ORD’s Strategy for Planning Research

Figure

Setting Research Prio!

+ ORD National Laboratories and Centers
* EPA Program Offices
* Research Coordination Council
*EPA Regional Offices

Identify Research Topi

External Scientific Community Input:

* EPA Science Advisory Board
* National Research Council
* Private Sector

ics

Is the
Topic Clearly
Mandated?"

Yes

‘the Topic
Within ORD's
Mission and
Goals?

Reject for
ORD
Funding?

Apply Evaluation Criteria:

Human Health/Ecological Health |
* Risk Management
* Methods/Models

Determine Research Needs:
ORD Make * Effects
a Significant * Exposure
Contribution? * Risk Characterization
* Risk Management

Reject for
‘ORD
Funding?

Conduct Research
(In-house, Grant, Coop, Contract, etc.) |

Research Products

‘in other words, ORD has no discretion to reject or delay this research.
2EPA Program Offices and Regions may still choose to fund, using ORD labs, grants, contracts, etc., or a research source outside of ORD.



ummary of EPA/ORD Research Program for Six High-P.

ics (Continued)

Research Topics Strategic Focus Tasks Products Uses

Pollution How can we best identify, Develop working partnerships between EPA Program Office and Regional _To establish partnerships for
Prevention and develop, and apply technology developers and environmental _ Needs Inventories, NASA identifying specific monitoring
New advanced measurement policy makers and managers to enhance the Technology Workshops, EPA/DOE __ technology needs and requirements,

Technologies for tools and enabling use of policy drivers in the development Partnerships, internal research on and subsequent matches with

Environmental _ technologies to support and adoption of new technologies. remote sensing applications to relevant environmental
Protection environmental protection? environmental measurements, technologies.
(Continued) Organize ongoing activities in EPA to focus advanced monitoring pilot projects

them on applying and adopting advanced
measurement and companion technologies

to environmental protection needs.

Work with organizations to leverage their

investments in advanced technologies.

to evaluate currently feasible
applications, research to address
fundamental concepts of ecosystem
rehabilitation, and identification of
opportunities for developing
domestic and international
commercial markets for applying
advanced technologies to
environmental issues.

To sponsor a number of directed
technology application projects and
demonstrations.

To facilitate the commercial
adoption of advanced monitoring
technologies to meet the needs of
EPA, the regulated community, and
the public.

To facilitate the export of American
technologies to international
markets.

*FQPA = Food Quality Protection Act.
>sDWA = Safe Drinking Water Act.

yoaeasay Ayolid-481H S,a80


ORD's High-Priority Research

Atmospheric Administration) are working cooperatively
to identify, evaluate, and develop new advanced tech-
nology solutions.

Specifically, ORD has initiated a program—the
Advanced Measurement Initiative (AMI)—to guide the
identification, research, and application of advanced
monitoring tools and enabling technologies in support
of EPA’s mission. Examples of the kinds of technologies
to be evaluated include:

@ Thermal infrared sensing of water and watersheds

@ Light Detection and Ranging (LIDAR) measurements
of air pollutants

@ Very high-resolution, visible and infrared wavelength
imaging of polluted land areas

AMI’s initial emphasis has been applications for remote-
ly sensed information, with NASA and DOE as primary

partners. We will progress to investigating other (e.g., in
situ) monitoring approaches and will expand to include

other agencies and nonfederal developers.

In addition to AMI, the application of high-performance
computing to environmental science can improve our
ability to access and use data, environmental models,
and graphical /analytical tools for informed, risk-based
decision-making. Further, the demonstration of new tech-
nologies through activities such as the Environmental
Technology Verification Program will accelerate develop-
ment by independently and objectively verifying and
reporting technology performance under real-world
conditions.

Because of the broad applicability of these new or
improved technical solutions to environmental prob-
Jems, their significant potential for enhancing risk
assessment and risk management, the potentially large
economic and environmental benefits of these approach-
es, and the opportunities to leverage EPA’s resources,
pollution prevention and new technologies are of high
priority for ORD’‘s research agenda.



Table Particulate Matter

Subtopic

Strategic Focus

Tasks

Products

Uses

Health Effects

What health effects are caused
by particulate matter (PM) and
its components?

What is the role of copollutants
in producing PM toxicity?

Conduct epidemiologic studies of
mortality and morbidity coupled with
improved exposure characterization.

Conduct clinical studies of respiratory
effects in controlled human studies.

Qualitative and
quantitative data on
mortality and/or
respiratory diseases.

To provide health effects data for risk assessment
(Criteria Document) to support PM National
Ambient Air Quality Standards (NAAQS).

What are the causal
mechanisms particles that
explain/support epidemiologic
observations?

Conduct animal and clinical studies of
biochemical and physiologic events
initiated by PM and its components.

Dose-response data
describing biochemical
and physiologic events
induced by PM and their
relationship to disease.

To provide health effects data for risk assessment
(Criteria Document) to support PM NAAQS.

What is the relationship
between PM exposure and
dose?

What is the role of dose for
effects in sensitive
subpopulations?

Develop dosimetric model of particle
deposition in the lungs under various
exposure and population conditions.

Dosimetric model
linking animals to
humans and normal
humans to sensitive
subpopulations (e.g.,
children, individuals
with preexisting disease).

To provide health effects data for risk assessment
(Criteria Document) to support PM NAAQS.

Exposure

What species and concentration
levels of PM, and important
copollutants, are people
exposed to?

Develop ambient PM measurement
methodology capable of discriminating
particles by size and species.

Methods for measuring
fine-particle mass and
characterizing species
(eg, acid aerosols,
inorganic and organic
species).

To serve as a Federal Reference Method for new
fine-particle NAAQS.

To provide PM methodology for atmospheric
chemistry research and total exposure research.

Conduct PM size and species
characterization studies.

PM characterization
data.

To assess PM size and concentration levels for
regulatory development and epidemiologic study
design.

To identify sources of PM and address PM
formation, transport, and fate.

To help develop control strategies for
implementing PM regulation(s).

(Continued)


include characterizing the sources of environmental
problems; identifying risk management options and
evaluating their performance, cost, and effectiveness;
and monitoring improvements in environmental quality
and public health that result from risk management
activities. ORD contributes to many of the areas depict-
ed in Figure 2. In this way, ORD not only identifies and
characterizes environmental problems but also helps to
find and implement efficient, cost-effective solutions

to these problems.

Audiences for This Document

This Strategic Plan is an important document for many
different groups:

m Within ORD, the plan provides ORD staff with a
blueprint for designing and implementing ORD’s
research program in the years to come. Also, it
enables ORD staff to relate the individual research
projects for which they are responsible to ORD’s
strategic goals and objectives, as well as to the
Agency’s environmental goal of “ensuring that the
nation’s environmental policies are based on the best
science and information available.”

@ For our many stakeholders, including EPA’s Program
and Regional Offices, academia, the private sector,
and other government agencies, the plan serves as a
roadmap that:

¢ Explains how we plan research and translate our
plans into a research program.

¢ Defines an explicit role for stakeholders in crafting
and reviewing ORD’s research agenda.

¢ Specifies goals, objectives, and products that can
be used to measure and hold us accountable for
our progress in environmental research.

Critical Players and Linkages for
Implementing ORD’s Strategic Plan

The success of ORD’s Strategic Plan relies on the contri-
butions of many individuals, institutions, and sectors,
as described below.

ORD Staff

First and foremost, ORD staff are crucial to the plan’s
success. ORD’s scientists and engineers, in particular,
are the repository of the core scientific and engineering
capability in the Agency, as well as a vital conduit for

introduction

the needs and potential contributions of ORD’s research
clients and partners.

Successful implementation of the Strategic Plan will
depend on the success of ORD managers in communi-
cating the plan to all our staff and in earning a sense of
ownership of the plan and a shared vision of the work
to be accomplished. While leadership for communicat-
ing this plan must cascade through ORD’s management
to our scientific, engineering, managerial, administra-
tive, and clerical staff, ownership and implementation
of the plan will depend on the expertise and dedication
of our work force. ORD will place a continuing priority
on “360-degree” communication and support to enable
and inspire effective implementation of this plan.

At its First Annual Workshop on Managing Change in
December 1996, ORD identified five cross-organiza-
tional improvement opportunities to improve our
products, processes, and work environment. These five
improvement opportunities (described in more detail
on page 23 of this document) are: reducing red tape,
improving communications, enhancing career develop-
ment, providing adequate infrastructure to support
ORD science, and integrating science with EPA’s mis-
sion. In summarizing the next steps for implementing
these organizational improvement measures, ORD staff

igure 3. ORD’s Strategic Pl

Role of
Science
at EPA

Long-Term
Goals

Strategic
Principles PDP

Activities to
Meet the a
Objectives q Y

High-
Priority
Research
Topics



(
ORD Management Structure

Office of Resource Assistant Administrator for Research and Development -
Management and Deputy Assistant Deputy Assistant Office of Science Policy
‘Administration Administrator for Administrator for Director
Director Management Science

National Center for National Risk Management National Center for
Environmental Assessment Research Laboratory Environmental Research and
Quality Assurance:

National Health and
Environmental Effects
Research Laboratory

National Exposure
Research Laboratory

> xipueddy


Products

Uses

Table 9. Research to Improve Health Risk Assessment (Continued)
Subtopic Strategic Focus Tasks
Hazard How can we Develop screening methods to set
Identification improve our ability _ testing priorities.
and to detect hazards?
Characterization

Validated screening protocols
using, for example, in vivo, in
vitro, and structural activity
relationship (SAR) methods.

To identify and rank existing pesticides and industrial
chemicals in terms of potential toxicity.

To screen new chemicals as they enter the regulatory
system; to assess relative toxicity.

Develop cost-effective methods
for toxicity data collection.

New and revised standard
toxicity testing protocols.

To develop Agency test guidelines.

To support regulatory activities (e.g., TSCA* test rules
and consent agreements, FIFRA® data call-ins).

How can we better
interpret toxicity
data to predict and
define hazards?

Develop improved methods for
data interpretation. For example,
identify biomarkers of exposure
and effect and validate the use of
biomarkers in human populations.

Guidance document on
interpretation of toxicity data.

For incorporation into risk assessment guidelines.

Dose-Response
Relationship

How can we reduce
uncertainty in
extrapolations (e.g.,
from high doses in

Develop quantitative models for
predicting tissue and organism
response to target tissue dose (i.e.,
biologically based dose-response
animals to models).
environmental

exposures in

Models for predicting toxicity
due to chemical exposures, which
can be modified and applied in
chemical-specific risk
assessments.

To provide critical examples of development and use of
mechanistic models; to evaluate the potential of these
models for replacing default approaches for cancer and
noncancer risk assessment.

To provide a state-of-the-science basis for replacing
default, primarily empirical risk assessment approaches.

humans)? Develop improved empirical

dose-response models (e.g,,
benchmark dose models)

Validated benchmark dose
models and guidelines for
applications.

To improve reference dose concentration procedures and

thereby improve the basis for risk management decisions.

*TSCA = Toxic Sub:
>EIFRA = Federal I

stances Control Act.
Insecticide, Fungicide, and Rodenticide Act.

yoaeasay Ayolid-4Y3IH S,qduO


Table 8. arch to Improve Ecosystem Risk Assessment (Continued)
Subtopic Strategic Focus Tasks Products Uses
Risk What options are available Evaluate alternative Risk managment strategies that To assist researchers and stakeholders in identifying
Management to manage the risk? management options. take advantage of pollution cost-effective risk management options and to
prevention and the provide guidance on how best to maintain or improve
How are degraded systems Conduct ecosystem self-purifying potential of conditions now, and in the future.
best restored? restoration studies. natural systems.

Document techniques for
restoring valued ecosystems.



Table 10.

Pollution Prevention and New Technologies for Environmental Protection (Continued)

Subtopic Strategic Focus Tasks Products Uses

Risk How can reliable and Develop process cost models for Cost-estimating and reporting protocols To improve cost-estimating tools for use in
Management appropriate cost data be pollution prevention approaches. and standards. cost-effectiveness and cost-benefit
(Continued) generated for pollution methods development and analysis.

prevention approaches?

Develop cost data reporting
standards and protocols for
improved cost comparability.

To provide reliable, scientifically credible
cost-estimation packages for
environmentally preferable approaches to
preventing pollution.

Develop engineering and
performance costs for pollution
prevention approaches.

Cost data for pollution prevention
approaches.

To improve cost-benefit assessments by
EPA and other regulatory and
nonregulatory decision-makers.

How can pollution
prevention results and
information be disseminated
to affect a reduction in
environmental risk
worldwide?

Identify specific industry and
government audiences
worldwide, their needs for
information, and appropriate
products to meet those needs
(e.g., seminars, bulletins,
demonstrations).

A variety of technology transfer
products disseminated via the Internet,
teleconferencing, electronic bulletin
board, and other more conventional
means (e.g., reports, workshops).

To increase the awareness and knowledge
of environmental professionals and others
about the validity and benefits of
pollution prevention, thereby leading to
its increased application and broader use.

To improve decision-making among
pollution prevention practitioners and
permitting officials.

To support widespread use of applicable
pollution prevention approaches that
maximize risk reduction.

Industry-targeted information
dissemination that includes 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 as
the first or only preference for
environmental protection and compliance.

How can we encourage

The Small Business Innovative

private sector development of Research Program was

advanced technologies?

established for this purpose.

Private sector development of advanced
monitoring sensors, instruments, and
data systems.

To support private sector developers of
innovative technologies.

(Continued)

yoseesey Atsolsd-y2IH $,a4NO


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

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

Objectives
Within this goal area, ORD will work to:

@ Integrate fate and transport modeling techniques
with biologically based models needed in human
health and ecological risk assessment.

@ Integrate human health and ecological exposure and
trends monitoring research.

@ Better understand the relationship between human
health and the condition of ecosystems (e.g., to assess
the impact of human consumption of contaminated
fish or wildlife or the influence of landscape
characteristics and climate interactions on disease
vectors such as mosquitoes, ticks, and rodents).

@ Develop tools and techniques to facilitate the
assessment of relative risks to human health and the
environment.

@ Harmonize extrapolation methodologies for relating
data on toxicity mechanisms for endocrine
disruptors, immunotoxins, developmental hazards,
and other chemicals with effects in sensitive human
subpopulations, wildlife, and aquatic organisms.

@ Improve extrapolation models by integrating
toxicologic and mechanistic data obtained in laboratory
and field investigations (epidemiology and ecology).

Appendix A

@ Identify and validate wildlife species as sentinels for
human health risks.

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

To enhance the practicality and cost-effectiveness of the
products of ORD’s risk management research, we are
changing the way we study pollution control and pre-
vention, contaminated site and spill remediation, and
technology development. To the extent possible, we are
integrating our air, water, and waste-related research,
and we are increasingly focusing on emerging, high-risk
problems—all so that we can better help regions, com-
munities, and the private sector analyze pollution
problems and achieve risk reductions efficiently and
cost-effectively. This common-sense approach will seek
to maximize the health and environmental benefits of
risk management by focusing risk management research
on those aspects of a process or situation that cause the
greatest risks.

To that end, our pollution prevention and control
research will now focus on multimedia life-cycle analy-
ses, green technologies, and pollution prevention meth-
ods that small- and medium-sized companies can use to
achieve significant reductions in risk across media. Our
maturing site and spill remediation program will con-
centrate on developing cleanup options for complex risk
situations and faster, lower-cost natural recovery sys-
tems. In addition, we will continue forging partnerships
with the private sector to analyze high-risk needs and to
develop, evaluate, and verify new pollution prevention
and risk reduction technologies.

We have also begun efforts in ecosystem restoration and
cost-benefit assessment. Our ecosystem restoration
research (connected to that described under Goal 1
above) will focus on developing and demonstrating
principles, technologies, and guidance materials that
regions and communities can use to help restore local
ecosystems. Our cost-benefit assessment research will
focus on developing a systematic approach to identify-
ing and reporting the benefits and costs of risk manage-
ment technologies and alternatives. Such an approach is
needed to satisfy the rapidly growing demand for cost-
benefit analyses to support environmental decision-
making—a demand engendered by the rising cost of
environmental protection in an era of limited resources.

_



Table 7. Endocrine Disruptors (Con\
Subtopic Strategic Focus

nued)

Tasks

Products

Linkage of Developing risk management
Effects, approaches to reduce or
Exposure, __¢liminate environmental

and Risk exposure to EDCs.
Management

(Continued)

Identify major sources of EDCs
entering the environment.

Develop tools for risk
management, such as
biodegradation processes or
pollution prevention strategies.

Risk management tools for
elimination or prevention of
exposures to significant EDCs.

To develop remedial actions where adverse effects
of EDCs have been documented.

*EDC = endocrine-disrupting chemical.
EQPA = Food Quality Protection Act.
“SDWA = Safe Drinking Water Act.



he steps involved in translating ORD’s

Strategic Plan into a research program are illus-

trated in Figure 7. Once we have identified our

high-priority research topics, we develop and
implement a research program based on these topics.
This involves:

m@ Developing science research strategies and plans.

m Deciding whether the work will be conducted in-
house or extramurally. (ORD’s research program is
comprised of intramural and extramural research.)

¢ For intramural research, developing budget operat-
ing plans and laboratory implementation plans.

* For extramural research, selecting and implement-
ing the appropriate mechanisms to access the
external scientific community.

TM Integrating information management into research
planning.

Developing Science Research
Strategies and Plans

Once ORD has identified its high-priority research top-
ics using the process described in pages 11 to 13, teams
composed of ORD scientists and engineers as well as
representatives of EPA’s Program and Regional Offices
develop science research strategies and plans for each
topic. These plans:

@ Lay out the major research components and
directions we will pursue over the next few years.

m Describe how these components fit into the risk
assessment/risk management paradigm.

@ Describe how the data and information to be
generated by the research will be used and managed.

@ Delineate the major outputs to be produced over the
next several years.



Table 5: Safe Drinking Wate fection
Subtopic Strategic Focus Tasks Products Uses
Health What dose levels of Conduct dose-response studies on Data for risk assessment models _To provide health effects data for risk assessments to

pathogens cause
illness in exposed
populations?

Effects

waterborne pathogens.

to predict disease incidence.

support upcoming surface water and ground-water
treatment rules.

What are the endemic
and epidemic illness
rates for waterborne
microbial disease?

Conduct epidemiology studies for
pathogen-caused disease.

Indication of magnitude of risks
and verification of risk models.

To provide health effects data for risk assessments to
support upcoming surface water and ground-water
treatment rules.

What are the relative
risks of disinfection
by-products (DBPs)
from different
disinfection processes?

Conduct epidemiology studies on
reproductive /developmental effects
and, if feasible, on cancer.

Qualitative/quantitative data on
cancer, reproductive effects, and
other effects.

Conduct toxicity studies on
individual DBPs and mixtures if
feasible.

Risk assessments for individual
DBPs.

To assess the risks of different disinfection processes,
combining epidemiology, toxicity, and mixtures
information, to support DBP rules.

What levels of
pathogens are people
exposed to?

Exposure

Develop analytical methods that
detect viable /infective organisms.

Practical analytical methods for
pathogens.

Identify sources of pathogens and
factors affecting occurrence levels,
transport, and fate in surface and
ground waters.

Analyses of pathogen occurrence
in source waters.

Information on pathogen
exposures in drinking water.

Information on microbial
pathogen survival, fate, and
transport in subsurface
environments.

Survey tool for developing occurrence data; basis for
compliance methods for water utilities.

‘To support exposure assessments to predict
pathogen occurrence in drinking water under
different treatment processes.

(Continued)


Appendix C

Management Structure
for Implementing
ORD’'s Strategic Plan

Successful implementation of ORD’s Strategic Plan
requires coordinated input and involvement by all ORD
Laboratories, Centers, and Offices as well as EPA’s
Program and Regional Offices. Several councils and
teams, illustrated and described below, provide mecha-
nisms for this participation. Collectively, these groups
involve all levels of ORD senior management from
ORD’s Assistant Administrator through to ORD’s
Assistant Laboratory Directors (see figure). The Research
Coordination Council and ORD’s Research Coordination
Teams, described below, provide mechanisms for
Program and Regional Office involvement. One of the
important roles of the councils and teams is to assure
upward communication from the experts in ORD’s
Laboratories and Centers.

Executive Council

ORD’s Executive Council is chaired by ORD’s Assistant
Administrator and consists of ORD’s Deputy Assistant
Administrators for Science and Management and the
Directors of ORD’s National Laboratories, Centers, and
Offices. The Executive Council serves as the primary
decision-making body for major planning and manage-
ment decisions. Based on input from the Management
and Science Councils, Research Coordination Council,
and Research Coordination Teams, the Executive
Council coordinates major policy and budget issues
across ORD, including consensus recommendations to
ORD’s Assistant Administrator.

Management Council

ORD’s Management Council is chaired by ORD’s
Deputy Assistant Administrator for Management and
includes the Deputy Assistant Administrator for Science

as an ex officio member, the Director of ORD’s Office of
Resources Management and Administration (who
serves as the Vice Chair), and the Deputy Directors for
Management of ORD’s Laboratories and Centers.
ORD’s Management Council provides senior manage-
ment leadership for developing and implementing
effective management policies, procedures, and sys-
tems. For example, the Management Council is leading
the development of ORD’s Management Information
System, a management system to ensure that ORD’s
resources are efficiently administered. The Management
Council also provides input, feedback, and guidance on
issues that significantly affect ORD’s overall manage-
ment operations.

Science Council

ORD’s Science Council is chaired by ORD’s Deputy
Assistant Administrator for Science and includes the
Deputy Assistant Administrator for Management as an
ex officio member. Science Council members provide a
balance between health and ecological research. They
include the Associate Directors for Health and Ecology
of ORD’s National Laboratories and Centers, the
Associate Director for Science of ORD’s National Center
for Environmental Research and Quality Assurance, the
Associate Director for Science of ORD’s Office of
Science Policy (OSP), and the Director of OSP.

The Science Council serves as the principal forum for
identifying, discussing, and providing advice and
recommendations to ORD’s Assistant Administrator on

scientific and technical issues that significantly affect
ORD’s overall scientific and technical operations. For
example, the Science Council had the lead role in
developing ORD’s first Strategic Plan and will review all
research plans.



Chapter 4: ORD’s High-Priority Research ..........0..00eeeeeeeeeee 25

Evolution of ORD Priority Areas Over Time .... 20.0.6... cece ccc cence nent ene n enn een en ees 26
Selection of the Six High-Priority Research Topics ........6 0.00. e cece cect e cnet e eee nent ene n teen eee 26
Appendix A: ORD’s Long-Term Goals and Objectives ............-..-. 55
Appendix B: The ORD Organization ..............0.0eceneeeeecees 63

Appendix C: Management Structure for Implementing
ORD’s Strategic Plan .. 2.0... eee eee eee 67

Appendix D: Relationship of Fiscal Year 1997 STAR Focused
Requests for Applications to ORD’s High-Priority Research ............ 71

Appendix E: Relationship of Fiscal Year 1997 and 1998
Program Enhancements to ORD’s High-Priority Research ............- 73



Appendix D

Relationship of Fiscal Year
1997 STAR Focused
Requests for Applications
(RFAs) to ORD’s High-
Priority Research



Human Resources Council

In fiscal year 1996, ORD established a Human Resources
Council to provide guidance and direction to ORD man-
agement in implementing ORD’s Human Resources
Program. Chaired by an ORD Laboratory Director as the
executive lead, the Council has 25 appointed employees
who represent each ORD Office, Laboratory, and Center,
with at least one representative from each geographical
unit. The representatives reflect ORD’s diversity in terms
of job types, gender, ethnicity, and grade. In addition,
the Council includes representatives from EPA’s Human
Resources Office; the labor unions who serve ORD
Offices, Laboratories, and Centers; and EPA’s Office of
Civil Rights. ORD’s Office of Resources Management
and Administration provides staff support and serves as
the executive secretary to the Council.

Research Coordination Council

The Research Coordination Council comprises the
Assistant Administrators from key Program Offices and
the EPA Regional Administrators, supported on a day-
to-day basis by their senior staff. The Research
Coordination Council serves as a focal point for integra-
tion between ORD and EPA’s Program and Regional
Offices. The Council provides ORD with a cross-agency
perspective, participates in ORD’s planning process,
and recommends potential topics for ORD’s research
agenda and extramural grants program. The Council is
supported by a steering committee made up of senior
scientists from their respective EPA offices

Appendix ¢

Research Coordination Teams

The Research Coordination Teams coordinate ORD’s
research program with ORD’s clients and across ORD
Laboratories and Centers. Organized by environmental
media (air, water, waste, toxics/pesticides, and multime-
dia), the teams assess ORD clients’ needs, recommend
research priorities, monitor ORD progress toward meet-
ing these priorities, facilitate integration of intramural
and extramural research activities, and ensure communi-
cation of results to ORD clients. Each Research
Coordination Team includes a Team Leader from ORD’s
Office of Science Policy, the Assistant Laboratory
Directors from ORD’s Laboratories and Centers, a
program analyst from ORD’s Office of Resources
Management and Administration, a representative from
ORD’s National Center for Environmental Research and
Quality Assurance to provide input on ORD’s grants
program, and representatives from EPA’s Program and
Regional Offices. The Research Coordination Teams take
the lead in developing ORD’s science research plans and
in organizing and conducting media-based program
reviews of ORD progress and outputs.



Appendix E

Relationship of Fiscal Year
1997 and 1998 Program
Enhancements to ORD’s
High-Priority Research



ORD’s High-Priority Research

government-wide framework to coordinate research
that specifically targets improving the risk assessment
process for EDCs. Primary endocrine-disruptor ques-
tions include:

m@ What are the effects of EDCs in exposed human and
wildlife populations?

@ What are the chemical classes of interest and their
potencies?

mTM What are the dose-response characteristics in the
low-dose region?

m Do ORD’s testing guidelines adequately evaluate
potential endocrine-mediated effects?

= What extrapolation tools are needed?

m What are the effects of exposure to multiple EDCs
and will a Toxicity Equivalence Factor approach be
applicable?

m How and to what degree are human and wildlife
populations exposed to EDCs?

m What are the major sources and environmental fates
of EDCs?

@ What is needed to assess risks to humans and
ecological systems?

m How can unreasonable risks be managed?

Answering these questions will require a coordinated
effort by the international research community.

At present, EDC research focuses heavily on develop-
ing methods for characterizing the hazards and risks of
EDCs, quantifying exposure levels, determining the
fate and transport of EDCs in the environment, and
developing extrapolation tools. If future research con-
cludes that humans and/or ecosystems are at signifi-
cant risk due to EDC exposure, research on how best to
lower the risks will be needed. At present, EDC sources
are poorly characterized and we know little about how
effectively current controls reduce EDC emissions. For
some EDCs, current controls may be inadequate or too
costly; for others, new approaches may be needed that
minimize generation and use of EDCs. As the EDC
research program matures, we anticipate increasing
attention on risk management activities.

Research to Improve Ecosystem
Risk Assessment

Ecosystems provide valuable renewable resources and
services such as food, water storage and flood control,

wood for construction, biodegradation and removal of
contaminants from air and water, pest and disease con-
trol, and moderation of climatic extremes. If these bene-
fits are impaired by man-made environmental stresses,
they must be replaced at great expense by civil works,
man-made chemicals, and increased use of nonrenew-
able energy supplies. In addition, healthy ecosystems
contribute to our quality of life through recreational
opportunities and scenic beauty.

We have made considerable progress in reducing the
most egregious forms of ecological harm from pollution,
such as areas of devastation around industrial plants
and burning rivers devoid of fish. However, much
remains to be understood if we are to avoid future dis-
asters, such as vector-borne epidemic disease, global cli-
mate change, forest decline, widespread epidemics of
toxic microorganisms in estuaries, reproductive failure
of wildlife, and destruction of critical habitat. In particu-
Jar, we need to better understand the vulnerability and
sustainability of our ecological resources within the con-
text of multiple stresses affecting multiple endpoints at
multiple scales. And, we need to develop the scientific
understanding and tools to better measure, model, and
maintain or restore the integrity and sustainability of
ecosystems at local, regional, and national scales now
and in the future. Specific research needs include:

TM@ Monitoring research to identify and characterize
those ecosystems most sensitive to anthropogenic
stresses.

m Processes and modeling research to predict future
stressor exposures and ecological effects at multiple
scales.

@ Risk assessment research to define the relative risk
posed by multiple stressors on the vulnerability and
sustainability of ecosystems.

@ Risk management and risk reduction research to
provide efficient options to manage and reduce the
risk of ecosystem degradation.

@ Research to maintain or restore the integrity and
sustainability of ecosystems.

This research is essential to significantly reduce the
uncertainty surrounding the difficult decisions we must
make to protect our ecological resources at local, regional,
and national levels. Because of the broad applicability

of this research (particularly its potential to help local
communities avoid costly environmental management
failures by better understanding the exposures to, effects
on, and restoration of our nation’s ecological resources)



© We then further narrow this pool of topics by
retaining only those areas where ORD can make a
significant contribution to environmental science.
Factors we consider at this stage include: Is the
work feasible from a scientific and resource per-
spective? Does ORD have access to the appropri-
ate expertise? What contributions are other
research organizations making to this area of
research?

@ For these remaining topics where ORD can make
a significant contribution, as well as all
nondiscretionary 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,

Figure

+ What type of effect would the research
investigate/mitigate and how severely
might this effect impact humans or
ecosystems?

* Over what time scale might this effect
occur?

* How easily can the effect be reversed,
and will it be passed on to future
generations?

+ What level of human or ecological
organization would be impacted by the
effect?

* On what geographic scale might this
effect impact humans or ecosystems?

ORD‘s Strategy for Planning Research

risk characterization, and risk management. At this
stage, we give priority to research that will make the
greatest contribution to reducing the uncertainty
associated with risk characterization, or will improve
the efficacy of or reduce the cost of risk management.

This approach to strategic planning clearly indicates the
following areas where ORD will reduce or eliminate
resources:

Exposure or effects research in areas of low risk or
where the risk is well characterized.

Risk reduction research in areas of low risk or where
cost-effective risk reduction approaches already exist.

Routine measurements and monitoring where
R&D has been completed or that does not support
R&D efforts.

Evaluating and Ranking Potential Research Topics

+ 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?

isk Masromment Citra :
+ 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?



Translating ORD’s Strategy into a Research Program

@ Planning and incorporating policies for information
management.

@ Making potential users aware that information exists.
B® Making the information accessible to users.
TM Making the information usable.

The plan sets forth an approach to managing all levels
and types of ORD information—from the scientific data
and information that result from ORD’s in-house or
extramural research (e.g., raw data collected at field
sites, health or ecological risk assessments, aggregated
data sets) to the administrative information needed to
manage ORD research (e.g., resource data, grant award
information, and laboratory implementation plans).

ORD’s information management plan will provide a
consistent, ORD-wide approach to efficiently planning
for, collecting, documenting, manipulating, exchanging,
archiving, and distributing science data and informa-
tion. It will address the full spectrum of ORD’s informa-
tion management needs, including data management;
policies and standards; management, staffing, and bud-
get issues; and electronic information technologies.

Information management planning for specific research
projects will commence as soon as ORD has identified
its specific project needs. For each research project, ORD
management and budget decisions will be made consid-
ering the entire project, from data collection through
long-term archiving of data sets. Information manage-
ment planning will, to differing degrees, encompass all
ORD research projects—including in-house research as
well as the extramural research that ORD funds with
contracts, cooperative agreements, and grants.

Measures of Success

In general, the success of a research organization can be
measured in several ways: by the number of articles
published in prestigious scientific journals, by the num-
ber of times that articles written by the organization’s
scientists are cited in other journal articles, and so on.
However, for a mission-oriented organization like ORD,
measures of the extent that we help and support EPA in
meeting its goals are equally crucial. In measuring the
success of this Strategic Plan, the quality of ORD’s
work, and the usefulness of our research products, we
will use the following measures of success.

Significance: Is ORD Working on the
Right Issues?

This is a measure that the EPA Program Offices and
Regions and the broad scientific community can help us
judge. For our research, development, and support
efforts to be useful, we must work on the most impor-
tant environmental issues and target areas for research
that will significantly improve risk assessment and/or
risk management in the Agency and elsewhere. Peer
review by scientists in the external scientific community
will assist us in judging significance.

Relevance: Is ORD Providing Data That
the Agency Can Use?

This question can best be answered by the rest of the
Agency and is best judged by the degree to which
ORD’s contributions support EPA decisions. ORD will
strive to ensure that its work is useful to the Agency and
has a positive impact on advancing EPA’s mission.
ORD’s new information management plan seeks to
ensure that we make our stakeholders aware of and able
to access ORD’s science data and information products.

Credibility: Is ORD Doing Research of
the Highest Quality?

ORD’s credibility can best be judged by the external sci-
entific community through such mechanisms as peer
review of ORD products, reviews of programs at the
ORD Laboratories, peer-reviewed journal articles, scien-
tific citations, and external recognition of both ORD and
its people. Further, we will be judged by the external
scientific community on the extent to which we advance
the state of environmental science.

Timeliness: Is ORD Meeting EPA’s
Expert Consultation and Assessment
Needs in a Timely Manner, Providing
Research Products According to
Schedule, and Addressing Long-Term
Issues With Adequate Forethought and
Preparation?

The first part of this question can best be answered by
EPA’s Program Offices and Regions as they determine
whether ORD consultations and assessments are being
provided in time to be optimally useful for Agency
decisions. The middle part of this question can be



Risk Management Research Criteria

Risk management criteria are applied to those research
topics that concern risk management. These criteria,
listed in Figure 5, are designed to give priority to
research that will produce the most effective and useful
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. Applying these
factors directs us toward research investments in areas
where risk problems are adequately characterized and
where risk management options do not exist, are poorly
characterized, are out-dated or inefficient, are too costly,
or might be significantly improved (Figure 6b). (Con-
versely, areas where risk problems are as yet poorly
characterized or where management options are already
optimized typically need the least new research.)

Methods/Models Development Criteria

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

ORD‘s Strategy for Planning Research

nity, and the degree to which the method or model
would improve risk assessment or risk management.

Asa result, ORD can then direct research attention to
those areas where tools would be most broadly appli-
cable and where uncertainty in risk assessment or risk
management would be most reduced (Figure 6c).
(Conversely, tools with narrow applicability or low
potential for reducing uncertainty reduced will typically
receive the least support.)

Strengths of ORD‘s Research
Planning Process

Our planning approach has many strengths:

mw It encompasses both scientific and stakeholder
Priorities.

@ It ensures that ORD will continue to fully support
EPA in fulfilling its mandates.

It focuses our resources where we can make our most
significant contributions.

@ It reinforces our sense of direction and
accomplishment as we see our objectives met
and goals realized.

@ It establishes a structure linking us to Agency-wide
strategic planning and the GPRA.

m It enables us to generate practical, credible
information and tools for risk-based decision-
making.

Figure Setting Research Priorities
a. Human and Ecological Health Effects, b. Risk Management (RM) Research © Methods and Models Research
Exposure, and Assessment Research
Greatest Greatest Greatest
Lite Need for Need for RM More Need for Tool
‘Under- Research Research Uncertainty, Development
‘standing Reduction
Low Risk High Risk puch Choate Wa eet Narrow Applicability Broad Applicability
Less
Options
Weil tncertainty
Least Least Aiready.
Need for Keown Need for Optimized beast for tool Reduction
Research RM Research Development
Adapted from Paul Slovic, Risk Perception



and the significant potential for enhancing ecological
risk assessment and risk management, ORD has selected
research to improve ecosystem risk assessment as a high-
priority topic for its research agenda.

Research To Improve Health
Risk Assessment

Health risk assessment is the process EPA uses to iden-
tify and characterize environmental health problems.
The results of health risk assessment are crucial to deci-
sions on health protection measures. ORD’s research to
improve health risk assessment addresses major defi-
ciencies and uncertainties in health risk assessment
(including both problem- or agent-specific risk assess-
ment, as well as cross-cutting or generic risk assessment).
For example, ORD’s research to improve health risk
assessment includes:

m Developing state-of-the-art testing approaches for
noncancer and cancer endpoints.

TM Conducting mechanistic and toxicokinetic research to
improve the exposure and dose-response steps in the
risk assessment process.

@ Identifying biomarkers that can be used to measure
exposure or effects.

@ Determining how individuals vary in their response to
toxic insults, so that EPA can better identify sensitive
subpopulations, such as children and the infirm.

Research to improve health risk assessment provides
the essential foundation for reliable and scientifically
strong risk assessments based on new science and state-
of-the-art methods. In addition, this research area sup-
ports the development of:

m= Computer-based tools to assist risk assessors at the
federal, state, and local levels.

@ Information management databases that EPA uses to
effectively communicate risk information to
stakeholders.

Ultimately, the results of this research will enhance risk
assessments to support national environmental goals,
such as safe drinking water, safe indoor environments,
clean air, and safe food. Because of the broad applicabil-
ity of improved methods for health risk assessment to
many user communities, research to improve health risk
assessment is a high priority for ORD’s research agenda.

ORD’s High-Priority Research

Pollution Prevention and New
Technologies for Environmental
Protection

Pollution prevention, or anticipating and stopping prob-
lems before they occur, is a powerful risk management
tool because it is far more cost-effective and protective of
the environment than solving environmental problems
after they have been created. Pollution prevention, sup-
ported by objective scientific and technical data, actually
reduces or eliminates the need for legal actions and reg-
ulatory standards, which can be costly and difficult to
implement. It also offers an opportunity for meaningful
stakeholder input and participation as part of the risk
management research and development process.

Pollution prevention will be the first strategy consid-
ered for all EPA programs and EPA will lead the nation
in efforts to reduce and eliminate pollution at its source.
Because of the broad applicability of pollution preven-
tion strategies and the potentially large economic and
environmental benefits of this approach to risk manage-
ment, pollution prevention is a high priority for ORD’s
research agenda. This research builds on ORD’s com-
mitment to support and respond to the needs of EPA’s
Program and Regional Offices for prevention options
and information on how best to implement them.

ORD’s intramural and extramural research programs
support cutting-edge research and development of new
tools, techniques, and processes for preventing pollu-
tion. This includes analysis tools, such as Life Cycle
Assessment, and fundamental precompetitive research
on cleaner processes through competitive extramural
research solicitations, such as Technology for a
Sustainable Environment (a joint program with the
National Science Foundation). In addition, the Small
Business Innovation Research Program accesses the
expertise of private innovators for pollution prevention
and other environmental technologies.

The accelerating development of new environmental
technologies (e.g., remote sensing, information systems,
and computer technologies) has created growing oppor-
tunities for managing environmental threats to public
health and natural resources. To capitalize on these
opportunities, EPA and several other agencies (e.g., the
National Aeronautics and Space Administration
[NASA], U.S. Department of Energy [DOE], U.S.
Geological Survey, and National Oceanic and



ORD's Strategy for Planning Research

ORD’s Key Role

Public and private sector institutions have long been
significant contributors to our nation’s environmental
and human health research agenda. EPA's Office of
Research and Development, however, is unique
among scientific institutions in this country in combi
ing research, analysis, and the integration of scientific
information across the full spectrum of health and
ecological issues and across both risk assessment and
tisk management. This broad scope has resulted in
scientific and engineering expertise, physical facilities,
and equipment that permit and encourage integrated
multimedia and multidisciplinary research on environ-
mental issues. As part of a regulatory Agency that
establishes national priorities and sets national stan-
dards, ORD research is conducted to protect human
and ecosystem health in a cost-effective manner and
to provide a firm scientific and technical foundation
for environmental decisions and standards.

objectives are detailed in Appendix A. The objectives
add another level of detail to our goals that will aid us
in organizing and setting more detailed priorities in our
annual research planning efforts. Some of the objectives
also include a set of specific activities that we will
undertake to achieve those objectives. These activities
allow both internal and external stakeholders to see
how we will conduct our work. Activities are listed
under each objective.

We are working on refining our research goals and
objectives to make them more specific and to enable us
to clarify intended outcomes of ORD’s science agenda.
This refinement will not only better align our program
with Agency-wide strategic planning, but will also
allow us to track our progress toward achieving our
program goals, as required by the Government
Performance and Results Act of 1993 (GPRA).

Identifying Specific Research Topics
The objectives and activities listed in Appendix A of this

ORD’s Long-Term Goals and
Objectives

ORD’s four mission areas translate into six long-term,
overarching goals (Table 2) that we will strive to meet in
order to fulfill our mission. ORD’s long-term goals and

Table 2. OR als

ng-Term

Mission Area

plan provide detail about how ORD will go about meet-
ing its long-term goals. Each objective and activity still
represents a relatively broad research area. ORD, there-
fore, has developed a priority-setting process and crite-
ria, illustrated in Figures 4 and 5 and described below,
for identifying specific research topics that are of prima-
ry importance to our vision, mission, and goals. We will
use this priority-setting process and criteria periodically

Goals

Perform research and development to identify,
understand, and solve current and future
environmental problems.

To develop scientifically sound approaches to assign and
characterize risks to human health and the environment.

To integrate human health and ecological assessment methods into a
comprehensive multimedia assessment methodology.

To provide common-sense and cost-effective approaches for
preventing and managing risks.

Provide responsive technical support of EPA’s
mission.

To provide credible, state-of-the-art risk assessments, methods,
models, and guidance.

Integrate the work of ORD’s scientific partners.

To exchange reliable scientific, engineering, and risk assessment/risk
management information among private and public stakeholders.

Provide leadership in addressing emerging
environmental issues and in advancing the science
and technology of risk assessment and risk
management.

To provide leadership and encourage others to participate in
identifying emerging environmental issues, characterizing the risks
associated with these issues, and developing ways of preventing or
reducing these risks.



Appendix D

ystems Indicators

Issues in Human Health Risk Assessment,
including human health effects of complex
exposure patterns, variability in human responses to
environmental agents, and consumer right-to-know

Ambient Air Quality, including tropospheric ozone and
fine particulate matter and urban air toxics

Health Effects and Exposures to Particulate Matter ar
‘Associated Air Pollutants

Drinking Water, including microbial pathogens in
drinking water systems and drinking water
disinfection by-products

Sontaminated Sediments.
Approaches to Multi-scale Ecological Assessment in the
Middle Atlantic Region

Terrestrial Ecology and Global Change

Water and Watersheds, including community-based _
__ research, and urban/suburban research

Technology for a Sustainable Environment, including
chemistry and engineering for pollution prevention,
and measurement, assessment, and feedback
techniques

Decision-Making and Valuation for Environment Policy,
including benefits and costs of environmental policies

rograms, ecosystem valuation and protection,
normative behaviors and environmental decision-making

Bioremediation



Appendix A

ORD’‘s Long-Term Goals

and Objectives

To help focus selection of research priorities, ORD has
defined a set of long-term research objectives within
each of the six long-term goal areas listed in Table 2.
Variations in the specificity of the objectives listed
below reflect differences in the maturity and complexity
of the science underlying each objective. Many of the
objectives include a set of activities (listed under the
objective) that support the objective.

The goals and research objectives described here will
assist decisions about research directions for years to
come. Each year ORD senior management, working
with the Research Coordination Teams, will apply
ORD’s priority-setting process to review current topics
and identify specific new research topics that best fur-
ther program goals and objectives. We would not expect
to make major changes in priorities every year, but we
will evaluate the continuing timeliness and importance
of our research topics on an annual basis. The resulting
set of research topics will constitute the basis for ORD’s
research program. ORD is currently refining its strategic
goals and objectives to better align with Agency strate-
gic planning and priorities.

The research objectives state, in a more specific and con-
crete manner than do the goals, what ORD will work

to achieve in each of its focal research areas. We intend,
after further refinement, to use the objectives and cor-
responding activities to introduce another level of
accountability for results into the ORD planning process,
as required by the Government Performance and Results
Act (GPRA). Senior management will review the
research objectives periodically to ensure that appropri-
ate progress is being made toward their achievement,
per GPRA. As necessary, adjustments in focus or
approach will be made early on to avoid wasting time
or resources. Once ORD has achieved its research objec-
tives, we will devote resources to other high-priority
areas. When new high-priority research areas are devel-
oped, we will craft new objectives as appropriate.

Goal 1: To Develop Scientifically
Sound Approaches to Assessing and
Characterizing Risks to Human Health
and the Environment

Risk assessments and the associated risk management
decisions are often based on limited data obtained in
species or under exposure conditions that differ from
real-world circumstances. Inevitably, scientists must
extrapolate from these data sets to the human or environ-
mental setting of concern to characterize human health or
ecological risks. Extrapolation injects uncertainty into risk
characterizations, which EPA relies on to develop risk
management strategies and research priorities.

Greater certainty in risk assessment would improve the
efficiency and effectiveness of EPA’s risk management
efforts and provide a better foundation for establishing
the Agency’s research priorities. ORD, therefore, will
work to improve existing risk assessment data,
methods, and models and to develop new methods for
high-risk areas where data currently are inadequate.

Already, for example, the science has advanced suffi-
ciently to warrant more refined approaches to risk
assessment in several areas, including ecological
impacts, effects on vulnerable subpopulations of people
or environmental species, and noncancer effects in
humans. As ORD develops improved methods, we will
work with other parts of the Agency to ensure that
these methods are credible and used in ways that are
scientifically sound.

In recent years, we have begun to recognize the inter-
dependence of ecosystems and to understand that we
must consider the landscape as a whole to maintain the
integrity of vital ecosystems into the next century. While
continuing to develop and refine scientifically sound
approaches to assessing risks to human health, we
intend to expand our ecological research. For example,



cience provides the foundation for credible envi-

ronmental decision-making. It is vital to achiev-

ing a healthy population, thriving environment,

and robust economy. Only through adequate
knowledge about the risks to human health and ecosys-
tems, and innovative solutions to prevent pollution and
reduce risk, can we continue to enjoy a high quality of
life. EPA has identified strong science and credible data
as one of the guiding principles to fulfill the Agency’s
mission to protect human health and environmental
quality. While all of EPA uses science for policy and reg-
ulatory decision-making, and various EPA offices con-
tribute to the scientific underpinnings of the Agency’s
decisions, the responsibility for leadership in science at
EPA and for the bulk of EPA’s research and develop-
ment work resides in EPA’s Office of Research and
Development (ORD).

ORD and the Risk Assessment/Risk
Management Paradigm
We at ORD have shaped our organization and research

agenda to strengthen EPA’s science base and improve
the Agency’s and our nation’s ability to effectively

respond to the complex environmental challenges of the
future. These efforts are based on a set of strategic prin-
ciples we have developed (Table 1) that draw on the
many recommendations we have received from outside
groups and our own staff in recent years. The most
important of these principles is the explicit use of the
risk paradigm.

Risk assessment has been defined many times over the
years, most notably in 1983 by the NAS (Figure 1),
which consolidated and gave context to terms that had
been defined in different ways up to that point. Risk
assessment is the process that scientists use to under-
stand and evaluate the magnitude and probability of
risk posed to human health and ecosystems by environ-
mental stressors, such as pollution or habitat loss or
change. The resulting risk characterization, together
with other public health, statutory, legal, social, eco-
nomic, political, and technical factors, provides the criti-
cal input for deciding whether and how to manage the
risk associated with a particular stressor. Risk manage-
ment options may include both regulatory programs
and voluntary activities (e.g., recycling) to reduce or
eliminate the stressor or the consequences of subse-
quent risks.



ORD‘s High-Priority Research

m Ecosystem water quality
@ Air toxics

ORD’s research agenda also includes additional topics
necessary to help the Agency fulfill its nondiscretionary
mandates.

Other topics were considered during the planning
process, but they did not meet the criteria to be includ-
ed in ORD’s research program. In general, these include
exposure or effects research in areas of low risk, risk
reduction research in areas of low risk, and routine
measurements and monitoring where R&D has been
completed. In general, ORD will not pursue major
research programs in areas where other research organi-
zations are capable of making a more significant impact.

ORD’s entire research program will be captured in more
detail in the science research plans being developed by
the Research Coordination Teams. These research plans
will be finalized after a rigorous peer review. Interested
readers should consult these documents.

ORD also uses the principles and priorities of this
Strategic Plan as a basis for developing its annual bud-
get requests to fund our research agenda. Our fiscal
year 1997 and 1998 requests were based on this plan, as
will be our fiscal year 1999 budget proposals.

Evolution of ORD Priority
Areas Over Time

The six high-priority areas intentionally are a mixture
of:

TM Research targeted at specific pollution problems (i.e.,
safe drinking water, high-priority air pollutants, and
emerging issues).

m Broad-based research in methods and approaches to
advance the fields of risk assessment and risk
management (i.e., research to improve ecosystem and
health risk assessment, and pollution prevention and
new technologies for environmental protection).

We will evaluate progress on all research targeted at
specific pollution problems periodically to ensure that
our research program continues to focus on the most
significant problems. As work on problem-specific
topics progresses and moves toward closure, we will
redirect our research and resources to emerging high-
priority areas. For example, as we successfully com-
pleted work in one of our former priority areas (the
health risks of ozone), we shifted resources to particu-

late matter, one of our current high-priority topics. In
the future, the particulate matter research likely will
give way to other topics of emerging priority.

We will also evaluate progress on our broad-based
methods, measurement, and models development
research annually. These cross-media areas, which
reflect ORD’s fundamental risk assessment and risk
management research programs, will remain high-
priority topics. However, the individual projects within
these areas will change to reflect research progress and
emerging concerns. As the individual projects change,
we will revisit and revise research plans for these areas.

Selection of the Six High-Priority
Research Topics

The following summaries illustrate how application of
the selection criteria described in Chapter 2 gave rise to
the six high-priority research topics.

Safe Drinking Water (Microbial
Pathogens, Disinfection By-Products,
and Arsenic)

The 1996 Safe Drinking Water Act Amendments reem-
phasized the importance of EPA research on disinfec-
tants, disinfection by-products, and pathogens in
drinking water. The Amendments also stressed the need
for research on arsenic, sulfates, and radon; risk assess-
ment in sensitive subpopulations (e.g., children); mix-
tures; and estimating the risk-reduction benefits of
drinking water regulations. ORD’s near-term focus in
this research will be to address uncertainties in drinking
water disinfection and arsenic.

Disinfection of drinking water has been one of the
greatest public health success stories of the twentieth
century. Nevertheless, some public health concerns still
remain. For example, many hundreds of thousands of
people have become ill and some have died during
recent outbreaks of exposure to the protozoan
Cryptosporidium in drinking water. Recent studies
demonstrate that there is a low threshold of infectivity
for Cryptosporidium and that people with compromised
immune systems—such as the elderly, HIV-positive
individuals, and persons receiving chemotherapy—may
be at greater risk. In addition, other microorganisms
exist in drinking water that may also pose serious risks
of infection.

We still lack methods to measure many known path-
ogens in water and are uncertain about their infectivity



Appendix B

The ORD Organization

ORD’s organization, depicted below, mirrors the risk of ORD’s National Laboratories, Centers, and Offices
assessment/risk management paradigm. The functions are described on the following pages.

ORD‘s Risk-Based Organizatiot
Assistant Administrator for Research and Development
Office of Science Policy |

4

Office of Resources

Management and Deputy Assistant Administrator Deputy Assistant
Admi ration | for Management Administrator for Science

I a

National Health and National National Center |! National Risk National Center
Environmental Effects Exposure for Environmental |: Management for Environmental
Research Laboratory Research Assessment Research Research and
Laboratory ET Laboratory Quality Assurance
L Reproductive aR = NCEA RTP, NC :
Toxicology Division ‘Atmospheric Office L- Water Supply and Environmental
(RTP. NC) }- Processes Research Water Resources Engineering
NCEA Washington,
L- Experimental Division (RTP, NC) DC Office Division Research Division
Toxicology Di Air Measurements Co (Cincinnati, OH) (Washington, DC)
NCEA Cincinnati,
(RTP, NC) }- Research Division OH Office [- Land Remediation Environmental
Environmental (RTP, NC) and Pollution Sciences Research
L Carcinogenesis Atmospheric Control Division Division
Division (RTP, NC) | Modeling Division (Cincinnati, OH) (Washington, DC)
3
|_ Neurotoxicology (RTP, NC) L Sustainable his Quality Assurance
ivi fe los ivision
Division (RTP. NC) Air Exposure (Gncinnaty OF) (Washington, DC)
Human Studies [> Research Division
| Division (RTP, NC) (RTP, NC) L Air Pollution Peer Review Division
- Prevention and (Washington, DC)
Gulf Ecology Division Human Exposure Control Division
I (Gulf Breeze, FL) / Research Division contrat
oS (Cincinnati, OH) (RTP, NC)
LL resis Deon Ecological Exposure - Subsurface 4
(Duluth, MN) [- Research Division rotection and —
n Remediation Division
w ; (Cincinnati, OH) (aoe oe)
L piste Ecology Characterization Techvology Trans
(Corvallis, OR) [+ Research Division [> Technology Transfer
. and Support Division
(Las Vegas, NV) Pe
Atlantic Ecology (Cincinnati, OH)
LL Division Ecosystems Research Techno!
(Narragansett, Rl) — Division y Coordinccon Staff
. (Athens, GA) ‘oordination

(Washington, DC)



and nonchemical stressor distributions. Major
programs include fate, transport, and transformation
research and advanced multimedia modeling.

@ Environmental Characterization Research focuses on
increasing understanding of stressors, receptors, and
the related portions of the environment (e.g., ambient
air, water, soil, biological quality, and a wide variety
of microenvironments). Major program activities
include landscape characterization, multimedia-
multipathway human exposure measurement, and
microbial identification and occurrence.

@ Exposure Assessment and Analysis Research is
conducted to estimate current and future exposures
to humans and ecosystems. Major programs focus on
developing total human exposure models and
landscape assessment models.

m Exposure/Dose Research modeling provides the
bridge between the exposures that occur and the
dose to the target which ultimately can lead to
effects. To improve the bridging and obtain data
for the modeling, research collaborations with
NHEERL exist.

National Center for Environmental
Assessment

ORD’s National Center for Environmental Assessment
(NCEA) serves as the national resource center for the
overall process of human health and ecological risk
assessments and the integration of hazard, dose-
response, and exposure data and models to produce risk
characterizations. Also, NCEA occupies a critical posi-
tion in ORD between (1) the researchers in other ORD
components who are generating new findings and data,
and (2) the regulators in the EPA Program Offices and
Regions who must make regulatory, enforcement, and
remedial action decisions. Thus, NCEA is uniquely posi-
tioned to influence ORD’s future research agenda to
ensure that it addresses research needs identified by risk
assessments and to serve as consultants to the Programs
and Regions on the use of science in environmental
decision-making. In support of these functions, NCEA.
focuses its work in three major areas:

@ Development of methodologies that reduce
uncertainties in current approaches:

* Dose-response models and factors
¢ Exposure models and factors

¢ Probabilistic models

Ee

Appendix B

@ Community-based risk assessment

@ Assessments of contaminants and sites of national

significance

@ Guidance and support to risk assessors:
¢ Databases
¢ Risk assessment guidelines
¢ Expert tools
¢ Expert consultation and program support
* Risk assessment training

Also, through the Risk Assessment Forum staff, NCEA is
responsible for coordinating and implementing the
health and ecological assessment activities of the Forum.
These activities include scientific and science policy
analysis of selected precedent-setting or controversial
risk assessment issues of Agency-wide interest, such as
risk assessment guidelines and development of cross-
Agency positions on important risk assessment issues.

National Risk Management
Research Laboratory

Research by ORD’s National Risk Management Research
Laboratory (NRMRL) provides the scientific basis for
environmental risk management. Specifically, NRMRL
conducts research to reduce the uncertainty associated
with making and implementing risk management deci-
sions. This research focuses on two important areas:

@ Characterizing pollutant sources that require
management.

m Identifying, developing, and evaluating tools and
technologies for prevention, control, restoration, and
remediation of environmental problems that are high
tisk, high cost, or that lack effective management
alternatives.

NRMRL catalyzes the development and commercial
application of some of the more cost-effective risk
management alternatives through joint efforts with
public and private sector partners, and through pro-
grams to verify the performance and cost of innovative
technologies.

NRMRL also provides technology transfer and technical
support to risk management stakeholders to encourage
improved risk management decision-making.



Appendix B

National Center for Environmental
Research and Quality Assurance

ORD’s National Center for Environmental Research
and Quality Assurance (NCERQA) represents a major
and renewed commitment by ORD to help EPA achieve
the highest possible quality of science. In particular,
NCERQA has made a major commitment to ensure the
high quality of ORD’s extramural research by establish-
ing the Science to Achieve Results (STAR) program.
The primary purpose of the STAR program is to
include the foremost research scientists from universi-
ties and nonprofit centers around the country in the
ORD research program to meet the specific science
needs of the Agency. STAR consists of four compo-
nents—focused Requests for Applications, an
Exploratory Research Grants Program, a Graduate
Fellowships Program, and targeted Environmental
Research Centers—all of which address issues of
importance to EPA. All applications to the STAR pro-
gram must pass rigorous external peer review by
national experts before being considered for funding. A
portion of the STAR program is conducted jointly with
other federal agencies.

In addition to the STAR program, NCERQA manages
the Environmental Research Centers Program and the
Hazardous Substance Research Centers and provides
managerial oversight of EPA’s quality assurance pro-
grams. Finally, NCERQA has a major Agency-wide
leadership and oversight role in peer review and quality
assurance activities.

Office of Resources Management
and Administration

The Office of Resources Management and Administration
(ORMA) ensures that ORD’s management operations
promote sound science and efficient operations.
Geographically dispersed and encompassing a wide
array of scientific and engineering disciplines, ORD
poses significant management challenges. ORMA, in

partnership with ORD’s Management Council, provides
the administrative and operational framework integrat-
ing ORD’s Laboratory and Center activities into a cohe-
sive unit. Serving as the principal staff office to ORD’s
Senior Resource Official, ORMA provides leadership in
budgeting, financial management, procurement, informa-
tion systems, organizational development, facility opera-
tions, and infrastructure. In this capacity, ORMA
independently evaluates ORD Laboratory and Center
management, bench-marking success against the contri-
bution of administrative processes toward the attainment
of ORD’s strategic goals.

Office of Science Policy

ORD’s Office of Science Policy (OSP) is a bridge
between ORD and its many constituents and is a key
link between ORD science and EPA policies and regula-
tion. OSP supports current Agency science needs by
participating in ongoing regulatory and science policy
activities of EPA’s Laboratories, Program and Regional
Offices, and the Agency-wide EPA Science Policy
Council. OSP provides for future Agency science needs
by leading ORD and Agency research planning activi-
ties. Working closely with ORD’s National Laboratories
and Centers and EPA’s Program and Regional Offices,
OSP coordinates their input into ORD’s research
agenda. Further, OSP provides scientific information,
counsel, and assistance in policy formulation and other
regulatory development activities. These functions all
support strategic planning of ORD’s research program.

In addition, OSP administers the Science Policy Council,
a standing interoffice committee comprising senior EPA
science managers and chaired by EPA’s Deputy
Administrator. Focusing on selected environmental
issues that go beyond program and regional bound-
aries, the Council develops information and policies to
guide EPA decision-makers in their use of scientific and
technical information.



Translating ORD’s Strategy into a Research Program

and leaders in the environmental sciences, to the general
scientific literature and community (e.g., through publi-
cation of scientific articles in peer-reviewed journals

and participation in national and international scientific
conferences).

Further, our work force support must include an effec-
tive human resources program that encourages an
increasingly diverse cadre of employees to continuously
learn new skills and a career development program that
promotes career development in directions congruent
with ORD’s mission. In addition, we must anticipate
work force needs and recruit new, culturally diverse
employees with the appropriate skills and experience to
support ORD’s mission.

ORD’s organizational structure (see Appendix B) relies
on a relatively small headquarters staff and places pro-
gram management responsibilities in the hands of
ORD’s field Laboratories and Centers. This flattened
organizational structure requires a team-based, matrix-
management approach in place of the traditional, more
hierarchical approach to management.

ORD’s Organizational
Improvement Activities

ORD held its First Annual Workshop on Managing Change
in Williamsburg, Virginia, on December 2-5, 1996. This
meeting marked the beginning a long-term process for
managing change within ORD. The overarching pur-
pose of the workshop was to improve the delivery of
high-quality science in EPA by:

@ Understanding the new directions in ORD.

@ Building the ORD team and improving
communications.

TM@ Sharing ideas and listening to all participants’ views.

TM Developing action plans and identifying change agents
to achieve specific organizational improvements.

TM Strengthening strategic management of ORD’s
research program.

The workshop was the first of its kind for ORD in terms
of its scope, design, and breadth of participation.
Participants included a cross-section of staff from ORD
Laboratories, Centers, and Offices. ORD’s Strategic Plan
provided the overall framework for the deliberations.

Participants identified 564 issues and then consolidated
and prioritized them to specify five focal areas for
improvement:

@ Reduce red tape—Empower staff by reducing
unnecessary paperwork.

m= Communications—Develop and implement a
comprehensive communications plan to improve
two-way communication and make electronic
communications more effective within ORD.

m Career advancement and development—Provide
career enhancement opportunities for all employees.

m Resources and infrastructure—Define “infrastructure”
and provide adequate resources to support science.

@ Integrate science with EPA’s mission—Take action to
put science first at EPA and to better integrate science
with EPA’s mission.

Follow-on activities to address these five improvement
opportunities include: “local” initiatives to keep com-
mitments made at the workshop; Laboratory /Center/
Office groups to identify additional specific actions; the
development and administration of the second ORD
Organizational Climate Survey to assess progress in
implementing improvement in the five areas of concen-
tration; and establishing an ORD-wide Improvement
Network that enhances the communications among
and between the various ORD Laboratories, Centers,
and Offices.

Common problems identified through the Network will
be addressed utilizing the Executive, Management,
Science, and Human Resource Councils. The Network
will also assist in the annual organizational survey and
the next annual workshop.

In addition to supporting the innovative actions taken
within each ORD Laboratory, Center, and Office, the
Network showcases new ideas as models for replication,
thereby keeping alive the “spirit” of Williamsburg. Key
to this “spirit” is the participation of all levels of employ-
ees, an ORD atmosphere of openness, and a commitment
to action by a management team that listens.

Systems and Equipment

To promote successful implementation of this Strategic
Plan by our work force, ORD is committed to providing
safe, environmentally sound, well-maintained, state-of-
the art laboratories, equipment, and supplies. Further,
by implementing our information management plan
described on pages 19 and 20, we will provide ORD
staff with data management, technical, and fiscal infor-
mation systems to support the conduct of research, as
well as the management, planning, budgeting, and



Executive Summary

he U.S. Environmental Protection Agency’s

Office of Research and Development (ORD)

has instituted significant changes in its organi-

zation and management procedures to provide
the vision and direction for the scientific foundation of
EPA’s mission.

TM First, ORD has aligned its organizational structure to
comport with risk assessment and risk management
principles and has made these principles central to
our strategy for determining risk-based research
Priorities. In this way ORD can assure that science
resources are directed to the most pressing
environmental problems nationwide—pollution
posing the greatest risks to people or the
environment; environmental risks most difficult to
understand and describe; and areas where we most
need to improve the effectiveness and efficiency of
managing environmental risk.

TM Further, ORD has strengthened interactions with the
larger scientific community in two ways:

* By expanding our competitive extramural grants
and graduate fellowship programs, we are work-
ing to stimulate research in areas vital to EPA by
more broadly involving universities and other
not-for-profit institutions.

¢ By intensifying our peer review process, we
ensure that all major facets of our science program
are independently reviewed by experts external to
our organization.

Both of these activities leverage and potentiate our
scientific expertise and capabilities.

@ Most importantly, ORD’s strategic planning and
management process for selecting research priorities,
instituted in 1995, has set us firmly on course to meet
the science needs of today while positioning
ourselves to identify and aid in resolving the
environmental problems of tomorrow.

The mission of the United States Environmental
Protection Agency is to protect public health and to
safeguard and improve the natural environment—air,
water, and land—upon which life depends. EPA's
purpose is to ensure that:

@ Federal environmental laws are implemented and
enforced fairly and effectively.

@ Environmental protection is an integral
consideration in U.S. policies concerning economic
growth, energy, transportation, agriculture, industry,
international trade, and natural resources.

@ National efforts to reduce environmental risk are
based on the best available scientific information.

& All parts of society—business, state, and local
government, communities, and citizens—have full
access to information so that they can become full
participants in preventing pollution and protecting
human health and the environment.

May 6, 1996

This 1997 Update to the ORD Strategic Plan describes
our revised strategy for research planning, the process
for deploying our research plan, and our current
research priorities.

Strategic Principles

The ORD Strategic Plan is based on nine strategic oper-

ating principles, summarized below, which draw on the
many recommendations ORD has received from outside
groups in recent years:

TM Focus research and development on the greatest
risks to people and the environment.

m Focus research on reducing uncertainty in risk
assessment and improving cost-effectiveness in risk
prevention and management.



List of Acronyms

AMI

CRADA

DBP
DOE

EDC
EPA

GPRA
IRIS
LCA

NAE
NAS
NASA
NCEA
NCERQA
NERL
NHEERL
NOAA
NRC
NRMRL

ORD
ORMA
OSP
PM

R&D
RFA

SAB
STAR

USGS

Advanced Measurement Initiative
Cooperative Research and Development Agreement

disinfection by-product
U.S. Department of Energy

endocrine-disrupting chemical
USS. Environmental Protection Agency

Government Performance and Results Act
Integrated Risk Information System
life-cycle assessment

National Academy of Engineering

National Academy of Sciences

National Aeronautics and Space Administration

National Center for Environmental Assessment

National Center for Environmental Research and Quality Assurance
National Exposure Research Laboratory

National Health and Environmental Effects Research Laboratory
National Oceanic and Atmospheric Administration

National Research Council

National Risk Management Research Laboratory

Office of Research and Development
Office of Resources Management and Administration
Office of Science Policy

particulate matter

Research and Development
Request for Applications

Science Advisory Board
Science to Achieve Results

U.S. Geological Survey


to identify high-priority research topics that will help us
achieve ORD’s goals and objectives.

Each year since 1995 we have applied our priority-
setting process and criteria to examine our ongoing
research and identify important new initiatives. This
year we have retained and refined our six priority
research topics from 1996. As before, some of our priori-
ties are specific to a particular environmental problem
and others are broad-based, since they contribute basic
science improvements in both risk assessment and risk
management. These six research topics are described in
Chapter 4 of this document.

Many topics will remain a high priority for several
years. Each year, working with our program partners
and external advisory bodies, we will examine the pre-
vious year’s topics to add new topics as appropriate
and remove previous topics for which sufficient
research has been conducted.

Identifying Emerging Issues,
Anticipatory Research, and
Exploratory Research

In recent years, EPA has begun moving beyond environ-
mental regulation to environmental protection in its
broadest sense, including anticipating and preventing
problems before they mushroom into major concerns.
To support EPA in this endeavor, ORD is evaluating the
best means to anticipate tomorrow’s environmental
problems and provide EPA with the necessary informa-
tion to evaluate findings, interact with other agencies
and organizations, and possibly act on early warnings
of emerging environmental issues.

The EPA Science Advisory Board’s January 1995 report
Beyond the Horizon: Using Foresight to Protect the
Environmental Future suggests many useful measures
we will evaluate for possible implementation. One
measure we are currently considering is the creation of
“lookout panels” comprised of individuals from inside
and outside the federal government to identify, screen,
evaluate, and prioritize emerging issues. As a first step
in this direction, the National Research Council estab-
lished, at ORD’s request, a Committee on Research
Opportunities and Priorities for EPA. This committee
was tasked with thinking creatively about ORD’s
research areas and identifying high-priority research
topics key to solving some of our nation’s most press-
ing current and future environmental problems. Such
research could spark entirely new approaches to envi-

ORD‘s Strategy for Planning Research

ronmental management in the future. Each year, we
will consider high-priority topics related to anticipatory
research as we review and revise our research agenda.

ORD’s Priority-Setting Process

ORD’s priority-setting process, depicted in Figure 4,
involves the following steps:

@ First, we seek input from all parts of EPA, including
ORD’s own researchers and staff. The Research
Coordination Council, the Science Council, and
Research Coordination Teams (see Appendix C)
consisting of senior representatives from ORD’s
National Laboratories and Centers, the EPA Program
Offices, and EPA's Regional Offices identify the most
important and relevant areas for our research efforts.
(As state and local governments play a larger role in
environmental protection, their research needs must
also be considered at this stage.) We also work with
EPA’s Science Advisory Board, the National Research
Council, and the private sector early in the planning
process to obtain recommendations from the external
scientific community regarding the major scientific
directions and priorities for our research program.
Finally, we consider the status and results of our
recent research activities. Based on this information,
ORD identifies potential research topics, for both
intramural and extramural investments.

m We then separate the pool of potential topics into two
categories:

¢ Those that are clearly mandated because of statu-
tory requirements or court orders (i.e., EPA may
have no discretion to reject or delay the research).

¢ All other topics.

@ For all other topics, we narrow the pool by retaining
only those that are within ORD’s mission and goals.

© We then apply a series of human health, ecological
health, and risk management criteria (Figure 5) to
compare the mission-related topics according to
their potential to support effective risk reduction.
We use comparative risk analyses to help ascertain
the most pressing environmental problems. We
also apply criteria to consider whether the
research would develop broadly applicable meth-
ods and models needed by EPA programs.
Through this screening process, we set priorities
among the research topics.



High-Priority Research

ORD has used the process described above to establish
our research priorities for the next few years. Using our
risk-based planning process and criteria, ORD has iden-
tified six high priorities that will receive special,
expanded attention within the broader ORD program.
These high priorities include three areas of research on
environmental problems and three broad-based areas of
research on methods and approaches that will impact
many additional topics:

Environmental Problem Areas

@ Safe drinking water (with a near-term focus on
microbial pathogens, disinfection by-products, and
arsenic)

@ High-priority air pollutants (with a near-term focus
on particulate matter)

@ Emerging environmental issues (with a near-term
focus on endocrine disruptors)

Broad-Based Methods and
Approaches Areas
@ Research to improve ecosystem risk assessment

@ Research to improve health risk assessment

@ Pollution prevention and new technologies for
environmental protection

Executive Summary

Planning for the Future

The Strategic Plan provides a blueprint for designing
and implementing a research program to produce the
sound science needed to support EPA’s mission. In the
years to come, ORD will place a continuing priority on
providing the communication, infrastructure, and sup-
port necessary for successful implementation of the plan.

For ORD’s stakeholders, including the EPA Program
and Regional Offices, academia, the private sector, and
other government agencies, the plan serves as a
roadmap that explains ORD’s research planning and
implementation process, defines how our stakeholders
contribute to this process, and specifies the goals, objec-
tives, and products they can use to hold us accountable
for our progress in environmental research. This plan is
intended to serve as a practical tool for ensuring the
constructive involvement of our stakeholders in estab-
lishing and executing ORD’s research agenda during
the coming years.



Translating ORD’s Strategy into a Research Program

Figure 7. Translating ORD's Strategic Plan Into a Research Program

ORD'S STRATEGIC PLAN

Strategic
Principles

Priority-
Setting
Process
and
Criteria

Science
Research

P| Plans

=TH e

re

| Requests for
nett g Applications
Plans
@ = EPA Program and Regional Office Involvement v e v A
A = External Scientific Community Involvement
Peer Review
Laboratory of Proposals
Implementation
Plans 7 te
Y Award of EB
Grants or
Intramural Cooperative
researc Agreements

Evaluation e

Research plans are important tools for measuring research will be effectively communicated to our clients
accountability because they make clear to our clients and stakeholders. Research plans also enable ORD to
and stakeholders the rationale for and intended prod- clearly track its progress toward achieving its goals, as
ucts of our research. And, by explicitly specifying required by the 1993 Government Performance and
up-front how we will manage our scientific data and Results Act.

information products, we ensure that the results of ORD



SEPA

United States Research and EPA/600/R-97/015
Environmental Protection Development April 1997
Agency (8101)

1997 Update to
ORD’s Strategic Plan



Table 6.

Particulate Matter (Contin

Subtopic Strategic Focus Tasks Products Uses

Risk What options (e.g., process Investigate options for reducing Technical reports and _To support evaluations of competing regulatory
Management changes, upgrades of existing _fine-particle emissions: data on the performance _ strategies, cost/benefit analyses, and development
(Continued) controls, application of new ~Demonstrate the extent to which and cost-effectiveness of of guidance documents.

technologies) are available that
both reduce fine-particle and
precursor emissions to
acceptable levels and are
cost-effective?

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.

competing risk

management approaches.

User-friendly computer
models and other
technical assistance tools
that transfer risk
management
information to key users.

To provide guidance to states and the regulated
community on the performance and cost of
competing fine-particle risk management
approaches.

yoaeasay Ayisoid-43IH 5,au0



introduction

The Risk Assessment/Risk Management Paradigm

Risk Assessment — Risk Management

Statutory and Legal
Considerations

Public Health Social
Considerations \ Factors

Dose-Response
Assessment

, \ *Adapted from:

Hazard Ris! » Risk Assessment in the

Identification Characterization —>Risk Management } federal Government:
Decision Managing the Process.

National Academy of
Risk . Sciences. 1983
Management / Economic

Exposure Options Factors Science and Judgement
Assessment in Risk Assessment.
ae National Research
Political Council, 1994.

Considerations

The risk assessment process consists of four kinds of analyses:

@ Hazard identification involves the description by scientists of the adverse effects (e.g., short-term illness, cancer,
reproductive effects) that might occur due to exposure to the environmental stressor of concern. To identify
potential hazards, scientists use the results of experimental studies on test organisms, reports about accidental
exposure, and epidemiologic research.

@ As part of the dose-response assessment, scientists determine the toxicity or potency of a stressor. The dose-
response assessment describes the quantitative relationship between the exposure to a stressor and the extent
of injury or disease.

TM@ Exposure assessment involves scientists describing the nature and size of the population(s) or ecosystem(s)
exposed to a stressor and the magnitude, duration, and spatial extent of exposure. It includes a description of
the pathways (e.g., air, food, water) by which the stressor travels through the environment; the changes that a
stressor undergoes en route; the environmental concentrations of the stressor relative to time, distance, and
direction from its source; potential routes of exposure (oral, dermal, or inhalation); and the distribution of sensi-
tive subgroups, such as pregnant women and children.

In risk characterization, assessors use the data collected in the three previous analyses to predict the effects of
human or ecological exposure to the stressor of concern. They estimate the likelihood that a population will
experience any of the adverse effects associated with the stressor under known or expected conditions of expo-
sure. This estimate can be qualitative (e.g., high or low probability) or quantitative (e.g., one in a million proba-
bility of occurrence).

The NAS paradigm was developed mainly in terms of principles relating to risk assessment and risk management
for human health. While ORD recognizes that there are distinctions for ecological risk assessment and that scientific
approaches to risk assessment have evolved and expanded since development of the NAS paradigm, the general
principles set forth in the NAS paradigm are useful as an organizing focus for ORD's strategic thinking, and they
have been supplemented by new guidelines relating to ecological risk assessment.



introduction

The risk assessment process is one component of the
overall process of risk management. The risk manage-
ment process involves the recognition of a potential
new risk and a decision by authorities to respond to
concern about the risk. It includes risk assessment as
well as a series of other scientific and technical activi-
ties, illustrated in Figure 2, that provide the scientific
and technical data for making and implementing a risk

TM@ Focus research and development on the greatest
risks to people and the environment, taking
into account their potential severity, magnitude,
variability, and uncertainty.

@ Focus research on reducing uncertainty in risk
assessment and on cost-effective approaches for
preventing and managing risks.

@ Balance human health and ecological research.

TM@ Infuse ORD's work with a customer/client ethic
that breaks down organizational barriers and
ensures responsiveness to ORD’s internal and
external customers.

& Give priority to maintaining the strong and viable
scientific and engineering core capabilities that
allow us to conduct an intramural research and
technical support program in areas of highest risk
and greatest importance to the Agency.

@ Through an innovative and effective human
resources development program, nurture and sup-
port the development of outstanding scientists,
engineers, and other environmental professionals
at EPA.

TM@ Take advantage of the creativity of the nation’s best
research institutions by supporting competitively
awarded research grants to further EPA’s critical
environmental research mission.

@ Ensure the quality of the science that underlies our
risk assessment and risk reduction efforts by requir-
ing the very highest level of independent peer
review and quality assurance for all our science
products and programs.

@ Provide the infrastructure required for ORD to
achieve and maintain an outstanding research and
development program in environmental science.

management decision. The risk management process
concludes with the selected risk management option(s)
being implemented and the resulting environmental
and/or public health improvements being monitored.

Figure 2 expands on the Risk Management Options por-
tion of the original NAS paradigm to show the many
scientific and technical activities, in addition to risk
assessment, that are part of risk management. These

History of This Docum:

Work on this Strategic Plan began in 1995 by a task
force comprised of staff from ORD’s National
Laboratories and Centers, as well as our Headquarters
Offices. As we developed the plan, we consulted with
our clients in EPA’s Program and Regional Offices, and
external stakeholders, to ensure that the plan would
enable ORD to effectively meet their needs and main-
tain good customer relations. We also relied heavily
on the advice of the National Research Council and
EPA's Science Advisory Board.

In May 1996, we finalized our Strategic Plan and it has
guided our program for a year. The plan has been fully
peer-reviewed and reflects ORD’s maturing process for
evaluating and setting research priorities. The basic
principles and priorities outlined in the 1996 plan
remain unchanged, and substantial portions of the
original text are intact. We are continually improving
this process, based on our interactions with outside
stakeholders and our own internal deliberations. For
example, ORD staff identified several organizational
improvements at our First Annual Workshop on
Managing Change. This revision to our Strategic Plan
reflects ORD’s continuing evolution, as we address
these recommendations. Major changes appearing in
the 1997 plan include:

@ Elaboration on the evaluation criteria for determin-
ing research priorities.

@ Clarification of high-priority research topics/areas.

@ Inclusion of information on and commitments from
ORD's First Annual Workshop on Managing
Change in Williamsburg, Virginia, December 1996.

@ Expansion of the plan's discussion of technical sup-
port to EPA Program and Regional Offices.

@ Information on ORD's new Information
Management Plan.



Table 10. Pollution Prevention and

w Technologies for Environmental Protection (Cc

inued)

Products

Uses

Subtopic Strategic Focus Tasks

Risk How can the performance of _ Create technology verification
Management _ innovative technical solutions entities for high-priority human
(Continued) to environmental problems _health and environmental

that threaten human health or problems.
the environment be verified?

Performance verification of
commercially available advanced
environmental technologies and
products.

To enhance the diffusion of environmental
technologies, both domestically and
worldwide.

To increase the acceptance of innovative
technologies by both regulators and the
regulated community.

*NASA = National Aeronautics and Space Administration.
DOE = U.S. Department of Energy.
“USGS = U. S. Geological Survey.


Table 5b.
Subtopic

Safe Di

Strategic Focus

Tasks

Products

Health Effects

What are the health effects
and dose-response
associated with arsenic
exposures?

Conduct epidemiologic studies
on arsenic health effects.

Conduct animal studies on
important health endpoints
(developmental, reproductive,
cardiovascular, neurologic, etc.).

Data on the relationship (linear or
nonlinear) between arsenic
exposure and adverse health
effects.

To provide health effects data for risk
assessment /characterization to support the
arsenic drinking water rulemaking.

What are the dose-responses
for various effects at low
doses?

Develop biomarkers of effect and
susceptibility and model systems
to assess mechanisms of arsenic
toxicity.

Biomarkers to assess effects and
susceptibility, data on arsenic
mechanisms of toxicity, and an
improved PBPK* model.

To provide improved understanding of
arsenic-induced adverse health effects in humans
and to improve the risk assessments.

What are the modifiers of
susceptibility and
dose-response?

Determine the factors that affect
human susceptibility.

Assessments of the factors that
influence arsenic dose-response
and susceptibility in humans.

To provide an improved understanding of
human susceptibility to arsenic exposure and to
support improved risk assessments used in
arsenic drinking water rulemaking.

Exposure

What arsenic species and
concentrations are present in
drinking water, diet, and
biological tissues?

Develop validated analytical
methods for speciating arsenic in
drinking water, diet, and
biological tissues.

Develop a National Database on
arsenic occurrence and
concentrations in drinking water,
soils, and dietary constituents.

Practical analytical methods for
arsenic species in various media.

National Database on arsenic.

To support developing occurence data
compliance methods for water utilities, methods
for mechanistic studies and for exposure risk
assessments.

To support exposure risk assessments necessary
for the arsenic drinking water rulemakings, now
and into the future.

What are the biomarkers of
arsenic exposure?

Develop biomarkers of exposure
in biological media.

Standardized biomarkers to assess
arsenic exposure from various
media.

Standardized biomarkers protocols for assessing
exposures in epidemiological studies and to
improve the precision of risk assessments.

What is the bioavailability of
arsenic species from various
media?

Conduct research to determine
the bioavailability of arsenic
species found in water, soils, and
food constituents.

Empirically derived
bioavailabililty (oral absorption)
factors for each arsenic species in
each media.

To support improved risk assessments necessary
for the arsenic drinking water rulemaking.

(Continued)


ic

Ihe goals and objectives listed in Appendix A of

this plan define an ambitious research program

for ORD. Within this program, however, the

extent of research we can actually perform will
be limited by the available resources. Therefore, in con-
sultation with EPA’s Program Offices, ORD uses the pri-
ority-setting process to select from its overall program
those topics that are of highest priority for research.
Priorities to be emphasized for the next few years are
(in no particular order):

TM Safe drinking water (with a near-term focus on
microbial pathogens, disinfection by-products, and
arsenic)

@ High-priority air pollutants (with a near-term focus
on particulate matter)

m Emerging environmental issues (with a near-term
focus on endocrine disruptors)

@ Research to improve ecosystem risk assessment
@ Research to improve health risk assessment

® Pollution prevention and new technologies for
environmental protection

ne

These areas will receive more intense research attention
(and resources). Intramural efforts will be supplement-
ed with the talents of extramural scientists through
external grants, cooperative agreements, interagency
agreements, and contracts.

Proposed research for the six high-priority areas is sum-
marized in Table 4. Tables 5 through 10 provide a break-
out, by risk assessment/risk management area, of the
strategic issues and proposed research tasks, products,
and applications in each of the six topic areas. Tables 4
through 10 can be found at the end of this chapter on
pages 31 through 54.

Other areas of high importance that will continue to be
a major part of ORD’s research program include:

@ Tropospheric ozone
m@ Global change
@ Environmental monitoring

TM Contaminated sites—ground water, soils, and
sediments

uw Exposures to pesticides and toxic substances



Table 7.
Subtopic

Strategic Focus

Tasks

Products

Uses

Biological
Effects

Defining the classes of
chemicals that act as EDCs*
and their potencies.

Develop in vitro/in vivo
methods and structure-activity
models to screen for EDC action.

Methods to describe the hazard
potential of EDCs and likely
modes of action and potencies.

Hazard characterization to support
implementation of the FQPA and the SDWA“

Evaluating current testing
guidelines and monitoring
procedures for adequacy of
assessment of EDCs.

Enhance ability of existing test
methods (e.g,, multigenerational
studies in mammals and
life-cycle tests in fish and
wildlife) to evaluate
manifestations of endocrine
disruption and underlying
modes of action.

Revised testing guidelines that
are more indicative of the most
sensitive lifestage, sex, and
target tissue for chemicals that
act through the endocrine
system.

To improve regulatory testing requirements and
data interpretation.

Determining the shapes of
dose-response curves for EDCs
at relevant exposures and the
tissue levels associated with
adverse effects.

Assess effects of EDC exposure
on neuroendocrine,
immunological, and
reproductive function in
developing and adult animals
in support of pharmacokinetic
and biologically based
dose-response models, with
emphasis on animal models of
EDC-induced diseases.

Animal models of EDC-induced
health effects that provide
increased understanding of the
types and magnitudes of risks
for exposure to EDCs during
various phases of the life cycles.

To provide quantitative dose-response evaluation
and reduced uncertainties for human health
extrapolations.

Describing the normal
endocrine profiles in wildlife
species.

Provide baseline endocrine
information for wildlife
populations and their
laboratory surrogates, with
emphasis on comparative
endocrinology and
developmental control of sex
differentiation, especially for
species with little historical
attention.

Databases of endocrine profiles
in species from multiple
phylogenetic levels and
improved understanding of the
role of the endocrine system in
sex differentiation.

To assess the impact of EDCs in wildlife
populations.

(Continued)


Translating ORD’s Strategy Into a Research Program

accountability functions.

As we implement our Strategic Plan, we will monitor
work force needs and strive to provide other programs,
mechanisms, and support as necessary to ensure that
our work force has the tools, work environment, and
equipment it needs to achieve ORD’s vision and goals.

Challenges for the Future

ORD is continuing to study peer reviewer and internal
staff recommendations for use in future updates of our
Strategic Plan. Comments we are considering include
the following:

m Reviewers recommended that ORD periodically
reexamine the basis for its Strategic Plan to
accommodate ongoing changes in risk assessment
concepts generally, and in the risk assessment/risk
management framework in particular. Such
reexamination is a central feature of the process
envisioned by this plan, and ORD is committed to
the concept that its risk-based priority-setting system
will evolve with evolving risk assessment and risk
management concepts.

mTM Reviewers also commented that the risk assessment

paradigm has limited applicability for some EPA
programs, thus limiting the utility of a plan based on
the paradigm. ORD recognizes the validity of this
comment in particular cases. As we implement this
Strategic Plan, we will be working in close
collaboration with EPA’s Program and Regional
Offices to ensure that our research agenda is tailored
to their particular programs and priorities. Based on
this experience, we will consider modifications to
the plan over time to accommodate these special
circumstances, as necessary.

In addition, ORD is currently involved in several activi-
ties that will impact future updates of this plan:

@ We will continue our work to refine the evaluation
criteria for determining research priorities.

@ In cooperation with the EPA Program Offices, we will
continue to merge ORD’s goals and objectives into
EPA’s strategic planning process and GPRA activities.

@ Finally, and most importantly, we will examine
emerging environmental issues and new scientific
information to determine whether we need to adjust
our major scientific directions, goals, or objectives in
light of new knowledge and developments.



Appendix A

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.

TM Develop partnerships (via research grants,
cooperative agreements, CRADAs, and other
mechanisms) with other federal agencies, the White
House Committee on Environment and Natural
Resources, industry, and academia.

m Provide national and international leadership in risk
assessment and its application for risk reduction and
risk management.

TM Conduct/sponsor workshops and symposia that will
provide forums for stimulating interest and
discussion on current or emerging environmental
issues (e.g., endocrine disruptors), reaching
consensus on crucial research needs, and defining the
role of ORD and others in addressing those needs.



Executive Summary

@ Balance human health and ecological research.
@ Infuse ORD’s work with a customerl/client ethic.

@ Give priority to maintaining strong and viable core
capabilities.

m Nurture and support the development of outstanding
scientists, engineers, and other environmental
professionals.

m Recruit and engage the best scientists from outside
EPA through competitively awarded grants and
fellowships.

m Require the highest level of independent peer review
and quality assurance.

m Provide the infrastructure to achieve and maintain an
outstanding R&D program.

Most important of these principles is the explicit use of
the risk paradigm to shape and focus our organizational
structure and research agenda.

ORD’s Vision, Mission, and
Long-Term Goals

ORD’s commitment to develop a risk-based research
agenda requires us to examine our vision, mission, and
goals and to develop a risk-based process for selecting
and ranking those research areas of primary importance
to EPA. ORD’s vision and mission for the future arise
from a consideration of the key role that ORD science
plays within EPA and in the broader context of our
nation’s environmental research agenda. Our vision is
that ORD will provide the scientific foundation to sup-
port EPA’s mission. Our mission statement is divided
into four main components: research and development,
technical support, integration of scientific information,
and anticipatory research. This translates into six long-
term, overarching goals—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.

Setting ORD Research Priorities

Essential to meeting our long-term goals is a process
we use to set priorities within the universe of possible
research and to focus our efforts on those areas of pri-
mary importance to EPA’s mission. Our priority-setting
process involves the following steps:

@ First, we involve all parts of EPA, including ORD’s
own researchers and staff, in helping us set research
priorities. The Research Coordination Council, the
Science Council, and Research Coordination Teams
consisting of senior representatives from ORD’s
National Laboratories and Centers and EPA’s
Program and Regional Offices each identify
important and relevant areas for our research efforts.
We also work with EPA’s Science Advisory Board, the
National Research Council, and the private sector
early in the planning process to obtain
recommendations from the external scient:
community regarding the major scientific directions
and priorities for our research program. Based on this
input, we identify potential research topics.

m We then narrow the pool of potential topics by
selecting areas that clearly will contribute to
fulfilling Agency mandates.

@ To these remaining areas falling within ORD’s
mission and goals, we apply a series of human
health, ecological health, and risk management
criteria to set priorities according to their potential
to support effective risk assessment and enhance risk
reduction—for example, by reducing the
uncertainties in risk assessment. We use comparative
risk analyses, as needed, to ascertain the most
pressing problems. We also consider whether the
research would develop broadly applicable methods
and models needed by EPA programs. We then
ascertain whether ORD can make a significant
contribution. Through this screening process, we set
priorities among the research topics.

TM We then define our specific R&D projects by
considering each topic area in totality. For each topic
area, we systematically examine the research needs
within each component of the risk paradigm: effects,
exposure, assessment, and risk management. Based
on this analysis, we define a series of high-priority
research activities across the risk paradigm that will
produce a comprehensive set of useful risk-based
results.

TM Once we have identified our high-priority topics, we
develop and implement a research program with
specified roles for intramural and extramural
participants, identifiable products, and provisions for
accountability and visibility regarding progress on
our commitments.



ORD‘s Strategy for Planning Research

Criteria for Setting ORD
Research Priorities

A key component of ORD’s planning process is the
criteria we use to set priorities among research topics.
We currently employ three sets of criteria: human and
ecological health research criteria, risk management
research criteria, and methods/models development cri-
teria (Figure 5). These criteria, described below, are not
set in concrete, nor are they universally applicable to all
research areas. Additional or alternative criteria may be
used in some cases as appropriate.

We are continuing to refine these criteria. In particular,
the criteria have been undergoing extensive discussion
and review during fiscal year 1997 with the twin goals
of creating a system that will more directly link ORD’s
work to the important issues facing the Agency and that
will more closely integrate human health and ecological
research. We anticipate future modifications to these

criteria that will both improve our ability to evaluate the
effectiveness of ORD research and help our scientists
understand how their research will be used to answer
the Agency’s most important risk-based questions.

Human and Ecological Health
Research Criteria

ORD’s human and ecological health criteria are based.
on five broad categories: the severity, time scale, and
permanence of the response; the level or organization
where the response is expected to occur; and the geo-
graphic extent of the response. Table 3 lists criteria ORD
has developed in each of these five categories. These
factors help us determine the importance of a human or
ecological health problem in terms of its magnitude of
tisk and extent of scientific uncertainty, and thus point
to the areas most needing research (Figure 6a).
(Conversely, areas of low risk or well-understood risk
typically need the least new research.)

Table 3. ORD’s Human and Ecological Health Resear
Ecological Health Human Health
Severity of Response/ © Mortality * Mortality

Function of Stressor * Morbidity

* Degree of physical disruption

* Morbidity

* Immediate effects
Effects that will occur in the future

Time Scale of Response * Acute effects
* Subchronic effects
* Chronic effects or effects with a

long latency period

* Irreversible effects
* Effects that can be reversed only by

Permanence of Response  Transgenerational effects
* Nontransgenerational effects
human intervention
* Temporary effects that reverse
naturally over a long time
* Temporary effects that reverse

naturally over a short time

Level of Organization Effects on an entire ecosystem/community

Effects on a single species

* Effects on the general population
* Effects on a subpopulation
* Effects on a population within a single species * Effects on individuals

* Effects on individual animals or organisms

Extent of Response * Global effects
* Ecoregional effects!
* Effects on several localities

* Localized effects

* Global effects
¢ International effects
* National effects
° Effects on several localities
* Localized effects

An ecoregion is a geographic area that has similar topography, climate, and biota across the entire area.



Table 10. Pollution P ion and New Technologies for Environmental Protection (Continued)
Subtopic Strategic Focus Tasks Products Uses
Risk Develop pollution prevention Generic and specific LCA case studies —_To establish partnerships to demonstrate
Management modules for industrial plant, with private and public sector partners. risk-based pollution prevention design
(Continued) product, and process design and a process simulation opportunities.

procedures.

Mathematical models and
computer-based simulators for process
design.

For commercial plant and process design
methods, models, and procedures.

To provide technology transfer to the
private sectors through Cooperative
Research and Development Agreements
and licensing agreements.

Develop pollution prevention
measurement and audit tools for
small businesses.

Pollution prevention accounting,
methods and models.

Audit procedures for pollution
prevention.

To provide tools for measuring and
estimating “pollution prevented” in small
businesses.

To provide technical guidance for
regulatory programs and private sector
needs.

How can pollution be
prevented using innovative
approaches?

Develop precompetitive and
enabling pollution prevention
approaches for major industrial
sectors.

Pollution prevention approaches 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
approaches keyed on Common Sense
Initiative industries and other high-risk
problems.

To encourage the use of pollution
prevention approaches for a wide array of
U.S. industrial sectors and high-risk
problem areas.

Evaluate and verify these
approaches 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 approaches.

To provide credible information that
informs decision-makers about pollution
prevention options emphasizing both
performance and cost.

To create a basis for developing
scientifically credible and commercially
available pollution prevention approaches
in both U.S. and foreign markets.

(Continued)


demonstrating new approaches to risk assessment
or will respond to Agency needs by assessing multi-
media, multiprogram, or contentious or sensitive
issues.

ORD will support other risk assessment efforts by
providing guidance, consultation, training, and
information products to assist colleagues, both inside
and outside EPA, in conducting their own risk
assessments. These efforts will respond directly to the
needs of the risk assessment community and will
target areas of uncertainty in the science and conduct
of risk assessment.

ORD will improve the state-of-the-science of risk
assessment by developing scientifically sound and
defensible approaches for incorporating and integrat-
ing data and models developed by ORD and the gen-
eral scientific community into risk assessment efforts.

ORD will integrate human health and ecological con-
cerns into all these activities.

Objectives
Within this goal area, ORD will work to:

m Prepare risk assessments for those stressors currently
considered of high risk to humans and the environ-
ment. This will include:

¢ Assessing ubiquitous pollutants in the air that
affect human health (e.g., fine particles, ozone).

* Assessing the risks associated with highly toxic
and persistent environmental contaminants (e.g.,
chlorinated dioxins, mercury).

* Assessing the risks to ecosystems from nonchemi-
cal stressors (e.g., habitat loss and UvB due to
stratospheric ozone depletion).

¢ Conducting comparative risk assessment of com-
peting risks (e.g., those posed by microorganisms
in drinking water versus those posed by disinfec-
tion by-products).

Complete development of new cancer risk guidelines
and other guidelines and provide support to the
Program Offices and Regions to facilitate their
implementation. This will include:

¢ Developing and supporting the implementation of
guidelines for assessing the ecological impacts of
environmental stressors.

Appendix A

¢ Supporting the implementation of new guidelines
for cancer, neurotoxicity, and reproductive risks.

@ Provide expert advice and technical support to EPA
staff, other agencies, and EPA stakeholders. This
effort will include:

¢ Integrating scientific and technical information
from ORD Laboratories and other sources to pro-
vide a sound scientific base and technical support
for Agency decisions and policy.

* Developing and supporting the implementation of
guidelines for assessing the ecological impacts of
environmental stressors.

¢ Supporting the implementation of new guidelines
for cancer, neurotoxicity, and reproductive risks.

* Supporting chemical- and site-specific risk assess-
ments for criteria air pollutants, hazardous air
pollutants, waste sites, and drinking water.

¢ Providing training in risk assessment to state and
local stakeholders.

¢ Continuing to support and improve the Integrated
Risk Information System (IRIS) and expert systems
such as Risk Assistant.

* Assuring adequate quality assurance for all
research, testing, and applications.

TM Develop methods and assess methods developed
by others for providing quality-assured data for
environmental assessment. This will include:

* Supporting the development of models that can be
readily used by Regions and states.

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

Effective risk assessments and risk management deci-
sions depend on the availability of accurate sources of
scientific and engineering data and information, risk
assessments, analytical methods, and guidance. As a
leader in the development of such methods and infor-
mation, we are committed to providing, coordinating,
and exchanging expertise and information to decision-
makers inside and outside EPA. We will work to identi-
fy and fulfill user needs by providing appropriate tools
and information through interconnected communica-
tion and technical support networks.



Table 4.
Research Topics Strategic Focus

Summary of EPA/ORD Research Program for Six High

Tasks

riority Research Topics (Continued)

Products

Understanding the potential
scope of the endocrine
disruption in humans and
wildlife, including: defining
the range of health effects,
critical life stages, sensitive
species, and exposures
relevant to alterations in
endocrine function;
developing risk
management options to
reduce or prevent
additional adverse effects in
populations.

Endocrine
Disruptors

Develop screening methods for endocrine
disruptors; construct predictive
dose-response and ecological risk models
with emphasis on low-dose effects and
effects of combined exposure to endocrine
disruptors on the reproductive,
neuroendocrine, and immunological
systems; provide predictive fate, transport,
and exposure models; link exposure models
to effect models and characterize effects of
ambient exposure to demonstrated
endocrine disruptors.

Field data and monitoring tools and
delineated effects and predictive
models that clarify the health and
ecological impact of specific
endocrine disruptors and related
exposure levels for improved risk
assessment and risk management
activities.

To develop risk management
options for reducing exposures; to
ensure that present testing
guidelines are adequate for
detecting hazards and risks posed
by endocrine disruptors, and to
assist in implementing the FQPA®
and SDWA’ of 1996.

Research to How can we determine

Improve ecosystem risk and capacity
Ecosystem Risk _ to tolerate stress?
Assessment

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
ecosystem effects/risks, national
land-cover map, baseline data for
documenting future changes,
ecosystem exposure profiles, and
information on risk reduction
approaches for ecosystems.

To inform stakeholders about
ecosystem protection, ecosystem
assessment, environmental
planning, and ecosystem risk
reduction/restoration.

(Continued)

yoaeesay Ayrzolsd-431H S,a40


Appendix E

Fiscal Year 1997

Drinking Water Disinfection
and By-Products

Particulate Matter
Endocrine Disruptors
Community-Based

Environmental Protection
and Ecosystems Research

Benefit /Cost Research

Fiscal Year 1998

Particulate Matter and
Urban Toxics

Endocrine Disruptors
Global Change
Contaminated Sediments

Children’s Health and Food
Quality Protection Act

Superfund

Advanced Measurement
Initiative

Environmental Information
for Communities

€Ntio,
N a,
or nq
i
‘Atay

10}
on Prey
. Biles ¢
On 'O)

hno,
fectin

Pow,
Reepy
Pro,



Table Summary of EPA/ORD Research Program for Six High-Priority Research Topics (Continued)
Research Topics Strategic Focus Tasks Products Uses
Research to How can we better Develop or improve methods for screening Hazard screening/testing protocols To rank/screen chemicals, develop
Improve Health _ define/predict hazards, hazard data, collecting toxicity data, and and models for predicting chemical _ test guidelines, and provide
Risk Assessment improve dose-response interpreting hazard data; develop models to disposition and biological response. guidance and methods for more
extrapolation, characterize __ estimate target tissue dose and responses to confident risk assessment.
variation in human those doses following exposures of varying

susceptibility, and estimate _ pattern, frequency, and magnitude; identify
risks from varying exposure and characterize factors conferring,

scenarios? enhanced susceptibility to pollutant

exposures.
What is the population Determine how exposure is influenced by Improved exposure measurement To support exposure assessment
distribution of total age, lifestyle, behavior, and socioeconomic and assessment methods, models, _ during risk-based decision-making.
exposure? factors. Develop total human exposure and data.

models, which include source/pathway
What are the contributions to total exposure.

source-exposure-dose
relationships?

Pollution How can pollution Study engineering/ performance costs for Pollution prevention cost accounting To evaluate and implement
Prevention and prevention be integrated _ pollution prevention; develop technologies; protocols, cost data, technology pollution prevention approaches.
New into environmental identify audiences needing technical transfer products, life-cycle analysis

Technologies for decision-making? assistance; develop life-cycle analysis/audit tools, audit procedures, pollution

Environmental tools; and assist in disseminating prevention technologies, and

Protection technologies to the commercial sector. performance data.

(Continued)



Research to Impro

Strategic Focus

alth Risk Assessment

Tasks

Products Uses

What is the
source-exposure
relationship?

Develop verified models that trace
the prospective and retrospective
relationship between sources and
total exposure.

Verified source-exposure models,
that incorporate fate and
transport processes.

To identify the most effective risk management targets.

What is the
population
distribution of
exposures from all
media?

Develop quantitative total human
exposure models based on sound
theoretical and experimental
information.

Improved methods for exposure To support health risk assessments; to measure
measurements: effectiveness of risk management decisions.
- Activity pattern database.
- Microenvironmental exposure
measurements.
- Field studies of populations
with a variety of exposure risk
factors.
- Computer-based exposure
model platform.

What are the Determine which behavioral, Multimedia/pathway exposure To identify at-risk subpopulations for risk assessment and
determinants of socioeconomic, or lifestyle factors data for disadvantaged to ensure adequacy of rules/regulations.
exposure? increase exposure to pollutants; —_ populations, children, the elderly,
determine the relationship of age _ and persons living near selected
(young and old) and preexisting sources (eg,, pesticide use).
disease to exposure.
Exposure models for highly
exposed subpopulations.
Dose What is the For pollutants having multiple Models of relative intakes of To identify the pathways that contribute most to risk and
Estimation exposure-dose pathways, determine the persistent chemicals from hence require mitigation.
relationship for quantitative contribution of each inhalation, oral, and dermal
pollutants from pathway to total exposureand —_ routes based on measurement
each pathway? target-site dose. data.

How can we
improve dose
estimations across
species and
exposure scenarios?

Develop methods and models for
estimating dose to target tissues
(ie., physiologically based
pharmacokinetic models).

Models for predicting disposition
of chemicals in the body from all
routes.

To improve the scientific basis for cancer and noncancer
risk assessments.

To reduce uncertainty in risk assessment and risk
management decisions.

(Continued)

yoaeasey Ayisotsd-43iH s,a4u0


Translating ORD’s Strategy Into a Research Program

answered by ORD managers and EPA’s Program Offices
and Regions through annual program reviews and
other activities. The final aspect of timeliness is more
subjective and therefore more difficult to assess. ORD
has accepted the challenge of anticipating important
environmental issues that are just emerging and may
not become critical problems until well into the next
century. The U.S. public is the ultimate judge of how
successful ORD has been in this effort. ORD will strive
to regularly gather the public’s view on this issue.

Mechanisms for Evaluation
and Accountability

ORD has several mechanisms for evaluating its perfor-
mance, communicating progress and results, and mea-
suring success. These include:

@ Annual research program reviews, jointly organized
by ORD’s Research Coordination Teams and EPA’s
Program and Regional Offices, that present to EPA
senior managers the entire EPA research portfolio in
a given area. These joint reviews focus on the status
and accomplishments of the ORD research program
to ensure that ORD’s research continues to meet ORD
and client objectives. They also present the ongoing
research being conducted by the Program Offices and
Regions so that the total research agenda can be
viewed. The objectives of these reviews are to
evaluate progress in completing planned research
projects, to track and evaluate research results, and to
generally obtain feedback on ORD’s work and any
adjustments that may be needed to help us better
meet our clients’ needs. These reviews complement,
rather than supplant, external peer reviews.

@ ORD review of its science research plans. ORD
examines its research plans periodically and adjusts
them if warranted by our research results, by changes
in EPA or national priorities, or by emerging issues
and concerns.

@ External peer reviews of ORD science research plans
and products and overall progress in meeting our
goals and objectives. These reviews are conducted at
key intervals in our research planning and
implementation process.

m External peer reviews of research proposals received
from extramural research scientists in response to the
Requests for Applications.

@ External peer reviews of ORD Laboratories and of
ORD'’s use of peer review through our Board of
Scientific Councilors under the Federal Advisory
Committee Act.

m Annual science workshops designed to make the
progress and results of all ORD research (including
the external grants program) accessible to EPA’s
Program Offices and Regions.

@ A data tracking system, part of ORD’s Management
Information System, which tracks resources and.
progress.

@ Yearly evaluations under the Government
Performance and Results Act.

Through these mechanisms, ORD will strive to develop
and conduct the most responsive, scientifically justifi-
able research program possible within the constraints of
our available resources.

Closing Out Completed Work

Through the continuing involvement of the Research
Coordination Teams and the annual program reviews
mentioned above, ORD will assess ongoing research to
evaluate:

m Whether the research is on track for meeting its goals
and schedule.

m When the research should be concluded.

Prudent management of evolving priorities and declin-
ing resources requires that we clearly define our research
and conclude it within an appropriate time frame, so we
can begin work on new priorities without delay.

Technical Support

One of ORD’s most important functions is to provide
technical support to EPA Program Offices and Regions
and states. ORD is committed to a strong and sustained
technical support program.

In 1996, the EPA Program Offices, ORD, and the EPA
Regions initiated the first comprehensive assessment of
all technical support activities within EPA, with particu-
lar emphasis on ORD’s roles and responsibilities for
technical support. The purpose of this evaluation was to
ensure that ORD:

m Provides the types and quantities of technical
support most needed by the Program and Regional
Offices, states, and others.



ntion and

Environmental Protection (Continued)

Subtopic

Strategic Focus

Tasks

Products

Uses

Exposure
(Continued)

Initiate pilot projects.

Demonstrations of the use of remote
sensing in a range of environmental
applications such as air and water
quality monitoring, ecosystem
evaluation, and site assessment.

To evaluate currently feasible applications
leading to broader implemenation
involving key stakeholders.

Establish joint EPA/NASA
research program.

Scientific framework to allow the
application of remote sensing
technologies to diagnose existing
ecosystems, establish the basis to
prioritize ecosystems that should be
restored, describe effectiveness criteria
for improvements, and describe
desirable endpoints for ecosystem
restoration and rehabilitation.

To address fundamental concepts of
ecosystem rehabilitation.

What other advanced
measurement technologies
are available for real-time
monitoring?

Establish an internal research
program.

Development of cost-effective, real-time
monitoring technologies.

To provide regulators and the public with
timely and relevant environmental
information.

Risk Assessment

How can we use monitoring
information to better assess
the risks to human health and
ecological resources, and how
can we better characterize
and communicate these risks?

Develop techniques to
characterize monitoring
information and communicate
this information to the public.

Easily accessible and understandable
information about environmental
conditions for the public and
communities.

To provide better, more consistent
environmental information to the public,
enabling more informed decision-making.

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 can address
high-priority health and environmental
problems.

To demonstrate how LCA can evaluate
options for multimedia pollution
prevention and risk management that are
keyed to the greatest risks.

To provide objective, scientifically credible
LCA procedures for regulatory and private
sector use,

(Continued)


Appendix A

Our goal is to facilitate information that is impartial,
up-to-date, and relevant to user needs. To that end,
we must improve and update existing information
systems and develop new systems and information
transfer solutions to meet future needs. Working with
other EPA offices, we will help to develop an opera-
tional communication and information transfer system
for on-line scientific, engineering, and risk information
that can be accessed by professionals or by members
of the public who are involved in community-level
analysis and decision-making.

Objectives
Within this goal area, ORD will work to:

m Provide current and relevant technical information to
a broad user community. This will include:

* Developing plain-language guidance and training
that adequately and clearly communicate the
appropriate use of technical information and that
describe limitations and inappropriate applica-
tions.

¢ Developing electronic communication and other
information dissemination systems that can be
accessed and understood by broad and diverse
user communities.

® Complete the development of the new cancer risk
guidelines and provide support to the Program
Offices and Regions to facilitate their implementation.

@ Maintain and increase support for existing scientific,
engineering, and risk information systems. This will
include:

¢ Ensuring that current information resources are
accurate, relevant, and up-to-date.

* Developing electronic and other methods of bring-
ing databases (e.g., IRIS, ECOTOX) to state and
local governments and other stakeholders.

* Developing data management systems that make
data readily available to all ORD Laboratories and
Centers, EPA Program Offices and Regions, and
states.

Goal 6: To Provide Leadership and
Encourage Others To Participate in
Identifying Emerging Environmental
Issues, Characterizing the Risks Associated
With These Issues, and Developing Ways
of Preventing or Reducing These Risks

With our very broad missions, we in ORD and the
Agency as a whole must have some means of evaluat-
ing, comparing, and setting priorities for competing
needs. We use risk as the common denominator for
comparing divergent issues and making decisions. Our
focus on relative risks and risk-based decision-making
demands that we look beyond the obvious problems of
yesterday and today to identify and assess issues just
over the horizon; we must determine the potential risks
that these issues pose and work to solve them. Often,
however, few data exist to support assessments of
emerging issues. Thus, we must develop and dissemi-
nate data and methods to permit credible decision-
making in the face of very high uncertainty. At ORD,
we are committed to working with other groups within
EPA, the Agency’s Science Advisory Board (SAB), the
National Academies of Science and Engineering (NAS
and NAE), and others to develop new ways of analyz-
ing emerging issues. We recognize that ORD cannot and
should not assume leadership in every area of environ-
mental science. Our challenge is to be cognizant of
where others are already leading and where ORD
should undertake that role.

EPA’s general approach to environmental manage-
ment—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 should
be expected to provide leadership in the development

of new, more credible ways of comparing and ranking
risks. In providing this leadership, we renew our commit-
ment to encouraging and enabling others in the public
and private sectors to participate in identifying, character-
izing, and resolving emerging environmental issues.



Contents

List of Acronyms ..............+

See ey eee

Executive Summary .......0.00ce eee cece nee e eee tee e een n sees Vil

Strategic Principles ...........--+..005-
ORD’s Vision, Mission, and Long-Term Goals .
Setting ORD Research Priorities
High-Priority Research
Planning for the Future

Chapter 1: Introduction ........2.02- 2c eee cece cence eee een

ORD and the Risk Assessment/Risk Management Paradigm ..........0 000s cece e ence ete teen eet e een ees 1
Audiences for This Document
Critical Players and Linkages for Implementing ORD’s Strategic Plan ...
Looking Ahead
Evolution of the Strategic Plan Over Time
A Roadmap for This Document .....

Chapter 2: ORD’s Strategy for Planning Research ........ wee oD

ORD’s Vision ...
ORD’s Mission . .
ORD’s Long-Term Goals and Objectives
Identifying Specific Research Topics
Identifying Emerging Issues, Anticipatory Research, and Exploratory Research
ORD’s Priority-Setting Process ......
Criteria for Setting ORD Research Priorities ...
Strengths of ORD’s Research Planning Process

Chapter 3: Translating ORD’s Strategy Into a Research Program .......17

Developing Science Research Strategies and Plans
Deciding Who Will Do the Work .
Internal Research .....
Extramural Research .
Integrating Information Management Planning Into the Process
Measures of Success
Mechanisms for Evaluation and Accountability
Closing Out Completed Work ..
Technical Support
ORD Customer Focus ........--..+4-
Human Resources and Infrastructure .
Challenges for the Future ..



Table 6. Particulate Matter (Continued)
Subtopic Strategic Focus Tasks Products Uses
Exposure What PM species and Conduct prospective epidemiologic and Verification of current To determine the effects of ambient fine and coarse
(Continued) concentration levels are people human exposure studies. epidemiologic PM on adults’ lung function and daily mortality.
exposed to? observations.
To evaluate and extend findings on size-specific
Improved estimates of _ PM exposure and daily mortality.
human exposure to PM
Reduced uncertainty
regarding the size and
physical properties of
PM that may cause
health effects.
Risk How can we reduce Conduct statistical reanalyses of existing Quantitative data To provide health effects data for risk assessment
Assessment uncertainties associated with —_ epidemiologic databases to further analyses providing (Criteria Document) to support PM NAAQS.
estimates of the PM characterize: reduced uncertainties in
mortality /morbidity risks at The shape of exposure-response PM risk estimates,
low ambient levels? relationships (possible ‘thresholds’).
~The influence of synoptic weather
patterns.
-The size/chemical composition of key
PM components.
Risk What are the emission rates and Characterize fine-particle emissions from Technical reports and To provide emissions data to focus regulatory
Management physical and chemical sources of concern (e.g., heavy duty data on the size strategies on the most critical sources.

characteristics of fine particles
and precursors from sources
that pose the greatest risk to
public health?

diesel trucks, fugitive sources,
combustion systems, other stationary
sources).

distribution, chemical
composition, and
quantity of fine-particle
emissions from key
mobile and stationary
sources.

To provide methods and models for states to
develop fine-particle emissions inventories.

(Continued)

yoaeesey Ajlioid-43IH 5,040


Table 5b. Safe Drinking rsenic (Continued)
Subtopic Strategic Focus Tasks Products Uses
Risk Assessment What additional risk Develop dose-response Improved risk assessment To provide the risk basis for arsenic drinking

assessment tools and models
are needed to assess arsenic
risks?

predictive models for adverse

effects and assessing interactions.

procedures and risk estimates for

arsenic.

water rulemaking.

What risk assessment /
characterization guidance
can be provided for arsenic
exposure scenarios?

Develop guidances for states and
EPA regions concerning arsenic
exposures.

Interim guidances and reports

characterizing human exposures.

To support states and EPA regions in developing
regulations and permits and for refinement of
risk estimates for EPA rulemaking.

What technologies are
available for effective
arsenic treatment of
drinking water?

Risk
Management

Conduct and evaluate laboratory
and field tests on different
arsenic control technologies.

Series of reports describing the
technical performance of the
different arsenic control
technologies.

To demonstrate the capabilities and performance
of arsenic control technologies for use in
determining Best Available Technologies and in
rulemaking.

What are the technical and
economic considerations of
arsenic control for small
drinking water systems?

Complete cost evaluations for all
arsenic control technologies

Series of reports describing the
economic considerations

associated with the operation of
each arsenic treatment technology.

To provide data on any adverse economic
considerations that may impact small systems
and that can be taken into consideration during
rulemaking and granting variances to
compliance.

How can arsenic-enhanced
residuals be effectively
managed from drinking
water systems?

Conduct studies on the arsenic
characterizations of the residual
materials generated from
different arsenic control
technologies.

Series of reports outlining the

composition of the residual arsenic

and its mobility in treatment
wastes.

To provide data on the recycle /disposal options
for the residual material generated and for
support in rulemaking decisions.

*PBPK = physiologically based pharmacokinetic.

yoseasoy Aqisolsd-YSIH S,auO


Appendix B

National Health and Environmental
Effects Research Laboratory

ORD’s National Health and Environmental Effects
Research Laboratory (NHEERL) performs laboratory
and field research to help EPA answer two fundamental
questions:

m What are the health and/or ecological effects of
exposures to man-made stressors?

m What is the likelihood that these effects will occur
under conditions of environmental exposure?

NHEERLs research contributes to improving three
steps in the risk assessment process:

@ In the hazard identification area, NHEERL works to
improve both assessment test methods and the
interpretation of data developed by these methods
(ie., the relationship of effects measures to
health/ecological outcome).

@ In the dose-response assessment area, NHEERL
performs mechanistic research to address major
uncertainties, as well as research to develop and
improve extrapolation and multi-tier models.

m In the risk characterization area, NHEERL provides
data on carefully selected priority problems.

National Exposure Research
Laboratory

The work of ORD’s National Exposure Research
Laboratory (NERL) improves the scientific bases for
human and ecosystem exposure assessments that are
part of the risk assessment, risk management, and com-
pliance processes. Researchers from NERL conduct
methods, measurement, and modeling research to eval-
uate multimedia and multipathway exposures to a wide
variety of physical, chemical, and biological stressors.
They also apply their expertise to special problems, as
in providing technical consultation to the Program
Offices and Regions. The main components of NERL’s
program are:

@ SourcelExposure Research focuses on investigating the
emissions of chemicals from sources. Although most of
ORD’s research is in this category, NERL has unique
expertise and interests here for sources that are part of
the pathway of subsequent NERL exposure studies.

TM Chemical, Physical, and Biological Process Modeling
Research seeks to understand and predict chemical

Location of ORD's National Laboratories Centers

Newport, OR

Corvallis, OR

Duluth, MN
Grosse Ile, MI
Cincinnati, OH,



intreduction

noted that each measure has both a “head” and “heart”
component. Each measure simultaneously provides for
meeting organizational (head) needs for time, informa-
tion, expertise, tools, and strategic direction, as well as
personal (heart) needs for empowerment, access,
respect, opportunity, and alignment of each individ-
ual’s work with Agency and ORD goals.

EPA Program and Regional Offices

Linkages between ORD and its primary clients (EPA’s
Program and Regional Offices) are essential to success-
ful implementation of this plan. One important linkage
is the day-to-day contact that ORD scientists and engi-
neers have with EPA’s Program and Regional Offices.
This ongoing informal contact helps ensure that the
ORD scientists and engineers involved in our planning
process understand our client’s needs.

In addition, this Strategic Plan establishes formal areas
of linkage to ensure client input as we plan our
research. We directly solicit input on priority needs and
products from the Program and Regional Offices during
the planning process.

ORD’s Research Planning Advisors

Our planning process also relies on the contributions

of many other groups who provide crucial input for
formulating and executing our research program and
priorities. These include other federal agencies (both
directly and through the National Science and Tech-
nology Council and its Committee on Environment and
Natural Resources), as well as the National Research
Council, EPA’s Science Advisory Board, and ORD’s
Board of Scientific Counselors.

ORD’s Research Partners

Successful plan implementation also relies on ongoing
partnerships between ORD and other research organiza-
tions in academia, the private sector, and other govern-
ment agencies. These partnerships benefit all parties.
They provide a common-sense and cost-effective way for
ORD to utilize the special expertise residing outside our
organization, while also reducing overlapping and
duplicative work. Our partners enrich our research plan-
ning process and help ensure that our research products
are appropriately targeted to stakeholder needs. ORD
accesses and involves partner organizations in imple-
menting our research program through a variety of
cooperative arrangements and funding mechanisms.

Shared Leadership

In the context of environmental science, ORD serves
both as a team leader for research planning within EPA
and as a national leader within the larger scientific
community for conducting the nation’s environmental
science. ORD implicitly shares responsibility for this
leadership through our peer review protocols, which
ensure both internal and external vetting of each critical
step in our research process—from identifying research
priorities to evaluating our eventual success.

Looking Ahead

As ORD implements its Strategic Plan in the years to
come, we will strengthen our links with our clients and
partners. We will work to expand our partnerships with
other agencies, universities, and the private sector and
to integrate our planning efforts with EPA’s overall
planning based on the Agency’s Strategic Plan. Also, we
will strive to forge links with the planning efforts of
other federal agencies and other nations as appropriate.

Evolution of the Strategic Plan
Over Time

ORD’s Strategic Plan is designed to be a robust “living”
document. The plan provides a solid underpinning for
ORD research that will allow us to maintain continuity
and momentum in our work in the coming years, while
also constructively adapting to changing EPA and
national priorities over time. EPA is currently develop-
ing a new Agency strategic plan. ORD will work with
other Agency offices to ensure that science is a strong
element of that plan and supports Agency decision-
making. We will adapt the ORD Strategic Plan as appro-
priate to ensure that it supports the Agency’s strategy.

Additionally, we will periodically revisit and, as neces-
sary, modify our Strategic Plan to ensure the continued
productivity of ORD’s research and development efforts
to meet EPA, national, and international environmental
goals. At the same time, we will work to ensure that, as
the plan evolves, it continues to reflect goals and objec-
tives that are shared throughout ORD.



Table 1
Subtopic

Pollution Prevention and New Technol

Strategic Focus

ies for Environmental Pi

Tasks

Products

Exposure

What are the environmental
monitoring needs of the EPA
Program and Regional
Offices?

Develop a monitoring,
information needs assessment
inventory.

Inventory of specific monitoring,
technology needs and requirements.

To serve as a starting point for discussion
with Federal and commercial technology
developers to explore possible matches
between information needs and
technology capabilities.

Match environmental monitoring

needs with relevant
environmental technologies.

Inventory of environmental monitoring
needs matched with relevant
technologies.

To focus research on those technologies
that best meet the needs of EPA and the
public.

How can we best leverage the
research, technologies, and
information of others?

Stage a series of workshops with

NASA* Mission to Planet Earth.

Joint pilot projects, demonstrations, and
collaborative research and development
opportunities.

To match the monitoring technolgoy
needs of the EPA Program Offices and
Regions with the technology capabilities
of NASA.

Sponsor a joint EPA/DOE”
workshop.

Demonstrations of advanced
monitoring technologies and their
potential applications.

To identify and showcase new and
innovative environmental monitoring
technologies that can better meet the
nation’s needs for ensuring protection of
the environment.

How can we better focus on
remote sensing applications
research applied to
characterizing landscape
composition and pattern?

Establish an internal research
program.

An interagency (EPA, USGS, NOAA)
program (called the Multi-Resolution
Landscape Characterization, or MRLC),
which is producing land cover
information for the United States in
accordance with Federal Geographic
Data Committee standards for
vegetation classification and
documentation. (The MRLC has
completed mapping of Standard
Federal Region 2 and 3. Mapping of
Regions 4 and 5 is planned to be
completed in 1997.)

Assessment tools for analyzing and
interpretating landscape composition
and pattern at a number of scales,
ranging from local communities to
Standard Federal Regions.

To provide more comprehensive
information about ecological resources to
be used for environmental planning
purposes.

To assess the conditions of watersheds
(water quality, terrestrial wildlife habitat
suitability and terrestrial ecosystem
condition) across the mid-Atlantic region
of the U.S,, using the landscape tools.

(Continued)

‘

‘
‘
‘
'



Appendix A

we intend to study concurrent impacts of multiple
anthropogenic and natural stressors and to develop
techniques to examine nonchernical 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 noncancer
health risks with more scientifically grounded,
biologically plausible approaches and models. This
will include:

* Studying the heightened sensitivity /susceptibility
of certain subpopulations (e.g., children).

* Studying the predictive relationship between toxi-
cologic endpoints and human disease (e.g., to
facilitate animal-to-human extrapolation).

Developing integrated mechanistic information to
support biologically credible health assessments.

w Develop methods and models founded on
measurement data and sound theoretical concepts
that can be used to better characterize, diagnose, and
predict total human exposures to chemical and
microbial hazards, to improve and validate exposure
models, and to reduce uncertainties in exposure
assessments, risk assessments, and risk management
decisions. This will include:

¢ Determining the relationship between exposure
sources and multiple exposure pathways, includ-
ing characterizing the sources and determining the
influence of transport, transformation, and fate on
exposure.

* Developing and evaluating an integrated mass-
balance/multimedia/multipathway exposure
model that incorporates state-of-the-science pollu-
tant fate and transport process descriptions for use
in risk assessment.

* Developing and applying exposure measurement
methods to reduce the uncertainty in exposure-
dose relationships, especially analytical methods
for identifying and enumerating microbial
pathogens and biomarker and chemical marker
methods for estimating site-specific exposures.

* Continuing activity pattern research to reduce
uncertainty in models and assessments that pre-
dict exposure levels, frequencies, and distributions
in populations.

* Delineating and quantifying the role of exposure
in the development of effects in individuals and
populations, including susceptible populations.

m Establish approaches to characterizing and
understanding risks to ecosystems and, in
cooperation with other agencies, develop a national,
multiscale, integrated environmental status and
trends program. This will include:

¢ Developing indicators of the condition of repre-
sentative ecosystems.

Supporting hypothesis-driven, long-term moni-
toring of important exposure and effects indicators
at national reference sites.

* Characterizing national land-cover/land-use pat-
terns and developing measures of landscape
condition at multiple scales for specific sites, water-
sheds, landscapes, and ecoregions.

* Conducting pilot studies in ecologically important
regions (e.g., the mid-Atlantic Highlands) to evalu-
ate alternative monitoring designs and to develop
techniques to integrate data across geographic
scales.

m@ Understand and predict ecosystem exposures,
responses, and vulnerabilities to high-risk chemical
and nonchemical stressors at multiple levels of
biological organization and geographic scales. This
will require:

¢ Developing ecological criteria for water (both
freshwater and marine), air, soil, and sediment
quality (1) as needed for the Agency’s risk assess-
ment and risk reduction efforts, and (2) to measure
progress toward meeting environmental goals.

¢ Developing diagnostic tools at all levels of biologi-
cal organization for retrospective assessments and
for characterizing the key sources and stressors in
multistressed ecosystems.

* Developing tools for predicting the vulnerability
of ecosystems at multiple geographic and tempo-
tal scales to ecosystem stressors (e.g., climate
change, altered land use, changes in air, soil, or
water quality).



Chapter 2

 ORD’s Strategy for

~ Planning Research

RD’s commitment to develop a risk-based

research agenda undergirds our vision, mis-

sion, and long-term goals. This commitment

also is embodied in our risk-based process
for selecting and ranking those research topics of pri-
mary importance to ORD and EPA.

ORD’s vision and mission for the future arise from a
consideration of the importance of science at EPA and
in the broader context of our nation’s environmental
research agenda and of ORD’s key role in environmen-
tal science. Our vision, described below, represents the
overall level of achievement that we will strive for in all
our research and development work. Our mission state-
ment, also described below, defines the broad areas of
research and development where we believe ORD can
and must make important contributions to EPA’s mis-
sion and mandates and to our nation’s overall environ-
mental research agenda.

ORD’‘s Vision

ORD will provide the scientific foundation to support
EPA’s mission.

ORD’s Mission

ORD’s mission is to:

@ Perform research and development to identify,
understand, and solve current and future
environmental problems.

m Provide responsive technical support to EPA’s
mission.

m Integrate the work of ORD’s scientific partners
(other agencies, nations, private sector organizations,
and academia).

TM@ Provide leadership in addressing emerging
environmental issues and in advancing the science
and technology of risk assessment and risk
management.



Foreword

am pleased to present the 1997 Update to the Strategic Plan for the U.S. Environmental Protection
Agency’s (EPA’s) Office of Research and Development (ORD). This plan summarizes the basis for
the actions we have taken to respond to recommendations of numerous expert advisory groups
committed to improving science at EPA. The plan serves as a framework for ORD to provide the
highest possible quality environmental science to meet today’s needs and lead us into the next century.

Central to our strategy is a system for determining research priorities based on risk assessment and risk
management principles. We use this system to direct our resources to the nation’s most important
environmental issues—those areas with the greatest risk to people or the environment, those areas of
greatest uncertainty in characterizing risk, and those areas with the greatest need to improve the efficacy
of, or reduce the cost of, risk management.

We continue to enhance the quality of ORD’s science products through independent peer review of all
major aspects of the program, including research plans and proposals, science products, and even our
own organization. We augment the efforts of our in-house cadre of experts through our expanding
Science to Achieve Results program, which engages the best environmental scientists and technologists
from United States universities and laboratories outside EPA. The plan also promotes greater partner-
ship between ORD and our primary clients, EPA’s Program and Regional Offices, as well as the external
scientific community.

This plan is the foundation for ORD’s future. We have designed our strategy to endure and yet be
dynamic in the face of advancing scientific knowledge and understanding. While the plan details our
current research planning process, long-term research goals and objectives, and near-term priority
research topics, these components continue to evolve. Thus, this 1997 Update presents a snapshot of
ORD’s scientific and management evolution at this point in time. We are continuing to hone our
strategic goals and objectives to better focus our work and align ORD’s mission and activities with
Agency priorities under EPA’s new strategic planning process. Also, we have already begun to consider
how advances in the state of environmental science and new human health and ecological issues on the
horizon provide important perspectives for our 1998 planning efforts.

I take tremendous pride in being part of the team that is keeping ORD a strong and cogent scientific
organization. I look forward to achieving ORD’s vision for providing the scientific foundation to
support EPA’s mission guided by the continuing evolution of our Strategic Plan.

[eb Zigat

Robert J. Huggett
Assistant Administrator, Office of Research and Development


Table 4. Summary of EPA/ORD Research Program for Six High Research Topics
Research Topics Strategic Focus Tasks Products Uses
Safe Drinking | Whatisthe comparative Develop methods for measuring Data on effects, dose-response, To support DBP/ microbial risk
Water— risk between waterborne _pathogen/DBP exposure from drinking exposure, comparative risk, and assessment/risk reduction
Disinfection microbial disease and the _ water, determine effects and dose-response _ treatment for pathogens/DBPs. rulemaking and compliance
disinfection by-products __ for them, develop/apply a microbial risk monitoring.
(DBPs) formed during assessment framework, improve DBP risk
drinking water disinfection? assessments, and evaluate alternative
treatment processes for DBP/ microbial
How can both be control.
simultaneously controlled?
Safe Drinking What are the health risks of Develop methods for measuring arsenic Analytical methods for arsenic To improve the risk
Water—Arsenic arsenic at low doses found __ species in drinking water and diet, develop _ species, data on effects, assessment / characterization of
in US. drinking water? improved dose-response and risk dose-response and treatment arsenic in drinking water and
assessments for arsenic species, and processes, and improved risk ultimately for rulemaking and
What cost-effective evaluate cost-effective treatment processes. _ assessment/characterization of compliance monitoring.
technologies will be arsenic in drinking water.
available for removing
arsenic from drinking
water?
Particulate What morbidity/mortality | Conduct clinical /epidemiology/toxicology Morbidity /mortality, dose-response, To improve criteria documents and
Matter is associated with low studies of effects of PM and copollutants, and mechanistic data; dosimetric _risk assessments in support of PM

ambient levels of particulate
matter (PM) alone, and in
combination with other
high-priority air pollutants,
and what cost-effective
methods are available to
reduce PM and
copollutants’ emissions to
an acceptable level?

reanalyze past epidemiology studies and
develop improved methods; conduct
dosimetric and mechanistic studies;
characterize the size/species of PM; conduct
human exposure studies; and develop,
evaluate, and demonstrate methods to
identify and characterize emissions of PM
and precursors and technologies to reduce
these emissions.

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.

National Ambient Air Quality
Standards review; to provide
information for evaluating
alternative PM control strategies.

(Continued)

youeesoy Aiotid-y8in s,auO


S€-9 “ON LINYSAd
Vda
dlvd S434 8 SDVLSOd
alvg 41ng

“4euu09 puey-ye| addon
‘84 U! SSOUPPE By) 0} WUMIe1 PUR “eAod SIU} doo 40 ‘YORIaP

![D)3Y3H YOSHO Suode: ese aniedes 0} YsIM 10U Op NOK j1

“eus0o pUeY-H9|
seddn eu ut sseuppe ayy 0} uma pue ‘Adoo 40 yoeIep
‘yeqe| Mojeq eut Uo seGueYo Aressooou jTe yew asEalg

SLO/Z6-4/009/Vd3

ooe$
BS() OYEAU 10) Ayeued
SsauIsng [III

892Sb HO ‘HeUUIOUID

UONBWWOJU] YOeESaY JeJUSWUOIIAUI JO} 19]U8D,
Aouaby u0jda}O1g je}UaWUOJIAUQ

saleig pan


Translating ORD’s Strategy Into a Research Program

We consult ORD’s main research clients—the EPA
Program and Regional Offices—to ensure that the final
research plans clearly include the research products
they will need to fulfill their responsibilities. In addi-
tion, all our research plans are subjected to rigorous
external peer review.

Deciding Who Will Do the Work

This is the point of ORD’s planning process where we
decide whether the work would best be accomplished
internally at ORD or externally through one of several
mechanisms: grants to universities or nonprofit centers;
cooperative agreements with another government
agency or with universities; or by contract. Many factors
influence this decision, including:

m Which organization has the most appropriate
expertise.

m What type of work is called for (risk assessment and
regulatory support work are generally retained in-
house, whereas research, including assessment
methods research work, may be done externally).

= How urgently the research products are needed
(since some mechanisms are faster than others).

m If there would be value in involving multiple
institutions.

@ The extent to which we can specify what is needed
(contracts). The extent to which we must rely on the
creativity and insight of the researcher (grants).

m@ What is our available in-house capacity.

m@ What are the opportunities for leverage.
Internal Research

Development of Budget
Operating Plans

For internal research, ORD integrates the science
research plans with budgetary decisions in order to allo-
cate resources to the selected research topics by labora-
tory program and research component. This helps
ensure that our priority-setting decisions (guided by
science) also reflect budgetary realities.

Development of Laboratory
Implementation Plans

Based on the science research plans and budgetary deci-
sions, ORD’s Laboratories and Centers develop detailed
plans for implementing each area of research to be under-
taken internally. These laboratory implementation plans
provide a blueprint for Laboratory and Center work and
form the basis for managerial oversight and guidance.

Extramural Research

Extramural research is conducted via grants, coopera-
tive agreements, or contracts. Rigorous external peer
review is a key mechanism we use to evaluate both the
proposals for and results of external research.

One of ORD’s primary mechanisms for involving exter-
nal scientists is the Science to Achieve Results (STAR)
program. STAR targets the best scientists from universi-
ties and nonprofit centers because they are an integral
and important part of the environmental research
community. STAR consists of focused Requests for
Applications (RFAs), investigator-initiated exploratory
research grants, graduate fellowships, and several
“critical mass” environmental research centers.

The bulk of the STAR program supports RFAs that focus
on specific research needs to support the mission of the
Agency. Working with EPA’s Program and Regional
Offices, we write these RFAs to be consistent with ORD’s
Strategic Plan and science research plans, and comple-
mentary to ORD’s in-house work. The RFAs are
announced annually to scientists at U.S. academic and
nonprofit institutions. Proposals from the external scien-
tific community are peer-reviewed and projects are then
selected for funding, in consultation with EPA’s Program
Offices and Regions, through grants or cooperative
agreements. ORD leverages the STAR program resources
by jointly funding research with other federal agencies.
Appendix D shows how the fiscal year 1997 RFA topic
areas relate to ORD’s high-priority research topics.

Integrating Information Management
Planning Into the Process

To further enhance the quality and value of our work,
we have been developing a plan for managing data and
information in ORD. The plan is based on coordinating
and enhancing existing ORD and EPA systems and
resources. It is built on four fundamental tenets of suc-

cessful information management:



EPA/600/R-97/015
April 1997

1997 Update to
ORD’s Strategic Plan

Office of Research and Development

U.S. Environmental Protection Agency
Washington, DC 20460


cod
:
i

i

@

Table 7. Endocrine Disruptors (Continued)
Subtopic Strategic Focus Tasks Products Uses
Biological _Extrapolating effects at the Translate results from Models predicting population To facilitate ecological risk assessment based on
Effects individual level to populations measurement endpoints at level effects from studies at effects in individuals.
(Continued) for fish and wildlife lower levels of biological lower levels of biological
organization to impacts on organization.
populations and communities
through use of microcosms and
mesocosms.
Identify appropriate sentinel
species for environmental
monitoring.
Characterizing the effects of Systematically study the Assessment of the validity of To reduce uncertainties associated with assessment
exposure to multiple EDCs. interactions of EDCs at low, the additivity principal for of exposure to multiple EDCs.
relevant dose levels to EDCs and predictive models for
understand potential for synergistic interactions.
synergism.
Exposure Developing a framework to Use physicochemical attributes Validated models to predict and To conduct preliminary environmental exposure
Studies characterize and to diagnose to identify transport, assess transport, fate, and assessments and set priorities for additional

and predict ecological and
human exposure to EDCs.

transformation, and
environmental fate
characteristics associated with
exposure scenarios of concern
to biological organisms.

Construct compartmental
models to predict
environmental behaviors.

exposure to EDCs from source
to receptor.

focused research.

Providing adequate tools to
estimate exposure to EDCs.

Develop new methods and
refine existing ones (e.g.,
analytical chemistry, sample
extraction, biomarkers) to
acquire data for compartmental
models, with emphasis on the
transport and transformation in
sediments and tools for
assessing exposure in
individuals.

Field and laboratory tools to
better quantitate EDCs in
multimedia.

To improve characterization of exposure to EDCs.

(Continued)

yoaeesey Ayisolidg-4y3in s,aq40


doses and risks. There is also a high degree of uncer-
tainty about whether disinfection by-products—the
chemical by-products that result when disinfectants
react with organic matter in drinking water—pose a sig-
nificant human health threat. Because of the high uncer-
tainty, the widespread human exposure to drinking
water, the severity of the known effects from certain
microbes, and the potentially high costs of further regu-
lation of drinking water, this issue is the highest priori-
ty to EPA’s Office of Water and ORD’s water research
agenda.

The current U.S. standard for arsenic in drinking water
is based on policy recommendations developed in 1942
that predate modern cancer and other health-related
data. Even today, regulation of arsenic in drinking
water is controversial because of the health risk uncer-
tainties and the costs of removing arsenic from drinking
water. However, legislation now requires EPA to issue a
revised standard for arsenic by 2001. Reports of hun-
dreds of thousands of people being poisoned by arsenic
in their drinking water in other countries (Taiwan,
China, India, Bangladesh, and Chile)—as well as the
fact that people in the U.S. on public and private water
supplies are exposed to arsenic, particularly in the
Southwest—have also heightened the need to address
these health uncertainties. Accordingly, this issue is also
of high priority to EPA’s Office of Water and ORD’s
water research agenda.

High-Priority Air Pollutants
(Particulate Matter)

Recent publications in the scientific literature indicate
that exposure to particulate matter (PM) poses a high
potential human health risk. These studies suggest
exposures to PM alone, and in combination with other
priority pollutants such as ozone, may shorten the
human life span of susceptible subpopulations (e.g., the
elderly) and cause illness in these and other susceptible
groups such as children. There is, however, a high
degree of uncertainty about the size and composition of
the particles that may be responsible for these effects,
the biological mechanisms of action, and the nature of
the concentration-response relationship across a wide
range of concentrations and conditions. In addition,
control costs are potentially very high. For all these rea-
sons, this area is of very high priority to EPA’s Office of
Air and Radiation and of high priority to ORD’s
research agenda.

ORD’s High-Priority Research

Emerging Environmental Issues
(Endocrine Disruptors)

Through the 1990s, concern has grown that humans and
wildlife have suffered adverse health effects from expo-
sure to environmental chemicals that interact with the
endocrine system. Collectively these substances are
known as endocrine-disrupting chemicals (EDCs). The
endocrine system as the central mediator of toxicity
may explain effects ranging from increased incidence of
some birth defects in humans and wildlife, to dimin-
ished semen quality in adult males, to increases in cer-
tain cancers (breast, prostate, testes). For example, we
have clear evidence of a cause-and-effect relationship in
the nearly complete mortality of Lake Ontario lake
trout in the sac-fry stage, presumably from exposure to
dioxin-like EDCs.

Despite these reports, we still know relatively little
about the causes of many of the adverse health out-
comes in humans of endocrine disruption. However, we
do know that endocrine factors regulate the normal
functions of all organ systems. Even small disturbances
in endocrine function, especially during certain stages
of the life cycle, can lead to profound and lasting effects.
Developing offspring are likely to be the most sensitive
to EDC exposure.

ORD is already committed to explicitly considering
health risks to children when assessing environmental
risks. EDC issues only heighten our concern that this
special population be provided adequate levels of pro-
tection from environmental exposures.

Based on the potential scope of the EDC problem, the
possibility of serious effects on the health of popula-
tions, and the persistence of some endocrine-disrupting
chemicals in the environment, this area has been desig-
nated as a high priority for ORD research. Consistent
with ORD’s long-term goals and objectives, particularly
pollution prevention, ORD leads international efforts to
define the scope of the EDC problem, identify the areas
of scientific uncertainty, and develop recommendations
for research. Working via an Endocrine Disruptor

Work Group under the Committee on the Environment
and Natural Resources of the National Science and
Technology Council, we have helped develop a



Table 5a. Safe Drinking Water—Disinfection (Continued)
Subtopic Strategic Focus Tasks Products Uses
Exposure What levels of DBPs Develop methods for measuring Improved practical field and To support exposure assessments for DBPs from
(continued) _are people exposed to? _ occurrence of DBPs in drinking research methods for DBPs in different treatment processes; provide basis for
water. drinking water. compliance methods for water utilities.
Study the level of DBPs in drinking __ Identity of new DBPs under
water supplies. different disinfection practices.
Data on DBP exposure from
drinking water.
Risk What are the Develop appropriate risk assessment _ Improved risk assessment To provide a comparative risk framework for risk
Assessment comparative risks paradigm for microbes, including _ procedures and risk estimates assessments for surface water treatment rules and
from DBPs and dose-response models. for microbes. DBP rules.
microbes?
Apply advances in cancer and Improved risk assessment
noncancer risk assessment to procedures and risk estimates
individual DBPs and mixtures of DBPs. for DBPs.
Risk What risk Evaluate treatment processes for Data on the effectiveness of To evaluate different treatment options and
Management management pathogen control, including different processes. regulatory strategies for reducing DBP and microbial

strategies can
simultaneously control
pathogens and DBPs?

identification of surrogate measures
of treatment effectiveness,
technologies for small systems,
control of bacterial growth in
distribution systems, and prevention
of pathogen intrusion into the
distribution system.

Simultaneously evaluate processes
for controlling DBPs (including
chlorine vs. alternative disinfectants)
and practices for removing DBP
precursors (granular activated
carbon, membrane filtration).

Evaluate vulnerability to microbial
pathogens of source waters used by
public water supplies.

Source water protection
protocols for public water
supplies, including
geohydrologic computer
modeling and GIS mapping
techniques.

risks.

To provide guidance for operation of treatment
plants and distribution systems.

yoaeasay Ajisolid-q3IH $,ayN0


Translating ORD’s Strategy into a Research Program

@ Focuses its technical support efforts in areas where
ORD has unique capability or where the support is
not readily available outside EPA.

@ Fosters greater involvement of the EPA Program
Offices and Regions in guiding ORD’s technical
support activities.

m Promptly develops exit or entrance strategies for
activities that are being phased out or newly
introduced.

As an outgrowth of this initial effort, ORD comprehen-
sively assessed its technical support function. We
defined the term technical support, developed criteria for
setting support priorities, inventoried the current distri-
bution of our technical support resources, and devel-
oped a process for making teclinical support decisions.

As defined by our assessment, ORD technical support
comprises activities ORD conducts in response to spe-
cific requests by the Program Offices, Regions, or states
to address well-defined needs that are not covered by
ORD’s research program. For example, ORD’s current
technical support activities include maintaining the
Integrated Risk Information System for the Agency and
consulting with the Office of Water on sediment quality
criteria guidelines.

The criteria ORD will now use to set its technical sup-
port priorities are the extent to which:

m The proposed technical support will provide
fundamental support for regulatory programs.

@ ORD has unique scientific and or technical
capabilities to address the problem.

@ Environmental quality and human health will
directly benefit from the activity, relative to the
resource requirements of the technical support.

= ORD can help solve the problem.

ORD technical support decisions for fiscal year 1998
were made during fiscal years 1996 and 1997 using a
process that involved the Research Coordination Teams,
the Research Coordination Council, the Environmental
Monitoring Management Council, and others. This
allowed participants to resolve long-standing issues and
develop a common reference point for making future
decisions. In the future, decisions about the type and
quantity of ORD technical support will be made as part
of ORD’s overall research planning process.

ORD Customer Focus

ORD is committed to providing excellent service to
all external and internal customers. To this end, we
will support our employees in applying the Agency’s
customer service standards, and our senior executives
will provide leadership in advocating high quality
customer service.

Human Resources and Infrastructure

The success of ORD’s Strategic Plan depends on an
adequately funded and well-managed infrastructure,
including ORD’s work force, systems, and equipment.
ORD’s recognition of the importance of our infrastruc-
ture is reflected in our strategic principles (Table 1),
which highlight the critical role of infrastructure in
achieving and maintaining an outstanding research and
development program in environmental science.

Because we recognize that scientific excellence must
be built on a strong foundation, we are committed.

to constant improvement of our organization and.
infrastructure. As we implement this Strategic Plan, we
will continue to devote leadership and resources to
developing and fostering our work force, modeling
effective management, and creating a supportive work
environment.

ORD’s Work Force

By far the most important component of ORD’s infra-
structure is our work force of scientists, engineers, man-
agers, other environmental professionals, and support
staff. ORD can achieve its vision of providing the scien-
tific foundation to support EPA’s mission only if we can
attract, nurture, and support a productive work force.
ORD’s strategic principles (Table 1) emphasize the
importance of nurturing and supporting the develop-
ment of outstanding scientists, engineers, and other
environmental professionals at EPA.

The cutting-edge nature of research and development at
ORD places great demands on our scientists and engi-
neers to continually upgrade their skills and knowledge
in response to and anticipation of new scientific develop-
ments. ORD maintains its commitment to building and
maintaining solid linkages to the external scientific
community, with an emphasis on scientist-to-scientist
interactions (e.g., through ORD-sponsored scientific
workshops). In addition, we will provide opportunities
for ORD scientists and engineers to increase their contri-
bution, as respected members of the scientific community



introduction

Figure 2. The Sci

Identification of Future Problem,
Initiating Event, or Public Policy Mandate

Risk Managemént

. Dose-Response
Risk Assessment Assessment

+ Public Health
Considerations

+ Statutory and Legal
Considerations

+ Social Factors

+ Economic Factors

+ Political Considerations

Reduced Environmental
and/or
Public Health Risk

Scientific and technical activities contribute to every stage of the risk management process. Environmental risk management
is initiated when a potential new environmental risk comes to light (such as an unusually high disease rate in a particular
population) and authorities decide or are mandated to investigate it.

First, the problem must be formulated. This involves such activities as determining which stressor(s) (e.g., pollutants, habitat
loss) is causing the problem, characterizing the sources of the stressor(s), how these stressor(s) reach target populations,
and which human or ecological populations are affected. Once the problem has been sufficiently formulated, the risk
assessment process can begin.

If sufficient information is available at this point, scientists and engineers can also begin to define risk management objec-
tives (i.e., the degree to which the risk should be managed or reduced) and identify risk management options that can
meet the objectives. Frequently, however, these activities must await further information, provided by the risk assessment,
on which populations are at risk and how great that risk is. Once potential options have been identified, scientists and
engineers evaluate the options to determine their performance and cost. Risk management options may include, for exam-
ple, pollution control technologies, banning or controlling the use of certain chemicals, cleaning up or preventing access to
con-taminated areas, implementing educational programs to encourage voluntary behavior changes on the part of the pub-
lic or industry, and redesigning industrial processes to reduce or eliminate toxic waste production.

The resulting information on the feasibility of potential risk management options, together with the risk characterization
(and public health, statutory, legal, social, economic, and political factors), is used to make a risk management decision.
Typically, this will involve selecting one or more of the potential risk management options and designing a regulatory
and/or nonregulatory strategy for implementing the chosen option(s).

Upon selecting a risk management strategy, scientists and engineers then develop compliance assurance models and meth-
ods (if the strategy is regulatory) and measures of environmental and public health improvement to monitor the success of
the strategy in reducing risk to humans or ecosystems. Once the selected option(s) is implemented, scientists and engi-
neers monitor the environmental and public health improvement. Monitoring data provide feedback to the risk manage-
ment decision-makers about whether the risk management strategy is achieving the desired goals. Decision-makers may
then amend the strategy, as necessary, based on these results. The final outcome of a successful risk management process
is reduced environmental and/or public health risk.



Appendix A

Objectives

Within this goal area, ORD will work to:

@ Provide cost-effective risk management technologies
and approaches for high-risk threats to human health
and the environment. This will include:

¢ Characterizing sources of fine-particulate emis-
sions, air toxics, and ozone precursors, and identi-
fying, adapting, and developing risk management
approaches that control emissions to acceptable
levels.

* Providing cost-effective, reliable technologies and
management approaches that reduce drinking
water exposures to disinfectant by-products while
protecting water supplies from microbial contami-
nation.

¢ Providing communities with proven technologies
for wet weather flow watershed management,
wellhead protection, and restoration of contami-
nated areas.

Provide pollution prevention approaches and
analytical tools to the private sector. This will
include:

¢ Providing risk-based systems and tools to analyze
options for multimedia pollution prevention for
major industrial sectors.

* Identifying and evaluating the performance and
costs for pollution prevention options for small-
and medium-sized businesses.

m Develop advanced air quality simulation models that

relate sources, emissions, and receptors. This will
include:

* Developing models based on high-performance
computing systems to predict the fate of pollu-
tants through the multimedia pathways leading
to human and ecosystem exposure to these
pollutants.

Catalyze the development and use of cost-effective
risk management approaches for the most difficult
and costly environmental management problems.
This will include:

* Developing cost-effective techniques for character-
izing and remediating soils and ground water
contaminated with nonaqueous-phase liquids,
chlorinated and other hazardous organics, and
toxic metals.

* Developing cost-effective techniques for character-
izing and remediating contaminated sediments.

¢ Verifying the performance of innovative risk
reduction and measurement/monitoring technolo-
gies and accelerating their commercial use.

@ Provide cost-estimating/engineering assessment
tools and methods for more accurate and meaningful
cost-benefit analyses. This will include:

* Developing data standards and cost reporting
protocols.

¢ Developing methods and cost analyses for emerg-
ing, high-risk environmental problems (e.g., fine
particulates, drinking water, wet weather flow
controls).

m Develop and provide risk management alternatives
to maintain and/or restore ecosystems. This will
include:

¢ Developing diagnostic and characterization
methods and protocols for use in determining
appropriate ecosystem restoration goals and
requirements for specific sites, watersheds,
landscapes, and ecoregions.

¢ Identifying, testing, and providing risk manage-
ment approaches and technical guidance for
restoring riparian zones, remediating contaminated
soils and sediments, and applying best manage-
ment practices to restore or maintain ecosystems
in urban, suburban, and urbanizing areas.

* Developing methods to restore and maintain soil
ecosystems.

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

ORD continues to be a national leader in the field of
risk analysis of human health and ecological effects and
will continue to serve as a catalyst for advances in the
science of risk assessment. ORD will achieve this goal
by working to facilitate cooperation and the exchange of
ideas between and among federal, state, and local scien-
tists as well as scientists in the environmental, industri-
al, and academic communities. In addition, ORD will
focus on three primary activities:

@ Using an open and participatory process, ORD will
conduct timely, state-of-the-art risk assessments.
These assessments either will serve as prototypes



Table Endocrine Disruptors (Continued)
Subtopic Strategic Focus Tasks Products Uses
Exposure Determining total ecosystem Examine multigenerational Exposure assessments for EDCs To monitor the environmenal signals of EDC
Studies and human exposures to EDCs _ transfer of EDCs in ecosystems, in key wildlife species and the _ exposure and effects.
(Continued) of concern. including biomagnification general human population.
processes important to higher
vertebrates.
Provide information on EDC
exposure distribution in the
general human population.
Linkage of _ Integrating human and Construct framework to Coordinated process for To conduct preliminary risk assessments and assist
Effects, ecological effects research with identify, characterize, and identifying exposure and effects research prioritization.
Exposure, Xposure research within the _ prioritize potential exposure __of concern for additional
and Risk risk assessment paradigm. to EDCs and provide database _ intensive characterization of risk.
Management for preliminary risk

characterization.

Determining classes and
concentrations of EDCs
associated with observations of
endocrine disruption.

Develop informational database
for EDCs, including biological
effects, environmental
concentrations, and historical
trends from existing monitoring
programs.

Conduct integrated toxicology
and exposure studies in areas or
human populations with
suspected contamination or
exposure to EDCs.

Database on EDC levels in the
human environment and
various ecosystems associated
with biological effects of
concern.

Centralized information source for environmental
monitoring of EDCs.

Establishing status and trends of
human and wildlife endocrine
disruption and EDC exposure.

Identify sites within geographic
proximity to ORD laboratories
for long-term intensive
observation of potential EDC
effects.

Examine existing exposure and
effect registries for indications
of EDC effects.

Consolidated databases of
status and trends relevant to
EDC exposures and effects.

For environmental monitoring and comparison of
effects with more intensive exposures.

(Continued)

yraeasay Ayrsolid-43tH S,a¥0


Table 8. Research to Improve Ecosystem Risk Assessmen

Subtopic Strategic Focus Tasks Products Uses
Exposure and What is the current Develop indicators of National Land Cover Database _To assist researchers and stakeholders in identifying
Effects condition of the ecological condition. for all Regions and indicators of environmental hazards at multiple scales and evaluating
environment? landscape vulnerability and relative condition. To serve as guidance on how to measure
human stress at watershed and regulatory and management success.
larger scales.
Suites of new, field applicable
biological indicators /criteria for
measuring, understanding, and
diagnosing ecosystem
exposures and effects.
What stressors are most Develop multiscale exposure Multimedia, multistress To assist researchers and stakeholders in evaluating the
significant in affecting the __ profiles for important exposure models for defining __ magnitude and extent of environmental stressors at local,
condition? Where are they? _ stressors. the distribution of stresses, regional, and national scales. To serve as a tool for
How are they distributed? alone and in combination, at __ predicting the results of alternative source reduction
local, watershed, and larger regulations.
scales.
What are the mechanisms — Conduct cause/effects Ecosystem models for To assist researchers and stakeholders in developing risk
of adverse effects? How _research at multiple levels of _ predicting the response of management alternatives and predicting ecosystem
sensitive are ecosystems to _ biological organization. ecosystems to multiple responses to these alternatives.
chemical and nonchemical stressors, at multiple scales.
exposures?
‘Assessment What is the relative risk Develop multiple scale, ‘Assessment techniques and To assist researchers and stakeholders at local, regional,

posed by stressors, now
and in the future? What is
the sustainability and/or
vulnerability of ecosystems?

multistressor, multi-endpoint
relative risk methods.

guidelines for defining
ecosystem sensitivity,
developing associated exposure
profiles, and quantifying
ecosystem vulnerability and
sustainability.

and national scales make cost-effective management
decisions on the protection of ecological resources by
knowing what the most important problems are, how to
get the desired result, how to verify/measure that result,
and how to improve conditions now and in the future.

(Continued)


A Roadmap for This Document

= Chapter 2 of this plan defines strategic directions
(including ORD’s vision, mission, and long-term
goals) for ORD research; describes how we identify
specific research topics; lays out an approach to
identifying emerging issues; establishes a risk-based.
process for determining our research priorities; and
discusses the criteria used in priority setting.

@ Chapter 3 discusses ORD’s new plan for information
management; describes how we translate our
Strategic Plan into a specific research program

(including research plans, operating plans, laboratory

implementation plans, and Requests for
Applications); relates how we determine who does
the work and when to close it out; describes how we
will determine priorities for technical support;
presents approaches to measuring success, as well as
mechanisms for evaluation and accountability; and
describes ORD’s commitment to our human
resources and infrastructure, including commitments
to organizational improvement made at our First
Annual Workshop on Managing Change in ORD.
Finally, it identifies challenges for future
consideration by ORD.

introduction

Chapter 4 describes the six high-priority research
topics and areas selected when we applied our
priority-setting process to the array of science needs
identified by the Agency, and in the context of our
long-term goals and objectives.

Appendix A expands on ORD’s long-term goals and
lists the specific research objectives and activities
ORD will pursue to achieve its goals.

Appendix B describes ORD’s organization built
around the risk assessment/risk management
paradigm.

Appendix C describes ORD’s management structure
for implementing the Strategic Plan.

Appendix D shows how ORD’s extramural
investments (in the form of Requests for Applications
for research grants) relate to the high-priority
research described in Chapter 4.

Appendix E shows how ORD’s fiscal year 1997 and
1998 program enhancements correlate to our high-
priority research.