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HEA L TH E FF E CTS I N STI T U T E HEI STRATEGIC PLAN FOR UNDERSTANDING HEALTH EFFECTS OF AIR POLLUTION 2005–2010 April 2005 Charlestown Navy Yard 120 Second Avenue Boston MA 02129-4533 USA +1-617-886-9330 www.healtheffects.org

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Page 1: H E A L T H

H E A L T HE F F E CTSINSTITUTE

HEI STRATEGIC PLAN

FOR UNDERSTANDING HEALTH

EFFECTS OF AIR POLLUTION

2005–2010

April 2005

H E A L T HE F F E CTSINSTITUTE

Charlestown Navy Yard

120 Second Avenue

Boston MA 02129-4533 USA

+1-617-886-9330

www.healtheffects.org

Page 2: H E A L T H

The Health Effects Institute was chartered in 1980 as an

independent and unbiased research organization to provide

high quality, impartial, and relevant science on the health

effects of air pollution. All results are provided to industry

and government sponsors, other key decisionmakers, the

scientific community, and the public. HEI funds research

on all major pollutants, including air toxics, diesel exhaust,

nitrogen oxides, ozone, and particulate matter. The Institute

periodically engages in special review and evaluation of key

questions in science that are highly relevant to the regulatory

process. To date, HEI has supported more than 220 projects

at institutions in North America, Europe, and Asia and has

published over 160 Research Reports and Special Reports.

Typically, HEI receives half of its core funds from the

US Environmental Protection Agency and half from 28

worldwide manufacturers and marketers of motor vehicles

and engines who do business in the United States. Other

public and private organizations periodically support special

projects or certain research programs. Regardless of funding

sources, HEI exercises complete autonomy in setting its

research priorities and in reaching its conclusions.

An independent Board of Directors governs HEI. The

Institute’s Health Research Committee develops HEI’s five-

year Strategic Plan and initiates and oversees HEI-funded

research. The Health Review Committee independently

reviews all HEI research and provides a Commentary

on the work’s scientific quality and regulatory relevance.

Both Committees draw distinguished scientists who

are independent of sponsors and bring wide-ranging

multidisciplinary expertise.

The results of each project and its Commentary are

communicated widely through HEI’s home page, Annual

Conference, publications, and presentations to professional

societies, legislative bodies, and public agencies.

Daniel S Greenbaum President

Robert M O’Keefe Vice President

Jane Warren Director of Science

Sally Edwards Director of Publications

Jacqueline C Rutledge Director of Finance and Administration

Deneen Howell Corporate Secretary

Cristina I Cann Staff Scientist

Aaron J Cohen Principal Scientist

Maria G Costantini Principal Scientist

Wei Huang Staff Scientist

Debra A Kaden Principal Scientist

Sumi Mehta Staff Scientist

Geoffrey H Sunshine Senior Scientist

Annemoon MM van Erp Senior Scientist

Terésa Fasulo Science Administration Manager

L Virgi Hepner Senior Science Editor

Jenny Lamont Science Editor

Francine Marmenout Senior Executive Assistant

Teresina McGuire Accounting Assistant

Kasey L Oliver Administrative Assistant

Robert A Shavers Operations Manager

Mark J Utell ChairProfessor of Medicine and Environmental Medicine, University of Rochester

Melvyn C BranchJoseph Negler Professor of Engineering, Mechanical Engineering Department, University of Colorado

Kenneth L DemerjianProfessor and Director, Atmospheric Sciences Research Center, Universityat Albany, State University of New York

Peter B FarmerProfessor of Biochemistry, Cancer Studies, and Molecular Medicine,University of Leicester

Helmut GreimProfessor, Institute of Toxicology and Environmental Hygiene, Technical University of Munich

Rogene HendersonSenior Scientist Emeritus, Lovelace Respiratory Research Institute

Stephen I RennardLarson Professor, Department of Internal Medicine, University of Nebraska Medical Center

Howard RocketteProfessor and Chair, Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh

Jonathan M SametProfessor and Chairman, Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University

Ira TagerProfessor of Epidemiology, School of Public Health, University of California, Berkeley

HEALTH RESEARCH COMMITTEE

BOARD OF DIRECTORSRichard F Celeste ChairPresident, Colorado College

Purnell W ChoppinPresident Emeritus, Howard Hughes Medical Institute

Jared L CohonPresident, Carnegie Mellon University

Alice HuangSenior Councilor for External Relations, California Institute of Technology

Gowher RizviDirector, Ash Institute for Democratic Governance and Innovations, Harvard University

Richard B StewartUniversity Professor, New York University School of Law, and Director, New York University Center on Environmental and Land Use Law

Robert M WhitePresident (Emeritus), National Academy of Engineering, and Senior Fellow, University Corporation for Atmospheric Research

Archibald Cox Founding Chair, 1980–2001

Donald Kennedy Vice Chair EmeritusEditor-in-Chief, Science; President (Emeritus) and Bing Professor of Biological Sciences, Stanford University

HEALTH REVIEW COMMITTEEDaniel C Tosteson ChairProfessor of Cell Biology, Dean Emeritus, Harvard Medical School

Ross AndersonProfessor and Head, Department of Public Health Sciences, St George’s Hospital Medical School, London University

John R HoidalProfessor of Medicine and Chief of Pulmonary/Critical Medicine, University of Utah

Thomas W KenslerProfessor, Division of Toxicological Sciences, Department of Environmental Sciences, Johns Hopkins University

Brian LeadererProfessor, Department of Epidemiology and Public Health, Yale University School of Medicine

Edo D PellizzariVice President for Analytical and Chemical Sciences, Research Triangle Institute

Nancy ReidUniversity Professor, University of Toronto

William N RomProfessor of Medicine and Environmental Medicine and Chief of Pulmonary and Critical Care Medicine, New York University Medical Center

Sverre VedalProfessor, Department of Environmental and Occupational Health Sciences, University of Washington

OFFICERS & STAFF

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Health Effects Institute Strategic Plan © 2005

PREFACE

We are pleased to provide you with this copy of the HEIStrategic Plan for Understanding Health Effects of Air Pol-lution 2005–2010. Since we published our first plan in1994, we have come a long way in our quest to providehigh-quality, independent, impartial, and timely science toinform public and private decisions about cleaning the airwe breathe.

Over the next five years, HEI will pursue four priorityareas that have emerged from initiatives launched in the2000–2005 Strategic Plan. All the while, we will strive toinfuse innovation and validation in everything we do, bybringing the latest genomics, proteomics, and statisticaltechniques to our work and continuing to pioneer in Web-based access to data from our studies.

Health Effects of Air Pollution Mixture. HEI will com-plete existing projects and build new initiatives that takean increasingly integrated approach.

• PM and Gases We will launch a systematic, multidis-ciplinary program to examine and compare toxicity of PM components, gases, and sources; and conduct an expert review of scientific literature of health effects of exposure to traffic.

• Air Toxics We will synthesize current scientific knowl-edge on exposure to and health effects of major mobile-source air toxics; and study population exposure to and health effects of air toxics in potential hot spots (areas likely to have high levels of some air toxics).

• Health Effects of the Mixture We will also produce an expert monograph on innovative approaches to study-ing health effects of the air pollution mixture.

Emerging Technologies. In keeping with our long-standing mission to track and assess health consequencesof emerging technologies and fuels, HEI will conduct peri-odic reviews of the current knowledge of key technologiesand will launch the Advanced Collaborative EmissionsStudy (ACES) to characterize emissions and possiblehealth effects of heavy-duty diesel technologies and fuelsdesigned to meet stringent particulate matter and nitrogenoxides emission standards.

Assessing the Public Health Impact of Air QualityActions (accountability). Building on HEI Communication11 (the accountability monograph), we will support thedevelopment of a sustainable public health tracking net-work by state public health agencies and the US Centersfor Disease Control and Prevention; and conduct majornew research and methods development to assess the long-term and short-term public health impacts of domestic airquality actions.

Enhanced International Perspective. HEI will continueits modest but sustainable program in international sci-ence. We will apply the best science from throughout theworld to inform US decisions; continue the PAPA programto build the capacity of Asian scientists in conductinglocal health effects studies to inform decisions; and con-duct limited capacity building with health scientists inother parts of the world.

HEI will also attempt to integrate into its programs cer-tain cross-cutting issues, especially health effects of airpollution on elderly people and children.

We are grateful to many for their ideas and activeinvolvement in the development of this Strategic Plan: toHEI’s sponsors and other stakeholders, to HEI’s HealthResearch and Review Committees, and to HEI staff.

With your help and the continued interest of our spon-sors, we look forward to the coming years of accomplish-ment as we refine and focus our efforts to answer keyquestions of air pollution and health with timely and rele-vant science.

Sincerely,

Dick CelesteChair

Dan GreenbaumPresident

To Our Readers:

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CONTENTS

HEI Strategic Plan for Understanding Health Effects of Air Pollution 2005–2010

Health Effects Institute . . . . . . . . . . . . . . . . . . . . . . . . 1Mission and Goals . . . . . . . . . . . . . . . . . . . . . . . . . . 1Constituents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1Funding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Progress: HEI Strategic Plan 2000–2005 . . . . . . . . . 4Content . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Accomplishments. . . . . . . . . . . . . . . . . . . . . . . . . . . 4HEI’s Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Envisioning the Future: A Research Strategy to Meet Emerging Needs . . . . . . . . . . . . . . . . . . . . . . . . 8

Air Pollution Trends and Policy Issues . . . . . . . . . 9Trends in Knowledge and Technology . . . . . . . . . 9Informing the Increasingly Global Debate . . . . 10

Choosing the Future . . . . . . . . . . . . . . . . . . . . . . . . .10What Does HEI’s Strategic Plan 2005–2010

Address? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12What Does HEI’s Strategic Plan 2005–2010

NOT Address? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Major Research Opportunities 2005–2010. . . . . . 12Innovation and Validation . . . . . . . . . . . . . . . . . . 12Priority Research and Review Topics . . . . . . . . . 13

Health Effects of Air Pollution Mixture . . . . . 13Emerging Technologies and Fuels . . . . . . . . . 16Assessing the Public Health Impact of Air

Quality Actions (Accountability) . . . . . . . . . 17Enhanced International Perspective . . . . . . . 18Cross-Cutting Issues . . . . . . . . . . . . . . . . . . . . . 18

Implementing the HEI Strategic Plan 2005–2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Innovation and Validation . . . . . . . . . . . . . . . . . . 18Priority Topics and Timetable . . . . . . . . . . . . . . . 18

Health Effects of Air Pollution Mixture . . . . . 20Emerging Technologies. . . . . . . . . . . . . . . . . . . 20Assessing the Public Health Impact of Air

Quality Actions (Accountability) . . . . . . . . . 20Enhanced International Perspective . . . . . . . 20Cross-Cutting Issues . . . . . . . . . . . . . . . . . . . . . 21

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Abbreviations and Other Terms. . . . . . . . . . . . . . . . 21

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Publishing history: This document was posted as a preprint on www.healtheffects.org and then finalized for print.

Citation for whole document:

Health Effects Institute. April 2005. HEI Strategic Plan for Understanding Health Effects of Air Pollution 2005–2010. Health Effects Institute, Boston MA.

When specifying a section of this report, cite it as a chapter of the whole document.

Page 7: H E A L T H

Health Effects Institute Strategic Plan © 2005 1

HEI Strategic Plan for Understanding Health Effects of Air Pollution 2005–2010

HEALTH EFFECTS INSTITUTE

Health Effects Institute is an independent nonprofit cor-poration chartered to conduct and to evaluate research andtesting related to the health effects of air pollution and toprovide the results to the public and interested govern-mental agencies. Since 1980, HEI has provided high-quality science on the health effects of a broad range of airpollutants.

This plan describes the HEI research program andreview activities for assessing the health effects of air pol-lution for 2005 through 2010. We have attempted to iden-tify and anticipate the major questions about the healtheffects of pollutants and new technologies that are likely tobe facing policymakers, industry, and others. In the draftStrategic Plan 2005–2010, we considered a wide range ofchoices for HEI’s activities in coming years. In May 2004,we asked sponsors and others to review the draft. On thebasis of their review, HEI revised the draft plan into anintegrated set of strategies designed to guide the develop-ment of detailed, annual research and review plans. Theseplans will deliver research results on the potential healtheffects of greatest concern in a timely manner.

MISSION AND GOALS

HEI’s mission is to provide public and private decision-makers with independent, unbiased, timely, and high-quality science on health effects of air pollution. HEIaccomplishes its mission by seeking to achieve six prin-cipal goals.

• Identify areas of highest priority for health effectsresearch: those that target pollutants and issues of great-est concern, avoid unnecessary duplication of otherresearch, and respond to the rapidly changing publicand technologic environments.

• Fund and oversee the conduct of high-quality researchin the priority areas, fostering integrated and multiinsti-tute efforts whenever possible.

• Conduct, as needed, intensive reanalyses of studies anddata sets and evaluate methods that are central to impor-tant policy decisions.

• Review HEI-supported and related research andreanalysis. Such review evaluates, summarizes, andimproves the understanding and credibility of results.

• Integrate HEI’s research results with those of otherinstitutions into broad evaluations of the health effectsof a pollutant, fuel, or technology.

• Communicate results of HEI research and analyses topublic and private decisionmakers and the scientificcommunity in an understandable and timely manner.

CONSTITUENTS

HEI’s success depends on cooperation, coordination,and communication among its many constituents. Theseinclude our sponsors in government and industry, the sci-entific community from which we draw investigators,Health Research and Review Committee members, expertpanel members and reviewers, and a broad range ofexternal stakeholders from all levels of government,industry, environmental public interests, and other non-governmental organizations.

HEI’s Board of Directors, president, and senior staff con-sult periodically with sponsors, consider and respond totheir diverse priorities, and then set HEI’s goals andoversee its work. The Board, president, and senior staffalso consider the views of others in the public and privatesectors who have an interest in environmental and healthissues and who are important audiences for HEI’s publica-tions. Without broad stakeholder acceptance of the qualityand independence of HEI’s work, HEI’s effectiveness andimpact would be reduced.

HEI’s sponsors recommend research priorities to HEI onthe basis of projected research needs associated with regula-tory activities, changes in the use of technologies and fuels,and new scientific information that raises concerns. In addi-tion, HEI encourages scientists and others in government,industry, and environmental and health organizations tohelp prioritize HEI research topics and to participate in HEIactivities. Contributions of diverse sponsors and otherstakeholders both in and outside the US will lead to a com-prehensive, broadly relevant strategic plan that stands thebest chance of accurately anticipating emerging questionsabout science and regulation.

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HEI Strategic Plan 2005–2010

The HEI Health Research and Review Committeesselect, oversee, and evaluate the Institute’s scientific activi-ties. These committees are multidisciplinary and are com-prised of distinguished scientists who are knowledgeableabout scientific issues related to studying the health effectsof air pollution. The Research Committee and the Institute’sscientific staff develop and oversee HEI’s research program.The Review Committee, which neither selects nor overseesthe studies, works with other scientific staff members toevaluate and interpret each study. (See Table 1 for a moredetailed description of the research and review processes.)

HEI’s scientific staff is highly qualified and activelyengaged in all scientific activities. Other staff provideexpertise in administration, finance, and scientific pub-lishing. The scientists at universities and research organi-zations who carry out HEI’s selected studies are essentialto the quality of HEI’s research program and its broad con-tent and diverse approaches. HEI uses highly competitivenational and international selection processes. The Insti-tute has thereby attracted a community of scientists whocreate new collaborations and apply fresh approaches toproblems of air pollution and public health.

Ultimately, it is the public whose health is to be protectedby air quality standards and regulatory decisions based inpart on studies funded and reviewed by HEI. Thus thepublic may be our most important constituent of all.

FUNDING

Current Funding

HEI’s annual budget has averaged approximately $8.0million per year over the last five years. During thatperiod, HEI spent approximately 76% on its research pro-gram, an additional 5% on special scientific projects (suchas reanalyses and the diesel epidemiology project), and19% on administrative expenses. Economies of scaleachieved at higher funding levels allow a growing propor-tion of HEI funds to go to extramural research while main-taining appropriate levels of research planning, qualityassurance, and review.

The core of HEI’s annual budget is funded jointly by theUS Environmental Protection Agency (EPA*) and world-wide manufacturers and marketers of motor vehicles andengines that do business in the United States. The motorvehicle industry contribution is shared by 28 US, Euro-pean, and Asian companies according to their vehicle andengine sales in the United States.

HEI has also received support in several areas from avariety of public and private sponsors over the last fiveyears. In government, these include the European Com-mission and the US Federal Highway Administration. Inindustry, these include the chemical industry and theAmerican Petroleum Institute. HEI’s current activities inAsia have received substantial additional support from theUS Agency for International Development, the AsianDevelopment Bank, and the William and Flora HewlettFoundation.

This additional support has allowed HEI to increase thesize of its research program beyond what its annual$7.5 million core budget would allow. Thus, an importantcomponent in the Institute’s strategic planning is to con-siderably increase the size and pace of our research pro-grams on certain pollutants.

HEI expects to use the ongoing strategic planning pro-cess to identify further opportunities for HEI initiativesand broadening of funding support. In addition, HEI willintensify efforts to leverage its core budget with additionalspecial purpose funds and research programs fundedjointly with other institutions. Two recent examples of thekind of collaborations that HEI continues to seek andimplement are its collaborations with the European Com-mission’s Directorate-General for Research (to support theAir Pollution and Health—A Combined European andNorth American Approach, or APHENA, project) and withthe Mickey Leland National Urban Air Toxics ResearchCenter (to support a multicity study of air pollution expo-sure: the Relationships of Indoor, Outdoor, and PersonalAir study). Such collaborations allow both HEI and apartner institution to gain more research and benefits thaneither institution could gain alone.

Future Funding

HEI’s funding base has been, and will likely continue tobe, a blend of core funding provided by long-term sponsorsand program-specific funds provided over three to fiveyears by both existing and new contributors. This combi-nation has enabled HEI to build a stronger, larger researchprogram than core funds alone would allow. The longer-term core funding commitments ensure that HEI’s researchdecisions maintain the independence that guarantees thecredibility of HEI’s research.

HEI faces the challenge of undertaking the major initia-tives outlined in this plan with relatively stable fundingbut increasing research costs. One key aim of the StrategicPlan 2005–2010 is to increase the number of core sponsorsof the highest-priority initiatives. HEI also expects to con-tinue to obtain program-specific funding for research inpriority areas from a wide range of other contributors.* A list of abbreviations and other terms appears at the end of the Strategic

Plan.

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Health Effects Institute

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Table 1. HEI Research and Review Processes

RESEARCH PROCESS

Research Program Development

• Solicit sponsors’ views• Develop information on new research areas• Assess ongoing research by other institutions• Identify critical research needs• Develop Requests for Applications for specific research

objectives and distribute to scientific community

Project Selection

• Ad hoc panel of experts reviews applications• Research Committee evaluates top-ranked

applications for relevance to HEI objectives and contribution to a coherent research program

• Research Committee recommends studies for funding to the Board of Directors

• Board approves evaluation process and recommended studies

• Research Committee requests study modifications as needed (for example, eliminating aspects of low interest or changing exposure concentrations)

Project Oversight

• Science staff organizes workshops to encourage interaction and collaboration among investigators conducting related new studies

• Research Committee reviews progress reports; science staff communicates recommendations to investigators

• Investigators present results and interact with HEI community at HEI annual conference

• Research Committee and other experts conduct site visits at investigators’ institutions

• HEI applies quality assurance program for studies with potential regulatory significance

Final Report

• HEI requires a comprehensive final report at the end of each study

Special Attributes of Research Process

• In-depth external and internal review of proposals

• Research Committee funds extramural research that draws on strengths of scientific community and includes a broad range of studies

• Oversight methods encourage formation of coordinated program with communication and collaboration among investigators

REVIEW PROCESS

Objectives

• Provide critical and impartial evaluation of HEI-funded research

• Ensure credibility of research findings• Place results into scientific and regulatory context• Identify future research opportunities

Process

• External peer reviewers evaluate investigator’s final report

• Review Committee discusses report and recommends revisions

• Investigator submits revised final report• Review Committee and science staff develop Commentary,

which critiques study and interprets findings

• Editorial staff prepares report for publication• Review Committee approves Commentary;

Board approves process• HEI publishes Research Report on website

and in print

Special Attributes of Review Process• In-depth external and internal review• Independence from Research Committee

that selected and monitored research• Results of all HEI-funded work, both positive

and negative, are available to the public• Review Committee’s Commentary on

research and results

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HEI Strategic Plan 2005–2010

PROGRESS: HEI STRATEGIC PLAN 2000–2005

CONTENT

The HEI Strategic Plan for the Health Effects of Air Pol-lution 2000–2005, issued in March 2000, had three majorpriority research topics: the air pollution mixture,assessing the public health impact of regulation and otherair quality actions (accountability), and emerging technol-ogies. An overall theme of the plan, based on the increas-ingly global nature of industry and on the growingknowledge of global air pollution levels and how theyinfluence the US, was an enhanced international perspec-tive in HEI’s work.

Air Pollution Mixture

Polluted air is a complex mixture of vapors, liquids, andsolids that varies greatly across the US and around theworld owing to differences in sources and in weather,topography, and other factors. Because air quality regula-tions usually focus on specific compounds, research hasalso tended to focus on single pollutants. However, dif-ferent pollutants can cause similar responses, sometimesthrough different mechanisms; and two or more pollutantstogether may elicit a response that is additive, more thanadditive, or less than additive. The Strategic Plan 2000–2005 designated three parts of the ambient pollutant mix-ture as priority research topics: PM and gases, air toxics,and diesel exhaust.

Assessing the Public Health Impact of Air Quality Actions (Accountability)

Air pollution regulations and other actions that areintended to improve public health can be complicated toimplement and costly for industry and ultimately for thepublic. Regulators must therefore demonstrate that theinterventions reduce pollution and that those reductionsin turn reduce human exposures and health effects. Manyother factors that can affect public health (such as medicalcare, the economy, and dietary preferences) may change inthe time frame during which air quality regulations orother interventions are implemented, however. HEI’s Stra-tegic Plan 2000–2005 made conducting accountabilitystudies that adequately account for all of the factorsinvolved a priority topic.

Emerging Technologies and Fuels

HEI has been involved since its inception in many activ-ities related to evaluating health effects of fuels, fuel addi-tives, and new technologies. Research and developmentconcerning fuels and technologies has substantially

increased, driven by new air pollution regulations andconcerns about fossil fuel availability and climate change.As a result, the Strategic Plan 2000–2005 identified a moreproactive role for HEI in this area, including formation of anew technology committee to help identify and evaluatekey technologies.

ACCOMPLISHMENTS

Air Pollution Mixture

Over the past five years, HEI has investigated severalaspects of the three mixtures of interest: PM and gases, airtoxics, and diesel exhaust.

PM and Gaseous Pollutants The Strategic Plan 2000–2005 highlighted exposure to and health effects of PM andgases. The plan stated that, over five years, HEI wouldcomplete and review the many PM studies it had underway and would conduct additional PM research followingnew planning on the basis of ongoing PM assessment (inthe EPA’s Criteria Document and in discussions by theClean Air Scientific Advisory Committee). Specifically,HEI would: (1) continue and expand implementation forEPA of the Web inventory of PM research; (2) complete andextend major projects evaluating health effects of PM andgaseous pollutants (eg, the National Morbidity, Mortality,and Air Pollution Study [NMMAPS] and the Particle Epi-demiology Reanalysis Project); (3) complete ongoingstudies of personal exposure, controlled human exposure,and toxicity of the concentrated ambient PM mixture andits components; and (4) initiate, if feasible and with appro-priate partners, epidemiologic investigations of long-termexposure to PM and gaseous pollutants.

In fact, HEI has accomplished all of these goals and hasalso initiated, peer reviewed, and published (in 12 months)a comprehensive set of revised analyses of HEI’s and othermajor time-series studies from North America and Europe.These accomplishments include:

• Research. HEI published some 32 Research Reports andtwo major reanalyses of PM epidemiology; prepared (inpress or in review) an additional 6 Research Reports onexposure assessment, PM components, and susceptiblepopulations; and initiated 38 pilot and full studies,including studies of long-term effects and the APHENAstudy (cosponsored by the European Commission).

• HEI Perspectives. HEI published the first two HEI Per-spectives, which summarize HEI and other research:Airborne Particles and Health: HEI Epidemiologic Evi-dence (June 2001) and Understanding the Health Effectsof Components of the Particulate Matter Mix: Progressand Next Steps (April 2002).

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Health Effects Institute

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• Web access. HEI expanded and updated the PMResearch Activities database (www.pmra.org) to includeall federal as well as other research projects; and sup-ported the launch of the first Web-accessible database ofair pollution, health, and weather through the InternetHealth and Air Pollution Surveillance System at theJohns Hopkins Bloomberg School of Public Health(www.ihapss.jhsph.edu).

• PM components and sources. HEI initiated detailedplanning for a systematic approach to examine the con-tributions to toxicity of different PM components, gases,and sources.

Air Toxics The overall goal of HEI’s air toxics researchprogram over the past decade has been to provide informa-tion that will reduce uncertainties in evaluating humanhealth risks associated with exposure to air toxics. The HEIStrategic Plan for Health Effects of Air Pollution 2000–2005presented three goals for HEI’s air toxics program: (1) buildon ongoing air toxics research on benzene, 1,3-butadiene,and aldehydes; (2) convene a workshop on research needsand identify priorities for new air toxics research; and(3) initiate priority research. HEI has made progress onfour key topics:

• Benzene and 1,3-butadiene. For these two importantcompounds, HEI published seven reports related to thedevelopment of biomarkers of exposure and effects. HEIthen funded and published validation studies of putativebiomarkers of benzene and 1,3-butadiene in workersexposed in China and the Czech Republic, as well asadditional toxicology and epidemiology studies.

• Aldehydes and other carbonyl compounds. HEI pur-sued a research program to fill a key knowledge gap—exposure to aldehydes—including studies to examineenvironmental concentrations of various aldehydes andother carbonyls and a multicity study to examine per-sonal, ambient, and indoor exposures.

• Metals. HEI funded several studies of metals, includingstudies focusing on metals as components of PM, themovement of manganese (part of a fuel additive) acrossthe blood–brain barrier in rats, and exposure to noncom-bustion metals from vehicles.

• Mixtures of mobile-source air toxics. After holding aworkshop on research needs for air toxics in spring2001, five new air toxics studies have been initiated toassess ambient concentrations and personal exposure tomobile-source air toxics in areas or situations in whichsome air toxics concentrations are likely to be elevated(hot spots).

Diesel Exhaust HEI has had a long-term interest in thehealth effects of diesel exhaust. The Strategic Plan 2000–2005 stated three objectives for diesel exhaust research:(1) complete and review feasibility studies undertaken aspart of the Diesel Epidemiology Planning Project;(2) launch, if feasible and with appropriate funding, a majornew investigation of cancer and other long-term effects ofexposure to diesel exhaust at near-ambient levels; and (3)initiate new studies on acute noncancer effects of exposureto diesel exhaust, placing them in the context of other com-ponents of the air pollution mixture. HEI has pursued anumber of targeted diesel effects studies (see HEI ProgramSummary, Research on Diesel Exhaust and Other Particles,October 2003). We have also instituted two major programs:

• Improving information for diesel risk assessment. TheHEI Diesel Epidemiology Working Group reviewedreports from six feasibility studies funded to provideinformation about potential epidemiologic studies. TheGroup also developed a new research agenda to seekbetter information for quantitative risk assessment forlung cancer and other chronic diseases. In a SpecialReport, Research Directions to Improve Estimates ofHuman Exposure and Risk from Diesel Exhaust (April2002), the Group proposed a number of short-, medium-,and long-term activities that will substantially improvequantitative estimates of risk. The results of an HEIDecember 2002 workshop were published in Communi-cation 10, Improving Estimates of Diesel and OtherEmissions for Epidemiologic Studies.

• Studies of exposure to diesel exhaust and exacerbationof asthma. Although most attention regarding dieselexhaust has focused on cancer, emerging data on acuteeffects need to be understood better and should beaddressed in further research. In December 2000, HEIissued a Request for Applications (RFA) seeking researchon the “Effects of Diesel Exhaust and Other Particles onthe Exacerbation of Asthma and Other Allergic Diseases.”Studies funded include:

a human controlled-exposure study;

a study in rats to compare the effects of ambient par-ticles and whole diesel exhaust; and

a panel study of people with asthma.

Emerging Technologies and Fuels

Although since its inception HEI has been involved inmany activities related to evaluating health effects of fuels,fuel additives, and new technologies, the Strategic Plan2000–2005 laid out a more proactive role in this area. Theplan noted that HEI is interested in expanding into twoareas: (1) health research and testing related to changes in

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HEI Strategic Plan 2005–2010

emissions caused by use of new fuels and technologies and(2) comprehensive comparative assessments of alternativetechnologic approaches to decreasing emissions of toxicpollutants and greenhouse gases. Specific HEI activitieshave included:

• New technology committee. The HEI Special Committeeon Emerging Technologies (SCET) was formed to helpHEI forecast use of emerging fuels and technologies andto inform the Research Committee about possible healtheffects issues related to their use. SCET developed andpublished on its website matrices of timing, likelihood,and health effects information in two areas: (1) newfuels and the feedstocks from which they derive; and (2)advances in diesel technology under rapid developmentto meet new heavy-duty diesel emission standards thatwill go into effect in 2007 and 2010.

• Research and reports. During the past five years HEIpublished key reports on several fuel-related issues: themetabolism of methyl tert-butyl ether and other ethersused as oxygenate fuel additives; movement of manga-nese, a component of the fuel additive methylcyclo-pen-tadienyl manganese tricarbonyl (MMT), into and out ofthe brain; and cerium, an additive used in conjunctionwith particulate filters on diesel engines (Communica-tion 9, Evaluation of Human Health Risk from CeriumAdded to Diesel Fuel, August 2001).

• Advanced Collaborative Emissions Study (ACES). Plan-ning for this major effort was initiated over the past twoyears. ACES provides an opportunity to comprehen-sively evaluate new diesel technologies with muchlower emissions before they are in widespread use, todocument improvements in emissions and effects and todetect possible inadvertent adverse effects. The Coordi-nating Research Council is responsible for emissionscharacterization in ACES; HEI is responsible for healtheffects testing as well as report writing and review.

Assessing the Public Health Impact of Air Quality Actions (Accountability)

Assessing the extent to which air quality regulationsand other actions are delivering the protections to publichealth that they were intended to provide (accountability)was a major component of the HEI Strategic Plan 2000–2005. On the basis of the plan, we embarked on a programthat included focused research planning and newlyfunded research:

• Research planning. In 2003 HEI published an expertmonograph, Communication 11, Assessing HealthImpact of Air Quality Regulations: Concepts and Meth-ods for Accountability Research. Communication 11

seeks to rigorously define terms of reference in account-ability assessment, identify scientific methods to guideresearch, and most importantly to recommend a specificresearch agenda to guide HEI and other organizations.Communication 11 presents a chain of accountability asa working model for capturing the breadth of relevantconsiderations when assessing accountability, including:(1) Were source control technologies developed andimplemented? (2) Did pollutant concentration levelsdecline? (3) Have human exposure and dose declined?(4) Have human health endpoints shown improvementas a result?

The monograph provides the basis for ongoing researchefforts funded by HEI and focused on the latter part ofthe chain of accountability: exposure to dose to health.

• Research. Since launching the accountability initiative,HEI has issued several RFAs for accountability studies.We also sought to extend our research program by estab-lishing a Request for Preliminary Applications processto uncover new, possibly time-sensitive research pro-posals. The result includes several studies currentlyunder way and continued efforts to identify (1) multi-disciplinary teams for comprehensive assessments ofthe effects of long-term interventions; (2) research todevelop the methods necessary to track changes inexposure and health (and concomitant changes in otherfactors); and (3) ways to increase links betweenresearchers and state and federal public health agencieswho are building public health tracking systems.

Enhanced International Perspective

For its Strategic Plan 2000–2005, HEI was encouragedby sponsors to take an increasingly international perspec-tive in conducting, disseminating, and integrating theresults of its research in key international forums. Thissuggestion reflected the increasingly global nature of theair pollution debate, the growing scientific knowledgeabout global transport of air pollutants, and the fact thatmany HEI sponsors are companies and environmental reg-ulators with international interests and challenges thatwould benefit from greater use of high-quality science. Overthe last five years, HEI has increased the scope of its interna-tional involvement, and its sponsor base to support theseefforts, while still focusing most of its activities in the US.At each step, we have evaluated the relevance of our activi-ties to domestic needs and to health science more broadly.

To date, through this approach, HEI has systematicallyincreased its access to the broadest pool of qualified inves-tigators, thus increasing the quality and cost effectivenessof funded research that is relevant to decisions in NorthAmerica; established regular contacts with sponsors and

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decisionmakers in Europe, Japan, and Asia in general;increased its involvement in World Health Organization(WHO) and International Agency for Research on Cancerforums; and initiated two major projects:

• APHENA. This project, jointly funded by HEI and theEuropean Commission’s Directorate-General forResearch, has brought together leading investigators fromEurope and North America to conduct joint time-seriesanalyses on separate and combined databases, evaluateand strengthen methods used in time-series analysis (par-ticularly in response to issues raised in HEI’s review ofgeneralized additive model analyses), and better estimateshort-term effects of air pollution on morbidity and mor-tality using the increased power of joint data sets.

• The Public Health and Air Pollution in Asia (PAPA)program has been undertaken in cooperation withClean Air Initiative for Asian Cities (CAI-Asia) andfunded primarily with new support from the US Agencyfor International Development, the Hewlett Foundation,and others. This additional funding has enabled HEI toadd staff dedicated to the program. The PAPA programaims to understand the health effects of air pollution inrepresentative Asian cities. To date, in coordinationwith WHO, EPA’s International Office, and others, it hasreviewed and synthesized existing Asian studies (inSpecial Report 15, Health Effects of Outdoor Air Pollu-tion in Developing Countries of Asia: A LiteratureReview); initiated new studies in eight Asian cities; andbegun scientific capacity building.

HEI’S EFFECTIVENESS

As described above, HEI has initiated and completed alarge number of projects that were undertaken to imple-ment the HEI Strategic Plan 2000–2005. Beyond theseactivities, however, other measures should be examined tomeasure how effective HEI’s work has been in informingboth our scientific and policy audiences. Some questionswe have considered are:

• How many studies did we start and complete over thelast five years in priority areas?

• How well did we disseminate these results in print andthrough the Internet?

• Did the scientific community make use of these studiesin its research?

• Did the policy community make use of these studies ininforming decisions about air quality standards andother actions?

We have tracked several initial measures of effective-ness to begin to address these questions.

Studies Started and Completed

HEI initiated 59 studies of air pollution health and expo-sure over the five years of the 2000–2005 Strategic Planand published 59 Research Reports of HEI-funded studies(Table 2). In addition, eight other documents were pre-pared in several priority areas: a monograph to developaccountability methods and research approaches, threeSpecial Reports and two HEI Perspectives on PM, and aSpecial Report and a Communication on issues related toimproving information for cancer risk assessment.

Study Dissemination

Since its inception, HEI has distributed scientificreports and summaries of those reports (HEI Statements) toa growing list of HEI sponsors, scientists, and interestedparties in government, environmental organizations, andindustry. From 2000 to 2005, HEI has distributed nearly3000 copies of Research Reports and over 17,000 copies ofHEI Statements each year.

The past five years have also marked the first wide-spread distribution of HEI Reports online through www.healtheffects.org. Our website has proved to be an increas-ingly effective means of extending HEI’s reach. Websitedownloads may be the best measure of the value of HEIpublications, because downloading is an active processundertaken by people who think a report is of value. HEIhas seen substantial distribution of its scientific docu-ments via the Web. More than 11,000 research and otherscientific reports are downloaded each year, as well asmore than 4000 HEI Statements, Program Summaries, andother, shorter summaries of HEI’s work.

Citation of HEI Reports in the Scientific Literature

Another measure of HEI’s impact is the extent to whichthe scientific community reads and uses its scientific

Table 2. Numbers of HEI Studies and Publications 2000–2005

TopicStudiesInitiated

ReportsUnder Review

Research Reports

Published

Other Science

Publications

Accountability 3 0 0 1 Air toxics 10 1 13 0Diesel exhaust 7 0 7 2Fuels and fuel additives 0 0 4 1

PM 38 6 32 5Other 1 0 3 0

Total 59 7 59 9

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reports. HEI recently analyzed the extent to which 50 HEIResearch Reports and other scientific publications pub-lished in 2000 through 2004 have been cited in the scien-tific literature. Results of this analysis suggest that HEI’simpact is substantial (Figure 1).

• The HEI reports were cited some 490 times in over 100health and atmospheric science journals.

• Nearly 180 additional peer-reviewed scientific articles,based on HEI-funded research, were published; thosearticles were cited some 1900 times.

• Some older HEI reports (for example, reports about die-sel exhaust and asbestos) continue to be widely cited.

• HEI-funded research reports during this period gener-ated an average of nearly 50 citations per report (cita-tions of the original report or its related journal articles)in over 125 journals, an extraordinarily high number ofcitations for any scientific report.

Role of HEI Reports in Key Decisionmaking Arenas

Beyond HEI’s efforts to better inform the science com-munity about the health effects of air pollution, a centralpart of HEI’s mission has been to ensure that its workinforms key decisionmaking actions at the state, federal,and international levels. From 2000 to 2005, HEI scientificresults have been presented in many key forums, and sev-eral HEI efforts have been central to important decisionsabout air quality standards. These presentations andefforts have included:

• Frequent testimony and presentations before Congress,the Clean Air Scientific Advisory Committee, and theCalifornia Air Resources Board on health effects of PMand diesel.

• A central role for the results of the HEI reanalysis of theHarvard Six Cities and American Cancer Society studies

(Krewski et al 2000) in the regulatory impact analysis forthe EPA 2007 Highway Diesel rule and in WHO develop-ment of Europe and worldwide Air Quality Guidelines;and

• Numerous contributions on dosimetry, animal andhuman effects, and improving the quantification of riskcited in the EPA’s Health Assessment Document for Die-sel Exhaust (2002).

One additional measure of HEI’s impact on decision-making is that HEI studies are increasingly cited in keyregulatory scientific documents. For example, HEIResearch Reports are far more widely cited in the integra-tive synthesis of the EPA Criteria Document and in theStaff Paper for PM now than they were in the 1996 ver-sions of these documents (Figure 2).

ENVISIONING THE FUTURE: A RESEARCH STRATEGY TO MEET EMERGING NEEDS

Key to the success of the HEI Strategic Plan for Under-standing Health Effects of Air Pollution 2005–2010 will bethe Institute’s ability to anticipate major trends in air pol-lution policymaking and science and then to designresearch and other scientific programs for meeting theneeds that emerge from those trends. While decision-makers often focus on the decisions they face over the nexttwo to three years, experience has shown that both majorpolicy changes and scientific understanding occur overlonger cycles. As initial scientific results are reported, ini-tial decisions are made; then as science matures, decisionsare revisited and refined over 5, 10, or more years.

Figure 1. Citations of HEI reports (published in 2000–2004) and accom-panying journal articles in the scientific literature.

Figure 2. Citations of HEI Research Reports in EPA documents. For thePM Criteria Document integrated synthesis, we compared the 1996 ver-sion (EPA 1996a) and the 2004 version (EPA 2004). For the PM StaffPaper, we compared the 1996 version (EPA 1996b) and the 2003 draftversion (EPA 2003).

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To ensure that HEI’s scientific contributions are astimely and relevant as possible, we must identify thesemajor trends and use them to guide strategic planning forboth the short and long term. Of course, because no effortto forecast the future is perfect, any strategic plan must beable to be adjusted to trends as they actually emerge. Atany given point, major trends can be identified that are notonly current but are likely to last for some time into thefuture and to be major enough to affect scientific needs andopportunities.

Over the past 30 years, the science and regulation of airpollution have evolved and changed. As air pollutants ofconcern (eg, ozone and carbon monoxide) were identifiedthrough scientific research, measures were taken to reducetheir ambient levels. Continuing research identifiedwhether society had achieved a level of air quality suffi-cient to protect public health or whether further regulationwas necessary. Looking forward, one can identify severalmajor issues and trends that are likely to shape science andpublic debate for the next several decades. At the sametime, several emerging trends in scientific knowledge andtechnology will shape the type of science that can be doneto inform that debate.

AIR POLLUTION TRENDS AND POLICY ISSUES

Major Future Policy Challenges

Recently, the National Research Council (NRC) Com-mittee on Air Quality Management in the United Statesissued a report of its three-year investigation into pastaccomplishments and future challenges for air quality(NRC 2004a). That report, while concluding that muchprogress had been made over the last three decades in theUnited States, identified seven major challenges facing airquality management in coming years:

• New ozone and PM standards.

• Toxic air pollutants.

• Health effects at low pollutant concentrations.

• Environmental justice.

• Protecting ecosystem health.

• Multistate, cross-border, and intercontinental transport.

• Air quality management and climate change.

These challenges identify broad and daunting tasks forthe entire research and air quality management commu-nity, far beyond the scope of what an organization like HEIcan contribute. Within the challenges, however, are anumber of specific areas where targeted work by HEI onhuman exposure and health effects may be able to make adifference in future decisions.

Near-Term Regulatory Initiatives

Future challenges are further amplified by a series of newregulatory initiatives moving forward around the world:

• In the US: continued review of the US National AmbientAir Quality Standards (NAAQS) for PM and other pol-lutants; initial steps on state implementation plans;implementation of existing regulations for diesel fueland new on-road and nonroad technology; proposedinterstate regulations for sulfur dioxide, nitrogen diox-ide, and mercury; pending regulations for mobile-sourceair toxics; and others.

• In Europe: completion of the WHO–Europe review ofexisting science and input of that review into the CleanAir for Europe (CAFÉ) program to identify new inte-grated standards for air quality; proposed Euro 5 stan-dards for vehicles; proposals for chemical testing; andother major initiatives.

• In Asia: active development of new fuel quality andauto emissions standards in most Asian countries;efforts to develop active retrofit programs for high-pol-luting older vehicles; and proposals for use of fuel addi-tives to replace lead; among others.

In each of these cases, HEI will need to track emergingdevelopments, identify key decisions that its science onhuman exposure and health could most effectively inform,and monitor emerging technologies in order to assess theirlikely benefits and any issues that arise.

TRENDS IN KNOWLEDGE AND TECHNOLOGY

A number of emerging changes that were cited in theHEI Strategic Plan 2000–2005 posed both opportunitiesand challenges for HEI’s scientific activities: new knowl-edge about the human genome, dramatic improvements inlarge-scale data processing, and rapidly expanding andimproving information about air quality monitoring. Morerecently, the NRC Committee on Research Priorities forAirborne Particulate Matter published its final report onthe national PM research program. In that report, it identi-fied several key scientific challenges for the future that arerelevant to HEI’s strategic planning for 2005–2010 (NRC2004b). These include:

• Developing a systematic program to assess toxicity ofdifferent components of the PM mixture. Answeringkey questions concerning the hazardous components ofPM will require a carefully coordinated, long-term mul-tidisciplinary research effort that goes well beyond worknow under way.

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• Enhancing air quality monitoring for research. Meetingkey PM research priorities will require a shift in the cur-rent air monitoring paradigm from primarily assessingcompliance with the NAAQS toward serving multiplepurposes, such as air quality forecasting, episode alerts,exposure characterization in populations at high risk,health studies, atmospheric process studies, evaluatingemission-source zones of influence, and assessing long-term effectiveness of control strategies.

• Investigating health effects of long-term exposure to airpollution. Long-term epidemiologic studies are likely toremain central to assessing the public health burdencaused by air pollution.

• Improved toxicologic approaches. The Committee rec-ognized the need for complementary epidemiologic andtoxicologic studies and enhanced toxicologic approachesto take advantage of emerging genomics and other tech-niques.

• From a PM research program to a multipollutantresearch program. Another challenge lies in the scien-tifically artificial separation of research on PM fromresearch on air pollution generally.

• Integrating across disciplines. Expanding multidisci-plinary strategies and programs will be essential toimplementing a multipollutant approach.

As with other challenges for air quality management,these findings by the NRC PM Committee pose a wide rangeof opportunities and challenges for HEI and the broader airquality science community. Some, such as examining tox-icity of components of the PM mixture, fit squarely into thetypes of priorities that HEI should address. Others, such asusing improved toxicologic approaches and integratingacross disciplines, will be integrated into HEI’s planning ascross-cutting issues.

INFORMING THE INCREASINGLY GLOBAL DEBATE

During the past 35 years, nations around the world havemade decisions about emissions controls and testing pro-cedures for air quality. Recently, three trends have madethe issues nations face increasingly global:

• Atmospheric research has found that local contributionsof air pollutants can have global implications.

• Industries that produce products that create pollution—such as vehicles, fuels, and combustion boilers used infactories and electric power plants—are now globalindustries with worldwide manufacturing and market-ing. These industries need to address a variety ofincreasingly complex emissions standards and testingprocedures in different countries and regions.

• The growing sophistication of scientists around theworld has increased the degree to which science createdin many different countries plays a role in air qualitydecisions on an international scale (such as US deci-sions, the WHO’s air quality guidelines, and the Interna-tional Agency for Research on Cancer’s determinationsof carcinogenicity).

These trends, along with increasing international scien-tific collaboration, are making air pollution a globaldebate. To inform that debate with the best scientific infor-mation will require a research program designed to answerquestions posed by different countries and regions in avariety of settings that also interprets research consistentlyacross diverse cultures. Obviously, these and other airquality and scientific trends pose a far-reaching set of chal-lenges and opportunities beyond the reach of any oneresearch institution. However, given the importance ofthese issues, HEI needs to identify those trends and tar-geted opportunities in which its research efforts can cost-effectively meet the needs of its sponsors in the US andothers who constitute our growing sponsorship base.

CHOOSING THE FUTURE

HEI has considered a spectrum of air pollution andbroader issues in developing the 2005–2010 Strategic Plan.A draft plan was distributed for discussion at HEI’s AnnualConference in May 2004. Figure 3 presents the topics dis-cussed in the draft, the process for evaluating them, and thepriority topics chosen for this final plan. The draft plan laidout broad opportunities as well as many narrower topicsrelated to concerns about specific pollutants. It was dis-cussed with representatives from HEI’s EPA and motorvehicle industry sponsors, from the chemical and oilindustry, and from scientific, regulatory, and environmentalcommunities at the Annual Conference. Smaller meetingswere held during summer 2004. The plan was also discussedat meetings of the HEI Board of Directors, Health ResearchCommittee, and Health Review Committee.

HEI received much valuable input in these discussionsand also received written comments. In considering thisinput carefully, HEI staff and committee members addressedseveral criteria in selecting priority topics for the next fiveyears:

• the current state of knowledge about topics of interest,

• their importance for public health and upcoming regula-tory and technology decisions,

• how well they are being addressed by other organiza-tions, and

• the likelihood that scientific work will produce usefulfindings at this time.

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HEI Strategic Plan 2005–2010

WHAT DOES HEI’S STRATEGIC PLAN 2005–2010 ADDRESS?

On the basis of these comments, foreseeable regulatoryand scientific issues, and our criteria, HEI has identifiedfour priority areas for its Strategic Plan (Figure 3):

• Health effects of the air pollution mixture (with a focuson PM and gases and air toxics).

• Emerging technologies (including both reviewing exist-ing exposure and health science on fuels and enginesand testing the newest technologies).

• Assessing the public health impact of air qualityactions (accountability).

• A modest, sustainable enhanced international perspec-tive.

These activities largely mirror and take the logical nextsteps on the key initiatives of HEI’s 2000–2005 plan. In addi-tion, at the urging of our sponsors and others, HEI will infuseinnovation and validation throughout its program to bringinto the mainstream of health risk research the latestemerging molecular biology techniques (eg, genomics, pro-teomics) and to continuously identify, validate, and improvestate-of-the-art statistical techniques for epidemiology.

WHAT DOES HEI’S STRATEGIC PLAN 2005–2010 NOT ADDRESS?

Inevitably, HEI must make choices about where to focusits efforts and where to not invest resources. One majortopic considered in the draft plan (Figure 3), health effectsof climate change, was given lower priority than theothers. Commenters with diverse interests consistentlyexpressed the view that, although this issue is important,HEI should focus its attention and resources on higher-pri-ority air pollution issues while monitoring research on cli-mate change. These commenters did, however, stronglysupport a role for HEI in assessing health effects of newfuels and technologies that are being developed to addressconcerns about emissions of greenhouse gases.

The Institute made several other choices for this plan aswell:

• Outside of its emerging technologies work, HEI will notpursue major new studies solely aimed at exposure toand health effects of diesel exhaust. Rather, it expects toaddress these in the context of its broader examinationof toxicity of PM and gaseous components and sources.

• In light of the recent NRC recommendation for a morecomprehensive inventory of all PM research results aswell as studies (NRC 2004b), HEI will cease to maintainthe PM Research Activities Database but will work with

EPA to transition that inventory to a new, broader data-base as envisioned by NRC.

• Of the long list of possible special reviews identified inthe draft plan, HEI will focus on a subset: air toxics, traf-fic and health, PM, and selected emerging fuel additivesand technologies.

• HEI’s plan now identifies health effects on reproduc-tion and development and on sensitive subpopulationsas cross-cutting issues that may be addressed whilepursuing priority topics, rather than as separate priorityinitiatives.

The next sections describe the rationale for selecting thepriority topics and how HEI will address them, as well asthe timetable for implementation.

MAJOR RESEARCH OPPORTUNITIES 2005–2010

Several substantial projects and research programs cur-rently under way are being continued in the Strategic Plan2005–2010. HEI will focus these initiatives on the topics towhich we can best contribute and on bringing HEI’s capa-bilities in innovation and validation into every aspect ofour work.

INNOVATION AND VALIDATION

HEI’s mission is to provide high-quality science that isreviewed, interpreted, and communicated thoughtfullyand completely so that the best information is available forregulatory and other decisionmaking. An important aspectof quality science is to seek out new methods, both experi-mental and statistical, to design better, more informativestudies. Several examples of ways in which HEI’s work canbe enhanced by using new methods and improving andvalidating current methods are summarized below.

Innovative Techniques

HEI has sought to develop a community of scientistswho can generate new collaborations and fresh approachesto air pollution problems, to attract scientists from otherfields who could bring innovative methods to the study ofair pollution, and then to subject those approaches to rig-orous analysis and review to ensure they are appliedthoughtfully. Under this strategic plan, we will increaseour efforts to incorporate new methods and types of healthendpoints. One important example is identifying andapplying new genomic, proteomic, and other methods inways that will provide meaningful information about sus-ceptibility to effects of air pollutants and about changes

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relevant to health effects induced by air pollutants. Wewill also strengthen our efforts to encourage investigatorsto collaborate with scientists in other fields so that newmethods appropriate to the questions of interest can bebrought more quickly and successfully into HEI studies.

Improvement in Epidemiology Methods

In May 2003, HEI issued a Special Report on revisedanalyses of nearly 30 time-series epidemiologic studiesalong with Commentaries from a Special Review Panel.Investigators conducted revised and alternative analysesafter HEI and other investigators identified importantquestions about the statistical package that has been usedwidely for time-series analyses of air pollution and health.In their Commentaries, the Panel raised questions aboutpossible continuing confounding of time-series results byfactors (such as weather) that may covary in time with airpollutants. In the APHENA study, investigators from NorthAmerica and Europe are addressing these questions bytesting different statistical approaches and applying themacross 120 US, Canadian, and European cities. A new Spe-cial Panel will rigorously review these new methods andwill prepare a Commentary on how well the investigatorshave addressed confounding. HEI will oversee closely anyfuture time-series studies, as well as other types of epide-miologic studies, to ensure that they adhere to the latest,most effective ways to control for time-covarying factorsand address any remaining issues.

Increased Access to Research Data

HEI has always required that investigators report all oftheir results and has always made data from HEI studiesavailable. In the coming years, HEI will be able to providenot only results but also access to databases and softwarepackages on the Web. In response to widespread interest inthe data and methods used in the NMMAPS project andgrowing calls and requirements for data access, HEIfunded the Internet Health and Air Pollution SurveillanceSystem (IHAPSS) at the Johns Hopkins Bloomberg Schoolof Public Health to build a fully Web-accessible database ofall NMMAPS air pollution, health, and weather data andall programs used to analyze these data. HEI and theNMMAPS investigators brought together a user group ofscientists, government officials, industry, and others toevaluate the website, to consider the value of maintainingand updating its offerings, and to advise its future direc-tions. For other studies of high regulatory relevance thatdraw as broad interest as NMMAPS did, HEI will considerfunding similar website development.

PRIORITY RESEARCH AND REVIEW TOPICS

Health Effects of Air Pollution Mixture

Polluted air is a complex mixture of gaseous, liquid, andsolid components that varies greatly in composition andconcentration across the US and around the world owingto differences in sources, weather, and topography. It alsovaries from day to day and by season within a region. Mostair quality standards regulate specific compounds (exceptPM standards, which regulate a mixture). Because of theregulatory focus on specific compounds or groups of com-pounds, research has also tended to focus on single pollut-ants. However, different pollutants can cause similarresponses, often through different mechanisms. Two ormore pollutants together may elicit biological or healtheffects that are additive, more than additive, or less thanadditive. Current knowledge about these interactions istaken into account in setting the NAAQS, but a more com-prehensive understanding is needed.

Despite a great deal of interest over several decades inunderstanding more about assessing toxicity of mixturesand how to regulate them, little progress has been madebeyond understanding interactions among small numbersof pollutants. HEI has identified two steps toward a betterunderstanding:

• Undertake targeted research programs on PM and gasesand on air toxics, two important mixtures within thebroader air pollution mixture.

• Convene a workshop and an expert working group toexamine and evaluate innovative approaches to conduct-ing research on and regulating health effects of mixturesand to write a monograph on this topic.

PM and Gases A major element of HEI’s research overthe past decade has been investigating health effects of PMand gaseous pollutants. We expect in the near term to com-plete the review and publication of a number of ongoingstudies, to continue to address recently identified method-ologic issues in time-series epidemiology studies, and toincrease access to PM research and data. Most importantly,for 2005–2010 HEI has launched planning initiatives for asystematic approach to assessing the relative toxicity ofcharacteristics and sources of PM along with other parts ofthe ambient air pollution mixture.

Completing, Reviewing, and Communicating Results of HEI Studies In the near term HEI is continuing its work on PMwith 23 studies under way and 6 reports under review.These PM studies cover several major topics: dose andexposure assessment, effects of diesel and other PM on

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allergic responses, initial efforts to measure toxicity of PMcomponents and sources, mechanisms of health effects,and epidemiologic studies of short- and long-term effectsin North America, Europe, and Asia.

Assessing Toxicity of PM Components, Gases,and Sources Building on HEI and other research onmechanisms of PM health effects and PM componentsrelated to toxicity (HEI Perspectives, April 2002), HEI hasbeen developing plans to address more systematically thetoxicity of specific components and characteristics of PM(and ultimately sources of those components). Althoughepidemiologic evidence associates PM with health effects,the components that may cause the greatest effects remainunknown. As initial decisions to reduce overall PM levelsgo forward—decisions based on the premise that all fineparticles are problematic—the need to better understandtoxicity of PM components and gases becomes increasinglyimportant for the long-term agenda to reduce exposure. TheNRC Committee on Research Priorities for Airborne Particu-late Matter (NRC 2004b) and HEI (Strategic Plan 2000–2005)have noted the importance of this area.

Over the past year, an HEI Research Committee WorkingGroup with expertise in epidemiology, toxicology, airquality, and statistics took steps to gather and evaluateinformation needed to design a multisite research programon health effects of PM components. The Group had twomain goals:

• Develop a database of relevant air quality and otherinformation. In February 2003, in order to move rapidlyto meet the health science community’s need for anaccessible and complete source of air quality data, HEIfunded a group to develop a database that will provideinformation useful in designing and conducting epide-miologic and toxicologic studies of health effects of PMcomponents in different regions. These data are air pol-lution data from the EPA PM speciation network andother monitoring stations across the US (maintained bythe EPA and state and local air quality agencies) thatmeasure levels of PM and gaseous pollutants. The dataare being characterized in terms of spatial and temporalvariation and proximity to sources. Other information,such as how to access health and weather data, will beincluded in the database. A Web-accessible databasewill be available in mid 2005.

• Hold a workshop to discuss information and studydesigns. HEI held this workshop in August 2004. Partic-ipants presented and discussed papers on available airpollution and health data and on toxicologic and epide-miologic approaches that could be used in designingmultisite studies.

The Research Committee is now deciding exactly howto frame an RFA for research on toxicity of PM compo-nents, which will be issued in mid 2005. Recognizing thatany scientific advances in this complex area must beattained through collaboration across scientific disci-plines, the Committee is developing plans that will enableinvestigators to have time to put together multidisci-plinary teams involving toxicologists, epidemiologists, airquality experts, statisticians, and other experts to evaluatethe feasibility of testing various hypotheses of interest andto design a sound study. The RFA is likely to allow appli-cations for a pilot study or a full study because some scien-tists may be ready to design a full study and others mayneed time to develop a team, evaluate air quality and otherinformation to determine what hypotheses of interest maybe testable at this time, and design a study. A second RFA,expected to be issued approximately 1.5 years later, wouldseek additional full studies; investigators who had alreadyconducted planning studies, as well as other scientists,could apply for these. With this dual approach, HEI hopesto get one or two major studies and several planningstudies under way in the next year and then start one ortwo large studies the following year.

This major, multidisciplinary undertaking will involvenumerous investigators and careful research design, exten-sive quality control and quality assurance, and innovativeapproaches. HEI intends to bring together diverse parties inindustry, government, and the environmental community tosupport this effort and maximize the utility of its results.

Critical Reviews and Perspectives HEI will produce twoor three new HEI Perspectives, a publication series writtenby the Health Review Committee for a broad audienceinterested in environmental health. HEI Perspectives inte-grate findings across several HEI studies and relatedresearch and interpret how the results bear on importantand timely issues. Topics of interest are:

• Assessment of what we have learned about cardiovas-cular effects of PM exposure. Results of time-series epi-demiologic studies suggesting that people withcardiovascular disease are more sensitive to PM expo-sure have led to toxicologic and panel studies investi-gating cardiovascular effects in more depth. Thepossible importance of the findings makes it critical toevaluate the consistency of the results across studiesand the overall picture they present and to considerwhat future research is needed to provide more defini-tive results.

• Summary and evaluation of PM exposure assessmentissues, including those related to assessing exposure inepidemiologic studies, such as the relation between

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central and regional site monitors and personal PMexposure, as well as relations between indoor, outdoor,and personal exposure for the general population andalso for susceptible subpopulations.

• Updated discussion of time-series and other epidemio-logic studies of exposure to PM. This discussion wouldintegrate information from the revised analyses ofNMMAPS and other time-series studies, the new meth-ods to address time-varying confounding factors devel-oped in APHENA, progress on long-term and otherrelevant studies, and suggestions for future directions.

HEI will also convene an expert panel to develop a crit-ical review of the literature on traffic-related healtheffects, which will be published as an HEI Special Report.A number of studies have reported increased adversehealth effects, such as exacerbation of asthma or allergicresponses in people living near roads with high traffic orspending time in traffic. These findings have often beeninterpreted as effects of exposure to mobile-source emis-sions, but how well studies have evaluated exposure orother possible risk factors is unclear. The literature shouldbe reviewed critically in order to interpret current findingsand to make recommendations for future studies.

Air Toxics Mixture The overall goal of HEI’s air toxicsprogram has been to provide information that will reduceuncertainties in evaluating human health risks associatedwith exposure to mobile-source air toxics. These activitieshave been driven by current and future air toxics regula-tory programs. These include the EPA National Air ToxicsAssessment and its efforts to assess health effects of andprioritize among major air toxics, state and local efforts toassess health effects and regulate air toxics (eg, SouthernCalifornia’s Multiple Air Toxics Exposure Study), andsource-specific regulatory programs (eg, the EPA MobileSource Air Toxics rule).

HEI has ongoing research on mechanisms of butadieneeffects and exposure to and health effects of aldehydes. Weare interested in continuing to fund similar studies thatcould provide a greater understanding of human exposureand effects. However, our main interest in near-term futurework is to increase understanding of health effects ofambient air toxics mixtures to which people are exposed.

Review of Exposure and Health Effects In addition to tar-geted research initiatives, in order to inform key shorter-term decisions about air toxics, an HEI expert panel isdeveloping a concise synthesis of information about expo-sure to and health effects of mobile-source air toxics thatwill be understandable to nonscientists and useful to

senior decisionmakers in government and industry. It willassess and summarize what we know about air toxics, aswell as identify research gaps and unresolved questions.Because of the large number and diverse nature of thesecompounds and groups of compounds and the variabilityin available health effects and exposure information aboutthem, this effort will likely focus on our understanding ofeffects of each of the major compounds rather than onreviewing the overall impact of exposure to the air toxicsmixture (although the studies described below may even-tually be able to examine these questions).

Studies of Population Exposure to Air Toxics in Potential Hot Spots Five studies are measuring a broad range ofmobile-source air toxics (many of which also have othersources) in areas where air levels are expected to be high(hot spots). A variety of site types and air toxics sources areincluded. Specific sites include:

• the Peace Bridge border crossing area and nearby neigh-borhoods where trucks idle or move slowly.

• a residential area in Camden, New Jersey, close to indus-trial and mobile sources of air toxics.

• areas involving exposure to diesel trucks: industrialparks upwind of truck terminals; neighborhoods down-wind from truck terminals; and in-vehicle exposures oftruck drivers on city, suburban, and rural streets andhighways.

• microenvironments dominated by mobile sources: com-muter corridors, street canyons, and parking garages inthe Los Angeles area.

• residential locations near heavy, moderate, and lighttraffic.

Many predictions of health risks from exposure to airtoxics in the environment are based on modeled estimatesof exposure and either potency estimates (for cancereffects) or comparison to reference concentrations (fornoncancer effects). All of these measures have sizeableuncertainties related to exposure and toxic potency. Thus,information on exposure from these studies will reducethe uncertainty about health effects projections, but actualhealth data are also needed.

Studies in Confirmed Hot Spot Areas Follow-on healthstudies in some hot-spot areas, selected on the basis ofexposure information, will enable comparison of healtheffects in areas with different combinations of air toxicsand will thus provide needed information about contribu-tion of air toxics to adverse health effects. The rationalefor these studies is that people exposed in places withhigher concentrations of air toxics would be expected to

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exhibit greater health effects. Testing whether effects arefound in such locations will provide meaningful informa-tion for future risk assessment.

Emerging Technologies and Fuels

Rapid development of diesel technologies and alterna-tive fuels, as well as longer-term technologies (such as fuelcells), aims to address concerns about air pollution, fossilfuel availability, and climate change. In light of such devel-opment, the need to evaluate future technologies isincreasingly important. HEI will rely on SCET, sponsors,and others to provide input about the most important tech-nologies and fuels over the next five years. From 2005 to2010, we expect to conduct assessments of existing scienceon emission control technologies and alternative fuels. Inaddition, ACES will be a component of HEI’s technologyactivities and will serve as a model for future testing ofimportant new technologies.

Review and Assessment Projects HEI sponsors andSCET members have suggested several critical reviews ofnew technologies, fuels, and fuel additives that might beused in the future. Because health effects testing is expen-sive and time consuming, we should evaluate possibleemissions and health effects at early stages of developmentto determine whether research on certain emissions com-ponents is needed. We expect to undertake up to two ofthese recommended projects (the diesel projects might becombined into one).

• Evaluation of NOx aftertreatment technologies foradvanced diesel engines. Possible emissions and healtheffects of aftertreatment technologies that will be avail-able to reduce oxides of nitrogen (NOx; such as selectivecatalytic reduction or NOx adsorbers) should be evalu-ated. For example, selective catalytic reduction technol-ogy uses urea to react with NOx to produce nitrogen andwater. Questions have been raised about the emission ofnew, possibly toxic nitrogen-containing compounds(such as urea decomposition products and nitroxyal-kanes) and increased production of nitro-polycyclicaromatic hydrocarbons and aldehydes. To the extentthat emission and health information are available, thepossible health effects of these compounds could beassessed.

• Comparison of fuels for diesel engines. In addition todiesel fuel, and low-sulfur diesel fuel starting in 2006,alternative fuels are being considered for truck and busfleets. Fuels of interest include compressed natural gas,Fischer-Tropsch fuel (a clean-burning liquid that can bemade from natural gas, coal, and low-value refinery

products), and biodiesel (which can be made from avariety of renewable sources, including animal fat andvarious plant oils from agricultural feedstocks or usedcooking oil). These fuels are of interest because theyenable taking advantage of feedstocks other than oil, mayproduce lower emissions of toxic pollutants from engines,and may reduce overall greenhouse gas emissions.

• Studies of metals in fuel additives. Some have raisedconcerns about persistent bioaccumulation of platinum,manganese, and other elements from mobile sourcesand whether these emissions are in toxic or nontoxicforms. Ferrocene, an iron-containing molecule that canbe added to diesel fuel, is of possible interest dependingon the likelihood of its future use. MMT, a manganese-containing compound, is being used or actively consid-ered for use as a gasoline additive.

• Assessment of increased use of ethanol and other alterna-tive fuels in gasoline engines. The US has a growing inter-est in phasing out methyl tert-butyl ether (MTBE) as a fueladditive and in substantially increasing use of ethanol as agasoline additive (eg, through national energy legislation).Assessment of possible implications of this increase foremissions, exposure, and health, and a plan for anaccountability assessment of the increase, could be timelyand important.

ACES is a cooperative, multiparty effort designed tocharacterize emissions of new, controlled heavy-dutydiesel engines being prepared for market to meet heavy-duty emission standards taking effect in 2007 (requiringreduction of PM and NOx levels) and in 2010 (to meet evenlower NOx standards using new NOx reduction technolo-gies). In addition, the 2010 engines will undergo extensivehealth effects testing (of both chronic and key shorter-termeffects) to evaluate the safety of their emissions.

HEI is responsible for study design, health study proto-cols, implementation, and overall reporting of results forACES. The Coordinating Research Council is responsiblefor emission characterization and exposure setup. Theoverall effort is being guided by an ACES Steering Com-mittee consisting of key stakeholders and funders of theeffort (eg, public agencies including EPA, Department ofEnergy, California Air Resources Board; the private sectorincluding the Engine Manufacturers Association, oil com-panies, emission control manufacturers, and others; andenvironmental organizations). A Health Oversight Com-mittee, comprising several members of the HEI ResearchCommittee and other experts, is being organized to guideplanning and oversight of health effects studies in ACES.A Health Advisory Committee, made up of scientists fromfunding organizations and other stakeholders, will provide

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input. If fully funded, ACES will provide HEI with anopportunity to contribute considerably to assessing a newset of technologies before they are in widespread use.

The timeline for ACES involves detailed planning andsecuring of final funding by mid 2005. Assuming all neces-sary funding is obtained, ACES is planned to take place inthree phases:

1. In phase 1, extensive emission characterization wouldbe conducted for production-intent prototype engineand control systems designed to meet 2007 standards forPM and NOx.

2. In phase 2, extensive emission characterization wouldbe conducted for a group of production-intent prototypeengine and control systems meeting the 2010 standards,which require further NOx reduction (using new typesof NOx control technologies such as selective catalyticreduction or NOx adsorbers). This characterization willbe the basis for selecting heavy-duty diesel engine/after-treatment system(s) for health testing.

3. In phase 3, a core chronic bioassay of cancer and non-cancer endpoints in rats and mice, similar to the stan-dard National Toxicology Program bioassay, would beconducted. In addition to assessing potential carcinoge-nicity of whole diesel exhaust, the chronic bioassaywould provide information on chronic toxicity throughhistopathologic analyses of multiple organs at interimstages and at the end of the study, on in vivo mutage-nicity, and on noncancer health endpoints associatedwith exposure to diesel exhaust. In addition, selected,established shorter-term respiratory and other noncancerendpoints would be evaluated in shorter exposures afterthe chronic bioassay.

Assessing the Public Health Impact of Air Quality Actions (Accountability)

Building on the foundation laid out in Assessing HealthImpact of Air Quality Regulations: Concepts and Methodsfor Accountability Research (HEI Communication 11, 2003),HEI has issued several RFAs for accountability researchand currently has a small number of studies under way. Weare also building a much larger base of possible researchteams. With new applications for accountability researchdue in spring 2005, we expect to add several more studiesthat will make for a more comprehensive accountabilityprogram, including much-needed methods development.

Ongoing Research Three accountability studies are underway from RFAs in 2002 and January 2004. They are evalu-ating health effects of air quality changes such as govern-mental bans on the sale of coal, changes in former East

Germany after natural gas replaced brown coal in powerplants and home heating and use of diesel-powered carsand trucks increased, and effects of an urban congestion-charging program intended to reduce traffic and vehicleemissions.

Future Research HEI issued a September 2004 RFA,“Measuring the Health Impact of Actions Taken to ImproveAir Quality.” This RFA sought applications for studiesdesigned (1) to assess the health effects of actions taken toimprove air quality, and (2) to develop methods for con-ducting such research. HEI is especially interested in eval-uation of national actions such as the NAAQS, which areimplemented over relatively long time scales; local actionssuch as state implementation plans; and shorter-termactions such as converting bus systems from diesel to alter-native fuels or retrofitting them with control technologies.HEI is also interested in supporting important long-rangepublic health initiatives in areas such as environmentalhealth tracking.

As we focus increasingly on studying the health impactof long-term changes in air quality that result from regula-tory or other action, further development and refining ofepidemiologic and statistical methods are more criticalthan ever. Regulatory interventions to improve air quality,especially large national programs such as the US CleanAir Act, may not have immediate effects on either airquality or public health. Ensuing changes in emissions,ambient concentrations, and human exposure may not bedemarcated sharply in space or time. And dynamics of bio-logical processes of injury that underlie adverse healtheffects of air pollution may not directly follow the changesin exposure that result from regulatory action. The longerthe time between promulgation of regulations and theireffects, the greater the possibility that other risk factors foradverse health outcomes may come into play and interferewith measuring effects of the intervention itself. Devel-oping assessment methods and tracking systems forchanges that affect public health (such as medical practice,standard of living, lifestyle, and diet) will be critical forassessing the efficacy of standards and regulations forwhich changes in emissions play out over a long time. Inaddition, changes in behavior as a result of improved airquality, such as spending more time outdoors, will need tobe taken into account. HEI will continue to build networkswith the US Centers for Disease Control and Preventionand state public health tracking programs to facilitateaccountability research. HEI will focus on methods to:

• Use data produced by environmental health tracking andsurveillance systems to evaluate changes in populationhealth over time in relation to changes in air pollution

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levels due to actions taken through federal control pro-grams and state implementation plans to meet theNAAQS for PM, ozone, and other pollutants.

• Better measure and integrate into accountability assess-ments other time-varying factors that may also influenceobserved changes in health.

Enhanced International Perspective

HEI’s efforts to integrate international science intoefforts to inform US decisions, and to be cognizant of howthat same science can help inform decisions in Europe andother relevant areas, have borne substantial benefit—andwill continue in the coming five years. Our initial efforts tobring high-quality and impartial science to bear on inter-national air quality decisions have begun to mature into amodest but sustainable program of targeted research,review, and capacity building, with additional supportprovided by new public, industry, and government spon-sors. Although HEI’s core scientific programs will con-tinue to focus on science to inform US decisions, in thenext five years HEI will continue this targeted, modest pro-gram in international science. Overall, HEI’s internationalefforts will encompass:

• Continued international contributions to HEI’s US-focused scientific efforts. This includes the APHENAproject (cofunded with the European Union) to bringstrong teams from Europe and North America togetherto test the latest statistical approaches and compare dif-ferences in effects across more than 120 cities, as well asother relevant studies of long-term health effects, doseresponse, and other topics.

• Continuing the PAPA program to build the capacity ofAsian scientists to conduct rigorous local health effectsstudies to inform decisions. In conjunction with theAsian Development Bank and others, the PAPA programwill begin to target possible links among air pollution,health, and poverty.

• Conducting limited capacity building with health scien-tists in other parts of the world to enhance the quality oftheir research (eg, Latin America).

Cross-Cutting Issues

HEI will integrate certain cross-cutting issues into itsnew research. For 2005–2010, we will focus on two sus-ceptible populations at both ends of the age spectrum:fetuses and children and older people. Because senior citi-zens have become a large fraction of the US population, weneed to understand their health risks and how they areinfluenced by diet, lifestyle choices, medical care, andother factors. In recent years, concern has increased about

exposure of children and fetuses to air pollution, in partic-ular developmental effects from exposure in utero.

HEI will also continue to pay attention to basic cross-cut-ting issues laid out in the previous Strategic Plan: (1) expo-sure assessment; (2) other susceptible groups who aresupposed to be protected by air quality standards; (3) mech-anisms of toxicity; (4) extrapolation from high to low doseand across species, in order to use information from var-ious studies to understand human health effects at near-ambient pollutant levels; (5) biomarkers for assessing per-sonal exposure, metabolic activation and detoxification,and internal dose of activated compounds; (6) diseases ofparticular importance that may be affected by multiplepollutants, such as asthma; and (7) methods development,in order to contribute to methods needed to support HEI’sresearch goals.

IMPLEMENTING THE HEI STRATEGIC PLAN 2005–2010

On the basis of extensive comments from HEI sponsors,other stakeholders, and the scientific community, HEI hasidentified the following activities for implementing theHEI Strategic Plan 2005–2010 according to the timeline inFigure 4.

INNOVATION AND VALIDATION

Over the next five years, HEI will strive to infuse inno-vation and validation in everything it does. In a world ofrapidly changing science, three key areas of innovation arecentral:

• Identifying the latest genomics, proteomics, and othertools for health investigation, bringing state-of-the-artpractitioners into the field of air pollution and health,and working to validate these emerging tools for healthand risk assessments.

• Continuously improving and validating state-of-the-artstatistical techniques for epidemiologic analysis.

• Increasing Web-based access to data for studies of broadinterest.

PRIORITY TOPICS AND TIMETABLE

Over the next five years, HEI will pursue four priorityareas that have emerged from initiatives launched in the2000–2005 Strategic Plan:

• Health effects of the air pollution mixture.

• Emerging technologies.

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HEI Strategic Plan 2005–2010

• Assessing the public health impact of air quality actions(accountability).

• Enhanced international perspective.

Health Effects of Air Pollution Mixture

Building on its efforts on PM, gases, and air toxics, HEIwill complete existing projects and build new initiativesthat take an increasingly integrated approach to assessinghealth effects of all pollutants and exposures.

PM and Gases HEI will conduct several activities relatedto these critical air pollutants.

• Complete, review, and communicate results of existingstudies of health effects of PM and gases, including:

key current studies of health effects of long-termexposure,

animal and human studies of effects of exposure todiesel and other particles on allergic response, and

individual studies of mechanisms and health effectsof pollutant components.

• Launch a systematic, multidisciplinary program thatwill use toxicology, epidemiology, and exposureresearch to examine and compare toxicity of PM compo-nents, gases, and sources.

• Produce new HEI Perspectives on topics includingexposure and updated epidemiology findings.

• Conduct an expert review of current and emerging sci-entific literature of health effects of exposure to traffic.

Air Toxics Recognizing growing interest of agencies, citi-zens, and others in health effects of air toxics, HEI willcontinue and extend efforts to assess and investigate expo-sure to and health effects of key compounds. These effortswill include:

• In the near term, conducting a review and synthesis ofcurrent scientific knowledge on exposure to and healtheffects of major mobile-source air toxics.

• Completing current studies of population exposure toair toxics in potential hot spots (areas likely to have highlevels of some air toxics).

• In confirmed hot spots, launching comprehensive stud-ies of health effects.

Understanding Health Effects of the Mixture For decades,scientists have grappled with the best way to assess effectsof exposure to a pollutant mixture. To move beyond pastefforts, in the spirit in which HEI took on the challenge oflaying groundwork for better approaches to accountability,

we will convene a workshop and write and publish anexpert monograph on developing and implementing inno-vative approaches to studying health effects of the air pol-lution mixture.

Emerging Technologies

In keeping with our long-standing mission to track andassess health consequences of emerging technologies andfuels, HEI will work with SCET to:

• Conduct periodic reviews of current knowledge of keytechnologies (eg, alternative fuels, metallic fuel addi-tives, and other topics).

• Launch ACES (in collaboration with the CoordinatingResearch Council and partners in government, industry,and the environmental community) to test 2007 and2010 heavy-duty diesel engines and fuels.

Assessing the Public Health Impact of Air Quality Actions (Accountability)

Building on HEI Communication 11 (the accountabilitymonograph), we will pursue efforts to improve trackingand assessment of the public health effects of actions takento improve air quality:

• Completion and communication of results of HEI’s ini-tial accountability studies;

• Outreach and support for the development of a sustain-able tracking network by state public health agenciesand the US Centers for Disease Control and Prevention(who are implementing local and national health track-ing systems); and

• Major new research and methods development to assesslong-term and short-term effects of domestic air qualityactions on public health.

Enhanced International Perspective

HEI’s initial efforts to bring high-quality and impartialscience to bear on international air quality decisions havebegun to mature into a modest but sustainable programwith added funds from new public, industry, and govern-ment sponsors. In the next five years HEI will continuethis focused program in international science by:

• Applying the best science from throughout the world toinform US decisions, for example by completing theAPHENA project to test the latest statistical approachesand undertaking other key long-term and dose–responsestudies.

• Continuing, with additional resources, the PAPA pro-gram to build the capacity of Asian scientists to producerigorous local health effects studies to inform decisions

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and to begin to target possible links among air pollution,health, and poverty.

• Conducting limited capacity building with health scien-tists in other parts of the world (eg, Latin America).

One important element of these modest efforts will be reg-ular communication to HEI’s current sponsors of key healthand regulatory developments in these international settings.

Cross-Cutting Issues

HEI will attempt to integrate into its programs certaincross-cutting issues, especially health effects of air pollu-tion on two possibly susceptible populations:

• The growing number of elderly in the US population;

• Children (including possible developmental effects aftermothers are exposed during pregnancy).

In bringing these cross-cutting issues into its program,HEI hopes to attract a wide range of medical and populationhealth experts who can help place effects of air pollutioninto the broader context of health issues facing these groups.

REFERENCES

Environmental Protection Agency (US). 1996a. Air QualityCriteria for Particulate Matter. EPA-600/P-95/001aF. Officeof Research and Development, Research Triangle Park NC.

Environmental Protection Agency (US). 1996b. Review ofthe National Ambient Air Quality Standards for Particu-late Matter: Policy Assessment of Scientific and TechnicalInformation. Office of Air Quality Planning and StandardsStaff Paper. EPA-452\R-96-013. OAQPS, Research TrianglePark NC.

Environmental Protection Agency (US). 2002. HealthAssessment Document for Diesel Engine Exhaust. EPA/600/8-90/057F. National Center for Environmental Assess-ment, Washington DC.

Environmental Protection Agency (US). 2003. Review ofthe National Ambient Air Quality Standards for Particu-late Matter: Policy Assessment of Scientific and TechnicalInformation. Office of Air Quality and Planning and Stan-dards Staff Paper—First Draft. EPA-452/D-03-001. OAQPS,Research Triangle Park NC.

Environmental Protection Agency (US). 2004. Air QualityCriteria for Particulate Matter. Fourth External ReviewDraft. EPA/600/P-99/002bD. Office of Research and Devel-opment, Research Triangle Park NC.

Krewski D, Burnett RT, Goldberg MS, Hoover K, SiemiatyckiJ, Jerrett M, Abrahamowicz M, White WH. 2000. Reanalysisof the Harvard Six Cities Study and the American CancerSociety Study of Particulate Air Pollution and Mortality.Special Report. Health Effects Institute, Cambridge MA.

National Research Council (US). 2004a. Air Quality Manage-ment in the United States. Committee on Research Prioritiesfor Airborne Particulate Matter, Board on EnvironmentalStudies and Toxicology, Division on Earth and Life Studies.The National Academies Press, Washington DC.

National Research Council (US). 2004b. Research Priori-ties for Airborne Particulate Matter, IV. ContinuingResearch Progress. Committee on Air Quality Managementin the United States, Board on Environmental Studies andToxicology, Board on Atmospheric Sciences and Climate,Division on Earth and Life Studies. The National Acade-mies Press, Washington DC.

ABBREVIATIONS AND OTHER TERMS

ACES Advanced Collaborative Emissions Study

APHENA Air Pollution and Health—A Combined European and North American Approach

CAFÉ Clean Air for Europe Program

CDC Centers for Disease Control and Prevention (US)

EPA Environmental Protection Agency (US)

MMT methylcyclo-pentadienyl manganese tricarbonyl

NAAQS National Ambient Air Quality Standards (US)

NMMAPS National Morbidity, Mortality, and Air Pollution Study (US)

NOx oxides of nitrogen

NRC National Research Council

PAPA Public Health and Air Pollution in Asia [HEI program]

PM particulate matter

RFA Request for Applications

SCET Special Committee on Emerging Technologies

SIP state implementation plan

WHO World Health Organization

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The Health Effects Institute was chartered in 1980 as an

independent and unbiased research organization to provide

high quality, impartial, and relevant science on the health

effects of air pollution. All results are provided to industry

and government sponsors, other key decisionmakers, the

scientific community, and the public. HEI funds research

on all major pollutants, including air toxics, diesel exhaust,

nitrogen oxides, ozone, and particulate matter. The Institute

periodically engages in special review and evaluation of key

questions in science that are highly relevant to the regulatory

process. To date, HEI has supported more than 220 projects

at institutions in North America, Europe, and Asia and has

published over 160 Research Reports and Special Reports.

Typically, HEI receives half of its core funds from the

US Environmental Protection Agency and half from 28

worldwide manufacturers and marketers of motor vehicles

and engines who do business in the United States. Other

public and private organizations periodically support special

projects or certain research programs. Regardless of funding

sources, HEI exercises complete autonomy in setting its

research priorities and in reaching its conclusions.

An independent Board of Directors governs HEI. The

Institute’s Health Research Committee develops HEI’s five-

year Strategic Plan and initiates and oversees HEI-funded

research. The Health Review Committee independently

reviews all HEI research and provides a Commentary

on the work’s scientific quality and regulatory relevance.

Both Committees draw distinguished scientists who

are independent of sponsors and bring wide-ranging

multidisciplinary expertise.

The results of each project and its Commentary are

communicated widely through HEI’s home page, Annual

Conference, publications, and presentations to professional

societies, legislative bodies, and public agencies.

Daniel S Greenbaum President

Robert M O’Keefe Vice President

Jane Warren Director of Science

Sally Edwards Director of Publications

Jacqueline C Rutledge Director of Finance and Administration

Deneen Howell Corporate Secretary

Cristina I Cann Staff Scientist

Aaron J Cohen Principal Scientist

Maria G Costantini Principal Scientist

Wei Huang Staff Scientist

Debra A Kaden Principal Scientist

Sumi Mehta Staff Scientist

Geoffrey H Sunshine Senior Scientist

Annemoon MM van Erp Senior Scientist

Terésa Fasulo Science Administration Manager

L Virgi Hepner Senior Science Editor

Jenny Lamont Science Editor

Francine Marmenout Senior Executive Assistant

Teresina McGuire Accounting Assistant

Kasey L Oliver Administrative Assistant

Robert A Shavers Operations Manager

Mark J Utell ChairProfessor of Medicine and Environmental Medicine, University of Rochester

Melvyn C BranchJoseph Negler Professor of Engineering, Mechanical Engineering Department, University of Colorado

Kenneth L DemerjianProfessor and Director, Atmospheric Sciences Research Center, Universityat Albany, State University of New York

Peter B FarmerProfessor of Biochemistry, Cancer Studies, and Molecular Medicine,University of Leicester

Helmut GreimProfessor, Institute of Toxicology and Environmental Hygiene, Technical University of Munich

Rogene HendersonSenior Scientist Emeritus, Lovelace Respiratory Research Institute

Stephen I RennardLarson Professor, Department of Internal Medicine, University of Nebraska Medical Center

Howard RocketteProfessor and Chair, Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh

Jonathan M SametProfessor and Chairman, Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University

Ira TagerProfessor of Epidemiology, School of Public Health, University of California, Berkeley

HEALTH RESEARCH COMMITTEE

BOARD OF DIRECTORSRichard F Celeste ChairPresident, Colorado College

Purnell W ChoppinPresident Emeritus, Howard Hughes Medical Institute

Jared L CohonPresident, Carnegie Mellon University

Alice HuangSenior Councilor for External Relations, California Institute of Technology

Gowher RizviDirector, Ash Institute for Democratic Governance and Innovations, Harvard University

Richard B StewartUniversity Professor, New York University School of Law, and Director, New York University Center on Environmental and Land Use Law

Robert M WhitePresident (Emeritus), National Academy of Engineering, and Senior Fellow, University Corporation for Atmospheric Research

Archibald Cox Founding Chair, 1980–2001

Donald Kennedy Vice Chair EmeritusEditor-in-Chief, Science; President (Emeritus) and Bing Professor of Biological Sciences, Stanford University

HEALTH REVIEW COMMITTEEDaniel C Tosteson ChairProfessor of Cell Biology, Dean Emeritus, Harvard Medical School

Ross AndersonProfessor and Head, Department of Public Health Sciences, St George’s Hospital Medical School, London University

John R HoidalProfessor of Medicine and Chief of Pulmonary/Critical Medicine, University of Utah

Thomas W KenslerProfessor, Division of Toxicological Sciences, Department of Environmental Sciences, Johns Hopkins University

Brian LeadererProfessor, Department of Epidemiology and Public Health, Yale University School of Medicine

Edo D PellizzariVice President for Analytical and Chemical Sciences, Research Triangle Institute

Nancy ReidUniversity Professor, University of Toronto

William N RomProfessor of Medicine and Environmental Medicine and Chief of Pulmonary and Critical Care Medicine, New York University Medical Center

Sverre VedalProfessor, Department of Environmental and Occupational Health Sciences, University of Washington

OFFICERS & STAFF

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H E A L T HE F F E CTSINSTITUTE

HEI STRATEGIC PLAN

FOR UNDERSTANDING HEALTH

EFFECTS OF AIR POLLUTION

2005–2010

April 2005

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