Strategic Plan for the Office of Research and Development ... · 1EPA Strategic Plan for the Office...

1EPA Strategic Plan for theOffice of Research andDevelopment

United StatesEnvironmental Protection Agency

Research andDevelopment (8101)

EPA/600/R-96/059May 1996

2 Printed on paper that contains at least 20% postconsumer fiber.

ORD’s Strategic Plan

Office of Research and Development

U.S. Environmental Protection Agency

Washington, DC 20460

May 1996

Foreword

I am very pleased to present this new Strategic Plan for environmental research at the U.S.Environmental Protection Agency’s (EPA’s) Office of Research and Development (ORD). Inrecent years, many important groups—including EPA’s Science Advisory Board and blueribbon panels convened by the National Academy of Public Administration and the

National Research Council—have made many excellent suggestions for improving science atEPA. This plan incorporates and builds on these ideas to provide a blueprint for charting a courseof strong, credible science at EPA into the next century.

This plan is the culmination of a number of strategic changes to institute a more effective,risk-based research program at ORD. For example, we reorganized our nationwide system oflaboratories to conform to the fundamental components of the widely used risk assessment andrisk management processes. With this Strategic Plan, we have instituted a new system fordetermining research priorities based on risk assessment and risk management principles. Wewill use this system to sharpen the focus of our research by directing our resources where we cancontribute most effectively to understanding and solving environmental problems, while alsofully supporting EPA in fulfilling its mandates.

By providing clear mechanisms and opportunities for stakeholder involvement, this plan promotesgreater partnership between ORD and its primary clients—EPA’s Program and Regional Offices—as well as the external scientific community. And, by clearly delineating ORD’s research planningprocess, goals, and objectives, this plan is a tool our stakeholders can use to measure our success inproviding practical, credible, and timely information and tools for risk-based decision-making. Toensure the utmost transparency, this plan also includes a detailed description of how ORD translatesits research priorities into a research program, as well as a discussion of our commitment to providingthe infrastructure needed to conduct high quality research.

This plan is a foundation for the future. We have designed this Strategic Plan to endure and yetbe dynamic in the face of continually advancing scientific knowledge and understanding. That iswhy we have selected time-tested risk-based organizing and decision-making principles thattranscend economic and political changes. At the same time, we have designed the plan to beflexible, providing capacity for our planning mechanisms to constructively adapt to changingEPA and national priorities over time.

We invited other EPA offices and Regions as well as numerous external organizations to peer review a draft of this plan. This final version of the plan now incorporates many of their usefulsuggestions. We will periodically revisit and, as necessary, modify this Strategic Plan to ensurethe continued productivity of ORD’s research and development efforts to meet EPA and nationalenvironmental goals.

I firmly believe that this Strategic Plan, coupled with the other strategic changes we haveinstituted at ORD (listed on the back inside cover), offer unparalleled opportunities for ORD toimprove the overall quality and relevancy of EPA research and development. I am confident that,in the coming years, these changes will serve as essential catalysts for moving EPA into the highest echelon of leadership in environmental science.

Robert J. HuggettAssistant Administrator, Office of Research and Development

Contents

List of Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viiStrategic Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

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

Setting ORD Research Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

High-Priority Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

Looking Ahead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1ORD’s Reinvention Around the Risk Paradigm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Audiences for This Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Critical Players and Linkages for Implementing ORD’s Strategic Plan . . . . . . . . . . . . . . . . . . . . . . . . . 5

Evolution of the Strategic Plan Over Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

A Roadmap for This Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Part A: ORD’s Research Strategy . . . . . . . . . . . . . . . . . . . . . . . 9ORD’s Vision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

ORD’s Mission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

ORD’s Long-Term Goals and Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Identifying Specific Research Topics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Identifying Emerging Issues, Anticipatory Research, and Exploratory Research . . . . . . . . . . . . . . . . . . . 12

ORD’s Priority-Setting Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Criteria for Setting ORD Research Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Strengths of ORD’s Priority-Setting Process and Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Translating ORD’s Strategic Plan Into a Research Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Measures of Success . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Mechanisms for Evaluation and Accountability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Closing Out Completed Work . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Human Resources and Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Challenges for the Future . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

S t rat e g i c P l a n f o r O R D i i i

Part B: ORD’s Long-Term Goals and Objectives . . . . . . . . . . . . . . 21Goal 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Goal 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Goal 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Goal 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Goal 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Goal 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Appendix I: ORD’s High-Priority Research . . . . . . . . . . . . . . . . 29

Appendix II: The ORD Organization . . . . . . . . . . . . . . . . . . . . 51

Appendix III: Management Structure for Implementing ORD’s Strategic Plan . . . . . . . . . . . . . . . . . . . . 55

Appendix IV: Relationship of Fiscal Year 1996 Requests for Applications to ORD High-Priority Research Topics . . . . . . . . . . 59

i v S t rat e g i c P l a n f o r O R D

List of Acronyms

CRADA Cooperative Research and Development Agreement

EPA U.S. Environmental Protection Agency

IRIS Integrated Risk Information System

NAE National Academy of Engineering

NAPA National Academy of Public Administration

NAS National Academy of Sciences

NCEA National Center for Environmental Assessment

NCERQA National Center for Environmental Research and Quality Assurance

NERL National Exposure Research Laboratory

NHEERL National Health and Environmental Effects Research Laboratory

NRC National Research Council

NRMRL National Risk Management Research Laboratory

ORD Office of Research and Development

ORMA Office of Resources Management and Administration

ORSI Office of Research and Science Integration

OSP Office of Science Policy

RCC Research Coordination Council

RCT Research Coordination Team

R&D research and development

RFA Request for Application

ROPE Research Opportunities and Priorities for EPA

SAB Science Advisory Board

STAR Science to Achieve Results

S t rat e g i c P l a n f o r O R D v

Executive Summary

Executive SummaryThe U.S. Environmental Protection Agency’sOffice of Research and Development(ORD) has undertaken some of the mostdramatic changes in its organizational

history, setting the vision and direction for theresearch that will provide the scientific foundationto support EPA’s mission:

ORD realigned its organizational structure to userisk assessment and risk management as organiz-ing principles for its nationwide laboratorysystem.

ORD strengthened its interaction with the largerscientific community by expanding its competi-tive extramural grants and graduate fellowshipprograms. These programs stimulate research inareas vital to EPA by involving universities andother not-for-profit institutions.

ORD intensified its peer review process to ensurethat all science meets our standards for excel-lence.

And, most importantly, ORD instituted a newstrategic planning and management process bywhich we identify and select our research priori-ties. This new process sets us on a course that willallow us to more clearly define the next genera-tion of environmental needs and identify theresearch to address those needs.

Describing this strategic planning and managementprocess, and providing the framework for researchpriorities, is the ORD Strategic Plan.

Strategic PrinciplesThe ORD Strategic Plan is based on nine strategicoperating principles, summarized below, whichdraw on the many recommendations ORD has received from outside groups in recent years:

Focus research and development on the greatestrisks to people and the environment.

Focus research on reducing uncertainty in risk assessment.

Balance human health and ecological research.

Infuse ORD’s work with a customer/client ethic.

Give priority to maintaining strong and viablecore capabilities.

Nurture and support the development of out-standing scientists, engineers, and otherenvironmental professionals.

Increase competitively awarded research grants.

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

Provide the infrastructure to achieve and main-tain an outstanding R&D program.

Most important of these principles is the explicit useof the risk paradigm to shape and focus ourorganizational structure and research agenda.

ORD’s Vision, Mission, and Long-Term GoalsORD’s commitment to develop a risk-based researchagenda has required us to rethink our vision, mission,and goals and to develop a risk-based process forselecting and ranking those research areas of primaryimportance to EPA. ORD’s vision and mission for thefuture arise from a consideration of the key role thatORD science plays within EPA and in the broadercontext of our nation’s environmental researchagenda. Our vision is that ORD will provide thescientific foundation to support EPA’s mission. Ournew mission statement is divided into four maincomponents: research and development, technicalsupport, integration of scientific information, andanticipatory research. This translates into sixlong-term, overarching goals—broad areas ofresearch and development where we believe ORDcan and must make important contributions to

S t rat e g i c P l a n f o r O R D v i i

EPA’s mission and mandates and to our nation’soverall environmental research agenda.

Setting ORD Research PrioritiesEssential to meeting our long-term goals is a processwe will use to set priorities within the universe ofpossible research, and to focus our efforts on thoseareas of primary importance to EPA’s mission. Ournew priority-setting process involves the followingsteps:

First, we involve all parts of EPA, includingORD’s own researchers and staff, in helping usset research priorities. The Research Coordina-tion Council, the Science Council, ResearchCoordination Teams consisting of senior repre-sentatives from ORD’s new National Laboratoriesand Centers and EPA’s Program and Regional Of-fices identify the most important and relevantareas for our research efforts. We also work withEPA’s Science Advisory Board, the National Re-search Council, and the private sector early in theplanning process to obtain recommendationsfrom the external scientific community regardingthe major scientific directions and priorities forour research program. Based on this input, weidentify potential research topics.

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

To these remaining areas falling within ORD’smission and goals, we apply a series of humanhealth, ecological health, and risk managementcriteria to set priorities according to their poten-tial to support effective risk assessment andenhance risk reduction—for example by reducingthe uncertainties in risk assessment. We use com-parative risk analyses, as needed, to ascertain themost pressing problems. We also considerwhether the research would develop broadly ap-plicable methods and models needed by EPAprograms. We then ascertain whether ORD canmake a significant contribution. Through thisscreening process, we set priorities among the research topics.

We then define our specific R&D projects by con-sidering each topic area in totality. For each topicarea, we systematically examine the researchneeds within each component of the risk para-digm: effects, exposure, assessment, and risk

management. Based on this analysis, we define aseries of high-priority research activities acrossthe risk paradigm that will produce a comprehen-sive set of useful risk-based results.

Once we have identified our high-priority topics,we develop and implement a research programwith specified roles for intramural and extramu-ral participants, identifiable products, andprovisions for accountability and visibility regard-ing progress on our commitments.

High-Priority ResearchORD has used the process described above to establishour research priorities for the next few years. Usingour new risk-based planning process and criteria,ORD has identified six high priorities that will receivespecial, expanded attention within the broader ORDprogram. These high priorities include three discreteresearch topics and three broad-based areas that canincorporate many additional specific topics:

Drinking water disinfection

Particulate matter

Endocrine disruptors

Research to improve ecosystem risk assessment

Research to improve health risk assessment

Pollution prevention and new technologies

Looking AheadThe Strategic Plan provides a blueprint fordesigning and implementing a research program toproduce the sound science needed to support EPA’smission. In the years to come, ORD will place acontinuing priority on providing thecommunication, infrastructure, and supportnecessary for successful implementation of the plan.

For ORD’s stakeholders, including the EPA Programand Regional Offices, academia, the private sector,and other government agencies, the plan serves as aroadmap that explains ORD’s research planning andimplementation process, defines how our stakeholderscontribute to this process, and specifies the goals, objectives, and products they can use to hold us accountable for our progress in environmental research. This plan is intended to serve as a practicaltool for ensuring the constructive involvement ofour stakeholders in establishing and executingORD’s research agenda during the coming years.

E x e c u t i v e S u m m a r y

v i i i S t r at e g i c P l an f o r O R D

IntroductionIn recent years, a convergence of thinking hasoccurred about science at the U.S. Environ-mental Protection Agency (EPA). The Agency’sown Science Advisory Board (an independent

group of engineering and science advisors to EPA)and expert blue-ribbon panels convened by the National Academy of Sciences (NAS)1 and the National Academy of Public Administration(NAPA)2 all have emphasized the importance of science at EPA and made many recommendationsconcerning its role and direction.

As these groups affirmed, science provides thefoundation for credible environmentaldecision-making. It is vital to achieving a healthypopulation, thriving environment, and robusteconomy. Only through adequate knowledge aboutthe risks to human health and ecosystems, andinnovative solutions to prevent pollution andreduce risk, can we continue to enjoy a high qualityof life. In July 1994, EPA published a Five-YearStrategic Plan3 that adopts strong science andcredible data as one of seven guiding principles to

fulfill the Agency’s mission to protect human healthand environmental quality. While all of EPA usesscience for policy and regulatory decision-making,and various EPA offices perform research, theresponsibility for leadership in science at EPA andfor the bulk of EPA’s research and developmentwork resides in EPA’s Office of Research andDevelopment (ORD).

ORD’s Reinvention Around theRisk ParadigmIn the past two years, we at ORD have substantiallychanged our organization and operation so that we

1 Interim Report of the Committee on Research and Peer Review at EPA.National Academy of Sciences Board on Environmental Studies and Toxicology. 1995. National Academy Press.2 Setting Priorities, Getting Results. A New Direction for EPA. Na-tional Academy of Public Administration. 1995. Washington, DC.3 The New Generation of Environmental Protection. A Summary of EPA’s Five-Year Strategic Plan. U.S. Environmental Protection Agency. 1994. EPA200-2-94-001. Washington, DC.

Introduction

Science is one of the soundest investmentsthe nation can make for the future. Strongscience provides the foundation for credibleenvironmental decision-making. With abetter understanding of environmentalrisks to people and ecosystems, EPA cantarget the hazards that pose the greatestrisks, anticipate environmental problemsbefore they reach a critical level, anddevelop strategies that use the nation’s,and the world’s, environmental protectiondollars wisely.

Expert Panel on the Role of Science atEPA

Safeguarding the Future: CredibleScience, Credible Decisions

Introduction

S t rat e g i c P l a n f o r O R D 1

can strengthen EPA’s science base and improve theAgency’s and our nation’s ability to effectivelyrespond to the complex environmental challenges ofthe future. These changes represent a significantdeparture from the past. They are based on a set ofstrategic principles we have developed (Table 1) thatdraw upon the many recommendations we havereceived from outside groups in recent years. Themost important of these principles is the explicit use ofthe risk paradigm to shape and focus ourorganizational structure and research agenda.

The risk assessment paradigm has been defined manytimes 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 tothat point. Risk assessment is the process thatscientists use to understand and evaluate themagnitude and probability of risk posed to humanhealth and ecosystems by environmental stressors,such as pollution or habitat loss or change. Theresulting risk characterization, together with otherpublic health, statutory, legal, social, economic,political, and technical factors, provides the criticalinput for deciding whether and how to manage therisk associated with a particular stressor. Riskmanagement options may include both regulatoryprograms and voluntary activities (e.g., recycling) toreduce or eliminate production of the stressor.

The risk assessment process is one component of theoverall process of risk management. The riskmanagement process begins when a potential new

Focus research and development on the greatestrisks to people and the environment, taking intoaccount their potential severity, magnitude, anduncertainty.

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

Balance human health and ecological research.

Infuse ORD’s work with a customer/client ethicthat breaks down organizational barriers andensures responsiveness to ORD’s internal andexternal customers.

Give priority to maintaining the strong and viablescientific and engineering core capabilities that allow us to conduct an intramural research andtechnical support program in areas of highestrisk and greatest importance to the Agency.

Through an innovative and effective human resources development program, nurture andsupport the development of outstanding scien-tists, engineers, and other environmentalprofessionals at EPA.

Take advantage of the creativity of the nation’sbest research institutions by increasing competi-tively awarded research grants to further EPA’scritical environmental research mission.

Ensure the quality of the science that underliesour risk assessment and risk reduction efforts byrequiring the very highest level of independentpeer review and quality assurance for all our science products and programs.

Provide the infrastructure required for ORD toachieve and maintain an outstanding researchand development program in environmental science.

Table 1. ORD’s Strategic Principles

Work on this Strategic Plan began in 1995 by a taskforce comprised of staff from ORD’s National Labo-ratories and Centers, as well as our headquartersOffices. As we developed the plan, we consultedwith our clients in EPA’s Program and Regional Of-fices to ensure that the plan would enable ORD toeffectively meet their needs and maintain good cus-tomer relations. We also relied heavily on theadvice of the National Research Council and EPA’sScience Advisory Board. In late 1995, we distributeda review draft of the plan to solicit comments fromour external partners and stakeholders. Based onpeer reviewer comments, we refined and expandedour plan to produce this final version. Majorchanges reflected in the final plan include:

Clarification of our vision, mission, and researchgoals.

Better linkage between our research plan-ning process and our criteria for settingresearch priorities.

A better balance of health and ecological con-cerns.

Clarification of our approach to anticipatory research and emerging environmental problems.

Discussion of ORD’s role in providing enhancedtechnical support to EPA’s Program Offices.

A more complete discussion of our grants process.

A brief discussion of "Challenges for the Future"that peer reviewers brought to our attention andto which we plan to devote further study.

History of This Document

I n t r o d u c t i o n

2 S t rat e g i c P l a n f o r O R D

risk comes to light and authorities decide or aremandated to respond to concern about the risk. Itinvolves risk assessment as well as a series of otherscientific and technical activities, illustrated inFigure 2, to provide the scientific and technical datafor making and implementing a risk managementdecision. The risk management process ends whenthe selected risk management option(s) isimplemented and the resulting environmentaland/or public health improvements are monitored.

Figure 2 expands on the “Risk ManagementOptions” portion of the original NAS paradigmto show the many scientific and technicalactivities, in addition to risk assessment, that areessential to risk management. These includecharacterizing the sources of environmentalproblems; identifying risk management optionsand evaluating their performance, cost, andeffectiveness; and monitoring improvements inenvironmental quality and public health that result

Risk Assessment

Dose-Response Assessment

Hazard Identification

Exposure Assessment

Statutory and Legal Considerations

Risk Management

OptionsEconomic

Factors

Political Considerations

Risk Management Decision

Social Factors

Risk Characterization

Risk Management

*Adapted from: Risk Assessment in the Federal Government: Managing the Process. National Academy of Sciences. 1983. Science and Judgement in Risk Assessment. National Research Council. 1994.

Public Health Considerations

Figure 1. The Risk Assessment/Risk Management Paradigm

The risk assessment process consists of four steps:

During hhaazzaarrd d iiddeennttiiffiiccaattiioonn, scientists describe the adverse effects (e.g., short-term illness, cancer, reproduc-tive effects) that might occur due to exposure to the environmental stressor of concern. To identify potentialhazards, scientists use the results of experimental studies on test organisms, reports about accidental expo-sure, and epidemiologic research.

During ddoossee--rreessppoonnsse e aasssseessssmmeenntt, scientists determine the toxicity or potency of a stressor. The dose-response assessment describes the quantitative relationship between the amount of exposure to a stressorand the extent of injury or disease.

During eexxppoossuurre e aasssseessssmmeenntt, scientists describe the nature and size of the population(s) or ecosystem(s) exposed to a stressor and the magnitude and duration of exposure. Exposure assessment includes a description of the pathways (e.g., air, food, water) by which the stressor travels through the environment;the changes that a stressor undergoes en route; the environmental concentrations of the stressor relative totime, distance, and direction from its source; potential routes of exposure (oral, dermal, or inhalation); andthe distribution of sensitive subgroups, such as pregnant women and children.

During rriissk k cchhaarraacctteerriizzaattiioonn, scientists use the data collected in the three previous steps to predict the effects of human or ecological exposure to the stressor of concern. They estimate the likelihood that apopulation will experience any of the adverse effects associated with the stressor, under known or expectedconditions of exposure. This estimate can be qualitative (e.g., high or low probability) or quantitative (e.g.,one in a million probability of occurrence).

The NAS paradigm was developed specifically to define risk assessment and risk management for humanhealth. While ORD recognizes that there are distinctions for ecological risk assessment and that scientific ap-proaches to risk assessment have evolved and expanded since development of the NAS paradigm, the generalprinciples set forth in the NAS paradigm are still useful as an organizing focus for ORD’s strategic thinking.



Dose-Response Assessment

Hazard Identification

Exposure Assessment

Identification of Future Problem, Initiating Event, or Public Policy Mandate Define the Problem Define Risk Management Objectives Identify and Evaluate Risk Management Options Risk Management Decision Implement Option(s) Monitor Environmental and Public Health Improvement

Risk Characterization

Develop Measures of Environmental and

Public Health Improvement

Develop Compliance Assurance Models and Methods

Risk Assessment

Risk Management

Reduced Environmental and/or

Public Health Risk

• Public Health Considerations • Statutory and Legal Considerations • Social Factors • Economic Factors • Political Considerations

Figure 2. The Scientific and Technical Contributions to Risk Management

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

The first step is to ddeeffiinne e tthhe e pprroobblleemm. This involves such activities as determining which stressor(s) (e.g., pollutants,habitat loss) is causing the problem, characterizing the sources of the stressor(s), how these stressors reach targetpopulations, and which human or ecological populations are affected. Once the problem has been sufficiently char-acterized, the risk assessment process can begin.

If sufficient information is available at this stage, scientists and engineers can also begin to ddeeffiinne e rriissk k mmaannaaggeemmeennttoobbjjeeccttiivveess (i.e., the degree to which the risk should be managed or reduced) and iiddeennttiiffy y rriissk k mmaannaaggeemmeennt t ooppttiioonnssthat can meet the objectives. Frequently, however, these steps must await further information, provided by the riskassessment, on which populations are at risk and how great that risk is. Once potential options have been identi-fied, scientists and engineers eevvaalluuaatte e tthhe e ooppttiioonnss to determine their performance and cost. Risk managementoptions may include, for example, pollution control technologies, banning or controlling the use of certain chemi-cals, cleaning up or preventing access to contaminated areas, implementing educational programs to encouragevoluntary behavior changes on the part of the public or industry, and redesigning industrial processes to reduce oreliminate toxic waste production.

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

Once a risk management strategy has been selected, scientists and engineers then ddeevveelloop p ccoommpplliiaanncce e aassssuurraanncceemmooddeells s aannd d mmeetthhooddss (if the strategy is regulatory) and mmeeaassuurrees s oof f eennvviirroonnmmeennttaal l aannd d ppuubblliic c hheeaalltth h iimmpprroovveemmeennttto monitor the success of the strategy in reducing risk to humans or ecosystems. Once the selected option(s) is im-plemented, scientists and engineers mmoonniittoor r tthhe e eennvviirroonnmmeennttaal l aannd d ppuubblliic c hheeaalltth h iimmpprroovveemmeenntt. Monitoring dataprovide feedback to the risk management decision-makers about whether the risk management strategy is achiev-ing the desired goals. Decision-makers may then amend the strategy, as necessary, based on these results. The finaloutcome of a successful risk management process is rreedduucceed d eennvviirroonnmmeennttaal l aanndd//oor r ppuubblliic c hheeaalltth h rriisskk.



from risk management activities. ORD contributesto many of the areas depicted in Figure 2. In thisway, ORD not only identifies and characterizesenvironmental problems but also helps to find andimplement efficient, cost-effective solutions to theseproblems.

The first major step in ORD’s reinvention was toreorganize ORD so that its new structure mirrors therisk paradigm shown in Figure 1. This new structureis described in Appendix II. ORD’s new StrategicPlan—described in this document and illustrated inFigure 3—is the second major step. This StrategicPlan is the blueprint for ORD’s risk-based researchprogram.

Audiences for This DocumentThis Strategic Plan is an important document formany different groups:

Internally at ORD, the plan provides ORD staffwith a blueprint for designing and implementingORD’s research program in the years to come.Also, it enables ORD staff to relate the individualresearch projects for which they are responsibleto ORD’s strategic goals and objectives, as well asto the Agency’s environmental goal of "ensuring

that the nation’s environmental policies are basedon the best science and information available."

For our many stakeholders, including EPA’s Pro-gram and Regional Offices, academia, the privatesector, and other government agencies, the planserves as a roadmap that:

• Explains how we plan research and translateour plans into a research program.

• Defines an explicit role for stakeholders incrafting and reviewing ORD’s research agenda.

• Specifies goals, objectives, and products that canbe used to measure and hold us accountable forour progress in environmental research.

Critical Players and Linkages forImplementing ORD’s Strategic PlanThe success of ORD’s Strategic Plan relies on thecontributions of many individuals, institutions, andsectors, as described below.

ORD StaffFirst and foremost, ORD staff are crucial to the plan’ssuccess. ORD’s scientists and engineers, in particular,are the repository of the core scientific and engineeringcapability in the Agency, as well as a vital conduit forthe needs and potential contributions of ORD’sresearch clients and partners.

Successful implementation of the Strategic Plan will depend on the success of ORD managers incommunicating the plan to all our staff and inevoking a sense of ownership of the plan and ashared vision of the work to be accomplished. Whileleadership for communicating this plan mustcascade through ORD’s management to ourscientific, engineering, professional, and supportstaff, ownership and implementation of the planwill depend on the strength of our work force. ORDwill place a continuing priority on internalcommunication and support to enable and inspireeffective implementation of this plan.

EPA Program and Regional OfficesLinkages between ORD and its primary clients—EPA’s Program and Regional Offices—are essentialto successful implementation of this plan. Oneimportant linkage is the day-to-day contact thatORD scientists and engineers have with EPA’sProgram and Regional Offices. This ongoinginformal contact helps ensure that the ORD

Vision

Mission

Long-TermGoals

Objectives

Activities ToMeet the

Objectives

StrategicPrinciples

Priority-SettingProcess

andCriteria

Role ofScienceat EPA

High-Priority

ResearchTopics

Figure 3. ORD’s Strategic Plan



scientists and engineers involved in our planningprocess understand our client’s needs.

In addition, this Strategic Plan establishes formalareas of linkage to ensure client input duringresearch planning. As Part A of this plan describes,we directly solicit input on priority needs andproducts from the Program and Regional Officesduring the planning process.

ORD’s Research Planning AdvisorsAs described in Part A of this document, our planningprocess also relies on the contributions of many othergroups who provide crucial input for formulating andexecuting our research program and priorities. Theseinclude other federal agencies (both directly andthrough the National Science and Technology Counciland its Committee on Environment and NaturalResources), as well as the National Research Counciland EPA’s Science Advisory Board.

ORD’s Research PartnersSuccessful plan implementation also relies on ongoingpartnerships between ORD and other researchorganizations in academia, the private sector, andother government agencies. These partnerships benefitall parties. They provide a common sense andcost-effective way for ORD to utilize the specialexpertise residing outside our organization, while alsoreducing overlapping and duplicative work. Ourpartners enrich our research planning process andhelp ensure that our research products areappropriately targeted to stakeholder needs. ORDaccesses and involves partner organizations inimplementing our research program through a varietyof competitive, grant, and contractual mechanisms.

Shared LeadershipIn the context of environmental science, ORD servesboth as a team leader for research planning withinEPA and as a national leader within the largerscientific community for conducting our nation’senvironmental science. ORD implicitly sharesresponsibility for this leadership through our peerreview protocols, which ensure both internal andexternal vetting of each critical step in our researchprocess, from identifying research priorities toevaluating our eventual success.

Looking AheadAs ORD implements its Strategic Plan in the years tocome, we will strengthen our links with our clientsand partners. We will work to expand ourpartnerships with other agencies, universities, andthe private sector and to integrate our planningefforts with EPA’s overall planning based on theAgency’s Strategic Plan. Also, we will strive to forgelinks with the planning efforts of other federalagencies and other nations as appropriate.

Evolution of the Strategic PlanOver TimeORD’s Strategic Plan is designed to be a robust"living" document. The plan provides a solidunderpinning for ORD research that will allow us tomaintain continuity and momentum in our work inthe coming years, while also constructively adaptingto changing EPA and national priorities over time.

We will periodically revisit and, as necessary,modify our Strategic Plan to ensure the continuedproductivity of ORD’s research and developmentefforts to meet EPA, national, and internationalenvironmental goals. At the same time, we willwork to ensure that, as the plan evolves, it continuesto reflect goals and objectives that are communallyderived and universally shared throughout ORD.

A Roadmap for This DocumentPart A of the plan defines strategic directions (including ORD’s vision, mission, and goals) forORD research; lays out an approach to identify-ing emerging issues; establishes a risk-basedprocess for determining our research priorities;describes how we translate this Strategic Planinto a specific research program (including re-search plans, operating plans, laboratoryimplementation plans, and Requests for Applica-tions); describes how we determine who does thework and when to close it out; describes how wewill determine priorities for technical support;presents approaches to measuring success; anddescribes ORD’s commitment to our human re-sources and infrastructure that are essential toimplementing the Strategic Plan. Finally, Part Aidentifies challenges for future consideration byORD.



Part B expands on ORD’s goals and lists the specific research objectives and activities ORDwill pursue to achieve its goals.

Appendix I describes the six high-priority research topics and areas selected when we ap-plied our new priority-setting process (describedin Part A) to our long-term objectives and activi-ties (described in Part B).

Appendix II describes ORD’s new organizationaround the risk assessment/risk managementparadigm.

Appendix III describes ORD’s management struc-ture for implementing the Strategic Plan.

Appendix IV shows how ORD’s extramural invest-ments (in the form of Requests for Applicationsfor research grants) relate to the high-priorityresearch described in Appendix I.



ORD’s Research StrategyORD’s commitment to develop arisk-based research agenda has requiredus to rethink our vision, mission, andgoals and to develop a risk-based

process for selecting and ranking those researchtopics of primary importance to ORD and EPA.

ORD’s vision and mission for the future arise from aconsideration of the importance of science at EPAand in the broader context of our nation’senvironmental research agenda, and of ORD’s keyrole in environmental science. Our vision, describedbelow, represents the overall level of achievementthat we will strive for in all our research anddevelopment work. Our mission statement,described below, defines the broad areas of researchand development where we believe ORD can andmust make important contributions to EPA’smission and mandates and to our nation’s overallenvironmental research agenda.

ORD’s VisionORD will provide the scientific foundation tosupport EPA’s mission.

ORD’s MissionORD’s mission is to:

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

Provide responsive technical support to EPA’smission.

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

Provide leadership in addressing emerging envi-ronmental issues and in advancing the scienceand technology of risk assessment and risk man-agement.

Part A

ORD’sResearchStrategy

Part A

ORD’sResearchStrategy

[A] strategic plan should consist at aminimum of a vision statement, amission statement, and a plan forachieving them. [It] should be robust andspecific enough to enable [evaluation of]the intended role of ORD and itsorganizational components in providingscientific and technical knowledge tosupport national environmentalprograms, policies, and decisions, as wellas to identify unnecessary geographicaland functional duplication andsignificant gaps in ORD activities.

National Research Council

Interim Report of the Committee onResearch and Peer Review in EPA(March 1995)


ORD’s Long-Term Goals andObjectivesORD’s four mission areas translate into sixlong-term, overarching goals that we will strive tomeet in order to fulfill our mission (Table 2). Part Bof this plan describes these goals in detail andbreaks each goal down into a series of specificresearch objectives and activities that ORD willpursue to achieve its goals.

Identifying Specific ResearchTopicsThe objectives and activities listed in Part B of thisplan provide detail about how ORD will go aboutmeeting its goals. Each objective and activity stillrepresents a relatively broad research area. ORD,therefore, has developed a priority-setting processand criteria, illustrated in Figures 4 and 5 anddescribed below, for identifying specific researchtopics within the objective and activity areas that areof primary importance to our vision, mission, andgoals. Each year, we will use this priority-settingprocess and criteria to identify high-priorityresearch topics that will help us achieve ORD’sgoals and objectives.

We applied our new priority-setting process andcriteria for the first time in 1995, when we usedthem to reexamine our ongoing research andidentify important new initiatives. Based on thisfirst application, we identified six high-priorityresearch topics—some specific and others broad-based—for the next few years. These six topics aredescribed in Appendix I.

Many topics will remain a high priority for severalyears. Each year, working with our programpartners and external advisory bodies, we willexamine the previous year’s topics to add newtopics as appropriate and remove previous topicsfor which sufficient research has been conducted.

Public and private sector institutions have longbeen significant contributors to our nation’s environ-mental and human health research agenda. EPA’sOffice of Research and Development, however, isunique among scientific institutions in this countryin combining research, analysis, and the integrationof scientific information across the full spectrum ofhealth and ecological issues and across both risk assessment and risk management. This broadscope has resulted in scientific and engineering expertise, physical facilities, and equipment that permit and encourage integrated multimedia andmultidisciplinary research on environmental issues.As part of a regulatory Agency that establishes nationalpriorities and sets national standards, ORD researchis conducted to protect human and ecosystemhealth in a cost-effective manner and to provide afirm scientific and technical foundation for environ-mental decisions and standards.

ORD’s Key Role

Mission Area Goals

Perform research and development to identify,understand, and solve current and future

To develop scientifically sound approaches to assessing andcharacterizing risks to human health and the environment.

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

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

Provide responsive technical support of EPA’smission.

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/riskmanagement information among private and public stakeholders.

Provide leadership in addressing emergingenvironmental issues and in advancing the scienceand technology of risk assessment and riskmanagement.

To provide leadership and encourage others to participate inidentifying emerging environmental issues, characterizing the risksassociated with these issues, and developing ways of preventing orreducing these risks.

Table 2. ORD’s Long-Term Goals

environmental problems.

O R D ’ s R e s e a r c h S t r a t e g y

1 0 S t rat e g i c P l a n f o r O R D

Is theTopic ClearlyMandated?1

Isthe Topic

Within ORD’sMission and

Goals?

Apply Evaluation Criteria:

• Human Health/Ecological Health(Use Comparative Risk Analyses

as Appropriate)• Risk Management• Methods/Models

Prioritized Research Topics

CanORD Makea Significant

Contribution?

Reject forORD

Funding2

Reject forORD

Funding2

YesNo

Determine Research Needs:• Effects

• Exposure• Risk Characterization

• Risk Management

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

Research Products

No

Yes

No

1If so, EPA may have no discretion to reject or delay this research.2EPA program offices and regions may still choose to fund, using ORD labs, grants, contracts, etc., or a research source outside of ORD.

Yes

External Scientific Community Input:

•EPA Science Advisory Board• National Research Council

• Other Government Agencies•Private Sector

• ORD National Laboratories and Centers• EPA Program Offices•EPA Regional Offices

•Research Coordination CouncilIdentify Research Topics andEvaluate Research Products

Conduct ExternalPeer Review of

ExtramuralResearch Proposals

Figure 4. Setting Research Priorities


S t rat e g i c P l a n f o r O R D 1 1

Identifying Emerging Issues,Anticipatory Research, andExploratory ResearchIn recent years, EPA has begun moving beyondenvironmental regulation to environmentalprotection in its broadest sense, includinganticipating and preventing problems before theymushroom into major concerns. To support EPA inthis endeavor, ORD is evaluating the best means toanticipate tomorrow’s environmental problems andprovide EPA with the necessary information toevaluate findings, interact with other agencies andorganizations, and possibly act on early warnings ofemerging environmental issues.

The EPA Science Advisory Board’s January 1995report Beyond the Horizon: Using Foresight to Protectthe Environmental Future suggests many useful

measures we will evaluate for possible imple-mentation. One measure we are currentlyconsidering is the creation of "lookout panels"comprised of individuals from inside and outsidethe federal government to identify, screen, evaluate,and prioritize emerging issues. As a first step in thisdirection, the National Research Council hasestablished, at ORD’s request, a Committee onResearch Opportunities and Priorities for EPA(ROPE). This committee is tasked with thinkingcreatively about ORD’s research areas andidentifying high-priority research topics key tosolving some of our nation’s most pressing currentand future environmental problems. Such researchcould spark entirely new approaches to environ-mental management in the future. Each year, wewill consider any high-priority topics related toanticipatory research as we review and revise ourresearch agenda.

• Have the problem's source(s) and risk beencharacterized sufficiently to develop riskmanagement options?

• Do risk management options (political, legal,socioeconomic, or technical) currentlyexist? If so, are they acceptable tostakeholders, implementable, reliable, andcost-effective?

• Could new or improved technical solutionsprevent or mitigate the risk efficiently, cost-effectively, and in a manner acceptable tostakeholders?

• Are other research organizations (e.g.,agencies, industry) currently investigating/developing these solutions or interested inworking in partnership with ORD on thesesolutions?

Risk Management Criteria

• How broadly applicable is the proposedmethod or model expected to be?

• To what extent will the proposed method ormodel facilitate or improve risk assessmentor risk management?

• How large is the anticipated user communityfor the proposed method or model?

Methods/Models Criteria

FFiigguurre e 55..OORRD D CCrriitteerriia a ffoor r EEvvaalluuaattiinng ag annd d RRaannkkiinnggPoPotteennttiiaal l RReesseeaarrcch h TTooppiiccss

Apply When Appropria

te

Apply When Appropriate

• What type of effect would the researchinvestigate/mitigate and how severelymight this effect impact humans orecosystems?

• Over what time scale might this effectoccur?

• How easily can the effect be reversed,and will it be passed on to futuregenerations?

• What level of human or ecologicalorganization would be impacted by theeffect?

• On what geographic scale might thiseffect impact humans or ecosystems?

Human Health andEcological Health Criteria

Figure 5. ORD Criteria for Evaluating and Ranking Potential Research Topics



ORD’s Priority-Setting ProcessORD’s new priority-setting process, depicted inFigure 4, involves the following steps:

First, we seek input from all parts of EPA, includ-ing ORD’s own researchers and staff. TheResearch Coordination Council, the Science Council, and Research Coordination Teams (seeAppendix III) consisting of senior representativesfrom ORD’s National Laboratories and Centers,the EPA Program Offices, and EPA’s Regional Of-fices identify the most important and relevantareas for our research efforts. (As state and localgovernments play a larger role in environmentalprotection, their research needs must also be con-sidered at this stage.) We also work with EPA’sScience Advisory Board, the National ResearchCouncil, and the private sector early in the plan-ning process to obtain recommendations from theexternal scientific community regarding the major scientific directions and priorities for ourresearch program. Finally, we consider the statusand results of our recent research activities. Basedon this information, ORD identifies potential re-search topics, for both intramural and extramuralinvestments.

We then separate the pool of potential topics intotwo categories:

• Those that are clearly mandated because ofstatutory requirements or court orders (i.e.,EPA may have no discretion to reject or delaythe research).

• All other topics.

For all other topics, we narrow the pool by retain-ing only those that are within ORD’s mission andgoals.

• We then apply a series of human health, eco-logical health, and risk management criteria(Figure 5) to compare the mission-related topics according to their potential to supporteffective risk reduction. We use comparativerisk analyses to help ascertain the most press-ing environmental problems. We also applycriteria to consider whether the researchwould develop broadly applicable methodsand models needed by EPA programs.Through this screening process, we set priori-ties among the research topics.

• We then further narrow this pool of topics byretaining only those areas where ORD can

make a significant contribution to environ-mental science. Factors we consider at thisstage include: Is the work feasible from a scien-tific and resource perspective? Does ORDhave access to the appropriate expertise?What contributions are other research organi-zations making to this area of research?

For these remaining topics where ORD can make a significant contribution, as well as allnondiscretionary topics, we then define specificresearch and development projects by consider-ing each topic in totality. For each topic, wedetermine what the research needs are withineach component of the risk paradigm: effects (hazardidentification and dose-response assessment), expo-sure assessment, risk characterization, and riskmanagement. At this stage, we give priority to research that will make the greatest contributionto reducing the uncertainty associated with riskcharacterization, or will improve the effectivenessof risk management.

This approach to strategic planning clearly indicatesthe following areas where ORD will reduce oreliminate resources:

Exposure or effects research in areas of low risk.

Risk reduction research in areas of low risk.

Routine measurements and monitoring whereR&D has been completed or that does not sup-port R&D efforts.

Criteria for Setting ORD ResearchPrioritiesA key component of ORD’s new planning process isthe criteria we will use to set priorities amongresearch topics. Three sets of criteria are used:human and ecological health criteria, riskmanagement criteria, and methods/models criteria(Figure 5). These criteria, described below, are notset in concrete, nor are they universally applicable toall research areas. We will periodically revisit thecriteria, and they likely will evolve with use andexperience. Additional or alternative criteria may beused in some cases as appropriate.

Human and Ecological Health CriteriaORD’s human and ecological health criteria arebased on five broad categories outlined in the EPAScience Advisory Board’s 1990 report, Reducing Risk:Setting Priorities and Strategies for Environmental



Protection: the severity, time scale, and permanenceof the response; the level or organization where theresponse is expected to occur; and the geographicextent of the response. Table 3 lists the criteria thatORD has developed for each of these five categories.

Risk Management CriteriaRisk management criteria are applied to thoseresearch topics that concern risk management.These criteria, listed in Figure 5, are designed to givepriority to research that will produce the mosteffective and useful risk management options. Thecriteria consider whether sufficient riskcharacterization information is available to setmeaningful objectives for the risk managementresearch; the availability, acceptability tostakeholders, reliability, and cost-effectiveness of

existing options; the potential benefits of theproposed research; and whether other researchorganizations are already conducting or interestedin this type of research.

Methods/Models CriteriaThe methods/models criteria are applied toresearch concerning the development or applicationof methods or models for gathering or analyzingrisk-related data. These criteria give priority toresearch that will likely produce the most usefulresults. The criteria consider how broadly themethod or model would be used, the size of theanticipated user community, and the degree towhich the method or model would improve riskassessment or risk management.

Ecological Health Human Health

Severity of Response/Function of Stressor

• Mortality• Morbidity

• Degree of physical disruption

• Mortality• Morbidity

Time Scale of Response • Immediate effects• Effects that will occur in the future

• Acute effects• Subchronic effects

• Chronic effects or effects with a long latency period

Permanence of Response • Irreversible effects• Effects that can be reversed only by human

intervention• Temporary effects that reverse naturally over

a long time• Temporary effects that reverse naturally over

a short time

• Transgenerational effects• Nontransgenerational effects

Level of Organization • Effects on an entire ecosystem/community• Effects on a single species

• Effects on a population within a single species• Effects on individual animals or organisms

• Effects on the general population• Effects on a subpopulation

• Effects on individuals

Extent of Response • Global effects• Ecoregional effects1

• Effects on several localities• Localized effects

• Global effects• International effects

• National effects• Effects on several localities

• Localized effects

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

Table 3. ORD’s Human Health and Ecological Health Criteria



Strengths of ORD’sPriority-Setting Process andCriteriaOur new process and criteria for setting researchpriorities have many strengths. They encompassboth scientific and stakeholder priorities. Theyensure that ORD will continue to fully support EPAin fulfilling its mandates. They focus our resourceswhere we can make the most significantcontributions. And, they enable ORD to generatepractical, credible information and tools forrisk-based decision-making.

Translating ORD’s Strategic PlanInto a Research ProgramThe steps involved in translating ORD’s StrategicPlan into a research program are illustrated inFigure 6. Once we have identified our high-priorityresearch topics, we develop and implement aresearch program based on these topics. Thisinvolves:

Developing science research plans.

Deciding whether the work will be conducted in-house or extramurally. (ORD’s research programis comprised of intramural and extramural re-search; however, resources for these two areas arekept separate.)

For intramural research, developing budget oper-ating plans and laboratory implementation plans.

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

Developing Science Research PlansFor each selected research topic, ResearchCoordination Teams composed of ORD scientistsand engineers as well as representatives of EPA’sProgram and Regional Offices develop scienceresearch plans that:

Lay out the major research components and direc-tions we will pursue over the next few years.

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

Delineate the major outputs to be produced overthe next three years.

Research plans are important tools for measuringaccountability because they make clear to our clients

and stakeholders the rationale for and intendedproducts of our research. They also enable ORD toclearly track its progress toward achieving its goals,as required by the Government Performance andResults Act of 1993.

We consult ORD’s main research clients—the EPAProgram and Regional Offices—to ensure that thefinal research plans clearly include the researchproducts they will need to fulfill their responsibilities.In addition, all our research plans are subjected torigorous external peer review.

Deciding Who Will Do the WorkAfter modifying the science research plans inresponse to peer reviewer comments, ORD thendecides whether the work would best beaccomplished internally at ORD or externallythrough one of several mechanisms: grants touniversities or nonprofit centers; CooperativeResearch and Development Agreements (CRADAs)with the private sector; cooperative agreements withanother government agency or universities; or bycontract. Many factors influence this decision,including:

Which organization has the most appropriate ex-pertise?

What type of work is called for (risk assessmentand regulatory support work are generally re-tained in-house, whereas research work may bedone externally)?

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

Would there be value in involving multiple insti-tutions?

To what extent can we specify what is needed(contracts)? To what extent must we rely on thecreativity and insight of the researcher (grants)?

What is our available in-house capacity?

What are the opportunities for leverage?

Internal ResearchDevelopment of budget operating plans. For internalresearch, ORD integrates the science research planswith budgetary decisions in order to allocateresources to the selected research topics bylaboratory program and research component. Thishelps 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 budgetarydecisions, ORD’s Laboratories and Centers developdetailed plans for implementing each area ofresearch to be undertaken internally. Theselaboratory implementation plans provide ablueprint for Laboratory and Center work and formthe basis for managerial oversight and guidance.

Extramural Research Extramural research is conducted via grants,cooperative agreements, CRADAs, or contracts.Rigorous external peer review is a key mechanismwe use to evaluate both the proposals for andresults of external research.

One of ORD’s primary mechanisms for involvingexternal scientists is the Science to Achieve Results

ORD’S STRATEGIC PLAN

ScienceResearch

Plans

BudgetOperating

Plans

LaboratoryImplementation

Plans

ProgramReview andEvaluation

Vision

Mission

Long-TermGoals

Objectives

Activities ToMeet the

Objectives

StrategicPrinciples

Role ofScienceat EPA

Priority-SettingProcess

andCriteria

= EPA Program and Regional Office Involvement

= External Scientific Community Involvement

Requests forApplications

Peer Reviewof Proposals

Award ofGrants or

CooperativeAgreements

IntramuralResearch

High-Priority

ResearchProjects

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



(STAR) program. STAR targets the best scientistsfrom universities and nonprofit centers because they are an integral and important part of theenvironmental research community. STAR consistsof focused Requests for Applications (RFAs),investigator-initiated exploratory research grants,graduate fellowships, and several "critical mass"environmental research centers.

The bulk of the STAR program derives from RFAsthat focus on specific research needs to supportthe Agency. Working with EPA’s Program andRegional Offices, Research Coordination Teamswrite these RFAs to be consistent with ORD’sStrategic Plan and science research plans, andcomplementary to ORD’s in-house work. TheRFAs are announced annually to scientists at U.S.academic and nonprofit institutions. Proposalsfrom the external scientific community arepeer-reviewed and projects are then selected forfunding through grants or cooperativeagreements. ORD leverages the STAR programresources by jointly funding research with otherfederal agencies. Appendix IV shows how thefiscal year 1996 RFA topic areas relate to ORD’shigh-priority research topics.

Measures of SuccessIn general, the success of a research organizationcan be measured in several ways: by the numberof articles published in prestigious scientificjournals, by the number of times that articleswritten by the organization’s scientists are cited inother journal articles, and so on. However, for amission-oriented organization like ORD, measuresof the extent that we help and support EPA inmeeting its goals are equally crucial. In measuringthe success of this Strategic Plan, the quality ofORD’s work, and the usefulness of our researchproducts, we will use the following measures ofsuccess.

Significance: Is ORD Working onthe Right Issues? This is a measure that the EPA Program Officesand Regions and the broad scientific communitycan help us judge. For our research, development,and support efforts to be useful, we must work onthe most important environmental issues andtarget areas for research that will significantlyimprove risk assessment and/or risk management

in the Agency and elsewhere. Peer review byscientists in the external scientific community willassist us in judging significance.

Relevance: Is ORD Providing DataThat the Agency Can Use? This question can best be answered by the rest ofthe Agency and is best judged by the degree towhich ORD’s contributions support EPAdecisions. ORD will strive to ensure that its workis useful to the Agency and has a positive impacton advancing EPA’s mission.

Credibility: Is ORD Doing Researchof the Highest Quality? ORD’s credibility can best be judged by the externalscientific community through such mechanisms aspeer review of ORD products, reviews of programsat the ORD Laboratories, peer-reviewed journalarticles, scientific citations, and external recognitionof both ORD and its people.

Timeliness: Is ORD Meeting EPA’s Expert Consultation and AssessmentNeeds in a Timely Manner, ProvidingResearch Products According toSchedule, and Addressing Long-TermIssues With Adequate Forethoughtand Preparation? The first part of this question can best be answeredby EPA’s Program Offices and Regions as theydetermine whether ORD consultations andassessments are being provided in time to beoptimally useful for Agency decisions. The middlepart of this question can be answered by ORDmanagers and EPA’s Program Offices and Regionsthrough annual program reviews and otheractivities. The final aspect of timeliness is moresubjective and therefore more difficult to assess.ORD has accepted the challenge of anticipatingimportant environmental issues that are justemerging and may not become critical problemsuntil well into the next century. The U.S. public isthe ultimate judge of how successful ORD has beenin this effort. ORD will strive to regularly gather thepublic’s view on this issue.



Mechanisms for Evaluation andAccountabilityORD has implemented, or plans to implement,several mechanisms for evaluating its performance,communicating progress and results, and measuringsuccess. These include:

Annual research program reviews, jointly organ-ized by ORD’s Research Coordination Teams andEPA’s Program and Regional Offices, that presentto EPA senior managers the entire EPA researchportfolio in a given area. These joint reviews focus on the status and accomplishments of theORD research program to ensure that ORD’s research continues to meet ORD and client objec-tives. They also present the ongoing researchbeing conducted by the Program Offices and Regions so that the total research agenda can beviewed. The objectives of these reviews are toevaluate progress in completing planned researchprojects, to track and evaluate research results,and to generally obtain feedback on ORD’s workand any adjustments that may be needed to helpus better meet our clients’ needs. These reviewscomplement, rather than supplant, external peerreviews (see below).

Annual ORD review of its science research plans.ORD examines its research plans annually and ad-justs them if warranted by our research results,by changes in EPA or national priorities, or byemerging issues and concerns.

External peer reviews of ORD science researchplans and products and overall progress in meet-ing our goals and objectives. These reviews areconducted at key steps in our research planningand implementation process.

External peer reviews of research proposals re-ceived from extramural research scientists inresponse to the Requests for Applications.

External peer reviews of ORD Laboratories andof ORD’s use of peer review through our Board ofScientific Councilors under the Federal AdvisoryCommittee Act.

Annual science workshops designed to make theprogress and results of all ORD research (includ-ing the external grants program) accessible toEPA’s Program Offices and Regions.

A data tracking system, part of ORD’s Manage-ment Information System, which tracks resourcesand progress.

Through these mechanisms, ORD will strive todevelop and conduct the most responsive,scientifically justifiable research program possiblewithin the constraints of our available resources.

Closing Out Completed WorkThrough the continuing involvement of theResearch Coordination Teams and the annualprogram reviews mentioned above, ORD will assessongoing research to evaluate:

Whether the research is on track for meeting itsgoals and schedule.

When the research should be concluded.

Prudent management of evolving priorities anddeclining resources requires that we clearly defineour research and conclude it within an appropriatetimeframe, so we can begin work on new prioritieswithout delay.

Technical SupportORD is refining its process for providing technicalsupport to EPA’s Program Offices. Using anInteroffice Management Work Group and theEnvironmental Monitoring Management Council,we are working to:

Define technical support/assistance.

Create a plan for new and existing technical assis-tance.

Create transition and exit strategies for some tech-nical assistance areas where appropriate.

Areas where technical support will continue includedevelopment of new methods, models, andmeasures or approaches; litigation; regulatorysupport; and scientific advice. ORD will notcontinue to conduct routine monitoring and qualityassurance/quality control for studies other than itsown, but will design transition and exit strategies sothat the Program Offices and Regions are preparedto assume these responsibilities.

Human Resources andInfrastructureThe success of ORD’s Strategic Plan depends on anadequately funded and well-managedinfrastructure, including ORD’s work force, systems,and equipment. ORD’s recognition of theimportance of our infrastructure is reflected in ourstrategic principles (Table 1), which highlight the



critical role of infrastructure “to achieve andmaintain an outstanding research and developmentprogram in environmental science.”

Because we recognize that scientific excellence mustbe built on a strong foundation, we are committedto constant improvement of our organization andinfrastructure. As we implement this Strategic Plan,we will continue to devote leadership and resourcesto developing and fostering our work force,modelling effective management, and creating asupportive work environment.

ORD’s Work ForceBy far the most important component of ORD’sinfrastructure is our work force of scientists,engineers, managers, other environmentalprofessionals, and support staff. ORD can achieveits vision of providing the scientific foundation tosupport EPA’s mission only if we can attract,nurture, and support a productive work force.ORD’s strategic principles (Table 1) emphasize theimportance of nurturing and supporting “thedevelopment of outstanding scientists, engineers,and other environmental professionals at EPA.”

The cutting edge nature of research anddevelopment at ORD places great demands on ourscientists and engineers to continually upgrade theirskills and knowledge in response to andanticipation of new scientific developments.Therefore, our work force support must include aneffective human resources program that encouragesan increasingly diverse cadre of employees tocontinuously learn new skills and a careerdevelopment program that promotes careerdevelopment in directions congruent with ORD’smission. In addition, we must anticipate work forceneeds and recruit new, culturally diverse employeeswith the appropriate skills and experience tosupport ORD’s mission.

ORD’s recent reorganization has introduced a neworganizational structure (see Appendix II) andstaffing pattern into ORD. For example, our neworganization eliminates certain mid-levelmanagement positions and broadens the controlspan of many supervisors. This flattenedorganizational structure will require a team-based,matrix-management approach to replace our former,more hierarchical approach to management.

ORD is addressing these needs and challenges bytaking several steps to ensure a productive, effectivework force. These include:

Developing and implementing innovative, effec-tive management approaches to accomplishingORD’s mission, such as matrix management andteam-based operation.

Supporting senior managers, via training andother mechanisms, in implementing these newmanagement approaches.

Developing tools to accurately assess current jobeffectiveness and determine development needs.

Providing training and development programs toadvance the knowledge and skills of ORD’s staff.

Providing effective career management supportwith an emphasis on self-directed career plan-ning (e.g., through mentoring, in-placement andout-placement services, and career counselingand development services).

Creating opportunities for professional and per-sonal growth.

Taking measures to maintain and enhance the sci-entific and technical competence and quality ofORD staff.

Building and maintaining solid linkages to the ex-ternal scientific community, with an emphasis onscientist-to-scientist interactions (e.g., throughORD-sponsored scientific workshops).

Providing opportunities for ORD scientists andengineers to contribute, as respected members ofthe scientific community and leaders in the envi-ronmental sciences, to the general scientificliterature and community (e.g., through publica-tion of scientific articles in peer-reviewed journalsand participation in national and international sci-entific conferences).

Systems and EquipmentFor our work force to successfully implement theStrategic Plan, we must provide them with:

Safe, environmentally sound, well-maintained,state-of-the-art laboratories, equipment, and supplies.

Environmental data management systems andadvanced communications systems.

Upgraded technical and fiscal information sys-tems to support the conduct of research,



management, planning, budgeting, and account-ability functions.

A host of other management, administrative, andsystems support.

As we implement our Strategic Plan, we willmonitor work force needs and strive to provideother programs, mechanisms, and support asnecessary to ensure that our work force has the toolsand equipment it needs to achieve ORD’s vision andgoals.

Challenges for the FutureThe 1995 peer review of the Strategic Planproduced many useful recommendations thatORD incorporated in this final version of the plan(see History of This Document on page 2). ORD iscontinuing to study other peer reviewerrecommendations for possible use in futureupdates of our Strategic Plan. Recommendationswe are considering include:

Periodic reexamination of the plan in light ofchanges in the risk assessment/risk managementframework. Reviewers recommended that ORDperiodically re-examine the basis for the StrategicPlan to accommodate ongoing changes in risk as-sessment concepts generally, and in the riskassessment/risk management framework in par-ticular. Such reexamination is a central feature ofthe process envisioned by this plan, and ORD iscommitted to the concept that its risk-based prior-ity-setting system will evolve with evolving riskassessment and risk management concepts.

Reviewers also commented that the riskassessment paradigm has limited applicability forsome EPA programs, thus limiting the utility of a

plan based on the paradigm. ORD recognizes thevalidity of this comment in particular cases. As weimplement this Strategic Plan, we will be workingin close collaboration with EPA’s Program andRegional Offices to ensure that our research agendais tailored to the particular programs and prioritiesof each EPA office. Based on this experience, we willconsider modifications to the plan over time toaccommodate these special circumstances, asnecessary.

Attention to cost-benefit considerations. Review-ers recommended that ORD give more attentionto using information on economics and potentialcosts and benefits in its research prioritizationprocess.

Value of information analysis. Reviewers recom-mended that EPA undertake a "value ofinformation" analysis and conduct a pilot projecton a selected research topic to determine whereto make our best time and resource investments,and to identify potential customers.

Expansion of strategic goals. Reviewers recom-mended that ORD expand its strategic goals togive additional attention to economics, cost-benefit analyses (including incentives),community-based environmental protection, cumulative risk, environmental justice, andmulti-pathway analyses.

Capacity and incentives for long-term research.Reviewers recommended that ORD give more at-tention to building capacity and incentives forlong-term environmental research.

Each of these areas warrants special attention andstudy.



ORD’s Long-Term Goals and Objec-tivesTo help focus selection of research priorities,ORD has defined a set of long-termresearch objectives within each of the sixbroad ORD goal areas listed in Table 2.

Variations in the specificity of the objectives listedbelow reflect differences in the maturity andcomplexity of the science underlying each objective.Many of the objectives include a set of activities(listed under the objective) that ORD intends toundertake to achieve the objective given sufficientresources. This detail allows ORD’s internal andexternal stakeholders to understand specificallyhow ORD plans to accomplish its objectives.

Designed to be robust and stable, the goals andresearch objectives described here will guidedecisions about research directions for years tocome. Each year ORD senior management, workingwith the Research Coordination Teams, will applyORD’s priority-setting process (described in Part A)to review current topics and identify specific newresearch topics that best further these objectives. Wewould not expect to make major changes inpriorities every year, but we will evaluate the

continuing timeliness and importance of ourresearch topics on an annual basis. The resulting setof research topics will constitute the basis for ORD’sresearch program. Appendix I describes the first setof high-priority research topics that resulted fromapplying this process.

Goal 1: To Develop ScientificallySound Approaches to Assessing andCharacterizing Risks to Human Healthand the Environment

Risk assessments and the associated riskmanagement decisions are often based on limiteddata obtained in species or under exposureconditions that differ from real-worldcircumstances. Inevitably, scientists must extrapolatefrom these data sets to the human or environmentalsetting of concern to characterize human health orecological risks. Extrapolation injects uncertaintyinto risk characterizations, which EPA relies on to

Part B

ORD’sLong-TermGoals andObjectives

The Agency must improve thescientific data and analyticalmethodologies needed to makesound decisions; to set risk-basedpriorities for protecting health andthe environment; to support a newemphasis on protecting the healthof the nation’s ecosystems (such asforests, lakes, and wetlands); and tocontribute to internationalenvironmental efforts.

The Expert Panel on the Role ofScience at EPA

Safeguarding the Future: CredibleScience, Credible Decisions

Part B

ORD’sLong-TermGoals andObjectives


develop risk management strategies and researchpriorities.

Greater certainty in risk assessment would improvethe efficiency and effectiveness of EPA’s riskmanagement efforts and provide a better foundationfor establishing the Agency’s research priorities.ORD, therefore, will work to improve existing riskassessment data, methods, and models and todevelop new methods for high-risk areas wheredata currently are inadequate. Already, for example,the science has advanced sufficiently to warrantmore refined approaches to risk assessment inseveral areas, including ecological impacts, effectson vulnerable subpopulations of people orenvironmental species, and noncancer effects inhumans. As ORD develops improved methods, wewill work with other parts of the Agency to ensurethat these methods are credible and used in waysthat are scientifically sound.

In recent years, we have begun to recognize theinterdependence of ecosystems and to understandthat we must consider the landscape as a whole tomaintain the integrity of vital ecosystems into thenext century. While continuing to develop andrefine scientifically sound approaches to assessingrisks to human health, we intend to expand ourecological research. For example, we intend to studyconcurrent impacts of multiple anthropogenic andnatural stressors and to develop techniques toexamine nonchemical stressors. The results of thisresearch—including enhanced data on andunderstanding of ecosystems at multiple levels oforganization and geographic and temporalscales—will provide a scientific foundation fordeveloping risk assessment/risk managementstrategies and techniques for restoring vitalecosystems (see Goal 3).

ObjectivesWithin this goal area, ORD will work to:

Replace the current approach to assessing non-cancer health risks with more scientificallygrounded, biologically plausible approaches andmodels. This will include:

• Studying the heightened sensitivity/suscepti-bility of certain subpopulations (e.g., children).

• Studying the predictive relationship betweentoxicologic endpoints and human disease (e.g.,to facilitate animal-to-human extrapolation).

• Developing integrated mechanistic informa-tion to support biologically credible healthassessments.

Develop methods and models founded on meas-urement data and sound theoretical concepts thatcan be used to better characterize, diagnose, andpredict total human exposures to chemical andmicrobial hazards, to improve and validateexposure models, and to reduce uncertainties inexposure assessments, risk assessments, and riskmanagement decisions. This will include:

• Determining the relationship between expo-sure sources and multiple exposure pathways,including characterizing the sources and deter-mining the influence of transport,transformation, and fate on exposure.

• Developing and evaluating an integratedmass-balance/multimedia/multipathwayexposure model that incorporates state-of-the-science pollutant fate and transport processdescriptions for use in risk assessment.

• Developing and applying exposure measure-ment methods to reduce the uncertainty inexposure-dose relationships, especially analyti-cal methods for identifying and enumeratingmicrobial pathogens and biomarker andchemical marker methods for estimating site-specific exposures.

• Continuing activity pattern research to reduceuncertainty in models and assessments thatpredict exposure levels, frequencies, and distri-butions in populations.

• Delineating and quantifying the role ofexposure in the development of effects inindividuals and populations, includingsusceptible populations.

Establish approaches to characterizing and under-standing risks to ecosystems and, in cooperationwith other agencies, develop a national, multi-scale, integrated environmental status and trendsprogram. This will include:

• Developing indicators of the condition of rep-resentative ecosystems.

• Supporting hypothesis-driven, long-termmonitoring of important exposure and effectsindicators at national reference sites.

• Characterizing national land-cover/land-usepatterns and developing measures of land-

O R D ’ s L o n g -Te r m G o a l s a n d O b j e c t i v e s


scape condition at multiple scales for specificsites, watersheds, landscapes, and ecoregions.

• Conducting pilot studies in ecologically impor-tant regions (e.g., the mid-Atlantic Highlands)to evaluate alternative monitoring designsand to develop techniques to integrate dataacross geographic scales.

Understand and predict ecosystem exposures,responses, and vulnerabilities to high-risk chemi-cal and nonchemical stressors at multiple levelsof biological organization and geographic scales.This will require:

• Developing ecological criteria for water (bothfreshwater and marine), air, soil, and sedimentquality (1) as needed for the Agency’s riskassessment and risk reduction efforts, and (2)to measure progress toward meeting environ-mental goals.

• Developing diagnostic tools at all levels ofbiological organization for retrospectiveassessments and for characterizing the keysources and stressors in multistressed ecosys-tems.

• Developing tools for predicting the vulnerabil-ity of ecosystems at multiple geographic andtemporal scales to ecosystem stressors (e.g.,climate change, altered land use, changes inair, soil, or water quality).

Goal 2: To Integrate Human Healthand Ecological Assessment MethodsInto a Comprehensive MultimediaAssessment Methodology

Human health risk assessments and ecological riskassessments have different histories at EPA and havetraditionally been thought of as involving differentdisciplines. As a result, EPA has developed and usedseparate methodologies for those assessments. Aswe have begun to take a more integrated view ofrisk, however, we have noted that human healthand ecological risk assessments actually make use ofsimilar types of data and science. We have realizedthat we must use a more integrated, multimediaapproach to risk assessment if we are to understandand reduce many current and future risks. We willtherefore conduct research to develop an accessible,seamless, common methodology for combinedhuman health and ecological risk assessments sothat we can provide decision-makers at all levels

with the integrated view of risk that they need tomake sound decisions.


Integrate fate and transport modeling techniqueswith biologically based models needed in humanhealth and ecological risk assessment.

Integrate human health and ecological exposureand trends monitoring research.

Better understand the relationship betweenhuman health and the condition of ecosystems(e.g., to assess the impact of human consumptionof contaminated fish or wildlife or the influenceof landscape characteristics and climate interac-tions on disease vectors such as mosquitos, ticks,and rodents).

Develop tools and techniques to facilitate theassessment of relative risks to human health andthe environment.

Harmonize extrapolation methodologies for relat-ing data on toxicity mechanisms for endocrinedisruptors, immunotoxins, developmental haz-ards, and other chemicals with effects in sensitivehuman subpopulations, wildlife, and aquaticorganisms.

Improve extrapolation models by integratingtoxicologic and mechanistic data obtained inlaboratory and field investigations (epidemiologyand ecology).

Identify and validate wildlife species as sentinelsfor human health risks.

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

To enhance the practicality and cost-effectiveness ofthe products of ORD’s risk management research,we are changing the way we study pollution controland prevention, contaminated site and spillremediation, and technology development. To theextent possible, we are integrating our air, water,and waste-related research, and we are increasinglyfocusing on emerging, high-risk problems—all sothat we can better help regions, communities, andthe private sector analyze pollution problems andachieve risk reductions efficiently and cost-effectively. This common sense approach will seek



to maximize the health and environmental benefitsof risk management by focusing risk managementresearch on those aspects of a process or situationthat cause the greatest risks.

To that end, our pollution prevention and controlresearch will now focus on multimedia life-cycleanalyses, “green” technologies, and pollutionprevention methods that small- and medium-sizedcompanies can use to achieve significant reductionsin risk across media. Our maturing site and spillremediation program will concentrate ondeveloping cleanup options for complex risksituations and faster, lower cost natural recoverysystems. In addition, we will continue forgingpartnerships with the private sector to analyzehigh-risk needs and to develop, evaluate, and verifynew pollution prevention and risk reductiontechnologies.

We have also begun efforts in ecosystem restorationand cost-benefit assessment. Our ecosystemrestoration research (connected to that describedunder Goal 1 above) will focus on developing anddemonstrating principles, technologies, andguidance materials that regions and communitiescan use to help restore local ecosystems. Ourcost-benefit assessment research will focus ondeveloping a systematic approach to identifying andreporting the benefits and costs of risk managementtechnologies and alternatives. Such an approach isneeded to satisfy the rapidly growing demand forcost-benefit analyses to support environmentaldecision-making—a demand engendered by therising cost of environmental protection in an era oflimited resources.


Provide cost-effective risk management technolo-gies and approaches for high-risk threats tohuman health and the environment. This willinclude:

• Characterizing sources of fine-particulateemissions, air toxics, and ozone precursors,and identifying, adapting, and developing riskmanagement approaches that control emis-sions to acceptable levels.

• Providing cost-effective, reliable technologiesand management approaches that reducedrinking water exposures to disinfectant

by-products while protecting water suppliesfrom microbial contamination.

• Providing communities with proven technolo-gies for wet weather flow watershedmanagement, wellhead protection, and resto-ration of contaminated areas.

Provide pollution prevention approaches andanalytical 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 performanceand costs for pollution prevention options forsmall- and medium-sized businesses.

Develop advanced air quality simulation modelsthat relate sources, emissions, and receptors. Thiswill include:

• Developing models based on high-perform-ance computing systems to predict the fate ofpollutants through the multimedia pathwaysleading to human and ecosystem exposure tothese pollutants.

Catalyze the development and use of cost-effec-tive risk management approaches for the mostdifficult and costly environmental managementproblems. This will include:

• Developing cost-effective techniques for reme-diating soils and ground water contaminatedwith nonaqueous-phase liquids, chlorinatedand other hazardous organics, and toxicmetals.

• Developing cost-effective techniques for reme-diating contaminated sediments.

• Verifying the performance of innovative riskreduction technologies and accelerating theircommercial use.

Provide cost-estimating/engineering assessmenttools and methods for more accurate and mean-ingful cost-benefit analyses. This will include:

• Developing data standards and cost reportingprotocols.

• Developing methods and cost analyses foremerging, high-risk environmental problems(e.g., fine particulates, drinking water, wetweather flow controls).



Develop and provide risk management alterna-tives to maintain and/or restore ecosystems. Thiswill include:

• Developing diagnostic and characterizationmethods and protocols for use in determiningappropriate ecosystem restoration goals andrequirements for specific sites, watersheds,landscapes, and ecoregions.

• Identifying, testing, and providing risk man-agement approaches and technical guidancefor restoring riparian zones, remediating con-taminated soils and sediments, and applyingbest management practices to restore or main-tain ecosystems in urban, suburban, andurbanizing areas.

• Developing methods to restore and maintainsoil 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 ofrisk analysis of human health and ecological effectsand will continue to serve as a catalyst for advancesin the science of risk assessment. ORD will achievethis goal by working to facilitate cooperation andthe exchange of ideas between and among federal,state, and local scientists as well as scientists in theenvironmental, industrial, and academiccommunities. In addition, ORD will focus on threeprimary activities:

Using an open and participatory process, ORDwill conduct timely, state-of-the-art risk assess-ments. These assessments either will serve asprototypes demonstrating new approaches to riskassessment or will respond to Agency needs byassessing multimedia, multiprogram, or conten-tious or sensitive issues.

ORD will support other risk assessment efforts byproviding guidance, consultation, training, andinformation products to assist colleagues, bothinside and outside EPA, in conducting their ownrisk assessments. These efforts will responddirectly to the needs of the risk assessmentcommunity and will target areas of uncertainty inthe science and conduct of risk assessment.

ORD will improve the state-of-the-science of riskassessment by developing scientifically soundand defensible approaches for incorporating and

integrating data and models developed by ORDand the general scientific community into riskassessment efforts.

ORD will integrate human health and ecologicalconcerns into all these activities.


Prepare risk assessments for those stressors cur-rently considered of high risk to humans and theenvironment. This will include:

• Assessing ubiquitous pollutants in the air thataffect human health (e.g., fine particles, ozone).

• Assessing the risks associated with highlytoxic and persistent environmental contami-nants (e.g., chlorinated dioxins, mercury).

• Assessing the risks to ecosystems from non-chemical stressors (e.g., habitat loss and UvBdue to stratospheric ozone depletion).

• Conducting comparative risk assessment ofcompeting risks (e.g., those posed by microor-ganisms in drinking water versus those posedby disinfection by-products).

Complete development of new cancer risk guide-lines and other guidelines and provide support tothe Program Offices and Regions to facilitate theirimplementation. This will include:

• Developing and supporting the implementa-tion of guidelines for assessing the ecologicalimpacts of environmental stressors.

• Supporting the implementation of new guide-lines for cancer, neurotoxicity, andreproductive risks.

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

• Integrating scientific and technical informa-tion from ORD Laboratories and other sourcesto provide a sound scientific base and techni-cal support for Agency decisions and policy.

• Developing and supporting the implementa-tion of guidelines for assessing the ecologicalimpacts of environmental stressors.

• Supporting the implementation of newguidelines for cancer, neurotoxicity, andreproductive risks.

• Supporting chemical- and site-specific risk assessments for criteria air pollutants,



• hazardous air pollutants, waste sites, anddrinking water.

• Providing training in risk assessment to stateand local stakeholders.

• Continuing to support and improve the Inte-grated Risk Information System (IRIS) andexpert systems such as Risk Assistant.

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

Develop methods and assess methods developedby others for providing quality-assured data forenvironmental assessment. This will include:

• Supporting the development of models thatcan be readily used by Regions and states.

Goal 5: To Exchange ReliableScientific, Engineering, and RiskAssessment/Risk ManagementInformation Among Private and PublicStakeholders

Effective risk assessments and risk managementdecisions depend on the availability of accuratesources of scientific and engineering data andinformation, risk assessments, analytical methods,and guidance. As a leader in the development ofsuch methods and information, we are committed toproviding, coordinating, and exchanging expertiseand information to decision-makers inside andoutside EPA. We will work to identify and fulfilluser needs by providing appropriate tools andinformation through interconnected communicationand technical support networks.

Our goal is to facilitate information that is impartial,up-to-date, and relevant to user needs. To that end,we must improve and update existing informationsystems and develop new systems and informationtransfer solutions to meet future needs. Workingwith other EPA offices, we will help to develop anoperational communication and informationtransfer system for on-line scientific, engineering,and risk information that can be accessed byprofessionals or by members of the public who areinvolved in community-level analysis anddecision-making.


Provide current and relevant technical informa-tion to a broad user community. This will include:

• Developing plain-language guidance andtraining that adequately and clearly communi-cate the appropriate use of technicalinformation and that describe limitations andinappropriate applications.

• Developing electronic communication andother information dissemination systems thatcan be accessed and understood by broad anddiverse user communities.

Complete the development of the new cancer riskguidelines and provide support to the programoffices and regions to facilitate their implementa-tion.

Maintain and increase support for existing scien-tific, engineering, and risk information systems.This will include:

• Ensuring that current information resourcesare accurate, relevant, and up-to-date.

• Developing electronic and other methods ofbringing databases (e.g., IRIS, ECOTOX) tostate and local governments and other stake-holders.

• Developing data management systems thatmake data readily available to all ORD Labsand Centers, EPA Program Offices and Regions, and states.

Goal 6: To Provide Leadership andEncourage Others To Participate inIdentifying Emerging EnvironmentalIssues, Characterizing the RisksAssociated With These Issues, andDeveloping Ways of Preventing orReducing These Risks

With our very broad missions, we in ORD and theAgency as a whole must have some means ofevaluating, comparing, and setting priorities forcompeting needs. We use risk as the common



denominator for comparing divergent issues andmaking decisions. Our focus on relative risks andrisk-based decision-making demands that we lookbeyond the obvious problems of yesterday andtoday to identify and assess issues just over thehorizon; we must determine the potential risks thatthese issues pose and work to solve them. Often,however, few data exist to support assessments ofemerging issues. Thus, we must develop anddisseminate data and methods to permit credibledecision-making in the face of very high uncertainty.At ORD, we are committed to working with othergroups within EPA, the Agency’s Science AdvisoryBoard (SAB), the National Academies of Science andEngineering (NAS and NAE), and others to developnew ways of analyzing emerging issues. Werecognize that ORD cannot and should not assumeleadership in every area of environmental science.Our challenge is to be cognizant of where others arealready leading and where ORD should undertakethat role.

EPA’s general approach to environmentalmanagement—assessing risks, evaluating thepotential benefits of risk reduction, and devisingrisk management and risk reduction strategiesaccordingly—is increasingly being adopted byothers in this country and abroad. More than anyother organization, ORD has been in the forefront ofdeveloping the risk assessment and riskmanagement methods that undergird thisrisk-based approach to environmental management.More than any other organization, therefore, we

should be expected to provide leadership in thedevelopment of new, more credible ways ofcomparing and ranking risks. In providing thisleadership, we renew our commitment toencouraging and enabling others in the public andprivate sectors to participate in identifying,characterizing, and resolving emergingenvironmental issues.


Collaborate with other parts of the Agency, theSAB, the NAS, and others to develop methods ofidentifying emerging issues and assessing theirpotential risks.

Develop partnerships (via research grants, cooperative agreements, CRADAs, and othermechanisms) with other federal agencies, theWhite House Committee on Environment andNatural Resources, industry, and academia.

Provide national and international leadership inrisk assessment and its application for risk reduc-tion and risk management.

Conduct/sponsor workshops and symposia thatwill provide forums for stimulating interest anddiscussion on current or emerging environmentalissues (e.g., endocrine disruptors), reaching con-sensus on crucial research needs, and definingthe role of ORD and others in addressing thoseneeds.



Appendix I

ORD’s High-PriorityResearchThe goals and objectives listed in Part B of this plandefine an ambitious research program for ORD.Within this program, however, the extent of researchwe can actually perform will be limited by theavailable resources. Therefore, in consultation withEPA’s Program Offices, ORD uses the priority-setting process (described in Part A) to select fromits overall program those topics that are of highestpriority for research. Priorities to be emphasized forthe next few years are (in no particular order):

Drinking water disinfection

Particulate matter

Endocrine disruptors

Research to improve ecosystem risk assessment

Research to improve health risk assessment

Pollution prevention and new technologies

These areas will receive more intense researchattention (and resources). Intramural efforts will besupplemented with the talents of extramuralscientists through external grants, cooperativeagreements, interagency agreements, and contracts.

Proposed research for the six high-priority areas issummarized in Table I-1. Tables I-2 through I-7provide a breakout, by risk assessment/riskmanagement area, of the strategic issues andproposed research tasks, products, and applicationsin each of the six topic areas.

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

Air pollutants

Indoor air

Global change

Drinking water (in addition to disinfection issues)

Waste site risk characterization

Waste management and site remediation

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

Other topics were considered during the planningprocess but they did not meet the criteria to beincluded in ORD’s research program. In general,these include exposure or effects research in areas oflow risk, risk reduction research in areas of low risk,and routine measurements and monitoring whereR&D has been completed. In addition, ORD will notpursue research in areas where other researchorganizations are capable of making a moresignificant impact.

ORD’s entire research program will be captured inmore detail in the science research plans beingdeveloped by the Research Coordination Teams.These research plans will be finalized after arigorous peer review. Interested readers shouldconsult these documents.

ORD also uses the principles and priorities of thisStrategic Plan as a basis for developing its annualbudget requests to fund our research agenda. Ourfiscal year 1997 budget request was based on thisplan, as will be our fiscal year 1998 budgetproposals.

Evolution of ORD Priority AreasOver TimeThe six high-priority areas intentionally are amixture of:

Research targeted at specific pollution problems(i.e., drinking water disinfection, particulate matter, and endocrine disruptors).


Broad-based fundamental research in risk assess-ment and risk management (i.e., research toimprove ecosystem and health risk assessment,and pollution prevention and new technologies).

The tables in this appendix reflect the differences inthese two areas of research. Tables I-2 through I-4,which describe the more specific research areas, tendto have more details than Tables I-5 through I-7, whichdescribe the broad-based, fundamental areas.

We will evaluate progress on all research targeted atspecific pollution problems annually to ensure thatour research program continues to focus on themost significant problems. As work on problem-specific topics progresses and moves towardclosure, we will redirect our research focus andresources to emerging high-priority areas. Forexample, as we successfully completed work in oneof our former priority areas (the health risks ofozone), we shifted resources to particulate matter,one of our current high-priority topics. In the future,the particulate matter research likely will give wayto other topics of emerging priority.

We will also evaluate progress on our broad-basedfundamental research annually. These broad-based areas, which reflect ORD’s fundamentalrisk assessment and risk management researchprograms, will remain high-priority topics.However, the individual projects within theseareas will change to reflect research progress andemerging concerns. As the individual projectschange, we will revisit and revise research plansfor these areas.

Selection of the Six High-PriorityTopicsThe following summaries illustrate how applicationof the selection criteria described in Part A gave riseto the six high-priority research topics.

Drinking Water DisinfectionDisinfection of drinking water has been one of thegreatest public health success stories of thetwentieth century. Nevertheless, some public healthconcerns still remain. For example, hundreds ofpeople have died and many hundreds of thousandshave become ill during recent outbreaks of exposureto the protozoan Cryptosporidium in drinking water.Recent studies demonstrate that there is a lowthreshold of infectivity for Cryptosporidium and thatpeople with compromised immune systems—such

as the elderly, HIV-positive individuals, and personsreceiving chemotherapy—may be at greater risk. Inaddition, other microorganisms exist in drinkingwater that may also have serious adverse effects.

There still is a high degree of uncertainty about howto measure microorganisms in water and what theirinfectivity level is. Additionally, there is a highdegree of uncertainty about whether disinfectionby-products—the chemical by-products that resultwhen disinfectants react with organic matter indrinking water—pose a significant human healththreat. Because of the high uncertainty, thewidespread human exposure to drinking water, theseverity of the known effects from certain microbes,and the potentially high costs of further regulationof drinking water, this issue is of high priority toEPA’s Office of Water and to ORD’s research agenda.

Particulate MatterRecent publications in the scientific literatureindicate that exposure to particulate matter poses ahigh potential human health risk. At the same time,however, there is a high degree of uncertainty aboutthe size and composition of the particles that may beresponsible for these effects, the biologicalmechanisms of action, and the dose-responserelationships at low levels of exposure. In addition,control costs are potentially very high. For all thesereasons, this area is of high priority to EPA’s Officeof Air and Radiation and of high priority for ORD’sresearch agenda.

Endocrine DisruptorsEvidence has been accumulating that humans andwildlife have suffered adverse health consequencesresulting from exposure to environmental chemicalsthat interact with the endocrine system. Severalreports of declines in the quality and quantity ofsperm production in humans over the last fourdecades, and reported increases in the incidence ofcertain cancers that may have an endocrine-relatedbasis, have led to speculation about environmentalcauses.

There is considerable scientific uncertaintyregarding the causes of these reported effects.However, we do know that endocrine factorsregulate the normal functions of all organ systemsand that small disturbances in endocrine function—especially during certain stages of the life cycle suchas development, pregnancy, and lactation—can leadto profound and lasting effects. The critical issue is

A p p e n d i x I


whether there are sufficiently high levels ofendocrine-disrupting chemicals in the ambientenvironment to exert effects in the generalpopulation.

Given the potential scope of the problem, thepossibility of serious effects on the health ofpopulations, and the broad occurrence andpersistence of some endocrine-disrupting agents inthe environment, this area is of high priority forORD’s research agenda. Research will focus on themost critical gaps in our knowledge base to promotemore informed decisions on public health,ecosystem effects, and related management options.

Research To Improve Ecosystem RiskAssessmentWe have made considerable progress in reducingthe most egregious harm to our environment fromair and water pollution and from areas ofdevastation around industrial plants. Much remainsto be done, however, if we are to avoid potentialdisasters on a tragic scale—such as forest decline,widespread epidemics of toxic microorganisms inestuaries, reproductive failure of wildlife because ofglobal pollutant transport or destruction of criticalhabitat, the reappearance of vector-borne epidemicdiseases, and global climate change.

Ecological research has the potential to significantlyreduce many of the uncertainties associated withour understanding of ecosystems. In particular, it iscritical that EPA develop:

Techniques for quantitative risk assessments sothat decisions about where to focus ecological research and what solutions are most appropriatecan be based on sound science.

Risk management strategies that take maximumadvantage of pollution prevention and the self-purifying potential of natural systems.

To accomplish these goals, research in ecosystemmonitoring, processes, modelling, risk assessment,risk management, and restoration is needed forchemical and nonchemical stressors, multiple scalesof effects and exposures, and multiple levels ofbiological organization. Because of the broadapplicability of these methods and their significantpotential for enhancing ecological risk assessment

and risk management, ORD has selected research toimprove ecosystem risk assessment as a highpriority for its research agenda.

Research To Improve Health RiskAssessmentHealth risk assessment is the process EPA uses toidentify and characterize environmental healthproblems. The results of health risk assessmentare crucial to decisions on health protectionmeasures. ORD’s research to improve health riskassessment addresses major deficiencies anduncertainties in health risk assessment (includingboth problem- or agent-specific risk assessment, aswell as cross-cutting or generic risk assessment). Forexample, ORD’s research to improve health riskassessment includes:

Developing state-of-the-art testing approaches fornoncancer and cancer endpoints.

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

Identifying biomarkers that can be used to meas-ure genetic and other biological events.

Determining how individuals vary in their re-sponse to toxic insults, so that EPA can betteridentify sensitive groups.

Research to improve health risk assessmentprovides the essential foundation for reliable andscientifically strong risk assessments based on newscience and state-of-the-art methods. In addition,this research area supports the development of:

Computer-based tools to assist risk assessors atthe federal, state, and local levels.

Information management databases that EPAuses to effectively communicate risk informationto stakeholders.

Ultimately, the results of this research will enhancerisk assessments to support national environmentalgoals, such as safe drinking water, safe indoorenvironments, clean air, and safe food. Because ofthe broad applicability of improved methods forhealth risk assessment to many user communities,research to improve health risk assessment is a highpriority for ORD’s research agenda.

A p p e n d i x I


Pollution Prevention and NewTechnologiesPollution prevention, or anticipating and stoppingproblems before they occur, is a valuable riskmanagement tool because it is far morecost-effective and protective of the environmentthan solving environmental problems after theyhave been created. Pollution prevention, supportedby objective scientific and technical data, canactually reduce or eliminate the need for legalactions and regulatory standards, which can becostly and difficult to implement.

Pollution prevention will be the first strategyconsidered for all EPA programs and EPA will leadthe nation in efforts to reduce and eliminatepollution at the source. Because of the broadapplicability of pollution prevention strategies andthe potentially large economic and environmentalbenefits of this approach to risk management,pollution prevention and new technologies are ofhigh priority for ORD’s research agenda. Thisresearch builds on ORD’s commitment to supportand respond to EPA’s Program Offices’ and Regions’needs for prevention options and information onhow to best implement them.

A p p e n d i x I


Res

earc

h T

opic

sSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Dri

nk

ing

Wat

erD

isin

fect

ion

Wha

t is

the

com

para

tive

risk

bet

wee

n w

ater

born

em

icro

bial

dis

ease

and

the

dis

infe

ctio

n by

prod

ucts

(DB

Ps) f

orm

ed d

urin

gd

rink

ing

wat

er d

isin

fect

ion?

Dev

elop

met

hods

for

mea

suri

ngpa

thog

en/D

BP

expo

sure

from

dri

nkin

gw

ater

, det

erm

ine

effe

cts

and

dose

-res

pons

efo

r th

em, d

evel

op/a

pply

a m

icro

bial

ris

kas

sess

men

t fra

mew

ork,

impr

ove

DB

P ri

skas

sess

men

ts, a

nd e

valu

ate

alte

rnat

ive

trea

tmen

t pro

cess

es fo

r D

BP/

mic

robi

alco

ntro

l.

Dat

a on

eff

ects

, dos

e-re

spon

se,

expo

sure

, com

para

tive

ris

k, a

ndtr

eatm

ent f

or p

atho

gens

/D

BPs.

To s

uppo

rt D

BP/

mic

robi

al r

isk

asse

ssm

ent/

risk

red

ucti

onru

lem

akin

g an

d co

mpl

ianc

em

onit

orin

g.

How

can

bot

h be

sim

ulta

neou

sly

cont

rolle

d?

Par

ticu

late

M

atte

r

Wha

t mor

bidi

ty/m

orta

lity

is a

ssoc

iate

d w

ith

low

ambi

ent l

evel

s of

par

ticu

late

mat

ter

(PM

), an

d w

hat c

ost-

effe

ctiv

e m

etho

ds a

reav

aila

ble

to r

educ

e PM

emis

sion

s to

an

acce

ptab

lele

vel?

Con

duct

clin

ical

/ep

idem

iolo

gy s

tud

ies

ofPM

eff

ects

; rea

naly

ze p

ast e

pid

emio

logy

stud

ies;

con

duc

t pha

rmac

okin

etic

and

biol

ogic

al s

tud

ies;

cha

ract

eriz

e th

esi

ze/s

peci

es o

f PM

; con

duc

t a h

uman

expo

sure

stu

dy; a

nd e

valu

ate,

dev

elop

, and

dem

onst

rate

tech

nolo

gies

to r

educ

e PM

emis

sion

s.

Mor

bid

ity/

mor

talit

y, d

ose-

resp

onse

,an

d m

echa

nist

ic d

ata;

dos

imet

ric

mod

el; m

etho

ds

for

mea

suri

ng P

Mm

ass/

spec

ies;

impr

oved

hum

anex

posu

re e

stim

ates

; dat

a on

emis

sion

s co

mpo

siti

on; i

mpr

oved

risk

est

imat

es; a

nd d

ata

onco

st-e

ffec

tive

ness

of P

M c

ontr

olst

rate

gies

.

To im

prov

e cr

iter

ia d

ocum

ents

and

risk

ass

essm

ents

in s

uppo

rt o

f PM

Nat

iona

l Am

bien

t Air

Qua

lity

Stan

dar

ds

revi

ew; t

o pr

ovid

ein

form

atio

n fo

r ev

alua

ting

alte

rnat

ive

PM c

ontr

ol s

trat

egie

s.

En

doc

rin

eD

isru

pto

rs

Wha

t is

know

n ab

out

endo

crin

e d

isru

ptor

(ED

C)

expo

sure

, hum

an/

eco-

effe

cts,

and

ris

kas

sess

men

t?

Rev

iew

exi

stin

g lit

erat

ure

on E

DC

s, c

ond

uct

wor

ksho

ps o

n re

sear

ch n

eed

s, d

evel

opQ

SAR

/PB

PK/

BB

DR

a met

hod

s/m

odel

s,co

nduc

t fie

ld m

easu

rem

ents

of E

DC

s, a

ndas

sess

eff

ects

on

high

ly e

xpos

ed c

ohor

ts.

Rep

orts

on

rese

arch

nee

ds,

anal

ytic

al m

etho

ds,

ris

k as

sess

men

tm

etho

ds,

dat

a fr

om fi

eld

mea

sure

men

ts, a

nd c

ause

-eff

ect

dat

a.

To p

rior

itiz

e re

sear

ch n

eed

s, r

evie

wte

st g

uid

elin

es, a

nd c

ond

uct

haza

rd/e

ffec

t and

pre

limin

ary

expo

sure

/ri

sk a

sses

smen

ts.

Wha

t res

earc

h st

ill n

eeds

tobe

don

e?

Res

earc

h T

oIm

pro

veE

cosy

stem

Ris

kA

sses

smen

t

How

can

we

det

erm

ine

ecos

yste

m r

isk

and

cap

acit

yto

tole

rate

str

ess?

Stud

y ec

osys

tem

vul

nera

bilit

y an

dst

ress

or-r

espo

nse

rela

tion

ship

s; id

enti

fyec

o-ef

fect

mea

sure

s; c

hara

cter

ize

habi

tat

dis

trib

utio

n an

d ch

emic

al e

xpos

ures

;d

evel

op/

appl

y ec

o-ri

sk a

sses

smen

tm

etho

ds;

and

stu

dy

eco-

risk

red

ucti

on.

Eco

syst

em c

rite

ria,

mod

els

to p

red

ict

ecos

yste

m e

ffec

ts/

risk

s, n

atio

nal

land

-cov

er m

ap, b

asel

ine

data

for

doc

umen

ting

futu

re c

hang

es,

ecos

yste

m e

xpos

ure

prof

iles,

and

info

rmat

ion

on r

isk

redu

ctio

nap

proa

ches

for

ecos

yste

ms.

To in

form

sta

keho

lder

s ab

out

ecos

yste

m p

rote

ctio

n, e

cosy

stem

asse

ssm

ent,

envi

ronm

enta

lpl

anni

ng, a

nd e

cosy

stem

ris

kre

duc

tion

/re

stor

atio

n.W

hat a

re th

e ch

emic

al a

ndno

nche

mic

al e

xpos

ures

toth

e m

ost s

ensi

tive

sys

tem

s?

Whi

ch e

cosy

stem

s ar

evu

lner

able

? W

here

?

How

can

we

red

uce

risk

ina

cost

-eff

ecti

ve m

anne

r?

Tab

le I

-1.

Sum

mar

y of

EPA

/OR

D R

esea

rch

Prog

ram

for

Six

Hig

h-Pr

iorit

y Re

sear

ch T

opic

s

(Con

tinu

ed)

St rat e g i c P l an f o r O R D 33

A p p e n d i x I

Res

earc

h T

opic

sSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Res

earc

h T

oIm

pro

ve H

ealt

hR

isk

Ass

essm

ent

How

can

we

bett

erd

efin

e/pr

edic

t haz

ard

s,im

prov

e do

se e

xtra

pola

tion

,an

d b

ette

r un

der

stan

dm

ixtu

re to

xici

ty?

Dev

elop

or

impr

ove

met

hod

s fo

r sc

reen

ing

haza

rd d

ata,

col

lect

ing

toxi

city

dat

a, a

ndin

terp

reti

ng h

azar

d da

ta; d

evel

op m

odel

s to

esti

mat

e ta

rget

tiss

ue d

ose

and

resp

onse

s to

thos

e d

oses

; and

dev

elop

met

hods

/mod

els

for

asse

ssin

g m

ixtu

res

toxi

city

.

Haz

ard

scr

eeni

ng/t

esti

ng p

roto

cols

,m

odel

s fo

r pr

edic

ting

che

mic

ald

ispo

siti

on in

the

bod

y, a

nd te

stpr

otoc

ols/

mod

els

for

mix

ture

sto

xici

ty.

To r

ank/

scre

en c

hem

ical

s, d

evel

opte

st g

uid

elin

es, p

rovi

de g

uida

nce

for

risk

ass

essm

ent,

and

iden

tify

mix

ture

s to

xici

ty.

Wha

t is

the

popu

lati

ond

istr

ibut

ion

of to

tal

expo

sure

?

Det

erm

ine

how

exp

osur

e is

infl

uenc

ed b

yag

e, li

fest

yle,

beh

avio

r, an

d so

cioe

cono

mic

fact

ors.

Dev

elop

tota

l hum

an e

xpos

ure

mod

els,

whi

ch in

clud

e so

urce

/pa

thw

ayco

ntri

buti

ons

to to

tal e

xpos

ure.

Impr

oved

exp

osur

e m

easu

rem

ent

and

ass

essm

ent m

etho

ds,

mod

els,

and

dat

a.

To s

uppo

rt e

xpos

ure

asse

ssm

ent

dur

ing

risk

-bas

ed d

ecis

ion-

mak

ing

Wha

t are

the

sour

ce-e

xpos

ure-

dose

rela

tion

ship

s?

Pol

luti

onP

reve

nti

on a

nd

New

Tech

nol

ogie

s

How

can

pol

luti

onpr

even

tion

be

inte

grat

edin

to e

nvir

onm

enta

ld

ecis

ion-

mak

ing?

Stud

y en

gine

erin

g/pe

rfor

man

ce c

osts

for

pollu

tion

pre

vent

ion;

dev

elop

tech

nolo

gies

;id

enti

fy a

udie

nces

nee

din

g te

chni

cal

assi

stan

ce; d

evel

op li

fe-c

ycle

ana

lysi

s/au

dit

tool

s; a

nd a

ssis

t in

diss

emin

atin

gte

chno

logi

es to

the

com

mer

cial

sec

tor.

Pollu

tion

pre

vent

ion

cost

acc

ount

ing

prot

ocol

s, c

ost d

ata,

tech

nolo

gytr

ansf

er p

rodu

cts,

life

-cyc

le a

naly

sis

tool

s, a

udit

pro

ced

ures

, pol

luti

onpr

even

tion

tech

nolo

gies

, and

perf

orm

ance

dat

a.

To e

valu

ate

and

impl

emen

tpo

lluti

on p

reve

ntio

n ap

proa

ches

.

a QSA

R =

qua

ntita

tive

str

uctu

re-a

ctiv

ity r

elat

ions

hips

.PB

PK =

phy

siol

ogic

ally

bas

ed p

harm

acok

inet

ic.

BBD

R =

bio

logi

cally

bas

ed d

ose-

resp

onse

.

Tab

le I

-1.

Sum

mar

y of

EPA

/OR

D R

esea

rch

Prog

ram

for

Six

Hig

h-Pr

iorit

y Re

sear

ch T

opic

s (C

ontin

ued)

St rat e g i c P l an f o r O R D34

A p p e n d i x I

St rat e g i c P l an f o r O R D

Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Hea

lth

Eff

ects

Wha

t dos

e le

vels

of

path

ogen

s ca

use

illne

ss in

exp

osed

popu

lati

ons?

Con

duc

t dos

e-re

spon

se s

tudi

es o

nw

ater

born

e pa

thog

ens.

Dat

a fo

r ri

sk a

sses

smen

t mod

els

to p

red

ict d

isea

se in

cide

nce.

To p

rovi

de

heal

th e

ffec

ts d

ata

for

risk

ass

essm

ent t

osu

ppor

t upc

omin

g su

rfac

e w

ater

and

gro

und

-wat

ertr

eatm

ent r

ules

.

Wha

t are

end

emic

and

epid

emic

illn

ess

rate

sfo

r w

ater

born

em

icro

bial

dis

ease

?

Con

duc

t epi

dem

iolo

gy s

tud

ies

for

path

ogen

-cau

sed

dis

ease

.In

dica

tion

of m

agni

tud

e of

ris

ksan

d v

erif

icat

ion

of r

isk

mod

els.

To p

rovi

de

heal

th e

ffec

ts d

ata

for

risk

ass

essm

ent t

osu

ppor

t upc

omin

g su

rfac

e w

ater

and

gro

und

-wat

ertr

eatm

ent r

ules

.

Wha

t are

the

rela

tive

risk

s of

dis

infe

ctio

nby

prod

ucts

(DBP

s)fr

om d

iffer

ent

disi

nfec

tion

pro

cess

es?

Con

duc

t epi

dem

iolo

gy s

tud

ies

onre

prod

ucti

ve/d

evel

opm

enta

l eff

ects

and,

if fe

asib

le, o

n ca

ncer

.

Qua

litat

ive/

quan

tita

tive

dat

a on

canc

er, r

epro

duc

tive

eff

ects

, and

othe

r ef

fect

s.

To a

sses

s th

e ri

sks

of d

iffer

ent d

isin

fect

ion

proc

esse

s,co

mbi

ning

epi

dem

iolo

gy, t

oxic

ity,

and

mix

ture

sin

form

atio

n, to

sup

port

DB

P ru

les.

Con

duc

t tox

icit

y st

udie

s on

indi

vidu

al D

BPs

and

mix

ture

s if

feas

ible

.

Ris

k as

sess

men

ts fo

r in

divi

dual

DB

Ps.

Exp

osu

reW

hat l

evel

s of

path

ogen

s ar

e pe

ople

expo

sed

to?

Dev

elop

ana

lyti

cal m

etho

ds

that

dete

ct v

iabl

e/in

fect

ive

orga

nism

s.Pr

acti

cal a

naly

tica

l met

hods

for

path

ogen

s.Su

rvey

tool

for

deve

lopi

ng o

ccur

renc

e da

ta; b

asis

for

com

plia

nce

met

hod

s fo

r w

ater

uti

litie

s.

Iden

tify

sou

rces

of p

atho

gens

and

fact

ors

affe

ctin

g oc

curr

ence

leve

ls in

surf

ace

and

grou

nd w

ater

s.

Ana

lyse

s of

pat

hoge

n oc

curr

ence

in s

ourc

e w

ater

s.

Info

rmat

ion

on p

atho

gen

expo

sure

s in

dri

nkin

g w

ater

.

To s

uppo

rt e

xpos

ure

asse

ssm

ents

to p

red

ict

path

ogen

occ

urre

nce

in d

rink

ing

wat

er u

nder

diff

eren

t tre

atm

ent p

roce

sses

.

Wha

t lev

els

of D

BPs

are

peop

le e

xpos

ed to

?D

evel

op m

etho

ds

for

mea

suri

ngoc

curr

ence

of D

BPs

in d

rink

ing

wat

er.

Impr

oved

pra

ctic

al fi

eld

and

rese

arch

met

hod

s fo

r D

BPs

ind

rink

ing

wat

er.

To s

uppo

rt e

xpos

ure

asse

ssm

ents

for

DB

Ps

from

diff

eren

t tre

atm

ent p

roce

sses

; pro

vid

e ba

sis

for

com

plia

nce

met

hod

s fo

r w

ater

uti

litie

s.

Stud

y th

e le

vel o

f DB

Ps in

dri

nkin

gw

ater

sup

plie

s.Id

enti

ty o

f new

DBP

s un

der

diff

eren

t dis

infe

ctio

n pr

acti

ces.

Dat

a on

DB

P ex

posu

re fr

omd

rink

ing

wat

er.

Ris

kA

sses

smen

t

Wha

t are

the

com

para

tive

ris

ksfr

om D

BPs

and

mic

robe

s?

Dev

elop

app

ropr

iate

ris

k as

sess

men

tpa

rad

igm

for

mic

robe

s, in

clud

ing

dose

-res

pons

e m

odel

s.

Impr

oved

ris

k as

sess

men

tpr

oced

ures

and

ris

k es

tim

ates

for

mic

robe

s.

To p

rovi

de

a co

mpa

rati

ve r

isk

fram

ewor

k fo

r ri

skas

sess

men

ts fo

r su

rfac

e w

ater

trea

tmen

t rul

es a

ndD

BP r

ules

.

App

ly a

dvan

ces

in c

ance

r and

nonc

ance

r ris

k as

sess

men

t to

indi

vidu

al D

BPs

and

mix

ture

s of

DBP

s.

Impr

oved

ris

k as

sess

men

tpr

oced

ures

and

ris

k es

tim

ates

fo

r D

BPs

.

Tab

le I

-2.

Drin

king

Wat

er D

isin

fect

ion

(Con

tinu

ed)

A p p e n d i x I

35


Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Ris

kM

anag

emen

t

Whi

ch te

chno

logi

esca

n si

mul

tane

ousl

yco

ntro

l pat

hoge

ns a

ndD

BPs

?

Eva

luat

e tr

eatm

ent p

roce

sses

for

path

ogen

con

trol

, inc

lud

ing

iden

tifi

cati

on o

f sur

roga

te m

easu

res

of tr

eatm

ent e

ffec

tive

ness

,te

chno

logi

es fo

r sm

all s

yste

ms,

and

cont

rol o

f bac

teri

al g

row

th in

dis

trib

utio

n sy

stem

s.

Dat

a on

the

effe

ctiv

enes

s of

diff

eren

t pro

cess

es.

To e

valu

ate

diff

eren

t tre

atm

ent o

ptio

ns a

ndre

gula

tory

str

ateg

ies

for

red

ucin

g D

BP a

nd m

icro

bial

risk

s.

To p

rovi

de g

uida

nce

for

oper

atio

n of

trea

tmen

tpl

ants

and

dis

trib

utio

n sy

stem

s.

Sim

ulta

neou

sly

eval

uate

pro

cess

esfo

r co

ntro

lling

DB

Ps (

incl

udin

gch

lori

ne v

s. a

lter

nati

ve d

isin

fect

ants

)an

d p

ract

ices

for

rem

ovin

g D

BP

prec

urso

rs (g

ranu

lar

acti

vate

dca

rbon

, mem

bran

e fi

ltra

tion

).

Tab

le I

-2.

Drin

king

Wat

er D

isin

fect

ion

(Con

tinue

d)

A p p e n d i x I

36


Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Hea

lth

Eff

ects

Wha

t hea

lth

effe

cts

are

caus

edby

par

ticu

late

mat

ter

(PM

) and

its

com

pone

nts?

Con

duc

t epi

dem

iolo

gic

stud

ies

ofm

orta

lity

and

mor

bid

ity

coup

led

wit

him

prov

ed e

xpos

ure

char

acte

riza

tion

.

Qua

litat

ive

and

quan

tita

tive

dat

a on

mor

talit

y an

d/or

resp

irat

ory

dise

ases

.

To p

rovi

de h

ealt

h ef

fect

s da

ta fo

r ri

sk a

sses

smen

t(C

rite

ria

Doc

umen

t) to

sup

port

PM

Nat

iona

lA

mbi

ent A

ir Q

ualit

y St

and

ard

s (N

AA

QS)

.

Con

duc

t clin

ical

stu

die

s of

res

pira

tory

effe

cts

in c

ontr

olle

d h

uman

stu

die

s.

Wha

t are

the

caus

alm

echa

nism

s/pa

rtic

les

that

expl

ain/

supp

ort e

pid

emio

logi

cob

serv

atio

ns?

Con

duc

t ani

mal

and

clin

ical

stu

die

s of

bioc

hem

ical

and

phy

siol

ogic

eve

nts

init

iate

d b

y PM

and

its

com

pone

nts.

Dos

e-re

spon

se d

ata

desc

ribi

ng b

ioch

emic

alan

d ph

ysio

logi

c ev

ents

indu

ced

by

PM a

nd th

eir

rela

tion

ship

to d

isea

se.

To p

rovi

de h

ealt

h ef

fect

s da

ta fo

r ri

sk a

sses

smen

t(C

rite

ria

Doc

umen

t) to

sup

port

PM

NA

AQ

S.

Wha

t is

the

rela

tion

ship

betw

een

PM

exp

osur

e an

ddo

se?

Dev

elop

dos

imet

ric

mod

el o

f par

ticl

ede

posi

tion

in th

e lu

ngs

und

er v

ario

usex

posu

re a

nd p

opul

atio

n co

ndit

ions

.

Dos

imet

ric

mod

ellin

king

ani

mal

s to

hum

ans

and

nor

mal

hum

ans

to s

ensi

tive

subp

opul

atio

ns (e

.g.,

child

ren,

ind

ivid

uals

wit

h pr

eexi

stin

g d

isea

se).

To p

rovi

de h

ealt

h ef

fect

s da

ta fo

r ri

sk a

sses

smen

t(C

rite

ria

Doc

umen

t) to

sup

port

PM

NA

AQ

S.

Wha

t is

the

role

of d

ose

for

effe

cts

in s

ensi

tive

subp

opul

atio

ns?

Exp

osu

reW

hat P

M s

peci

es a

ndco

ncen

trat

ion

leve

ls a

re p

rese

ntin

am

bien

t air

?

Dev

elop

am

bien

t PM

mea

sure

men

tm

etho

dolo

gy c

apab

le o

f dis

crim

inat

ing

part

icle

s by

siz

e an

d sp

ecie

s.

Met

hods

for

mea

suri

ngfi

ne-p

arti

cle

mas

s an

dch

arac

teri

zing

spe

cies

(e.g

., ac

id a

eros

ols,

inor

gani

c an

d o

rgan

icsp

ecie

s).

To s

erve

as

a Fe

dera

l Ref

eren

ce M

etho

d fo

r ne

wfi

ne-p

arti

cle

NA

AQ

S.

To p

rovi

de P

M m

etho

dol

ogy

for

atm

osph

eric

chem

istr

y re

sear

ch a

nd to

tal e

xpos

ure

rese

arch

.

Con

duc

t PM

siz

e an

d s

peci

esch

arac

teri

zati

on s

tud

ies.

PM c

hara

cter

izat

ion

data

.To

ass

ess

PM s

ize

and

con

cent

rati

on le

vels

for

regu

lato

ry d

evel

opm

ent

and

epi

dem

iolo

gic

stud

yd

esig

n.

To id

enti

fy s

ourc

es o

f PM

and

ad

dres

s PM

form

atio

n, tr

ansp

ort,

and

fate

.

To h

elp

dev

elop

con

trol

str

ateg

ies

for

impl

emen

ting

PM

reg

ulat

ion(

s).

Tab

le I

-3.

Part

icul

ate

Mat

ter

(Con

tinu

ed)

37

A p p e n d i x I


Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Exp

osu

re(C

onti

nu

ed)

Wha

t PM

spe

cies

and

conc

entr

atio

n le

vels

are

peo

ple

expo

sed

to?

Con

duc

t pro

spec

tive

epi

dem

iolo

gic

and

hum

an e

xpos

ure

stud

ies.

Veri

fica

tion

of c

urre

ntep

idem

iolo

gic

obse

rvat

ions

.

To d

eter

min

e th

e ef

fect

s of

am

bien

t fin

e an

d c

oars

ePM

on

adul

ts’ l

ung

func

tion

and

dai

ly m

orta

lity.

To e

valu

ate

and

exte

nd fi

ndin

gs o

n si

ze-s

peci

fic

PM

exp

osur

e an

d d

aily

mor

talit

y.Im

prov

ed e

stim

ates

of

hum

an e

xpos

ure

to P

M.

Red

uced

unc

erta

inty

rega

rdin

g th

e si

ze a

ndph

ysic

al p

rope

rtie

s of

PM th

at m

ay c

ause

heal

th e

ffec

ts.

Ris

kA

sses

smen

t

How

can

we

redu

ceun

cert

aint

ies

asso

ciat

ed w

ith

esti

mat

es o

f the

PM

mor

talit

y/m

orbi

dit

y ri

sks

atlo

w a

mbi

ent l

evel

s?

Con

duc

t sta

tist

ical

rea

naly

ses

of e

xist

ing

epid

emio

logi

c d

atab

ases

to fu

rthe

rch

arac

teri

ze:

–The

sha

pe o

f exp

osur

e-re

spon

se

rel

atio

nshi

ps (p

ossi

ble

’thre

shol

ds’

).–T

he in

flue

nce

of s

ynop

tic

wea

ther

p

atte

rns.

–The

siz

e/ch

emic

al c

ompo

siti

on o

f key

P

M c

ompo

nent

s.

Qua

ntit

ativ

e d

ata

anal

yses

pro

vidi

ngre

duce

d u

ncer

tain

ties

inPM

ris

k es

tim

ates

.

To p

rovi

de h

ealt

h ef

fect

s da

ta fo

r ri

sk a

sses

smen

t(C

rite

ria

Doc

umen

t) to

sup

port

PM

NA

AQ

S.

Ris

kM

anag

emen

t

Wha

t are

the

emis

sion

rat

es a

ndph

ysic

al a

nd c

hem

ical

char

acte

rist

ics

of fi

ne p

arti

cles

from

sou

rces

that

pos

e th

egr

eate

st r

isk

to p

ublic

hea

lth?

Cha

ract

eriz

e fi

ne-p

arti

cle

emis

sion

s fr

omso

urce

s of

con

cern

(e.g

., he

avy

duty

dies

el tr

ucks

, fug

itiv

e so

urce

s,co

mbu

stio

n sy

stem

s, o

ther

sta

tion

ary

sour

ces)

.

Tech

nica

l rep

orts

and

data

on

the

size

dist

ribu

tion

, che

mic

alco

mpo

siti

on, a

ndqu

anti

ty o

f fin

e-pa

rtic

leem

issi

ons

from

key

mob

ile a

nd s

tati

onar

yso

urce

s.

To p

rovi

de e

mis

sion

s d

ata

to fo

cus

regu

lato

ryst

rate

gies

on

the

mos

t cri

tica

l sou

rces

.

To p

rovi

de m

etho

ds a

nd m

odel

s fo

r st

ates

tod

evel

op fi

ne-p

arti

cle

emis

sion

s in

vent

orie

s.

Tab

le I

-3.

Part

icul

ate

Mat

ter

(Con

tinue

d)

(Con

tinu

ed)

38

A p p e n d i x I


Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Ris

kM

anag

emen

t(C

onti

nu

ed)

Wha

t opt

ions

(e.g

., pr

oces

sch

ange

s, u

pgra

des

of e

xist

ing

cont

rols

, app

licat

ion

of n

ewte

chno

logi

es) a

re a

vaila

ble

that

both

red

uce

fine

-par

ticl

eem

issi

ons

to a

ccep

tabl

e le

vels

and

are

cost

-eff

ecti

ve?

Inve

stig

ate

opti

ons

for

redu

cing

fine

-par

ticl

e em

issi

ons:

–Dem

onst

rate

the

exte

nt to

whi

ch

im

prov

ed o

pera

tion

and

mai

nten

ance

o

f exi

stin

g co

ntro

l equ

ipm

ent f

or

com

bust

ion

syst

ems

can

furt

her

red

uce

em

issi

ons.

–Dev

elop

ad

vanc

ed, m

ore

cost

-eff

ecti

ve

tec

hnol

ogie

s (e

.g.,

impr

oved

e

lect

rost

atic

pre

cipi

tato

rs a

nd fa

bric

f

ilter

s) to

con

trol

fine

par

ticl

es fr

om

sta

tion

ary

sour

ces.

–Det

erm

ine

the

effe

ctiv

enes

s of

indo

or

air

cle

aner

s fo

r re

duc

ing

pers

onal

e

xpos

ure

to fi

ne p

arti

cles

.

Tech

nica

l rep

orts

and

data

on

the

perf

orm

ance

and

cost

-eff

ecti

vene

ss o

fco

mpe

ting

ris

km

anag

emen

t app

roac

hes.

To s

uppo

rt e

valu

atio

ns o

f com

peti

ng r

egul

ator

yst

rate

gies

, cos

t/be

nefi

t ana

lyse

s, a

nd d

evel

opm

ent

of g

uida

nce

docu

men

ts.

To p

rovi

de g

uida

nce

to s

tate

s an

d th

e re

gula

ted

com

mun

ity

on th

e pe

rfor

man

ce a

nd c

ost o

fco

mpe

ting

fine

-par

ticl

e ri

sk m

anag

emen

tap

proa

ches

.

Use

r-fr

iend

ly c

ompu

ter

mod

els

and

othe

rte

chni

cal a

ssis

tanc

e to

ols

that

tran

sfer

ris

km

anag

emen

tin

form

atio

n to

key

use

rs.

Com

pare

the

cost

s of

thes

e an

d ot

her

appr

oach

es.

Tab

le I

-3.

Part

icul

ate

Mat

ter

(Con

tinue

d)

39

A p p e n d i x I

Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Iden

tify

Res

earc

hN

eed

s

Wha

t do

we

know

abo

ut th

eso

urce

s, c

hem

ical

and

phy

sica

lpr

oper

ties

, tra

nspo

rt p

athw

ays,

ecol

ogic

al a

nd h

uman

eff

ects

of

EDC

s,a

and

whe

re a

re th

e m

ajor

gaps

in o

ur k

now

led

ge b

ase?

Con

duc

t wor

ksho

ps in

volv

ing

prin

cipa

l sta

keho

lder

s in

deve

lopi

ng c

onse

nsus

on

the

rese

arch

nee

ds

for

expo

sure

,an

d he

alth

and

env

iron

men

tal

effe

cts.

Rep

orts

on

the

rese

arch

nee

dsfo

r (1

) rep

rodu

ctiv

e, n

euro

logi

c,im

mun

olog

ic, a

nd c

arci

noge

nic

effe

cts

of E

DC

s, (2

) eco

logi

cal

risk

, and

(3) e

xpos

ure

asse

ssm

ent.

To d

evel

op p

rior

itiz

ed r

esea

rch

need

s.

Eff

ects

Wha

t are

the

impo

rtan

tch

emic

al c

lass

es fo

r in

tera

ctio

nw

ith

the

end

ocri

ne s

yste

m, a

ndw

hat i

s th

eir

rang

e of

pot

ency

?

Dev

elop

QSA

Rb m

odel

s fo

rho

rmon

e re

cept

or-l

igan

dbi

ndin

g an

d tr

ansc

ript

iona

lac

tiva

tion

.

QSA

R m

odel

s to

iden

tify

and

prio

riti

ze in

viv

o re

sear

ch to

defi

ne d

ose-

resp

onse

eff

ects

.

As

firs

t-ti

er c

ompu

ter

mod

els

to p

red

ict h

azar

d.

Do

our

curr

ent t

esti

ng a

ndm

onit

orin

g ap

proa

ches

adeq

uate

ly e

valu

ate

and

ass

ess

effe

cts

on th

e en

docr

ine

syst

em?

Dev

elop

in v

ivo

and

in v

itro

test

pro

cedu

res

and

bio

mar

kers

to d

etec

t the

act

ion

of E

DC

s an

dto

iden

tify

cri

tica

l lif

e st

ages

at

mul

tipl

e ph

ylog

enet

ic le

vels

.

Rec

omm

end

atio

ns fo

rm

odif

ying

the

test

ing

guid

elin

esfo

r po

tent

ial a

dver

se e

colo

gica

lan

d hu

man

hea

lth

effe

cts.

To r

evis

e te

stin

g gu

idel

ines

and

impr

ove

dat

ain

terp

reta

tion

.

Fiel

d a

nd la

bora

tory

tool

s to

bett

er q

uant

itat

e ef

fect

s of

puta

tive

ED

Cs.

Wha

t are

the

shap

es o

f the

dose

-res

pons

e cu

rves

for

EDC

sat

rel

evan

t exp

osur

es, a

nd w

hat

tiss

ue le

vels

are

res

pons

ible

for

indu

cing

adv

erse

eff

ects

?

Dev

elop

PB

PKc

and

BBD

Rd

mod

els

that

incl

ude

rele

vant

spec

ies-

spec

ific

par

amet

ers.

Incr

ease

d u

nder

stan

ding

of t

heco

mpa

rati

ve e

xpos

ure

leve

lsas

soci

ated

wit

h ri

sks.

To r

educ

e un

cert

aint

y in

che

mic

al-s

peci

fic

risk

asse

ssm

ents

and

rel

ativ

e po

tenc

y co

mpa

riso

ns.

Def

ine

pote

ncy

of E

DC

s in

targ

et s

peci

es.

Red

uced

unc

erta

inty

inex

trap

olat

ing

effe

cts.

Wha

t is

the

norm

al e

ndoc

rine

prof

ile in

targ

et w

ildlif

e sp

ecie

son

a s

easo

nal a

nd r

egio

nal b

asis

?

Stud

y po

pula

tion

s an

dde

term

ine

norm

al p

rofi

les

for

end

ocri

ne fu

ncti

on d

urin

gva

riou

s lif

e st

ages

, sea

sons

, and

regi

ons.

Dat

abas

e on

end

ocri

ne fu

ncti

onin

wild

life

expo

sed

to p

oten

tial

EDC

s.

To im

prov

e in

terp

reta

tion

of e

ndoc

rine

dat

a fr

omfi

eld

stud

ies

and

to im

prov

e un

ders

tand

ing

of th

em

agni

tud

e of

the

ED

C p

robl

em in

wild

life

popu

lati

ons.

Wha

t are

hea

lth

outc

omes

expe

rien

ced

by p

opul

atio

nsre

ceiv

ing

high

-lev

el e

xpos

ure

toED

Cs?

Ass

ess

spec

trum

of e

ffec

ts in

high

ly e

xpos

ed c

ohor

ts,

part

icul

arly

thos

e w

ith

deve

lopm

enta

l exp

osur

es.

Del

inea

tion

of c

ause

s an

d e

ffec

tsth

at c

an s

et th

e bo

unds

on

effe

cts

in le

ss h

ighl

y ex

pose

dpo

pula

tion

s.

To c

ondu

ct p

relim

inar

y ri

sk a

sses

smen

ts.

To d

evel

op r

emed

ial a

ctio

ns w

here

adv

erse

eff

ects

of E

DC

s in

the

envi

ronm

ent h

ave

been

con

firm

ed.

Tab

le I

-4.

Endo

crin

e D

isru

ptor

s

A p p e n d i x I


(Con

tinu

ed)

Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Eff

ects

(Con

tin

ued

)

For

wild

life

spec

ies,

wha

tpr

oced

ures

are

ava

ilabl

e fo

rex

trap

olat

ing

effe

cts

of th

ein

divi

dual

to p

opul

atio

ns?

Dev

elop

mod

els

for

extr

apol

atin

g ef

fect

s m

easu

red

in in

div

idua

ls to

rep

rodu

ctiv

eca

paci

ty in

wild

life

popu

lati

ons.

Mod

els

for

pred

icti

ngpo

pula

tion

-lev

el e

ffec

ts fr

omst

udy

at lo

wer

leve

ls o

fbi

olog

ical

org

aniz

atio

n.

To fa

cilit

ate

ecol

ogic

al r

isk

asse

ssm

ent b

ased

on

effe

cts

obse

rved

in in

div

idua

ls.

Wha

t are

the

stat

us a

nd tr

end

sof

sen

tine

l and

key

ston

e sp

ecie

sin

the

vari

ous

ecol

ogic

al a

reas

?

Iden

tify

and

per

iodi

cally

cond

uct c

ensu

sing

of s

enti

nel

and

keys

tone

spe

cies

.

Earl

y w

arni

ng in

dica

tors

of

envi

ronm

enta

l qua

lity,

espe

cial

ly in

term

s of

cont

amin

atio

n by

ED

Cs.

For

envi

ronm

enta

l mon

itor

ing.

Wha

t are

the

effe

cts

of e

xpos

ure

to m

ulti

ple

ED

Cs?

Det

erm

ine

pote

ntia

l for

syne

rgis

m o

r po

tent

iati

onw

ithi

n an

d a

mon

g va

riou

sm

odes

of a

ctio

n.

Ass

essm

ent o

f the

pot

enti

al fo

rno

n-ad

diti

vity

am

ong

ED

Che

alth

end

poin

ts.

To im

prov

e ef

fect

s as

sess

men

t for

env

iron

men

tally

impo

rtan

t mul

tipl

e ex

posu

res

to E

DC

s.

Exp

osu

reW

hat a

re th

e pa

thw

ays

ofex

posu

re o

f ED

Cs?

Dev

elop

sou

rce-

rece

ptor

mod

els

to a

sses

s ex

posu

re fr

omsp

ecif

ic s

ourc

es v

ia m

ulti

med

iapa

thw

ays.

Val

idat

ed m

odel

s to

ass

ess

expo

sure

to E

DC

s.To

impr

ove

sour

ce-r

ecep

tor

rela

tion

ship

sde

term

ined

via

hyb

rid

mod

els.

Do

we

adeq

uate

ly u

nder

stan

dm

ulti

med

ia tr

ansp

ort (

incl

udin

gph

ase

equi

libri

um a

ndde

posi

tion

mec

hani

sms)

,pe

rsis

tenc

e, b

ioac

cum

ulat

ion,

and

biom

agni

fica

tion

of E

DC

s?

Dev

elop

met

hod

s to

mon

itor

expo

sure

to E

DC

s an

d m

etho

dsto

cha

ract

eriz

e ex

posu

reha

lf-l

ife,

spe

ciat

ion,

upt

ake,

and

phas

e eq

uilib

rium

.

Ana

lyti

cal m

etho

ds

adeq

uate

toch

arac

teri

ze E

DC

s in

mul

tim

edia

, to

asse

ss tr

ansp

ort,

fate

, and

exp

osur

e, a

nd to

prov

ide

inpu

t to

sour

ce-r

ecep

tor

mod

els.

To im

prov

e so

urce

and

rec

epto

r m

odel

s an

das

sess

men

ts o

f ED

C e

xpos

ure.

Do

we

have

ade

quat

e (s

ensi

tive

,re

liabl

e, a

nd in

expe

nsiv

e) to

ols

to m

onit

or p

opul

atio

ns fo

rex

posu

res

to E

DC

s?

Dev

elop

bio

mar

kers

for

expo

sure

of E

DC

s ap

plic

able

toth

e ph

ylog

enet

ic le

vels

cons

ider

ed to

be

at g

reat

est r

isk

to E

DC

s.

Fiel

d a

nd la

bora

tory

tool

s to

bett

er q

uant

itat

e th

e ex

posu

res

and

effe

cts

of p

utat

ive

ED

Cs.

To im

prov

e da

ta in

terp

reta

tion

.

Impr

oved

alg

orit

hms

toca

lcul

ate

EDC

exp

osur

e.

Wha

t are

the

envi

ronm

enta

lco

ncen

trat

ions

of E

DC

s in

all

prin

cipa

l med

ia?

Con

duc

t fie

ld s

tudi

es to

mea

sure

hig

h-pr

iori

ty E

DC

s.D

atab

ase

on E

DC

leve

ls in

the

hum

an e

nvir

onm

ent a

ndva

riou

s ec

osys

tem

s to

ass

ist i

nde

sign

ing

futu

re e

xpos

ure

stra

tegi

es.

Prel

imin

ary

envi

ronm

enta

l exp

osur

e as

sess

men

ts.

Tab

le I

-4.

Endo

crin

e D

isru

ptor

s (C

ontin

ued)

A p p e n d i x I


(Con

tinu

ed)

Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Exp

osu

re(C

onti

nu

ed)

Wha

t exp

osur

es a

re e

xper

ienc

edby

pop

ulat

ions

aff

ecte

d b

yED

Cs?

Qua

ntit

ate

expo

sure

inpo

pula

tion

s sh

owin

g ef

fect

s of

EDC

s, p

arti

cula

rly

thos

e w

ith

deve

lopm

enta

l exp

osur

es.

Del

inea

tion

of c

ause

s an

d e

ffec

tsw

hich

can

set

the

boun

ds o

nef

fect

s in

less

hig

hly

expo

sed

popu

lati

ons.

To c

ondu

ct p

relim

inar

y ri

sk a

sses

smen

ts.

To d

evel

op r

emed

ial a

ctio

ns w

here

adv

erse

eff

ects

of E

DC

s in

the

envi

ronm

ent h

ave

been

con

firm

ed.

Ass

essm

ent

Wha

t str

engt

hs a

nd w

eakn

esse

sar

e pr

esen

t in

asse

ssm

ent o

fex

isti

ng in

form

atio

n on

ED

Cs

and

rela

ted

topi

cs?

Con

vene

EPA

wor

king

gro

up to

crit

ical

ly r

evie

w e

xist

ing

biol

ogic

al e

ffec

ts in

form

atio

n.

Rep

ort o

f lit

erat

ure

revi

ew.

To r

efin

e O

RD

’s r

esea

rch

stra

tegy

.

To d

evel

op r

egul

ator

y po

licy

on E

DC

s.

a ED

C =

end

ocri

ne-d

isru

ptin

g ch

emic

al.

b QSA

R =

qua

ntit

ativ

e st

ruct

ure-

acti

vity

rel

atio

nshi

p.c PB

PK =

phy

siol

ogic

ally

bas

ed p

harm

acok

inet

ic.

dBB

DR

= b

iolo

gica

lly b

ased

dos

e-re

spon

se.

Tab

le I

-4.

Endo

crin

e D

isru

ptor

s (C

ontin

ued)

A p p e n d i x I



Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Eff

ects

Wha

t lev

els

ofan

thro

poge

nic

stre

ss(c

hem

ical

and

non

chem

ical

)ca

n ec

osys

tem

s to

lera

te a

ndst

ill b

e su

stai

ned

/m

aint

aine

d?

Und

erst

and

and

dev

elop

mod

els

to p

redi

ct e

cosy

stem

vuln

erab

ility

to a

lter

nati

vem

anag

emen

t pra

ctic

es a

ndch

angi

ng s

tres

sors

at m

ulti

ple

scal

es.

Dev

elop

scr

eeni

ng a

nd te

stin

gm

etho

ds to

ass

ess

viab

ility

and

sust

aina

bilit

y at

mul

tipl

ele

vels

of b

iolo

gica

lor

gani

zati

on.

Qua

ntit

ativ

e m

odel

s pr

edic

ting

com

plex

and

cas

cadi

ng e

ffec

tsof

mul

tipl

e st

ress

ors

at m

ulti

ple

geog

raph

ic a

nd te

mpo

ral s

cale

s.

To in

form

deb

ate

on s

ocie

tal v

alue

s w

ith

resp

ect t

oec

osys

tem

pro

tect

ion;

to p

rovi

de

info

rmat

ion

to s

uppo

rtfu

ture

com

mun

ity-

base

d e

cosy

stem

pro

tect

ion.

To p

rovi

de

info

rmat

ion

to e

valu

ate

com

para

tive

ris

ks a

nddr

ive

stra

tegi

c re

sear

ch p

lann

ing.

Cri

teri

a fo

r m

aint

aini

ngec

osys

tem

s.

How

do

ecos

yste

mco

mpo

nent

s re

spon

d to

chan

ging

exp

osur

es to

stre

ssor

s?

Con

duc

t res

earc

h to

quan

tita

tive

ly u

nder

stan

dst

ress

or-r

espo

nse

rela

tion

ship

s.

Qua

ntit

ativ

e m

odel

s re

lati

ngle

vels

of e

xpos

ure

to e

ffec

ts fo

rsi

ngle

str

esso

rs.

To s

uppo

rt e

colo

gica

l eff

ects

asse

ssm

ent.

Wha

t are

the

best

mea

sure

sof

eco

syst

em e

ffec

ts?

Iden

tify

indi

cato

rs (m

easu

res)

of e

ffec

t tha

t cor

resp

ond

ascl

osel

y as

pos

sibl

e to

asse

ssm

ent e

ndpo

ints

.

Eval

uati

on o

f ind

icat

ors

of

effe

ct.

To p

rovi

de

ind

icat

ors

that

can

ser

ve a

s st

ate

vari

able

s in

risk

ass

essm

ent m

odel

s an

d a

s m

easu

res

of c

ondi

tion

for

stat

us a

nd tr

ends

mon

itor

ing.

To s

uppo

rt o

bjec

tive

eva

luat

ion

of s

ucce

ss in

ris

km

anag

emen

t dec

isio

n-m

akin

g.

Exp

osu

reW

hat a

re th

e m

ost

sign

ific

ant s

ourc

es o

fst

ress

ors

in v

ario

us

ecor

egio

ns o

f the

Uni

ted

Stat

es?

Dev

elop

met

hod

s fo

rch

arac

teri

zing

sou

rces

of

rele

vant

str

esso

rs.

Met

hods

for

char

acte

rizi

ngso

urce

s of

exp

osur

es.

As

tool

s fo

r ex

posu

re a

sses

smen

ts.

As

com

pone

nts

of e

xper

t sys

tem

s to

pre

dict

exp

osur

e.

Wha

t is

the

exte

nt a

ndd

istr

ibut

ion

of h

ighl

yvu

lner

able

sys

tem

s ba

sed

on p

red

icte

d ch

ange

s in

stre

ssor

s at

mul

tipl

e sc

ales

?

Dev

elop

met

hod

s to

effi

cien

tly

char

acte

rize

regi

onal

land

scap

es a

ndha

bita

t dis

trib

utio

n.

Base

line

dat

a fo

r re

gion

alas

sess

men

ts.

To s

upp

ort r

elat

ive

risk

ass

essm

ents

.

To id

enti

fy v

ulne

rabl

e sy

stem

s at

wat

ersh

ed a

nd r

egio

nal

scal

es.

Ass

essm

ents

of h

ighl

yvu

lner

able

eco

syst

ems,

wit

hin

and

amon

g ec

oreg

ions

.

A n

atio

nal l

and-

cove

r m

ap o

fth

e U

nite

d St

ates

.

Tab

le I

-5.

Rese

arch

to Im

prov

e Ec

osys

tem

Ris

k As

sess

men

t

(Con

tinu

ed)

43

A p p e n d i x I


Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Exp

osu

re(C

onti

nu

ed)

Wha

t is

the

curr

ent

dis

trib

utio

n of

exp

osur

e to

thes

e st

ress

ors

acro

ssvu

lner

able

eco

syst

ems?

Dev

elop

mod

els

to li

nktr

ansp

ort,

tran

sfor

mat

ion,

and

fate

of s

tres

sors

to e

xpos

ure

toec

osys

tem

s at

app

ropr

iate

tim

e an

d s

pace

sca

les.

Supp

ort a

n in

tera

genc

yex

posu

re r

efer

ence

sit

ene

twor

k.

Con

duc

t exp

osur

evu

lner

abili

ty a

sses

smen

ts a

tm

ulti

ple

geog

raph

ic a

ndte

mpo

ral s

cale

s.

Met

hods

for

asse

ssin

g ex

posu

re.

To s

upp

ort r

elat

ive

risk

ass

essm

ents

.

To id

enti

fy v

ulne

rabl

e sy

stem

s at

wat

ersh

ed r

egio

nal a

ndna

tion

al s

cale

s.

Wha

t sou

rces

are

now

caus

ing

the

mos

t sig

nifi

cant

expo

sure

s?

Dev

elop

dia

gnos

tic

tool

s fo

rre

tros

pect

ive

asse

ssm

ents

.In

dic

ator

s of

sou

rce/

expo

sure

rela

tion

ship

s.To

app

orti

on s

ourc

e st

reng

ths.

To id

enti

fy s

ourc

es fo

r ri

sk r

educ

tion

tech

nolo

gyde

velo

pmen

t.

How

will

cur

rent

pat

tern

sof

exp

osur

e ch

ange

in 5

, 10,

25, a

nd 5

0 ye

ars?

Con

duc

t dem

ogra

phic

and

econ

omic

stu

die

s to

ass

ist i

npr

edic

ting

futu

re s

ourc

es o

fst

ress

ors.

Link

land

scap

e an

d po

lluta

ntm

odel

s to

pre

dict

futu

reen

viro

nmen

ts.

Doc

umen

tati

on o

f hig

hest

prio

rity

str

esso

rs.

Dat

a fo

r pr

edic

tive

mod

els.

Pred

icti

ve m

odel

s fo

r us

e by

com

mun

ity-

base

d e

cosy

stem

prot

ecti

on p

lann

ers.

Pred

icti

ons

of fu

ture

pol

luta

ntan

d st

ress

or d

istr

ibut

ions

To s

uppo

rt e

nvir

onm

enta

l pla

nnin

g at

mul

tipl

e sc

ales

.

To a

ssis

t in

avoi

ding

the

unin

tend

ed c

onse

quen

ces

of o

urcu

rren

t man

agem

ent d

ecis

ions

.

Ass

essm

ent

Wha

t are

the

asse

ssm

ent

endp

oint

s of

pri

mar

yco

ncer

n to

loca

l, w

ater

shed

,an

d r

egio

nal c

omm

unit

ies?

Dev

elop

an

OR

D-w

ide

ecol

ogic

al d

ata

man

agem

ent

syst

em.

Dat

a sy

stem

s to

sup

port

ris

km

anag

emen

t.To

sup

port

eco

logi

cal r

isk

asse

ssm

ent.

To c

ondu

ct c

ompa

rati

ve e

colo

gica

l ris

k as

sess

men

ts to

prio

riti

ze r

esea

rch

and

ecol

ogic

al p

rote

ctio

n ef

fort

s.

Tab

le I

-5.

Rese

arch

to Im

prov

e Ec

osys

tem

Ris

k As

sess

men

t (

Con

tinue

d)

(Con

tinu

ed)

44

A p p e n d i x I


Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Ass

essm

ent

(Con

tin

ued

)

Wha

t are

the

com

para

tive

risk

s to

pop

ula

tion

s,co

mm

unit

ies,

and

ecos

yste

ms

from

mul

tipl

est

ress

ors?

Dev

elop

ris

k as

sess

men

t and

char

acte

riza

tion

met

hod

s fo

rsi

ngle

/m

ulti

ple

reso

urce

s an

dst

ress

ors.

Impr

oved

ris

k as

sess

men

tm

etho

ds.

As

tool

s fo

r ec

olog

ical

ris

k as

sess

men

t.

To c

ondu

ct c

ompa

rati

ve e

colo

gica

l ris

k as

sess

men

ts.

Ass

ess

the

risk

s an

d th

eir

econ

omic

impl

icat

ions

.Q

uant

itat

ive/

qual

itat

ive

regi

onal

, com

para

tive

ris

kas

sess

men

ts.

To s

uppo

rt r

egio

nal a

nd lo

cal c

omm

unit

y-ba

sed

ecos

yste

mpr

otec

tion

pla

ns.

To a

ssis

t in

prio

riti

zing

res

earc

h an

d ec

olog

ical

pro

tect

ion

effo

rts.

Dev

elop

an

expe

rt s

yste

m fo

ras

sess

ing

ecol

ogic

al b

enef

its

of a

lter

nati

ve m

anag

emen

tst

rate

gies

at m

ulti

ple

scal

es.

Link

s be

twee

n hu

man

hea

lth

and

ecol

ogic

al r

isks

.A

s a

tool

for

envi

ronm

enta

l man

agem

ent a

t wat

ersh

edsc

ales

.

To a

ssis

t in

envi

ronm

enta

l man

agem

ent a

nd p

lann

ing

atm

ulti

ple

scal

es.

Con

duc

t com

para

tive

ris

kas

sess

men

ts.

Ris

kM

anag

emen

t

Wha

t are

the

mos

tco

st-e

ffec

tive

and

eff

icie

ntw

ays

to r

educ

e ri

sk to

ecos

yste

ms?

Iden

tify

and

eva

luat

epr

omis

ing

opti

ons

for

risk

redu

ctio

n.

Ris

k m

anag

emen

t tec

hnol

ogie

sfo

r co

ntam

inan

ts, s

edim

ents

,ha

zard

ous

was

tes,

and

oth

erst

ress

ors.

As

tool

s to

sel

ect a

nd im

plem

ent a

ppro

ache

s fo

r re

duci

ngec

olog

ical

ris

k.

To a

void

an

ecol

ogic

al “

trai

n-w

reck

.”

Dat

a on

tech

nolo

gyef

fect

iven

ess.

Rec

omm

end

atio

ns o

n op

tim

alec

osys

tem

man

agem

ent

appr

oach

es.

How

are

deg

rade

dec

osys

tem

s be

st r

esto

red

?C

ond

uct f

ield

res

tora

tion

proj

ects

.R

esto

rati

on te

chni

ques

.To

impr

ove

rest

orat

ion

tech

niqu

es.

To r

esto

re e

cosy

stem

s.

To p

rovi

de

man

uals

and

gui

dan

ce o

n m

anag

emen

tpr

acti

ces.

Tab

le I

-5.

Rese

arch

to Im

prov

e Ec

osys

tem

Ris

k As

sess

men

t (C

ontin

ued)

45

A p p e n d i x I

Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Exp

osu

reW

hat i

s th

eso

urce

-exp

osur

ere

lati

onsh

ip?

Dev

elop

ver

ifie

d m

odel

s th

at tr

ace

the

pros

pect

ive

and

retr

ospe

ctiv

ere

lati

onsh

ip b

etw

een

sour

ces

and

tota

l exp

osur

e.

Veri

fied

sou

rce-

expo

sure

mod

els

that

inco

rpor

ate

fate

and

tran

spor

t pro

cess

es.

To id

enti

fy th

e m

ost e

ffec

tive

ris

k m

anag

emen

t tar

gets

.

Wha

t is

the

popu

lati

ondi

stri

buti

on o

fex

posu

res

from

all

med

ia?

Dev

elop

qua

ntit

ativ

e to

tal h

uman

expo

sure

mod

els

base

d on

sou

ndth

eore

tica

l and

exp

erim

enta

lin

form

atio

n.

Impr

oved

met

hod

s fo

r ex

posu

rem

easu

rem

ents

:- A

ctiv

ity

patt

ern

data

base

.- M

icro

envi

ronm

enta

l exp

osur

e m

easu

rem

ents

.- F

ield

stu

dies

of p

opul

atio

ns

wit

h a

vari

ety

of e

xpos

ure

risk

f

acto

rs.

- Com

pute

r-ba

sed

exp

osur

e m

odel

pla

tfor

m.

To s

uppo

rt h

ealt

h ri

sk a

sses

smen

ts; t

o m

easu

reef

fect

iven

ess

of r

isk

man

agem

ent d

ecis

ions

.

Wha

t are

the

dete

rmin

ants

of

expo

sure

?

Det

erm

ine

whi

ch b

ehav

iora

l,so

cioe

cono

mic

, or

lifes

tyle

fact

ors

incr

ease

exp

osur

e to

pol

luta

nts;

dete

rmin

e th

e re

lati

onsh

ip o

f age

(you

ng a

nd o

ld) a

nd p

reex

isti

ngdi

seas

e to

exp

osur

e.

Mul

timed

ia/p

athw

ay e

xpos

ure

data

for d

isad

vant

aged

popu

latio

ns,

child

ren,

the

elde

rly,

and

pers

ons

livin

g ne

ar s

elec

ted

sour

ces

(e.g

., pe

stic

ide

use)

.

To id

enti

fy a

t-ri

sk s

ubpo

pula

tion

s fo

r ri

sk a

sses

smen

t and

to e

nsur

e ad

equa

cy o

f rul

es/

regu

lati

ons.

Expo

sure

mod

els

for

high

lyex

pose

d su

bpop

ulat

ions

.

Dos

e E

stim

atio

n

Wha

t is

the

expo

sure

-dos

ere

lati

onsh

ip fo

rpo

lluta

nts

from

each

pat

hway

?

For

pollu

tant

s ha

ving

mul

tipl

epa

thw

ays,

det

erm

ine

the

quan

tita

tive

con

trib

utio

n of

eac

hpa

thw

ay to

tota

l exp

osur

e an

dta

rget

-sit

e do

se.

Mod

els

of r

elat

ive

inta

kes

ofpe

rsis

tent

che

mic

als

from

inha

lati

on, o

ral,

and

derm

alro

utes

bas

ed o

n m

easu

rem

ent

data

.

To id

enti

fy th

e pa

thw

ays

that

con

trib

ute

mos

t to

risk

and

henc

e re

quir

e m

itig

atio

n.

How

can

we

impr

ove

dos

ees

tim

atio

ns a

cros

ssp

ecie

s an

dex

posu

re s

cena

rios

?

Dev

elop

met

hod

s an

d m

odel

s fo

res

tim

atin

g d

ose

to ta

rget

tiss

ues

(i.e

., ph

ysio

logi

cally

bas

edph

arm

acok

inet

ic m

odel

s).

Mod

els

for

pred

icti

ng d

ispo

siti

onof

che

mic

als

in th

e bo

dy fr

om a

llro

utes

.

To im

prov

e th

e sc

ient

ific

bas

is fo

r ca

ncer

and

non

canc

erri

sk a

sses

smen

ts.

To r

educ

e un

cert

aint

y in

ris

k as

sess

men

t and

ris

km

anag

emen

t dec

isio

ns.

Tab

le I

-6.

Rese

arch

to Im

prov

e H

ealth

Ris

k As

sess

men

t


(Con

tinu

ed)

46

A p p e n d i x I

Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Haz

ard

Iden

tifi

cati

onan

dC

har

acte

riza

tion

How

can

we

impr

ove

our

abili

tyto

det

ect h

azar

ds?

Dev

elop

scr

eeni

ng m

etho

ds

to s

ette

stin

g pr

iori

ties

.V

alid

ated

scr

eeni

ng p

roto

cols

usin

g, fo

r ex

ampl

e, in

viv

o, in

vitr

o, a

nd s

truc

tura

l act

ivit

yre

lati

onsh

ip (S

AR

) met

hod

s.

To id

enti

fy a

nd r

ank

exis

ting

pes

tici

des

and

indu

stri

alch

emic

als

in te

rms

of p

oten

tial

toxi

city

.

To s

cree

n ne

w c

hem

ical

s as

they

ent

er th

e re

gula

tory

syst

em; t

o as

sess

rel

ativ

e to

xici

ty.

Dev

elop

cos

t-ef

fect

ive

met

hods

for

toxi

city

dat

a co

llect

ion.

New

and

rev

ised

sta

ndar

dto

xici

ty te

stin

g pr

otoc

ols.

To d

evel

op A

genc

y te

st g

uid

elin

es.

To s

upp

ort r

egu

lato

ry a

ctiv

itie

s (e

.g.,

TSC

Aa te

st r

ules

and

cons

ent a

gree

men

ts, F

IFR

Ab d

ata

call-

ins)

.

How

can

we

bett

erin

terp

ret t

oxic

ity

data

to p

red

ict a

ndde

fine

haz

ards

?

Dev

elop

impr

oved

met

hod

s fo

rda

ta in

terp

reta

tion

. Fo

r ex

ampl

e,id

enti

fy b

iom

arke

rs o

f exp

osur

ean

d ef

fect

and

val

idat

e th

e us

e of

biom

arke

rs in

hum

an p

opul

atio

ns.

Gui

dan

ce d

ocum

ent o

nin

terp

reta

tion

of t

oxic

ity

data

.Fo

r in

corp

orat

ion

into

ris

k as

sess

men

t gui

del

ines

.

Dos

e-R

esp

onse

Rel

atio

nsh

ip

How

can

we

redu

ceun

cert

aint

y in

extr

apol

atio

ns (e

.g.,

from

hig

h do

ses

inan

imal

s to

envi

ronm

enta

lex

posu

res

inhu

man

s)?

Dev

elop

qua

ntit

ativ

e m

odel

s fo

rpr

edic

ting

tiss

ue a

nd o

rgan

ism

resp

onse

to ta

rget

tiss

ue

dose

(i.e

.,bi

olog

ical

ly b

ased

dos

e-re

spon

sem

odel

s).

Mod

els

for

pred

icti

ng to

xici

tydu

e to

che

mic

al e

xpos

ures

, whi

chca

n be

mod

ifie

d an

d ap

plie

d in

chem

ical

-spe

cifi

c ri

skas

sess

men

ts.

To p

rovi

de

crit

ical

exa

mpl

es o

f dev

elop

men

t and

use

of

mec

hani

stic

mod

els;

to e

valu

ate

the

pote

ntia

l of t

hese

mod

els

for

repl

acin

g de

faul

t app

roac

hes

for

canc

er a

ndno

ncan

cer

risk

ass

essm

ent.

To p

rovi

de

a st

ate-

of-t

he-s

cien

ce b

asis

for

repl

acin

gde

faul

t, pr

imar

ily e

mpi

rica

l ris

k as

sess

men

t app

roac

hes.

Dev

elop

impr

oved

em

piri

cal

dose

-res

pons

e m

odel

s (e

.g.,

benc

hmar

k d

ose

mod

els)

.

Val

idat

ed b

ench

mar

k d

ose

mod

els

and

guid

elin

es fo

rap

plic

atio

ns.

To im

prov

e re

fere

nce

dose

con

cent

rati

on p

roce

dure

s an

dth

ereb

y im

prov

e th

e ba

sis

for

risk

man

agem

ent d

ecis

ions

.

Sp

ecia

l Pro

ble

ms

Wha

t tox

icit

ies

are

asso

ciat

ed w

ith

mix

ture

s?

Dev

elop

met

hod

s to

ass

ess

the

toxi

city

of c

hem

ical

mix

ture

s.V

alid

ated

and

sta

ndar

dize

dte

stin

g pr

otoc

ols.

To id

enti

fy c

hem

ical

mix

ture

s w

ith

pote

ntia

l tox

icit

y th

atis

oth

er th

an a

ddi

ctiv

e.

To a

sses

s si

te-s

peci

fic

rela

tive

ris

k; to

sup

port

pol

luti

onpr

even

tion

and

ris

k m

anag

emen

t dec

isio

ns.

Dev

elop

mod

els

to p

red

ict t

heto

xici

ty o

f che

mic

al m

ixtu

res.

Val

idat

ed a

nd s

tand

ardi

zed

pred

icti

ve m

odel

s.To

iden

tify

che

mic

al m

ixtu

res

likel

y to

hav

e sy

nerg

isti

c or

supr

a-ad

dit

ive

toxi

c ef

fect

s.

To im

prov

e ri

sk m

anag

emen

t dec

isio

ns c

once

rnin

g ri

sks

pose

d b

y m

ixtu

res.

a TSC

A =

Tox

ic S

ubst

ance

s C

ontr

ol A

ct.

b FIFR

A =

Fed

eral

Inse

ctic

ide,

Fun

gici

de, a

nd R

oden

ticid

e A

ct.

Tab

le I

-6.

Rese

arch

to Im

prov

e H

ealth

Ris

k As

sess

men

t (C

ontin

ued)


A p p e n d i x I

Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Ris

kM

anag

emen

t

How

can

pol

luti

onpr

even

tion

str

ateg

ies

bein

tegr

ated

into

fed

eral

,st

ate,

and

pri

vate

sec

tor

deci

sion

-mak

ing?

Dev

elop

life

-cyc

leas

sess

men

t (L

CA

) too

ls a

ndm

odel

s.

LC

A to

ols

that

incl

ude

heal

than

d e

colo

gica

l im

pact

s.To

dem

onst

rate

how

LC

A c

an e

valu

ate

opti

ons

for

mul

tim

edia

pol

luti

on p

reve

ntio

n an

d r

isk

man

agem

ent t

hat

are

keye

d to

the

grea

test

ris

ks.

As

obje

ctiv

e, s

cien

tifi

cally

cre

dibl

e L

CA

pro

ced

ures

for

regu

lato

ry a

nd p

riva

te s

ecto

r us

e.

Dev

elop

pol

luti

onpr

even

tion

mod

ules

for

ind

ustr

ial p

lant

, pro

duc

t,an

d p

roce

ss d

esig

npr

oced

ures

.

Gen

eric

and

spe

cifi

c L

CA

cas

est

ud

ies

wit

h pr

ivat

e an

dpu

blic

sec

tor

part

ners

.

To e

stab

lish

part

ners

hips

to d

emon

stra

te r

isk-

base

d p

ollu

tion

prev

enti

on d

esig

n an

d pr

oces

s si

mul

atio

n op

port

uni

ties

.

For

com

mer

cial

pla

nt a

nd p

roce

ss d

esig

n m

etho

ds,

mod

els,

and

proc

edur

es.

To p

rovi

de

tech

nolo

gy tr

ansf

er to

the

priv

ate

sect

ors

thro

ugh

Coo

pera

tive

Res

earc

h an

d D

evel

opm

ent A

gree

men

ts a

ndlic

ensi

ng a

gree

men

ts.

Mat

hem

atic

al m

odel

s an

dco

mpu

ter-

base

d s

imul

ator

sfo

r pr

oces

s de

sign

.

Dev

elop

pol

luti

onpr

even

tion

mea

sure

men

tan

d a

udit

tool

s fo

r sm

all

busi

ness

es.

Pollu

tion

pre

vent

ion

acco

unti

ng m

etho

ds a

ndm

odel

s.

As

tool

s fo

r m

easu

ring

and

est

imat

ing

“pol

luti

on p

reve

nted

”in

sm

all b

usin

esse

s.

To p

rovi

de

tech

nica

l gui

danc

e fo

r re

gula

tory

pro

gram

s an

dpr

ivat

e se

ctor

nee

ds.

Aud

it p

roce

dur

es fo

rpo

lluti

on p

reve

ntio

n.

How

can

pol

luti

on b

epr

even

ted

? D

evel

op p

reco

mpe

titi

vean

d e

nabl

ing

pollu

tion

prev

enti

on a

nd in

nova

tive

tech

nolo

gies

for

maj

orin

dus

tria

l sec

tors

.

Pollu

tion

pre

vent

ion

and

inno

vati

ve te

chno

logi

es fo

rC

omm

on S

ense

Initi

ativ

e-re

late

d in

dust

rial

sect

ors

and

high

-ris

k pr

oble

ms,

incl

udin

g in

form

atio

n on

tech

nolo

gy c

osts

.

To im

prov

e te

chni

cal a

nd c

ost d

ata

and

des

igns

for

pollu

tion

prev

enti

on a

nd in

nova

tive

tech

nolo

gies

key

ed o

n C

SIin

dust

ries

and

oth

er h

igh-

risk

nee

ds.

To p

rovi

de

a ba

sis

for

com

mer

cial

ly a

vaila

ble

pollu

tion

prev

enti

on a

nd in

nova

tive

tech

nolo

gies

for

a w

ide

arra

y of

U.S

. ind

ustr

ial s

ecto

rs a

nd h

igh-

risk

pro

blem

are

as.

Eva

luat

e an

d ve

rify

thes

ete

chno

logi

es fo

r te

chni

cal

perf

orm

ance

and

cost

-eff

ecti

vene

ss.

Tech

nolo

gy v

erif

icat

ion

prot

ocol

s, th

ird

-par

tyve

rifi

cati

on o

rgan

izat

ions

, and

outr

each

to te

chno

logy

enab

lers

and

use

rs.

Enha

nced

and

mor

e cr

edib

le in

form

atio

n to

info

rmde

cisi

on-m

aker

s ab

out p

ollu

tion

pre

vent

ion

and

inno

vati

vete

chno

logy

opt

ions

em

phas

izin

g bo

th p

erfo

rman

ce a

nd c

ost.

As

a ba

sis

for

deve

lopi

ng s

cien

tifi

cally

cre

dibl

e an

dco

mm

erci

ally

ava

ilabl

e po

lluti

on p

reve

ntio

n an

d in

nova

tive

tech

nolo

gies

for

both

U.S

. and

fore

ign

mar

kets

.Pe

rfor

man

ce a

nd c

ost d

ata

for

pollu

tion

pre

vent

ion

and

inno

vati

ve te

chno

logi

es.

Tab

le I

-7.

Pollu

tion

Prev

entio

n an

d N

ew T

echn

olog

ies


(Con

tinu

ed)

48

A p p e n d i x I

Sub

top

icSt

rate

gic

Focu

sTa

sks

Pro

du

cts

Use

s

Ris

kM

anag

emen

t(C

onti

nu

ed)

How

can

rel

iabl

e an

dap

prop

riat

e co

st d

ata

bege

nera

ted

for

pollu

tion

prev

enti

on a

ndin

nova

tive

tech

nolo

gies

?

Dev

elop

pro

cess

cos

tm

odel

s fo

r po

lluti

onpr

even

tion

and

inno

vati

vete

chno

logi

es.

Cos

t est

imat

ing

and

rep

orti

ngpr

otoc

ols

and

sta

ndar

ds.

To im

prov

e co

st e

stim

atin

g to

ols

for

use

in c

ost-

effe

ctiv

enes

san

d co

st-b

enef

it m

etho

ds

deve

lopm

ent.

To p

rovi

de

relia

ble,

sci

enti

fica

lly c

red

ible

cos

t-es

tim

atio

npa

ckag

es fo

r en

viro

nmen

tally

pre

fera

ble

appr

oach

es a

ndte

chno

logi

es.

Dev

elop

cos

t dat

a re

port

ing

stan

dar

ds

and

prot

ocol

s fo

rim

prov

ed c

ost

com

para

bilit

y.

Dev

elop

eng

inee

ring

and

perf

orm

ance

cos

ts fo

rpo

lluti

on p

reve

ntio

n an

din

nova

tive

tech

nolo

gies

.

Cos

t dat

a fo

r po

lluti

onpr

even

tion

and

inno

vati

vete

chno

logi

es.

For

cost

-ben

efit

ass

essm

ents

by

EPA

and

oth

er r

egul

ator

y an

dno

nreg

ulat

ory

dec

isio

n-m

aker

s.

How

can

pol

luti

onpr

even

tion

and

inno

vati

ve te

chno

logi

esbe

dis

sem

inat

ed to

eff

ect

a re

duct

ion

inen

viro

nmen

tal r

isk

wor

ldw

ide?

Iden

tify

spe

cifi

c in

dus

try

and

gov

ernm

ent a

udie

nces

wor

ldw

ide,

thei

r ne

eds

for

info

rmat

ion,

and

appr

opri

ate

prod

ucts

tom

eet t

hose

nee

ds (e

.g.,

sem

inar

s, b

ulle

tins

,d

emon

stra

tion

s).

A v

arie

ty o

f tec

hnol

ogy

tran

sfer

pro

duct

sd

isse

min

ated

via

the

Inte

rnet

,te

leco

nfer

enci

ng, e

lect

roni

cbu

lleti

n bo

ard,

and

oth

er m

ore

conv

enti

onal

mea

ns (e

.g.,

repo

rts,

wor

ksho

ps).

To in

crea

se th

e aw

aren

ess

and

know

ledg

e of

env

iron

men

tal

prof

essi

onal

s an

d ot

hers

abo

ut th

e va

lidit

y an

d b

enef

its

ofpo

lluti

on p

reve

ntio

n an

d in

nova

tive

tech

nolo

gies

, the

reby

lead

ing

to th

eir

incr

ease

d ap

plic

atio

n an

d br

oade

r us

e.

To im

prov

e de

cisi

on-m

akin

g am

ong

inno

vati

ve te

chno

logy

user

s an

d pe

rmit

ting

off

icia

ls.

To s

uppo

rt w

ides

prea

d us

e of

app

licab

le p

ollu

tion

pre

vent

ion

and

inno

vati

ve te

chno

logi

es th

at m

axim

ize

risk

red

ucti

on.

Indu

stry

-tar

gete

d in

form

atio

nd

isse

min

atio

n pr

oduc

ts th

atw

ill in

clud

e te

chni

cal a

nd c

ost

dat

a an

d pe

rfor

man

cean

alys

es.

To im

prov

e en

viro

nmen

tal c

ompl

ianc

e an

d re

duce

com

plia

nce

cost

s.

To e

ncou

rage

the

priv

ate

sect

or to

val

ue a

nd r

outi

nely

use

pollu

tion

pre

vent

ion

and

inno

vati

ve te

chno

logi

es a

s th

e fi

rst

or o

nly

pref

eren

ce fo

r en

viro

nmen

tal p

rote

ctio

n an

dco

mpl

ianc

e.

Tab

le I

-7.

Pollu

tion

Prev

entio

n an

d N

ew T

echn

olog

ies

(Con

tinue

d)


A p p e n d i x I

49

Appendix II

The ORD OrganizationORD’s new organization, depicted below, mirrorsthe risk assessment/risk management paradigm.The functions of ORD’s National Laboratories,

Centers, and Offices are described on the followingpages.

Office of ResourcesManagement andAdministration

Assistant Administrator for Research and Development Office of Science Policy

Office of Research andScience Integration

National Centerfor Environmental

Assessment

National Centerfor Environmental

Research andQuality Assurance

National RiskManagement

ResearchLaboratory

Water Supply andWater ResourcesDivision(Cincinnati, OH)

Land Remediationand PollutionControl Division(Cincinnati, OH)

SustainableTechnology Division(Cincinnati, OH)

Air PollutionPrevention andControl Division(RTP, NC)

SubsurfaceProtection andRemediation Division(Ada, OK)

Technology Transferand Support Division(Cincinnati, OH)

TechnologyCoordination Staff(Washington, DC)

EnvironmentalEngineeringResearch Division(Washington, DC)

EnvironmentalSciences ResearchDivision(Washington, DC)

Quality AssuranceDivision(Washington, DC)

Peer Review Division(Washington, DC)

Deputy AssistantAdministrator for Science

Deputy Assistant Administratorfor Management

National Health andEnvironmental EffectsResearch Laboratory

ReproductiveToxicology Division(RTP, NC)

ExperimentalToxicology Division(RTP, NC)

EnvironmentalCarcinogenesisDivision (RTP, NC)

NeurotoxicologyDivision (RTP, NC)

Human StudiesDivision (RTP, NC)

Gulf Ecology Division(Gulf Breeze, FL)

Mid-ContinentEcology Division(Duluth, MN)

Western EcologyDivision(Corvallis, OR)

Atlantic EcologyDivision(Narragansett, RI)

NCEA RTP, NCOffice

NCEA Washington,DC Office

NCEA Cincinnati,OH Office

NationalExposureResearch

Laboratory

AtmosphericProcesses ResearchDivision (RTP, NC)

Air MeasurementsResearch Division(RTP, NC)

AtmosphericModeling Division(RTP, NC)

Air ExposureResearch Division(RTP, NC)

Human ExposureResearch Division(Cincinnati, OH)

Ecological ExposureResearch Division(Cincinnati, OH)

CharacterizationResearch Division(Las Vegas, NV)

Ecosystems ResearchDivision(Athens, GA)

ORD’s New Risk-Based Organization


National Health andEnvironmental Effects ResearchLaboratoryORD’s National Health and Environmental EffectsResearch Laboratory (NHEERL) performslaboratory and field research to help EPA answertwo fundamental questions:

What are the health and/or ecological effects ofexposures to man-made stressors?

What is the likelihood that these effects will occurunder conditions of environmental exposure?

NHEERL’s research contributes to improving threesteps in the risk assessment process:

In the hazard identification area, NHEERL worksto improve both assessment test methods and theinterpretation of data developed by thesemethods (i.e., the relationship of effects measuresto health/ecological outcome).

In the dose-response assessment area, NHEERLperforms mechanistic research to address majoruncertainties, as well as research to develop andimprove extrapolation and multi-tier models.

In the risk characterization area, NHEERLprovides data on carefully selected priorityproblems.

National Exposure ResearchLaboratoryThe work of ORD’s National Exposure ResearchLaboratory (NERL) forms the basis for the humanand ecosystem exposure assessments that are part ofthe risk assessment process. NERL researchersmeasure, predict, and apply multimedia data toassess with known certainty the multiple routes bywhich humans and ecosystems are exposed toenvironmental stressors. This work includes:

Characterizing the physical and chemicalproperties that govern exposure in atmospheric,terrestrial, aquatic, benthic, and aquiferenvironments in order to identify and quantifyphenomena that result in exposure.

Developing, testing, and demonstratingmathematical and computerized models to:

• Predict multimedia exposure routes.

• Describe the status of ecological systems.

• Evaluate stressor fate and transportmechanisms that affect mitigation, restoration,prevention, and risk management options tominimize exposure.

Research TrianglePark, NC

Washington, DC

Cincinnati, OH

Las Vegas,NV

Athens, GA

Gulf Breeze, FL

Corvallis, OR

Duluth, MN

Narragansett, RI

Ada, OK

Grosse Ile, MI

Newport, OR

Edison, NJ

Location of ORD’s National Laboratories and Centers

A p p e n d i x I I


National Center forEnvironmental AssessmentORD’s National Center for EnvironmentalAssessment serves as a national resource center forthe overall process of risk assessment: integratinghazard, dose-response, and exposure data andmodels to produce risk characterizations.

National Risk ManagementResearch LaboratoryResearch by ORD’s National Risk ManagementResearch Laboratory (NRMRL) provides thescientific basis for environmental risk management.Specifically, NRMRL conducts research to reduce the uncertainty associated with making andimplementing risk management decisions. Thisresearch focusses on two important areas:

Characterizing pollutant sources that requiremanagement.

Identifying, developing, and evaluating tools andtechnologies for prevention, control, restoration,and remediation of environmental problems thatare high risk, high cost, or that lack effectivemanagement alternatives.

NRMRL catalyzes the development and commercialapplication of some of the more cost-effective riskmanagement alternatives through joint efforts withpublic and private sector partners, and throughprograms to verify the performance and cost ofinnovative technologies. NRMRL also providestechnology transfer and technical support to riskmanagement stakeholders to encourage improvedrisk management decision-making.

National Center forEnvironmental Research andQuality AssuranceORD’s National Center for Environmental Researchand Quality Assurance (NCERQA) represents amajor and renewed commitment by ORD to helpEPA achieve the highest possible quality of science.In particular, NCERQA has made a majorcommitment to ensure the high quality of ORD’sextramural research by establishing the Science toAchieve Results (STAR) program. The primary

purpose of the STAR program is to access theforemost research scientists from universities andnonprofit centers around the country to meet thespecific science needs of the Agency. STAR consistsof three components—a focused Requests forApplications, an Exploratory Research GrantsProgram, and a Graduate Fellowships Program—all of which are targeted to issues of importance toEPA. All applications to the STAR program mustpass rigorous external peer review by nationalexperts before being considered for funding. Aportion of the STAR program is conducted jointlywith other federal agencies.

In addition to the STAR program, NCERQAmanages the Environmental Research CentersProgram and the Hazardous Substance ResearchCenters and provides managerial oversight of EPA’squality assurance programs.

Office of Resources Managementand Administration The Office of Resources Management andAdministration (ORMA) provides support servicesand leadership to ORD’s Laboratories and Centersin many areas: budgeting, finance, human resources,training, information systems and technology,administrative procedures, health and safety, facilityoperations, and ORD’s equipment and laboratoryinfrastructure. ORMA also serves as the principalstaff office to ORD’s Senior Resource Official. In thiscapacity, ORMA oversees all of ORD’s contractingand assistance activities and conducts independentreviews of ORD Laboratory and Centermanagement to ensure efficient operations insupport of sound science.

Office of Research and ScienceIntegrationORD’s Office of Research and Science Integration(ORSI) is the bridge between ORD and its manyconstituents:

ORSI is the key link between ORD science andEPA policies and regulation. ORSI coordinatesORD input into the policy and regulatorydevelopment process, as well as ORD feedbackon proposed policies and regulations. ORSI also

A p p e n d i x I I


coordinates ORD’s support to EPA’s Program andRegional Offices.

ORSI coordinates EPA’s research planningprocess, working closely with ORD’s NationalLaboratories and Centers and EPA’s Program andRegional Offices to constructively coordinatetheir input into ORD’s research agenda.

Office of Science PolicyORD’s Office of Science Policy administers theprograms of two standing interoffice committees:the Science Policy Council and the Risk Assessment Forum.

The Science Policy Council is an EPAorganization comprising senior EPA sciencemanagers and chaired by EPA’s DeputyAdministrator. Focusing on selected

environmental issues that go beyond programand regional boundaries, the Council developsinformation and policies to guide EPAdecision-makers in their use of scientific andtechnical information.

The Risk Assessment Forum is comprised ofsenior agency scientists who study and developguidance on generic risk assessment issues. TheRisk Assessment Forum program includestechnical analysis and consensus-building on asmall set of selected risk science issues, usuallycontroversial or precedent-setting, that relate toevaluating health and ecological risks.

In addition, the Office of Science Policy isresponsible for supporting ORD’s AssistantAdministrator in selected projects.

A p p e n d i x I I


Appendix III

Management Structure forImplementing ORD’sStrategic Plan

Successful implementation of ORD’s StrategicPlan requires coordinated input andinvolvement by all ORD Laboratories,Centers, and Offices as well as EPA’s

Program and Regional Offices. Several councils andteams, illustrated and described below, providemechanisms for this participation. Collectively, thesegroups involve all levels of ORD senior manage-ment from ORD’s Assistant Administrator throughto ORD’s Assistant Laboratory Directors (see figure).The Research Coordination Council and ORD’sResearch Coordination Teams, described below,provide mechanisms for Program and RegionalOffice involvement. One of the important roles ofthe councils and teams is to assure “upward”communication from the experts in ORD’sLaboratories and Centers.

Executive CouncilORD’s Executive Council is chaired by ORD’sAssistant Administrator and consists of ORD’sDeputy Assistant Administrators for Science andManagement and the Directors of ORD’s NationalLaboratories, Centers, and Offices. The ExecutiveCouncil serves as the primary decision-makingbody for major planning and managementdecisions. Based on input from the Managementand Science Councils, Research CoordinationCouncil, and Research Coordination Teams, theExecutive Council coordinates major policy andbudget issues across ORD, including consensusrecommendations to ORD’s Assistant Administrator.

Management CouncilORD’s Management Council is chaired by ORD’sDeputy Assistant Administrator for Managementand includes the Deputy Assistant Administrator forScience as an ex officio member, the Director ofORD’s Office of Resources Management andAdministration (who serves as the Vice Chair), andthe Deputy Directors for Management of ORD’sLaboratories and Centers. ORD’s ManagementCouncil provides senior management leadership fordeveloping and implementing effective manage-ment policies, procedures, and systems. Forexample, the Management Council is leading thedevelopment of ORD’s Management InformationSystem, a management system to ensure that ORD’sresources are efficiently administered. TheManagement Council also provides input, feedback,and guidance on issues that significantly affectORD’s overall management operations.

Science CouncilORD’s Science Council is chaired by ORD’s DeputyAssistant Administrator for Science and includes theDeputy Assistant Administrator for Management asan ex officio member. Science Council membersprovide a balance between health and ecologicalresearch. They include the Associate Directors forHealth and Ecology of ORD’s National Laboratoriesand Centers, the Associate Director for Science ofORD’s National Center for Environmental Researchand Quality Assurance, and the Director of ORD’sOffice of Research and Science Integration.


Offi

ce o

f Res

ourc

esM

anag

emen

t an

dA

dmin

istra

tion

Dire

ctor

Assis

tant

Adm

inist

rato

r for

Res

earc

h an

d D

evel

opm

ent

Offi

ce o

f Sci

ence

Pol

icy

Dire

ctor

Offi

ce o

f Res

earc

h an

dSc

ienc

e In

tegr

atio

n

Dire

ctor

Nat

iona

l Cen

ter

for

Envi

ronm

enta

l Ass

essm

ent

Dire

ctor

Dep

uty

Dire

ctor

for

Man

agem

ent

Assis

tant

Cen

ter D

irect

ors

for A

ir, W

ater

, Was

te,

Toxi

colo

gy/P

estic

ides

, and

Mul

timed

ia

Nat

iona

l Cen

ter

for

Envi

ronm

enta

l Res

earc

h an

dQ

ualit

y A

ssur

ance

Dire

ctor

Dep

uty

Dire

ctor

Nat

iona

l Risk

Man

agem

ent

Res

earc

h La

bora

tory

Dire

ctor

Dep

uty

Dire

ctor

for

Man

agem

ent

Assis

tant

Lab

orat

ory

Dire

ctor

sfo

r Air,

Wat

er, W

aste

,To

xico

logy

/ Pe

stic

ides

, and

Mul

timed

ia

Man

agem

ent

Co

un

cil

Sci

en

ceC

ou

nci

l

Re

sear

chC

oo

rdin

atio

nT

eam

s

Dep

uty

Assis

tant

Adm

inist

rato

r for

Man

agem

ent

Dep

uty

Assis

tant

Adm

inist

rato

r for

Scie

nce

Ex

ecu

tive

Co

un

cil

Re

sear

chC

oo

rdin

atio

nC

ou

nci

lR

epre

sent

ativ

es fr

om t

heEP

A P

rogr

am a

nd R

egio

nal

Offi

ces

advi

se O

RD

on

rese

arch

nee

ds a

ndpr

iori

ties.

Nat

iona

l Hea

lth a

ndEn

viro

nmen

tal E

ffect

sR

esea

rch

Labo

rato

ry

Dire

ctor

Dep

uty

Dire

ctor

for

Man

agem

ent

Assis

tant

Lab

orat

ory

Dire

ctor

s fo

r Air,

Wat

er,

Was

te, T

oxic

olog

y/Pe

stic

ides

, and

Mul

timed

ia

Asso

ciat

eD

irect

or fo

rH

ealth

Asso

ciat

eD

irect

or fo

rEc

olog

y

Nat

iona

l Exp

osur

eR

esea

rch

Labo

rato

ry

Dire

ctor

Dep

uty

Dire

ctor

for

Man

agem

ent

Assis

tant

Lab

orat

ory

Dire

ctor

s fo

r Air,

Wat

er,

Was

te, T

oxic

olog

y/Pe

stic

ides

, and

Mul

timed

ia

Asso

ciat

eD

irect

or fo

rH

ealth

Asso

ciat

eD

irect

or fo

rEc

olog

y

Asso

ciat

eD

irect

or fo

rH

ealth

Asso

ciat

eD

irect

or fo

rEc

olog

y

Asso

ciat

eD

irect

or fo

rH

ealth

Asso

ciat

eD

irect

or fo

rEc

olog

y

Asso

ciat

eD

irect

or fo

rSc

ienc

e

OR

D M

anag

emen

t St

ruct

ure

A p p e n d i x I I I


The Science Council serves as the principal forumfor identifying, discussing, and providing adviceand recommendations to ORD’s AssistantAdministrator on scientific and technical issues thatsignificantly affect ORD’s overall scientific andtechnical operations. For example, the ScienceCouncil had the lead role in developing ORD’sStrategic Plan and will review all research plans.

Research Coordination CouncilThe Research Coordination Council comprises theAssistant Administrators from key Program Officesand the EPA Regional Administrators, supported ona day-to-day basis by their senior staff. The ResearchCoordination Council serves as a focal point forintegration between ORD and EPA’s Program andRegional offices. The Council provides ORD with across-agency perspective, participates in ORD’splanning process, and recommends potential topicsfor ORD’s research agenda and extramural grantsprogram.

Research Coordination TeamsThe Research Coordination Teams coordinateORD’s research program with ORD’s clients andacross ORD Laboratories and Centers. Organizedby environmental media (air, water, waste,toxics/pesticides, and multimedia), the teamsassess ORD clients’ needs, recommend researchpriorities, monitor ORD progress toward meetingthese priorities, facilitate integration of intramuraland extramural research activities, and ensurecommunication of results to ORD clients. EachResearch Coordination Team includes a TeamLeader from ORD’s Office of Research and ScienceIntegration, the Assistant Laboratory Directors fromORD’s Laboratories and Centers, a program analystfrom ORD’s Office of Resources Management andAdministration, a representative from ORD’sNational Center for Environmental Research andQuality Assurance to provide input on ORD’sgrants program, and representatives from EPA’sProgram and Regional Offices. The ResearchCoordination Teams take the lead in developingORD’s science research plans and in organizing andconducting media-based program reviews of ORDprogress and outputs.

A p p e n d i x I I I


Appendix IV

Relationship of Fiscal Year1996 Requests forApplications (RFA’s) to ORDHigh-Priority Research Topics

Drinkingwaterdisinfection

Particulatematter inthe air

Endocrinedisruptors

Research toimproveecosystemriskassessment

Research toimprovehealth riskassessment

Pollutionpreventionand newtechnologies

Ecological Assessment,including regionalecosystem protection andrestoration and globalclimate change

✔ ✔

Exposure of Children toPesticides

✔ ✔

Air Quality, includingtropospheric ozone, airtoxics, and indoor air

✔ ✔

Analytical and MonitoringMethods, including fieldanalytical methods,continuous measurementmethods, and leachabilityprediction

✔ ✔ ✔

Drinking Water, includingmicrobial pathogens anddisinfection by-products

✔ ✔


Drinkingwaterdisinfection

Particulatematter inthe air

Endocrinedisruptors

Research toimproveecosystemriskassessment

Research toimprovehealth riskassessment

Pollutionpreventionand newtechnologies

Environmental Fate andTreatment of Toxics andHazardous Wastes,including fate and mobilityof contaminants in salts andground water and theassessment of risks ofcontaminated soils andtreatment residuals

✔ ✔ ✔

Environmental Statistics ✔ ✔ ✔

High PerformanceComputing

✔ ✔ ✔

Risk-based Decisions forContaminated Sediments

✔ ✔ ✔

Endocrine Disruptors ✔ ✔ ✔

Role of InterindividualVariability in HumanSusceptibility to Cancer

✔

Water and Watersheds ✔ ✔

Technology for aSustainable Environment,including green chemistry

✔ ✔ ✔

Decision-making andValuation forEnvironmental Policy

✔

Bioremediation ✔ ✔

A p p e n d i x I V


Recommended Action ORD Response

EPA should take steps to improve sciencequality and enhance peer review.c,i

We instituted standard operating procedures for peer review in 1994.

To engage the nation’s best research institutions, we expanded our program forextramural research grants selected from competitive, peer-reviewed proposals.

We created a Peer Review Division in our National Center for Environmental Researchand Quality Assurance.

ORD needs a coherent research-planningprocess, a robust mission statement, and avision statement.c,d,i,j

We developed the ORD Strategic Plan (this document) and distributed it for commentin November 1995.

We implemented a risk-based research planning process.

We realigned ORD’s organizational structure to use risk assessment and riskmanagement as principal priority-setting criteria.

ORD should enhance environmentaleducation programs for training the nextgeneration of scientists.a,d,e

We initiated an expanded graduate fellowship program initiated, with 100 awards in1995.

ORD should streamline its existinglaboratory organization by collapsing thetwelve laboratories into four nationallaboratories.d,f,h

We consolidated ORD laboratories into three national laboratories and two centers in1995 to align laboratories according to risk assessment and risk managementcomponents.

ORD should improve its managementsystems to track planning resources andaccomplishments.g,h

We are developing the ORD Management Information System to track resources andprojects on an ORD-wide basis.

We established a Management Council, a Science Council, and (together with theprogram offices and regions) a Research Coordination Council (see Appendix C of thisStrategic Plan).

We will conduct annual research program reviews to evaluate the status andaccomplishments of our research.

We are developing research plans to inform internal and external audiences about thepolicy relevance, specific objectives, technical approaches, and expected products of ourresearch.

ORD should balance short-term andlong-term research.a,e,g,j

In 1995, we created the Science To Achieve Results (STAR) Program of peer-reviewedinvestigator-initiated grants relevant to ORD’s mission.

As described in this Strategic Plan, we give equal consideration to short- and long-termresearch needs in our priority-setting process.

ORD should balance health and ecologicalresearch.a,c

We have adopted a balance between ecological risks and human health risks as a majorstrategic principle (see Table 1 of this Strategic Plan).

We appointed Laboratory Associate Directors for Health and Ecology for each nationallaboratory.

EPA should designate ORD’s AssistantAdministrator (AA/ORD) as the Agency’sChief Scientific Officer.j

The EPA Deputy Administrator appointed the AA/ORD as EPA’s Scientific andTechnical Activities Planner in March 1995.

EPA must improve its capability toanticipate environmental problems.a-c

EPA signed an agreement in 1995 with the National Research Council to establish agroup to review environmental issues for the next decade and recommend necessaryresearch.

aFuture Risk: Research Strategies for the 1990s. U.S. EPA, Science Advisory Board. 1988.bReducing Risks: Setting Priorities and Strategies for Environmental Protection. U.S. EPA, Science Advisory Board. 1990.cSafeguarding the Future: Credible Science, Credible Decisions. Report of the Expert Panel on the Role of Science at EPA. U.S. EPA. 1992.dEnvironmental Research and Development: Strengthen the Federal Infrastructure. The Carnegie Commission. 1992.eResearch to Protect, Restore, and Manage the Environment. National Research Council. 1993.fAssessment of the Scientific and Technical Laboratories and Facilities of the U.S. EPA. MITRE Corporation. May 1994.gAn SAB Report: Review of the MITRE Corp. Draft Report on the EPA Laboratory Study. U.S. EPA, Science Advisory Board/Research Strategy Advisory Council. May 1994.hA Review, Evaluation and Critique of a Study of EPA Laboratories by the MITRE Corporation and Additional Commentary on EPA Science and Technology Programs. National Academy of Public Administration. June 1994.iSetting Priorities, Getting Results: A New Direction for EPA. National Academy of Public Administration. April 1995.jInterim Report of the Committee on Research and Peer Review in EPA. National Research Council. March 1995.

ORD Response to Blue-Ribbon Panel Recommendations

Strategic Plan for the Office of Research and Development ... · 1EPA Strategic Plan for the Office...

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