January 29, 1999
EPA-SAB-CASAC-LTR-99-001
Honorable Carol M. Browner
Administrator
U.S. Environmental Protection Agency
401 M Street SW
Washington, DC 20460
Subject: Review of the Office of Research and Development's Ozone Research
Needs Document
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
November 16, 1998 to review the March 31, 1998 draft document, "Ozone Research Needs to
Improve Health and Ecological Risk Assessment" (EPA/600/R-98/031), in a public meeting in
Research Triangle Park, NC. At the meeting and in the written comments of Panel members
provided to EPA staff, the Panel assessed the adequacy of the draft document as a statement of
research needs regarding the health and welfare effects of atmospheric ozone. Key issues raised
by the Panel's are summarized below. More detailed comments are contained in the attached
report and appended comments, and in the transcript of the meeting.
The Panel would like to express an overriding concern that it considers more important
than comments pertaining specifically to the draft document. It was the consensus of the Panel
that the Agency should develop and sustain a substantive, well-prioritized and integrated program
of research on the health and welfare effects of ozone. The present level of research and the likely
funding portrayed by EPA Staff falls far short of an adequate effort. The Panel proposes the
recommendations for particulate matter research developed by the National Research Council as
an example of the scope of integration and prioritization that the Agency needs to apply to ozone
information needs. Information on the scope, costs, and time dimensions of an adequate ozone
research program is crucial to ensuring that the program is appropriately linked to the Agency's
budgeting priorities and to the Agency's schedule for review and promulgation of the ozone
standard. The Panel also noted the likely importance of co-pollutant effects, and encourages
greater integration of research strategies for ozone, parti culate matter, and other air contaminants.
The Panel did not consider the draft ozone research needs document in isolation, but rather in
view of its value in helping to frame such an analysis.
Additional integration of the information contained in the draft document is needed to
provide a useful basis for development of an ozone research strategy. The draft document
appropriately notes a number of important research needs within numerous categories, but does
little to integrate or prioritize the needs across categories. The document is comprised of two
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independent sections consisting of two workshop reports, one on health and one on plants and
ecosystems, which were developed using different approaches and are formatted differently in the
document. Neither section integrates research needs or priorities adequately across categories
and the Executive Summary does little to integrate the information across the two reports. The
addition of an integrative overlay to each section and to the Executive Summary, perhaps
developed by EPA staff together with the workshop rapporteurs, would greatly enhance the value
of the document.
The value of the document could also be enhanced by the addition to the Executive
Summary of a brief description of the information playing a key role in decisions regarding the
ozone standard at recent reviews. The present document provides little sense of the factors
influencing recent decisions and the key issues remaining unresolved at those times. Those critical
information gaps provide a platform from which the extensive list of current questions regarding
the health and welfare effects of ozone can be developed into a prioritized list of research needs
which, if met, would significantly improve the basis for future reviews of the standard.
In summary, the Panel strongly urges the Agency to develop an ozone research strategy
that prioritizes information needs and describes the resources and time required to meet those
needs. The Panel views the draft research needs document as identifying a number of appropriate
unanswered questions regarding the health and welfare effects of ozone, but strongly recommends
that the effort be expended to improve the description and justification of critical information gaps
and to integrate the prioritization of research needs across categories and between sections.
Although publication of the two workshop reports has some value, the value of the effort to EPA
and other researchers and research sponsors can be greatly enhanced by attention to the issues
raised above and in the Panel's more detailed comments. CASAC would be pleased to review a
revised ozone research needs document and a draft ozone research strategy.
Sincerely,
/signed/
Dr. Joe L. Mauderly, Chair
Clean Air Scientific Advisory Committee
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CASAC REVIEW OF DRAFT OZONE RESEARCH NEEDS DOCUMENT
1. Introduction
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
November 16, 1998 to review the March 31, 1998 draft document, "Ozone Research Needs to
Improve Health and Ecological Risk Assessment" (EPA/600/R-98/031), in a public meeting in
Research Triangle Park, NC. This meeting follows the completion of the CASAC's scientific and
technical peer review of EPA's Air Quality Criteria Document for Particulate Matter PM), and its
Staff Paper on PM. The purpose of the research needs review is to engage Agency staff and the
public in a dialogue concerning research that will be needed in support of the next Congressionally
mandated paniculate matter national ambient air quality standard (NAAQS) review cycle.
The 14 Panel members were each assigned specific sections for review and comment (See
Table I - Discussant Assignments), but encouraged to review the entire document. Each of the
Table I - Discussant Assignments
Section #
Section Title
Lead Discussant
Associate Discussants
Part I - Health Risk Assessment
2
3
4
5
Exposure Assessment
Controlled Exposures
Dosimetry /Extrapolation
Epidemiology
Wolff
Lippmann
McClellan
Vedal
Hopke, Middleton
Upton, McClellan
Lippmann, Mauderly
Ayres, Lippmann
Part II - Crops, Forests and Natural Ecosystems
3
4
5
6
7
8
9
10
11
Methodology
Mode of Action/ Species
Response
Modifying Factors
Exposure Dynamics
Role of Modeling
Ecosystem Response
Scaling
Economic Assessment
Monitoring/Modeling
Jacobson
Legge
White
Middleton
Legge, Pell
Jacobson, Pell
Elston, Legge
Wolff, Hopke
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sections other than the Executive Summary and the introductory sections of the two workshop
reports were assigned a primary reviewer and multiple secondary reviewers. These individuals
were asked to summarize their comments verbally at the meeting, and then the section was
opened for additional comment and discussion by the entire panel. EPA staff are directed to the
attached written and verbal comments for the complete critique of the draft report. The body of
this report summarizes selected key issues, but does not reiterate all comments of the Panel.
2. General Comments
2.1 Charge to the Panel
The October 16, 1998 letter to the CAS AC Chair from Dr. Lester Grant, Director of the
National Center for Environmental Assessment (NCEA), Research Triangle Park, NC,
transmitting the draft document did not contain a charge to the Committee, requests for attention
to specific issues, or specific questions. Thus, the Panel of CASAC members and consultants
reviewed the document from their individual perspectives on its adequacy as a foundation for
developing a strategy for research to mitigate key information gaps regarding the health and
welfare effects of ozone.
2.2 General Issues
2.2.1 Intentions of the Agency Regarding Ozone Research
The Panel expressed serious concern about the lack of evidence that the Agency intends to
develop an ozone research strategy and to conduct a substantive program to mitigate key
information gaps regarding the effects of ozone on human and plant health. The Panel raised this
concern from the viewpoint of its consensus that ozone remains a criteria air pollutant of
important concern for both its individual effects and its effects as a co-pollutant with paniculate
matter and other air contaminants. Together, the lack of timeliness in summarizing research needs
after the last review of the ozone standard, the small size of the existing ozone research portfolio,
the small budget for ozone research portrayed by EPA staff at the meeting, the lack of
identification in the draft document of the key information gaps at the last review, and the lack of
effort to integrate and prioritize the research needs identified in the two workshops were taken as
evidence that the Agency does not envision conducting a substantive program of ozone research
in preparation for the next review of the standard. Indeed, this was confirmed when staff told the
Panel at the meeting that the Agency does not have a plan to develop a formalized strategy for
ozone health effects and exposure research.
EPA staff outlined the Agency's current ozone research as consisting of a single, although
large, epidemiological study, a plant and ecosystem program at its Corvalis laboratory,
atmospheric research done through the efforts by NARSTO, and research on particulate matter
that might include ozone as a co-pollutant. The Panel expressed its view that the small current
effort on exposure assessment and the near absence of effort involving controlled exposures of
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humans and animals represented important deficiencies. The Panel noted that the Agency's
intramural research resources provided good capabilities for such research, and expressed concern
that those resources had been directed so completely toward research on particulate matter.
The Panel recognizes that substantial attention and resources are currently being directed
nationwide toward research on particulate matter, and understands the potential for that effort to
detract from research on other pollutants. The Panel emphasizes, however, that important
information gaps remain concerning the effects of ozone, and cautions that inattention or lack of
timeliness in defining the most important gaps and resolving them can only increase the difficulty
the Agency faces at the next review of the standard.
As the sole document presenting the Agency's perspective on ozone research, the present
draft is inadequate by failing to describe the scope, time dimensions, and projected cost of the
research effort required to meet important information needs. Information on the scope and time
dimensions of prospective research is crucial to ensuring that the research program is
appropriately linked to the Agency's schedule for review and promulgation of future ozone
standards and implementation of control programs. Information on projected costs is needed by
the Administrator and other senior Agency officials to place ozone research needs in perspective
relative to other priorities in the Agency's budgeting process. Information on costs will also be of
interest to Congress as it evaluates competing requests for scarce financial resources. The 1998
National Research Council report on Research Priorities for Airborne Particulate Matter provides
an excellent example of an approach to developing and conveying the range of information needed
for an ozone research strategy.
Overall, the Panel does not view as acceptable the Agency's apparent lack of intention to
move forward at this time with development of a formalized ozone research strategy, or an
integrative research strategy for ozone together with other pollutants.
2.2.2 Approach to Developing the Research Needs Document
The job of summarizing ozone research needs was only partially completed, and not in a
timely manner. The majority of the Panel views the document as it presently exists to have limited
value.
The document consists of the binding together of reports from two workshops conducted
independently. The formats of the two workshop reports differ, but neither contains an
integration of the information developed by the several working groups in each workshop. As a
result, there are duplicative statements of research needs and no prioritization of needs across
categories (working groups). EPA staff noted at the meeting that the Agency recognized that the
two workshops and their reports differed and had debated whether or not to bind them into a
single document.
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An Executive summary was added to introduce the two reports, but it does not identify
the key information gaps that existed at the last review of the standard, it does not adequately
integrate the information contained in the reports, and it presents no summary prioritization of
needs across the two reports. As a result, the present draft is limited largely to a listing of
uncertainties about the effects of ozone.
To become an effective starting point for developing an ozone research strategy, the
information in the draft document requires an overlay of effort to integrate the information and
prioritize research needs. The Panel was told at the meeting that additional integrative
information was provided by working group rapporteurs. Subsequent to the meeting, the Panel
received copies of the rapporteurs' reports from the four working groups of the health workshop.
A review of these reports suggests that they would be a useful starting point for better integration
of the information and prioritization of research needs within and among the four health areas.
In many cases, too little information is given to inform the reader why a research need
received the priority it was assigned relative to other needs.
The two workshops were conducted in March and May 1997. The draft is dated March
1998, but it was not submitted to CAS AC for review until October 1998, a year and a half after
the workshops. The value of the identification and prioritization of research needs for ozone and
other criteria pollutants would be greatly enhanced by beginning the process immediately after the
review of the standard, perhaps as a natural extension of the development of the Criteria
Document.
3. Comments by Section
3.1 Executive Summary
The Panel did not engage in an extended discussion of the Executive Summary beyond its
lack of portrayal of key information gaps at the last review of the standard, and the role this
section should play in addressing the integration and prioritization needs described above. It was
the general view that this section would be largely re-written in an appropriately revised
document.
See Appendix A for individual comments by Dr. Mauderly.
3.2 Research Needed to Reduce Uncertainty in Health Risk Assessment for Ozone
3.2.1 Introduction
No summary comments.
See Appendix A for individual comments by Dr. Mauderly.
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3.2.2 Exposure Assessment
Overall, this section does a good job of identifying important research needs, but
additional information would be useful to define the needs in more specific and descriptive terms.
There is a need to integrate research on the assessment of ozone exposure with research
on exposure assessment for other pollutants. Overall, the potential role of ozone as a co-pollutant
together with other criteria and non-criteria pollutants should be emphasized more throughout the
document.
There is also a need to integrate, or at least coordinate, this information with that in the
epidemiology section. Most of these needs are related to obtaining better information for
epidemiological studies of ozone effects; thus, the two sections need to be complementary.
Research needs 4 and 5, on pages 1-18 and 1-19 would seem to be more appropriately
listed in the Controlled Exposure Section
One of the present limitations of the assessment of personal exposure to ozone is the
difficulty of making measurements on an individual basis. The need for developing a practical
personal monitor for ozone should be mentioned as a research need.
See Appendix A for individual comments by Dr. Hopke, Mauderly, Middleton, and Wolff.
3.2.3 Controlled Exposures in Humans, Laboratory Animals, and
In Vitro Test Systems
Controlled human and animal exposure studies have provided a large portion of the key
information we presently have on the health effects of ozone, and the Panel urges the Agency to
include such work as a strong part of their ozone research program. The five priority 1 needs,
one priority 2 need (unlabeled as such on page 1-33), and three priority 3 needs comprise a menu
of needs that is very comprehensive, but broadly described and poorly focused. A very high
priority should be given to controlled exposure studies of normal and susceptible humans, and
perhaps the second highest priority should be given to chronic studies in non-human primates.
See Appendix A for individual comments by Drs. Lippmann and Mauderly.
3.2.4 Dosimetry and Interspecies Extrapolation
This section describes dosimetry research needs in reasonably well-developed, concise,
and comprehensive manner, and the relative assignments to priority 1 and priority 2 categories are
appropriate. Several of the priority 1 needs are interrelated, and could be addressed effectively in
an integrated manner.
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The description of research need 4 (anatomical data) should be edited to clarify that better
interspecies information on the effect of anatomical path length for ozone delivery to the
respiratory tract is needed.
See Appendix A for individual comments by Drs. Lippmann andMauderly.
3.2.5 Epidemiology
It is appropriate that the need for improved epidemiological assessment of the chronic
effects of ozone is given high priority. The long-term effects of ozone remain a key uncertainty.
While the study of young adult lungs in the Los Angeles area is appropriately noted as a type of
study which is needed, it is important that future studies address the lack of controls and
specificity of the histologic findings that severely limit the value of this example study. The
development and epidemiological use of biological markers more specific for ozone exposure and
effects is an important associated need, and one that might be addressed by controlled exposure
research. It is not clear that there is information suggesting that cardiovascular disease should be
a focus of research on the chronic effects of ozone.
There were mixed views regarding the importance and likely benefit of additional research
on the relationship between ozone and daily mortality and morbidity. It may be appropriate for
the existing database to be reviewed by an independent group, as done for paniculate matter, to
explore alternate interpretations before investing in additional data collection.
Some of the research needs mentioned in this section, such as numbers seven and eight,
deal with exposure assessment, and would more appropriately be covered in that section.
Research needs three through six might be more appropriately assigned to the priority two
category.
See Appendix A for individual comments by Drs. Vedal, Lippmann, and Wolff.
3.3 Research Needed to Assess Ozone Effects on Crops, Forests, and
Natural Ecosystems
The discussion of this portion of the report largely ranged across the numerous sections
simultaneously rather than proceeding section-by-section as done with the health portion. Staff is
directed to the individual written comments of the assigned reviewers for comments that were
offered on specific sections.
The reviewers were somewhat confused by the approach taken to developing this half of
the report. First, the difference between "research issues" and "recommendations" was not clear.
Second, it was not clear that the order in which the recommendations were listed was to be taken
as the order of priorities, as finally explained by staff at the meeting. Many of the
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recommendations appeared to focus on the need to develop studies or design experiments, rather
than describing specific information needs. The Panel noted that the document would most
appropriately focus on describing key information gaps and justifying their prioritization, rather
than describing studies. Overall, the specific information gaps and their priorities were portrayed
far less clearly than in the health section.
As was the case with the health portion of the document, the current information needs
were not adequately framed within the context of information gaps at the last review of the
standard and how the additional information might impact the next round of decision-making.
The Panel expressed skepticism regarding the need to develop exposure chambers for
plants that simulated all of the variables that occur in the environment. The value of experimental
exposures often lies in the ability to control exposures precisely and eliminate variables in order to
test hypotheses. Skepticism was also expressed regarding the value of foliar injury for assessing
damage from ozone, both in linking foliar changes specifically to ozone effects and in linking
foliar injury to plant health and economic outcome.
It was not clear that current information gaps are preventing development of a rural ozone
monitoring network. Such a network would have two values, assessing the dose-response for
crop loss due to ozone, and gaining a better understanding of the background levels of ozone.
In assessing the economic impacts of ozone on plants and ecosystems, it may be
appropriate to consider "non-use", or aesthetic, values as well as "use", or direct damage, values.
Another consideration that is not mentioned, but which might be questioned, is the possible value
of ozone-resistant plants as an ozone sink.
See Appendix A for individual comments by Drs. Elston, Legge, Pell, White, and Wolff.
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Appendix A
Individual Written Comments of Panel Members
Panelist Page;
Dr. Joe Mauderly A-2
Mr. John Elston A-5
Dr. Philip Hopke A-5
Dr. Eva Pell A-6
Dr. Sverre Vedal A-8
Dr. Warren White A-11
Dr. Steven Ayres A-15
Dr. Jay Jacob son A-16
Dr. Allan Legge A-17
Dr. Morton Lippmann A-19
Dr. Roger McClellan A-22
Dr. Paulette Middleton A-24
Dr. George Wolff A-25
Note: These are individual comments from Panelists and do not necessarily represent Panel
consensus positions. Some of these comments were obtained from electronic (fax, e-mail and
scanned) files, therefore, some minor translation errors may still be present.
A- 1
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Dr. Joe L. Mauderly, DVM
General Comments
1. No context is given for this document. We are not told in the introductory material how this
document will fit into the development and maintenance of the Agency" ozone research program.
Indeed, we are not told if the Agency plans to sustain a significant program of research on ozone
at all. This is perhaps the most important overall issue, and one that supercedes the importance of
the critique of this document. Ozone is considered to be one of the most important criteria
pollutants with regard to both human and plant health. The Agency needs to develop a plan by
which meaningful research on the human and plant health effects of ozone is conducted despite
the current political and scientific emphasis on particulate matter. The apparent lack of a plan to
do so is another manifestation of the failure of our current mode of considering, and studying, one
pollutant or pollutant class at a time.
2. It would be useful for the introductory material to include a brief summary of the principal
findings that drove the setting of the past two standards for ozone. This would provide a
foundation for the logical sequence of considering whether or not the same issues are considered
the principal "drivers", whether or not we now have an adequate understanding of those effects
(ie, plausibility, mechanisms, exposure-dose-response relationships, magnitude of national health
and ecological impact) and thus, the existing research needs. Without this background, it is
difficult for the reader to frame a correct view of the current status of our understanding.
3. A major problem with this document is that it consists of the binding together of two
workshop reports with an almost complete absence of a summary or synthesis that extends across
the two reports. While this approach is acknowledged by the Agency, the acknowledgement
doesn't mitigate the fact that the approach does not result in an adequate presentation of current
research needs. The two sections (workshop reports) are structured differently. There is no
synthesis of research needs and priorities across categories even within each report, much less
across the two sections. Apparently, the workshops were planned and conducted without thought
that the reports would contribute to a single document. A step is missing; the Agency did not
undertake an overlay synthesis that would meld the information into a single, easily understood
document.
4. Research priorities are presented independently for a number of topics in each of the two
sections. This results in a large number of "number one" priorities. Although listing research
needs is an important step, prioritizing them is also important. The Agency acknowledges this by
presenting priorities; thus, it cannot state that the document was not intended to prioritize the
needs. Once committed to prioritization, the Agency should carry the job through at least one
more step. That would be the synthesis of a list of priorities that span each section. That level
might be acceptable, but a synthesis across the two sections is really needed as well.
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Specific Comments
Executive Summary
P E-l, 1 19: Exposure doesn't "entail" health effects, it produces them.
P E-2,1 16: The workshops might have prioritized needs within the two general areas but if so,
these priorities are not presented in the document. Did this really occur, and if so, what happened
to the results?
P E-3,1 24: Different "disciplines" are mentioned several times in the Executive Summary. Care
to tell us what disciplines you had in mind?
P E-4,1 10-11: All pollutants have subtle effects - what's special about ozone in that regard?
P E-6,1 6: Do a universal search for the word, "insure". Here and almost everywhere else, you
really mean ensure.
P E-6,1 25: If exposure measurement error is important, why isn't it listed as an exposure
priority? Is that the same as "exposure assignment" error?
Health Research Needs
Introduction
P 1-1,1 27: Changes at the anatomical level reported would not increase measured small airways
resistance, because of the minimal mass flow at that level.
P 1-2,13:1 know of no evidence that environmental ozone exposure has caused, or could cause,
"severe, progressive changes" that would result in the effects listed.
P 1-6, 111: Are you uncertain about the marked increase in asthma? Why do you say it "may" be
increasing?
P 1-8,1 2: The foregoing material just stated that epidemiology can't characterize the health
burden. What do you mean here by "characterize"?
Exposure Assessment
P 1-13, entire section: You need to define "exposure" and "dose" up front, and stick with those
definitions. They sometimes get confused in this section.
P 1-16,1 9 (heading): The terms, "statistical level" and "causal level" are not adequately defined
in this section.
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P 1-16,1 27: Why is there no value in also conducting studies in places and at times where the
NAAQS is not exceeded? I'd argue with this philosophy.
P 1-19,1 18: This research need more appropriately fits in the controlled exposure section.
P 1-24 (and in other charts): Are the "number one" priorities in order; ie, is the first one listed
considered a higher priority than the second?
Controlled Exposures
P 1-29, 111: This seems an example of PM-related tunnel vision. Why wouldn't one envision that
PM would enhance the effects of ozone as well as the opposite?
P 1-30,1 20: What in the world is a "normal sensitive" individual?
P 1-31,1 4-5: How does one study "repair and remodeling" in human subjects?
P 1-33,1 4: The "Priority 2" heading is missing here.
P 1-33,1 23: It is not clear how this research would differ from that performed to meet other
research needs. How is this different?
Dosimetry
Overall, this is probably the best-written of the sections. Little editing is needed.
P 1-45,1 20: It is not stated clearly that information on anatomical path length is included in this
research need. Path length is very important, and it should be called out clearly.
P 1-46,1 15: Data on unrestrained animals are important, but isn't it also important to get better
data on "unrestrained" humans during various activities? Do we have enough information on
that?
Epidemiology
P 1-59,1 19: Isn't this research need covered in the exposure section?
P 1-61,1 1: Again, isn't this need in the exposure section, or shouldn't it be?
Ecological Research Needs
P II-7,1 20: The acknowledgement of duplication simply points out a deficiency in the process.
Duplications should have been sorted out.
P II-8, 111: It should be "study of crops, etc.".
P 11-10,1 8 (and other sections): Are the "recommendations" listed in order of priority? Are they
all of first priority rank, or what?
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P II-11,1 23: Presumably, you mean site instead of "cite".
P 11-16,1 20: Most readers probably won't know what "mesic" means. I don't', and it's not in
my trusty dictionary.
P 11-18,1 27-29: It was stated, or strongly implied, in the foregoing material that injury occurs
from stomatal uptake. Now cuticular uptake is discussed. Please sort out for the reader the
presumed importance of the various exposure pathways.
P 11-30,1 2: Why would the model run for 400 days instead of a year?
Mr. John Elston
I am responding to your request to comment on EPA's draft documment Ozone Research
Needs to Improve Health And Ecological Assessments (EPA/600/R-98/031).
Please note that I am in agreement with the CAS AC panel general conclusion that within
the Context of each of the scientific workshop proceedings (Public Health and Ecological Risk)
there needs 1) an overall ozone research mission with specific research strategies neccessary to
address each of the listed topics; 2) a prioritization of of those strategies; and 3) a "state-of-the-
art" summary of where we are currently for each of the the strategies so that the reader can make
reasonable judgements on where to place added emphasis. In summary a "grand" organization is
needed.
More specifically, with regard to my assigned topic, economic research, I suggest: 1)
differentiate and indicate separate analyses for evaluting "use and non-use values"; 2) incorporate
the value of public perception (i.e., visibility) into the non-monetary discussion; 3) determine if it
is possible to place a value on endangered species (i.e., Cost of extinction!); and 4) if certain plant
species can absorb ozone without any apparent effect what is the likelihood, economically that
such species can be considered as a biocontrol method and thus be cost beneficial.
Dr. Philip Hopke
Exposure Assessment
The EPA Administrator wisely promulgated new NAAQS for both ozone and particulate matter
at the same time because of the recognition or the substantial interrelationships between these two
pollutants. There is currently a major expansion in the research program on particulate matter,
and it is important that these studies include important co-pollutants like ozone. Similarly, the
ozone program needs to be carefully coordinated with the PM program. In the exposure
assessment part as m most of the document, the needs for ozone research are presented in very
broad terms and generally described as focusing only on the ozone measurements with co-
pollutants only being included as the 9th topic in the Priority I research needs. There are co-
exposures suggested in topic 4 for controlled exposure experiments. However, it would make
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more sense to integrate the exposure assessment program more intimately with other copollutants
particularly PM. The research topics listed are the traditional list of topics that have been
presented over arid over. It seems to be the time for a more explicit plan to be developed that
indicates more specific goals that can be accomplished within the time and budget constraints that
are likely to apply over the next 5 years. The topics as presented are appropriate areas of study,
but really do not provide a clear prioritized set of specific needs that will really inform the
development of the next ozone criteria document and provide improved confidence that we can
set a NAAQS for ozone that will effectively protect public health.
Monitoring and Modeling
The monitoring and modeling issues are presented in the ecosystem part of the document and are
not integrated with the health effects research needs. It is important to take this document as a
starting point arid develop an integrated set of needs that address both the health and ecosystem
effects from ozone and the co-pollutants that are simultaneously present in the atmosphere. The
document is silent on one of the most important problem with the modeling efforts which is the
quality of emission inventories in most of the United States. There are major uncertainties is the
emissions from both anthropogenic and biogenic sources. We clearly need a more extensive
network of monitors in non-urban areas if we are to be able to assess the effects on ozone on
ecosystems arid crops. These monitors can potentially be useful in conjunction with IMPROVE
and other remote area PM monitors. These would provide data for testing regional scale models
although they would have only limited value without more detailed chemical speciation. There
need to be statistically valid personal exposure studies in order to provide adequate test data for
exposure assessment models. There are modeling and measurement needs at both urban and rural
scales for exposure assessment for both health arid ecosystem/crop effects. Without better
measurements of the rural ozone concentrations, it will not be possible to extend the
exposure/effect studies to the broader population and thus, the effects cannot be adequately
quantified.
Dr. Eva J. Pell
Methodology
In my view the most important methodological need is to determine "how to scale up", and how
to interpret data from experiments with smaller and/or younger plants when predicting effects on
older and larger organisms. This theme permeates recommendations in many sections of the
document. Clearly, we understand little about the implications of ozone exposure on natural and
managed forests, and only by addressing this issue will we get there. From an economic point of
view, these systems are of great importance.
I am less persuaded about the value of searching for the perfect chamber. Similarly expending
significant resources to determine the accuracy of the open-top chambers and resultant NCLAN
data is probably of less value than addressing the issue discussed above. I am in favor of
developing new methods and evaluating current methods, but in a context. For example when
addressing issues related to factors which modify plant response to ozone it would be possible to
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try different designs and protocol, thus learning more about plant response while considering the
way it is being studied.
In several sections including the methodology section there is a great deal of emphasis on
determining how foliar injury relates to effects. I have never been persuaded that this is an
approach worthy of high priority. It is certainly true that if foliar injury could be a predictor of
economic effects it would be very useful. But investing in this avenue of research suggests some
certainty that such a relationship exists. It is my view that (a) there probably are other stresses
which will mimic the type of lesion induced by ozone; hence, identification of "ozone injury" may
be a risky business; and (b) it is very possible that depending on plant sensitivity you can lower
plant assimilatory capacity or pollen viability, for example, without ever inducing visual injury.
Mode of Action
I am comfortable with this section and believe that if developing superior methods and predictive
models is a long term goal, then establishing an understanding of how this gas exerts its toxic
effects is essential. I concur with the priority of recommendations and would emphasize the value
of developing a better understanding of the fundamentals surrounding ozone flux. Response of
guard cells to ozone impacts both the uptake of the pollutant and associated uptake of carbon
dioxide which is essential for photosynthesis.
Factors That Modify Plant Response
This sections fits reasonably with the important issues in the Methodology, Modeling and Scaling
sections.
Exposure Dynamics
I see recommendations 2 and 3 as preceding recommendation 1. You really need to be able to
estimate ozone flux both at the leaf and stand level before determining the meaning of exposure
indices.
The Role of Modeling in Assessing Ozone Effects
I suggest that recommendations 1,2, 5 & 6 are the important recommendations. These
recommendations get at the heart of issues that include an iterative process of model and system
evaluation. Here modeling addresses the issue of scaling. Lastly, the modeling recommendations
acknowledge the importance of having a mechanistic understanding if models are to stand a good
chance of being predictive.
Ecosystem Response
There are several recommendations which seem highly relevant particularly 3,4, 6 and 8. The
major issues touched on here relate to how ozone affects nutrient cycling and the issue of ozone
as one stresses amongst many. The latter is also discussed under the section on Factors Modifying
Plant Response. In this section there also appear two recommendations, numbers 4 and 6, that
deal with determination of ozone effects on biodiversity, and on wetland and desert species.
These are large ecosystem questions that have been almost completely neglected.
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Scaling
These recommendations are redundant with those appearing earlier. I find recommendations 1
and 2 the most compelling. Again I am unconvinced about the emphasis on relating foliar injury
to important plant responses. Utilization of direct measures of biomass would be more
instructive. To attribute changes in biomass to ozone exposure will require the use of models
which account for other major determining factors including, e.g. water and nitrogen.
Dr. Sverre Vedal
CASAC Review of the Ozone Research Needs Document
Part 1. Section 5: Epidemiology
In general, this is a very thorough research needs assessment that could benefit from improved
focusing on the most critical needs, as well as some combining of needs. Furthermore, one or two
important needs are underemphasized. When thinking about ozone epidemiologic research needs,
one should consider most seriously the type of work that is likely to truly advance our
understanding of ozone health effects, as well as work that is in some degree innovative.
Performing more of the same types of studies that have been performed merely to add to the
"weight of evidence" is, in my opinion, less desirable.
The most critical ozone "research need" is to evaluate the long-term effects of ozone exposure in
humans. It is therefore appropriate that addressing this need is assigned the priority 1 need for
epidemiological studies. The external review draft makes several mentions of the importance of
findings from a lung histology study of young accident victims in Los Angeles (Sherman, 1991).
This is a very important type of study that is needed to make one all important link between the
animal studies of long-term ozone exposure and the human epidemiological studies of purported
long-term exposure effects. Unfortunately, this particular study from L.A. was uncontrolled, and
the histologic findings described were nonspecific. The findings are therefore uninterpretable.
First, then, considerable weight should be given in the document to the need for rigorous studies
of this type that can be interpreted with respect to long-term ozone exposure.
Another type of epidemiologic study that needs more emphasis in the needs document, and which
has the potential to more directly test the effects specifically of long-term exposure, is one that
assesses health outcomes in populations With similar current ozone exposure, but considerably
different long-term exposures previously. This study design ensures that any observed effects are
not due to recent exposure. The West Point, the Yale (Kinney) and the Berkeley (Tager) studies
are examples of this type of study. The problem with such studies is that it is not clear that when
effects are observed, that they can be attributed specifically to ozone exposure, since settings with
high ambient ozone concentrations also typically have high concentrations of other pollutants.
Nevertheless, negative studies of this type would be interpretable, and some positive studies might
also be interpretable depending on the setting. Second, then, more emphasis should be placed on
the types of epidemiologic studies that take this approach.
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The only other need that I would like to include as Priority 1, of those listed, is to identify the
independent effects (that is, independent of other pollutants) of long- term ozone exposure and
short-term exposure. The problem here is that I believe that epidemiology has only limited ability
to do this successfully, although studies from complementary settings may offer some hope.
Because of this difficulty, I would not include these studies as first priority.
The final need that I would include under Priority 1 is to utilize biological markers of ozone
exposure in epidemiologic studies in order avoid the vagaries of ozone exposure measurement
based on ambient concentrations. The problem here is initially to identify relevant markers that
can be feasibly used in an observational study.
Additional specific comments on each recommended research needs section:
1. Long-term exposure effects: Attempts to perform epidemiological studies on populations
that have experienced decreasing concentrations of ozone over time are unlikely to be very
informative. First, it is unlikely that populations that have experienced significant decreases in
concentrations will be found. Second, it is difficult to imagine that studies on changes in some
health outcomes over time would be interpretable with reference to ozone effects. It would be
preferable, as noted above, to focus on people moving to areas of different concentrations rather
than focusing on regions with changing concentrations. I would not include cardiovascular
disease under this need, since the evidence for such effects is weak at best, and dilutes the focus
of this research need.
2. Lift-shortening studies: Given the controversy over the recent epidemiology of particulate
matter, in which studies were performed that are much like those proposed to address this need, it
is unlikely that pursuing this tack for ozone is going to provide much, if any, conclusive evidence.
3. Exposure metrics: This is a very difficult issue to address with epidemiologic data.
Various metrics tend to be very highly correlated, making it difficult to determine which are the
most relevant measures. Determining appropriate (or improved) ozone exposure metrics should
therefore probably be in the Priority 2 group of needs. "Non-anthropogenic" ozone needs to be
clarified. Is this due to ozone generated from non-combustion hydrocarbon sources, or
atmospheric ozone drawn down to the troposphere? Presumably, regardless of the source, the
effects of ozone should be the same. This must then refer to the contribution of these' non-
combustion ozone precursors to ozone exposures.
4, Independent and interactive effects: Although this should belong in the Priority 1 group of
needs, the difficulty of performing epidemiological studies that can effectively address issues of
independent pollution effects, or interaction effects, should not be underestimated. It may be that
the only feasible way in which this can be done is through studies performed in different settings
with varying pollutant mixes, again taking an example from parti culate matter epidemiology. The
problem with this approach is that the populations in different settings are different, making some
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compansons across setting difficult. The interactive effects with aeroallergens in asthma would be
particularly interesting.
5. Sensitive copulations: This should include other morbid conditions besides asthma, given
the observations in some studies of an association between daily ozone concentrations and total
mortality.
6. Relationship between acute and chronic effects: I have difficulty comprehending what,
with respect to epidemiological studies, is actually being suggested here. There is no obvious
application of these interesting observations to epidemiologic studies. It should not be in the
Priority I group, and I would drop it as a need until it is clear that this is relevant.
7. Central vs. other monitoring sites: Much of this work comparing fixed site and personal
monitoring correlations has already been done, and is being done in the USC studies.
8. Measurement errors: The issue of exposure measurement error and its effects is common
to all air pollution epidemiology and is very important. This need and #7 above should be
combined.
9. Exposure response relationship: I am not sure if further epidemiological studies, of the
type that has already been performed, are going to provide much useful information on the dose-
response relationship. Again, the comparison with particulate matter epidemiology is appropriate.
As has been seen in the PM work and in the few ozone studies in which it has been addressed,
these studies will typically find a linear concentration-response relationship that extends to the
lowest concentrations observed. Performing studies in settings with very low concentrations may
be more helpful in defining the effects at low concentrations.
10. Short-term effects on cardiovascular outcomes: I don't believe many would postulate that
the adverse effect of particles is based on "hypoxia and its consequences", as noted here.
11. Knowledge of diseases caused bv ozone exposure: To propose that learning more about
the diseases that ozone affects will improve ozone epidemiology is probably true. But is unlikely
to focus the research. This need should be dropped.
Based on both need and feasability, I would group the epidemiology research needs in the
following way:
Priority 1: 1. Effects of long term ozone exposure
- lung histology studies
- West Point, Yale, Berkeley type studies
2. Biomarkers of exposure
3. Sensitive populations
Priority II: 4. Independent and interactive ozone effects
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5. Various ozone exposure metrics
6. Measurement error
- central sites vs. other sites vs. personal exposures
- statistical issues
7. Cardiovascular outcomes
8. Concentration-response relationship
Dr. Warren White
COMMENTS ON OZONE RESEARCH NEEDS
Personal circumstances limited the time I was able to put into this document, so I restricted my
attention to Part II. My overall comment is that this document reads like what it is: an
incompletely edited collation of bullets from two workshops. Considering my inexperience in this
topic area, I was disappointed at how little I found that I couldn't have generated a priori: non-
specific calls to consider interactions between variables, for more cooperation between
researchers, for improvements in every area. I doubt that this document merits the expert-hours
and jet fuel that are being spent in the present review.
5. FACTORS THAT MODIFY PLANT RESPONSE
Do the two paragraphs of introduction, taken together, say anything more than the following?
Plant response to oxidants must be understood as a function of factors both internal and
external to the plant. Internal factors include genetic makeup and developmental stage.
External factors include weather, competition from other plants, the presence of pests and
pathogens, and other pollutants and agricultural chemicals.
11-14, lines 5-10
The genetic makeup (e.g., cultivar) and the developmental stage play critical roles In the way
individual plants respond to ozone and other external stresses. Whereas the magnitude of
response of a particular species or variety depends on external environmental factors such as...
What is the distinction being drawn with this "whereas"? Is it between the individual and the
population? Between internal and external factors?
11-14, lines 15-16
The issues are ozone versus environmental stressors, degrees of importance, and ranking of
stressors,
Does this say anything more than that you'd like to rank the various stressors by their importance?
To the degree that they may be synergistic as you suggest above, can you necessarily expect to
succeed? If a plant can survive A or B but not both, which stressor is the more important?
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11-14, line 19
...drivers of atmospheric conductivity...
We talking lightning bolts here?
11-16, lines 13-14
(2) Long, term studies in forest systems should further understanding of the range of
responses of seedlings, saplings, and mature trees In stands and forests to ozone.
This is formulated as a recommendation rather than an issue. As an issue it might read "Long-
term studies in forest systems are needed to understand the range of responses
As a recommendation, it is so vague as to be meaningless. It can be read as anything from a
platitude to an action item:
(2a) [Existing] long-term studies in forest systems [can be expected to] further
understanding of the range of responses
(2b) Long-term studies in forest systems should [be initiated in order to] further
understanding of the range of responses -
(2c) [Ongoing] long-term studies in forest systems should [be refocused toward] further
understanding of the range of responses
11-17, line 28
(9) There are a number of reports in the literature that indicate ...
More studies of this type are needed...
No! We don't need more studies of this type. We presumably need information not yet obtained
by studies of this type. What is the missing information?
8. ECOSYSTEM RESPONSE
The research issues in this section are parodies of scientific bureaucratise.
11-25, lines 4-6
Criteria used to determine the parts the life cycle of a tree that should be investigated. . . should
be determined.
This sentence swallows its own tail.
11-25, lines 6-12
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As community-level studies proceed, It will be necessary to follow ecosystems over long time
periods. Forest health monitoring is a good example of this type of study. Other critical
research should include long-term ecosystem studies, strengthening the current Forest Health
Monitoring Program.
No wonder the report seems interminable!
11-25, line 21
The significance of stress-induced outcomes must be evaluated as to their severity
Prolixity strikes again.
11-25, line 27-28
Visible foliar injury, as an endpoint, could suggest that no foliar injury be considered
acceptable.
Again, don't be afraid to go back and erase the beginning of your sentence if you thought of a
better way of expressing your meaning halfway through, and incorporated that in the ending.
11-25, lines 29-30+
There was considerable discussion of the need to conduct research on important relationships
between foliar injury, tree function and growth, previsible physiological effects, carbon
budgeting and allocation, and predisposition to insect and disease attack.
I think you mean ". . relationships [of] foliar injury [to] tree function and growth, previsible
physiological effects," etc. i.e., you are concerned with the relationship of foliar injury to
everything else, not of everything to everything. And our need is to understand, not "to conduct
research".
11-26, lines 6-7
Included are the dynamics of leaf area index, carbon fixation, and ozone effects on net carbon
acquisition and associated respiration effects.
That's a lot of dynamics and effects, and what is it they're included in?
11-26, 12-13
Of concern also is the possible loss of individual species within populations and between species
within a community (i.e., loss of biodiversity) from exposure to ozone.
I think you mean to distinguish loss of individuals within populations from loss of species within a
community.
11-26, 13-15
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Changing root/shoot ratios, vegetative structure, species composition, and year-to-year variation
have been related to changes in growth and reproduction.
This is a tautalogical statement, carrying no non-trivial information.
The recommendations on 11-27 are refreshingly succinct. But (6) has no evident connection to
any of the enumerated research issues. And (8) is focused only by the qualifier "on managed
forests." If you added a similar recommendation "on croplands", and another "on unmanaged
ecosystems", you would be recommending all possible research on plant growth.
10. ECONOMIC ASSESSMENT
This chapter is better than some others, because it actually contains some non-trivial statements.
One is issue 4; the economic valuation of crop losses from ozone exposure is relatively well
known when compared with other potential valuation Impacts. Another is issue 5: With a few
exceptions, loblollypine in particular, estimates of the economic effects of ozone on managed
forests are not based on a sound understanding. . . Unfortunately these firm conclusions, which
would seem useful guidelines for research planners, didn't make it to the recommendations
section.
Much attention is given here and elsewhere to potential interactions between ozone and other
stressors. Recommendation 7 is to Develop economic valuation techniques that will permit
separation of the effects of ozone from other stressors as they interact to cause damage . . .
Likewise, issue 2 observes that Existing economic valuation techniques may not be capable of
discerning the harm to ecosystems solely and directly caused by exposure to ozone. The
problem, however, is that any apportionment of economic damages among significantly
interacting causes is unavoidably arbitrary, dependent on convention rather than advances in
valuation techniques. If a plant can survive A or B but not both, then what do we mean when we
attribute specific damages to A or B? The inherent limitations of cost-accounting as an analytical
framework should be acknowledged.
Issue 6 claims that The potential harm of ozone exposure to individual plant species in natural
ecosystems is under stood in terms of foliar injury, plant physiology, etc. This seems contradicted
by issue 3 of Chapter 8, which states Ozone responses are known for only a few native plants; no
data is available for the great majority of native species. And if we don't know the ozone
responses of most native species, then the economic analyses developed under recommendation 2
are not going to be able to measure changes in the value of natural ecosystems. Economic
sophistication doesn't replace data.
Issue 3 notes that Harm to threatened and endangered flora and fauna deserve special attention
because of their protected status under the Endangered Species Act. In fact, this "special
attention" is in the form of a constraint that must be imposed outside the utilitarian framework of
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the usual welfare accounting. The limitations of the utilitarian framework are suggested in
recommendation 3, but should be more explicitly recognized.
Dr. Stephen Ayres
My comments on the need for additional ozone research follow the conversations I initiated when
we met together at Raleigh. Some of the comments seemed quite unusual to many of the
members and I hope that some of my suggestions could be seriously debated.
As you know, I have been involved in the relationships between environmental pollution of the
ambient air since 1965 when I served on Mayor John Lindsay's task force on clean air. Since then
there has been a good deal of study on the various criteria air pollutants, studied separately, but
little attention on important linkages to that effect human health. I made the perhaps outrageous
suggestion that some of EPA's efforts be aimed at the etiology of chronic pulmonary disease and
asthma rather than the pollutants themselves, of advantage of dealing with ALL of the possible
environmental contaminants, including physical stressors such as heat and cold, which could be
causative agents.
The reason this has not been seriously considered in the past is in part on the contaminant
background cf most regulators and the paucity of lung scientists who have dedicated themselves
to identifying the causes of chronic pulmonary disease and asthma. I feel strongly that only a tight
collaboration between the environmental scientists funded by the EPA and the lung scientists
funded by the Pulmonary Division of the National Heart, Lung, and Blood Vessel Institute could
cost-effectively deal with the needed research approaches. Indeed, much of that information is
already available in the separate programs. I would strongly suggest that the EPA and NHLBI
sponsor a national a national symposium around the question: DO AIR POLLUTANTS CAUSE
OR SIGNIFICANTLY EXACERBATE CHRONIC PULMONARY DISEASE?
The cancer society has been very successful in assembling the talents of a broad array of experts in
studying the cause and treatment of cancer. I would propose that the EPA marshal the services of
pulmonary disease specialists, immunologists, lung injury experts, geneticists, cell biologists,
epidemiologists, lung pathologists, and others.
Spirometry in all of its transmutations and morbidity and mortality indices have been quite useful
in pointing the finger at paniculate and ozone pollution as causal agents of lung disease. They
lack both specificity and sensitivity, however, and new indicators of effect must be identified.
Very little attention, for example, has been given to studying morphologic changes in the lung in
people living under various environmental conditions. Newer techniques of lung inflation and
morphometry, aided by scanning and transmission electron microscopy can identify subtle changes
in lung structure. A national registry of lung sections removed from the lungs of accident victims,
supported by epidemiologic questioning, could produce a good deal of useful information.
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Ptimate exposure studies with these types of sophisticated evaluation could supplement the
morphologic approach.
Many years ago, Ishikawa, Bowden and Wyatt (Arch Env Health 18.60-666 1969) studied using
advanced methods of lung preservation studied lungs in Winnipeg and Saint Louis. They showed
the combined effects of air pollution and cigarette smoking and demonstrated what could be done
with innovative studies of lung biology. I do not believe that these etudes are much quoted or
replicated.
I am not suggesting we ignore the study of individual air pollutants. I am only pointing out that
such studies can never help us identify the irritant mix that must be responsible for the evidence of
Lung injury that has been reported since the earliest episodes in cities such as London.
Dr. Jay Jacobson
1. Part II is a compilation of research issues and recommendations that seems to have two main
objectives: a. to recommend research that supports EPA regulatory needs and b. to recommend
research suitable for the environmental missions of other governmental agencies.
2. The document should clearly state that the research issues and recommendations are listed in
priority order within each major topic.
3. I agree with the research objectives listed in 3.2.1 regarding open-top chamber studies with the
exception of the statement that actual exposures should mimic ambient conditions. As soon as a
chamber is used, ambient conditions are affected. The question is to what extent the response to
ozone is influenced by the changes in ambient conditions. For many but not all purposes, the
changes may be insufficient to undermine the aims of the experiment.
4. I agree with the items listed in priority order in section 3.2.2 Use of Chamberless Designs. An
important missing component, however, is the need to match ambient conditions such as sunlight,
temperature, rainfall and soil conditions across gradients of ozone deposition. This will greatly
restrict opportunities to use this approach and it is necessary to know the degree to which ambient
conditions are similar among sites. The section is deficient if it doesn't make this point.
5. There is a mismatch between the research needs section and the recommendations section
(3.3). Some research needs are not listed under recommendations and some recommendations are
not discussed in resarch needs.
6. I do not agree with recommendation no. 2 that methodology should be developed for
verification and validation of NCLAN data. It's time to move on and focus efforts on new and
improved research approaches rather than trying to use resources to validate experiments that
were completed years ago.
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7. The research issues and recommendations in section 4 seem appropriate with the exception
that no. 4 in section 4.3 seems to me to be the same as recommendation no. 3.
8. The priority arrangement of recommendations in section 5 'Factors that Modify Plant
Response' seem reasonable with the exception that I would give a higher priority to no. 8, the
influence of climate change on response to ozone.
9. In section 6 Exposure Dynamics, I have difficulty with the wording of the first
recommendation. The 'best' exposure index depends on the criteria applied. It already seems
abundantly clear that there is no one statistic that will serve for all species under all conditions for
all end-points and be acceptable from a policy perspective. This wording sets up an impossible
goal.
10. In general, the report would benefit from improvements in clarity and organization.
Providing a brief statement of what is known for each research issue followed by
recommendations would give readers an understanding of what has been accomplished as well as
what needs to be done. Better explanation of the need for the individual research items would
greatly improve the value of this report.
Dr. Allan Legge
I have reflected on my initial written comments and the discussions which took place at the
November 16,1998 CAS AC Meeting in Chapel Hill and feel that more focussed written comments
would be more appropriate. The emphasis will be on Part II, "Research-Needs to Address Ozone
Effects on Crops, Forests, and Natural Ecosystems". My initial comments were born out of
frustration. As I indicated in my verbal comments at the CASAC meeting, I did not find the
document to be of much use to EPA. Essentially, 'we' were presented with a research needs "wish
list" which was formatted in a fragmented and piecemeal fashion. There was little or no
justification for any of the research needs listed as well as no attempt at synthesis arid integration
of the research needs. A critical point is that one was left with the impression that the plant/air
pollution effects research community had not learned anything over the past 30 years and needed
to start over. Additionally, as, noted by a number of the CASAC members, Part II was simply a
report of the outcome of a workshop held in May, 1996 In Raleigh, NC. The above were the
sources of my frustration.
When CASAC deliberated on the Ozone CD and- Staff Paper, a number of points were raised and
uncertainties identified especially in the CASAC closure letters to -the Administrator of EPA. It
would seem logical to me that these uncertainties would be 'prime' candidates for research and
identified as such in the text of an "Ozone Research Needs" document so that the Agency could
address these uncertainties in a timely fashion and be prepared for the next ozone review cycle in
2001-2002. This was not done in the text. Further, an inordinate amount of time has elapsed
since the Ozone CD and Staff Paper were reviewed by CASAC and the 'Ozone Research Needs'
document provided to CASAC for review. The Workshop on "Ecological Research Needs and
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Ozone" was held in May, 1997 while the Workshop on "Health Research Needs and Ozone" was
held in March, 1997. The "Ozone Research Needs" document is dated March 31, 1998 but only
given to CASAC for review in October, 1988 for open discussion in November, 1998. With
respect to "Ecological Effects and Ozone" almost two years have elapsed. Valuable time has been
lost. One is left with the sense that the Agency does not view the ozone effects issue as
important. This was confirmed at the November 16,1998 CASAC meeting when very direct
questions were required to determine what the "Agency" had budgeted for ozone research in
fiscal 1998-99 and 1999-2000. The sense which I obtained from the answers to the budget
questions was that the budget for fiscal 1998-99 was approximately $900,000 for ozone research
for both health and ecological effects while the budget-for this research in fiscal 1999-2000" was
'ZERO'. The clear conclusion that one can draw from all of this is that the Agency will not be
ready for the next ozone review in 2001-2002. I suspect that this would still be the case even if
the Agency had an "Ozone Research Needs" document that it could use. The fundamental
question is as follows: 'Why is the Agency not committed to health and ecological effects research
given the uncertainties identified by CASAC in their review of the CD and Staff Paper and given
the fact that ambient ozone concentrations are increasing with ozone being the most toxic of the
criteria air pollutants?'. The Clean Air Act (CAA) is very clear as noted on page II-1 of the
"Ozone Research Needs" document where the following is said: '"Any national, secondary
ambient air quality standard, as defined under Section 109(b)2, must specify a level of air quality
the attainment and maintenance of which in the judgement of the Administrator, based on such
criteria, is requisite to protect the public welfare from any known or anticipated adverse effects
associated with the presence of such air pollutant in the ambient air" (see lines 13-17). The key
point is that it "is requisite to protect the public welfare from any known or anticipated adverse
effects". By displaying a lack of commitment to health and ecological effects research related to
ozone the 'Agency' has chosen to ignore their responsibility as defined under the CAA. It seems
to me that CASAC should point this out very clearly or we will be viewed as part of the problem
rather than helping provide the solution.
The above comments are harsh but in my view can help the Agency' regain the 'perspective'
which it seems to have lost.
RECOMMENDATIONS:
The following is list of suggestions to help the Agency in the future.
1. At the time of the review of the CD and Staff -Paper for a given criteria air pollutant, the
staff of the Agency has an excellent command of the research which has been done and the
research which is needed to reduce identified uncertainties. This is when the "Research Needs"
document should be written.
2. Given (1) above in terms-of timing, the 'Research Needs' document should provide a
framework for research in a given area with the key uncertainties clearly identified as to where
they fit into the overall framework.
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3. Given (2-) above in terms of framework, the "Research Needs" document should identify
the linkages to other criteria air pollutants so that research efforts can be coordinated and made
more cost effective.
4, The "Research Needs" document must not be a 'wish list' of research projects — but rather
a document which reflects integration and synthesis of our understanding in the light of identified
uncertainties which need to be addressed "to protect the public welfare from any known or
anticipated adverse effects".
5. More emphasis should be placed on interdisciplinary research within the "Research Needs"
document. To say that there will be interagency cooperation is not adequate or sufficient
especially given the Agency's reliance on risk assessment in decision making.
In summary, I found the "Ozone Research Needs' document with respect to Part II very
unsatisfactory and in my opinion of very little use to the Agency in its current form. The
inordinate delay in preparing the "Ozone Research Needs" document for review by CASAC and
the apparent lack of commitment by the Agency to health and ecological ozone effects research
given the inadequate budgets for fiscal 1998-99 and 1999-2000, will result in the Agency being
unprepared for the 2001-2002 review of the ozone standard. The Agency needs to regain
perspective on one hand and rethink its' approach to the preparation of "Research Needs"
documents.
Dr. Mort Lippmann
REVIEW COMMENTS ON CONTROLLED EXPOSURES
Introduction and Background:
Research involving controlled human exposures to ozone have greatly influenced all of the
revisions to the 1971 ozone NAAQS. The NAAQS relaxation of 1979 relied on a LOAEL of 150
ppb for a 1 hr exposure of exercising adult asthmatics (Delucia, AJ. and Adams, W.C. J. Appl.
Physiol. 43:75, 1977). The 1993 NAAQS retention was based primarily on the absence of effects
deemed adverse in numerous controlled human exposure studies to ozone in pure air lasting 2
hours or less at concentrations below 180 ppb, and discounting evidence for substantial effects on
respiratory function at lower concentrations from several field studies (Spektor, D.M., et al.,
ARRD 137:313, 1988; AARD) 138:821, 1988), and one controlled 6.5 hr chamber study
(Folinsbee, L.J., et al., JAPCA 38:28, 1988). The 1997 NAAQS revision placed a considerably
greater reliance on the results of 6.6 and 8 hr controlled human exposure studies to ozone in pure
air, documenting functional, inflammation, and airway reactivity responses at 80 ppb with
moderate exercise during exposure, but also on the results of both numerous field studies of
functional responses at very low ambient levels and on numerous macroepidemiologic studies
showing increasing rates of hospital admissions for respiratory causes with increasing levels of
ambient ozone concentration.
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One lesson that can be drawn from this brief history is that controlled human exposure studies that
ask some of the right questions, such as the influence of age and exercise level, as well as the
extent of response in terms of a range of responses of interest (function, inflammation, airway
reactivity, airway permeability, symptoms, performance) can be very valuable in showing the
nature, extent and substantial interindividual variability of short-term responses in groups of
relatively healthy individuals exposed to ozone in pure air.
Other important lessons derived from controlled human exposures to ozone in pure air include:
1) Different individuals are responsive in terms of the different endpoints.
2) The search for biomarkers predictive of responsiveness has been unproductive.
3) Functional responses are smaller in controlled exposures to ozone in pure air then for
exposures to ozone in ambient air.
Controlled exposure studies in animals have also been highly informative. For example:
1) Short-term controlled exposures to rats can produce many of the same acute responses
seen in the controlled human exposure studies, but require much higher ozone
concentrations for comparable responses.
2) Subchronic 8 hr-daily controlled exposures of monkeys at 250 ppb have produced
structural and functional changes that could be indicative of progressive and cumulative
lung damage, and some changes are greater over 18 months with intermittent months of
exposure as compared to continuous daily exposures throughout the 18 months.
Comments on Chapter 3 on Controlled Exposures in Humans, Laboratory Animals and in vitro
Test Systems:
The chapter presents five Priority 1 needs, 1 Priority 2 need, and three Priority 3 needs that are
each rather bland statements on things that it would be nice to know more about. There is,
however, no indication why any one of them belongs in its assigned priority class. Also, each
need is very broadly stated, with no indication of: 1) priorities within the need area; 2) promising
approaches or opportunities to expeditiously or efficiently address the outlined need; or 3) which
parts of the needs can best be addressed by controlled human acute-exposure studies, controlled
animal acute exposure studies, controlled subchronic or chronic animal exposure studies, or in
vitro exposure studies. This is a glaring deficiency in a document whose only possible utility is to
guide the selection of studies that could produce useful results over the next 5 years.
With the very limited research resources that are likely to be available for ozone research over the
next few years, the real questions should be:
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1) What questions are the most important ones that EPA's Clinical Studies Branch can
effectively address in its new and grand Chapel Hill facility?
2) What other controlled human exposure study objectives should be the focus of an RFA
for STAR grants or cooperative agreements in the near future?
3) What chronic exposure studies in rats, if any, should the Toxicology group at RTF be
conducting in the near future?
4) What will the focus of an RFA on the most critical issues for a chronic primate ozone
exposure studies be?
5) Will any other ozone research resources likely be available for other high priority whole
animal or in vitro studies? If so, what would the RFA specify for such research?
6) How will the various studies performed by the clinical research investigators, the animal
inhalation investigators, and the in vitro investigators be coordinated so that the individual
studies will provide a basis for the whole controlled exposure program to be greater than
the sum of its parts?
7) How will the controlled exposure program be integrated with the dosimetry and
epidemiology research to ensure that the most critical uncertainties about the ozone
exposure-response relationships in humans be clarified for future NAAQS revisions?
From the nature of the questions that I posed above, it is evident that I believe that the menu
provided in Chapter 3 is hopelessly comprehensive and unfocussed on really critical needs in
relation to any realistic assessment of anticipated amounts of tine and resources. I would give
highest priority to: 1) clinical lab studies that focussed on lavage and serum biomarkers that
Correlate with responsiveness to the various effects produced by short-term ozone and mixed
exposures to healthy and asthmatic individuals (as a means of getting at the mechanisms of
response); and 2) chronic ozone-exposures in primates that extended the duration of intermittent
ozone exposures and included measures of lavage and serum biomarkers at periodic intervals
during the extended exposures (as a means of directly addressing the nature and extent of
progressive chronic effects of long-term ozone exposure in a relevant animal model, and relating
biomarkers of response to those determined in controlled short-tern exposures in the human
volunteers).
REVIEW COMMENTS ON DOSIMETRY AND INTERSPECIES EXTRAPOLATION
M. Lippmann
The research priorities summarized in Chapter 4 on Dosimetry and Interspecies Extrapolation are
reasonably concise, well developed, and comprehensive. The basis for priority assignment was
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not made clear, nor was the distinction of the time-frame for the research. However, the
assignments to Priority 1 and Priority 2 status seen reasonable.
Many of the Priority I needs overlap and could most effectively be addressed in a unified program
of research. Based upon the need to address all of these high priority needs at an early stage of
future ozone dosimetry and modeling research, and the high probability of, at best, only a modest
amount of funding for this kind of research, attention should be devoted to the development of a
more comprehensive multidisciplinary RFA for such research.
REVIEW COMMENTS ON EPIDEMIOLOGY
Lippmann
The research priorities summarized in Chapter 5 on Epidemiology are well targeted on important
knowledge gaps and provide appropriate rationales for their implementation. There are, however,
too many Priority 1 topics.
The first Priority 1 topic clearly deserves its prominent place. The second one, addressing lifespan
shortening is clearly also a high priority area for research, but it is not at all clear how the
influence of short-term exposures can be investigated. This topic should be more clearly focussed
on the influence of longer-term cumulative exposure. The needs identified as #s 3, 4, 5 and 6
belong under the Priority 2 heading, along with #s 7, 8 and 9. The inclusion of needs 10 and 11 in
the Priority 3 category seems to be appropriate.
An issue that is not addressed in this chapter is the feasibility of research focussed on the needs
that are outlined. Some of these needs can be at least Partially addressed effectively by further
analyses and regression of large data Sets that are already in existence (AIRS, fine particle
network (1979-1983], mortality and hospital admissions by cause from federal and state data
bases, population cohort outcome data [Am. Cancer Soc., Nurses Health Study, NHANES, etc.])
Such analyses can be performed at relatively modest costs, and can yield very useful information
within 2-5 years. More definitive results will require the creation of new cohorts and the
widespread collection of additional ambient air quality and personal exposure data at considerably
greater costs and over a considerably longer time-frame (> 10-20 years).
If the creation of new cohorts is possible, it would be highly desirable. If not, then research
resources should be focussed on the attainable goals of analyses of pre-existing data sets, and
these should he explicitly addressed and prioritized.
Dr. Roger McClellan
COMMENTS ON EPA DOCUMENT
Ozone Research Needs to Improve Health and Ecological Assessments
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General Comments
1. There is a need for the Agency to periodically develop documents such as this one to describe
research that has the potential for reducing uncertainties in the scientific database for the various
National Ambient Air Quality Standards. Thus, the present document is of substantial value in
providing a general context for research on ozone and other air pollutants. However, the long
delay between issuance of the 1 last Criteria Document and the Staff Position Paper and
promulgation of the standard has left a period of time when SPA research on ozone may have
drifted due to an absence of clear strategic direction.
2. The document identifies a number of general research objectives that might be pursued to
reduce uncertainties in setting the National Ambient Air Quality Standards for Ozone.
Descriptions of the objectives are generally very broad. The authors are to be commended for
advancing some broad prioritization of the objectives, i.e., Priority 1, 2 and 3. However, the
document in most cases does not provide adequate discussion of how the research findings arising
from successfully addressing each of the objectives would really impact on the setting of the
National Ambient Air Quality Standards for Ozone. While all of the objectives have scientific
merit, it is very likely that they vary considerably and how the research would have potential
impact on the setting of the ozone standard. In finalizing the document or developing the next
iteration, the Agency might consider following the lead of the NAS/NRC Particulate Matter
Research Committee and for each objective provide a statement on (a) scientific merit, and (b)
potential regulatory impact.
3. A serious deficiency in the present document is that it fails to provide an adequate description
of the time and scope dimensions of each of the research needs. It is likely some of the research
could be accomplished in a year or two with a few person years of effort. Other research will
very likely take five or more years to complete and require 50 or more person years of effort to
complete.
4. A related serious deficiency of the document is the failure to justify the estimated financial
resources required to carry out the needed research. The absence of information on financial
resource needs renders the document almost useless for planning purposes within the Agency in
developing the Agency's/President's budget and equally useless to the U.S. Congress in deciding
on funding priorities for this research. The primary objective of the Agency's research program, in
my opinion, should be to conduct "goal achievement" research in support of the Agency's
regulatory mission. This requires planning at the research strategy level that demands information
on financial resource needs. The failure of the Office of Research and Development to develop
public documents that outline strategic research needs and the associated financial needs is an
invitation to the Program Officers and the EPA Administrator to regularly "shortchange" the
Agency's research program. I am disappointed that this document does not do anything to correct
that deficiency.
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5. The document tends to project a "silo view" of air pollution with an almost exclusive focus on
ozone and a failure to adequately consider how health responses attributed to ozone are, in many
cases, very likely responses to exposure to complex mixtures of ozone and other pollutants,
especially paniculate matter. The last review of the scientific basis for both the ozone and
particulate matter National Ambient Air Quality Standards clearly indicated the need to avoid
concentrating on single poUntants. The statements on page 1-8 of the present document attempt
to explain away the document's failure to lay out a research strategy for multiple pollutant
research. However, recognizing the importance of multiple pollutants, it is disappointing that the
Agency again failed to seize the opportunity to provide a research strategy context for addressing
the multiple pollutant issue. In my opinion, debate during the next round of reviews of the
scientific basis for both the ozone and particulate matter National Ambient Air Quality Standards
will very likely center on the multiple air pollutant issue.
In summary, the present draft is a useful start in outlining most of theresearch activities one can
envision carrying out on ozone. There is something for everyone to address. Unfortunately, this
approach and the lack of information on the projected scope, time schedule, and financial resource
requirements of the research outline does not provide an adequate scientific justification for the
kind of research program that is needed to address the ozone issue and its relationshipto other
pollutants. Intuitively, I suspect that $25-5O million per year will be required over a 5-8 year
period if the scientific community is to provide input for setting a science-based standard. In the
absence of a science based standard, Isuspect that the alternative, a technology, will result. The
estimated implementation costs and estimated health costs of the ozone standard and particulate
matter standard would appear to justify a substantial research investment to ensure that these
standards are science based.
Dr. Paulette Middleton
General comment. The report needs to be better integrated. I agree with Joe's requests in the
letter of a few days ago calling for additional commentary on priorities and rationale.
Exposure. Priorities 1, 4 and 9 are highest on my list. They all address particularly important and
less well understood areas. All are aimed at providing relevant information on exposure as it
occurs in reality. They each begin to address the potential synergies of multiple stresses that exist.
Monitoring and Air Quality Modeling. Issue 10, dealing with communications and problem
solving, should be turned into a recommendation.
EPA has been using a variety of models in studies of ozone and particulate matter. An in depth
assessment of the appropriateness and applicability of the models in determining best management
strategies is very important. Many states and other stakeholders will be developing approaches to
deal with real and potential ozone violations. Guidance on model use is essential. This is not
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formally noted, however, it could be the most important barrier to directing defensible policy
decision making.
Dr. George Wolff
I. General Comments
It is my understanding that the research "needs" document serves at least two purposes. First, it
contains an outline for a long-term research program that addresses the major uncertainties and
unanswered questions without consideration of the time frame. The second purpose is to
prioritize the "needs" in order to maximize the reductions in uncertainties and to provide answers
to some of the unanswered questions before the next NAAQS review. The present document is a
collection of lists, which, if combined and integrated, might address the long term component.
However, the second purpose is completely ignored.
II. Health Effects
It is apparent that the four different groups who put together the four lists did not communicate
with each other as there is considerable overlap between some of the "needs" and no attempt to
integrate them into a coordinated program.
An overriding concern for many aspects of the health effects program is the importance of
background ozone. Based on relatively sparse data, the U.S. summertime continental background
is estimated to be 0.03 - 0.05 ppm for both a 1-hour and 8-hour time frame. However, as
indicated by the range, it is variable and it has a distribution that extends beyond this range. At
least two epidemiology studies which found a statistical association between ozone and hospital
admissions were conducted in locations (Spokane and Tacoma, WA) where the ozone
concentrations were dominated by changes in the daily ozone background. For example, in
Spokane the daily 1-hour ozone varied from 0.029 ppm (lower 10%) to 0.054 ppm (90%) and it
was slightly lower in Tacoma. Consideration should also be given to background concentrations
in controlled human and animal exposure studies. Control subjects should be exposed to
background ozone concentrations rather than zero concentrations.
A. Exposure Assessment
I think the key exposure uncertainties have been identified. It is not clear, however, how much
the uncertainties will be reduced if the proposed research plan is carried out. It is not sufficient to
just identify data gaps, but the question of how much new data are needed to make a difference in
reducing uncertainty must be addressed. The other area that needs more consideration is how the
various "needs" can best be addressed in a coordinated research program. It is my opinion that a
number of the highest priority "needs" could be addressed simultaneously in a well designed
research project that includes an epidemiology component. Let me elaborate on these points.
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1. I agree "need number 1" is the highest priority, but it poses some important questions
which have not been mentioned. Which microenvironments do we need additional data for? How
much data do we need for a given microenvironment before we have reduced uncertainty to a
comfortable level? What is a comfortable level? How many comparisons between "statistical-
level" and "causal-level" relationships do we need until we have enough? Until these questions
are addressed, we cannot design an effective research plan for "need number 1."
2. "Need 2" is also a top priority, but again a program cannot be designed until an
assessment of how much new data on activity patterns and breathing patterns are needed. We
know that data on activity patterns are sparse and this probably introduces one of the largest
uncertainties to the risk assessments. However, a determination of how much data are needed to
reduce this uncertainty must be addressed first. Also, the focus should be on the populations of
concern: outdoor children and asthmatics.
3. "Need 3" is also a top priority and the questions that first have to be addressed are how
many geographic locations, which ones, arid how much data need to be collected. The locations
should be chosen because they are representative of larger areas of the country so that we can
minimize the number of areas needed to characterize the maximum amount of the country. For
ozone, the studies need to only focus on the summer. Also, the focus should be on the
populations of concern: outdoor children and asthmatics.
4. "Needs 1, 2, 3, 6 and 7" have common data needs that should make them amenable to an
integrated study. Although "need 3" will have other geographic components that can be done
separately, one of the geographic areas could be used to simultaneously address "needs 1-3, 6 and
7." In addition, they should be integrated with simultaneously occurring epidemiological studies.
5. It seems to me "need 4" belongs in the controlled human exposure category rather than
the exposure assessment. It also is a "need" that is on a longer time-frame. It is a complex issue
which will not likely produce meaningful results in a 5-year time frame of the time frame of a
NAAQS review. Consequently, as an ozone exposure assessment "need," I give it a lower
priority.
6. "Need 5" also seems more like a controlled human exposure issue.
7. "Need 8" needs to be more clearly articulated. The acute component is addressed in the
daily time series epidemiological studies and in the summer camp type studies. However, it is not
clear how the Agency intends to address the chronic component. Also it is not clear how or why
we need to differentiate between the health effect contributions from anthropogenic and now
anthropogenic caused ozone.
Certainly the acute component of "need 8" is important, but it will be addressed elsewhere.
The remaining parts of this "need" appear to me to be a low priority.
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8. Referring to "need 9," I agree that it is important that measurements of other potentially
important pollutants be measured and included in the statistical analyses used to determine
relationships between concentrations and health endpoints. All present and future studies should
incorporate such measurements as part of the standard protocol. Consequently, such
measurements should be included in the efforts to simultaneously address needs 1-3, 6 and 7.
However, I question why PAN was singled out here. In all previous CASAC reviews, PAN was
never cited as a health concern at the levels typically observed.
9. I agree that "needs 10 ands 13" are lower priority, but not "needs 11 and 12." Data for
"need 11" (aeroallergens) should be collected as part of an asthma epidemiological study
occurring simultaneously with the measurements to address "needs 1-3, 6 and 7." Concerning
"need 12," I recommend that the Agency examine the ozone and PM trends in the South Coast
Air Basin. Significant improvements in air quality have occurred since the 1960s.
B. Controlled Exposures
What are the priority 2 issues?
C. Epidemiology
1. I believe that "need 2", the statistical association between ozone and daily mortality is the
top priority because that will be the prime focus of the next review if it holds up. A data base
should be generated and made available to several different groups for rigorous independent
analyses. Ideally, this should be coordinated with the exposure assessment project so that issues
of exposure and exposure misclassification are also addressed.
2. Not included as a "need" are reanalyses of the ozone/morbidity time series data. Unlike
the PM studies, none of these studies have ever been examined by an independent group to see if
alternative explanations exist. In addition, the exposure assessment program could be a source of
a rich new data base that could be made available. I believe these types of analyses are needed
because the studies that found similar statistical associations between ozone and hospital
admissions at background concentrations, as compared to the studies carried out in the eastern
U.S. cities, raise questions concerning the causal nature of these associations.
3. "Needs 7 and 8" are high priority exposure assessment "needs" that hopefully will be
addressed by that program.
II. Ecological Effects
As with the health section, this section is made up of lists of needs by nine different groups with
no attempt to develop an integrated program.
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An overriding concern for all aspects of the ecological effects program as well is the importance
of background ozone. Based on relatively sparse data, the U.S. summertime continental
background is estimated to be 0.03 0.05 ppm for both a 1-hour and 8-hour time frame.
However, as indicated by the range, it is variable and it has a distribution that extends beyond this
range. Consequently, the determination of the background distributions would be one of the
goals of a rural monitoring network. I do not believe we have any information of the background
ozone distribution for a measure like SUM06. In addition, background needs to be considered in
chamber and field exposure studies. Background concentrations, not charcoal-filtered air, should
be used for the control plants. Background should be considered when deriving dose-response
relationships.
A. Monitoring and Modeling
The purposes of the monitoring and modeling are not clearly articulated. The purposes need to be
stated in the beginning. There are at least three purposes for monitoring: 1) to establish a national
rural data network to estimate crop losses from dose-response functions, 2) to determine
background concentrations, and 3) to support local ecological effects research. The purposes of
the modeling are to calculate ozone concentrations in areas where there are no monitors and to
develop ozone reduction strategies.
1. Establish national rural data network -1 think we know enough about the spatial behavior
of ozone so that we could design a network now that would cover most croplands. All we need
is money. On the other hand, we probably will never be able to afford a network in complex
terrain that would provide the same degree of spatial resolution as the network in the croplands.
2. Monitoring in support of effects research - This would range from merely relating
observed damage to ozone concentrations with a single monitor to more sophisticated
experimental setups to determine ozone fluxes.
3. Modeling - We already have regional photochemical grid models that can be used to
address both purposes. Probably the weakest link here are the emissions inventories for both
anthropogenic and biogenic species. In particular, the biogenic inventories are thought to have an
uncertainty of a factor of 3.
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SCIENCE ADVISORY BOARD
CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE
Casac Review Panel on Ozone Research Needs
Chair
Dr. Joe L. Mauderly, Director of External Affairs, 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 and Dean of the Graduate School, Clarkson
University, Potsdam, NY
Dr. Eva J. Pell, Steimer Professor of Agriculture Sciences, The Pennsylvania State University, University
Park, PA (DID NOT ATTEND MEETING)
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
Dr. Stephen M. Ayres, M.D., Director, Office of International Health Programs, Virginia Commonwealth
University, Medical College of Virginia, Richmond, VA
Dr. Jay S. Jacobson, Plant Physiologist, Boyce Thompson Institute, Cornell University, Ithaca, NY
Dr. Allan Legge, President, Biosphere Solutions, Calgary, Alberta Canada
Dr. Morton Lippmann, Professor, Institute of Environmental Medicine, New York University, Medical
Center, Tuxedo, NY
Dr. Roger O. McClellan, President, Chemical Industry Institute of Toxicology, Research Triangle Park,
NC (DID NOT ATTEND MEETING)
Dr. Paulette Middleton, Deputy Director, RAND Center for Science and Policy, Boulder, CO
Dr. George T. Wolff, Principal Scientist, General Motors Environmental & Energy Staff, Detroit, MI
Science Advisory Board Staff
Mr. A. Robert Flaak, Designated Federal Officer, U. S. Environmental Protection Agency, Science
Advisory Board, Washington, DC
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Ms. Diana Pozun, Management Assistant, U. S. Environmental Protection Agency, Science Advisory
Board, Washington, DC
NOTICE
This report has been written as a 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 faced by 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 Protection Agency or
other agencies in the Federal government. Mention of trade names or commercial products does
not constitute a recommendation for use.
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