Board of Scientific Counselors
       Office of Research and Development
       United States Environmental Protection Agency
        Particulate Matter and
        Ozone Research
        Program Review

        Report of the Subcommittee on
EPA      Particulate Matter and Ozone Research
600
2005.12 A  April 14,2005
     J  Revised August 11,2005
                               AUG 2,5 2006

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This report was written by the Particulate Matter and Ozone Research
Subcommittee of the Board of Scientific Counselors, a public advisory
committee  chartered under  the Federal  Advisory  Committee  Act
(FACA) that provides  external  advice, information, and recommen-
dations to the Office of Research and Development (ORD). This report
has not been reviewed for approval by EPA, and therefore, the report's
contents and recommendations do not necessarily represent the views
and policies of the EPA, or other agencies of the federal government.
Further, the  content of this  report does not represent  information
approved or disseminated by EPA, and, consequently, it is not subject
to EPA's Data Quality Guidelines.  Mention of trade names or com-
mercial products does not constitute a recommendation for use.  Re-
ports of the Board of Scientific Counselors are posted on the Internet at
http:// www.epa.gov/osp/bosc.

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                      REPORT OF THE
             BOARD OF SCIENTIFIC COUNSELORS
     PARTICULATE MATTER AND OZONE
         RESEARCH PROGRAM REVIEW
             Office of Research and Development
            U.S. Environmental Protection Agency

                      APRIL 14,2005
                  REVISED AUGUST 11,2005
SUBCOMMITTEE ON PARTICULATE MATTER AND OZONE RESEARCH

       Dr. Rogene Henderson (Chair)—Lovelace Respiratory Research Institute
           Dr. Juarine Stewart (Vice-Chair)—Morgan State University
              Mr. Bart Croes—California Air Resources Board
            Dr. Kenneth Demerjian—State University of New York
              Dr. Brian Lamb—Washington State University
          Dr. Michael Lipsett—California Department of Health Services
               Dr. Peipei Ping—UCLA School of Medicine
              Dr. Charles Rodes—Research Triangle Institute
       Dr. Christian Seigneur—Atmospheric and Environmental Research, Inc.

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                         TABLE OF CONTENTS
I.   EXECUTIVE SUMMARY	  1
      Overall Goals, Charge, and Structure of the Review	  1
      Background for the Paniculate Matter and Ozone Research Program	  2
      Overarching Conclusions and Recommendations	  4

II.  CHARGE QUESTION 1: PROGRAM DESIGN AND DEMONSTRATED
    LEADERSHIP	  8

III. CHARGE QUESTION 2: SCIENCE QUALITY	14

IV. CHARGE QUESTION 3: RELEVANCE	18

V.  CHARGE QUESTION 4: DEMONSTRATED OUTCOMES	28

APPENDIX A: CHARGE QUESTIONS	34

APPENDIX B: BIOGRAPHICAL SKETCHES OF THE SUBCOMMITTEE MEMBERS	40

APPENDIX C: AGENDA FOR THE MARCH 30-31,2005 MEETING	47

APPENDIX D: LIST OF ACRONYMS	.'.	53
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                            EXECUTIVE SUMMARY

The National Academy of Sciences (NAS) has recommended independent expert review for
evaluating federal research programs. The U.S. Environmental Protection Agency's (EPA)
Office of Research and Development (ORD) is committed to independent expert review of its
environmental research programs for objective evaluation of research at the program level to
establish "best practices" in federal research program design, management, and evaluation and to
assist the Agency in preparing performance and accountability reports to Congress under the
Government Performance and Results Act (GPRA) of 1993.

The Board of Scientific Counselors (BOSC) Executive Committee agreed in September 2004, to
undertake four program reviews:  Human Health Research Program, Drinking Water Research
Program, Ecological Research Program, and Particulate Matter and Ozone (PM & Os) Research
Program. The BOSC formed a Subcommittee of experts (see Appendix A) to conduct a program
review of ORD's PM & Os  Research Program.  This Subcommittee was charged with reviewing
ORD's PM & Os Research Program and providing a report to the BOSC Executive Committee.

This review differs from previous Multi-Year Plan (MYP) reviews in that it included a
retrospective, as well as a prospective evaluation, examining progress made to date and the
future direction of the EPA  research in this program. The program review is intended to provide
guidance that will help ORD to: (1) assess the progress and direction of the PM & Oa Research
Program; (2) plan, implement, and strengthen the program; (3) evaluate research investment
decisions over the next 5  years; (4) compare the program with any programs designed to achieve
similar outcomes in other parts of EPA and in other federal agencies; (5) prepare EPA's
performance and accountability reports to Congress under GPRA; and (6) consider options for
the reporting of outcomes as defined by the Office of Management and Budget (OMB) Program
Assessment Rating Tool (PART) review process.

The objective of the PM & Oj Research Program review was to review the relevance, quality,
performance, scientific leadership, and resources of the program.  The Subcommittee responded
to a series of questions organized into four broad charges that were framed to solicit comments
on the program's: (1) design and leadership; (2) quality of science; (3) relevance; and (4) dem-
onstrated program outcomes (see the charge questions to the Subcommittee in Appendix B).
The Subcommittee chose to organize the review and report around the four charge questions.

Following an initial administrative conference call, the Subcommittee met in March by
conference call to discuss the proposed charge questions and scope of work. The Subcommittee
members were sent background information on the program, including copies of the integrated
posters to be presented at the face-to-face meeting, which was to be held March 30-31, 2005, in
Research Triangle Park (RTP), North Carolina. The Chair of the Subcommittee assigned
specific charge questions to each member and asked them to prepare preliminary comments prior
to the face-to-face meeting.  During the meeting in RTP, EPA researchers and air program
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managers, as well as university faculty whose research has been supported by ORD, presented
information to the Subcommittee about PM and ozone research and linkages to the regulatory
and non-regulatory programs of the EPA Office of Air and Radiation (OAR), the program's
principal client. During the meeting, the Subcommittee members revised the preliminary review
comments they had prepared before the meeting, and a conference call was convened on April
12,2005, to complete the draft review report. The Subcommittee members agreed to forward the
draft with recommended edits to the Air National Program Director (NPD) and to the BOSC
Executive Committee for review at its June 2-3,2005, meeting. A key issue for the
Subcommittee at the outset of the face-to-face meeting was to reach a clear understanding of the
difference between a research "output" and an "outcome" within the context of this review. The
insights described and commentary provided in this report are based on the technical content and
organizational structure of the EPA PM & 03 Research Program. Detailed resource allocations
by research program area were not provided to the Subcommittee. The Subcommittee concluded
that although such information might have provided some useful insights in selected areas, it was
not required to address the charge questions posed to the BOSC by EPA.

EPA provided the Subcommittee with voluminous materials related to the charge questions. The
Subcommittee reviewed the background material for the PM & 03 Research Program and
extracted the following highlights to provide a context for the remainder of the report.

Over the last decade, a wealth of studies has underscored anthropogenic air pollution—notably
PM and ozone—as environmental factors that can adversely impact human health and welfare,
despite clear evidence that overall air quality has improved.1 OMB has estimated an annual
savings of $101 to $119 billion in hospitalizations and emergency room visits, lost workdays,
and premature deaths averted between 1992 and 2002 that can be attributed to air pollution
regulations, especially those that resulted in decreased PM.2 To further increase these benefits,
the EPA PM & Os program is focused on reducing the uncertainties regarding the source-
associated attributes of PM responsible for these impacts and the biological factors that underlie
susceptibility to them so that even more cost-effective strategies for environmental regulation
and control can be developed.

In 1997, EPA promulgated new national ambient air quality standards (NAAQS) for fine
particles (PMaj), based primarily on time-series studies of morbidity and mortality and on two
long-term cohort mortality studies. At that time, however, there were many uncertainties
regarding, for example, the relationship of fixed-site monitors and actual human exposures, the
biological plausibility of the responses to ambient PM, and, assuming a causal relationship
between PM exposures and the various adverse health outcomes, which PM constituents were.
most likely responsible for these effects. These uncertainties prompted Congress to augment the
President's recommended EPA budget of $27.8 million in 1998 with a supplement of $22.4
1  These data are summarized in the recently released NCEA Air Quality Criteria Documents for PM-( 10/29/04 -
  http://cfpub.epa.gov/ncea/cmi/recordisplay.cfin?deid=87903) and Ozone and Related Photochemical Air Pollutants (01/31/05 -
  http://cfpub.epa.gov/ncea/cfin/recordisplay.cftn?deid=l 14523). Trends in air quality and emissions can be found on the
  OAQPS Web Site at http://www.epa.gov/air/oaqps/cleanair.html.

2  http://www.whitehouse.gov/omb/inforeg/2003_cost-ben_final_rpt.pdf.
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million per year and an additional $18.0 million in Fiscal Year (FY) 1999. These additional
resources became part of the base PM Research Program and have been included in the
Agency's budget requests since that time.  The charge to EPA was to accelerate investigations of
the role of PM in air pollution-associated health outcomes, and to implement health risk
reductions via scientifically defensible regulatory actions. President Clinton emphasized the
national scope of the issue when he stated, "The EPA,-in partnership with other federal agencies,
will develop a greatly expanded coordinated interagency PM research program. The program
will contribute to expanding the science associated with PM health effects, as well as developing
improved monitoring methods and cost-effective mitigation strategies." To assist in this national
effort, Congress mandated the formation of a committee of air pollution experts via the NAS
National Research Council (NRC). This NRC Committee met initially to define the scope of the
issue and to compile the pressing research  needs to advance the science and support the
regulatory agenda.3 The Committee met periodically through 2004, completing a series of four
documents delineating the PM research needs in health, and, beginning with the second report,
aspects of air quality management. This series of documents also provided, most recently in
Volume IV published in April 2004,4 ongoing assessments of progress, both scientific and
administrative, in  reducing the uncertainties associated with the relationships of PM and adverse
health outcomes, as well as recommendations regarding the direction and implementation of the
program.

Following the release of another related NRC report in 2004 entitled Air Quality
Management in the United States,5 the Clean Air Act Advisory Committee (CAAAC)—
established in 1990 to periodically address issues more specific to air quality—formed a work
group to develop recommendations for improvements to air quality management. This Air
Quality Management (AQM) Work Group is comprised of representatives from EPA, state and
local agencies, tribes, industry, and environmental and research organizations.  The charge to the
AQM Work Group was to evaluate the NRC AQM findings and develop its own
recommendations for consideration by the CAAAC.

Nearly 7 years of intensive research activity have taken place since the initial NRC
Research Priorities Report, yielding significant advances in the understanding of PM. In
February 2004, ORD released Paniculate  Matter Research Program: Five Years of Progress,6
which summarized the achievements of EPA's research program in advancing the understanding
of both health/exposure and air quality issues.  The report, although aimed at the knowledgeable
public, is the most comprehensive account of the progress in the PM Research Program through
early 2003. The Report summarized the advances in the PM Research Program over the last
several years into three broad areas: (1) the credibility and extent of PM-associated health
effects and the complex roles of PM attributes and human host factors that contribute to the
health outcomes; (2) the factors determining public and individual exposures, including
characterization of the sources and atmospheric processes needed to aid implementation of the
3 http://www4.nas.edu/cp.nsf7Projects+_by+_PIN/BEST-K-98-02-A?OpenDocument.

"http://books.nap.edu/catalog/10957.html.

5 http://www.nap.edu/catalog/10728.html.

6 http://www.epa.gov/pmresearch/pm_research_accomplishments.


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NAAQS; and (3) the development and improvement of "tools" and state-of-the-art technologies
needed by the regions, states, and tribes to implement the NAAQS to achieve EPA's Strategic
Air Quality Goal (i.e., "Protect and improve the air so it is healthy to breathe and risks to
human health and the environment are reduced. ").7
The Subcommittee was generally pleased with the content and progress of the PM dimensions of
ORD's PM & Oj Research Program. Based on the review, it was clear that the large group of
investigators, both within and outside EPA, worked diligently together to present the program in
an integrated and readily comprehensible manner that facilitated the job of the reviewers. The
following statements summarize the Subcommittee's conclusions and recommendations.

CONCLUSIONS

1.  The Subcommittee finds that the PM & O3 Program directly addresses NRC (and OMB)
    concerns in terms of the Agency's long-term goals, the plans to meet these goals, and the
    ways to measure progress toward these goals.  The ORD PM & Oa Research Program has
    resulted  in significant reductions in scientific uncertainty in critical areas, especially the
    distribution and dosimetry of inhaled fine and ultrafine particles, the relationship of ambient,
    fixed-site PM monitoring to real-world human exposures, the identification of susceptible
    subpopulations, the identification of biologically plausible mechanisms of PM toxicity
    (including cardiovascular effects), the validity of PM epidemiological studies, including in
    particular confounding and misclassification of exposure, as well as improved emissions
    monitoring and air quality modeling.

2.  The Subcommittee finds that the outputs produced by research to support these reductions in
    uncertainty have provided a sound basis for subsequent improvements in public health
    (outcomes). The current ORD PM program provides a balanced blend of research outputs
    targeted  at uncertainty reduction and outcome-directed research to assist OAR in protecting
    public health.  The Subcommittee considers that this blend of output- and outcome-directed
    research is critical to the long-term success and relevance of the program.

3.  The Subcommittee finds that the PART process for evaluating the useful outcomes of the
    activities of governmental agencies is difficult to apply in evaluating scientific research. The
    purpose  of the EPA research effort is to reduce the uncertainties associated with setting
    regulations to protect public health and the environment. This type of focused, applied
    research is not usually funded by the National Institutes of Health, and proprietary research
    conducted by industry is not available for public use. The metric of success for the ORD
    research effort is the extent to which the outputs of the research are used by the regulatory
    offices to set appropriate regulations for protection of public health and the environment
    (outcome).
7 EPA Strategic Plan: http://www.epa.gov/ocfo/plan/2003sp.pdf.
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4. The Subcommittee finds that the strategic decision to terminate ozone-related health research
   undercuts part of ORD'S first long-term goal (i.e., "In 2012, reduced uncertainties in the air
   pollution sciences will lead to more effective and efficient PM and ozone standard setting
   and air quality management during each regulatory cycle to minimize adverse risks to
   human health and the environment"). The Subcommittee identified two areas of concern if
   the ozone-related research is curtailed: (1) continuing uncertainty around health effects and
   the association with increased mortality, and (2) uncertainties around unresolved issues
   regarding sources of ground-level ozone.

5. The Subcommittee finds a high degree of integration in the conduct of intramural and
   extramural research across the various laboratories, centers, and scientific disciplines.

6. The Subcommittee finds that ORD has been responsive to the needs of its primary client,
   OAR, and to its other stakeholders, particularly the EPA Regions and the states. The
   stakeholders have multiple opportunities for involvement in ORD's assessment and
   prioritization of research needs.

7. The Subcommittee finds the overall science being conducted by the ORD PM & O3 Research
   Program in both intramural and extramural research laboratories to be of high quality as
   indicated  by: (a) scholarship and scientific publications; (b) credentials of participating
   investigators; (c) integrative and outcome-oriented program design; and (d) building of a
   knowledge and information database.

8. The Subcommittee finds that the funding for extramural research is based on a highly
   competitive, merit-based process.  The process for intramural funding is not as transparent
   but is based on the recommendations of the Air Research Coordination Team (RCT), which
   includes the Air NPD, high-level representatives of ORD's laboratories and the extramural
   research program, a regional representative, senior scientists from OAR, and others.

9. The Subcommittee concludes that the recent appointment of a permanent director for the Air
   Research Program is a step forward to improve the overall management of the program.

10. The Subcommittee finds that intra- and interagency communications are excellent.
   . Communication of research results is sufficient and is done through regional, national, and
   international presentations at scientific conferences and workshops, through publications in
   peer-reviewed journals, through the EPA Web Site, and through press releases.

RECOMMENDATIONS

1. The Subcommittee recommends that ORD maintain a periodic, formalized process for
   assessing its primary stakeholders' perceptions of and satisfaction with its role in the source-
   to-health  outcome process. Such an assessment should provide information needed for the
   PART review. As stated in the conclusions, the metric of success for the program is the
   extent to which the outputs of the research are used by the regulatory offices to set
   appropriate regulations for protection of public health and the environment.
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2. The Subcommittee recommends that the two long-term goals read as follows:

       (a) By 2012, reduced uncertainties in the air pollution sciences will lead to more effective
       and efficient PM and ozone standard setting and air quality management during each
       regulatory cycle to minimize adverse risks to human health and the environment.

       (b) By 2015, reduced uncertainty in the integrated linkages of pollutant sources to health
       outcomes will ensure that ORD clients target air pollutant strategies most effectively and
       efficiently to best protect human health and the environment.

3. The Subcommittee recommends structuring the performance of the second long-term goal
   around two to three hypothesis-driven pilot studies that would demonstrate the source-to-
   health outcome concept and should provide a reasonable metric to measure the success of the
   program, both from a science and policy perspective. The Subcommittee recommends the
   use of an expert panel or workshop to review the pilot studies and to follow their progress on
   a regular basis.  The staff should work with the expert panel or workshop participants to
   define a baseline of the major current uncertainties for each program component on which
   future research efforts should be focused. Then the expert panels can assess the reduction of
   or alterations in uncertainties at regular intervals.

4. Recognizing that EPA faces serious research resource constraints, the Subcommittee
   nevertheless recommends that ORD reconsider the decision to completely disinvest in ozone
   research. Continuing research is required for effective ozone standard setting to protect
   public health and for improved air quality management in regard to sources of ground-level
   ozone.

5. The Subcommittee reinforces the NRC recommendation that includes the establishment of
   multi-agency goals and measures of success in meeting national goals, preparation of an
   MYP for PM/Os that incorporates input from other federal agencies, as well as states and
   private organizations, defines the roles of individual agencies, provides for input from
   nonfederal organizations into the federal planning process, and expands communication of
   the planning process to the public. These remain worthwhile recommendations and areas
   where ORD can assume a leadership role.

6. The Subcommittee recommends that the PM & 03 Research Program maintain the strong
   balance between intramural and extramural research that has resulted in the productive
   program they have today. If funding is reduced, that balance still should be maintained.

7. The Subcommittee recommends that funding decisions for any active intramural project
   undergo review by the Air RCT.

8. The Subcommittee recommends that the MYP include a discussion indicating how the goals
   set out by the NRC flow into the crosscutting research issues and how these are embodied
   under the two long-term goals. If this discussion is in the Research Strategy for the program,
   the MYP needs to be organized to make obvious the connection between the research and the
   NRC goals.
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9. The Subcommittee recommends that funding be set aside for anticipatory research needs, and
   that steps be taken by ORD to identify and highlight key anticipatory research needs to
   inform longer term research and to ensure that current and out-year funded levels of research
   will be consistent with potential long-term regulatory needs.

The remainder of the report is the more detailed review of the ORD PM & Oj Research Program
organized according to the four charge questions.
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             CHARGE QUESTION 1: PROGRAM DESIGN AND
                        DEMONSTRATED LEADERSHIP
                ^
The science needs of the PM & 63 Research Program largely have been identified and refined
through the NRC review process, culminating in the NRC Volume IV report. The NRC has
identified several research priorities for the program. In the most recent report, five crosscutting
issues across the research priorities were identified:  (1) an increasing number of adverse health
outcomes associated with PM and the related susceptible subpopulations; (2) particle toxicity in
relation to different particle characteristics and emission-source types; (3) increasing emphasis
on exposure-dose-response relationships; (4) considering PM health effects within the broader
context of other pollutants in the ambient air; and (5) designing PM research programs to inform
most effectively the setting and implementation of the PM NAAQS.  At the  same time and in
line with crosscutting issue 4, EPA and the science community have begun to crystallize the
concept of "one atmosphere" when dealing with multiple pollutants; this is particularly true in
terms of the close correlation between Oa and PM precursor emissions and chemistry.  Finally,
the recent assessment of the EPA PM Program using the OMB PART analysis highlighted the
need for identified research targets and associated measures of success in achieving these targets.
Together, the 10 research priorities, the 5 crosscutting research issues, recognition of the value of
the one atmosphere concept, and the need to develop clear targets and associated measures
provide the foundation for the PM & O3 MYP.  The  research priorities and crosscutting issues
form the science needs that must be addressed in the MYP, whereas the one  atmosphere
approach and the need for program assessment require the integration and leveraging of human
and fiscal resources.

     Is the PM & Oj MYP structure strategic by  design, implementation, and review?

The structure of the MYP is designed to address two long-term goals (LTGs):

LTG 1: In 2012, reduced uncertainties in the air pollution sciences will lead to more effective
        and efficient PM and ozone standard setting and air quality management during each
        regulatory cycle to minimize adverse risks  to human health and the environment.8
 The Subcommittee has suggested changes in the wording for LTG 1 as follows: By 2012, enhance understanding
  in the air pollution sciences and reduce associated uncertainties leading to more effective and efficient PM and
  ozone standard setting and air quality management during each regulatory cycle to minimize adverse risks to
  human health and the environment.
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LTG 2:  By 2015, reduced uncertainty in the integrated linkages of pollutant sources to health
         outcomes will ensure that ORD clients target air pollutant strategies most effectively
         and efficiently to best protect human health and the environment.9
                                                                     i
The research needed to address LTG 1 provides the sound, specific science required to develop
NAAQS for PM and ozone and also the proven tools and support required for implementation of
NAAQS. An important aspect of this LTG is the need to communicate PM & 63 research results
to EPA clients to ensure that results are properly interpreted and tools are used effectively to
implement NAAQS.

LTG 2 encompasses a shift in approach in proposing to link health outcomes with pollutant
source attributes. Because LTG 2 explicitly links emissions with health impacts, it inherently
requires integration across disciplines within the EPA research community. These two LTGs
explicitly address the science needs identified by the NRC review process,  and require that EPA
adopt full integration of research activities across disciplines and throughout both the intramural
and extramural research programs. Thus, the MYP provides a strategic plan to address science
needs and integration of the resources required to achieve results. The LTGs within the MYP
also provide the targets and a basis for measuring progress toward those goals as highlighted by
the recent PART analysis. The Subcommittee would suggest that the identified measures to
track progress in meeting LTG 2 might be better served by identifying two to three hypotheses-
driven pilot studies that would demonstrate the source-to-health outcome concept.  These
proposed studies should consider source-health outcome relationships that  likely will have the
largest return on demonstrating cost-effective strategies for improving public health.

    Does the PM & Os MYP structure provide a reasonable "roadmap" of the program,
       demonstrating a well thought-out plan, identifying critical paths, clear goals,
                                 priorities, and schedules?
There are specific measures of success that accompany each LTG.  These provide the roadmap
for the PM & Os Research Program. Under LTG 1, research results must be provided that:
(1) establish concentration-effect relationships showing that lower doses of PM lead to lower
health impacts; (2) show steady improvement in the quality of predictions from and a reduction
of uncertainty in atmospheric models for both PM and ozone; and (3) document that real-world
emission reductions lead to improved air quality and reductions in adverse health outcomes.
Progress toward these goals requires results that will be measured in terms of periodic reviews of
the program and through compilations of EPA peer-reviewed literature.  Under LTG 2, results
are needed to show:  (1) coherence across disciplines that attribute health impacts to sources; and
(2) these source-health linkages lead to cost-effective strategies for improving public health.
LTG 2 also specifically requires the full integration across the sciences, including the regulatory
process, to provide a built-in feedback between science results and  regulatory action. The
  The Subcommittee has suggested changes in the wording for LTG 2 as follows: By 2015, demonstrate the
  integrated linkages of pollutant sources to health outcomes and reduce their associated uncertainties to ensure that
  ORD clients target air pollutant strategies most effectively and efficiently to best protect human health and the
  environment.
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outcome will be an ability to create flexible and cost-effective strategies for protection of public
health. As suggested above, structuring LTG 2,performance around hypothesis-driven pilot
studies that would demonstrate the source-to-health outcome concept should provide a
reasonable metric to measure the success of the program from both a science and policy
perspective.                          .

The overall timeline for the MYP is fixed by the NAAQS review and revision process, which
specifies the next NAAQS revision cycle begins in FY 2012.  Within this timeframe, the MYP
will establish intermediate Annual Performance Goals (APGs) and associated Annual
Performance Measures (APMs).  Beyond an example of these short-term goals, the draft MYP
does not appear to include a complete set of APGs and APMs. These will need to be provided in
the final MYP.

In the overall structure of the MYP and as part of this review, the Subcommittee has reviewed
the original 10 research priorities identified in the initial NRC PM review, 5 crosscutting
research issues identified by the NRC Volume IV report, 2 LTGs that form the center piece of
the MYP, and, finally, 3 EPA themes within which research results are presented for review.
These latter themes include: (1) Health and Exposure; (2) Air Quality; and (3) Source-to-Health
Outcomes.  It woujd be useful in the MYP to  have a clear delineation among these different ways
of addressing the research needs and corresponding research plans. How do the original 10
research priorities flow  into the 5 crosscutting themes? How are these embodied in the two
LTGs, and how are these addressed in an integrated way within the three EPA research themes?
It also would be useful to show the linkage between development of integrated teams (via the
existing laboratories, centers, and extramural  projects) and the LTGs.

   Is the extramural program adequately  integrated into the program MYP and goals?

The extramural program includes PM Centers, PM Supersites, and other projects funded via the
Science To Achieve Results (STAR) grants program. These are critical pieces in the overall
research program because they provide intensive regional efforts across the country, which are
yielding important new data regarding PM (and ozone) air quality data and health impacts, and,
thus, the beginnings of linked emissions-health outcomes.  The extramural program represents a
significant fraction of PM and ozone funding by EPA, and there are close ties via relevance
reviews and project reports reviewed by EPA staff. STAR grant requests are developed through
a process that specifically addresses EPA research needs. Thus, there appears to be adequate
integration of the extramural program within the MYP.

Does the PM & 03 MYP structure reflect an "outcome" orientation that provides measures
          demonstrating the true impact on public health and the environment?

It seems clear that the LTGs have been written specifically to address the need for an "outcome"
orientation. The measures of success that accompany each LTG, as described above, are aimed
at documenting how public health is affected by changes in regulation of PM and Os and at
understanding the mechanisms by which these changes occur.  Further details regarding short-
term goals are needed.
 10
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       Is the ORD PM & Oa Research Program responsive to the recommendations
                      of the NRC in terms of products and outputs?
            Are the near- and long-term visions of the program consistent with
                      the NRC-noted "challenges for the future"?

The PM & O3 MYP appears to address directly NRC (and OMB) concerns in terms of the LTGs,
the plan to meet these goals, and the ways to measure progress toward these goals. In turn, the
MYP also addresses the near- and long-term visions in a manner consistent with the NRC
crosscutting research issues. To a large extent, this effort to be responsive is embodied in the
source-attribute-health outcome concept that underlies the LTGs.  By adopting this source-to-
health outcome concept, it is necessary to have emissions and air quality scientists working
closely with health outcome investigators. This moves EPA toward integration of efforts across
disciplines, and it is necessary to develop and apply tools—measurement, modeling, and health
impact methods—to move beyond PM mass toward PM biochemical properties. The source-to-
health outcome concept will require the development of innovative proximity measurement
techniques and demonstration studies to evaluate source apportionment modeling approaches.  In
addition, the adoption of the one atmosphere concept that ties PM with ozone as a foundation for
research will have common threads with air toxics and hazardous air pollutants, which also will
have linkages with the source-to-health outcome paradigm.
 iTaffiflffoarffifr^^
As noted in the MYP, each ORD laboratory is focused on one aspect related to the risk
assessment paradigm.  With the growing emphasis on source-to-health outcome, however, close
coordination of efforts between various laboratories is essential.  Examples of this coordination,
as noted by EPA, include collaborative work between the National Health and Environmental
Effects Research Laboratory (NHEERL) and the National Exposure Research Laboratory
(NERL) for the study of PM effects on highway patrol troopers and collaborative  work between
NHEERL and the National Risk Management Research Laboratory (NRMRL) to  study health
effects of various combustion sources. In addition, the development of the MYP inherently
includes input from the laboratories, as well as from the ORD administration so there is feedback
in research planning among all of the participants.

             Is the work within the ORD laboratories and centers integrated
                           to maximize resource investment?

As noted above, there is coordination of research among the laboratories and centers, and the
MYP outlines LTGs that require an integrated effort by each specialty area. It is more difficult,
however, to judge the degree of integration that currently exists and the degree of integration that
is targeted. It would be helpful in this regard to develop measures of integration and measures of
success that such integration produces.  Documenting the contributions to key findings by
different disciplines and the mix of disciplines represented by co-authors on peer-reviewed
papers might help measure the success of these integration efforts.
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            Is EPA ORD providing evident and appropriate science leadership
                              and program management?

The responsiveness of the PM & Oj Research Program to NRC recommendations, the
development of appropriate LTGs, integration of research across EPA laboratories, and the
overall structure of the MYP are all indications of successful program management.  Science
leadership comes from the role EPA has assumed as the lead federal agency on PM issues, as
well as from the quality of the science that has evolved in the EPA PM & 63 Research Program.
Key steps that will continue to provide science leadership have been the adoption of the one
atmosphere approach and the incorporation of the emission source-to-health outcome paradigm.
These are guiding concepts for moving the research program ahead.

          Are there changes or refinements in management or science leadership
	that are needed to improve the Program?	

The NRC Volume IV report noted that there have been frequent personnel changes of the NPD
and that more stability in this position would improve overall program management. As noted
by EPA, a permanent director has recently been appointed, which should  improve overall
management stability. EPA also notes that there is close coordination between ORD and OAR;
this coordination will be critical in meeting the MYP LTGs as they relate to responsiveness
between science and regulatory action. The NRC also recommended implementation of modern
computer-based management tools to help track short- and long-term goals, resources, and
integration of efforts. The Air NPD reports that ORD has established a PM Research Web
Page10 as a portal to the PM research information available from each ORD laboratory and
center. The link to ORD's National Center for Environmental Research (NCER) Web Site
provides access to project abstracts, progress and final reports, and publication listings for all PM
research grants; however, EPA is only in the initial stages of implementing the NRC
recommendation to develop this resource into a single repository that includes a comprehensive,
easily accessible database of all ongoing research projects. ORD reportedly plans to develop a
multipurpose PM & 03 Web site that will be built on information access starting with the latest
NCER listing of PM and  ozone publications, inclusive of reference citation and an abstract for
each.  This database will  be maintained in a commonly available commercial bibliographic
scheme that can be easily downloaded and used  by the science community.  Similarly, updated
project descriptions and linkages to other relevant Web sites (e.g., EPA, PM Centers, and other
federal agencies, etc.) also will be available.
  fa ffhra FiiM (oIMJ) mi ilfcfertjlf (WTry7iTrrTftei||T|g jfe nmrfTigi fte fte pfFfoffte errtfl ffire
The NRC recommended implementation of methods to focus on communication of research
needs from OAR and research results from ORD; EPA responded to this recommendation and
noted that working groups were formed to address specific issues.  In addition, an executive
steering committee composed of the three Laboratory Directors and the Director of OAR's
Office of Air Quality Planning and Standards was formed. ORD also employs a variety of
methods to maintain communication with the EPA regions and other OAR offices. These
  http://www.epa.gov/pmresearch.
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include annual briefings, assignment of an ORD liaison to each region, and regular electronic
conferences.

Communication with the broader scientific community occurs through the peer-reviewed
literature, via presentations by EPA scientists at national and international scientific conferences,
and via EPA Web" sites. Scientific results also are communicated to the public via the Web and
through press releases and public documents.

         What can be done to improve communication and access to information
                        by regulatory and science communities?

The NRC recommended development of a PM (and ozone) database that is searchable via the
Web. EPA plans to implement this database, but it does not yet exist. This kind of database,
encompassing all of the crosscutting research issues, would promote greater exchange of
scientific knowledge between EPA and the broader community, and it also would promote
greater integration of knowledge across disciplines both within and outside the Agency. Within
the air quality community, there has been an effort to promote the Community Multiscale Air
Quality (CMAQ) system as a community model through ready availability of the code and
updates, annual workshops, and limited support for a center of CMAQ activities. This effort is a
good example of how EPA can communicate results and, in turn, take advantage of independent
work in the broader community.

        To what extent has EPA established and utilized other agencies (inside and
           outside the government) in advancing the Agency's research agenda?
       Is the interaction and leadership role of EPA ORD with other federal agencies
         through the Committee on Environment and Natural Resources (CENR)
                       effectively providing national coordination?

The cross-Agency Particulate Matter Work Group, co-chaired by EPA and the National Institute
of Environmental Health Sciences (NIEHS), has tasks to: (1) integrate health, exposure,
ecology, atmospheric process, and source characterization research pertaining to PM matter;
(2) coordinate efforts among U.S. federal  agencies and, as feasible, the private sector; and
(3) address the highest research priorities  first to inform public policy choices for standard
setting and air quality management.  Through periodic meetings and a coordinated response to
the NRC recommendations and other reports, it appears that this group, with leadership from
ORD, is an effective way to promote a unified federal research response to PM (and ozone). The
NRC reviewed the situation with respect to a coordinated federal PM research agenda and
offered several recommendations. These  included establishing multi-agency goals and measures
of success in meeting national goals, preparing an MYP for PM that incorporates other federal
agencies, as well as states and private organizations, defining the roles of individual agencies,
obtaining input from nonfederal organizations into the federal planning process, and expanding
communication of the planning process to the public. These remain worthwhile
recommendations and areas where ORD can assume a leadership role.
Particulate Matter and Ozone Research Program Review Report
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                CHARGE QUESTION 2:  SCIENCE QUALITY

The Subcommittee review of the research program finds the overall science being conducted by
the EPA ORD intramural research laboratories to be high quality; the scientific investigative
activities contracted to individual research laboratories as well as the PM Centers in various
regions of the nation also are recognized as high quality. These evaluations are formulated on
the basis of supporting evidence as represented in the following four categories: (1) scholarship
and scientific publications; (2) credentials of participating investigators; (3) integrative and
outcome-oriented program design; and (4) building a knowledge base and information database.

The scholarship and scientific publications have demonstrated their high quality. More than
1,100 publications between 1998 and February 2005 address various key issues in PM research
and document high productivity and scholarly activity.  These publications received a high
number of citations (e.g., more than 320 manuscripts are among the top 10 percent being cited—
and the overall average citations of all manuscripts is 10 times higher than the average for the
entire environmental literature), documenting a strong impact in the scientific community and
society on PM-related issues. In the most recent iteration of the PM Staff Paper (January 2005),
approximately 40 percent of the post-1998 citations involve work conducted under the intramural
PM & 63 Research Program, according to OAR staff.

The high quality of the science is demonstrated by the credentials of the participating
investigators.  Review of the biographic sketches of the participating investigators finds that
participating scientists in both the intramural program and the extramural programs possess
excellent to outstanding scientific credentials.  Evidence of their individual scholarly
achievements includes excellent to outstanding track records, leadership roles in particular
scientific subjects, and knowledgeable presentations at program review (poster sessions).  The
diversity and the collection of the investigator expertise serve to enhance the overall quality of
the science. Multiple participating investigators are national- or world-known scholars with
expertise and specialty in an array of scientific disciplines and communities. The credentials of
the participating investigators served to assure a high scientific quality; however, members of the
Subcommittee expressed the opinion that future BOSC reviews would  benefit from more
detailed information on how projects were actually executed, particularly, identification of all
key investigators, whether EPA staff, partner agencies, or researchers under contract.

High quality is demonstrated in the integrated and outcome-oriented program design. This is
evidenced by a comprehensive design of an outcome-based research program with a well-
qualified and effective management team; scientific approaches that integrate multiple models
and utilize validated approaches with the appropriate mix of state-of-the-art technologies;
scientific goals that link emission sources to health effects; and publications in the scientific
literature, active Web sites, program calls/conferences, and communication programs.  ORD
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promotes communication of its science and strives to enhance the distribution of its information
database.

High quality is demonstrated in building a knowledge base in PM and its related information
database. The building of the scientific  knowledge base and the collection of its related
information database have served to define what was largely unknown. This knowledge base
and information database have served to identify and characterize the toxic source (physical and
chemical characteristics and the temporal profile and distributions of PM, e.g., roadways as
mobile sources and associated PM distributions along the freeway) and its related health effects.
Thus, these scientific accomplishments have effectively reduced uncertainties in understanding
the adverse toxicity of PM exposure and informed the regulatory process, contributing to
improving health outcomes.  Scientific discoveries are made in  defining and quantifying the
toxicity of PM, which served to build a knowledge base that previously did not exist. The
knowledge base and information database are used to build air pollution models to analyze and
predict exposure outcomes and associated health effects. Scientific progress made in the PM
Research Program established biological plausibility, linking health effects to components
toward sources. The knowledge base and  information  database are used to educate the public
(e.g., white papers by the American Heart Association formulated on the knowledge base
provided by EPA  PM research), to facilitate prevention, and to minimize disease occurrence
(e.g., myocardial infarction), linking scientific discoveries to improve human health. The
scientific progress made has advanced significantly our understanding pertaining to how PM
contributes to the  pathogenesis of various disease phenotypes, documenting that the adverse
effects of PM are  multifaceted in nature and, therefore, providing novel information  for potential
therapeutic regimens. Several projects and centers have attempted to establish potential
genomic, proteomic, and physiological biomarkers/parameters to  assess the sensitivity and
susceptibility on population subsets to PM exposure. These investigations have the potential to
aid the identification, monitoring, and regulation of air pollution exposure to humans. They have
profound implications in serving the EPA  goals to improve human health.

The Subcommittee review of the  research  program finds that the overall science being conducted
by the ORD laboratories and centers is targeted to address the perceived needs. These
evaluations are formulated on the basis of supporting evidence as represented below.
                         i
Three specific themes are organized to comprehensively address the perceived needs. The theme
on Health and Exposure research addresses the following specific questions:
    1. What are the PM components responsible for its adverse effects?
   2. Who is susceptible to the adverse effects of PM?
   3. How does PM cause adverse health effects?
   4. What are the effects of long-term exposure to PM?

The theme on Air Quality Management addresses targeted issues, such as:
    1. What is the atmospheric characterization of PM and its co-pollutants; its mass,
       composition, and variability?
   2. What are the sources of PM and co-pollutants and precursors?
   3. What are the processes that govern PM (and co-pollutants)? .
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Through research topics and program management, this theme tackles important scientific and
regulatory issues of PM with respect to atmospheric environment, exposure impacts, and
regulatory policies.

The theme on Source-to-Health Outcome recognizes that health outcomes are linked to sources
by a continuum of interconnected biological, chemical, and physical behaviors. It supports
research projects to facilitate a greater degree of integration across disciplines and to improve our
understanding of the overall impact of PM.  Insights provided by studies in this theme
characterized multisource or single-source effects (e.g., Utah Valley), clues to toxic attributes,
ambient particles  in controlled exposures, distribution of pollutants, and air quality models to
track PM from specific sources; delineated the effects of complex mixtures; and ultimately
supported decision making.

NRC research priorities are implemented for PM research to meet the perceived needs. Program
management and the planning process set research priorities to facilitate the implementation of
NRC priorities. The program review process assures the directions and quality of the science
projects.

There is integration of the LTGs to address the perceived needs.  The LTGs are established to
reduce uncertainty in exposure and health effects and to serve the perceived needs. The LTGs
are organized to link and integrate source-to-health outcome with more efficient strategies.

         Is program  integration across laboratories, centers, and science discipline
                     making full advantage of research opportunities?

The Subcommittee finds that there is high integration across the various laboratories, centers,
and scientific disciplines. This is evidenced in the information presented  below.

Program integration ensures synergistic interactions. There is  a strong interaction, coordination,
and synergism among various laboratories and centers, as is evidenced in the oral presentations,
poster presentations, and  documents provided to the Subcommittee. It also is apparent that the
management of these projects includes planning and procedures that ensure vibrant scientific
communications (such as conference calls, investigator meetings at various locations, and the
active management of Web site information).

Resource and information sharing maximize research opportunities. With limited resources, the
program design has aimed at leveraging resources wherever and whenever possible to maximize
the research opportunities.  A large portfolio on these issues is funded through the global priority
($30 million over the past 4 or 5 years).  Investigators at various laboratories and centers are
encouraged to share resources.  It is clear from the poster presentations that multiple laboratories
have shared specimens, samples, technologies, scientific discoveries, and an information
database. The global view of ORD has integrated tightly, and  this has transpired  in the research
program across both the intramural laboratories and the extramural centers. The scientific
information sharing process has stimulated research development and discoveries among
different centers and laboratories.
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                    i^ ilfarea f Ofte rowm jmnn^ (Ttrrft f?ffl? to rrnfrfofNtrrefi?
The extramural programs are funded through Requests for Applications (RFAs), which undergo
the normal competitive, merit-based review processes. Investigators across the nation are
encouraged to apply to these grants, and the review process has ensured high-quality research
that is targeted to NRC priorities.

The funding priorities for the intramural programs are set according to NRC and ORD research
priorities for PM, but the exact criteria are less transparent than those for the extramural grants.
Based on the high productivity and high quality of science that is coming out of these programs,
however, it is clear that the funding process is highly directed and prioritized, and the decisions
made were appropriate. The Subcommittee was informed at the meeting that each intramural
laboratory distributes the resources differently. Principal investigators (Pis) are invited to
provide proposals, and they are encouraged to be interactive among different laboratories. In
general, the funds are distributed internally based on the demonstrated ability to deliver the
products, the productivity, and the credentials of the PI.
Particulate Matter and Ozone Research Program Review Report

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                    CHARGE QUESTION 3: RELEVANCE
The OMB PART criteria for relevance are articulated as follows:

"RELEVANCE" refers to the contextual framework for the identification of priority research
questions related to EPA's regulatory mission and is related to the following questions:

"v* Is there an overall conceptual framework with clear goals and priorities?

4- Is the program based on Agency priorities and does it include input from potential users of
   the research outputs?

$• Is the core research relevant to problem-driven areas of high priority to the Agency?

•$• Does the program leverage its efforts with federal and other laboratories to study high-impact
   environmental questions?"

The charge questions presented below were posed to the Subcommittee by EPA to address the
issue of relevance.
      (fie SJSK <•& (Ife S£M? @8JQMOB exafi SfeMMb IMgMEQ dM% o^jfea) to Qssm
The BOSC Subcommittee finds that the research directions and rationales for the PM
components of the MYP are clearly articulated both in EPA documents, such as the 2003 PM
MYP, and in a variety of assessments undertaken by external organizations, most notably the
NRC. Congress and EPA requested guidance on PM research from the latter institution, which
established a blue-ribbon Committee on Research Priorities for Airborne Particulate Matter in
1998. The NRC committee was charged with formulating a research agenda and with
periodically monitoring progress in reducing the uncertainties in the evidence used as the basis
for setting the NAAQS for PM. The NRC has undertaken extensive reviews of prior and
ongoing research and has issued four reports, most recently in 2004. Initially, the NRC proposed
10 areas of emphasis, focusing mainly on issues related to health research, but, in subsequent
reports, added 2 additional topic areas to its research portfolio, specifically atmospheric
measurements and methods and source-to-health outcome assessments. An overarching focus
for all of these issues was conducting research that would reduce the inherent level of uncertainty
in each area. In the opinion of the BOSC Subcommittee, the NRC research recommendations
have formed a central intellectual core around which much of the ORD PM Research Program
has been structured. Within the compass of the Subcommittee's review, all of EPA's PM
research projects, both  intramural and extramural, have been designed to answer questions or
develop methods within the broad categories recommended by the NRC.

The most recent NRC assessment of research progress on PM indicates substantial progress in
some areas and less in others. The NRC recognized that investigations in certain areas would
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 have to be addressed serially, which is reflected in part in the sequencing of EPA's intermediate-
 and longer term research objectives. For other topics, the NRC intimated that it would have
 liked to see greater progress. The Subcommittee, however, finds that, viewed in toto, the EPA
 PM Research Program has resulted in dramatic reductions in scientific uncertainty in critical
 areas, especially (among many others) the relationship of ambient (outdoor), fixed-site PM
 monitoring to real-world human exposures; the identification of susceptible subpopulations; the
 identification of biologically plausible mechanisms of PM toxicity (including cardiovascular
 effects); and the validity of PM epidemiological studies, critically examining the potential effects
 of confounding by co-pollutants and misclassification of exposure.  The Agency's current
 research agenda will build on these achievements and help strengthen the basis for the PM
 standards' protection of public health.

 The Subcommittee finds that the outputs produced by the research to support these reductions in
 uncertainty have provided a sound basis for subsequent improvements in public health
 (outcomes) in the out-years estimated in the most recent (2005) PM Staff Paper to result from
 revising the PM NAAQS.  The current ORD PM program appears to provide an exceptional
 blend of research outputs targeted at uncertainty reduction and outcome-directed research to
 assist OAR in protecting public health. The Subcommittee considers this blend of output- and
 outcome-directed research critical to the long-term success and relevance of the program.

 In contrast to EPA's strong commitment to multidimensional PM-related research, there is little
 rationale adduced by EPA for the decision to end health-related research on ozone. In
 epidemiological  studies examining the relationship of PM with various health outcomes, the
 potential confounding influence of ozone must be considered; however, this is not an optimal
 strategy to investigate ozone's effects. Although  it is clear that exposures to ambient PM impart
 significant risks to public health at  and below the levels of the current ambient air quality
 standards, similar considerations also may apply to ozone. During the 1980s and early 1990s,
 ORD researchers demonstrated that controlled, multi-hour ozone exposures of exercising adults
 resulted in lung inflammation, airway hyperreactivity, reduced lung function, and respiratory
 symptoms, even at the lowest concentration tested (0.08 ppm).11 The federal ambient air quality
 standard for ozone of 0.08 ppm, averaged over 8 hours, provides little, if any, margin of safety
 against these and possibly other effects.  Moreover, recent epidemiological studies suggest that
 ozone exposure is, like PM, associated with increased daily mortality. 2

 Although the importance of continued research emphasis on PM is clear, the strategic decision to
 terminate ozone-associated health research effectively undercuts part of ORD's LTG 1: "In
 2012, reduced uncertainties in the air pollution sciences will lead to more effective and efficient
 PM and ozone standard setting and air quality management during each regulatory cycle to
 minimize adverse risks to human health and the environment." The extent to which ozone is
 associated with increased mortality or other health effects (e.g., new cases of asthma13)
 represents an area of scientific uncertainty that impinges on the health-protectiveness of the
 existing ozone NAAQS. These concerns are echoed in the most recent formal peer review of
'  " Horstman,,et al., 1990 ; Devlin, et al., 1991; McDonnell, et al., 1991.

  l2See,e.g., Bell, etal., 2004.

  13 See McConnell, et al., 2002.
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ORD's NERL (September 30 - October 2, 2003): "There are concerns about the yet unresolved
issues regarding sources of ground-level ozone, the ability to adequately model its formation and
fate, and to fully understand its effects on human health. It is hoped that research on knowledge
gaps regarding ground-level ozone can be funded adequately so that important control policy
questions can be answered." Therefore, absent a renewed commitment to ozone health research,
the ozone component of LTG 1 is not adequately addressed in the PM & Os MYP.  Recognizing
that EPA faces serious research resource constraints, the Subcommittee nevertheless
recommends that ORD reconsider the decision to completely disinvest in ozone health
research.14

Although a stated commitment (in the material provided to the Subcommittee by ORD) has been
made to fund several key research efforts to completion within the PM & 63 plan (notably the
Multi-Ethnic Study of Atherosclerosis-Air Study and the PM Centers), similar guarantees for
funding out-years of other long-term programs do not appear to exist.  EPA staff described an
internal review process to make focused program reductions, when necessary, but this process
was not transparent to the Subcommittee.  The Subcommittee recommends that decisions to
significantly reduce funding for any activated intramural project within the PM & Os Program
should undergo a review by the Air RCT.  This would take full advantage of the integrated
oversight and review mechanism already in place to guide the PM & Oj Program. Such
structured review is considered critical to ensure long-term funding accountability, especially
when resource reductions are unavoidable or new scientific findings warrant project redirection
or reprioritization.
 to t&3                           SB OajGBB of                           mM
The Clean Air Act directs EPA to set ambient air quality standards with an adequate margin of
safety "that are requisite to protect public health." This legislative mandate represents the
ultimate authority and rationale for EPA's research program, which is intended to provide the
scientific support for such standards. Epidemiological research described in the most recent
(2004) Air Quality Criteria Document (AQCD) has convincingly demonstrated that ambient PM
exposures are linked with increased risks of premature mortality, hospital admissions and
emergency room visits for both cardiovascular and pulmonary disease, asthma attacks, missed
14                                                                                \
  Bell ML, McDermott A, Zeger SL, Samet JM, Dominici F. Ozone and short-term mortality in 95 U.S. urban
  communities, 1987-2000. JAMA 2004;292(19):2372-2378.
  Devlin RB, McDonnell WF, Mann R, Becker S, House DE, Schreinemachers D, Koren HS. Exposure of humans
  to ambient levels of ozone for 6.6 hours causes cellular and biochemical changes in the lung. AmJRespir Cell
  Afo/fl/o/1991;4(l):72-81.
  Horstman DH, Folinsbee LJ, Ives PJ, Abdul-Salaam S, McDonnell WF. Ozone concentration and pulmonary
  response relationships for 6.6-hour exposures with five hours of moderate exercise to 0.08,0.10, and 0.12 ppm.
  Am Rev Respir Dis 1990;142(5):1158-1163.
  McConnell R, Berhane K, Gilliland F, London SJ, Islam T, Gauderman WJ, Avol E, Margolis HG, Peters JM.
  Asthma in exercising children exposed to ozone: a cohort study. Lancet 2002;359(9304):386-391.
  McDonnell WF, Kehrl HR, Abdul-Salaam S, Ives PJ, Folinsbee LJ, Devlin RB, OT^eil JJ, Horstman DH.
  Respiratory response of humans exposed to low levels of ozone for 6.6 hours. Arch Environ Health
  1991;46(3):145-150.
  National Research Council.  Committee on Research Priorities for Airborne Particulate Matter.  Washington, DC,
  National Academy of Sciences, 2004, 240 pp.
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school and work days, long-term effects on children's lung growth and development, and other
adverse effects.  Studies of the associations of both long- and short-term exposures to ambient
PM indicate that the risks of adverse effects increase with increased levels of exposure.  This
evidence is presented in encyclopedic detail in the AQCD produced by ORD and applied in the
Staff Paper, which is compiled by OAR with extensive input from ORD scientists.

The logical corollary to the increase in health risks associated with increased ambient PM is that
sustained decreases in pollutant concentrations would result in significant improvements in
public health. ORD is intent on  increasing research to ascertain the extent to which
improvements in air quality result in improvements in public health, an area that has been
dubbed "accountability research."  At first blush, this would seem to be a relatively
straightforward enterprise; however, such research is actually quite difficult to undertake in a
scripted manner in the absence of abrupt changes in pollution. Nevertheless, there have been a
few "natural experiments" that have corroborated the notion that reductions in air pollution result
in observable decreases in adverse health events. One dramatic example involved the Utah
Valley, where respiratory hospital admissions decreased substantially during a steel mill closure
in the mid-1980s, increasing again when the mill reopened (Pope, 1989). Recent ORD research
provided biological support for this epidemiological finding in a toxicological investigation of
the pro-inflammatory effects of PM collected in the Utah Valley both when the mill was
operating and when it was not.15 Similarly, after coal distribution was banned in 1990 in Dublin,
Ireland, nontraumatic mortality, including respiratory and cardiovascular deaths, dropped
substantially within the next few years, coincident with  the decrease in coal combustion
emissions.16  New, as-yet-unpublished analyses of mortality in the Harvard Six Cities study also
indicate that tliere is markedly less PM-associated mortality in cities where there have been
substantial reductions in ambient PM.

Until additional accountability research is undertaken, however, the public health benefits of
pollution control will have to be based on estimates derived from existing epidemiological
studies.  Such benefits are enormous. In 2003, OMB produced a  report estimating that air
pollution regulations resulted  in an annual savings of $101 to $119 billion from 1992 to 2002,
due to avoidance of premature deaths, hospitalizations, emergency room visits, and lost
workdays.17

An additional public benefit resulting from ORD research has been the provision of tools to the
general public, health care providers, and certain institutions (e.g., schools) to raise awareness of
pollution-associated health effects and to allow for nonregulatory, individual actions to reduce
15 Dye JA, Lehmann JR, McGee JK, Winsett DW, Ledbetter AD, Everitt JI, Ghio AJ, Costa DL. Acute pulmonary
  toxicity of participate matter filter extracts in rats:  coherence with epidemiologic studies in Utah Valley
  residents. Environ Health Perspect 2001;109(Suppl 3):395-403.

16 Clancy L, Goodman P, Sinclair H, Dockery DW. Effect of air-pollution control on death rates in Dublin, Ireland:
  an intervention study, iawef 2002;360(9341):1210-1214.
  Goodman PG, Dockery DW, Clancy L. Cause-specific mortality and the extended effects of particulate pollution
  and temperature exposure. Environ Health Perspect 2004; 112(2): 179-185.

17 See Table 2, p. 8 of OMB report.
  Pope CA III.  Respiratory disease associated with community air pollution and a steel mill, Utah Valley. AmJ
  Public Health 1989;79(5):623-628.
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personal exposures to ozone and PM. ORD staff members have worked in collaboration with
their primary client, OAR, to develop a nationally uniform air quality index (AQI), which is
transmitted via local media and on the Web so that potentially susceptible populations can alter
their activities to reduce exposures, depending on local air quality. The utility of the AQI has
been critically dependent on ORD's continually improving air quality modeling efforts, which
are used to predict local pollutant concentrations, facilitating the transmission of relevant
information in a timely manner.  Other OAR tools developed with ORD assistance include
educational materials for health care providers, such as downloadable pollutant fact sheets, a
Web-based course on air pollution and health, and a medical office poster for patient education.

During the face-to-face meeting, Dr. Mark Utell  clearly illustrated the dramatic strides the PM
Research Program has made in the past decade in convincing clinicians of the adverse impacts of
minute quantities of air pollutants.  He noted that neither cardiologists nor cardiovascular
physiologists seriously linked cardiac mortality and morbidity with air pollution in 1999. By
2004, however, the American Heart Association  issued a formal statement acknowledging the
linkage.18 This change in thinking was accomplished in only 5 years, clearly indicating the
strength and relevance of the science, as well as the effectiveness of the mechanisms used to
convey the messages to the medical community,  particularly through publication in high-caliber
medical journals.
 S®mSIGQfip®9S3^rt
             "•"..'...,.    . ,.'     •  • '       ..   /'..  •  ,-'. '  .•   ;"'.  ..  •:'.-
ORD's primary client for the PM & Oa Research Program outputs within EPA is OAR, which is
responsible for periodically reviewing and, if necessary, revising the NAAQS. In general, the
Subcommittee believes the primary clients and stakeholders for the PM & 63 Research Program
(i.e., OAR and the EPA regions) have multiple opportunities for involvement in ORD's
assessment of research needs and direction (see response to Charge Question 4) and that ORD
has provided useful information to these groups. ORD staff and programs play critical roles in
assisting OAR to fulfill its mission. First and foremost, ORD's National Center for
Environmental Assessment and other scientific staff develop AQCDs, encyclopedic compilations
of relevant scientific results with multiple OAR applications, specifically: (1) providing the
scientific foundations for air quality standards and other regulations; (2) identifying important
gaps to be addressed in future research; (3) providing input into assessments of the benefits of air
quality regulations; and (4) serving as a resource for the development of OAR's public outreach
and education efforts, such as the AQI or posters for health care professionals. OAR staff
members synthesize the materials presented in the AQCD to formulate policy-relevant
recommendations for the NAAQS.  ORD  scientists also provide technical peer review and
consultation in the development of both the staff paper and the NAAQS.
Regarding the utility of the information developed for OAR, the Subcommittee believes that the
compass of research sponsored by or conducted intramurally under the auspices of the PM
18 Brook ED, Franklin B, Cascio W, Hong Y, Howard G, Lipsett M, Luepker R, Mittleman M, Samet J, Smith SC
   Jr, Tager I. Air pollution and cardiovascular disease: a statement for healthcare professionals from the Expert
   Panel on Population and Prevention Science of the American Heart Association. Circulation 2004;109(21):2655-
   2671.
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Program since 1997, has been extremely important in reducing major scientific uncertainties
related to the PM NAAQS.  For example, in 1997 the scientific database regarding the biological
plausibility of serious human toxicity from ambient PM exposures was quite thin. In contrast,
caused in large part by research sponsored by or conducted intramurally by ORD, there is a
substantial body of evidence supporting biological plausibility, including major contributions on
potential mechanisms such as oxidative stress and inflammation (Froines and Ohio posters),
cellular signal transduction (Samet poster), perturbations of hemostasis and cardiac autonomic
balance (Cascio poster), alterations of vascular function (Frampton and Dreher posters), focal
hyperdeposition of particles in'individuals with preexisting lung disease (Kim poster), and
ultrafine particle uptake and reactivity (Froines and OberdOrster posters).  Most of this work was
undertaken directly by ORD scientists or by investigators funded by NCER, notably the Southern
California and the Rochester PM Centers. In its intramural research, ORD scientists have
provided many of the important reports utilized by OAR in developing Staff Papers.  In the most
recent iteration of the PM Staff Paper (January 2005), approximately 40 percent of the post-1998
citations involve work undertaken by the intramural PM Research Program, according to OAR
staff.

A number of other research projects highlighted during the Subcommittee Meeting illustrated
forward-looking efforts to examine source-to-health outcome relationships among the general
population and among those with the high exposures, including both healthy and compromised
individuals. In the Detroit Exposure and Aerosol Research Study, subjects within the Detroit
metropolitan area have been selected in part based on their residential proximity to localized
sources (Vette poster).  Other ORD studies examine the impact of high-level experimental
exposures to mobile source emissions among both healthy adults (the Car-related Occupational
PM and Air Toxics Exposure to Patrolmen Study) and potentially compromised older subjects
(the St. Louis bus study; Suh poster). The Baldauf poster described mobile source emission
characterizations, allowing for the examination of a wide range of source strengths and exposure
proximity.  The latter posters illustrate  the relevance of the development of science within ORD
that will inform OAR's future regulatory processes. The Subcommittee supports the
development of research characterizing the  intersection of the most exposed with the most
susceptible subpopulations as important components in evaluating the potential health benefits of
different regulatory scenarios.

Throughout the research planning process in ORD, there are frequent opportunities for OAR and
the other principal EPA internal clients (the regions) to provide input.  The Air RCT, which plays
a pivotal role in all research planning for the air programs, includes a regional representative and
senior scientists from OAR.  The RCT holds weekly teleconferences; another weekly conference
call is dedicated specifically to PM-related research. The regional representative receives input
from the various regions and from the states regarding their needs for implementation-related
research, such as improvements to CMAQ modeling. In addition, ORD representatives attend
annual meetings of the regional offices, both to provide information about the current state of
relevant research and to elicit input from the Regions on their needs. In addition, representatives
of the NCER STAR program go to the regional offices to present information on STAR research
and to receive regional feedback. Thus, there are many opportunities for ORD's primary
stakeholders to provide input to research planning.

With respect to research intended to  assist states and tribes with implementation of standards, the
Subcommittee believes that EPA has made  substantial progress in recent years. Standing

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committees have been established to provide formal outreach to states and tribes to help assess
and address the needs of both of the latter groups with respect to measurement technology,
emissions inventories, and air quality modeling. For instance, EPA staff and extramural grantees
have been developing measurement technologies for coarse particles, including quality
assurance/quality control protocols, which will be needed at the local level to implement any
future coarse particle standard.

Some Subcommittee members voiced concerns, however, that EPA has not undertaken sufficient
anticipatory  research for coarse particles, as it has been clear for nearly 5 years that an NAAQS
for PMio-2.5  would be required by the courts.  Moreover, the poster by Vanderpool highlighted
Subcommittee concerns that some aspects of the PMio-2.5 research within ORD and the potential
monitoring network deployment by OAR should be revisited. Specifically, the apparent absence
of siting criteria for PM 10-2.5 monitors and very limited funding to deploy significant numbers of
samplers may seriously affect the representativeness of any data collected.  PMio-2.5 is known to
be much more spatially variable in metropolitan areas.  The influences of factors such as
proximity to localized sources (e.g., roadway dust resuspension), ground cloud concentrations by
height, bluff body biases from nearby obstructions, and so forth, need to be considered.
Otherwise, the data produced could seriously be biased. Having an insufficient number of
PMio-2.5 samplers to characterize these potential spatial biases also could produce databases
lacking the robustness needed to support epidemiological studies or other outcome assessments.
The organizational integration between ORD and OAR in the PM & 03 Research Program that
was demonstrated to the Subcommittee should, in principle, facilitate addressing technical issues
such as these, which require blending research and regulatory requirements to meet multiple
objectives in the most technically sound and cost-effective manner.

In addition to its pursuit of policy- and implementation-relevant research objectives, ORD has
continued to pursue  other long-range anticipatory research components to answer  questions not
considered necessary for its primary client's near-term programmatic needs. With input from
OAR and other stakeholders, ORD supports research that could play important roles in out-year
Staff Papers. Examples include research on source and exposure characterization, dosimetry,
and health effects of ultrafine particles (UFPs). Recent findings now clearly demonstrate  that
UFP can generate significant oxidative stress relative to either PM^s or PMi 0-2.5 and can produce
adverse responses both in the lung and at distal sites (OberdSrster and Froines posters). Ambient
concentrations of UFP are markedly elevated on and near roadways (Suh and Sioutas posters)
and may explain some of the adverse respiratory and other effects associated with residences
near heavily trafficked streets. As with coarse particles, however, some Subcommittee members
expressed concern that the timing and magnitude of ORD research funding may not have  been
commensurate with the apparent toxicity of or the breadth of population exposures to UFP.

Overall, the  Subcommittee finds that ORD has been responsive to the needs of its primary client,
OAR, and to its secondary stakeholders, particularly the Regions and the states. ORD staff
members and officials regularly interact with these and other stakeholders and make
conscientious and frequently productive efforts to meet their needs.

During the Subcommittee's review, it transpired that there is no institutionalized formal
mechanism for ORD to assess stakeholders' perceptions of its performance. Such a mechanism
could be a useful means for ORD to help gauge its progress in providing relevant  information
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and tools to its clients. Therefore, the Subcommittee recommends that ORD consider
establishing a periodic formalized process for assessing its primary stakeholders' perceptions of
and satisfaction with its efforts.

Since the inception of the enhanced PM & Oj Research Program in 1998, ORD has incorporated
the recommendations of the NRC Committee on Research Priorities for Airborne Paniculate
Matter into its research planning process.  These general recommendations have formed the core
of the PM research effort in ORD and are clearly reflected in the PM MYP (2003).  These
research directions have been supplemented by the Fine Particle Assessment of NARSTO19,
which focused mainly on issues related to standards implementation, and those of the Clean Air
Act Advisory Committee. In general, the Subcommittee recognizes that ORD seriously
considers the research recommendations of these independent expert panels.

Two of the ORD laboratories (NHEERL and NERL) have institutionalized periodic formal peer
review processes to address not only the technical quality of their scientific programs, but also
their relevance to EPA needs.  Excerpts from the most recent peer review of NHEERL provided
to the Subcommittee indicate strong support for the Human Studies Division's (HSD) research
on PM components, susceptibility, and mechanisms (e.g., "HSD scientists have a proven track
record of identifying major scientific  uncertainties and then designing and carrying out
appropriate research approaches to address them"), balanced with recommendations for
improvements.

Although NCER has not established formal periodic reviews of its programs, the NRC conducted
an assessment of the STAR program in 2002-2003, including an evaluation of NCER's PM
research.20 The NRC review committee provided a highly favorable assessment of the STAR
program's research scope, process, and relevance to EPA's mission, indicating at the same time,
however, that the STAR program was still too young to assess in terms of its programmatic
impact. In addition, EPA's Science Advisory Board evaluated NCER's PM Center program in
2002,21 likewise providing positive, complimentary feedback on this program, along with
guidance for future directions, which  EPA has incorporated into its research planning. The
RFAs issued by NCER are developed with iterative input from  the RCTs, and are intended to
complement EPA's intramural research program. Proposals submitted in response to NCER
RFAs are rigorously reviewed by independent scientists; those proposals receiving favorable
assessments then are evaluated by ORD's Programmatic Review Panel (including representation
from OAR and the Regions, as well as ORD), which makes funding recommendations based on,
" Formerly an acronym for the North American Research Strategy for Tropospheric Ozone, the term NARSTO has
become simply a wordmark signifying a tri-national (U.S., Canada, and Mexico), public-private partnership dealing
with multiple features of tropospheric pollution, including ozone and suspended PM.

20 http://books.nap.edu/catalog/! 0701 .html.

21 http://www.epa.gov/sab/pdfec02008.pdf.
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among other things, relevance to EPA's mission and the addition of balance to the existing
research portfolio.

One of the primary venues for the identification of research gaps has been the cyclic
development of AQCDs by ORD and the Staff Paper by OAR. This process affords numerous
opportunities for the identification of important research gaps by both ORD scientists and those
associated with OAR and other stakeholders. The process of compiling an assessment of
research illuminates not only what is known, but also what is still unknown. One result of the
Staff Paper development is to identify important research gaps; for instance, Section 5.5 of the
most recent PM Staff Paper (January 2005) is entitled "Summary of Key Uncertainties and
Research Recommendations Related to Setting Primary PM Standards," and includes seven high-
priority areas for PM research prior to the next cycle of review.  Development of the AQCD and
the Staff Paper are very public processes, during which there are multiple occasions for input
from OAR and other stakeholders with  respect to the identification of research needs. Toward
the end of the AQCD/Staff Paper process, EPA holds workshops to provide input into the
Research Needs Document, with OAR as the lead office. -This Research Needs Document is
incorporated into all aspects of the Air RCT's planning processes. Thus, OAR plays a large role
in determining that the allocation of research funding is relevant to its programmatic needs.

Although the results of research endeavors may reduce important scientific uncertainties, they
may raise additional previously unrecognized questions. As discussed in the Subcommittee's
response to the previous charge question, recent research on UFP deposition and clearance
indicated that such tiny particles can cross the lung surface into the bloodstream to be transported
to other organs, elevating the importance of their potential toxicity. Although this finding
narrowed one aspect of uncertainty about a potential mechanism by which particles in the lung
could cause systemic effects (i.e., could particles act directly on distant organs?), it also raised
questions about whether such particles also could cross another tissue barrier to go directly into
the brain (via the olfactory nerve). Toxicological experiments recently undertaken at the
University of Rochester PM Center, funded by ORD, have demonstrated that such translocation
of particles into the brain does indeed occur, resulting in inflammation in the area of deposition.
This in turn creates additional uncertainties (e.g., can exposure to PM cause chronic, low-level
neurological inflammation, resulting in brain damage and dementia?).  Thus, although research
can lay to rest some uncertainties, it also can generate new and often highly relevant questions.
The absence of funding to permit followup on promising lines of research  undermines the
strength of the PM & Os Research Program, which is at a stage of discovery that would likely
yield important new understanding from opportunities to expand research  in key areas.  The
Subcommittee finds that, were such funds set aside for anticipatory research projects, the PM &
03 Research Program would effectively employ them.

Both the AQCD and the Staff Paper are reviewed by the Clean Air Scientific Advisory
Committee (CASAC), which generally includes not only academic experts, but also at least one
representative each from industry, public health organizations, and the states. The CASAC
provides advice to the EPA Administrator and essentially has de facto authority with respect to
the quality and relevance of the science contained in both documents.  Given CASAC's
institutional prominence and the high visibility of it reviews, ORD must address that committee's
concerns regarding research needs.  Although other stakeholders are afforded opportunities at
CASAC meetings to voice their opinions regarding the quality of the science in the AQCD and
Staff Paper, this does not appear to represent an optimal setting to identify research gaps that
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EPA incorporates into its planning process. A more appropriate public forum would be the
workshops sponsored by OAR during the development of the Research Needs Document.

An additional avenue by which ORD identifies research needs is through interactions and
collaborations with other organizations that fund research on air pollution, including federal
agencies, the Health Effects Institute (HEI), and industry institutes. Along with NIEHS, EPA co-
chairs the Particulate Matter Workgroup of the interagency CENR that comprises 22 federal
agency representatives, including several of the National Institutes of Health, the Centers for
Disease Control and Prevention, the Department of Energy, the Department of Transportation,
and the Department of Defense, among others. This CENR workgroup meets bimonthly with the
goals of integrating and prioritizing PM-related research and coordinating their efforts to
eliminate duplication.  One recent outgrowth of this collaboration was the issuance of a joint
EPA-NIEHS RFA soliciting research proposals to examine the role of PM in cardiovascular
disease. The explosion of recent research suggesting major health impacts of traffic emissions
has created an area of common concern to many of the CENR participants that may result in
cross-agency partnerships to examine traffic-related exposures and health effects.

The HEI owes its existence to funding provided by ORD, OAR, and industry. A joint OAR-
ORD committee coordinates research priorities with HEI, which has funded several major efforts
that have complemented EPA's PM research, including the National Morbidity, Mortality, and
Air Pollution Study of the largest metropolitan areas in the United States, as well as detailed re-
analyses of the two large longitudinal epidemiological studies that serve as the principal
foundation of the annual average PM NAAQS.

ORD also has, on occasion, worked jointly with industry funders on specific research projects,
such as the extension of the Atlanta Supersite research into the Aerosol Research and Inhalation
Epidemiology Study, which is largely supported by the Electric Power Research Institute. ORD
also has partnered with HEI and the Coordinating Research Council on the Advanced
Collaborative Emissions Study, which was originally  proposed by the Engine Manufacturers
Association  to measure emissions and examine potential health  effects of new diesel engines
designed to meet on-road heavy-duty emissions standards. Though somewhat opportunistic,
these examples indicate ORD's willingness to leverage its scarce resources by investing with the
private sector in pursuit of research objectives of mutual interest.  Such partnering appears easily
facilitated through existing linkages to organizations such as HEI and NARSTO and can
potentially provide significant leveraging of available PM & Oa resources. Neither the criteria
by which such projects are selected nor the process of prioritization of these efforts relative  to
other research needs, however, was obvious to the Subcommittee.
                                            U.S.


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         CHARGE QUESTION 4: DEMONSTRATED OUTCOMES


The two LTGs of ORD's PM & Os Research Program were introduced under Charge Question 1.
These LTGs are qualitative, and there must be quantitative goals/measures to assess progress and
success.

As discussed under Charge Question 1: Program Design and Demonstrated Leadership, some
minor changes in the wording of the two LTGs identified in the MYP for the PM & Oj Research
Program have been suggested and, most importantly, the Subcommittee proposes consideration
of a hypothesis-driven approach in tracking and quantifying progress in LTG 2. The linking of
health outcomes to sources entails unraveling the complex interactions and contributions of
primary and secondary pollutants to human exposure and demonstration of the overall toxicity of
source-specific components.  The Subcommittee believes that demonstration of the viability of
the source-to-health outcome concept would be best served through well-designed hypothesis-
driven pilot studies.

The following questions raised in the "Charge to the BOSC Subcommittee" are aimed at
assessing whether EPA has developed quantitative goals/measures and how well EPA is doing
with respect to those goals/measures.
                 ixsiBam
The program has defined several specific long-term performance measures that adequately focus
on outcomes and that are consistent with the purpose of the ORD program. EPA provided
examples of possible measures to the BOSC Subcommittee on page 11 of Section 2 - Multi-Year
Plan Development. Those measures are listed below in italics for each LTG. Many of those
measures are, at this point, qualitative rather than quantitative. EPA acknowledges that "[t]he
measures require a degree of quantification." We provide below some guidance to quantify
those measures so that progress made by the program can be assessed.

                                      LTG1

         By 2012, enhance understanding in the air pollution sciences and reduce
       associated uncertainties leading to more effective and efficient PM and ozone
       standard setting and air quality management during each regulatory cycle to
              minimize adverse risks to human health and the environment.

ORD publications in AQCD will exceed 20 percent. This is a reasonable measure because the
AQCDs for ozone and PM provide a comprehensive review of the state-of-the-science. Another
additional measure could be added; for example, 20 percent of citations in the air quality,
exposure, and health effect literature will correspond to ORD-sponsored publications. Such
measures (20 percent) seem realistic based on the current level of high-quality research
sponsored by ORD;
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Atmospheric models -will show incremental improvements in predicting real-world ambient PM
and ozone levels—every 2 years an improved model will be formally released and adopted for
field use. This measure as currently stated is too vague. The term "improved" should be
quantified because improvements can range from minor to significant. The performance of
CMAQ has improved significantly over the past few years because of improvements in model
formulation and inputs (emissions). The performance of CMAQ (and other similar air quality
models), however, is still poor for PM components because of our limited understanding of
atmospheric processes (e.g., formation of secondary organic aerosols from volatile organic
compounds [VOCs]) and uncertainties in model inputs (mostly meteorology and emissions).
The CMAQ update cycle, as proposed, will provide a steady stream of "new and better"
chemical kinetic modules, but unless the essential model inputs also improve (especially 3-D
meteorology and emissions), state, local government, and tribal entities may construct State
Implementation Plans that do not reflect the best information. The Subcommittee recommends
that an independent expert panel be responsible to define the current uncertainties associated
with the modeling of ozone and PM ambient air concentrations. Those uncertainties could be
characterized according to a ranking similar to that used in the NARSTO report for PM air
quality modeling. To better track progress, five uncertainty categories could be used: very high,
high, moderate, low, and very low. Then, the expert panel would evaluate progress made for
each of the areas under consideration according to a realistic schedule (e.g., every 2 years).

Real-world reductions yield less health impacts (accountability. This is an important measure.
Some examples of progress made over the past several years were provided by EPA using results
from the Harvard Six Cities study (evolution of annual average PM concentrations and mortality
relative risk). EPA should propose some quantification of this measure along the same lines.
EPA also should consider quantifying the health benefits.  Research into improved
methodologies for estimating health benefits may be needed in that regard.

The accumulated peer-reviewed literature in the air pollution sciences will be compiled and
interpreted about every 5 years for review in AQCD. This is a valuable measure of the use of
ORD's sponsored research for the development of NAAQS. The schedule is consistent with that
for the AQCD (although some delays will typically be associated with CASAC review for the
preparation of the final versions of the AQCD).

At 3-4 year intervals, ad hoc expert review panels assess progress on the NRC Topic Areas or
through the use of "expert elicitation "-like approaches. This measure is important as it provides
outside expert judgment on EPA ORD's progress toward the stated LTG 1. One of the expert
review panels should address the improvements made in the air quality model CMAQ (see
recommendation above).  The Subcommittee recommends that, in addition to the NRC topic
areas, those ad hoc expert review panels also address the eight NARSTO "policy questions." To
facilitate the evaluation of progress, a baseline of the current uncertainties should first be
established for each component of the program. The expert panels then can assess the
uncertainties at regular intervals and measure progress accordingly. The frequency of the
reviews should be selected to correspond to the pace of anticipated progress in the various
components of the program (i.e., it should be about 2 years for the evaluation of improvement in
CMAQ).
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                                        LTG 2

        By 2015, demonstrate the integrated linkages of pollutant sources to health
          outcomes and reduce their associated uncertainties to ensure that ORD
        clients target air pollutant strategies most effectively and efficiently to best
                       protect human health and the environment.

Multi-city approaches show coherence across disciplines attributing health impacts to hazardous
components/sources—a hierarchy of source risk will be established (10 percent per year).
Coherence across disciplines is an important point. The Utah Valley smelter study (poster
presented by Alice Dye)  is one example of how coherence among different disciplines can
provide an answer to a real-world air pollution problem. The EPA goal of one city per year
seems reasonable.

Actions lead to most cost-effective strategies for improving public health.  This cost-
effectiveness measure is  very valuable as the costs associated with the control of air pollution
can be significant. EPA needs to develop a methodology to clarify how this cost-effectiveness
will be quantified. There needs to be recognition that cost-benefit analyses can be biased as
control costs are frequently overestimated and health benefits are underestimated.

At regular and frequent intervals, ad hoc expert review panels assess progress on the source-to-
health outcome. The ad hoc expert review panels will play a similar role as for LTG  1. The
Subcommittee recommends that the frequency of the reviews be less than 5 years (e.g., 3 to 4
years) to provide for a minimum of three reviews through 2015 and to ensure a continuous
evaluation of progress toward LTG 2.

The program -willfully integrate from the sciences to the regulatory process to create flexible
and cost-effective approaches to protecting the public from air pollution.  The  use of hypotheses
(e.g., "primary PM causes health effects") was proposed above as an effective way to measure
progress toward LTG 2.  The Subcommittee recommends that the hypotheses proposed by EPA
should first be reviewed by an expert panel. EPA then may revise some hypotheses based on
comments received from the panel.  Then, the expert panel will review progress on the work
conducted to address those hypotheses every 5 years.  At the time of those reviews, some
hypotheses may be confirmed, whereas others may not.  New hypotheses then  may be proposed
based on new available information. This approach will provide the flexibility needed for the
integrated source-to-health outcome process by allowing ORE) to adjust its hypotheses (and the
related research) at regular intervals.
Key science questions include the questions raised by the NRC Committee that focus mostly, but
not exclusively, on health effects and the questions raised by the NARSTO Assessment that
focus mostly on the emissions/PM concentrations relationships (the NARSTO questions are
actually called "policy questions," but they are technical questions meant to address policy
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issues).  One question is similar in the NRC and NARSTO lists (relationship between emissions
and PM concentrations) that would give a list of 17 questions. NARSTO also raises the key
question: "How can we measure progress?" that relates to this entire section.

Based on the review of the work accomplished by ORD's program (as presented in the oral
presentations and the corresponding posters), the Subcommittee concluded that significant
progress has been made in the various areas of the research program.

Although the PM program has made significant strides in addressing some of the key health
issues, there remains much that needs to be done.  As with any well-designed research program,
new and unexpected questions have arisen from the findings of research completed to date.
Based on the funded projects and their timelines, the program seems to have some flexibility to
follow promising new leads when identified.

Since the late 1990s, EPA's research program has focused on PM.  Recently, EPA staff has
recognized that there are still significant questions remaining with reference to the public health
impacts of ozone.  Consequently, the PM research program has been expanded to include ozone.
The return to investigation of ozone impacts is welcome and overdue.

In many cases, the questions and data gaps with reference to ozone readily fit into the same
topics as those that have guided the PM Research Program. Since the beginning of the emphasis
on PM research, only a few studies have included ozone, and much remains to be done in
planning an effective ozone research plan to move forward. There does not, however, appear to
be a developed plan-for ozone health research, at least based on the materials presented for
review.

The following charge questions in the "Charge to the BOSC Subcommittee" are broken down
into sub-questions.

         Has the program made adequate progress in meeting its long-term goals?

Several independent reviews (e.g., Fourth NRC report) have stated that'EPA was making
significant progress. The Subcommittee review of the posters also suggests that EPA is making
significant progress.

   Are there baselines and appropriate targets and timeframes for long-term measures?

Baselines need to be established for the various areas of the programs. The Subcommittee
recommends that expert panels define the current levels of uncertainties in the various areas of
the program. Those uncertainties would constitute the baselines.  The NARSTO Assessment
report provides a suitable listing of the current state-of-the-science for the air quality portion that
can be used to provide the baselines for the emissions/ambient concentration component.
Perhaps the NRC report can provide baselines for the health and exposure components. EPA
then can define quantitative targets with associated timeframes to reduce the uncertainties. For
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example, what uncertainties are associated with organic PM? The expert panels then would
review progress with respect to the baselines and those targets.

         Have the research products been consistent with the program's goals and
                               supportive of client needs?

The overall answer is "yes." There are, however, some areas where ORD work products have
been lagging behind the needs of the community because of a lack of resources. One example is
the development of emission inventories for biogenic VOCs that are PM precursors. Although
EPA has conducted.some excellent research work to characterize emissions of biogenic VOCs
from vegetation, the incorporation of the resulting information into practical tools (such as the
emission models) is slow. Although the biogenic emission inventory system, BEIS3, now
includes monoterpene speciation, it took several years before it became available and it still does
not include sesquiterpenes. This problem is caused in part by a lack of resources (i.e., not
enough full-time equivalents) but possibly also in part to insufficient planning across disciplines.
The Subcommittee recommends that adequate resources be assigned to the timely transfer of
fundamental research products to practical tools that can be used for air quality management.

      Are the research program findings incorporated into regulation and standards,
              published in the peer-reviewed literature, or do they otherwise
                         demonstrate superior scientific quality?

The overall answer is "yes." The ORD-sponsored research includes some scientific products of
high quality (see answer to Charge Question 2).

Results from EPA-funded research are normally published in the peer-reviewed literature. It
contributes significantly to NAAQS reviews, review of AAQS in California, and to air quality
standards abroad as well.
It appears that there are several mechanisms in place for independent evaluations of ORD's
research (pp.  19-21 of Response Question 3).  Those evaluations seem to focus on the overall
quality and quantity of the results, the major uncertainties and scientific gaps, and future
directions.  Independent detailed technical reviews could be set up for specific work products;
for example, independent review of a biostatistical analysis of epidemiological data (such a
review was done a few years ago for the Harvard Six Cities and American Cancer Society data),
independent review of the CMAQ computer code,.and so on.  Such reviews would be expensive
and would have to be selected carefully.
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        Does the program demonstrate improved efficiencies and cost effectiveness
                         in achieving program goals each year?

The program demonstrates an effective use of research funding to advance the state-of-the-
science with real-world benefits in terms of material that is used by OAR to develop air quality
standards and manage air quality.

EPA-ORD has shown some flexibility in adjusting to the changes resulting from new standards
(switch in emphasis from ozone to PM) and from new scientific results (addition of
cardiovascular PM risk). The review by expert panels of research conducted to address
hypotheses (see above) at regular intervals will provide the opportunity for EPA to adjust its
program's science and emphasis based on the results of the research and comments received
from the expert panel. It also will provide the opportunity to the expert panelto assess EPA's
flexibility.

 Is the program appropriately structured to allow for flexibility in direction and emphasis?


The program offers some flexibility to adjust to the needs of ORD's clients.  Examples include
the switch of health science from ozone to PM, the new focus on UFP and coarse particles, the
new interest in cardiovascular health effects of PM, and the increased interest in source-to-health
outcomes.
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                    APPENDIX A: CHARGE QUESTIONS
                     Charge for the BOSC Subcommittee on
                     Particulate Matter and Ozone Research
1.0  Objective

The objective of this review is to evaluate the relevance, quality, performance, as well as the
scientific and managerial leadership of Office of Research and Development's (ORD) Particulate
Matter and Ozone (PM & Os) Research Program.  The Subcommittee's evaluation and
recommendations will provide guidance to ORD to help:

•$• Plan, implement, and strengthen the Program;

•$• Make research investment decisions over the next 5 years;

•$• Refine the integration of the ORD Program with those of other federal agencies;

•$• Prepare EPA's performance and accountability reports to Congress under the Government
   Performance and Results Act; and

•$• Respond to evaluations of federal research such as those conducted by the Office of
   Management and Budget (OMB highlights the value of recommendations from independent
   expert panels in guidance to federal agencies1'2).

2.0  Background Information

Independent expert review is used extensively in industry, federal agencies, congressional
committees, and academia. The National Academy of Sciences (NAS) has recommended this
approach for evaluating federal research programs.3

Because of the nature of research, it is not possible to measure the creation of new knowledge as
it develops, or the pace at which research progresses or  scientific breakthroughs occur.
Demonstrating research contributions to outcomes is very challenging4 when federal agencies
conduct research to support regulatory decisions, and then rely on third parties,5 such as state
environmental agencies, to enforce the regulations and demonstrate environmental
improvements.  Typically, many years may be required for practical research applications to be
developed, and decades may be required for some research outcomes to be achieved.

Most of EPA's environmental research programs investigate complex environmental problems
and processes—combining use-inspired basic research6'7 with applied research and integrating
several scientific disciplines across a conceptual framework8 that links research to environmental
decisions or environmental outcomes. In multidisciplinary research programs such as these,
progress toward outcomes cannot be measured by outputs created in a single year. Rather,
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research progress occurs over several years as research teams explore hypotheses with individual
studies, interpret research findings, and then develop hypotheses for future studies.

In designing and managing its research programs, ORD emphasizes the importance of
identifying priority research questions to guide the research. Similarly, ORD recommends that
its programs develop a small number of performance goals that serve as indicators of progress.
Short-term outcomes are accomplished when research is applied by specific clients to strengthen
environmental decisions or regulations. These decisions and resulting actions (e.g., the reduction
of contaminant emissions or the reduction of uncertainties in risk assessment) ultimately
contribute to improved environmental quality and health.

In a comprehensive evaluation of science and research at EPA, the National Research Council
(NRC) recommended9 that the Agency substantially increase its efforts to explain the
significance of its research products and to assist clients inside and  outside the Agency in
applying them. In response to this recommendation, ORD has engaged science advisors from
client organizations to serve as members of its research program teams. These teams help
identify research contributions with significant decision-making value and help plan for their
transfer and application.

For EPA's environmental research programs, periodic retrospective analysis at intervals of 4 or 5
years is needed to characterize.research progress, to identify when clients are applying research
to strengthen environmental decisions, and to evaluate client feedback about the research.
Conducting program evaluation at this interval enables assessment  of research progress, the
scientific quality and decision-making value of the research, and whether research progress has
resulted in short-term outcomes for  specific clients.

In 1998, Congress augmented the budget for PM-related research and mandated the
establishment of an NRC Committee to assess the research needs for PM. The NRC Committee
since has published four reports of Research Priorities for Airborne Paniculate Matter, with
Volume IV published in October 2004.10 The four volumes have provided guidance to the PM &
Os Research Program in the form of an initial 10 (and eventually 12) priority research  areas
(needs). In these same reports, the NRC has submitted peer-expert evaluations of the Agency's
PM & Os Research Program that identify its strengths, productivity, and shortcomings, as well as
challenges for the future. Since 1998, ORD has aligned its research program with the NRC
priorities, evolving the relative emphases on these priorities with the development of the science,
client needs, and frequent peer reviews of all or selected parts of the program.

It is essential to appreciate that the ORD PM Program comprises an intramural research program
in health and implementation, as well  as an extramural (grant funded) program that is
complimentary and integrated by design to meet the needs of its client, the Office of Air and
Radiation. In completing the final report (Volume IV), the NRC provided its assessment of the
PM & Os  Research Program and its accomplishments and delineated a series of challenges for
the years ahead.  These challenges were provided in the presentation of the Committee Chair, Dr.
Jonathan Samet of Johns Hopkins University, to ORD at the completion of Volume  IV.  The
charge to the NRC Committee reviewing the PM Program now is complete, and the formal
Committee will cease to exist; however, it is expected that ad hoc committees will be convened
at points in the future to revisit the program priorities and directions.
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Beginning in 1997, ORD gradually redirected its long-standing Ozone Research Program,
initially focused on health and ecology, to allow for the growth and emphasis in health research
in PM. Agency-supported ozone-specific research in these areas currently is minimal. More
recently, an analogous adjustment has occurred in the implementation program as well. In the
latter case, the atmospheric science research in ozone and PM were merged in research of
atmospheric processes and modeling, as they are inextricably linked in the air environment.
With the disinvestment in the ozone-specific research and its emergence in a more integrated
form within the PM Program efforts in atmospheric chemistry and co-pollutant health research,
these two largely independent research programs have been fully merged, which is evidenced by
plans to revise the Multi-Year Plans (MYP) for PM and Ozone into a merged, single MYP.

In 2003, the PM Program underwent review by OMB using a novel approach to assess program
success. This approach used the Program Assessment Rating Tool (PART) that, in brief, focused
on:  (1) the relevance of the PM Program to its clients; (2) the clarity and specificity of its long-
term goals and resultant outcomes that could be linked explicitly with measurable improvements
in health and the environment; (3) research progress and performance; and (4) the resource
management that ensures high-quality research. Overall, the PM Program scored well in this
process, except in the areas designated in focus (2) requiring demonstrated measurable outcomes
in public health and the environment. As the PM and Ozone Programs have been merged and
enter a second PART review, the intent is to use this BOSC assessment of the program's new
structure, its management and leadership,  as well as its scientific achievements and directions to
guide preparations for the PART review, which will be conducted' in spring/summer 2004.

3.0   Draft Charge Questions for ORD's Participate Matter & Ozone Research Program

The following charge questions will help evaluate the relevance, quality, performance, as well as
management and scientific leadership of ORD's PM & Oa Research Program:

1.  Program Design and Demonstrated  Leadership

    •$•  Does the new draft PM & Os MYP structure reflect the identified science needs of the
       program and show integration and leveraging of human and fiscal resources?
       •   Is the PM & Os MYP structure strategic by design, implementation, and review?
       •   Does .the PM & Os MYP structure provide a reasonable "road-map" of the program
          demonstrating a well thought-out plan and identifying critical paths, clear goals,
          priorities, and schedules?
       •   Is the extramural program adequately integrated into the program MYP and goals?
       •   Does the PM & Os MYP structure reflect an "outcome" orientation that provides
          measures demonstrating the true impact on public health and the environment?
       •   Is the ORD PM & Os Program responsive to the recommendations of the NRC in
          terms of products and outputs?
       •   Are the near and long-term visions of the program consistent with the NRC -noted
          "challenges for the future"?

    4-  Is ORD sufficiently coordinating research across categories of the risk assessment
       paradigm (source, exposure, health, assessment, and management)?
       •   Is the work within laboratories and centers integrated to maximize resource
          investment?
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       Is EPA-ORD providing evident and appropriate science leadership and program
       management?
       •  Are there changes or refinements in management or science leadership that are
          needed to improve the program?

       Is EPA-ORD sufficiently communicating its results to its clients and the broader
       scientific community?
       •  What can be done to improve communication and access to information by regulatory
          and science communities?

       Are there important interagency or extramural collaborations that should and can be
       improved to advance the Agency's research agenda?
       •  To what extent has EPA established and utilized other organizations (inside and
          outside governments) in advancing the Agency's research agenda?
       •  Is the interaction and leadership role of EPA-ORD with other federal agencies
          through the Committee on Environment and Natural Resources effectively providing
          national coordination?
2. Science Quality
       Is the research being conducted by EPA-ORD laboratories and centers of recognized high
       quality and appropriate to the perceived needs?

       Is program integration across laboratories, centers, and science disciplines making full
       advantage of research opportunities?

       Does the program ensure high-quality research through competitive, merit-based
       funding? If funds are not competitively awarded, what process does the program use to
       allocate funds?  Does this process ensure that quality is maintained?
3.  Relevance
       Does the PM & O^ MYP structure and Research Program clearly reflect its focus and the
       rationale behind its research direction and out-year emphasis?

       Are the potential public benefits in terms of public health protection and pollution
       abatement clearly articulated?

       Has the PM & 03 Research Program effectively engaged stakeholders in its assessment
       processes and provided useful information and tools in a timely manner?
       Has the program begun to establish a process for using the results of assessments, along
       with stakeholder feedback, to identify key research gaps and to update the program's
       research agenda?
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4. Demonstrated Outcomes

   ^  Does the program have a limited number of specific long-term performance measures
       that focus on outcomes and meaningfully reflect the purpose of the program?

   4-  Has the program made significant progress in the conduct of the planned research and in
       answering the key science questions related to public health and pollution abatement?

   •$•  Does the program have ambitious targets and timeframes for long-term measures?
       •  Has the program made adequate progress in meeting its long-term goals?
       •  Are there baselines and appropriate targets for the program's annual measures?
       •  Have the program's research products been consistent with the program's goals and
          supportive of client needs?
       •  Are the research program's findings incorporated into regulations and standards,
          published in the peer-reviewed literature, or do they otherwise demonstrate superior
          scientific quality?

   •0-  Do independent evaluations of sufficient scope and quality indicate that the program is
       effective and is achieving results?
       •  Does the program demonstrate improved efficiencies and cost effectiveness in
          achieving program goals each year?

   4-  Do EPA-ORD and program leadership make adjustments in the program's science and
       emphasis to meet the evolving science and research needs?
       •  Is the program appropriately structured to allow for flexibility in direction and
          emphasis?

4.0  Potential BOSC Approach for Program Review

   •$•  Hold conference call(s) in the month preceding a face-to-face meeting.
       »•  Goal: Familiarize the Subcommittee with review objectives, introduce review
          materials, and make assignments for the face-to-face meeting.
          1. The Designated Federal Officer distributes  background materials and documents
             requested by the Subcommittee 4 weeks in  advance of the first conference call.
          2. ORD presents background materials to the Subcommittee during the first call for
             initial  orientation.
          3. The Subcommittee reviews and comments on the charge.
          4. The Subcommittee asks clarifying questions about the program  under review,
          5. The Subcommittee Chair makes review and writing assignments to Subcommittee
             members in advance of the face-to-face meeting.

   •^  Hold a 2 to 3 day face-to-face meeting for the program review at a location where a
       critical mass of ORD scientists is located.
       >  Goal:  A draft Subcommittee report is available for circulation and comment at the
          end of the face-to-face meeting that thoroughly addresses all charge questions.
          1. The first segment of the  meeting: ORD presentations and poster sessions,
             Subcommittee questions and discussion, identification of issues for further
             resolution.
38
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          2.  The second segment of the meeting: the Subcommittee discusses prepared
              written assignments in context of presentations and discussion, identifies and
              agrees to areas for change, elaboration, or other adjustment of the text as
              necessary.
          3.  The third segment of the meeting:  the Subcommittee revises written assignments
              and assembles them into a draft report.

   •$•  As necessary, hold one to two conference calls to complete the draft report in the month
       following the face-to-face meeting.
       *  Goal: A report approved by the Subcommittee is available for BOSC Executive
          Committee discussion/approval at the May 2005 BOSC Executive Committee
          meeting, with a final draft completed within 30 days following the meeting.

5.0  References

1  Budget Data Request 04-31.  Executive Office of the President, Office of Management and Budget.
   March 22,2004. "Completing the Program Assessment Rating Tool (PART) for the FY06 Review
   Process," pp. 50-56.

2  Memorandum for the Heads of Executive Departments and Agencies. Executive Office of the
   President, Office of Management and Budget. June 5,2003. "FY 2005 Interagency Research and
   Development Priorities," pp.  5-10.

3  Evaluating Federal Research Under the Government Performance and Results Act, National
   Research Council, Washington, DC, 1999.

4  The House Science Subcommittee. Letter to Dr. Bruce Alberts, President of the National Academy
   of Sciences, from F. James Sensenbrenner, Jr. and George E. Brown. October 23,  1997.

5  The Government Performance and Results Act: 1997 Government-wide Implementation Will Be
   . Uneven.  U.S. General Accounting Office (GAO/GGD), Washington, DC, 1997.

6  Building a Foundation for Sound Environmental Decisions, National Research Council, Washington,
   DC, 1997.

7  "Renewing the Compact between Science and Government," Stokes DE, in 1995 Forum Proceedings,
    Vannevar Bush II—Science for the 21st Century.  Sigma Xi, Research Triangle Park, NC, 1995, pp.
    15-32.

8  Risk Assessment in the Federal Government: Managing the Process, National Research Council,
   Washington, DC, 1983.
                                r
9  Strengthening Science at the U.S. Environmental Protection Agency, National Research Council,
   Washington, DC, 2000, p.  141.

10 National Research Council of the National Academies:  Research Priorities for Airborne Paniculate
   Matter IV, The National Academies Press, Washington, DC, 2004 (http://www.nap.edu; Volume IV -
   http://www.nap.edu/books/0309091993/html/).
Note: A PDF file of the OSTP/OMB Research and Development Investment Criteria was included with the
Charge.


Particulate Matter and Ozone Research Program Review Report                                     39

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            APPENDIX B:  BIOGRAPHICAL SKETCHES OF THE
                           SUBCOMMITTEE MEMBERS
Rogene Henderson, Ph.D.
Juarine Stewart, Ph.D.
Bart E. Croes, P.E.
40
Dr. Henderson is Director of the Lovelace Respiratory Symposium at the
Lovelace Respiratory Research Institute (LRRI), and Clinical Professor
at the University of New Mexico's College of Pharmacy.  She is a
National Associate of the National Academy of Sciences (NAS), and has
participated on NAS committees and EPA's Science Advisory Board.
Her research interests include: biochemistry of the lung; mechanisms by
which pulmonary inflammation leads to repair or chronic disease;
pharmacokinetics of inhaled xenobiotics; and chemical-specific
biomarkers of chemical exposure.  Dr. Henderson has studied the use of
biological markers of exposure and effects to link environmental
exposure to induced disease.  LRRI is an independent research institution
focused on respiratory health, funded by government agencies, industry
associations, private companies, health advocacy groups, and private
donors.

Dr. Stewart is the interim Dean of the School of Computer,
Mathematical, and Natural Sciences at Morgan State University in
Baltimore, Maryland. She received her Ph.D. in Biomedical Sciences
from the Oak Ridge Graduate School of Biomedical Sciences, University
of Tennessee at Knoxville, in 1978. She was a post-doctoral fellow in
Biochemistry at the Department of Chemistry at Clark Atlanta
University, Atlanta, Georgia, from 1979 to 1981. She has conducted
research and published on the subject of complex sphingolipids  at the
enzyme activity, protein, and mRNA levels. Dr. Stewart has served in
many professional capacities and presently is a member of the Visiting
Committee, Commission on Colleges, Southern Association of Colleges
and Schools; and Chair of the Department of Defense Review Committee
for Historically Black Colleges and Universities Prostate Cancer
Program. Prior to her position at Morgan State, Dr.  Stewart was a
Professor in the Department of Biological Sciences at Clark Atlanta
University.

Mr. Croes is the Chief of the Research Division of the California Air
Resources Board. He received his M.S. in Chemical Engineering from
the University of California at Santa Barbara, and is licensed by the State
of California as a Professional Engineer (P.E.). His  responsibilities for
the Research Division include: setting California ambient air quality
standards for paniculate matter, ozone, and nitrogen dioxide;  assessing
personal exposure and indoor air quality for homes,  schools, and in
vehicles; incorporating health impacts, cost/benefit analysis, and model
of the California economy  into the Diesel Risk Reduction Program and
other major state regulations; managing a research portfolio with $5 to
10 million in new projects  each year; and developing a 10-year strategic
research plan, annual research plans, and research plan for vulnerable
populations. Other recent research related activity includes: serving as a
consultant for projects in Canada (reactivity of alternative fuels), Mexico

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                            (air quality modeling), Germany (emission inventory reconciliation, *
                            hydrocarbon reactivity), The Netherlands (emission inventory
                            reconciliation, field study design), China (monitoring network design,
                            forecasting, modeling), and Thailand (reformulated fuels); serving as a
                            Program Manager for the $6 million 1997 Southern California Ozone
                            Study (SCOS97)-North American Research Strategy for Tropospheric
                            Ozone (NARSTO) and the $1 million SCOS97-NARSTO Aerosol
                            Program and Radiation Study (comprehensive efforts to better
                            understand the processes involved in the formation of high ozone and
                            PM concentrations in southern California); guided development of
                            hydrocarbon reactivity scale for California's Low Emission Vehicle/
                            Clean Fuel regulations; planned modeling and analysis of the $14 million
                            Southern California Air Quality Study in Los Angeles and designed the
                            data management process; and developed modeling guidelines for New
                            Source Review to include impacts of secondarily formed particles on
                            PMio and sulfate standards. His other professional services include:
                            invited participant to EPA's workshops to set national policy for
                            modeling in PMio State Implementation Plans; member of Ambient Air
                            Monitoring and Methods Subcommittee of the Clean Air Scientific
                            Advisory Committee (CAS AC), 2004-present; member of the Clean Air
                            Technical Advisory Group of the American Lung Association of
                            California (ALAC), 2004-present; member of the South Coast Air
                            Quality Management District (SCAQMD) Asthma Consortium Advisory
                            Committee, 2003-present; member of the SCAQMD Research Advisory
                            Committee, 2002-present; Public Sector Co-Chair for NARSTO, 2002-
                            2004; member of the Haagen-Smit Symposium Steering Committee,
                            2001-present; member of the California EPA-Resources Agency-
                            University of California at Davis Memorandum of Understanding Joint
                            Steering Committee, 2000-present; member of NARSTO Executive
                            Assembly, 2000-present; member of National Research Council
                            Committee on Research Priorities for Airborne Particulate Matter,  1998-
                            2004.

Kenneth Demerjian, Ph.D.   Dr. Demerjian is the Director of the Atmospheric Sciences Research
                            Center at the Albany State University of New York. He received his
                            Ph.D.  from The Ohio State University in Physical Chemistry in 1973 and
                            an M.S. in Physical Chemistry in 1970. Dr. Demerjian's research
                            interests include: chemical kinetics and mechanistic pathways of
                            elementary atmospheric reactions and the development of reaction
                            mechanisms of polluted and clean atmospheres; instrumentation
                            development and measurement of atmospheric trace gases and particulate
                            matter; development and evaluation of air quality forecast models and
                            diagnostic analysis of atmospheric processes  within  air quality modeling
                            systems; experimental and theoretical studies of actinic solar flux and
                            atmospheric photolytic rate constants; sources and evaluation of
                            uncertainty in theoretical models of atmospheric processes, air quality,
                            and pollutant exposures; and the articulation and effective use of
                            scientific uncertainty in the decision-making process. His awards include
                            the EPA Bronze Medal for Commendable service, and his professional
                            service includes:  Health Effects Institute Research Committee; CASAC
                            National Ambient Air Monitoring Strategy Subcommittee; Executive
                            Committee, Board on Oceans and Atmosphere of the National


Particulate Matter and Ozone Research Program Review Report                                       41

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Brian Lamb, Ph.D.
Association of State Universities and Land Grant Colleges; University
Corporation of Atmospheric Research Members' Nominating
Committee; National Research Council (NRC) Committee on
Atmospheric Chemistry, Co-Chair, Synthesis Team-NARSTO, 1996 to
2000; Coordinating Committee for the Atmospheric Chemistry and
Environmental Education in Global Change, 1994 to 1999; Chairman,
Peer Review Panel - NOX/VOC Science Program, Environment Canada,
1993; NRC/NAS Committee on Tropospheric Ozone Formation and
Measurement, 1989 to 1991; International Joint Commission Air Quality
Advisory Board/Expert Group on Monitoring, 1987 to 1991; Desert
Research Institute National Science Advisory Committee, 1988 to 1992;
Office of Technology Assessment, and U.S. Congress Advisory Panel
on the Assessment of New Clean Air Act Issues, 1987 to 1989. He has
published widely and recent invited lectures include: United Nations
Economic Commission for Europe EMEP Workshop on Paniculate
Matter Measurement and Modeling sponsored by the U.S. EPA and
Environment Canada, New Orleans, LA, April 19-23,2004; EPA
Carbonaceous PM:  The State of the Science (CPM II), Carbonaceous
PM2.s: Lessons [Being] Learned from the New York Supersite, April 11-
12; and Health Effects Institute, 2003 Annual Conference, Committee on
Health Impact of Regulations to Improve Air Quality, "What Is
Accountability?", Boulder, CO, May 4-6,2003.

Dr. Lamb is the Boeing Distinguished Professor of Environmental
Engineering at Idaho State University. He received his Ph.D. in
Chemistry in 1978 from the California Institute of Technology. Dr.
Lamb has been involved in atmospheric pollutant transport and
dispersion studies for more than 20 years.  This has involved a
combination of atmospheric tracer field studies and the development,
evaluation, and application of a variety of air quality models. Currently,
Dr. Lamb is directing the development of a real-time urban air quality
forecast system for the Puget Sound region of Seattle, as well as a project
to demonstrate the application of the EPA Community Multi-Scale Air
Quality model to the Pacific Northwest for regional haze. This has
involved development of detailed emission inventories, incorporation of
prognostic meteorological modeling, and evaluation of model
performance using an array of available monitoring data.  Dr. Lamb also
has directed the development of a regional windblown dust  air quality
model for the Columbia Plateau region of eastern Washington.  In related
work, Dr. Lamb has developed atmospheric tracer  instrumentation—
portable syringe samplers and real-time continuous tracer analyzers—
that have been widely used at Washington State  University (WSU) and
by others to probe the nature of pollutant transport and dispersion over
scales ranging from a few meters to hundreds of kilometers. Dr. Lamb
helped to pioneer the use of numerical 3-D turbulence models applied to
flow near buildings, and he was responsible for the development of one
of the first plume models designed to yield concentration fluctuation
statistics related to the instantaneous behavior of a plume. Dr. Lamb also
is involved in research concerning biogenic trace gas emissions and their
role in atmospheric chemistry. The EPA Biogenic Emission Inventory
System was originally developed under his direction at WSU.  Ongoing
work includes isoprene flux measurements in northern Michigan as  part
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                             of the National Science Foundation PROPHET program, measurement of
                             terpene emissions at an old growth Douglas fir forest using the Wind
                             River Crane Research Facility as part of the Department of Energy's
                             (DOE) terrestrial carbon exchange research, and development of a
                             revised biogenic emission inventory in the Pacific Northwest. These
                             studies  involve the application of eddy flux, relaxed eddy accumulation,
                             ambient sampling, and leaf/needle cuvette measurement methods.

Michael Lipsett, M.D., J.D.    Dr. Lipsett is the Chief of the Exposure Assessment Section in the
                             Environmental Health Investigations Branch of the California
                             Department of Health Services. He is licensed to practice medicine and
                             law in California and Board Certified in Public Health and General
                             Preventive Medicine. Dr. Lipsett received his J.D. from the University
                             of California at Berkeley in 1976, and his M.D. from the University of
                             California at San Diego in 1980. Current and recent research includes:
                             childhood asthma prevalence and risk factors at the border funded by the
                             Centers for Disease Control and Prevention; air pollution and
                             cardiovascular disease in the California Teachers Study, funded by the
                             California Air Resources Board; the relationship of ambient particulate
                             matter to heart rate variability and cardiac arrhythmias in a population of
                             elderly adults with coronary artery disease, supported by EPA; and the
                             Center  for the Health Assessment of Mothers and Children of Salinas.
                             He has an academic appointment as Associate Clinical Professor in the
                             University of California at San Francisco Department of Epidemiology
                             and Biostatistics.  His awards include: Gold Superior Achievement
                             Award (in recognition of exceptional contribution and service to state
                             government), Air Resources Board, 2002; Clean Air Award, ALAC,
                             1998; Clean Air ENVY (Environmental) Award, American Lung
                             Association, San Francisco/San Mateo, 1996; and Phi Beta Kappa, 1971.
                             Dr. Lipsett is a reviewer for numerous professional journals, including:
                             Environmental Health Perspectives,  Environmental Research, Journal of
                             Exposure Analysis and Environmental Epidemiology, American Journal
                             of Epidemiology, Epidemiology, New England Journal of Medicine,
                             American Journal of Respiratory and Critical Care Medicine, Inhalation
                             Toxicology, Israel Journal of Medical Sciences, International Journal of
                             Occupational and Environmental Medicine, Journal of Environmental
                             Medicine, and Thorax.  Additionally, he was a reviewer for the National
                             Science and Technology Council, Executive Office of the President of
                             the United States, "Interagency Assessment of Potential Health Risks
                             Associated with Oxygenated Gasoline," in 1996; and for the U.S. Global
                             Change Research Program, "U.S. National Assessment of the Potential
                             Consequences of Climate Variability and Change," submitted as a report
                             to the U.S. Congress in 2000.  His professional service includes: Multi-
                             Ethnic  Study of Atherosclerosis External Scientific Advisory Committee;
                             American Heart Association, Expert Panel on Population and Prevention
                             Science; American Thoracic Society, Environmental and Occupational
                           -  Health Assembly and the Committee to Update the Statement on "Health
                             Effects of Tremolite"; the ALAC Clean Air Technical Advisory Group;
                             and the Advisory Committee, University of California at Davis,
                             Environmental/Occupational Medicine Academic Award.
                                                            u.S. EPA He&.ci:>rrrv- Lbrary
                                                                   Mai! Cocb 34<>rr
                                                           1200 Pennsvivarfsa Avenue,  NW
Particulate Matter and Ozone Research Program Review Report          .<      2Q2-ilo6-u656        43

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Peipei Ping, Ph.D.
Charles E. Rodes, Ph.D.
Dr. Ping is a professor in the Department of Physiology and Division of
Cardiology at the University of California at Los Angeles (UCLA) and
Director of the Ischemia Biology Program and Proteomic Laboratory at
UCLA.  She received her Ph.D. in Physiology at the University of
Arizona in 1990. From 1991 to 1992, she was a fellow at the University
of North Carolina at Chapel Hill in Molecular Physiology and at the
University of California at San Diego from  1992 to 1994 in Molecular
Cardiology.  Dr. Ping has numerous ongoing research projects including:
PKC and Src protein tyrosine kinase signaling in preconditioning, the
long-term objective of which is to elucidate the signaling mechanisms
underlying the early and late phases of ischemia and NO donor-mediated
preconditioning; signaling mechanisms in pharmacological
preconditioning, the long-term objective of which is to explore the
signaling mechanisms of Src tyrosine kinases in pharmacological
preconditioning; mitochondria and Cardiac  Cell death, the long-term
objective of which is to explore the electrical property and signaling
event of mitochondrial permeability transition in hypoxia^induced
mitochondrial injury; and functional  proteomic characterization of
cardiac mitochondria, the objective of which is to  identify and
characterize multiprotein complexes in the cardiac mitochondria.  Dr.
Ping has received many honors including: University Scholar (University
of Louisville), 2000; Young Investigator Award (American Heart
Association [AHA]),  1998; Young Investigator Award (AHA), 1993;
Henry Christian Memorial Award (American Federation for Clinical
Research [AFCR]), 1993; Trainee Investigator Award (Association of
American Physicians, American Society for Clinical Investigation,
AFCR), 1993; Caroline turn Suden Professional Opportunity Award
(American Physiological Society), 1992; and Excellence in Research
Award (AHA), 1990. Her professional service includes: Fellow,
American Physiological Society, Cardiovascular Section, 2001-present;
Fellow, AHA Basic Science Council, 1999-present; Group Leader,
Myocardial Ischemia/Basic Science Council AHA, 2002; Founding
Council Member of Human Proteome Organization (HUPO), 2001;
Member of Executive Committee, 2002; Co-Leader, Cell Model
Proteome Initiative, 2002; Human Plasma Proteome Initiative, Member
of the Executive Committee, 2002-present;  Chair of Education/Training
Committee; Chair of HUPO Award Committee, 2003-2006; Chair of
Scientific Program Committee, HUPO, 2004 and 2006. Dr. Ping also is
a consulting and associate editor and on the editorial board of the
American Journal of Physiology Heart and Circulatory Physiology.

Dr. Rodes is a Senior Research Environmental Engineer at the Research
Triangle Institute (RTI) for planning^ conducting,  and managing
technical research covering a wide range of topics and technologies
associated with multimedia exposure assessment, with a focus on
aerosols. Dr. Rodes received his Ph.D. in Environmental Engineering
from the University of North Carolina at Chapel Hill in 1992.  He
received his M.S. in Chemical  Engineering from North Carolina State
University in 1971, and a B.S.  in Chemical  Engineering from Clemson
University in 1966. Dr. Rodes has more than 38 years of experience in
planning, conducting, managing, and reporting research, developmental,
and assessment activities across a broad range of environmental insults.
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                              Prior to joining RTI, Dr. Rodes worked for 23 years at EPA (1966-1988)
                              conducting both laboratory and field "bench" studies and managing
                              research.  His activities incorporate a diverse range of skills including:
                              multimedia/multiroute human exposure assessment; personal, indoor air,
                              and microenvironmental air sampling for size-specific aerosols and
                              gases; characterization of particle and gas phase collection media
                              performance for immune building application; designing sensor systems
                              for bio-chem threats; compartmental, receptor, and dispersion modeling
                              of contaminants in indoor and urban environments; relating exposures to
                              health indicators in panel study settings for adults and children; dermal
                              transfer characterization of dusts and residues; activity pattern
                              assessments for adults and children; in-vehicle contaminant exposure
                              assessment; indoor air velocity and turbulence characterizations; indoor
                              aerosol resuspension studies from carpeted flooring; pollution prevention
                              from indoor sources, PM2.j, PMjo, PMCOM5e, and total inspirable aerosol
                              sampler evaluations; and PM2.5 and PMio ambient aerosol sampling
                              studies in support of both health and visibility regulations. Presently, Dr.
                              Rodes is the Principal Investigator for the Detroit Exposure and Aerosol
                              Research Study in Detroit, Michigan, under contract to EPA. The
                              contract is supporting an indoor/outdoor/personal exposure study of
                              recruited adult participants in a multisource, multiseason metro area to
                              assess the relative contributions of sources to selected aerosol and
                              gaseous exposures in private residence settings. He has served in a
                              number of advisory roles including: a peer reviewer for the Health
                              Effects Institute, a topic-area expert (indoor aerosols) for the NRC, an
                              invited attendee for EPA workshops in dermal assessment and exposure
                              assessment planning for the National Children's Study, and an invited
                              writer for chapters of EPA's Air Quality Criteria Documents. In addition
                              to numerous conference presentations and peer-reviewed journal articles,
                              Dr. Rodes has co-authored three book chapters in the area of aerosol
                              exposure characterization, the most recent of which focuses on breathing
                              zone exposure issues.

Christian Seigneur, Ph.D.     Dr. Seigneur currently is Vice  President of the Air Quality Division at
                              Atmospheric & Environmental Research, Inc. (AER). AER was founded
                              in 1977 to provide government and industry with research and consulting
                              services in the atmospheric and environmental sciences.  Dr. Seigneur
                              received his Ph.D. in Chemical Engineering from the University of
                              Minnesota in 1978, and his M.S. in Chemistry from the Ecole Nationale
                              Supe>ieure de Chimie, in Paris, France, in 1974. Dr. Seigneur has more
                              than 20 years of experience in  air quality modeling and has developed
                              several atmospheric chemical kinetic mechanisms, including
                              mechanisms,for mercury, chromium, stack plumes, and acid formation  in
                              droplets and particles. He led the effort that provided the first published
                              demonstration of the nonlinearities of the SO2/sulfate and N0x/nitrate
                              relationships. He was the Principal Investigator for the development of
                              several air quality models that now are used by regulatory agencies in the
                              United States and abroad. His experience in the development,
                              evaluation, and application of air quality models spans a wide range of
                              air pollution issues, including photochemical smog (i.e., ozone and other
                              oxidants), particulate matter (PM2.5 and PMio), air toxics (dioxins,
                              mercury, volatile organic compounds, chromium, etc.), atmospheric


Particulate Matter and Ozone Research Program Review Report                                        45

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                             visibility, acid deposition, accidental releases of toxic and hazardous
                             chemicals, and indoor air pollution.  Dr. Seigneur has about 10 years of
                             experience in public health risk assessments. He has conducted research
                             for the development of new models and methodologies for risk
                             assessment  He was the Principal Investigator for the development of a
                             methodology to include uncertainties in risk assessments; this
                             methodology provided the basis for the approach recommended by the
                             NRC in the report entitled "Science and Judgment in Risk Assessment."
                             He has managed health risk assessments for fossil-fuel fired power
                             plants, refineries, oil production facilities, research and teaching
                             facilities, incinerators, and hazardous waste treatment, storage, and
                             disposal facilities. Dr. Seigneur was a member of the CASAC Panel on
                             Particulate. Matter that reviewed the new PM2.s NAAQS.  He also has
                             been invited to participate in numerous workshops, including the Expert
                             Panel on Atmospheric Processes of Mercury, the Society of
                             Environmental Toxicology and Chemistry Workshop on Criteria for
                             Persistence and Long-Range Transport of Chemicals in the Environment,
                             the Society for Risk Analysis Workshop on Probabilistic Risk
                             Assessment, and several DOE and EPA workshops on air quality and
                             risk assessment.
46
Particulate Matter and Ozone Research Program Review Report

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                     APPENDIX C:  AGENDA FOR THE
                      MARCH 30-31,2005 MEETING
                 U.S. EPA BOARD OF SCIENTIFIC COUNSELORS
                Participate Matter and Ozone Program Subcommittee

                              MEETING AGENDA
                          March 30,2005 - April 1,2005

                       U.S. Environmental Protection Agency
             109 T. W. Alexander Drive, Research Triangle Park, NC 27711

Wednesday. March 30.2005 (Room C-lll B/O	

8:00-8:30 a.m.       Registration

8:30-8:45 a.m.       Welcome and Opening Remarks             Dr. Rogene Henderson
                  Subcommittee Chair

8:45-8:50 a.m.       DFO Welcome and Charge                 Lawrence Martin (EPA)
                  - Administrative Procedures and FACA Rules   DFO
                  - Objective of This Subcommittee and Charge

8:50-9:00 a.m.       ORD's Welcome                         Dr. William Farland (EPA)
                  Acting DAA-Science, ORD

9:00-9:30 a.m.       Overview of ORD's Air Program             Dr. Daniel Costa (EPA)
                                                        ORD National Program
                                                        Director for Air

9:30-9:45 a.m.       Discussion of General Program Issues         Dr. Daniel Costa (EPA)
                                                        ORD National Program
                                                        Director for Air

9:45-10:00 a.m.      Break

Session 1:  NAAQS Health and Exposure Research

10:00-10:30 a.m.     Overview: Health and Exposure      -       Dr. Robert Devlin (EPA)
                                                        ORD/NHEERL

10:30 a.m.-12:00 noon Poster Session (Atrium)                    Subcommittee

12:00-12:30 p.m.  •   Discussion                              Subcommittee
             I

12:30-1:30 p.m.      Working Lunch                          Subcommittee
Paniculate Matter and Ozone Research Program Review Report                                 47

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                       LIST OF ACRONYMS (CONTINUED)
PM
PPM
RCT
RFA
RTF
SCAQMD
SCOS
STAR
UCLA
UFPs
VOCs
WSU
Paniculate Matter
Parts Per Million
Research Coordination Team
Request for Applications
Research Triangle Park           "
South Coast Air Quality Management District
Southern California Ozone Study
Science To Achieve Results
University of Cal ifornia at Los Angeles
Ultrafine Particles
Volatile Organic Compounds
Washington State University
             ws-,
54
                 Particulate Matter and Ozone Research Program Review Report

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                     APPENDIX C:  AGENDA FOR THE
                      MARCH 30-31,2005 MEETING
                 U.S. EPA BOARD OF SCIENTIFIC COUNSELORS
                Particulate Matter and Ozone Program Subcommittee

                              MEETING AGENDA
                          March 30,2005 - April 1,2005

                       U.S. Environmental Protection Agency
             109 T.W. Alexander Drive, Research Triangle Park, NC 27711

Wednesday. March 30.2005 (Room C-lll B/O	
8:00-8:30 a.m.       Registration

8:30-8:45 a.m.       Welcome and Opening Remarks
                  Subcommittee Chair

8:45-8:50 a.m.       DFO Welcome and Charge
                  - Administrative Procedures and FACA Rules
                  - Objective of This Subcommittee and Charge

8:50-9:00 a.m.     '  ORD's Welcome
                  Acting DAA-Science, ORD

9:00-9:30 a.m.       Overview of ORD's Air Program
9:30-9:45 a.m.       Discussion of General Program Issues



9:45-10:00 a.m.      Break

Session 1:  NAAQS Health and Exposure Research

10:00-10:30 a.m.     Overview: Health and Exposure


10:30 a.m.-12:00 noon Poster Session (Atrium)

12:00-12:30 p.m.     Discussion

12:30-1:30 p.m.      Working Lunch
Dr. Rogene Henderson
Lawrence Martin (EPA)
DFO
Dr. William Farland (EPA)
Dr. Daniel Costa (EPA)
ORD National Program
Director for Air

Dr. Daniel Costa (EPA)
ORD National Program
Director for Air
Dr. Robert Devlin (EPA)
ORD/NHEERL

Subcommittee

Subcommittee

Subcommittee
Particulate Matter and Ozone Research Program Review Report
                      47

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Session 2:  Air Quality Management Presentation

1:30-2:00 p.m.        Overview
2:00-3:30 p.m.

3:30-3:45 p.m.

3:45-4:15p.m.

4:15-5:30 p.m.

5:30 p.m.
                    Poster Session (Atrium)

                    Break

                    Discussion

                    Working Session

                    Adjourn
James VSckery (EPA)
ORD/NERL

Subcommittee
Subcommittee

Subcommittee
Thursday. March 31.2005 (Room C-lll B/Q
8:30-8:40 a.m.        Review of Wednesday's Activities
                    Overview of Today's Agenda
                                                             Dr. Rogene Henderson
                                                             Subcommittee Chair
Session 3:  Pollutant Source to Health Outcome: Moving Toward a "One Atmosphere'
Understanding of Air Pollution
8:40-9:10 a.m.
                    Overview
9:10-10:45 a.m.

10:45-11:00 a.m.

ll:00-ll:30a.m.

ll:30-ll:45a.m.
                    Poster Session (Atrium)

                    Break

                    Discussion

                    General Discussion Across Sessions

11:45 a.m.-12:45 p.m.  Working Lunch

Session 4: Perspectives on the Air Program

12:45-1:10 p.m.       Science Perspective
l:10-l:30p.m.


l:30-l:50p.m.

1:50-2:00 p.m.



2:00-5:00 p.m.
                    OAR Perspective


                    Public Perspectives

                    Science/Program Wrap-Up



                    Break/Work Session
Dr. Andy Miller (EPA)
ORD/NRMRL

Subcommittee
Subcommittee

Subcommittee

Subcommittee
Dr. Mark Utell
Co-Director PM Center/
University of Rochester

John Bachmann (EPA)
OAQPS/OAR
Dr. Daniel Costa (EPA)
ORD National Program
Director for Air

Subcommittee
48
                                       Paniculate Matter and Ozone Research Program Review Report

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5:00-5:30 p.m.        Debrief                                    Subcommittee
                    Oral Report on Charge Questions

5:30 p.m.            Adjourn


Friday. April 1.2005 (Room C-lll B/Q	

8:00-8:10 a.m.        Review of Thursday's Activities               Dr. Rogene Henderson
                                                               Subcommittee Chair

8:10 a.m.-12:00 noon  Work Session

12:00 noon           Adjourn
Paniculate Mailer and Ozone Research Program Review Report                                      49

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                 PARTICULATE MATTER
              RESEARCH PROGRAM REVIEW
               List of Themes and Poster Titles
! ? ;* -^TSiSsX 'rJHS^r^rvisfe!/^ ^si'^fc^fcyi* 4 <;.„, a-"' -.-,: ^ , • •": ' ; . ' ' : • .
%ii*ifS«ESSI®MtSHE^^ •" : ••••-.- '
3~--!^:&«r8SSa!tedSS^^ vs-r,-;i!ij..i"!. ;;,- ,.• „ :: ' •-.,, •
What Are the Adverse Health Effects Associated With Exposure to PM and How Are
These Effects Caused?
What Is the Relationship Between Personal Exposure and Ambient Fixed Site
Measurements?
What Are the Uncertainties Associated With the Epidemiological Estimates of
PM Health Risks and the Methods Employed in Developing Those Estimates?
What Are the Physiological Mechanisms by Which PM Causes Adverse Cardiac
Effects?
Does Inhalation of Air Pollution Particles Affect Vascular Function?
What Are the Physiological Mechanisms by Which PM Causes Adverse
Respiratory Effects?
What Are the Cellular and Molecular Mechanisms by Which PM Causes Adverse
Health Effects?
What Are the Long-Term Health Effects of PM?
What Are the Long-Term Health Effects of PM?
ORD Science Contributes to the Development of National Ambient Air Quality
Standards for PM.
ORD Research Affects Public Health Action and Community Outreach.
Ron Williams (NERL)
Joel Schwartz
(Harvard University)
William P. Watkinson
(NHEERL)
Mark W. Frampton MD
(University of Rochester)
Steve Gavett (NHEERL)
James M. Samet
(NHEERL)
Morton Lippmann (New
York University)
Barbara Glen (NCER)
Joel Kaufman (University
of Washington)
Mary Ross (OAQPS)
Susan Stone (OAQPS)
Who Is Susceptible?
What Do Exposure and Dosimetry Studies Tell Us About the Dose to the
Susceptible Populations?
How Does PM Impact Subpopulations with Cardiovascular Disease (Elderly)?
Does Particulate Matter Cause or Exacerbate Asthma?
Chong Kim (NHEERL)
Wayne Cascio (East
Carolina University)
David B. Peden, University
of North Carolina Center
for Environmental
Medicine, Asthma & Lung
Biology
50
Paniculate Matter and Ozone Research Program Review Report

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How Does Underlying Cardiopulmonary Disease Influence Response to PM in
Animals?
How Are Emerging PM Susceptible Populations Being Identified and
Characterized?
How Do Gene/Environment Interactions Modulate PM-Induced Adverse Heath
Effects?
Urmila P. Kodavanti
(NHEERL)
Kevin Dreher (NHEERL)
Yuh-Chin Tony Huang
(NHEERL)
What Physical/Chemical Attributes of PM Are Responsible for Adverse Health Effects?
What Are the Effects of Ultrafine Particles?
What Are the Bioactive Components in Coarse Paniculate Matter?
What Are the Effects of Metals?
Chemical Mechanisms of Paniculate Matter Toxicity
How Can Statistical Approaches (e.g., PCA) Be Used To Link PM Components
With Health Effects?
GUnter OberdOrster
(University of Rochester)
Jan Gilmour (NHEERL)
Andrew Ohio (NHEERL)
John R. Froines, A.K. Cho,
A. Nel, C. Sioutas
(Southern California
Particle Center and
Supersite)
John Godleski (Harvard
University)

•:;•':•'• ••/-, ; ' •"~';-:SESSl6N7:'MRiQl^LlfY;MANAGE3«
* • ' '- ' ' S 	 i - v , •• >^ -»;<-,:«(, j,,(,'i, ji'i""- -•••. • ?! . 'i'«"T 'J^jV
[ENT, .•::. :... :,>>:•:.'
What Are the Sources of PM (and Co-pollutants)?
How Have Recent Advances in Emission Estimation Methods and Models
Improved Inventories of Primary PM and Precursor Gases That Form Secondary
PM and Ozone?
How Can We More Accurately Measure Emission Fluxes of Precursor Gases
Emitted From Area Sources That Form Secondary PM?
What Are the Contributions to Ambient PM and Ozone From Biogenic and Other
Natural Emission Sources?
What Are the Contributions to Ambient PM and Ozone Concentrations From On-
road Diesel and Gasoline Vehicles?
How Well Can We Control Emissions of Multiple PM Precursors From Coal-
Fired Power Plants?
How Can Emissions Inventories Be Improved for Source Apportionment and
Health Associations?
David Mobley (NERL), Sue
Kimbrough (NRMRL), Bill
Kuykendal (OAQPS)
Bruce Harris (NRMRL),
John Walker (NRMRL)
Chris Geron (NRMRL),
Tom Pierce (NERL)
Rich Baldauf (NERL), John
Kinsey (NRMRL)
Andy Miller (NRMRL)
Ted Russell (Georgia Tech),
Alice Giliiland (NERL)
What Is the Atmospheric Characterization of PM (and Co-Pollutants)?
How Can We Measure Ambient Concentrations of Fine and Coarse PM Mass for
Regulatory Purposes?
How Can We Measure Ambient Concentrations of Speciated Fine and Coarse PM
Mass To Support Improvements in the Ambient Air Quality Standards?
ORD Science Supports Air Quality Modeling
How Can We Measure Rapid Fluctuations in Carbonaceous Aerosol
Composition?
Bob Vanderpool (NERL)
Paul Solomon, Tim Watkins
(NERL)
Rich Scheffe (OAQPS)
Jose Jimenez (University of
Colorado at Boulder)
What Are the Processes That Govern PM (and Co-Pollutants)?
What Are the Precursors to and Formation Processes for Secondary Organic
Aerosols?
How Are Results From ORD's Community Multi-Scale Air Quality Model
(CMAQ) Used To Forecast Air Quality?
Ed Edney (NERL)
Ken Schere (NERL)
Paniculate Matter and Ozone Research Program Review Report
51

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How Well Does CMAQ Predict Ambient Concentration of PM Components, PM,
and Ozone?
Air Quality Models Are Used To Predict Reductions in Air Pollution
What Characteristics of Source Emissions Can Be Used to Identify the
Contribution of Different Source Types to Ambient PM Concentrations?
How Is CMAQ Used To Support State and Tribe Implementation Plans for
Regional Haze?
How Can Receptor Models Be Applied To Estimate the Contribution of Different
Source Types to Ambient PM Concentrations?
Alice Gilliland, Robin
Dennis, Brian Eder, Prakash
Bhave (NERL)
Joe Paisie (OAQPS)
Mike Hays (NRMRL)
Gail Tonnesen (University
of California at Riverside)
Shelly Eberly (NERL)
SSESfl^^
Do Exposures to Mobile Source Particles Damage Health?
Physical and Chemical Characteristics of PM Near Freeways Impacted by Heavy-
and Light-Duty Traffic
Health Effects Associated With Paniculate Matter Near Southern California
Freeways
What Are the Effects From Controlled Exposures to Specific Sources?
Pulmonary Toxicity of Utah Valley PM: Are Empirical Indices of Adverse
Health Effects Coherent With the Epidemiology?
Source Apportionment and Multi-City/Multi-Pollutant Studies
Can Laboratory Chambers Be Used To Create a Complex Atmosphere for Use in
Animal Exposure Studies?
How Can Organic Tracers and Source Apportionment Modeling Be Used in
Health Studies?
How Can Concentrated Ambient Particles Used in Health Studies Be Tied to
Specific Source Types?
How Can Air Quality Models Provide Detailed Source Attribution and
Component Distributions for Health Studies?
How Are Ambient Monitoring, Personal Exposure, and Health Related?
ORD Research Supports Mobile Source Regulatory Decisionmaking
Accountability: Measuring Improvements in Public Health From Reduced Air
Pollution
•:%::. '•"•;!.. '• '.; ' " •.''•=: ! .-
Helen H. Suh (Harvard PM
Center)
Constantinos Sioutas, John
R. Froines (Southern
California Particle Center
and Supersite)
John R. Froines (Southern
California Particle Center
and Supersite)
Michael Madden
(NHEERL)
Janice A. Dye (NHEERL)
Lucas Neas (NHEERL)
Tad Kleindienst (NERL)
James Schauer (University
of Wisconsin)
Gary Norris (NERL)
Mike Kleeman (University
of California at Davis)
Allen Vette (NERL)
Rich Baldauf
(OTAQ/NERL)
Susan Stone, John
Bachmann (OAQPS)
52
Paniculate Matter and Ozone Research Program Review Report

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                   APPENDIX D:  LIST OF ACRONYMS
AER
AFCR
AHA
ALAC
APGs
APMs
AQCD
AQI
AQM
BEIS3
BOSC
CAAAC
CASAC
CENR
CMAQ
DOE
EPA
FY
GPRA
HEI
HSD
HUPO
LRJRI
LTGs
MYP
NAAQS
NARSTO
NAS
NCER
NERL
NHEERL
NIEHS
NPD
NRC
NRMRL
03
OAQPS
OAR
OMB
ORD
OTAQ
PART
Pis
Atmospheric & Environmental Research, Inc.
American Federation for Clinical Research
American Heart Association
American Lung Association of California
Annual Performance Goals
Annual Performance Measures
Air Quality Criteria Document
Air Quality Index
Air Quality Management
Biogenic Emission Inventory System
Board of Scientific Counselors
Clean Air Act Advisory Committee
Clean Air Scientific Advisory Committee
Committee on Environmental and Natural Resources
Community Multiscale Air Quality
U.S. Department of Energy
U.S. Environmental Protection Agency
Fiscal Year
Government Performance and Results Act
Health Effects Institute
Human Studies Division
Human Proteome Organization
Lovelace Respiratory Research Institute
Long-Term Goals
Multi-Year Plan
National Ambient Air Quality Standards
North American Research Strategy for Tropospheric Ozone
National Academy of Sciences
National Center for Environmental Research
National Exposure Research Laboratory
National Health and Environmental Effects Research Laboratory
National Institute of Environmental Health Sciences
National Program Director
National Research Council
National Risk Management Research Laboratory
Ozone
Office of Air Quality Planning and Standards
Office of Air and Radiation
Office of Management and Budget
Office of Research and Development
Office of Transportation and  Air Quality
Program Assessment Rating Tool
Principal Investigators
Particutate Matter and Ozone Research Program Review Report
                                                            53

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                        LIST OF ACRONYMS (CONTINUED)
PM
PPM
RCT
RFA
RTF
SCAQMD
SCOS
STAR
UCLA
UFPs
VOCs
wsu
Particulate Matter
Parts Per Million
Research Coordination Team
Request for Applications
Research Triangle Park
South Coast Air Quality Management District
Southern California Ozone Study
Science To Achieve Results
University of California at Los Angeles
Ultrafine Particles
Volatile Organic Compounds
Washington State University
              US


54
                  Particulate Matter and Ozone Research Program Review Report

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