August 10, 1999
EPA-SAB-CASAC-LTR-99-004
Honorable Carol M. Browner
Administrator
U.S. Environmental Protection Agency
401 M Street SW
Washington, DC 20460
RE: C ASAC Review of the Draft Document Airborne Particulate
Matter: Research Strategy (EPA/600/R-99/045)
Dear Ms. Browner:
The Clean Air Scientific Advisory Committee (CASAC) of EPA's Science Advisory
Board, supplemented by expert consultants (together referred to as the "Panel"), met on June 10,
1999 to review the May 1999 draft document, Airborne P articulate Matter: Research Strategy
(EPA/600/R-99/045), in a public meeting in Research Triangle Park, NC. This was the second
draft of the particulate matter (PM) research strategy reviewed by CASAC. Comments resulting
from the November 1996 review of the first draft were transmitted to the Administrator on
March 12, 1997
1. SUMMARY
The Panel complimented the Agency staff (referred to as "Staff) for its effort in
developing a revised document substantially different in scope and format than the previous
draft, and one that clearly demonstrated intent to be responsive to both CASAC's previous
comments and to the recommendations of the National Research Council (NRC) PM Research
Committee (Research Priorities for Airborne Particulate Matter -I - Immediate Priorities and
a Long-Range Research Portfolio, National Research Council, National Academy press,
Washington, DC 1998, 195p).
The Panel recommends revising the introductory material substantially to focus on the
need for the information to be developed by the PM research program, rather than on the
mission, structure, and capabilities of the Office of Research and Development. Background
information on the PM NAAQS and current uncertainties would provide a much more useful
context for the following material, especially for the broad audience likely to be interested in the
document.
The Panel agreed with the Agency's selection of key research topics, and noted its
general consistency with recommendations of the NRC Committee. The Panel recommended
strengthening the descriptions of relative priorities and the prioritization process. The strategy
also needs strengthening in the areas of coordination with other PM research activities within and
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outside the Agency, monitoring progress, communication, measuring success in meeting specific
information needs, and human resources.
The Panel was unanimous in its opinion that, although the revised document was
substantially improved from the last draft, it needs further revision and re-review by CASAC.
2. DETAILED FINDINGS
When queried at the end of the discussion of the document on June 10, Staff stated its
view that the charge issues had been adequately addressed by the discussions and the Panel's
comments. Accordingly, only selected summary responses to the charge are given here.
2.1 Research Directions
Review and comment on the research directions EPA has selected to focus on and the
approaches EPA is planning to use to address those questions/issues.
The research directions are appropriate and are responsive to both CASAC comments on
the first draft and to the recommendations of the NRC PM Research Committee. Several
suggestions were offered by individual panelists regarding specific research needs and
approaches, but the Panel developed no consensus views on research directions that conflict with
the topics listed by the Agency. There was inadequate description of a strategy for coordinating
the Agency's PM research program with those of other organizations.
2.2 Priorities
Comment and make recommendations regarding relative priorities for the various stated
research topics.
The description of relative priorities among research topics and the process by which
those priorities were developed and will be reviewed in the future needs improvement. The
Panel did not attempt to develop a consensus ranking of priorities, and did not take strong
exception to the relative priorities portrayed by the Agency. Rather, the Panel viewed the
document's present description of priorities and the prioritization process as inadequate.
2.3 Effectiveness in conveying directions and anticipated results
Comment on the effectiveness of the document in conveying the strategic directions and
anticipated results of the research program.
The effectiveness of the document is diminished by the overriding emphasis in the first
two chapters on ORD organization, goals, and capabilities. The Panel considered this
information, however accurate, to be of secondary importance to the document, and
recommends that the introductory information focus instead on the genesis of the need for the
research (i.e., Clean Air Act, NAAQS process, PM debate, and knowledge gaps). The document
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contained little information directly addressing the nature and timing of the anticipated results,
and how the results of this program and others will be synthesized to fill specific knowledge gaps
and provide a scientific framework for NAAQS decisions. The description of the management
strategy needs strengthening in the areas of prioritization, inter-program coordination, measures
of success, and human resources. Thus, although the document effectively communicated key
research topics, its effectiveness in describing a research and management strategy and placing
them in context can be improved substantially.
3. COMMENTS BY CHAPTER
Only selected general points are summarized below; no attempt is made to recapitulate
the Panelist's comments in their entirety. Numerous other points are raised and examples given
in the comments of individual Panel members (Appendix A) and the transcript of oral comments
during the June 10, 1999 meeting. The appended comments are considered an integral part of
the Panel's report, and Staff is urged to review them in detail for a complete understanding of the
points which should be given consideration.
3.1 Chapters 1: Vision and Goal, and 2: Overview of ORD
These two interrelated chapters were discussed together; thus, the following comments
apply to the collective material contained in the two chapters.
The Panel recommends that the material in the first two chapters be merged into a single
chapter aimed much more toward readers outside the "inner circle" of the Agency and its
advisors. At present, the material is strongly oriented toward descriptions of the nature and
mission of the Office of Research and Development (ORD), and promotion of ORD's intramural
capabilities and efforts. The Panel does not argue with the facts presented, but it views as much
more important for the present purpose to focus on the events and issues leading to the PM
research program; i.e., on the need for the information that will result from the strategy described
in subsequent chapters. For example, rather than focusing on ORD's vision and mission, it would
be more appropriate to focus on the more specific mission of providing the new information
required to adequately understand, and protect the public from, the health effects of airborne
PM. The introductory material might appropriately include a brief summary of the history of the
Clean Air Act and PM NAAQS, as related to their forming the basis for present PM research
needs.
Internal Agency organization and capabilities are of secondary importance to the
document, and most relevant to the management of the program and the conduct of the
intramural research portion of the program. These issues would fit best into the present Chapter
4. If Staff desires to show organizational structure, interrelationships, and capabilities in detail,
this material might best be included as an appendix.
Because the lack of ecological focus in the program may be taken as a deficiency in the
strategy, it is important to clearly note in the first chapter where the ecological research needs
are being addressed in other programs.
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3.2.2 Chapter 3: Research Directions
In general, the research directions presented in this chapter are appropriate, and are
responsive to both CASAC's comments on the first draft and the recommendations of the NRC
Particulate Matter Research Committee.
Some, if not most, of the background information given at the beginning of this chapter
would be more appropriately covered in the revised first chapter. Background information in this
chapter should focus on how specific elements, or requirements, of the NAAQS drive selection
of research topics.
The numerous references to the accomplishments of the ORD intramural program,
however legitimate the claims, do not add value to the description of research topics and
priorities that is needed in this chapter. They detract by appearing self-promoting and out of
place.
The chapter does not adequately portray the priorities of the research topics, or how
prioritization is accomplished. The issue of prioritization is relevant to both the research topics
and effort allocation presented in Chapter 3 and to the management of the program presented in
Chapter 4, and must be addressed in both chapters. Several comments on relative priorities
among research topics and on specific research approaches were offered by individual panelists,
as recorded in both the written comments and transcript. Although these suggestions should be
considered, the Panel did not attempt to review priorities methodically, or to develop consensus
views.
In the same vein, listing of the funding for FY-1998-1999, and proposed FY-2000 for
each research topic, and inclusion of summary funding information in Figure 3.1 should be
considered. If the width of the topical "boxes" in the figure is the only portrayal of the relative
and absolute funding levels, that should be made more explicit in the labeling and figure legend.
In addition, the title of Figure 3.1 is inaccurate; the topics shown extend beyond those
recommended by the NRC Committee.
The chapter does not adequately portray the relationship between the EPA PM research
program and PM research sponsored by other organizations. Even if the Agency intends for its
program to encompass all of the topics described, it needs to be clear that the program is not
intended to "cover all the bases" in all topics. The NRC Committee's recommendations
described research needs without regard to the division of effort among the several programs
underway in the U.S. and elsewhere. To comprise a credible research strategy, the Agency's
efforts, and allocations of effort among topics, need to be placed in context within the broader
perspective.
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3.2.3 Chapter 4: Program Management
The program management strategy should more explicitly address two important issues
raised above in regard to Chapter 3: prioritization, and relationships to the research programs of
other organizations. To manage the program well, both issues will require continued attention,
and a management approach that lets the strategy evolve as the programs of the Agency and
other organizations progress and interim information is developed.
The interaction between the ORD research program and the Agency's OAQPS monitoring
program is a special case of the need for coordination between programs. If a significant goal of
the monitoring program is to facilitate or inform the research effort, it needs to be an integral part
of the research planning process. Coordination of priorities and activities between ORD and
OAR is another example.
Both coordination with other organizations and communication with other stakeholders,
such as Congress, industry, and the public, will require a communication strategy for the
program. The Communications Section on page 44 lists general communication pathways, but
does not describe a communication strategy sufficiently focused on the needs of this program.
The section on Measures of Success presents several general performance indicators and
assessment processes, but does not adequately describe a strategy for determining the success of
the PM research program in filling specific NAAQS-related knowledge gaps in an efficient and
timely manner. A strategy is needed for assessing the productivity of the program in reducing
key uncertainties.
The section on Monitoring Research Progress does not mention any role for the NRC
PM Research Committee. If, as the Panel understands, the NRC Committee is intended to have
a continuing role in monitoring progress, it should be acknowledged and incorporated into the
Agency's strategy.
The management strategy does not adequately address the issue of human resources. An
appropriate strategy might deal with the need to ensure succession of program management over
several years, might incorporate graduate and postdoctoral training programs and incentives, and
might describe a process by which human resource needs will be reviewed and addressed.
3.2.4 Chapter 5: Summary
This chapter consists of two paragraphs that add little value to the document. The
"chapter" does not integrate the foregoing information in a substantive manner. The Panel
offered no specific comments on this material. Staff should revisit the need for, and best use of,
this chapter once the preceding chapters have been revised.
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4. CONCLUSIONS
The Panel was unanimous in its opinion that, although the revised document was
substantially improved from the last draft, it needs further revision and re-review by CASAC.
We appreciate the opportunity to review this draft document and to provide comments
and advice to the Agency. We look forward to your response.
Sincerely,
Dr. Joe L. Mauderly, Chair
Clean Air Scientific Advisory Committee
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U.S. Environmental Protection Agency
Science Advisory Board
Clean Air Scientific Advisory Committee (CASAC)
Particulate Matter Research Review Panel
Chair
Dr. Joe Mauderly, DVM, Director of External Affairs, Senior Scientist, and Director of
National Environmental Respiratory Center, Lovelace Respiratory Research Institute,
Albuquerque, NM
Members
Mr. John Elston, Administrator, Office of Air Quality Management, State of New Jersey,
Department of Environmental Protection and Energy, Trenton, NJ
Dr. Philip K. Hopke, R. A. Plane Professor of Chemistry, Clarkson University, Potsdam, NY
Dr. Eva J. Pell, Steimer Professor of Agriculture Sciences, Buckhout Laboratory, The
Pennsylvania State University, University Park, PA
Dr. Arthur C. Upton, M.D., Director, Independent Peer Review, CRESP, Environmental and
Occupational Health Sciences Institute, Piscataway, NJ
Dr. Sverre Vedal, M.D., Professor of Medicine, Vancouver General Hospital, Vancouver, BC
Canada
Dr. Warren White, Senior Research Associate, Washington University, Chemistry Department,
St. Louis, MO
Consultants for PM Research Strategy Review
Dr. Allan Legge, President, Biosphere Solutions, Calgary, Alberta Canada (via teleconference)
Dr. Paulette Middleton, Deputy Director, RAND Center for Science and Policy, Boulder, CO
(via teleconference)
Dr. Roger O. McClellan, Chemical Industry Institute of Toxicology, Research Triangle Park,
NC
Dr. Carl Shy, Professor, Dept. Of Epidemiology, University of North Carolina at Chapel Hill,
School of Public Health, Chapel Hill, NC
Science Advisory Board Staff
Mr. Robert Flaak, Designated Federal Officer (DFO) and Team Leader, Committee Operations
Staff, US Environmental Protection Agency, Science Advisory Board (1400),
Washington, DC
Ms. Diana Pozun, Management Assistant, US Environmental Protection Agency, Science
Advisory Board (1400), Washington, DC
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NOTICE
This report has been written as part of the activities of the Science Advisory Board, a
public advisory group providing extramural scientific information and advice to the
Administrator and other officials of the Environmental Protection Agency. The Board is
structured to provide balanced, expert assessment of scientific matters related to problems facing
the Agency. This report has not been reviewed for approval by the Agency and, hence, the
contents of this report do not necessarily represent the views and policies of the Environmental
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nor does mention of trade names or commercial products constitute a recommendation for use.
Distribution and Availability: This Science Advisory Board report is provided to the EPA
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public, and is posted on the SAB website (www.epa.gov/sab). Information on its availability is
also provided in the SAB's monthly newsletter (Happenings at the Science Advisory Board).
Additional copies and further information are available from the SAB Staff.
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