmental
Research and













— Environmental
Engineering
Research Division
(Washington, DC)
— Environmental
Sciences Research
Division
(Washington. DC)
— Quality Assurance
Division
(Washington, DC)
L- Peer Review Division
(Washington. DC)
Protection and
Remediation Division
(Ada. OK)
— Technology Transfer
and Support Division
(Cincinnati. OH)






(Cincinnati. OH) - lecnnologv
Coordination Staff
— Characterization (Washington. DC)
Research Division
(Las Vegas. NV)
I— Ecosystems Research
(Corvallis, OR) Division
Atlantic Ecology (Athens. GA)
"— Division
(Narragansett. Rl)



































                     STRATEGIC Pi AN FOR OR0
                       4S

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Appendix B

   work provides the scientific basis for hazard identi-
   fication and dose-response assessment.
•  The National Exposure Research Laboratory
   measures and predicts the extent to which hu-
   mans and ecological resources are exposed to
   pollutants and other stressors. This work pro-
   vides the basis for exposure assessment.
•  ORD's National Center for Environmental
   Assessment serves as a national resource center
   for the overall process of risk assessment:
   integrating hazard, dose-response, and exposure
   data and models to produce risk characterizations.
•  ORD's National Risk Management Research
   Laboratory supports risk management by develop-
   ing, evaluating, and disseminating effective tools
                    and approaches for preventing or reducing cur-
                    rent and anticipated risks to human health and
                    the environment.
                    ORD also has created a National Center for Envi-
                    ronmental Research and Quality Assurance
                    (NCERQA), which represents a major and
                    renewed commitment by ORD to help EPA
                    achieve the highest possible quality of science.
                    NCERQA's main purpose is to direct ORD's
                    newly expanded external grants and fellowship
                    programs, which are designed to involve the
                    nation's top scientists and engineers in research
                    issues of importance to the Agency. NCERQA
                    also provides managerial oversight of EPA
                    quality assurance programs.
  40
STRAT86JC PlAN FOB  ORD

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Appendix  C
Management  Structure  for
Implementing  ORD's
Strategic  Plan
      Successful implementation of ORD's Strategic
      Plan requires coordinated input and involve-
      ment by all ORD laboratories, centers, and
      offices as well as EPA's program and
regional offices. Several councils and teams,
illustrated and described below, provide mecha-
nisms for this participation. Collectively, these
groups involve all levels of ORD senior manage-
ment from ORD's Assistant Administrator through
to ORD's Assistant Laboratory Directors (see figure).
The Research Coordination Council and ORD's
Research Coordination Teams, described below,
provide mechanisms for program and regional
office involvement.

Executive Council

ORD's Executive Council is chaired by ORD's Assis-
tant Administrator and consists of ORD's  Deputy
Assistant Administrators for Science and Manage-
ment and the Directors of ORD's national
laboratories, centers, and offices. The Executive
Council serves as the primary decision-making
body for major planning and management deci-
sions. Based on input from the Management and
Science Councils, Research Coordination Council,
and Research Coordination Teams, the Executive
Council coordinates major policy and budget issues
across ORD, including consensus recommendations
to ORD's Assistant Administrator.

Management Council

ORD's Management Council is chaired by ORD's
Deputy Assistant Administrator for Management
and includes the Deputy Assistant Administrator for
Science as an ex officio member, the Director of ORD's
Office of Resource Management and Administration
(who serves as the Vice Chair), and the Deputy Di-
rectors for Management of ORD's laboratories and
centers. ORD's Management Council provides sen-
ior management leadership for developing and
implementing effective management policies, proce-
dures, and systems. For example, the Management
Council is leading the development of ORD's Man-
agement Information System, a management system
to ensure that ORD's resources are efficiently admin-
istered. The Management Council also provides
input, feedback, and guidance on issues that signifi-
cantly affect ORD's overall management operations.

Science Council

ORD's Science Council is chaired by ORD's Deputy
Assistant Administrator for Science and includes the
Deputy Assistant Administrator for Management as
an ex officio member. Science Council members pro-
vide a balance between health and ecological
research. They include the Associate Directors for
Health and Ecology of ORD's national laboratories
and centers, the Associate Director for Science of
ORD's National Center for Environmental Research
and Quality Assurance, and the Director of ORD's
Office of Research and Science Integration.
The Science Council serves as the principal forum
for identifying, discussing, and providing advice
and recommendations to ORD's Assistant Adminis-
trator on scientific and technical issues that
significantly affect ORD's overall scientific and tech-
nical operations. For example, the Science Council
had the lead role in developing ORD's Strategic
Plan and will review all research plans.
                             STRATEGIC FIAN FOR OR0
                                  47

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QB ORD Management Structure







^
?
n
n
H
t
o
»
O
50
G>









Office of Resource
Management and


H



Assistant Administrator for Research and
Deputy Assistant Del
AU 	 1»lldUu" " Administrator for
Director Management



I 1
1 1













National Health and
Environmental Effects
Research Laboratory
Director
Deputy Director for
/Management


Associate Associate
Ofrecwrfor C8nec«w&f
Ecotogy Health
Assistonf laboratory
Directors for Air, Water,
Waste, Twdcahgy/
Pesticides, and Multimedia














National Exposure
Research Laboratory

Director
Deputy Director for
Management


Associate Associate
Director for Directorfor
Ecotegy HeaWi
Assistant laboratory
Waste, Toxicology/
Pestfeiaes,ondrVtuftimeuty Assistant
Administrator for

Office of Science Policy
Director
Office of Research and
Cf-irtnrn
JC'LrM-1- """" •" Science Inlegialion
* Director
*
• Research
Coordination
II Representatives from the
1 EPA program «nd regional
National Center for
Environmental Assessment


OJrector
Deputy Director for
Manai


Associate
Director fcr
£<«%
Cement


Associate
Direcwrfor
HeoWi
Assistant Cenf i Directors
/or Air, Water, Waste,
raxta*^/rV
>$ticWes,and
Multimedia













National Risk Management
Research Laboratory

Director
Deputy Director for
Management


Associate Associate
Directorfor Directorfor
MV IM»
Assistont Laboratory Direaors
for Air, Water, Waste,
Toxteofogy/ P«*c«
-------
Research Coordination Council
The Research Coordination Council is a group of
senior staff representing all EPA program and
regional offices and their respective Assistant
Administrators or Regional Administrators. The
Research Coordination Council serves as a focal
point for integration between ORD and EPA's
program and regional offices. The Council provides
ORD with a cross-agency perspective, participates
in ORD's planning process, and recommends poten-
tial topics for ORD's research agenda and
extramural grants program.

Research Coordination Teams
The Research Coordination Teams coordinate ORD's
research program with ORD's clients and across ORD
laboratories and centers. Organized by environmental
media (air, water, waste, toxics/pesticides, and
                               Appendix C

multimedia), the teams assess ORD clients' needs,
recommend research priorities, monitor ORD pro-
gress toward meeting these priorities, facilitate
integration of intramural and extramural research
activities, and ensure communication of results to
ORD clients. Each Research Coordination Team
includes a Team Leader from ORD's Office of
Research and Science Integration, the Assistant
Laboratory Directors from ORD's laboratories and
centers, a program analyst from ORD's Office of
Resource Management and Administration, a
representative from ORD's National Center for
Environmental Research and Quality Assurance to
provide input on ORD's grants program, and repre-
sentatives from EPA's program and regional offices.
The Research Coordination Teams take the lead in
developing ORD's research plans and in organizing
and conducting media-based program reviews of
ORD progress and outputs.
                                   STRATEGIC Ft AN  FOR ORJ>

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THIS PAGE INTENTIONALLY
        BLANK

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 ORD Response to Blue-Ribbon Panel Recommendations
 Recommended Action
                          ORD Response
 EPA should take steps to improve science
 quality and enhance peer review.^'
 ORD needs a coherent research-planning
 process, a robust mission statement, and a
 vision statement.1"1
c.d.i.i
 ORD should enhance environmental
 education programs for training the next
 generation of scientists
     , a.d.e
We instituted standard operating procedures for peer review in 1994.
To engage the nation's best research institutions, we expanded our program for
extramural research grants selected from competitive, peer-reviewed proposals.
We created a Peer Review Division in our National Center for Environmental Research
and Quality Assurance.
We developed the ORD Strategic Plan (this document) and distributed it for comment
in November 1995.
We implemented a risk-based research planning process.
We realigned ORD's organizational structure to use risk assessment and risk
management as principal priority-setting criteria.
We initiated an expanded graduate fellowship program initiated, with 100 awards in
1995.
 ORD should streamline its existing
 laboratory organization by collapsing the
 twelve laboratories into four national
 laboratories.11'h
                          We consolidated ORD laboratories into three national laboratories and two centers in
                          1995 to align laboratories according to risk assessment and risk management
                          components.
 ORD should improve its management
 systems to track planning resources and
 accomplishments.glh
                          We are developing the ORD Management Information System to track resources and
                          projects on an ORD-wide basis.
                          We established a Management Council, a Science Council, and (together with the
                          program offices and regions) a Research Coordination Council (see Appendix C of this
                          Strategic Plan).
                          We will conduct annual research program reviews to evaluate the status and
                          accomplishments of our research.
                          We are developing research plans to inform internal and external audiences about the
                          policy relevance, specific objectives, technical approaches, and expected products of our
                          research.
 ORD should balance short-term and
 long-term research.11'6'8'1
 ORD should balance health and ecological
 research.ax
 EPA should designate ORD's Assistant
 Administrator (AA/ORD) as the Agency's
 Chief Scientific Officer.1
                          In 1995, we created the Science To Achieve Results (STAK) Program of peer-reviewed
                          investigator-initiated grants relevant to ORD's mission.
                          As described in this Strategic Plan, we give equal consideration to short- and long-term
                          research needs in our priority-setting process.
                          We have adopted a balance between ecological risks and human health risks as a major
                          strategic principle (see Table 1 of this Strategic Plan).
                          We appointed Laboratory Associate Directors for Health and Ecology for each national
                          laboratory.
                          The EPA Deputy Administrator appointed the AA/ORD as EPA's Scientific and
                          Technical Activities Planner in March 1995.
 EPA must improve its capability to
 anticipate environmental problems.'
                          EPA signed an agreement in 1995 with the National Research Council to establish a
                          group to review environmental issues for the next decade and recommend necessary
                          research.
'Future Risk:  Research Strategies for the 1990s. U.S. EPA, Science Advisory Board.  1988.
b Reducing Risks:  Setting Priorities and Strategies for Environmental Protection. U.S. EPA, Science Advisory Board. 1990.
''Safeguarding the Future: Credible Science, Credible Decisions. Report of the Expert Panel on the Role of Science at EPA.  U.S. EPA. 1992.
 Enrironmental Research and Dei'elopment: Strengthen the Federal Infrastructure. The Carnegie Commission. 1992.
"Research to Protect, Restore, and Manage the Environment.  National Research Council. 1993.
'Assessment of the Scientific and Technical Laboratories and Facilities of the U.S. EPA. MITRE Corporation. May 1994.
sAn SAB Report:  Re-cieu* of the MITRE Corp. Draft Report on the EPA Laboratory Study. U.S. EPA, Science Advisory Board/Research Strateo
 Advisory Council. May 1994.
hA Rerieu',  Evaluation and Critique of a Study of EPA Laboratories by the MITRE Corporation and Additional Commentary on EPA Science and TV ••
 Programs. National Academy of Public Administration.  June 1994.
'Setting Priorities, Getting Results: A Netu Direction for EPA. National Academy of Public Administration.  April 1995.
'Interim Report of the Committee on Research and Peer Review in EPA.  National Research Council. March 1995.

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