&EPA
United State
EirviroiiwiU Protection
Agnncy
Health Risk and Exposure Assessment
for Ozone
Second External Review Draft

Executive Summary

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                                    DISCLAIMER
       This draft document has been prepared by staff from the Risk and Benefits Group, Health
and Environmental Impacts Division, Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency. Any findings and conclusions are those of the authors and do
not necessarily reflect the views of the Agency. This draft document is being circulated to
facilitate discussion with the Clean Air Scientific Advisory Committee to inform the EPA's
consideration of the ozone National Ambient Air Quality Standards.

       This information is distributed for the purposes of pre-dissemination peer review under
applicable information quality guidelines.  It has not been formally disseminated by EPA.  It
does not represent and should not be construed to represent any Agency determination or policy.

       Questions related to this preliminary draft document should be addressed to Dr. Bryan
Hubbell, U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards,
C539-07, Research Triangle Park, North Carolina 27711  (email: hubbell.bryan@epa.gov).

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                                                   EPA-452/P-14-004f
                                                       February 2014
Health Risk and Exposure Assessment for Ozone
               Second External Review Draft
                    Executive Summary
               U.S. Environmental Protection Agency
                    Office of Air and Radiation
             Office of Air Quality Planning and Standards
             Health and Environmental Impacts Division
                     Risk and Benefits Group
             Research Triangle Park, North Carolina 27711

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 Health Risk and Exposure Assessment f<
  Ozone, Second External Review Draft
               (January 2014)
                                                   Executive Summary
  Introduction
A
    s part of the review of the ozone
    National Ambient Air Quality Standards
    (NAAQS), EPA has prepared this Risk
and Exposure Assessment (REA) to provide
estimates of exposures to O3 and resulting
mortality and morbidity health risks. The
health effects evaluated in this REA are
based on the findings of the O3 ISA (U.S.
EPA, 2012) that short term O3 exposures are
causally related to respiratory effects, and
likely causally related to cardiovascular
effects, and that long term O3 exposures
are likely causally related to respiratory
effects. The assessment evaluated total
exposures and risks associated with the full
range of observed O3 concentrations. In
addition, the REA estimated the incremental
changes in exposures and risks between just
meeting the existing standard of  75 ppb
and just meeting potential alternative
standard  levels of 70, 65, and 60 ppb using
the form and averaging time of the existing
standard, which is the annual 4th highest
daily maximum 8-hour O3 concentration,
averaged over three consecutive years.
The results of the REA help to inform the O3
Policy Assessment (PA) in considering the
adequacy of the existing O3 standards, and
potential  risk reductions associated with
potential  alternative levels of the standard.

As described in the conceptual framework
and scope in Chapters 2 and 3,
respectively, the health REA discusses air
quality considerations (Chapter 4) and
evaluates exposures and lung function risk in
15 urban case study areas (Chapters 5 and
6, respectively) and risks based on
application of results of epidemiology
studies in a subset of 12 urban case study
areas (Chapter 7) . In addition, to place the
urban area analyses in a broader context,
the assessment estimated the national
burden of mortality associated with recent
O3 levels, and evaluated the
representativeness of the urban areas in
characterizing O3 exposures and risks across
the U.S. (Chapter 8). To further facilitate
interpretation of the results of the exposure
and risk assessment, Chapter? provides a
synthesis of the various results, focusing on
comparing and contrasting those results to
identify common patterns, or important
differences. It also includes an overall
integrated characterization of exposure and
risk in the context of key policy relevant
questions.


Conceptual Framework

and Scope

     The REA provides information to answer
     key policy-relevant risk questions with
     regards to evaluation of the
     adequacy of the existing standards
and evaluation of potential alternative
standards such as:

"To whaf extent do risk and/or exposure
analyses suggest that exposures of concern
for Os-re/afed health effects are likely to
occur with existing ambient levels of Os or
with levels that just meet the Os standard?

To what extent do alternative standards,
taking together levels, averaging times and
forms, reduce estimated exposures and risks
of concern attributable to Os and other
photochemical oxidants, and what are the
uncertainties associated with the estimated
exposure and risk reductions?"
In answering these questions, the REA
evaluates total exposures and risks
associated with the full range of observed
Os concentrations, as well as the
incremental changes in exposures and risks
for just meeting the existing standard and
just meeting several alternative standards.
With regard to selecting alternative levels for
the 8-hour Os standards for evaluation in the
quantitative risk assessment,  we base the
range of levels on the evaluations of the
evidence provided in the first draft PA,
which received support from the CASAC in
their advisory letter on the first draft PA. The
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      Executive Summary
  first draft PA recommended evaluation of 8-
  hour maximum concentrations in the range
  of 60 to 70 ppb, with possible consideration
  of levels somewhat below 60 ppb.

  Os concentrations from 2006-2010 are used
  in estimating exposures and risks for the 15
  urban case study areas. Because of the
  year-to-year variability in Os concentrations,
  the assessment evaluates scenarios for
  meeting the existing and potential
  alternative standards based on multiple
  years of Os data to better capture the high
  degree of variability in meteorological
  conditions, as well as reflecting years with
  higher and lower emissions of Os precursors.
  The  15 urban case study areas were
  selected to be generally representative of
  U.S.  populations, geographic areas,
  climates, and different Os and co-pollutant
  levels. These urban case study areas include
  Atlanta, GA; Baltimore, MD; Boston, MA;
  Chicago, IL; Cleveland, OH; Dallas, TX;
  Denver, CO; Detroit, Ml; Houston, TX; Los
  Angeles, CA; New York, NY; Philadelphia,
  PA; Sacramento, CA; St. Louis, MO; and
  Washington, D.C.

  We have identified the following goals for
  the urban area exposure and risk
  assessments: (1) to provide estimates of the
  percent of people in the general population
  and in at-risk populations and lifestages with
  Os exposures above health-based
  benchmark levels; (2) to provide estimates
  of the percent of people in the general
  population and in at-risk populations and
  lifestages with  impaired lung function
  (defined based on decrements in FEV1)
  resulting from exposures to Os; (3) to provide
  estimates of the  potential magnitude of
  premature mortality associated with both
  short-term and long-term Os exposures, and
  selected morbidity health effects associated
  with short-term Os exposures; (4) to evaluate
  the influence of various inputs and
  assumptions on risk estimates to the extent
  possible given available methods and data;
  (5) to gain insights into the spatial and
  temporal distribution of risks associated with
Os concentrations just meeting existing and
alternative standards, patterns of risk
reduction associated with meeting
alternative standards relative to the existing
standard, and uncertainties in the estimates
of risk and risk reductions.

In working towards these goals, we follow a
conceptual framework, shown in the figure
below, comprised of air quality
characterization, review of relevant
scientific evidence on health effects,
modeling of exposure, modeling of risk, and
risk characterization. As  shown in this
framework, modeling of  personal exposure
and estimation of risks, which rely on
personal exposure estimates, are
implemented using the Air Pollution
Exposure model (APEX)1  (U.S. EPA, 2012a,b).
Modeling of population level risks for
endpoints based on application of results of
epidemiological studies is implemented
using the environmental  Benefits Mapping
and Analysis  Program (BenMAP)2, a peer
reviewed software tool for estimating risks
and impacts associated with changes in
ambient air quality (U.S. EPA, 2013).  The
overall characterization of risk draws from
the results of  the exposure assessment and
both types of risk assessment.
1 APEX is available for download at
http://www.epa.gov/ttn/fera/human_apex.html
2 BenMAP is available for download at
http://www.epa.gov/air/benmap/
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                            Executive Summary
                                     Policy Relevant Exposure
                                       and Risk Questions
                                          (Chapter2)
                 Exposure Assessment
                    APEX
                      Urban Scale
                      Assessment of
                    Individual Exposure
                       (Chapters)
                     Urban Scale Risk
                    Analyses Based on
                      Application of
                      Results from
                     Controlled Human
                     Exposure Studies
                       (Chapters)
I
                                     Air Quality Characterization
                                          (Chapter4)
                                     Review of Health Evidence
                                         (Chapter2)
                                                                   RiskAssessment
                                                              BenMAP
                          Urban Scale Risk
                          Analyses Based on
                           Application of
                            Results from
                           Epidemic logical
                             Studies
                            (Chapter?)
National Scale Risk
 Burden Basedon
  Application of
  Results from
 Epidemiological
   Studies
  (Chapters)
                                     Risk Cha racte rization
                                       (Chapters)
  Air Quality Considerations


    In this analysis, we employed a
    photochemical model-based adjustment
    methodology (Simon et al, 2012) to
  estimate the change in observed hourly O3
  concentrations at a given set of monitoring
  sites resulting from across-the-board
  reductions in U.S. anthropogenic NOx
  and/or VOC emissions. This information was
  then used to adjust recent O3
  concentrations (2006-2010) in the 15 case
  study areas to reflect just meeting the
  existing standard of 75 ppb and just meeting
  potential alternative standard levels of 70,
  65, and 60 ppb. Because the form of the
  existing O3 standard is based on the 3-year
  average of the 4th highest daily 8-hour
  maximum, we simulate just meeting the
  standard for two periods, 2006-2008 and
  2008-2010.

  The use of the model-based adjustment
  methodology is an example of how we
                      have brought improvements into this review
                      that better represent current scientific
                      understanding. The model-based
                      adjustment methodology represents a
                      substantial improvement over the quadratic
                      rollback method used to adjust O3
                      concentrations in past reviews.  For example,
                      while the quadratic rollback was a purely
                      mathematical technique which attempted
                      to reproduce the distribution of observed O3
                      concentrations just meeting various
                      standards, the new methodology uses
                      photochemical modeling to simulate the
                      response in O3  concentrations due to
                      changes in precursor emissions  based on
                      current understanding of atmospheric
                      chemistry and transport. Second, quadratic
                      rollback used the same mathematical
                      formula to adjust concentrations at all
                      monitors within  each urban case study area
                      for all hours, while model-based adjustment
                      methodology allows the adjustments to vary
                      both spatially across each case study area
                      and temporally across hours of  the day and
                      across seasons. Finally, quadratic rollback
                      was designed to only allow decreases in O3
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  concentrations, while the model-based
  adjustment methodology allows both
  increases and decreases in O3
  concentrations, which more accurately
  reflects the scientific understanding that
  increases in O3 concentrations may occur in
  response to reductions in NOx emissions in
  some situations, such as in urban areas with
  a large amount of NOx emissions.
  Several general trends are evident in the
  changes in O3 patterns across the case
  study areas and across the different
  standards under consideration. In all 15
  case study areas, peak O3 concentrations
  tended to decrease while the lowest O3
  concentrations tended to increase as the
  concentrations were adjusted to meet the
  existing and potential alternative standards.
  In addition, high and mid-range O3
  concentrations generally decreased in rural
  and suburban portions of the case study
  areas, while O3 response to NOx reductions
  was more varied within urban core areas. In
  particular, while the annual 4th highest daily
  maximum 8-hour concentrations generally
  decreased in the urban core of the case
  study areas in response to reductions in NOx
  emissions, the seasonal mean of the daily
  maximum 8-hour O3 concentrations did not
  change significantly, though  it did exhibit
  some increases or decreases in the various
  case study areas as the distribution of O3
  was further adjusted to meet lower potential
  alternative standards.

  The adjustments to O3 to reflect just meeting
  existing and potential alternative standards
  are conducted by decreasing only
  emissions of anthropogenic NOx and VOC
  within the U.S. As such, the estimated
  changes in exposure and risk, based on
  these air quality changes, are solely
  attributable to changes in U.S. emissions.


  Human Exposure Modeling
T
he population exposure assessment
evaluated exposures to O3 using the
APEX exposure model which uses time-
activity diary and anthropometric data
coupled with local meteorology, population
demographics, and O3 concentrations to
estimate the percent of study groups above
exposure benchmarks. The analyses
examined exposure to O3 for the general
population, all school-aged children (ages
5-18), asthmatic school-aged children (ages
5-18), asthmatic adults (ages > 18), and
older persons  (ages 65 and older), with a
focus on populations  engaged in moderate
or greater exertion, for example, children
engaged in outdoor recreational activities.
Exposure is assessed in the 15 urban case
study areas for recent O3 (2006-2010) and
for O3 adjusted to just meet existing and
potential alternative standards for two
design value periods  (2006-2008 and 2008-
2010). The analysis provided estimates of the
percent of several populations of interest
exposed to concentrations above three
health-relevant 8-hour average O3
exposure benchmarks: 60, 70, and 80 ppb.
These  benchmarks were selected so as to
provide some perspective on the public
health impacts of OS-related health effects
that have been demonstrated in human
clinical and toxicological studies, but
cannot currently be evaluated in
quantitative risk assessments, such as lung
inflammation and increased airway
responsiveness. The ISA includes studies
showing significant effects at each of these
benchmark levels (U.S. EPA, 2012).
The analysis found that children are the
population of greatest concern for O3
exposures due to the  greater amount of
time they spend outdoors engaged in
moderate or higher exertion activities and
the fact that children have the highest
percent of exposures of concern of any of
the at-risk populations. As a result, we focus
on the results for children in this discussion.
The two figures below show the average
across 2006-2010 of the percentage of
school-aged children experiencing 8-hour
exposure greater than 60 ppb for at least
one exposure (top) and for at least two
exposures (bottom) per year. Based on this
information, no more  than 26 percent of any
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Atlanta

Baltimore

Boston

Chicago

Cleveland

Dallas

Denver

Detroit

Houston

Los Angeles

New York

Philadelphia

Sacramento

St. Louis

Washington
Atlanta

Baltimore

Boston

Chicago

Cleveland

Dallas

Denver

Detroit

Houston

Los Angeles

New York

Philadelphia

Sacramento

St. Louis

Washington
      0%    1%    2%    3%    4%    5%    6%    7%    8%
        Percent of All School-Age Children with at Least Two 8-hr Daily Max Exposure >= 60 ppb
         standard level (ppb)  I  I 60  I   I 65   E^H 70  ^CD 75

Average percent increases in percent of all school-age
children exposed at or above 60 ppb-8hr for each study
area over all years, for at least one exposure (left) and for at
least two exposures (right) per year.
Note: New York level 60 was not modeled. We do not know what the
percent risk would be for NY under the 60 ppb alternative standard, but it
would not necessarily be zero.

       study group in any study area was exposed
       at least once at or above the 60 ppb-8hr
       benchmark, when meeting the existing
       standard. When meeting a standard level of
       70 ppb, less than 20 percent of any study
    group in any study area was exposed
    at least once at or above the 60 ppb-
    8hr exposure benchmark. Meeting a
    standard level of 65 ppb is estimated to
    reduce the percent of persons at or
    above an exposure benchmark of 60
    ppb-8hr to 10 percent or less of any
    study group and study area.

    For the exposure benchmark of 70 ppb-
    8hr, less than 10 percent of any study
    group, including all school-age
    children, in any study area, was
    exposed at least once at or above the
    exposure benchmark when meeting
    the existing standard. For the highest
    exposure benchmark of 80 ppb-8hr, less
    than 1 percent of any study group in
    any study area was exposed at least
    once at or above the exposure
    benchmark when meeting the existing
    standard. These percentages are even
    smaller when meeting the lower
    alterative standard levels.

    For two or more exceedances at the 60
    ppb-8hr benchmark, less than  15
    percent of any study group in any study
    area experience 8-hour exposure
    greater than 60 ppb-8hrwhen meeting
    the existing standard. There were no
    persons estimated to experience any
    multi-day exposures at or above  80
    ppb-8hr for any study group in any
    study area, while 2.2 percent or less of
    persons were estimated to experience
    two or more exposures at or above 70
   ppb-8hr, when meeting the existing
   standard or any of the alternative
   standard levels.
   In addition, the exposure assessment
   also identified the specific
   microenvironments and activities that
   contribute most to exposure and
evaluated at what times and how long
individuals were in key microenvironments
and were engaged in key activities, with a
focus on persons experiencing the highest
daily maximum 8-hour exposure within each
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      Executive Summary
  study area. That analysis found that: (1)
  Children are an important exposure
  population subgroup, largely as a result of
  the combination of high levels of outdoor
  time and engagement in moderate  or high
  exertion level activities. (2) Persons spending
  a large portion of their time outdoors during
  afternoon hours experienced the highest 8-
  hour O3 exposure concentrations given that
  O3 concentrations in other
  microenvironments were simulated to be
  lower than ambient concentrations.  (3)
  Highly exposed children on average spend
  half of their outdoor time engaged in
  moderate or greater exertion levels,  such as
  in sporting activities.  Highly exposed adults
  also spent their outdoor time engaged in
  moderate or greater exertion levels though
  on average, not as frequently as children.


  Health Risks Based on

  Controlled  Human Exposure

  Studies


      This analysis uses  the estimates of
     exposure from APEX, combined with
     results from controlled human exposure
  studies, to estimate the number and
  percent of at-risk populations (all children,
  children with asthma, adults aged 18-35,
  adults aged 36-55, and outdoor workers)
  experiencing selected decrements in lung
  function. The analysis focuses on estimates
  of the percent of each at-risk population
  experiencing a reduction in  lung function for
  three different levels of impact: 10, 15, and
  20 percent decrements in FEV1. These levels
  of impact were selected based on the
  literature discussing the adversity associated
  with increasing lung function decrements
  (US EPA, 2012, Section 6.2.1.1; Henderson,
  2006). Lung function decrements of 10
  percent and 15 percent in FEV1 are
  considered moderate decrements; 10
  percent is considered potentially adverse for
  people with lung disease, while a 15
  percent is potentially adverse for active
healthy people. A 20 percent decrement in
FEV1 is considered a large decrement that is
potentially adverse for healthy people and
can potentially cause more serious effects in
people with lung disease.

Two models were used to estimate lung
function risks. One model was based on
application of a population level exposure-
response (E-R)  function consistent with the
approach used in the previous O3 review,
and the other  model was based on
application of an individual level risk
function (the McDonnell-Stewart-Smith (MSS)
model), which is being introduced in this
review. The main differences between the
two models are that the MSS model includes
responses for a wider range of exposure
protocols (under different levels of exertion,
lengths of exposures, and patterns of
exposure concentrations) than the
exposure-response model of previous
reviews. Both models have a logistic form
and are less sensitive to changes at very low
concentrations of O3 than to higher O3
concentrations.  As a result, the models
show very few FEV1 responses > 10% when
ambient concentrations are below 20 ppb
and very few FEV1 responses > 15% when
ambient concentrations are below 40 ppb.
Because the individual level E-R function
approach allows for a more complete
estimate of risk, we focus on the results of
the MSS model for this discussion.
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.Atlanta

Baltimore

Boston

Chicago

Cleveland

Dallas

Denver

Detroit

Houston


New York

Philadelphia

Sacramento

St Lotlis
     0°o   2°o   4°o   6°o   S°o   10°o   12°o  14°o  16°o   18°o
              percent of school-aaeclclukkeu \\itliFEVl decrement > 10°o
          standard level (ppb)     I riO  I   165  I   I "0  I   I "5

Average percent increases in percent of all school-age
children with FEV1 decrement > 10 percent in each study
area over all years

Note: New York level 60 was not modeled. We do not know what the
percent risk would be for NY under the 60 ppb alternative standard, but it
would not necessarily be zero.
                                                        the existing standard level of 75 ppb
                                                        and aboutl 3.3 percent for the
                                                        alternative standard level of 70 ppb.
                                                        The length of the brown bar is the
                                                        incremental risk reduction (3 percent)
                                                        in going from the existing standard of
                                                        75 ppb to the 70 ppb alternative
                                                        standard. The pattern of reductions
                                                        for lung function decrements larger
                                                        than 15 and 20 percent are similar.
      Health Risks Based on
      Application of Results
      of Epidemiological
      Studies
    T.
     Lung function risks were estimated for each
     of the 15 urban case study areas for recent
     air quality (2006-2010) and for air quality
     adjusted to just meet existing and
     alternative standards for two design value
     periods (2006-2008 and 2008-2010). As with
     the exposure assessment, we focus on lung
     function decrements in children as they are
     the populations likely to have the greatest
     percentage at risk due to higher levels of
     exposure and greater levels  of exertion. The
     figure above shows the risks just meeting
     the existing and potential alternative
     standard levels, where risk is  taken to be the
     average value for each study area (over all
     years) of the percent of school-aged
     children with FEV1 decrement of 10 percent
     or greater. This figure shows that there are
     significant decreases in incremental risk for
     all 15 cities in the progression from  the level
     of the existing standard, 75 ppb to the
     alternative standard levels of 70, 65, and 60
     ppb. The risks in this figure for Washington,
     DC, for example, are about  16.3 percent for
                                                            he epidemiology-based risk
                                                            assessment evaluated mortality
                                                            and morbidity risks from short-
                                                        term exposures, as well as mortality
                                                        risks from long-term exposures to O3,
                                                        by applying concentration-response
                                                   (C-R) functions derived from epidemiology
                                                   studies. Most of the endpoints evaluated in
                                                   epidemiology studies are for the entire study
                                                   population.  Because most mortality and
                                                   hospitalizations occur in older persons, the
                                                   risk estimates for this portion of the analysis
                                                   are thus more focused in adults rather than
                                                   children, and thus differ in focus compared
                                                   to the human exposure  and lung function
                                                   risk assessments. The analysis included both
                                                   a set of urban area case studies and a
                                                   national-scale assessment.
The urban case study analyses evaluated
mortality and morbidity risks, including
emergency department (ED) visits,
hospitalizations, and respiratory symptoms
associated with recent O3 concentrations
(2006-2010)  and with O3 concentrations
adjusted to  just meet the existing and
alternative O3 standards. Mortality and
hospital admissions (HA) were evaluated in
12 urban areas (a subset of the 15 urban
areas evaluated in the exposure and lung
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  function risk assessments), while ED visits and
  respiratory symptoms were evaluated in a
  subset of areas with supporting
  epidemiology studies. The 12 urban areas
  were: Atlanta, GA; Baltimore, MD; Boston,
  MA; Cleveland, OH; Denver, CO; Detroit, Ml;
  Houston, TX; Los Angeles, CA; New York, NY;
  Philadelphia, PA; Sacramento, CA; and St.
  Louis, MO. The urban case study analyses
  focus on risk estimates for the middle year of
  each three-year attainment
  simulation period (2006-2008 and
  2008-2010) in order to provide
  estimates of risk for a year with
  generally higher O3 levels (2007) and
  a year with generally lower O3 levels
  (2009).
  In previous reviews, O3 risks were
  estimated for the portion of total O3
  attributable to North American
  anthropogenic sources (referred to in
  previous O3 reviews as "policy
  relevant background"). In contrast,
  this assessment provides risk estimates
  for the urban areas for O3
  concentrations down to zero,
  reflecting the lack of evidence for a
  detectable threshold in the C-R
  functions (ISA, 2012), and the
  understanding that U.S. populations
  may experience health risks
  associated with O3 resulting from
  emissions from all sources, both
  natural and anthropogenic, and
  within and outside the U.S.
  The two figures to the right show the
  results of the mortality (top) and
  respiratory hospital admissions
  (bottom) risk assessments for all 12
  urban areas associated with short-
  term exposure to O3, showing the
  effect on the incidence per 100,000
  population just meeting the existing
  75 ppb standard and potential
  alternative O3 standards of 70, 65,
  and 60 ppb in 2007. The overall trend
  across urban areas is small decreases
  in mortality and morbidity risk as air
  quality is adjusted to just meet
          incrementally lower standard levels. In New
          York, there are somewhat greater
          decreases, reflecting the relatively large
          emission reductions used to adjust air quality
          to just meet the 65 ppb alternative
          standard, and the substantial change in the
          distribution of O3 concentrations that
          resulted. Risks vary substantially across
          urban areas; however, the general pattern
          of reductions across the alternative
         Trend in ozone-related mortality across standard
                  levels (deaths per 100,000)
                                                 -Atlanta, GA

                                                 -Baltimore, MD

                                                 Boston, MA

                                                 -Cleveland, OH

                                                 -Denver.CO

                                                 Detroit, Ml

                                                 -Houston, TX

                                                 -LosAngeles, CA

                                                 New York, NY

                                                 -Philadelphia, PA

                                                 -Sacramento, CA

                                                 St. Louis, MO
         75ppb
                   70ppb
                             65ppb
                                       60ppb
         Trend in ozone-related HA across standard levels
                      (HA per 100,000)
                                                -Atlanta, GA

                                                -Baltimore, MD

                                                 Boston, MA

                                                -Cleveland, OH

                                                -Denver.CO

                                                 Detroit, Ml

                                                •Houston, TX

                                                -LosAngeles, CA

                                                 New York, NY

                                                -Philadelphia, PA

                                                -Sacramento, CA

                                                 St. Louis, MO
         75ppb
                   70ppb
                             65ppb
                                      60ppb
Impacts of just meeting existing and alternative standard
levels on short-term  mortality risk per 100,000 population (top)
and on respiratory hospital admissions risk per 100,000
population for 2007  (bottom)

Nofe: New York level 60 was not modeled. We do not know what the
percent risk would be for NY under the 60 ppb alternative standard, but it
would not necessarily be zero.
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      standards is similar between urban areas.
      Risks are generally slightly lower in 2009
      relative to 2007; though the patterns of
      reductions are very similar between the two
      years. On average, compared with
      meeting the existing standard, mortality and
      respiratory hospitalization risks decrease by
      5% or less for a level of 70 ppb, 10% or less for
      a level of 65 ppb, and 15% or less for a level
      of 60 ppb.  Larger risk reductions are
      estimated on days with higher O3.

      We also evaluated mortality risks in the 12
      urban areas associated with long-term O3
      exposures (based on the April to September
      average of the peak daily one-hour
      maximum concentrations). The figure below
      shows the results of long-term mortality risk
      assessments for all 12 urban areas, showing
      the effect on the incidence per 100,000
      population just meeting the existing
      standard and potential alternative O3
      standard levels of 70, 65, and 60 ppb in
      2007. Risks from long-term exposures after
      just meeting the existing standard are
      substantially greater than risks from short-
      term exposures, ranging from 16 to 20
      percent of respiratory mortality across urban
      areas. However, the percent reductions in
       Trend in ozone-related mortality across standard
                 levels (deaths per 100,000)
  o 25
  E 10
         75ppb
                  70ppb
                            65ppb
                                      60ppb
Impacts of just meeting existing and alternative standard levels on
long-term mortality risk per 100,000 population for 2007
risks are similar to those for mortality from
short-term exposures, e.g., less than 10
percent reduction in risk relative to just
meeting the existing standard in most areas
when just meeting the 70 ppb and 65 ppb
alternative standards, and less than 20
percent reductions when just meeting the
60 ppb alternative standard level.

Mortality and  morbidity risks generally do not
show large responses to meeting existing or
alternative levels of the standard for several
reasons. First,  these risks are based on C-R
functions that are approximately linear
along the full range of concentrations, and
therefore reflect the impact of changes in
O3 along the  complete range of 8-hour
average O3 concentrations. This includes
days with low  baseline O3 concentrations
that are predicted to have increases in O3
concentrations, as well as days with higher
starting O3 concentrations that are
predicted to have decreases in O3
concentrations as a result of just meeting
existing and potential alternative standards.
Second, these risks reflect changes in the
urban-area wide monitor average, which
will not be as responsive to air quality
adjustments as the design value monitor,
       and which includes monitors with
       both decreases and increases in 8-
       hour concentrations. Third, the days
       and locations with predicted
       increases in O3 concentrations
       (generally those with low to
       midrange starting O3
       concentrations) resulting from just
       meeting  the existing or alternative
       standard levels generally are
       frequent enough to offset days and
       locations with predicted decreases
       in O3. The focus of the
       epidemiological studies on urban
       area-wide average O3
       concentrations, and the lack of
       thresholds coupled with the linear
       nature of the C-R functions mean
       that in this analysis, the impact of a
       peak-based standard (which seeks
       to reduce peak concentrations
•Atlanta, GA

•Baltimore, MD

Boston, MA

 leveland,OH

Denver, CO

Detroit, Ml

•Houston, TX

•Los Angeles, CA

New York, NY

•Philadelphia, PA

Sacramento, CA

St. Louis, MO
Note: New York level 60 was not modeled. We do not know what the percent risk would
be for NY under the 60 ppb alternative standard, but it would not necessarily be zero.
                                              ES-9

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Health Risk and Exposure Assessment f<
  Ozone, Second External Review Draft
               (January 2014)
      Executive  Summary
  regardless of effects on low or mean
  concentrations) on estimates of mortality
  and morbidity risks based on results of those
  studies is relatively small. However, we are
  not able to draw strong conclusions about
  the results across urban areas, because of
  the limited number of urban areas
  represented for most of the endpoints.

  The national-scale epidemiology-based risk
  assessment evaluated only mortality
  associated with recent O3 concentrations
  across the entire U.S for 2006-2008. The
  national-scale assessment is a complement
  to the urban scale analysis, providing both a
  broader assessment of OS-related health
  risks across the U.S.  It demonstrates that
  there are O3 risks across the U.S, not just in
  urban areas, even though the O3 levels in
  many areas were lower than the existing
  standard level.  We estimated 15,000
  premature OS-related non-accidental
  deaths (all ages) annually associated with
  short-term exposure to recent O3 levels
  across the continental U.S. for 2007, May-
  September. For long-term mortality, we
  estimated 45,000 premature OS-related
  adult (age 30 and older) respiratory deaths
  annually for 2007, April-September. While we
  did not assess the changes in risk at a
  national level associated with just meeting
  existing  and potential alternative standards,
  just meeting existing and potential
  alternative standards would likely reduce O3
  concentrations  both in areas that are not
  meeting those standards and in locations
  surrounding those areas, leading to risk
  reductions that  are not captured by the
  urban scale analysis.


  Representativeness of

  Exposure and  Risk  Results


      As part of this assessment, we conducted
      several analyses to determine the
      extent to which our selected urban
  areas represent: (1) the highest mortality
and morbidity risk areas in the U.S.; and (2)
the types of patterns of O3 air quality
changes that we estimate would be
experienced by the overall U.S. population
in response to emissions reductions that
would decrease peak O3 concentrations to
meet the existing standard or lower
alternative O3 standard levels.

We selected urban areas for the exposure
and risk analyses based on criteria that
included O3 levels, at-risk populations, and
related factors that were designed to
ensure we captured areas and populations
likely to experience high O3 exposures and
risks. Based on the comparisons of
distributions of risk characteristics, the
selected urban case study areas represent
urban areas that are among the most
populated in the U.S., have relatively high
peak O3 levels, and capture well the range
of city-specific mortality risk effect estimates.
The analyses found that the O3 mortality risk
for short-term O3 exposures in the  12 urban
study areas are representative of the full
distribution of U.S. OS-related mortality,
representing both high end and low end risk
counties. For the long-term exposure
related mortality risk metric, the 12 urban
study areas are representative of the central
portion of the distribution of risks across all
U.S. counties, however, the selected 12
urban areas do not capture the very highest
(greater than 98th percentile) or lowest (less
than 25th percentile) ends of the national
distribution of long-term exposure-related
OS-related risk.

While we selected urban areas to represent
those populations likely to experience
elevated risks from OS exposure, we did not
include amongst the selection criteria the
responsiveness of OS in the urban area to
decreases in OS precursor emissions that
would be needed to just meet existing or
potential alternative standards. The
additional analyses we conducted suggest
that many of the urban case study areas
may show OS responses that are typical of
other large urban areas in the U.S., but may
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Health Risk and Exposure Assessment f<
  Ozone, Second External Review Draft
               (January 2014)
      Executive  Summary
  not represent the response of O3 in other
  populated areas of the U.S. These other
  areas, including suburban areas, smaller
  urban areas, and rural areas, would be
  more likely than our urban case study areas
  to experience area-wide average
  decreases in mean O3 concentrations and,
  therefore, decreases in mortality and
  morbidity risks, as O3 standards are met.
  Even though large urban areas have high
  population density, the majority of the U.S.
  population lives outside of these types of
  urban core areas, and thus, a large
  proportion of the population is likely to
  experience greater mortality and morbidity
  risk reductions in response to reductions in 8-
  hour O3 concentrations than are predicted
  by our modeling in the 12 selected urban
  case study areas.

  Because our selection strategy for risk
  modeling was focused on identifying areas
  with high risk, we tended to select large
  urban population centers. This strategy was
  largely successful in including urban areas in
  the upper end of the O3 risk distribution.
  However, this also led to an
  overrepresentation of the populations living
  in locations where we estimate increasing
  mean seasonal O3 would occur in response
  to decreases in O3 precursor emissions that
  would be needed to just meet existing or
  alternative standards. The implication of this
  is that our estimates of mortality and
  morbidity risk reductions for the selected
  urban areas should not be seen as
  representative of potential risk reductions for
  most of the U.S. population, and are likely to
  understate the average risk reduction that
  would be experienced across the
  population.
  Synthesis
     To facilitate interpretation of the results
     of the exposure and risk assessment, this
     assessment provides a synthesis of the
  various results, focusing on comparing and
  contrasting those results to identify common
patterns, or important differences.
Consistent with the available evidence, we
estimated exposures relative to several
health-based exposure benchmarks, lung
function risks  based on a threshold
exposure-response model of lung function
decrements,  and mortality and morbidity
risks based on non-threshold C-R functions.
These three different analyses result in
differing sensitivities of results to changes in
O3. Because the three metrics are affected
differently by changes in O3 at low
concentration levels, it is important to
understand these changes in O3 at low
concentrations in interpreting differences in
the results across metrics.

The exposure benchmark analysis is the least
sensitive to changes in O3 in the  lower part
of the distribution of starting O3
concentrations, because the lowest of the
exposure  benchmarks is at 60 ppb, above
the portion of the distribution of starting O3
concentrations where we saw increases.
Since the modeled exposures will always be
less than or equal to the monitor
concentrations, a benchmark of exposure
at 60 ppb is above the range of O3
concentrations where the model-based
adjustment approach estimates  increases in
concentrations. Thus, this metric is most
reflective of the decreases in O3 at high
concentrations that are expected to result
from just meeting the existing and potential
alternative standards.

The lung function risk analysis is less sensitive
than the mortality and morbidity risk
assessments to changes at very low
concentrations of O3, because the risk
function is logistic and shows little response
at lower O3 dose rates that tend to occur
when ambient concentrations are lower
(generally less than 20 ppb for the 10
percent FEV1 decrement and generally less
than 40 ppb  for the 15 percent FEV1
decrement).  However, because  there are
still some increases that occur in  the 50 to 60
ppb range where the estimated  risk is more
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Health Risk and Exposure Assessment f<
  Ozone, Second External Review Draft
               (January 2014)
      Executive Summary
  responsive, there may be some reduction in
  the net risk decrease.
  The mortality and morbidity risk assessment is
  the analysis that is most sensitive to the
  increases in O3 in the lower part of the
  distribution of starting O3 concentrations
  that we estimated would occur as the
  existing and alternative standards are met in
  some urban areas. Mean O3 concentrations
  for the urban areas change little between
  air quality scenarios for meeting  the existing
  and alternative standards, because mean
  concentrations reflect both the increases in
  O3 at lower concentrations and the
  decreases in O3 occurring on days with high
  O3 concentrations.  This  leads to small net
  changes in mortality and morbidity risk
  estimates for many of the urban  case study
  areas. However, both the net change in risk
  and the distribution of risk across the range
  of O3 concentrations may be relevant in
  considering the degree of additional
  protection provided  by just meeting existing
  and alternative standards.

  In conclusion, we have estimated that
  exposures and risks remain after just meeting
  the existing standards and that that in many
  cases, just meeting potential alternative
  standard levels results in  reductions in those
  exposures and risks. Meeting potential
  alternative standards has larger impacts on
  metrics that are not sensitive to changes in
  lower O3 concentrations. When  meeting the
  70, 65, and 60 ppb alternative standards,
  the percent of children experiencing
  exposures above the 60 ppb health
  benchmark falls to less than 20 percent, less
  than 10 percent, and less than 3 percent in
  the worst O3 year for all  15 case  study urban
  areas, respectively. Lung function risk also
  drops considerably as lower standards are
  met. When meeting the  70, 65, and 60 ppb
  alternative standards, the percent of
  children with lung function decrements
  greater than or equal to 10 percent in the
  worst year falls to less than 21 percent, less
  than 18 percent, and less than 14 percent in
  the worst O3 year for all  15 case  study urban
  areas, respectively. Mortality and respiratory
hospitalization risks decrease by 5% or less
for a level of 70 ppb, 10% or less for a level of
65 ppb, and 15% or less for a level of 60 ppb.
These smaller changes in the mortality and
morbidity risks, relative to the exposures and
lung function risk reductions, reflect the
impact of increasing O3 on low
concentration days, and the non-threshold
nature of the C-R function. Larger mortality
and morbidity risk reductions are estimated
on days with higher baseline O3
concentrations.
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United States                              Office of Air Quality Planning and Standards              Publication No. EPA-452/P-14-004f
Environmental Protection                   Air Quality Strategies and Standards Division                                February 2014
Agency                                           Research Triangle Park, NC

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